It is increasingly clear that to end the COVID-19 pandemic, we must guarantee timely and equitable access to quality medicines. To meet this goal, we need resilient pharmaceutical supply chains backed by strong regulatory systems to ensure the safety of future COVID-19 drugs and to limit the spread of substandard and falsified medical products.
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."
When we started this coalition in 2018, we knew quality and trust were at the center of every health system and the key to achieving our collective health goals. However, we could not have predicted what these two years would look like. Our work is far from over.
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.
As more coronavirus patients were admitted to intensive care, Drayton Hammond, a clinical pharmacist in Chicago, Illinois, frantically tried to order more sedatives. At one point, his hospital was down to a single day’s supply of propofol, one of the main anesthetics used to keep Covid-19 patients comfortable while they’re connected to ventilators in intensive care. The hospital’s use of this drug had increased fivefold since the pandemic hit, forcing staff to ration supplies and use alternative drugs with worrying side effects.
The new coronavirus has exposed the staggeringly uneven distribution of life-saving medical equipment across the world. Ventilators are an essential tool in the treatment of respiratory illnesses, including severe cases of Covid-19, yet across 41 African countries there are fewer than 2,000 apparatus serving hundreds of millions of people.
When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.
COVID-19 has paralysed the world. Apart from directly affecting the lives of people globally, the pandemic has led to a domino effect on other health outcomes. With the lockdown of entire countries, global supply chains of health commodities are at risk. This could lead to shortages of medicines across the world, including treatments for critical illnesses, as highlighted by the US Food and Drug Administration.
Fifty pharmaceutical manufacturing facilities have shuttered their operations in Baddi, Himachal Pradesh, Asia’s largest pharmaceutical hub, while others are operating at significantly reduced capacities after the region was declared a containment zone, raising concerns about the shortage of supply of medicines in the country.