pharmaceutical management

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system’s functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. 

Despite Uganda’s long-standing commitment to its medicines policy, the pharmaceutical supply chain has faced many well-documented constraints. In an effort to improve medicines management capacity at health facilities, Uganda developed and implemented a multi-pronged, evidence-based supervision, performance assessment, and recognition strategy (SPARS). We wanted to estimate the costs and cost effectiveness of SPARS implementation in public (government and private not-for-profit) health facilities in Uganda. This information is critical for further SPARS scale up in Uganda and for SPARS implementation in countries with similar contexts that want to consider rolling out SPARS as a national strategy. SPARS has been implemented by Uganda’s Ministry of Health since 2010 with support from the US Agency for International Development. SPARS is implemented by district-level health care staff who are trained as MMS to provide on-the-job supervision and training of health workers. Evidence shows that SPARS is an effective intervention to improve performance in key medicines management domains. Based on our estimates from this study, implementing and operating SPARS costs about US$370,000 annually for 1460 facilities, which would extrapolate to approximately US$760,000 for about 3000 government sector facilities or about 0.3% of the total government- and donor-funded EMHS budget.

Using antiretrovirals (ARVs) as tracer products, we identified the following key practices that may affect supply chain management at the facility level: order verification, actions taken when stock is received, changes in prescription and dispensing due to ARV stock-out, actions to ensure patient adherence, and communication with other affiliated facilities and higher-level supply chain management. We propose a set of indicators to measure these practices.

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. 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. 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.

The success of the Namibian government’s “treatment for all” approach to control and stop the country’s HIV epidemic is dependent on an uninterrupted supply of antiretrovirals (ARVs) for people living with HIV. The public health system in Namibia, however, was constrained by an inefficient paper-based pharmaceutical information system resulting in unreliable and inaccessible data, contributing to persistent stock-outs of ARVs and other essential pharmaceuticals. This article describes the incremental implementation of an integrated pharmaceutical management information system to provide timely and reliable commodity and patient data for decision making in Namibia’s national antiretroviral therapy (ART) program and the Ministry of Health and Social Services (MoHSS). Namibia’s pharmaceutical management information system demonstrates the feasibility and benefits of integrating related tools while maintaining their specialized functionality to address country-specific information and inventory management needs.

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). 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. 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.

We examined how different training modalities have been employed and adapted in 12 countries to meet country-specific needs by a global pharmaceutical systems strengthening program in collaboration with a country’s Ministry of Health and local stakeholders. Case-based learning, practice and feedback, and repetitive interventions such as post-training action plan, supportive supervision and mentoring approaches are effective, evidence-based training techniques. In Ethiopia and Bangladesh, over 94% of respondents indicated that they have improved or developed skills or competencies as a result of the program’s training activities. Supportive supervision structures and mentorship have been institutionalized with appropriate management structures. National authorities have been sensitized to secure funding from domestic resources or from Global Fund grants for post-training follow-up initiatives. The Pharmaceutical Leadership Development Program is an effective, case-based training modality that motivates staff to develop quality-improvement interventions and solve specific challenges. Peer-to-peer learning mechanisms rather than traditional didactic methods was a preferred intervention among high level government officials both within country and between countries.

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).

Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of 455 inspected public health facilities meet Good Pharmacy Practice (GPP) standards. Facilities using SPARS (the Supervision, Performance Assessment, and Recognition Strategy) tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. Non-compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular National Drug Authority inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.

The global demand for artemisinin-based combination therapy (ACT) has grown sharply since its recommendation by the World Health Organization in 2002. However, a combination of financing and programmatic uncertainties, limited suppliers of finished products, information opacity across the different tiers in the supply chain, and widespread fluctuations in raw material prices have together contributed to a market fraught with demand and supply uncertainties and price volatility. Various short-term solutions have been deployed to alleviate supply shortages caused by these challenges; however, new mechanisms are required to build resilience into the supply chain. This review concludes that a mix of strategies is required to stabilize the artemisinin and ACT market. First, better and more effective pooling of demand and supply risks and better contracting to allow risk sharing among the stakeholders are needed. Physical and financial buffer stocks will enable better matching of demand and supply in the short and medium term. Secondly, physical buffers will allow stable supplies when there are procurement and supply management challenges while financial buffer funds will address issues around funding disruptions. Finally, in the medium to long term, significant investments in country level system strengthening will be required to minimize national level demand uncertainties. In addition a voluntary standard for extractors to ensure appropriate purchasing and sales practices as well as minimum quality and ethical standards could help stabilize the artemisinin market in the long term.


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