The Central Drugs Standard Control Organisation (CDSCO) has released an advisory aimed at healthcare personnel, pharmacists, retailers, distributors, hospitals, and the general public, emphasising the dangers associated with the indiscriminate use of painkillers and antibiotics. This advisory has been prompted by concerns about the connection between such medications and Chronic Kidney Disease (CKD).

In a notice dated September 21, the Directorate General of Health Services (DGHS) urged that painkillers, specifically Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and antibiotics should only be administered when there is a clinical necessity. Administration should occur at the correct dosage for an appropriate duration and under the guidance of a Registered Medical Practitioner.

The DGHS indicated that the regulation of drug import, manufacturing, sale, and distribution is governed by the Drugs and Cosmetics Act, 1940. Various medications, including NSAIDs and antibiotics, are categorised under Schedules G, H, H1, and X of the Drugs Rules, 1945, based on their potential risks and require specific warnings and conditions for sale.

Prescribing Guidelines for Healthcare Professionals

According to the advisory, most NSAIDs fall under Schedule H of the Drugs Rules, 1945, which mandates that they cannot be sold without a prescription from a Registered Medical Practitioner, as stipulated in Rule 97 of the same regulations. The DGHS observed that antibiotics are typically included in Schedule H1 and are subject to strict warnings regarding their use.

The advisory cautions against the indiscriminate, repeated, or prolonged consumption of NSAIDs and antibiotics without professional medical guidance. It specifically highlights that antibiotics should not be utilised for self-medication, particularly in cases of uncomplicated viral infections where antibiotic treatment is not warranted.

Patients are advised to adhere strictly to their healthcare professional’s instructions when taking prescribed antibiotics and to avoid sharing them with others or using leftover medication. Furthermore, individuals with existing kidney issues or other risk factors should consult their healthcare providers prior to using NSAIDs.

Guidance for Distributors and Healthcare Institutions

Healthcare professionals are encouraged to prescribe NSAIDs and antibiotics solely when clinically warranted. The DGHS recommends considering the patient’s overall condition, age, existing health issues, and other relevant factors when making prescribing decisions. It suggests administering the lowest effective dosage for the minimal effective duration, particularly for patients at heightened risk for renal impairment.

In the case of prescribing antibiotics, the DGHS advocates for prudent practices, aligned with antimicrobial stewardship principles. This includes consideration of the likely causative organisms, the site and severity of infections, and any applicable microbiological investigations and local susceptibility data.

The advisory alerts pharmacists, retailers, and distributors to comply strictly with the legal requirements surrounding the sale and distribution of Schedule H and H1 medications. It stresses that these drugs should not be sold at retail without adherence to existing regulations and that self-medication with these products should not be encouraged.

Healthcare institutions and hospitals are also urged to enhance their procedures for the rational prescribing and monitoring of NSAIDs and antibiotics. There is a focus on promoting antimicrobial stewardship, conducting prescription reviews, and providing appropriate patient counselling. Additionally, State and Union Territory Drugs Control Authorities have been tasked with raising awareness regarding this advisory.

Long or Short, get news the way you like. No ads. No redirections. Download Newspin and Stay Alert, The CSR Journal Mobile app, for fast, crisp, clean updates!

App Store –  https://apps.apple.com/in/app/newspin/id6746449540 

Google Play Store – https://play.google.com/store/apps/details?id=com.inventifweb.newspin&pcampaignid=web_share