India has a quarter of the world’s disease burden of tuberculosis. In 2014, the World Health Organisation estimated that there were 2.2 million cases of tuberculosis throughout the country. If that didn’t sound bad enough, a new statistical analysis suggests that there are 2.2 million tuberculosis patients seeking treatment at private healthcare facilities alone, in addition to the 1.6 million cases in government hospitals.

As an indicator of the number of cases of the disease, Nimalan Arinaminpathy, a researcher at the School of Public Health at Imperial College London, and his colleagues from various Indian institutions, analysed the sales of tuberculosis drugs in private healthcare facilities in 2014. They adjusted the data to account for possible over-prescription of drugs and other factors. What they found is that India is more likely to have had 3.8 million tuberculosis cases that year, an increase of a third from the WHO estimate.

“We've known for a while that it is critical to engage with the private sector, to control India's TB epidemic,” said Arinaminathy, the lead author of the paper that has been pubished in Lancet Infectious Diseases. “There are innovative new schemes being developed and piloted, such as efforts to engage with the private sector in Mumbai and Patna. However, our results show that the scale of the problem is even greater than has previously been recognised.”

Inadequate surveillance

Public health experts have repeatedly pointed out the gaps in reporting incidence of tuberculosis and possibility of underestimating the number of cases for the lack of a robust TB surveillance system. Previous estimates of tuberculosis cases in the private sector have relied on informed opinion, which is a reflection of the number of cases that fail to be reported to public health authorities.

In this study, Arinaminpathy and his team turned to data from the ground instead. Despite this, as Arinaminpathy cautions, the results serve to indicate that TB incidence is much higher than previously recognised but better surveillance will still be needed to pin down the true number.

"One of the things we have tried to do is try and divide them by state and we hope that will be a useful instrument for the government to target the states necessary for increase in notification," he added.

The huge gap in recording TB cases might also be due to the fact that many patients with TB symptoms do not approach doctors at the initial stages. “Patients from low-income communities especially, people from urban slums and rural areas, when they develop cough and its persistent, they seek advice from pharmacies,” said Srinath Satyanarayana, a PhD candidate at the McGill International TB Centre at Montreal.

Satyanarayana is the lead author of another study that shows how pharmacies in India contribute to delays in TB diagnosis.

Pharmacy first

Looking at previous analysis that showed that 25% of TB patients have their first contact with the healthcare system at pharmacies, Satyanarayana and his collaborators devised patient simulation study to check how the system works. They trained healthy people to enact symptoms of TB, visit the pharmacists and report the care received. A "simulated patient” would not carry a doctor’s prescription but simply would simply tell a pharmacists that he had a cough.

In some cases a pharmacist would ask about the duration of the cough and if there were other symptoms. The patient would then elaborate with symptoms typical of TB – a cough for more than two weeks, fever and weight loss.

“We found that in only about 13% of cases, [the pharmacist] asked them to go to healthcare providers without providing antibiotics and steroids,” said Satyanarayana. “The remaining 87% of the pharmacies gave them some medicine and in 40% of the cases these contained antibiotic.”

This practice of prescribing antibiotics not only delays a TB patients diagnosis and treatment, it also increases the chances of the disease spreading from the infected person. Secondly, the antibiotics given by the pharmacist will not help a person suffering from TB.

Moreover, unnecessary use of antibiotics only increases anti-microbial resistance, a immense and growing threat in India.

Plugging the gaps

The Revised National Tuberculosis Control Programme, the flagship programme in India for the control of the disease, and the Indian Pharmaceutical Association have out a policy document saying that pharmacists should be able to recognise people with TB symptoms and refer them to the nearest healthcare facility. But the new study shows that a very different reality on the ground.

The silver lining, however, is that in none of the cases did pharmacists give TB drugs without a prescription, a practice that would increase multi-drug resistance TB and make it more difficult to treat. Also, once simulated patients approached pharmacists with sputum tests that confirmed TB, the pharmacist immediately referred patients to hospitals without giving them antibiotics or steroids.

“What RNTCP should recognise is that pharmacies are an important source of healthcare for patients with TB,” said Satyanarayana. “Once they recognise that, they should have a formal mechanism in every district to identify all the pharmacies and inform them what their roles and responsibilities are, and how their practices can help TB control.”