New Schedule H1 drugs Implementation and public awareness

Dr Rashmi Sharma
Drug resistance is emerging as a serious health hazard. The emergence of multi drug resistant TB in India and several other Asian and African countries is due to improper use of TB drugs by the poor patients. Similarly repeated and inadequate use of antibiotics for common ailments makes these drugs ineffective in patients when some serious infections take place. There is tendency of the physicians to prescribe newer broad-spectrum antibiotics as an easy option even for a minor infection as there is no control over the prescription practices of doctors in public hospitals and private clinics. It is important that the use of last line antibiotics should be restricted to serious infections and only when simpler drugs do not work. Similarly, prescribing of codeine containing cough syrups to patients having even mild cough is a very common practice amongst general practitioners. Moreover, easy availability of drugs like antibiotics, cough and cold remedies, pain killers etc. results in increased proportions of drugs used as self medication compared to prescribed drugs. Although, OTC (over the counter) drugs are meant for self medication and are of proved efficacy and safety, their improper use due to lack of knowledge of their side effects and interactions could have serious implications, especially in extremes of ages (children and oldage) and special physiological conditions like pregnancy and lactation. The Government of India has brought 46 drugs and their formulations under a new category called ‘Schedule H1’. From March 1 2014, all medicines under this schedule will be dispensed by a pharmacist only on prescription of a registered medical practitioner as defined under Drugs and Cosmetics Act. These drugs mainly include potent antibiotics (like anti-tuberculosis drugs), habit forming painkillers like Tramadol and anti-anxiety drugs that induce sleep. The Ministry of Health and Family Welfare had issued a notification in this regard on August 30 last year by amending the Drugs and Cosmetics Act 1940. None of these drugs can now be sold over the counter (OTC).   The formulation packs of these drugs should have a warning printed in a box with a red border on the label.
These specified list of drugs can only be sold by chemists after retaining a copy of the prescription and  maintaining a separate register by them. In Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are covered.The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border-“Schedule H1 Drug-Warning:-It is dangerous to take this preparation except in accordance with the medical advice.-Not to be sold by retail without the prescription of a Registered Medical Practitioner.”
The state drug inspectors or FDA inspectors are authorized to conduct surprise inspection at any retail medicine shop and check the register. However, the schedule provides no disincentives for prescribers in selecting the listed drugs without due care. Keeping acts aside, public can fight this deadly threat of drug resistance by knowing that  every fever is not because of an infection, and does not require an antibiotic ,  using antibiotics only when prescribed by a doctor; completing the full prescription, even if they feel better and  never sharing antibiotics with others or using leftover prescriptions. Health workers and pharmacists can help tackle resistance by: enhancing infection prevention and control; only prescribing and dispensing antibiotics when they are truly needed; prescribing and dispensing the right antibiotic(s) to treat the illness. Policymakers can help tackle resistance by: strengthening resistance tracking and laboratory capacity; regulating and promoting appropriate use of medicines.

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