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On 23 March, experts in medicine quality and substandard and falsified (SF) medicines gathered in Oxford for an informal one-day meeting following the workshop ‘The relationship between substandard and falsified antimicrobials and antimicrobial resistance and patient outcomes’. Over 60 participants from multiple countries attended the meeting in the Theatre of the Department of Sociology at Oxford, and participated in focussed discussions and intense sharing of challenges and successes in medicine quality and countering SF medicines. Mainly from academia, participants also included representatives from international organisations, the private sector and NGOs.

Group photo of participants to the Medicine Quality meeting in March 2023

“Much has happened since the MQPH conference in 2018, the first conference dedicated to Medicine Quality and Public Health,” said Prof Paul Newton, head of MORU’s and IDDO’s Oxford-based Medicine Quality Research Group (MQRG) and organizer of the informal meeting. “Importantly, the consensus Oxford Statement manating from the Conference stated that every person has the right to expect that when they use a medical product, whether medicine, vaccine or diagnostic kit, it works.”

“Five years on, as academia, NGOs and WHO work together to improve medicine quality, we’ve made important collective progress: Medicine quality is now embedded in various levels of education, including undergraduate pharmacy curricula, Masters’ and DPhil programmes. Healthcare workers are being trained to detect SF medicines and to alert national organisations. And the WHO is working on expanding the prevention, detection and response to SF medicines,” said Paul Newton.

Following initial presentations, the floor was open for attendees to present their own work and perspectives and it was agreed to hold a second global MQPH conference in 2024/2025.

Presenters at the informal meeting included:

Raffaella Ravinetto, from the Institute of Tropical Medicine (ITM) Antwerp (www.itg.be), gave an overview of ITM’s research, educational and policy work in pharmaceutical public health. She also mentioned the past research collaboration with QUAMED (quamed.org); the current research and education partnership with the University of the Western Cape (uwc.ac.za); and the plans to further develop the informal French-speaking platform on access to quality medicines, for partners in West Africa.

Saleh Aljadeeah, also from ITM, discussed his research on access to medicines in humanitarian settings, and in particular the case of access to antibiotics in northern Syria. He aims to include quality surveys in his research, by adapting the MEDQUARG guidelines to conflict settings. In case of suspected substandard or falsified medicine, frontline workers should be empowered to quarantine the suspected medicine, then escalate to the local organisation who may then raise a complaint to the supplier.

Christa Cepuch and Jessica Burry, from Médecins sans Frontières (MSF) discussed WHO’s benchmarking programme which seeks to build capacity of national regulators towards assuring quality and safety of medicines for their populations.  As the programme evolves, MSF continues to take a risk-based approach towards procurement decisions within its Quality Assurance Policy. MSF believes countries – whether ‘major producing’ or ‘primarily importing’ – should actively engage in the programme. WHO should fully integrate their different programmes and mechanisms addressing substandard medicines.

Julia Gabel, from the University of Tübingen, Germany, reviewed her group’s medicine quality study with a faith-based organization in Nigeria and showed that only two out of 22 investigated dexamethasone samples passed quality control, leading to product recalls by the Nigerian regulatory authority. The potential use of low-cost, portable near-infrared (NIR) spectrometers for medicine quality screening was demonstrated and discussed.

Dara Fitzpatrick, University College Cork, Ireland, detailed how sounding out falsified medicines using Broadband acoustic resonance dissolution spectroscopy (BARDS) can be used to detect SF medicines and plans to generate a database of BARDS spectra for genuine medicines.

Rutendo Kuwana, lead of the WHO Incidents and Substandard/Falsified (ISF) medical products team, provided overview of their current and planned activities. These include: work on prevention; detection (with strategies and tools); and response (timely and proportionate) to SF medical products. Noting WHO’s interest in the use of hand-held screening devices for detecting SF medicines, they intend to use Big Data and artificial intelligence (AI) to build a global library of spectra, in a single repository accessible to national authorities and approved users. WHO has produced handbooks, norms and guidance, and is working with universities, and other UN agencies on investigating incidents of SF medicines and disseminating alerts. WHO has also set up a system of benchmarking to evaluate countries’ regulatory systems and regulator competencies.

Annelie Monnier, Radboud University Medical Center, the Netherlands, discussed the AntiBiotics ACcess and USe (ABACUS) project. ABACUS phase I (2016-2019) explored antibiotic access and use practices in 6 countries in Africa (Mozambique, Ghana and South Africa) and Asia (Bangladesh, Thailand and Vietnam), to identify key drivers of use and targets for intervention. ABACUS phase II (2020-2023) surveys medicine quality in 4 low- and middle-income countries, with work in the lab starting this week. ABACUS II is also exploring how to improve the identification and recognition of oral antibiotics to nudge their responsible use (www.abacus-project.org).

Céline Caillet, Cathrin Hauk and Paul Newton, of the Oxford-based Medicine Quality Research Group (MQRG), within MORU and IDDO, reviewed current activities and future plans. These include:

  • Research to better understand SF epidemiology and impact, the use of screening technologies and forensic tools, and engagement with policy makers.
  • Epione, an electronic tool for post-market surveillance that gathers all survey data and results in one database; it can be used on desktops and phones, also off-line. Epione tracks the location of samples with a barcode system, includes a map with the provenance of samples, dashboards for the monitoring of the survey and the results. It aims to help medicines regulatory authorities in low- and middle-income countries to implement and conduct post-marketing surveillance.
  • FORESFA, which conducts research to tracks the origin and trade routes of falsified antimicrobials using genetics (testing DNA), stable isotope analysis and social network analysis of trade routes and geographic nodes for falsified medicines. Visit the FORESFA pages on the NDM-CGHR website
  • VIE (Vaccine Identity Evaluation), which evaluates repurposed devices to detect SF COVID and non-COVID vaccines. Visit the VIE pages on the NDM-CGHR website

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