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

Objectives:

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

fifteen days

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

positive sign.

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