Trends in access to anti-malarial treatment in the formal private sector in Uganda: an assessment of availability and affordability of first-line anti-malarials and diagnostics between 2007 and 2018.

BACKGROUND: Malaria is the single largest cause of illness in Uganda. Since the year 2008, the Global Fund has rolled out several funding streams for malaria control in Uganda. Among these are mechanisms aimed at increasing the availability and affordability of artemisinin-based combination therapy (ACT). This paper examines the availability and affordability of first-line malaria treatment and diagnostics in the private sector, which is the preferred first point of contact for 61% of households in Uganda between 2007 and 2018. METHODS: Cross-sectional surveys were conducted between 2007 and 2018, based on a standardized World Health Organization/Health Action International (WHO/HAI) methodology adapted to assess availability, patient prices, and affordability of ACT medicines in private retail outlets. A minimum of 30 outlets were surveyed per year as prescribed by the standardized methodology co-developed by the WHO and Health Action International. Availability, patient prices, and affordability of malaria rapid diagnostic tests (RDTs) was also tracked from 2012 following the rollout of the test and treat policy in 2010. The median patient prices for the artemisinin-based combinations and RDTs was calculated in US dollars (USD). Affordability was assessed by computing the number of days' wages the lowest-paid government worker (LPGW) had to pay to purchase a treatment course for acute malaria. RESULTS: Availability of artemether/lumefantrine (A/L), the first-line ACT medicine, increased from 85 to100% in the private sector facilities during the study period. However, there was low availability of diagnostic tests in private sector facilities ranging between 13% (2012) and 37% (2018). There was a large reduction in patient prices for an adult treatment course of A/L from USD 8.8 in 2007 to USD 1.1 in 2018, while the price of diagnostics remained mostly stagnant at USD 0.5. The affordability of ACT medicines and RDTs was below one day's wages for LPGW. CONCLUSIONS: Availability of ACT medicines in the private sector medicines retail outlets increased to 100% while the availability of diagnostics remained low. Although malaria treatment was affordable, the price of diagnostics remained stagnant and increased the cumulative cost of malaria management. Malaria stakeholders should consolidate the gains made and consider the inclusion of diagnostic kits in the subsidy programme.

Article 4: Impact assessment of supervision performance assessment and recognition strategy (SPARS) to improve supply chain management in health facilities in Uganda: a national pre and post study.

BACKGROUND: To strengthen medicines management capacity, including supply chain management, at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged supervision, performance assessment, and recognition strategy (SPARS). The aim of this study was to assess the impact of SPARS on improving supply chain management. A series of four papers on SPARS described the SPARS concept, its impact on overall and domain practices and appropriate medicines use, and now in the fourth paper describing the effect on supply chain management. METHODS: District-based health workers trained as supervisors build facility-level capacity in medicines management using an indicator-based performance assessment followed by targeted supervisory visits. From 2010 to 2013, 1222 SPARS visits were implemented, and the SPARS performance indicator scores determined. This article assesses impact on 13 indicators in three of the five SPARS domains-stock management, storage management, and ordering and reporting quality-using a pre-post design. We also explored factors that may have influenced these outcomes. RESULTS: Between the first and last visit within one year of SPARS implementation, we found an average improvement of 16 percentage points (p < 0.001) in supply chain management measures across all levels of care. The improvement in scores for stock management, storage management, and ordering and reporting was 22 (ns), 16 (p < 0.001), and 11 (p = 0.032) percentage points, respectively. The study identified the key predictors of positive change as a low initial indicator score, frequent supervisory visits, and engagement of the district health officer. CONCLUSIONS: The multipronged SPARS approach was effective in building supply chain management capacity in lower-level health care facilities with statistically significant improvements in supply chain management overall and in almost all stock and storage- management and ordering and reporting measures after one year of implementation. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen supply chain management in low-income countries. TRIAL REGISTRATION: The study did not involve or use human participants or identifiable personal data, human tissue, or animals and thus did not require ethical approval or a waiver. It is a study implemented in collaboration with the Ministry of Health and does not require trial registration.

Article 3: 1-year impact of supervision, performance assessment, and recognition strategy (SPARS) on prescribing and dispensing quality in Ugandan health facilities.

BACKGROUND: To strengthen appropriate medicine use (AMU) including the prescribing and dispensing quality at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged approach known as the Supervision, Performance Assessment, and Recognition Strategy (SPARS). This paper assesses the impact of the first year of SPARS implementation on key AMU indicators. METHODS: District-based health workers trained as supervisors provide in-service training in medicines management complemented by indicator-based performance assessment and targeted supervision during each SPARS facility visit. From 2010 to 2013, health facilities that started the SPARS intervention were assessed during the first and last visit during a period of 12 months of implementing SPARS. This study examines 12 AMU indicators with 57 individual outcomes covering prescribing and dispensing quality. We also explored factors influencing 1-year improvement. RESULTS: We found an overall increase in AMU indicators of 17 percentage points (p < 0.000) between the first and last visit during a period of 12 months of supervisions, which was significant in all levels of health care facilities and in both government and private not-for-profit faith-based sectors. Appropriate dispensing (25 percentage points, p < 0.005) improved more than appropriate prescribing (12 percentage points, p = 0.13). Specific facilities that reached an average score of over 75% across all AMU measures within the first year of supervision improved from 3 to 41% from the first visit (baseline). The greatest overall impact on AMU occurred in lower-level facilities; the level of improvement varied widely across indicators, with the greatest improvements seen for the lowest baseline measures. Supervision frequency had a significant impact on level of improvement in the first year, and private not-for-profit faith-based health facilities had notably higher increases in several dispensing and prescribing indicator scores than public sector facilities. CONCLUSIONS: The multipronged SPARS approach was effective in building appropriate medicine use capacity, with statistically significant improvements in AMU overall and almost all prescribing and dispensing quality measures after 12 months of supervision. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen appropriate medicine use in low-income countries.

Inter-rater reliability and validity of good pharmacy practices measures in inspection of public sector health facility pharmacies in Uganda.

BACKGROUND: The National Drug Authority (NDA) inspects and certifies private and public sector pharmacies in Uganda using an indicator-based inspection tool that measures adherence to good pharmacy practices (GPP). 67 measures identify the situation in the domains of premises, dispensing quality, stores management, and operating requirements. Although the GPP measures are well-recognized and used internationally, little is known about their validity and reliability. The study aimed to assess validity, which measures agreement of GPP measures between a gold standard inspector and NDA inspector and inter-rater reliability (IRR), which measures agreement among NDA inspectors, of GPP measures. METHODS: We assessed validity and IRR by four teams of inspectors in eight government health facilities that represent three levels of care. Each team inspected two facilities, resulting in 24 total inspections. Each team comprised one central-level inspector, one district-level inspector, and one gold-standard inspector (i.e., a very experienced central-level inspector). We calculated median validity and IRR for each GPP measure, overall, indicator categorized as either critical, major, or minor, by domains, by the inspection decision (i.e., certified or not certified) and by adequatevalidity and IRR score (i.e., score ≥ 75%). RESULTS: The median validity for all GPP measures was 69%, with 29 (43%) measures having an adequate validity of ≥75%. The median IRR for all GPP measures was 71%, with 31 (46%) having an adequate IRR measure of ≥75%. Validity did not differ significantly by indicator category, domain or level of care. Adequate IRR and validity score (≥75%) was lowest for critical measures, which are key determinants of the certification decision, scoring 20 and 40% respectively. District inspectors had lower median validity for critical indicators and premises and higher validity for store management. Compared to central inspectors, the validity of district inspectors'certification decisions was lower; in the eight facilities, three district inspectors agreed with gold standard inspector vs. all eight central inspectors. CONCLUSIONS: Our findings question the validity and reliability of many GPP inspection measures, particularly critical measures that greatly impact certification decision. This study demonstrates the need for assessments of, and interventions to improve, validity and reproducibility of GPP measures and inspections.

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.

Evaluating inter-rater reliability of indicators to assess performance of medicines management in health facilities in Uganda.

BACKGROUND: To build capacity in medicines management, the Uganda Ministry of Health introduced a nationwide supervision, performance assessment and recognition strategy (SPARS) in 2012. Medicines management supervisors (MMS) assess performance using 25 indicators to identify problems, focus supervision, and monitor improvement in medicines stock and storage management, ordering and reporting, and prescribing and dispensing. Although the indicators are well-recognized and used internationally, little was known about the reliability of these indicators. An initial assessment of inter-rater reliability (IRR), which measures agreement among raters (i.e., MMS), showed poor IRR; subsequently, we implemented efforts to improve IRR. The aim of this study was to assess IRR for SPARS indicators at two subsequent time points to determine whether IRR increased following efforts to improve reproducibility. METHODS: IRR was assessed in 2011 and again after efforts to improve IRR in 2012 and 2013. Efforts included targeted training, providing detailed guidelines and job aids, and refining indicator definitions and response categories. In the assessments, teams of three MMS measured 24 SPARS indicators in 26 facilities. We calculated IRR as a team agreement score (i.e., percent of the MMS teams in which all three MMS had the same score). Two sample tests for proportions were used to compare IRR scores for each indicator, domain, and overall for the initial assessment and the following two assessments. We also compared the IRR scores for indicators classified as simple (binary) versus complex (multi-component). Logistic regression was used to identify supervisor group characteristics associated with domain-specific and overall IRR scores. RESULTS: Initially only five (21%) indicators had acceptable reproducibility, defined as an IRR score ≥ 75%. At the initial assessment, prescribing quality indicators had the lowest and stock management indicators had the highest IRR. By the third IRR assessment, 12 (50%) indicators had acceptable reproducibility, and the overall IRR score improved from 57% to 72%. The IRR of simple indicators was consistently higher than that of complex indicators in the three assessment periods. We found no correlation between IRR scores and MMS experience or professional background. CONCLUSIONS: Assessments of indicator reproducibility are needed to improve IRR. Using simple indicators is recommended.