SPS technical assistance in the development of a

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SPS technical assistance in the development of a pharmacovigilance curriculum package in Kenya: July–November 2008 Abdinasir Amin Lawrence Nzumbu Gladys Tetteh Jayesh Pandit Simon Kangethe Michael Thuo November 2008

Strengthening Pharmaceutical Systems Center for Pharmaceutical Management Management Sciences for Health 4301 North Fairfax Drive, Suite 400 Arlington, VA 22203 USA Phone: 703.524.6575 Fax: 703.524.7898 E-mail: [email protected]

SPS technical assistance in the development of a pharmacovigilance curriculum package in Kenya

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 #GHN-A-00-07-00002-00. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of 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 This report may be reproduced if credit is given to SPS. Please use the following citation. Amin, A.A., Nzumbu, L., Tetteh, G., Pandit, J, Kangethe, S. and M. Thuo. 2008. SPS technical assistance in the development of a pharmacovigilance curriculum package in Kenya: July–November 2008. Submitted to the U.S. Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health. Key Words pharmacovigilance, curriculum development

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 E-mail: [email protected]

Web: www.msh.org/sps.org

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CONTENTS

ACRONYMS ............................................................................................................................ vi

ACKNOWLEDGMENTS ..................................................................................................... viii

EXECUTIVE SUMMARY ....................................................................................................... x

BACKGROUND ....................................................................................................................... 1

PROCESS AND OUTPUTS ..................................................................................................... 3 Needs assessment workshop .................................................................................................. 3 Pharmacovigilance curriculum development workshop ........................................................ 5 Pharmacovigilance reviewers’ workshop and other review processes .................................. 6

Kenyan Expert Committee for Clinical Trials ................................................................... 6 International communications consultant .......................................................................... 7 World Health Organization Geneva ................................................................................... 8

Summary of major recommendations to implement a comprehensive pharmacovigilance program .................................................................................................................................. 9

ANNEX 1: SAMPLE LESSON PLAN ................................................................................... 11

ANNEX 2: CURRICULUM DEVELOPMENT WORKSHOP AT THE NAIROBI SAFARI CLUB, 10–11 AND 14–15 JULY, 2008 .................................................................. 13

ANNEX 3: SAMPLE TIMETABLE FOR A GIVEN PHARMACOVIGILANCE TRAINING .............................................................................................................................. 17


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ACRONYMS

ADR adverse drug reaction MSH Management Sciences for Health PPB Pharmacy and Poisons Board SPS Strengthening Pharmaceutical Systems [Program] USAID U.S. Agency for International Development WHO World Health Organization


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ACKNOWLEDGMENTS

We wish to thank all the various people and organizations that made the preparation of the curriculum a success. To the U.S. Agency for International Development for providing continuous financial support during the process and to the Pharmacy and Poisons Board, the provincial pharmacists, Moi Teaching and Referral Hospital, the Division of Malaria Control, World Health Organization (WHO) Geneva, WHO Uppsala Monitoring Centre, the Expert Committee on Clinical Trials, and all others who contributed to the success of this venture in one way or another, we acknowledge your support.


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EXECUTIVE SUMMARY

In mid-2007, Kenya’s drug regulatory authority, the Pharmacy and Poisons Board (PPB), launched a pharmacovigilance system that entails passive reporting of adverse drug reactions (ADRs) to all medicines. As part of its rollout of the national pharmacovigilance system, the PPB proposed developing a standard curriculum for training health workers on pharmacovigilance. Stakeholders carried out the curriculum development process through a series of three workshops, held in July and August 2008. At the first workshop, representatives from Management Sciences for Health’s Strengthening Pharmaceutical Systems (MSH/SPS) Program, Moi Teaching and Referral Hospital, and the PPB assessed curriculum needs and planned a subsequent curriculum development workshop, which would bring together representatives from the Division of Malaria Control, the SPS Program, and the PPB to develop the materials for the proposed national pharmacovigilance course. By the end of the curriculum development workshop, participants had produced the following documents—

• Curriculum and implementation guide • Pretest/posttest questions for Modules 1–6 • PowerPoint presentation slides for Modules 1, 2, 3, and 6 • Trainers’ manual • Participants’ manual • Sample timetable for the upcoming trainings • Proposed workshop evaluation tool • Letter to experts requesting curriculum review

At a final reviewers’ workshop, participants commented on and edited the curriculum and implementation guide and the trainers’ and participants’ manuals. In addition, international and national experts reviewed the materials, and their input contributed to the finalization of the national pharmacovigilance curriculum.



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BACKGROUND Pharmacovigilance is “the science and activities relating to the detection, monitoring, assessment, understanding and prevention of adverse effects or any other drug related problems.”1 Pharmacovigilance protects public health by identifying, evaluating, and minimizing safety issues relating to medicines to ensure that medicines’ overall benefits outweigh their risks. The focus of pharmacovigilance is also to educate health care professionals and the public on medicine safety issues. In mid-2007, Kenya’s drug regulatory authority, the Pharmacy and Poisons Board (PPB), launched a pharmacovigilance system that entails passive reporting of adverse drug reactions (ADRs) to all medicines. To date, the government has developed national guidelines and reporting tools and conducted a national sensitization workshop for pharmacists, pharmaceutical technologists, clinicians, clinical officers, and nurses from all the provinces. However, the national pharmacovigilance system is yet to be rolled out in its entirety.2 The health care sector personnel and management share a broad consensus on having a standard approach and tools to teach health workers to ensure the uniform communication of key messages and to avoid the use of nonstandard teaching materials. Furthermore, Ministry of Health divisions have embraced the concept of standardized curricula for a range of health system issues; for example, the National AIDS & STI Control Programme, Division of Reproductive Health, and Division of Malaria Control addressed standardized management of related medicines and commodities, and the Division of Malaria Control developed a national curriculum on malaria case management and training for shopkeepers and community volunteers on the use of antimalarial medicines. As part of its rollout of the national pharmacovigilance system, the PPB proposed developing a standard curriculum for training health workers on pharmacovigilance through a series of steps—

1) Convene a small group of experts, including a curriculum development expert, to scope out the learning units comprising the proposed curriculum.

2) Identify and harmonize diverse pharmacovigilance curriculum materials (e.g., PowerPoint slides) that the PPB and stakeholders currently use to train health workers.

3) Develop learning units to fill identified gaps in the curriculum. 4) Develop a curriculum and implementation guide, a training facilitators’ manual,

and a training participants’ manual to use during cascade trainings at the provincial level.

1 World Health Organization. 2002. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization. 2 Ministry of Health. 2007. Guideline for the National Pharmacovigilance System in Kenya, pp 8-12, Nairobi: Republic of Kenya.

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5) Conduct a small stakeholder workshop to finalize slides, the curriculum package (curriculum and implementation guide, trainers’ and participants’ manuals), and other draft materials.

6) Disseminate materials widely.


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PROCESS AND OUTPUTS This report documents the process and outputs of the SPS Program’s technical assistance to the Pharmacy and Poisons Board to rollout the national pharmacovigilance system. Needs assessment workshop Representatives from MSH/SPS, Moi Teaching and Referral Hospital, and the PPB met on 3 July, 2008 at the PPB offices to assess curriculum needs and plan the upcoming curriculum development workshop, which would bring together key stakeholders to develop the curriculum and implementation guide and the trainers’ and participants’ manuals for the proposed pharmacovigilance course. During the needs assessment, the workshop participants tentatively identified the major areas for the course to cover (Table 1), and developed the template to guide the curriculum development process. They also reviewed and identified reference materials to use at the workshop. Furthermore, resource persons to develop content for the key thematic areas were identified to form the basis of the workshop discussions. Participants e-mailed the course modules and units outlined in Table 1 to the identified key resource persons. Respondents were then asked to develop a one-page lesson plan (see example in Annex 1) for each module and to collect resource materials to develop the presentation slides and other curriculum materials. Needs assessment meeting participants made the following recommendations—

• The head of the PPB’s pharmacovigilance department will inform resource persons and stakeholders not represented at the needs assessment workshop of important decisions made at the needs assessment workshop.

• The curriculum needs to address the core concerns in pharmacovigilance. • The training format should allow for plenty of discussion to give participants a

chance to assimilate the content. • The curriculum needs to be of the highest quality to ensure its longevity in Kenya,

and also to promote its adoption by other countries in the region • The training materials should be colorful and dynamic to avoid the traditional

format of black-and-white stapled photocopies. • The curriculum should eventually be posted on the Internet.

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Table 1: Key modules, units, and resource persons identified during the needs assessment exercise of 3 July, 2008

Module Proposed Units Resource Person Organization

Module 1: OVERVIEW OF MEDICINES REGULATION IN KENYA

Unit 1—Policy framework for medicines regulation Unit 2—Legal framework for medicines regulation Unit 3—PPB: roles and responsibilities, products and services Unit 4—Safety, efficacy, quality, and cost- effectiveness criteria and the national pharmacovigilance guideline

Abdinasir Amin MSH/SPS

Module 2: PHARMACOVIGILANCE

Unit 1—What is pharmacovigilance? Unit 2—Why pharmacovigilance? (benefits) Unit 3—When pharmacovigilance? (life cycle/ clinical development of medicines) Unit 4—How does pharmacovigilance influence medicines regulation? Unit 5—What are the goals of pharmacovigilance?

George Muthuri and Jayesh Pandit

PPB

Module 3: ADVERSE DRUG REACTIONS

Unit 1—Definitions Unit 2—Classification Unit 3—Types of ADRs Unit 4—Predisposing factors Unit 5—Assessment of severity and causality Unit 6—Recognition and prevention in daily practice

George Muthuri and Jayesh Pandit

PPB

Module 4: PHARMACOVIGILANCE IN SPECIAL TREATMENT PROGRAMS

Unit 1—Malaria Unit 2—HIV/AIDS Unit 3—Tuberculosis Unit 4—Pictures and case reports

Jude Nwokike MSH/SPS

Module 5: REPORTING

Unit 1—Different methods (passive and active) Unit 2—Detail on cohort event monitoring and spontaneous reports Unit 3—Information management (structure and flow of information, feedback

Jude Nwokike MSH/SPS


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Module Proposed Units Resource Person Organization

[dear doctor letters, bulletins, newsletters, text messaging, etc.], data management, signal generation) Unit 4—Roles and responsibilities

Module 6: ADR PRACTICUM

Unit 1—Pharmacovigilance tools Unit 2—Demonstration and walk-through of each tool Unit 3—Self-exercise

Andrew Nyandigisi

Division of Malaria Control

Pharmacovigilance curriculum development workshop The curriculum development workshop was held at the Nairobi Safari Club on the 10–11 and 14–15 July 2008 with an objective of developing a draft curriculum for training health workers on pharmacovigilance and creating an action plan on how to roll out a comprehensive pharmacovigilance system (see Annex 2 for the workshop schedule). The expected workshop outputs included drafts for a curriculum and implementation guide, trainers’ and participants’ manuals, and associated PowerPoint slides for the trainers to teach the modules during the cascade trainings. The meeting comprised representatives from the Division of Malaria Control, MSH/SPS, and the PPB. Workshop participants came to consensus on the template for the curriculum development process and worked through revisions of the entire document, starting from the cover page and front matter. Participants discussed and refined Modules 1, 2, and 3. They observed that Modules 4 and 5 did not match the tone and style of the other modules, and asked the lead resource person, Jude Nwokike of MSH/SPS (who was not present), to revise them accordingly. These two modules were finalized after the workshop and melded into the curriculum in consultation with the PPB and MSH/SPS. By the end of the workshop, participants had produced hard and soft copies of the following documents—

• Curriculum and implementation guide • Pretest/post-test questions for Modules 1–6 • PowerPoint presentation slides for Modules 1, 2, 3, and 6 • Trainers’ manual • Participants’ manual • Sample timetable for upcoming trainings (see Annex 3 for an example of the final

timetable) • Proposed workshop evaluation tool • Letter to experts requesting curriculum review

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Pharmacovigilance reviewers’ workshop and other review processes We conducted a reviewers’ workshop from 30 July–1 August 2008 at the Outspan Hotel in Nyeri. Review workshop participants commented on and edited the draft curriculum and implementation guide and the trainers’ and participants’ manual during the plenary sessions. In addition, we solicited curriculum reviews from international experts, including a health communication consultant and representatives from the WHO Geneva office and WHO Uppsala Monitoring Centre, and national experts, including representatives from the Expert Committee for Clinical Trials, under the aegis of the Pharmacy and Poisons Board, whose members come from public and private sector and academic and research organizations. We later addressed their additional comments, examples of which follow. Kenyan Expert Committee for Clinical Trials

• Improve the introduction and the foreword because they are important sections that all users will read.

• Emphasize the scenario in Africa and Kenya in the introduction and foreword, not just the global situation. Describe why the PPB is carrying out such activities.

• Develop a convenient method for health care workers to send feedback. Base this

feedback loop on the already existing health management information system.

• Institute scanning documents and sending reports directly to the PPB to prevent unnecessary delays and bottlenecks.

• In Module 4, incorporate the list of drugs used in each public health program

including their drug class, pharmacological information, and identified ADRs; make the content of Module 4 more substantial and introduce it earlier in the curriculum.

• In Module 4, add slides on the global perspective on pharmacovigilance; emphasize the importance of pharmacovigilance and also the framework within which it will operate in Kenya.

• Inculcate a feeling of ownership by identifying key stakeholders and naming them as partners in the process from the start.

• Keep Module 5 brief because its complicated description of the law is unnecessary for users of these materials.

• Include a slide or two on the global scenario, Africa scenario and WHO view of

pharmacovigilance.


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• Emphasize the substantial time and resources that are wasted on avoidable drug-induced disorders (related to adverse drug reactions and errors) and risk to patients, which could be decreased with a strong pharmacovigilance program.

• For each of these pharmacovigilance partners, identify the outcome challenges;

examples of key partners include—

o Pharmacist/health care workers o Nurses/clinical Team o Doctors o Health administrators o MOH headquarters staff

• Identify the strategic partners and learn their vested interests; examples of

strategic partners include—

o Sponsors o Media o Consultants

• Strategize on challenges that may arise for each partner.

• Involve both divisions of the Ministry of Health, by having the Director of Medical Services and his public health counterpart, the Director of Public Health and Sanitation, sign the curriculum preambles and by having the PPB Registrar sign off on the foreword. This will ensure that health care workers do not feel like they are reporting to the wrong department.

• Provide project updates to the provincial health management teams and the provincial medical officers to ensure their continued enthusiasm.

• Assure that the overall foreword and preambles complement the Ministry of Medical Services’ and the Ministry of Public Health and Sanitation’s view of pharmacovigilance.

International communications consultant

• The curriculum has obviously been carefully, thoughtfully, and thoroughly prepared. The materials are attractive and well presented, and cover most of the important issues.

• The ultimate purpose of the training should be to inspire participants with a vision of the importance of pharmacovigilance and stimulate their enthusiasm to take part in the national scheme by becoming observant professionals and active reporters.

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• The opening sessions should include the vivid videos on ADRs and information and statistics about incidence and costs to patients, health care, and the economy, so that from the first moment, everyone is clear on the topic’s importance.

• Some of the modules are very input-heavy on difficult, technical issues, which

training participants will find demanding. Wherever possible, include frequent breaks for refreshment and drawing breath (at least every hour). The second half of the mornings, and the first half of the afternoons as scheduled are much too long to go without at least one break. Another idea is to incorporate techniques such as the rapid assembly of small groups to discuss issues for 10–15 minutes in the middle of full sessions (this process is greatly helped by having participants sitting at tables of six, not in traditional classroom style).

• The number one priority of patient safety needs to be consistently woven into the

material. There is always a risk of the subject becoming technical and distant and losing the focus on patient safety. Facilitators need to constantly refer to the impact of the material on patients and on improving health care.

• Pharmacovigilance materials need to include the issue of medication errors. The

cost and damage related to medication errors are huge; the curriculum should include how pharmacovigilance methods can help identify and reduce such errors.

World Health Organization Geneva

• Preventing ADRs is important, but the materials confuse the concepts of ADRs and medication errors. Consider discussing medication errors first, including the levels at which these errors occur (wrong medicines, wrong patient, wrong dose, route, etc.) and then preventing these errors through checks at these levels. When and whether an error will actually lead to an ADR or an adverse event could be an additional detail.

• Overall, the pharmacovigilance in public health programs section is a bit thin.

Incorporate additional benefits of including pharmacovigilance in public health. This is very important for Africa, with its huge public health programs, so this module should be expanded. Highlight the cost of public health programs, and emphasize that the cost of pharmacovigilance, by comparison, would be very small.

• Consider linking pharmacovigilance/adverse events and poor quality/counterfeit

medicines. Pharmacovigilance is the primary mechanism to detect decreased efficacy due to poor and substandard medicines, which is particularly important in the context of malaria treatment. Therefore, identifying 'trigger' adverse events to flag the circulation of poor quality medicines and reinforcing pharmacovigilance efforts with good procedures of routine sampling and working with quality testing labs are important.


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Summary of major recommendations to implement a comprehensive pharmacovigilance program Developing a pharmacovigilance curriculum is just one of many efforts to improve ADR reporting among health care workers and should not be considered the answer to all pharmacovigilance problems. However, a number of recommendations regarding establishing a pharmacovigilance program came out of the curriculum development process—

• Conduct further assessments to understand the reasons why health care workers do not report and address ADRs.

• Synchronize efforts and pool resources among disparate pharmacovigilance stakeholders to ensure that Kenyans receive standard pharmacovigilance messages.

• Do not implement pharmacovigilance programs in haste; use a phased approach. For example, initiating pharmacovigilance programs within public health programs can lead to scale-up success, because those initial lessons learned can inform national system rollout. In addition, sentinel ADR surveillance and reporting can introduce the concepts and procedures, and then reporting can roll out in phases.

• Strengthen the PPB’s pharmacovigilance center by equipping it with enough staff

and a reliable network to communicate with sites. This will ensure that sites report information at the right time and that reporters receive periodic feedback.

• Fast-track efforts to link Kenya’s pharmacovigilance system with the WHO’s

Uppsala Monitoring Centre. The WHO program’s database and support services are available to support the development of emerging national pharmacovigilance systems, such as Kenya’s.

• Print sufficient quantities of pharmacovigilance reporting tools and guidelines to

ensure continuity. Stock-outs of these materials will be a major impediment to the reporters and cause confusion.

• Source sufficient program funds immediately; like any other program, the success

of the pharmacovigilance program will depend on its training workshops, materials, guidelines, and reporting tools, all of which are expensive.

• Promote a good working relationship between the PPB and the media to ensure that the public learns about medicine safety issues and its role in pharmacovigilance.

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• Immediately pretest the pharmacovigilance curriculum as soon as the documents are in print, preferably in November 2008; start training with the national policy makers and provincial heads.

Table 2: Proposed implementation plan for pharmacovigilance activities in Kenya

Timeline Activity Responsibility

September 2008 Incorporate comments from all remaining reviewers

Head pharmacovigilance, PPB

October 2008 Copyedit and print the curriculum MSH/SPS November 2008 Pretest the pharmacovigilance

curriculum on policy makers and provincial heads

Head pharmacovigilance, PPB, MSH/SPS

December 2008 Plan for training rollout and national implementation


January–March 2009

Train district heads in 8 provinces Head pharmacovigilance, PPB, MSH/SPS

Establish drug and therapeutics committees in hospitals

Department of Pharmacy, Hospital pharmacists

April- July 2009 Cascade health facility trainings under supervision of provincial heads

Provincial pharmacists

August 2009 Review and revise the curriculum, as needed


Evaluate ADR reports and feedback

Head pharmacovigilance, PPB

September 2009 Monitoring and evaluation (continuous) Head pharmacovigilance, PPB


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ANNEX 1: SAMPLE LESSON PLAN MODULE 1: PHARMACOVIGILANCE: ENSURING SAFE USE OF MEDICINES

INTRODUCTION

“Some remedies are worse than the disease” Publilius Syrus, Roman writer, 1st century BC.

Pharmacovigilance is being conducted by large numbers of people who are concerned about protecting their populations from serious unintended adverse reactions to medicines taken. The thalidomide disaster in the early 1960’s led to the establishment of drug regulatory mechanisms we see today. No medicine, however well established, can be claimed safe in any individual prior to its use. Drugs do good… and do harm! In spite of being used to improve the health of a person, or used to prevent an individual from potential threats, medicines can make its consumer feel more ill, or lead to long term complications or may also kill. Drug induced disorders cause a significant burden to the health care system. Though many of them originate in the ambulatory care settings, they can produce acute symptoms that necessitate costly emergency and casualty visits and subsequent hospitalizations. Their early identification may minimize the impact that ADRs have on patients and ultimately reduce the costs to the health care system. The following module attempts to briefly introduce this important concept from its pre-clinical phase into the post-marketing phase. The concept is so important that most regulatory decisions are dependent on safety data collected during these phases. Thus the need for pharmacovigilance becomes the need of the hour!

MODULE OBJECTIVES

At the end of this module, the participants will be able to: 1. Define pharmacovigilance 2. Outline the goals of pharmacovigilance 3. Explain the need and importance of pharmacovigilance 4. Describe the scope and components of pharmacovigilance 5. Explain how information obtained from pharmacovigilance influences medicines

policy and regulation CONTENT

• Definition: The origin of the word pharmacovigilance, history, aims and widening scope of pharmacovigilance.

• Goals of pharmacovigilance: rational use of medicines, communication of risk and benefit of medicines, health worker and patient education.

• Need and importance of pharmacovigilance: burden of ADRs; morbidity and mortality, cost burden of ADRs, benefits of pharmacovigilance.

• Development of medicines: phases of clinical trials, safety-efficacy and quality issues, how pharmacovigilance fits in.

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• Pharmacovigilance information influencing medicines policy and regulation: recall, labeling changes, reschedule withdrawal, policy change.

LESSON PLAN GUIDE: MODULE 1

STEP CONTENT ACTIVITY TIME

UNIT 1 What is pharmacovigilance • Brainstorming • Presentation • Video clip

30 minutes

UNIT 2 Goals of pharmacovigilance • Presentation 40 minutes

UNIT 3 Why pharmacovigilance: need and importance

• Brainstorming • Presentation • Video clip • Discussion

90 minutes

UNIT 4 Scope and components of pharmacovigilance

• Presentation 40 minutes

UNIT 5 Influence on medicines regulation • Presentation • Demonstration • Discussion

30 minutes

Total time for this module: 3 hours, 50 minutes REFERENCES AND READINGS

1. Ministry of Health. 2007. Guideline for the National Pharmacovigilance System in Kenya, pp 8-12, Nairobi: Republic of Kenya.

2. World Health Organization. 2002. The Importance of Pharmacovigilance—Safety Monitoring of Medicinal Products, pp 5-34. Geneva: World Health Organization.


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ANNEX 2: CURRICULUM DEVELOPMENT WORKSHOP AT THE NAIROBI SAFARI CLUB, 10–11 AND 14–15 JULY, 2008

Experts/contributors in attendance 1. Jayesh Pandit, PPB 2. George Muthuri, PPB 3. Lawrence Nzumbu, PPB 4. Andrew Nyandigisi, Division of Malaria Control Case Management 5. Abdinasir Amin, MSH/SPS 6. Gladys Tetteh, MSH/SPS 7. Professor Simon Kangethe, Moi University 8. Christine Onyango, MSH/SPS 9. Rahab Kabeberi, Rapporteur 10. Richard Miano, Information Technology Support Workshop objectives

• Develop a curriculum on training health workers on pharmacovigilance • Develop an action plan on how to roll out the pharmacovigilance system

Expected outputs

• Curriculum and implementation guide • Trainers’ manual • Participants’ manual with PowerPoint slides

Workshop Agenda

DATE Time Activity Facilitator THURSDAY,

10 JULY, 2008

Day Chair: PPB 8:30 a.m.–9:00 a.m.

Opening remarks, introductions, official opening of workshop

PPB

9:00 a.m.–9:30 a.m.

Workshop norms and objectives Prof. Kangethe, Moi University

9:30 a.m.–10:30 a.m.

Overview of the curriculum producer’s workshop: methods and program

Prof. Kangethe, Moi University

10:30 a.m.–10:45 a.m.

TEA BREAK

10:45 a.m.–11:45 a.m.

Presentation on key challenges in pharmacovigilance and expected outputs of the workshop

PPB

11:45 a.m.–1:00 p.m.

Plenary discussion on format of workshop

Prof. Kangethe

1:00 p.m.–2:00 LUNCH

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p.m. 2:00 p.m.–3:00 p.m.

Plenary discussion on key areas or learning units to be covered by the workshop

PPB and Prof. Kangethe

3:00 p.m.–4:00 p.m.

Group and task allocation—group chairs, secretaries, deliverables

All

4:00 p.m.–4:15 p.m.

TEA BREAK

4:15 p.m.–5:00 p.m.

First draft by groups on lesson plans for allocated learning units

Presentation by group leaders

FRIDAY, 11 JULY, 2008

Day Chair: DOMC 8:30 a.m.–9:00 a.m.

Recap/reorientation Day chair

9:00 a.m.–9:30 a.m.

Group work—Development of PowerPoint slides

Groups

9:30 a.m.–10:30 a.m.


Groups

10:30 a.m.–10:45 a.m.

TEA BREAK

10:45 a.m.–11:45 a.m.


Groups

11:45 a.m.–1:00 p.m.


Groups

1:00 p.m.–2:00 p.m.

LUNCH

2:00 p.m.–3:00 p.m.

Group presentations of slides and plenary comments

Group leaders

3:00 p.m.–4:00 p.m.


Group leaders

4:00 p.m.–4:15 p.m.

TEA BREAK

4:15 p.m.–5:00 p.m.


Group leaders

MONDAY,

14 JULY, 2008

Day Chair: MSH 8:30 a.m.–9:00 a.m.


9:00 a.m.–9:30 a.m.

Refinement of curriculum and implementation guide

All

9:30 a.m.–10:30 a.m.

Development of pre- and post-test questions for learning units

Groups

10:30 a.m.–10:45 a.m.

TEA BREAK

10:45 a.m.–11:45 a.m.

Production of curriculum and implementation guide

All

11:45 a.m.–1:00 Production of PowerPoint slides Groups


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p.m. 1:00 p.m.–2:00 p.m.

LUNCH

2:00 p.m.–4:00 p.m.

Production of trainer notes for PowerPoint slides

Groups

4:00 p.m.–4:15 p.m.

TEA BREAK

4:15 p.m.–5:00 p.m.

Production of trainer notes for PowerPoint slides

Groups

TUESDAY, 15 JULY,

2008

Day Chair: PPB 8:30 a.m.–9:00 a.m.


9:00 a.m.–9:30 a.m.

Refinement of curriculum and implementation guide

All

9:30 a.m.–10:30 a.m.

Refinement of Trainers’ Manual All

10:30 a.m.–10:45 a.m.

TEA BREAK

10:45 a.m.–11:45 a.m.

Refinement of Participants’ Manual and pre- and post-test questions

All

11:45 a.m.–1:00 p.m.

Development of workshop timetable and workshop evaluation tools

All

1:00p.m.–2:00 LUNCH 2:00 p.m.–4:00 p.m.

Action plan, way forward, and evaluation of current workshop

All

4:00 p.m.–4:15 p.m.

TEA BREAK

4:15 p.m.–5:00 p.m.

Workshop closure

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ANNEX 3: SAMPLE TIMETABLE FOR A GIVEN PHARMACOVIGILANCE TRAINING

TIME MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY 8:00–8:30 a m. • Climate setting

• Introductions • Workshop opening • Participant

Expectations • Group norms • Pretest

Recap Recap Recap Recap 8:30–9:00 a m. Module 2:

Pharmacovigilance: Ensuring Patient Safety

Module 4: Reporting

Module 6: ADR Practicum

Plenary: Technical updates by pharmacovigilance experts

9:00–10:00 a m. Module 1: Overview of medicines regulation in Kenya

Module 2: Pharmacovigilance: Ensuring Patient Safety

Module 4: Reporting


Plenary: Technical updates by pharmacovigilance experts

10:00–10:30 a m. T E A B R E A K 10.30–11:30 a m. Module 1: Overview of

medicines regulation in Kenya

Module 3: Adverse Drug Reactions

Module 4: Reporting


Posttest

11:30–12:00 p.m. Module 1: Overview of medicines regulation in Kenya


Module 4: Reporting


Workshop Evaluation

12:00–1:00 p m. Module 1: Overview of medicines regulation in Kenya


Module 5: Pharmacovigilance in Public Health


Certification and closure

1:00–2:00 p m. L U N C H 2:00–3:00 p m. Module 2:





Departure

3:00–4:00 p m. Module 2: Pharmacovigilance: Ensuring Patient Safety




4:00–4:30 p m. T E A B R E A K 4:30–5:30 p m. Module 2:




Documents

SPS technical assistance in the development of a