Moving from assessments to implementation: promising practices for strengthening multisectoral antimicrobial resistance containment capacity.

BACKGROUND: Antimicrobial resistance (AMR) poses a global threat to human, animal, and environmental health. AMR is a technical area in the Global Health Security Agenda initiative which uses the Joint External Evaluation tool to evaluate national AMR containment capacity. This paper describes four promising practices for strengthening national antimicrobial resistance containment capacity based on the experiences of the US Agency for International Development's Medicines, Technologies, and Pharmaceutical Services Program work with 13 countries to implement their national action plans on AMR in the areas of multisectoral coordination, infection prevention and control, and antimicrobial stewardship. METHODS: We use the World Health Organization (WHO) Benchmarks on International Health Regulations Capacities (2019) to guide national, subnational, and facility actions that advance Joint External Evaluation capacity levels from 1 (no capacity) to 5 (sustainable capacity). Our technical approach is based on scoping visits, baseline Joint External Evaluation scores, benchmarks tool guidance, and country resources and priorities. RESULTS: We gleaned four promising practices to achieve AMR containment objectives: (1) implement appropriate actions using the WHO benchmarks tool, which prioritizes actions, making it easier for countries to incrementally increase their Joint External Evaluation capacity from level 1 to 5; (2) integrate AMR into national and global agendas. Ongoing agendas and programs at international, regional, and national levels provide opportunities to mainstream and interlink AMR containment efforts; (3) improve governance through multisectoral coordination on AMR. Strengthening multisectoral bodies' and their technical working groups' governance improved functioning, which led to better engagement with animal/agricultural sectors and a more coordinated COVID-19 pandemic response; and (4) mobilize and diversify funding for AMR containment. Long-term funding from diversified funding streams is vital for advancing and sustaining countries' Joint External Evaluation capacities. CONCLUSIONS: The Global Health Security Agenda work has provided practical support to countries to frame and conduct AMR containment actions in terms of pandemic preparedness and health security. The WHO benchmarks tool that Global Health Security Agenda uses serves as a standardized organizing framework to prioritize capacity-appropriate AMR containment actions and transfer skills to help operationalize national action plans on AMR.

National Health Insurance Fund's relationship to retail drug outlets: a Tanzania case study.

BACKGROUND: Achieving universal health coverage will require robust private sector engagement; however, as many low- and middle-income countries launch prepayment schemes to achieve universal health coverage, few are covering products from retail drug outlets (pharmacies and drug shops). This case study aims to characterize barriers and facilitators related to incorporating retail drug outlets into national prepayment schemes based on the experience of the Tanzanian National Health Insurance Fund's (NHIF) certification of pharmacies and accredited drug dispensing outlets. METHODS: We reviewed government documents and interviewed 26 key informants including retail outlet owners and dispensers and central and district government authorities representing eight districts overall. Topics included awareness of NHIF in the community, access to medicines, claims processing, reimbursement prices, and how the NHIF/retail outlet linkage could be improved. RESULTS: Important enablers for NHIF/retail outlet engagement include widespread awareness of NHIF in the community, NHIF's straightforward certification process, and their reimbursement speed. All of the retail respondents felt that NHIF helps their business and their clients to some degree. As for barriers, retailers thought that NHIF needed to provide more information to them and to its members, particularly regarding coverage changes. Some retailers and government officials thought that the product reimbursement prices were below market and not adjusted often enough, and pharmacy respondents were unhappy about claim rejections for what they felt were insignificant issues. All interviewees agreed that one of the biggest problems is poor prescribing practices in public health facilities. They reiterated that prescribers need more supervision to improve their practices, particularly to ensure adherence to standard treatment guidelines, which NHIF requires for approving a claim. In addition, if a prescription has any problem, including a wrong date or no signature, the client must return to the health facility to get it corrected or pay out-of-pocket, which is burdensome. CONCLUSIONS: Little published information is available on the relationship between health insurance plans and retail providers in low- and middle-income countries. This case study provides insights that countries can use when designing ways to include retail outlets in their health insurance schemes.

How to assure access of essential RMNCH medicines by looking at policy and systems factors: an analysis of countdown to 2015 countries.

BACKGROUND: In 2000, the Millennium Development Goals set targets for social achievements by 2015 including goals related to maternal and child health, with mixed success. Several initiatives supported these goals including assuring availability of appropriate medicines and commodities to meet health service targets. To reach the new Sustainable Development Goals by 2030, information is needed to address policy and systems factors to improve access to lifesaving commodities. METHODS: We compiled indicator data on 15 commodities related to reproductive, maternal, newborn, and child health (RMNCH) and analyzed them across 75 Countdown to 2015 countries from eight regions to identify problems with specific commodities and determinants of access. The determinants related to policy, regulatory environment, financing, pharmaceutical procurement and supply chain, and information systems. We mapped commodity information from four datasets from the World Health Organization and the United Nation's Commission on Life Saving Commodities creating a stoplight dashboard to illustrate countries' environment to assure access. We also developed a dashboard for policy and systems indicators for select countries. RESULTS: The commodities we identified as having the fewest barriers to access had been in use longer, including oral rehydration solution and oxytocin injection. Looking across the different systems and policy determinants of access, only Zimbabwe had all 15 commodities on both its essential medicines list and in its standard treatment guidelines, and only Cameroon and Zambia had at least one product registered for each commodity. Senegal alone procured all tracer commodities centrally in the previous year, and 70% of responding countries had costed plans for maternal, newborn, and child health. No country reported recent stock-outs of all the 15 commodities at the central level-countries always had some of the 15 commodities available; however, products with frequent stock-outs included misoprostol, calcium gluconate, penicillin injections, ceftriaxone, and amoxicillin dispersible tablets. CONCLUSIONS: This analysis highlights country deficiencies in policies and systems, such as incoherent policy guidelines, problems in product registration, lack of logistics data, and central-level stock-outs that may affect access to essential RMNCH commodities. To tackle these deficiencies, countries need to integrate commodity-related indicators into other health monitoring activities to improve service quality.

Pharmaceutical system strengthening in Uganda: implementing a holistic, evidence-informed, long-term strategy.

A strong pharmaceutical sector is a precondition for effective and efficient health care and financing systems, and thus for achieving the best possible health of a population. Supported by visionary, long-term donor funds, in conjunction with mutual trust, the USAID-funded Securing Ugandans Rights to Essential Medicines (SURE) and Uganda Health Supply Chain (UHSC) program engaged in a close, more than 10 year-long (in 2018) collaboration with the Ministry of Health of Uganda. Over time, the partnership implemented numerous multi-pronged comprehensive changes in the pharmaceutical sector and conducted research to document successes and failures. We describe the evolution and key characteristics of the SURE/UHSC interventions.

Article 2: Longitudinal study assessing the one-year effects of supervision performance assessment and recognition strategy (SPARS) to improve medicines management in Uganda health facilities.

BACKGROUND: In late 2010, Uganda introduced a supervision, performance assessment, and recognition strategy (SPARS) to improve staff capacity in medicines management in government and private not-for-profit health facilities. This paper assesses the impact of SPARS in health facilities during their first year of supervision. METHODS: SPARS uses health workers trained as Medicines Management Supervisors (MMS) to supervise health facilities and address issues identified through indicatorbased performance assessment in five domains: stock management, storage management, ordering and reporting, prescribing quality, and dispensing quality. We used routine data generated during SPARS visits to 1222 health facilities to evaluate performance changes during the first year of supervision as well as the time until achieving an adequate score in this period. We also explored variables related to facilities, MMS, and intensity of implementation as predictors of performance improvement and time until achieving an adequate score. RESULTS: Health facilities received an average of 3.4 MMS visits during the first year of supervision, with an average of 88 days between visits; each MMS implemented a median of 28 visits per year. Overall SPARS scores (maximum of 25) improved by 2.3 points (22.3%) per visit from a mean baseline score of 10.3. The adjusted improvement in overall SPARS score was significantly higher in primary health care facilities (2.36) versus higher-level health facilities and hospitals (2.15) (p = 0.001). The incremental improvement was highest at visit 2, with decreasing but continuing positive gains in subsequent visits. The adjusted mean incremental improvement per visit was highest in the prescribing quality domain, followed by dispensing quality, ordering and reporting, stock management, and storage management. Adjusted improvement in SPARS scores varied by region, year of implementation, and facility ownership. After one year of SPARS, 22% of facilities achieved an adequate score of 18.75 (75% of maximum score). CONCLUSIONS: SPARS was effective in building health facility capacity in medicines management, with a median overall improvement of almost 70% during the first year. The greatest improvements occurred in prescribing quality and at lower levels of care, although the highest level of performance was achieved in storage management. We recommend broad dissemination of the SPARS approach in all Ugandan health facilities as well as in other countries seeking a practical strategy to improve medicines management performance.

Multidisciplinary and multisectoral coalitions as catalysts for action against antimicrobial resistance: Implementation experiences at national and regional levels.

The multi-faceted complexities of antimicrobial resistance (AMR) require consistent action, a multidisciplinary approach, and long-term political commitment. Building coalitions can amplify stakeholder efforts to carry out effective AMR prevention and control strategies. We have developed and implemented an approach to help local stakeholders kick-start the coalition-building process. The five-step process is to (1) mobilise support, (2) understand the local situation, (3) develop an action plan, (4) implement the plan, and (5) monitor and evaluate. We first piloted the approach in Zambia in 2004, then used the lessons learned to expand it for use in Ethiopia and Namibia and to the regional level through the Ecumenical Pharmaceutical Network [EPN]. Call-to-action declarations and workshops helped promote a shared vision, resulting in the development of national AMR action plans, revision of university curricula to incorporate relevant topics, infection control activities, engagement with journalists from various mass media outlets, and strengthening of drug quality assurance systems. Our experience with the coalition-building approach in Ethiopia, Namibia, Zambia, and with the EPN shows that coalitions can form in a variety of ways with many different stakeholders, including government, academia, and faith-based organisations, to organise actions to preserve the effectiveness of existing antimicrobials and contain AMR.

Competency in supportive supervision: a study of public sector medicines management supervisors in Uganda.

BACKGROUND: Supportive supervision has been found to be more effective than corrective fault-oriented inspections. Uganda's Ministry of Health in 2012 implemented a comprehensive strategy (SPARS) to build medicines management capacity in public sector health facilities. The approach includes supportive supervision. This structured observational study assesses supportive supervision competency among medicines management supervisors (MMS). METHOD: The study used structured observations of two groups of five purposely selected MMS-one group supervising facilities with greater medicines management improvement during one year of SPARS and one group with less improvement, based on quantitative metrics. We observed and scored behaviors and skills of supervisors in 11 categories deemed critical for effective and supportive supervision. RESULTS: Supportive supervision was not evenly or adequately implemented, with the median supportive supervision competency score for all observed supervisors being 38%. Supervisors' main strengths were problem identification, data interpretation, education, and providing constructive feedback (45%-47%). Their weakest areas were assuring continuity and setting targets (17%), and most MMS were fair to strong in effective communication, use of tools, and problem solving. MMS of facilities with little improvement in medicines management over time were weak in setting targets and promoting participation. There was a 33 percentage point difference in the median supportive supervision competency scores between MMS of facilities with more versus less improvement (57%-24%) and a 77 percentage point difference in competency between the highest and lowest scoring MMS (77%-0%). We did not find a relationship between MMS experience (number of visits implemented) and their supportive supervision competency or facility improvement in medicines management. However, there is a likely relationship between supportive supervision competency and facility improvement. CONCLUSION: Competency of MMS in supportive supervision among the sampled MMS was generally weak, but with much individual variation. Our results suggest that MMS' supportive supervision competency is positively related to the SPARS effectiveness scores of the facilities they supervise. We recommend strategies to strengthen supportive supervision behaviors and skills.

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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: Registry for International Development Impact Evaluations ID-55310280d8757.

Can formalizing links among community health workers, accredited drug dispensing outlet dispensers, and health facility staff increase their collaboration to improve prompt access to maternal and child care? A qualitative study in Tanzania.

BACKGROUND: In Tanzania, progress toward achieving the 2015 Millennium Development Goals for maternal and newborn health was slow. An intervention brought together community health workers, health facility staff, and accredited drug dispensing outlet (ADDO) dispensers to improve maternal and newborn health through a mechanism of collaboration and referral. This study explored barriers, successes, and promising approaches to increasing timely access to care by linking the three levels of health care provision. METHODS: The study was conducted in the Kibaha district, where we applied qualitative approaches with in-depth interviews and focus group discussions. In-depth interview participants included retail drug shop dispensers (36), community health workers (45), and health facility staff members (15). We conducted one focus group discussion with district officials and four with mothers of newborns and children under 5 years old. RESULTS: Relationships among the three levels of care improved after the linkage intervention, especially for ADDO dispensers and health facility staff who previously had no formal communication pathway. The study participants perceptions of success included improved knowledge of case management and relationships among the three levels of care, more timely access to care, increased numbers of patients/customers, more meetings between community health workers and health facility staff, and a decrease in child and maternal mortality. Reported challenges included stock-outs of medicines at the health facility, participating ADDO dispensers who left to work in other regions, documentation of referrals, and lack of treatment available at health facilities on the weekend. The primary issue that threatens the sustainability of the intervention is that local council health management team members, who are responsible for facilitating the linkage, had not made any supervision visits and were therefore unaware of how the program was running. CONCLUSION: The study highlights the benefits of approaches that link different levels of care providers to improve access to maternal and child health care. To strengthen this collaboration further, health campaign platforms should include retail drug dispensers as a type of community health care provider. To increase linkage sustainability, the council health management team needs to develop feasible supervision plans.

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

INTRODUCTION: 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. METHODS: 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. RESULTS AND DISCUSSION: 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. CONCLUSIONS: 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.

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.

Household Knowledge of Antimicrobials and Antimicrobial Resistance in the Wake of an Accredited Drug Dispensing Outlet (ADDO) Program Rollout in Tanzania.

INTRODUCTION: Private sector drug shops are an important source of medicines in Tanzania. In 2003, the government introduced the accredited drug dispensing outlet (ADDO) program to improve access to good-quality medicines in rural and peri-urban areas that have frequent drug shortages in public health facilities and few or no registered pharmacies. However, increasing access may also contribute to antimicrobial resistance (AMR) due to the potential overuse and misuse of drugs. METHODS: We conducted a cross-sectional household survey in four regions in mainland Tanzaniato characterize consumer care-seeking habits and medicines use and to determine the extent to which members of the community are knowledgeable about antimicrobials and AMR. Within the regions, we applied a multistage cluster sampling design, cascading from districts, wards, and villages to households. Multivariate logistic analysis was done to determine variables influencing knowledge of antimicrobials and AMR, while controlling for confounding factors. Variables included age, occupation, level of education, membership in an insurance scheme, and wealth status. RESULTS AND DISCUSSION: We revealed that communities in four Tanzanian regions have low levels of knowledge of the concepts of antimicrobials and their use and AMR. Level of public understanding rose with wealth status and education. Only one-third of 1,200 respondents (33.6%) had ever heard of a medicine called an antimicrobial, and 5-15% could name at least one antimicrobial spontaneously. Some thought other medicines, such as paracetamol were antimicrobial (7.5%). People were equally likely to agree that pneumonia should be treated with an antimicrobial (21.4%) as well as common cold (28.4%). Understanding of AMR risks was better, particularly related to HIV and AIDS (32.2%) and malaria (38.6%)-most likely due to information campaigns focused on those two diseases. The level of knowledge decreased the further away respondents lived from an ADDO (p = 0.0001) and where ADDO density was lower (p = 0.001), which supports the use of ADDO dispensers as sources of community information and change agents for more appropriate medicine use. CONCLUSION: Lack of knowledge about antimicrobials and AMR in Tanzanian communities needs to be addressed through multi-pronged strategies that focus on prescribers and the public-especially those who are poorer and less educated.

Article 1: Supervision, Performance Assessment, and Recognition Strategy (SPARS) - a multipronged intervention strategy for strengthening medicines management in Uganda: method presentation and facility performance at baseline.

BACKGROUND: Uganda introduced a multipronged intervention, the supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public and not-for-profit health facilities. This paper, the first in a series, describes the SPARS intervention and reports on the MM situation in Uganda before SPARS (baseline). METHODS: To build MM capacity at health facilities, health workers were trained as MM supervisors to visit health facilities, assess MM performance, and use the findings to provide support and standardize MM practices. Performance is assessed based on 25 MM indicators covering five domains: dispensing quality (7 indicators), prescribing quality (5), stock management (4), storage management (5) and ordering and reporting (4). From the end of 2010 to 2013, MM supervisors assessed baseline MM performance of 1384 government (85 %) and private not-for-profit facilities at all levels of care in about half of Uganda's districts. RESULTS: The overall MM baseline median score was 10.3 out of a maximum of 25 with inter-quartile range (IQR) of 8.7-11.7. Facility domain scores (out of a maximum of 5) were as follows: storage management, median score of 2.9 (IQR 2.3-3.4); stock management 2.3 (IQR 2.0-2.8), ordering and reporting 2.2 (IQR 1.3-2.5), and dispensing quality 2.1 (IQR 1.7-2.7). Performance in prescribing quality was 0.9 (IQR 0.4-1.4). Significant regional differences were found: overall scores were highest in the Northern region (10.7; IQR 9.2-12.4) and lowest in the Eastern region (9.6; (IQR 7.8-11.2) (p < 0.001). Overall scores did not differ by facility ownership; however, government facilities scored lower in dispensing and storage and higher in ordering and reporting. Hospitals scored higher overall and in domains other than prescribing and stock management. Districts classified a priori as having high capacity for implementing SPARS had higher scores at baseline compared to lower-capacity districts. CONCLUSION: Assessing and building national capacity in MM is needed in both private not-for-profit and government facilities at all levels of care. The indicator-based, multipronged SPARS assessment has been described here, while the strategy's impact has yet to be documented.

Erratum to: Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study.

[This corrects the article DOI: 10.1186/s40545-015-0044-4.].

Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study.

INTRODUCTION: Retail drug sellers are a major source of health care and medicines in many countries. In Tanzania, drug shops are widely used, particularly in rural and underserved areas. Previously, the shops were allowed to sell only over-the-counter medicines, but sellers who were untrained and unqualified often illegally sold prescription drugs of questionable quality. CASE DESCRIPTION: In 2003, we worked with Tanzania's Ministry of Health and Social Welfare to develop a public-private partnership based on a holistic approach that builds the capacity of owners, dispensers, and institutions that regulate, own, or work in retail drug shops. For shop owners and dispensers, this was achieved by combining training, business incentives, supervision, and regulatory enforcement with efforts to increase client demand for and expectations of quality products and services. The accredited drug dispensing outlet (ADDO) program's goal is to improve access to affordable, quality medicines and pharmaceutical services in retail drug outlets in rural or peri-urban areas with few or no registered pharmacies. The case study characterizes how the ADDO program achieved that goal based on the World Health Organization's health system strengthening building blocks: 1) service delivery, 2) health workforce, 3) health information systems, 4) access to essential medicines, 5) financing, and 6) leadership and governance. DISCUSSION AND EVALUATION: The ADDO program has proven to be scalable, sustainable, and transferable: Tanzania has rolled out the program nationwide; the ADDO program has been institutionalized as part of the country's health system; shops are profitable and meeting consumer demands; and the ADDO model has been adapted and implemented in Uganda and Liberia. The critical element that was essential to the ADDO program's success is stakeholder engagement-the successful buy-in and sustained commitment came directly from the effort, time, and resources spent to fully connect with vital stakeholders at all levels. CONCLUSIONS: Beyond improving the quality of medicines and dispensing services, availability of essential medicines, and the regulatory system, the impact of a nationwide accredited drug seller approach on the pharmaceutical sector promises to provide a model framework for private-sector pharmaceutical delivery in the developing world that is sustainable without ongoing donor support.

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.

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.

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.

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

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.

Risk-based evaluation of Escherichia coli monitoring data from undisinfected drinking water.

Drinking water regulations in the United States and elsewhere are based on the occurrence of fecal indicator bacteria. Though not meeting all the criteria of an ideal indicator, nonpathogenic strains of Escherichia coli (E. coli) are used worldwide as an indicator of potential fecal contamination for drinking water and for distribution systems. This is, in part, because real illnesses are related to human pathogens, such as E. coli O157:H7, whose presence may be predicted better by E. coli than by total coliform bacteria. Our objective was to estimate the number of E. coli O157:H7 illnesses attributable to drinking water exposures in the United States and the feasible relationships between positive occurrences of the indicator bacteria E. coli and E. coli O157:H7 in drinking water. Results of the modeling indicate that in undisinfected drinking water systems, the ratio of bacterial indicator E. coli positives to E. coli O157:H7 organisms is estimated to be between 6:1 and 90:1 with few model parameters accounting for the vast majority of the uncertainty. These results provide context for considering the potential public health implications of a positive E. coli result from routine monitoring of undisinfected drinking water.