Publications by authors named "Delese Mimi Darko"

Article Synopsis
  • * In children, Lassa fever presents symptoms similar to adults, with high case fatality rates (6-63%), particularly concerning in neonates (66.7%-75%) and significant risks such as bleeding and altered mental status.
  • * Developing a safe and effective vaccine is crucial, especially since current trials do not adequately include pregnant/breastfeeding women and young children; targeted strategies for diagnosis, management, and prevention in these high
View Article and Find Full Text PDF

Introduction: The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.

View Article and Find Full Text PDF

Vaccines are important public health tools and formed part of the fight against the COVID-19 pandemic. Five COVID-19 vaccines were given Emergency Use Authorization in Ghana and deployed during the pandemic. Early phase trials of the vaccines were mostly not conducted in Africans.

View Article and Find Full Text PDF
Article Synopsis
  • The search for effective ways to prevent respiratory syncytial virus (RSV) in infants has continued for over 60 years, leading to the approval of two new products in higher-income countries: a monoclonal antibody called nirsevimab and a maternal vaccine known as RSVpreF.
  • These products are currently unavailable in low-income regions, where most RSV-related deaths occur, highlighting a significant global health disparity.
  • The paper also reviews the safety and effectiveness of these treatments, discusses potential implementation strategies in various countries, and emphasizes that with political commitment and affordable pricing, preventing RSV in infants could be achievable worldwide.
View Article and Find Full Text PDF

Substandard and falsified (SF) medical products pose a major threat to public health and socioeconomic development, particularly in low- and middle-income countries. In response, public education campaigns have been developed to alert consumers about the risks of SF medicines and provide guidance on 'safer' practices, along with other demand- and supply-side measures. However, little is currently known about the potential effectiveness of such campaigns while structural constraints to accessing quality-assured medicines persist.

View Article and Find Full Text PDF

Background: The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new.The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted.

View Article and Find Full Text PDF

Background: Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018.

View Article and Find Full Text PDF

Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current status of the initiative's operating model by the pharmaceutical industry users. This study examined the challenges being encountered and identified strategies that would strengthen the ECOWAS-MRH initiative moving forward. The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from manufacturers who have submitted applications to the joint assessment procedure and had identified recommendations for improving the performance of the ECOWAS-MRH initiative.

View Article and Find Full Text PDF

The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and effective medicines and vaccines by the 15 countries in the Economic Community of West African States region. Although this project has made significant progress towards the realisation of its goals, challenges still remain. The aims of this study were to evaluate the effectiveness and efficiency of the WA-MRH, examine what challenges are being encountered and identify strategies that would strengthen the process for realising the initiative's goals.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

Capacity building programmes for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients.

View Article and Find Full Text PDF

Introduction: COVID-19 is a global pandemic seen in modern times. The clinical characteristics, treatment regimen and duration of hospitalization of COVID-19 patients remain unclear in Ghana.

Methods: we retrospectively reviewed the secondary data of 307 discharged COVID-19 patients to characterize their demographics, clinical symptoms, treatment regimen given and duration of hospitalization.

View Article and Find Full Text PDF

WHO convened an Advisory Group (AG) to consider the feasibility, potential value, and limitations of establishing a closely-monitored challenge model of experimental severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in healthy adult volunteers. The AG included experts in design, establishment, and performance of challenges. This report summarizes issues that render a COVID-19 model daunting to establish (the potential of SARS-CoV-2 to cause severe/fatal illness, its high transmissibility, and lack of a "rescue treatment" to prevent progression from mild/moderate to severe clinical illness) and it proffers prudent strategies for stepwise model development, challenge virus selection, guidelines for manufacturing challenge doses, and ways to contain SARS-CoV-2 and prevent transmission to household/community contacts.

View Article and Find Full Text PDF

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

View Article and Find Full Text PDF

Introduction: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries.

Objective: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana.

Methods: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana.

View Article and Find Full Text PDF