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The need for Pharmacovigilance Mary R Couper and Shanthi Pal Quality Assurance and Safety of Medicines. Medicine Safety. To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine. Molière. Risk.
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The need for PharmacovigilanceMary R Couper and Shanthi PalQuality Assurance and Safety of Medicines
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
This applies throughout the life cycle of a medicine equally to
the pre-approval stage as to the post-approval.
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment
A reaction which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function
Examples of serious and unexpected adverse events leading to withdrawal of medicine
Nephrotoxicity, cholestatic jaundice
Torsade de pointes
Anxiety, depression, movement disorders
Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005
It has been suggested that ADRs may cause 5700 deaths per year in UK.
Pirmohamed et al, 2004
ADRs were 4th-6th commonest cause of death in the US in 1994
Lazarou et al, 1998
(59%) were avoidable
Reason 3: ADRs are expensive !!
Cost £446 million per annum
Promoting rational use of medicines and adherence
Monforte et al. AIDS 1999
Reason 5: Ensuring public confidence
If something can go wrong, it will – Murphy's law
Known about SSRI prescribing at unsafe doses for a decade
March 18-24 2004
PV in Emerging Countries, CPT2008 29th July 2008
Need for Pharmacovigilance
Freetown, Sierra Leone 19th Aug. 2008
Reason 6: Ethics
To know of something that is harmful to another person who does not know, and not telling, is unethical
valid for everyone