The World Health Organization released a report in November 2017 estimating that 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. Poor-quality products can cause serious illness, fatalities, and even allow infections to further spread by causing antimicrobial resistance.
USP believes safeguarding the effectiveness of existing antibiotics is one way to protect against the growing threat of AMR.
“Product quality surveillance is important for safeguarding the effectiveness of existing antimicrobials and reinforces antimicrobial resistance stewardship interventions, including rational use of antimicrobials, infection control, and patient adherence to prescribed regimens,” said Jude Nwokike, director of the Promoting the Quality of Medicines program — a U.S. Agency for International Development-funded program implemented by USP.
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Many global health programs, he explained, rely on medicines that are assumed to be of good quality, but as the WHO report demonstrates, that is not a safe assumption.
“Failure to examine product quality can lead to subtherapeutic treatment and contribute to the growing problem of AMR,” Nwokike said.
Talking to Devex, Nwokike detailed how addressing the issue of substandard and falsified medicines can help with AMR and outlined ways development and global health practitioners can help tackle this problem.
Below are highlights from the conversation, edited for length and clarity.
What key measures can be taken to reduce the availability of poor-quality medicines and increase the availability of quality-assured medicines?
I think that the recently released report from the WHO truly puts things in perspective in terms of the size of the problem. When 10 percent of medicines are poor quality, it has a significant impact both on public health and the economy. Global health experts should be running to wrap our minds around possible solutions.
And the two-part nature of your question is exactly right. Addressing quality requires both reducing the availability of poor-quality medicines and increasing the availability of quality-assured medicines; they are two sides of the same coin. Addressing both sides often comes down to issues of surveillance and supply.
Through the USAID-funded PQM program, USP is working to improve the quality of medicines by emphasizing the need to build strong product-quality surveillance systems. These enable countries and regulators to be in a position to understand the size of the problem within their own markets.
And because some of the medicines used in global health programs treat diseases and conditions that don’t have the market size to be financially attractive to major pharmaceutical companies, we work with local manufacturers who are not traditionally in the global space to help them achieve international standards of quality assurance. This is a prerequisite for inclusion in the global health procurement of essential medicines. So, by helping local manufacturers meet international standards, we’re able to close the gap between those global health programs and the reliable, sustainable supply of quality medicines they need to reach their targets. An added benefit is that, in the process, we’re helping the local economy.
In terms of poor-quality medicines contributing to the problem of AMR, can you give us a sense of scale here?
Usually the issue of poor-quality medicines is more prominent in environments where you have weak regulatory systems. Typically, the products most often targeted are those that are most commonly used in developing countries, which include antibiotics and antimalarials. Thanks to disease-specific data, we know that exposure to medicines with low levels of active ingredients can contribute to the development of drug resistance. However, comprehensive data on the extent to which poor-quality medicines contribute to resistance are lacking. The WHO report is a good first step to understanding the scope and impact of this problem. And the evidence is such that any effort to optimize the use of antimicrobials should be accompanied by adequate consideration of the antimicrobial’s quality. We were pleased that data we collect as part of PQM’s medicines quality database could contribute to this ground-breaking report.
“Global health practitioners in the countries where we work are vital to our understanding of poor-quality medicines. We rely on their input and insights to develop programs that ensure greater access to medicines, as well as interventions to detect poor-quality medicines and remove them from the market.”— Jude Nwokike, director of the Promoting the Quality of Medicines program, USP
Locally, it’s important for individual countries to create or strengthen their own regulatory systems to monitor and ensure medicine quality. Accredited laboratories are an important component of surveillance efforts. We have seen that in environments where lab capacity is low, the problem of substandard and falsified products is much more pronounced — especially where local manufacturers may not meet specifications because of issues with production capacity, and even negligence. The PQM program supports countries in strengthening their lab capacity because strong regulatory systems and capacity to reliably test products to international standards enable regulators to identify and remove poor-quality medicines from the market.
I think it’s also important to realize that storage and distribution practices contribute to this problem. It’s not uncommon for a product to be reviewed, approved, and found to be of good quality before it gets in-country, only to have it go out of specification because there are no systems in place to ensure good storage and distribution conditions.
What strategies are PQM and others implementing to eliminate AMR as a result of ineffective medicines?
WHO has called on member states to include medicine quality assurance as part of their national action plans for combating AMR, so I think making sure that medicine quality is incorporated into those plans is really important. AMR is a serious global threat and we need to address this problem in a comprehensive and sustainable way.
One way USP has been working to improve surveillance is through a program called the Network of Official Medicines Control Laboratories, or NOMCoL, which was established through USAID support via the PQM program. PQM implemented NOMCoL-Africa to facilitate South-South collaboration and provide a forum for sharing best practices on medicines quality issues at regional and national levels.
Today, NOMCoL-Africa is achieving a major milestone as it is transitioning to African leadership, in partnership with the Africa Union’s New Partnership for Africa’s Development, and will now be known as the African Medicines Quality Forum.
This is not a one-off issue. Strategies for eliminating the contribution of poor-quality medicines to AMR should be all encompassing, addressing interventions to strengthen pre- and postapproval regulation of antimicrobial medicines and establishment of internationally accredited laboratories that can test products and produce reliable results. I recently co-authored a paper that details several approaches to ensure antimicrobial quality as part of a special issue of the WHO Bulletin that focuses on infectious diseases and AMR. The paper provides examples from Bangladesh, Indonesia, and South Africa of how efforts to address product quality can be incorporated in national action plans on antimicrobial resistance. These examples have been aligned with WHO’s prevent, detect, respond model for addressing poor-quality medicines.
Ultimately, it’s important that action take place locally, regionally, and globally — building on the work that PQM and other programs are doing to expand technical capacity — both within the regulatory system and with local manufacturers.
Are there key actions that those working within the development space can be taking to expedite this mission to eliminate poor-quality medicines?
Absolutely. Public health practitioners are uniquely positioned to help because nurses, pharmacists, and health practitioners are on the frontline. What can they do? It’s important they understand the scope of the problem so they can incorporate an appropriate level of attention to medicines quality into their work. They should maintain a high index of suspicion and report products they suspect to be of poor quality. Health practitioners should also understand that they don’t have the tools onsite to make this determination on their own, which is why if they suspect a medicine may be of poor quality, they must report it so it can be checked. Most countries have reporting systems in place, so they should approach the national regulatory authority to report any suspected cases.
Development professionals can also follow the example of the Global Fund to Fight AIDS, Tuberculosis and Malaria and incorporate medicines quality surveillance into their programs. Global health practitioners in the countries where we work are vital to our understanding of poor-quality medicines. We rely on their input and insights to develop programs that ensure greater access to medicines as well as interventions to detect poor-quality medicines and remove them from the market.
Lastly, global development experts must realize that medicines quality is more than simply a health issue; it’s also an important trade and security issue. So addressing this problem will require advocacy beyond health stakeholders.
To find out more about PQM and the work it is doing in tackling substandard and falsified medicines, click here.