Monitoring the quality of medicines plays a crucial role in an integrated medicines quality assurance system. In a publicly available medicines quality database (MQDB), the U.S. Pharmacopeial Convention (USP) reports results of data collected from medicines quality monitoring (MQM) activities spanning the period of 2003–2013 in 17 countries of Africa, Asia, and South America. The MQDB contains information on 15,063 samples collected and tested using Minilab® screening methods and/or pharmacopeial methods. Approximately 71% of the samples reported came from Asia, 23% from Africa, and 6% from South America. The samples collected and tested include mainly antibiotic, antimalarial, and antituberculosis medicines. A total of 848 samples, representing 5.6% of total samples, failed the quality test. The failure proportion per region was 11.5%, 10.4%, and 2.9% for South America, Africa, and Asia, respectively. Eighty-one counterfeit medicines were reported, 86.4% of which were found in Asia and 13.6% in Africa. Additional analysis of the data shows the distribution of poor-quality medicines per region and by therapeutic indication as well as possible trends of counterfeit medicines.

BackgroundThe spread of substandard and falsified (SF) medical products constitutes a growing global public health concern. Some countries use portable, handheld screening technologies (STs) in the field to accelerate detection of SF medicines and reduce the number of medicine samples that undergo costly and time-consuming confirmatory analysis.MethodsA multi-country, multi-stakeholder landscape assessment utilizing qualitative methodology was used to examine practices and perceptions related to the use of STs. Qualitative interview guides were designed using the results of a literature review and comprised of open-ended questions with the study participants, who were from national medicine regulatory authorities, pharmaceutical manufacturers, pharmacies, and distributors. Ten geographically and economically diverse countries were selected: Argentina, China, Egypt, India, Jordan, Mexico, Nigeria, Philippines, the United States, and Zimbabwe. Of the completed 53 interviews, 32 were in-person, 16 were phone interviews, and 5 were via written questionnaires.ResultsData analysis shows a wide variation in understanding and usage of STs in different sectors. Virtually all of the study participants indicated a lack of objective, accessible information on STs to advise them on what technologies would be beneficial for their needs. Study participants also described their ideal capabilities of the next generation of STs, including shareable spectral libraries, lower acquisition costs, lesser training requirements, and in-country maintenance and technical support.ConclusionThe results and recommendations presented in this article can be used to help regulators communicate and justify their needs to acquire and invest in new STs. There is a need for additional standardized, trustworthy and scientifically sound evaluations of STs, and to support regulators to effectively deploy the most promising technologies. ST manufacturers can take into account some of the limitations of the technologies the interviewees identified in this article, such as a dearth of technologies, which provide quantitative information about the active ingredient, and take steps to address them to better serve their customers. These results and recommendations, can catalyze research and actionable interventions into the development, review, application, and use of STs.Electronic supplementary materialThe online version of this article (10.1186/s12992-018-0360-y) contains supplementary material, which is available to authorized users.

The primary purpose of this study was to test the impact of the first year of a 3-year intervention designed to enhance the use of behavioral data in the Massachusetts HIV Prevention Community Planning Group (MPPG). A one-group, pretest-posttest, nonequivalent independent variables, quasi-experimental design was used to assess changes before and after the first year of implementing strategies to enhance the use of behavioral data in decisionmaking. Over 90% of the CPG members completed surveys at baseline and at the end of the first year of the intervention. Consistent with the focus of the MPPG intervention in Year One, significant improvements were found from baseline to follow-up in member perceptions of decision-making structure and leadership, satisfaction with prevention planning processes, and intervention prioritization decisions. Findings provide preliminary evidence for the impact on member satisfaction of changes in CPG organizational structures and processes, including redistribution of power and broader constituent representation.

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