Abuse And Misuse Potential of Commonly Used Non Steroidal Anti Inflammatory Drugs (Nsaids) In Indian Scenario, A Pharmacovigilance Model Study
Vijay Bhalla*1, Uma Kant Bajaj2
1. To find out the incidences and study various aspects of Adverse Drug
Reactions (ADR) in the patients receiving NSAIDs for more than 15 days
2. To test the impact of pharmcovigilance model study in reporting ADR.
Setting: 400 subjects on NSAID’s who are on drug treatment for not less than
Method: Study in patients on NSAID’s therapy, the data was obtained from
Physician records, Community Pharmacists and patients by individual
interactions using structured format based on the guidelines of CDSCO.
Observations: Out of 400 patients 47 cases of ADRs were reported showing
following demographic, 17% population consumed NSAID’s for more than one
year period, 36% for more than 6 months, 29% for over 3 months and 13% for
more than one month and 6 % for more than 15 days. 49% patients did not
follow up with the physician and continued the same therapy while 51 % visited
their Physician for follow up check up. 20 % patients were given increased per
day dosage while 10% got reduced per day dosage and remaining 70% continued
on same dosage regimen. ADR cases in fixed dosage combination were 7% while
on monotherapy 5%. ADR cases associated with Etoricoxib 1.9%, Diclofenac
2.1%, Aceclofenac 1.5%, Nimuselide 1.1%, Ibuprofen 1.4% and Paracetamol
0.4%. Commonly encountered ADR reported were of Drowsiness, Diarrhea,
Gastro intestinal ulcer, Flatulence, elevated hepatic enzymes during LFT and bio
chemical changes in KFT.
Conclusion: The evaluation of pharmacovigilance study demonstrated that
NSAIDs are the most widely prescribed drugs in the management of pain.
Monitoring of ADR is an important tool to prevent the damage to a organ system
like Gastrointestinal, Renal system and hepatic functions. Fixed dose
combinations of NSAIDs are less prescribed defining rationale use of NSAIDs in
Indian scenario. Majority of the ADR reported were of mild to moderate in nature
and no serious or severe reaction developed after prescribing NSAIDs which is a
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