Patients increasingly expect to be provided with information about their health and to participate in decisions about medical interventions. The pharmaceutical industry is increasingly attempting to market their products directly to the end user rather than via the learned intermediary, the doctor.
Both industry and regulators are struggling to develop a consistent and clear method of communicating directly to the patients. The EU Directive requiring patient information leaflets (PILs) is legally binding from January 1999 - it will impact on products currently in development as well as those on the market.
This time-sensitive report provides practical advice and an in-depth guide to the regulations companies must comply with when providing medical information for patients. It will inform you of: what information must be included in a PIL; what other sources of information are available to the patient; how the interface between the health professional and the patient is changing; the expectations of the patient as a consumer; and the legal constraints on the content and format of a PIL.
This report critiques examples of current PILs and lists 10 essential criteria for readability.
CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS AND GLOSSARY
CHAPTER 1 INTRODUCTION
1.1 What type of information?
1.2 How is the information provided?
1.3 Patient information and compliance
1.4 Patient information and the Internet
1.5 Clinical trial information
CHAPTER 2 THE REGULATORY PERSPECTIVE
2.1 The European directive
2.1.1 Interpreting the directive
2.1.2 Order of headings
2.1.3 Compliance with the summary of product characteristics
2.1.4 Comprehensibility
2.1.5 Technical terms
2.2 The legal requirements for a patient information leaflet
2.3 Identification of the medicinal product
2.3.1 Name of the medicinal product
2.3.2 Excipients
2.3.3 Pharmaco-therapeutic group
2.3.4 Holders of marketing and manufacturing authorisations
2.3.5 Therapeutic indications
2.4 List of information necessary prior to taking the medicine
2.4.1 Contraindications
2.4.2 Appropriate precautions for use
2.4.3 Forms of interactions
2.4.4 Instructions for proper use
2.4.5 Description of undesirable effects under normal use
2.4.6 Additional information
2.4.7 Storing instructions
2.5 Date of last revision
2.6 Implementation of the directive in Europe
2.7 National interpretation
2.7.1 UK
2.7.2 The Netherlands
2.7.3 France
2.7.4 Italy
2.7.5 Spain
2.7.6 Sweden
2.8 The US
2.8.1 Prescription drugs
2.8.2 Over-the-counter drug products
CHAPTER 3 LEGAL ISSUES
3.1 What safety information must be included?
3.2 How often should a leaflet be reviewed?
3.3 Consequences of non-compliance
CHAPTER 4 PRACTICAL IMPLEMENTATION
4.1 The right information
4.1.1 Communicating with the patient effectively
4.1.2 Presentation
4.1.3 Addressing the doctor's and patient's point of view
4.2 Achieving a single version across Europe
4.2.1 Label text and translation
4.2.2 Process to write a single version in all 11 languages
4.2.3 Version control
4.2.4 Templates
4.2.5 Document exchange
4.2.6 PIL format content and printing
4.2.7 Combined languages
4.2.8 Device/drug combinations
4.2.9 Combined PILs for different pharmaceutical forms
4.2.10 Post-submission, pre-approval
4.2.11 Post CPMP opinion
4.3 Established products
4.4 User testing
4.4.1 Choice of subjects
4.4.2 Testing items
4.4.3 Acceptance of user testing
4.5 Conclusion
CHAPTER 5 PATIENT INFORMATION LEAFLETS FOR THE 21ST CENTURY
CONSUMER
5.1 The medicine information gap
5.2 People prefer conversations
5.3 User testing bridges gaps and simulates conversation
5.4 Changing roles for regulators
5.5 Case studies: antibiotic leaflets seek meaningful relationship with users
5.5.1 Distaclor: plain speaking - but some confusing signals
5.5.2 Augmentin: helpful hints and a friendly tone
5.5.3 Erymin suspension: tables turn the leaflet round
5.5.4 Cefzil: a conversational approach
5.6 Case studies: OTC leaflets for ibuprofen
5.6.1 A culture shock
5.6.2 Advil: neat-looking, but flaws in readability
5.6.3 Cuprofen: no nonsense, but no advice either
5.6.4 Nurofen: marketing-led dynamism makes warnings look dull
5.7 A note on consistency
5.8 Testing the guidelines: user testing of medicine leaflets
5.8.1 Writing and testing two leaflets: 'EC model' and 'Mark II'
REFERENCES
APPENDIX I COUNCIL DIRECTIVE 92/27/EEC OF 31 MARCH 1992 ON THE
LABELLING OF MEDICINAL PRODUCTS FOR HUMAN USE AND ON
PACKAGE LEAFLETS
APPENDIX II PART 1: A GUIDELINE ON THE EXCIPIENTS IN THE LABEL
AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE
(FINAL 12/6/97)
APPENDIX II PART 2: A GUIDELINE ON THE PACKAGING INFORMATION
OF MEDICINAL PRODUCTS FOR HUMAN USE AUTHORISED BY THE
COMMUNITY (FINAL 12/6/97)
APPENDIX II PART 3: A GUIDELINE OF THE READABILITY OF THE LABEL
AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE
(FINAL 29/9/98)
APPENDIX III QRD PRODUCT LITERATURE TEMPLATES: MEDICINAL
PRODUCTS FOR HUMAN USE (VERSION 3.0 18/9/1998)
APPENDIX IV
PUBLISHED: DECEMBER 1998
REF: BS979E
PAGES: 100+
PRICE: £370/$780/¥89,000
© PJB Publications Ltd. 2001 All rights reserved. |