Using comprehensive disease modeling to assess the burden of substandard and falsified oxytocin in Kenya

BACKGROUND Substandard and falsified (SF) oxytocin threatens the health of pregnant patients, resulting in prolonged illness and severe avertable disease outcomes. Additionally, SF oxytocin leads to an economic burden on the healthcare system and society due to increased treatment costs and productivity losses from sickness and premature death. While oxytocin is widely accessible, there are concerns about its quality and the burden of SF oxytocin remains understudied. OBJECTIVE To develop an impact model to estimate the health and economic burden of SF oxytocin in Kenya. This paper presents the methodology and the findings of assessing SF oxytocin in Kenya. METHODS A decision tree model was developed to compare health outcomes and costs with and without SF oxytocin from a healthcare sector and societal perspective. This model incorporates healthcare seeking behavior, epidemiological parameters, medicine quality, health outcomes and costs. The main assumption of the model is that lower active pharmaceutical ingredient (API) percentage results in lower medicine efficacy. Sensitivity analyses were performed to evaluate parameter uncertainty. FINDINGS For 1.1 million pregnant patients delivering in a healthcare facility in Kenya and a 7% prevalence of oxytocin with 75%-90% API, the model estimates that the presence of SF oxytocin in Kenya is associated with 1,484 additional cases of mild PPH, 583 additional cases of severe PPH, 15 hysterectomies, 32 deaths, 633 DALYs accrued, 560 QALYs lost, and 594 years of life lost yearly. The economic burden of SF oxytocin was $1,970,013 USD from a societal perspective, including $1,219,895 from the healthcare sector perspective. Productivity losses included $12,069 due to missed days of work and $725,979 due to premature death. CONCLUSIONS By providing local estimates on the burden of SF medicines, the model can inform key policy makers on the magnitude of their impact and support initiatives that facilitate greater access to quality medicines. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The author(s) received no specific funding for this work ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: N/A I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable All relevant data are within the manuscript and its Supporting Information files.