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Substandard and falsified medicines are harmful to patients, causing prolonged illness, side effects, and preventable deaths. Moreover, they have an impact on the health system and society more broadly by leading to additional care, higher disease burden, productivity losses and loss of trust in health care. Models that estimate the health and economic impacts of substandard and falsified medicines can be useful for regulators to contextualize the problem and to make an economic case for solutions. Yet these models have not been systematically catalogued to date. We reviewed existing models that estimate the health and economic impact of substandard and falsified medicines to describe the varying modeling approaches and gaps in knowledge. We compared model characteristics, data sources, assumptions, and limitations. Seven models were identified. The models assessed the impact of antimalarial (n = 5) or antibiotic (n = 2) quality at a national (n = 4), regional (n = 2), or global (n = 1) level. Most models conducted uncertainty analysis and provided ranges around potential outcomes. We found that models are lacking for other medicines, few countries’ data have been analyzed, and capturing population heterogeneity remains a challenge. Providing the best estimates of the impact of substandard and falsified medicines on a level that is actionable for decision-makers is important. To enable this, research on the impact of substandard and falsified medicines should be expanded to more medicine types and classes and tailored to more countries that are affected, with greater specificity.

Substandard and falsified medicines are often reported jointly, making it difficult to recognize variations in medicine quality. This study characterized medicine quality based on active pharmaceutical ingredient (API) amounts reported among substandard and falsified essential medicines in low- and middle-income countries (LMICs). A systematic review and meta-analysis was conducted using PubMed, supplemented by results from a previous systematic review, and the Medicine Quality Scientific Literature Surveyor. Study quality was assessed using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). Random-effects models were used to estimate the prevalence of medicines with N = 9,724), 25.9% (95% CI: 19.3–32.6%) reported having

Substandard and falsified antimalarials contribute to the global malaria burden by increasing the risk of treatment failures, adverse events, unnecessary health expenditures, and avertable deaths. Yet no study has examined this impact in Western Francophone Africa to date. In Benin, where malaria remains endemic and is the leading cause of mortality among children under age five, there is a lack of robust data to combat the issue effectively and inform policy decisions. We adapted the Substandard and Falsified Antimalarial Research Impact (SAFARI) model to assess the health and economic impact of poor-quality antimalarials in this population. The model simulated population characteristics, malaria infection, care-seeking behavior, disease progression, treatment outcomes, and associated costs of malaria. We estimated approximately 1.8 million cases of malaria in Benin among children under age five, which cost $177 million (95% CI: $176 – $178 million) in treatment costs and productivity losses annually. Substandard and falsified antimalarials were responsible for 2.8% (n=165) of deaths and nearly $4.9 million in annual costs. Moreover, we found that replacing all antimalarials with quality-assured artemisinin combination therapies (ACTs) could result in $13.6 million in cost-savings, and increasing pediatric malaria care-seeking by 20% could bring $19.4 million in cost-savings. These results highlight the value of improving access to quality-assured ACTs for malaria treatment and increasing care-seeking in Benin. Policymakers and key stakeholders should use these findings to advocate for increased access to quality-assured antimalarials, inform policies and interventions to improve healthcare access and quality, and reduce the burden of malaria.

Summary and Conclusion One hundred Egyptian village children were immunized with 1.0 ml. of a Shigella flexneri 3 vaccine, given in three divided doses of 0.3 ml., 0.3 ml. and 0.4 ml. at weekly intervals. A similar group of unvaccinated children were observed as controls. During a six month observation period following vaccination, 25 (26.8 per cent) of the children who received the vaccine were found to be infected with Shig. flexneri 3 organisms as compared with 18 (20.4 per cent) of the children in the control group. The number of infections with other Shigella organisms, and the number of episodes of diarrheal disease, was approximately the same in both groups of children. Immunization with a Shigella flexneri 3 vaccine was not effective in preventing Shigella flexneri 3 infections, or diarrheal disease associated with these organisms, in a group of Egyptian village children living in a highly endemic environment.

Summary Egyptian village children in the first six months of life, while exposed to a highly endemic environment and experiencing a higher incidence of diarrheal disease, were less frequently infected with Shigella organisms than were older children. Shigella organisms were not recovered from infants in the neonatal period even during seasons of high incidence of infection in older subjects. Shigella infections were most prevalent during the second and third years of life.