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Though medicines come as a blessing to a patients in dire need of remedy, but no medicine is 100% safe for every patient at all times. We get to know about many of the benefits and harms of a medicine in clinical trials. These trials involve only a few hundred or thousand carefully selected people, which possibly cannot represent the whole pool of patients to eventually use the drug. Besides, different people react differently to medicines, because everyone has different risk factors due to variations in genetics, other diseases and medication, allergies, social conditions, psychology and so on. In every treatment decision, the prescriber and patient must decide if the benefits of medicines outweigh the possibility of discomfort or harm associated to it.
These minor or serious harm may already be known and recorded on the patient leaflet or may be totally unexpected at times. Reporting of unexpected effects is particularly important in building up a full picture of a drug’s safety profile. The more we know about what patients have experienced after drug use, the more accurately informed we are, and any harm can be prevented in the future. This very idea instigated the concept of Pharmacovigilance.
Pharmacovigilance (or vigilant monitoring of pharmaceutical products) encompasses the science and activities relating noticing, assessing, understanding, managing and preventing adverse effects of drugs and medicinal devices for use in individuals and populations. It was conceptualized and established in 1968 (Source: The origins of The WHO Programme and UMC) by World Health Organization (WHO) in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level to enhance patient care and patient safety in relation to the use of medicines by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines and related products. Currently, more than 150 countries are members of the WHO Programme for International Drug Monitoring (130 Full-member countries and 26 associate member countries) [source: Uppsala Monitoring Center WHO Programme Members].
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