Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities.

PURPOSE: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making practices and evaluating the overall regulatory performance from 2019 to 2021, as well as the challenges and opportunities for improvement. METHODS: The FDA Ghana representatives completed the optimising efficiencies in regulatory agencies (OpERA) questionnaire, including data identifying the milestones and overall approval times for all products registered by the FDA Ghana from 2019 to 2021. RESULTS: Of the new active substances approved from 2019 to 2021, 91% were biologicals processed by full or abridged reviews pathways. Timelines for these reviews were within authority targets but were longer compared with generics. Of generics approved from 2019 to 2021, 97% were pharmaceuticals processed by the full review pathway, with timelines within authority targets and shorter compared with new active substances. Regardless of the review model used, approval times for new active substances increased from 84 to 355 calendar days 2019-2021 due to the impact of the pandemic. Guidelines, standard operating procedures and review templates were in place and the majority of indicators for good review practices were implemented. Several quality decision-making practices were implemented, although currently there is not a systematic structured approach. CONCLUSION: The FDA Ghana monitors regulatory performance and currently meets its target timelines. To achieve World Health Organization Maturity Level 4 status, an electronic tracking system, benefit-risk assessment framework and template and the publication of assessment reports are recommended.

Priorities and Understanding of Pregnancy Among Women With Congenital Heart Disease: A Mixed-Methods Study.

Background: Many women with congenital heart disease (CHD) desire safe and successful pregnancies, but a significant proportion does not seek prepregnancy counseling. Objectives: This study aims to distinguish the personal priorities and perceptions about pregnancy in this growing population. Methods: Women aged 18 to 50 years with CHD were enrolled from 2 sites. Using a mixed-methods approach (Q-methodology), 179 participants sorted 23 statements representing a collection of views on pregnancy using priority forced ranking along a scale from "strongly agree" to "strongly disagree." Results: Majority of women were between 25 and 29 years of age, had moderate or severely complex CHD, and were married. Five unique group identities were elucidated from patient responses. Group 1 was centered around a strong desire to start a family. Women in group 2 had significant anxiety, and their psychological wellbeing interfered with their decision to start a family. Women in group 3 were concerned about premature death; if they do have kids, they want to be alive to see them grow old. Women in group 4 had strong objections to termination. Group 5 valued health care engagement. Group identities were unrelated to CHD complexity and demographic factors such as age and marital status. Six differentiating statements were identified that help distinguish which group a woman aligns with. Conclusions: Women with CHD have diverse priorities and values relating to pregnancy and heart disease. This study used a mixed-methods approach to provide a framework identifying several domains for targeted prepregnancy counseling in women with CHD.

Atypical presentation of COVID-19 in a patient with type 2 diabetes at an urban primary care facility in Accra, Ghana.

This is a case report of a 55-year-old man with Type 2 Diabetes Mellitus who presented with progressive breathlessness, chest pain and hyperglycaemia. An initial impression of a chest infection was made. Management was initiated with antibiotics, but this was unsuccessful, and he continued to desaturate. A screen for Coronavirus Disease of 2019 (COVID-19) returned positive. There was no prodrome of fever or flu-like illness or known contact with a patient known to have COVID-19. This case is instructive as he didn't fit the typical case definition for suspected COVID-19. There is significant community spread in Ghana, therefore COVID-19 should be a differential diagnosis in patients who present with hyperglycaemia and respiratory symptoms in the absence of a febrile illness. Primary care doctors must have a high index of suspicion in cases of significant hyperglycaemia and inability to maintain oxygen saturation. Patients known to have diabetes and those not known to have diabetes may develop hyperglycaemia subsequent to COVID-19. A high index of suspicion is crucial for early identification, notification for testing, isolation, treatment, contact tracing and possible referral or coordination of care with other specialists. Early identification will protect healthcare workers and patients alike from cross-infection.