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Engaging community pharmacists in tuberculosis-directly observed treatment: a mixed-methods study

Published online by Cambridge University Press:  22 March 2023

Yen Jun Wong*
Affiliation:
School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Subang Jaya, Selangor, Malaysia
Chern Choong Thum
Affiliation:
Department of Psychiatry, Hospital Sultan Abdul Aziz Shah Universiti Putra Malaysia, Persiaran Mardi – UPM, 43400 Serdang, Selangor, Malaysia
Khuen Yen Ng
Affiliation:
School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Subang Jaya, Selangor, Malaysia
Shaun Wen Huey Lee
Affiliation:
School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Subang Jaya, Selangor, Malaysia School of Pharmacy, Taylor’s University Lakeside Campus, Jalan Taylors, 47500 Subang Jaya, Selangor, Malaysia Center of Global Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
*
Author for correspondence: Yen Jun Wong, School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Subang Jaya, Selangor, Malaysia. E-mail: [email protected]
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Abstract

Aim:

This study aimed to evaluate the feasibility of implementing community pharmacy-based tuberculosis-directly observed treatment (TB-DOT) in Malaysia.

Background:

Tuberculosis (TB) eradication is one of the top priorities in the public health agenda in Malaysia. While public-private mix (PPM) initiatives have been launched, community pharmacists remain undervalued assets in TB management.

Methods:

A two-phase mixed-methods study targeting community pharmacists was conducted in Malaysia between March and October 2021. The first phase was an online self-administered survey developed according to the Consolidated Framework for Implementation Research (CFIR). The second phase was a semi-structured interview to allow deeper understanding on the quantitative results. Quantitative data were analysed using descriptive analysis while qualitative data were analysed using thematic analysis with a semi-inductive approach. The data were triangulated to enhance comprehensiveness and credibility of the findings.

Findings:

The survey was completed by 388 community pharmacists, and 23 pharmacists participated in the interview. Most community pharmacists indicated their willingness to serve as TB-DOT supervisors (70.1%). Qualitative results supported the findings. Community pharmacy-based TB-DOT service was perceived as an avenue to improve TB management and outcomes and to enhance the professional role of pharmacists in TB service at primary care settings. This was also perceived as a feasible intervention with the potential to strengthen the National TB Control programme. This initiative needs be reinforced with adequate support from the public healthcare sector for a strong partnership in ensuring success.

Type
Research
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2023. Published by Cambridge University Press

Introduction

In the late 1800s, tuberculosis (TB) was one of the leading causes of mortality, accounting for one in every seven deaths in Europe and the United States (Centers for Disease Control and Prevention, 2016). With social and economic development alongside the discovery of effective drug treatment, the number of TB cases has declined significantly. While TB diagnosis and treatment had successfully prevented 66 million deaths in the last two decades, TB still affects 10.6 million people worldwide, resulting in 1.6 million deaths in 2021 (World Health Organization, 2022).

In addressing the global TB epidemic, the directly observed treatment-short course (DOTS) programme has been used as a TB control strategy (World Health Organization, 1999). The DOTS programme combines five components: government commitment, case detection by sputum smear microscopy, regular drug supply, a standardized recording and reporting system, and the TB-directly observed treatment (TB-DOT). TB-DOT is a process where TB patients consume their daily medications under the supervision of a qualified healthcare worker for the first two months of treatment (World Health Organization, 1999). While DOTS programme is a cost-effective approach to manage TB patients, treatment failure due to non-adherence is still an issue (Tola et al., Reference Tola, Tol, Shojaeizadeh and Garmaroudi2015). This can be attributed to socioeconomic and behavioural factors, including the lack of transportation, cost, social support, and poor communication between patients and health care workers (Tola et al., Reference Tola, Tol, Shojaeizadeh and Garmaroudi2015; Cai et al., Reference Cai, Wang, Ma, Wang, Han and Li2015). In response to these barriers, multi-sectorial partnerships for the Public-Private Mix (PPM)-DOTS have been suggested (Malmborg et al., Reference Malmborg, Mann and Squire2011; Uplekar, Reference Uplekar2003). The PPM-DOTS is also known as the ‘PPM for TB Care and Control’ (Malmborg et al., Reference Malmborg, Mann and Squire2011).

Studies have shown that TB management through PPM is a substantially accessible and supportive platform for patients to receive TB service especially in resource limited settings (Lei et al., Reference Lei, Liu, Escobar, Philogene, Zhu, Wang and Tang2015; Malmborg et al., Reference Malmborg, Mann and Squire2011). With improved patient accessibility, this led to increased case detection and better treatment outcomes. For example, the private practitioners in India, Indonesia, Bangladesh, and the Philippines had contributed to TB management in the primary care settings (Lei et al., Reference Lei, Liu, Escobar, Philogene, Zhu, Wang and Tang2015; Malmborg et al., Reference Malmborg, Mann and Squire2011). In addition, evidence has also shown the implementation of TB-PPM in several low-middle income countries (LMICs), namely Cambodia, Myanmar, and Vietnam had strengthened the collaboration between the public and private sectors in facilitating the referral, TB screening, and diagnosis (Bell et al., Reference Bell, Ilomaki, Pichenda, Duncan and Saini2015; Lonnroth et al., Reference Lonnroth, Karlsson, Lan, Buu and Dieu2003; Mihalea and Richardson, Reference Mihalea and Richardson2011; Thu, Reference Thu2015; Wong et al., Reference Wong, Ng and Lee2022; Zawahir et al., Reference Zawahir, Le, Nguyen, Beardsley, Duc, Bernays, Viney, Cao Hung, McKinn, Tran, Nguyen Tu, Velen, Luong Minh, Tran Thi Mai, Nguyen Viet, Nguyen Viet, Nguyen Thi Cam, Nguyen Trung, Jan, Marais, Negin, Marks and Fox2021). However, community pharmacists, as healthcare providers from the private sector, are underutilized in the delivery of TB service, in particular TB-DOT (Konduri et al., Reference Konduri, Delmotte and Rutta2017; Lei et al., Reference Lei, Liu, Escobar, Philogene, Zhu, Wang and Tang2015).

Malaysia currently has an estimated TB incidence rate of 92 per 100, 000 population, with around 80% of treatment success rate. The TB burden and treatment success rate had not improved over the past five years (World Health Organization, 2021). To meet the ambitious milestone of ending TB epidemics by 2035, imperative efforts are required to provide an equitable access of high-quality TB diagnosis, treatment, care, and prevention to all levels of communities (Stop TB Partnership, 2015; World Health Organization, 2015). The participation of community pharmacists in TB management could be an untapped opportunity for Malaysia.

Studies to date have reported that community pharmacists-led interventions have successfully improved treatment adherence and disease outcomes. Some of these services include the medication review (Al-babtain et al., Reference Al-babtain, Cheema and Hadi2022; Jokanovic et al., Reference Jokanovic, Tan, Sudhakaran, Kirkpatrick, Dooley, Ryan-Atwood and Bell2017) and smoking cessation services (Carson-Chahhoud et al., Reference Carson-Chahhoud, Livingstone-Banks, Sharrad, Kopsaftis, Brinn, To-A-Nan, Bond and Carson-Chahhoud2019). In these pharmaceutical care services, community pharmacists focus on person-centred care and patient engagement. This enables drug and ailment-related concerns, and patients’ unmet needs to be addressed promptly, leading to positive outcomes in their health management.

Incorporating community pharmacists in the PPM remains a novel concept in Malaysia. However, this could potentially be an avenue to enhance TB management and health outcomes of the TB-affected communities. Therefore, it is important that we explore the barriers and facilitators at the pre-implementation stage, in order to better facilitate the integration of TB-DOT service as part of community pharmacists’ professional practice. This study aimed at evaluating the feasibility of implementing TB-DOT service at community pharmacies in Malaysia.

Methods

Study design

This mixed-methods study was conducted online between March and October 2021. The survey was conducted from March to August 2021, while the semi-structured interviews took place from September 2021 to October 2021 after the survey period ended to gather additional insights based on the results from the survey. The study consisted of two phases: Phase 1 where participants answered an online self-administered questionnaire and Phase 2 which involved an online one-on-one semi-structured interview. The study was approved by the Monash Health Human Research Ethics Committee (Project ID: 27294).

Phase 1 self-administered survey

Questionnaire

A questionnaire was developed based on TB guidelines and published literature using the Consolidated Framework for Implementation Research (CFIR) (Supplementary material S1 and S2) (Damschroder et al., Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery2009; Ministry of Health Malaysia, 2012). This implementation science framework was selected as it could guide continuous evaluation of an evidence-based intervention including both the pre-implementation and post-implementation stages of a pharmaceutical service. It consists of a comprehensive listing of constructs that aims at identifying potential factors affecting the intervention. This allows researchers to improve constructs that affect the process of implementation.

Nine constructs from four CFIR domains were selected to evaluate the feasibility of implementing community pharmacy-based TB-DOT service in Malaysia. The definitions and reasons of selecting the CFIR domains and constructs are described in Table 1. The survey questions were then developed according to the selected constructs in English.

Table 1. The Consolidated Framework for Implementation Research (CFIR) domains and constructs selected in developing the study

CFIR = Consolidated Framework for Implementation Research; TB = tuberculosis.

Content validity of the questionnaire was evaluated by an expert panel comprising 12 international and local experts with more than 10 years of experience from community pharmacies, pharmacy research, and TB research. Following comments from the experts, amendments were made on the structures and flow of the questions. The questionnaire was then pilot-tested in 10 community pharmacists for face validity before the study recruitment. Five additional questions were posted at the end of the survey, to receive feedback from the participants on the suitability, appropriateness, relevance, clarity, and usefulness of the questionnaire. All agreed that the questionnaire fulfilled the abovementioned criteria without further comment.

The final questionnaire comprised 42 questions, including demographic information. The questions were a mixture of multiple-choice structures, with a binary response (‘Yes’, ‘No’), multiple-choice list, Likert-type scale, order ranking, checkboxes (where participants could select multiple answers from the available choices), and open-ended questions to collect the demographic data (Supplementary material S2). For questions with binary response and factual questions, responses of ‘Yes’ or correct answers were coded with 1, whereas ‘No’ or wrong answers were coded with 0. For questions with multiple-choice list, checkboxes, order ranking and Likert scale, each response option was pre-coded with a numerical value, for example ‘Extremely willing = 5; Very willing = 4; Moderately willing = 3; Slightly willing = 2; Not willing at all = 1’.

Data collection

In the year of 2021 when the study was conducted, there were approximately 6,000 pharmacists practising in the private sector for the entire country of Malaysia (Pharmacy Board Malaysia, 2022; Pharmacy Services Programme, 2022; Pharmacy Services Programme, 2021). Assuming a margin of error of 5%, confidence level of 95%, and 5% drop-out (Dong and Peng, Reference Dong and Peng2013; Schafer, Reference Schafer1999), a minimum sample size of 380 participants was required (Supplementary material S3). Participants were recruited through convenience sampling. Invitations were sent through emails, the Malaysian Pharmacists Society electronic newsletter, and social media (Facebook, Twitter, and LinkedIn). Fifteen fortnightly reminder emails and social media posts were sent out to increase the response rate. A total of 6330 study invitations, including reminders, were sent via emails. To ensure the sample could better represent the population of practising community pharmacists in Malaysia, 500 paper copies of the study invitation were also sent to community pharmacists from the states with higher TB incidence rates and rural areas.

Phase 2 semi-structured interview

The qualitative study was explanatory in nature and built upon the Phase 1 quantitative study. The semi-structured interview was conducted after the quantitative data collection. The topic guide was developed based on a priori on the CFIR domains and preliminary survey results that enabled the researchers to have a deeper understanding of the quantitative data during the interview (Supplementary material S4).

Convenience sampling was applied to recruit participants. The inclusion criteria for participant recruitment include practising community pharmacists in Malaysia who agreed to participate in the interview. Moreover, the interviewer should have no acquaintance with the interviewee. The interview invites and the link directing participants to a separate sheet of sign-up form were posted at the end of the online survey. Participants who signed-up were contacted by the researcher (Author 1) via email to schedule the interview. The interview was conducted by Author 1 and supervised by Author 4, through phone call or video call using Zoom. The interviews averaged 44 min (range: 26 to 63 min). All interview sessions were audio-recorded and transcribed verbatim. The recordings and transcripts were de-identified. Data collection and analysis were carried out concurrently. The first five interviews were used as the base case with two interview sessions for each subsequent run. Recruitment continued until data saturation where there was no new information emerged. Data saturation was achieved in the twenty-third interview with 23 participants in total.

Data analysis

Quantitative data were analysed using IBM SPSS Statistics version 28.0 (IBM Corporation, Armonk, NY, USA). Data were presented as mean with standard deviation (SD), median with interquartile range (IQR), or frequency with percentages (%). In the event of incomplete demographic data, these were excluded from the analysis.

Qualitative data were analysed using QSR Nvivo version 20.3 (QSR International Pty Ltd, Burlington, MA, USA). The data were analysed using thematic analysis with a hybrid approach of deductive and inductive methods (Fereday and Muir-Cochrane, Reference Fereday and Muir-Cochrane2006). This hybrid method was applied as the deductive approach allowed codes to be mapped into core themes derived from the CFIR domains. Where appropriate, the inductive approach could also allow the enrichment of findings if there were new themes and subthemes to be derived from the codes. The transcripts were coded after each interview. Each transcript was cross-checked and read repeatedly by the researchers (Author 1 and Author 2) to identify the code pattern. A coding framework was developed by Author 1 and then reviewed by Author 2 through pre-testing for validation. Subsequent coding process was conducted by Author 1 and guided by the coding framework developed. A total of 132 codes were generated from the transcripts. Both authors discussed on the codes generated, and 22 (16.7%) of the codes were re-coded or merged, resulting in 110 codes in total. The codes were then organized into themes aligned with a priori CFIR domains by Author 1 and cross-checked by the team members for consensus.

Information trustworthiness was established through methodological triangulation of both results from the quantitative survey which was validated in our semi-structured interview. Through this method, we could conduct a comparison of results between the quantitative and qualitative findings to enhance data credibility. Constant discussions among the team members also facilitated the process of refining the organization of the codes.

Results

Participants’ characteristics

A total of 624 participants responded to the survey, and 388 of them completed the survey. Among the incomplete survey, 111 had only responded to the electronic consent form, and the remaining 125 had fully or partially completed the demographic details, but they did not progress further to the next session of the questionnaire. The participants had a mean age of 31.2 ± 6.8 years old with 5.0 ± 6.2 years of working experience as a community pharmacist (Table 2). Another 23 participants completed the interview. The interviewees had a mean age of 29.9 ± 3.9 years old with 5.2 ± 4.1 years of experience practising as a community pharmacist.

Table 2. Demographics of participants

SD = standard deviation; IQR = interquartile range; * Respondents could have experience in more than one specialized pharmacy service; #Other specialized pharmacy services include retroviral disease management, lungs disease management, methadone replacement therapy, skin/wound care, pain management, warfarin adherence monitoring and management, compounding.

Phase 1 quantitative findings

The perceived facilitators and barriers in adopting community pharmacy-based TB-DOT service based on the CFIR domains and constructs were evaluated and described as follows (Table 3).

Table 3. Findings from the phase 1 survey

CFIR = Consolidated Framework for Implementation Research; TB = tuberculosis; DOTS = directly observed therapy-short course; TB-DOT = tuberculosis-directly observed treatment; vDOT: video directly observed treatment; * According to the Malaysian Clinical Practice Guidelines – Management of Tuberculosis, 3rd edition.

Inner setting

Most community pharmacies were often managed by one or two pharmacists (79.4%) and assisted by one to four staffs (55.7%) per shift. Approximately half of the community pharmacies also had a private consultation room (46.6%) which could be used for TB-DOT. Most participants believed that community pharmacists could contribute to TB referral (89.2%), TB education (87.1%), TB treatment side effect monitoring (78.4%), and TB medication counselling (75.3%). While only 54.4% of the participants believed community pharmacists could contribute as a TB-DOT supervisor, more than two-thirds of them were willing to introduce and provide TB-DOT to TB patients (70.1%). There was a mixed reaction on their willingness to provide TB-DOT through a drive-through service (54.1%) or via video DOT (vDOT, 49.0%). Only 28.6% of the participants were confident that their employers would be supportive of integrating DOTS as part of the community pharmacy-based pharmaceutical services.

Outer setting

Nearly one in three participants had encounters with customers who experienced TB symptoms requiring further referrals for TB screening over the past one year (30.9%). Since there was an absence of a systematic referral pathway in Malaysia, approximately 83.5% of the participants believed it is important to have an official and structured referral system to ensure all individuals with presumptive TB complete the medical screening for diagnosis.

While less than half of the participants had requests from customers for TB medications over the past one year (more than one request per month, 24.7%; rarely, 16.5%), almost three quarters believed there was a need to dispense TB medications at community pharmacies. Most participants also believed there was a need to provide TB-DOT at community pharmacies (73.5%) to address the challenges faced by TB patients during their treatment. The challenges include non-adherence to TB medications (40.0%), side effects resulting from TB medications (23.6%), and TB patients lacking awareness of the disease severity (22.6%).

Most participants believed pharmacists should receive reimbursement, remuneration, or incentives for providing DOTS at community pharmacies (91.2%). They also believed that audits would be moderately effective in monitoring the quality of TB service at the pharmacy (42.8%), and most were moderately willing to be audited for the monitoring and regulations in providing TB service (47.7%). They believed the scopes of infection control (91.2%), training of the staff on infection control (87.6%), and staff personal protective respiratory measures (80.2%) would most likely be audited.

Intervention characteristics

Participants agreed that community pharmacy-based TB-DOT would be beneficial to TB patients as it could provide better time flexibility (83.8%), better accessibility (80.4%) with lesser waiting time spent at the community pharmacies to receive TB-DOT compared to hospitals or clinics (78.6%).

Almost three quarters of them thought TB-DOT was difficult to implement (72.9%). The top three concerns were the regulation requirements (74.0%); workload of the pharmacists in delivering TB-DOT (55.9%); and stigma against TB patients which might affect pharmacy business (51.3%). Considering TB is an airborne infectious disease, there were also concerns that TB-DOT at community pharmacies that could put the health of people at the pharmacies at risk (78.9%). In view of the concerns, most participants believed the pharmacies require facility upgrade (70.4%), with private consultation room or counter shield to accommodate the delivery of TB-DOT. Approximately 59.8% of them were willing to invest in the personal protective equipment.

In evaluating the adaptability of this intervention, less than half of the participants reported having previous experience working in the Government healthcare facilities (41.5%) and were certified to provide specialized pharmacotherapy services (31.4%).

Characteristics of individuals

Most participants were aware of the National TB Control Programme (70.6%). Nevertheless, less than half of them were aware of all the symptoms (38.7%), all the approved regimens (18.0%), and side effects of TB medications (25.0%). Slightly more than half of them were confident to provide TB-DOT service (53.4%).

Phase 2 qualitative findings

Findings from the survey were further explored in the interview. Quotes from the interviews are tabulated in Table 4.

Table 4. Quotes from participants during the phase 2 semi-structured interviews

CFIR = Consolidated Framework for Implementation Research; TB = tuberculosis; TB-DOT = tuberculosis-directly observed therapy.

Inner setting

The participants were concerned about the availability of manpower to provide TB-DOT, especially during peak hours and shift handover. To address this, they suggested scheduling appointments with TB patients to ensure they receive adequate monitoring and support during TB-DOT (Statement 1). Moreover, they believed a safe space should be set up to administer TB-DOT. This could be a private consultation room or a designated entrance and exit for TB patients (Statement 2).

In circumstances where there were constraints on manpower or space to build a private consultation room, participants were more receptive to the idea of providing TB-DOT through the drive-through service compared to vDOT. They were concerned about patients’ commitment to participate in vDOT where some might not be tech-savvy while some might have issues with internet connectivity (Statement 3).

In addition to TB-DOT, the participants agreed community pharmacists could contribute significantly in health promotion on TB. They could collaborate with the public health sector for public health campaigns to enhance public awareness on TB (Statement 4).

Interestingly, the participants were confident their employers would be supportive of adopting DOTS to improve the health outcomes of TB patients. The participants and their employers believed community pharmacy-based TB interventions could enable them to expand their professional role in TB management. This allows them to focus on patient-centred care to support patients’ treatment in primary care settings.

The positive treatment outcomes resulted from good patient-provider engagement could then improve the reputation of the pharmacy, which would likely be able to contribute to customer loyalty (Statement 5).

Outer setting

In terms of TB treatment, participants who had experience interacting with TB patients reported numerous challenges that TB patients encountered during their treatment process. The most observed barrier was non-adherence to TB medications due to a lack of understanding on the duration of treatment, pill burden, treatment side effects, and logistic difficulties. They felt that close supervision by community pharmacists who are just a stone’s throw away from TB patients could help improve their treatment adherence and health outcome (Statement 6 and Statement 7).

In addition to regulations, guidelines, and audits, they also believed a policy is needed for them to establish a strong collaboration with doctors to facilitate the transition of care for TB patients (Statement 8). The participants also expected reimbursement, remuneration, or incentives from the Government for their professional service and to cover the costs for personal protective equipment while providing TB-DOT to TB patients (Statement 9).

Intervention characteristics

The participants agreed that community pharmacy-based TB-DOT provides better accessibility, time flexibility, and convenience to TB patients in fulfilling the daily TB-DOT requirements. Moreover, community pharmacists are approachable where patients can easily engage with them for additional medical advice. These could help to ensure treatment adherence among patients (Statement 10). However, the participants also shared their concerns on stigma for community pharmacy-based TB-DOT, especially in the early stages of implementation. This is because the public generally has a low awareness and negative perception on TB. As mentioned, infection control and public education are essential in the efforts to destigmatize TB (Statement 11 and Statement 12). Therefore, community pharmacy-based TB-DOT service would enable pharmacists to contribute to treatment adherence among TB patients, build rapport with patients for customer loyalty, and improve public’s awareness on TB (Statement 13 and Statement 14).

The participants felt that community pharmacists who had working experience in the Government healthcare facilities would be better equipped with the skills to provide TB-DOT service at primary care settings. This is because TB cases are mainly managed in the Government-funded hospitals and clinics where pharmacists would have had the exposure of serving TB patients (Statement 15).

Characteristics of individuals

As participants had limited exposure, experience, and confidence in managing TB cases, they welcomed trainings to enhance their knowledge on TB management. They also felt that accreditation was important to increase confidence among TB patients and the public towards pharmacists’ competence in implementing DOTS programme (Statement 16 and Statement 17).

Triangulation of data

Findings from the qualitative study were agreeable with the quantitative data where the participants acknowledged the benefits of community pharmacy-based TB-DOT. Several concerns were also raised with proposed suggestions to ensure the practicality of this intervention. The comparison of quantitative and qualitative data according to the CFIR domains was narrated as follows.

  • Inner setting: Factors such as the availability of manpower and designated areas for TB-DOT might be the limitations for some pharmacies. Delivery of TB-DOT using the drive-through service was a considerably acceptable alternative for the participants. Qualitative data showed more positive response on employers’ support to expand the role of community pharmacists in adopting TB service at their pharmacies.

  • Outer setting: Participants acknowledged the gaps in TB management, in particular non-adherence to TB treatment. Qualitative data indicated while community pharmacists have the potential to contribute to TB management, there is a need of policy and incentive schemes to strengthen the public-private partnerships.

  • Intervention characteristics: In addressing the common concern on stigma against TB, qualitative findings found that community pharmacy-based TB-DOT should be viewed as an opportunity to engage with TB patients and the public, where pharmacists could help clearing up the misconceptions towards TB in the community.

  • Characteristics of individuals: As participants lacked confidence and experience in managing TB, they believed trainings, accreditation, and support from the Government are essential prior to the implementation of TB service at community pharmacies.

Discussion

This study highlighted the potential of DOTS programme as a feasible TB intervention at community pharmacies in Malaysia. Community pharmacists are regarded as highly trustable healthcare professionals and are easily accessible to members of community. The scope of pharmacy practice continues to expand and incorporates various pharmaceutical services that focus on patient-centred care. Participants in this study believed that community pharmacy-based DOTS programme could further expand their professional role in primary care. For example, a recent review reported that community pharmacists have the potential to improve TB outcomes with their role in TB screening, referrals, and TB-DOT (Wong et al., Reference Wong, Ng and Lee2022).

While the Malaysia National TB Control Strategy Plan 2015 to 2022 indicated the importance of PPM in tackling TB, the role of community pharmacists was not explicitly outlined in the strategy plan (Ministry of Health Malaysia, 2016). In order to address the gaps in TB case detection and treatment outcomes, it is important to consider the incorporation of community pharmacists as an indispensable ally in the National TB Control programme. As suggested in the findings, community pharmacists established good rapport with their patients. This drove trust in patients and empowered them to work towards their health goals with the pharmacists to improve treatment outcomes. Indeed, studies that evaluated the impact of community pharmacist-led TB-DOT showed improvements in patients’ treatment completion (Antunes et al., Reference Antunes, Gomes, Belchior, Loureiro, Carvalho, Madeira and Duarte2012; Juan et al., Reference Juan, Lloret, Perez, Lopez, Navarro, Ramón, Cortijo and Morcillo2006). In addition, as pharmacists interact with TB patients daily for TB-DOT, this rapport could also contribute to customer loyalty which drives profit to the pharmacy. The study by Guhl and colleagues has shown that personal interaction was one of the most significant factors that contributed to perceived customer value and customer loyalty for community pharmacies (Guhl et al., Reference Guhl, Blankart and Stargardt2018).

Nevertheless, the concern on knowledge gap has been raised by the participants in this study. The lack of knowledge, experience, and confidence among community pharmacists coupled with public stigma against TB could be the challenge for community pharmacy-based DOTS programme. There is a need for training and education to ensure community pharmacists are equipped with adequate knowledge and experience prior to the implementation of pharmaceutical care services at community pharmacies (Loh et al., Reference Loh, Chua and Karuppannan2021). In addressing public stigma against TB, the study by Balogun and colleagues highlighted the impact of community health education on TB which had successfully improved public’s knowledge towards TB and reduced the stigma against TB (Balogun et al., Reference Balogun, Sekoni, Meloni, Odukoya, Onajole, Longe-Peters, Ogunsola and Kanki2015). As shown in the findings of this study, community pharmacists could expand their role in providing public education through campaigns in enhancing public awareness on TB.

To address issues on the limitations of space and manpower for TB-DOT at community pharmacies, the use of modified DOT, such as vDOT or drive-through service, received a mixed reaction. While several studies had found vDOT to improve treatment adherence among TB patients (Garfein et al., Reference Garfein, Liu, Cuevas-Mota, Collins, Muñoz, Catanzaro, Moser, Higashi, Al-Samarrai, Kriner, Vaishampayan, Cepeda, Bulterys, Martin, Rios and Raab2018; Sekandi et al., Reference Sekandi, Buregyeya, Zalwango, Dobbin, Atuyambe, Nakkonde, Turinawe, Tucker, Olowookere, Turyahabwe and Garfein2020; Story et al., Reference Story, Aldridge, Smith, Garber, Hall, Ferenando, Possas, Hemming, Wurie, Luchenski, Abubakar, McHugh, White, Watson, Lipman, Garfein and Hayward2019), the findings of this study showed that pharmacists had concern on patients’ commitment to attend vDOT. Therefore, in-depth counselling for TB patients and their caregivers must be conducted before their enrolment into vDOT, to ensure they strictly adhere to the vDOT appointment. As there was no study on TB-DOT through drive-through service that could be identified to date, research on this topic could be useful to evaluate its feasibility, practicality, and impact.

This study offers several strengths. This is the first study in Malaysia which introduced the concept of engaging community pharmacists in the DOTS programme. Moreover, a validated implementation science framework, the CFIR, was used to develop this study, which allows continuous guided evaluation of the intervention for improvement. However, this study needs to be interpreted considering the limitations. Since convenience sampling was used in this study, there was potential risk of sampling bias. While the minimum sample size for this study was achieved, it was noted that respondents were of younger age and most were serving at the urban areas. Therefore, the findings might not be generalizable to pharmacists who are more senior in age and those serving in suburban or rural areas. As details of the demographic and practice characteristics for community pharmacists in Malaysia were unavailable, the sample representativeness could not be compared. One of the demographic information on the states where the participants located was not collected from the participants. This was to avoid prejudice towards targeted states and locations in the country. Self-selection bias could also be resulted when pharmacists who had stronger interest in TB and pharmacy practice might have higher likelihood to respond and complete the survey and participate in the interview. While this was a self-reported study, there could be potential risk of desirability bias, where the respondents might answer the questions in a way which would be viewed more socially acceptable to others. Another limitation to note was the reliability test for the questionnaire was not performed. While this study aimed to understand the feasibility and practicality of the community pharmacy-based TB-DOT, a more pragmatic approach was taken with content and face validity assessments for the questionnaire before study recruitment. In the study recruitment, a total of 6330 study invitations, including reminders, were sent via emails. In addition, 500 paper copies of study invitations were sent by post. As the study invitations and reminders were also shared through electronic newsletters and social media platforms, the total number of questionnaires distributed could not be determined. Since this was the initial step to analyse the acceptability of community pharmacists towards community pharmacy-based TB intervention in Malaysia, detailed components such as costings and medication supplies were not discussed. These would be studied following the engagement sessions with the key stakeholders.

Conclusion

This study highlighted the potential for community pharmacy-based TB-DOT service to be implemented in Malaysia. Community pharmacists who participated in this study believed that TB intervention at community pharmacies could help to improve TB outcomes. While they showed readiness to engage in TB-DOT service, there were regulatory concerns. A strong partnership with continuous engagement between the pharmacists and the Government needs to be established to develop an effective implementation plan to facilitate the decentralization of TB-DOT service at community pharmacies. This is to ensure an accessible and quality TB care to be provided for all levels of communities in the primary care settings.

Supplementary material

To view supplementary material for this article, please visit https://doi.org/10.1017/S1463423623000105

Acknowledgements

Not applicable.

Authors’ contribution

YJW: conceptualization, methodology, data collection, formal analysis, data curation, and writing – original draft; CCT: data collection, formal analysis, data curation, and writing – original draft; KYN: formal analysis, data curation, writing – critical revision, and supervision; SWHL: methodology, data collection, formal analysis, data curation, writing – critical revision, and supervision. All authors have read and approved the final manuscript.

Funding

None.

Declaration of interest

The authors have no conflict of interest to declare.

Ethics approval

Ethics approval to conduct this study was obtained from the Monash Health Human Research Ethics Committee (Project ID: 27294).

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Table 1. The Consolidated Framework for Implementation Research (CFIR) domains and constructs selected in developing the study

Figure 1

Table 2. Demographics of participants

Figure 2

Table 3. Findings from the phase 1 survey

Figure 3

Table 4. Quotes from participants during the phase 2 semi-structured interviews

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