Engaging the private sector to improve antimicrobial use in the community: experience from accredited drug dispensing outlets in Tanzania

OBJECTIVES: A public-private partnership in Tanzania launched the accredited drug dispensing outlet (ADDO) program to improve access to quality medicines and pharmaceutical services in rural areas. ADDO dispensers play a potentially important role in promoting the rational use of antimicrobials, which helps control antimicrobial resistance (AMR). The study objectives were to 1) improve dispensing practices of antimicrobials, 2) build ADDO dispensers’ awareness of the consequences of misusing antimicrobials, and 3) educate consumers on the correct use of antimicrobials through the use of printed materials and counseling. METHODS: Our intervention targeted ADDO dispensers and community members in Kilosa district. We promoted AMR awareness using posters hung in public places, health facilities, and ADDOs; sensitizing 84 health care providers on AMR issues; and providing training and on-site support for 124 ADDO dispensers to increase their AMR knowledge and dispensing skills. Baseline and endline assessments included direct observation of dispensers’ practices; interviews with ADDO dispensers (71 at baseline and 68 at endline) regarding dispensing experiences; 230 exit interviews with ADDO customers regarding use of antimicrobials during monitoring visits; and review of ADDO records. Indicators were based on product availability, dispensing practices, customers’ knowledge of how to take their medicines, and dispenser and public awareness of the AMR threat. RESULTS: Availability of tracer antimicrobials increased by 26% (p = 0.0088), and the proportion of ADDOs with unauthorized items decreased from 53% to 13% (p = 0.0001). The percentage of ADDO dispensers following good dispensing practices increased from an average of 67% in the first monitoring visit to an average of 91% during the last visit (p = 0.0001). After the intervention, more dispensers could name more factors contributing to AMR and negative consequences of inappropriate antimicrobial use, and over 95% of ADDO customers knew important information about the medicines they were dispensed. CONCLUSIONS: Providing educational materials and equipping ADDO dispensers with knowledge and tools helps significantly improve community medicine use and possibly reduces AMR. The number of community members who learned about AMR from ADDO dispensers indicates that they are an important source of information on medicine use

The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania.

The purpose of this study was to investigate the quality of a select group of medicines sold in accredited drug dispensing outlets (ADDOs) and pharmacies in different regions of Tanzania as part of an in-depth cross-sectional assessment of community access to medicines and community use of medicines.We collected 242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine from selected ADDOs and pharmacies in Mbeya, Morogoro, Singida, and Tanga regions. The analysis included physical examination and testing with validated analytical techniques. Assays for eight of nine products were conducted using high-performance thin-layer chromatography (HPTLC). For ALu tablets, we used a two-tiered approach, where tier 1 was a semi-quantitative Global Pharma Health Fund-Minilab® method and tier 2 was high-performance liquid chromatography (HPLC) as described in The International Pharmacopoeia's monograph for artemether-lumefantrine.The physical examination of samples revealed no defects in the solid and oral liquid dosage forms, but unusual discoloration in an injectable solution, ergometrine maleate. For ALu, the results showed that of 38 samples, 31 (81.6%) passed tier 1 testing and 7 (18.4%) gave inconclusive drug content results. The inconclusive ALu samples were submitted for tier 2 testing and all met the quality standards. The pass rate using the HPTLC and TLC/HPLC assays was 93.8%; the failures were the ergometrine maleate samples purchased from both ADDOs and pharmacies. The disintegration testing of the solid dosage forms was conducted in accordance with US Pharmacopeia monographs. Only two samples of paracetamol, 1.2% of the solid dosage forms, failed to comply to standards. The study revealed a high overall rate of 92.6% of samples that met the quality standards. Although the overall failure rate was 7.4%, it is important to note that this was largely limited to one product and likely due to poor distribution and storage rather than poor manufacturing practices.Over 90% of the medicines sold in ADDOs and pharmacies met quality standards. Policy makers need to reconsider ergometrine maleate's place on the list of medicines that ADDOs are allowed to dispense, by either substituting a more temperature-stable therapeutically equivalent product or requiring those sites to have refrigerators, which is not a feasible option for rural Tanzania

What motivates antibiotic dispensing in accredited drug dispensing outlets in Tanzania? A qualitative study

Background: Tanzania introduced the accredited drug dispensing outlet (ADDO) program more than a decade ago. Previous evaluations have generally shown that ADDOs meet defined standards of practice better than non-accredited outlets. However, ADDOs still face challenges with overuse of antibiotics for acute respiratory infections (ARI) and simple diarrhea, which contributes to the emergence of drug resistance. This study aimed to explore the attitudes of ADDO owners and dispensers toward antibiotic dispensing and to learn how accreditation has influenced their dispensing behavior. Methods: The study used a qualitative approach. We conducted in-depth interviews with ADDO owners and dispensers in Ruvuma and Tanga regions where the government implemented the ADDO program under centralized and decentralized approaches, respectively; a secondary aim was to compare differences between the two regions. Results: Findings indicate that the ADDO program has brought about positive changes in knowledge of dispensing practices. Respondents were able to correctly explain treatment guidelines for ARI and diarrhea. Almost all dispensers and owners indicated that unnecessary use of antibiotics contributed to antimicrobial resistance. Despite this knowledge, translating it to appropriate dispensing practice is still low. Dispensers’ behavior is driven by customer demand, habit (“mazoea”), following inappropriate health facility prescriptions, and the need to make a profit. Although the majority of dispensers reported that they had intervened in situations where customers asked for antibiotics unnecessarily, they tended to give in to clients’ requests. Small variations were noted between the two study regions; for example, some dispensers in Ruvuma reported sending clients with incorrect prescriptions back to the health facility, a practice that may reflect regional differences in ADDO implementation and in Integrated Management of Childhood Illness training. Dispensers in rural settings reported more challenges in managing ARI and diarrhea than their urban counterparts did. Conclusion: To reduce inappropriate antibiotic use, integrated interventions must include communities, health facilities, and ADDOs. Periodic refresher training with an emphasis on communication skills is crucial in helping dispensers deal with customers who demand antibiotics. Responsible authorities should ensure that ADDOs always have the necessary tools and resources available

Increasing Access to Subsidized Artemisinin-based Combination Therapy through Accredited Drug Dispensing Outlets in Tanzania

Abstract Background In Tanzania, many people seek malaria treatment from retail drug sellers. The National Malaria Control Program identified the accredited drug dispensing outlet (ADDO) program as a private sector mechanism to supplement the distribution of subsidized artemisinin-based combination therapies (ACTs) from public facilities and increase access to the first-line antimalarial in rural and underserved areas. The ADDO program strengthens private sector pharmaceutical services by improving regulatory and supervisory support, dispenser training, and record keeping practices. Methods The government's pilot program made subsidized ACTs available through ADDOs in 10 districts in the Morogoro and Ruvuma regions, covering about 2.9 million people. The program established a supply of subsidized ACTs, created a price system with a cost recovery plan, developed a plan to distribute the subsidized products to the ADDOs, trained dispensers, and strengthened the adverse drug reactions reporting system. As part of the evaluation, 448 ADDO dispensers brought their records to central locations for analysis, representing nearly 70% of ADDOs operating in the two regions. ADDO drug register data were available from July 2007-June 2008 for Morogoro and from July 2007-September 2008 for Ruvuma. This intervention was implemented from 2007-2008. Results During the pilot, over 300,000 people received treatment for malaria at the 448 ADDOs. The percentage of ADDOs that dispensed at least one course of ACT rose from 26.2% during July-September 2007 to 72.6% during April-June 2008. The number of malaria patients treated with ACTs gradually increased after the start of the pilot, while the use of non-ACT antimalarials declined; ACTs went from 3% of all antimalarials sold in July 2007 to 26% in June 2008. District-specific data showed substantial variation among the districts in ACT uptake through ADDOs, ranging from ACTs representing 10% of all antimalarial sales in Kilombero to 47% in Morogoro Rural. Conclusions The intervention increased access to affordable ACTs for underserved populations. Indications are that antimalarial monotherapies are being "crowded out" of the market. Importantly, the transition to ACTs has been accomplished in an environment where the safety and efficacy of the drugs and the quality of services are being monitored and regulated. This paper presents a description of the pilot program implementation, results of the program evaluation, and a discussion of the challenges and recommendations that will be used to guide rollout of subsidized ACT in ADDOs in the rest of Tanzania and possibly in other countries.</p

Understanding the Role of Accredited Drug Dispensing Outlets in Tanzania’s Health System

Introduction: People in many low-income countries access medicines from retail drug shops. In Tanzania, a public-private partnership launched in 2003 used an accreditation approach to improve access to quality medicines and pharmaceutical services in underserved areas. The government scaled up the accredited drug dispensing outlet (ADDO) program nationally, with over 9,000 shops now accredited. This study assessed the relationships between community members and their sources of health care and medicines, particularly antimicrobials, with a specific focus on the role ADDOs play in the health care system. Methods: Using mixed methods, we collected data in four regions. We surveyed 1,185 households and audited 96 ADDOs and 84 public/nongovernmental health facilities using a list of 17 tracer drugs. To determine practices in health facilities, we interviewed 1,365 exiting patients. To assess dispensing practices, mystery shoppers visited 306 ADDOs presenting one of three scenarios (102 each) about a child’s respiratory symptoms. Results and Discussion Of 614 household members with a recent acute illness, 73% sought outside care—30% at a public facility and 31% at an ADDO. However, people bought medicines more often at ADDOs no matter who recommended the treatment; of the 581 medicines that people had received, 49% came from an ADDO. Although health facilities and ADDOs had similar availability of antimicrobials, ADDOs had more pediatric formulations available (p<0.001). The common perception was that drugs from ADDOs are more expensive, but the difference in the median cost to treat pneumonia was relatively minimal (US$0.26 in a public facility and US$0.30 in an ADDO). Over 20% of households said they had someone with a chronic condition, with 93% taking medication, but ADDOs are allowed to sell very few chronic care-related medicines. ADDO dispensers are trained to refer complicated cases to a health facility, and notably, 99% of mystery shoppers presenting a pneumonia scenario received an antimicrobial (54%), a referral (90%), or both (45%), which are recommended practices for managing pediatric pneumonia. However, one-third of the dispensers needlessly sold antibiotics for cold symptoms, and 85% sold an antibiotic on request. In addition, the pneumonia scenario elicited more advice on handling the illness than the cold symptoms scenario (61% vs. 15%; p<0.0001), but overall, only 44% of the dispensers asked any of the shoppers about danger signs potentially associated with pneumonia in a child. Conclusion: ADDOs are the principal source of medicines in Tanzania and an important part of a multi-faceted health care system. Poor prescribing in health facilities, poor dispensing at ADDOs, and inappropriate patient demand continue to contribute to inappropriate medicines use. Therefore, while accreditation has attempted to address the quality of pharmaceutical services in private sector drug outlets, efforts to improve access to and use of medicines in Tanzania need to target ADDOs, public/nongovernmental health facilities, and the public to be effective

What roles do accredited drug dispensing outlets in Tanzania play in facilitating access to antimicrobials? Results of a multi-method analysis

Background: People in low-income countries purchase a high proportion of antimicrobials from retail drug shops, both with and without a prescription. Tanzania’s accredited drug dispensing outlet (ADDO) program includes dispenser training, enforcement of standards, and the legal right to sell selected antimicrobials. We assessed the role of ADDOs in facilitating access to antimicrobials. Methods: We purposively chose four regions, randomly selected three districts and five wards per district. Study methods included interviews at 1200 households regarding care-seeking for acute illness and knowledge about antimicrobials; mystery shoppers visiting 306 ADDOs posing as a caregiver of a child with 1) pneumonia, 2) mild acute respiratory infection (ARI), or 3) a runny nose and request for co-trimoxazole; and audits of antimicrobial availability and prices at 84 public health facilities (PHFs) and 96 ADDOs. Results: Four hundred sixty seven (76 %) members from 367 (77 %) households had recently sought care outside the home for acute illness; 128 had purchased antimicrobials, of which 61 % had been recommended by a doctor or nurse and 32 % by an ADDO dispenser. Only 29 % obtained the antimicrobial at a PHF, whereas, 48 % purchased them at an ADDO. Most thought that ADDOs are convenient place for care, usually have needed medicines, and have high quality services and products, contrasting with 66 % who reported dissatisfaction with PHF waiting times and 56 % with medicine availability. One-third (34 %) of mystery shoppers presenting the mild ARI scenario were inappropriately sold an antimicrobial and 85 % were sold one on request; encouragingly, 99 % presenting a case of pneumonia received either an antimicrobial, referral to a trained provider, or request to bring the child for examination. Overall, 63 and 60 % of the 15 tracer antimicrobials were in stock in ADDOs and PHFs, respectively; ADDOs had significantly more antimicrobial formulations for children available (83 vs. 51 %). Of 369 records of antimicrobial sales in 47 ADDOs, 63 % were dispensed on prescription. Conclusion: ADDOs have increased access to antimicrobials in Tanzania. Community members see them as integral to the health system. Antimicrobials are overused due to poor ADDO dispensing, poor PHF prescribing, and inappropriate public demand. Multi-pronged interventions are needed to address all determinants. Electronic supplementary material The online version of this article (doi:10.1186/s13756-015-0075-2) contains supplementary material, which is available to authorized users

A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania

<div><p>Introduction</p><p>In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic.</p><p>Methods</p><p>We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment tracking and community outreach systems on the rate of missed appointments and number of days covered by dispensed antiretroviral medications among women previously established on antiretroviral therapy. We used interrupted time series analysis to assess study outcomes. Clinic staff and patients in intervention clinics were aware of the intervention because of change in clinic procedures; data collectors knew the study group assignment.</p><p>Results</p><p>Three months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days.</p><p>Conclusion</p><p>Appointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions.</p><p>Trial registration</p><p>Registry for International Development Impact Evaluations ID-<a target="_blank">55310280d8757</a></p></div

Time series of monthly study outcomes in intervention and control clinics and their differences over time among established patients.

<p>The figures present the monthly values of the eight study outcomes from August 2014 until March 2016 averaged across all clinics in the intervention (solid lines) and control (long dashed lines) groups, as well as the monthly differences between these values (short dashed lines). The intervention began in July 2015 (represented by the solid vertical lines) and continued with monthly supervisory visits in the following four months.</p

Results of aggregate interrupted time series models predicting post-intervention changes in level and trend in the monthly differences between intervention (n = 1924)^& and control (n = 1226)^& groups, and estimated differences at six months post-intervention.

<p>Results of aggregate interrupted time series models predicting post-intervention changes in level and trend in the monthly differences between intervention (n = 1924)<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0184591#t002fn002" target="_blank">^&</a> and control (n = 1226)<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0184591#t002fn002" target="_blank">^&</a> groups, and estimated differences at six months post-intervention.</p

Participant selection and flow during the trial.

<p>The waterfall diagram presents sample sizes and exclusions in selecting clinics to participate in the study (top), and in selecting and following patients in intervention (left) and control (right) clinics following random assignment in relation to dates of assessments and the intervention (middle).</p