Leveraging WHO's Global Benchmarking Tool to strengthen capacity in clinical trials oversight for public health emergencies: the GHPP VaccTrain model.

BACKGROUND: A stable, well-functioning and integrated national medicines regulatory system is a core component of health systems resilient against infectious disease outbreaks. In many low- and middle-income countries, however, sizable gaps exist in the emergency preparedness framework of national regulatory authorities (NRAs). RegTrain-VaccTrain is a project of Germany Ministry of Health's Global Health Protection Programme that contributes to global efforts aimed at strengthening such regulatory systems by providing technical support and advice to partner NRAs. In this study, we probed the outputs of our capacity-strengthening activities for clinical trials oversight (CTO) to take stock of progress made and examine remaining priorities in order to provide specialized technical assistance in addressing them to improve operational readiness for emergencies. METHOD: Data validated from NRA self-benchmarking results in 2017 and worksheet records of November 2021 were utilized to assess the emergency preparedness capacity for CTO in three VaccTrain partner NRAs (Liberia, Sierra Leone, The Gambia) before and after interventional capacity-strengthening partnership, using specific public health emergency-related (sub-)indicators of the WHO Global Benchmarking Tool. RESULTS: A generally weak and vulnerable structural framework for CTO characterized the emergency preparedness capacity in all three partner NRAs at baseline, thus putting their operational readiness for public health emergencies at risk. VaccTrain's collaborative work was successful at supporting individual NRAs to develop the full spectrum of operational structures (including (draft) regulations, guidelines, and standard operating procedures) required to improve regulatory preparedness. A gap in the formal approval and implementation of developed legal documents in two of three NRAs still remains. Notwithstanding, a robust emergency framework now exists and the NRAs stand better prepared to respond to (future) locally-concerning health emergencies, during which time clinical trials activity was observed to heighten. CONCLUSIONS: These results exemplify a north-south capacity-strengthening partnership model that effectively contributes in developing structures to enhance regulatory oversight and support expeditious product development in response to crises. They further underscore the equally critical role local/national processes play in facilitating the full implementation of developed structures.

Availability of psychiatric medication in an urban area of The Gambia/West Africa.

The use of a wide and differentiated arsenal of psychopharmacological substances is integral part of modern psychiatric treatment in addition to non-pharmacological interventions (e.g., psychotherapy). However, worldwide the access to such medication can vary considerably. In this study, access to a wide range of psychiatric medication including antidepressants, antipsychotics, tranquilisers, mood stabilisers and ADHD medication was analysed for the Western African country of The Gambia by surveying private pharmacies within the urban and sub-urban areas of Banjul, the country's capital. The results show that most of these pharmacies tend to keep a very limited range of psychiatric drugs in stock. In many instances only a tricyclic antidepressant (e.g., amitriptyline), the neuroleptic haloperidol and the benzodiazepine diazepam were readily available. None of the pharmacies kept ADHD medication in stock, and only very few had mood stabilisers. However, several pharmacies reported to be able to obtain at request most of the drugs from international sources, including atypical antipsychotics, SSRIs, and dual-acting antidepressants. Therefore, it can be concluded that in rapidly growing urban centres of developing countries exemplified by Banjul, the infrastructure for modern psychopharmacotherapy is well established, and that the lack of immediate access to modern psychopharmacological compounds represents not so much a genuine lack of availability, but rather a lack of demand which may be associated with the considerable cost-implications of such treatment and the absence of prescribers (i.e. psychiatrists and other doctors with an expertise in modern psychopharmacotherapy). To our knowledge this is the first such study for The Gambia and results might be representative for the wider Western African region. It also exemplifies the challenges psychiatry is facing in developing countries worldwide. It is essential that government-sponsored so-called "essential medication lists" are continuously updated in order to reflect the progress in medical research including psychopharmacology. Further research into how to facilitate psychopharmacotherapy is urgently needed in order to further improve psychiatric services.