The WHO publication entitled The importance of pharmacovigilance: safety monitoring of medicinal products, describes pharmacovigilance as follows.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of drugs or any other possible drug-related problems.
Recently, its concerns have been widened to include:
♦ traditional and complementary medicines
♦ blood products
♦ medical devices
Many other issues are also of relevance to the science:
♦ substandard medicines
♦ medication errors
♦ lack of efficacy reports
♦ use of medicines for indications that are not approved and for which there is inadequate scientific basis♦ case reports of acute and chronic poisoning
♦ assessment of drug-related mortality
♦ abuse and misuse of medicines
♦ adverse interactions of medicines with chemicals, other medicines and food.
The specific aims of pharmacovigilance are to:
♦ improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions
♦ improve public health and safety in relation to the use of medicines
♦ contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use
♦ promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
These aims of pharmacovigilance can be achieved by:
♦ early detection of hitherto unknown adverse reactions and interactions
♦ detection of increases in frequency of (known) adverse reactions
♦ identification of risk factors and possible mechanisms underlying adverse reactions
♦ estimation of the quantitative aspects of benefit/risk, and analysis and dissemination of the information needed to improve the prescription, dispensing, provision and regulation of medicines.
The ultimate goal of pharmacovigilance is the safe and proper use of effective medicines of all types.
Source : WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems, World Health Organization, Geneva, 2004