The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2–8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2–121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5–48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely substandard brands of misoprostol tablets were found. The Rwandan authorities reacted quickly and efficiently, and recalled these substandard medicines from the market. For oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to medicines which are WHO-prequalified or which have been manufactured in countries with stringent regulatory authorities.
Quality assurance in anti-tuberculosis drug procurement by the Stop TB Partnership—Global Drug Facility
Quality-assured medicines are a principal means of achieving health-related Sustainable Development Goals. An example of quality assurance/quality control (QA/QC) procedures in drug procurement is provided by the operation of the Global Drug Facility (GDF) of the Stop TB Partnership, the largest provider of tuberculosis (TB) medicines to the public sector worldwide.
An 'informal online gathering' of researchers, experts and policy makers interested in the links between medicines quality and public health, took place on 3 December 2020. It was the third of a series of informal events that started in person in 2019, thanks to the initiative of Paul Newton at Oxford University/IDDO/MORU, with the intent to share research projects, brainstorm on research ideas and identify synergies and collaborations among relevant stakeholders.
Report: The link between constrained access to quality, safe, efficacious and affordable medical products and substandard and falsified medical products
At its eighth meeting, the Member State mechanism on substandard and falsified medical products agreed a list of prioritized activities for the period 2020–2021. Activity D of that list aims to increase Member States’ knowledge around the links between substandard and falsified medical products and access to quality, safe, efficacious and affordable medical products.
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.
Substandard and falsified medicines pose a major threat to global health. Poor-quality medicines cause more than one million deaths per year, reduce the effectiveness of authentic medical treatment, waste national resources, and contribute to antimicrobial resistance. Global pandemics like COVID-19 can disrupt the supply of quality-assured medicines and lead to increased proliferation of substandard and falsified medicines.
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.
Emergency efforts are underway to find optimum medical products to prevent infection and diagnose and treat patients during the coronavirus disease 2019 (COVID-19) pandemic. Production and supply chains for COVID-19 candidate drugs (such as chloroquine and hydroxychloroquine), and for many other essential medical products, are being impaired by this crisis.