African Palliative Care Association Guidelines for Ensuring Patient Access to, and Safe Management of, Controlled Medicines Notice Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy are required. APCA and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of this publication. However, in view of the possibility of human error or changes in sciences, neither APCA nor the publisher nor any other party who have been involved in the preparation or publication of this work warrants that the information contained in this publication is complete and correct and they disclaim all responsibility for any errors or omission or for the results obtained from use of the information contained herein. African Palliative Care Association Foreword The 59th Session of the World Health conventions. Several countries make the Assembly of the UN adopted resolution importation, storage, distribution and 58.22, thereby recognising the dispensing of controlled medicines more importance of improving pain relief restrictive than is needed. Additionally, using opioid analgesics and calling on it is a requirement for countries to member states to remove barriers to provide detailed annual estimates and their medical use and availability. reports for narcotic substances to the International Narcotic Control Board to While advances have been made pursuing procure or produce controlled medicines. this agenda in Africa (e.g. legalisation of However, formulating reliable estimates oral morphine prescription rights for nurses is often a barrier to accessing controlled and clinical officers in Uganda, approval medicines, while the procurement of access to morphine for hospices of opioids is subject to complex and in Zambia, and advocacy progress in lengthy exportation and importation Malawi and Kenya), challenges remain. systems of licences and certificates A key challenge that hinders access to In an attempt to provide straightforward opioids is the fact they are controlled information with regard to these medicines and therefore only available regulations and supply chain issues, the under tight regulations. Controlled African Palliative Care Association (APCA) medicines are legally classified by their has developed these guidelines. It is benefit when used in medical treatment intended to be a signpost for palliative and their harm if misused. In this care providers, palliative care national regard, a balanced access to controlled associations and other stakeholders to medicines is needed to maximise their the relevant legislation and guidance from availability for the safe treatment of competent authorities, narcotic control medical conditions and minimise their boards, the World Health Organisation, availability for abuse and dependency. governments, professional bodies and However, achieving this balance is often other agencies with regard to the safe use problematic. Indeed, in many countries and management of controlled medicines. access to controlled medicines is impacted on by overly restrictive regulations In developing the guidelines, APCA and a lack of enabling policies. recognises the need to increase awareness of the existing obligations for governments National legislation in many countries and providers in the management of includes provisions that are beyond the controlled medicines and the expectation requirements of the international drug that such obligations will not hinder 2-3 Administering Opioids Guidelines patients from accessing the treatment they need. APCA is also aware that there are national laws and regulations that exist to guide the use and management of controlled substances. It is our hope, therefore, that these guidelines will be adapted in accordance to existing country-specific guidelines for the handling of Schedule I and II medicines. It is also intended that key country players, such as national palliative care associations, will use these guidelines to support their advocacy work with governments around drug availability. We believe that, if properly used, these guidelines will preserve the Central Principle of Balance – in other words, they will provide robust safeguards against abuse, while at the same time allowing controlled medicines to address the real and often unmet needs of patients requiring effective pain management and relief. Dr. Faith Mwangi-Powell Executive Director African Palliative Care Association African Palliative Care Association Acknowledgements The African Palliative Care Association All rights are reserved, whether the whole or a part of the material is concerned, particularly the Model Guidelines for Patient Access to, and rights to reproduce images or text, or to translate or Safe Management of, Controlled Medicines reprint. Requests for permission to reproduce text or images, or to translate APCA publications, or any other inquiries, should be directed to APCA, PO Box 72518, Kampala, Uganda, Tel: +256 414 266251, Editors Fax: +256 414 266217 email: [email protected]. David Joranson, MSSW Distinguished Scientist The production of these guidelines was made possible by the support of the True Colours Trust, UK. The Founder, Pain & Policy Studies Group contents of this document are the sole responsibility (PPSG) / WHO Collaborating Center for of the African Palliative Care Association and do not Policy and Communications in Cancer Care necessarily reflect the views of the True Colours Trust. School of Medicine and Public Health University of Wisconsin Carbone Cancer Center Martha Maurer, MSSW, MPH, PhD Associate Researcher Pain & Policy Studies Group / WHO Collaborating Center for Policy and Communications in Cancer Care School of Medicine and Public Health University of Wisconsin Carbone Cancer Center Faith Mwangi-Powell, Ph.D. Executive Director African Palliative Care Association ISBN 978 9970 204 038 © African Palliative Care Association (APCA) 2010 4-5 Administering Opioids Guidelines Table of Contents FOREWORD ............................................................................................................ 3 Acknowledgements. ......................................................................................... 5 Table of Contents ....................................................................................... 6 DEFINITION OF TERMS AND ABBREVIATIONS ........................................................ 8 Abbreviations ............................................................................................ 8 Definition of Terms .................................................................................... 9 INTRODUCTION. ..................................................................................................... 11 PURPOSE OF THE GUIDElINES .............................................................................. 11 INTERNATIONAl REGUlATIONS ............................................................................. 11 The International Control Organs ............................................................... 12 Estimating the Required Amount of Schedule I/II Drugs ............................ 13 Supplementary Estimates ......................................................................... 14 Statistical Returns to INCB ........................................................................ 15 Inspection and Supervision ....................................................................... 15 IMPORTATION, MANUFACTURING AND WHOlESAlE GUIDElINES ......................... 16 PROCEDURE FOR IMPORTATION OF SCHEDUlE I/II MEDICINES. ............................ 16 MANUFACTURING .................................................................................................. 18 licensing ................................................................................................... 18 Record keeping ......................................................................................... 18 Storage ...................................................................................................... 18 Packaging and labelling ............................................................................ 21 WHOlESAlE SUPPlY .............................................................................................. 22 licences .................................................................................................... 22 Records ..................................................................................................... 22 What happens on receipt of an order: ....................................................... 23 African Palliative Care Association DISTRIBUTION OF SCHEDUlE I/II MEDICINES: ....................................................... 25 REGUlATIONS WITH REGARD TO TRANSPORTATION. ............................................. 25 POSSESSION OF SCHEDUlE I/II MEDICINES .......................................................... 25 Who can prescribe Schedule I/II medicines? ............................................. 26 The prescription details: ............................................................................ 26 Dispensing of Schedule I/II medicines ...................................................... 28 WARD SUPPlIES OF SCHEDUlE I/II MEDICINES ..................................................... 30 GUIDE FOR HOSPITAl WARD STAFF .......................................................................