Title:Why Pharmacovigilance of Non-steroidal Anti-inflammatory Drugs is
Important in India?
Volume: 24
Issue: 7
Author(s): Subhransu Dash, Preet Amol Singh*, Neha Bajwa, Abinash Choudhury, Preeti Bisht and Rajiv Sharma
Affiliation:
- University Institute of Pharma Sciences (UIPS), Chandigarh University, Mohali, 140413, Punjab, India
Keywords:
Adverse drug reaction, drug safety design, NSAIDS, patient safety, pharmacovigilance, regulatory affairs.
Abstract:
Background: Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are among the
drugs that are most regularly administered to manage inflammation and pain. Over-the-Counter
(OTC) NSAIDs are widely accessible, particularly in developing countries like India. This casual
approach to using NSAIDs may operate as a magnet for NSAID-related adverse drug reactions
(ADRs) among patients.
Objectives: As patients in India are less informed about the appropriate use of NSAIDs and consumption
patttern, adverse drug reactions, and the importance of reporting ADRs, the current
study's objective is to promote patient safety by using pharmacovigilance as a tool to educate
patients.
Methods: A targeted literature methodology was utilized to gather the data pertaining to
NSAIDs, their ADRs and their pharmacovigilance. Different scientific databases, such as Science
Direct, PubMed, Wiley Online Library, Springer, and Google Scholar, along with authentic
textbooks, were explored as reference literature.
Results: In general, NSAIDs consumption pattern depends upon the different age groups.
Around 1.6 billion tablets of NSAIDs are consumed in India for ailments, such as headaches,
arthritis, menstrual cramps, osteoarthritis, back pain, rheumatoid arthritis, gout, osteoporosis,
tendinitis, cancer pain and chronic pain. Common ADRs of NSAIDs include nausea, vomiting,
headache, gastritis, abdominal pain, and diarrhoea. Also, they can cause renal damage and cardiovascular
problems if not consumed in a dose-dependent manner. However, Diclofenac and
Ibuprofen have both been linked to depression and dementia. There have been reports of aplastic
anaemia, agranulocytosis linked to phenylbutazone, Stevens-Johnson, and Lyell's syndrome
linked to isoxicam and piroxicam, as well as the vulnerability of new-borns to Reye's syndrome
after aspirin use. Lack of awareness, time constraints and unpredictability, poor training in
ADRs identification, etc., are some of the reasons for the under-reporting of ADR of NSAIDs in
India.
Conclusion: In order to rationally prescribe NSAIDs, it is essential to be aware of probable
ADR’s and establish prescription guidelines. Prescribers' behaviour can be changed toward excellent
prescribing practices by conducting routine prescription assessments dealing with
NSAIDs and providing feedback. In the near future, it will be critical to strengthen ADR data
management and expand the reach of pharmacovigilance programs, ADR monitoring centers,
and healthcare professionals' especially pharmacists’ training in rural locations.
