The 7th meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) (IHR) regarding the coronavirus disease (COVID-19) took place on 15 April 2021. On COVID-19 vaccination, the Committee advised to “Strengthen WHO and support strengthening of States Parties’ capacities to prevent, detect and respond to the growing threat of substandard and falsified vaccines.
A review of prospective pathways and impacts of COVID-19 on the accessibility, safety, quality, and affordability of essential medicines and vaccines for universal health coverage in Africa
The ongoing pandemic of coronavirus disease 2019 (COVID-19) has the potential to reverse progress towards global targets. This study examines the risks that the COVID-19 pandemic poses to equitable access to essential medicines and vaccines (EMV) for universal health coverage in Africa.
The COVID-19 Vaccine Handling Toolkit is developed by over 30 independent expert volunteers led by USP’s Healthcare Safety and Quality Expert Committee with representation from several other Expert Committees including U.S. government representatives from the Centers for Disease Control and Prevention (CDC) and the U.S. Food & Drug Administration (FDA). It is informed by USP’s public quality standards for compounding, microbiology, containers, distribution, stability and storage.
A critical part of the Asia Pacific Leaders’ Malaria Elimination Roadmap (‘the Roadmap’) endorsed in 2015 was the decision to develop a mechanism to track progress and achievements in malaria control and elimination across Asia and the Pacific. The APLMA Leaders’ Dashboard is the mechanism to help countries track progress towards the 2030 goal. It highlights bottlenecks, encourages prompt action, serves as a key advocacy tool to demonstrate progress in the region, and leverages Governments’ and partners continued support for financing malaria elimination. The Dashboard was key in developing the 5 Year Review of Progress since the launch of the Roadmap.
The African Medicines Agency (AMA) aims to provide a platform for the coordination and strengthening of ongoing medicines regulatory harmonization initiatives across the continent, and to ensure optimal use of scarce resources by pooling expertise, capacities and strengthening existing networks - for contributing to enhanced accessibility of quality-assured and affordable medical products. This review maps the key entities, milestones, implementation targets and anticipated challenges related to the domestication of the African Union (AU) Model Law on Medical Products Regulation, and the establishment of the AMA.
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.
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.
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.