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I'm delighted to have been invited to present at the Global Health Challenges seminar series, organised by the Global Health Network and the Centre for Tropical Medicine and Global Health (at the University of Oxford). My talk was one of several on the theme of "Ensuring Quality", in a session chaired by Prof Paul Newton. In this 13 min (ish) talk I discuss my current area of research and explore the exceptionally complex moral mazes that arise in real-world settings due to the uncertainty of medical product quality. I'd love to hear your thoughts and feedback - please do get in touch or leave a comment below. The other talks in this wonderful series are freely available to view, here: https://www.tropicalmedicine.ox.ac.uk/events/global-health-challenges-seminar-series-2021

Danini Marin Socials: LinkedIn - www.linkedin.com/in/ninimarinc

Yesenia Rodríguez, Gisela Pecho, Elisa Gálvez Pharmacovigilance and Medical Devices Surveillance | Social Security of Health of Peru (EsSalud) Conflict of Interest: None declared

Authors: P.H. Ciza , P.-Y. Sacre, M. Kanyonyo, C. Waffo, M. Borive , L. Coïc, J.K. Mbinze 2, Ph Hubert, E. Ziemons, R.D. Marini Research group: CIRM | ViBra-Santé Hub | Department of Pharmacy | Laboratory of Pharmaceutical Analytical Chemistry | University of Liege | Belgium https://www.cirm.uliege.be/cms/c_4264401/en/cirm Conflict of Interest: No response provided.

David Jenkins, PhD Scientist II | Product Quality and Compliance | FHI360 Many thanks to David Jenkins from FHI360 for highlighting these articles, which may be of interest to our 2021 delegates. (Please click on the images to follow the links). If you would like to highlight further articles of interest, please create a post of your own (via the blog page), or do so in the comments panel. Eady, M.; Payne, M.; Changpim, C.; Jinnah, M.; Sortijas, S.; Jenkins, D.; “ Establishment of instrument operation qualification and routine performance qualification procedures for handheld near-infrared spectrometers used at different locations within a laboratory network ”, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 2022, 267, 120512. https://doi.org/10.1016/j.saa.2021.120512 Eady, M.; Payne, M.; Sortijas, S.; Bethea, E.; Jenkins, D.; “ A Low-cost and Portable Near-infrared Spectrometer using Open-source Multivariate Data Analysis Software for Rapid Discriminatory Quality Assessment of Medroxyprogesterone Acetate Injectables ”, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 2021, 259, 119917. https://doi.org/10.1016/j.saa.2021.119917 Monge, M.E.; Dwivedi, P.; Zhou, M.; Payne, M.; Harris, C.; House, B.; Juggins, Y.; Cizmarik, P.; Newton, P.N.; Fernández, F.M.; Jenkins, D. “ A Tiered Analytical Approach for Investigating Poor Quality Emergency Contraceptives .” PLoS ONE 9(4): 2014, e95353. https://doi.org/10.1371/journal.pone.0095353 Tremelling, J.; All, A.; Lleras, L.; Cancel, A.; Jenkins D.; Pina, C.; Goldstein, D.; Broxton, C.; Hamel, S; “ Poor quality male latex condoms found in Dominican Republic: quality assurance evaluation and public health impact ”, PLoS ONE 14(1): 2019, e0210150. https://doi.org/10.1371/journal.pone.0210150

Biset Asrades MSc (Pharmaceutical Analysis and Quality Assurance) Instructor | Department of Clinical Pharmacy | Bahir Dar University | Ethiopia Background : Medicines can save lives and prevent diseases if they are safe, efficacious, of good quality and are used rationally. The use of substandard/Falsified drugs can be harmful to the health and well-being of the individual patient as well as to a wider section of the population. They also undermine confidence in the health service, health professionals who treat patients, prescribers, as well as those who manufacture, distribute and dispense/sale medicines. Objective : The aim of this systematic review is to overview the prevalence of substandard/falsified drugs and its associate factors in Africa, 2020. Methods : Twenty relevant literatures published from February 28, 2010 to February 29, 2020 a ten years period on prevalence of substandard/falsified drugs and its associated factors by using different databases (Hinari, Google scholar, Medline, Pub med and Embase) were reviewed. Results: The average prevalence of substandard/falsified drugs in Africa was 39%. Among of those substandard/falsified drugs, Antibiotics and antimalarial drugs are commonly targeted by counterfeiters in Africa on average 34.6% and 39% respectively and also anti -TB drugs accounts around 16.6%. Weak drug regulatory authority, lack of regulation by exporters within free trade zones, small pharmaceutical industries, high demand for curative and preventive drugs, high prices and inefficient cooperation among stakeholders and lack of good manufacturing practice in local pharmaceutical industries are the major factors w/c contribute on prevalence of substandard/falsified drugs and also it leads to the greatest socioeconomic and public health impact in Africa. Conclusion/Recommendation: Substandard/falsified drugs are the most hazards in developed and developing countries. Attention isn’t given to SF drugs in Africa. In order to address the this problem require an urgent close collaboration between the government, regulatory bodies, pharmaceutical companies, consistent supply systems of high quality products, applying GMP to manufacturing to ensure massive public enlightenment and the effective enforcement of the existing drug laws in Africa. Preventing drugs from Sub- standardization/falsifying problems are a primary duty of every responsible nation in order to save lives. Conflict of Interest: None declared.

Dr Ushehwedu Kufakurinani Research Fellow | History Department | University of Warwick Research Associate | University of Johannesburg When I got to the Avenues, a mixed residential and commercial area in the periphery of the CBD in Harare, I was quite convinced of the existence of fake enhancers flourishing in the streets. After the ban of over-the-counter sex enhancers in 2013 by the Medical Control Authority of Zimbabwe (MCAZ) and following a protracted economic crisis, the streets of the Avenues, which also doubles up as a red-light district, became a haven for illegal traders in sex tonics. I was part of the project “What’s at stake in the fake? Indian pharmaceuticals, African markets and global health” where we were exploring the “fake talk” as opposed to engaging on whether fake drugs exists or not. As soon as I embarked on my ethnographic research, the first question I asked was “do fake sex tonics exist”? Of course, I tried to avoid being blunt and asking them if they sold fake drugs. The response I received was intriguing and fascinating and was to open a whole door of research and interpretation of fake sex tonics. “There are no fake sex enhancers” I was told. And then I asked do they always work then? “No, but this is not because they are fake, it is all about compatibility with one’s blood system”. This was a profound response. It shifted our attention from the drug to the consumer. It echoed van der Geest et al’s (1996:166) notion of “compatibility”. Hayden (2012:276) also notes complexity of factors that shape drug efficacy go beyond the drug itself “since the people who consume drugs are likely to have different metabolisms, and hence may process drugs at different rates, and may experience different side effects as well”. Indeed, a closer analysis would throw us into deeper and wider discourses around drug efficacy as something determined by such aspects as “individual metabolism, brand loyalty, and inactive chemical components used in drug delivery” (Hardon and Sanabria 2017:121). My interest therefore shifted to understanding how efficacy was constructed and construed and what this meant for the trade in sex tonics. It is also my submission that the trade has its-self establish self-regulatory mechanism where the market shuns or promotes drugs depending on their known efficacy. Unpopular drugs, for one reason or the other, simply lose a market. I hope to share my ethnographic research experience regarding the trade of illegal sex tonics in streets of Harare. Oral presentation of abstract: Head to podcasts (under "audio-visual submissions" on the event webpage) to listen to Ushehwedu's discussion of this abstract and his research. Project: Wellcome Trust Collaborative Award in Humanities and Social Science, "What’s at stake in the fake? Indian pharmaceuticals, African markets and global health". https://warwick.ac.uk/fac/arts/history/research/projects/fake/team/ Acknowledgements: I would like to thank Profs Sarah Hodges and Julia Hornberger (and the rest of the "What's at stake with the fake" research team) for their comments, guidance, and encouragement in this exciting journey of medical anthropology. Socials: Twitter - @ushehwedu LinkedIn - https://www.linkedin.com/in/ushehwedu-kufakurinani-5bb56960/ Research Group - https://warwick.ac.uk/fac/arts/history/research/projects/fake/team/ Conflict of Interest: None declared.

Zelalem Mamo Sahile Technical Advisor (regulatory System Strengthening | Promoting the Quality of Medicines Plus (PQM+) Program | US Pharmacopeia (USP) Introduction : Market Surveillance and Control (MSC) is an essential function for national medicine regulatory authorities (NMRAs) seeking Maturity Level 3 or 4, as measured by WHO’s Global Benchmarking Tool. The COVID-19 pandemic has forced NMRAs to shift resources to prioritize access to COVID-19 related products while still carrying out regular MSC activities. Risk-based post-marketing surveillance (RB-PMS) has emerged as a critical way for NMRAs in low- and middle-income countries (LMICs) to sustainably institutionalize the function while maximizing available resources. This approach has proved particularly useful during health emergencies, such as COVID-19. Methods : The USAID-funded and USP-implemented Promoting the Quality of Medicines Plus (PQM+) program supports NRMAs in LMICs in institutionalizing RB-PMS programs. This includes development of customized national guidelines and practical RB-PMS sampling protocols using the Medicines Risk Surveillance (MedRS) tool. MedRS enables countries to determine which medical products pose the greatest risk to the population and calculate a representative sample size for collection. A risk-based and tiered approach is also used for sample testing to reduce laboratory testing costs while maintaining the ability to detect poor-quality products. Results : Since 2018, USP has supported RB-PMS in 20+ LMIC countries with 150+ staff trained. Results from several countries indicate RB-PMS programs yield significant cost-savings. For example, prior to adoption of RB-PMS, laboratory testing in Ethiopia averaged approximately $875 (USD). With RB-PMS, the cost of sampling and testing has been reduced by 70%, to approximately $200. Other countries, such as Bangladesh, are expanding surveillance activities to new COVID-19 vaccines. Discussion : Effective RB-PMS programs optimize the use of limited resources and can help enable NMRAs to leverage resources for maximum public health benefit. During health emergencies, such as COVID-19, RB-PMS programs can help expand surveillance activities to critical new products such as vaccines, even as testing capacity for new products is being established. Acknowledgements: I would thank Souly Phanouvong and Timothy Ngowo Conflict of Interest: None declared.

BBC What’s New and BBC Actu Jeunes are the BBC’s first bilingual programmes for teenagers, brought to you by the BBC World Service to discuss important issues for young people across Africa. BBC Actu Jeunes et BBC What’s New, l’actualité qui parle aux jeunes en Afrique, en français et en anglais. Des émissions du Service Mondial de la BBC. Abonnez-vous ici! Subscribe to #BBCWhatsNew and #BBCActuJeunes This fab episode is presented Dr Bahijja Raimi-Abraham, a pharmacist, lecturer in Pharmaceutics at King’s College London, and head of the 'The Raimi-Abraham Group'. Links ~ https://www.bahijjaraimiabraham.com/

AntTail Story: In our years of helping Pharmaceutical companies with their internal audits, we got very frustrated by the fact that hardly any temperature monitoring solution provided the necessary answers for the industry. Based on the industry needs, we dreamed up the ideal solution and decided to actually build it. So here we are: AntTail Vision: The pharmaceutical industry is the only focus of AntTail. We work with our customers to create value in the distribution of medicines. Getting the original (not counterfeit) products in good condition from the production facility to the patient is our vision. As we all know, the logistic chain in the pharmaceutical industry is long and complex. Technology: As experienced and knowledgeable professionals we help design innovative solutions for our customers based the strengths of wireless capabilities of our sensors and flexibility of the back-office. Everything is securely hosted in the AntTail cloud. Local software, local storage and docking stations we do without. Links: https://anttail.net/virtual-vault/ https://anttail.net/ This is not an endorsement of this product or the company.

International Pharmaceutical Federation (FIP) From the executive summary: "Thoroughly understanding the global threat posed from SF medical products is important to better prevent them from reaching patients. Healthcare professionals are key in responding to them proportionately and consistently —quickly detecting SF medical products when they have penetrated supply chains and reporting them to authorities, as well as educating and advising patients who have been exposed to them. "Although an accurate and reliable source of SF reports, healthcare professionals cite a variety of barriers to reporting, including but not limited to a lack of awareness, a lack of feedback, overcomplicated reporting systems, and even fear of being reprimanded by their superiors.7 As a result, the WHO proposed a solution with the production of a modular educational curriculum to improve reporting and intervening behaviours of frontline healthcare professionals, specifically pharmacists, in high-risk regions of the world like sub-Saharan Africa." Reference: International Pharmaceutical Federation (FIP). Curriculum for pharmacy students on substandard and falsified medicines: Curriculum guide and competency framework. The Hague: International Pharmaceutical Federation; 2021. Available at: https://www.fip.org/file/4917

Tupaia Tupaia is a data aggregation, analysis and visualisation platform that works to map health systems in the Indo-Pacific region. This is used to strengthen services, manage projects and help governments fairly distribute resources. Tupaia has developed an easy to use, interactive online map that gives a bird’s eye view to decision makers, health workers, donors and members of the public on medicines, equipment, infrastructure, staff, services and research. They run a wealth of impressive technology projects. Here is an example - a Bluetooth temperature-tracking innovation that was rolled out in Vanuatu: https://info.tupaia.org/news/saving-vaccines-with-bluetooth-temperature-tracking-innovation/ Follow the link to read the story and click below to watch the video. Links: https://www.tupaia.org/explore/explore/General https://info.tupaia.org/about-us/