The Medicine Quality Research Group has published a new Medical Product Quality Report focussing on increasing issues around substandard and falsified (SF) COVID-19 vaccines. With the implementation of the key innovations of COVID-19 vaccines, there have been growing numbers of reports of SF vaccines in the public domain. Given the vital role they will play in ending the pandemic and protecting the global population but severe issues with equitable access, SF vaccines are highly likely to be a growing problem.
In vitro growth competition experiments that suggest consequences of the substandard artemisinin epidemic that may be accelerating drug resistance in P. falciparum malaria
Acceleration of antimicrobial resistance (AMR) is often theorized to be exacerbated by the use of subtherapeutic dosages of drugs (“substandard” drug), which for ACTs has been well documented over the last decade. Troublingly, in 2017, the WHO estimated that nearly 1 in 10 medical products tested in low- and middle-income countries failed to meet quality standards. We have developed a tissue culture-based approach for testing possible connections between substandard treatment and the spread of ACT resistant blood stage forms of P. falciparum.
More than a year into the pandemic, all eyes are on the global rollout of COVID-19 vaccines. As manufacturers sprint to answer unprecedented demand, countries around the world are facing daunting challenges in vaccine delivery, distribution and uptake. At this critical turning point, ensuring that the highest quality COVID-19 vaccines are delivered through the world’s supply chains couldn’t be more important. Furthermore, while attitudes toward COVID-19 vaccines continue to improve, reaching the last mile needed to achieve population immunity will require greater transparency to foster public trust. This year, the world has watched closely as diagnostics, treatments and vaccines have gone from aspiration to reality in response to the COVID-19 pandemic. For months, people have followed the COVID-19 product development journey from clinical trials to regulatory authorization or approval. Along the way, we have become more informed about the challenges in ingredients quality, inspections and regulatory enforcement, supply chain resilience, as well as the benefits of multi-stakeholder and global collaborations.
Substandard and falsified COVID-19 vaccines are vital interventions to help end the pandemic. However, with severe issues with equitable global access, falsified, diverted and substandard (especially degraded) vaccines are highly likely to become increasing global public health problems, leading to vulnerable communities thinking that they are protected when they are not. In order to facilitate our understanding of such reports and to inform interventions, we summarise reports in the public domain relevant to substandard and falsified (SF) COVID-19 vaccines since the start of the pandemic. The report will be updated monthly and aims to aid national medicine regulators, international organizations, vaccine manufacturers and distributors and civil society by summarising the current public domain literature, to inform action and policy.
Disruption in the medicines supply-chain as a result of COVID-19 means it is more susceptible to a global surge in substandard and falsified medical products, according to Sireesha Yadlapalli, senior director of regional program operations in India at USP — a global health organization that improves lives through public standards to ensure the quality, safety, and benefit of medicines and foods.
The COVID-19 pandemic has resulted in massive disruptions in global supply chains. Nigeria is particularly vulnerable with respect to pharmaceuticals since there is reduced local production and about 70% of the drug supply is imported creating a huge supply–demand disparity particularly in times like COVID-19. Nigeria is in need of huge quantities of quality-assured health commodities to effectively respond to the pandemic. Significant shortages of other essential medicines and medical products across the country could be imminent. Drug scarcity in Nigeria during the COVID-19 pandemic period is because of several accumulated factors, majorly as a result of global lockdown, decreased manufacturing, unaddressed regulatory affairs, poor access to resources by the population, lack of buffer stocks, security instability, and poor funding of the healthcare system. This situation if left unattended, could cause serious drawbacks to the health of the populace as well as the quality of life of Nigerians amid the COVID-19 Pandemic. Appropriate measures should be directed to ensure ethical processes on drug production, importation, pricing, and distribution to avoid such events during unavoidable scenarios, like the COVID-19 pandemic and other public health emergencies.
COVID-19 is a threat to health systems around the world and Rwanda is not an exception. The impact of the pandemic is far-reaching and access to health commodities is not spared. Proper drug supply is critical for a robust healthcare system. It determines the extent at which the population are likely to have access to essential medicines and treatments. In Rwanda, the pharmaceutical sector heavily relies on imports. With the emergence of COVID-19 pandemic, the drug supply system was interrupted leaving many stores from small local pharmacies to the big medical stores running out of stock. The reasons were limited importation of goods from abroad, and the panic buying practice among the customers and some institutions when responding to the pandemic. Drug and medicines accessibility, availability and affordability should be the core of any drug management policy. It is with no doubt that, Rwanda has made a tremendous work to mitigate the effect of COVID-19 on the country’s drug supply; however, efforts are still needed to invest in local pharmaceutical production as a way to minimize import expenses in the country. Good policy on drug importation, production and distribution should be enforced to avoid any drug shortage that may be encountered in the Rwandan drug market.
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.
Who could have predicted that in 2020, the intricacies of pharmaceutical supply chains and the importance of medicines quality would take center stage around the world? This year, the world has watched closely as diagnostics, treatments and vaccines have gone from aspiration to reality in response to the COVID-19 pandemic. For months, people have followed the COVID-19 product development journey from clinical trials to regulatory authorization or approval. Along the way, we have become more informed about the challenges in ingredients quality, inspections and regulatory enforcement, supply chain resilience, as well as the benefits of multi-stakeholder and global collaborations.
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.