Medicines

Fast facts on Pharmacovigilance

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Pharmacovigilance (PV) is defined as
"the science and activities relating to the detections, assessment, understanding and prevention of adverse effects or any other drug-related problem" [1].

The WHO Programme for International Drug Monitoring came into effect
in 1968, in response to the thalidomide disaster in the 1960s[1].

Close to 10,000 babies
were born with deformities as a result of the adverse effects of thalidomide[2].

The programme started out as a pilot project
with 10 participating countries, it now comprises 134 member countries[3][4].

In 2000,
there were 5 African countries with 'good pharmacovigilance' capacity; this figure has now reached 34 in 2010[4].

There is now an increased opportunity to promote PV within and beyond Africa:
UMC-A (Africa) is a new technical arm of the UMC for Africa. The University of Ghana Medical School (UGMS) has also been accorded the status of a WHO Collaborating Center for Training and Advocacy in Pharmacovigilance[4].

Today the scope of PV includes issues related to:
- Herbal, traditional and complimentary medicines.
- Blood products, biologicals, medical devices and vaccines.
- Substandard and counterfeit medicines.
- Medication errors and irrational use of medicines[1].
- Antimicrobial resistance.

When a drug is released on the market,
it has rarely been exposed to more than 5000 individuals, less than 0.1% of the global population[3].

Adverse reactions to drugs (ADRs)
are estimated to be between fourth and sixth leading cause of death in USA[5].

More than 10% of ADRs
lead to hospitalization according to some studies[5].

Worldwide
more than 50% of all medicines are prescribed, dispensed or sold inappropriately, and 50% of patients fail to take them correctly[6].

30% of the total health budget
accounts for use of medicines in many countries[6].


For PV to be effective, there should be timely, effective and responsible
communication of the collected evidence, with all stakeholders.

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Last update:

15 April 2011 14:52 CEST