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Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

Yemeke et al., BMJ Open, doi:10.1136/bmjopen-2022-068923

Jun 2023

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Ivermectin for COVID-19

4th treatment shown to reduce risk in August 2020

^*, now known with p < 0.00000000001 from 102 studies, recognized in 22 countries.

Lower risk for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19ivm.org

Review of the quality of medical products in Zimbabwe during the pandemic, noting reports of inauthentic ivermectin in South Africa that was tested and found to have low or no active ingredient.

Reviews covering ivermectin for COVID-19 include Adegboro, Al-kuraishy, Babalola, Behl, Bray, DiNicolantonio, DiNicolantonio (B), Elkholy, Fordham, Formiga, Heidary, Jagiasi, Jans, Jans (B), Kory, Kory (B), Kory (C), Kory (D), Kow, Lind, Liu, Loo, Low, Santin, Scheim, Schwartz, Semiz, Turkia, Turkia (B), Turkia (C), Vora, Wang, Wehbe, Yagisawa, Yagisawa (B), Yemeke, Zaidi.

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1. Adegboro et al., A review of the anti-viral effects of ivermectin, African Journal of Clinical and Experimental Microbiology, doi:10.4314/ajcem.v22i3.2.ajol.info, doi.org.

2. Al-kuraishy et al., Central effects of Ivermectin in alleviation of Covid-19-induced dysautonomia, Current Drug Targets, doi:10.2174/1389450123666220810102406.eurekaselect.com, doi.org.

3. Babalola et al., The Place of Ivermectin in the Management of Covid-19: State of the Evidence, Medical Research Archives, doi:10.18103/mra.v11i4.3778.esmed.org, doi.org.

4. Behl et al., CD147-spike protein interaction in COVID-19: Get the ball rolling with a novel receptor and therapeutic target, Science of The Total Environment, doi:10.1016/j.scitotenv.2021.152072.sciencedirect.com, doi.org.

5. Bray et al., Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors' responses, Antiviral Res., doi:10.1016/j.antiviral.2020.104805.nih.gov, doi.org.

6. DiNicolantonio et al., Anti-inflammatory activity of ivermectin in late-stage COVID-19 may reflect activation of systemic glycine receptors, Open Heart, doi:10.1136/openhrt-2021-001655.bmj.com, doi.org.

7. DiNicolantonio (B) et al., Ivermectin may be a clinically useful anti-inflammatory agent for late-stage COVID-19, Open Heart, doi:10.1136/openhrt-2020-001350.bmj.com, doi.org.

8. Elkholy et al., Ivermectin: A Closer Look at a Potential Remedy, Cureus, doi:10.7759/cureus.10378.cureus.com, doi.org.

9. Fordham et al., The uses and abuses of systematic reviews, OSF Preprints, doi:10.31219/osf.io/mp4f2.osf.io, doi.org.

10. Formiga et al., Ivermectin: an award-winning drug with expected antiviral activity against COVID-19, J. Control Release, doi:10.1016/j.jconrel.2020.10.009.nih.gov, doi.org.

11. Heidary et al., Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen, The Journal of Antibiotics, 73, 593–602, doi:10.1038/s41429-020-0336-z.nature.com, doi.org.

12. Jagiasi et al., Variation in therapeutic strategies for the management of severe COVID-19 in India- A nationwide cross-sectional survey, The International Journal of Clinical Practice, doi:10.1111/ijcp.14574.wiley.com, doi.org.

13. Jans et al., The broad spectrum host-directed agent ivermectin as an antiviral for SARS-CoV-2 ?, Biochemical and Biophysical Research Communications, doi:10.1016/j.bbrc.2020.10.042.sciencedirect.com, doi.org.

14. Jans (B) et al., Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?, Cells 2020, 9:9, 2100, doi:10.3390/cells9092100.mdpi.com, doi.org.

15. Kory, P., The Global War on Ivermectin, International Covid Summit III, European Parliament, Brussels, covid19criticalcare.com/wp-content/uploads/2023/05/GLOBAL-WAR-ON-IVERMECTIN-PARLIAMENT.pdf.covid19criticalcare.com.

16. Kory (B), P., The Criminal Censorship of Ivermectin's Efficacy By The High-Impact Medical Journals - Part 1, Pierre Kory’s Medical Musings, pierrekory.substack.com/p/the-criminal-censorship-of-ivermectins.substack.com.

17. Kory (C) et al., Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19, American Journal of Therapeutics, doi:10.1097/MJT.0000000000001377.lww.com, doi.org.

18. Kory (D) et al., Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19, Frontiers in Pharmacology, doi:10.3389/fphar.2021.643369.archive.org, doi.org.

19. Kow et al., Pitfalls in Reporting Sample Size Calculation Across Randomized Controlled Trials Involving Ivermectin for the treatment of COVID-19, American Journal of Therapeutics, doi:10.1097/MJT.0000000000001441.lww.com, doi.org.

20. Lind et al., Increase in Outpatient Ivermectin Dispensing in the US During the COVID-19 Pandemic: A Cross-Sectional Analysis, Journal of General Internal Medicine, doi:10.1007/s11606-021-06948-6.springer.com, doi.org.

21. Liu et al., Crosstalk between neutrophil extracellular traps and immune regulation: insights into pathobiology and therapeutic implications of transfusion-related acute lung injury, Frontiers in Immunology, doi:10.3389/fimmu.2023.1324021.frontiersin.org, doi.org.

22. Loo et al., Recent Advances in Inhaled Nanoformulations of Vaccines and Therapeutics Targeting Respiratory Viral Infections, Pharmaceutical Research, doi:10.1007/s11095-023-03520-1.springer.com, doi.org.

23. Low et al., Repositioning Ivermectin for Covid-19 treatment: Molecular mechanisms of action against SARS-CoV-2 replication, Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease, doi:10.1016/j.bbadis.2021.166294.sciencedirect.com, doi.org.

24. Santin et al., Ivermectin: a multifaceted drug of Nobel prize-honored distinction with indicated efficacy against a new global scourge, COVID-19, New Microbes and New Infections, doi:10.1016/j.nmni.2021.100924.sciencedirect.com, doi.org.

25. Scheim et al., Sialylated Glycan Bindings from SARS-CoV-2 Spike Protein to Blood and Endothelial Cells Govern the Severe Morbidities of COVID-19, International Journal of Molecular Sciences, doi:10.3390/ijms242317039.mdpi.com, doi.org.

26. Schwartz, E., Does ivermectin have a place in the treatment of mild Covid-19?, New Microbes and New Infections, doi:10.1016/j.nmni.2022.100989.sciencedirect.com, doi.org.

27. Semiz, S., SIT1 transporter as a potential novel target in treatment of COVID-19, Biomolecular Concepts, doi:10.1515/bmc-2021-0017.degruyter.com, doi.org.

28. Turkia, M., A Continuation of a Timeline of Ivermectin-Related Events in the COVID-19 Pandemic [June 30, 2021], ResearchGate, doi:10.13140/RG.2.2.16973.36326.researchgate.net, doi.org.

29. Turkia (B), M., A timeline of ivermectin-related events in the COVID-19 pandemic, Research Gate, www.researchgate.net/publication/350610718_A_Timeline_of_Ivermectin-Related_Events_in_the_COVID-19_Pandemic_April_3_2021.researchgate.net.

30. Turkia (C), M., FLCCC Alliance MATH+ ascorbic acid and I-MASK+ ivermectin protocols for COVID-19 — a brief review, ResearchGate, www.researchgate.net/profile/Mika_Turkia/publication/345694745_FLCCC_Alliance_MATH_ascorbic_acid_and_I-MASK_ivermectin_protocols_for_COVID-19_-_A_Brief_Review/links/5fab010f4585150781078260/FLCCC-Alliance-MATH-ascorbic-acid-and-I-MASK-ivermectin-protocols-for-COVID-19-A-Brief-Review.pdf.researchgate.net.

31. Vora et al., White paper on Ivermectin as a potential therapy for COVID-19, Indian Journal of Tuberculosis, doi:10.1016/j.ijtb.2020.07.031.sciencedirect.com, doi.org.

32. Wang et al., Minimum manufacturing costs, national prices and estimated global availability of new repurposed therapies for COVID-19, medRxiv, doi:10.1101/2021.06.01.21258147.medrxiv.org, doi.org.

33. Wehbe et al., Repurposing Ivermectin for COVID-19: Molecular Aspects and Therapeutic Possibilities, Front. Immunol., doi:10.3389/fimmu.2021.663586.frontiersin.org, doi.org.

34. Yagisawa et al., Global trends in clinical trials of ivermectin for COVID-19—Part 2, The Japanese Journal of Antibiotics, doi:10.11553/antibiotics.77.1_45.doi.org, doi.org.

35. Yagisawa (B) et al., Global trends in clinical studies of ivermectin in COVID-19, The Japanese Journal of Antibiotics, 74-1, Mar 2021, jja-contents.wdc-jp.com/pdf/JJA74/74-1-open/74-1_44-95.pdf.wdc-jp.com.

36. Yemeke et al., Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders, BMJ Open, doi:10.1136/bmjopen-2022-068923.bmj.com, doi.org.

37. Zaidi et al., The mechanisms of action of ivermectin against SARS-CoV-2—an extensive review, The Journal of Antibiotics, doi:10.1038/s41429-021-00491-6.nature.com, doi.org.

Yemeke et al., 8 Jun 2023, peer-reviewed, 4 authors.

This Paper Ivermectin All

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

Tatenda T Yemeke, Farouk A Umaru, Rashida A Ferrand, Sachiko Ozawa

BMJ Open, doi:10.1136/bmjopen-2022-068923

Objective To explore the impact of the Coronavirus disease 2019 (COVID-19) pandemic on the quality of medical products in Zimbabwe, including market risks for substandard and falsified products and impacts on quality assurance activities. Design Qualitative study based on in-depth key informant interviews. Setting Health system stakeholders across the medical product supply chain in Zimbabwe. Participants 36 key informants were interviewed between April and June 2021. Results We found that the COVID-19 pandemic disrupted quality assurance and regulatory activities of medical products in Zimbabwe, resulted in observations of poorquality personal protective equipment (PPE) and other COVID-19-related products and led to increased risks to quality. Risks to quality due to COVID-19-related disruptions included increased layers of agents in the supply chain and an influx of non-traditional suppliers. COVID-19-related movement restrictions reduced access to health facilities and thus may have increased the usage of the informal market where smuggled and unregistered medical products are sold with less oversight by the regulator. Most reports of poor-quality medical products were for PPE, such as masks and infrared thermometers, used for the COVID-19 response. Besides these reports, many participants stated that the quality of essential medicines in the formal sector, not related to COVID-19, had largely been maintained during the pandemic due to the regulator's stringent quality assurance process. Incentives for suppliers to maintain quality to retain large donor-funded contracts, and the need for local wholesalers and distributors to comply with quality-related aspects of distribution agreements with global manufacturers of brand-name medical products, mitigated threats to quality. Conclusions The COVID-19 pandemic presented opportunities and market risks for circulation of substandard and falsified medical products in Zimbabwe. There is a need for policymakers to invest in measures to safeguard the quality of medical products during emergencies and to build resiliency against future supply chain shocks.

Competing interests None declared. Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details. Patient consent for publication Not applicable. Ethics approval The study received ethical approval from the research ethics review boards at the University of North Carolina at Chapel Hill (IRB # 20-3065) and from the Medical Research Council of Zimbabwe (MRCZ/A/2596). Additional permission to interview key informants affiliated with the Ministry of Health and Child Care (MOHCC) was granted by the National Institute of Health Research within the MOHCC. Participants gave informed consent to participate in the study before taking part. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental file. Study interview guide and codebook are available as article supplementary files. De-identified qualitative memos summarizing participant interviews are available upon reasonable request. Requests should be directed to the corresponding author. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of..

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