Pharmacies in India may not be causing TB drug-resistance

Pharmacy - Photo R. Prasad

Thirty-seven per cent of 622 pharmacies in Mumbai, Delhi and Patna handed out antibiotics to TB ‘patients’ with symptoms. – Photo: R. Prasad

If an earlier study revealed the tendency of private practitioners to liberally use antibiotics to treat tuberculosis leading to a delay in TB diagnosis and treatment and increase the chances of TB spreading within a community, pharmacies in Delhi, Mumbai and Patna are no better. A study published on August 25, 2016 in the journal The Lancet found that a majority of 622 pharmacies in the three cities dispensed antibiotics to TB patients even when they did not carry a prescription.

According to government guidelines, “pharmacies are required to counsel patients with TB, identify and refer persons with tuberculosis symptoms to the nearest public health facilities for testing” and dispense TB drugs. Much like the private practitioners, pharmacies tend to be the first point of contact for primary care in India.

Srinath Satyanarayana, the first author of the paper from McGill University, Montreal, Canada used standardised TB patients — healthy individuals trained to pose as TB patients and interact with pharmacists — to understand how pharmacies in the three cities treated patients presenting with TB symptoms or microbiological confirmation of pulmonary TB. The other main objective was to determine whether the pharmacies were contributing to the inappropriate use of antibiotics.

The standardised patient 1 presented with 2-3 weeks of cough and fever and was directly seeking drugs from a pharmacy. The standardised patient 2 presented with one month of cough and microbiological confirmation of TB from a sputum test.

Only 13 per cent of simulated patients with TB symptoms and 62 per cent of patients with microbiological confirmation were correctly managed.As expected, liberal dispensation of antibiotics was seen in the case of standardised patient 1. Only 96 of 599 pharmacies (16 per cent) refereed such patients to health-care providers. But ideal case management was in only 13 per cent of the cases as a few pharmacies handed out antibiotics to the patients even while referring them to a physician. Antibiotics (37 per cent), steroids (8 per cent) and fluoroquinolones (10 per cent) were given to standardised patients with symptoms.

“That nearly 37 per cent of the pharmacies are handing our antibiotic to persons presenting with TB symptoms is really worrisome,” says Dr. Satyanarayana in an email to me. But more worrying is the dispensation of fluoroquinolones. “Fluoroquinolones are an essential part of MDR-TB treatment regimen and emerging regimens, so quinolone abuse is a concern,” they write.

In stark contrast, in the case of standardised patient 2 who had a microbiological confirmation of TB disease 67 per cent (401 of 601) of pharmacies referred the patient to a health-care provider.  Like in the earlier case, ideal case management was seen in only 62 per cent as the standardised patient did receive antibiotics (16 per cent) or steroids (3 per cent) even while being referred to a health-care provider.

“In case of TB patients with microbiological confirmation of TB disease, antibiotics (without anti-TB properties) will be ineffective and un-necessary, and can delay the initiation of proper therapy for patients. These patients will continue to spread the disease in the community and TB disease will continue to progress in the concerned individual. Steroids reduce body immunity, suppress symptoms temporarily and can worsen the TB disease,” Dr. Satyanarayana says.

Silver lining

The only silver lining is that none of the pharmacies in all the three cities handed out first-line anti-TB drugs to these “patients.” So pharmacies are unlikely sources of irrational drug use that contributes to multidrug-resistant tuberculosis. “Also, pharmacies are not trying out high end antibiotics such as fluoroquinolones when they realise that the patient has some underlying illness such as TB,” he says.

“TB Drug resistance occurs primarily due to incorrect regimens, intake of drugs irregularly or intake of drugs for very short duration of time. From our study, it appears that pharmacies are not playing a role in deciding the anti-TB regimens and are also not dispensing anti-TB drugs over-the-counter, at least in the three cities that we studied. So the drug resistance in India could be due to either patient related factors or provider related factors or due to health system related factors (which has not created a system for all TB patients in country to access quality assured diagnosis and treatment free of cost and seamlessly),” Dr. Satyanarayana says.

One reason why pharmacies did not dispense anti-TB drugs could be because they belong to a more stringent Schedule H1 category of drugs where details of the prescription and name of the doctors and patients have to be documented and the registry has to be retained for two years.

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