Assessing the Change of Community Pharmacist’s Knowledge on Tuberculosis and Attitude to practice as a Tuberculosis DOTS provider after an Educational Intervention

Rajeswari Ramasamy*1, Guru Prasad Mohanta2, Shobha Rani R Hiremath3, Raman Dang4, Chandramouli R5, Manjiri S Gharat6 1Department of Pharmacy Practice, Krupanidhi College of Pharmacy, Carmelaram Post, Sarjapura Road, Bengaluru-560035, Karnataka, India 2Department of Pharmacy, Annamalai University, Annamalai Nagar, Chidambaram-608002, Tamil Nadu, India 3Department of Pharmacy Practice, Al-Ameen College of Pharmacy, Opp. Lalbagh Main Gate, Hosur Road, Bengaluru560027, Karnataka, India 4Department of Pharmacy, KLE College of Pharmacy, 2nd Block, Rajajinagar, Bengaluru560010, Karnataka, India 5Department of Quality Assurance, Krupanidhi College of Pharmacy, Bengaluru-560035, Karnataka, India 6Department of Pharmacy, Prin.K.M.Kundnani Pharmacy Polytechnic, Ulhasnagar, Mumbai-400005, Maharashtra, India


INTRODUCTION
World Health Organization (WHO) declared Tuberculosis (TB) as a global emergency in 1993; and devised Directly Observed Treatment-Short course (DOTS) strategy, to implement in all countries (TB Control in India , 2016;Jaggarajamma et al., 2007). Government of India of icially launched DOTS in 1997 under the Revised National Tuberculosis Control Program (RNTCP) strategy (Konduri et al., 2017). Three recently renamed as National Tuberculosis Elimination Program (NTEP) in January 2020 (Singhania, 2020). Under this strategy, DOTS providers need to observe and assist the tuberculosis patient in taking their TB medicine and document the same after each dosing (Choi et al., 2016).
In India, the outpatient care for any ailments is provided majorly by private healthcare sectors; it is approximately about 80%. It necessitates leveraging their capacity to involve them in TB care roles for better health coverage (Ruru et al., 2018). Public-Private Mix (PPM) partnership approaches being tried to engage private healthcare providers and community pharmacists to report individual TB cases and; also to extend TB care services to them in Partnership with the public health sector (Ruru et al., 2018). Retail pharmacy or community pharmacy outlets are generally the irst points of contact for any common illness including any respiratory ailments (Padmanabhan, 2016). Hence, Central TB division of India developed a module in 2003, to train the community pharmacists to become DOTS provider and TB suspect referral services (RNTCP, 2013). The expected TB care services from private medical sectors are notifying individual patients to District TB Of ice, referring TB suspects to RNTCP designated laboratory for early screening and for providing DOTS medicines to TB patients as per the advised treatment schedule of RNTCP medical of icers after necessary evaluations (Cohen, 1960) .
This training module was prepared in association with Indian Pharmaceutical Association (IPA)'s Community Pharmacy division. TB-DOTS pharmacist lead from IPA has taken the initiative in India, to bring the community pharmacists in TB care role in Mumbai between 2010-2012, with few pilot studies. It continues even now in some pockets, with an excellent tie-up between RNTCP and Chemist association (Krampe and Kuhnt, 2016). Later the pilot study was tried in Gujarat in 2013, and few other cities (Krampe and Kuhnt, 2016). However, the awareness and training of community pharmacists were not attempted at Karnataka region by IPA-CPD. The potential role of retail, medical stores in providing DOTS treatment for Tuberculosis under RNTCP program is still untapped. Basic Knowledge of Tuberculosis is essential for any DOTS providers, which contributes to the success of the RNTCP programme. Hence, to support the delivery of DOTS through community pharmacies and to meet the public health needs of the community, authors devised a liaison model (Ramasamy et al., 2020) and arranged an educational intervention programme as a pilot study for community pharmacists in Bangalore City.

Objectives
To assess the change of community pharmacist's basic knowledge on tuberculosis; and attitude to practice as tuberculosis DOTS provider after an educational intervention in Bangalore City, India.

MATERIALS AND METHODS
The study was conducted after getting requisite approvals from the Institutional Ethical Committee from a tertiary care teaching hospital. An educational intervention method was followed to assess the change in knowledge and attitude.
The plan for enrolling the trained pharmacist was discussed with to District Tuberculosis Of ice (DTO) and Drugs Control Board Drug Inspectors of the selected Jurisdiction for the proper coordination to create liaison (Ramasamy et al., 2020) between multiple stakeholders. An appeal from the Drug Control Department was circulated and was detailed to the community pharmacists by the investigator with the active support of the Drugs Control Department personnel.
A pre-test was administered to participants using a validated questionnaire to assess the baseline Knowledge on TB, and TB suspects referral programme, their attitude towards practising as DOTS provider for their neighbouring community. The training was given as per the RNTCP training module for Community Pharmacist, developed jointly by Indian Pharmaceutical Association (IPA) Community Pharmacy Division and Government of India, central TB division and in 2013 (RNTCP, 2013).
The Schematic low Diagram for the training program (model 1) is given in Figure 1. After the training programme, post-test was taken to analyze the change in Knowledge and Attitude of participants. The interested community pharmacy representatives were enrolled as a DOTS provider under publicprivate Partnership RNTCP programme. The difference in the knowledge on the basics of tuberculosis and their attitude to practice were analyzed using inferential statistical tests. These tests were done using JMP Pro (SAS Inc., USA) Version 13.2.
Researchers, who are interested in replicating the study in their Jurisdiction, must consider the participant's time concern and type of resource members. Hence authors have shared the model training plan in Table 1, which may give an idea on time considerations and preferred resource members.

Statistical Analysis
The data collected from the pre-test and post-test were posted as contingency tables, and the chisquares were computed to understand the changes in the proportions of choices the subjects made  (Cohen, 1960;Krampe and Kuhnt, 2016).
Cohen's kappa coef icient measures the inter-rater agreement for qualitative (categorical) items. It takes into account the possibility of the agreement occurring by chance, is a measure of interrater agreement. When the observed agreement exceeds chance agreement, kappa is positive, with its magnitude re lecting the strength of agreement. Bowker's test (symmetry of disagreement) computes the disagreement levels among the inter-rater agreement occurring in between the subjects by measuring the frequency of dissenting answers. The observed disagreement is inversely related to the lower values of the observed result.

RESULTS AND DISCUSSION
One forty-nine members from 125 community pharmacies participated in the TB -DOTS training programme. From the computed agreement statistic measures and in the light of education intervention given during the study, the signi icant changes in the Knowledge and Attitude for practising as DOTS pharmacist occurred for each question is mentioned in Table 2.
The change in the Level of basic TB knowledge for retail pharmacists after the educational intervention programme was highly signi icant. Still, the difference in the attitude towards the practice was not much signi icant. This question was directed to the CPs to assess their basic knowledge of the type of pathogen causing TB disease. The subjects were able to distinguish the different causative paradigms of infectious diseases, and they were able to consolidate their knowledge on the causation of TB.

Question 2: Knowledge | Presenting symptoms of TB (n=125)
The prominent presenting symptoms of TB are varied, and the CPs in the role of a counsellor for TB suspect referral for an early diagnostic procedure, needs to know about it. Hence this question with distracting choices was put forth to make sure the CPs are capable of this role. A signi icant difference was observed in the subjects between the pre and post-test conditions on the symptoms of TB.

Question 3: Knowledge| TB Transmission (n=125)
The transmission of TB from one person to other poses by air poses challenges for the family members who are in direct contact. Subjects demonstrated a signi icant difference in different forms of TB and their routes of transmission. One of the signi icant challenges of combating TB is the type of TB. The clinical presentations of TB vary with its type of TB. Hence this question was put forth. The most infectious form of TB, in terms of fast transmission, was correctly discerned by the subjects, and there was a signi icant difference between the pre and post-test knowledge as exhibited by the subjects.

Question 5: Knowledge| Counseling aspects (n=125)
This question tested how the TB cases are presented, and the subjects were able to correctly learn and counsel the needs to the patients cared for by the CPs.

Question 6: Knowledge | DOTs (n=125)
The abbreviations for the DOTS were presented to the subject with distracting choices, and they were not able to make a signi icant difference in the learn-ing pre and post-test. Given this sample size and sample homogeneity, it is of concern because the CPS were not able to demonstrate a considerable difference in their learning.

Question 7: Knowledge | DOTS Providers as per RNTCP (n=125)
This question constituted the crux of the study objective. The subjects were not able to make a statistically tenable difference pre and post-test. This is of concern since this question was aimed to test the DOTS provision choices. The outcome points to the evidence that CPs needs to be sensitized about their roles in DOTS provision.

Question 8: Knowledge | Responsibilities of CPs in DOTS provision (n=125)
This question, too, was aimed to test the roles of CPs in the current paradigm of TB prevention. The subjects were not able to make a difference pre and post-test and the multiple roles they can play in the TB prevention and mitigation, which needs to be communicated to them.

Question 9: General Attitude | Pharmacists as DOTS providers (n=125)
The CPs were divided on their opinion on what their roles as a DOTS provider would be. This evidence points to the fact that CPs needs to be sensitized. Given the dissenting options given by the subjects -points to the fact that the policy level changes in the ease of enrolling them to be DOTS providers and counsellors need to be revisited and rethought in its strategy.

Question 10: Practicing Attitude | willingness to be DOTS providers (n=125)
On asked on their willingness to be DOTS providers, the CPs gave an emphatic choice on their desire; however, the proportion of their change in the willingness was not statistically signi icant. This might be due to the sequence of questions, and to the inherent fact due to the conviction of CPs to becoming DOTS, providers have not changed to a negative attribute post-test. Many pharmacists raised the question on the bene it for the pharmacist to do this service for the neighbouring community.
The 'DOT' centre is a place where DOT is given, convenient to both patient and DOT provider. Retail pharmacists are the most accessible primary healthcare provider. Despite the inclusion of chemists in Public-Private Partnership programme under RNTCP in India, for being DOT provider, case inder, and counsellor in the training manual designed by central TB division, the awareness and training the pharmacist by primary TB centre is found inadequate in Karnataka due to lack of support from chemist association (Ramasamy et al., 2020).
Chemists were unaware of the government policy on TB-DOTS pharmacist in the study area. When investigator approached for the TB DOTS training awareness and enrollment, most of the pharmacists were not ready to join for the training programme as they had a concern about their losing the business hours.
Most of the chemists were enquiring, what will be their bene it if they attend the training programme.
This is the irst scienti ic study conducted in India, to understand the change in awareness level, Knowledge Attitude and practising interest of chemist in Bangalore as DOTS provider for TB patients in their neighbouring community. This study used dynamic method (Ramasamy et al., 2020) discussed in the research article from the same authors, to bring the chemists in a single platform. This has been the main challenge for TB centre, to enrol the pharma-cist under RNTCP programme.
Strategies for honorary remuneration for community pharmacist must be assured and publicized by the concerned department controlling PPM partnership. Many community pharmacist attended the programme were enquiring about their beneits in taking up this tedious documentary works and attending any regulatory concerns about storing Government supply medicines in their commercial premises. Assuring honorarium payment for the services, and making policy-level changes for getting NOC from drugs control department for PPM TB care role may encourage the community pharmacists to take part in DOTS provider and TB suspect referral role. Future research should be focusing on creating awareness in all the states and districts in India, to tap the potential of the community pharmacist in TB eradication should be taken up.
Participation of community pharmacist in TB suspects' referral role and DOTS provision will give special recognition for the pharmacist in society. Flexibility in regulations for making the DOTS medicines available in retail, medical stores, will improve the accessibility to the needy population. In turn, it may contribute to the reduction of non-adherence to TB medicines, and possibly may contribute to the decrease of TB burden in the society.

CONCLUSIONS
State Pharmacy Council and drugs control department in all states in India can come forward to create awareness amongst CPs on their DOTS provision role. This initiative will encourage the community pharmacists to take part in the DOTS treatment provision and TB suspect referral role, which can contribute to early diagnosis of TB and better treatment outcomes.
Future research should be focusing on creating awareness, inding the impact of pharmacist role in TB elimination should be taken up. The common factors affecting/inhibiting the community pharmacist for enrolling as TB-DOTS pharmacist has to be studied in detail for the better understanding of the practical dif iculties of chemists to deliver their role.

ACKNOWLEDGEMENT
Authors wish to thank Drugs Control Department, District Tuberculosis and State tuberculosis Of ice authorities, Bengaluru Jurisdiction, Karnataka. Dr Shalini Rajneesh, IAS, former Principal Secretary, Ministry of Health and Family Welfare, Government of Karnataka, for taking a personal interest to support the study and involve community pharmacists in DOTS provision and TB suspect referral programme.

Funding Support
This study was supported by Indian Pharmaceutical Association-Community Pharmacy Division (IPA-CPD) for the air travelling allowances of the resource member to the study location. The author (s) received no inancial support for any other activity other than self-air travel expenses of IPA-CPD resource member.

Con lict of Interest
The authors declare no con lict of interest for this study.