Tag Archives | S Saleeb

Regulatory Systems Assessment Tool

As the availability of pharmaceutical products in low- and middle-income countries (LMICs) has improved in recent years, the need for functional national regulatory systems is becoming paramount in ensuring the safety, quality, and efficacy of those products. However, national regulatory authorities in LMICs struggle to fulfill their respective mandates to meet this increasing demand for their services in line with international standards. Outdated legal frameworks, inadequate staffing, inefficient processes, weak information systems, and insufficient financing are among the challenges they face. Increasingly, donors and development agencies are acknowledging the importance of regulatory systems strengthening and are looking for ways to work with national regulatory authorities to define and prioritize their system needs, identify feasible evidence-based and cost-effective system strengthening interventions, and support regulatory authorities to monitor progress toward their goals. RSAT examines the system components and regulatory functions of a national medicines regulatory system. It can be implemented by either National Medicines Regulatory Agency (NMRA) staff for the purpose of self-assessment and monitoring or independent assessors and technical assistance providers that provide support to NMRAs to pinpoint and prioritize the specific areas of the regulatory system that most need improvement to achieve greater efficiency and effectiveness. The tool is designed to populate a combination of quantitative and qualitative data from multiple pre-existing sources.

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Identifying Indicators for Tracking Pharmaceutical Expenditure in Low- and Middle-Income Countries

SIAPS endeavored to help low- and middle-income countries track Pharmaceutical expenditures (PE) systematically to inform decisions related to the mobilization and allocation of domestic resources and to formulate necessary pharmaceutical finance policies as a key strategy for achieving UHC. Working with its partner, Results for Development (R4D), in 2014, SIAPS reviewed existing approaches that track health and/or PEs. One of the key recommendations from that review was to explore the feasibility of adopting the System of Health Accounts (SHA) methodology to capture PEs. This paper presents the SHA/NHA methodology as a potential platform for capturing PEs and discusses some of the challenges encountered in collecting such expenditure data. It identifies key policy questions that underpin the need for LMICs to comprehensively monitor PEs and discusses a set of proposed indicators they would need to formulate and monitor effective financing policies, particularly toward achieving UHC. It also provides information that enables LMICs and their development partners to realize the challenges in applying the SHA methodology to PE tracking and/or to data collection so that they can take them into consideration during the next phase of piloting these indicators.

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“Continuing Pharmaceutical Education: Guide to Establishing Quality Assured and Accredited Programs”

“Continuing Pharmaceutical Education: Guide to Establishing Quality Assured and Accredited Programs” aims to establish and/or improve systems for the quality assurance and accreditation of continuing education/continuing professional development (CE/CPD) activities. The document outlines the rationale and framework for establishing CE/CPD programs, as well as the necessary elements for these programs to be effective, including: 1) The development of a quality-assured process; 2) Ensuring the quality of training activities; and 3) Establishing a CE/CPD accreditation body.
To assist in the practical application of these points, the guide provides criteria and standards for accreditation bodies, as well as checklists for assessing the quality of CE/CPD activities.
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Pharmaceutical System Strengthening Interventions to Improve Access to Antiretroviral Therapy

The world’s response to the AIDS pandemic of dramatically increased financial assistance to provide affordable medicines for HIV and AIDS did not automatically lead to access to antiretrovirals (ARVs). The effectiveness of these multimillion dollar initiatives was recognized to be limited by the capacity of the health care and pharmaceutical supply systems to deliver these lifesaving medicines. Constraints to improving access to ARVs included inadequate capacity in clinics and hospitals that provide antiretroviral therapy (ART); inadequate pharmaceutical planning and information systems; and an inefficient supply chain.

A holistic approach to access looks beyond product availability and price to include other essential components, such as the availability of quality pharmaceutical services and the ability of the patient to benefit from both products and services that support the safe, effective, and appropriate use of the medicines.

Countries have stepped up to meet this challenge. This paper illustrates pharmaceutical systems’ strengthening interventions and their impact on improving access to ARVs and related services as well as continuing challenges and some recommendations.

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Adoption of the Integrated Management Information System for Pharmaceuticals and Medical Supplies (SUGEMI) to Optimize ARV Supply in the Dominican Republic

Ghoneim R, Nfor E, Tukai M, Barillas E, Saleeb S, Valdez C (2014, November). Adoption of the integrated management information system for pharmaceuticals and medical supplies (SUGEMI) to optimize ARV supply in the Dominican Republic. Presentation at the 7th Global Health Supply Chain Summit. Copenhagen, Denmark.

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Use of a Supply Chain Management Portal to Ensure an Uninterrupted Supply of Contraceptives in Bangladesh

Kibria MG, Hussain Z, Peprah SA, Sameh S, Tukai M. (2013, November). Use of a supply chain management portal to ensure an uninterrupted supply of contraceptives in Bangladesh. Presentation at the Global Health Supply Chain Summit. Addis Ababa, Ethiopia.

View the presentation (under World Cafe 2)

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Haiti Pharmaceutical Sector Technical Assistance Priorities


Access to medicines remains a major issue for the Haitian population. National-level statistics show that less than half the population has acceptable access to medicines. In addition, for those who have access, there is no guarantee of the quality of medicines. As part of the strategy to reform the health system, the MSPP has decided to develop a new NMP. This policy is a commitment from the nation to provide quality pharmaceutical services to the Haitian population on the basis of equity and justice.

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