1

Foreword

Medication safety and provision of quality care to patients are the first and foremost priority in the

delivery of medical services of the Hospital Authority. Towards this aim, the Hospital Authority has

for years been maintaining a close watch on the high risk areas of the drug administration system

which may require improvement or change in practices. In 2000, the Report on Drug

Administration Procedures and Practices was published. Since then, the 2000 Report has been

valued as an indispensable piece of guidance for the medical, pharmacy and nursing staff in the

Hospital Authority.

However, with the passage of time, the advancement in new technology leading to more complex

treatment protocols and the increasing public demand for high quality services, new issues and new

potential risk areas continue to emerge in the drug administration process. Thus, in 2004/2005,

medication incident has become one of the priority areas in the annual plan of the Risk

Management Committee. A working group was appointed by the Risk Management Committee to

review commonly occurred medication incidents in the Hospital Authority and to make

recommendations for improving patient safety. As a step forward, the working group was also

given the task by the Drug Utilization Review Committee to review the 2000 report founding on the

spirit and principle of the recommendations.

The essential theme of the recommendations is to nurture a culture of high quality patient care with

zero medication incidents as the ultimate goal of all personnel involved in the drug administration

process. Medication incidents do occur for a variety of reasons and at almost every stage of the drug

administration process. With the increasing complexity in treatment protocols, the possibility and

frequency of the occurrence of medication incidents will correspondingly increase. Maximum

awareness of each health and medical professionals involved in the drug administration process

would be one of the important factors to reduce medication incidents. Standardisation of procedures

and their strict compliance will also help to minimize medication incidents. Risk management thus

calls for the highest vigilance of every one of us.

With the above in mind, the Working group had carried out a comprehensive revision of the 2000

Report. The revised guidance will help to make medicine safer for all the patients.

Dr. W L Cheung

Chairman, Drug Utilization Review Committee

2

Executive Summary In 2000, the Report on Drug Administration Procedures and Practices was published. A set of

recommended practices and requirements were drawn up with respect to all the then identified risk

areas in the drug administration process. The 2000 Report has already laid a good foundation for

safe medication.

In mid 2004, a working group comprising of medical, pharmacy and nursing staff from different

clusters was set up with two objectives. The first one is to identify gaps between the recommended

procedures and the actual practices and to make recommendations for improvement. The second

objective is to review and update the 2000 Report. The 2005 Report on Drug Administration

Procedures and Practices is thus an updated version of the 2000 Report.

To maintain easy reference, the 2005 Report adopts substantially the same format and layout of the

2000 Report.

Chapter 1 outlines the composition, terms of reference and objectives of the working group.

Chapter 2 provides an overview of the progress on the implementation of the recommendations of

the 2000 Report.

Chapter 3 identifies those areas where improvements are needed in the drug administration process.

Satellite Pharmacy model and the Cluster Pharmacy model which have been operating for some

time in certain hospitals are included in addition to the conventional In-patient model for in-patient

drug administration review.

Chapter 4 consolidates the updated recommendations on the different procedures and practices in

the drug administration process. The recommendations on certain high risks areas have been

emphasized and strengthened. The high risk areas are, for example drug allergy, electronic

prescribing on discharge prescription, drug repackaging and drug replenishment. New evolving

areas such as management of drug samples, handling of specific drug groups, hazardous chemicals,

resuscitation medications and Chinese Medicine are also included.

Chapter 5 sets out various Quality Assurance Programmes regarding Drug Therapy Administration

with specific highlights on the implementation of the Advanced Incidents Reporting System (AIRS).

3

Chapter 6 summarizes the specific recommendations in order to facilitate a speedy reference on

various major tasks for priority implementation.

As with the 2000 report, it is recommended that clusters’ and hospitals’ DTC should use this new

report as a framework to review their local practices, to promulgate and disseminate the

recommended practices extensively and effectively to all staff concerned, and to carry out audit

programmes on staff adherence to the recommended practices.

Lastly, members of the Working Group would like to express their gratitude to all the hospital staff

and professionals who had provided invaluable feedbacks and constructive proposals. It is only with

the collaborative efforts of the multidisciplinary team that this Report can be successfully published.

4

TABLE OF CONTENTS Reference

Paragraphs Foreword Executive Summary Abbreviations Chapter 1 The Working Group Membership of the Working Group 1.1 Terms of Reference 1.2-1.3 Objectives 1.4

Chapter 2 The Progress Report Progress Report of HA Hospitals based on the 10 Recommendations of the Report on Drug Administration Procedures & Practices (2000 Edition)

2.1

Chapter 3 Areas for Improvement in the Existing Drug Administration Procedures

Flow Chart of Existing In-patient Drug Administration Procedure

Existing In-patient Drug Administration Procedure

Prescription Practices Pharmacy Drug Supply System Delivery of Drugs Storage of Drugs Administration of Drugs in the Wards Reporting of Medication Incidents & Adverse Drug Reactions Disposal / Return of Drugs

Chapter 4 Recommended Practices and Requirements

Prescription Practices / Procedures 4.3-4.50 Pharmacy Drug Supply System 4.51-4.79 Delivery / Storage Of Drugs 4.80-4.92 Drug Administration Procedures In The Wards 4.93-4.127 Handling Requirements For Specific Drugs 4.128-4.135 Information Technology In Patient Care 4.136-4.137 Quality Assurance Programmes 4.138-4.140

Chapter 5 Quality Assurance Programmes Medication Incident Reporting Programme

5.1-5.5

Adverse Drug Reactions Reporting Programme 5.6-5.8 Quality Complaint on Pharmaceutical Items 5.9-5.11 Drug Recall 5.12-5.15

Chapter 6 Conclusions and Recommendations Team Approach to the Promulgation, Dissemination and Implementation of Procedural Guidelines

6.1-6.7

Recommended Development Programmes Standardization on Medication Administration Processes 6.8 Information Technology in Patient Care 6.9-6.11 Medication Incident Reporting Programme 6.12 Adverse Drug Reactions Reporting Programme 6.13 Implementation of MAR, CARS, & Barcode Topping Up Systems 6.14 24 hours or Extended Pharmacy Service 6.15 Aseptic Dispensing Services 6.16 Clinical Pharmacy Service 6.17 Continuing Education 6.18-6.19 Audit Programme 6.20-6.21 List of Reference Appendices Appendix 1 IV Fluid and Drug Additives Administration Form Appendix 2 Insulin Administration MAR Forms Appendix 3a Lists of HA-wide Approved / Standard Abbreviations in Prescribing Appendix 3b “Do Not Use Abbreviations” Appendix 4 Schedule for the Administration of “tds” Drugs Appendix 5 Mechanism for the Management of Drug Samples in the HA Appendix 6 HA Guideline on Safe Management of Potassium Chloride IV Solutions Appendix 7 Supply of Antidotes and Detoxifying Agents in HA Hospitals Appendix 8 Guideline for Supply of Medication for Patients during Inter-Hospital Transfer Appendix 9 Samples of the Line Labels Appendix 10 Guidelines on the use of Three-way / Four-way Stopcocks Appendix 11 Guidelines on Patient Self Medication for General Patients Appendix 12 Guidelines on Patient Self Medication for Psychiatric In-patient Appendix 13 Guidelines on the Disposal of Pharmaceutical Chemical Waste Appendix 14 Guidelines on the Handling of Dangerous Drugs in HA Hospitals Appendix 15 Medication Incident Reporting Programme Appendix 16 Adverse Drug Reaction Reporting Programme Appendix 17 Procedure for Quality Complaints on Pharmaceutical Items

Updated in Oct 08 5

6

Abbreviations The abbreviations used in this book are listed in the table below for your easy reference. ADR Adverse Drug Reactions HCE Hospital Chief Executive

A&E Accident and Emergency ICP Intra-cranial Pressure

AIRS Advanced Incidents Reporting System

IT Information Technology

CARS Computerized Automatic Refill System

IV Intravenous

CCE Cluster Chief Executive KCl Potassium Chloride

CDDH Corporate Drug Dispensing History LKSSC Li Ka Shing Specialist Clinic

CE Chief Executive MAR Medication Administration Record

CIVAS Centralized Intravenous Admixture Service

MI Medication Incident

CM Chinese Medicine MIRP Medication Incident Reporting Programme

CMS Clinical Management System MOE Medication Order Entry

COS Chief of Service MOEMET Medication Order Entry Major Enhancement Task

CPO Chief Pharmacist’s Office NCR No Carbon Required Multi-part Carbonless Paper

CSC Clinical Service Coordinator PMH Princess Margaret Hospital

CVP Central Venous Pressure PMS Pharmacy Management System

D Director PMS-OP Pharmacy Management System – Out-patient

DM Department Manager PYNEH Pamela Youde Nethersole Eastern Hospital

DTC Drug and Therapeutics Committee QMH Queen Mary Hospital

DURC Drug Utilization Review Committee SOPD Specialist Out-patient Department

EDS Express Dispensing System TKOH Tseung Kwan O

GM(N) General Manager (Nursing) TMH Tuen Mun Hospital

GOPD General Out-patient Department TPN Total Parenteral Nutrition

HA Hospital Authority YOOPD Yan Oi Out-patient Department

HAHO Hospital Authority Head Office

7

CHAPTER ONE

THE WORKING GROUP

MEMBERSHIP OF THE WORKING GROUP 1.1 The Working Group was appointed to review and update the contents of the Report on

Drug Administration Procedures and Practices in Public Hospitals (2000 edition). All the safety issues associated with the whole process of drug administration would be reviewed. Its membership was selected from the three professional groups involved namely, doctors, nurses and pharmacists from the institutions under Hospital Authority.

The composition of the working group is as follows: Convenor: Mr Pak Wai LEE Chief Pharmacist, HAHO Members: Dr S Y AU Service Director (Community Care), NTWC / Consultant

(Geriatrics), TMH

Dr Eric CHAN Executive Manager (Nursing), HAHO

Ms C C CHENG Department Operation Manager (Medicine & Geriatrics), KWH

Ms Sau Chu CHIANG Senior Pharmacist (Pharmacy Practice Management), HAHO

Mr Dalton CHONG Manager (Nursing)2, HAHO

Ms Pauline CHU Cluster Coordinator, NTWC (PHARM)

Mr William CHUI HKWC Chief of Pharmacy Service / QMHPHA DM

Ms Betty KU Department Operation Manager 5, Team (3,5,7), KCH

Dr C B LAW Consultant (Medicine & Geriatrics), PMH

Ms Anna LEE Senior Pharmacist (Professional & Clinical Services Development), HAHO

Dr Benjamin LEE Department Manager (Pharmacy), PWH

Dr Petty LEE Pharmacist, (Professional & Clinical Services Development), HAHO

Mr Michael LING Department Manager (Pharmacy), KWH

Dr Siu Fai LUI Cluster Co-ordinator (Pharmacy), NTEC / Service Director (RM&QA), PWH / Co-ordinator (Clinical Services), PWH / Consultant (Medicine), PWH

Mr William POON Senior Nursing Officer (Central Nursing Division), UCH

Dr Cheung San TJIU Resident (Surgery), UCH

Dr Tak Cheung WONG Chief of Service (Medicine), TKOH

Mr Alan WONG General Manager (Nursing), QMH/TYH/SYP

Dr Loretta YAM CSC(Medicine), HKEC / Clinical Coordinator 4, PYNEH / Chief of Service (Medicine), PYNEH

Secretary:

Ms Teresa NGAN Executive Partner (CPO), HAHO

8

TERMS OF REFERENCE 1.2 To identify gaps between the recommended procedures and actual practices and to

recommend guidelines for improvement. 1.3 To review and update the Report on Drug Administration Procedures and Practices in

Public Hospitals. OBJECTIVES 1.4 The following objectives were laid down to guide the deliberation of the Working Group:

(a) Patient Safety

The Working Group regards patient safety as the single most important objective in the entire process of drug administration. The latter is composed of the prescribing, dispensing and administration processes. It requires that a continuous effort is made by all the three professional groups, namely doctors, nurses and pharmacists and this must be coordinated. Procedural guidelines should be drawn up and enforced to maximize patient safety, facilities and equipment must be optimized to minimize medication error.

(b) Professional Standards

In an endeavour to devise policies to optimize patient safety, the Working Group accepts that there are professional standards relevant to the medical, pharmacy and nursing grades that should be considered. Taking into account their different roles, these professional standards must be coordinated and incorporated into procedures and practices, so that medical, pharmacy and nursing staff can discharge their duties smoothly and effectively.

(c) Optimizing the Utilization of Resources

Considerations must also be given to optimize the systems used for drug administration procedure within the institutions. Procedures must be streamlined to utilize better the resources available, whether it be manpower, drugs or facilities.

9

CHAPTER TWO

THE PROGRESS REPORT

2.1 Progress Report of HA Hospitals based on the 10 Recommendations of the Report on Drug Administration Procedures & Practices (2000 Edition)

No. Recommendations Current Status (December 2004)

I HAHO should encourage the

promulgation, dissemination & implementation of the recommended practices & procedural guidelines in the 2000 Report on Drug Administration Procedures and Practices in Public Hospital

A presentation had been made to all HCE in the HCE Roundtable Meeting in January 2000.

A briefing session of the Report had been held for all DTC chairpersons and representatives from pharmacy and nursing sections in April 2000.

Pocket version of the Drug Administration Procedures and Practices was published and distributed to all medical, pharmacy and nursing staff in 2000.

II Hospitals DTC should adopt the procedural guidelines and promulgate them at the local hospital level. Following their adoption the DTC should commence the continuous review of staff adherence to these guidelines.

Hospitals are required to report the level of compliance to the recommendations of the Report on Drug Administration Procedures and Practices (2000) as stipulated in HA Annual Plan Section 3 Standard 29 (Medication Use). Reports should be supported by DTC minutes and evidence of relevant audit programmes / documents.

III Hospital should follow the Central list of HA-wide approved/standard abbreviations in prescribing.

A central “List of HA-wide Approved / Standard Abbreviations in Prescribing” consisted of standard abbreviations for drug names, routes of administration, drug administration frequencies and dosages was drawn up and included in both the standard and pocket versions of the Report.

IV Hospitals should review the

Model Intravenous (IV) Fluid & Drug Additives Administration Form. They should reassess their existing hospital IV drug administration forms and make any modifications necessary.

A model “IV Fluid and Drug Additives Administration Form” was recommended to the Hospital DTCs for appropriate modification of their hospital IV drug administration form.

V Hospitals should seek to optimize turnaround times and prevent any possible tampering or losses during the process of drug delivery to wards.

Various designs of drug receptacles to be used for drug delivery had been sourced and recommended to the hospital pharmacies.

Hospital pharmacies were recommended to review their drug transportation process and rectify deficiencies which could possibly result in misappropriation or tampering of drugs.

VI

Hospitals should prioritize their resources for the purpose of ensuring the safe drug use, improving the efficiency of drug distribution systems and the quality of patient care.

Round-the-clock pharmacy service was introduced in QMH, PMH and TMH in Oct 2001.

Clinical Pharmacy Service was introduced as an on-going initiative in various hospitals at the ward level of nephrology unit, critical care unit, paediatrics unit, oncology unit etc, and satellite pharmacies were established in PYNEH, PMH, TKOH and TMH.

Clustering of the aseptic dispensing services, in-patient drug

10

No. Recommendations Current Status (December 2004)

VI (continued)

distribution and drug procurement was developed along the line of the cluster development plan to improve the efficiency of the drug distribution systems.

The current IT system was continuously updated to facilitate drug administration processes in patient care: -

Individual patient dispensing for in-patients including CARS, non-CARS and Aseptic Dispensing (TPN dispensing, Cytotoxic dispensing and CIVAS)

Ward stock processes including barcode topping up system Discharge / Out-patient dispensing (GOPD, SOPD, Staff,

A&E ) including PMS-OP, MOE system, EDS, Refill Prescription, Pre-pack Label and MOEMET

Computer-linked automated dispensing system, namely Baker Cell Dispensing System (introduced in various hospital pharmacies) and Robotic Prescription Dispensing System (introduced in LKSSC and YOOPD in Mar 2002)

With the introduction of the CDDH in PMS & CMS in 1996 and 1999 respectively, patient’s medication dispensing history can be made readily available in PMS and CMS.

VII Medical, nursing and pharmacy

staff should keep abreast of the fast changes in the field of medicine, drug therapy & related technology, to enable them to be competent in providing a professional service.

On-going education in the form of seminars, lectures and workshops has been organized, and various drug information leaflets have been produced by HAHO and local hospitals.

Drug bulletins such as Drug Education Bulletin and New Product Bulletin are published on an on-going basis; and Drug Information Leaflets on Asthma, Cardiovascular Disease, Diabetes, Parkinson’s Disease and Renal Disease have been published by the HAHO.

VIII Hospitals should comply with the Medication Incident Reporting Programme (MIRP) with the aim of minimizing/preventing the occurrence of medication incidents.

MIRP Bulletins are published on an on-going basis at half-yearly interval by the HAHO, and 19 bulletins have been published at present.

“Insulin Administration / Blood Glucose Monitoring Form” and “Intravenous Insulin Administration Form” were recommended by the insulin working group convened by HAHO to the hospital DTCs with the aim of minimizing medication incidents.

Electronic reporting of medication incidents through AIRS is being implemented in phases since 2002.

IX A standard reporting

mechanism/format to be established to collect information on Adverse Drug Reactions (ADR) from hospitals.

The ADR Reporting Programme was established and implemented in October 2001.

X Individual hospitals to set up audit programmes to monitor staff adherence to the various guidelines.

Hospitals are required to report the level of compliance to the recommendations of the Report on Drug Administration Procedures and Practices (2000) as stipulated in HA Annual Plan Section 3 Standard 29 (Medication Use) supported by DTC minutes and evidence of relevant audit programmes / documents.

Compliance of hospitals to the Report will be monitored periodically in the Service Management Meeting (Pharmacy).

11

Orders verified correct by clinical Pharmacist

CHAPTER THREE

AREAS FOR IMPROVEMENT IN THE EXISTING DRUG ADMINISTRATION PROCEDURE

Flow Chart of Existing In-patient Drug Administration Procedure

NO

Prescriber writes the drug order

Nurse reviews the drug order

Prescriber initiates the drug order

Nurse prepares drugs (e.g. ward stock, clinical trial medications & patient’s “brought in” drugs) in the ward to administer to patients

Orders verified correct by pharmacy

Drugs prepared & supplied by pharmacy

Drugs delivered to the wards

Drugs stored in the wards

Nurse prepares drugs to administer to patients

Pharmacy reviews the drug order

Nurse identifies the patient in the ward

Nurse administers drugs to patient in the ward

Nurse records drug administration in the ward

The monitoring & reporting of the patients’ responses to medications

Nurse disposes or returns ward drugs to pharmacy

Nurse screens all the drug orders and decides which one to be sent down to pharmacy for drug supply

Drugs prepared & dispensed directly into the drug trolley by pharmacy staff of Satellite Pharmacy

Satellite Pharmacy Model

Drugs stored in the drug trolleys

Drug orders that bypass the pharmacy vetting system

Cluster Pharmacy Model

Drugs delivered to the wards of other hospitals

Automatic CARS refills until “off”MAR sent/ faxed to Pharmacy by nurse

Drugs stored in the wards of other hospitals

Drug orders that go through the pharmacy vetting system Clinical Pharmacist reviews the drug order in ward

12

Existing In-patient Drug Administration Procedure 3.1 The existing drug administration procedure consists of a number of sequential actions

carried out by doctors, nurses and pharmacists. The ideal sequence should be the doctor initiates and writes drug order, the pharmacist reviews the order and supplies the drugs, the nurse administers the drugs to the patient.

3.2 The following flow chart indicates the sequential steps of the existing in-patient drug administration process, from ordering, through dispensing to administration. Each step has its own unique opportunities for error. Most of the steps are critical control points, where unchecked errors at those points can lead to a chain of errors.

Prescriber initiates the drug order Prescriber writes the drug order Existing Problems: • Patient information such as medical history,

patient biodata & drug history including drug allergy, is needed in initiating a drug order and might not be readily available.

• Drug information might not be easily available at the time when it is needed.

Existing Problems: • Illegible handwriting. • Use of non-standard drug name

abbreviations. • Dose of medication is not in exact dosage. • Unclear abbreviations for time of drug

administration, e.g. q.d. & q.i.d. • Use of non-standard abbreviations for the

route of administration. • Intravenous drug order not available for

pharmacy for vetting. • Different interpretation of “start date” on

the drug order.

Prescriber initiates the drug order

Prescriber writes the drug order

13

Existing In-patient Drug Administration Procedure (continued) Nurse reviews the drug order

Nurses will be responsible for reviewing the drug order and dispensing when ward stocks are prescribed. In some cases of Individual Patient Dispensing, for reasons of quick access, nurses might administer drugs from overnight ward stocks or belonging to another patient to patients before their individual medications are dispensed. This is undesirable as the following problems might occur. Ideally there should be a balance between the pharmacy and nursing staff involvement in the process of reviewing drug orders. Counterchecking is more important and should be practised wherever possible. Existing Problems: • The nurse needs to interpret accurately

the new order after it has been written so that the correct drug can be given.

• Might not be aware of any inherent problems in the prescription order, e.g. potential drug interactions, adverse drug reactions.

• Illegible orders can be misinterpreted or presumed to be the wrong drug.

• Verbal orders can be misheard or misinterpreted.

(i) Drug orders that go through the pharmacy vetting system (ii) Drug orders that bypass the pharmacy vetting system

Nurse prepares drug orders in the ward

This includes the drug orders for ward stock, clinical trial medications & patient’s “brought in” drugs.

Existing Problems: • Some medications may be administered to

patients directly in wards prior to order vetting by the pharmacy.

• Nurses may not be familiar with the use & administration of certain drugs.

• Upon order receipts, pharmacies do not input the orders into the patients’ profiles.

• It is sometimes impossible to identify medications brought in by patients.

Nurse reviews the drug order

Nurse screens all the drug orders and decides which

one to be sent down to pharmacy for drug supply

14

Existing In-patient Drug Administration Procedure (continued) Nurse sends the drug order to pharmacy for drug supply

The MAR forms are used in all the HA hospitals. The MARs are transmitted either by fax or NCR to the pharmacy for dispensing. This practice can reduce the chances of transcribing error and the workload of the nursing staff.

Existing Problems: • Time-lag between drug orders by ward and

medication supplies from pharmacy may render the use of “unused” stocks in wards in urgent situations.

• Transcribing errors still exist owing to the illegibility of the original order and misinterpretation during transcribing onto the new MAR forms.

Pharmacy reviews the drug order Existing Problems: • The complete drug profile for each patient

not being available to the pharmacy for checking of any potential drug interactions.

• The pharmacist might not have all the necessary information, such as drug information & patient information including diagnosis available when reviewing the order.

• Not every order can be checked by pharmacist due to resource & manpower constraints.

Satellite Pharmacy Model The clinical pharmacist reviews the drug orders in wards soon after prescribing or with the prescriber during the ward rounds. The drugs will be dispensed by the pharmacy staff of the satellite pharmacy directly into the drug trolleys in wards.

Nurse sends the drug order to

pharmacy for drug supply

Pharmacy reviews the drug

order

15

Existing In-patient Drug Administration Procedure (continued) Yes No Illegible/ambiguous/problematic drug orders Existing Problems: • It is possible for an illegible/ambiguous order

to be misinterpreted or presumed to be another drug.

• Extra time or effort will be needed in confirming the order.

Drugs prepared & supplied by pharmacy

There are 2 methods of drug supply from pharmacy, which are Individual Patient Dispensing and Ward Stock Supply. Ward stock are still needed due to the lack of a 24 hours pharmacy service: Existing Problems: i) Individual Patient Dispensing

Dispensing errors arise from : • Similar drug item codes • Similar drug names & sound-alike

drug names • Look-alike packages of drug items • Wrong dose calculation • Wrong information on labels • Non-compliance with the double

check system ii) Ward Stocks

• Larger variety of ward stocks holding, pooling & transferring of ward stock and improper rotation of ward stock may still exist in those wards without the ward topping-up system.

• Prescriptions for ward stock items are not sent to pharmacy, thus the drug profiles of patients compiled by pharmacy are incomplete.

• Pharmacy does not have the opportunity to verify these prescriptions and cannot monitor the actual consumption of non-controlled ward stocks.

• Nurses are not specifically trained to dispense drugs.

Order verified correct by

pharmacy

Drugs prepared and supplied by pharmacy

16

Existing In-patient Drug Administration Procedure (continued)

Most of the drugs are delivered to wards in properly locked receptacles except for the delivery by satellite pharmacy where drugs dispensed are placed directly into the drug trolley in ward. Drugs delivered to the wards within the same hospital (except for Satellite Pharmacy model ) Existing Problems: • Physical constraints, e.g. insufficient locked receptacles for the transportation of drugs. • Locked receptacles are not absolutely safe and secure if plastic seals of no number-

identification are used to lock the receptacles, tampering of seals is possible. Drugs delivered to the wards of the other hospitals (Cluster Pharmacy model) Some hospitals may provide in-patients drug dispensing service to other hospitals within the same cluster. The drugs will be dispensed against the MARs faxed from the receiving-hospital to the dispensing-hospital. The drugs will then be delivered to / picked up by the inter-hospital porter team. Existing Problems: • Inadvertent dispensing for drugs prescribed outside the hospital formulary of the receiving-

hospital is possible. • In the receiving-hospital, a larger variety and higher stock level may be required in wards and

the emergency drug cupboards for urgent requirement. • Longer duration of drug supply may be required as daily delivery service may not be

available and this may increase the drug returns and drug wastage. • If more than one receiving-hospital is served, drugs may be placed in the wrong receptacles

and transported to the wrong hospitals resulting in treatment delay or medication incidents.

Drugs delivered to the wards within the same hospital and

of other hospitals

17

Existing In-patient Drug Administration Procedure (continued) Drugs stored in the wards Existing Problems: • Inadequate storage cupboards or storage

space for drugs. • Drugs may be stored in a disorganised

manner or at inappropriate locations e.g. refrigerated items are not being refrigerated and items not required refrigeration are being refrigerated.

• Domestic refrigerators without any locking device or without an adequate temperature controlling function are used for the storage of drugs.

• Other non-pharmaceutical items (e.g. blood samples, food) may be stored with the drugs and that will create a contamination hazard.

• Unused pre-diluted / reconstituted medications may not be discarded and kept for future use.

Nurse prepares drugs to administer to patients

Existing Problems: • Different hospitals have different

practices regarding the level of nursing personnel involved in drug administration.

• Non-compliance with the guidelines regarding drug administration practice.

• Some of the medications are not supplied in the most ready-to-administer form, for example, injectable drugs. Their dose calculation & reconstitution are more likely to generate errors. The workload of nurses and their lack of familiarity with certain drugs can also give rise to medication errors.

Drugs stored in the wards

Nurse prepares drugs to administer to patients

18

Existing In-patient Drug Administration Procedure (continued) Nurse identifies the patient in the ward

Existing Problems : • No requirement for patients to wear identity

bracelets in some hospitals. • Wrong patient gum labels on the MAR.

Nurse administers drugs to the patient in the ward

Existing Problems: Medications errors often arise from: • Non-compliance with the standard

practice guidelines, especially the 3 checks and 5 rights.

Each route has its own risk, especially the parenteral route : • Injectable drugs are not supplied in the

most ready-to-administer form. • Technical factors can also cause errors

including equipment malfunction or pump failure.

Nurse identifies the patient

in the ward

Nurse administers drugs to

the patient in the ward

19

Existing In-patient Drug Administration Procedure (continued) Nurse records drugs administration in the ward Under the existing practices, there are two groups of patients regarding medication administration. The first group of patients participate in the self-administration programme, and can self-administer their own drugs. The other group of patients will take their medications under the supervision of the nursing staff. Existing Problems: • For the second group of patients, nurses

may not wait to confirm that the medication has been consumed by the patient in some busy wards. Unattended drugs left on a patient’s over-bed table may lead to the omission of doses or drugs being consumed by the wrong patient.

• The medications for a particular patient may be charted in more than one place and multiple records can potentially lead to confusion and errors.

• Nurses may not be aware of the discontinued medications on the MAR and may continue to administer to patients.

• Medications may not be administered according to the recommended time / intervals of administration.

The monitoring & reporting of patients’ responses to medications

Adverse Drug Reaction (ADR) Reporting There is a standard procedure or mechanism to record clinically significant ADR in HA hospitals. Existing Problems: • Some ADR may not be reported. Medication Incident (MI) Reporting There is a standard procedure or mechanism to report MI in HA hospitals. Reporting of MI by electronic means via the AIRS will be rolled out in phrases to more hospitals of the HA. Existing Problems: • Some medication incidents such as near-

miss cases may not be reported. • Those medication errors which have been

rectified before drug administration are under reported in some hospitals. These ‘near-miss’ cases can actually be used for educational purposes.

• Insufficient follow-up action & education following medication incidents.

Nurse records drug

administration in the ward

The monitoring & reporting of

the patients’ responses to medications

20

Existing In-patient Drug Administration Procedure (continued) Nurse disposes or returns ward drugs to pharmacy

Some dispensed drugs are unused due to the discharge or death of patients or other reasons for the discontinuation of treatment. These left-over needed to be returned to pharmacy or disposed of in other ways.

Existing Problems: • Over-prescribing, frequent changes in drug

therapies and inefficient drug distribution systems have all contributed to the huge amounts of ward drugs returned for disposal. This has created much unnecessary and costly drug wastage.

• A lot of manpower and time are used in sorting out the returned drugs.

• Unused drugs might be pooled together in wards to form ‘unofficial’ ward stocks.

• Refrigerated drugs are left in room temperature for a certain period of time prior to returning to pharmacy render the drugs inappropriate for reuse.

Nurse disposes or returns ward drugs to pharmacy

21

CHAPTER FOUR

RECOMMENDED PRACTICES AND REQUIREMENTS

4.1 Based on the problem areas detailed in the preceding chapter and considering the overall

objective of ensuring quality patient care, the Working Group has come up with the following sets of recommended practices and requirements to prevent medication errors and encourage the economical use of drugs.

4.2 The Working Group recognised that there are different constraints in the various institutions

and has accordingly incorporated certain flexibilities into these recommended practices and requirements. Individual institutions should therefore be able to use this document as a framework to draw up/review their existing guidelines.

(A) RECOMMENDATIONS ON PRESCRIPTION PRACTICES / PROCEDURES 4.3 The Medication Administration Record (MAR), commonly called the Drug Chart, should be

recognised as the official document for the entire in-patient drug administration process. As such, it should be the ONLY document on which doctors prescribe, for which the pharmacy staff dispense drugs, and according to which the nurses administer drugs. The only exception is when computerised order entry arrangement has obviated the need for a paper MAR.

Design of the MAR 4.4 The MAR should be designed so as to facilitate prescribing by doctors, administration by

nurses and dispensing by pharmacy staff. The following are regarded as essential information to be provided in the design of any MAR :

(a) Personal details

Information on personal details should include name, HKID no., sex, age (or in the case of neonates, the date of birth, body weight in kg and the identity of the mother), drug allergy, hospital identification number, and preferably the diagnosis of the patient. Before prescribing, doctors MUST ensure that the MARs have already been labelled with the correct patient’s information. (b) Drug allergy

The drug or any substance that the patient is or becomes allergic to MUST be recorded in the appropriate areas of the drug orders and patient’s medical records. Doctors should verify and amend the drug allergy information where appropriate. Patients without drug allergy must be recorded as “NIL” or “No Known Drug Allergy (NKDA)”. Prior to the prescribing of medications, drug allergy records of the patients must be re-checked by the doctors.

22

Standard Intravenous Fluid and Drug Additives Administration Form 4.5 The administration of intravenous infusion and drug additives has been found to be

associated with serious medication errors, therefore its prescription order and administration should be documented as part of the MAR. A model “IV Fluid and Drug Additives Administration Form” has been recommended to hospitals’ DTCs for appropriate modification for their local use (refer to Appendix 1). The IV form should be made available to doctors, nurses and pharmacists and allow the pharmacist to review and verify the safety of the intravenous drug order, to check the accuracy of the dose calculation as well as the dilution and infusion rate of the intravenous infusion before administration. In order to minimize the occurrence of medication incidents, the prescribers should review intravenous prescription orders on a daily basis.

4.6 The prescription order and administration of the other routes of parenteral administration

such as intramuscular injection, subcutaneous injection, have already been documented and included in the normal MAR.

Standard Insulin Administration MAR Form 4.7 It has been shown that insulin administration is one of the most frequently reported

medications incidents in the HA. To ensure patient safety and to safeguard against medication incidents in the utilization of insulin in the HA, two structured MAR forms, namely “Insulin Administration / Blood Glucose Monitoring Form” and “Intravenous Insulin Administration Form (DKI or IV insulin pump)” which serve as the templates for prescribing, dispensing and administration of insulin have been recommended to hospitals’ DTCs for appropriate modification for their local use (refer to Appendix 2).

Legibility 4.8 The MAR is the official document detailing the drug treatment for the patient. It is essential

for doctors to prescribe in a clear and legible manner so as to be understood by all personnel handling the MAR. Illegible or doubtful prescriptions should always be verified with the prescriber.

4.9 Clear and legible prescriptions are an essential requirement of good clinical practice. This

should be strongly emphasised in all hospital drug administration guidelines. In addition, a number of other measures should be considered :-

(a) Doctors should be required to write FIRMLY on the MAR with indelible ink, e.g.

using a black ball pen. (b) A regular feedback mechanism should be established, in order to enhance the

awareness of prescribers to the problem of illegibility. Start Date 4.10 This should be included to record the date on which a drug treatment is to commence.

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Drug Name 4.11 There should be a hospital Formulary available. This Formulary should be regularly updated

and be easily accessed by medical & nursing staff. This Formulary should list the approved names, i.e. the generic names and the dosage formulations of the drugs in stock. The habit of using trade names for drugs should be discouraged particularly when generics are being dispensed.

4.12 Prescriptions should be made in the most appropriate conventional form and dosage of drugs,

as according to the hospital Formulary. 4.13 All drugs should be prescribed by their approved name and should preferably be printed in

full in BLOCK LETTERS. It is essential that all entries made on the MAR are complete and legible. Only approved abbreviations should be accepted.

4.14 A list of standard, HA-wide approved drug name and frequency abbreviations has been

established. Doctors should either prescribe in full text or adhere to this list of abbreviations (refer to Appendix 3).

4.15 A ‘Hospital Authority Drug Formulary’ has been drawn up. The professional staff can refer

to this list for cross reference and information. Dosage 4.16 The dose of medications should be prescribed using the METRIC system. Also dosage

should be expressed in terms of the active ingredients and NOT, for example, the number of tablets or volume of liquid, except in the case of compound preparations.

4.17 Dosage abbreviations and decimal points should be avoided. eg. 0.5g should be expressed as

500 mg. To avoid any confusion with milligram (mg), Microgram should be written in full instead of mcg or μg. Units should be written in full instead of i.u.

4.18 It is recommended that standardized dosing and dilution methods for a list of commonly

used IV medications should be devised and endorsed by the hospitals’ DTC. Doctors should prescribe the IV medications by their standardized dilution concentrations and choice of diluents in normal circumstances.

Routes of Administration 4.19 A list of unambiguous, standard abbreviations should be drawn up. Doctors should either

prescribe in full text or adhere to this list of standard abbreviation in prescribing the route of administration (refer to Appendix 3). In case of doubt, the staff member who is responsible for the drug administration must verify with the prescriber the abbreviations used.

Times of Administration 4.20 Times of administration schedule should be clearly given. As an alternative, this can be pre-

printed on the MAR for regular medications. Doctors should need only to select the appropriate times on the chart. This will save the doctors’ time in stating the frequency of

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administration in full. If abbreviations are to be used, prescribers should adhere to the list of standard abbreviations of time for drug administration listed in Appendix 3. For drug administering on a three times daily basis, ‘Schedule for the Administration of “tds” Drugs’ in Appendix 4 may be referred to.

4.21 For once ONLY medications, the date and time of administration should be specified. For

‘as required’ medications, they should include the reasons for treatment, the maximum frequency of administration and/or the times of administration if appropriate. For once DAILY medications, it is recommended that the full text ‘daily’ should be used but NOT ‘q.d.’ and the time of administration should also be specified.

Valid Period 4.22 When it is anticipated that a certain medication is to be given for a defined period, this

should be clearly stated. Automatic ‘stop’ arrangements for a normal course of treatment should be agreed beforehand for certain groups of medication, e.g. antibiotics. Continued use after such agreed period should then be subject to physician’s review.

Signature 4.23 The doctor must put their identification code or full name in block letters together with their

authorised signature on all the prescriptions. The prescribing physicians’ most updated specimen signatures should be made available for reference by nursing and pharmacy staff for checking purposes.

Transcription of Drug Order 4.24 A copy of the MAR in the doctor’s original handwriting should be sent to the pharmacy in

order to avoid transcribing errors. This can be done, for example, by using the NCR paper or by fax. In future this process would be replaced by a computerised order entry system.

Alterations to a prescription 4.25 No prescription item should be altered in part. Changes in a prescription order should

involve the complete cancellation of the existing prescription item and the writing of a new one to avoid any ambiguity and consequent administration errors.

Discontinuing and cancelling a prescription 4.26 Prescriptions should be reviewed regularly by doctor. Medications should be cancelled or

discontinued by drawing a diagonal line through the drug name and/or a slanted double-line across the administration section corresponding to the “discontinued” medication on the MAR in order to minimize the risk of continuous administration. Cancellations and discontinuations of instructions must be signed and dated.

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Electronic prescribing (Medication Order Entry -- MOE) 4.27 Discharge and home leave prescriptions can be prescribed through the Medication Order

Entry (MOE) system. While electronic prescriptions improve legibility and remove the ambiguity of orders, this should be developed in the in-patient section (In-patient MOE).

Verbal Orders 4.28 Only in emergency and approved circumstances may a verbal order be given if the doctor is

unable to attend personally. The instruction may only be accepted by an Enrolled or Registered nurse who must immediately record the instruction in the patient’s MAR and annotate it a ‘verbal order’.

4.29 After the instruction has been written, it must be READ BACK to the doctor checking the

patient’s identity, drug name, dosage, frequency and method of administration. It is the responsibility of the doctor giving the verbal order to ensure the correct interpretation of the verbal order.

4.30 The nurse receiving the message must, after following the normal checking procedure,

administer the drug and personally give both verbal and written instructions to the nurses taking over from him/her.

4.31 A verbal order must be confirmed in writing by the doctor concerned as soon as possible

and within 24 hours at the latest [refer to Pharmacy & Poisons Regulations, Cap. 138A, Section 23(4)].

4.32 Dangerous Drugs should not be ordered through verbal orders (refer to Dangerous Drugs

Regulations, Cap. 134A, Section 3). Patient’s Own Medications 4.33 Patients should always be asked if they have brought any medications into hospital with

them. To prevent unauthorised self-administration, brought-in medications should be taken into safe custody by the nursing staff and shown to the doctor and/or pharmacist.

4.34 The patient’s own medications should not normally be administered in hospital unless they

have been positively identified, specifically prescribed by the doctor and when supplies are not immediately available from hospital sources. The general practice of allowing patients to continue their own brought-in medications without verification should not be encouraged.

(Identification of medications currently used in the HA may be searched by the Tablet Identifier on HA intranet http://cpointra/tabident.php; Registered Pharmaceutical in Hong Kong may be searched on the website of Department of Health http://www.info.gov.hk/pharmser/Reg_ir/download_pharm.html)

4.35 The protocol / logistics for identification, prescribing and administration of brought-in

medications to patients should be endorsed by the hospitals’ DTC.

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4.36 If the patient’s own medications are to be administered in hospital, the prescription order and administration of brought-in medications should then be recorded in the patient’s MAR and the MAR should be sent / faxed to the pharmacy for order vetting and computer input.

4.37 These medications should be returned to patients on discharge with a clear indication as to

whether they are to be continued / discontinued. Drug Samples 4.38 Drug samples should include not only new drugs but also post-marketing drugs which are

new to that hospital. In 2002, a mechanism for the management of drug samples in the HA has been endorsed by the DURC (refer to Appendix 5). The hospital DTC or an equivalent committee should establish policies and procedures to approve, control and monitor the use of drug samples in the hospitals and their affiliated clinics.

4.39 As with all medications, the drug samples approved for use must be dispensed by the

pharmacy. This will enable HAHO to keep an updated record of all the drug samples used in the HA.

4.40 The standards, drug recalling and incidents reporting mechanisms applicable to medications

use in the hospitals should apply to drug samples. 4.41 The introduction of drug samples to the Hospital Formulary should follow the normal new

drug application procedures as established by the hospital DTCs. 4.42 Patients should be fully informed that drug samples are prescribed to them for trial only over

a definite period. Clinical Trial Medications 4.43 Individual hospitals should draw up their own protocols regarding the supply, storage,

preparation and distribution of clinical trial medications. Appropriate details regarding such clinical trial medications should be supplied to the pharmacy before the commencement of the clinical trial.

Record of all Medications 4.44 All medications including routine drugs, clinical trial medications, brought-in drugs, drug

sample, intravenous fluid, insulin and TPN should be prescribed properly and their administration recorded accordingly.

Chinese Medicines (CM) 4.45 The use of CM in the HA hospitals should follow the guiding principles of the “Hospital

Authority Guidelines on Interface Issues between Chinese Medicine and Conventional Western Medicine” (refer to Clinical Manuals / Guidelines of Chinese Medicine on HA intranet).

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4.46 When the use of CM is permitted to be given to the patients treated in the HA hospitals, either under research protocols or authorized by the doctors, the details of CM prescribed by the CM practitioners should be properly recorded in the patients’ medical records.

4.47 In any case, the use of CM should be indicated by the doctors on the MARs as “Chinese

Medicines”. The MARs should be sent / faxed to the Pharmacy for computer entry so that it will be indicated in the patient’s profile that “Chinese Medicines” are being used. The administration of CM should be properly recorded as with the practices for other conventional medications.

Nurse-initiated Medications 4.48 In order to facilitate effective patient care, under the authority of appropriate written

protocols approved by Hospital DTC, qualified nurses may be allowed to initiate certain medications on their own. Individual hospitals may consider and approve a list of nurse-initiated medications. Such protocols should specify the rank of nurses allowed to initiate medication on the approved list and specify limits on the number of doses, dosages to be given. Medications initiated by nurses should be checked and countersigned by a doctor within :

(a) 48 hours in the case of non-poisons, (b) 24 hours in the case of poisons (i.e. controlled medicines which are under the

classification of Schedule I to III in the Pharmacy and Poisons Ordinance.) Discharge Medications 4.49 Doctors should prescribe all the medications that the patients are currently taking and not

just those required for discharge. However, when the supplies of certain medications are not required, they should be clearly indicated in the MOE with the action status (dispense in clinic / purchase by patient / keep record only). When the manual discharge prescriptions are made, the action status used in the MOE should be written on the prescriptions.

4.50 Particular care should be taken when patients are taking two or more similar drugs or the

same drugs in different dosage forms. The possibility and consequences of drugs being prescribed previously or subsequently at outpatient clinics should be considered.

(B) RECOMMENDATIONS ON PHARMACY DRUG SUPPLY SYSTEM Pharmacy Drug Supply System 4.51 The Pharmacy drug supply system should be designed so as to facilitate drug distribution, to

establish a complete drug profile for each patient and to minimise the amount of ward drug return. All in-patient prescriptions should go through the pharmacy vetting system which acted as a safe guard before the drugs administered to the patients. All drug orders received by the pharmacy must be input into the system in order to maintain a complete patient’s medication profile.

4.52 The Computerised Automatic Refill System (CARS) is one of the drug supply systems

currently being used in HA hospitals. This system facilitates the drug distribution process

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and generates a complete drug profile for each patient. It is a medication refill system designed to save nursing time. The refill duration should be decided locally with the aim of minimising the amount of ward drug return and drug wastage.

Individual Patient Dispensing 4.53 The majority of inpatient medications should be supplied on an individual patient basis by

the pharmacy. Individual patient dispensing enables the pharmacist to verify the safety and appropriateness of each prescription order and to detect and deal with any potential problems such as drug interactions and drug allergies before supplying medications to wards. The correct dispensing of medications is the professional responsibility and duty of the pharmacy staff.

Involvement of Pharmacists in the Drug Administration Process 4.54 Pharmacists should take an active role in the drug administration process which is an

integral part of patient care. This should be achieved through having a Clinical Pharmacy Service at the ward level. All information available including that contained within the patients’ notes as well as that obtained on ward rounds and by direct communication with the doctor and patient should be used by the clinical pharmacists to offer advice to doctors and nurses on appropriate medications and potential medication-related problems.

4.55 Pharmacists should ensure that medications are used rationally, cost-effectively and in their

proper therapeutic context. Verification by the prescribing doctors must be made should there be ambiguity or doubt in the appropriateness of the drug orders.

Clinical Pharmacy Service 4.56 A Clinical Pharmacy Service involves the practice of pharmacy in a multidisciplinary

healthcare team with the objective of achieving the best possible quality use of medications and thus providing optimal patient care. The service includes medication history taking, drug supply, drug therapy monitoring, drug information, discharge patient counselling and pharmacokinetic interventions. The Clinical Pharmacist-run Compliance and Refill Clinics have been set up, as part of the clinical pharmacy service initiatives, in many specialist clinics of the hospitals.

4.57 A Satellite Pharmacy Service is a mode of operation in the Clinical Pharmacy Service. It has

already been implemented in PMH, PYNEH, TKOH and TMH with satisfactory results. The Satellite Pharmacy is in close proximity to the wards. It enhances the involvement of the clinical pharmacy service and the efficiency of the in-patient pharmacy service. It optimises the drug distribution system and minimises the amount of ward drug supply. This results in reduced ward drug return and unnecessary drug wastage. Nurse dispensing duties are reduced and more nursing time can be given to patient care. It also allows a unit dose dispensing system to be practised.

Preparation of Drugs 4.58 Pharmacists are recommended to supply drugs in the most appropriate form or the most

ready-to-administer form in order to minimise errors. Therefore, the provision of TPN,

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cytotoxic and central intravenous admixture services by pharmacy would improve quality and safety. In addition, a number of issues have been considered :

(a) Limiting the choices of available drugs in pharmacy and the dose concentration or

strength for each drug would help to reduce the chances of errors.

(b) Complete, updated information on the reconstitution, dilution and compatibility of intravenous drugs should be supplied by pharmacy to the nurses on the wards for educational and cross-checking purposes.1

(c) Doctors who have prescribed unconventional strengths or forms of a drug should be

contacted by a pharmacist in order to discuss for modifying the prescription.

Accuracy in Dispensing 4.59 Proper in-house checking procedures should be built into the dispensing system in the

pharmacy. The pharmacy staff must remain alert in the process of data entry, as similar drug codes often give rise to medication errors. It is important to recognise that the mere checking of the label against the content is not sufficient. Reference should always be made to the ORIGINAL prescription in checking the end product of the dispensing process for the correctness of the drugs and any possible undesirable interactions amongst them. The double check system should be practised whenever possible.

4.60 For high risk drug items e.g. digoxin, or those known to be associated with serious

medication errors, all steps in the dispensing process especially the calculation of dose, should be checked independently by another member of the pharmacy staff, preferably a pharmacist.

4.61 Every prescription order and all dispensed medications should preferably be checked by a

pharmacist, for detecting and dealing with any potential medication errors and potential problems such as contraindicated drug, drug interactions. Any necessary clarification in a prescription order must be resolved with a doctor before the medication is dispensed and administered to the patient.

Labelling of Dispensed Medications 4.62 The labelling of dispensed medications allows for the positive identification of the drug and

the patient to whom the drug is supplied. Proper labelling should be provided on all dispensed medications in compliance with the requirements of the Hong Kong Medical Council and the Pharmacy and Poisons Board. The list of requirements for the labelling of medications is as follows :

(a) Name of patient (b) Date of dispensing (c) Trade name or pharmacological name of the drug 2 (d) Dosage per unit

1 Cross-checking is defined as checking the correctness of the information or a calculation by a different person

while double-checking is defined as checking the correctness twice by the same person or by a different person. 2 In HA, this will be in the form of approved pharmacological name or when unavoidable, trade name of the medication

(i.e. in the case of compound preparation). Exemption might be made for approved research when patients have given their fully informed consent, the drug name might not be included.

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(e) Method and dosage of administration (f) Precautions where applicable All of the above labelling requirements are applicable to the dispensing of medications for out-patients. In the case of in-patient medications, such as Individual Patient Dispensing and Ward Stock, appropriate labelling should be used.

Containers of Dispensed Medications 4.63 All medications should be supplied in clean, safe and appropriate containers. Manufactures’ Original Packaging and Labelling 4.64 In order to reduce errors that could arise from inappropriate packaging and labelling of the

manufactures’ original products, users’ immediate feedback to the CPO on the issues is deemed necessary. This will facilitate the CPO in future products selection, advising vendors on improvement and liaising with the Department of Health on the regulatory control on packaging and labelling of pharmaceutical products.

Re-packaging of Medications from the Manufacturers’ Original Containers 4.65 Re-packaging of medications refers to re-packaging and re-labelling of commonly used drug

products from the manufacturers’ original packages to suitable and convenient quantities for dispensing and drug distribution.

4.66 The process of re-packaging must be supervised and checked by authorized personnel in the

pharmacy and proper in-house rules should be in place to safeguard the procedures. 4.67 The process of re-packaging should be performed in a suitable demarcated area in the

pharmacy with appropriate lighting and minimal distraction. 4.68 The re-packaged unit should be properly labelled with clear identification of the drug, a

retraceable batch reference and any other relevant information to fit on the label as far as possible.

4.69 Proper records of re-packaged drugs should be kept in case of any future recall. Drug Replenishment 4.70 Drug replenishment includes replenishment to the drug shelf and automated dispensing

machines should be performed and counterchecked by well-trained dispensing staff. Proper recording and checking mechanisms should be in place to facilitate the replenishment and recall of drugs.

4.71 Replenishment of stocks should follow the “First In, First Out” principle to ensure proper

stocks rotation. The stocks should be placed in the correct locations against the shelves’ labels clearly marked with the proper drug names, strengths and dosage form etc in an orderly and tidy manner.

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4.72 Special precautions should be taken in situations such as replenishment of re-packed drugs, drugs from the ward return and medications not picked up by patients, etc.

Pharmacy Service Hours 4.73 In order to improve the quality of services, round-the-clock pharmacy services were

introduced in QMH, PMH and TMH in October 2001. The 24 hours pharmacy service should be further rolled-out to all acute general hospitals when resources are available.

Ward Stock Supplies 4.74 To maintain the continuity of drug supplies outside pharmacy service hours and for various

other operational reasons, ward stocks will still be required to facilitate the process of supply and administration of medications to patients. In order to maintain a proper ward stock system, the following points should be considered :

(a) The reasons for keeping ward stocks must be well established. The items included in the

ward stock list must be appropriate to the practice/activity of each individual specialty/unit.

(b) Particular caution should be exercised regarding the drug items that have commonly

been involved in potential medication errors, such as concentrated forms of drug items that required dilution into larger volume, e.g. concentrated KCl injection (refer to Appendix 6). These drug items should not be kept as ward stock in general care areas. All ward stock items must be supplied in appropriate labelled containers.

(c) The range of ward stocks and the quantity kept for each item should be minimised. The

ward stock item level should be updated periodically. (d) A list of ward stock items should be maintained and periodically reviewed. Any

unnecessary items should be deleted. The addition of any item to the list must be examined critically.

(e) Pharmacy staff should be actively involved and responsible for the whole process of

ward stock management e.g. by using a bar-code topping up system. (f) In the absence of barcode topping up system due to resource constraints, the “two bottle

system” should be employed. This will help the nursing staff monitor the levels of ward stocks more easily.

Emergency Drug Supplies outside Pharmacy Service Hours 4.75 When a 24 hours pharmacy service is not feasible, access to a limited supply of medications

from the Night Cabinet should be available to doctors or nursing staff for use in initiating urgent medication orders. For the “Cluster Pharmacy Model”, an effective and efficient ward stock replenishment system and special arrangement for ad hoc / urgent requirements must be in place.

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4.76 A small quantity of the drug items should be kept in the night cabinet which is kept locked when not in use. The drug items to be kept in the night cabinet, should be chosen with safety in mind. The container for each item should be labelled with the drug’s name, strength, quantity, expiry date and retraceable lot number.

4.77 Where an emergency drug supply is made and a prescription is to be provided later, a

medication order must be made at the time of emergency drug supply. Such medication order should be verified by the pharmacy staff and the drug item replenished within 24 hours.

Supply of Antidotes and Detoxifying Agents in HA hospitals 4.78 Certain antidotes and detoxifying agents are stocked by some HA hospitals (refer to

Appendix 7). Clinical departments should check with their hospital pharmacies for the most updated version of the list. Arrangement should be made through the hospital pharmacy if any of these agents are required.

Supply of Medications for Patients during Inter-hospital Transfer

4.79 The continuity of drug supply must be considered as the top priority regarding the supply of

medications for patients during inter-hospital transfers. The medications should be properly labelled. The detailed HAHO guidelines are shown in Appendix 8.

(C) RECOMMENDATIONS ON THE DELIVERY / STORAGE OF DRUGS Delivery of Drugs 4.80 Delivery of drugs includes the drugs delivered to within and outside (Cluster Pharmacy

Model) the hospitals. Hospitals should continue to improve their existing facilities for transportation of drugs to prevent possible misappropriation or tampering by the use of locked receptacles. Plastic seals with control number printed on each seal or combination locks can be used.

4.81 For the “Cluster Pharmacy Model”, designated personnel to handle the drug delivery / pick-

up are recommended. Use of different coloured / colour-coding receptacles for different hospitals should help to minimize the chances of mix-up of drugs delivery between hospitals.

4.82 Separate receptacles should be used for refrigerated items and cytotoxic drugs. Auxiliary

signs to accompany items that require special handling instruction, such as “drugs required refrigeration” and “CHEMOTHERAPY — HANDLE WITH CARE, DISPOSE OF PROPERLY”, in both English and Chinese should be made available.

Storage of Drugs 4.83 All drugs must be stored under suitable conditions, appropriate to the nature and stability of

the drug concerned. They must be protected from contamination, sunlight, atmospheric moisture and adverse temperatures, kept in safe custody with locks.

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4.84 To prevent mixing up medications for different patients, it is essential that drug trolleys with separate receptacles for keeping the individual patients’ medications should be used on the wards.

4.85 Ward drug cupboards and drug trolleys have to be kept locked when not in use and to be

kept out of reach of patients. 4.86 DD should be kept under lock and key in a designated drug cabinet and the key should be

kept by the nurse in-charge at all times. 4.87 Some medicinal products require storage at a low temperature. Pharmacy and ward staff

should check the labelling on the product for the appropriate storage requirements. Pharmaceutical refrigerators, wherever possible, should be used for the proper storage of drugs in wards and in pharmacy. It should be equipped with a maximum/minimum thermometer. The temperature should be checked regularly and should be in the range of 2°C to 8°C. The refrigerators used for storing medications, should be used solely for this purpose

4.88 It is important that medicinal products for external use be stored separately from the drug

items that are for internal use. Medicinal products for external use e.g. liquid antiseptics, have to be stored in a SAFE place and labelled with the warning “For external use only”.

Inspection of Storage and Records of Drugs 4.89 The designated registered pharmacist(s) or medical practitioner(s) should inspect the storage

conditions of poisons in places, such as pharmacies and wards, where poisons are required to be stored at regular intervals of time not exceeding three months in accordance with the requirements as stipulated in the Pharmacy & Poisons Regulations, Cap. 138A, Section 24(5).

4.90 The person(s) appointed by the medical officer in charge of the hospitals / clinics should

examine the storage, supplies and stocks of the DD in the hospitals / clinics at least once in every month in accordance with the requirements as stipulated in the Dangerous Drugs Ordinance, Cap. 134, Section 23(5).

Storage of Dangerous Goods (DG) 4.91 Dangerous Goods (DG) should be stored at designated places in the clearly labelled

chemical storage cabinets. Only minimum amount should be kept at the place of work according to OSH recommendation. For details, end-users should refer to (1) Factories and Industrial Undertakings (fire precautions in notifiable workplaces) Regulation, Cap. 59V, Section 9 for storage of inflammable substances and (2) Dangerous Goods General from the Fire Services Department.

Storage of Medical Gas Cylinders/Containers 4.92 The storage of medical gas cylinders must comply with the provisions of the Dangerous

Goods (General) Regulations. For details, end-users should refer to the Medical Gas System Operation Manual on cpo.home of HA intranet.

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(D) RECOMMENDATIONS ON DRUG ADMINISTRATION PROCEDURES IN THE WARDS No medications should be administered to a patient if a drug order is unclear or when there is doubt in the appropriateness and safety of the patients. Level of Nursing Personnel involved in Drug Administration 4.93 Under normal circumstances, a Registered Nurse is competent to administer medications on

his/her own. However, it is advisable to have a second person counter check the process especially in situations where skill, experience and familiarity with the clinical conditions are required to ensure safe practice, such as with paediatric medication, intravenous injections, dangerous drugs, cytotoxic drugs and drugs added to infusion fluids. In any case, nurses should exercise care to double check themselves and not to rely solely on others with regard to the checking process.

4.94 Enrolled Nurses should work within their qualification and training. In normal

circumstances, they can administer medications, when delegated this duty by Registered Nurses. In the case of the extended and expanded role of the Enrolled Nurse, an enabling course or clear guidelines should be provided.

4.95 Nurse learners who have undergone training in medication administration and are deemed to

be competent, may administer medications under the supervision of qualified nurses. Order and Receipt of Drug Supplies from the Pharmacy 4.96 All drugs orders should be sent (e.g. by fax or by NCR) to the pharmacies for vetting

irrespective of whether the supplies of drugs are required. Prior to sending of the drug orders, authorized nurses should screen the information on the orders to ensure the correct patient’s label has been affixed and all important information for drug dispensing and administration have been clearly written.

4.97 All “discontinued” medications on the MAR should be faxed to the pharmacy as soon as

possible so that unnecessary re-dispensing of discontinued drugs can be avoided. In the cases of urgent / uncertain situations, the pharmacy department should be called to confirm the receipt of the drug orders.

4.98 All drugs delivered to wards must by checked by the authorized nursing staff as soon as they

are received. Drugs with special storage instructions such as refrigerated items must be put in the refrigerator promptly. The patient’s name on each of the drug label and the name and condition of each of the drug dispensed must be checked for accuracy and acceptability before putting them into the drug trolleys.

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The Principle of Three checks and Five Rights Check patient’s identity according to the patient identification guidelines. 4.99 In drug administration, the principle of “three checks and five rights” should always be

observed. These include :-

(a) Careful checking BEFORE taking the medication out from the container,…………(first check)

(b) Careful checking AFTER removing the medication from the

container,………………(second check) (c) Final checking of the medication against the container before disposal/putting it

away………………...(third check) (d) Right patient (e) Right drug (f) Right dose (g) Right route (h) Right time

4.100 To ensure the practice of three checks and five rights, the related checking procedures are

described below :

(a) READ the prescription. Ascertain which drug is due to be given. If the prescription is illegible, the nurse must refer back to the prescriber to have the prescription re-written.

(b) Nurses should refer to the MAR for the administration of drugs. Transcription of the

drug order onto a separate work sheet should be avoided. The MAR for long stay patients in convalescent hospitals should be appropriately designed. It should be used as the record of administration of drugs to patients.

(c) Check the identity of the patient according to the patient identification guidelines.

(d) Check the patient’s name and that the name of the drug corresponds with the

prescription. It is very important that the RIGHT patient and drug are positively identified.

(e) Check the patient’s drug allergy.

(f) Check the name, strength, and expiry date of the drug (where available), the dose to

be given and route and time of administration, and that the drug order is still valid.

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(g) Caution should be exercised in the calculation of dose. For high risk drug items, all work especially the calculation of dose should be checked independently by another nursing staff member.

4.101 Should nurses have any doubt during the course of the procedure, they should withhold drug

administration until verification by the prescribing doctor or, exceptionally, by another Registered Nurse.

Administration of Intravenous Medications 4.102 As injectable drugs can be associated with very serious medication errors, special caution

must be exercised in the administration of intravenous drugs. 4.103 Administration guidelines for parenteral drugs which provides information on the dilution

and administration of injectable drugs that are commonly used in the HA is available in the pharmacy and on cpo.home of HA intranet. Nurses should always make reference to the guidelines and in the case of any uncertainty about the information provided, nurses should refer to the product inserts or contact the pharmacy department of their hospitals.

4.104 When a high risk intravenous medication is prescribed, the prescription order must be

independently checked by 2 nurses to ensure that the order has been correctly interpreted and that the drug, dose calculations, preparations, route & mode of administration are accurate.

4.105 Extreme care should be exercised with those intravenous drugs which can never be given by

bolus but only by infusion. In such cases, the dose calculation should preferably be done by a pharmacist. However, pre-defined charts for dilutions and protocols for standardized infusion rates should be used when intravenous infusions are to be prepared by nurses in the wards.

4.106 The bolus of IV dangerous drugs should preferably be administered by a doctor. 4.107 The administration of IV fluids and drug additives should always be documented. The IV

chart together with the date, time and the amount of drug to be given should be signed. 4.108 Syringes containing drugs should be properly identified in order to prevent any mix-up of

medications. In no circumstances should any unidentified drugs be given to patients and they MUST BE discarded immediately when found.

4.109 Patients who simultaneously have an IV line and other types of non-IV tubing in place, are

at risk of a potential mix-up in the lines. It is important that the tubing lines are traced back carefully to the site of insertion before drugs or feeds are administered. It should have access line label if it is more than one line. (refer to Samples of the Line Labels in Appendix 9)

4.110 Nursing staff using medication administration devices such as infusion pumps, should

understand their operation and the risks of error that might occur with the use of such devices. Double checking should be practised when setting up infusion pumps for infusing high risk drugs. Limiting the types of infusion pump available to a minimum would also help to reduce the chances of error.

37

4.111 Three-way (red and blue) and four-way stopcocks (blue only) are predominantly used for the administration of intravenous solutions and intermittent injection of drugs. A uniform colour-code for stopcocks has been adopted to facilitate line identification with blue colour denoting venous line and the red colour denoting arterial line or intra-cranial pressure line. Since simultaneous dual access may be required for venous access only, Four-way stopcock would only be available in blue colour. The guidelines on the use of three-way and four-way stopcock are shown in Appendix 10.

Record of Administration 4.112 The MAR should be used as the record of the administration of drugs to patients. This will

eliminate any error inherent in other transcribed reference. The supervising Registered Nurse and nurse learner administering the drugs should sign the MAR.

4.113 The date, time of administration and signature should be entered immediately AFTER the

drug has been given and CONSUMED by the patient. Recording and Reporting 4.114 Whenever a patient refuses or vomits back a drug, the matter should be recorded on the

patient’s MAR. Other reasons leading to an omission in drug administration should also be recorded, e.g. patient was fasting, drug unavailable. If a dangerous drug has to be discarded because it has been spoilt or rejected by a patient, the event should be reported to Nurse in-charge and entry made in the appropriate ledger. The doctors concerned should always be informed.

4.115 As part of the ongoing process (not solely at the times of administration of medications) the

effects and side-effects of the treatment experienced by the patient or observed by nurses should be recorded and reported.

Self-medication Programme 4.116 Patients are encouraged and trained to self-administer their own drugs as part of their

rehabilitation programme. 4.117 Individual hospitals should establish protocols for carrying out this programme. Such

protocols should specify the selected patient group, the required physical & mental conditions of the patient, maturity, level of consciousness and educational background. Nurses may refer to Appendix 11 for Guidelines on Patient Self Medication for General Patients and Appendix 12 for Guidelines on Patient Self Medication for Psychiatric In-patient. For specific procedure such as patient controlled analgesia, ‘Nursing Standards for Patient Care’ formulated by the Nursing Section of HAHO should be referred to.

4.118 Pharmacist should provide patient education and counselling on the use of drugs.

Appropriate supervision by the nursing staff must be provided and the assessment of the patient should be documented.

38

The Supply of Ward Stocks 4.119 Ward stocks should be stored in an orderly manner. The practice of the rotation of stock

should be observed. Any changes in requirements e.g. stock levels, should be referred to the pharmacy for appropriate action.

Pooling of Drugs 4.120 Pooling, transferring, repackaging and relabelling of ward stocks should be avoided. 4.121 Drugs supplied to the ward whether as ward stocks or on an individual patient basis should

not be pooled together. Neither should unused medications be pooled together to form ‘unofficial’ ward stocks.

Relabelling 4.122 Labels originally provided by the pharmacy should NOT be altered or amended. In cases

where labels are inadvertently destroyed or soiled, the container with its contents should be returned to pharmacy for relabelling.

Dispensing outside Pharmacy Service Hours 4.123 For the dispensing of A&E and other prescriptions outside pharmacy service hours, the local

policy of individual hospital should be followed. Dispensing of ward stock medications by doctors or nurses for home leave and on discharge is not recommended. When this is unavoidable, the medication dispensed should still be clearly labelled and comply with the requirement of the Hong Kong Medical Council and the Pharmacy and Poisons Board. The list of Requirements for the Labelling of Medications is as follows:

(a) Name of patient (b) Date of dispensing (c) Trade name or pharmacological name of the drug (refer to Para. 4.62c) (d) Dosage per unit (e) Method and dosage of administration (f) Precautions where applicable

Borrowing of Drugs 4.124 Borrowing drugs from another patient’s supply or from other wards should be restricted to

exceptional circumstances. Method of Drug Return / Disposal 4.125 In order to minimise the amount of ward drugs returned, it is important to optimise

prescribing and drug distribution. This would reduce much unnecessary drug wastage and associated costs. Unused drugs left over by patients because of discontinuation of treatment

39

or their discharge or death, should be returned to the pharmacy. Local policies regarding ward drug returns and disposal should be followed and any other required documentation completed.

4.126 Substances prepared for administration and subsequently not used in the treatment of the

patient concerned, must be disposed of immediately. Procedures for handling of unused refrigerated drugs should be established. In the case of DD, this must be recorded in the ledger book by both nurses involved.

4.127 Antibiotics, dangerous drugs, poisons, other pharmaceutical products and cytotoxic drugs in

bulk or significant residue volume3 in container (e.g. unused or partially used drugs in ampoules or syringes) are classified as Pharmaceutical Chemical Waste and should be disposed according to the Chemical Waste Disposal Regulation. Each hospital unit should follow the guidelines set up by Environmental Protection Department for disposal as stipulated in Appendix 13.

(E) RECOMMENDATIONS ON HANDLING REQUIREMENTS FOR SPECIFIC DRUGS Dangerous Drugs 4.128 The guidelines on the handling of DD in HA hospitals was revised in April 1998. For details,

Appendix 14 should be referred to. Cytotoxic Drugs 4.129 Cytotoxic Drugs have both anti-cancer activity and the potential to damage normal tissues.

Thus they must be handled with extreme care. Individual hospital should draw up local policies with regard to their handling and disposal procedures. (refer to the HA Safety Manual on Cytotoxic Drugs Safety)

Hazardous Chemicals 4.130 Each hospital should establish a Comprehensive Chemical Safety Programme to ensure all

hazardous chemicals used in the hospital are properly managed to minimize the risk involved. The principles and guidelines established must comply with the Occupational Safety and Health Ordinance (OSHO) and Subsidiary Regulations. (refer to the HA Safety Manual on Chemical Safety, Material Data Safety Sheet, reference fact sheets and the updated version of ChemWatch)

High Risk Drugs 4.131 Particular caution should be exercised regarding the high risk drugs that have been involved

in potential or serious medication errors, e.g. digoxin, concentrated KCl injection. These drug items should not be kept as ward stock in general care areas.

3 Significant residue volume means more than 3% volume of container holding the cytotoxic drugs. Ampoules or

syringes holding less than 3% volume of cytotoxic drugs in containers can be placed in sharp boxes and disposed as Group I Clinical Waste.

40

Medications used in Resuscitation 4.132 Standard lists of resuscitation medications meeting the national and international trend of

evidence based approaches in different patient groups should be defined. Pharmacological management plans for safe and precise medication administration in different situations should be formulated by the hospital DTC and followed strictly in CPR.

4.133 The medications used in resuscitation are stocked in the emergency trolley and emergency-

kit (E-kit):-

(a) Medications in emergency trolley The medications in the emergency trolleys must be specific and consistent within the same specialty of the cluster / hospital and they must be stored in areas with easy accessibility. The conditions and expiry dates of the medications should be checked periodically and records kept of such check.

(b) Medications in emergency-kit (E-kit)

i. All E-kits should be prepared in the pharmacy. The contents of the E-kit should be properly labelled, concentrations of the medications standardized and layout of the E-kit consistent within the same cluster / hospital / specialty.

ii. A mechanism should be in place in the pharmacy for medication replenishment and

replacement/exchange of the E-kit. Once the security lock/seal is broken, the E-kit should be returned to the pharmacy department as soon as possible to exchange for a new one with lock/seal. A proper record should be kept in the pharmacy to monitor the expiry dates of the medications and the location of the E-kit.

4.134 Clinical staff must be well-acquainted with the medications used in CPR in terms of their

indications, dosages, units, routes of administration and other special considerations 4.135 All medications ordered and administered should be documented in the MAR / resuscitation

forms as soon as possible or within 24 hours of the CPR process whichever is the earlier. All orders on the MAR / resuscitation forms should be signed by the clinicians making the orders and administration signed by the nurses giving the medications.

(F) INFORMATION TECHNOLOGY IN PATIENT CARE 4.136 The improvement made in clinical practice, for example, in the areas of pharmacy service,

through the use of information technology system, has been successfully demonstrated. This is evident in the implementation of PMS through system functions, such as the dispensing modules, the CARS, the CDDH, the Bar code Ward Stock Topping Up and the MOE etc. All these systems have significantly enhanced the efficiency of the daily pharmacy operations and have facilitated the process of drug distribution.

4.137 It is noted that there is also the use and development of the CMS in the HA to support the

clinical care of the patients for use by clinicians and the related parties. This system requires active and collaborative participation from clinicians, pharmacists and nursing staff. It can be used to review and reform operational procedures. Not only will this facilitate

41

operational requirement but also it will help meeting the clinical needs of users for better quality patient care.

(G) QUALITY ASSURANCE PROGRAMMES 4.138 The purpose of quality assurance programmes is to ensure that every drug reaching the

patients is safe, effective and is of quality standard. A number of corporate programmes have been developed to facilitate the continuous quality assurance of medication use in the hospitals.

4.139 These programmes include Medication Incident Reporting Programme, Adverse Drug

Reactions Reporting Programme, Quality Complaints on Pharmaceutical Items and Drug Recall.

4.140 All medical, pharmacy and nursing staff involved in prescribing, dispensing and

administration of drugs should adhere to the reporting guidelines and procedures as stipulated in each programme for continuous quality assurance. Details of each of the programmes are provided in Chapter Five.

42

CHAPTER FIVE

QUALITY ASSURANCE PROGRAMMES

Medication Incident Reporting Programme 5.1 Medication incidents including “near-miss” cases in HA hospitals should be reported locally

in each hospital using standardised forms. The reporting is on a voluntary basis. Any staff member encountering a medication incident should be encouraged to make a report, irrespective of whether patients have been involved (refer to Appendix 15).

5.2 Completed reports are directed to the hospital DTC or its equivalent which monitors and

identifies the underlying causes for each incident and recommends appropriate preventive or remedial measures to the HCE. The Committee should also report quarterly statistical data as well as the details of cases of severity index 1-6 to the HAHO using the standardised return forms.

5.3 The HAHO will monitor the overall trend of medication incidents and consider appropriate corporate-wide measures. Apart from this, HAHO also issues MIRP bulletins at half yearly intervals to HA staff for educational purposes and to the lay press for public accountability.

5.4 At the hospital level, each hospital unit is recommended to establish a quality assurance/risk

management mechanism. In such mechanism, medication errors would be reviewed and appropriate recommendations and educational programmes would be organized to alert and educate front-line staff.

5.5 Reporting of MI by electronic means via the AIRS is being piloted in certain HA hospitals

and will continue to be rolled out to more hospitals of the HA. The value-added factors in AIRS would be the enhanced tools of analysis to assist management in probing root causes of incidents. The promulgation of safety concept and development of learning culture through a systematic reporting and reviewing process would be the ultimate goal of the new system.

Adverse Drug Reactions Reporting Programme 5.6 The World Health Organisation defines an Adverse Drug Reaction as “any response to a

drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological functions.”

5.7 Doctors, nurses and pharmacists must be alert to the potential for or presence of ADR. A

standard procedure to record and report clinically significant ADRs has been established (refer to Appendix 16).

5.8 These reports should be reviewed and evaluated on a regular basis, so that any necessary

actions including intervention, documentation, prevention and the provision of educational feedback to prescribers and other health care professionals can be done to maximise the safety of drug use.

43

Quality Complaints on Pharmaceutical Items 5.9 A quality complaint regarding a pharmaceutical item is defined as concern that is raised on

discrepancies in efficacy, appearance, packaging, possible contamination or any other circumstances observed that may jeopardize or cause reasonable doubt on the routine and intended utilization of that item.

5.10 In order to provide safe and effective pharmaceutical items to all patients, the quality

complaints should be handled in a systematic manner. The procedure must be complied with and all cases of quality complaints must be reported by using the standard report form. For detailed procedure, Appendix 17 should be referred to.

5.11 Whenever an alert with batch suspension is issued, immediate action must be taken to

quarantine all affected batches in all stores both within and outside pharmacy in the hospital. Close liaison with nursing staff should be maintained in order that the situation is fully understood by all parties concerned. All subsequent recommendations including product suspension, replacement, withdrawal or recall should be executed immediately and to all ward levels.

Drug Recall 5.12 Pharmacists must comply immediately with any warning or recall about defective medicines.

A drug recall system must be maintained so that all problematic batches can be traced and retrieved in order to protect patients from any harmful effects due to defective medicines.

5.13 All drugs should preferably be kept in their original containers with their unique lot/batch

number. If it is necessary for drugs to be transferred to another container, such as pre-packs, the retraceable lot/batch number should be marked on the label of the drug item.

5.14 When a drug recall is activated, pharmacy must notify all parties concerned immediately,

such as the unit head and nurse-in-charge, of the product to be recalled, the reason for its recall and the batch number involved.

5.15 All affected stock must be quarantined pending further instructions.

44

CHAPTER SIX

CONCLUSIONS AND RECOMMENDATIONS

This report attempts to address the very important issues of patient safety, system efficiency and quality improvement related to the in-patient drug administration process, which includes drug prescribing, dispensing and administration. The majority of activities related to the assessment of the in-patient drug administration process are driven by HAHO but promulgated and implemented in the individual hospitals. In order to achieve the objectives of this report, effective teamwork is essential particularly in the promulgation, dissemination and implementation of the procedural guidelines and recommended practices to all HA hospitals. Team Approach to the Promulgation, Dissemination and Implementation of Procedural Guidelines 6.1 6.2

It is recommended that a team approach involving the HAHO, individual hospitals’ top management such as the CCE / HCE, COS and the professional front-line staff, should be used in the promulgation, dissemination and implementation of the procedural guidelines in this report. Doctors, nurses and pharmacists have different but integrated roles to play in the whole process of drug administration. They should work together as a team with an ultimate aim of providing quality patient care. Such team work is particularly important in Hospital DTC, Department Quality Assurance Programme/Risk Management Forums and Review Panels on medication incidents.

The Mechanism of the Team Approach to the Promulgation, Dissemination and Implementation of Procedural Guidelines 6.3 The following flow chart illustrates an example of the mechanism of the team approach

and provides a structural accountability framework for the effective promulgation, dissemination and implementation of the procedural guidelines in hospitals.

45

LEVELS TOOLS & MECHANISM TEAM WORK 6.4 The commitment and support from the HAHO and the top management of the individual

hospitals are very important. In order to disseminate the procedural guidelines effectively, hospitals should prioritize their resources for the purpose of conducting more training workshops, seminars and forums and train-the-trainer workshops for all staff concerned and especially front-line staff.

6.5 Individual hospitals’ DTC should include doctors, nurses and pharmacists. They should adopt the procedural guidelines and enhance their roles and responsibilities to coordinate the various professionals in the promulgation, dissemination and enforcement of guidelines, to monitor and review cases of medication errors, and to audit staff adherence to these guidelines.

6.6 The drug administration guidelines are to be widely distributed and easily accessed by every doctor, nurse and pharmacist. Wherever necessary, relevant parts of the guidelines should be extracted for use and reference by the relevant staff groups.

6.7 The establishment of a mechanism for effective communication between management and front-line staff should be encouraged. Regular feedback should be obtained from the various professional groups, so that problems can be identified and effective recommendations/corrective measures made.

HAHO CE / D

CCE / HCE

COS / CSC

DM (Pharmacy) GM (N)

Pharmacy staff

Medical staff

Nursing staff

DURC

DTC

46

To achieve these objectives, the following range of development programmes are recommended to be implemented in all HA hospitals.

Standardization on Medication Administration Processes

The working party has acknowledged the importance of standardization of medication processes in establishing uniformity in practice to prevent medication incidents. A number of areas have been identified and recommended as priority areas for such standardization.

6.8

It is strongly recommended that standardization should be implemented at the appropriate level such as specialty, hospital, cluster or HA-wide. These include the standardization of

MAR forms (cluster) Times of administration of medications (HA) Dosing and dilution methods of IV solutions (hospital / cluster) Medications used in resuscitation (specialty / hospital / cluster)

Information Technology in Patient Care 6.9 The introduction and extensive use of information technology in the areas of prescribing

and pharmacy service have had a positive impact on existing practices. The importance of information technology in patient care has already been discussed in paragraph F of chapter four.

6.10 Successful application of the various information technology systems, e.g. PMS, the CARS, the CDDH, the Bar-code Ward Stock Topping Up has brought significant improvement in the pharmacy service. It facilitates putting many principles of the drug administration procedures discussed in this Report into practice and provides impetus for further development. The systems should be extended to more HA hospitals. Use of the MOE module for discharge-patients and out-patients in the CMS improves clinicians’ access to patients’ drug information and the prescribing process. Further enhancement of the medication order entry functions and integration with the pharmacy systems should be developed to improve the utilisation of the systems and to provide decision support to clinicians in drug prescribing and dispensing.

6.11

It is recommended that feasibility study should be conducted on the development of in-patient MOE. Robust mechanisms to prevent the prescribing of potentially harmful medications to patients with known allergy must be established.

47

Medication Incident Reporting Programme

One of the most important methods for preventing medication errors is for individual, unit or hospital to learn from the mistakes and problems that have already been encountered.

6.12

It is recommended that each hospital should strengthen their mechanism for the review of all medication errors and make appropriate recommendations or corrective measures. Information on medication incidents should be discussed and presented in the form of workshops and lectures for educational purposes. Electronic reporting through AIRS should be pursued.

Adverse Drug Reaction Reporting Programme

HA has developed a comprehensive, ongoing programme for reporting, monitoring, reviewing and evaluating adverse drug reactions.

6.13

It is important that each hospital should strengthen their mechanism to collect information on ADRs for analysis on a regular basis. Educational feedback should be provided to the prescribers and other health care professionals.

Implementation of MAR, CARS & Bar-code Topping Up Systems

MAR, CARS and Bar-code Topping Up systems are systems implemented by individual hospitals’ pharmacy department and have made a great impact on the drug administration procedure and have enhanced the drug distribution process. The importance of these systems has already been discussed in paragraphs 4.51, 4.52 & 4.74 (e). All these systems are important components in the process of eliminating medication errors during drug administration.

6.14

It is highly recommended that these systems be implemented comprehensively in all HA hospitals in the absence of any better alternative at present.

48

24 hours or Extended Pharmacy Service

The working party has acknowledged the need to provide a 24-hour or at least an extended pharmacy service in acute general hospitals. A number of problems were identified in the in-patient drug administration procedure arising from the limitations in pharmacy service hours.

6.15

It is strongly recommended that a 24 hours or at least an extended pharmacy service be introduced in acute general hospitals when manpower and other resources are available.

Aseptic Dispensing Services

Pharmacies are recommended to prepare and dispense medications in the most ready-to-administer form in order to minimize the opportunities for errors. Aseptic dispensing services, such as TPN, cytotoxic and central intravenous admixture services, are recognized as important pharmacy services to improve efficiency and accuracy through standardization and specialization. It is recommended that the provision of Aseptic Dispensing Services by the pharmacy be extended to or through clustering of service by the acute general hospitals.

6.16

Clinical Pharmacy Service

The importance of the Clinical Pharmacy Service and the benefits of Satellite Pharmacy Services and Compliance and Refill Clinics have already been discussed in paragraphs 4.54, 4.55, 4.56 and 4.57. A Clinical Pharmacy Service can undertake risk management studies, improve safety and quality as well as reducing the chances for medication errors and enhancing a multi-disciplinary approach.

6.17

It is recommended that priority be given to establishing Clinical Pharmacy Services in acute hospitals.

49

Continuing Education 6.18 In order to keep abreast of the fast changes in the field of medicine, drug therapy and

related technology, doctors, nurses and pharmacy staff including pharmacists and dispensers must receive continuing education and training to enable them to be competent in providing professional services. Information on drug therapy, methods of administration and the use of intravenous administration devices, should be made available to all personnel in order to maintain their standard of knowledge.

6.19

It is recommended that continuing education in the form of seminars, workshops and lectures should be organized. Information leaflets, drug bulletins and on-line drug information, for example via the intranet should be prepared for dissemination to all staff concerned, especially the front-line staff on a regular basis.

Audit Programme 6.20 The Working Group recommended that local feedback systems should be set up to

increase staff awareness of the risk areas in drug administration procedures and an audit programme should be established in all hospitals to monitor staff adherence to these guidelines.

6.21 At the corporate level, the HAHO will facilitate the adoption of these guidelines and continuously monitor and review their implementation.

50

List of Reference 1. Medicines, Ethics and Practice, A Guide for Pharmacists 1998, Royal Pharmaceutical

Society of Great Britain. 2. Practice Standards of ASHP, American Society of Health System Pharmacists. 3. Practice Standards and Definitions, The Society of Hospital Pharmacists of Australia 1996.

4. Guidelines on Hospital Pharmacy Practice, Second Edition 1997, Society of Hospital

Pharmacists of Hong Kong. 5. Good Dispensing Practice Manual 1998, Department of Health. 6. Reducing Adverse Drug Events 1998, Lucian L. Leape, Andrea Kabcenell, Donald M.

Berwick, Jane Rosessner, Institute For Healthcare Improvement. 7. Medication Incidents, The Australian Journal of Hospital Pharmacy Vol 29, No 1 1999,

Vol 28, No 2, 4, 5, 6, 1998. 8. ISMP Medication Safety Alert, Institute for Safe Medication Practices , Vol 2, issue 23

1997, Vol 3, issue 2, 3, 5, 8, 14, 18, 19, 20, 1998. 9. Medication Incidents Reporting Programme Bulletin, Hospital Authority, No. 1 - 10 10. Hong Kong Government, Dangerous Drugs Regulations, Dangerous Drugs Ordinance,

Pharmacy and Poisons Ordinance, Cap. 134, 138. 11. U.K.C.C. Standards for the Administration of Medicines, U.K.C.C., London, 1992. 12. Patient Self-administration of Medicine: A Review of the Literature, Collingsworth S., et

al, International Journal of Nursing Studies, Vol. 34, No. 4, pp. 256-269, 1997. 13. Nursing Standards for Patient Care, Nursing Section, Hospital Authority, Hong Kong. 14. Foundations of Nursing, Christensen BL. & Kockrow EO, St. Louis, Mosby, 1995. 15. Clinical Nursing Skills: Nursing Process Model Basic to Advanced Skills, Smith SF., &

Duell DJ., Norwalk, Appleton & Lange, 1992. 16. Basic Nursing: A Psychophysiologic Approach, Sorensen & Luckmann’s, Philadelphia,

W.B. Saunders, 1994. 17. Fundamentals of Nursing : Human health and function (2nd ed.), Craven, R.F. & Himle, C.J.

(1996), Philadelphia : Lippincott, 18. Clinical Skills in Nursing Practice (2nd ed.), Earnest, V.V. (1993), Philadelphia: Lippincott.

Updated in Apr 08

APPENDICES

Appendix 1 IV Fluid and Drug Additives Administration Form

Appendix 2 Insulin Administration MAR Forms

Appendix 3 Lists of HA-wide Approved / Standard Abbreviations in Prescribing

Appendix 4 Schedule for the Administration of “tds” Drugs

Appendix 5 Mechanism for the Management of Drug Samples in the HA

Appendix 6 HA Guideline on Safe Management of Potassium Chloride IV Solutions

Appendix 7 Supply of Antidotes and Detoxifying Agents in HA Hospitals

Appendix 8 Guideline for Supply of Medication for Patients during Inter-Hospital Transfer

Appendix 9 Samples of the Line Labels

Appendix 10 Guidelines on the use of Three-way / Four-way Stopcocks

Appendix 11 Guidelines on Patient Self Medication for General Patients

Appendix 12 Guidelines on Patient Self Medication for Psychiatric In-patient

Appendix 13 Guidelines on the Disposal of Pharmaceutical Chemical Waste

Appendix 14 Guidelines on the Handling of Dangerous Drugs in HA Hospitals

Appendix 15 Medication Incident Reporting Programme

Appendix 16 Adverse Drug Reaction Reporting Programme

Appendix 17 Procedure for Quality Complaints on Pharmaceutical Items

Appendix 1

IV Fluid and Drug Additives Administration Form

1

Hospital Authority Hospital No. : ID No. :

Hospital Name : ( ) Intravenous Fluid And Drug Additive Administration Form Date of Birth : Age/Sex : All IV infusions must be written by the prescribers and reviewed on a daily basis Ward : Bed No. : Dept : Weight : Kg Height :

Known Drug Sensitivity/Allergy : Diagnosis :

IV Fluid Prescription Record of Administration Line C/P Date/time IV fluid Volume Drug Additives Infusion rate Dr. sign. Time

start Given by

Checked by

Volume infused Pharmacy use

C = central P = peripheral

HAHO Aug 00

Appendix 2 Insulin Administration MAR Forms

1

Insulin Administration /Test strip glucose Monitoring Form

(For Doctors / Nurses Use)

Hosp # ______________ ID # _____________________

Name __________________________________________

Sex _____ Age ____ CName ______________________

Ward____ Bed ____ Dept ______________________ Date Sensitivity: H’stix glucose

monitoring Freq. Page #

Prescription/ route with Doctors’ signature & code

Date Time Urine ketone

H’stix Treatment Given Check-ed by

Given by

Remarks

On Off

On Off

On Off

On Off

Stat Dose Prescription (Please record under “Remarks”) Date Time Prescription/ route Dr. Check-

ed byGiven

by. Date Time Prescription/ route Dr. Check-

ed byGiven

by

• PRN insulin should be given before meal • Avoid frequent use of sliding scale which can lead to fluctuating blood glucose control • Capillary blood glucose should be done before or 2-hour post meal or when patient is symptomatic

HAHO Apr 02

2

Interval of test strip glucose monitoring

Date/Time ordered Interval

Intravenous Insulin Administration Form

(DKI or IV insulin pump)

Drug allergy ________________

Hospital No: ____________ ID No. _______________ Name _________________________________________ Sex ______ Age_____ Chinese name_______________ Ward______ Bed_____ Department________________

Dr’s prescription Nurse Record IV Insulin Pump Dextrose Potassium Insulin (DKI) regimen

IV fluid Date/ Time Insulin prescription

Dr S

ig.

Time

Blo

od g

luco

se

mm

ol/L

Urin

e ke

tone

Insulin (Units/hr)

Che

cked

by

Giv

en

by

Timestart

Time end IV fluid Vol (ml)

Insulin added (units)

K+

added (mmol)

Other additives

IV fluid infused

(ml) Che

cked

by

Giv

en b

y Remarks

Insulin pump

Time Checked by Prepared by

HAHO Apr 02

Appendix 3a

Lists of HA-wide Approved/Standard

Abbreviations in Prescribing

1

Lists of HA-wide Approved / Standard Abbreviations in Prescribing Prescribers should either prescribe in full text or adhere to the following lists of approved Abbreviations: 1) Standard Drug Name Abbreviations DRUG ABBREVIATION Acetomenaphthone Vit. K Adenosine Triphosphate ATP Adrenocorticotrophic Hormone ACTH Adsorbed Diphtheria & Tetanus Vaccine DT Adsorbed Diphtheria, Tetanus & Pertussis Vaccine DTP Alpha Tocopheryl Acetate Vit. E Alpha Tocopheryl Nicotinate Vit. E Ascorbic Acid Vit. C Bacillus Calmette Guerin Vaccine BCG Vaccine Calcium Carbonate CaCO3 Calcium Chloride CaCl2 Carmustine BCNU Cisplatin CDDP Cyanocobalamin Vit. B12 Cytarabine Ara-C Desmopressin DDAVP Ergocalciferol, Calciferol Vit. D2 Erythropoietin EPO Etoposide VP-16 Ferrous Sulphate FeSO4 Filgrastim G-CSF Fluorouracil 5-FU Glyceryl Trinitrate GTN, TNG Hepatitis B Immune Globulin HBIG Isoniazid INAH Lomustine CCNU Magnesium Chloride MgCl2 Magnesium Sulphate MgSO4 Measles/Mumps/Rubella Vaccine MMR Vaccine Mercaptopurine 6-MP Methotrexate MTX Molgramostim GM-CSF Phenoxymethylpencillin Pencillin V Phytomenadione Vit. Kl Potassium Chloride KCl Potassium Iodide KI Potassium Permanganate KMnO4 Propylthiouracil PTU Prostaglandin E2 PGE2 Pyridoxine Hydrochloride Vit. B6 Riboflavine Vit. B2 Sodium Bicarbonate NaHCO3 Sodium Chloride NaCl

2

DRUG ABBREVIATION Teniposide VM-26 Thiamine Vit. B1 Thyrotrophin-releasing hormone TRH Thyroxine T4 Liothyronine Sodium T3 Zinc Oxide ZnO

Reference : 1. Martinadale, The Extra Pharmacopoeia, 34th edition, The Royal Pharmaceutical Society of

Great Britain. 2. American Hospital Formulary Service (AHFS) Drug Information 2002, Authority of the Board

of Directors of the American Society of Health-System Pharmacists 3. Medline Plus® (Medical Dictionary – The US National Library of Medicine and the National

Institutes of Health) HA-wide Approved Local Drug Name Abbreviations DRUG ABBREVIATION Balance Salt Solution BSS Dihydrocodeine Tartrate DF118 Expectorant Stimulant MES Hydrocortisone 1% & Clioquinol 3% H1V3 Multivitamin MV Vitamin B Complex Vit.B Co

2) Standard Abbreviations for the Route of Administration ABBREVIATION EXPLANATION I.D. Intradermal I.M. Intramuscular I.V. Intravenous

For intravenous injection, whether it is bolus, slow IV or infusion should be specified.

I.P. Intraperitoneal N.G. Nasogastric P.O. Per oral P.R. Per rectum P.V. Per vagina S.C. Subcutaneous S.L. Sublingual

3

3) Standard Abbreviation for Drug Administration Frequency INSTRUCTION LATIN ABBREVIATION once daily once daily twice a day bis die b.d. twice a day bis in die b.i.d. three times daily ter die sumendus t.d.s. three times daily ter in die t.i.d.1 four times daily quater in die q.i.d.2 four times daily quater die sumendus q.d.s. at bedtime hora somni h.s. at night nocte noct. every night omni nocte o.n. every morning omni mane o.m. before noon ante meridiem a.m. afternoon post meridiem p.m. when required pro re nata p.r.n. used as directed more dicto utendus m.d.u. immediately statim stat. alternate alternus alt. before food ante cibum a.c. after food post cibum p.c.

_______________________ 1 t.i.d. is preferable to be used in prescription 2 q.i.d. is preferable to be used in prescription because q.d.s. is easily mistaken with q.d. 4) Standard Abbreviations for Dosage Forms DOSAGE FORM LATIN ABBREVIATIONS capsule capsula cap. drops guttae gtt. for the eye oculo ocul. irrigation irrigatio irrig. mixture mistura mist. ointment unguentum ung. pessary pessus pess.. powder pulvis pulv. suppository suppositorium supp. syrup syrupus syr. tablet tabletta tab. tincture tinctura tinct.

Reference : Pharmaceutical Handbook, The Pharmaceutical Press Pharmaceutical Practice, D.M. Collect, M.E. Aulton

The Chief Pharmacist’s Office is responsible for coordinating the procedures involved in the addition of drug abbreviation. Any request for addition of drug abbreviation should be made through the hospital pharmacy.

HAHO 2000 (revised in Jan 05)

Appendix 3b

“Do Not Use Abbreviations”

Updated in Oct 2008

“Do Not Use Abbreviations”

Do Not Use

Use Instead Potential Problem

u or U (unit) units Misinterpreted for ‘0’ (zero) or ‘4’ (four)

iu or IU (International unit) units Misinterpreted for IV (intravenous) or ‘10’ (ten)

q.d., qd, Q.D., QD (daily) daily Misinterpreted as qid (four times daily)

q.o.d, qod,

Q.O.D., QOD (every other day) on alternate days

Misinterpreted as qd (daily) or

qid (four times daily)

mcg, µg microgram Misinterpreted for mg (milligrams) Reference

1. Joint Commission. “Do Not Use” List

2. ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. 2006.

Appendix 4 Schedule for the Administration of “tds” Drugs

1

NMS/C Paper 31/2

Schedule for the Administration of “tds” Drugs

Background The administration time of tds drugs in hospitals was raised as an issue following a recent incident. Although it was recognised that tds regime cannot be at an 8 hourly interval even under normal circumstances. The administration schedule for tds drug regimen was found to be unevenly distributed and in some cases the interval between administration can be as long as 15 hours between. 2. This issue has been raised at the 30th Nursing Management Sub-committee Meeting. It was recognised that hospital routine and patient’s activities of daily would need to be taken into account in the scheduling of a more evenly distributed drug administration regime for tds drug. A review of existing practices in selected hospitals was conducted in consultation with nurse managers. Principle of Drug Administering Schedule for tds Regimen 3. The review indicated that it is not possible to restrict to one single drug administration time for tds drug in all hospitals given the differences in ward routine and patient meal time. The following two schedules for tds drugs have been recommended in consultation with Chief Pharmacist’s Office :

8 am 12N 8 pm 7:30am 11:30am 7:30pm

Recommendation 4. It is recommended hospitals should adopt one of the tds drug administration schedules in paragraph 3.

Nursing Section HAHO

August 2000

Appendix 5

Mechanism for the Management of Drug Samples in the HA

1

Mechanism for the Management of Drug Samples in the HA ________________________________________________________________________________ Background 1. Drug samples are offered freely by the pharmaceutical companies for doctors’ trial use in

hospitals and clinics. This has always been the practice, and certainly not one that is unique to Hong Kong. Although there exists a well established and accountable system for the whole administration process for all medications in HA institutions, drug samples are not subjected to the same extent of control. Moreover, the number of drug samples kept in each hospital is also substantial. A rough estimate of over 100 different drug samples are stocked in major acute hospitals in the HA, with approximately 11,000 to 12,000 dispensing transactions for each major hospital in the year 2000-2001 alone.

Advantages of using drug samples 2. The provision of drug samples offers certain benefits for the HA. First, although

pharmaceutical companies provide drug samples as a means of introducing new products to doctors and patients, and may try to change their utilization behaviour in due course, drug samples provide doctors and patients with an opportunity to obtain first hand experience with newly released drugs which are otherwise available only on properly conducted clinical trials. Second, patients who have previously failed all other therapeutic choices on the existing drug formulary or those who are suitable may benefit from the new drug therapy. Third, by prescribing free drug samples, doctors may help to contain departmental drug budgets.

Problem with using drug samples 3. However, liberal distribution of free drug samples within the institutions is not without

problem. Being new drugs, information regarding these drug samples is often very limited. Doctors usually prescribe based on information supplied by pharmaceutical representatives, and not necessarily on the best scientific evidence available in the medical literature. In deviating from clinical guidelines that are derived from best evidence, it is possible that drug samples may not be the most beneficial therapeutic choice for patients, bearing in mind the risk of undetermined efficacy (relative to established therapy) or unknown adverse effects associated with their use. For the introduction of new pharmaceuticals, (and likewise, for the introduction of new technologies), a well-founded system is already available in the HA. The central Drug Advisory Committee has been serving this particular role since 1996, by evaluation the cost-effectiveness of new pharmaceuticals based on scientific evidence, through a panel of experts from different medical disciplines with a rotating membership. Free drug samples, being prescribed as non-formulary drugs, however, fall outside this system, and may not have been subjected to any formal evaluation before being widely used within the HA. HA normally provides coverage to all staff on liability arising from patients treatment including drug therapy and medical procedures conducted within the organisation. However, since drug samples are used without a formal evaluation process, it is not certain whether HA would be able to provide the same extent of professional indemnity coverage should any medication incidents or adverse effects that are associated with the drug sample occur.

2

4. As with all medications, there should be an efficient and effective mechanism for recalling drug samples when circumstances require. Different hospitals may have different practices in the record keeping of drug samples, and, to date, there is still an absence of a quick and effective way for retrieving the medication records for drug samples and recalling them from patients. For instance, cerivastatin (Lipobay®) was withdrawn globally in August 2001 due to the occurrence of a fatal adverse effect of rhabdomyolysis and myopathy when it was co-prescribed with fibrates. Although cerivastatin was not yet listed in the HA drug formulary at the time, it was being used as a drug sample in many HA hospitals. The global withdrawal necessitated an urgent recall from the hospitals. However, being a non-formulary drug, cerivastatin was not coded in the same way as other formulary drugs in the HA computerized pharmaceutical system. The recall had to be conducted by a manual search through each individual dispensing record under the Corporate Drug Dispensing History (CDDH) system, which had proved to be an inaccurate and lengthy process. Mishandling of these situations could even result in delayed actions and serious consequences.

5. The provision of free drug samples poses another problem of managing patients’

expectation. When the drug samples are no longer free, doctors will face the dilemma of either continue prescribing the new drug, which in many cases are more expensive than the current ones, or to change back to their usual preferred drugs. However, once the medical conditions of the patients are stabilised with the drug sample, it would be difficult to convince them that their therapy would be discontinued or changed to an alternative, unless the situation has been clearly explained to them prior to commencement of the drug sample.

HA Drug Sample Policy 6. In view of the above discussed issues associated with the handling of drug samples, it is

important that a formal mechanism should exist for the control of drug samples in the HA. The JCAHO (Joint Commission on Accreditation of Healthcare Organisations) provides standards for medication use in hospitals and institutions in the US. The JCAHO standard requires that there should be a policy and procedure related to the control of drug samples throughout the institution. In addition, all other standards applicable to medication use apply to drug samples to the same extent as they apply to regular prescription medications dispensed by the hospital pharmacy.

7. Proposed mechanism for the management of drug samples in the HA : 7.1 There should be a system (defined by policy and procedure) for the control,

accountability and security of all drug samples throughout the hospital and affiliated clinics. The hospital Drug & Therapeutics Committee (DTC) (or an equivalent committee) would be a suitable body for overseeing the system.

7.2 Only registered drugs should be used as drug samples. 7.3 Hospitals are not required to introduce drug samples as formulary drugs before

allowing for trial use in their institutions. 7.4 Request for the use of drug samples by an individual doctor within the hospital will

be submitted through the COS to the hospital DTC for record. The COS will decide on and be accountable for all the drug samples used within his/her department. Each request will clearly indicate the following details :

7.4.1 indications for the use of drug sample; whether it is the only treatment option

or an alternative treatment option with claimed benefits over existing formulary drugs

3

7.4.2 types of patients to be treated 7.4.3 estimated number of patients to be treated 7.4.4 duration of treatment for each patient 7.4.5 total trial period 7.5 Patients should be fully informed that the drug samples prescribed for them are for

trial use over a definite period only. The efficacy and safety of the drug samples would require further evaluation. HA could not commit to provide these drug samples on a long-term basis. An information pamphlet for patients receiving drug samples will be designed by HAHO and issued to hospitals for future distribution.

7.6 Hospital DTC will inform HAHO (via CPO) of the use of drug sample in its

institutions. This will enable HAHO to keep an updated record of all the drug sample used in the HA, and facilitate appropriate action to be taken promptly if any urgent situation such as recall or medication incidents should occur.

7.7 Hospital DTC is responsible for the monitoring of the progress of the use of drug

samples in its institutions. If hospital DTC and the CPO have been notified of the use of the drug sample, and that it is prescribed according to hospital guidelines, HA should be able to cover liability associated with its use as with other formulary drugs.

7.8 All drug samples must be stored by the pharmacy according to the manufacturer’s

specifications and prevailing law and regulation. 7.9 Drug samples should be labeled and dispensed according to the same standardised

method that the hospital uses for non-sample medications i.e. dispensed through hospital pharmacy.

7.10 Documentation requirements for drug samples should be the same as for other non-

sample medications ordered and dispensed by the hospital i.e. written records for ordering and administering in hospitals should be kept on the MAR, and on MOE or prescriptions for out-patients. Computerised records should be kept on the CDDH (Corporate Drug Dispensing History) system and should be easily retrieved when required.

7.11 The recall mechanism for drug samples should be efficient and effective, and should

follow the same procedure that exists for other formulary drugs in the HA. In addition to the computerized records, a manual record may be kept by the hospital pharmacy if such record keeping facilitates the recall procedures and is convenient to update.

7.12 As with other medications, it is expected that significant medication errors and

significant adverse drug reactions that occur with sample drugs are identified, reported and reviewed according to the same procedures for other drugs listed in the HA i.e. using the same MIRP and ADR reporting systems and indicating that the drugs implicated are drug samples.

Action 8. All hospitals are advised to observe the recommendations outlined above in para 7 and to

devise a hospital drug sample policy accordingly. These should be forwarded to HAHO for record.

HAHO Feb 02

Updated in Apr 08

Appendix 6

HA Guideline on Safe Management of

Potassium Chloride IV Solutions

Page 1/3

HA Guideline on Safe Management of Potassium Chloride IV Solutions

First Issue Date: Dec 1998

Reviewed Date: May 2007

Effective Date: 1 July 2007 Subject Officers: Chief Manager (Q&RM)

Chief Pharmacist

File No: MSC/001 Prepared By: HAHO Medication Safety Committee

Approved By: Central Committee on Quality and Risk Management Drug Utilisation Review Committee

1. Background Intravenous potassium chloride is indicated in the treatment of potassium deficiency states when oral replacement is clinically inappropriate. Concentrated potassium chloride (14.9%) IV solution has potential risks to cause serious harm to patients, and can be fatal if given inappropriately. This guideline is the revised version of the previous “Handling and Storage Guidelines of Potassium Chloride Injection” issued in 1998 which has been included in the Drug Administration Procedures & Practices in Public Hospitals 2005 edition. It aims to introduce procedures for the safety controls of potassium chloride IV solutions, to limit and ensure safe use of concentrated potassium chloride in clinical areas. 2. Supply A. Concentrated potassium chloride injection (MUST BE DILUTED before use)

• Potassium chloride 14.9% (20mmol) in 10ml ampoule B. Pre-mixed Concentrated potassium chloride minibags (For use only with a calibrated

infusion device) for exceptional circumstances e.g. acute correction

In 100ml preparations • Potassium chloride 10mmol (10mEq) in 100ml water for injection (New) • Potassium chloride 20mmol (20mEq) in 100ml water for injection (New)

C. Pre-mixed potassium chloride solutions (Ready to Use)

- should be used whenever possible In 500ml preparations • Potassium chloride 10mmol in 500ml D5 (5% Dextrose) • Potassium chloride 10mmol in 500ml NS (0.9% Sodium Chloride) • Potassium chloride 10mmol in 500ml ½:½ (0.45% Sodium Chloride:2.5% Dextrose) • Potassium chloride 20mmol in 500ml D5 (5% Dextrose) • Potassium chloride 20mmol in 500ml NS (0.9% Sodium Chloride) • Potassium chloride 20mmol in 500ml ½:½ (0.45% Sodium Chloride:2.5% Dextrose)

In 1L preparation • Potassium chloride 20mmol in 1L NS (0.9% Sodium Chloride)

Page 2/3

2.1 Concentrated potassium chloride injection

Critical care units • Supply of concentrated potassium chloride injection as floor stock should only

be limited within these critical care areas, ICU, CCU or equivalent.

General wards • No floor stock of concentrated potassium chloride injection is allowed in

general wards (1,2). • Supplies of concentrated potassium chloride injection to general wards must

be made on individual patient basis with a completed MAR order sent to pharmacy (preferably including required concentration, diluent, volume of infusion and infusion rate) and checked by pharmacists.

• All unused concentrated potassium chloride injections obtained on individual patient basis with MAR have to be returned to pharmacy immediately upon discontinuation of treatment.

• After pharmacy hours, concentrated potassium chloride injection can be obtained in emergency cupboard if necessary.

Supply from Pharmacy

• Supplies of concentrated potassium chloride injection to wards in sealed bag with distinctive warning label and physically separated from other medications.

2.2 Pre-mixed Concentrated potassium chloride minibags and Pre-mixed potassium chloride solutions

All wards (Both critical care units and general wards included)

• Both pre-mixed minibags and solutions could be supplied as floor stock and replenished by pharmacy similar to other ward stock items.

3. Storage 3.1 Concentrated potassium chloride injection

All wards (Both critical care units and general wards included) • All concentrated potassium chloride injection, including those issued for

individual patient in general wards or as floor stock in critical care units, must be stored in DESIGNATED and LOCKED cupboard which must be PHYSICALLY SEPARATED from other similarly packaged frequently used diluents e.g. ampoules of 0.9% sodium chloride and water for injection.

1 Under very exceptional circumstances, the respective COS should (i) apply with justifications to CCE via DTC for stocking concentrated potassium chloride solution in areas other than critical care areas and Paediatrics, (ii) be responsible for the establishment of a safe management system similar to that of Dangerous Drugs.

2 Exception is granted for Paediatrics pending further review and sourcing of suitable pre-mixed potassium chloride infusion for use in Paediatrics

Page 3/3

3.2 Pre-mixed Concentrated pre-mixed potassium chloride minibags and Pre-mixed potassium chloride solutions

All wards (Both critical care units and general wards included)

• Storage requirements for pre-diluted potassium chloride solutions are the same as other ward stock IV solutions, which should be clearly segregated away from one another, aiming to prevent any mix-up among different ward stock IV solutions.

4. Administration of Potassium Chloride Injection

4.1 Concentrated potassium chloride injection (a) Concentrated potassium chloride MUST BE DILUTED before use. (b) For dilution of concentrated potassium chloride, it is recommended to invert the

mixed infusion bag several times to avoid accumulation of the drug. (c) COUNTER-CHECK during the retrieval for correct product, dosage dilutions, mixing

and labeling during the preparation and before administration of the product is essential. Staff should remain alert and be aware of the potential danger of incorrect use.

4.2 Pre-mixed Concentrated Pre-mixed potassium chloride minibags (a) For use only with a CALIBRATED INFUSION DEVICE for exceptional

circumstances e.g. acute correction (b) COUNTER-CHECK during the retrieval for correct product and before administration

of the product is essential. Staff should remain alert and be aware of the potential danger of incorrect use.

4.3 Other recommendations (a) A rate controlled infusion pump should be used if the infusion rate of potassium

chloride is faster than 10mmol/hr. (b) Concentration higher than 40mmol/L (i.e. 4 mmol per 100ml) of potassium must

be used with extreme caution. Infusion flow rate and infused volume must always be closely monitored and regulated for this high dose therapy.

(c) Patients should be monitored for signs and symptoms of hyperkalaemia during and after infusion.

(d) In cases where a patient complains of severe pain at injection site, the prescriber should immediately be notified to consider adjustment of the infusion rate or the concentration of potassium chloride content.

The Drugs and Therapeutics Committee (or equivalent) of individual hospital should formulate its policy on the dosage range and preferred diluents applicable to the clinical needs of its patients. Staff education and training on the risks associated with concentrated potassium chloride would be pivotal for improved patient safety.

Appendix 7

Supply of Antidotes and Detoxifying Agents in HA hospitals

複本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 1 of 6 Pages

Antidotes and Emergency Drug List April 2008

LEVEL§ ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC※

A. SPECIFIC ANTIDOTES & ANTAGONISTSI 1a Acetylcysteine Inj. 2g/10ml ACET14 amp YI 1b Acetylcysteine Infusion 200mg/ml x 25ml ACET38 Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

III 2 Acetamide Inj 0.5gm/ml x 5ml ACET42 50 Y Y 50 50 50 225II 3 Calcium Disodium Versenate Inj 200mg/ml x 5ml CALC39 amp 23 6 7* 36 18 6 0 6 6 1I 4 Bromocriptine tab 2.5mg BROM07 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y

5a Calcium Folinate Inj. 15mg/2ml (Leucovorin Ca) CALC23 amp 5 5 180 250 263 105b 100mg(base) (Leucoverin Ca) CALC24 400 1095c 300mg(base)(Leucoverin Ca) CALC32 394 175 400 270 411 10 15d 30mg (Base)(Leucoverin Ca) CALC55 654 214

I 6 Desferrioxamine Mesylate Inj. 500mg DESF01 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 7a Digitalis Antidote Inj. DIG101 amp Y Y 6 Y Y

7b Digoxin immune Fab (Ovion) Inj 40mg DIGO07 Y 10 6 10 (CCU) Y Y 10 Y 10I 8 Dimercaprol Inj. 50mg/ml 2ml DIME09 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 9 Dimercaptopropone Sod Sulphonate Inj 125mg/2ml (China) (DMPS) DIME22 amp Y Y Y Y* Y Y Y Y Y Y Y Y* Y Y Y Y 600

10 Disodium Edetate (Sod Edetate) Inj. 1% SODI96 ampI 11 Flumazenil Inj. 0.1mg/ml 5ml FLUM02 amp Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y

12a Folinic Acid 15mg tab FOLI09 tab Y12b Folinic Acid 15mg cap FOLI02 cap Y Y Y Y Y Y Y

III 13 Fomepizole 1gm/ml x 1.5mlΔ FOME01 vial 4I 14 Glucagon (HCl) Inj. 1mg GLUC37 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

III 15 Hydroxocobalamin Inj 2.5gm Δ HYDR53 vial Y Y* 2 2 2 4* 2 2416 Mesna Inj. 100mg/ml x 4ml MESN04 amp Y Y Y 0 Y Y Y Y Y Y Y Y Y

III 17 Methionine tab 250mg Δ METH76 tab Y 40 120 40I 18 Methylene Blue Inj 1% 5ml METH24 amp Y Y Y Y Y Y Y Y Y Y Y* Y Y Y YI 19 Naloxone HCL Inj. 0.4mg/ml NALO02 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 20 Penicillamine Tab. 250mg PENI04 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 21a Phytomenadione <Vit K1> Inj.10mg/ml PHYT04 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

21b Phytomenadione <Vit K1> tab 5mg PHYT05 Y Y Y 50 Y Y 50 Y YI 22 Pralidoxime Iodide Inj. 500mg/20ml PRAL02 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 23 Pralidoxime Chloride Inj. 250mg per ml x 2ml PRAL04 amp Y Y Y Y Y Y Y Y 130 Y Y Y Y YI 24 Protamine Sulphate Inj. 50mg/5ml PROT12 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 25 Sodium Nitrite Inj. 3% 10ml SODI51 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 26 Sodium Thiosulphate Inj. 25% 50ml SODI48 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

III 27 Succimer (DMSA) cap 100mg Δ SUCC05 cap Y28 Ethanol 95% & 70% for external use Y

I 29 Alcohol Absolute Injection 5ml ALCO11 ampI 30 Alcohol Dehydrated Injection 20ml ALCO17 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Pending orderII 31a Levocarnitine Injection 0.2G/ml 5ml LEVO10 amp 2 Y 30 10 10 28 0 10 21 1II 31b Levocarnitine Solution 0.3gm/ml x 20ml LEVO06 bot 197 198 Y Y Y 24 16

B. DRUGS FOR POISONING OR OVERDOSE32a Charcoal Activated Powder 1000gm CHAR03 gram Y32b Activated Susp. 50G/300ml CHAR02 bot Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y32c Tablet 300mg CHAR01 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y33 Cholestyramine 4G/Bag CHOL04 bag Y Y Y Y Y Y Y Y Y Y Y Y Y Y34 Fuller's Earth 60G/ Box FULL01 gram Y Y Y Y35 Ipecacuanha Syr(Emetic) APF (Note 1) IPEC03 ml Y* Y Y Y Y Y Y36a Polystyrene Sulphonate Calcium POLY07 gram Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y36b Powder (Resonium ) Sodium POLY08 Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

I 36c Polyethylene glycol ELE (Klean-prep) 68.8gm per pack POLY19 pack Y Y Y Y Y Y Y Y YC. SYMPTOMATIC TREATMENT IN DRUG POISONING37 Acetic Acid Soln. 5% ACET22 ml Y Y Y Y Y Y Y Y Y Y Y Y38a Adrenaline Inj 1:1000 amp ADRE01 amp Y Y Y Y

amp(no antimicrobial agent) ADRE12 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y38b vial ADRE02 vial Y Y Y# Y Y Y Y Y Y

II

複本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 2 of 6 Pages

Antidotes and Emergency Drug List April 2008

LEVEL§ ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC※

39 Metaraminol Tartrate Aramine Inj. 10mg/ml x 1ml META04 ampI 40a Atropine Sulphate Inj. 0.6mg ATRO01 amp Y Y Y Y Y Y Y Y Y Y

40b Atropine Sulphate Inj. 1.2mg ATRO03 amp Y Y Y Y Y41 Cardioplegia Inj 20ml CARD03 amp Y

I 42 Dantrolene Inj 1mg/ml 20ml DANT01 vial Y Y Y Y Y Y Y Y Y Y Y** Y Y Y Y43a Dopamine Inj. 50mg/5ml DOPA01 amp43b 200mg/5ml DOPA02 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y44 Edrophonium Chloride Inj.10mg/ ml EDRO01 amp Y Y Y Y Y Y Y Y Y Y Y 0 Y Y Y Y45 Isoprenaline Inj. 1mg/5ml ISOP12 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y46a Lignocaine Inj. 1% 50ml (1% 20ml for FH) LIGN02 vial Y Y Y Y Y Y Y Y Y Y Y Y Y46b 1% 5ml LIGN53 amp Y Y Y Y Y Y Y Y Y46c 1.5% 50ml LIGN03 vial47 Neostigmine 2.5mg/ml luer-fit NEOS06 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

I 48 Pyridoxine Inj. (preservative free) 100mg/ml x 1ml PYRI13 amp Y Y Y Y Y Y Y Y Y* Y Y Y YI 49a Pyridoxine Inj. 50mg/ml 2ml PYRI14 amp Y 100

49b Pyridoxine HCl (No preservative) Inj 100mg/ml x 10ml PYRI15 YD. SNAKE ANTIVENENE SERA

III 50 Agkistrodon Actus 2000u/amp,China AGKI02 amp 4 2 2 8 8 8II 51 Agkistrodon halys 6000u/amp,China AGKI03 amp 2 4 2 2 4 4 4 4 6 4 1II 52 Bungarus Multicinctus antivenin Inj 10000u/amp BUNG02 amp 2 2 2 8 2 4 5 5 2 4 4 2III 53 Cobra Antivenene 0.6mg/ml,Thailand COBR01 vial 2 2 5* 6 8 8 4

54 Green Pit Viper 0.6mg/ml, Thailand GREE01 vial 4 4 8 3* 10 4 4 6 1255 King Cobra Antivene 1mg/ml, Thailand KING01 vial 10* 6 8 8 3 3

III 56 Krait Banded 0.6mg/ml Thailand KRAI01 vial 2 4 2 7 5* 5 5 10 2 7 5 2II 57 Naja Naja 1000u/amp, China NAJA01 amp 2 4 2 8 2 4 4 4 2 8 4III 58 Russells Viper 0.64mg/ml Thailand RUSS01 vial 2 4 2 4 4 20 20 6 12 6III 59 Tiger Snake Antivenene Inj 3000u, Australia TIGE01 vial 1 1 1 4 4 6

E. RADIATION EMERGENCY60 Aluminium Hydroxide Suspension 6% ALUM03 bot Y Y Y Y Y Y Y Y Y

I 61a Calcium Gluconate Inj. 10% x 10ml CALC16 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 61b Calcium Chloride Dihydrate Inj 10% x 10ml CALC08 Y Y Y Y Y Y Y Y YII 62 CaNa2EDTA (see item 2) CALC39 vial 6 7* 29 9 9 6 6 6 1I 63 Desferrioxamine (see item 5) DESF01 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 64 Dimercaprol Inj 50mg/ml x 2ml (see item 7) DIME09 amp Y Y Y Y Y Y Y Y Y Y Y Y Y

65a DTPA - Diethylenetriamine Calcium salts CALC38 vial Ypenta-acetic acid inj. Zinc salts ZINC15 vial Y

66 Ipecac. Syrup (see item 33) IPEC03 bot Y* Y Y Y Y Y Y67a Magnesium Sulphate Soln. 49.3% X 5ML MAGN11 amp67b MAGN13 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

I 68a Penicillamine (see also item 20) PENI04 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y68b Potassium iodide tab 130mg POTA63 tab Y Y Y Y Y Y

III 69 Prussian Blue (Potassium Ferric Ferrocyanide) 500mg Δ PRUS01 cap 120 150 150 310I 70 Sodium Bicarbonate Inj. 8.4% X 100ML SODI07 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

F. IMMUNOGLOBULINS & ANTITOXINS71 Anti-D(RHO)Immunoglobulin Inj. 300mcg ANTI01 vial Y Y Y Y Y Y Y Y Y Y Y Y72 Anti- hepatitis B 2ml ANTI19 vial73 Antirabies Immunoglobulin Inj. 150iu/ml 2ml ANTI07 vial Y Y Y Y Y Y Y Y Y Y* Y Y Y

III 74 Botulism Trivalent Antitoxin Δ BOTU04 vial 2 2 3 275 Botulism Type A Toxin Inj 100u BOTU03 vial Y Y Y Y Y Y Y Y Y Y Y 176 Diphtheria Antitoxin 10000u DIPH08 vial Y Y Y Y77a Hepatitis B Vaccine Inj. 20mcg/ml x 1ml (Engerix) HEPA12 vial Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y77b Hepatitis B Immunoglobulin Inj. 109u/0.5ml HEPA36 vial77c Hepatitis B Immunoglobulin Inj. 220u/1ml HEPA38 vial Y Y Y Y Y Y* Y Y77d Hepatitis B Inj prefilled Syringe 110 iu/0.5ml HEPA39 Y Y Y Y Y Y Y Y77e Hepatitis B Immunoglobulin Inj 220u/1ml HEPA40 vial Y Y Y Y

複本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 3 of 6 Pages

Antidotes and Emergency Drug List April 2008

LEVEL§ ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC※

77f Hepatitis B Immunoglobulin im injection 220 iu/ml x 5ml HEPA43 Y Y Y Y Y Y Y Y Y Y78 Immunoglobulin(Human) IV Inj 3G NORM15 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y79 Rabies Vac. (Inactivated) Inj. 2.5iu RABI01 vial Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y80 Tetanus Adsorbed Vaccine Inj. 5ml TETA03 vial Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y81 Tetanus immuno Globulin, human prefilled syringe 250iu TETA10 syringe Y Y Y Y Y Y Y Y Y Y Y* Y Y

II 82 Stone Fish Anti-venom 2000u STON01 vial 1*+1 2 2 2 2 1II 83 Phentolamine Methanesulphonate Inj. 10mg/ml 1ml PHEN21 amp 8 5 20 8 14 25 29 21 8 22 16 11 6II 84 Octreotide Acetate Inj. 0.1mg/ml 1ml OCTR01 amp 20 138 638 20 28 129 319 189 189 402 745 923 99II 85 Octreotide Acetate 1ml Inj. 0.05mg/ml OCTR02 amp 21 666 21 36 139 139 60 50I 86 Physostigmine Salicylate Inj 1mg/ml x 2ml PHYS03 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 87 Cyprohepatadine HCl 4mg/tab CYPR01 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

88 Silymarine tab 70mg Y

KEYS§: Levels of antidotes stock with reference to memo (Ref: HA820/130/4/7/3) issued by DD(PS) on 9 May 2006. Level I Items (in blue)- HA Acute Hospital Level;Level II Items (in green) - HA Cluster Level; Level III Items (in red) - HA Central Level.

※: Hong Kong Poison Information Centre (tel: 26351111 from 9am to 9pm OR tel: 35134125 from 9pm to 9am daΔ: For the use of Level III antidotes, prior consultation with the Hong Kong Poison Information Centre (HKPIC) is strongly advi*: Stocked in A&E and not in Pharmacy**: Stocked in OT only#: Stocked in ICU and not in Pharmacy^: Stocked only in Emergency Cupboard in 2nd Floor and not in Pharmacy(1): In ICU and not in Pharmacy

Note 1: Ipecacuanha Syr. Emetic (A.P.F.) = Ipeca. Liq. Extract 0.6ml/10ml = 12mg (total alkaloids)/10ml or BP

Items deleted from the table:Agkistordon Actus Thailand (Agki 01)Amyl Nitrite vitrillae (Amyl 01)Anti-hepatitis B Immunoglobulin syringe 100iu/0.5ml(Anti23) Barium sulphate (Bari 01)Bungarus Multicinctus 8000u/amp (Bung01)Dimercaptopropone Sod Sulphonate Inj 50mg/ml x 5ml (Germany) (Dime21)Gas gangrene antitoxin (Gas 01)Hepatitis B Immunoglobulin Inj 200u/ml x 2ml (Hepa35)Hydrochloric Acid Dilute Inf 0.15N x 500ml (Hydr 34)Ipecacuanha Paed Mixt 14mg/10ml (=Ipeca Liq Extract 0.7ml/10ml=14mg total alkaloids/10ml) Isoprenaline inj 0.2mg/ml x 10ml (Isop 06)Malayan Pit Viper Antivene 2mg/ml (Mala04)Metaraminol Tartrate Inj 10mg/ml x 1 ml (meta04)Neostigmine metasulphite inj 12.5mg/5ml (Neos 05)Neostigmine metasulphite inj 1mg/mll (Neos 07)Nikethamide inj 25% x 1.5ml (Nike 01)Penicillamine cap 250mg (Peni 02)Pralidoxime chloride inj 50mg per ml x 10ml (Pral03)Protamine sulphate inj 10mg/ml x 10ml (Prot 02)Pyridoxine Inj 100mg/ml x 10ml (Pyri05)Sodium Bicarbonate + 0.01% EDTA Infusion 1.26% x 500ml (Sodi10)Sodium Calcium Edetate Inj 200mg/ml x 5ml (Sodi 10)

Appendix 8

Guidelines for Supply of Medication for Patients

during Inter-Hospital Transfer

1

GUIDELINES FOR SUPPLY OF MEIDCATION FOR PATIENTS DURING INTER-HOSPITAL TRANSFER

Background There is currently no laid-down policies in the HA on the supply of medications for patients during inter-hospital transfers. Individual discharge or recipient hospitals may or may not have any agreed arrangements regarding the issue or acquisition of medications for these patients. In a survey conducted by CPO, several problems relating to such transfers have been observed. 1. Disruption of supply of medication occurs if a non-formulary drug of the recipient hospital

has been prescribed and is not issued by the discharging hospital upon transfer. 2. Disruption of supply of medication if the patient transfer is made after Pharmacy opening

hours when no drugs accompany the patient upon transfer. 3. Medications issued directly from ward of discharging hospital to ward of recipient hospital

do not have proper labeling may be in violation of legal requirements. 4. If only items within the Drug Formulary of the recipient hospital are allowed to be

prescribed upon transfer-out, doctors of the originating hospital must be very familiar with the Formulary of the recipient hospital in order to avoid disruption of supply of medicine due to non-formulary items being prescribed.

Issues to be considered When drawing up the Inter-Hospital Transfer Policy, the patient’s benefit must be considered as the top priority. Continuity of supply of medication must be ensured when working out details for the procedures for inter-hospital transfer. The operation of the transfer procedure must be practicable and the financial implications, if any, must be worked out between the discharging and recipient hospitals. Recommendations 1. To simplify the procedure, it is recommended that each inter-hospital transfer can be

viewed as a discharged case for the hospital transferring out the patient, and an admission case for the recipient hospital. It is a shared responsibility for both the discharge and recipient hospital to ensure the continuity of supply of medicine for the patient.

2. A 5-working days’* discharge medication order covering all the patient’s current medication profile should be written up and sent to the pharmacy of the discharging hospital for dispensing. The 5-working day’s medication supply would allow ample time for the pharmacy of the recipient hospital to make arrangement for the continued supply of drugs. For antibiotics or certain rarely used items, the discharge hospital may consider to prescribe the full course*. If non-formulary drugs have been prescribed, there should also be sufficient time for the pharmacy to contact the case medical officer for

2

substitution with other drugs in accordance with the prescribing policies of the recipient hospital. If consensus is reached between the case medical officer and the Pharmacy that no substitution can be made, urgent arrangement must be made to acquire medication in order to ensure continued supply.

3. Sample code can be used for inputting dispensing information for the non-formulary item

prescribed until the item code for the new item can be downloaded from CPO. 4. Mechanism for stocking or acquiring the non-formulary item should be according to the

individual hospital’s operation procedures. 5. Financial issues must be worked out between the discharge and recipient hospitals.

Pharmacies of recipient hospitals finding difficulties in maintaining the continuity of supply of medications due to financial implications should bring their problems forward to the Hospital Drugs and Therapeutics Committee or any concerning committee for discussion and formulation of appropriate actions. Financial data relating to inter-hospital transfer dispensing activities will be available from the PHS for monitoring and analytical purposes. HCE’s of both discharging and recipient hospitals must have consensus on the procedures and financial arrangement for inter-hospital transfer.

Workflow Arrangement for the supply of patient’s medication during inter-hospital transfer should be according to the following procedure. * Or otherwise agreed between the discharge and recipient hospitals

3

A) Discharging hospital 1. Use an appropriate prescription form to write up a discharge medication order for a

duration of 5 working days*. The transfer status of the patient should preferably be clearly indicated on the prescription.

2. The prescriber should write up the discharge medication order as soon as the decision for

transfer has been made. The prescription should then be promptly sent to the Pharmacy for dispensing to enable the medication to be dispensed by the Pharmacy in time to accompany the patient to recipient hospital. This way, medicines having proper labeling can always be ensured.

3. After confirming that the contents of the prescription is complete and appropriate, the

pharmacy of the discharging hospital faxes the prescription to the pharmacy of the recipient hospital*.

4. The pharmacy dispenses the prescription with labeling that complies with the legal

requirement. 5. The patient is transferred to the recipient hospital together with the transfer-out

medication dispensed by the pharmacy. B) Recipient hospital 1. After receiving the faxed prescription from the pharmacy of the discharging hospital, the

pharmacy of the recipient hospital should check the availability of the medication prescribed*. Necessary action should be taken if non-formulary items are involved.

2. The recipient ward sends a copy of the MAR or the discharge medication summary to the

pharmacy for information and necessary action. 3. If a non-formulary item has been prescribed, use sample code to input dispensing

information until the new item code can be downloaded from CPO. 4. If the non-formulary item is to be used on a one-off basis, suspend the item code after the

treatment course has been completed. 5. The recipient hospital may also consider to review its formulary to include commonly

prescribed non-formulary items by the discharge hospital. * Or otherwise agreed between the discharge and recipient hospitals

HAHO Jan 99

Appendix 9

Samples of the Line Labels

1

HAHO Feb 99

Samples of the Line Labels

Colour

Yellow

Green

Purple

Brown

Blue

Red

Appendix 10

Guidelines on the use of Three-way / Four-way Stopcocks

1

GUIDELINES ON THE USE OF THREE-WAY / FOUR-WAY STOPCOCKS 1. Three-way and Four-way stopcocks are predominantly used for the administration of

infusion solutions and intermittent injection of drugs. 2. The tap of the Three-way stopcock can be turned 180°, and that of the Four-way stopcock

can be turned 360°. Simultaneous dual access to the connected line can only be achieved with Four-way stopcock, as described below :

All ports open for two simultaneous infusions or for one infusion with “simultaneous” injection

Only “side port” open for infusion, injection or CVP-measurement

Only “main port” for one infusion

Access

Main Port only Side Port only Simultaneous Close

3-way

4-way

3. It is intended that the colour-code of stopcocks should be uniformed to facilitate line

identification, in such a way that the blue colour denotes venous line and the red colour denotes arterial line or intra-cranial pressure line. Since simultaneous dual access may be required for venous access only, Four-way stopcock would solely be available in the blue colour.

4. Stopcocks should not be used on other connections other than those specified. 5. If other versions of stopcocks are required through local purchases, the guideline on

colour-code should always be followed.

HAHO DEC 97

(revised in FEB 05)

Appendix 11

Guidelines on Patient Self Medication

for General Patients

1

Approved COC(N) Paper 2/2000

Guidelines on Patient Self Medication

(For General Patients) Introduction The purpose of this paper is to introduce the guidelines on the implementation of patient self medication. Background 2. Patient self-medication has been introduced in UCH for post-partum women and patients with chronic renal failure since 1998. With positive results in drug compliance, medication knowledge of patients, staff job satisfaction and cost saving presented at the OBEM(N) in August 1998, hospitals were encouraged to implement this practice. 3. To facilitate the implementation of patient self-medication in hospitals, COC(N) has decided to establish guidelines to carrying out this program in collaboration with Chief Pharmacist’s Office. A task group was then formed in May 1999 to develop the guidelines. Definition 4. Patient self-medication program is a program in which patients are educated and given the responsibility to manage and take their prescribed medication when in hospital or discharged home. Objectives 5. The objectives of the guidelines are : 5.1 To heighten/maximise patient’s self-care ability 5.2 To enhance patient’s drug knowledge and proper handling of medications 5.3 To improve medication compliance Criteria for Selection 6. The selective criteria of patients are : 6.1 Willingness to participate in self-medication program 6.2 Ability to perform self-care, comprehensive with sound mind 6.3 Ability to communicate and understand medication instructions 6.4 Undisturbed by mental symptoms 6.5 No detectable suicidal tendency 6.6 Stabilised medication regime 6.7 Inclination to seek information in pursuit of better health

2

Operational Guidelines 7. The operational guidelines include the followings : 7.1 Preparation of patients 7.1.1 Obtain consent form patient (either verbal or written) 7.1.2 Educate patient to ensure

(a) Understanding on effects, side-effects, missing dose and special precautions of drugs, proper method and time schedule in administering

(b) Bringing of updated “prescription” upon admission (c) Proper storage of medications (d) Proper documentations of self-medication record

7.1.3 Provide training program to elderly patients with multiple medications if required

7.2 Preparation of medications - Individualised packing of medication for each patients

- Provision of relevant information on medication regime for patients upon admission

7.3 Supervision of patients

- Nurses are responsible to supervise individual patients, monitor patients’

- Compliance and observe for adverse drug reactions throughout the program

7.4 Handling of non-compliance

- Investigate the causes of non-compliance - Record any unfavourable medication incidence - Re-educate the patient on the proper way of drug administration - Re-assess the patient’s ability in self-medication

7.5 Monitoring and evaluation

- Monitor the process, compliance, unfavourable incidence and problems encountered

- Evaluate the outcomes, such as : drug compliance, patient satisfaction, staff satisfaction, cost saving etc.

Responsibility of the hospital 8. Though self-medication can foster a feeling of independence and control in the patient, the hospital is responsible to provide professional support whenever necessary. The hospital should have a mechanism in place to ensure that the operational guidelines are adhered to. It is important that the right patient receives the right medication with the right dosage, through the right route and at the right time.

Nursing Section HAHO April, 2000 (further revised in August 2000)

Appendix 12

Guidelines on Patient Self Medication

for Psychiatric In-patient

1

COC(N) Paper 12/2004 Approved by COC(N) at 56th Meeting held on 3 June 04

Guidelines on Patient Self Medication

(For Psychiatric In-Patients) Introduction The purpose of this paper is to introduce the guidelines on the implementation of self-medication programme for psychiatric in-patients. Background 2. Medication non-compliance is the major factor, which leads to relapse and accounts for most psychiatric re-hospitalization. With the increased awareness of patient’s right, medication education will enable the psychiatric patients to acquire knowledge on medication, to make informed choices and promote their commitment in the treatment plan. 3. The self-medication programme has been implemented in Psychiatric in-patient service as part of the rehabilitation training. It aims at enhancing the patients’ knowledge on drug classification, the expected therapeutic effect / side effect and the proper storage of the drugs. It also enforces the patients’ understanding on the importance of medication compliance and having the medication taken by self accurately. 4. To standardize the practice among clusters, COC(N) decided to establish guidelines to carrying out this programme for Psychiatric in-patients with input from Chief Pharmacist’s Office. Definition 5. Patient self-medication programme is a programme in which patients are educated and given the responsibility to manage and to take their prescribed medication when in hospital or discharged home. Objectives 6. The objectives of the guidelines are : 6.1 To heighten/maximize patient’s self-care ability 6.2 To enhance patient’s drug knowledge and proper handling of medications 6.3 To improve medication compliance 6.4 To promote patient’s commitment in the treatment plan

2

Operational guidelines 7. Operational guidelines on implementation of the programme for individual psychiatric hospital / psychiatric unit should be in place. The guidelines should be endorsed by local hospital Drug Committee and include the followings : 7.1 Selective criteria of patients are :

Scope of patient selection e.g. patient with history of non compliance Participation of the health care team in patient selection Mode of obtaining consent and its documentation

7.2 Supply and storage of the medication

Mechanism in place to state Agreement with the Pharmacy of individual hospital/ unit for the drug supply

policy, provision of the individualized packing of medication, procedures in requesting / revising / returning of drugs for self-medication etc.

Appropriateness of the medication storage place in respect of patients’ safety and accessibility and local hospital / unit structure

Appropriateness of DD storage in respect of the Dangerous Drug Act

7.3 Training and monitoring Availability of the training kits and assessment tools e.g. content of each

training session Personnel involved in the training and their responsibilities e.g. medical officer,

nurse or pharmacist Protocol for stepping up and stepping down the training for individual patient Documentation of patients’ knowledge assessment and suitability for the

practical part after the theory sessions Documentation of patients’ self-medication practice and it should be in line

with the local hospital / unit policy on AOM e.g. to keep patient’s self administration form together with the MAR

Level of supervision and mechanism in ensuring patients’ medication compliance in different stages of self-medication e.g. issuing of medication reminder card for forgetful patients

3

7.4 Evaluation Record and report the positive indicators e.g. successful rate of early discharge,

patient’s level of drug knowledge, patient satisfaction etc. Record and report the negative indicators e.g. medication incidents (MIRP),

adverse drug reaction (ADR) & medication incident (MIRP) due to non compliance, failure cases and other unfavorable incidents

Outcome evaluation by studying the indicators Responsibility of the Hospital 8. Self-medication is a part of the rehabilitation training that carries out in the hospital / unit for psychiatric patients. Apart from following the guidelines of individual hospital / unit in implementing the programme, patients’ safety in taking their medications in this aspect is utmost important. It is the responsibility of the hospital to establish a control mechanism to monitor the process and to diminish the risk in implementing the programme.

COC(N) June 2004

Appendix 13

Guidelines on the Disposal of Pharmaceutical Chemical Wastes

1

DISPOSAL OF HOSPITAL PHARMACEUTICAL CHEMCIAL WASTES 1. Scope of Service 1.1. The service covers the collection and disposal of the following categories of

unwanted materials; a. Antibiotics (as defined in Antibiotics Ordinance, Cap. 137); b. Dangerous Drugs (as defined in Dangerous Drugs Ordinance, Cap. 134); c. Poisons (as defined in Pharmacy and Poisons Ordinance, Cap. 138); d. Other pharmaceutical products and medicines, not elsewhere specified. 2. Containers & Labels 2.1 Solids a. Wide mouth screw open top 20 Litre HDPE pails will be provided by

Enviropace for collection of : (i) tablets, capsules with and without packing, and other totally solid materials, (ii) vials and ampoules containing liquids or slurries not exceeding 50ml each.

b. Wastes should be filled to occupy maximum 70% of the volume of the pails

(i.e. maximum 14 litres/pail). Liquid content in each container should not exceed 500 ml in total. A Liquid Waste Tracking Label (See Appendix 1) will be attached to the pail at time of despatching. The slip is to be updated each time when liquid waste is disposed into the pail.

c. Please refer to Appendix IIA for the design of the solid pharmaceutical waste

container label. 2.2 Liquids a. Closed top screw cap 20 litre HDPE pail will be provided for collection of

wastes other than those described in Item 2.1 above, e.g. bottles containing more than 50ml of liquid.

b. All wastes should be decanted from original packing into the collection pail.

In case there are reactions during decanting, stop the process and report to Enviropace, Miss Dandy Wong at 2434 6450. Instructions on handling and safety precautions would be provided.

c. Please refer to Appendix IIB for the design of the liquid pharmaceutical

waste container label. d. Emptied containers properly rinsed with water are not considered as

chemical wastes and can be discarded as ordinary refuse. 3. Collection Plan 3.1 One open top container for solids and one closed top container for liquids will be

dispatched to each hospital, upon their request, for pharmaceutical wastes. Additional containers will be provided on a case by case basis.

2

3.2 Collection of pharmaceutical wastes will be scheduled at time of collection of other chemical wastes from hospitals.

3.3 The Chemical Waste Service Co-ordinator appointed by each hospital, should take

charge of co-ordination of this service. 4. Documentation of Part A Chemical Waste 4.1 On disposal of materials categorized under Item 1.1a to 1.1c above, waste

producers are required by law to notify EPD prior to disposal using Form EPD-132. In such case Enviropace would arrange collection service only upon receipt of copy of EPD’s Part A Waste disposal directions on Form EPD-131 specifying the CWTF as the designated disposal point.

4.2 A Part A Waste Verification Label (Appendix III) will be attached to each

container at time of dispatching. If the container contains Part A waste at time of collection, a packing list must accompany the container. If the container does not contain any Part A waste, the Chemical Waste Service Co-ordinator or an appropriate designated person in charge shall sign next to the confirmation statement to verify (Appendix III).

4.3 Form EPD-132 should be sent to : Environmental Protection Dept

Waste & Waster Management Group 25/F, Southorn Centre 130 Hennessy Road Wan Chai Hong Kong Enquiry Hotline : 2835 1082 Fax : 2305 0453

[Appendix I, IIA, IIB, III are not included]

HAHO Sept 95

(revised in Jan 05)

Appendix 14

Guidelines on the Handling of

Dangerous Drugs in HA Hospitals

1

REVISED GUIDELINES ON THE HANDLING OF DANGEROUS DRUGS IN HA HOSPITALS

Process Authorised Staff Particulars (1) Issuance of a signed order for the procurement of DD from pharmacy.

Ward Manager (WM) i/c; Nurse Specialist (NS) i/c; Nursing Officer (NO) i/c; Registered Nurse (RN) i/c; Enrolled Nurse (EN) (If no registered nursing staff are on-duty)

Each ward to supply a list of authorized nursing staff with specimen signatures to pharmacy. For practical purpose, the list should be kept small and up-dated regularly. The nursing staff issuing the signed order should sign and indicate her title and name clearly for verification by pharmacy staff

(2) Delivery of DD to/from wards

As advised by the Department of Heath, the pharmacist i/c or an authorized nursing staff can appoint a designated hospital staff acting as his/her agent for the collection, delivery and transportation of DD to/from wards

Lockable receptacles should be used in the transportation of DD.

(3) DD records and stocks in wards

A DD register will be kept in each ward to record DD transactions. Copies of the signed order issued should also be kept for the statutory 2 years.

Pharmacist should inspect the DD register and stocks in the wards monthly. Any irregularity should be rectified immediately. Any irregularity that cannot be rectified have to be reported to the Director of Health as required under the Dangerous Drug Ordinance.

(4) Disposal of DD records

The expired register and the signed orders in the wards can be disposed of only with the approval of the pharmacist i/c in accordance with agreed procedures with hospitals.

For administrative convenience, the pharmacist i/c will be appointed as the person approving of the disposal. Pharmacy would work out the agreed procedure with the nursing staff.

(5) Transfer of DD from 1 ward to another for emergency use after office hours when pharmacy is closed.

The designated WM, NS, RN i/c of the hospital at after-office hours should be informed and approved of such transfer. The ‘recipient’ ward should send a qualified nurse or a student nurse to the ‘donor’ ward for the collection of the DD and the MAR of the patient should be presented. The qualified nurse in the ‘donor’ ward should record the patient particulars in its DD register.

The pharmacist should be informed of the incident and to review the optimal ward stock level. It is not necessary for the ‘recipient’ ward to record the quantity of DD received in its register because technically, the DD is only administered to its patient and not stocked.

(6) Retrieval of DD from locked DD cupboard in wards

WM, NS, NO and designated RN and EN who are performing the duty of the sister i/c.

Should exercise 3C 5R principle. Advisable to have a second person to countercheck.

(7) Administration of DD to patients in accordance to doctors’ prescriptions or directions in the bed cards or case sheets.

Any qualified nurse which include: Registered Nurse (General); Registered Nurse (Psychiatric); Enrolled Nurse (General); Enrolled Nurse (Psychiatric); Registered Midwife; Nurse Learner under supervision.

Should exercise 3C 5R principle. Advisable to have a second person to countercheck.

7ddguide5 HAHO 17 April 98

Appendix 15

Medication Incident Reporting Programme

1

QUALITY ASSURANCE IN DRUG THERAPY HOSPITAL AUTHORITY MEDICATION INCIDENTS REPROTING PROGRAMME

Purpose 1. This memo announces the setting up of the Hospital Authority’s Medication Incidents

Reporting Programme and its implementation. Background 2. The goal of any drug therapy is the achievement of defined and desired therapeutic

outcomes with minimal side effects and “risks” to the patients. “Risks” in the course of drug therapy may arise because of “adverse reaction” to drug appropriately prescribed and properly administered. Alternatively, patient may suffer from medication errors which are preventable through effective systems controls and implementation of sound procedural guidelines.

3. In the course of reviewing the drug delivery systems in public hospitals, the “Working

Party on Drug Administration Procedures and Practices” has considered in detail, the causation and prevention of medication errors, and the principles involved in the setting up and operation of any monitoring mechanism on medication errors.

4. The feasibility of having a Medication Incidents Reporting Mechanism for Hospital

Authority has since been discussed at the HA’s Central Drug and Therapeutics Committee. Further and more intensive discussion by professional staff in Hospitals have also been promoted by the publication of Hospital Authority Drug Education Bulletin Issue No. 4 and the organisation of a series of 3 seminars on the subject in October 1993.

Medication incidents reporting 5. It is certainly important to take proactive measures to prevent medication errors by

improving procedural guidelines, staff education and system support. It is equally important that we can learn retroactively through errors that have been committed. In this regard, there are sound support from overseas experience, for a medication incidents reporting mechanism to be in place in all in-patient health care facilities so that medication incidents could be identified and documented and their causes studied in order to develop systems that minimize recurrence. A variety of different reporting mechanisms are being used overseas in health care facilities. They may differ in the definition of cases to be reported, the reporting format, details of inquisition and the approach taken to deal with the staff and patients involved.

6. It is held however, that any effective incident reporting system should stress the quality

assurance and constructive aspect of the process and avoid a punitive or disciplinary approach. In this regard, the Hospital Authority already have appropriate procedures in place to deal with serious cases of medication error which warrant medical-legal considerations. Immediate assistance could be solicited from the Legal Liaison Officers at HAHO in accordance with HAHO General Administration Circular No. 2/92.

7. Recognizing the need and benefit of medication incidents reporting and monitoring, a

number of HA Hospitals have already set up their own reporting systems within the last year.

2

Hospital Authority Medication Incident Reporting Progamme (MIRP) 8. With more than 11/2 years’ period of discussion since the idea was first recommended by

the Working Party on Drug Administration Procedure and Practices, and positive developments in a number of HA Hospitals, it is time for an overall Medication Incident Reporting Programme (MIRP) to be set up for the Hospital Authority. The MIRP will comprise the local Reporting Programme at each HA Institution and an overall monitoring and supporting function at the HAHO. Hospitals which already have a MIRP set up along the lines described below would continue to operate the programme whilst all other Hospitals are requested to set up their MIRP by 1 April 1994. The mode of operations of the MIRP are set out as follows:

(a) Hospital staff are required to report all Medication Incidents (MI) irrespective of

whether patients have been involved. (b) Any staff coming to knowledge of a Medication Incident (MI) could report. In

particular, managers responsible for operational units e.g. COS, DOM, WM, DM, should report.

(c) The reports are to be made on a standard proforma. A sample of such proforma is

at Appendix I. Hospitals already with MIRP could retain their forms and other hospitals could adapt the sample form at Appendix I for their own use.

(d) The identity of the staff involved in the Incident and the patient are NOT

REQUIRED to be reported. (e) The incidents reports are to be directed to the Hospital Drug Committee or

equivalent mechanism. A panel consisting of at least one doctor, one pharmacist and one nurse will be appointed by the Hospital Drug Committee to review all reported cases in conjunction with the respective managers on a periodic basis.

(f) The Hospital Drug Committee will identify the underlying causes of each incident

and recommend appropriate preventive on remedial measures to the HCE. Hospital Drug Committee will also report the statistical data and any recommended action to the HAHO using the proforma at Appendix II.

(g) Documents related to these quality assurance activities are to be separately and

securely filed by the Committee. This include the incidents reports which should NOT be filed into the patients medical record.

(h) These quality assurance related procedures should not interfere with any necessary

corrective and supportive therapy to the patient. (i) Medication errors resulting in injury to the patient should be reported to the

HAHO Legal Liaison Officer in parallel and handled separately according to HA General Admin Circular No 2/92.

Continuous Review and Follow-up action 9. Whilst Hospitals will take appropriate remedial / preventive actions regarding problems

unveiled by reviewing medication incidents occurring locally, HAHO would monitor the overall trend of medication incidents and consider appropriate global measures against major or service wide problems and to support the Hospitals in this area.

[Appendix I & II are not included] HAHO Feb 94

Appendix 16

Adverse Drug Reaction Reporting Programme

1

QUALITY ASSURANCE IN DRUG THERAPY HOSPITAL AUTHORITY ADVERSE DRUG REACTION REPORTING PROGRAMME

Purpose 1. This memo announces the setting up of the Hospital Authority’s Adverse Drug

Reaction Programme and its implementation. Background 2. As unexpected or undesirable effect may arise during the course of drug therapy,

appropriate quality assurance system for medication use should be in place to identify the causation and prevent the occurrence of these events.

3. Currently, central quality assurance programs regarding medication incidents and

pharmaceutical product quality are in place at the Hospital Authority. The Medication Incident Reporting Program (MIRP), initiated by the Drug Utilization Review Committee (DURC), was set up to identify opportunities for quality improvement and to assist health professionals in reducing and avoiding medication errors. As for the monitoring of the quality of pharmaceutical products, there are central procedural guidelines for the reporting and the handling of quality complaints set forth by the Chief Pharmacist’s Office.

Adverse Drug Reaction reporting 4. It is well aware that adverse drug reaction (ADR) may cause unnecessary physician

visits, hospital admissions, and increased length of hospital stay. Local study showed that 4.4% of acute admissions to a general ward were due to adverse drug reactions. To reduce these unnecessary admissions or hospitalization, it is thus important to identify those ADRs which may be avoidable.

5. Many overseas countries have a national ADR reporting system in place, which

collects ADR reports from health care professionals for the purpose of assessing the safety of the marketed drugs. Although the reporting of ADR is voluntary, many hospitals have set up internal reporting programs to further improve the quality of care in their institutions. The ADR reports collected in the hospitals are forwarded to their respective agency for central review.

6. Currently there is no systematic ADR reporting program in HA. A few hospitals are

collecting their own ADR reports without any inter-hospital communications or sharing of the reports. In order to unify the ADR reporting systems and to encourage more active reporting throughout the HA, a centralized reporting system is considered desirable.

7. The potential problem of setting up a separate ADR reporting program in parallel to

the existing MIRP had been thoroughly considered and a pilot exercise had been conducted in OLMH and QMH from October 2000 to March 2001. Taking reference from the pilot exercise and overseas experience it is now proposed that the HA ADR reporting program would be set up as from 1 January 2002.

2

Hospital Authority Adverse Drug Reaction (ADR) Reporting Programme 8. The ADRs would be reported via a similar mechanism (See Fig.1) as the medication

incidents and the mode of operation are set out as follows : a) A local reporting program set up at each HA institution. b) Suspected ADRs will be reported on a standard form, filled by a doctor or a

pharmacist. A sample of the form is attached in Appendix I. c) The reports are directed to the ADR sub-committee of the hospital’s Drug &

Therapeutic Committee -

Each ADR report is evaluated and given a causality rating.

Educational feedback will be provided to the prescribers and other health care professionals.

The completed ADR reports are to be forwarded to the CPO on a quarterly basis.

d) The CPO would analyse the overall trend of the ADRs and take appropriate measures to enhance safety in medications.

9. As recommended in the 2000 Edition of the “Report on Drug Administration Procedures and Practices”, a standard reporting mechanism/format should be established to collect information on ADRs from the hospitals for analysis on a regular basis. Doctors, pharmacists and nurses should be alert to the potential occurrence of ADR.

[Appendix I is not included] HAHO Oct 01

3

HAHO Oct 01

Fig. 1: ADR voluntary reporting system in HA

Level I : Hospital – Local reporting program

Doctors / Pharmacists (Reporters)

ADR sub-committee (Reviewers)

Suspected

ADRS

Drug & Therapeutic Committee

Educational

Feedback

Evaluate & rate all ADRs

based on the algorithms

CPO / HAHO Central Data analysis Notify frontline health professional Alert Dept of Health &/ Manufacturer Consider withholding the use

Completed ADR

Reports

Educational

Feedback Level II : HAHO

Appendix 17

Procedure for Quality Complaints on Pharmaceutical Items

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PROCEUDRE FOR QUALITY COMPLAINTS ON

PHARMACEUTICAL ITEMS Introduction A quality complaint of a pharmaceutical item is defined as concern that is raised on discrepancies in efficacy, appearance, packaging, possible contamination or any other circumstances observed that may jeopardise or cause reasonable doubt on the routine and intended utilization of that item. This procedure and the standard “Pharmaceutical Product Quality Complaint Report Form” are designed to provide a standardised and comprehensive mean for reporting and recording quality complaints of pharmaceutical items. The report form will also be used as a base for communications and correspondences. E-mail should not be used as a mean to report complaint. The report form must be used for all cases of quality complaints. The following guidelines should be observed in order to proceed and handle such complaints in a systematic manner. Apart from the head of pharmacy, a co-ordinator should also be nominated to receive and handle quality complaint promptly. The co-ordinator should be made known and updated to both the Chief Pharmacist’s Office and all departments within your hospital as a one stop contact on complaint matters. The Pharmacist (Procurement) or his delegate Chief Dispenser (Procurement) will be the co-ordinator of complaint at Chief Pharmacist’s Office. Whenever an alert with batch suspension is issued, immediate action must be taken to quarantine all affected batches in all stores both within and outside pharmacy. Close liaision with nursing staff should be maintained in order the situation is fully understood by all parties concerned. All subsequent recommendation including product suspension, replacement, withdrawal or recall should be executed immediately and to all ward levels. Possible Actions Class I Removal of all traceable quantity of a product within your hospital. Class II Retrieval of all affected batches within your hospital and hold in quarantine pending

further follow up actions. Class III General alert to all users where specific guidelines or procedures needed to be

followed for safety reason. Class IV The affected batch is released for use. Class V No immediate action but will keep in view of the development.

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Part I Pharmacy Department 1. Receiving the Complaint 1.1 The co-ordinator or his delegate must attend to the complaint immediately. 1.2 Identify the item concerned, the particular manufacturer in question and record the

batch. 1.3 Note and understand the nature, when and how the complaint is identified. 1.4 Note the originating Department/Ward, name and rank of the complainant. 1.5 Inform the head of pharmacy about the complaint. 2. Immediate Action 2.1 The head of pharmacy and the co-ordinator must first assess and understand the

situation, collect the complaint sample and decide what actions to be taken. 2.2 Start a case file on the complaint. 2.3 Alert all pharmacy staff of the situation. 2.4 In case where the batch is suspended from use, consolidate the affected batch within

your hospital and hold in quarantine. 2.5 Complete the “Pharmaceutical Product Quality Complaint Report Form”. All

required details and any immediate actions taken must be documented. 2.6 Notify either Pharmacist or Chief Dispenser of the Procurement Section by

telephone before forwarding the completed report form by fax to the Procurement Section of Chief Pharmacist’s Office.

2.7 Make urgent arrangement to despatch the relevant complaint sample and two units

of the circulating stock of the same batch to Chief Pharmacist’s Office. 2.8 Follow-up with the officer previously notified if acknowledgement of complaint by

return fax is not received. 3. Follow-up Action 3.1 Continue to monitor the progress of the complaint and follow up with Chief

Pharmacist’s Office where necessary. 3.2 Inform Chief Pharmacist’s Office on any subsequent actions taken within your

hospital where appropriate. 3.3 Observe the recommended action or outcome from Chief Pharmacist’s Office. 3.4 Inform and follow-up with the concerned department/ward/personnel on the

outcome of complaint and the progress of any recommended actions. 3.5 Report to Chief Pharmacist’s Office when recommended action is completed.

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Part II Procurement Section, CPO 1. Receiving the Complaint 1.1 The officer receiving the call must ensure the complaint form is received after

being notified by the institution initiating the complaint. 1.2 The officer receive the complaint must acknowledge the complaint by return fax to

the initiating institution immediately. 1.3 The Pharmacist (Procurement) or his delegate must follow up with the initiating

institution to ensure full understanding of the nature of the complaint and receipt of relevant samples where appropriate.

1.4 Open case file which must be endorsed by Senior Pharmacist (Procurement) and

circulate within the procurement section. 1.5 The report form must be used to document and communicate with relevant parties

by fax on all the activities taken throughout the entire exercise. 2. Immediate Action 2.1 The Pharmacist (Procurement) will assess the situation and seek endorsement from

Senior Pharmacist (Procurement) on the course of actions to be taken. 2.2 Organise, arrange and document all evaluation testing on both the complaint

sample and circulating stock respectively. 2.3 Inform users, supplier, the Department of Health, the Government Supplies

Department and HA Central Procurement Unit if necessary on all actions taken as appropriate.

2.4 Evaluate the situation and make necessary arrangement to ensure continuity of

supply of the affected item if necessary. 2.5 All actions and steps taken are properly documented on the report form. 3. Follow-up Action 3.1 Follow up on the progress of investigation by supplier/manufacturer. 3.2 Validate the outcome of the any investigation by independent testing or consult

expert opinion where necessary. 3.3 Assess the validity, accept or reject the submitted explanation and proposed

improvements to be implemented by the supplier/manufacturer. 3.4 Inform users, supplier, the Department of Health, the Government Supplies

Department and HA Central Procurement Unit if necessary on any proposed actions or recommendation as appropriate.

3.5 All actions and steps taken are properly documented on the report form.

HAHO Aug 96