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19 Sep 2021, Edition - 2259, Sunday

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‘Robust Pharmacovigilance System is a surrogate marker of quality’

Covai Post Network


Pharmacovigilance (PV) as a discipline is a pure science attributed by the World Health Organisation (WHO). The mainstay of this discipline is detection, assessment, understanding and prevention of drug related adverse effects.

Aiming to improve patient care and safety in relation to use of medicine and medical and paramedical interventions Pharmacovigilance strives to improve public health scenario in the country, said Dr. J. Vijay Venkataraman, Managing Director and CEO of Oviya Medsafe.

Speaking at the “Drug Diligence 2017”, a two-day conference and workshop on Pharmacovigilance here, he said that Pharmacovigilance contributes in a big way to the assessment of benefit, harm, effectiveness and risk factors in medicines and thus encourages the safe, rational, and effective use of medicines.

While noting that taking medicines involves both benefits and risk factors and when risk of taking a particular drug outweighs its benefit it is deemed as Adverse Drug Reaction (ADR). While citing the case of Rosiglitazone, a common diabetic drug, which was withdrawn from the market after adverse effects of heart failures were reported in the many patients he said, though the drugs hit the market after many phases of controlled clinical trials there is always lurking “risk factors” involved in a commonest of drugs. “In the real world scenario, things such as dose changes, off label use (using it for various health maladies), and co-morbidities might contribute to these adverse impacts” Dr. Venkataraman said.

A common drug like Paracetamol, when taken in larger dosages might cause hepatotoxicity (chemical induced liver damage). While 500 mg four times a day is the prescriptive limit, patients often do not adhere to these dosage limits resulting in adverse effects as these over the counter (OTC) medicines are easily available. On the event of adverse impact experienced by patients, they can directly report to the Pharma Company, which is the drug -manufacturer and the companies have a mandate to analyze and report such complaints to Central Drug Standard Control Organisation (CDSCO).

Drug monitoring systems should be strengthened to supervise mistakes committed at the various points of drug delivery system, including pharmacies. “Ironically there is no available data to mistakes and mess ups occurring at various points of drug delivery system.” An untrained seller would get confused by similar sounding drugs like Lipril, a BP medication and Loprin, which is an aspirin and dispense the wrong medicine.” he said.

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