FIJI ESSENTIAL MEDICINES FORMULARY -1- FOREWARD This edition arises out of the revision of the 1999 Fiji Essential Drug List (EDL) which has now been retitled as the Fiji Essential Medicines Formulary (2006). It is a compilation of work consistently undertaken by the three Divisional Drug & Therapeutic Committees, the National Drug & Therapeutic Committee (NDTC) using Standard Treatment Guidelines and protocols. The Essential Medicines Concept adopted by the World Health Organisation ensures that priority medicines such as Antiretroviral, diseases suffered by the majority of the population and the application of the Vital, Essential and Non Essential Analysis for procurement of cost effective medicine will facilitate the accessibility and affordability of these medicines to the citizens of Fiji. Further, the Formulary includes relevant policies formulated by the NDTC, forms and procedures for reporting, Vital Drug list and an attempt to portray estimated cost of all medicines procured through our system. The work by NDTC in compiling a listing of medicine which have been selected of the basis of quality, safety and efficacy primarily and cost as secondarily for the Ministry of Health service providers and other stakeholders must be recommended. Pharmaceutical services are integral component of clinical services and every effort be directed towards regular improvement in accessibility, availability and affodability of these safe and efficacious medicines via best practice such as rational use of antibiotics as basis of benchmarking these services. We should all aspire to achieve and providing the best for our patients and clients. Lepani Waqatakirewa(Dr) CEO, Health December 2006
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FIJI ESSENTIAL MEDICINES FORMULARY -1-
FOREWARD
This edition arises out of the revision of the 1999 Fiji Essential Drug List (EDL) which has now been retitled as the Fiji Essential Medicines Formulary (2006).
It is a compilation of work consistently undertaken by the three Divisional Drug & Therapeutic Committees, the National Drug & Therapeutic Committee (NDTC) using Standard Treatment Guidelines and protocols.
The Essential Medicines Concept adopted by the World Health Organisation ensures that priority medicines such as Antiretroviral, diseases suffered by the majority of the population and the application of the Vital, Essential and Non Essential Analysis for procurement of cost effective medicine will facilitate the accessibility and affordability of these medicines to the citizens of Fiji.
Further, the Formulary includes relevant policies formulated by the NDTC, forms and procedures for reporting, Vital Drug list and an attempt to portray estimated cost of all medicines procured through our system.
The work by NDTC in compiling a listing of medicine which have been selected of the basis of quality, safety and effi cacy primarily and cost as secondarily for the Ministry of Health service providers and other stakeholders must be recommended.
Pharmaceutical services are integral component of clinical services and every effort be directed towards regular improvement in accessibility, availability and affodability of these safe and effi cacious medicines via best practice such as rational use of antibiotics as basis of benchmarking these services.
We should all aspire to achieve and providing the best for our patients and clients.
Lepani Waqatakirewa(Dr)CEO, Health
December 2006
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ACKNOWLEDGEMENT
The National Drugs & Therapeutic Committee (NDTC) gratefully acknowledges the invaluable contribution to this edition of the following;
• Consultants at base hospitals• Chief Medical Offi cers in hospitals and Community Health• Divisional Drugs & Therapeutics Committees• Doctors, Medical Assistants, Nurse Practitioners, Pharmacist, Nurses, and Paramedical.
World Health OrganisationFiji School of MedicineNational NCD CommitteeNational Advisory Committee on AIDSProfessor Richard Fox of Melbourne
Ms Praveena Lata - for the electronic input of the formulary
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DISCLAIMER
The authors do not warrant the accuracy of the information contained in the Fiji Essential Medicines Formulary and do not take responsibility for any death, loss, damage or injury caused by using the information in this Formulary.
While every effort has been made to ensure that this Formulary is correct and in accordance with current evidence based and clinical practices, the dynamic nature of medicines information requires that users exercise in all cases independent professional judgement and understand the individual clinical scenario when referring, prescribing or providing information from the Fiji Essential Medicines Formulary
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MISSION STATEMENT
We commit ourselves to create health by providing cost-effective, effi cacious and safe essentials medicines within the National Drug Policy framework for the people of Fiji.
NATIONAL DRUGS & THERAPEUTICS COMMITTEE
Mrs. Rigieta Nadakuitavuki – Director Nursing & Health System Standards – Chairperson
Dr. Ganeshwar Rao – Consultant Medicine, CWMH – Vice Chairperson
Mr. Peter Zinck – Chief Pharmacist, Fiji Pharmaceutical Services Centre (FPSC) - Member
Professor Robert Moulds – Consultant Medicine/Pharmacologist – Fiji School of Medicine (FSM)
Mrs Vinita Ram – Principal Pharmacist – CEHS Clinical Representative
Dr. Frances Bingwor, Acting Chief Medical Offi cer – CEHS Community Health Representative
Dr. Omar Niazi – Consultant Medicine, Labasa MoH health facilities, NHS Clinical Representative
This Formulary is in line with the National Drug Policy 1994 in promoting Rational Use of Medicines by prescribing within the Formulary with reference to Standard Treatment Guidelines to reduce unwanted adverse events and wastage.
Since the formulary is undergoing constant change, the efforts of the National Drugs & Therapeutics Committee are directed towards the end, that it be constantly improved in order to provide the best clinical practices of patient care as economically as possible.
Please take time to read through each section of the Formulary and the Committee welcomes any constructive comments for continuous improvement of future publications.
We have published this professional formulary handbook to improve patient care and contain costs in Ministry of Health service/providers institutions. We have worked very hard to assure the accuracy and quality of this communication.
The use of ‘drug(s)” and “medicine(s)” are inter-changeable in this publication.
Please take a few minutes to read the following instructions on how to use this reference book.
There are three basic sections in our formulary: • Section I, contains policy and procedures which are pertinent to the formulary
system. • Section II, contains the Medicines List and Pharmacological Listing of the
Essential Medicines. • Section III, is comprised of NDTC endorsed forms. Browse through it for a
moment to familiarize yourself with its content.
SECTION I
Provides the user with a reference on policies and procedures endorsed by the National Drugs and Therapeutics Committee.
SECTION II
• Abbreviations of Levels of distribution
Table A - has an alphabetized listing of all formulary medications by:• Generic name• Formulation• Strength • Level of distribution to MoH Facilities• Weighted Average Cost per Unit of Measure i.e. per dose, per vial etc.• Remarks
Table B is an alphabetical list of all formulary Transfusion Fluids by both generic and trade name in parenthesis with weighted average cost per unit of measure i.e. bag
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Table C is an alphabetical list of all formulary Reproductive Health Commodities by both generic and trade name in parenthesis with weighted average cost per unit of measure i.e. each or ampoule or cycle
Table D is an alphabetical list of all formulary Immunological Preparations by both generic and trade name in parenthesis with weighted average cost per unit of measure i.e. vial
Table E – sorts all formulary listings into Pharmacological categories. Anaesthetics are followed by Analgesics, antipyretics & related agents, for example.
Table F – has the Vital Medicines List, sixty fi ve (65) have been considered Vital under the following fi ve (5) categories, that FPSC will endeavour to ensure 100% stock availability at all times.
i. Drugs used in life-threatening situationsii. No substitute available in the Fiji Essential Medicines Formularyiii. High demand – very commonly used vs. used by selective populationiv. Fatal consequence could result if not availablev. High risk of medico-legal liability if unavailable
Table G – Emergency Kit for Nursing Stations
SECTION III
Policy Forms and Adverse Drug Reaction Assessment Guideline
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TABLE OF CONTENTS
Foreward .............................................................................................................1Acknowledgement ..............................................................................................2Disclaimer ...........................................................................................................3Mission Statement .............................................................................................4Introduction .........................................................................................................5How to Use the Fiji Essential Medicines Formulary ...........................................6
SECTION I . FORMULARY POLICIES & PROCEDURES 1) Defi nition & Description of the Formulary .......................................... 11 2) The National Drugs & Therapeutics Committee (NDTC) ....................11 3) Medicines usage in Ministry of Health Facilities .................................13
SECTION II. FORMULARY LISTING• Abbreviations of level of distributions ......................................................32• Table A - Alphabetic Listing of Formulary Drug Profi le ..........................33• Table B – Alphabetic Listing of Transfusion Fluids ..................................56• Table C – Alphabetic Listing of Reproductive Health Commodities ........57• Table D – Alphabetic Listing of Immunological Preparations ..................58• Table E - Formulary listings into Pharmacological categories. ..............61 Anaesthetics are followed by Analgesics, antipyretics & related agents, for example. • Table F – has the Vital Medicines List of which 65 have ........................78 been considered Vital under the following fi ve (5) categories:
vi. Drugs used in life-threatening situationvii. No substitute in the Fiji Essential Medicines Formularyviii. High demand – very commonly used vs. used by selective
populationix. Fatal consequence will result if not availablex. High risk of medico-legal liability
• Table G –Emergency Kit for Nursing Stations .........................................80
B. REFERENCE FOR DETAILED MEDICINE INFORMATION ..................81
C. GUIDE FOR CAUSALITY ASSESSMENT - ...........................................82 ADVERSE DRUG REACTIONS – Naranjo ADR probability Scale
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SECTION III. POLICY FORMS
• Form 1 – Adverse Drug Reaction Reporting Form .................................83• Form 2 – Application of Drug to be included in the Fiji Essential Medicines Formulary Form ................................84• Form 3 – Request for Non-Formulary Drug Form ...................................85• Form 4 – Non-Formulary Drug request Purchases Flow Chart ..............86• Form 5 – Medication Incident Reporting Form ........................................87• Form 6 – Drug Quality Complaint Form .................................................88• Form 7 – Drug Reporting Quality Complaint Guidelines ........................89• Form 8 – Drug Recall Procedures – Initiated by Supplier ......................91• Form 9 – Drug Recall pro-forma – FPS Only ........................................92
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SECTION I: FORMULARY POLICIES & PROCEDURES
1) Defi nition & Description of the Formulary
The formulary is a continually revised compilation of pharmaceutical information (plus important ancillary information) that refl ects the current clinical judgment of the clinical staff. These essential medicines have been selected by Clinicians through respective Divisional Drugs & Therapeutics Committee (DDTC) before fi nal endorsement by the National Drugs & Therapeutics Committee (NDTC).
2) The National Drugs & Therapeutics Committee (NDTC)
The National Drugs & Therapeutics Committee formulates, endorses, promotes and audits policies and protocols pertaining to the Essential Medicines Concept and the National Drug Policy. This committee is composed of medical offi cers, pharmacists, and other health professionals of whom two each have been appointed by each Divisional Drugs & Therapeutics Committee representing Clinical and Community Health Services. The Chairperson is the appointee of the Chief Executive Offi cer – Health. A senior Clinician from the Fiji School of Medicine is the appointee of the Dean. The Chief Pharmacist and Secretariat are representatives of the Pharmacy Profession and Fiji Pharmaceutical Services Centre.
The primary purposes of the Committee are (1) policy formulation (2) policy enforcement and (3) educational. It recommends the adoption of, or assists in the formulation of, policies regarding evaluation, selection and therapeutic use of medicines. Further, the Committee recommends or assists in the formulations of programs designed to meet the needs of the professional staff (physician, nurse, pharmacists and other health-care practitioners) for complete current knowledge of matters relating to medicines and their usage.
The functions of the Committee are:• To serve in an advisory capacity to clinicians, allied health care workers
and executive management on matters pertaining to use of medicines including investigational and donated medicines.;
• To develop a formulary of medicines accepted for use in MoH health facilities and provide for its constant revision. The selection of items to be included in the formulary is based on objective evaluation of their relative therapeutic merits, safety, and costs. The Committee strives to minimize duplication of the same basic medicine type, medicine entity, or medicine product;
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• To ensure that Drug Use Evaluation activities are conducted and interventions carried out in order to decrease resistance to antimicrobials; promote rational prescribing habits; promote wise use of medicines by the public and minimize wastage;
• To establish programs and procedures that help ensure cost-effective medicine therapy;
• To initiate or direct drug use review/ drug use evaluation studies in public and private health facilities;
• To establish or plan suitable educational programs for all professional and clinical staff on matters related to medicine use;
• To participate in quality improvement activities related to the procurement, storage, distribution, administration, wise use and safe disposal of medicines;
• To review adverse drug reactions occurring in public health facilities and the private sector;
• To create health in the advocacy of the provision of drug and poisons information in promoting the prevention and better management of poisons;
• To ensure that proper inventory control practices in MoH facilities are practised and adequate inventory training for health care workers to decrease wastage and ensure that patients receive effi cacious and safe medicines.
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3) MEDICINES USAGE in MINISTRY of HEALTH FACILITIES
INTRODUCTION
This formulary consolidates the requirements of the Pharmacy and Poisons Act (Cap 115) the Dangerous Drug Act (Cap 114), the National Drug Policy 1994, and Ministry of Health directives in relation to good practice in all aspects of medicines acquisition, prescribing, dispensing, distribution, administration and storage of medicines. All personnel involved in the complex process of medication management must observe the provision set out in this document.
1. DRUGS AND THERAPEUTICS COMMITTEE
All Divisional and Sub divisional MoH health facilities which have a pharmacy department must have a drugs and therapeutics committee.
1.1 The membership of the committee will comprise of the following as outlined below:
Divisional Drugs & Therapeutics Committee (DDTC) Manager Clinical Services (MCS) or nominated Consultant Principal Pharmacist or Drug Information Pharmacist – Secretary Consultant or representative – From each discipline Consultant Radiology or representative Consultant Pathology or representative Dental Representative Manager Nursing Services – MoH health facilities/Community Health General Manager Community Health or representative
Sub-divisional Drugs & Therapeutics Committee (SDTC) Sub-divisional Medical Offi cer – Chair Pharmacy Technician – Secretary One Medical Offi cer practicing in the Sub-divisional MoH health facilities Medical Offi cers from Health Centres within the Sub-division Nursing Representative Dental Representative Laboratory Representative Radiology Representative
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1.2 The committee should meet six (6) times a year. Extraordinary meetings may be called by the Chairperson if any critical issues pertaining to drugs and therapeutics arise.
1.3 Minutes of the committee meetings will be referred to the National Drugs and Therapeutics Committee for information as soon as those meeting minutes have been confi rmed. Important issues should be highlighted with action points.
1.4 The Divisional Drugs and Therapeutics Committee will be responsible for defi ning therapeutic protocols at the local level, promoting, monitoring and rationalizing medication usage including the undertaking of medicines utilization review studies. The Committee will be responsible for the annual review of medicines requirements which will encompass requested additions to, and deletion from, the allocated medicines imprests or maximum stock levels for each health facility.
1.5 All drug therapy from the Essential Medicines Formulary for inpatient use is to be supplied free of charge by the MoH facilities in accordance with the National Drug Policy 1994. Non-formulary Medicines and Medicines for Paying Patients may be charged. All discharge medicines therapy from the Essential Medicines Formulary should be supplied free of charge by MoH health facilities in accordance with established policy. Medicines therapy for outpatient should be supplied in accordance with policies developed by the National Drug and Therapeutics Committee.
1.6 The Divisional Drugs and Therapeutics Committee should defi ne a system to monitor and report all medication incidents involving Doctors, Nurses, Pharmacist and allied Health Professionals. These reports must be reviewed thoroughly, and training introduced where necessary, and systems altered when necessary. Staff must be reassured that the objective of the system is the improvement of patient safety. All reports shall be confi dential.
1.7 If it is necessary for any medicines to be recalled this will be initiated by the Chief Pharmacist who will provide information to the General Managers Community Health, Managers Clinical Services and Principal Pharmacists. It will be the responsibility of GMCH/MCS to ensure that clinical staff are notifi ed within their institutions, and that any implicated medicines(s) is/are returned to the nearest Divisional MoH health facilities Pharmacy
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Department or Fiji Pharmaceutical Services Centre as requested in the recall notifi cation. The Drug Recall Proforma (Form 9) will be fi lled by FPSC for notifi cation to clinicians and all Committee members informed and tabulated at the next NDTC meeting.
Any suspected problem or defect with medicines should be notifi ed by facsimile or telephone to the Principal Pharmacist – Essential Medicines Section (Telephone 3388 000 or Facsimile 3388003).
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2.0 PRESCRIPTION OF MEDICINES
2.1 All prescription must clearly detail the following procedural and clinical requirements in the doctor’s handwriting in blue or black ink or biro.
• Name of Health Facility• the patient’s full name; address and NHN• age and weight for pediatric patients• generic medicines name• medicines strength• dosage regimen• quantity to be supplied or time period for treatment• registered prescriber’s signature, date and name printed or approved
rubber stamp with initials
2.2 Doses should be stated in mass units e.g. mg, microgram and not in number of tablets or ampoules, nor mL of mixture because the strength of the medication available may vary from time to time.
2.3 When writing a dose of less than one mass unit, a leading zero must be written before the decimal point e.g. 0.5mg. Failure to do this can result in ten times the desired dosage being administered.
2.4 Prescribing for MoH facilities inpatients must be charted on approved Ministry of Health Inpatient Drug Charts, Insulin Dosage Charts or Intravenous Fluids Charts with the name of the MoH facility specifi ed. These Charts must not be photocopied for dispensing or for administering of medicines. The use of Photocopies is prohibited. Treatment sheets must be regularly reviewed by the prescriber and at most every 7(seven) days.
2.4.1 The following details must be completed by the registered Prescriber: • Name of Health Facility• the patient’s full name; address and NHN• age and weight for pediatric patients• generic medicines name• medicines strength• dosage regimen• quantity to be supplied or time period for treatment• registered prescriber’s signature, date and name printed or approved rubber
stamp with initial. Each medicines order must be individually signed.
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2.4.2 When a prescriber wishes to alter any of the above particulars, he/she must cease the original order and write a new order.
2.4.3 When a prescriber wishes to cease an order a line must be placed through the order, signed and dated by the prescriber. The original order must not be obliterated.
2.4.4 The patient’s discharge medication must be reviewed by the Prescriber as part of the patient’s general review prior to discharge from the MoH health facility. Any discharge medication should be prescribed separately to the inpatient order in the special section on the treatment sheet or alternately, a separate discharge prescription may be written.
2.4.5 To avoid errors in interpretation abbreviations must not be used. E.g. “Units” must be written in full and not abbreviated to “U”. “Microgram” must be written in full and not abbreviated to “mcg” or “ug”. “Six hourly” must be written in full and not abbreviated to “6/24.”
2.4.6 For liquid medications or other mass units, the strength should always be specifi ed and the dose stated in milligrams (or micrograms as the case may be), not millilitres (mls). This is especially important when prescribing pediatric medication
2.5 All prescriptions for MoH facilities outpatients and clinic patients must be clear and unambiguous as these prescriptions may be taken by patients to retail pharmacies for dispensing. The prescribers’s name must be clearly printed on the prescription, to enable contact to be made if necessary.
2.6 Prescriptions for outpatients are to be restricted to the policy defi ned by the National Drugs and Therapeutics Committee and a maximum quantity for one month’s treatment for special outpatient department prescriptions and maximum of one week’s treatment for general outpatient department prescriptions. Exceptions to this limit will be rare but may be defi ned by the National Medicines and Therapeutics Committee e.g. depending on adequate stock situation a maximum of four month’s therapy for patient’s who are better controlled with their diseases such as epilepsy, thyrotoxicosis, rheumatic heart fever prophylaxis and patients who are well controlled who live in remote areas.
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2.7 Prescriptions for Special Outpatients Department patients who are intending to visit overseas will be supplied a maximum of three month’s supply, pending adequate stock situation.
2.8 Prescriptions for Special Outpatients Department presented at another health facility and where there is a stock problem will require the resident Medical Offi cer to review the patient again before medicines are dispensed.
2.9 Prescriptions for dangerous drugs for outpatienst are restricted to oral formulations which can be obtained from Divisional and Sub divisional MoH facilities only. Higher than usual dosage or a treatment period beyond four weeks requires approval from the Chief Executive Offi cer for Health. It is the Registered Medical Offi cer’s or Dentist’s responsibility to obtain this approval.
2.10 Prescriptions for parenteral dangerous drugs are restricted to inpatients only. Prescriptions for dangerous drugs must state exact administration schedules i.e. “prn” or “mdu” must be qualifi ed by a time schedule. E.g. “Pethidine 50mg IV every four hours when required for pain relief up to maximum of ten doses”.
2.11 Prescription of dangerous drugs for any patient cannot continue beyond four weeks without permission of the Chief Executive Offi cer for Health. Full patient details must be supplied including diagnosis, treatment program and prognosis.
2.12 In the interests of clarity and prevention of misinterpretation all prescription pads should be printed. All Ministry of Health prescribers must write prescriptions on the appropriate printed prescription pads for Schedule 4 and Schedule 8 medicines.
2.12.1 In the interests of safety, telephone orders are strongly discouraged. The acceptance of verbal order by telephone is restricted to the Nursing Supervisor or Senior Nurse. The Treatment Chart or Prescription must be written within 12 hours of the telephone order.
Should a nurse agree to accept a telephone order from a doctor in an emergency, she must record in ink on the treatment sheet the medicines, dosage, formulation and dosage regimen requested. This must be written in the “once only” section of the treatment chart.
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2.12.2 The doctor must countersign the telephone order within 12 (twelve hours), and prescribe any continuing therapy.
2.12.3 No drug is to be prescribed or transcribed by nurses unless outlined in the NP protocol or the IMCI protocol for nurses or medical offi cer’s recommendation.
2.13 If it is necessary to alter prescribed medication (e.g. dosage, frequency) then the complete medication order must be rewritten.
2.14 Inventory and prescribing of medicines is restricted to the range of medicines specifi ed in the Health Facility’s categorization in the Fiji Essential Medicines Formulary. The purpose of the Essential Medicines Formulary is to ensure rational use of medicines using the NDTC Standard Treatment Guidelines. One example is the restriction of certain antibiotics to ensure treatment success and to prevent the emergence of resistant micro-organisms
2.15 Medicines outside this range may only be used in the health facility with the knowledge of the Chairperson of the Sub-divisional or Divisional Drugs and Therapeutics Committee. Non Formulary Medicines Request forms are available if a non-formulary medicine is requested for treating a particular patient. A report on the necessity of this action must be sent to the National Drugs and Therapeutic Committee so that annual review of these non-fomulary medicines can be done.
2.16 Parenteral therapy should not be prescribed for outpatients when oral therapy is the most satisfactory choice.
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3. ADMINISTRATION OF MEDICINES
3.1 In all MoH facilities, no person may administer medication to a patient except on a written prescription from a doctor, dentist, medical assistant or nurse practitioner. It is accepted that a restricted range of medicines may be administered by a nurse in a nursing station according to the National Drugs & Therapeutics Committee approved protocols. See paragraph 2.12.3 above.
3.2.1 Medication must be administered to patients whilst referring to the prescriber’s instruction(s) on the drug treatment sheet.
3.2 2 The medication order must be rewritten for subsequent administration to a patient. This means that transcribing is not permitted.
3.2.3 All medication administered must be signed on the medicines treatment sheet by the registered clinician after administration.
3.3 Medication must be selected, administered and recorded by the same nurse, and must be counter-checked by a second nurse or doctor or dentist or registered pharmacist.
3.4 Medication must be administered to patients from the container supplied by the pharmacy department. Under no circumstances should nurses transfer medication from one container to another on the ward nor alter the label on any medicines container.
3.5 Ward Imprest and Dangerous Drug cupboards and trolleys are to be kept locked when not in use and the keys carried by the Sister-in-charge of the ward.
3.6 Patient’s own medication may not be routinely administered to them whilst they are inpatients. MoH facilities medication must be used except when the patient must be maintained on medication which is not available on the Essential Medicines Formulary.
3.7 Patients may self-administer medication only upon written order of the Medical Offi cer or Dental Offi cer. E.g. Metered Dose Inhalers
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3.8 Patients must not take any medication (including herbal preparation or traditional medicines) whilst an inpatient unless approved by the medical offi cer.
3.9 Medicines must not be given from the ward to any patient to take home. A prescription must be written for dispensing in the MoH facilities pharmacy inpatients section. A registered Pharmacist may counsel discharged patients or carers in the ward.
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4. Dangerous Drug Policy
4.1 A dangerous drugs register must be maintained by the sister in charge of the ward. Dangerous drugs must be kept locked in a dangerous drugs cupboard separate from other medicines. Administration of dangerous drugs must be checked by a second nurse and both nurses must sign the register. A book and stock balance must be undertaken at the beginning of every week and any problem, solved immediately. Both the Senior Matron/Matron and Pharmacist-in-charge must be notifi ed if any medicines or register is missing. Any remaining discrepancy which can not be solved at the time must be notifi ed to the Manager Clinical Services or Sub-divisional Medical Offi cer as appropriate.
4.2 The Sister-in-charge of the ward is responsible for the storage of all medicines on the ward. New issues of dangerous drugs must be checked by the sister on receipt, recorded in the register and immediately locked into the appropriate cupboard. The Sister-in-charge may delegate this responsibility to a senior nurse when she is absent from the ward.
4.3 No goods including money and documents shall be kept in the dangerous drugs cupboard.
4.3.1 The Dangerous drugs register must incorporate a record of all transactions involving dangerous drugs. The dangerous drugs register must be a bounded book with consecutively numbered pages. A separate page must be used for; each dangerous drug; each form of dangerous drug; each strength of dangerous drug.
4.3.2 The record in the register must include the following details for each transaction; date; name & address of person from whom medicines received or to whom supplied; quantity of medicines received or supplied; balance remaining; name of prescriber; signature of person making the entry; signature of person checking.
4.4. A person making an entry in the Dangerous Drugs Register must not make any false or misleading entry, and must not make any alterations, obliterations or cancellation (including crossing out or drawing a line through an entry). If a mistake is made it must be left as it is, marked with an asterisk, rewritten as appropriate, and a note explaining the error must be made in the margin or at the foot of the page, initialled and dated.
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4.4.1 The Dangerous drugs Register entry must record the following details: • date; • time of day; • patients name; • National Health Number (NHN) • amount administered; • amount discarded (if part ampoule administered); • balance remaining; • signature of person(s) making the entry; • signature of person checking; • name of the prescriber.
4.5 If a Dangerous drugs Register is lost or stolen, the action specifi ed in 4.1 must be taken immediately.
4.6 The Sister In Charge must conduct monthly dangerous drugs stock take and checked by the Pharmacy technician or registered pharmacist. Any discrepancies triggers the action specifi ed in 4.1. A red ink or biro pen must be used.
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5. PHARMACY MANAGEMENT OF MEDICINES
5.1 The Pharmacist-in-charge or Pharmacy Technician–in-Charge is responsible for the acquisition and supply of medication to MoH facilities patients in accordance with policies developed by the DDTC and NDTC.
5.2 The Pharmacist-in-charge or Pharmacy Technician–in-Charge is responsible for the provision of medicines information to MoH facilities staff, patients and members of public.
5.3 The Pharmacist-in-charge or Pharmacy Technician–in-Charge is responsible to the Chief Pharmacist, General Manager Hospital Services or Sub-divisional Medical Offi cer for the proper management of the pharmacy service.
5.4 The pharmacy is a restricted area and access is limited during opening hours to medical, nursing, allied health workers as authorized by the Pharmacist-in-charge or Pharmacy Technician in Charge. The outpatients pharmacy or dispensary is closed outside the normal working hours (except for Saturdays and public holidays from 8am to 12pm) with no access to any other personnel unless authorized by the Pharmacist-in-charge or in his/her absence the Sub-divisional Medical Offi cer. The Pharmacy personnel on-call will service wards via the inpatients section for replenishment of imprest stock or dispensing of newly charted medicines and Accident/Emergency Imprest.
5.5 Pharmacy locks must be of “dead-latch” type.
5.6 Reference resources available in the pharmacy must include recent editions of the following reference texts as a minimum “Martindale Extra Pharmacopoeia” and Australian Pharmaceutical Formulary or Australian Medicines Handbook or Prescription Proprietary Guide or similar.
5.7 All medicines for therapy entering the MoH facilities must be supplied through the pharmacy service so that actual MoH facilities requirements can be monitored.
5.8 All medicines for therapy supplied to discharged patients must be written on prescriptions and dispensed from the inpatients section of the MoH facilities pharmacy. The prescription should be written in the special discharge section of the treatment sheet. However, in special circumstances a special prescription may be used.
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5.9 All medicines for therapy supplied to outpatients must be in accordance with policies as defi ned by the National Drugs & Therapeutic Committee.
5.10 All medication for patients must be packaged properly and labelled clearly with:
• patient’s name • Patient’s National health Number (NHN) • date of dispensing • generic name of medicine and strength • dosage schedule • total quantity dispensed • prescriber’s name
Label should be typewritten or computer generated.
5.11 Pharmaceuticals supplied from the Pharmacy department to wards and other departments should preferably be in manufactures’ original packs. Where repackaging is necessary, this must be carried out by pharmacy support staff under the direct supervision of a Pharmacist with clear labeling and an expiration date 3 months from the date of repackaging.
5.12 Supply of medicines for therapy to inpatients should be by imprest system monitored by Pharmacy Imprest staff. For individual patient dispensing or non-imprest issuance, the Pharmacy Inpatients staff shall dispense from the Inpatients Medication Chart.
5.13 As pharmacy staffi ng permits, a Pharmacist should visit the wards on a regular basis and review inpatients medicines treatment charts. Where appropriate, advice should be given to nurses and prescribers on:
• Administration of medicines; • Therapy of medicines; • The Pharmacology of medicines in use; • The choice of antibiotic based on laboratory sensitivity report and
rational usage criteria; • The reasons behind the Essential Medicines Formulary; • Medicines which require intensive monitoring e.g. gentamicin, digoxin,
theophylline and warfarin in the interest of safety and avoidance of toxicity;
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• Any suspected adverse medicines reactions and report details of these to the Divisional Medicines and Therapeutics Committee. Adverse Drug Reactions (ADR) to medicines must be entered into the PATIS under the PMI section for allergies. The yellow ADR forms (form 1) should be available in all wards and units for reporting of any suspicious ADRs and forwarded to Secretary, National Drug & Therapeutics Committee, Essential Medicines Program, P.O. Box 106, SUVA.
These Ward based and community health pharmacy services are very important for the safe, appropriate, effective and economical use of medicines.
5.14 All medicines stocked in the storeroom must have stock cards and must be updated regularly. Monthly or quarterly stock balances must be conducted before monthly or quarterly orders are placed on FMIS order sheets or entering the Inventory Replenishment Report. Near expiration medicines or slow moving medicines must be re-distributed to the nearest divisional MoH health facilities and recorded on stock cards.
5.15 Regular and proper inventory control practices are practiced using FIRST EXPIRY, FIRST OUT (FEFO) concepts.
5.16 Expired medicines should never be used other than in very exceptional circumstances. If expired drugs are used then the patient or carer or family members must be informed and consent obtained before use. All expired medicines should be recorded and disposed of as per National Drug Policy.
5.17 Immunological preparations including vaccines must be stored in a refrigerator dedicated for that purpose e.g. Icelined. Vaccines must be place in the body of the domestic refrigerators and never packed in the door. Proper inventory control practices must be carried out regularly by practicing FEFO; updating of stock cards and Epicor entries; optimal storage and re-distribution of near expiring or slow moving commodities. Vaccine return forms must be fi lled completely and correctly for ordering from FPSC or nearest health facility.
5.18 Security of Family Planning Commodities must be ensured at all times. Proper inventory control practices must be carried out regularly by practicing FEFO; updating of stock cards and Epicor entries; optimal storage and re-distribution of near expiring or slow moving commodities. Family planning return forms must be fi lled completely and correctly for ordering from FPSC or nearest health facility.
FIJI ESSENTIAL MEDICINES FORMULARY -27-
6.0 OTHER ISSUES
6.1 Policy Regarding Medicine Samples
Distribution of medication samples by pharmaceutical company representatives in any of the MoH facilities is forbidden.
No sample medications shall be administrated to patients. In the event that a medicine is not available through normal channels, the Pharmacy Department must be contacted.
6.2 Policy regarding Drug Representatives
Ministry of Health care providers in public health service facilities shall not invite representatives from pharmaceutical companies or wholesalers to promote the use of any drug or clinical product unless approved by the NDTC Chairperson or his/her nominee.
6.3 Adding Medicines to the Formulary
Medicines are admitted to the formulary according to their non-propriety (generic) names. No medicine or preparation shall be admitted to the formulary unless its formula or composition is known and its therapeutic value has been established to the satisfaction of the National Drugs and Therapeutics Committee.
Any member of the Medical Staff may request the addition of a medicine to the formulary by submitting a request using the - Application for a New Drug to be included in the Fiji EMF Form (Form 2), along with supporting information, to the Secretary, Divisional Drugs & Therapeutics Committee (DDTC) for fi rst submission.
The Secretary of the DDTC will forward the request, along with supplemental information gathered by there Drug Information Service, to the NDTC. For each medicine, specifi c consideration is given to: • Pharmacologic classifi cation • Therapeutic indications • Dosage forms available • Bioavailablity and pharmacokinetics • Dosage range • Known side effects and toxicities • Special precautions required.
FIJI ESSENTIAL MEDICINES FORMULARY-28-
• Advantages of the medicine over similar agents • Disadvantage of the medicine compared to similar agents • Therapeutic comparisons with other medicines or treatments • Cost comparison with other medicines or treatments • Estimated usage rate per annum
The DDTC will then forward its fi ndings and submission to the NDTC for further literature search conducted by the National Poisons & Information Centre before a decision is made by the NDTC. The committee may invite the requesting party to attend this meeting and discuss the request.
6.4 Removing Medicines from the Formulary
Request for deletion of a medicine from the formulary shall be submitted in writing to the Chairperson, DDTC along with supplemental information gathered by the Offi cer and the Drug Information Service to the NDTC for action. The committee may invite the requesting party to attend this meeting and discuss the request.
The formulary is reviewed periodically in its entirely by the NDTC to assure that it contains only those medicines most useful for patient care.
6.5 Non-Formulary Drug Request
Request for purchase of a non-formulary medicine for (EMERGENCY PURPOSE ONLY) can be requested using the Request for Non-Formulary Drug Form (Form 3) and using the Non-Formulary Drug Request Purchases Flow Chart (Form 4) as a guide.
The form must be fi lled correctly and completely for ease of procurement. The fi lled form must be forwarded immediately to the Pharmacist In Charge and to the Secretary – NDTC, Fiji Pharmaceutical Services, Fax: 3388 003.
The estimated time of delivery of the non-formulary request is 72 hours and may vary for weekends and public holidays. The requestor is expected to present a feedback report to the NDTC on the effectiveness of the drug within 7 days of completion or suspension of therapy.
If the non-formulary drug is effective and has been requested at least three (3) times to the NDTC, then this can be considered for possible Formulary inclusion.
FIJI ESSENTIAL MEDICINES FORMULARY -29-
6.6 Donated Drugs
Any donated drugs from Non Governmental Organizations, Civil Societies, Religious Organizations, Foreign Governments & United Nations as aid for natural disaster consequences or outbreak and Overseas Teams must be within the Essential Medicines Formulary. The Ministry of Health has adopted the WHO Donated Guidelines following these four core principles: i. Maximum benefi t to the people of Fiji ii. Respect wishes and authority of the Ministry of Health iii. No double standards in quality, safety and effi cacy iv. Effective communication between donor/team coordinator and Pharmacy
Department/Fiji Pharmaceutical Services Centre
6.6.1 Selection of Drugs
All drug donations should be based on the Fiji Essential Medicines Formulary List and registered in Fiji.Should be relevant to the disease patterns of Fiji**If not on Formulary then approval should be sought from proper authority i.e. Chief Pharmacist and/or NDTC
6.6.2 Quality Assurance & Shelf –life
All donated drugs should be obtained from a supplier that has been approved by the Fiji Pharmaceutical Services and comply with the International Code of Good Manufacturing Practice (CGMP).
No drugs donated should be used for research purposes, nor recycled from previous patient use from the donated country (unless approved by authority) or should have been given to health professionals as free samples.
All donated drugs should have a remaining shelf-life of a minimum of 18 months upon arrival at designated MoH facility.
FIJI ESSENTIAL MEDICINES FORMULARY-30-
6.6.3 Presentation, packaging and labelling
All drug items should comply with the following:
• Labeling must be in the English language • Standard must be of British Pharmacopaeia (B.P) or United States
Pharmacopaeia (USP) or European Pharmacopaeia (EUP. P) or registered in approved countries as per Pre-qualifi cation requirements of the Regulatory Authority of FPSC.
• Generic name of drug • Strength • Dosage Form • Quantity of drug per primary container • Batch number • Expiry date • Name of manufacturer • Storage conditions • Have product leafl ets inserted (for reference)
FIJI ESSENTIAL MEDICINES FORMULARY -31-
6.6.4 Information and Management
Donor/coordinator/consultant should liaise with Chief Pharmacist or Principal Pharmacist at the Divisional MoH facilities at least four weeks before team or donation arrives in Fiji.
The initial correspondence should contain the following detailed information before approval of drug donations:
• The type and quantities of drug donated • Generic name of drug • Standard must be of British Pharmacopaeia (B.P)or USP or European
Pharmacopaeia or registered in approved countries as per Pre-qualifi cation requirements of the Regulatory Authority
• Strength and dosage form • Batch number • Expiry date • Manufacturer or wholesale supplier • The expected date of arrival and port of entry • Identity and contact address of donor
Costs of all freights and clearance (if not duty-free) should be met by the donor agencies or team.
The Warehouse Manager or Logistics Offi cer in the Divisional MoH health facilities will stock all donated drugs and document all transactions.
Any excesses from the visiting team will be discarded under the National Drug Policy 1994 or used appropriately by the consultant.
FIJI ESSENTIAL MEDICINES FORMULARY-32-
ABBREVIATIONS
The following abbreviations have been used in compiling the drug list:
HM - Hospital manufactured.Level 1 - Divisional hospital only.Level 2 - Divisional + Specialist hospital only.Level 3 - Divisional + Specialist + Sub divisional hospitals.Level 4 - Divisional + Specialist + Sub divisional hospitals + HealthCentres.Level 5 - Divisional + Specialist + Sub divisional hospitals + HealthCentres + Nursing Station.Level 5a - Nursing Station with medical offi cer’s authorizationRequest only - Those drugs which will only be purchased on request.Hub - Reproductive Health Clinic & Speciality Clinic for HIV/AIDS cases
Abbreviationsmg - milligramg - grammL - millilitreL - litrew/v - weight per volumev/v - volume per volumeMicrogram – To be written in fullUnits – To be written in fullInternational Units - To be written in full
Note: The number in superscipt following the drug name indicates the section under which the drug has been classifi ed in the Pharmacological Drug List.
For example, Amoxycillin6 . This means that Amoxycillin is included in the Pharmacological Drug List Section 6.
* For the treatment and prophylaxis of Pneumocystis carinii pneumonia and toxoplasmosis, treatment of norcadia infections, treatment of urinary tract infections and acute exacerbations of chronic bronchitis and treatment of acute otitis media in children where there is good reason to prefer, co-trimoxazole to a single antibiotic
Flucloxacillin Sodium6 cap 250mg 4 0.09Flucloxacillin Sodium6 inj 500mg 3 Alternative to Cloxacillin Inj, if hard to sourceFlucloxacillin Sodium6 cap 500mg 4 0.17Fludrocortisone18 tab 100 microgram 1 0.08Fluorescein14 eye drops 2% (minims) 1 31.06 EYE DEPARTMENT ONLY
5-Fluorouracil Sodium8 inj 500mg 1 1.34 CYTOTOXIC - CONSULTANT ONLY
DRUG NAME FORM STRENGTH LEVEL COST REMARKS
FIJI ESSENTIAL MEDICINES FORMULARY -41-
Fluphenazine inj 25mg/1mL 2 1.07Decanoate24
Folic Acid10 tab 5mg 5 0.01Folinic Acid4 inj 3mg/1mL 1 2.15 Also known as Leucovorin CONSULANT ONLY
Folinic Acid5 inj 100mg/10mL 1 45.64 Also known as Leucovorin CONSULANT ONLY
Paraffi n BP17 liq 500mL 5Paclitexal*8 inj 100mg in 16.7mL 1 FOR CONSULTANT USE ONLY Refer to protocol*Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum
Polyantibiotic* 21 eye drop 1 2.12 For Eye Department Only*Polymyxin B Sulphate - 500IU, Neomycin Sulphate - 1700 IU or 2.5mg, Gramicidin - 25 microgram/mL, Thiomersal 0.001%
Polyantibiotic* 21 eye oint 1 4.92 For Eye*Polymyxin B Sulphate - 500IU, Neomycin Sulphate - 5mg, Department OnlyBacitracin zinc 400 Units/g. Sterile
Acyclovir eye oint 30mg/gChloramphenicol eye drop 0.50%Chloramphenicol eye oint 1%Gentamicin eye drop 0.30%Polyantibiotic eye dropPolyantibiotic eye ointTetracycline eye oint 1%
Aciclovir
DRUG NAME FORM STRENGTH
FIJI ESSENTIAL MEDICINES FORMULARY-74-
Table E - Formulary listings in Pharmacological Categories
22.2 Anti-oxytocis
Salbutamol inj 1mg/1mLSalbutamol tab 4mg
21.2 Anti-Inflammatory Agents
Betamethasone-Neomycin eye oint 0.1%/0.5%Betamethasone-Neomycin eye drop 0.1%/0.5%Prednisolone Acetate/ eye drop 10mg-1.2mg/mLPhenylepherine HCI eye drop 10%
21.3 Local Anaesthetics
Oxybuprocaine (minims) eye drop 0.4%
21.4 Miotics and Anti-glaucoma Drugs
Acetazolamide tab 250mgAcetazolamide inj 500mgAcetylcholine Chloride inj 20mgPilocarpine eye drop 1%Pilocarpine eye drop 2%Pilocarpine eye drop 4%Timolol eye drop 0.25%Timolol eye drop 0.5%
21.5 Mydriatics
Atropine Sulphate eye drop 1%Homatropine eye drop 2%Phenylepherine eye drop 10%Tropicamide eye drop 1%
Table E - Formulary listings in Pharmacological Categories
Thiamine HCI inj 100mg/2mLVitamin A gel filled caps 50,000 IUVitamin A gel filled caps 100,000 IUVitamin A gel filled caps 200,000 IUVitamin K (1) inj 10mg/1mLVitamin K (1) inj 1mg/0.5mL
SECTION 28 EAR, NOSE AND OROPHARYNGEAL PREPARATIONS
The following medicine reference works are compulsory for Pharmacy Departments:
• National Drug Policy 1994• Essential Medicines Formulary – current edition• Fiji Standard Treatment Guidelines – All updated and current editions -
NDTC• Medical Supplies Management Manual – Ministry of Health, FIJI, 1998• Australian Medicines Handbook – current edition• Australian Pharmaceutical Formulary – current edition• Martindale – current edition• British Pharmacopaeia – current edition• SHPA - Book of Injectables – current edition
FIJI ESSENTIAL MEDICINES FORMULARY-82-
Naranjo ADR Probability Scale
(Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse reactions. Clin Pharmacol Ther 1981;30(2):239-45.
Question Yes No Don’t Know Score
1. Are there previous conclusive reports on this reaction?
+1 0 0
2. Did the adverse reaction appear after the suspected drug was administered?
+2 -1 0
3. Did the adverse reaction improve when the drug was discontinued, or a specific antagonist was administered?
+1 0 0
4. Did the adverse reaction appear when the drug was re-administered?
+2 -1 0
5. Are there alternative causes (other than the drug) that could on their own have caused the reaction?
-1 +2 0
6. Did the reaction reappear when a placebo was given?
-1 +1 0
7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?
+1 0 0
8. Was the reaction more severe when the dose was increased or less severe when the dose was decreased?
+1 0 0
9. Did the patient have a similar reaction to the same or similar drug in any previous reaction?
+1 0 0
10. Was the adverse event confirmed by any objective evidence?
+1 0 0
TOTAL
Score
<0 Unlikely
1-4 Possible
5-8 Probable
>9 Certain
C. GUIDE FOR CAUSALITY ASSESSMENT - ADVERSE DRUG REACTIONS
FIJI ESSENTIAL MEDICINES FORMULARY -83-
Outcome: Recovered Not recovered Unknown Fatal
Date of Death: / / Comments (e.g. relevant H2 allergies, previous exposure to this drug):
ESSENTIAL MEDICINES
(Note: Identities of Reporter, Patient and Institution will remain confi dential)Demographic DetailsPatient (Initials or National Health Number): __________________________________________
Age: _______ Sex: F M (Please circle
Wight: _______kg Height: ____ Race: ____
All Medicines in Use **Asterisk suspect medicine(s) include traditional medicines/supplements/OTCs.
ADVERSE DRUG REACTION REPORT
Please forward form as soon as Possible to: Secretary, National Drugs & Therapeutics Committee, FijiPharmaceuticl Service, P.O. Box 106, Suva or Facsimile: 338 8003
Reporting Person Name/Designation: ________________________________________________
(Send completed form to Inpatients Pharmacist for notification to NDTC Secretary - Fiji Pharmaceutical Services, fax No: 3388003)…………………………………………………………………………………………………………….NDTC Response: Approved/Not Approved
If Approved, State: Quantity Purchased: ___________ Cost/unit: ___________ Total Cost: _________ Item Code: ____________________
FIJI ESSENTIAL MEDICINES FORMULARY -85-
REQUEST NON FORMULARY DRUG FORM (FORM 3)
(To be filled in by REQUESTING officer)
Name of DRUG: _______________________________
Strength & Formulation of DRUG: ____________________________________
Indication of Use: ________________________________________________
Duration of Therapy: ______________________________________________
Provide Justification for purchase of this DRUG: (Please attach Literature review, diagnostic results including microbiology report, second opinion from the microbiologist, pathologist, infection control specialist etc)
(Send completed form to Inpatients Pharmacist for notification to NDTC Secretary - Fiji Pharmaceutical Services, fax No: 3388003)…………………………………………………………………………………………………………….
NDTC Non-Formulary Response or FPS response (Essential Medicines)
Request No: _______ Approved/ Not-Approved
If Approved, State:
Quantity Purchased: ___________ Cost/unit: ___________ Total Cost: _________
Item Code: ____________________
FIJI ESSENTIAL MEDICINES FORMULARY-86-
Proposed Non Formulary Drug Request Purchases Flow Chart (EMERGENCY PURPOSE ONLY) – FORM 4
Feedbackto
requestoron options
YES
NO
NDTC Secretary to log request and create database for future reference for possible EDL inclusion
Requestor presents feedback to NDTC on the effectiveness of the drug within 7 days of completion orsuspension of therapy
Non-formulary drug received at FPS and issued to Inpatients Pharmacy Department for patient use
Procurement to place order with approved supplier from Schedule of Quotes Evaluation for non-formulary drug to be delivered within 48 hours of the order.
Approval by NDTC or FPS EMA or CP??
Complete “Non-Formulary Drug Request Form” with justification attachments to principalPharmacist for notification to NDTC Secretary
If ActionPlan – toNDTCChair
NO
Need identified for purchaseDiscussion/review by other
clinicians/specialist. Literature review & Diagnostic report
Please submit the completed form to the Principal Pharmacist of your nearest Divisional Hospital as soon as possible. Principal Pharmacist to forward report to Secretary, NDTC, Fiji Pharmaceutical Services, P.O. Box106, Suva or by facsimile 3388 003, one week before the next scheduled NDTC meeting.
Please state Strength & Formulation
E��ENTIA� MEDICINE�
FIJI ESSENTIAL MEDICINES FORMULARY-88-
ESSENTIAL MEDICINES
Name of reporting officer: __________________ Signature: ____________________
Unit: ____________ Health Facility: _________________________
Date: ______________________
(Please note: Return drug and completed form to Pharmacist/Pharmacy technician in Charge to beforwarded to FPS) ________________________________________________________________________________________________
To be filled in by local Pharmacist/Pharmacy Technician In Charge:
Product re-examined and tested if possible: YES NO
Brand: __________________________ Country manufactured: _______________
Registration No (if applicable): __________________________________________
Please state problem/s encountered with product:1.
2.
FIJI ESSENTIAL MEDICINES FORMULARY -89-
DRUG REPORTING/PRODUCT COMPLAINT GUIDELINES (FORM 7)
All product complaints/problems should be reported in all instances where there is concern relatingto the safety of a drug or it fails to meet expectations.
What is a drug quality complaint?
Complaint can be anything which creates a hazard or places you or your patient at risk, eg:
Compromised sterilityPhysical Structure Defects e.g. mouldy tablet; poor dissolution
Incomplete instructions Poor design
Packaging or labelling defectsSub-therapeutic Effects in comparison to time of onset of action and desired therapeutic effects
i. DO NOT THROW THE FAULTY DRUG OUT, unless it is contaminated or personnel are putat risk. Place item in a specimen bag, if applicable, including packaging and batch number if available.
ii. Contact the Chief Pharmacist or nominated person for your health facility.
iii. Complete the Drug/Medicines Complaint Report form and forward to the Chief Pharmacist.
What happens to your Report?
Forward the completed form and product to the nominated person in your Facility.
The report is placed on a Register with National Drugs & Theapeutics Committee and a copyforwarded to the Supplier.
Depending on the nature of the fault a recall of that drug may occur.
A replenishment stock will be distributed until replacements stocks are received.
The Supplier will be contacted regarding the problem.
A report will be sent back to the unit as soon as possible and widely circulated.
Drug Quality Complaints
It is the responsibility of the person initiating the complaint to categorise the complaint and instigate the appropriate procedure as laid out below.
In all instances the Chief Pharmacist is to be advised as soon as practicable, in order to ensure theappropriate response is taken, actioned and Pharmacist/Pharmacy Technician in Charge notified.
Wherever possible the product and packaging should be retained (except in instances of contamination or personal risk).
A Drug Quality Complaint Report is to be completed and the FPS Chief Pharmacist advised.
ESSENTIAL MEDICINES
FIJI ESSENTIAL MEDICINES FORMULARY-90-
Category 1 - MAY CAUSE ADVERSE EVENT
1. The Chief Pharmacist will confirm the category and raise the concern with the supplier.
2. The Chief Pharmacist will reply to the initiator advising the response taken and the reply from supplier.
CAUSE ADVERSE EVENT
1. All product should be presumed to be effected and treated in the same manner.
2. The Chief Pharmacist will confirm the category, and will notify the suppliers senior management and:
advise of complaint request information relating to product/batch advise supplier that all product, in known locations, must be removed from
premises within five (5) working days request lead time of replacement stock
3. The Chief Pharmacist will advise the nominated person of the complaint and isolate the stock product/batch.
4. The Chief Pharmacist will advise if stock is to be replaced by supplier or ordered from an alternate supplier.
5. If the product is a stock item, end-users will be notified by the Chief Pharmacist by memo issued with non-affected stock and will be followed up by inclusion in hospitals newsletters and email.
6. Complaint will be minuted in National Medical & Surgical Supplies Management Committee minutes.
Category 3 - HAS CAUSED ADVERSE EVENT
1. As per Category 2. Plus:
2. The Chief Pharmacist will ensure product in all areas of all health facilities effected is removed.
3. The Chief Pharmacist confirms notification of incident to Health Service Manager and Director of Health Systems Standards Ministry of Health.
4. For out of hours notification, contact phone no 3388000 ext 126 (leave message) or fax no 3388003 or email [email protected]
ESSENT�A� MED�C�N
FIJI ESSENTIAL MEDICINES FORMULARY -91-
ESSENTIAL MEDICINES
DRUG RECALL PROCEDURE (FORM 8) (Initiated by Chief Pharmacist)
1. Chief Pharmacist issues Product Recall notice.
2. Notice forwarded to Clinical Managers and the Risk Manager.
3. FPS Warehouse Manager identifi es and facilitates area/s of product use and isolates any affected stock.
4. Risk Manager notifi es Warehouse Manager who notifi es Chief Pharmacist regarding fi ndings. If appropriate, a memorandum may be issued, or copies of the recall notice placed on maxibins where stock is held.
5. Any affected stock is quarantined by Infection Control Offi cer/Stores Offi cer for forwarding to FPS and documentation completed.
6. Replacement stock must be supplied by the supplier before any stock is removed from sites. Replacement stock is arranged for distribution by Warehouse Manager to appropriate health facilities, in cooperation with the Stores Offi cer.
** In the event of recall the supplier must supply an alternative equivalent for a minimum period of four to six (4 to 6) months normal usage (FPS minimum stock level)
** If all stock held within the health service division is subject to the recall, the Chief Pharmacist is to liaise with the company for immediate replacement of stock. If this is not possible, an alternative supplier is sought.