The Medicine Quality Research Group has published a six-month Medical Product Quality Report focused on COVID-19 today, using its Medicine Quality Monitoring Globe tool. New reports will be issued monthly from now on, following the first January - June publication.
Europe should lead in coordinated procurement of quality-assured medicines for programmes in low-income and middle-income countries
Thoughtful procurement policies in humanitarian and development medical programmes can mitigate the risk of purchasing poor-quality medicines, allowing to address fundamental moral obligation to equity, transparency and accountability. European donors are aware of the quality problems in the global pharmaceutical market, and some are already translating awareness into explicit procurement and quality assurance policies. However, a joint position and coordinated action is lacking. European donors should share existing knowledge and tools, seek the input of recipient countries, and develop a joint position on how the donor community can help to ensure access to affordable and quality-assured health products—also during public health emergencies such as the COVID-19 pandemic. Applying stringent and harmonised quality assurance requirements, European donors and their implementing organisations can help shaping the global pharmaceutical market towards affordable, quality assured products.
Development and selection of low-level multi-drug resistance over an extended range of sub-inhibitory ciprofloxacin concentrations in Escherichia coli
As large numbers of candidate drugs and vaccines for potential use in the Covid‐19 pandemic are investigated, medicines regulators globally must now make urgent, informed, contextually risk‐based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices."
Reports that chloroquine and hydroxychloroquine may be effective against COVID-19 have received worldwide attention, increasing the risk of the introduction of falsified versions of these medicines. Five different types of falsified chloroquine tablets were discovered between March 31, 2020 and April 4, 2020, in Cameroon and the Democratic Republic of Congo by locally conducted thin layer chromatographic analysis. Subsequent investigation by liquid chromatography and mass spectrometry in Germany proved the absence of detectable amounts of chloroquine and the presence of undeclared active pharmaceutical ingredients, that is, paracetamol and metronidazole, in four of the samples. The fifth sample contained chloroquine, but only 22% of the declared amount. Such products represent a serious risk to patients. Their occurrence exemplifies that once medicines or vaccines against COVID-19 may be developed, falsified products will enter the market immediately, especially in low- and middle-income countries (LMICs). Timely preparations for the detection of such products are required, including the establishment of appropriate screening technologies in LMICs.
The global prevalence of diabetes mellitus is increasing alarmingly. However, the quality of vital medicines and medical products used to treat and monitor diabetes remains uncertain but of potential great public health significance. Here, we review the available evidence on the quality of antidiabetic medicines and supplies for self-monitoring of blood glucose (SMBG) and discuss their potential impact for the patients and society.
Substandard and falsified medications pose significant risks to global health. Nearly one in five antimalarials circulating in low- and middle-income countries are substandard or falsified. We assessed the health and economic impact of substandard and falsified antimalarials on children under five in Nigeria, where malaria is endemic and poor-quality medications are commonplace.
Evolution of Rifampin resistance in Escherichia coli and Mycobacterium smegmatis due to substandard drugs
Poor-quality medicines undermine the treatment of infectious diseases, such as tuberculosis, which require months of treatment with rifampin and other drugs.
Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-and middle-income countries
The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors.
Artemisinin-based combination therapies are the frontline treatment of Plasmodium falciparum malaria.
Quality assurance of medicines supplied to low income and middle-income countries: poor products in shiny boxes?
In today's context of globalisation of pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa.