Daijiworld Media Network – New Delhi
New Delhi, Sep 23: The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory warning healthcare professionals, pharmacists, retailers, distributors, hospitals and the public against the indiscriminate use of painkillers, particularly Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and antibiotics, highlighting the associated risk of Chronic Kidney Disease (CKD).
According to the Directorate General of Health Services (DGHS), the circular dated September 21 stated that NSAIDs and antibiotics should be used only when clinically indicated, at the appropriate dose and for the appropriate duration, and under the supervision of a Registered Medical Practitioner.
The DGHS noted that the import, manufacture, sale and distribution of drugs are regulated under the Drugs and Cosmetics Act, 1940, and the rules framed under it. Various medicines, including NSAIDs and antibiotics, fall under Schedules G, H, H1 and X of the Drugs Rules, 1945, depending on their applicability and potential risks, and must carry prescribed warnings and conditions of sale.
Most NSAIDs are included in Schedule H and cannot be sold at retail without a prescription from a Registered Medical Practitioner, as required under Rule 97 of the Drugs Rules, 1945. Most antibiotics fall under Schedule H1 and carry specific warnings against use without medical advice and sale without a prescription.
The advisory cautioned against taking NSAIDs and antibiotics indiscriminately, repeatedly or for prolonged periods without medical advice. It also urged the public not to use antibiotics for self-medication or for conditions where they are not clinically indicated, including most uncomplicated viral infections.
Antibiotics prescribed by healthcare professionals should be taken strictly as directed and should not be shared with others or taken from leftover medicines, the circular stated.
People with pre-existing kidney disease or other risk factors for renal impairment have been advised to inform their healthcare professionals before using NSAIDs. The public has also been urged to seek medical advice if pain, fever or other symptoms persist or recur, rather than repeatedly using painkillers or antibiotics on their own.
The DGHS called on healthcare professionals to prescribe NSAIDs and antibiotics only when clinically necessary, after considering the patient's condition, age, co-morbidities, other medicines and relevant risk factors.
For NSAIDs, the circular recommended considering the lowest effective dose for the shortest appropriate duration, particularly for patients at increased risk of kidney impairment. It also called for precautions when treating patients with renal impairment, dehydration, cardiovascular disease or other conditions that could increase the risks associated with NSAID use.
Regarding antibiotics, the DGHS stressed judicious prescribing in line with antimicrobial stewardship principles. Prescriptions should take into account the likely causative organism, site and severity of infection and, where appropriate, microbiological investigations and local susceptibility patterns.
Unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged treatment should be avoided, the advisory stated.
Pharmacists, retailers and distributors have been directed to comply strictly with statutory requirements governing the sale and distribution of Schedule H, H1 and other prescription drugs. The circular advised them not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs.
Hospitals and healthcare institutions have also been urged to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics, while promoting antimicrobial stewardship, prescription reviews and appropriate patient counselling.
The State and Union Territory Drugs Control Authorities have been requested to create awareness about the advisory.