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Rulebook on TB treatment

New Delhi, March 23: India’s health ministry will tomorrow release the country’s first-ever rulebook on tuberculosis that medical experts hope will help curb wrong treatment in the private sector and improve results in public-sector clinics.

The Standards for TB Care in India (STCI) prescribe ways to diagnose and treat the disease, a bacterial infection that requires multiple drugs to be administered for at least six months — and up to two years in patients with drug-resistant TB.

The standards have emerged amid longstanding concerns in medical circles that many private doctors are prescribing wrong treatment that can put patients at risk of developing multi-drug-resistant (MDR) tuberculosis and threaten gains from the government’s TB control efforts.

Tuberculosis is among India’s biggest public health challenges, causing illness in an estimated two million people each year. About half the patients make use of the government’s free treatment programme that follows rigorous diagnostic and treatment standards. The others turn to private practitioners, many of whom have been caught writing wrong prescriptions.

The standards also seek to tweak the government’s TB treatment rules, turning away from a thrice-a-week regime to daily treatment for infected children, patients who cannot be directly seen to be swallowing their pills, and for TB patients co-infected with HIV.

“We want the STCI to bring in uniformity in diagnosis and uniformity in treatment — the correct drug therapy for all TB patients in the country,” said Radhay Shyam Gupta, the deputy director-general in the health ministry’s TB division.

Two studies separated by two decades have highlighted the problems with the TB prescriptions written by private practitioners.

Patients diagnosed with TB for the first time should be prescribed a combination of four so-called first-line drugs for two months and asked to continue two specific first-line drugs for an additional four months. Patients with MDR-TB need to be prescribed appropriate combinations of second-line drugs for up to two years.

A study published in the journal PLOS One in 2010 showed that of 106 private practitioners in Mumbai who had been asked to write one TB treatment prescription each, 63 wrote incorrect regimens. A 1991 study had shown 100 Mumbai doctors writing 80 incorrect regimens between them.

“We still see wrong prescriptions written by doctors every week,” said Rajendra Prasad, a pulmonary medicine specialist and director of the Vallabhbhai Patel Chest Institute at the University of Delhi, who was a member of a team of Indian and foreign experts who pencilled the STCI.

“It is sad, because TB — even MDR-TB, if diagnosed early and treated correctly — is curable,” Prasad told The Telegraph.

But public health experts estimate that about 220,000 people die from TB in India each year. “What this number tells us is that our control efforts can be improved.”

A health expert who requested not to be named said the introduction of the STCI would be a “very important development” in India’s TB control efforts.

“Current evidence shows that the intermittent (thrice-a-week) regimen may not be as good as the daily regimen in these categories of patients,” the health expert said.

The health ministry’s TB division will make the STCI public through its website. But health experts caution that the government will need to find ways to ensure that doctors adhere to its contents.

“The (STCI) document may not reach healthcare providers at the base of the pyramid,” said Madhukar Pai, a public health specialist at McGill University in Canada. Pai was among experts who had helped draft an international set of standards for TB care whose third edition was released earlier this year.

“The issue is, how do you educate doctors and hold them accountable?” Pai told this newspaper.

The standards encourage doctors to provide adequate counselling to patients with TB and to consider suggesting how they could improve their nutrition.

“These are unique elements in the STCI,” said Soumya Swaminathan, director of the Tuberculosis Research Centre, Chennai.

The standards recommend that health providers do not merely counsel TB patients on the need for adequate nutrition, but help link them with existing social welfare schemes.

The STCI is intended to help curb the emergence of MDR-TB amid indications last year that India has the world’s highest estimated burden of MDR-TB patients — 64,000, followed by China’s estimate of 59,000 and Russia’s 46,000.

The health ministry is urging private practitioners to pass on MDR-TB patients to the government. MDR-TB requires 18 to 24 months of treatment with drugs that are 100 times more expensive and more toxic than the first-line anti-TB drugs.

“The public sector is willing to support MDR-TB patients,” said Kuldeep Sachdeva, a senior health officer with the health ministry’s TB division.

“This is not a diktat — if we find that the MDR patients are in safe hands and can afford treatment, we’ll leave them there. But if doctors sense that their patients may not be able to adhere to the long treatment, they can approach the government to provide them care.”

While the government’s TB control programme offers the thrice-a-week regimen, most doctors in the private sector prescribe daily therapy. But health officials say the shift from intermittent to daily therapy advocated by the STCI does not undermine the success of intermittent therapy, which is sufficient for most patients when they are observed to be taking their pills.