Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries December 2009 Strengthening Pharmaceutical Systems Center for Pharmaceutical Management Management Sciences for Health 4301 N. Fairfax Drive, Suite 400 Arlington, VA 22203 USA Phone: 703.524.6575 Fax: 703.524.7898 E-mail: [email protected] IPAT: Manual for Conducting Assessments in Developing Countries 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 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. Strengthening Pharmaceutical Systems (SPS) Program. 2009. Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries. Submitted to the U.S. Agency for International Development by the SPS Program. Arlington, VA: Management Sciences for Health. Key Words pharmacovigilance, medicine safety, surveillance, capacity building 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 ii CONTENTS Acronyms ........................................................................................................................................ v Acknowledgments......................................................................................................................... vii Executive Summary ....................................................................................................................... ix Purpose ....................................................................................................................................... ix Scope .......................................................................................................................................... ix Development Process ................................................................................................................. ix Contents ...................................................................................................................................... x Intended Users of this Manual .................................................................................................... x Introduction ..................................................................................................................................... 1 Pharmacovigilance: A Comprehensive Systems Perspective ..................................................... 2 Capacity Building for Pharmacovigilance .................................................................................. 4 Constructing the IPAT ................................................................................................................ 5 Indicator-Based Pharmacovigilance Assessment Tool ................................................................. 13 Objectives ................................................................................................................................. 13 Limitations ................................................................................................................................ 13 About the IPAT Manual............................................................................................................ 13 Who Should Use IPAT?............................................................................................................ 15 How to Use IPAT? .................................................................................................................... 15 Summary of Indicators .................................................................................................................. 17 Detailed Description of Indicators ................................................................................................ 23 Indicator Presentation Format ................................................................................................... 23 Policy, Law, and Regulation ..................................................................................................... 24 Systems, Structures, and Stakeholder Coordination ................................................................. 28 Signal Generation and Data Management ................................................................................ 43 Risk Assessment and Evaluation .............................................................................................. 49 Risk Management and Communication .................................................................................... 57 Presentation of Assessment Findings............................................................................................ 67 Examples of How to Present Findings ...................................................................................... 67 Implementation of Assessment Using IPAT................................................................................. 73 Annex 1. FDA List of Products Requiring Risk Management ..................................................... 75 Annex 2. Reference Lists for Data Collection .............................................................................. 77 Annex 3. Stakeholder Identification Worksheet ........................................................................... 81 iii IPAT: Manual for Conducting Assessments in Developing Countries Annex 4. High-Alert Medicines .................................................................................................... 83 Annex 5. Pharmacovigilance-Related SWOT/BEEM Analysis ................................................... 85 Annex 6. Data Collection Tool for Public Health Programs ........................................................ 87 Annex 7. Data Collection at MoH and National Level ................................................................. 95 Annex 8. Data Collection at Health Facilities ............................................................................ 105 Annex 9. Glossary ....................................................................................................................... 115 iv ACRONYMS ADR adverse drug reaction ARV antiretroviral CMS Central Medical Stores DIC drug information center DTC drug and therapeutics committee EMEA European Medicines Agency FDA U.S. Food and Drug Administration HF health facility HQ headquarters ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use IPAT Indicator-Based Pharmacovigilance Assessment Tool MAH marketing authorization holder MoH Ministry of Health MRSCA medicines and related substances control act MSH Management Sciences for Health NDA national drug authority NMP National Medicines Policy NPMIC National Pharmacovigilance and Medicine Information Center PHP public health program PIC/S Pharmaceutical Inspection Co-operation Scheme QSL quality surveillance laboratory SOP standard operating procedure SPS Strengthening Pharmaceutical Systems TB tuberculosis UMC WHO Collaborating Centre for International Drug Monitoring, The Uppsala Monitoring Center WHO World Health Organization v IPAT: Manual for Conducting Assessments in Developing Countries vi ACKNOWLEDGMENTS This report was developed by― Jude Nwokike (SPS Technical Lead on Pharmacovigilance) Many persons have contributed to the development of this manual, and we are very grateful for their support and guidance. Some of the contributors are listed below; however, we acknowledge all contributors and thank them for their support. DELPHI GROUP Tenaw Andualem, Shabir Banoo, Willy Kabuya-Mutshipayi, Josephine Maundu, Negussu Mekonnen, Assegid Mengistu, Mireille Muhipunda, Thidiane Ndoye, Jude Nwokike (Moderator), Sue Potter, Peter Risha, Edmund Rutta, Evans Sagwa, Helena Walkowiak UNIVERSITY OF WASHINGTON Andy Stergachis (University of Washington Departments of Epidemiology and Global Health) RWANDA DATA COLLECTION TEAM Anicet Nyawakira and Alex Ruzindaza of the Pharmacy Task Force, PTF, Ministry of Health, Kigali, Rwanda; Felix Hitayezu, Mohan P. Joshi, Denise Murekatete, and Jude Nwokike of the Strengthening Pharmaceutical Systems Program, Management Sciences for Health (MSH/SPS) NAMIBIA CONSULTATIONS Johannes Gaeseb and Assegid Mengitsu of the Ministry of Health and Social Services, Namibia; David Mabirizi, Jude Nwokike, and Evans Sagwa of MSH/SPS SOUTH AFRICA CONSULTATIONS Shabir Banoo, Mohan P. Joshi, and Jude Nwokike REVIEWERS Shabir Banoo, Rick Berzon, Mohan P. Joshi, Douglas Keene, David Lee, Angelica Perez, and Helena Walkowiak of MSH/SPS; Andy Stergachis of the University of Washington Departments of Epidemiology and Global Health vii IPAT: Manual for Conducting