Indian pharmacies incorrectly supply drugs to suspected TB patients

Indian pharmacies frequently dispense antibiotics, steroids and fluoroquinolones to urban patients with suspected pulmonary tuberculosis, as opposed to appropriately referring these patients to a health care provider for proper treatment, according to data recently published in the Lancet Infectious Diseases.

Incorrect case management also was somewhat prevalent among case patients with microbiologically confirmed TB, although no dispensed first-line anti-TB drugs were linked to suspected or confirmed cases, according to Srinath Satyanarayana MD, PhD candidate at McGill University, Montreal, and colleagues.

“Many TB patients … seek medical advice and drugs from pharmacies, driven by the ease of access and the possibility of avoiding consultation charges by doctors,” they wrote. “[Delhi, Mumbai and Patna] are experiencing rising rates of drug-resistant TB, especially in the city of Mumbai, and it is widely believed that pharmacists are a key component of the dispensing landscape and often a first contact for primary care.”

Concerns of susceptible and resistant TB are further complicated by the size of India’s unregulated private sector, which is estimated to treat twice as many cases the country’s public health program, according to an accompanying study.

Improper treatment compromises India’s TB efforts

Satyanarayana and colleagues trained participants to seek care at pharmacies in Delhi (n = 54), Mumbai (n = 308) and Patna (n = 260) with one of two standardized presentations: presumed TB with 2 to 3 weeks of cough and fever (Case 1) or 1 month of chronic cough and fever and a positive sputum smear report for TB (Case 2). Standardized patients in both groups did not have a prescription for antibiotics or steroids. The researchers calculated the frequency of proper case management, defined by guidelines from the Indian government and the Indian Pharmaceutical Association as counsel and referral to public health, and the incidence of inappropriate dispensing for each case group.

Standardized patients were also used in a 2015 study in India by Das and colleagues, revealing a low level of compliance by health care providers with established TB care guidelines.

In the present study, ideal case management at pharmacies occurred for 13% (95% CI, 11-16) of Case 1 interactions, the researchers wrote. Among these, 37% (95% CI, 33-41) received antibiotics, 8% (95% CI, 6-10) received steroids, and 10% (95% CI, 8-13) received fluoroquinolones. Case 2 participants more frequently received proper case management (62%; 95% CI, 58-66), with less frequent provision of antibiotics, steroids and fluoroquinolones. Those with confirmed TB more frequently received ideal case management even after adjustment, the researchers said. The most common classes of drugs dispensed at all three cities were analgesics, antibiotics, cough syrups and anti-allergy drugs.

No pharmacies in any city dispensed first-line anti–TB drugs, the researchers wrote, suggesting that the role of these treatments in the development of multidrug-resistant TB may be overestimated. However, the other incorrectly dispensed drugs could hamper a patient’s TB diagnoses and result in resistant strains of common respiratory or enteric pathogens.

“Our study adds to the growing evidence in India on antibiotic abuse, but also underscores that the use of antibiotics is mediated by drug category and the information that patients present,” Satyanarayana and colleagues wrote. “Furthermore, the use of all antibiotics decreased sharply when the patient’s diagnosis was revealed to the pharmacists. These findings can inform interventions to engage pharmacies in tuberculosis control and antimicrobial stewardship.”

With more than 2 million cases of TB occurring yearly, new data describing the impact of over-the-counter drug dispensing on Indian TB control is welcome, Rajpal S. Kashyap, PhD, and Aliabbas A. Husain, PhD, both of the Central India Institute of Medical Sciences, wrote in a related editorial. Regardless, further research is needed to understand distribution practices in rural settings and refine private pharmacies’ role in TB control efforts.

“Despite sustainable efforts, the link between the public sector and private pharmacies remains underdeveloped,” they wrote. “A legislative and educational strategy is required in underdeveloped regions to prevent the misuse of antibiotics and to reduce cases of drug resistance. In the near future, increased advocacy in nonreferring pharmacies is needed to boost the [directly observed, treatment-short course] program in India.”

Private sector’s role exceeds previous estimation

The need for evaluation in India’s private health care sector is echoed in another analysis by Nimalan Arinaminpathy, DPhil, senior lecturer in the department of infectious disease epidemiology at Imperial College London’s School of Public Health, and colleagues, which suggests that approximately two-thirds of the country’s TB care may be supplied by these largely unchecked providers.

“Although standardized tuberculosis treatment in India is delivered by the public sector through the Revised National TB Control Program (RNTCP), early diagnosis and treatment are hampered by the presence of a vast and unregulated private health care sector,” they wrote in Lancet Infectious Diseases. “Poor diagnostic practices in this sector prolong tuberculosis transmission by delaying diagnosis, whereas a general lack of counseling and support of treatment adherence hampers successful, relapse-free cure.”

Arinaminpathy and colleagues examined a large, nationally representative dataset to quantify sales of 189 anti-TB drugs through India’s private sector. Using these data, they calculated the volume of TB treatment distributed between 2013 and 2014 in patient-months, and amended estimates using previously conducted validation studies. The researchers also adjusted their calculation for overdiagnoses and treatment duration to determine the total number of TB cases and compared both final estimates to treatment volume data reported through the RNTCP.

India’s private sector supplied 18.118 million patient-months (95% CI, 16.993-19.717) and 17.793 million patient-months (95% CI, 16.709-19.841) of anti-TB treatment in 2013 and 2014, respectively, the researchers wrote. Given the 9.18 million patient-months of treatment reported in the public sector during 2013, and the 9.34 million patient-months reported in 2014, it would appear that the private sector is supplying approximately twice as much TB treatment as the public sector, they wrote. Extrapolating these data, Arinaminpathy and colleagues then estimated that 2.2 million genuine cases of TB were treated in India’s private sector in 2014 (95% CI, 1.19-5.34), more than twice the burden assumed previously.

While these findings offer a clearer view of India’s TB burden and the scope of its private sector, Arinaminpathy and colleagues also highlighted the need for more accurate case data.

“The approach described here cannot replace traditional approaches to surveillance, including routine notifications and periodic surveys,” the researchers wrote. “Nonetheless, the implications of this analysis could offer additional perspectives on such a vast and complex health care system as in India.”

Peter Byass, PhD, professor in the department of public health and clinical medicine at Umeå University, Sweden, elaborated on this point in an accompanying editorial. Although he said the findings from Arinaminpathy and colleagues will be useful when tackling the challenges of TB control in India, Byass argued that the “fairly brave assumptions” inherent to such an approach are no replacement for accurate disease surveillance.

“An increasing number of countries with high tuberculosis burdens are also encountering growth in their private health sectors,” Byass wrote. “Private sector involvement might not be a bad thing in itself, but mechanisms to extract reliable public health data from private health providers on tuberculosis and other diseases of public health concern are essential. Just as public health systems implicitly capture data as one of their intrinsic functions, public resources must be more effectively deployed for capturing and curating data of public interest from the private sector.” – by Dave Muoio

References:

Arinaminpathy N, et al. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)30259-6.

Byass P. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)30334-6.

Das J, et al. Lancet Infect Dis. 2015;doi:10.1016/S1473-3099(15)00077-8.

Kashyap RS, et al. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)30262-6.

Satyanarayana S, et al. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)30215-8.

Disclosures: Arinaminpathy, Byass, Husain, Kashyap and Satyanarayana report no relevant financial disclosures. Please see the full studies for a list of all other authors’ relevant financial disclosures.