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 Table of Contents    
RESEARCH ARTICLE
Year : 2019  |  Volume : 51  |  Issue : 3  |  Page : 168-172
 

Partnership in tuberculosis control through involvement of pharmacists in Delhi: An exploratory operational research study


1 Department of Community Medicine, Maulana Azad Medical College, New Delhi, India
2 State TB Programme Officer, Chest Clinic (TB), Lok Nayak Hospital, New Delhi, India
3 Office of WHO Representative to India, New Delhi, India
4 Government of NCT Delhi, Delhi, India
5 New Delhi TB Centre, Delhi, India
6 Delhi State TB Programme, State TB Cell, Delhi, India

Date of Submission20-Jul-2018
Date of Acceptance27-Apr-2019
Date of Web Publication9-Jul-2019

Correspondence Address:
Dr. Saurav Basu
Department of Community Medicine, Maulana Azad Medical College, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijp.IJP_300_18

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 » Abstract 


BACKGROUND: There are over 12,000 chemists registered in the capital city, Delhi to support patient health needs. A study was conducted to improve the tuberculosis (TB) notification rates as conceptualized by the Revised National Tuberculosis Control Program (RNTCP). As part of the end TB mission, the feasibility of capturing data of TB patients coming to buy anti-TB drugs at the licensee level (chemists and drug shop owners) in Central Delhi area was assessed.
MATERIALS AND METHODS: The prospective study was conducted from July 2017 to March 2018. TB notification through a paper-based system and self-notification through online mode were the operational modality used for engagement with chemists. A team of paramedical workers was deployed for data collection from those pharmacists who chose to notify through the paper mode. Self-notification through online mode was through the RNTCP's NIKSHAY web-based reporting platform.
RESULTS: From the 330 chemists sensitized, 871 TB notifications were received during the study. Younger age groups comprised a majority of these cases with 198 (37.5%) from 21 to 30 years and 122 (23.1%) from 11 to 20 years. By the end of six visits, 28 (46%) of the 61 pharmacies that were eventually successfully sensitized had started returning the Folio cards with filled patient details. A total of 581 (66.6%) prescriptions received by the pharmacists were from government hospitals. The annual TB case notification in Central Delhi showed a significant increase from 271 TB patients/100,000 population to 871 TB patients/100,000 population during the study period when compared with expected trends in the past year (P < 0.05).
CONCLUSION: Self-notification of TB engenders successful TB notifications from chemists. This progenitor approach to TB notification in the capital emphasizes the need to categorize pharmacists as an independent private care provider for improving TB notification across high-burden settings.


Keywords: Chemists, India, operational research, pharmacists, tuberculosis


How to cite this article:
Sharma N, Khanna A, Chandra S, Mariam W, Basu S, Kumar P, Chopra KK, Babbar N. Partnership in tuberculosis control through involvement of pharmacists in Delhi: An exploratory operational research study. Indian J Pharmacol 2019;51:168-72

How to cite this URL:
Sharma N, Khanna A, Chandra S, Mariam W, Basu S, Kumar P, Chopra KK, Babbar N. Partnership in tuberculosis control through involvement of pharmacists in Delhi: An exploratory operational research study. Indian J Pharmacol [serial online] 2019 [cited 2019 Nov 13];51:168-72. Available from: http://www.ijp-online.com/text.asp?2019/51/3/168/262455





 » Introduction Top


Tuberculosis (TB) is a major health challenge in India having more than one-fifth of the global burden of disease.[1] Under the Revised National Tuberculosis Control Program (RNTCP), designated government health facilities provide the directly observed treatment short-course (DOTS) services free of cost. However, a large proportion of presumptive TB patients seek and initiate care from the private sector, more likely when living in underserved areas or being socioeconomically disadvantaged.[2],[3],[4] It is estimated from the drug sales data that anti-TB treatment in the private sector includes twice as many patients compared to the public sector.[5] Within the heterogeneous private health sector in India, private care providers and chemists often constitute the first point of contact.[6],[7]

The prevailing situation is unfavorable toward the achievement of end-TB targets due to the private sector's lack of quality control, and their treatment outcomes being less than adequate due to their frequent use of non-RNTCP approved therapy.[8],[9] Moreover, the patients who remain beyond the purview of RNTCP-DOTS suffer high out of pocket expenses which reduces medication adherence while the lack of close monitoring precipitates treatment interruption and default. Considering these impediments to TB control, the sale of anti-TB drugs without a prescription was prohibited (2013) and TB rendered a notifiable disease (2012) by the Union Health Ministry. A web-based portal, NIKSHAY was also developed for easy and efficient notification of TB cases by all stakeholders who detected or managed TB cases.[10],[11] The Drug Controller General of Delhi has made the notification of TB cases to the nearest DOTS center mandatory for all chemists and druggists in Delhi.[12] Nevertheless, these initiatives have not yielded adequate results which are suggested by the enormous number of patients being treated by the private sector who still go undetected.[5] The World Health Organization recommends establishing linkages with informal care providers like the pharmacists and chemists as an essential strategy for TB control.[13]

Engaging and sensitizing pharmacists and drug shop owners can thus act as a catalyst for disseminating useful information on TB promote rational dispensing of anti-TB drugs and efficient referral of TB cases. These linkages would help in bringing both TB suspects and private sector TB patients into the fold of RNTCP-DOTS, thereby enabling provision of timely and appropriate management without burdening the patient with out-of-pocket costs. This study was thereby conducted with the objective of assessing the feasibility of capturing data of TB suspects/patients who were coming to purchase anti-TB drugs at the licensee level (i.e., Pharmacist and drug shop owners). Furthermore, the present study also assessed the potential of bringing uncovered TB cases into the RNTCP-DOTS fold by developing a mechanism for effective recording and reporting of such cases.


 » Materials And Methods Top


The present exploratory prospective operational research study was conducted during July 2017–March 2018 in Delhi (National Capital Territory), the capital of India, which is spread across 1483 square kilometers with most of the population living in urban areas. The entire state is covered by the RNTCP since 2000. Based on feasibility, it was decided to include at least 300 retailers over 9 months (100 every 3 months) from the Central Delhi area.

A list of pharmacies was obtained from the website of the Drug Control Department (DCD), Delhi, India. This was as per the information provided by the office of DCD, Karkardooma, Delhi. This list had a total of five districts with a total of 642 pharmacies.[14] The chemist shops/pharmacies for inclusion in the study were selected from the Central Delhi area comprising Central Delhi district (Paharganj, Daryaganj, Karol Bagh, etc.) and adjoining New Delhi district (Connaught Place, etc.), and East Delhi district (Laxmi Nagar) areas. Finally, a total of 330 chemist shops, in which 108 from New Delhi area, 122 from Central Delhi area, and 100 from East Delhi area were enrolled to participate in this research study. The selection was based on probability proportional to size from the list of pharmacy/chemist shops.

The first step in the study was to develop a structured patient advisory card (folio) which was validated after several rounds of expert consultation. This card comprised two sections divided by a perforation which could be detached; the left folio consisted of patient details and a contact number which was retained by the pharmacist. The right folio was given to the: (i) TB suspects who came with prescription for anti-tubercular drugs and (ii) persons with presumptive TB symptoms. This was with the intention of persuading suspected TB cases to undergo sputum microscopy at a nearby RNTCP diagnostic center (designated microscopy center).

This portion of the card contained the following message in the local vernacular language “A cough for >2 weeks could be due to TB. It is very important to get tested for TB disease at an RNTCP Diagnostic Centre mentioned on this card. The sputum examination for the diagnosis will be done free of cost.” Once the TB suspect/patient arrived at the Diagnostic Center, the usual DOTS protocol would commence. The patients referred by the pharmacist reporting to the Designated Microscopy Centers were marked distinctly in the RNTCP TB Laboratory Register under the “Remarks” column.

The second step of the study involved the sensitization of the participating pharmacists and chemists in the study area who were trained to fill up the patient advisory card. The training was jointly conducted by State TB Cell Delhi with the International Union against TB and Lung Diseases and Department of Drug Control, Delhi Government. Role plays were actively used for the sensitization process.

Data collection was conducted during the final step of the study by two extensively trained field investigators who visited the selected retailers [Figure 1]. A total of 10 retailers/day were visited to ensure at least one weekly visit to every retailer. During each visit, information about the patients from the left folio of the patient advisory card was collated and shared with the senior treatment supervisor (STS), RNTCP at the TB unit of the subdistrict. The STS matched the details with the reporting patient's data from the TB Laboratory register. The nonreporting cases were tracked by house visits performed by the STS. The cases thus collected were notified through NIKSHAY by the DTO LN Hospital.
Figure 1: Timeline of the project

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Ethical waiver for the study was approved by the Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, New Delhi (F.1/IEC/MAMC/(54/03/2016/No/123).


 » Results Top


A total of 330 chemist shops of Central, New Delhi and East areas of Delhi were enrolled in the present study. Among these 330 chemist shops, 169 (51.2%) accepted the patient advisory card for filling patient details, whereas the remaining 161 (48.8%) did not accept the cards. The chemists attributed the following reasons for nonacceptance of the patient cards: the lack of medicines 54 (33.5%), too busy to respond 30 (18.1%), and closing or shifting of the shops from the area 14 (5.6%) while no response was given by 58 (36%) chemists.

A total of 871 TB patients were reported by the chemists, of which 486 (55.8%) were men and 385 (44.2%) were women. Younger age groups comprised a majority of these cases with 198 (37.5%) from 21 to 30 years and 122 (23.1%) from 11 to 20 years [Figure 2].
Figure 2: Distribution of tuberculosis patients by age

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Among the 169 chemist shops that had accepted the patient cards, 61 (36.1%) shops responded by returning the filled patient cards, whereas 108 (63.9%) shops did not return even a single patient card.

Compliance of the pharmacists and chemists improved on subsequent visits by the field investigators [Figure 3]. By the end of six visits, 28 (46%) of the 61 pharmacies that were eventually successfully sensitized had started returning the Folio cards with filled patient details.
Figure 3: Frequency of pharmacies successfully sensitized with increasing visits

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The present study found that 581 (66.6%) prescriptions received by the chemists were from government hospitals. However, there were no direct referrals to the DOTS center by the pharmacists in the cases where prescriptions were from the private sector. Nevertheless, 209 (24%) of the patients who visited informal or private facilities could be tracked and notified through the patient cards collected from the pharmacists.

The TB case notification in Central Delhi showed a significant increase from 271 TB patients/100,000 population to 871 TB patients/100,000 population for the study when compared with expected trends for the same period last year (P < 0.05).


 » Discussion Top


Both regulated and unregulated private-sector retail drug outlets, also known as pharmacies, chemists, or drug shops, are often the preferred first point of contact for common health ailments in the general population due to their ease of accessibility and lack of waiting time. The current operational research study was conducted to assess the feasibility of capturing data of TB suspects or patients coming to buy anti-TB drugs at private drug outlets, thereby enabling the potential of bringing uncovered TB cases into the DOTS fold. This progenitor approach to TB notification yielded an additional 871 TB cases during the 9 months of observation. The majority of the reported cases of TB were from the younger age groups and men were more affected than women which is consistent with the global and national trends.[1]

Our study also found two-thirds of the TB prescriptions were from government, mostly tertiary health facilities. This shows that a considerable proportion of patients purchased anti-tubercular medications from private chemist shops and did not opt for DOTS even when diagnosed and initiated on anti-tubercular treatment in government health-sector. This could be due to several reasons, including patient preference and perceived convenience, certain clinical departments prescribing non-DOTS regimens, and patients with social insurance having the facility for reimbursement of medicinal purchases.

Nearly four-fifths (80.4%) of the chemists enrolled in our study either refused to accept patient cards or failed to report any TB patients in the first visit. However, there was a subsequent improvement in reporting by the chemists observed by the field investigators suggestive of improved sensitization with time. Regardless, the response from the pharmacies which were located away from the tertiary care government health facilities was worse. This was possibly due to the perception of lack of oversight in the pharmacies that operated beyond the proximity of government health facilities and inadequate sensitization These results indicate that while there is scope for improvement of sensitization of chemists translating into a productive public–private partnership for improved reporting, nonadherence to the legal guidelines for universal reporting of TB cases is ubiquitous, especially in pharmacies which perceive lack of supervision and enforcement of such government directives.

Our study findings support previous evidence in support of partnerships with chemists for improving TB notification and early diagnosis and initiation of anti-tubercular therapy in presumptive TB patients. In a nationwide, public–private collaboration involving approximately 9% of the outlets (n = 75,000) in 12 selected districts across four states of India over a 4-year period around 10%–15% of suspected cases referred by 7000 pharmacists were found to be positive and placed on treatment.[15] A similar public–private partnership model to identify and refer TB suspects in Mumbai, India, involving training of pharmacists and distribution of health-information pamphlets to presumptive TB cases received promising results as some pharmacists became DOTS providers and themselves referred TB suspects to designated microscopy centers.[16] In some other developing countries in Asia such as Vietnam and Myanmar, the success rate of referrals from retail drug outlets ranged from 48% to 86%, respectively.[3] Nevertheless, our study did not detect pharmacists reporting presumptive TB cases to DOTS centers in spite of sensitization.


 » Conclusion Top


Linkages with pharmacists are an effective method of increasing notification of TB cases and thereby ensuring standardized treatment that promotes effective TB control. To achieve the end-TB targets, prioritizing and harnessing the power of private-sector retail drug outlets will be instrumental in accelerating the early detection and referral of the three million missing cases.[17] Our study observed that motivation and repeated sensitization for reporting TB cases to DOTS was effective in achieving TB notification from only a small proportion of the pharmacists or chemists. It was also seen that repeated visits achieved reporting of TB cases from more pharmacists/chemists, but the reasons for this apparent lack of public spiritedness need exploration through qualitative research which was beyond the scope of this study. However, the government notification mandating pharmacists to report all TB cases along with the provision of a NIKSHAY ID to them which corresponded with the last phase of our study increased the rate of TB notification manifold. This finding signifies that motivation and sensitization strategies need to be supported by appropriate legislation and strict implementation with scope for penal provisions and empowerment with NIKSHAY to realize the goals of pharmacist-driven TB case notification. Furthermore, our study provides valuable clues as to the characteristics of the patient population that prefer to obtain care from chemists. Targeted interventions for weaning this subset of TB cases from the private to the public sector need evaluation through future studies.

Financial support and sponsorship

This project was funded by the RNTCP, Government of NCT, Delhi.

Conflicts of interest

There are no conflicts of interest.



 
 » References Top

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World Health Organization. Global Tuberculosis Report 2017. World Health Organization; 2017. Available from: http://www.who.int/tb/publications/global_report/en/. [Last accessed on 2018 May 08].  Back to cited text no. 1
    
2.
Sreeramareddy CT, Qin ZZ, Satyanarayana S, Subbaraman R, Pai M. Delays in diagnosis and treatment of pulmonary tuberculosis in India: A systematic review. Int J Tuberc Lung Dis 2014;18:255-66.  Back to cited text no. 2
    
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Mistry N, Rangan S, Dholakia Y, Lobo E, Shah S, Patil A. Durations and delays in care seeking, diagnosis and treatment initiation in uncomplicated pulmonary tuberculosis patients in Mumbai, India. PLoS One 2016;11:e0152287.  Back to cited text no. 3
    
4.
Grover M, Bhagat N, Sharma N, Dhuria M. Treatment pathways of extrapulmonary patients diagnosed at a tertiary care hospital in Delhi, India. Lung India 2014;31:16-22.  Back to cited text no. 4
[PUBMED]  [Full text]  
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Arinaminpathy N, Batra D, Khaparde S, Vualnam T, Maheshwari N, Sharma L, et al. The number of privately treated tuberculosis cases in India: An estimation from drug sales data. Lancet Infect Dis 2016;16:1255-60.  Back to cited text no. 5
    
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Kashyap RS, Husain AA. Over-the-counter drug distribution and tuberculosis control in India. Lancet Infect Dis 2016;16:1208-9.  Back to cited text no. 6
    
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Kapoor SK, Raman AV, Sachdeva KS, Satyanarayana S. How did the TB patients reach DOTS services in Delhi? A study of patient treatment seeking behavior. PLoS One 2012;7:e42458.  Back to cited text no. 7
    
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Udwadia ZF, Pinto LM, Uplekar MW. Tuberculosis management by private practitioners in Mumbai, India: Has anything changed in two decades? PLoS One 2010;5:e12023.  Back to cited text no. 8
    
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Das J, Kwan A, Daniels B, Satyanarayana S, Subbaraman R, Bergkvist S, et al. Use of standardised patients to assess quality of tuberculosis care: A pilot, cross-sectional study. Lancet Infect Dis 2015;15:1305-13.  Back to cited text no. 9
    
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Central TB Division. TB India 2017. New Delhi: Revised National Tuberculosis Control Programme, Central TB Division; 2017.  Back to cited text no. 10
    
11.
NIKSHAY: Revised National Tuberculosis Control Programme. Revised National Tuberculosis Control Programme. Available from: http://nikshay.gov.in/User/Login.aspx. [Last accessed on 2018 May 08].  Back to cited text no. 11
    
12.
Gazette on Mandatory TB Notification; 10 May, 2018. Available from: https://tbcindia.gov.in/showfile.php?lid=3322. [Last accessed on 2018 May 31].  Back to cited text no. 12
    
13.
International Pharamceutical Federation. The Role of Pharmacists in Tuberculosis care and Control. International Pharamceutical Federation; 2011. Available from: [https://www.fip.org/files/fip/WHO/Signing%20ceremony_WHOFIPJointStatement.pdf. Last accessed on 2018 May 08].  Back to cited text no. 13
    
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XLN – Xtended Licensing, Laboratory & Legal Node. Available from: https://xlnindia.gov.in/frm_G_Cold_S_Query.aspx?ST=DL. [Last accessed on 2018 Nov 18].  Back to cited text no. 14
    
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Konduri N, Delmotte E, Rutta E. Engagement of the private pharmaceutical sector for TB control: Rhetoric or reality? J Pharm Policy Pract 2017;10:6.  Back to cited text no. 15
    
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Indian Pharamceutical Association. DOTS TB Pharmacist Project – Public-private Initiative in Mumbai. Indian Pharamceutical Association; 2010. Available from: http://www.ipapharma.org/news/IPA_DOTS_Project_News.pdf. [Last accessed on 2018 May 08].  Back to cited text no. 16
    
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Lilly MDR-TB Partnership. Creating Champions of Change. Enrolling Community Pharmacists in a National Tuberculosis Control Initiative. The Lilly MDR-TB Partnership; 2014. Available from: https://lillypad.lilly.com/WP/wp-content/uploads/Creating-Champions-of-Change.pdf. [Last accessed on 2018 May 08].  Back to cited text no. 17
    


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