INTRODUCTION TO PHARMACOVIGILANCE

Mohamed FouadQualified Person for Pharmacovigilance (QPPV)AUG Pharma

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

There must be always a side effects

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

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.

Phocomelia 15 % Death rate

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

SAFETY IN DRUG DEVELOPMENT

drug industry

efficacy

Safety

Quality

CLINICAL DEVELOPMENT OF MEDICINES

Animal studies

• Acute toxicity• Chronic toxicity• Carcinogenicity• Reproductive

toxicity• Mutagenicity• Teratogenicity

Clinical trials

The need for Pharmacovigilance

1. Humanitarian concern2. Safe use of medicines3. ADRs are expensive4. Promoting rational use of medicines5. Ensuring public confidence6. Ethical concern

Humanitarian concern

Hippocratic Oath: First Do No Harm

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

WHO program for Pharmacovigilance

Active ICSRs in the WHO Global ICSR database per million inhabitants and year

Country distribution in WHO Global ICSR database

Growth of the WHO Global ICSR database since its inception

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

Pharmacovigilance Process

Safety data communication

Thank You