Workshop Proceedings: Development of Draft Proclamation for …apps.who.int/medicinedocs/documents/s21056en/s21056en.pdf · 2013-09-10 · Workshop Proceedings: Development of Draft

Workshop Proceedings: Development of Draft Proclamation for Institutionalizing Auditable Pharmacy Services and Transaction Systems (APTS)

Tadeg Hailu Ayalew Adnew Getahun Sisay Solomon Nigussie Bizualem Adam July 8–12, 2011 Gorgora Hotel, Gondar

AMHARA NATIONAL REGIONAL STATE HEALTH BUREAU

Workshop Proceedings: Development of Draft Proclamation for Institutionalizing Auditable Pharmacy Services

and Transaction Systems (APTS)

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This report is made possible by the generous support of the American people through the U.S.

Agency for International Development (USAID), under the terms of cooperative agreement

number AID-OAA-LA-10-00002. The contents are the responsibility of the Management

Sciences for Health and do not necessarily reflect the views of Amhara Regional Health Bureau,

USAID, or the United States Government.

About SPS

The Strengthening Pharmaceutical Systems (SPS) Program strives to build capacity within

developing countries to effectively manage all aspects of pharmaceutical systems and services.

SPS focuses on improving governance in the pharmaceutical sector, strengthening

pharmaceutical management systems and financing mechanisms, containing antimicrobial

resistance, and enhancing access to and appropriate use of medicines.

Recommended Citation

Please use the following citation.

Hailu, Tadeg, Ayalew Adnew, Getahun Sisay, Solomon Nigussie, and Bizualem Adam. 2011.

Workshop Proceedings: Development of Draft Proclamation for Institutionalization of Auditable

Pharmacy Services and Transaction Systems (APTS). Submitted to the U.S. Agency for

International Development by the Strengthening Pharmaceutical Systems Program. Arlington,

VA: Management Sciences for Health.

Strengthening Pharmaceutical Systems

Center for Pharmaceutical Management

Management Sciences for Health

4301 North Fairfax Drive, Suite 400

Arlington, VA 22203 USA

Telephone: 703.524.6575

Fax: 703.524.7898

Web: www.msh.org/sps.org

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CONTENTS

Acronyms .........................................................................................................................................v

Executive Summary ...................................................................................................................... vii

Introduction ......................................................................................................................................1 Objectives of the Workshop ........................................................................................................1 Expected Outcome .......................................................................................................................2

Methodology ................................................................................................................................2 Participants ...................................................................................................................................2

Proceedings of the Workshop ..........................................................................................................5 Presentation and Discussion on the Concept of APTS and Nature of the Document to Be

Developed ....................................................................................................................................5 The Process of Developing the Draft Proclamation ....................................................................8 Next Steps ....................................................................................................................................9

Conclusion .....................................................................................................................................11

Annex A. Operational Standards for Pharmacy Services ..............................................................13



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ACRONYMS

APTS Auditable Pharmacy Services and Transaction Systems

ARHB Amhara Regional Health Bureau

ADR adverse drug reaction

AMR antimicrobial resistance

DTC Drug and Therapeutics Committee

EHRIG Ethiopian Hospital Reform Implementation Guideline

FMHACA Food, Medicine and Health Care Administration and Control Authority

FMOH Federal Ministry of Health

MSH/SPS Management Science for Health/Strengthening Pharmaceutical Systems

RHB Regional Health Bureau

SOP standard operating procedure



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EXECUTIVE SUMMARY

Ethiopia’s Federal Ministry of Health (FMOH) has been leading a sectorwide reform effort

aimed at improving the quality and accessibility of services at all levels of the health care

system. As part of this reform, the ministry developed the Ethiopian Hospital Reform

Implementation Guideline (EHRIG). The implementation of the pharmacy chapter of EHRIG, in

health facilities has been assisted by Management Sciences for Health’s Strengthening

Pharmaceutical Systems (MSH/SPS) program.

Observing and sharing the experience of hospitals in Addis Ababa, Debre Markos Referral

Hospital requested technical and financial assistance from MSH/SPS in June 2010. The request

focused on supporting the implementation of EHRIG pharmacy chapter as part of improving

systems of pharmaceutical management as a whole to resolve problems associated with the

overall pharmaceutical services in the hospital. As per the request, the Regional Health Bureau

(RHB) in collaboration with a team of experts from MSH/SPS started piloting EHRIG pharmacy

chapter implementation at Debre Markos Referral Hospital by preparing elaborative operational

procedures that are designed to guide the activities.

The joint effort of EHRIG implementation resulted in significant improvement in the

pharmaceutical services at the hospital. Looking into the improved service, in April 2011, the

Amhara Regional Health Bureau (ARHB) in collaboration with MSH/SPS organized an

experience-sharing workshop in an effort to scale up the best practices observed at Debre Markos

Hospital. The experience-sharing workshop participants were greatly impressed by the

achievements of the hospital in such a short time and by the new system being introduced to

bring about a change in management practices of pharmacy services and transactions.

Accordingly, at the end of the workshop, all participants strongly suggested the need to

institutionalize the system by means of a legal document that could be enforced at all health

facilities through the region. Based on this recommendation, RHB organized a workshop for July

8–12, 2011, to draft a proclamation so that the system could establish legal grounds for large-

scale implementation in the region.

The proclamation is intended to bring about change in the pharmaceutical management system of

Amhara region by improving access to medicines and helping establish transparent

pharmaceutical services and transaction systems. Ultimately, it will result in higher quality

pharmacy services, more effective use of resources, and greater patient satisfaction. Based on its

content, the proclamation is named

draft proclamation on ―System for Pharmaceutical

Supply, Handling, Transaction, and Service Provision in Amhara Region‖).



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INTRODUCTION

Governments in developing countries spend 20–50 percent of their national budgets on

pharmaceutical and medical supplies, making the impact of pharmaceuticals on these economies

substantial.1 In most developing countries, pharmaceuticals are the largest public expenditure on

health after personnel costs and the largest household health expenditure.2 The enormous amount

of resources spent on medicines point to the fact that the irrational use of medicines is a major

problem worldwide. The World Health Organization estimates that more than half of all

medicines are prescribed, dispensed, or sold inappropriately and that half of all patients fail to

take them correctly. The overuse, underuse, or misuse of medicines results in wastage of scarce

resources and widespread health hazards. In addition to wasting resources, the inappropriate use

of medicines may lead to drug resistance and tolerance, particularly if such use involves anti-

infective agents. The substantial expense put on medicines and the consequence of their

irrational use provide convincing reasons for countries all over the world to be concerned about

how medicines are handled and finally used by patients.

In that view, to efficiently promote the rational use of medicines, the government of Ethiopia

developed and introduced the Ethiopian Hospital Reform Implementation Guideline (EHRIG)

pharmacy chapter with the intention of being implemented in public health facilities operating in

all regions. Following the direction of the Federal Ministry of Health (FMOH), the Amhara

Regional Health Bureau (ARHB) in collaboration with Management Sciences for Health’s

Strengthening Pharmaceutical Systems (MSH/SPS) program takes the initiative to implement

EHRIG in the public health facilities of the region. This workshop was organized to pave the

way for the implementation of EHRIG pharmacy chapter in coordinated manner supported by

legal enforcement to ensure its implementation uniformly throughout the region.

Objectives of the Workshop General Objective

The general objective of the workshop was to develop a legal framework or document that will

help to institutionalize the implementation of the EHRIG pharmacy chapter in public health

facilities within Amhara Regional State.

Specific Objectives In addition to the general objective, five specific objectives were outlined. The specific

objectives of the workshop were to—

1 World Bank. 1994. The Importance of Pharmaceutical and Essential Drug Programmes: Better Health in Africa,

Experience and Lessons Learnt. Washington, DC: World Bank.

2 Ibid.



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Identify components of the EHRIG pharmacy chapter that need a legal framework for its

successful implementation

Examine the relationship, inclusion, and interaction of the components of the EHRIG

pharmacy chapter (including auditable pharmacy services and transaction systems [APTS])

with other related proclamations, regulations, and guidelines being exercised in Amhara

region

Determine the level of the legal framework required for enforcing implementation of the

EHRIG pharmacy chapter, particularly APTS (either at the level of directive, regulation, or

proclamation)

Review the basic changes on the new pharmaceutical vouchers and dispensing registers

developed and piloted at Debre Markos Referral Hospital

Define important and vague terms used in the EHRIG pharmacy chapter particularly APTS

Expected Outcome

The expected outcome of the workshop was a draft document that will help to institutionalize the

implementation of key components of the EHRIG pharmacy chapter, particularly APTS, in the

public health facilities of Amhara Regional State by providing legal grounds for those

components.

Methodology The draft document was developed by a team of experts, drawn from different regional

government offices, and established by ARHB in consultation with MSH/SPS. Many

proclamations, regulations, and guidelines developed at the national and regional levels were

used as a references to develop and enrich the draft document. The group used Power Point

slides, flip charts, and group discussions as important tools during the document development

process.

Participants A total of 14 participants drawn from various regional government bureaus and MSH/SPS staffs

attended the workshop:

1. Bizualem Adam ARHB, Pharmacy Department Head

2. Tesfaw Sileshie ARHB, Pharmacy Department

3. Zenebe Tesfaye Amhara Region, Food, Medicine and Health Care Administration and Control

Authority (FMHACA)

4. Mulu Tebabal Amhara Region, Bureau of Finance and Economic Development

5. Zelalem Yeheyis Amhara Region, Auditor General

Introduction

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6. Masresha Sidelel Amhara Region, Civil Service Bureau

7. Asmamaw Adane Amhara Region, Justice Bureau lawyer

8. Abere Alamnie Amhara Region, East Gojam Zone Justice Department

9. Edmaealem Admasu Debre Markos Referral Hospital, Pharmacy Head

10. Getachew Ayenew Pharmaceutical Funding and Supply Agency, Amhara Region Representative

11. Hailu Tadeg MSH/SPS, Institutional Capacity-Building Coordinator

12. Ayalew Adinew MSH/SPS, EHRIG Coordinator

13. Getahun Sisay MSH/SPS, Amhara Region senior regional pharmaceutical management

associate

14. Solomon Negussie MSH/SPS, Amhara Region regional pharmaceutical management associate



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PROCEEDINGS OF THE WORKSHOP Presentation and Discussion on the Concept of APTS and Nature of the Document to Be Developed

The event started at 9:00 a.m. on July 8, 2011 with an opening speech made by Bizualem Adam,

ARHB Pharmacy Department head. She welcomed the participants and gave an overview of the

existing pharmaceutical service provision and pharmacy transaction system in the region. She

pointed out that the wastage of pharmaceuticals is a prominent problem of the region. Wastage is

caused primarily by a lack of transparency and accountability of the current pharmaceutical

services being provided within the region. She stressed that establishing transparent, auditable,

and accountable pharmaceutical services and transaction systems in the region is vital in

minimizing the wastage of the region’s limited resources and saving the lives of many from

medicine-use related problems such as antimicrobial resistance (AMR) and adverse drug

reactions (ADR). (See figure 1.)

Figure 1. Opening remarks by Bizualem Adam invited by the session’s moderator,

Getahun Sisay

The workshop started with a presentation by Ato Ayalew Adinew, with focus on the basic

concept of APTS (comprising both service and transaction auditing), the achievements of the

APTS program piloted in Debre Markos Referral Hospital, the experience of Addis Ababa city

council pharmacies, and the expected outcome of the workshop.

The basic components of auditing service include the following:

Dispensing and counseling activities

Preparing a medicine list

Segregating the facility-specific medicine list by using the vital, essential, nonessential

(VEN) system



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Categorizing and analyzing consumption of pharmaceuticals by activity-based costing

(ABC) classification

Reconciling VEN and ABC analyses

Conducting medicine use and prescription reviews using standard methods

The basic components of APTS in the area of auditing or tracking the movement of

pharmaceuticals include the following:

Procurement

Receiving

Storage

Distribution

Use by patients

The implementation of APTS at the health facility level will help to monitor the circulation of

each pharmaceutical and help to minimize wastage due to loss, improper storage, pilferages, or

expiry. APTS can also be used to evaluate the quality of the service rendered by the facility. It

also contributes to the improvement of prescribing, dispensing, and patient use of medicine. The

ultimate result of APTS (transaction auditing augmented by the service auditing) is to contribute

to the containment of AMR; the recognition and prevention of ADR, medication errors, and drug

interactions; and overall, the promotion of rational medicines use.

Although the initiative to introduce the practice of APTS at all levels of the public health care

delivery system in the country is the aim of EHRIG as seen in the FMOH document of March

2010, some components of APTS have been exercised at 17 pharmacies in Addis Ababa city

council for the last 28 years and found to be effective. The pharmacy chapter of EHRIG has 12

standards (see annex A). Following the implementation of the EHRIG pharmacy chapter, in

Amhara region, APTS was developed as a standard operating procedure (SOP) to implement the

fourth standard (―all types of medicine transactions and all patient-medication related

information are properly recorded and documented‖).

APTS has been piloted in Debre Markos Referral Hospital. It was noted that APTS is integrated

with the Integrated Pharmaceuticals Logistics System, which is currently put into practice to

facilitate the intra-facility requisition and receiving of pharmaceutical and medical supplies. In

addition, the developed standard tools of APTS will also be used to monitor the performance of

health care providers involved in dispensing and counseling; it can easily be used to document

the number of patients served and the number of counseling sessions provided by each dispenser

and to reconcile the number of patients with the number of dispensers. The standard tools of

APTS developed to record the transactions of pharmaceuticals were presented and commented

on by the participants.

The presentation by Ayalew was concluded with emphasis on the importance of creating a

system to implement APTS at the regional level. The response from the participants was that of

an appreciation of the magnitude of the problem and an understanding of the need for

appropriate and timely action by the responsible bodies. After the presentation, the floor was

open for discussion. A summary of the points raised by the participants included the following:

Proceedings of the Workshop

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The government allocates a significant amount of the country’s budget for medicines, and

most hospitals allocate more than 50 percent of their budget for pharmaceutical and

medical supplies, but systems to account for the use of such resources for the intended

purposes are lacking.

The large number of expired medicines and the high level of irrational use contribute to

manmade medicine shortages.

Medicines sent to health facilities may be diverted before they are delivered to the

institution, and the system couldn’t trace them back, thus compromising the

government’s effort to improve access to essential medicines.

Distributing medicines in kits or cartons without an accompanying list leads to fraud.

A transparent system is lacking to clearly identify which medicines were dispensed, to

whom, and in what amount. As a result, facilities do not determine their actual

consumptions accurately, leading to poor pharmaceutical supply management and

irrational medicine use.

The illegal circulation of medicines, the presence of contraband, and the pilferaging of

medicines are all on the increase.

The increasing trend in irrational use of medicines in the country is contributing

significantly to AMR.

The existing pharmaceutical service delivery system is too complex and not transparent

enough to perform any audit. The situation is common in the lower levels of the service

structure such as at zones, woredas, and health facilities.

Given the scale and extent of the problem, ARHB and the Audit Bureau and Finance

Bureau are too late to act on the issue; however, participants agreed that it was a good

start.

After thorough discussions, all the participants agreed on the importance of implementing APTS

in the region as soon as possible. To successfully implement APTS in the region, team work and

commitment are needed, participants agreed. Therefore, designing and implementing a

transparent and concrete internal control system is supported by bureaus where participants came

from.

It was also concluded that APTS concepts were not well addressed in any of the proclamations,

regulations, and guidelines issued either federally or regionally. Therefore, for effective

implementation of APTS in the Amhara region, the team reached in a consensus to develop a

draft proclamation. (See figure 2.)



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Figure 2. Participants in discussion

The Process of Developing the Draft Proclamation

To come up with a draft legal framework, the participants were divided into two groups. The

members assigned to each group and the tasks accomplished are summarized in table 1.

The team identified all the activities of APTS that need a legal framework for their successful

implementation. To determine the level of the legal document (i.e., the level of directive,

regulation, or proclamation), participants compared APTS concepts with other existing related

proclamations, regulations, and guidelines being exercised in Amhara region and federal

government for any redundancy, relation, inclusion, and interaction. In the end, the team decided

to develop the document in the form of proclamation so that adequate emphasis woul be given by

all the concerned authorities..

Table 1. Group Members and Their Responsibilities

Group Number Names of Members Tasks Accomplished

Group I Tesfaw Sileshie Zenebe Tesfaye Mulu Tebabal Getachew Ayenew Hailu Tadeg Getahun Sisay Solomon Negussie

Preamble

Part one: General (title, definitions, objectives, principles, duties, and responsibilities of RHB; ethical issues)

Part five: Other rules

Group II Bizualem Adam Masresha Sidelel Asmamaw Adane Abere Alamnie Edmaealem Admasu Ayalew Adinew Zelalem Yeheyis

Part two: System for pharmaceutical supply and transactions

Part three: System for pharmaceutical handling and service provision

Part four: Reporting

Proceedings of the Workshop

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Each group prepared its draft material of the part assigned to it and presented the draft for

discussion in the larger group. The points and comments raised during those discussions were

incorporated into the draft. The first copy of the draft document was printed and distributed to all

members for review. The final draft of the proclamation was produced incorporating 5 parts and

24 articles.

This proclamation is intended to bring positive changes in the pharmaceutical management system

of Amhara region by improving access to medicines and helping to establish transparent

pharmaceutical services and transaction systems. Ultimately, it is expected to significantly improve

the quality of pharmaceutical service provision in the region. Based on the recommendation of the

group members, the proclamation is named

(―System for Pharmaceutical Supply, Handling,

Transactions, and Service Provision in Amhara National Region‖).

Next Steps

The draft proclamation is expected to pass through a number of formal procedures before it is

approved by the house of parliament in the region. The ARHB will be the prime office

responsible to follow the progress and speed up the processes.

In summary, the list of subsequent activities to be accomplished include the following:

The report of the workshop and the draft document will be submitted to the management

team of RHB and MSH/SPS, who will distribute them to all concerned parties for

comment. The final draft document will be produced by incorporating comments from

the RHB, MSH/SPS, and other concerned parties.

The final draft document will be submitted to the Regional Justice Bureau by ARHB for

the legal input.

The edited draft proclamation will be presented to the regional council for approval as

regional proclamation.

After approval of the proclamation, detailed guidelines to implement APTS in all public

health facilities will be developed by ARHB. Parallel to this, actual implementation will

continue at hospitals in the region.



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Figure 3. Group photo of workshop participants

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CONCLUSION

Establishing a transparent, auditable, and accountable pharmaceutical management system is

vital to improve pharmaceutical management and promote the rational use of medicines. The

five-day workshop was organized to develop a document that facilitates the institutionalization

of APTS implementation and was concluded successfully through the development of a draft

proclamation, which is the first of its kind in the region in particular and in the country in

general. This process is expected to improve the overall pharmaceutical management system in

the region and standardize the pharmaceutical services being provided at different levels of the

health institutions within the region.



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ANNEX A. OPERATIONAL STANDARDS FOR PHARMACY SERVICES 1. The hospital has a Drug and Therapeutics Committee (DTC), which implements measures to

promote the rational and cost-effective use of medicines.

2. The hospital has a medicines formulary listing all pharmaceuticals that can be used in the

facility. The formulary is reviewed and updated annually.

3. The hospital has outpatient, inpatient, and emergency pharmacies and a central medical store,

each directed by a registered pharmacist.

4. The hospital ensures that all types of medicine transactions and all patient-medication related

information are properly recorded and documented.

5. The hospital has standard operating procedures (SOPs) for all compounding procedures

carried out.

6. The hospital provides access to pharmaceutical information to both health care providers and

patients to optimize medicine use.

7. The hospital has policies and procedures for identifying and managing medicine use

problems, including monitoring adverse drug reactions, prescription monitoring, and

medicine use monitoring.

8. The hospital has a pharmaceutical procurement policy approved by the DTC that describes

methods of quantification, prioritization, medicine selection, supplier selection, and ordering

of pharmaceutical supplies that is in line with national guidance.

9. The hospital has a paper-based or computer-based inventory management system to reduce

the frequency of stock-outs, wastage, over supply, and medicine expiry.

10. The hospital conducts a physical inventory of all pharmaceuticals in the store and each

dispensing unit once a year at a minimum.

11. The hospital ensures proper and safe disposal of pharmaceutical wastes and expired

medicines.

12. The hospital has adequate personnel, equipment, premises, and facilities required to store

pharmaceutical supplies and to carry out compounding, dispensing, and counseling services.



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