Not playing a role
The study shows that pharmacies are not playing any role in increasing TB resistance in the country,” says Dr. Srinath Satyanarayana, from McGill University, Montreal, Canada, who is the lead author of the paper that was published on August 26, 2016. “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 health system related factors (which has not created a system for all TB patients in [the] country to access quality assured diagnosis and treatment free of cost and seamlessly),” he says in an e-mail to The Hindu.
One reason why pharmacies did not dispense first-line, 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 retained for two years.
Quinolone abuse a concern
However, the good news ends here. The researchers found that that a vast majority of these pharmacies did dispense antibiotics to TB patients even when they did not have a prescription. This links to an earlier study which showed the tendency of private practitioners to liberally use antibiotics in treating TB, leading to a delay in diagnosis and treatment and an increase in the chances of TB spreading within a community.
In the Lancet study, healthy individuals were trained to pose as TB patients and interacted with pharmacists — to understand how the pharmacies in these cities treated patients presenting themselves with TB symptoms. The objective was to determine whether the pharmacies were contributing to the inappropriate use of antibiotics. One patient presented with 2-3 weeks of cough and fever, was directly seeking drugs from a pharmacy while a second patient was presented with one month of cough and microbiological confirmation of TB from a sputum test. In the case of the first patient, only 96 of 599 pharmacies (16 per cent) referred the patient 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 patients with symptoms.
“That nearly 37 per cent of the pharmacies are handing out antibiotics to persons presenting with TB symptoms is really worrisome,” says Dr. Satyanarayana. But more worrying is the dispensation of fluoroquinolones. “Fluoroquinolones are an essential part of the MDR-TB [multi-drug-resistant tuberculosis] treatment regimen and emerging regimens, so quinolone abuse is a concern.”
In stark contrast, in the case of the second patient, who had a microbiological confirmation, 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 the case of TB patients with microbiological confirmation of TB disease, antibiotics (without anti-TB properties) will be ineffective and unnecessary, 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 individual concerned. Steroids reduce body immunity, suppress symptoms temporarily and can worsen the TB disease,” he says.
Pharm.D @ SRIPMS-CBE-TN