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A Proposal To Introduce Prescription Audits To Curb The Excessive Use Of Antibiotics Is Hanging Fire. Hemchhaya De Finds Out Why Published 07.11.11, 12:00 AM

Have you ever felt that your doctor is prone to prescribing antibiotics at the drop of a hat? Well, if the National Antibiotic Policy comes into force, your doctor and thousands of other medical practitioners would probably become less indiscriminate in prescribing these drugs for relatively minor ailments. The problem, however, is that various pharmaceutical lobbies are fighting tooth and nail to block this initiative to curb the overuse of antibiotics.

Earlier this year, the Indian health ministry and various regulatory bodies under it announced the ambitious National Antibiotic Policy that recomends, among other things, the introduction of prescription audit to monitor and restrict the use of antibiotics. This means that doctors have to write two prescriptions for antibiotics — one for the patients and another which may be retained by pharmacists or chemists for audit by the Drug Controller General of India or state drug controllers. Any violation would draw a hefty fine or imprisonment.

However, the recommendations are being vigorously opposed by the All India Organisation of Chemists and Druggists (AIOCD), a powerful body that is believed to control a major part of the pharmaceutical trade in India. The organisation also called for a nationwide strike recently to protest against prescription audit.

It’s no secret that antibiotic resistance is a growing menace in India and their excessive use is contributing to the problem. A recent study in the Indian Journal of Medical Research prepared by the Global Antibiotic Resistance Partnership (GARP) — India Working Group shows that between 2005 and 2009, the units of antibiotics sold across the country went up by about 40 per cent. The study says that antibiotics are often prescribed in “irrational ways” in India. “It is estimated that 20-50 per cent of all antibiotics use are inappropriate, resulting in an increased risk of adverse side effects, higher costs of therapy and higher rate of antimicrobial (antibiotic) resistance,” states the National Antibiotic Policy.

“Resistance is driven by antibiotic use, and antibiotic overuse enhances it. In India we see many instances of such overuse,” says Dr Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy and vice-president, research and policy, at the Public Health Foundation of India.

Consumer activists in the country have long been demanding prescription audit – a measure that exists in several Western countries like the US and the UK. Says Rijit Sengupta, associate director, CUTS International, a body which fights for pro-consumer policies in the health sector, “CUTS did a study on drug prescription practices in India as early as 1995. The study, conducted in West Bengal, Andhra Pradesh, Rajasthan, Maharashtra, Gujarat and Tamil Nadu, revealed that there was a gross tendency to prescribe useless medicines and a dire need for prescription audit.”

Another study conducted by CUTS this year in Assam and Chattisgarh threw up similar results. “The report recommends the need for closer monitoring of doctor’s behaviour at the micro level and reiterates the need for prescription audit — not only for antibiotics, but for all drugs,” adds Sengupta.

Yet, despite ample evidence of antibiotic overuse and the resultant health hazards, the government seems to be dragging its feet on implementing the National Antibiotic Policy. In fact, P.K. Singh, general secretary, AIOCD, which petitioned more than 200 members of Parliament against the audit recommendation, claims, “We have come to know that the government has put on hold the proposed audit.” AIOCD maintains that the measure would inconvenience consumers, particularly from the poorer sections of society. “How can you expect poor people in remote areas to provide us with prescriptions when they have no access to doctors,” he asks.

While the health ministry denies shelving the National Antibiotic Policy, the government is said to be taking a relook at it.

Health and consumer activists in favour of prescription audit are planning to intensify their campaign. They say that the need for prescription audit cannot be overemphasised, especially when collusive medical practices are the order of the day in India. “If the government has backtracked on prescription audit, it’s unfortunate,” says Sengupta. “The reason cited against such audits — that stringent measures to regulate antibiotic use might jeopardise the availability of such medicines among the poor — sounds juvenile. Why can’t the government improve its process of drug procurement and distribution to enable better access,” he asks.

But some caution against oversimplifying the issue. “We have a dual problem in India – the lack of access to effective antibiotics in rural areas and the overuse of powerful antibiotics in urban centres,” says Dr Laxminarayan. He says that measures like prescription audit could be useful in curbing overuse and misuse in cities. “In rural areas, though, we should focus less on prescriptions and more on providing effective, affordable antibiotics through trained healthcare workers and other avenues,” he says.

Medical experts admit that doctors do tend to prescribe medicines unnecessarily. “It’s a fact that some doctors abuse antibiotics — they prescribe drugs even when these are not needed,” says Dr Bhaskar Narayan Chaudhuri, consultant microbiologist, Fortis Hospital, Calcutta. “So prescription audit could be a kind of deterrent for them.”

Others point out that an effective system of prescription auditing could also save consumers from the depredations of quacks. “The biggest threat is posed by quacks who have no authority whatsoever to prescribe medicines,” says Dr B.B. Thakur, a senior official with the Association of Physicians of India, a professional body of about 15,000 consultant physicians. “So audit is necessary to deal with quacks as well.”

Dr Thakur reveals that the Medical Council of India has strict rules against irrational antibiotic use. The Code of Medical Ethics Regulations 2002, states: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.” But of course, these rules are hardly enforced, he admits.

Some doctors argue that their fraternity is not to be blamed alone. “Often patients insist on being prescribed antibiotics for minor ailments,” says Dr Chaudhuri. “We find it very difficult to explain to them that they don’t need antibiotics for aliments like viral fever!”

That said, it is always the consumer who is at the receiving end of the overuse and misuse of drugs by medical practitioners. One can only hope that the government will stand firm on prescription audit and introduce the measure at the earliest.

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