An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information.

The use of rapid and inexpensive nonlaboratory-based screening tests for drug quality assessments is recommended as a component of a drug quality assurance program in poor resource settings. We have established routine Minilab test procedures to screen product quality and a proficiency testing program to determine the competency of the inspectors and reliability of results. Samples for the proficiency testing were prepared by pulverizing a standard reference tablet of the appropriate drug and making serial dilutions with starch to obtain concentrations of 0, 40, and 100%. The samples, which were labeled only with the drug name and an identifying letter, were given to inspectors for quality screening using Minilab procedures. In round 1 of the proficiency test, only 3 of 28 substandard samples were correctly identified. Round 2 of the proficiency test, which was administered after a performance qualification test for the analytical method, showed much improvement: 19 of 27 substandard drugs were correctly identified, while 5 out of 9 inspectors made the correct inference on the quality of 45 samples. However, in both rounds, 2 inspectors failed to identify substandard samples, indicating that their technical competencies need to be improved for the reliability of the results. Although the thin-layer chromatography screening methods provide a rapid means for drug quality assessment, they need to be put in the hands of competent users. The inclusion of a proficiency test in the screening program provides a measure of determining competency of the personnel and reliability of the results.

In recent years, new global initiatives responding to the AIDS crisis have dramatically affected—and often significantly improved—how developing countries procure, distribute, and manage pharmaceuticals. A number of developments related to treatment scale-up, initially focused on AIDS-related products, have created frameworks for widening access to medicines for other diseases that disproportionally impact countries with limited resources and for strengthening health systems overall. Examples of such systems strengthening have come in the areas of drug development and pricing; policy and regulation; pharmaceutical procurement, distribution, and use; and management systems, such as for health information and human resources. For example, a hospital in South Africa developed new tools to decentralize provision of antiretroviral therapy to local clinics—bringing treatment closer to patients and shifting responsibility from scarce pharmacists to lower level pharmacy staff. Successful, the system was expanded to patients with other chronic conditions, such as mental illness. Progress toward universal access to HIV prevention, treatment, care, and support will continue the push to strengthen pharmaceutical sectors that serve not only HIV-related needs but all health needs; health experts can likely take these achievements further to maximize their expansion into the wider health system.

The objective of this study was to assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance program. Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations). Based on results from the primary test methods, the first batch of product was <80% compliant, whereas subsequent batches reached >99% compliance. This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost effective than traditional pharmaceutical testing techniques.

Ensuring that medicines which achieve important health outcomes are available, accessible to all, used appropriately, and sustainably affordable is essential for realizing universal health coverage. Stakeholder cooperation and use of information and financing system levers provide opportunities to work toward this goal.

Problems with the quality of medicines abound in countries where regulatory and legal oversight are weak, where medicines are unaffordable to most, and where the official supply often fails to reach patients. Quality is important to ensure effective treatment, to maintain patient and health-care worker confidence in treatment, and to prevent the development of resistance. In 2001, the WHO established the Prequalification of Medicines Programme in response to the need to select good-quality medicines for UN procurement. Member States of the WHO had requested its assistance in assessing the quality of low-cost generic medicines that were becoming increasingly available especially in treatments for HIV/AIDS. From a public health perspective, WHO PQP’s greatest achievement is improved quality of life-saving medicines used today by millions of people in developing countries. Prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Yet despite its track record and recognized importance to health, funding for the programme remains uncertain.

Recent studies in Guyana and Suriname revealed diminished efficacy of artemisinin derivatives based on day-3 parasitaemia. Data on malaria medicine quality and pharmaceutical management, generated in the context of the Amazon Malaria Initiative, were reviewed and discussed. Numerous substandard artemisinin-containing malaria medicines were identified in both countries, particularly in Guyana. The quality of malaria medicines and the availability and use of non-recommended treatments could have played a role in the diminished efficacy of artemisinin derivatives described in Guyana and Suriname.

Abstract Objective To assess the sustainability, robustness and economic advantages of high-performance thin layer chromatography (HPTLC) for quality control of pharmaceutical products. Method We compared three laboratories where three lots of cotrimoxazole tablets were assessed using different techniques for quantifying the active ingredient.

In developing countries, particularly in Africa, the provision of health services leans heavily towards today’s epidemics, including HIV and AIDS, malaria, tuberculosis and other infectious diseases. This calls for different approaches to the implementation of interventions from a public health perspective.

This review article discusses the sustainability and robust advantages of planar chromatography that are critical to the successful performance of product quality assessments in resource limited areas including field applications.


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