introduction to pharmacovigilance (1)
TRANSCRIPT
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INTRODUCTION TO PHARMACOVIGILANCE
Mohamed FouadQualified Person for Pharmacovigilance (QPPV)AUG Pharma
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Medicines are safe (X)Approved medicines are safe (X)No medicine is safe (X)No medicine is without a risk ()
Benefit Risk Balance of medications
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There must be always a side effects
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WHAT IS PHARMACOVIGILANCE
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems
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LEARNING FROM HISTORY
Thalidomide disaster
Tranquillizer launched 1957 1st reports of birth defects 1961 10000 infants affected by
Phocomelia No teratogenicity detected during
clinical trials and prior to launch.
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Phocomelia 15 % Death rate
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Kelsey received the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962
FDA refused to authorize Thalidomide because of lack of safety data
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SAFETY IN DRUG DEVELOPMENT
drug industry
efficacy
Safety
Quality
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CLINICAL DEVELOPMENT OF MEDICINES
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Animal studies
• Acute toxicity• Chronic toxicity• Carcinogenicity• Reproductive
toxicity• Mutagenicity• Teratogenicity
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Clinical trials
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The need for Pharmacovigilance
1. Humanitarian concern2. Safe use of medicines3. ADRs are expensive4. Promoting rational use of medicines5. Ensuring public confidence6. Ethical concern
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Humanitarian concern
Hippocratic Oath: First Do No Harm
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Economical concern
• 4th – 6th cause of death• 5% hospital admissions• Occurs in 11% patients• Double cost/length of stay• Double mortality rate• 50% potential preventable• Less than 1% reported
ADRS US study
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WHO program for Pharmacovigilance
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Active ICSRs in the WHO Global ICSR database per million inhabitants and year
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Country distribution in WHO Global ICSR database
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Growth of the WHO Global ICSR database since its inception
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Videos
https://www.youtube.com/watch?v=NeR8pen1T5M
Importance of reporting
UMC videohttps://www.youtube.com/channel/UC1SmOUUe6noAWVY4P2JEljw
https://www.youtube.com/watch?v=78uiRTdQysA&index=4&list=PLsycN1_DctNV9f4cic44EnEeaMqp-pqNx
Take and tell song
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Pharmacovigilance Process
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Safety data communication
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Thank You