The Need for National Pharmacovigilance Program

Transcription

1 The Need for National Pharmacovigilance Program ANAS BAHNASSI Presented at Order of Lebanese Pharmacists on March 10 th 2018

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3 All drugs are dangerous Some are also useful. N. Moore, BMJ, 2005, 330;

4 Dcemeber 16 th 1961, the infamous letter of the Australian physician McBride to the Lancet. Who blew the Whistle? Phocomelia

5 Concepts that may be overlooked in therapeutics There is no drug that is entirely safe. Every medical case patient is unique. Every therapeutic case is different from the other. We can not ignore individual differences.

6 Depression Paroxetine Things get more complicated when we take more than one medication Cholesterol Pravastatin

7 Definition Per WHO So what is exactly PHARMACOVIGILANCE? The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems The Importance of Pharmacovigilance: WHO 2002

8 Adverse Drug Reactions This definition expands the scope of Pharmacovigilance Ingredients Patient Product quality Inadequate Use Mass campaigns safety challenges GMP Distribution Storage Counterfeiting Lack of efficacy Medication errors Dependence and abuse Poisoning Immunization programs

9 Change in Terminology- Change in Priorities

10 Do No Harm

11 The human aspect Why do we need Pharmacovigilance?

12 Why do we need Pharmacovigilance? The human aspect The financial burden Rational use of medication Public confidence

13 How to collect safety information Voluntary Reporting Post-Marketing Specific info about safety Registration about medications? Phase III patients Efficacy and Safety Phase II patients Dose Phase I Volunteers Animal Studies Safety Post-Marketing Drug Development

14 The rule of 3: What statistics teach us There is 95% chance of observing one occurrence of an event in a population 3 times the size of the event s frequency if the incidence is 1 / then we need patients to find one case

15 The rule of 3: What statistics teach us Or, if no event is observed in a population of N There is a 95% chance that the event rate is less than one in N/3 If there is no event in 3000 patients rate < 1/1000

16 Why cannot we rely solely on information Subject Clinical Trials -Efficacy- collected from clinical trials Clinical Practice -Effectiveness- Number of patients Dozens, hundreds, rarely thousands Thousands to millions Length of time Days to weeks Days to years Population Pregnant, children, elderly are generally excluded. All population Other treatment Avoided Generally more than one Dose Fixed Variable Conditions Rigorous follow-up / more information Flexible follow-up / less informed patient

17 Can the results of a clinical study extrapolated from one population to another? We differ from each other genetically, culturally, healthcare system, and disease prevalence. Effectiveness and Risks differ

18 What information do we need? Responsibility of health authority: Authorities need to monitor: Adequate quality of medicines Acceptable benefit/harm balance Rational use of medicine

19 What information do we need? Responsibility of healthcare practitioners: Each patient is a unique challenge: Knowledge Therapeutic tools Updated continuing education Diet Surgery Medicine Others Rational Therapy

20 Principle communication Circles Reports provided by patients Therapeutic info provided by manufacturer Health Authorities

21 Principle Voluntary reporting of Adverse Drug Reactions A symptom connect to a medicine It is all about SUSPICION Communicate this suspicion to the national pharmacovigilance program

22 How big is the problem? 39 studies in US hospitals 6.7% : Percentage of serious ADRs 0.32%: Percentage of fatal ADRs 4 th to 6 th leading cause of death Lazarou et al JAMA 1998;279:

23 The cost??? Millions

24 It is all about ETHICS What could you have done?

25 Ethics: can it be affected? Will your decision be affected by: Geographic Distance Seriousness Should have known!

26 Ethics: can it be affected? What will happen if you keep silent? Is keeping silent acceptable?

27 In the end Why do we need Pharmacovigilance? Early detection of drug related problems Indicate the frequency of a specific incidence Identification of risk factors Quantitate risk factors Protect patients of preventable risks

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