COMPLIANCE. in a Pharmaceutical Industry Perspective. Copenhagen Compliance and Concordance Conference 30th May 2008

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1 COMPLIANCE in a Pharmaceutical Industry Perspective Copenhagen Compliance and Concordance Conference 30th May 2008 Alejandra Mørk, M.Sc.Pharm., Ph.D, CEO KLIFO A/S

2 Why is Compliance an issue? A succes criteria for the health care professions Important to reduce health care costs (caused by wrong/inappropiate use of drugs) Important to control health care costs (only pay for drugs that are used) Important to improve health

3 Why is Compliance an issue? A succes criteria for the health care professions Important to reduce health care costs (caused by wrong/inappropiate use of drugs) Important to control health care costs (only pay for drugs that are used) Important to improve health Improve therapy

4 Why is Compliance an issue? THE OBLIGATION FOR THE PHARMACEUTICAL INDUSTRY IS TO: Provide medicinal product that are Efficacious Safe Good Quality Patient s Perspective Makes a difference that I take the medicine I can accept and I can manage the side effects It is convenient to handle and take THE AMBITION OF THE PHARMACEUTICAL INDUSTRY IS TO: Improve therapy Regulatory Approval Price, reimbursement, recommendation lists Doctors prescribe Patients use and continue to use the medicine

5 The PATIENT S Perspective Am I ill NO YES Do I need/want treatment NO YES Do I want the treatment offered NO YES Do I understand and manage the treatment NO YES How do I remember to take the medicine right

6 The PATIENT S Perspective Am I ill PHARMACEUTICAL INDUSTRY NO YES Do I need/want treatment NO YES Do I want the treatment offered NO YES Do I understand and manage the treatment NO YES How do I remember to take the medicine right

7 The PATIENT S Perspective IT IS NOT ALL ABOUT DOCTOR-PATIENT RELATION! DOCTOR -Diagnosis - Prescription PHARMACEUTICAL INDUSTRY NURSE -Treatment -Training -Information PRIVATE NETWORK PATIENT ORGANISATIONS - Information PHARMACY -Supply -Information REIMBURSEMENT - Access - Payment

8 Improving Therapy THE OPTIONS FOR THE PHARMACEUTICAL INDUSTRY TO IMPROVE THERAPY RESEARCH PRODUCT DEVELOPMENT INFORMATION AND TRAINING DEVELOPMENT APPROVAL PRICE/ REIMBURSEMENT MARKET INTRODUCTION HIGH QUALITY SUPPLY PROVIDE INFORMATION AND TRAINING MONITOR AND DOCUMENT USAGE SALES NO MAJOR SAFETY PROBLEMS

9 Improving Therapy THE OPTIONS FOR THE PHARMACEUTICAL INDUSTRY TO IMPROVE COMPLIANCE RESEARCH PRODUCT DEVELOPMENT INFORMATION AND TRAINING DEVELOPMENT FORMULATION & DEVICE Minimum: Acceptable disp.form Stable Manufacturable Device no problem CLINICAL DEV. Minimum: Comply with regulatory Requirement challenges - Efficacy - Safety Controlled settings Ideally: Patient convenient Stability at practical conditions Device convenient and supporting compliance Ideally: Knowledge about in-use OBSTACLES! Lack of awareness Not a success criteria Delay of approval Increased risk Confusing data

10 Improving Therapy THE OPTIONS FOR THE PHARMACEUTICAL INDUSTRY TO IMPROVE COMPLIANCE RESEARCH PRODUCT DEVELOPMENT INFORMATION AND TRAINING DEVELOPMENT LAUNCH/MARKETING ACTIVITIY Lack of scientific approach to - Development - Testing

11 Improving Therapy THE OPTIONS FOR THE PHARMACEUTICAL INDUSTRY TO IMPROVE COMPLIANCE HIGH QUALITY SUPPLY PROVIDE INFORMATION AND TRAINING MONITOR AND DOCUMENT USAGE Improved collaboration with other health care professionals Easier flow of information and training to patients -Build on experience cross -countries

12 Improving Therapy THE OPTIONS FOR THE PHARMACEUTICAL INDUSTRY TO IMPROVE COMPLIANCE HIGH QUALITY SUPPLY PROVIDE INFORMATION AND TRAINING MONITOR AND DOCUMENT USAGE OBSTACLES Lack of incentive POST APRROVAL STUDIES Minumum: Regulaotory requirements Price/reimbursement Requirements Idealy: In use experience of drug In use experience of training and information In use experience of health care professionals

13 How to support patients? Usefull information and training Reminder tools Dispensing tools Monitoring Essential the basis for every thing else Helping Hand, Memory caps, Telephones? Dose dispensing, Dispensing boxes Diaries, Electronic capt., Plasma samples Be realistic, Take the patient s perspective, Include development of tools in the development programme

14 How to increase investment in compliance Demand training and information programmes as part of approval process (today required for safety management) Request compliance assessment as pre-requisite for maintaining price and/or reimbursement Award documentation of - efficient training and information progr. - in-use documentation by increase price and/or reimbursement Increase awareness and demand from health care professionals on compliance improving tools Improved methodology to assess effect of training, information and compliance improving tools

15 Compliance Improving therapy Patients focus Create incentives to include compliance in the product development process Devices and tools can be used more and smarter THANK YOU!