The coronavirus pandemic has affected virtually every country in the world, but the ability to combat it with essential medicines varies widely. Low- and middle-income countries (LMICs) are finding it especially tough to access medicines, and ensure the safety and quality of those products that are available. In this conversation with SupplyChainBrain Editor-in-Chief Bob Bowman, Jude Nwokike, vice president of the public health division of U.S. Pharmacopeia, discusses the medical supply-chain issues that LMICs face now and on a regular basis.
SCB: What challenges are government regulators and LMICs facing as they combat this pandemic?
Nwokike: We’re very much at the very beginning of this current pandemic. Most regulators have seen quite a lot of challenges because of preexisting weak systems. One challenge that agencies are facing is finding ways to mitigate shortages of essential medicines. Another is how to get greater visibility. How do they set up information systems that provide intelligence and early-warning alerts to let them know about imminent shortages, and how they should deal with it? There's also the unique challenge of protecting the population from poor-quality medicines during a period where inspections are not possible — where quality might not happening at all.
SCB: When it comes to getting essential medicines and products, what disadvantages are LMICs experiencing with regard to access, infrastructure, carrier services, and logistics?
Nwokike: The situation has become aggravated. There are issues about accessing information, managing it, and putting it out to the population. Access to products is difficult because you’re dealing with a lack of capacity to produce them. We know there’s not an effective vaccine yet. But essential medicines may run into shortages, either because of a lack of active ingredients or manufacturing capacity in the country. These things were preexisting, but as you can imagine, the current situation has escalated them.
SCB: Do LMICs has have a bigger problem than larger, richer countries when it comes to detecting poor-quality medicines and removing them from the market?
Nwokike: The short answer to that is yes. It's important to emphasize that every country bears the brunt of poor-quality, substandard, and falsified medicines. But it’s much more pronounced in LMICs, because of weak regulatory infrastructure. This includes limited preapproval processing and inspection capabilities. And the most important limitation is in post-marketing surveillance.
SCB: How can LMICs get faster access to coronavirus medicines and vaccines as they’re developed?
Nwokike: For timely access to medicine, you have to have a robust and functional preapproval process. It's a process that allows for the applicant to submit a dossier for review, and the physician to do an inspection. Then you need to be able to submit a sample of the products to be tested and approved. And keep in mind that this is for post-clinical trials. The agency also has to have the capability to review and approve a clinical trial. Then, after the product has been shown to work, you're able to receive dossier review, inspection, testing and approval of the product. And that’s just during normal time. In situations of disease outbreaks, epidemics, or pandemics, they need quicker ways of reviewing and assessing applications for clinical trials. During the Ebola epidemic, some of these issues came up. Beyond the fact that we found some drug shortages, there were problems in enabling LMICs to assess products that weren’t completely proven.
SCB: So what can they do going forward?
Nwokike: There has to be a preapproval process that is very agile and efficient. Part of the way of doing that is to rely on decisions of mature agencies — to pull from the expertise of multiple countries. The parties might not all reside in one country. They can jointly review a dossier, to quickly make a determination on whether they want the product in their countries.
SCB: Is this happening with the coronavirus pandemic?
Nwokike: In the immediate time, some of these things are beginning to be looked into. LMICs are at different at points in doing that, and that’s where the USP paper comes in as one resource. Countries are monitoring the situation and using the resources that are available, some to a greater extent than others. The issue of local manufacturing is bubbling up because of a shortage of essential medicines. They might not be indicated for COVID-19, but they’re essential medicines for managing everyday health cases in these countries. Whether they become successful for COVID-19 or not, they’re still needed in a functional health system. This has brought attention to the need to begin showing support for local manufacturing in some of these countries where it’s economically feasible — where there are opportunities to build that up. Some local manufacturing capabilities have been there. They’re small, but they have been trying.
SCB: So you’re hopeful that there’s progress being made?
Nwokike: We see this as a tipping point, an opportunity to revisit these issues. Irrespective of where medicines are manufactured, they have to be made according to international standards, and to the right levels of quality.
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