“Not even a single medicine is hundred percent safe for all patient in all medical conditions”
Because of this, regulatory authorities in many countries are introduced ‘Pharmacovigilance’ system to collect these adverse drug reactions and its related problems. Several adverse drug reactions are collected once the drug was reached to post-marketing phase particularly through pharmacovigilance system.
WHO defines pharmacovigilance as the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”
We know that, adverse drug reactions and drug related problems are one of the leading causes of morbidity and mortality in the current world. Hence, identification, reporting, documenting, assessment and sharing the same to pharmacovigilance center’s will be helpful to strengthen safety issues of the drugs.
Many drugs like Analgin, Phenformin, Rosiglitazone etc. are withdrawn from the pharmaceutical market due to severe adverse drug reactions.
In the year 2021, Indian Pharmacopoeia Commission (IPC) decided to observe ‘National Pharmacovigilance Week” every year from September 17th to 23rd. This year theme is “Encouraging Adverse Drug Reaction reporting by Patients.” With the same theme and intention many Adverse Drug Reaction Monitoring Centers (AMC) in India organizing various activities like community education and sensitization about ADR’s, webinar, quiz and sharing information through social medias. Till date 606 ADR Monitoring Centers under Pharmacovigilance Programme of India functioning in India. It shows that, how much significance given by IPC to collect the adverse drug reactions in India.
On 10th Jan 2017 Indian Pharmacopoeia Commission (IPC) has made Memoranda of Understanding (MoU) with National Accreditation Board for Hospital and Healthcare providers (NABH) to encourage accredited hospital in India to report and monitor adverse drug reactions. Majority of NABH accredited hospitals have clinical pharmacy services. So, this good initiative can boost the pharmacovigilance system.
Even Pharmacovigilance Programme of India (PvPI) has come up with helpline number 18001803024 and own mobile application named ‘ADR PvPI’. One can download from Google Play Store. As a healthcare professional it is our prime responsibilities to strengthen and support the pharmacovigilance system.
We know that “Every drop of water contributes to the formation of beautiful pond / lake / river / sea / ocean.” Similarly reporting of every adverse drug reaction provide safety profile of drug and strengthen pharmacovigilance system.1, 2
As a healthcare professional, we need to be highly vigilant and alert while we prescribed or dispensed drugs like narrow therapeutic range (Examples: Theophylline, Aminoglycosides, Cyclosporine, Digoxin, Phenytoin and Carbamazepine), black triangle drugs, anticancer, antibiotics and analgesics. Adverse drug reactions are more common especially in pediatrics, geriatrics, female gender, multiple and intercurrent disease and taking poly pharmacy and in impaired liver or kidney functions patients.3, 4, 5 These ADR’s not only increases morbidity and mortality even it can affect the quality of life of patient and financial burden. An average cost required to treat one ADR is approximately US $ 2500 in India 350 to 4000 INR.
By considering all these facts, I appeal to all the doctors, pharmacists, nurses to join your hands to support your respective countries Pharmacovigilance system. If you suspect or identify any ADR in your patient’s just report this. It may act as a signal generator to conduct further research activities related to the same.
