POLICY DOCUMENT CONTROL HEET - cddft.nhs.uk

POL/MM/0001 Version 6.1 i

POLICY DOCUMENT CONTROL SHEET

Title Trust Medicine Policy

Reference Number POL/MM/0001

Version number 6.1

Document Type Policy

Originating Directorate Pharmacy and Medicines Management

Author / Document Owner Trust Chief Pharmacist

Scope Trust-wide

Original Document date September 2005

Equality impact assessed on October 2015

Review & Approval Committee

Clinical Standards & Therapeutics Committee

Last review date June 2016

Ratifying Committee Quality and Healthcare Governance committee

Date Ratified 19th July 2016

Effective date 19th July 2016

Next review date 19th July 2019

Status Approved

Confidentiality Unrestricted

Keywords Medicines, Administration, Prescribing

Date superseded

Approval

Signature of Chairman of Ratifying Body

Name / job title of Chairman of Ratifying Body:

Chris Gray – Quality and Healthcare Governance Committee

Signed copy held at: (2 locations)

Corporate Records Office, DMH, & DMH Pharmacy

Trust Medicine Policy

POL/MM/0001 V6.1 Page 2 of 113

VERSION CONTROL TABLE

Date of Issue Version Number Status

September 2005 1.0 Superseded


October 2007 3.0 Superseded


December 2010 3.2 Superseded

April 2011 4.0 Superseded


Not issued 4.2 Superseded

March 2012 4.3 Superseded


November 2012 5.0 Superseded

May 2013 5.1 Superseded

February 2015 5.2 Superseded

October 2015 6.0 Superseded

June 2016 6.1 Approved

TABLE OF REVISIONS

Date Section Revision Author

September 2012

All Full review Pharmacy Performance & Quality Team

April 2013 7.6 13 18 Appendix 3 Appendix 4

Addition of flow chart for ensuring the accuracy of medication charts. Revised wording of section to provide clarity. Summary table added to provide clarity on medicines storage. Wording updated to reflect medication errors and not incidents. Updated – now can only use patients own drugs with no identifiable expiry date if dispensed within the last 3 months (previously 6 months). Over labelled issue log simplified

Chris Williams, Deputy Chief Pharmacist

February 2015 All

5.1

Policy put into new format –

resulted in new section numbers

Dietitians able to authorize

administration of supplements on

medication chart



5.7

9.3 & appendix 3

14

Appendix 7

High Risk medicines section

revised fully

Removed ref. to certain CDs

being able to be stored in bedside

locker

Security of FP10 prescriptions

revised

Additional care plan to support

covert medicines administration

August 2015

All Full Review Pharmacy

Leadership

Team

June 2016 6 Process for the

Administration of

Medicines

Inclusion of addendum approved

at Clinical Standards and

Therapeutics 14th October 2015

and effective from 20th October

2015; addition of section 6.23 and

amendment to section 6.4 to

facilitate specific exceptions to the

agreed process of administration

of medicines

Graeme

Kirkpatrick

Trust Chief

Pharmacist



POLICY Document Control Sheet ........................................................................................................................ i

Version Control Table ............................................................................................................................................ 2

Table of Revisions.................................................................................................................................................. 2

1 Introduction ......................................................................................................................................................... 9

2 Purpose ................................................................................................................................................................ 9

3 Duties ................................................................................................................................................................. 10

3.1 Line Manager Responsibilities ..................................................................................................................... 12

3.2 Individual Responsibilities ............................................................................................................................ 12

4 Mechanisms For The Prescribing, Supply And Administration Of Medicines ...................................... 13

4.1 Initiation of Treatment ................................................................................................................................... 13

4.2 Patient Specific Direction ............................................................................................................................. 13

4.3 Patient Group Direction (PGD) .................................................................................................................... 14

4.4 Specific exemptions covering supply or administration as contained in medicines legislation .......... 14

4.5 Separation of Prescribing, Supply and Administration ............................................................................. 14

5 Process For The Prescribing Of Medicines ................................................................................................. 14

5.1 Prescribers...................................................................................................................................................... 15

5.2 General Principles for Prescribing .............................................................................................................. 15

5.3 Principles for Use of the Medication Chart ................................................................................................ 16

5.4 Content of the Medication Chart.................................................................................................................. 17

5.5 Amendments to Medication Charts ............................................................................................................. 20

5.6 Process for ensuring the accuracy of medication charts ......................................................................... 20

5.7 Prescribing of High Risk Medicines ............................................................................................................ 22

5.7.1 Prescribing of High Risk Medicines .......................................................................................... 22

5.7.2 High Risk Medicines and authorised prescribers ................................................................... 22

5.7.3 Prescribing Insulin ....................................................................................................................... 23

5.7.4 Prescribing Oxygen ..................................................................................................................... 23

5.8 Prescribing Antibiotics and Anti-infectives ................................................................................................. 23

5.9 Prescribing unlicensed medicines or medicines outside of the terms of licence ................................. 24

5.10 Prescribing New Medicines ............................................................................................................. 24

5.11 Prescribing for Patients on Transfer of Care ................................................................................ 25

5.12 Prescribing of Critical Medicines .................................................................................................... 25

5.13 Prescribing for Outpatients ............................................................................................................. 25

5.14 Prescribing via Remote Prescriptions ........................................................................................... 26



6 Process For The Administration Of Medicines ........................................................................................... 28

6.1 Authority to Administer Medicines ............................................................................................................... 28

6.2 Accountability for Administration ................................................................................................................. 28

6.3 General Principles for Administration of Medicines .................................................................................. 28

6.4 Witnessed Administration of Medicines ..................................................................................................... 30

6.5 Calculation of medicine doses prior to administration .............................................................................. 31

6.6 Preparation of Medicines Prior to Administration...................................................................................... 31

6.7 Procedure for the Administration of Medicines ......................................................................................... 32

6.8 Use of Oral Syringes ..................................................................................................................................... 33

6.9 Recording of Administration of Medicines ................................................................................................. 33

6.10 Omitted doses of Medicines ........................................................................................................... 34

6.11 Covert Administration of Medicines (Disguising medicines in food or drink) ........................... 34

6.12 Administration of Critical Medicines ............................................................................................... 35

6.13 Administration of Injections ............................................................................................................. 36

6.14 Preparation of injections for administration .................................................................................. 36

6.15 Administration of insulin ................................................................................................................... 37

6.15.1 Administration of insulin inpatient settings ............................................................................... 37

6.15.2 Administration of insulin in non-inpatient Community Settings ............................................. 38

6.15.3 Administration of Insulin by Healthcare Assistants in Community Settings ........................ 38

6.16 Administration of Controlled Drugs ................................................................................................ 39

6.17 Administration of unlicensed medicines or medicines outside of the terms of licence .......... 39

6.18 Administration of medicines through enteral feeding tubes ....................................................... 39

6.19 Administration of patients own medicines (patients own drugs PODs) .................................... 40

6.20 Process for patient self–administration of medicines .................................................................. 40

6.21 Administration of Medicines in Specialist Areas .......................................................................... 41

6.21.1 Preparation of Medicines in Theatres ....................................................................................... 41

6.21.2 Administration of Medicines in Theatres .................................................................................. 42

6.21.3 Administration of Medicines in Paediatrics .............................................................................. 42

6.21.4 Midwives Exemptions and Administration and Supply of Medicines ................................... 43

6.21.5 Administration of systemic anti-cancer therapy preparations (e.g. chemotherapy) for both

treatment of cancer and other indications ................................................................................ 44

6.22 Administration of Medicines via Remote Prescriptions ............................................................... 45

6.23 Exceptions to the agreed Process of Administration of Medicines ........................................... 46

7 Specialist Use Of Medicines ........................................................................................................................... 46

7.1 Strong Potassium Chloride Concentrate and Potassium Acid Phosphate Injection............................ 46

7.2 Clinical Trials Involving Pharmaceutical Products .................................................................................... 47



7.3 Medical Gases ............................................................................................................................................... 47

8 Adverse Drug Reaction Reporting ................................................................................................................ 47

8.1 Drug Defect or drug recall Reporting .......................................................................................................... 48

8.1.1 Process for dealing with Drug Defects ..................................................................................... 48

8.1.2 Process for dealing with Drug Recalls...................................................................................... 48

9 Issue, Supply And Dispensing Of Medicines .............................................................................................. 49

9.1 Dispensing of Medicines ............................................................................................................................. 49

9.2 Issue / Supply of Medication from a ward or clinic setting....................................................................... 49

9.3 Labelling of medicine containers ................................................................................................................. 50

9.4 Use of Patients’ Own medicines.................................................................................................................. 51

9.5 Stock Medicines ............................................................................................................................................. 51

9.6 Non-stock medicines ..................................................................................................................................... 52

9.6.1 Supply of Non-stock Medicines to POMMS wards ................................................................. 53

9.6.2 Supply of Non-stock Medicines to non-POMMS wards / departments ............................... 53

9.6.3 Non patient-specific items .......................................................................................................... 53

9.6.4 Patient specific items .................................................................................................................. 53

9.6.5 Supply of insulin: ......................................................................................................................... 54

9.7 Supply of Medicines to Patients on Discharge .......................................................................................... 54

9.7.1 Discharge Medication ................................................................................................................. 54

9.7.2 Issue of Pre-packed, Pre-labelled (overlabelled) Medicines to patients ............................. 54

9.7.3 Handing over medication to patients to take home ................................................................ 55

9.7.4 Information to be given to patients with discharge medicines .............................................. 55

9.8 Using Medicines From Another Service Area ........................................................................................... 55

9.9 Access to the Out of Hours Emergency Drug Cupboard ......................................................................... 56

9.10 Verbal Requests for Supplies ......................................................................................................... 56

10 Security And Storage Of Medicines ............................................................................................................ 57

10.1 Receipt of medicines ........................................................................................................................ 59

10.2 Security of medicines in Pharmacy departments ........................................................................ 59

10.3 Storage of Medicines within the Pharmacy department ............................................................. 59

10.4 Security of medicines in wards and departments ........................................................................ 60

10.5 Storage of Medicines on wards and departments ....................................................................... 60

10.6 Storage of substances subject to control of substances hazardous to health regulation

(COSHH) ......................................................................................................................................................... 62

10.7 Storage of medicines in fridges ...................................................................................................... 62

10.8 Medicine Keys ................................................................................................................................... 63

10.8.1 Loss of medicine keys ................................................................................................................ 64



11 Transfer And Transport Of Medicines ........................................................................................................ 64

11.1 Transport of Patients’ Medicines in the Community .................................................................... 64

11.2 Transfer of medicines between CDDFT sites using contract taxi services .............................. 65

11.3 Transfer of patients’ medicines on handover between care settings ........................................ 65

12 Disposal of Medicines ................................................................................................................................... 65

12.1 General Principles for the Disposal of Medicines ........................................................................ 65

12.2 Disposal of Medicines in Acute Settings ....................................................................................... 66

12.3 Disposal of Medicines in Community Settings ............................................................................. 67

12.4 Disposal of date expired stock........................................................................................................ 67

12.5 Disposal of Patients Own Medicines ............................................................................................. 68

13 Company Representatives ........................................................................................................................... 68

14 Controlled Stationery And FP10s ............................................................................................................... 68

15 Medication Errors .......................................................................................................................................... 69

15.1 Process for Reporting Medication Errors ...................................................................................... 69

15.2 Process for Learning from medication incidents .......................................................................... 69

16 Definitions ....................................................................................................................................................... 70

16.1 Staff Definitions ................................................................................................................................. 70

16.2 Process Definitions........................................................................................................................... 71

16.3 Medicine Categories ........................................................................................................................ 73

17 Dissemination / Training Arrangements .................................................................................................... 74

18 Monitoring ....................................................................................................................................................... 75

18.1.1 Compliance and Effectiveness Monitoring .............................................................................. 75

19 References ...................................................................................................................................................... 76

20 Associated Documentation .......................................................................................................................... 76

Appendix 1 – Midwives Exemptions List 2011 ................................................................................................ 78

Appendix 2 - Prescribing, Supply and Use of Unlicensed Medicines ......................................................... 80

Appendix 3 - Guidelines For The Use Of Patient’s Own Medicines ............................................................ 87

Appendix 4 - Guideline For The Use And Issue Of Overlabelled Packs Of Medicines ............................ 90

Appendix 5 - Guidelines For The Management Of Refrigerated Medicines ............................................... 93



Appendix 6 - Transfer of medicines using the CDDFT Contract Taxi Service .......................................... 99

Appendix 7 - Care Plan For Covert Medication ............................................................................................. 103

Appendix 8 - Management Of FP10 Prescriptions ....................................................................................... 105

Appendix 9 - Equality Analysis / Impact Assessment ................................................................................. 110



1 INTRODUCTION

A medicine is the most frequent treatment provided for patients in the NHS. Medicines must

be prescribed, dispensed, administered, stored and handled safely and effectively. All

aspects of medicines management are important elements of clinical care. In order to

enhance care and protect patients by minimising risk of error at all stages of the medicines

management process it is vital that those involved understand their roles and responsibilities

and adhere to agreed procedures and current legislation.

As part of its commitment to ensuring that high standards of patient care are achieved and

maintained County Durham and Darlington Foundation Trust (CDDFT) recognises the

importance of medicines management and the multidisciplinary team approach required to

achieve safe and effective practice in this area.

CDDFT is committed to ensuring that all healthcare professionals employed by the Trust

involved in patient care understand the principles of medicines management and the legal

and professional requirements of them in relation to this area of practice.

This document outlines the responsibilities of those involved in the process of managing

medicines.

As with all other aspects of care, it is recognised that every patient has the right to make his

or her own decision regarding treatment and care and in order to make that decision, is

entitled to have full information about the material risks. It is the clinician’s duty to supply the

information in sufficient detail to enable the patient to make that decision.

The Trust Medicine Policy must be read in conjunction with the medicines related policies

outlined below:

Controlled Drugs Policy POL/MM/0010

Medicines Reconciliation Policy POL/MM/0006

Non-Medical Prescribing Policy POL/MM/0008

Patient Group Direction Policy POL/MM/0009

Pharmacy Staff Transcribing Policy POL/MM/0011

Pharmacy Staff ePMA Transcribing and Enablement Policy POL/MM/0018

2 PURPOSE

The Medicine Policy relates to all the processes associated with the prescribing,

administration, supply, storage, transfer and disposal of medicines in CDDFT. These

processes include those associated with the electronic prescribing and administration of

medicines.


POL/MM/0001 V6.1 Page 10 of 113

This policy applies to all wards, departments, units, services and settings within the

boundaries of CDDFT which use or handle medicines and for the purpose of this policy all of

these settings will be referred to as “wards and departments”.

The document takes account of current legislation, official guidance, recommendations and

professional codes of practice. These however change with time and all staff have a

responsibility to identify where new guidance may conflict with this policy. The clinical

elements of the management of medicines, such as therapeutic decisions and choice of

medication are beyond the scope of the policy.

This policy must be followed by all health care staff employed by the Trust on a substantive

or temporary basis involved in the prescribing, administration, ordering, supply, storage,

transfer and disposal of medicines.

In the policy the term medicine has the same meaning as medicinal products in the

Medicines Act 1968. Examples include medical gases, essential oils, medicated dressings

and dietetic products.

The policy is not intended to supersede or conflict with professional standards or codes of

practice which are in place.

The policy gives broad guidelines and principles governing the use of medicines. The

Medicine Policy and related policies within this document can be found on the Pharmacy

intranet site. More detailed local procedures may be required in particular departments.

Development of local medicines’ procedures must have input from a pharmacist employed

by CDDFT and be approved by the relevant Care Group Clinical Governance Group or

Policy Group.

During the deployment of the new electronic prescribing and medicines administration

system (ePMA) there are protocols and procedures outside of the Medicines Policy that

make reference to paper prescription charts. Where these policies and procedures have not

been updated to reflect the ePMA system, the Trust accepts that users of the ePMA system

should follow these processes as closely as the ePMA system permits.

3 DUTIES

The Trust Board is responsible for:

Ensuring that Trust policy, guidance and practice on medicines follow accepted legal

and professional requirements.

Ensuring that health care professionals are informed of and follow Trust policy and

guidance on medicines management.

Ensuring that an effective and economical system by which medicines are managed

safely, securely and effectively to meet the patients clinical needs is established,

documented and maintained.


POL/MM/0001 V6.1 Page 11 of 113

The Quality and Healthcare Governance Committee is responsible for:

Providing assurance to the Trust Board that patients receive high quality care with

regard to medicines.

Approval of medicines related policies.

The Trust Clinical Standards and Therapeutics Committee is responsible for:

Ensuring that the use of medicines within the Trust is safe, clinically and cost

effective and evidence based.

Ensuring clinicians are provided with information that ensures appropriate prescribing

practice across the Trust.

Trust Care Group Risk Management and Safety Committees are responsible for:

Producing and applying local solutions to medication incidents and ensuring safe

medication practice within the Care Group.

The Trust Medical Gas Committee is accountable to the Trust Safety Committee and is

responsible for:

Ensuring that medical gases are managed safely across the Trust and meet the

requirements of the Health Technical Memorandum (HTM 02).

Pharmacy and Medicines Management Team Responsibilities:

The Pharmacy and Medicines Management Team will ensure that the current policy

version is available on the Trust intranet in line with the Trust Policy for the

Development and Management of Procedural Governance Documents

(Corporate/POL/0001).

Updates to this policy and other medicine related policies, procedures and other

relevant information will be communicated via the Trust Pharmacy and Medicines

Management Bulletin.

Pharmacists are responsible for the quality of medicines held in the pharmacy

department through all stages of the medicines process from procurement,

manipulation, preparation, dispensing to supply to patients, wards and departments.

Authorised pharmacy staff may inspect stocks of medicines held on wards and

departments at any time to ensure they are stored under appropriate and legal

requirements.


POL/MM/0001 V6.1 Page 12 of 113

3.1 Line Manager Responsibilities

It is the line manager’s responsibility to ensure:

Staff are aware of how to access this policy via the intranet. It is not intended that hard

copies be held in ward or department areas.

Practitioners involved in medicines use implement the policy and report deficits via

their Care Group Risk Management and Safety Committee.

Ward and Department Managers are responsible for:

The stock of medicines held on their ward/department.

Ensuring all procedures for the safe and secure handling of medicines are followed

correctly and that the security of medicine stock is maintained.

3.2 Individual Responsibilities

Individual employee’s responsibility:

The safe and secure handling of medicines is the responsibility of every healthcare

professional who must ensure that they work within their respective professional

guidelines, ethics and codes of conduct.

All healthcare professionals are accountable for their actions. This accountability

cannot be delegated nor can anyone else answer for the actions of an individual

professional.

It is each individual employee’s responsibility to ensure that they have read,

understood and adhere to the sections of the policy relevant to their individual scope of

practice.

The Chief Executive of the Trust:

The Chief Executive of the Trust has overall responsibility for the safe use of

medicines as part of the Care Quality Commission’s Essential Standards of Quality

and Safety – Outcome 9 Management of Medicines.

The Medical Director of the Trust:

Has executive responsibility for Pharmacy and Medicines Management.

Is responsible for ensuring that adequate and appropriate training is available to

medical staff to ensure safe prescribing.

The Director of Nursing:


POL/MM/0001 V6.1 Page 13 of 113

Is responsible for ensuring that safe systems and practices are implemented,

maintained and monitored at ward and department level.

Is responsible for ensuring there are systems in place to provide relevant education

and training for nursing staff.

The Trust Chief Pharmacist:

Has been delegated responsibility for the delivery, management and development of

the Medicines Policy by the Trust Board.

Reports directly to the Medical Director and to the Chief Executive via the Quality and

Healthcare Governance Committee, Safety Committee and the Trust Management

Boards.

As the Trust Accountable Officer for Controlled Drugs is responsible for the safe and

secure management of Controlled Drugs throughout the Trust under statutory

provisions of the Health Act 2006.

4 MECHANISMS FOR THE PRESCRIBING, SUPPLY AND

ADMINISTRATION OF MEDICINES

4.1 Initiation of Treatment

Following diagnosis, a patient’s medical treatment is initiated via:

A patient specific direction.

A patient group direction (PGD) which has been formally approved by the Clinical

Standards and Therapeutics Committee.

Specific exemptions covering supply or administration as contained in medicines

legislation.

In life threatening circumstances the process may not be formally initiated in full but

retrospective records must be made to cover the treatment given.

4.2 Patient Specific Direction

A patient specific direction (PSD) is a written instruction signed by a doctor, dentist or

non-medical prescriber for a medicine to be supplied and/or administered to a named patient

after the prescriber has assessed the patient on an individual basis. Writing a PSD is a form

of prescribing. The majority of medicines are prescribed, supplied or administered using this

process.

As a patient specific direction is individually tailored to the needs of a single patient, it should

be used in preference to a patient group direction (PGD) wherever appropriate.


POL/MM/0001 V6.1 Page 14 of 113

4.3 Patient Group Direction (PGD)

A PGD is defined as the written instruction for the supply and/or administration of

medicines to groups of patients who may not be individually identified before

presentation for treatment. Patients within the group may or may not be known to the

service prior to presenting for treatment, depending on the circumstances. Using a

PGD is not a form of prescribing.

A PGD must be drawn up locally by doctors, pharmacists and other appropriate

professionals, approved by the Trust and approved by the Clinical Standards and

Therapeutics Committee.

A PGD does not enable practitioners to delegate supply or administration to others.

Refer to: The Patient Group Direction Policy POL/MM/0009

4.4 Specific exemptions covering supply or administration as contained in

medicines legislation

A number of health professions – for example, nurses providing occupational health

schemes, midwives, chiropodists, paramedics and optometrists – have specific

exemptions in medicines legislation to supply or administer medicines.

Registered midwives have exemptions under medicines legislation for parenteral

administration of a number of prescription only medicines (POMs) including lignocaine

and pethidine.

Refer to: 6.21.4 and Appendix 1 Midwives Exemptions List

4.5 Separation of Prescribing, Supply and Administration

In keeping with the principles of safe practice there should be a clear separation of

prescribing and supply / dispensing and administration:

Only in exceptional circumstances should these activities involve the same

practitioner.

Should such exceptional circumstances occur then a second competent practitioner

should independently check each stage of the process for appropriateness and

accuracy.

5 PROCESS FOR THE PRESCRIBING OF MEDICINES

(Including the process for ensuring the accuracy of medication charts)

Prescribing medicines is restricted to medical and non-medical practitioners who are

qualified and authorised to prescribe. They must be prescribers registered with their


POL/MM/0001 V6.1 Page 15 of 113

relevant professional body. Prescribing is a high risk activity and should only be carried

out by staff conversant with these risks and working within their scope of practice.

To ensure the accuracy of prescribing on medication charts or the electronic

prescribing system (ePMA), prescribers should comply with the relevant sections

detailed below, professional standards of practice and Department of Health guidance.

5.1 Prescribers

A prescription must be authorised by a registered medical practitioner, dentist, non-

medical independent or supplementary prescriber or community nurse prescriber.

F1 medical staff may prescribe medicines for inpatients and patients on discharge, but

must not prescribe for outpatients until they have achieved full registration.

Dietitians in an in-patient setting, are authorised to initiate the use of an approved

dietetic product (and only those contained within Appendix A2: borderline substances

of the BNF) by writing it on the medication chart or entering it onto the ePMA system.

The Dietitian must sign the entry to authorise administration.

o Dietitians can also stop nutritional supplements (as described above) that are not

suitable following review of the patient.

Medical students are not allowed to prescribe.

5.2 General Principles for Prescribing

Prescribers must prescribe within their own competency and comply with current

legislation, professional guidance and Trust policies for prescribing.

A prescription is a written or electronic order for the supply or administration of a

medicinal product and must only be written by an authorised prescriber for an

individual who is a registered patient of the Trust.

The guidance on prescribing within the current edition of the BNF must be used as a

primary source of reference.

Medicines may only be prescribed on official Trust controlled stationery or be

electronically generated.

Prescriptions must be completed fully, legibly and the record must be indelible.

Prescriptions must clearly identify for whom the medicine is intended. In most settings

this will include the patient’s name, address, date of birth and NHS number / hospital

number.

All prescriptions must be dated and signed by the registered prescriber on the

appropriate prescription form.


POL/MM/0001 V6.1 Page 16 of 113

The prescriber must clearly identify their name on each prescription (printed or clearly

handwritten).

Where requested on the form, the prescriber must also state their bleep number and/or

professional registration number.

Prescribed medicines should be approved for use by the Clinical Standards and

Therapeutics Committee and Area Prescribing Committee. Limited exception is given

to patient’s own medicines, medicines undergoing Clinical Trial and specialist therapy

for individual patients.

When medication is prescribed the prescriber must take into account any relevant

national and local guidance.

Prescribers must refer to the current version of associated medicines related policies

for particular issues relating to prescribing. These are available via the Trust intranet:

For prescribing on admission, transfer and discharge; Refer to the Medicines

Reconciliation Policy POL/MM/0006, Going Home Policy POL/NG/0005A, Clinical

Handover of Care on Transfer Policy POL/NG/0005B

For prescribing medicines requiring a loading dose; Refer to the Medicines

Requiring Loading Doses Policy POL/MM/0007

For prescribing controlled drugs; Refer to the Controlled Drug Policy POL/MM/0010

For prescribing antibiotics and anti infectives; Refer to the Antibiotic Formulary

For prescribing medicines subject to clinical trial; Refer to Clinical Trials Policy

POL/MM/0004

All prescribers are required to keep contemporaneous records which are

unambiguous, comprehensive and legible in accordance with the Trust Clinical Record

Keeping & Healthcare Records Management Policy (POL/NQ/0005).

Prescribers must not write prescriptions for themselves. They should not prescribe for

their families or other members of hospital staff. Members of staff should obtain drugs

they need for their own treatment or for their families in the same way as members of

the public. Where it is necessary to prescribe for friends, relatives or colleagues this

should only be undertaken in the context of that friend, relative or colleague being

seen in a professional capacity e.g. where a friend, relative or colleague is a registered

patient.

5.3 Principles for Use of the Medication Chart

Only medication charts approved for use within the boundaries of CDDFT or the

current ePMA system must be used for recording details of prescribing and

administration of medicines. ePMA SOPs and standards will be approved by ePMA


POL/MM/0001 V6.1 Page 17 of 113

Clinical Risk Committee and Clinical Standards and Therapeutics Committee (CSTC).

Flow sheets, decision support tools, and other items relating to safe prescribing will be

approved by the ePMA Clinical Risk Committee and escalated to CSTC if appropriate.

Directions should preferably be in English without abbreviation; if Latin abbreviations

are used these should be limited to the commonly used abbreviations listed in the

current edition of the BNF and those relating to the route of administration specified in

section 5.4 of this policy.

The medication chart or ePMA prescription must be accurate and complete.

The use of the term ‘as directed’ should be avoided.

The medication chart or ePMA prescription must be available to the prescriber or other

health practitioner whenever the patient’s treatment is reviewed.

On admission or re-admission a new medication chart or ePMA prescription must be

written to reflect current medication the patient is taking.

Where possible no more than one current medication chart should exist at any one

time for any patient. Where this is not possible and a second chart is required both

medication charts must indicate the existence of a second chart e.g. 1 of 2, 2 of 2.

Duplicate prescribing on medication charts and via the ePMA system should be

avoided.

Medication charts must be used only for the maximum period for which they are

designed. When the end of the chart is reached all current prescriptions must be

cancelled by a prescriber, signed and dated. The current therapy must then be

reviewed and re-written on to a new chart.

The cancelled charts must be filed in the patient’s records.

The main medication chart or ePMA prescription must make reference to any therapy

indicated on separate charts or record sheets e.g. anticoagulation record sheets,

insulin medication charts and record sheets.

Authorised practitioners are able to modify dose regimens or to initiate or stop

medicine therapy in accordance with protocols approved by the Clinical Standards and

Therapeutics Committee.

5.4 Content of the Medication Chart

The following details must be clearly identified on the medication chart or ePMA record:

Demographic information – The patient’s name, date of birth and hospital/NHS

number, ideally in the form of an addressograph.


POL/MM/0001 V6.1 Page 18 of 113

Medicine, food or other allergies and sensitivities – must be entered in the

appropriate section by a medical, nursing or pharmacy practitioner and transferred to

subsequent sheets. Where there are no known medicine sensitivities, "NIL KNOWN"

or “NKA” must be entered into the box on the paper chart and signed. An equivalent

entry should be made if using the ePMA system. It is the prescriber’s responsibility to

confirm whether or not the patient has a drug allergy/intolerance before a prescription

is written. Where this cannot be confirmed immediately this should be indicated.

The patient’s height, weight and surface area must be recorded where appropriate.

The weight of the patient is important where the dosage of medication is related to

weight.

The date treatment is prescribed and the intended date of commencement of

treatment if this differs. This start date should be carried forward to any rewritten

prescription sheets in the future.

The medicine form (tablets, suppositories etc.) and for ePMA prescriptions, the

medicine strength (e.g. levothyroxine 25microgram tablet).

The approved name of the medicine as recommended in the British National

Formulary (BNF). Abbreviations are not acceptable. The approved name is usually the

generic name. Brand names may be used in the following exceptions:

When different proprietary brands of a medicine are known to have differing

bioavailability which is clinically significant

If a medicine is a combination of two or more medicines

If there is potential for confusion

The prescribed dose must conform to the following:

The dose must be expressed in metric units, avoiding decimal points by using

whole units, e.g. 125 micrograms rather than 0.125mg

The word "micrograms" must be written in full (not abbreviated to mcg), to avoid

confusion with milligrams (mg)

The word "Unit" must be written in full rather than abbreviated to "U" or "O" (the

blood unit symbol)

Roman numerals must not be used

Approved dose abbreviations are:

o ml millilitres o mg milligram o g gram


POL/MM/0001 V6.1 Page 19 of 113

NOTE This policy supersedes previously approved Medicines’ Policies. The abbreviation

“microg” for microgram is no longer acceptable.

The intended route of administration must be specified. If a medicine is to be given

both orally and intravenously these must be prescribed separately. The following may

be used to indicate routes of administration:

PO by mouth

PV per vagina

IM intramuscular

SL sublingual

IV intravenous

TOP topical

SC subcutaneous

INH inhalation

PR per rectum

EXT external use

Neb nebulisation

PEG percutaneous endoscopic gastrostomy

NG nasogastric tube

All other routes of administration must be written out in full.

The intended site of administration or use must be specified, if appropriate e.g. ‘left

eye’.

The prescribed frequency of administration must be stated and include:

The timings for regular medicines

The prescribed frequency of administration, with defined stated intervals, the

maximum daily dose and the indication if medication is to be given on an 'if

required' basis (PRN), (e.g. 1mg 4 hourly if required for agitation, maximum 4mg in

24 hours)

The specific time of administration, if the effectiveness of the drug will be affected

by the time of administration


POL/MM/0001 V6.1 Page 20 of 113

A clearly defined day for once weekly administration and the remaining six days of

the week when a dose must not be administered must be clearly crossed out e.g.

prescribing of a once weekly dose of methotrexate

Clear and full instructions when administration is to be changed on specific days

over specific time periods to ensure there are no ambiguities e.g. one tablet once

daily on day one, day two and day three for one week

The prescribed duration of treatment must be specified where appropriate. Abbreviations are not acceptable e.g. 1/7 should be written in full as “for one day”.

Each prescription must be authorised by the full signature of the prescriber. The

signature should be legible or the printed name of the prescriber should be written next

to the signature at least once on each chart. For ePMA, an electronic signature is

generated automatically.

Cancellation of Treatment when a paper prescription is cancelled or a dose is

changed a line must be drawn across the prescription. The cancellation should be

dated and signed in full by an authorised prescriber, or staff member authorised by the

prescriber.

Any alterations to drug therapy must be written in full as a new prescription. Alterations

to an existing prescription are not acceptable.

5.5 Amendments to Medication Charts

All registered health professionals can and should add any missing demographic information

including weight, height and allergy status to medication charts or the ePMA system.

5.6 Process for ensuring the accuracy of medication charts

The process for ensuring the accuracy of medication charts is clearly outlined in the

following policies:

Medicine Reconciliation Policy POL/MM/0006


Pharmacy Staff ePMA Transcribing and Enablement Policy POL/MM/0018


POL/MM/0001 V6.1 Page 21 of 113

Admission

•Clinician will write required drugs on an approved medication chart or enter them onto ePMA system, according to the standards in the Trust Medicine Policy (Section 5.4)

•An entry regarding the patients medication on admission will be made in the notes (level 1 medicines reconciliation)

•This entry should detail any intentional changes

Pharmacy Involvement

•Pharmacists & technicians are available Mon-Fri (9-5pm) on adult admissions wards and many of the base wards (often the areas with most medication changes)

•Pharmacy staff will perform level 2 / 3 medicines reconciliation on these wards within 72 hours (aiming for within 24 hours)

Interventions

•Pharmacy staff will endorse the medication chart or amend the entry on the ePMA system, providing any necessary clarity. The pharmacy box will be signed when the item has been professionally checked or validated on the ePMA system

•Any items with an outstanding query will be marked in the pharmacy box with a Q and will have the query entered in the notes. Queries will be followed up with an appropriate clinician. Drugs with ePMA queries will not be validated

Discharge / Transfer of Care

•Pharmacists will professionally check any discharge prescriptions that require dispensing

•This involves reconciling the medication chart or ePMA record against the discharge prescription

•Any queries will be raised directly with the prescriber and necessary changes will be made on iSOFT

•When the prescription is ready to be dispensed the pharmacist will sign the discharge prescription


POL/MM/0001 V6.1 Page 22 of 113

In summary:

On admission, the admitting practitioner will make an entry in the patient’s notes

outlining the medicines the patient is currently taking (level 1 medicines reconciliation).

The required medicines will then be prescribed on the medication chart(s) or on the

ePMA system.

On medicines management wards (commonly those with patients with the greatest

number of medications and medication changes) the pharmacist or pharmacy

technician will perform level 2 medicines reconciliation (available Monday to Friday, 9-

5pm). This is intended to provide clear records in the patient’s notes of intentional and

unintentional discrepancies between the patient’s medication at the point of admission

and those prescribed. Any necessary changes will be acted upon and recorded on the

chart or in the notes.

Pharmacists will endorse medication charts or make amendments to the ePMA

system to provide any necessary clarity and will sign / date the pharmacy box on

the medication chart or validate the drug on ePMA to show that the entry has been

checked. This will also be completed, upon the next pharmacy review, for any new

items prescribed during the in-patient stay

Recommendations to change prescribed medicines (medicine, dose, route, frequency)

must be documented in the health record in addition to any verbal communication with

the prescriber.

5.7 Prescribing of High Risk Medicines

5.7.1 Prescribing of High Risk Medicines

A number of medicines have been classed as a high risk to patient safety if prescribed

incorrectly. As a result there are restrictions in place around who can prescribe.

5.7.2 High Risk Medicines and authorised prescribers

Therefore:

These medicines may only be prescribed by a Consultant, GP (for the community

hospitals) or Pharmacist prescriber. Additionally these medicines can be prescribed by

an approved specialist prescriber.

This applies to all types of prescriptions including FP10s, outpatient prescriptions and

inpatient medication charts.

A consultant may write to the Trust Chief Pharmacist requesting that their specialist

medical or non-medical prescriber be allowed to write prescriptions for the high risk

medicines within their speciality. The consultant must confirm that the individual is a

specialist in the area and is competent to prescribe the medications.


POL/MM/0001 V6.1 Page 23 of 113

High risk medicines should not be administered or dispensed without an authorised

prescriber’s signature. Any high risk medicine written / prescribed by someone other

than those named above must be countersigned by an authorised signatory.

Cytotoxic medicines for parenteral use must be prescribed on a standard

chemotherapy prescription form (for medicines prepared by pharmacy) or

chemotherapy electronic prescribing system.

High risk medicines include methotrexate, lithium and all oral chemotherapy drugs. A

full list can be obtained on the pharmacy intranet pages.

5.7.3 Prescribing Insulin

Insulin must be prescribed clearly on the patient medication chart and the Trust

approved insulin chart.

Units must be written in full and not abbreviated. Do not use iu or u abbreviations.

Avoid adding a zero to the units i.e. 14.0. The correct way to prescribe the dose is 14

units.

Ensure the correct insulin is prescribed. (Particularly note differences between

NovoRapid (fast acting) and NovoMix (biphasic) preparations).

5.7.4 Prescribing Oxygen

Oxygen is a treatment for hypoxia and should not be used for any other indication.

Oxygen should be prescribed on the medication charts or ePMA system, indicating the

required target saturations.

Patients prescribed oxygen should have the oxygen saturations monitored regularly

with the frequency dependent upon their clinical situation.

Oxygen flow rates and delivery methods must be adjusted to achieve target

saturations as indicated by the flow charts in the Trust oxygen protocol.

Oxygen delivery devices, flow rates and saturation must be recorded on the patient’s

observation chart or eObs system.

Oxygen administration must be recorded at each medicines round by the appropriate

healthcare practitioner.

Oxygen should be discontinued once the patient is no longer hypoxic.

5.8 Prescribing Antibiotics and Anti-infectives

Refer to: the Trust Antibiotic Formulary


POL/MM/0001 V6.1 Page 24 of 113

5.9 Prescribing unlicensed medicines or medicines outside of the terms of licence

Wherever possible a licensed medicine should be prescribed for a patient. An

unlicensed medicinal product should only be prescribed where their use is clearly

justified by the presence of a special clinical need that cannot be met by a licenced

alternative.

When a prescription is written for an unlicensed medicine or for an indication, which is

outside the product licence for the intended medicine, the practitioner signing the

prescription is professionally accountable for his judgement in so doing and may be

called upon to justify their actions. The expectation is that the prescriber acts in

accordance with appropriate current practice.

Where possible the patient should be informed, before the medicine is prescribed, that

the product is unlicensed or prescribed outside of its licensed indications and the

reason why an unlicensed preparation is required. The patient should understand that

the product might be less well understood than a licensed product. In circumstances

where the patient may be considered to be at increased risk clinicians are strongly

advised to obtain further informed consent (in writing) from the patient (or relative)

regarding the use of the product. Failure to provide adequate information may result in

an increased liability for the Trust and/or clinician should a mishap arise which results

in a complaint or possible litigation.

Where a prescriber recommends or advises the use of an unlicensed medicine or use

of a medicine outside its product license to another prescriber this must be stated

together with a justification of the unlicensed use.

Where a prescriber directs administration of an unlicensed medicine or a medicine

outside of its product license the nurse or professional administering the medicine

must be informed.

Where responsibility for ongoing care is to be transferred to the patient’s general

practitioner, the general practitioner must be informed of the unlicensed status of the

medicine and agreement sought that he or she is willing to accept clinical and legal

responsibility for prescribing. In many cases this will be via a formal shared care

agreement approved by the Area Prescribing Committee.

Refer to: Appendix 2 Prescribing, Supply and Use of Unlicensed Medicines

5.10 Prescribing New Medicines

The Clinical Standards and Therapeutics Committee (CSTC) must approve an

application to prescribe a new medicine before prescribing of the medicine can occur

within the Trust.


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The CSTC links closely with the Area Prescribing Committee (APC) to ensure that

transfer of prescribing issues are considered. The APC authorises new drug

applications within the wider County Durham & Darlington heath economy.

5.11 Prescribing for Patients on Transfer of Care

Transfer of care represents areas of significant risk in relation to medicines use.

Admission, discharge and transfer must be planned wherever possible to avoid

miscommunication, delay and to minimise risk in relation to medicines use.

Refer to: Going Home Policy POL/NG/0005A, Clinical Handover of Care on Transfer Policy

POL/NG/0005B

Medicines Reconciliation Policy POL/MM/0006

5.12 Prescribing of Critical Medicines

Medicine doses may be omitted or delayed in hospital for a variety of reasons. Whilst

only a small percentage of these occurrences may result in or have the potential to

cause harm, it is important to recognise that serious harm or death can arise from the

omission or delay of some critical medicines.

When admitting a patient, establish the medicines they are taking as soon as possible;

identify those medicines regarded as critical medicines and ensure they are prescribed

and administered as soon as possible.

Refer to: CDDFT Critical Medicines available on the pharmacy pages of the intranet

NPSA Rapid Response Report NPSA/2010/RRR009 - Reducing Harm from Omitted and

Delayed Medicines in Hospital

5.13 Prescribing for Outpatients

The hospital practitioner and the GP share the care of a patient attending the Out-

patient Department. The hospital practitioner who recommends a change in treatment

is responsible for ensuring either the treatment is prescribed or a prompt and

appropriate communication is sent to the GP.

The continuation of regular medication is normally the responsibility of the GP.

Exceptions to this general approach may be when the medication is a hospital only

product, the medication is required urgently or when, in the interests of patient care,

the hospital practitioner needs to retain clinical responsibility.

Refer to Outpatient Medication Supply Policy POL/MM/0017


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5.14 Prescribing via Remote Prescriptions

A remote prescription can be a telephone message, a fax, e-mail or a text message

instruction to a practitioner.

A nurse may accept a ‘Direction to Administer a Medicine’ via a remote prescription

using a fax, e-mail or text message but not via a telephone message.

A pharmacist may accept a ‘Direction to Supply a Medicine’ via a remote prescription

using a fax, e-mail, text message and telephone message.

A remote prescription refers to current medication amendments e.g. dose changes.

For e-mails where possible the remote prescriber should use an nhs.net email

address.

For text messages nhs.net email addresses can also be used by entering the

recipient’s mobile telephone number followed by @sms.nhs.net (e.g.

[email protected]). The remote prescriber should copy this to the recipient’s

nhs.net email address to maintain an audit trail. The recipient should print off the

email as soon as practicable and enter the print out into the patient’s notes.

A supply of the required medication must be available.

Regular and once only drugs are included.

Schedule 2 – 5 Controlled Drugs are excluded as they always require a written

prescription.

A registered nurse has the right to refuse to accept a remote prescription. When doing

so the nurse must notify the prescriber of refusal and document the reasons in the

patient’s record.

Medical prescribers

Refer to: GMC Prescribing guidance: Remote prescribing via telephone, video-link or online

for further information.

Non-medical prescribers

A non-medical prescriber may also prescribe remotely but only if they have assessed the

patient and prescribed the original medication that now requires an amendment.

Receiving the Prescription

The remote prescription must be received by a registered nurse before the new

dosage is administered.

mailto:[email protected]


POL/MM/0001 V6.1 Page 27 of 113

The nurse is accountable for ensuring all relevant information is communicated to the

prescriber and for recording the details of the prescription in the patient’s notes.

The dose must be stated by the prescriber and confirmed back by the nurse in words

and numbers e.g. fifteen (15) mg/milligrams.

A community nurse taking the message is responsible for ensuring the fax, email

prescription or text details is stapled to the patient’s existing medication chart.

A fax must have the correct date and time (24hour clock) on so that it can be shown

exactly when the direction was received.

In an acute hospital setting the remote prescription should be witnessed by a second

registered nurse who independently hears or reads the prescription/message from the

prescriber.

In the community setting where available the remote prescription should be witnessed

by a second registered nurse or health care assistant who independently hears or

reads the prescription/message from the prescriber.

The information should be recorded by the nurse on the appropriate Community

Patient Medication Administration Record or the appropriate Inpatient Medication

Administration Record, patient notes and nursing notes. The entry must be signed with

full name by the registered nurse and witness. The information recorded must include:

o name of the doctor, date, time, approved name of drug, dose and route of

administration

o phone number, email address it was sent from, time message was sent

For text messages the nurse must also document the full message written down

verbatim, the name of the person who sent the text, the telephone number it was sent

from, the time sent, any response given and the date when received.

All text messages should be deleted from the receiving handset after documentation to

maintain high standards of confidentiality.

In the community setting a new prescription signed by the prescriber who sent the

remote prescription must be written and sent to the person performing the drug

administration within 24 hours. The nurse taking the original remote prescription is

responsible for ensuring this is received and that the remote prescription details are

filed in the patient’s notes after the new prescription is received/prescription sheet is

amended.

In the acute hospital setting the prescriber is responsible for endorsing the drug on the

prescription as soon as possible and within 24 hours.

Refer to: Section 6.23 Administration of Medicines via Remote Prescriptions for further

administration guidance.


POL/MM/0001 V6.1 Page 28 of 113

6 PROCESS FOR THE ADMINISTRATION OF MEDICINES

6.1 Authority to Administer Medicines

All practitioners involved in the handling or administration of specific medicines must be

assessed as competent to do so by the appropriate manager and must adhere to their

profession specific protocols.

Medicines may be administered under the following provisions:

By an authorised member of staff in accordance with the directions of a registered

prescriber.

By an authorised health professional under a Patient Group Direction.

By an authorised member of staff on their own authority (e.g. doctor or nurse

prescriber); this does not remove the need for a signed record to be made.

Student staff must be supervised when administering medicines. The responsibility for

this lies with the supervising qualified health care professional.

By a patient to themselves as self-administration, after discussion with the multi-

disciplinary team and in accordance with a registered prescriber.

By ward nursing staff in accordance with the guidelines on the ePMA prescription,

medication chart or the administration chart.

Midwives can administer for parenteral use, prescription only medicines as detailed in

the Midwives Exemptions List. (See appendix 1).

6.2 Accountability for Administration

Any person administering a medicine will be held accountable for their own actions.

A practitioner may refuse to administer a medicine after discussion with the prescriber

if they consider that refusal is in the best interests of the patient. A record of such an

event must be made in the clinical notes detailing the rationale.

6.3 General Principles for Administration of Medicines

A practitioner must not administer any medicine unless they are competent to do so.

The registered practitioner must exercise their professional judgement and always act

in the best interests of the patient when administering medicines.

Medicines administered to patients in the Trust must be initiated via the mechanisms

outlined in section 5 of the Trust Medicine Policy.


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In an emergency, a medicine may be given on a verbal instruction from a medical

practitioner or a non-medical independent prescriber, provided that the name, dose,

and route of the drug are recorded in the nursing care plan by the nursing staff and the

prescriber updates the prescribing record within 24 hours. For the purposes of this

policy an emergency is defined as a life threatening situation.

Medicines administered to patients should be supplied by the Trust pharmacy service

or be the patient’s own medicines that have been approved for use. The Trust

pharmacy (procurement team or lead pharmacists) may authorise supply in

exceptional circumstances, from other reputable sources such as community

pharmacies.

Medicines dispensed for an individual patient must only be administered to that patient

and must not be shared with other patients. (This applies to patient specific medicines

– i.e. labelled with the patient’s name, dispensed from the pharmacy department as

well as to patients’ own medicines).

The identity of each medicine must be clear at all times up to and including the point of

administration. A practitioner who is unaware of the identity of a medicine must not

administer the medicine.

Delays in administration must be avoided; urgent medicines must be administered as

soon as possible, especially critical medicines.

If the prescription is ambiguous, illegible, incomplete, unsigned, the allergy box has not

been completed (and cannot be verified and completed by the administering

practitioner) or there is any uncertainty regarding the medicine e.g. suitability of the

dose, frequency, route etc. then the medicine must not be administered and the

prescription must be referred back to the prescriber.

Practitioners must be familiar with the medicine to be administered, its indications, the

BNF dose range, side effects, cautions, interactions and contra-indications;

practitioners must not administer a medicine they are unfamiliar with. If further details

are required a pharmacist must be contacted.

Variance between the prescribed method of administration and the recommended

method is a valid reason for refusal to administer until discussion and satisfactory

clarification with the prescriber and/or a pharmacist.

If errors or incidents in the administration of medicines are observed or discovered the

reporting processes outlined in the Trust Incident Management Policy should be

followed.

Refer to: Incident Management Policy POL/N&G/0001


POL/MM/0001 V6.1 Page 30 of 113

6.4 Witnessed Administration of Medicines

Although it is acknowledged that single practitioner administration of medicines is

routine practice a second independent check is recommended for prescribing,

preparation and administration of all medicines.

Second check witnessed administration must be undertaken in the following

circumstances, unless an exception has been agreed (see Section 6.23):

when a controlled drug is administered (Note single person administration may be

necessary in a community setting)

administration is to children under 16 years of age

medicines are for in specialist areas e.g. cytotoxic chemotherapy

a complex calculation of dosage is required (see section 8.6)

there is a locally agreed policy in place

the patient’s condition makes it necessary

The administering nurse must ensure that the second member of staff is competent to

undertake the task required. A check is required for the preparation of the drug and

any calculations required.

The second practitioner checking the administration should be a second registered

nurse, midwife, medical practitioner, pharmacist or other authorised healthcare

professional. Where this is not possible, the second checker may be an authorised

healthcare assistant who has completed Trust approved training and who has been

assessed as competent to perform a second check of administration by a registered

nurse.

Refer to: Controlled Drug Policy POL/MM/0010: Procedure for Witnessed Administration of

Controlled Drugs

Administration of Medicines by Student Nurses

A student nurse may only prepare or administer medicines under the direct supervision

of a supervising registered nurse, who must clearly countersign the signature of the

student on the paper chart. On the ePMA system, the supervising practitioner will log

on, and mark each administration as “user under assessment”, adding the student

nurse’s name in the comments box.

Responsibility for the administration of the medicine rests with the senior practitioner,

although each practitioner remains accountable for their own practice.


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6.5 Calculation of medicine doses prior to administration

The practitioner responsible for administering the medicine must ensure that the dose

to be administered is appropriate for the patient.

The administering practitioner must not assume that the prescribed dose is correct; a

check of the prescribed dose should be undertaken based on the recommended dose

range as per the BNF, BNF for Children and nationally or locally approved clinical

guidelines.

Prior to administration, a second practitioner is required to check the dose calculation

(although they do not necessarily have to be involved in the administration) in the

following situations:

When a complex calculation of dose is required

The medicine is prepared for administration to a child under 16 years of age

The medicine product is intended for intravenous administration

Calculations must be performed independently and an entry of the calculation details

must be made in the patient’s notes.

Practitioners working in the community should consider alternative ways of checking

calculations. The use of technology or checks over the phone can be used. Steps

must be put in place to ensure the second practitioner has all the relevant information

presented to them to enable an independent calculation. If a second check is not

possible then this should be recorded in the patient’s notes.

6.6 Preparation of Medicines Prior to Administration

The prescription must be read carefully to determine the medicine name, dose, diluent

and route of administration.

If the practitioner is unclear as to the correct medicine diluent or precise method for

medicine preparation, he/she must obtain this information from the pharmacy

department before proceeding. A range of drug protocols and an injectable drugs

guide are available on the pharmacy intranet pages to support these processes.

Medication must be prepared for administration at the time it is due to be given;

medication for multiple patients must not be prepared in advance.

Insulin doses must only be measured and prepared for administration using an insulin

syringe or commercial insulin pen device.

Medications should not be crushed for ease of administration unless approved by

Pharmacy. When a patient has difficulty in swallowing medicines refer to pharmacy for

advice.


POL/MM/0001 V6.1 Page 32 of 113

Medicines prepared for administration which are subsequently omitted must be

destroyed according to the Trust Waste Policy and Controlled Drug Policy.

6.7 Procedure for the Administration of Medicines

The practitioner responsible for administering the medication must:

Explain the procedure to the patient or carer whenever possible.

Check the identity of the patient using the hospital or NHS number and confirm this

with the patient or carer whenever possible. If the hospital or NHS number is

unavailable the patient name and date of birth must both be confirmed.

Confirm that the patient is not allergic to the medicine before administering it.

Confirm that the dose of medication prescribed for administration at the specified time

has not already been administered. Practitioners must be vigilant for ‘when required’

doses of same or similar medicines (these may affect whether the regular dose can be

given e.g. when required paracetamol).

Check that the prescription or the label on the medicine is clearly written and

unambiguous.

Consider the dosage, weight where appropriate, method of administration, route and

timing of administration.

Consider administering or withholding the dose, in the context of the patient’s condition

and co-existing therapies.

Check the expiry date of the medicine.

Expiry dates explained:

Date on box Actual expiry date

Use by Dec 15 01.12.15

Exp. Dec 15 31.12.15

Use before Dec 15 30.11.15

Check that the medicine has been stored correctly.

Check that medicines contained in a patient’s medicines’ bedside locker are correctly

labelled and only used for the current ‘named’ patient.

The prescriber or another registered prescriber must be contacted without delay if

contra-indications to the prescribed medication are discovered, where the patient


POL/MM/0001 V6.1 Page 33 of 113

develops a reaction to the medicine or where assessment of the patient indicates that

the medicine is no longer suitable.

Ensure that the patient takes or uses the medicine appropriately; the practitioner

should remain with the patient until the medicine has been administered.

6.8 Use of Oral Syringes

IV syringes MUST NOT be used to measure or administer oral liquid medicines by

mouth or enteral feeding tube.

A medicine cup or 5ml spoon should be used to measure and administer oral liquid

medication except in the following situations where a PURPLE oral/enteral syringe is

appropriate:

The dose cannot be accurately measured using a medicine cup or 5ml spoon e.g.

less than 5ml or not a multiple of 5ml, or where dose measurement is critical e.g.

digoxin, phenytoin

Administration is via an enteral feeding tube

Administration from a medicine cup or 5ml spoon is unsuitable, e.g. babies and

young children

Once an oral syringe has been used to administer medication directly to a patient or

via an enteral feeding tube, it must not be used to withdraw further doses of that or any

other medication from an original container.

Used oral syringes must be disposed of according to the Trust Waste Policy.

Whenever it is necessary to administer oral medications via an oral syringe and other

solutions for either IM/IV injection at the same time, the two procedures should be

carried out separately.

6.9 Recording of Administration of Medicines

A clear and immediate record must be made of all medication administered,

intentionally withheld or refused by the patient, ensuring that any written entries and

the signature are clear and legible.

The practitioner must not sign the administration record or on the ePMA system for

administration prior to the patient taking the medicine.

The medicine must be administered by the prescribed route and the details of

administration must be documented on the appropriate administration record.

The practitioner responsible for administration must sign the administration record or

login and log the entry in ePMA. If a second individual has acted as witness or


POL/MM/0001 V6.1 Page 34 of 113

checked a calculation that individual must also sign the administration record or log

this by entering their username and password in ePMA.

6.10 Omitted doses of Medicines

Medicines should be administered at the prescribed time and for most this can be

considered as plus or minus two hours of the time prescribed on the medication chart.

o An omitted dose is a failure to administer a dose before the next scheduled dose is

due

o A delayed dose is administration of a drug 2 hours or more after the prescribed

time of the scheduled dose

It is the responsibility of prescribers to provide clear written instructions with regard to

the intentional omission of prescribed medicines. This will usually be done with a

cross in the administration box(es) or text which defines specific clinical parameters.

For ePMA this must be done by suspending a medicine or adding text which defines

specific clinical parameters.

If a cross is not present in the administration box and a medication is not suspended

and the medicine is not administered, an approved non-administration code must be

entered on the medication chart or ePMA system to inform other practitioners of the

omitted medicine. Where the code indicates it is necessary an entry must be made in

the patient’s record, if appropriate.

Omissions and refusals must be reported to the prescriber if it is considered that the

non-administration may affect the patient’s condition.

The decision to omit or continue medicines prior to a diagnostic procedure or surgery

should be in line with approved Trust protocols and guidelines.

Patients sometimes refuse to take their medication. Where the patient is fully informed

and has capacity to understand their actions this should be respected and the

medicine should not be administered.

6.11 Covert Administration of Medicines (Disguising medicines in food or drink)

Covert administration of medicines should be used in exceptional circumstances and

will only be necessary or appropriate in the case of patients who lack capacity to

refuse treatment and the treatment has been determined to be in their best interests.

Where patients who lack capacity are being given medication covertly because they

are objecting and the treatment is treatment for mental disorder which has been

determined as in their best interests, then consideration should be given with regard to

whether the criteria for use of the Mental Health Act (MHA) applies. Where there is a

reasonable belief that a “deprivation of liberty” is occurring alongside covert


POL/MM/0001 V6.1 Page 35 of 113

administration of medication for a mental disorder due to objection from the patient,

then implementation of the MHA will be required.

Patients must be presumed to have capacity and where there are doubts about

capacity, a capacity assessment (using the organisations assessment tool) must be

carried out followed by a best interest’s determination where capacity is found to be

lacking.

The decision to disguise medication must be supported by members of the

multidisciplinary team including a pharmacist. A record of the meeting at which the

decision was taken with a clear indication of the justification must be made in the

patient’s notes and include the names of all involved. It is expected that the patient’s

family/carer is involved. Family support, whilst essential and helpful, cannot be

regarded as formal consent.

When administering medication the patient should always be given the opportunity to

accept the medication in its original form; if refused and it has been established that

the patient lacks capacity and it has been determined that it is in the best interests of

the patient, medication can be administered covertly.

The appropriateness of the decision to continue covert administration of medicines

should be regularly reviewed by the team and details of the review should be

documented in the patient’s clinical record. Legal advice should be sought in individual

cases, if necessary.

Covert administration of medication without proper authorisation is a safeguarding

issue and would need to be referred directly to Social Care.

Refer to: Consent to Examination or Treatment Policy POL/N&Q/0004

Policy and guidance notes for staff on The Mental Capacity Act 2005 POL/N&Q/0051

6.12 Administration of Critical Medicines

Medicine doses may be omitted or delayed in hospital for a variety of reasons. Whilst

only a small percentage of these occurrences may result in or have the potential to

cause harm, it is important to recognise that serious harm or death can arise from the

omission or delay of some critical medicines.

When admitting a patient, establish the medicines they are taking as soon as possible.

Identify those medicines regarded as critical medicines and ensure they are prescribed

and administered as soon as possible.

Refer to: CDDFT agreed list of Critical Medicines available on the pharmacy pages of the

intranet

NPSA Rapid Response Report NPSA/2010/RRR009 - Reducing Harm from Omitted and

Delayed Medicines in Hospital


POL/MM/0001 V6.1 Page 36 of 113

6.13 Administration of Injections

Injectable medicines represent a very high risk and particular care must be taken when

preparing and administering injectable medicines, as they often have a very rapid

onset of action.

Practitioners involved in the administration of parenteral medication must have

received formal training in preparation of undertaking the skill, have been assessed as

being competent at performing the skill and have this documented in their personal

record.

Injections licensed for single use must not be used on more than one occasion, either

for one or several patients.

Injections licensed for multiple use should be used in accordance with their Marketing

Authorisation.

Refer to: NMC Code of Practice

6.14 Preparation of injections for administration

Practitioners must not prepare medicines for injection in advance of their immediate

use or administer medication drawn into a syringe or container by another practitioner

when not in their presence.

Exceptions to this situation are:

the administration of an already established infusion, which has been instigated by

another practitioner following the principles set out below

the administration of medication prepared under the direction of a pharmacist from

a central intravenous additive service which is clearly labelled for that patient

where the specific summary of product characteristic or patient information leaflet

indicate it should be prepared in advance, for example, some chemotherapy

treatments. This process must be in line with approved Trust protocols and

procedures

The practitioner responsible for administering the medication must:

Check the injection to ensure the right medicine and strength have been selected

Select the most appropriate strength, vial size and quantity to avoid overdose or

wastage

Check the expiry date of the injection

Ensure that the injection has been stored appropriately and at the correct

temperature


POL/MM/0001 V6.1 Page 37 of 113

Prepare the injection according to the manufacturer’s instructions in a clean,

uncluttered area, avoiding contamination and interruptions

Ensure no more than one medicine and solution (vehicle for administration) is

mixed without further instruction or authorisation from the prescriber. (If more than

one medicine is to be mixed then compatibility should be checked with pharmacy

unless this information is available in nationally or locally approved guidelines)

Ensure that injectable medicines are not added to blood products or pre-prepared

products supplied by pharmacy

Identify an appropriate area for the preparation of intravenous infusions - in

inpatient units this area should be separated from the direct patient areas and

enclosed (all doors and windows should be closed). These precautions reduce the

risk of microbial contamination and interruptions, which can lead to medicine errors

Ensure pre-printed syringe labels or blank labels for injectable medicines are

applied during preparation to differentiate products and prevent medication errors

As a minimum, labels used on injectable medicines prepared in clinical areas

should contain the following information: name of the medicine, strength/dose in

syringe; patient’s name / identifier. The only exception to this is where a medicine is

drawn up and immediately administered to a patient by the same member of staff,

without putting down the product

Use a compatible administration set; if in doubt the practitioner must check with

pharmacy

6.15 Administration of insulin

6.15.1 Administration of insulin inpatient settings

Insulin must be prescribed clearly on the patient’s prescription chart and insulin chart.

For adults, this includes the insulin prescription chart and diabetes record.

‘Units’ should be written in full and never abbreviated with the units required clear and

unambiguous.

A CDDFT Insulin Device Guide is available to visually identify and check the device

with patients, if required.

Vials are kept as routine stock on wards, with the exception of paediatrics where a

presentation which is more acceptable in paediatrics, may be required.

Insulin vials for specific patients must not be shared between patients.

When opened the date of opening and patient’s name should be clearly written onto

the vial.


POL/MM/0001 V6.1 Page 38 of 113

The vial should be used within one month of opening.

For patients requiring pre-filled pens or cartridges on non-POMMS wards /

departments, the pharmacy requisition must be accompanied by the in-patient

medication chart and the insulin chart (where appropriate) signed by the doctor stating

the type of insulin required, device and frequency of administration. The order will not

be processed without this information. These pens or cartridges must be issued at

discharge and not retained in the fridge.

Wards / departments with POMMS will have supplies of pre filled pens or cartridges

initiated by the technician as is current practice.

6.15.2 Administration of insulin in non-inpatient Community Settings

The patient’s own labelled insulin must be available. The medication label must

contain the following correct information: the patient’s name, the insulin name in full

and the insulin strength.

A supporting document must also be available which has been signed and dated by a

prescriber (either a physical or electronic signature) and confirms: the patient’s name,

the insulin name, the insulin strength, the dose in units and the frequency.

The supporting document must be one of the following: a hospital discharge

prescription or a written ‘direction to administer’ on the medication chart signed by a

prescriber, or another form of prescription.

The supporting document cannot be a handwritten nursing discharge letter or

notification from a non-prescribing practice nurse

Where there is unclear or ambiguous labelling, or ambiguous information about the

dose, the prescriber must be asked to write and sign a clear ‘direction to administer’

(‘As required’ is not acceptable in a direction to administer).

‘Units’ should be written in full and never abbreviated.

Insulin already in use may be stored at room temperature for up to 28 days.

The date an insulin pen or vial commenced in use must be written on the vial or pen

and recorded in the patient’s records.

6.15.3 Administration of Insulin by Healthcare Assistants in Community Settings

Refer to Administration of Insulin to Adults by Health Care Assistants in Community

Services Policy POL/CHS/0060 V3 which provides a framework which clearly identifies

the roles, responsibilities and competencies required for Health Care Assistants to

safely administer insulin to specific adult patients within the community.


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6.16 Administration of Controlled Drugs

For detailed procedures relating to the administration of controlled drugs refer to the

Controlled Drug Policy POL/MM/0010.

The Trust Recommends that all aspects of controlled drug administration is checked

by a second competent healthcare professional. The Trust recognises that, in certain

circumstances this is not possible, for example community nurses and midwives

administering controlled drugs in the patient’s home.

A procedure is available to assess the competency of a non-registered individual to

witness controlled drug activity in a community setting.

Refer to: Section 15.2 Witnessed administration of medicines: Controlled Drug Policy

POL/MM/0010.

6.17 Administration of unlicensed medicines or medicines outside of the terms of

licence

Medical and dental practitioners, nurse, midwife and pharmacist independent

prescribers can prescribe and authorise the administration of unlicensed medicines or

medicines outside the terms of licence only where a special need for that medication

has been identified; this must be recorded and documented in the patient’s notes.

Practitioners administering medicines to patients should be aware of the unlicensed

status of any medicines they are using.

Practitioners administering unlicensed medicines or licensed medicines used outside

the product’s license should be satisfied that they have sufficient information to

administer the medicine safely and that there is acceptable evidence for the use of the

medicine for the intended indication. This does not mean withholding treatment. It

means actively seeking information from the prescriber and other appropriate sources.

Refer to: Appendix 2 Prescribing, Supply and Use of Unlicensed Medicines

6.18 Administration of medicines through enteral feeding tubes

Although practitioners are advised not to crush medication there will be occasions

where the patient is unable to swallow solid oral dosage forms or medication is

required to be administered via an enteral tube. If alternative formulations or methods

of administration are unavailable and the medication is required, then it may be

necessary to crush tablets or open capsules.

Practitioners should refer to the Handbook of Drug Administration via Enteral Feeding

Tubes for appropriate instructions of safe and effective administration. If this is not

available pharmacy should be contacted for advice on appropriate administration.


POL/MM/0001 V6.1 Page 40 of 113

As crushing medication or opening capsules prior to administration usually results in

unlicensed administration, the practitioner responsible for administration of medication

in this way must inform the prescriber.

Any adverse effects, including problems with feeding tubes, should be reported to the

prescriber and pharmacist immediately.

6.19 Administration of patients own medicines (patients own drugs PODs)

Patients are encouraged to bring their own medicines into hospital on admission.

Medicines brought into the hospital may, with the patient's permission, continue to be

used provided they have been formally assessed as appropriate for use and

prescribed on a hospital medication chart.

Assessment for use of patient’s own drugs must be performed by a registered nurse,

pharmacy assistant, pharmacy technician or pharmacist, who is familiar with the

procedure for the re-use of patients’ own medicines.

All medicines brought into the hospital by patients remain their property and should not

therefore be destroyed or otherwise disposed of without their agreement, or if this is

not possible, their relatives agreement.

A patient’s own medication must not be used for administration to another patient.

The admitting doctor should include herbal and homeopathic remedies brought into

hospital by patients as part of the medicines review on admission.

If the medicines are in an unsatisfactory condition, inadequately labelled or no longer

prescribed, the patient’s permission should be sought to have them destroyed. If the

patient refuses then an entry should be made in the patient’s record of the reasons

why destruction of the medicine is considered necessary and the patient’s refusal to

consent to this destruction. The medicines should be returned to the patient on

discharge or sent home with a relative. However, patients should be advised that

continued possession and use is medically inadvisable. The risk of use of medicines,

which are of an unsatisfactory quality, should be clearly stated.

The patient’s own medicines must be destroyed according to the Trust Waste Policy.

Refer to: Appendix 3 Guidelines for the use of Patients’ Own Medicines

6.20 Process for patient self–administration of medicines

Refer to: Self Administration of Medicines Policy POL/MM/0013


POL/MM/0001 V6.1 Page 41 of 113

6.21 Administration of Medicines in Specialist Areas

6.21.1 Preparation of Medicines in Theatres

All parts of the Medicines Policy apply to theatres but with the following additional

requirement and/or exceptions. Where Registered Practitioner is stated, this includes

Registered Operating Department Practitioners (ODP) and registered nurses.

Registered practitioners must only prepare medicines for use in theatres on the direct

verbal or written instructions of a medical practitioner and when the anaesthetist or

surgeon is present in theatre.

Controlled drugs must only be prepared against written orders. For the management of

controlled drugs in theatres refer to Controlled Drug Policy MM/POL/0010.

An anaesthetist or another registered practitioner must check all prepared medicines.

All injections must be drawn up directly from the source bottle or ampoule directly into

syringes; ‘open systems’ such as the use of gallipots, must never be used to contain

medication prior to injection.

An anaesthetist or prescribing doctor must clarify any uncertainties.

All syringes must be correctly labelled (but not pre-labelled in advance of being drawn

up).

Registered practitioners must only dilute agents for administration in the presence of a

second registered practitioner or medical practitioner; the diluted product must be

checked by the second registered practitioner or medical practitioner.

The bottle / syringe must be labelled with:

o the name of the drug, diluent and concentration

o date and signatures of the practitioner and checker

o the only exception to this is where a medicine is drawn up and immediately

administered to a patient by the same member of staff, without putting down the

product

Registered practitioners must only add medicines to an infusion in the presence of a

second registered practitioner or medical practitioner; the infusion must be checked by

the second registered practitioner or medical practitioner.

The bottle / bag must be labelled with:

o the name of the drug, diluent and concentration

o date and signatures of the practitioner and checker


POL/MM/0001 V6.1 Page 42 of 113

The prescribing doctor or registered practitioner must check all drugs prior to

administration of medicines in theatres.

6.21.2 Administration of Medicines in Theatres

Only registered practitioners who have received appropriate approved training and

been assessed as competent may undertake a role in the administration of medication

in theatres.

Newly qualified registered practitioners working in theatre and anaesthetic areas must

undergo a period of practice supervised by an experienced registered practitioner

during their preceptorship period to demonstrate their competence in administering

medicines.

A registered practitioner who has completed appropriate training can administer

medicines via oral, rectal, subcutaneous and intramuscular routes in the presence of

another registered practitioner or anaesthetist.

Registered practitioners must not administer drugs via the intravenous route (through

an established cannula or line) until they are assessed as fully competent to administer

drugs via all other routes and have completed the in house training package in IV drug

administration. A period of supervised practice will also be required during which the

registered practitioner will be assessed for competence in the administration of IV

drugs.

All administration of IV medicines in the theatre environment should be undertaken by

a registered practitioner (who is qualified to administer IV medications) and witnessed

by a second registered practitioner (who is also qualified to administer IV medications)

or alternatively be administered by an anaesthetist.

6.21.3 Administration of Medicines in Paediatrics

A Registered Sick Children’s Nurse or a Registered Nurse with Paediatric experience

who is familiar with paediatric drug calculations should perform the administration of

medications.

The general principles for the administration of medicines to patients apply equally to

adults and children.

Doses of less than 1ml in volume must be drawn up in a 1ml syringe graduated to

0.01mls. Oral syringes must be used for enteral medication.

Paediatric formulations must be used whenever possible.

The weight of the patient must be recorded in kilograms on the front of the medication

chart. A new prescription must be written if a change in weight occurs necessitating a

change in dose.


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In the event that a weight or surface area is estimated, e.g. in emergency departments,

two nurses must document that they agree with the weight or surface area estimated

in the nursing record.

The practitioner must assess the child’s level of understanding and all explanations

should be appropriate to the child’s level of cognitive development.

An explanation about the medication and the method of administration must be given

to the child and carer as appropriate.

The child must be positioned correctly; infants and toddlers may sit on the nurse or

carer’s knee. All children should be sat up where possible; do not tip the child’s head

backwards.

The medication should be administered slowly.

It may be preferable to allow the carer / parent to administer medicines when possible,

whilst observed.

In an in-patient environment the medication should be taken to the child and

identification bracelets must be checked.

(2 x identity bracelets are required for newborn babies in the care of maternity

services and babies in the care of the special care baby unit

The information on the identity bracelet should correspond to that on the medication

chart.

In a community setting identification (name and date of birth) must be confirmed with

the parent or guardian and the child (where possible).

Solid dosage forms may be used when a child is assessed capable of swallowing

these with a drink.

Infants and toddlers may receive oral medication via an oral syringe or dropper by slow

administration, just inside the mouth, pointing towards inside of cheek.

6.21.4 Midwives Exemptions and Administration and Supply of Medicines

Midwives Exemptions allow registered midwives to supply a list of specific prescription

only medicines on their own initiative in the course of their professional practice.

Midwives Exemptions also allow registered midwives to administer certain parenteral

medicines in the course of their professional practice. These include certain controlled

drugs which are also exempt from certain of the Home Offices’ Misuse of Drugs

Regulations.

In this context midwives are not prescribing medication.


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Student midwives may administer medicines on the exemption list if they are directly

supervised by a registered midwife. This does not include Controlled Drugs.

If a medicine on the midwives exemption list is supplied or administered this must be

recorded on the patient’s medicines administration chart. The words “Given via

Midwives Exemption” must be written across the prescriber’s signature box and then

signed and dated by the midwife. For ePMA, this will be added in the additional

comments box.

The rest of the drug details should be entered onto the drug chart or ePMA system and

administration recorded as per the Trust Medicines Policy.

Registered midwives must only supply and administer those medicines in which they

have received the appropriate training as to therapeutic use, dosage, side-effects,

precautions, contra-indications and methods of administration (NMC, 2004; 2007).

Additional training, continuing professional education and governance arrangements

should be in place with regard to the use of new medicines added to the midwives

exemptions list.

6.21.5 Administration of systemic anti-cancer therapy preparations (e.g. chemotherapy) for both treatment of cancer and other indications Practitioners involved in the administration of chemotherapy medication must:

Prior to administration of parenteral chemotherapy have received formal preparation in

undertaking the skill, have been assessed as being competent at performing the skill

and document a record of this assessment.

When administering oral chemotherapy either the administration should take place by

a chemotherapy trained nurse or in areas where no chemotherapy nurse is available,

the administration should be double checked by a second qualified nurse.

Inform their line manager of their condition if they are breast feeding, pregnant or

suspect they may be pregnant before undertaking the administration of cytotoxic

medicines; the line manager must undertake a risk assessment of the individual

practitioner’s situation.

Wear appropriate protective clothing in clinical areas or in the patient’s home when

administering cytotoxic medicines.

Ensure measures are taken to avoid skin contact with ORAL cytotoxic medicines. If

handling tablets or capsules is unavoidable, disposable gloves must be worn.

Take particular care when handling oral liquid cytotoxic medicines to avoid accidental

spillage / contact.

Ensure measuring spoons / cups etc. are washed thoroughly after use and reserved

for the use of that patient only.


POL/MM/0001 V6.1 Page 45 of 113

Do not crush or open tablets / capsules of cytotoxic medicines. If a patient is unable to

swallow tablets or capsules or a fraction of a tablet is required, pharmaceutical advice

should be sought.

Always confirm the dosage and clinical appropriateness (clinical indication, relevant

blood tests etc.) of all cytotoxic medicines prior to administration.

Patients who have been admitted to hospital while taking cytotoxic treatment may have

clinically deteriorated from when they were prescribed treatment. Advice from

specialist teams should be sought to ensure that continuation of treatment and dosage

(dose, frequency and duration) are appropriate. Until advice has been obtained that

continuation is appropriate, cytotoxic medication should be withheld.

A designated cytotoxic / cytostatic waste disposal bin must be used for disposal of all

cytotoxic medicines & cytotoxic contaminated material, sharps etc. Special

arrangements must be made for the recording and removal of the cytotoxic waste.

6.22 Administration of Medicines via Remote Prescriptions

A nurse may accept a ‘Direction to Administer a Medicine’ via a remote prescription

using a fax, e-mail or text message but not via a telephone message.

The use of fax or email is the preferred method. When this is not possible in a

community setting a text message instruction may also be considered.

A remote prescription should only be used in exceptional circumstances when the

prescriber is unable to issue a new prescription, but where changes to the dose are

considered necessary.

A remote prescription refers to current medication amendments e.g. dose changes.

The decision to accept the remote prescription is based on the registered nurse’s

professional judgement.

Exceptional circumstances include:

o Out of hours when Urgent Care Centres are accessed for medical support by the

community hospitals

o Working hours and out of hours for community nurses working in remote areas

where immediate administration is required to provide essential patient care or

where an actual prescription will not be received in time for future administration.

o In the Acute hospital where the nurse judges the prescriber is unable to leave another patient for medical reasons

Refer to: Section 5.16 Prescribing of Medicines via Remote Prescriptions for further guidance.


POL/MM/0001 V6.1 Page 46 of 113

6.23 Exceptions to the agreed Process of Administration of Medicines

In exceptional circumstances the Trust may approve a procedure that deviates from the

recommendations of Section 6 (Process of Administration of Medicines) of the Trust’s

Medicine Policy where this is deemed to be in the patient’s best interest. Under these

circumstances the service must submit documentation to the Clinical Standards &

Therapeutics Committee outlining the proposed procedure, highlighting the areas where

deviation is proposed, and an associated risk assessment. Only when the procedure

has been approved by the committee can it be introduced by the service.

Where the procedure includes the administration of medicines by a non-registered

healthcare professional NMC standards state “The delegation of nursing or midwifery

care must be appropriate, safe and in the best interests of the person in the care of a

nurse or midwife. The decision to delegate would be judged against what could be

reasonably expected from someone with their knowledge, skills and abilities when

placed in those particular circumstances.” In addition, the NMC standards state that the

registered nurse remains “responsible for the delegation of any aspects of the

administration of medicinal products and they are accountable to ensure that the patient,

carer or care assistant is competent to carry out the task.”

7 SPECIALIST USE OF MEDICINES

7.1 Strong Potassium Chloride Concentrate and Potassium Acid Phosphate

Injection

Ampoules of strong potassium chloride must not be issued to, or kept as a stock item

on general wards/departments where reconstitution and/or administration of medicines

takes place. Only clinical areas authorised to stock concentrated potassium chloride

where doses are routinely utilised under specialist advice and monitoring can do so.

In those authorised areas potassium chloride concentrate and potassium acid

phosphate injection must be stored in the ward/department controlled drugs cupboard

away from common diluting solutions such as sodium chloride solution.

Procedures for the order, supply, receipt and administration of potassium chloride

concentrate and potassium acid phosphate are the same as for Controlled Drugs.

Potassium chloride concentrate or potassium acid phosphate injection must not be

transferred between clinical areas. All supplies should be made directly from the

pharmacy department. In exceptional circumstances a supply of potassium chloride

concentrate sufficient for the preparation of a single infusion may be made from

another clinical area holding stock, only after authorisation by the on-call pharmacist.

Medical staff should prescribe from the range of pre-mixed potassium containing

intravenous fluids available (using licensed products whenever possible). Potassium


POL/MM/0001 V6.1 Page 47 of 113

chloride ampoules must not be used to prepare intravenous fluids when pre-mixed

bags are available.

Prescriptions for potassium chloride/acid phosphate infusions must state clearly the

dose and infusion fluid required as well as all other requirements stated within the

prescribing process.

A second practitioner must check for correct product, dosage, dilution, mixing and

labelling during the preparation of, and again prior to the intravenous administration of,

solutions prepared from potassium chloride concentrate or potassium acid phosphate.

7.2 Clinical Trials Involving Pharmaceutical Products

Refer to: Clinical Trials Policy POL/MM/0004

7.3 Medical Gases

All medical gases used in the Trust are Licensed Medicines and as such are subject to the

Medicines Act and must be treated in the same way as any other medicine.

Refer to: Section 7.8: Prescribing of Oxygen, Medical Gas Policy POL/EF/0016

8 ADVERSE DRUG REACTION REPORTING

Any medicine may produce unwanted or unexpected adverse reactions.

If a patient experiences an adverse drug reaction to a medication, action must be

taken to remedy any harm caused by the reaction. This must be recorded in the

patient’s notes.

Suspected adverse reactions should be reported to the Medicines and Healthcare

Products Regulatory Agency (MHRA) using the yellow card system (copies available in

the BNF or online via yellowcard.mhra.gov.uk). Patients are also encouraged to report

adverse reactions.

For intensively monitored medicines (identified by▼) report all suspected reactions

(including any considered not to be serious).

For newly licensed medicines all suspected adverse reactions should be reported,

including those not considered to be serious, even if it is not certain that the drug has

caused it.

For established drugs and herbal remedies report all serious adverse reactions in

adults and all serious and minor adverse reactions in children (under 18 years).


POL/MM/0001 V6.1 Page 48 of 113

8.1 Drug Defect or drug recall Reporting

8.1.1 Process for dealing with Drug Defects

All defects, including minor defects and suspected defects in medicines, should be

reported to the Pharmacy (or the on-call pharmacist out of hours).

Appropriate information should be reported to the Regional Quality Control Specialist

Pharmacist following the Regional Drug Defect Reporting procedure.

The following procedure applies when a defect is found or suspected in any medicine:

Report the issue to a member of the pharmacy team who will advise on all

reporting, recording and investigation regarding the defect

Retain any remaining product and any associated products or equipment (e.g.

administration set, infusion devices etc.)

Maintain a record of the details of the product and defect

If the product has been administered to a patient inform the prescriber responsible

for the patient and record the defect in the patient’s notes

Report the incident to the practitioner in charge of the ward / department

Report the incident via Safeguard incident management system

8.1.2 Process for dealing with Drug Recalls

Drug defects which result in drug recalls are cascaded to hospital pharmacy

departments.

A member of the pharmacy leadership team will take responsibility (or the on-call

pharmacist, out of hours) for ensuring that the recall is managed according to a locally

approved pharmacy procedure.

The action taken is determined by the class of medicines recall received:-

Class 1 - Action now (including out of hours)

Class 2 - Action within 48 hours

Class 3 - Action within 5 days

Class 4 - Caution in Use

Practitioners will be informed of the alert when pharmacy expects that practitioners

within the Trust or Community Setting are likely to encounter the affected product.

This may either be by a global cascade to all staff or a targeted cascade to affected

teams.


POL/MM/0001 V6.1 Page 49 of 113

The hospital pharmacy department will maintain a log of drug alerts and actions taken.

9 ISSUE, SUPPLY AND DISPENSING OF MEDICINES

Issue, supply and dispensing of medicines is usually, but not always, the responsibility

of the pharmacy department.

In specific circumstances, authorised practitioners may supply medication directly to

patients, e.g. such as via an approved PGD.

Once medicines are issued, supplied or dispensed by the pharmacy department and

transferred to wards / departments within the Trust, the responsibility for maintaining

the security of all medicines within their area rests with the ward / department

manager.

9.1 Dispensing of Medicines

The definition of dispense is “to label from stock and supply a clinically appropriate

medicine to a patient/carer, usually against a written prescription, for self-

administration or administration by another professional and to advise on safe and

effective use.” (MHRA, 2006). The act of dispensing includes the supply process but

also encompasses a number of other cognitive functions (e.g. checking the validity of

the prescription, the appropriateness of the medicine for an individual patient,

assembly of the product). These functions are usually performed under the supervision

of a pharmacist.

Nursing staff must not dispense medicines from ward / department stocks to patients

on discharge.

9.2 Issue / Supply of Medication from a ward or clinic setting

Prescription Only Medicines (POM) can only be issued (supplied) to patients if the following is in place:

1. Authorisation to supply which must be either:

a. A valid prescription (electronic, FP10, discharge prescription etc.) or

b. A valid Patient Group Direction (PGD)

2. Medication with appropriate labelling (matching the prescription or PGD) which will be either: a. Patient specific (i.e. dispensed for that individual patient)

or b. Appropriately annotated over-labelled medication

When supplying under a PGD an appropriate (as defined in the PGD)

registered healthcare professional can add the name of the patient and

date of supply to a label on an over-labelled item. In some cases this may


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also require the addition of the dose if the dose is not complete (for

products with variable doses)

When supplying against a prescription, registered nurses, doctors or

pharmacists can add the name of the patient and date of supply to a label

on an over-labelled item. In some cases this may also require the addition

of the dose if the dose is not complete (for products with variable doses)

Pharmacy Only Medicines (P) or General Sales List (GSL) medicines can only be

issued (supplied) to patients if the following is in place:

1. Authorisation to supply which could be either:

a. A valid prescription (electronic, FP10, discharge prescription etc.)

or

b. A valid Patient Group Direction (PGD)

2. Medication with appropriate labelling (matching the prescription or PGD) which must

be one of the following:

a. Patient specific (i.e. dispensed for that individual patient)

b. Appropriately annotated over-labelled medication

When supplying under a PGD an appropriate (as defined in the PGD)

registered healthcare professional can add the name of the patient and

date of supply to a label on an over-labelled item. In some cases this may

also require the addition of the dose if the dose is not complete (for

products with variable doses)

When supplying against a prescription, registered nurses, doctors or

pharmacists can add the name of the patient and date of supply to a label

on an over-labelled item. In some cases this may also require the addition

of the dose if the dose is not complete (for products with variable doses)

c. Appropriate packaging from the manufacturer with instructions for use relating

to the indication being treated– in this case a label must be applied (or

completed) stating the patient name and date of supply.

9.3 Labelling of medicine containers

All labelling must comply with legal requirements. Pharmacy staff are usually

responsible for the labelling of containers. The only permissible exceptions are:

Theatre staff and registered nurses may label filled syringes for immediate

administration

A registered nurse may add a patients name to a Total Parenteral Nutrition (TPN)

bag

A registered nurse may complete the details required on an ‘drugs added to this

infusion’ sticker which indicates the addition of a prescribed drug i.e. patient name,

ward, drug, amount, batch no, prepared by, checked by, diluent, date and time,


POL/MM/0001 V6.1 Page 51 of 113

expiry date and time and route, which is then placed on an intravenous fluid bag or

other container

The following additional information can be added to labels already attached to over-

labelled or pre-labelled medicines by registered practitioners:

The date the medicine was first opened and subsequent expiry date if applicable

When supplying a medicine against a valid patient Group Direction (PGD), FP10

prescription or discharge prescription a registered healthcare professional can add

the patients name and date of supply to a label on an over-labelled or per-labelled

item

Blank spaces are also required to be completed where doses or frequencies are

incomplete

Existing dosage or frequency information on labels MUST not be altered.

If a label on any container is damaged, altered or obliterated the container must be

returned to the pharmacy department for replacement.

Labels must not be removed from dispensed medicines (pharmacy may re-label

medicines previously supplied by a pharmacy).

9.4 Use of Patients’ Own medicines

Refer to: Appendix 3 Guidelines for the use of Patients’ Own Medicines.

9.5 Stock Medicines

The ward / department manager along with the pharmacy team is responsible for the

maintenance of the ward / department stock of medicines.

Each ward / department should have a stock list specifying which medicines are held,

and the quantity held. The list of stock medicines will vary with the nature of the clinical

area.

The pharmacy team, responsible for the ward / department and the ward / department

manager in consultation with relevant medical staff, should agree the list and review it

at least every six months or more or less frequently if necessary.

No medicine can be held as part of a stock list unless the Clinical Standards and

Therapeutics Committee have approved it for use.

Trust approval is required for storage and use of specific medicines, for example,

unlicensed medicines, “high risk” medicines, and specialist medicines outlined in

section 7.1 and 7.2 of the Medicines Policy.


POL/MM/0001 V6.1 Page 52 of 113

The pharmacy department will provide wards / departments with stock or ‘top-up’ lists

to enable the generation of an order. Stock orders can be generated electronically.

The stock or ‘top-up’ orders can be generated by a nurse or other suitable designated

competent person. This duty can also be undertaken by the pharmacy ‘top-up’ service.

In exceptional cases, if another heath care professional is required to order a

medicine, the pharmacy site Lead Technician should be contacted before a stock

order or requisition is submitted.

All stock or ‘top-up’ list and pharmacy requisition books must be stored securely in a

locked drawer or cupboard.

If a ward / department runs out of stock or requires additional supplies, they can be

obtained within pharmacy working hours by requesting further supplies directly from

the pharmacy department by completing an order in a pharmacy order (requisition)

book, under the section ‘stock item requisition’.

Both stock or ‘top-up’ orders and requisitions must be authorised by a registered

healthcare professional or a member of the pharmacy team.

Outside of the pharmacy department’s working hours supplies can be obtained:

from the emergency medicines stock cupboard by following local procedures

by or obtaining from another ward / department when the pharmacy is closed

by contacting the ‘on-call’ pharmacist via the site co-ordinator, for emergency items

not available, by usual procedures. Refer to the on call pharmacist procedure

The pharmacy department must retain pharmacy stock order forms (requisitions) for

two years and stock or ‘top-up’ lists for three months.

A designated person should be responsible for the ordering and receipt of stocks

delivered to the ward / department. The medicines delivered should be signed on

receipt of the order, checked against the delivery note or the pink copy of the

pharmacy (requisition) order, signed and dated. Any discrepancies should be reported

to the pharmacy department immediately. Delivery notes should be retained by the

ward / department for one month. Pharmacy (requisition) orders should be retained for

two years.

9.6 Non-stock medicines

Medicines not routinely kept as stocks by the ward / department are supplied by the

pharmacy department as a ‘temporary stock’ or to an individual patient.

The pharmacy (requisition) order book has a section to enable the requisition of such

items. All details requested on the order form must be completed. Supplies will be

made as a temporary stock supply.


POL/MM/0001 V6.1 Page 53 of 113

Responsibility for the order remains with the signatory. Any unused lines on the order

must be scored through to prevent addition of subsequent orders without the

knowledge of the signatory.

Ordering of non-stock medicines should routinely only be undertaken by a registered

nurse / midwife / ODP from the designated ward / department. In exceptional cases, if

another healthcare professional is required to order a medicine, the pharmacy site

Lead Technician should be contacted before the requisition is submitted.

9.6.1 Supply of Non-stock Medicines to POMMS wards

The designated member of ward staff must liaise with the POMMS team to arrange a

supply.

In the acute setting pharmacy should usually arrange a supply for a named patient.

Labelled medicines will only be issued for POMMS wards following a pharmacist

review of the medication chart and completion of a professional check.

9.6.2 Supply of Non-stock Medicines to non-POMMS wards / departments

The procedure for obtaining supply depends on whether or not the item is needed

specifically for that individual patient use.

9.6.3 Non patient-specific items

A pharmacy non-stock requisition must be completed in the pharmacy (requisition)

order book, which must then be presented to the pharmacy department. Supplies will

be made as a temporary stock supply (i.e. no patient’s name will be added).

This stock should be returned to the pharmacy department when no longer required.

Temporary stock orders received into the pharmacy from non POMMS wards /

departments are not routinely checked by a pharmacist.

9.6.4 Patient specific items

For example: inhaler devices, topical preparations (ointment / creams), eye / ear / nasal

drops and sprays.

A pharmacy non-stock requisition must be completed in the pharmacy (requisition)

order book and presented to the pharmacy department accompanied by the

medication chart. Both the medication chart and requisition must state the patient’s

name, name and strength of the medicine required, device (where appropriate) and

frequency of administration.

A pharmacist must perform a professional check of the requisition and endorse the

medication chart with the date a supply has been made and the quantity issued.

The medicine must be supplied labelled stating the patient’s name and full directions.


POL/MM/0001 V6.1 Page 54 of 113

Medicines supplied as patient specific are intended for individual patient use and must

not be shared with another patient.

Medicines supplied as patient specific must only be issued at discharge against a

discharge prescription.

Patient specific items should not be re-dispensed at discharge if a recent supply has

been made.

9.6.5 Supply of insulin:

For patients requiring pre-filled pens or cartridges on non-POMMS wards or

departments, the pharmacy non-stock requisition must be accompanied by the

medication chart and the insulin chart, signed by the doctor stating the type of insulin

required, device and frequency of administration.

The medicine must be supplied labelled with each pen or pack of cartridges stating the

patient’s name.

9.7 Supply of Medicines to Patients on Discharge

9.7.1 Discharge Medication

All medication specifically required for a patient’s discharge must be supplied by the

pharmacy department against a valid prescription.

Discharge medication must not be supplied from ward or department stocks or

temporary stocks, unless specifically labelled for the purpose of supply to the patient.

Patient’s own medication must be returned to the patient at the point of discharge.

All discharge medication must be stored in a locked cupboard, fridge or controlled drug

cupboard on the ward or department, separated from other medication and readily

identifiable, until the patient is ready for discharge.

Refer to: Going Home Policy POL/NG/0005A

Appendix 3 Guidelines for the use of Patients’ Own Medicines

Appendix 4 Guideline for the Use and Issue of Overlabelled Packs of Medicines

9.7.2 Issue of Pre-packed, Pre-labelled (overlabelled) Medicines to patients For some wards and departments procedures are in place to enable appropriate staff to supply an overlabelled pack of medication to a patient for use on discharge. The container must have been dispensed and labelled by the pharmacy department for the specific purpose. Refer to: Appendix 4 Guideline for the Use and Issue of Overlabelled Packs of Medicines.


POL/MM/0001 V6.1 Page 55 of 113

9.7.3 Handing over medication to patients to take home

When handing over medicines to patients to take home the practitioner has a responsibility

to:

Supply medicines to a patient on discharge via a valid prescription or PGD.

Ensure the prescription is complete, comparing the prescription and the supplied

medicine(s) with the patient’s medication chart.

Ensure that all medicines are collected and reconciled e.g. controlled drugs, fridge

items.

Confirm the patient’s identity.

Check medicines are fully labelled for discharge with legal requirements (patients

name, date supplied, full directions for use and cautionary warnings).

Ensure the patient or carer can open the medicine containers and read the labels.

Check the medication with the patient and ensure their understanding.


9.7.4 Information to be given to patients with discharge medicines

It is the responsibility of the practitioner who discharges the patient from the hospital to

ensure that the patient / carer have received adequate information about their medicines

with regard to:

The name and dose of the medicine

The purpose of the medicine

How to take the medicine

Any side effects they may experience

Any special instructions

How to obtain additional supplies

Information outlined in the patient information leaflet which must be provided whenever

possible


9.8 Using Medicines From Another Service Area

Medicines should not be “borrowed” from another area when a supply can be obtained

from the pharmacy department or the emergency medicines cupboard.


POL/MM/0001 V6.1 Page 56 of 113

When the pharmacy department is closed it is permissible to use medicines (apart

from those listed as exceptions below) from another ward / department. Lists of

individual ward / department stocks are available on the pharmacy department’s

intranet site for reference.

It is not permissible to use Controlled Drugs (Schedules 2 and 3) from another ward /

department except in a case of urgent clinical need. For the process and legislation

associated with using Controlled Drugs from another ward / department refer to the

Controlled Drugs Policy POL/MM/0010 Section 9.2.

High risk medicines or insulin should not be used from another ward / department

except in a case of urgent clinical need or life-threatening situation. The on-call

pharmacist must agree to all such use of high risk medicines.

When it is deemed necessary to use medicines from another ward / department the

complete, original, labelled container supplied by the pharmacy department must be

transferred to the receiving area. Medicines should never be decanted from one

container to another or parts of blister packs supplied to the receiving area.

Practitioners must be vigilant for patterns of “borrowing” medicines that cause concern.

Any issues must be reported directly to a senior member of the pharmacy team for

further investigation.

9.9 Access to the Out of Hours Emergency Drug Cupboard

Access to the cupboard is restricted to times when pharmacy is closed.

Access to the emergency pharmacy stock for in-patients is the responsibility of the site

co-ordinator.

The site co-ordinator must accompany the registered nurse to the cupboard and

ensure a record of the medicines removed is documented.

The medicine required should be removed from the cupboard in an original pack;

packs must not be split.

A record must be made of the patient’s details and the medicine removed from the

cupboard.

In line with approved Trust protocols, community based staff may access the

emergency drug cupboards in specific out of hours situations if palliative medication is

required.

9.10 Verbal Requests for Supplies

The pharmacy department can only accept verbal requests for either stock or non-

stock items in emergency circumstances.


POL/MM/0001 V6.1 Page 57 of 113

If a verbal order from a doctor / nurse in charge is accepted a supply will be made and

the appropriate documentation must be provided within 24 hours.

10 SECURITY AND STORAGE OF MEDICINES

Summary table


POL/MM/0001 V6.1 Page 58 of 113

The following must be stored in a

lockable cupboard which must be kept

locked at all times when not in use:

Controlled drugs

must be stored in an

approved designated

controlled drug (CD)

cabinet/cupboard

Internal and external

medicines

Segregation of internal

and external medicines

must be made if no

separate cupboard is

available

The following should be stored separately:

Intravenous

fluids and

sterile topical

fluids must be

stored securely

out of sight and

reach of patients

and visitors

Large volume

flammable

fluids and

gases must be

stored in a

secure area

away from

sources of direct

heat

Diagnostic

reagents,

disinfectants

and

antiseptics

must be stored

in separate

cupboards or

areas

Fridge items must be

stored in a lockable fridge

(not containing food or

drink) that is kept locked at

all times when not in use.

Maximum & minimum

temperatures should be

recorded as often as

possible (ideally daily).

Patients’ own medicines

suitable for use should be stored

in the individual patient locker or

ward medicines cupboard.

Patients’ own CDs must be

stored in the CD cupboard

Medicines should be received in

lockable/tamper evident security sealed

containers.

Ward/department staff must check medicines on

delivery and report any discrepancy within 24 hours.

(48 hours over bank holidays and weekends)

Medicine trolleys must be supervised when in use and locked and

immobilised by wall or floor anchorage, when not in use.

Medicine keys must be carried by a designated practitioner who is competent

to administer medicines and is assigned to the ward/department (or have a

risk assessed process which restricts access to authorised personnel)

The key to the controlled drug cupboard must be held separately from

other medicine cupboard keys

Following delivery, medicines must not be left

unattended or unsecured in any area

Medicines for clinical emergencies e.g. cardiac arrest must be stored in tamper evident boxes at strategic / accessible sites and be marked "for emergency use"

Receipt of Medicines

Storage of Medicines

Access to medicines

The nurse in charge is responsible for controlling access to the medicine cupboards and trolley

Disposal of Medicine- Refer to Section 12 of Trust Medicine Policy

An audit tool to support teams to identify areas for action to ensure adherence to the Safe and Secure Handling of Medicines requirements outlined in the Trust Medicine Policy is available at:

http://intranet/Directorates/Pharmacy/Pages/default.aspx

http://intranet/Directorates/Pharmacy/Pages/default.aspx


POL/MM/0001 V6.1 Page 59 of 113

10.1 Receipt of medicines

The receipt of medicines describes the formal activities undertaken when medicines

are received by the Trust from any external source or transferred from one location to

another within the organisation.

Medicines are received into wards / departments in response to formal orders.

Medicines transported between wards / departments must be in secure tamper-evident

boxes or bags or be in the custody of a designated person or be delivered via the

pneumatic tube delivery system.

All pharmacy deliveries must be signed for at the point of receipt by persons

authorised to receive orders by the practitioner in charge of the ward / department.

A designated person must check the medicines received against the original order.

This check must confirm compliance with legal and / or local requirements, the product

identity, quantity, quality and that deterioration through inappropriate storage, has not

occurred.

Ward / department staff must check delivery notes that accompany stock issues, upon

receipt and report any discrepancy to the originating source within 24 hours. (48 hours

over bank holidays and weekends).

Refer to: Controlled Drug Policy POL/MM/0010

10.2 Security of medicines in Pharmacy departments

From the time of receipt to issue, all medicines must be stored under secure conditions

within pharmacy controlled stores with access restricted to pharmacy staff and

authorised personnel only.

Access must be controlled via swipe cards / push button codes / key lock at all entries

to the store and the department must be alarmed when closed.

Access to the departments must be restricted to authorised key holders and the alarm

system must be maintained in accordance with standing operating procedures.

10.3 Storage of Medicines within the Pharmacy department

All drugs received into the pharmacy department must be stored in accordance with

their product storage instructions.

Storage conditions for both ambient and refrigerated products must be monitored

continuously to ensure that the product storage instructions are not breached.

The refrigerators / cold rooms must be linked to the hospital Building Management

System (BMS) system which will activate in case of a system breakdown. Out of

normal opening hours, procedures must be in place to deal with such events.


POL/MM/0001 V6.1 Page 60 of 113

10.4 Security of medicines in wards and departments

The practitioner in charge of the ward / department is responsible for the security of

medicines at ward or department level.

All medicines must be stored in separate, locked cupboards, trolleys or other secure

receptacles. This includes medicines for self-medication and discharge.

The only exceptions to this requirement are:

The storage of intravenous fluids and sterile topical fluids which, because of their

bulk, may be stored in a secure clean area

Drugs required for clinical emergencies, which may be held at strategic accessible

sites with appropriate surveillance to prevent unauthorised access

Medicines for clinical emergencies which should be stored securely when the clinic

is not in session

Emergency medication for self-administration by patients e.g. GTN spray or

inhalers, which should be kept out of sight of other patients and visitors, but not

locked away

Cupboards and trolleys should be kept locked and secured when not in use and held

at accessible sites with appropriate surveillance and security to prevent unauthorised

access.

If there is a suspicion of medicine abuse this must be reported to the ward /

department manager and a senior member of the pharmacy department. The stock

balance of suspected medicines should be recorded and regular checking introduced.

If this shows discrepancies further investigation under the guidance of the police

should be considered. If the medicine involved is a controlled drug, the Accountable

Officer for CDs must be informed. Refer to Controlled Drug Policy POL/MM/0010 for

further information.

When a hospital ward / department is closed for a period longer than seven days, all

medicines, including controlled drugs, must be returned to the pharmacy department

for safe and secure storage.

10.5 Storage of Medicines on wards and departments

The practitioner in charge of the ward/department is responsible for the secure storage

of medicines at ward or department level.

All medicines must be stored in locked cupboards, refrigerators, trolleys, medicine

lockers, bags and boxes reserved solely for the storage of medicines.


POL/MM/0001 V6.1 Page 61 of 113

Account must be taken of the manufacturers’ storage instructions and safe practice

recommendations. Medicines must be locked away as soon as they are received from

pharmacy.

Medical gases must be stored in a secure area away from sources of direct heat.

Safety chains or cylinder stands should be used to ensure that non-portable cylinders

are physically safe. Medical gases should be stored in accordance with their product

safety data sheet.

There should be designated storage areas for intravenous fluids, flammable liquids.

Flammable liquids should be stored in accordance with product safety data

information.

Medicine cupboards, refrigerators, trolleys, bags and boxes should be sited in a non-

public area, in a clean utility room with restricted access, or be sited in an area under

constant surveillance by nursing staff. Cupboards should not be sited above or near

radiators or major sources of heat.

Within Trust premises cupboards used for the storage of medicines must comply

with BS2881:1989 “Cupboards used for the Storage of Medicines in Health Care

Premises” i.e. the cupboard must meet the following criteria or otherwise be

approved by pharmacy: Be lockable, Solely for the use of medicines, Fixed in

position on an internal wall

Each ward / department is required to have separate lockable storage cupboards for

medicines for each of the following categories:

Controlled drugs cupboard –contain medicines controlled by the Misuse of

Drugs Act 1971 and other medicines specifically designated by the Trust, e.g.

potassium chloride ampoules

Internal medicines cupboard – to contain preparations for internal administration

excluding controlled drugs

External medicines cupboards or separate area – to contain preparations for

external use (segregation of internal and external medicines should be made if

no separate cupboard is available)

Cupboard for disinfectants and antiseptics

Reagent cupboard or separate area – substances for clinical tests, e.g. urine

testing

Medicine trolley – contains medicines in current use and must be securely

immobilised when not in use

Individual locked cupboards – for patients involved in self-medication

programmes and POMMS (i.e. patient’s own medicines)


POL/MM/0001 V6.1 Page 62 of 113

Drug refrigerator – specifically for the storage of refrigerated medicines

Wards/departments storing intrathecal chemotherapy products must have a dedicated

refrigerator for this purpose only.

In a community setting where services share premises with other clinics or practices,

stocks of medicines for each clinic/practice should be stored separately.

Medicines must not be stored overnight in car boots.

Medicines must never be left unattended in patient or public areas e.g. at the nursing

station or when the patient is absent or incapable of taking their medicines.

Medicines must be kept in their original labelled container (for easier identification).

Pre-filled insulin pens and cartridges should not routinely be kept as stock. Vials

should be stocked routinely, with the exception of paediatrics.

10.6 Storage of substances subject to control of substances hazardous to health

regulation (COSHH)

It is the responsibility of the practitioner in charge to perform an assessment of hazard

and risks of medicines stocked. The manufacturer can supply specific product safety

information.

All flammable liquids and gases should be stored in a metal cabinet.

10.7 Storage of medicines in fridges

Refrigerators being used to store medicines must:

Kept locked and should be sited in a non-public area, in a clean utility room with

restricted access, or be sited in an area under constant surveillance by nursing staff.

Ideally be a refrigerator designed to hold pharmaceutical products, which distribute the

cold air around the whole of the refrigerator (usually assisted by a fan) to ensure an

even temperature. Standard domestic refrigerators should only be used for storage of

medicines if they have been shown to evenly maintain a temperature within the correct

operating temperature, due to variable temperatures on different shelves. ‘Salad

drawers’ in the bottom of refrigerators are usually warmer than the rest of the

refrigerator and use of these for storage of medicines should be avoided.

Maintain a temperature between 2-8ºC at all times. The refrigerator temperature must

be monitored and recorded daily or every day that a ward/department is open for

services that are not open 24 hours a day. See Appendix 5 for Trust Fridge Monitoring

Chart.

The fridge temperature thermometer must be reset after each temperature reading.


POL/MM/0001 V6.1 Page 63 of 113

Be used solely used to store medicines. Do not store non-medicinal products e.g. food

or drink in a medicine fridge.

Have a planned preventative maintenance inspection at least annually.

Ideally be connected to the mains via a fused spur to prevent the fridge from

accidentally being switched off or at the very least the electricity socket must be clearly

labelled with a ‘Do Not Switch Off’ sticker.

Remedial action must be taken if the temperature falls out of range or the refrigerator

malfunctions.

Refer to: Appendix 5 for the Guideline for the Management of Refrigerated Medicines

10.8 Medicine Keys

Medicine keys and safe keeping of the medicine cupboards are the responsibility of

the practitioner in charge of the ward / department.

Medicine keys must remain on the hospital ward / department at all times and must be

carried by a designated practitioner who is competent to administer medicines and is

assigned to the ward / department.

In situations where a number of authorised practitioners require access to the

medicine cupboards at different times a secure system must be agreed locally.

On each ward / department the keys for the medicine cupboard and medicines

refrigerator should be on one key ring reserved solely for these keys. The keys must

be kept by the authorised staff only.

The key to the controlled drugs cupboard must be held separately from other keys

used in the service (it may be held in a secure key cabinet with restricted access) and

remains the responsibility of the practitioner in charge of the ward / department at all

times.

In community settings arrangements should be made for a spare set of keys to be

securely stored and held where they can be easily accessed in an emergency.

Keys must not be given to any unauthorised person, e.g. nurses or staff not assigned

to the ward / department and medical staff or other personnel.

Pharmacists, pharmacy technicians and pharmacy assistants may have access to the

keys in the course of their duties.

Registered theatre practitioners may, under the delegation of the practitioner in charge

have access to medicines cupboards and hold the keys providing the anaesthetist

remains responsible for all supplies made from the cupboards.


POL/MM/0001 V6.1 Page 64 of 113

10.8.1 Loss of medicine keys

The practitioner in charge must ensure that the keys are kept secure and are available

as necessary to staff running the service and that staff going off duty do not remove

the keys from the service.

If keys are removed from the service every effort must be made to retrieve them from

off duty staff. Should access to the medicine cupboard be required before the keys are

retrieved the practitioner in charge must be informed and a duplicate set of keys may

be obtained.

If keys to drug cupboards are out of possession of the ward / department for an

extended period of time and there is no duplicate set of keys, the practitioner in charge

should consider the advisability of changing the locks to the drug cupboards. If there

is any concern regarding the security of the keys the locks must be changed. The

Trust Chief Pharmacist should be informed on the next working day and a safeguard

incident report should be completed in these circumstances.

11 TRANSFER AND TRANSPORT OF MEDICINES

11.1 Transport of Patients’ Medicines in the Community

In all circumstances medication for a specific patient should be prescribed. If it is the

intention that a community nurse is to administer the drug to a housebound patient

then the drug must be dispensed either by a community pharmacy, dispensing practice

or hospital pharmacy. It must be appropriately labelled with the patients name and

directions for use (as well as all other standard labelling requirements).

Under most circumstances it would be anticipated that arrangements should be made

for the patient, carer or relative to collect the medication or that the pharmacy deliver it

to the patient.

In exceptional circumstances it is possible for the community nurse to collect the

medications on the patient’s behalf and transport the medicine in their car (as per NMC

guidance Standards for Medicines Management Section 3, Standard 7:

Transportation). However this must not be routine practice.

Exceptional circumstances are at the discretion of the community nurse who must

take into account the patient’s circumstances as well as professional and

organisational considerations

Patient Group Direction medication: A flu vaccine is not the patient’s property and is

instead a stock drug being administered to a pre-identified group of patients as

opposed to a medication required for an individual. Therefore, standard operating

procedures apply and the flu vaccine can be transported from appropriate medication

stocks.


POL/MM/0001 V6.1 Page 65 of 113

11.2 Transfer of medicines between CDDFT sites using contract taxi services

Refer to: Appendix 6 Guideline for the Transfer of medicines using the CDDFT Contract Taxi

Service

11.3 Transfer of patients’ medicines on handover between care settings

When a patient is transferred ward to ward, ward to service or to another care

provider, robust systems for handover or transfer are the responsibility of both the

healthcare professionals issuing and receiving the medication, to ensure that accurate

and complete communication of information accompanies the transfer and that patient

safety is not compromised and the audit trail is maintained.

The current medication chart and current medication specifically prescribed for the

patient must be transferred.

No controlled drugs are to be transferred unless they are the patient’s own drugs.

Ward / department stock drugs can be transferred if a supply cannot be obtained

directly from the pharmacy during normal working hours.

Medicines should be transferred securely in a sealed bag or box.

If there is a significant allergy the next team caring for the patient must be made aware

of the potential risk.

The responsible nurse on the receiving ward / department must check the medicines

against the patient’s medication chart.

Refer to: Going Home Policy POL/NG/0005A, Clinical Handover of Care on Transfer Policy

POL/NG/0005B

12 DISPOSAL OF MEDICINES

12.1 General Principles for the Disposal of Medicines

Medicinal waste must be destroyed in accordance with approved Trust policies and

guidelines.

Medicinal waste includes expired, unused, split and contaminated pharmaceutical

products, drugs and vaccines that are no longer required. This also includes discarded

items from use in the handling of pharmaceuticals, such as bottle or boxes with

residues, gloves, masks, connecting tubing, syringe bodies and drug vials.

Medicines requiring disposal should be segregated and placed into a dedicated

medicinal waste container. Empty medicine containers e.g. ampoules, vials,


POL/MM/0001 V6.1 Page 66 of 113

discharged syringes and giving sets must be disposed of by placing into either a

medicinal sharps container or a dedicated medicinal waste container.

For the purpose of the Hazardous Waste Regulations, medicinal waste is classified

into two categories:

1) cytotoxic and cytostatic medicines

2) medicines other than those classified as cytotoxic and cytostatic

All cytotoxic and cytostatic medicines must be disposed of in Trust approved purple

lidded sealed boxes. If in doubt about whether a medicine is hazardous advice must

be sought from the pharmacy department or the waste collector.

Other medicinal waste must be placed in the Trust approved medicinal waste

containers.

Medicinal liquids should be placed in leak proof approved containers. Liquids medicine

containers must have the lids secured and wrapped if necessary to prevent leakage

before placing into the designated waste bin.

Medicines and hazardous substances must not be placed in household waste, down

sinks or flushed into the sewage system.

Medicines must be placed in the waste container in its original package when this is

available. Blister packs can be removed from their outer container if in doing so the

handler does not come into contact with the medicines. However, the emptying of

bottles, for example is not allowed, except for controlled drugs which must be

destroyed in line with guidelines outlined in the Controlled Drug Policy POL/MM/0010.

Waste containers must not be over filled. Once the bin is full to the indicated line, it

must be sealed and collected by either a porter or waste contractor.

Once waste containers are sealed they must be signed, dated and labelled with the

relevant premises’ name.

Medicinal waste must only be collected by the Trust’s approved waste contractor.

Replacement medicinal waste containers are available to order from Cardea.

The Pharmacy Department must follow the approved Standard Operating Procedures

and guidelines for waste disposal.

12.2 Disposal of Medicines in Acute Settings

In addition to the principles outlined above:


POL/MM/0001 V6.1 Page 67 of 113

Medicines which are no longer required, expired or no longer fit for their intended use

must be returned to the pharmacy department for disposal except for schedule 2 and 3

controlled drugs which must be destroyed in line with guidelines outlined in the

Controlled Drug Policy POL/MM/0010. Additional requirements apply for

radiopharmaceuticals or blood products and appropriate advice must be sought from

the relevant department.

Medicines should be returned to the pharmacy department in their original containers.

Medicines must only be returned via a recognised secure route (i.e. via porters or

pharmacy staff). Medicines should be returned in a locked box or tamper evident bag.

Nominally empty medicine containers, all part-used infusion or injection containers

(including those for cytotoxic medicines) and anything which may be contaminated

with blood or body fluids must be disposed of on the ward / department in line with

Trust guidelines.

12.3 Disposal of Medicines in Community Settings

In addition to the principles outlined above:

Stock medicines which are past their expiry date or unsuitable for use due to damage,

breakages, inadequate labelling etc. should be disposed of on the premises in the

appropriate medicinal waste container (Exceptions to this are controlled drugs,

radiopharmaceuticals or blood products for which additional requirements apply and

patients’ own drugs which the patient refuses to surrender).

12.4 Disposal of date expired stock

The practitioner in charge is responsible for checking expiry dates of medicines on

their designated ward/department on a monthly basis with the exception of controlled

drug expiry dates which must be checked on a daily basis.

Date expired medicines must be returned to the pharmacy department for destruction

except for schedule 2 and 3 controlled drugs which must be destroyed in line with

guidelines outlined in the Controlled Drug Policy POL/MM/0010.

Expiry dates explained:

Date on box Actual expiry date

Use by Dec 15 01.12.15

Exp. Dec 15 31.12.15

Use before Dec 15 30.11.15


POL/MM/0001 V6.1 Page 68 of 113

12.5 Disposal of Patients Own Medicines

Refer to: Appendix 3 Guidelines for the use of Patients’ Own Medicines

Trust Waste Policy POL/NCRM/0004

Controlled Drugs Policy POL/MM/0010

13 COMPANY REPRESENTATIVES

Unplanned visits from company representatives are unacceptable.

Samples, clinical trial material or any other medicine (including interactive dressings)

must not be left by company representatives in wards / departments. Medicines must

only be supplied to wards / departments by the pharmacy department. This is

essential to ensure an appropriate audit trail exists and to ensure that all medicines are

assessed by the appropriate body, before use in the Trust.

As part of ensuring high rates of adherence, some departments will be permitted on a

department by department basis to issues samples. This must be agreed with a

member of the Pharmacy Leadership Team, and is only appropriate where patient

preference is a significant factor in maintaining adherence, e.g. emollients in

Dermatology.

Refer to: Procedure for Non-Trust Personnel Undertaking Clinical Associated Business on

Trust Premises PRO/NG/0001

14 CONTROLLED STATIONERY AND FP10S

14.1 General Principles for the Management of Controlled Stationery

Controlled Drug order books, Controlled Drug registers, FP10 prescription pads, FP10 blank prescription sheets and ward non-stock order books are examples of controlled stationery.

Controlled stationery must be stored and secured appropriately in the ward, department or by the individual non-medical prescriber. They must be stored in a locked drawer or cupboard when not in use and must not be left unattended at any time.

Prescribers who work for more than one employer must have separate FP10 prescription pads for each organisation, printed with the correct organisation details in the prescriber details area of the FP10 prescription.

The ward or department manager must ensure an up to date signature list of individuals authorised to order and / or collect controlled stationery on behalf of their designated ward or department is registered with the pharmacy department.

http://intranet/sites/policiesandprocedures/Published%20Documents/Procedure%20for%20Non-Trust%20Personnel%20Undertaking%20Clinical%20Associated%20Business%20on%20Trust%20Premises.pdf



POL/MM/0001 V6.1 Page 69 of 113

The pharmacy department must follow the pharmacy standard operating procedures for controlled stationery management.

The safe handling and security of controlled stationery is the responsibility of the individual prescriber or practitioner in charge of the individual ward or department.

Refer to: Appendix 8 Management of FP10 Prescriptions

15 MEDICATION ERRORS

If a medication error is observed or discovered, then immediate action must be taken to

ensure the safety of the patient and / or staff.

All medicines related incidents must be managed according to the principles which are

outlined in the CDDFT Incident Management Policy (POL/N&G/0001). Appendix 5 of the

Incident Management Policy offers additional information to support the management of

medication related incidents.

15.1 Process for Reporting Medication Errors

A Safeguard incident report should be completed for medication incidents as detailed

in the Trust Incident Management Policy POL/N&G/0001. This should be completed

online by the person who discovered the medication error.

The patient and / or carer should be informed where appropriate in line with the Trust

‘Being Open’ Policy and in accordance with the statutory duty of candour requirements

for organisations registered with the Care Quality Commission.

The line manager receiving the Safeguard incident report must ensure further

investigation or action in line with Trust policies, if required, when alerted to the

Safeguard incident.

Refer to: Trust Incident Management Policy POL/N&G/0001

Supporting Staff Involved in potentially traumatic stressful work related incidents Guideline for staff and managers GUID/N&G/0003

Being Open Policy POL/N&G/0009

15.2 Process for Learning from medication incidents

Individuals identified as being directly involved in the incident should undertake

reflective learning.

Key issues highlighted from root cause analyses carried out in line with Trust policies

should be shared at team and organisational level where appropriate.


POL/MM/0001 V6.1 Page 70 of 113

Themes identified from analysis of Trust wide incidents should be communicated via

Trust bulletins.

Key issues should be shared by regular reports at Trust Safety Committee and Care

Group Governance Groups.

16 DEFINITIONS

16.1 Staff Definitions

Accountable Officer

An officer or employee of the designated health care body, who is responsible for a range of

measures relating to the monitoring of the safe use and management of Controlled Drugs in

their organisation as required by Controlled Drugs (Supervision and Management of Use)

Regulations 2006.

Authorised Pharmacy Staff

Any qualified CDDFT pharmacist, pharmacy technician or pharmacy support worker

authorised by the Trust Chief Pharmacist as competent and appropriate to perform a specific

medicines related activity.

Independent Prescriber

A practitioner who is responsible and accountable for the assessment of patients with

undiagnosed or diagnosed conditions and for decisions about the clinical management

required including prescribing who can prescribe any medication available from the NHS,

within their area of competence.

Medical or Dental Practitioner

Any doctor or dentist registered to practice in the UK as an independent prescriber.

Non-Medical Prescriber

Non-medical prescribers are specially trained nurses, optometrists, pharmacists,

physiotherapists, podiatrists and radiographers, working within their clinical competence as

either independent and/or supplementary prescribers.

Refer to the Non-Medical Prescribing Policy POL/MM/0008.

Non-medical independent prescriber

There are two distinct forms:

i. A non-medical independent prescriber is a specially trained and registered health

professional (at the time of writing the policy this could only be a nurse, pharmacist or


POL/MM/0001 V6.1 Page 71 of 113

optometrist) who can prescribe any licensed medicine within the limits of their clinical

competence. Nurse and pharmacist independent prescribers can also prescribe

unlicensed medicines and controlled drugs. Non-medical independent prescribers are

also able to act as supplementary prescribers (see 3.1.9).

ii. A Community Practitioner Nurse Prescriber (CPNP) can independently prescribe from

a limited formulary called the Nurse Prescribers’ Formulary for Community

Practitioners, which can be found in the British National Formulary (BNF).

Practitioner

Throughout this policy, the term "practitioner" is used. This is a general term used to

describe a qualified medical practitioner, nurse, pharmacist or other authorised healthcare

employee. (See Section 4 for the responsibilities of these staff members).

Practitioner in training

An individual practitioner undertaking relevant training who must always act under

appropriate supervision until deemed to be proficient in specific medicine related activities.

The supervising practitioner has responsibility for specified medicines related procedures

undertaken by practitioners in training.

Supplementary Prescriber

A supplementary prescriber is a is a specially trained and registered health professional (at

the time of writing the policy this could only be a nurse, optometrist, pharmacist,

physiotherapist, podiatrist or radiographer) who prescribes via a voluntary partnership

arrangement with a doctor or dentist independent prescriber, the patient’s agreement and

within the limits of an agreed patient-specific clinical management plan (CMP).

16.2 Process Definitions

Administration

Administration is to give a medicine by introduction into the body, (e.g. orally, rectally, by

inhalation or by injection) or by external application (e.g. cream or ointment).

Controlled Stationery

Controlled stationery is all stationery, which in the wrong hands, could be used to obtain

medicines fraudulently. Examples include prescriptions, CD registers and order books and

non-stock requisition order books.

Dispense

The definition of dispense is “to label from stock and supply a clinically appropriate medicine

to a patient/client/carer, usually against a written prescription, for self-administration or

administration by another professional, and to advise on safe and effective use.” (MHRA

2006). The act of dispensing includes the supply process but also encompasses a number of


POL/MM/0001 V6.1 Page 72 of 113

other cognitive functions (e.g. checking the validity of the prescription, the appropriateness of

the medicines for an individual patient, assembly of the product). These functions are usually

performed under the supervision of a pharmacist.

Electronic Prescribing and Medicines Administration System (ePMA)

An electronic prescribing and recording system designed to replicate and enhance the

functions of a traditional paper-based prescription chart. Digital signatures are used to record

both prescribing and administration of medicines, and a full audit trail of changes is

recorded.

Medicine

A medicine is any substance or combination of substances presented for treating or

preventing disease whose primary mode of action is pharmacological, metabolic or

immunological. Any substance or combination of substances may be administered with a

view to making a medical diagnosis or restoring, correcting or modifying physiological or

psychological functions.

Medication Chart

This term refers to any chart used in any CDDFT setting which is used to prescribe and /or

record the administration of medication, i.e. medicines administration chart, medication

chart, drug kardex, drugs chart.

Medicines Management

Medicines management (MM) is a system of processes and behaviours that determines how

medicines are used by the NHS and patients.

Medicine Reconciliation

Medicine reconciliation is a process designed to ensure that all medication a patient is

currently taking is correctly documented on admission and at each transfer of care.

Overlabelling

Overlabelling is defined as the placing of a label onto a procured medicinal product either

onto the primary packaging (for example in the case of dropper bottles or cream/ointment

tubes), the secondary packaging (for example the box surrounding blister strip packaged

tablets) or sometime on both, depending on the local requirements. No other operation is

undertaken to manipulate the medicinal product in any other way.

Patient Group Direction (PGD)

A PGD is defined as the written instruction for the supply and/or administration of medicines

to groups of patients who may not be individually identified before presentation for treatment.

A PGD must be produced by doctors, pharmacists and other professionals within CDDFT

and formally approved by the Clinical Standards and Therapeutics Committee.


POL/MM/0001 V6.1 Page 73 of 113

Patient Specific Direction

A Patient Specific Direction is the traditional written instruction, from a doctor; dentist or

other independent prescriber, for a medicine to be supplied or administered to a named

patient after the prescriber has assessed that patient on an individual basis.

Patients Orientated Medicine Management Scheme (POMMS)

Patient Orientated Medicines Management Service (POMMS) is a whole system approach to

medicines management for hospital patients. It is focussed on the needs of the patient and

combines the inpatient supply with the discharge medication to individual patients.

Prescribe

To prescribe is to authorise in writing, the supply and/or administration of a medicine.

Prescription

A prescription is a written order for the supply or administration of a medicinal product and

must only be written by an authorised prescriber for an individual who is a patient of the

Trust.

Supply

In this policy, the term “supply” refers to the provision of a medicine directly to a patient or

carer for administration.

16.3 Medicine Categories

Medicines whether for internal or external use covered by this policy include the following:

Controlled Drug (CD)

A number of medicines and other substances are liable to be misused. These are controlled

by the Misuse of Drugs Act 1971 and Regulations and are termed ‘Controlled Drugs’. Refer

to the Controlled Drug Policy (POL/MM/0010) which covers all aspects of the management

of controlled drugs in the Trust and must be read in conjunction with this policy.

Prescription Only Medicine (POM)

A POM medicine is a medicine that is generally subject to the restriction of requiring a

prescription written by an appropriate practitioner before it can be supplied.

Pharmacy Only Medicine (P)

A Pharmacy only medicine is a medicinal product that can be sold from a registered

pharmacy premises by a pharmacist or person acting under the supervision of a pharmacist.


POL/MM/0001 V6.1 Page 74 of 113

General Sales List medicine (GSL)

GSL medicines are those that can be sold in registered pharmacies but also in other retail

outlets.

Other medicines and medicinal products

This category of medicines includes a range of medicines and medicinal products prepared

for administration to patients, that are controlled by the Medicines Act 1968 and includes

products such as diagnostic agents, X-Ray contrast agents and medical gases.

Complementary Medicines

Complementary medicines refer to a group of medicines that are not generally considered as

part of conventional medicine and include herbal or homeopathic remedies. These products

are used for therapeutic purposes and require the same safeguards as other medicines.

Other pharmaceutical preparations

This category of medicines includes chemicals or medical devices used by podiatrists,

chiropodists and other practitioners in the course of their practice.

17 DISSEMINATION / TRAINING ARRANGEMENTS

The updated policy will be cascaded via the Trust Medicines Management Bulletin.

Attendance at Essential Training is recorded by Workforce and Organisational

Development and entered onto the Trust Training Management System, OLM.

Monitoring of non-attendance will be in line with the Training Needs Analysis,

Monitoring and Evaluation Policy and carried out by Workforce and Organisational

Development. Please refer to this policy for detailed information.

Line managers are responsible for ensuring all staff are up to date with training as part

of their personal development. This is accessed via the training needs analysis for

each area held within P&OD. Records of training are maintained and monitored by

Workforce and Organisational Development.

All staff involved in the handling of medicines must be appropriately trained with regard

to safety and security of medicines and with regard to safeguarding themselves and

those under their supervision from any risks posed by products (e.g. cytotoxic

medicines).

Personnel whose duties may expose them to risk (e.g. portering staff, drivers, and

those carrying medicines in the community) should be trained to understand the need

for safety, security and standard operating procedures. This should include instruction

on the action to be taken in the event of a physical threat or spillage.


POL/MM/0001 V6.1 Page 75 of 113

18 MONITORING

18.1.1 Compliance and Effectiveness Monitoring

Monitoring Criterion Response

Who will perform the monitoring?

Safety Committee.

What are you monitoring? Medicines usage within the Trust is in line with all aspects of this policy.

When will the monitoring be performed?

Monthly - analysis of reported incidents and report to Safety Committee.

Review of Medicines Management domain of ward Quality Metrics programme.

Annual - Safe and Secure Handling of Medicines eAudit.

How are you going to monitor?

Thematic and analytical review of all reported medication incidents, including specific monitoring of the accuracy of prescribing on medication charts.

Results from the medication chart audit will be reviewed by the Lead Pharmacist for Performance and Safety who will report any concerns to Head of Service, Chief Pharmacist and Clinical Standards and Therapeutics Committee.

Results of the Safe and Secure Handling of Medicines eAudit will be reviewed by the Pharmacy Performance, Safety and Quality Team who will report outcomes and concerns to Head of Service, Chief Pharmacist, Care Group Governance Meetings and Safety Committee.

What will happen if any shortfalls are identified?

Action Plans will be produced and deadlines agreed to address any shortfalls.

Where will the results of the monitoring be reported?

As detailed above and including escalation to Quality Healthcare Governance Committee as necessary.

How will the resulting action plan be progressed and monitored?

Action plans will be monitored at Care Groups Governance Meetings and Safety Committee.

How will learning take place?

Outcomes will be shared via: the pharmacy intranet page, Trust intranet, e-mail forum, education opportunity, changes in practice, re-audit, Pharmacy and Medicines Management Bulletin.

In addition to the monitoring outlined in the table above, attendance at Essential Training is

recorded by Workforce and Organisational Development and entered onto the Trust Training

Management System, OLM. Monitoring of non-attendance will be in line with the Training

Needs Analysis, Monitoring and Evaluation Policy and carried out by Workforce and

Organisational Development. Please refer to this policy for detailed information.


POL/MM/0001 V6.1 Page 76 of 113

19 REFERENCES

Great Britain (1972) Medicines Act 1968 (as amended)

Great Britain Health Act 2006 and associated regulations

Great Britain (1984) The Misuse of Drugs Act 1971

Great Britain (2001) The Misuse of Drugs Regulations 2001 SI No 3998

Great Britain (1973). Misuse of Drugs (Safe Custody) Regulations 1973 [SI 1973 No 798]

Controlled Drugs (Supervision of Management and Use) Regulations 2006 (S1 2006 No 3148)

Great Britain (1999) Control of Substances Hazardous to Health (COSHH) Regulations 1999. The Stationery Office, London.

GMC : Good Practice in Prescribing and Managing Medicines and Devices (2013)

NMC standards for Medicines Management 2010

Implementation of Medicines for Human Use (miscellaneous Amendments) order 2010 – Midwives Exemption List

The Safe and secure handling of medicines: a team approach. A revision of the Duthie Report (1988) Royal Pharmaceutical Society of Great Britain March 2005

Royal Pharmaceutical Society: Medicines, Ethics and Practice: A Guide for Pharmacists.

Medicines and Healthcare Products Regulatory Agency (MHRA) Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 (Also known as "The Orange Guide")

MDA/2004/001 - Reporting Adverse Incidents and disseminating Medical Device Alerts. Medicines and Healthcare Products Regulatory Agency www.mhra.gov.uk

Medicines Matters: A guide to mechanisms for the prescribing, supply and administration of medicines July 2006 Department of Health Core Prescribing Group

Medicines and Healthcare Products Regulatory Agency (2014) Guidance Note 14: The supply of unlicensed medicinal products (‘specials’)

20 ASSOCIATED DOCUMENTATION This policy refers to the following CDDFT policies and procedures:

Administration of insulin to adults by Health Care Assistants in community services Policy POL/CHS/0060

Antibiotic Formulary

Being open Policy POL/N&G/0009

Clinical Handover of Care on Transfer Policy POL/NG/0005B

Clinical Record Keeping & Healthcare Records Management Policy POL/NQ/0005

Clinical Trials Policy POL/MM/0004

Consent to Examination or Treatment Policy POL/N&Q/0004

Controlled Drug Policy POL/MM/0010

Going Home Policy POL/NG/0005A

Incident Management Policy POL/N&G/0001


Medicines Requiring Loading Doses Policy POL/MM/0007

Non-Medical Prescribing Policy POL/MM/0008

Outpatient Medication Supply Policy POL/MM/0017

Patient Group Direction (PGD) Policy POL/MM/0009



POL/MM/0001 V6.1 Page 77 of 113

Pharmacy Staff electronic Prescribing and Medicines Administration (ePMA) Transcribing and Enablement Policy POL/MM/0018

Policy and guidance notes for staff on The Mental Capacity Act 2005 POL/N&Q/0051

Procedure for Non-Trust Personnel Undertaking Clinical Associated Business on Trust Premises PRO/NG/0001

Self-Administration of Medicines Policy POL/MM/0013

Supporting staff involved in a potentially traumatic stressful work related incident GUID/N&G/0003

Waste Policy POL/NCRM/0004 This Policy is referenced by the following CDDFT policies and procedures:

Controlled Drug Policy POL/MM/0010

Clinical Handover of Care on Transfer Policy POL/NG/0005B

Going Home Policy POL/NG/0005A


Outpatient Medication Supply Policy POL/MM/0017

Patient Group Direction (PGD) Policy POL/MM/0004


Pharmacy Staff electronic Prescribing and Medicines Administration (ePMA) Transcribing and Enablement Policy POL/MM/0018

Policy for the Management and Development of Policy and Guidance Documents POL/CA/0001

Resuscitation and Do Not Attempt Cardio Pulmonary Resuscitation Policy POL/NQ/0017

Training Needs Analysis, Monitoring & Evaluation Policy POL/PD/0053




POL/MM/0001 V6.1 Page 78 of 113

APPENDIX 1 – MIDWIVES EXEMPTIONS LIST 2011

Drug Name Use Route NMC advice for professional practice

Adrenaline 1:1000 Adult IM For use in anaphylaxis only

Anti-D immunoglobulin

Adult IM For antenatal and postnatal use to protect against haemolytic disease of the newborn

Carboprost Adult IM No particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage.

Treatment combinations for postpartum haemorrhage might include:

repeat bolus of oxytocin (intravenous)

ergometrine (intramuscular or cautiously intravenously)

intramuscular oxytocin with ergometrine (Syntometrine)

oxytocin infusion (Syntocinon)

carboprost (intramuscular)

Cyclizine Lactate Adult IM For management of actual or potential nausea and vomiting

Diamorphine Adult IM Diamorphine hydrochloride for pain relief in labour. May not be administered by a student midwife

Ergometrine Maleate

Adult IM/IV IV use with caution – risk of hypertension No particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage.

See carboprost for treatment combinations for postpartum haemorrhage

Gelofusine Adult IV For maternal resuscitation

Hartmann’s solution

Adult IV For maternal resuscitation

Lidocaine Adult SC/IM For use as a local anaesthetic

Lidocaine Hydrochloride

Adult SC/IM For use as a local anaesthetic

Morphine Adult IM Morphine sulphate for pain relief in labour. May not be administered by a student midwife

Naloxone Hydrochloride

Adult IM For reversal of respiratory depression resulting from opioid administration

Oxytocins, natural and synthetic

Adult IM/IV For active management of the third stage of labour and treatment of postpartum haemorrhage.

No particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage.

See carboprost for treatment combinations for


POL/MM/0001 V6.1 Page 79 of 113

postpartum haemorrhage

Pethidine Hydrochloride

Adult IM For pain relief in labour May not be administered by a student midwife

Prochlorperazine Adult IM For management of actual or potential nausea and vomiting

Sodium Chloride 0.9%

Adult IV For maternal resuscitation and IV flush

NEONATES

Hepatitis B Vaccine Neonate IM For use in protection against Hepatitis B

Hepatitis B Immunoglobulin

Neonate IM For use in protection against Hepatitis B

Naloxone Hydrochloride

Neonate IM For reversal of respiratory depression resulting from opioid administration to mother

Phytomenadione Neonate IM Prophylactic use to prevent vitamin K deficiency bleeding (haemorrhagic disease of the newborn)


POL/MM/0001 V6.1 Page 80 of 113

APPENDIX 2 - PRESCRIBING, SUPPLY AND USE OF

UNLICENSED MEDICINES

In most cases medicines prescribed and used within the Trust will hold a marketing

authorisation (MA) or product licence (PL) granted by the Medicines and Healthcare

products Regulatory Agency (MHRA) or European Agency for the Evaluation of Medicinal

Products (EMEA). This ensures that manufacture, storage and distribution conform to

agreed international standards and that when used for the purpose for which marketing

authorisation has been granted that clinical benefits outweigh any risks.

For good clinical reasons it is often necessary to prescribe a medication which does not hold

a product licence (unlicensed use) or to prescribe a medication outside the approved

marketing authorisation (off-label use). It is essential that such practice continues in order to

provide the best care for patients. However, it is necessary that prescribers, pharmacists

and nurses are aware of the increased risk and medico-legal implications associated with

the use of unlicensed medication. This appendix describes the correct use of unlicensed

medicinal products within County Durham and Darlington NHS Foundation Trust and sets

out the responsibilities of Pharmacists, Prescribers and nursing staff.

The purpose of this appendix is to ensure that appropriate systems for the procurement,

assessment and use of unlicensed medicines are in place in order to reduce the risk posed

to patients, prescribers, nursing staff and pharmacists from their use.

Before an unlicensed medicine is prescribed for the first time its use should be

approved by the Clinical Standards and Therapeutics Committee (CSTC) as specified

in the Medicines Policy section 5.11. Where urgent use is required this must be

discussed with the Chair or Vice-Chair for CSTC.

Where such systems have been applied in accordance with this appendix, County Durham

and Darlington NHS Foundation Trust will accept liability for the use of medicines that do not

have UK marketing authorizations granted by the MHRA or EMEA. In all other situations,

where unlicensed medications are used without express approval of the Trust as set out in

this appendix and associated protocols and procedures, liability for harm will rest with the

individual prescriber and pharmacist involved.

This guidance covers:

Medicines prepared by a UK manufacturer but not on sale in this country. Such

products may be awaiting a product licence, may have never had a product licence or

the product licence may have been abandoned, revoked or not renewed.

Products manufactured from licensed medications such as liquid formulations where

only a solid dosage form holds a licence. For example; low dose- formulations for

children.

Out-sourced aseptic products. For example; dose banded cytotoxic medicines and

supplemented Total Parenteral Nutrition (TPN).


POL/MM/0001 V6.1 Page 81 of 113

Products manufactured by companies or NHS manufacturing units holding a ‘specials’

licence.

Products supplied as part of a formal compassionate use or expanded access

programme

Products which are licensed but not for the intended route of administration

The appendix does not cover:

‘Off label use’ This is defined as the use of a licensed medication for an indication

other than that included in the marketing authorisation but by a licenced route of

administration. The crushing of tablets to ease administration in a patient with

swallowing difficulties and the administration of a licenced preparation by an

unlicensed route.

Products supplied as part of clinical trial. The use and supply of investigational

Medicinal Products are covered by the Clinical Trials Policy.

Extemporaneously prepared products manufactured for a specific patient under the

supervision of a pharmacist in accordance with section 10 of the Medicines act 1968

Unlicensed homeopathic or herbal remedies.

Prescriber Responsibilities

Unlicensed medicines must only be used where a special clinical need exists. Such use

must be informed and guided by a respectable and responsible body of professional opinion.

Their use must be clearly justified and clinical benefits must be considered to outweigh the

risks involved.

Unlicensed medicinal products must only be used when no pharmaceutically equivalent

licensed product or suitable alternative licensed product is available for use at the time the

patient requires it.

The existence of a ‘special need’ relates to clinical criteria. It does not relate to reasons of

cost, convenience or operational needs.

Prescribers of unlicensed products are responsible for and professionally accountable

for their actions; in the case of adverse events they may be called upon to justify their

actions.

Prescribing of some unlicensed medicines may be restricted to consultant only

prescribing on the decision of the Clinical Standards & Therapeutics Committee.

The prescriber must ensure:

The use of the unlicensed medicine is justified by the clinical condition of the patient.

Other prescribers who may be required to authorise or initiate treatment are familiar

with the status of the medicine and are familiar with relevant protocols associated with

its use.

Compliance with Trust policy relating to informed patient consent.

Complete and accurate records are kept.


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All medication incidents relating to the unlicensed medicine are recorded and reported

via the yellow card scheme and the Trust’s incident reporting scheme.

When responsibility for on-going care is to be transferred to the patient’s general

practitioner, that the general practitioner (GP) is informed of the unlicensed status of

the medicine and that he or she is willing to accept clinical and legal responsibility for

prescribing.

That appropriate arrangements are in place for continuing treatment if the GP is

unable to accept responsibility for continuing care of the patient.

That the patient understands the implications of using the unlicensed medicine.

Pharmacy Responsibilities

It is not unusual for several pharmacy staff to be involved in the decision making process

pertaining to the procurement and supply of an unlicensed medicine from the clinical

pharmacist who receives the request through to the person who signs the order or

authorises the invoice.

The Deputy Trust Chief Pharmacist is designated as having overall responsibility for:

Ensuring that written procedures to cover all aspects of the procurement and issue of

unlicensed medicines are produced, authorised, and reviewed.

Ensuring that the pharmacy department has in place an adequate system to ensure

the quality of unlicensed medicines. Each product must be subject to a risk

assessment.

Ensuring that arrangements are in place to ensure that prescribers are aware of the

unlicensed status and accept responsibility for use of the unlicensed medicine.

Ensuring that arrangements are in place to make sure that unlicensed medicines are

used only when an equivalent licensed product is unavailable.

Monitoring and auditing the handling of unlicensed medicines in the pharmacy

department.

Monitoring the range and quantities of unlicensed medicines purchased, keeping a list

of unlicensed medicines currently approved by the Trust.

Reporting to the Clinical Standards and Therapeutics Committee the use of unlicensed

medicines in the Trust.

Ensuring that submissions are made to the Clinical Standards and Therapeutics

Committee for approval to use unlicensed medicines that have not previously been

used in the Trust.

Preparing specifications for unlicensed medicines in conjunction with Quality Control

Northern Region.

Procurement

Pharmacy staff involved in procurement of unlicensed medicines are responsible for:

Ensuring that the person making the request is authorised to do so.


POL/MM/0001 V6.1 Page 83 of 113

Ensuring that purchases of unlicensed medicines are in accordance with locally

approved protocols and procedures.

Liaising with the supplier as appropriate.

Ensuring any special requirements of suppliers are met.

Processing deliveries in accordance with locally approved protocols and procedures.

Ensuring correct storage arrangements including, where appropriate, placing in

quarantine unlicensed medicines received within the Trust from non-NHS suppliers

until the appropriate assessment is carried out in accordance with locally approved

protocols and procedures.

All clinical pharmacists are responsible for:

Taking steps to ensure that the use of an unlicensed medicine is justified by the clinical

circumstances and clarifying and challenging the use of an unlicensed medicine where

appropriate.

Ensuring that no appropriate licensed alternative product is available.

Referring a prescription to an appropriate specialist senior clinical pharmacist (band 8a

or above) where a product is being requested for the first time or where otherwise

necessary.

Ensuring that the prescriber is made fully aware of the clinical and legal implications of

using the selected medicine.

In addition to the points listed above, senior clinical pharmacists are responsible for:

Assessing the evidence and challenging use when an unlicensed medicine is to be

ordered for the first time in order to ensure that the use of an unlicensed medicine is

justified.

Authorising new products for use that are needed for urgent clinical use before they

can be formally assessed and approved by the Clinical Standards and Therapeutic

Committee.

Communicating with the MHRA and the prescriber any reports of adverse reactions.

Inspecting the packaging and labelling of unlicensed medicines and assessing

certificates of analysis on receipt of unlicensed medicines from non-NHS suppliers.

Dispensing

Pharmacy staff involved in the dispensing of unlicensed medicines are responsible for:

Ensuring that requests for unlicensed medicines are processed in accordance with

Trust procedures.

Where appropriate, communicating with patients with regard to the implications of

using the unlicensed medicine.

If appropriate, making arrangements for patients to have continuing supplies of

treatment.

Where the use of an unlicensed medicine has been approved by CDDFT Clinical

Standards and Therapeutic Committee and sourced in accordance with this policy and


POL/MM/0001 V6.1 Page 84 of 113

accompanying locally approved protocols and procedures, CDDFT will assume liability

for the use of the product.

The prescribing of an unlicensed medicine may only take place in order to meet the special

needs of an individual patient. An unlicensed medicinal product must not be prescribed

where an equivalent licensed medicinal product can meet the special needs of the patient.

An unlicensed medicinal product may not be prescribed on the basis of cost or other non-

clinical considerations. ‘Special needs’ refers to the special clinical needs of the patient The

responsibility for determining whether a special need exists rests with the independent

prescriber.

The prescriber must be made aware of the unlicensed nature of a product. Where the

prescription has not been prescribed via ePMA, the clinical pharmacist carrying out the

clinical check of that prescription must ensure that the prescriber is aware of the unlicensed

nature of the product. Where the product has been prescribed using ePMA the system will

notify the prescriber at the point of prescribing.

Risk Assessment

Before purchasing for the first time the unlicensed product must be assessed for clinical and

pharmaceutical appropriateness in accordance with locally approved protocols and

procedures.

The purchasing pharmacist must satisfy themself that the product has been risk assessed

and that the manufacturer/source is appropriate prior to signing the purchase order. Where

an alternative source for an unlicensed medicine is used the procurement team must ensure

that a new risk assessment is carried out and bring this to the attention of the procuring

pharmacist.

Each product must be subject to a risk assessment. Unlicensed medicines will be assessed

as per locally approved procedures and placed into higher (category 1) and lower (category

2) risk bands.

The risk assessment will comprise 2 elements: A clinical risk assessment based on the risk

of harm to the patient from the medicine itself and a procurement risk assessment based on

the MHRA hierarchy for the use of unlicensed medicines.

Category 1: Unlicensed Medicines

a. Labelled in a foreign language.

b. Imported from countries outside the UK. This includes countries of mutual recognition

and within the EU for patient safety reasons as labelling and clinical information

translation may be required.

c. “One-off” medicines procured from NHS units holding a Specials Manufacturing

licence or other UK Specials licence holder, i.e. not batch produced.

d. Medicines licensed for use in animals.


POL/MM/0001 V6.1 Page 85 of 113

e. Out sourced aseptically manufactured products e.g. dose banded cytotoxic medicines

and supplemented total parenteral nutrition.

f. Unlicensed medicines that do not fit the category 2 criteria.

Category 2: Unlicensed Medicines

This group of unlicensed medicines consists of a range of medicines that meet all of the

following criteria:

a. Batch produced non-injectable medicines procured from NHS units holding a

“Specials” manufacturing licence, or other UK Specials licence holders.

b. Are considered to be of a suitable pharmaceutical quality.

c. Have a good clinical safety record, for example drugs that are included in the current

British National Formulary (BNF) or BNF for children excluding medicines that are

subsequently withdrawn on the grounds of safety.

Quality Assurance / Quality Control

Orders for unlicensed medicines from non-NHS suppliers must include a request for a

Certificate of Analysis.

Procurement of unlicensed medicines must be carried out following locally approved

procedures which have been developed in line with Regional Guidance and the hierarchy

described in MHRA Guidance Note 14.

The country of origin must be determined. For countries outside the EU or for those without

a mutual recognition agreement, Quality Control Northern Region must be contacted for

advice.

The language used on the packaging must be determined along with details of who will

supply the translation of the patient information leaflet and label.

An assessment of the supply chain must be carried out, and the ease with which further

supplies can be obtained. The cost of the drug and any special funding needs must be

determined. Responsibility for continued supply must be identified.

The assessment process should take into account any issues raised by Quality Control

Northern Region.

Receipt

Upon receipt, the medicines will be placed in quarantine. The unlicensed medicine and

associated documentation must be formally checked and any testing deemed necessary

carried out before it is released for use by an appropriate senior pharmacist.

Quality Assurance

The Trust Deputy Chief Pharmacist must liaise with contacts at Quality Control Northern

Region (QCNR) in:


POL/MM/0001 V6.1 Page 86 of 113

Ensuring samples of high risk products are sent to QCNR for testing where appropriate

and discussing with QCNR any deficiencies in supplied Certificates of Analysis.

Discussing with QCNR the information available from manufacturers on the purchasing

specifications.

Checking for the availability of a purchasing specification.

Storage

Unlicensed Medicines must be stored within specific area(s) within the pharmacy store

which are clearly designated to staff as the unlicensed medicines storage area(s).

Record Keeping

Receipt Records

On receipt of unlicensed medicines into the pharmacy, staff must ensure that the following is

included and where necessary added to the delivery note:

Product Description

Order No

Date received

Quantity received

Supplier Name

Batch No.

Expiry date

Confirmation of receipt of Certificate of Analysis

Purchasing information and certificates of conformity will be retained in the pharmacy for 5

years.

Issue Records

Category 1 unlicensed medicines will only be issued to a specific patient - see Medicines

Policy section 9.6.4. Records of issue to whom, quantity and batch number will be recorded

on the pharmacy ASCribe system and retained for 5 years. Where items are issued as

overlabelled stock from clinical areas, it is the responsibility of that area to record the name

of the patient and the batch number of the medication. This must be held for a period of at

least 5 years.

Pharmacy staff issuing unlicensed medicines must ensure that they are labelled clearly in

English and that the users have adequate information in English to use them properly.

Problems associated with the use of an unlicensed medicine (e.g. product defects, problems

with labelling/instructions) must be reported promptly to the hospital pharmacy. Adverse drug

reactions should be reported to the MHRA using the yellow card scheme as detailed in

section 8 of the Trust Medicine Policy.


POL/MM/0001 V6.1 Page 87 of 113

APPENDIX 3 - GUIDELINES FOR THE USE OF PATIENT’S

OWN MEDICINES

Introduction and general principles

These guidelines must be read in conjunction with the CDDFT Self Administration of Medicines Policy POL/MM/0013

Patients are encouraged to bring in their own medicines into hospital on admission. This helps compile an accurate medication history as well as allowing these medicines to be used for the patient throughout the inpatient stay, where appropriate.

All medicines brought into hospital by patients remain their own property and should not be destroyed or otherwise disposed of without their agreement or, if this is not possible, the agreement of their relative or carer. A patient’s own medication must not be used for administration to another patient.

Patients own medicines may continue to be used in hospital, with the patient’s permission. Therefore, it is important to ensure that any patients’ own medicines that are used have been properly assessed, since many may no longer be appropriate or suitable.

All medicines brought into hospital by patients including prescribed, over the counter, herbal and homeopathic remedies must be reviewed by the admitting doctor who may or may not wish to prescribe them.

Any patients’ own medicine including prescribed, homeopathic, herbal or over the counter medication must be written on the patients medication chart before it can be administered.

All controlled drugs brought into hospital by patients must be recorded in a controlled drugs register and stored in the controlled drug cupboard. Records must be made of any administration, returns to the patient or destruction of the controlled drug.

If at any time the controlled drug is administered during the inpatient stay, returned to the patient or transferred to another ward or department, a record must be made in the normal manner in the respective register.

Assessment of Patient’s Own Medicines for Administration

Before a patient’s own medicine can be used for administration in hospital it must be checked by a registered healthcare practitioner via the algorithm below and formally assessed as suitable for use.

If a medicine is returned to the patient it must be clearly marked to indicate whether this is still their current medication and suitable for use.

For each item available as “patients own”, the medication chart should be marked ‘POD’.

Re-labelling of Patient’s Own Medicines by Pharmacy Teams

Medicines may be relabelled at the ward pharmacist’s discretion if:

unlabelled medicines have an expiry date and can be positively identified.

the directions have changed. Any new label should be positioned so that the name and address of the original supplier when present, remains visible. The label should state “patients’ own relabelled” to signify re-labelling.

Storage of Patient’s Own Medicines

Patients’ own medicines suitable for use should be stored in the individual patient locker or ward medicines cupboard. Exceptions include inhalers and Glyceryl Trinitrate sprays, which may be kept out of sight in the patient’s bedside locker.

Patients’ own controlled drugs are not suitable for storage in the individual patient lockers. These should be stored in the ward controlled drug cupboard in the usual manner and returned on discharge if suitable.

On discharge or transfer, the patient’s own medicines must be either returned to the patient or transferred to the receiving ward or department. The individual patient’s locker must be checked to ensure that all medicines for that patient have been removed before the bed is occupied by another patient.


POL/MM/0001 V6.1 Page 88 of 113

Transfer of Patients own medicines

Patients own medicines must be transferred with the patient to the receiving ward. Controlled drugs must be transferred securely and a record made in the controlled drug register.

Destruction of Patient’s Own Medicines

Medicines brought from home are the patient’s own property. Consent for their destruction must be obtained. Consent can be made verbally and documented in the patients notes.

If a patient disagrees to the destruction of their medicines then they should be returned to the patient on discharge or sent home prior to this with a relative. Patients should be advised that continued possession and use is medically inadvisable. The risk of use of medicines which are of an unsatisfactory quality should be clearly stated.

Patient’s own medicines for disposal in hospital may be returned to the pharmacy department after consent from the patient is obtained. Patient identifiable labels must have the patient’s name made illegible or the label removed and disposed of in a confidential waste bin before the container is disposed of.

Community based patients should be instructed to return patients own medicines to a community pharmacy for destruction. Community based patients should also be directed to return ‘sharps bins’ to their GP for safe disposal or use arrangements made through their local authority for collection of clinical waste.

Staff in community settings must only remove from the premises or dispose of a patient’s own medicine in exceptional circumstances. A record should be made and signed by a witness. In some circumstances if a second healthcare professional is unavailable, a patient or their representative may be a suitable witness. For controlled drugs see separate guidance.

Patient own medicines for destruction must be destroyed according to Trust procedures.

Discharge using patients own drugs

Patients’ own medicines can be reissued on discharge. They MUST be:

Checked against the discharge summary to ensure that there have been no further changes i.e. that none of the medicines have been discontinued or that the label directions have been changed.

Checked to ensure there are sufficient supplies of the medicine. If there is less than 7 days remaining, or an insufficient quantity, a fresh supply should be made. The patient may also have further supplies at home.

All patients’ own medicines suitable for reissue should be returned to the patient.

Discharge prescriptions generated via iSOFT should be marked as ‘POD no supply” where appropriate prior to the prescription being sent to Pharmacy.

The patient’s locker must be checked to ensure all medicines have been returned or removed.

Safekeeping of Patient’s Own Medicines by Community Teams

Community Teams do not routinely retain patients own medicines.

In the event that these are kept, for example, when it is deemed unsafe to leave these in the patients home, these must be recorded, assessed, stored and destroyed as detailed above.

Patients own drugs must never be left overnight in staff cars.


POL/MM/0001 V6.1 Page 89 of 113

ASSESSMENT OF PATIENTS OWN MEDICINES FOR USE IN AN INPATIENT SETTING

Dispensed by a pharmacy or bought over the counter (OTC)?

Is the medicine in the original container (or dispensed container)?

Are the label, container & medicine in good condition?

Are all the medicines in the package the same?

The patient’s name on the label is the same as the patient?

(NOTE: does not apply to OTC meds)

Is it in date or, if expiry not available has it been dispensed in the last 3

months?

If tablets or capsules are in a bottle are they easily identifiable by their

colour or markings?

Medicine is safe to use

Do not

use

If the medication is a liquid, is the seal still intact?

If the medication is an eye drop / ointment was it opened in the last

28 days?

Yes

Medication Compliance Aids (MCA)

(e.g. Medidose, Dossette box etc.).

If the patient has brought an MCA

which has been dispensed by a

pharmacy then, medicines can be used

if they are easily identifiable and not

available from another source at the

required time.

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No

No

If the medicine is usually stored in the fridge, is it stable when

stored out of a fridge for 28 days (check with pharmacy if

unsure)?

AND

Has it been dispensed in the last 28 days?

Yes

No


POL/MM/0001 V6.1 Page 90 of 113

APPENDIX 4 - GUIDELINE FOR THE USE AND ISSUE OF

OVERLABELLED PACKS OF MEDICINES

Introduction

A limited range of overlabelled packs of medicines are available for use in specific ward / clinic areas. These are primarily issued at the point of discharge against a valid prescription to avoid unnecessary delays for the patient, but may also be used for administration to some patients during their inpatient stay. Overlabelled packs are also available in Urgent Care Centres and Emergency Departments to provide immediately necessary medicines for supply against a prescription or to supply against a valid Patient Group Direction (PGD). Overlabelled Medication

Medicinal products may be overlabelled under the supervision of a pharmacist for use within the same corporate body.

Overlabelling is defined as the placing of a label onto a licensed medicinal product, either onto the primary packaging (for example in the case of dropper bottles or cream and ointment tubes), the secondary packaging (for example the box surrounding blister strip packaged tablets) or onto both, depending on the local requirements. No other operation is undertaken to manipulate the licensed medicinal product in any other way.

Overlabelling of procured “specials” may also take place provided the requirements in Appendix 2 are adhered to.

Overlabelling operations are undertaken in anticipation of a prescription.

Overlabelled medications are over labelled in such a way that they satisfy most of the legal labelling requirements. However the person supplying will need to complete the following on the label to satisfy the legal requirements: Dosing directions and frequency in line with a valid prescription The patients name The date of supply

Supply of overlabelled packs on discharge, out of hours or in community settings

1. Overlabelled packs can be issued against an accurate and complete discharge prescription / electronic discharge letter (EDL), an FP10 prescription (out of hours or in community settings), a pre-printed prescription or a PGD. Overlabelled packs cannot be supplied against an in-patient medication chart at point of discharge.

2. Obtain a pharmacy copy of the electronic discharge letter (EDL), FP10 or pre-printed prescription. This form must be signed by an appropriate prescriber. This is not necessary if supplying against a PGD.

3. Select the appropriate overlabelled pack from the designated overlabelled cupboard. 4. Ensure the dose and frequency on the overlabelled pack match those documented on

the prescription or in the PGD. Pre-printed directions on overlabelled packs must NOT be changed. If a different dose or direction is required then a discharge prescription should be sent to pharmacy (during opening hours) or an FP10 issued by an appropriate prescriber. Please be aware that F1 doctors cannot legally write FP10 prescriptions.

5. Add the patients name and date of issue to the label and complete the dosing information (where necessary).

6. Annotate the prescription (or patient record if supplying against a PGD) to show which medications have been supplied as overlabelled packs.

7. Where possible, obtain a second check on the overlabelled pack from a qualified


POL/MM/0001 V6.1 Page 91 of 113

nurse, doctor, pharmacist or pharmacy technician and ask them to countersign the overlabelled pack log sheet. The check should include the drug name, strength, dose, quantity, expiry date, directions, patient name and date of issue.

8. Fill in all details required in the overlabelled pack issue log which should be kept in or near the overlabelled cupboard. The details required include date of issue, patient name/CRN, overlabelled pack issued, quantity issued and signatures of both issuing and checking health professional. Computer records (with appropriate PGD issue Read codes) in an urgent care centre, replace the need for the issue log.

9. Place the prescription in the overlabelled cupboard to allow stocks to be reconciled and replenished, unless supplying against a PGD.

10. If an overlabelled pack has been previously supplied for in-patient use then it is not necessary for the issue details to be recorded again on the overlabelled log sheet. All other process outlined in this section are to be followed.

11. Issue the medication to the patient and counsel appropriately.

Patient Information

A patient information leaflet (PIL) must always be supplied for any medicines to take home. It is good practice to also supply a PIL for drugs immediately administered, but this is not a legal requirement. If the PIL is not available with the product then these can be printed from www.medicines.org.uk.

All relevant patient information advice including the information in the “Patient Advice” section of the PGD (where appropriate) must be communicated to the patient. This may include advice such as the disposal of excess medicines (e.g. 3 days trimethoprim from a box of 14 tablets).

Details regarding the following should be communicated to the patient: The name and dose of the medicine The purpose of the medicine How to take the medicine Any side effects they may experience Any special instructions How to obtain additional supplies Storage and disposal of the medicine

Storage and replenishment of overlabelled packs

Overlabelled packs must be stored in a locked designated drug cupboard.

On acute hospital sites, overlabelled packs can only be replenished by the pharmacy staff as part of the ward top up, against a correctly completed overlabelled pack issue log.

In all other areas, a designated person(s) must reconcile the prescriptions with the overlabelled pack issue log on a regular basis. Any discrepancies must be highlighted to and addressed by the manager.

Replacements should be ordered on a pharmacy stock list or pharmacy (requisition) stock order form and sent to the appropriate pharmacy department with the prescriptions attached.

In areas supplying overlabelled packs against a PGD, the department should undertake regular audit as per the Patient Group Direction Policy POL/MM/0009. The audit should take into account usage of overlabelled packs against computer records or other records if computer systems are not in place.


POL/MM/0001 V6.1 Page 92 of 113

OVERLABELLED PACK ISSUE LOG

All issues of overlabelled packs must be logged below

Date Patient identifier/CRN

Prepack supplied Quantity Supply made against Issued by Checked by M

ed

icin

e

Ch

art

PG

D

Dis

charg

e

Pre

scrip

tion

or E

DL

FP

10

< Trust Medicine Policy >

POL/MM/0001 V6.1 Page 93 of 113

APPENDIX 5 - GUIDELINES FOR THE MANAGEMENT OF

REFRIGERATED MEDICINES

Introduction

A number of medicines are temperature sensitive and require storage in refrigerated conditions between (2-8ºC).

Storage of these medicines at too hot or too cold a temperature can cause degradation of the active ingredient resulting in a loss of clinical effectiveness.

Freezing of vials and ampoules can also cause hairline cracks (too small to see with the naked eye) in the glass which can lead to loss of sterility of injectable medicines.

Efficacy of vaccines and other medicines depends on maintaining the cold chain, which is a prescribed temperature range during distribution from manufacturer to the point of use. Inadequate temperature control during storage and transport of vaccines can reduce this efficacy and render the vaccine or medicine more susceptible to loss of potency.

A medicine’s licence may be affected if the medicine is stored outside of its recommended temperature range.

Medicine Refrigerators

A) Minimum Refrigeration Controls

Refrigerators used to store medicines must be used solely for that purpose. Do not store non- medicinal products e.g. food or drink in a medicine fridge.

Medicine refrigerators must be kept locked and should be sited in a non-public area, in a clean utility room with restricted access, or be sited in an area under constant surveillance by nursing staff.

Refrigerators used to store medicines must maintain a temperature between 2-8ºC at all times.

Refrigerators should ideally have built in thermometers.

Refrigerators must have a planned preventative maintenance inspection at least annually.

Refrigerators should ideally be connected to the mains via a fused spur to prevent the fridge from accidentally being switched off. At the very least the electricity socket must be clearly labelled with a ‘Do Not Switch Off’ sticker.

Pharmaceutical refrigerators are designed to distribute the cold air around the whole of the refrigerator (usually assisted by a fan) to ensure an even temperature and should be used where possible.

Standard domestic refrigerators tend to have variable temperatures on different shelves and should not be routinely used for storage of medicines. Standard refrigerators may only be used if they have been shown to evenly maintain a temperature within the correct operating temperature. ‘Salad drawers’ in the bottom of refrigerators are usually warmer than the rest of the refrigerator and use of these for storage of medicines should be avoided.

Medicine refrigerators do not generally require defrosting. If defrosting is necessary:

Refrigerators should be defrosted according to manufacturer's instructions on a regular basis, at least annually and recorded on the fridge temperature record log o An alternative refrigerator or insulated container(s) should be used for medicine

storage during defrosting of refrigerators to ensure that the temperature of the medicines does not go outside the special range

When ready for re-use after defrosting: o Turn the refrigerator on o Reset the maximum / minimum thermometer


POL/MM/0001 V6.1 Page 94 of 113

o When the temperature reaches between 2ºC and 6ºC replace the medicines (2ºC and 4ºC if also storing polio).

o Reset the maximum / minimum thermometer and recheck the temperature after 30 minutes to ensure the refrigerator is working correctly.

B) Monitoring and review of refrigerator temperatures

A designated person/deputy should be identified on each ward/department that will be responsible for ensuring these guidelines are followed and standards for safe and effective storage and / or distribution are maintained.

The names of the responsible persons should be clearly displayed on the refrigerator door or log.

The designated persons must be competent in reading and resetting a maximum and minimum thermometer, and in recognising the importance of maintaining the cold chain.

Refrigerators storing medicines must be checked on a daily basis, or every day that a ward/department is open for services that are not open 24 hours a day, to record maximum, minimum and current temperatures.

If using a maximum/minimum thermometer this should be placed on the middle shelf in refrigerators where vaccines are stored, irrespective of whether the refrigerator incorporates a temperature indicator dial.

Use of air temperature as a recording will provide a more sensitive alert to problems with a refrigerator and so should be the normal method used to monitor refrigerators with CDDFT.

The temperature must be recorded on a fridge temperature monitoring chart (see later).

A record of any action taken following a deviation in temperature must be clearly documented on the monitoring chart.

The method of recording the temperature may vary according to a number of factors: o Will the refrigerator alarm if it becomes too hot or cold? o Will the refrigerator alarm if it is accidentally switched off? o Is the area staffed 24 hours per day, if not who would hear the alarm? o Is a remote alarm needed? o Is the stock holding in the refrigerator necessary or could it be rationalised and

are there sufficient safeguards in place (such as alarms) taking into account the financial value and business critical nature of the stock?

A continuous data logger may help to mitigate the risk if a refrigerator falls out of specification for a short period of time, as the period of time will be known; unlike a daily log where it may be necessary to assume the refrigerator has been fault for 24 hours. Advice can be sought from the pharmacy department.

The Safe and Secure Handling of Medicines e-Audit must be completed annually by all wards and departments holding refrigerated medicines stock.

C) Actions to be taken when responding to deviations in refrigerator temperatures

All staff should be aware that they must inform the manager in charge or a designated person on the ward or department, immediately if a refrigerator temperature falls out of recommended range. The person in charge will be expected to address the following: If inside the range of 2 - 8ºC and it is possible to reconnect the power supply, no further action is required. Record the maximum / minimum temperature reached and the time and date the failure occurred, including the actions taken. If outside the range 2 - 8ºC, if possible reconnect the power supply, taking note of the time at which the supply was reconnected. Record the maximum / minimum temperature reached and the time and date the failure occurred, including the actions taken. If outside the range and it is not possible to reconnect the power supply:

Record the maximum / minimum temperature reached and the time / date failure occurred.

Promptly re-locate the medicines to an alternative working refrigerator, keeping them


POL/MM/0001 V6.1 Page 95 of 113

separate from the contents of the latter and taking care not to over-load the working refrigerator.

Ensure particular care is taken to ensure re-located medicines cannot be mistaken for unaffected stock. It is recommended that re-located medicines are stored in a container(s) sealed with tape and marked not to be used until it is confirmed that it is suitable for use.

Record details of the medicines, brands and strengths and seek advice from pharmacy. In some cases shorter expiry periods may be necessary and pharmacy will advise on how this should be achieved.

If transferring to another refrigerator is not possible, then keep the door of the malfunctioning refrigerator closed and keep regular checks on the temperature of the refrigerator.

Contact Estates Department to arrange an urgent repair.

Contact the pharmacy department during normal working hours to establish whether the affected stock can still be used.

Contact the On Call duty pharmacist via the switchboard if advice or replacement stock is urgently required outside of normal working hours.

Document details of any stock that has been destroyed and actions taken

Complete a safeguard incident report.

When ready for re-use after the fault has been rectified, or using a replacement refrigerator: o Turn the refrigerator on o Reset the maximum / minimum thermometer o When the temperature reaches between 2ºC and 6ºC replace the medicines (2ºC

and 4ºC if also storing polio). o Reset the maximum/minimum thermometer and recheck the temperature after 30

minutes to ensure the refrigerator is working correctly.

Management of Refrigerated Medicines and Vaccines on Wards and Departments

A) Transportation of refrigerated medicines from pharmacy

The temperature during transport should be kept at 2-8 ºC for all medicines and vaccines, (2ºC and 4ºC for storing polio [see manufacturer's information]).

Transport containers from pharmacy will indicate that an item requiring refrigeration is enclosed by the addition of a yellow ‘fridge’ sticker.

It is of crucial importance that appropriate procedures are instituted and monitored to ensure that for efficient and cost effective vaccination programmes a correct cold chain is operative for the storage and transport of vaccines.

Where it is necessary to transport cold chain medicines advice should be sought from the pharmacy department.

Cold chain medicines being returned to pharmacy must be stored at the correct temperature. Therefore, these must be handed directly to a member of pharmacy staff at the storage site, rather than sent via the porter or driver delivery system. Cold chain items received by pharmacy other than via this route will not be reused and will be destroyed.

B) Receipt and storage of refrigerated medicines and vaccines

On receipt:

All refrigerated medicines must be checked against the order upon receipt and examined for leakage or other damage, then immediately placed under the required storage conditions.

The date and time at which vaccines are received should be entered into a vaccine log, along with the time the vaccine spent outside a refrigerator.

Storage:

The principles for the storage of refrigerated medicines as detailed in section A should be followed. In addition: o Vaccines should be stored on the middle and upper shelves in the refrigerator,


POL/MM/0001 V6.1 Page 96 of 113

allowing air to circulate around the packages. They should not be stored on the shelves or in storage compartments of the refrigerator door. The door must not be left open and door opening should be kept to a minimum.

o Vaccines must always be stored according to the manufacturers' recommendations and must not be frozen. Vaccines that are frozen (below 0ºC) will be inactivated and must be discarded. Frozen ampoules of liquid diluents can develop hairline cracks on thawing resulting in loss of sterility and must therefore also be discarded.

C) Dispatch of vaccines between clinics in community settings

Vaccines should be assembled immediately prior to despatch.

Prior to removing vaccines from the fridge for transportation or use, check that correct vaccine storage conditions have been observed.

Remove only the quantity of vaccine required for the immunisation session.

The date and time of assembly of vaccine should be recorded on the vaccine log.

Recommended cool boxes or insulated containers must be used to transport vaccines to the vaccination session.

Cool boxes and cool packs should be stored either in a cold room or a refrigerator overnight before use. Commercial, not domestic, cool packs should be used. The use of frozen ice packs should be avoided if at all possible and should only be used in cool boxes designed to keep these from touching the vaccines.

Vaccines can be packed in plastic containers to prevent contact. Insulating filler material should be used to fill spaces in incomplete loads. At satellite clinics if a refrigerator is not available, the vaccines must remain in the closed cool box until they are required.

Use and disposal of vaccines in community clinic settings

Remove the minimum amount of vaccine necessary from the refrigerator or cool box at a time.

Always check identity, colour and expiry date of vaccines before use.

Reconstitute vaccines in accordance with the manufacturer's instructions and once reconstituted; use within the period specified by the manufacturer.

Record the date of immunisation, vaccine administered, batch number and expiry date of vaccine and diluent in the patient's notes.

At the end of each session, opened ampoules and vials and unused vaccines and diluents that have been removed from the refrigerator or cool box, should all be placed in a sharps container for incineration.

At the end of a session, unused vaccines and diluents that have not been removed from the cool box should be returned ON THE SAME DAY to the refrigerator and marked 'USE FIRST'. Such vaccines should not be recycled in this way for a second time but discarded into a sharps container for incineration.

Expired vaccines should be discarded into a sharps container for incineration.

All adverse reactions to vaccines must be reported so that any link between batches can be investigated. Report Adverse Drug Reactions using the Yellow Card system and safeguard reporting system.

Details to be included in a vaccine log in community settings

Order details

vaccine name

vaccine concentration

number of doses per vial

number of vials Receipt of order

date of receipt

time of receipt

time vaccine spent out of the refrigerator (hours / minutes)


POL/MM/0001 V6.1 Page 97 of 113

signature Assembly of vaccines for immunisation session

date

time

signature

vaccine name



number of vials

batch numbers Return of vaccines from immunisation session

date

time

signature

vaccine name



number of vials

batch numbers


POL/MM/0001 V6.1 Page 98 of 113

REFRIGERATOR TEMPERATURE MONITORING CHART

TEMPERATURE RANGE MUST BE BETWEEN 2 °C and 8 °C If temperature is outside of this range please report immediately to manager in charge or service lead Designated Lead / Deputy ………………………………………………………………….. Fridge Location: ……………………………………………………………………………. Month: …………………………… Year: ……………………………..

Date Current Temp

Max Temp

Min Temp

Temp Reset (√)

Action taken if outside range (if applicable)

Signature

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31


POL/MM/0001 V6.1 Page 99 of 113

APPENDIX 6 - TRANSFER OF MEDICINES USING THE

CDDFT CONTRACT TAXI SERVICE

Introduction

The contract taxi service is an approved Trust service and must be used in the event a taxi is required to transport urgent medicines. The taxi drivers carry identity badges and are authorised to conduct Trust business.

Transfer of medicines by taxi carries a number of risks, and must be avoided wherever possible by appropriate advance planning and the use of scheduled transport arrangements. When a taxi is required the request should be in line with the CDDFT taxi request procedure (see later).

These guidelines apply to the transfer of urgent medicines, including Controlled Drugs, using the contract taxi service in the following situations: o Transfer of medicines between NHS sites o Transfer of medicines from CDDFT NHS sites to relevant NHS or non NHS sites o Transfer of medicines from NHS sites to patient’s homes.

Transfer of medicines from pharmacy by the contract taxi service is covered by Standard Operating Procedures.

Taxi Request Procedure

All requests for a taxi should be made via the Travel Desk at DMH, extension 43764, 08.00am–16.30pm Monday – Friday (excluding Bank Holidays). At all other times requests should be made via the DMH Switchboard to ensure that ONLY CDDFT contracted taxis are used.

If the drugs are extremely urgent the member of staff requesting the order should explain this to the travel desk/switchboard to ensure that the most appropriate taxi company is used to expedite the transfer.

Callers must advise of the exact location for pick-up/drop-off, item to be carried, any special circumstances, contact name and number and highlight if a specific time is required.

During normal pharmacy opening times, if a taxi is required due to a pharmacy failure to meet scheduled deliveries then the appropriate pharmacy department must organise transport.

A) Requesting Medicines

Excluding Controlled Drugs: 1) Requests to transfer medicines using the taxi service must be made by suitably

qualified member of staff to suitably qualified member of staff. 2) A qualified member of staff from the requesting site must complete a signed order / ward

requisition clearly identifying the name, form, strength and quantity of the medicine to be transferred.

Including Controlled Drugs - In addition to the conditions specified above: 3) Transfers between sites of Controlled Drugs held as ward/dept stock must be

authorised by the Site Co-Ordinator, the pharmacy department or on-call pharmacist. 4) A Controlled Drug order or prescription must be faxed / delivered as appropriate.

B) Transferring Medicines


POL/MM/0001 V6.1 Page 100 of 113

Excluding Controlled Drugs 1) No member of staff must transfer medicines to another site unless they have received a

signed order / signed requisition form from the requesting site. 2) The qualified member of staff transferring the medicine must select the medicine and

ensure it is sealed in an appropriate bag or container and be tamper evident. 3) The qualified member of staff transferring the medicine must complete all sections of the

‘Emergency Medicine Supply Taxi Transfer’ Form (see later) and ensure that the taxi driver signs to confirm acceptance of the package and understands the delivery instructions.

4) The taxi driver must show their staff badge and confirm their identity with the member of staff requesting the taxi and transferring the medicine.

5) The ‘Emergency Medicine Supply Taxi Transfer’ Form must be photocopied and the photocopy given to the driver with the medicine. The original copy of this form must be retained by the transferring ward/dept. and filed according to procedure.

6) The member of staff handing over the medicine must be convinced that the taxi driver is genuine. If in any way concerned, medicines must not be handed over and advice should be sought from a manager and/or DMH travel desk or switchboard.

7) The taxi driver must be given explicit instructions regarding delivery. Medicines must only be given to an identified member of staff at the requesting site and not left unattended at any time. Ensure the taxi driver understands what to do in the event the medicine is not delivered.

Including Controlled Drugs - In addition to the conditions specified above: 8) Transfers of CDs must be recorded in the CD Register prior to transfer and on receipt. 9) The registered healthcare professional transferring the Controlled Drug must annotate the

Controlled Drug order book as ‘collected by taxi’ next to ‘accepted for delivery. 10) The original top copy of the Controlled Drug order must be retained as normal and the bag

containing the Controlled Drug sealed so ensure tamper evident. 11) The taxi driver must not be told this is a Controlled Drug but must be given explicit

instructions regarding delivery of the package i.e. the medicine must only be given to an identified member of staff at the requesting site and must not be left unattended at any time.

C) Receipt of Medicines

Excluding Controlled Drugs 1) On delivery, the taxi driver must obtain a signature for receipt of the medicine on the

‘Emergency Medicine Supply Taxi Transfer’ Form by a suitably qualified member of staff (e.g. sister, staff nurse, member of pharmacy staff etc.).

2) The Emergency Medicine Supply Taxi Transfer’ Form must be photocopied and a copy of the form returned to the supplying individual / ward or department either by fax or post within 24 hours of receipt.

3) The qualified staff member must phone the area that supplied the medicines to confirm receipt. If receipt of the medicine cannot be confirmed then an investigation must be carried out to locate the missing medicine.

4) If confirmation is not received by the transferring individual/ward or dept., action must be taken to determine if the medicines have actually been received.

5) Any discrepancies with the received order or if the order fails to arrive must be reported immediately to the transferring individual/ ward or dept. so an investigation may begin.

6) A Safeguard Incident Report must be completed in the event of missing medicine. Out of hours the on call pharmacist must be informed.

7) The ‘Emergency Medicine Supply Taxi Transfer’ Form must be retained within the transferring ward/dept. for 3 months.

Including Controlled Drugs - In addition to the conditions specified above: 8) A qualified staff member must open and check that the received Controlled Drug is correct

and sign for receipt of the Controlled Drug on the copy of the ‘Emergency Medicine Supply Taxi Transfer’ Form.

9) The ‘Emergency Medicine Supply Taxi Transfer’ Form must be photocopied and a copy of the form returned to the supplying individual / ward or dept. either by fax or post within 24


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hours of receipt. 10) The transferring individual/ ward or dept. must be phoned to confirm receipt of the

Controlled Drug with the named individual who made the transfer. 11) Any discrepancies with the received CD or if the order fails to arrive must be reported

immediately to the pharmacy department so an investigation may begin. The on call pharmacist and site co-ordinator must be informed out of working hours.

12) A Safeguard Incident Report must be completed in the event of a missing CD.


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EMERGENCY MEDICINE SUPPLY TAXI TRANSFER FORM A COPY OF THIS FORM MUST BE SUPPLIED WITH THE MEDICINE

TO BE COMPLETED BY INDIVIDUAL FROM SITE / WARD TRANSFERRING THE

MEDICINE

Medicine to be delivered to: Individual/ Ward / Department …………………………. ……… Hospital/Site ……………………………….. Address……………………………………………………………………………………………………………………..

Medicine transferred by: (Signature) …………………………………………. Print Name …………………………………………………….. Ward/Dept ………………………………. Date ………….………………. Time………………..

TO BE COMPLETED BY CDDFT CONTRACT TAXI DRIVER:

Medicine collected by: (Taxi Driver’s Signature) ……………………………. Print Name ……………….…………………………..……. Driver ID number…………………………………….. Vehicle Registration Number……………………………… Date …………………………. Time ……………………………………………

PLEASE DO NOT LEAVE THIS DELIVERY UNATTENDED. If YOU ARE UNABLE TO DELIVER THIS MEDICINE – RETURN TO THE REQUESTING WARD/DEPT. DURING WORKING HOURS.

CONTACT HOSPITAL SWITCHBOARD IF UNABLE TO RETURN.

TO BE COMPLETED BY INDIVIDUAL FROM SITE/ WARD RECEIVING MEDICINE:

Medicine received by: (Signature) …………………………………………. Print Name …………………………………… Ward/Dept ………………………………. Date ………….………………. Time…………………..

FOR ALL MEDICINES (including Controlled Drugs)

CDDFT Contract Taxi Services must be used.

This form must be signed and returned to the transferring individual either by fax or mail within 24 hours of receipt.

In Addition, FOR Controlled Drugs:

On receipt of the Controlled Drug, phone the transferring site to confirm receipt of the Controlled Drug with the individual named above who made the transfer.


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APPENDIX 7 - CARE PLAN FOR COVERT MEDICATION

Problem Patient refusing medication but does not have the capacity to make an informed, appropriate decision about medication. Need To administer covert medication in the best interests of the patient. (This must be in line with NMC guidelines, mental capacity act, local policy and duty of care implications i.e. if the patient does not have capacity and there are risks to the patient if medication is omitted then the nurse has a duty of care to ensure medication is administered). Capacity If the patient refuses medication, the registered nurse must check if the patient is making an informed / appropriate decision about refusing medication (i.e. if they have capacity). For example ask:

Why they are refusing?

Is it specific to one type of medication or is it all medication?

What they think they are taking the medication for?

What will happen if they don’t take the medication?

Do they think the medication will help or harm them? Actions

Discuss available support with Mental Health Liaison service. There are support workers trained to support registered nurses is successful administration (see available support).

Discuss with members of the ward team including (nurses, doctors, involved therapists, pharmacist).

Discuss with and explain to family/carers the rationale behind administering covert medication and discuss if they would like to be involved in administration.

Plan

Offer oral medication at each medication round giving reassurance as needed (utilise available support at this stage where possible).

If the patient refuses, offer again at 10 minute intervals up to 3 times.

If the patient continues to refuse oral medication it then needs to be given covertly.

Decide with the ward team which is priority medication.

Discuss with pharmacist if medications can be crushed, available in syrup etc.

If covert medication is in the best interests of the patient it is best given in food, as drinks can often be discarded, not fully consumed or easily accessible to others.

o Find out food likes and dislikes with family in order to make the best choice of food to use for covert medication and enlist help of family where possible and appropriate.

Available support There are support workers working within the Mental Health Services for Older Persons (MHSOP) liaison team, who may be able to assist / support registered nurses (RN) with medication adherence for patients referred to MHSOP liaison.

The MHSOP senior nurse will need to complete a full assessment / review (where appropriate) identifying the need for support workers to be involved in supporting medication adherence to assist the management of the patients mental health needs.


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The senior MHSOP nurse to complete relevant capacity forms for medication adherence.

The senior MHSOP nurse must complete an intervention plan specifically identifying the support required for the general hospital RNs to successfully administer medication.

An Intervention plan is to be placed in patients notes for reference by multidisciplinary team (MDT) involved in care.

The support worker will initially provide an educational role to help registered nurse manage patient with mental health issues utilising their skills, knowledge and experience to aid the RN to administer the medication themselves.

If patient is still refusing medication then support worker could administer medication to the patient under the direct supervision of the RN. The RN remains responsible for administration of the medication and will sign the administration record accordingly.

Before the medication is given the support worker and RN need to confirm what medications are essential to be given (based upon the care plan).

This outcome will be documented in the general hospital notes by the liaison support worker and on the mental health organisations documentation. This will be countersigned by MHSOP nurse involved with patient.


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APPENDIX 8 - MANAGEMENT OF FP10 PRESCRIPTIONS

General Principles for the Management of FP10 Prescriptions (Controlled Stationery)

FP10 prescription pads and FP10 blank prescription sheets are examples of controlled stationery.

Controlled stationery must be stored and secured appropriately in the ward, department or by the individual non-medical prescriber. They must be stored in a locked drawer or cupboard when not in use and must not be left unattended at any time.

Prescribers who work for more than one employer must have separate FP10 prescription pads for each organisation, printed with the correct organisation details in the prescriber details area of the FP10 prescription.

The ward or department manager must ensure an up to date signature list of individuals authorised to order and / or collect controlled stationery on behalf of their designated ward or department is registered with the pharmacy department.

The pharmacy department must follow the pharmacy standard operating procedures for controlled stationery management.

The safe handling and security of controlled stationery is the responsibility of the individual prescriber or practitioner in charge of the individual ward or department.

Refer also to Outpatient Medication Supply Policy POL/MM/0017

FP10 Prescription Types

(a) FP10s without pre-printed individual prescriber details

FP10HNC – hospital outpatient clinics hand written green prescription pads with pre-printed specialty name and Trust address

(b) FP10s with pre-printed individual prescriber details

FP10PN – non medical prescribers hand written lilac prescription pads

FP10D - dental hand written yellow prescription pads

(c) Electronic FP10s

FP10SS – blank hospital electronic generated green prescription sheet. These are used for SystmOne FP10s and iSOFT discharge prescriptions on wards. The prescriber details are printed onto the FP10SS electronically.

FP10 Prescription Cost Centres

When an FP10 is dispensed in a community pharmacy it is sent to the NHS Business Services Authority (NHSBSA) where the cost centre is identified and the organisation with that cost centre is charged.

The FP10 cost centres are called prescription codes. The codes are either pre-printed onto the FP10s or are printed on to the FP10s when an electronic FP10 is produced.

The required codes are either:

RXP code – for hospital FP10s without pre-printed individual prescriber detail. This is a Trust organisation code.

Y code – for non-medical prescribers (NMP). This is the parent code or dummy practice cod’. The NMP name and pin number is also required on each FP10.

6 code – for medical and non-medical prescribers in a community clinic. This is called the prescriber or spurious code. They may be specific for a doctor or general for a service.

FP10CNs and FP10 pads with an A code printed on them are no longer used.


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Ordering FP10 Prescriptions

The system of FP10 ordering is dependent on the environment in which subsequent prescribing will occur.

1. For FP10s without pre-printed individual prescriber details

Each team manager or team leader shall be responsible for appointing a nominated person and deputy for the ordering, storage and issuing of the FP10s.

Hospital wards, departments and outpatient clinics FP10s with Pre-printed Individual Prescriber Details (FP10PNs) should not be used in these areas.

FP10HNCs and FP10SSs for wards, departments and clinics are ordered by the Pharmacy Secretary at UHND from ‘NHS Forms’, via the internet.

The FP10HNCs are pre-printed with the speciality RXP code, name and address.

The FP10SSs are blank.

Community Hospitals FP10s with Pre-printed Individual Prescriber Details (FP10PNs) should not be used in these areas.

Sedgefield, Weardale and Richardson. o Order FP10HNCs and FP10SSs from ‘NHS Forms’, via the internet.

Shotley Bridge and Chester-Le-Street. o FP10HNCs and FP10SSs for wards, departments and clinics are ordered by the

Pharmacy Secretary at UHND from ‘NHS Forms’, via the internet.

Dental Clinics Order FP10Ds from ‘NHS Forms’, via the internet.

2. For FP10s with pre-printed individual prescriber details

Non-medical Prescribers (NMPs) FP10PNs Only to be used for nurses prescribing in the community for CCG patients

Register as a non-medical prescriber by contacting the BAH pharmacy department. Details will be added to the CDDFT NMP database.

Order by completing a FP10 Prescription Pad Requisition Form (intranet link). Send to a Care Closer to Home administrator. Their names are available from the BAH pharmacy department.

Order for each Clinical Commissioning Group (CCG) where work is undertaken. All orders can be sent to the same administrator.

Collect the FP10s from an identified CCG base. The locality administrator will ring when they are ready to collect.

14.5 Security of FP10 prescriptions

The security of FP10s is the responsibility of the Trust and the individual prescriber. Example logs are available on the pharmacy staffnet page

FP10s not in use must be securely locked away in the designated clinical area in a place with limited authorised access e.g. a locked drawer or cupboard in an inaccessible area.

Their receipt and issue should be recorded in an FP10 log.

Example logs are available on the pharmacy page of the intranet

FP10 logs should be kept separately from the FP10 pads/sheets.

Logs should be retained for two years.

FP10s must not be left unattended on a desk, in a folder or book, printer or in any unattended patient accessible area.

FP10s must not be pre-signed or pre-dated.


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Only FP10s issued to a particular Individual, or team may be used by that individual or clinical team.

In a hospital clinic or department:

Central outpatients and departments may issue an FP10 pad or FP10SS sheets to each clinic from a secure place. The details should be recorded in their Issues to Clinics Central FP10 log (Available on the pharmacy age of the intranet)

FP10HNCs (handwritten) – it is recommended that an identified member of staff should be responsible for the FP10HNCs and issue one FP10 to a prescriber as a prescription is required.

FP10SSs (electronic) – they must not be left in the printer in an unsupervised area. Consider how access can be limited e.g. place the printer in an area that is supervised at all times.

When the clinic ends the remaining FP10s should be returned to the central secure place and recorded back into the Issues to Clinics Central FP10 log (available on the pharmacy age of the intranet)

On a ward:

Staff should not carry the FP10s pads or sheets with them.

Blank FP10s should remain on the ward in a securely locked place with limited authorised access.

In a community clinic: For prescribers working in a community clinic and carrying FP10HNCs and FP10SSs issued from a hospital base, prescriptions must be:

Signed out of the Issues to Clinics Central FP10 log at the base.

Kept in a bag out of sight and must never be left unattended in the car.

A maximum of one full pad of FP10s should be carried by a person at any one time.

A record of all the FP10s issued must be kept on an Issues FP10 log including the FP10 serial number, name of prescriber and NHS number.

The FP10 pad must be signed back in onto the Clinics Central FP10 log at the base (available on the pharmacy age of the intranet)

Community Staff with FP10s with Pre-printed Individual Prescriber Details:

The FP10s should not be kept at home or in an unattended car.

It is recommended that prescribers issued with their own FP10 pads keep a record of the serial numbers of the FP10s issued to them using the Trust FP10s with Pre-printed Individual Prescriber Details (FP10PNs) Log (available on the pharmacy age of the intranet)

It is good practice to record the number of the first remaining FP10 in an in-use pad at the end of the working day. This will help to identify any FP10s lost or stolen.

Leaving Trust Employment

FP10s with Pre-printed Individual Prescriber Details:

Prescribers must ensure that any FP10s in their possession are returned to their line manager and logged for destruction as appropriate on the prescriber’s FP10s with Pre-printed Individual Prescriber Details (FP10PNs) log.

It is the responsibility of the prescriber and line manager to ensure this takes place on or before the last day of employment.

The serial numbers of FP10s to be destroyed must be recorded before they are destroyed by shredding.

The ward or department manager must maintain a record of details of FP10s that have been destroyed for a minimum of 18 months.

The destruction of FP10s must be witnessed by another member of staff.

FP10s must be shredded and placed in a confidential waste bin.

Both staff members must sign the destruction log.


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For prescribers who are registered with the NHS Business Service Authority (NHSBSA), the NHSBSA must be informed of the prescribers change in circumstance.


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Loss or Theft of FP10 Prescriptions

There is the possibility that an attempt could be made to forge FP10s. To maximise security, if FP10s are lost or stolen the following action must be taken:

Prescriber Responsibilities:

Inform the ward, department or service manager.

Inform the Chief or Deputy Chief Pharmacist.

Complete a Safeguard incident report.

Provide the following information when reporting the loss: o type of FP10 prescription e.g. FP10HNC o number of FP10s lost or stolen o serial numbers of affected forms o prescriber details and professional registration number (if applicable) o service name (if applicable) and address written on the FP10

Chief or Deputy Chief Pharmacist:

Inform the Trust Security Team.

Inform NHS Protect on 0191 2046340, when further checks have confirmed that the FP10s have been lost or stolen.

Security Team Responsibilities:

Inform the police, when further checks have confirmed that the FP10s have been lost or stolen.

Investigate the loss or theft.

Out of Hours Senior Manager On Call Responsibilities:

Out of normal working hours inform the police, when further checks have confirmed that the FP10s have been lost or stolen.

On the next working day inform the Chief or Deputy Chief Pharmacist.

On the next working day inform the Trust Security Team.


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APPENDIX 9 - EQUALITY ANALYSIS / IMPACT ASSESSMENT

Full Assessment Form v2/2011

Division/Department: Pharmacy and Medicines Management

Title of policy, procedure, decision, project, function or service:

Medicine Policy

Lead person responsible:

Chief Pharmacist

People involved with completing this:

Dawn Ledger Pauline Lockey Jillian Wilkins

Type of policy, procedure, decision, project, function or service: Existing New/proposed Changed Step 1 – Scoping your analysis

Step 1 – Scoping your analysis


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What is the aim of your policy, procedure, project, decision, function or service and how does it relate to equality?

To ensure that CDDFT staff comply with current legislation, follow guidance issued by the Department of Health and manage the risks to patients and staff arising from the use of medicines.

Who is the policy, procedure, project, decision, function or service going to benefit and how?

All staff who manage any process within the Policy and the patients that are treated within the organisation.

What outcomes do you want to achieve?

The aims as detailed above.

What barriers are there to achieving these outcomes?

Access to an electronic version of the Medicine Policy filed on the Trust intranet in some community settings. In exceptional circumstances where access is not immediate there is provision within the Policy to use telephone contact.

How will you put your policy, procedure, project, decision, function or service into practice?

Dissemination of the policy via the Pharmacy and Medicines Management Bulletin and email communication.

Does this policy link, align or conflict with any other policy, procedure, project, decision, function or service?

The Medicine Policy links to the following policies: Antibiotic Formulary, Being Open Policy POL/N&G/0009, Clinical Handover of Care on Transfer Policy POL/NG/0005B, Going Home Policy POL/NG/0005A, Clinical Record Keeping & Healthcare Records Management Policy POL/NQ/0005, Clinical Trials Policy POL/MM/0004, Consent to Examination or Treatment Policy POL/N&Q/0004, Controlled Drug Policy POL/MM/0010, Incident Management Policy POL/N&G/0001, Medicine Reconciliation Policy POL/MM/0006, Medicines Requiring Loading Doses Policy POL/MM/0007, Non-Medical Prescribing Policy POL/MM/0008, Pharmacy Staff electronic Prescribing and Medicines Administration (ePMA) Transcribing and Enablement Policy POL/MM/0018, Patient Group Direction (PGD) Policy POL/MM/0009, Pharmacy Staff Transcribing Policy POL/MM/0011, Policy and guidance notes for staff on The Mental Capacity Act 2005 POL/N&Q/0051, Procedure for Non-Trust Personnel Undertaking Clinical Associated Business on Trust Premises PRO/NG/0001, Self-Administration of Medicines Policy POL/MM/0013, Supporting staff involved in a potentially traumatic stressful work related incident GUID/N&G/0003, Waste Policy POL/NCRM/0004




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Step 2 – Collecting your information

What existing information / data do you have?

Information around medicine related incidents.

Who have you consulted with?

Clinical Effectiveness and Therapeutics Committee.

What are the gaps and how do you plan to collect what is missing?

Current incident analysis and trend reviews do not identify specific staff groups. This will be considered for future monitoring.

Step 3 – What is the impact?

Using the information from Step 2 explain if there is an impact or potential for impact on staff or people in the community with characteristics protected under the Equality Act 2010? Ethnicity or Race

Potential for issues around communication and understanding. Currently there is no evidence to support this.

Sex/Gender

No impact.

Age

Potential impact if related to a particular occupational or department staff group were there issues or concerns. Currently there is no evidence to support this.

Disability

Potential impact around undetected learning difficulties, hearing problems and sight related problems in terms of medicines processes. Currently there is no evidence to support this.

Religion or Belief

Potential impact around certain ethical prescribing and administration which may conflict with an individual’s religion or belief. Currently no evidence to support this.

Sexual Orientation

No impact.

Marriage and Civil Partnership

No impact.


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Pregnancy and Maternity

Potential impact in terms of administration which will be addressed at local level by the line manager through the pregnancy risk assessment process.

Gender Reassignment

No impact.

Other socially excluded groups or communities e.g. rural community, socially excluded, carers, areas of deprivation, low literacy skills

No impact.

Step 4 – What are the differences?

Are any groups affected in a different way to others as a result of the policy, procedure, project, decision, function or service?

Potential for impact but currently there is no evidence to support this.

Does your policy, procedure, project, decision, function or service discriminate against anyone with characteristics protected under the Equality Act? Yes No If yes, explain the justification for this. If it cannot be justified, how are you going to change it to remove or mitigate the affect?

n/a

Step 5 – Make a decision based on steps 2 - 4

If you are in a position to introduce the policy, procedure, project, decision, function or service? Clearly show how this has been decided.

Yes in a position to introduce the Policy to ensure a standard approach and meet legal requirements.

If you are in a position to introduce the policy, procedure, project, decision, function or service, but still have information to collect, changes to make or actions to complete to ensure all people affected have been covered please list:

Consider a process to monitor the incidents and complaints in relation to staff within protected characteristics as identified in stage 3.

How are you going to monitor this policy, procedure, project or service, how often and who will be responsible?

This Policy will be monitored as specified within the Policy and where possible including information from protected characteristics: