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UKMI 38th Professional Development Seminar 2012

Poster collation

7. MiDatabank ADR reporting – One year on

8. Identification of hospital-specific quality signals (QSig) using

documented enquiries to the drug information center (DIC) of the

pharmacy.

9. Improving patient perception on the provision of medicines

Information

10. Could analysis of Medicines Information enquiries help to determine

whether there is a need for a screening tool for women of child

bearing age in outpatient clinics?

11.Why do patients under the care of the Royal Eye Hospital contact the

Medicines Helpline?

MiDatabank ADR reporting

– One year on Mitul Jadeja, Medicines and Healthcare products Regulatory Agency & Christine Randall, North West Medicines Information Centre

MiDatabank version 3.1 (MiD V3.1), which enables Adverse Drug Reaction (ADR) reporting directly from MiDatabank to the MHRA’s systems in real time, was made available to the MI network at the end of October 2011 (piloted from Feb 2011).

Uptake of MiD V3.1 has been slower than predicted; one of the barriers has been lack of resources within NHS trusts to enable IT services to prioritise server updates and provide support for the work to be carried out. • In June 2012, Professor Sir Kent Woods, Chief Executive of the MHRA, wrote to all NHS chief executives via the Department of Health’s ‘The Week’ communication (number 236). • He asked for their support and encouraged them and their IT colleagues to prioritise installing updated software for MiDatabank. • The hope for 2013 is that this request will stimulate uptake on MiD V3.1 leading to increased ADR reporting across the UK.

How many reports to June 2012?

Who is reporting?

What is being reported? Top 10 reported drugs Top 10 reported serious reactions

1 Simvastatin

2 Immunoglobulin normal

3 Lansoprazole

4 Adalimumab

5 Amiodarone

6 Citalopram

7 Ramipril

8 Methotrexate

9 Piperacillin and tazobactam

10 Fluoxetine

Support for MI pharmacists, in the form of an ADR quick start guide, SOP and Good Practice Guide, are available via the Help function within the database or via the MiDatabank website at www.midatabank.com/ADRs/UsefulResources.aspx

5/12

reactions reported for simvastatin

were not listed in the

SPC

Liver function test abnormal 11

Arthralgia 8

Convulsion 5

Thrombocytopenia 5

Electrocardiogram QT prolonged 5

Amnesia 4

Anaphylactic reaction 4

Rhabdomyolysis 4

Renal failure acute 4

Confusional state 4

The next 12 months?

Abnormal LFTs were suspected to be associated with: • 3 antibiotics • 5 CNS drugs (3 antidepressants) • 2 cardiovascular drugs • 1 progestogen

57% of reporting centres are in an

MHRA Yellow Card Centre area

Areas where the regional centre has

MiD V3.1 have a higher local

reporting rate

CAMPUS GROSSHADERNCAMPUS GROSSHADERNCAMPUS GROSSHADERNCAMPUS GROSSHADERN

APOTHEKE APOTHEKE APOTHEKE APOTHEKE ---- ARZNEIMITTELINFORMATIONARZNEIMITTELINFORMATIONARZNEIMITTELINFORMATIONARZNEIMITTELINFORMATION

Table 5: Examples DIC Intranet Information Platform

excerpt of DIC intranet information platform

excerpt from intranet table: administration of oral medication excerpt from intranet table: administration of i.v. antiinfectives

Method

Documentation of all ward-based enquiries of medical doctors or nurses in the ADKA Documentation System (ADKA-DS) including also the answers of the drug information pharmacist and the references used. All enquiries are classified in different categories. Retrospective evaluation of enquiries concerning drug administration during 2010 with the statistics tool of the ADKA-DS. Besides a categorisation by content, type of enquirer and department all enquiries were classified to different subtopics of the chosen core category “drug administration”. This lead to identification of Qsig, i.e. alerts for areas of specific information need.

Proactive integration of generated QSig in departmental or hospital wide information products.

Identification of hospital-specific quality signals (QSig) using documented enquiries to the drug information center (DIC) of the pharmacyCornelia Vetter-Kerkhoff, Jacqueline Richter, Dorothea Strobach Drug Information Center Hospital of the University of Munich, Pharmacy Department , Munich Germany Drug Information Working Group of the ADKA (German Association of Hospital Pharmacists)

UKMI Practice Development Seminar Warwick 13th & 14th September 2012 email: [email protected]

Results

In 2010 1833 enquiries/answers out of 20 categories (table 1) were docu-mented. 248 (14%) were dealing with drug administration issues. 153 (14%) were asked by nurses, 85 (35%) by medical doctors, 7 (3%) couldn’t be allocated because of missing data (table 2). 47% were asked by internal medicine, 32% by pediatric, 15% by surgical and 6% by other departments (table 3). Identified QSig were f.e.:

- time of administration of oral drugs- administration of drugs through jejunal feeding tubes- administration of intravenous phenytoin- administration of intravenous potassium chloride solution on general wards- preparation of intravenous antiinfectives- rate of administration and maximal concentration of intravenous drug solutions- correct administration of inhalative medication- optimisation of SOD (selective oropharyngeal decontamination solution)

Qsig were used for optimisation of drug safety information by producing information leaflets or tables which were -according to the need- distributed only to a specific ward, to a specific department or published on the hospital wide Intranet on our DIC intranet information platform. The time-consuming preparation of information materials was also done by students, interns and trainees rotating through the DIC.Quality signals also helped to focus education and training materials for medical and nursing staff, medical and pharmacy students.

Introduction

The DIC of the teaching hospital of the University of Munich (2250 beds) operates since 1992. About 2000 enquiries to the DIC per year (2011) show the need for medicine information. Most enquiries refer to a single patient or a small group of patients in a single department of the hospital. Is it possible to develop quality signals out of enquiries concerning drug administration which will -after installing hospitalwide accessible information materials- possibly improve drug safety in different areas of the hospital? Ward-based pharmacists are not yet established.

Discussion

Information about drug administration is especially needed for tube and oral drug administration issues (39%) and for parenteral drug administration (31%). Single Qsig as well as combinations of Qsig lead to hospital wide publicationson the DIC intranet information platform.

Depending on the significance for the ward, the medical unit or the hospital as a whole we decided on the form or mode of publication and distribution.

Technical innovations should be used in the near future to implement interactiveinformation modules for distribution in different parts of the hospital.

QSig could be generated also for other categories (table 1) of enquiries. This way answers to enquiries referring to a single patient could add to hospital widequality improvement in different areas of drug therapy.

This could be intensified in the future, when Qsig as warning signals areincorporated in medical expert systems, which are able to link Qsig to medication or/and laboratory data of individual patients .

Conclusion

The evaluation of enquiries and answers for individual enquirers generated QSig which could be integrated in information products to help improving drug safety information hospital wide.

Also other types of enquiries should be evaluated to develop Qsig.

In the future enquiry-based quality signal information can be implemented and communicated by clinical pharmacists on the wards to enhance patient safety and reduce costs.

Table 2: drug administration – medical department of enquirer

Table 1: Categories of Enquiries of 2010

Table 4: Drug Administration - QSig

Table 3: Classificaton of drug administration enquiries

0

50

100

150

200

250

Sonstige (7)

Pflege (153)

Arzt (85)

all surgery internal medicine pediatrics other

choice of drug22%

drug administration14%

interaction10%

dosage8%

adverse drug reaction7%

stability6%

other5%

availability/approval5%

compatibility5%

economics4%

pharmacokinetic calculation4%

galenics3%

international medication2%

Pharmacokinetics2%

nutrition1%

contraindication1%

pregnancy/lactation1% toxikology

1%

Pharmacology1%

new drugs<1 %

alternative medicine< 1%

0 10 20 30 40 50 60 70 80

16

42

2

3

4

2

2

5

2

5

8

10

41

7

17

79

Kurzinformation

Galenik

Topika

Inhalativa

Lichtschutz

Medikationsfehler/CIRS

peripher/zentral

Teilbarkeit

feeding tube admin.

oral off lable admin.

tablet splitting

intravenous additives

compatibility

max. concentration

rate of infusion

peripheral/ central

medication error

stability

photostability

inhalative

topical

galenics

short information

other

other/short information (58)

galenics (2)

topical (3)

Inhalative (4)

stability (4)

Medication error (5)

parenteral (71)

tube and oral (96)

Qsig (examples) Type of publication

Advice and caution for oral formulary medication(Abb.5)Sodium content of i.v.-formulary drugsEthanol content of formulary drugsQT-prolongation of formulary drugs

Tables in the DIC intranet informationplatform

Administration of i.v. antiinfectives (Abb.5,6) (permanent update)

Potassium: Leaflet peripheral i.v.-adminstration

Phenytoin: Leaflet i.v.-administration

SOD-Mixture for reconstitution

pH-table for i.v.-administration standards ward-specific table

Compatibility information for i.v.-administration standards

presentations

i.v.-administration, max. concentration for centrallumen, max. administration rate

Premedication of oncologic patientschoice of drug, drug administration optimisationstrategies

trainees

Inhalative formulary drugs: Patient information

Revision of the mucositis protocol

Immunisation after splenectomy

Clostridium difficile infection protocol

Drug administration via feeding tubes presentation for nurses, medicalstudents, pharmacy students

other (7)

nurse (153)

doctor (85)

Central Manchester University HospitalsNHS Foundation Trust

Improving patient perception on the provision of medicines information

Aoidin Cooke, Medicines Information Manager. Medicines Information Dept, Central Manchester University Hospitals NHS Foundation Trust.

© Print by CMFT Clinical Photography & Medical Illustration Services, Tel: 0161 27 64671. September 2012.

Introduction

Provision of information to patients is key to empowering the patient to make choices which relate to their health and well-being. It is hoped that by ensuring that the patient is well-informed, they will actively engage in their medical treatment, which will improve their long-term outcomes.

The results from the National In-patient Survey highlighted that patients perceive we are not fully informing them about their medicines, including information relating to side-effects.

Within our Trust, we aim to put the patient at the centre of the services we provide. It was clear however, that we needed to alter the method by which we provided information about medicines, to improve patient perception of this aspect of the service.

Within the Medicines Information (MI) Department, a Pharmacy Medicines Helpline is provided for patients who are discharged with medicines. We aim to capture patients who have additional queries or seek additional advice relating to their discharge medicines when they get home. A large proportion of the calls we receive from patients are related to adverse effects. The MI Dept was therefore identified as having an important role in the reactive provision of information.

In an attempt to improve our proactive provision of information relating to medicines within our Trust, a multidisciplinary approach was deemed necessary. The MI manager and Lead Nursing staff began a project to improve patient perception on the provision of medicines information.

This is a unique project which involved a multi-disciplinary approach to proactive provision of medicines information. The project was developed with the QIPP agenda at its forefront. We aim to ensure the patient receives quality information in an appropriate way, using techniques which have not been employed elsewhere, advancing collaborative working among the multi-disciplinary team, to prevent harm to the patient through inappropriate use of medicines on non-adherence to prescribed regimes.

Actions

Pharmacy Admissions LeafletWe produced a pharmacy in-patient admissions leaflet which explains to patients about medicines use in general during their hospital stay. It is used as a means by which the pharmacy team can introduce themselves and advertise the service. In the leaflet we encourage patients to ask questions about their medicines with a member of the Pharmacy team.

Core Discharge Checklist

A discharge checklist was produced with nursing input to ensure adequate information was provided at the point of discharge. Patients should be receiving information regarding their medicines

throughout their in-patient stay, but reiteration of

this information when they are given their discharge prescription and re-enforcing this is important. This checklist covers 10 key points to ensure the patient has adequate level of information for a safe discharge with medicines. The patient is given a copy of the completed checklist as a record of the information provided.

EducationAn interactive e-learning package was developed on the use of the Discharge Checklist and rolled out to all clinical staff (mandatory for pharmacy and nursing staff) after an initial local pilot highlighted any pitfalls. This highlighted the necessity behind patient counselling

and the consequences of inadequate information provision. The Organisational Development and Training department were able to provide the responses to the course evaluation forms which indicated staff

felt positively about the e-learning package. Local pharmacy staff were provided with a teaching template

presentation to adapt to their local ward area requirement for additional training for nurses and refreshers on commonly used drug in particular clinical areas. The roles of both the nursing and pharmacy staff as collaborative in providing information to patients was highlighted in all training provided.

Discussion

The roll out of this project in a Trust this size has had it difficulties. Engaging large numbers of staff across multiple sites has logistically been problematic. In its development, the project became not only about providing information proactively to patients, but the tools with which to do this have become integral to ensuring good discharge practice along with medicines safety and governance.

The provision of medicines information to patients is now a focus for all healthcare professionals. There are already specialist pharmacists developing patient counselling tools for their specific clinical areas. Training and counselling competency packs have been developed for key areas where departmental audit has highlighted a deficient area in patient counselling.

The National Inpatient Survey results for this year will hopefully show an improvement on previous results. We will be able to break down the results and target areas where results indicate a need for improvement. The implementation and documentation of the completion of the checklist is to become part of the local ward based quality initiatives. Local audit should highlight where further improvements are required. Incidents picked up by the Pharmacy Medicines Helpline, relating to poor provision of information to patients should reduce.

Central Manchester University Hospitals

NHS Foundation Trust

Could analysis of Medicines Information enquiries help to

determine whether there is a need for a screening tool for

women of child bearing age in outpatient clinics?By Laura Smith, Pre-registration Pharmacist. Supervisor: Charlotte Hay, Medicines Information Pharmacist.

Results

Between 1st January 2006 and 30th April 2011 a total of 459 enquiries about

drugs in pregnancy were made to the CMFT MI service. Of these, 146 related to

the use of chronic medication.

These enquiries were analysed to determine for which trimester pregnancy

enquiries were made (figure 2). For enquiries relating to chronic medication use

in pregnancy the majority were made retrospectively. Enquiries were

predominantly made in the first trimester (60%) whereas only 16% of enquiries

were made prior to conception. Enquiries were also made in the second and

third trimester and two enquiries were made after birth.

173 enquiries about drugs in breast milk were made to the service between 1st

January 2008 and 17th November 2011. Enquiries which were patient specific

and regarding existing prescribed medication, rather than enquiries regarding

appropriate prospective selection of treatment, were further analysed.

Enquiries without details of whether breastfeeding was established or not were

not further analysed.

99 enquiries were analysed. Most of the enquiries were made after the birth of

the child (73%). Of the retrospective breast-feeding enquiries, 43% involved

long term medication which the mother would be continuing with. These

included scenarios where medication had been taken during the pregnancy,

and cases where breastfeeding had been established prior to the

commencement of medication for chronic/long-term treatment.

The Medicines Information Department at the Central Manchester Foundation

Trust (CMFT) covers a specialist Obstetrics & Gynaecology hospital (St. Mary’s) and

therefore receives calls relating to the safety of medications in pregnancy and

lactation. It is hoped that an analysis of these calls will identify whether enquiries

relating to the use of chronic medication in planned pregnancies are made

prospectively and whether outpatient clinic areas could benefit from a screening

tool.

Figure 1: Picture representing the stages of pregnancy.1

Objectives

To analyse all drugs in pregnancy enquiries recorded on MiDatabank between

the years 2006 and 2011 and drugs in breast feeding enquiries between 2008

and 2011.

To determine who and where these calls are originating from.

To determine when the call was made in relation to the date of conception.

In order to collect appropriate data for this audit two searches of MiDatabank

were carried out. Reports for the categories “Drugs in pregnancy” and “Drugs in

breast milk” were produced for set time frames, allowing all enquiries relating to

these topics to be analysed. Each enquiry form was then examined to determine

whether the medication asked about was acute or chronic. For those relating to

existing chronic medication the timing was also considered to determine

whether the enquiry was made prospectively (pre-conception for pregnancy

enquiries, before commencement of breastfeeding for lactation enquiries) or

retrospectively, documenting the stage of pregnancy or the age of neonate.

Conclusion

The results of this audit show that only 16% of pregnancy enquiries were made

prior to conception. These calls came from a variety of clinical areas including In

Vitro Fertilisation (IVF) clinics and Renal Transplant clinics. There is potential for an

increase in the proportion of prospective enquiries from these areas if a screening

tool were to be utilised with women of childbearing age. Figure 4 is an example of a

prototype screening tool we hope to pilot in targeted areas, such as IVF clinics, and

develop in the future, to offer an enhanced service to patients.

Drugs used in pregnancy and breast feeding need to be safe for mum and baby. If medication is necessary then medications with best safety evidence are preferable. Medicines

Information can review the current safety information for medicines your patient is taking. Please contact them on 0161 276 6270 (Mon-Fri 9-5) or via e-mail

[email protected]

↓ For patients who answer yes:

YES

Will these medicines need to be reviewed during breast feeding? NO

YESDo these medicines need to be reviewed in pregnancy? NO

YESIs the patient planning on becoming pregnant? NO

YESIs the patient of child bearing age?NO

Prior to

ConceptionTrimester 1

Trimester 2

Trimester 3

After birth

Figure 2: Graph to show at which stage of pregnancy enquiries were made.

Table 1: Table to show who made pregnancy enquiries relating to chronic/long term

medications between 2006 and 2011. 1.Picture taken from NHS Choices website “From birth to conception” www.nhs.uk

When were breast feeding enquiries made?

Before or after birth?

Prospective (Beforebirth)Retrospective (afterbirth)

Figure 3: Pie chart to show breast feeding enquiries made before and after the birth.

Figure 4: Prototype screening tool for outpatient clinics.

22Other

21Nurse/ Midwife

17Consultant

8Registrar

41GP

4Community Pharmacist

24Hospital Pharmacist

9Patient

Table 1 shows where these pregnancy enquiries originated. The majority of

these calls originated from secondary care (48%). GPs made 28% of calls. 6% of

enquiries were made by patients. Prospective pregnancy enquiries tended to

come from secondary care, however the majority of enquiries from clinicians

were retrospective.

Primary care clinicians tend to ask about safety of medication in pregnancy

retrospectively. There is potential for further promotion of the MI service to GP

surgeries within the catchment area. This would hopefully encourage primary care

colleagues to consider whether patients are of childbearing age when they are

reviewing medication, which could increase the number of prospective pregnancy

enquiries made by GPs.

Some of the Drugs in Lactation enquiries were made after birth despite the

medication already being established in the mother before the birth. Ideally long

term medication which the mother is already taking would be considered for its

safety before the child is born. Promotion of the MI service in antenatal clinics

should encourage earlier consideration of the safety of the medication in

breastfeeding. However, prospective lactation enquiries are not always possible to

deal with in full as there would be unknown information about the neonate’s

gestational age at birth and their medical condition. General safety information,

however, can still assist with potential plans for management of the mother’s

medical condition.

Patients make their own enquiries about medications in pregnancy and

breastfeeding. Promotion of the service to patients attending the clinics by means

of posters in the waiting areas could encourage more patients to be proactive

about their medication.

In view of the findings of this audit, we feel that there is huge potential for a

screening tool to prompt clinicians and patients alike to consider in advance the

suitability of their medicines during pregnancy and breast feeding.

WHY DO PATIENTS UNDER THE CARE OF THE ROYAL EYE HOSPITAL

CONTACT THE MEDICINES HELPLINE?Charlotte Hay- Medicines Information Pharmacist

Medicines Helpline calls from patients

under the care of the Royal Eye

Hospital constitute a third of the total

patient line enquiries in the

September 2010-2011 period.

The enquiries were assigned a category as follows:

A.Side effect. Enquiries from patients concerned about side effects or

had experienced an adverse reaction.

B.Stock problem. Patients unsure where to obtain further supplies of

their medication or had experienced difficulty in obtaining supply.

C.Product integrity. Queries regarding how to store a product or

stability of a product following incorrect storage.

D.Regime enquiry. Patient called wanting clarification of their dosage

instructions; information about what order to administer drops, the

duration or frequency of administration.

E.Query related to the product dispensed. For example, enquirers

were checking whether the product dispensed in community

matched the product dispensed at CMFT.

F.Suitability of product. Enquirers were asking whether the prescribed

product was suitable given existing conditions or concurrent

medication or allergy status.

G.Alternative treatments. Enquirer asked about alternative therapies

to the one prescribed.

H.Cannot administer. Patient having difficulties administering their

prescription.

15%

19%

10%30%

5%

19%

1%

1%

A=Side effect

B=Supply problem

C=Product integrity

D=Regime query

E=Product query

F=Suitability

G=Alt. treatments

H=Cannot administer

Figure 2- Eye patient helpline calls categorised according to enquiry type

Analysis was carried out to assess whether these helpline calls may

have been pre-empted, and looked at which health professionals

could have anticipated the query or been more proactive in

counselling the patient. Calls were classed as attributable to lack of

counselling by the hospital pharmacy, the clinician, the ward or the

community pharmacy staff. Two thirds of the total enquiries were

deemed preventable by effective counselling from hospital staff (in

pharmacy, in clinics and on the eye wards), see figure 4.

Those that were deemed to be preventable by the community

pharmacist included calls relating to stock shortages due to

manufacturing problems and where an alternative prescription was

required. This category also included queries relating to the product

dispensed in the community, which may differ from the product

dispensed in hospital. Counselling on the product when collecting

from the community pharmacy may reduce this type of enquiry.

However, there is little the hospital pharmacy can do to reduce this

type of call as they are outside of the Trust.

The Pharmacy Medicines Management Team at Central Manchester

Foundation Trust plan to create and implement a counselling

framework and competency pack specifically for counselling

prescriptions from the Royal Eye Hospital. The pack will be designed to

ensure all aspects of effective patient counselling for eye prescriptions

are covered. Pharmacy staff who will be handing out prescriptions to

eye patients will be required to demonstrate competency and to

achieve and maintain high standards.

12 months following introduction of the pack there will be a repeat of

the analysis of eye patient helpline calls to see whether the proportion

of enquiries deemed preventable by hospital pharmacy staff has

reduced.

Figure 5- Discharge checklist

This highlights the areas where counselling may be improved.

These medicines helpline calls from eye patients were analysed to find

out the nature of enquiries and whether they could have been pre-

empted by improved patient counselling; either by pharmacy, the

discharging ward or the clinician. It is hoped that these enquiries can

highlight aspects of patient counselling that may be improved thus the

proportion of these type of calls could be reduced.

Comparison of the enquiry numbers to

a similar audit of the calls taken over

the preceding 12 months shows that

the volume of these has increased by

332%. This increase is likely due to

increased promotion of the medicines

helpline service. Figure 1: Medicines Helpline Card

Figure 3 – Breakdown of Regime Enquiries

Ten patients with multiple eye

drops enquired regarding the

order in which they should be

instilled. Some patients enquired

about how often they should use

their drops and some about

length of treatment.

Regimes enquiries were broken down into a further five

subcategories (figure 3).

46

6

30

16

0

5

10

15

20

25

30

35

40

45

50

Number of enquiries

Hospital

Pharmacy

Ward Clinician Community

Pharmacy

Figure 4- Who could have prevented calls with effective advice?

Six enquiries may have been

prevented by improved ward-

based counselling on their eye

drops; the introduction of the

discharge checklist (figure 5) on

all wards in the trust should help

this.

The checklist aims to ensure

explanation to the patient of:

indication, dose, when and how

often they need to use their

medication, special requirements

for storage, that they know how

to administer their medication

and how to obtain further

supplies of their medication.

10

6

12

7

3

D1=Order of installation D2=Duration of treatment

D3=Conflicting/unclear instructions D4=Frequency of dosing

D5=Administration