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

© The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License,. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.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.Peer reviewe

The Prevalence and Risk Factors of Hepatitis B Virus Infection Among Dwellers in A Peri-Urban District of Ghana: A Cross-Sectional Study

Hepatitis B virus (HBV) infection is a significant health issue affecting about 296 million people worldwide. The disease is of great public health concern in Ghana as the country is within the endemic region of HBV infection. This study sought to determine the prevalence of HBV infection and associated risk factors among dwellers in a peri-urban district of Ghana. This cross-sectional descriptive study was conducted in the Sunyani West District of the Bono Region of Ghana. Respondents aged ≥18 years were purposively recruited from the four major towns in the District with health centres. A questionnaire was used to collect data from participants, and a rapid diagnostic test for the sero-presence or otherwise of hepatitis B infection was conducted. A total of 992 respondents took part in the study, with the prevalence of HBV infection using HBsAg as a marker among all the study participants being 2.9% (male 4.0% (12/298), female 2.5% (17/694)). Females aged between 20-29 years had a comparatively higher prevalence of hepatitis B infection than their corresponding males. The intake of alcohol (RR=4.23; 95% CI:2.05-8.74, p <0.000), previously diagnosed of having a sexually transmitted disease (RR= 2.43; 95% CI: 1.03-5.71, p = .04) and having multiple sexual partners (RR= 2.27; 95% CI: 1.11-4.65, p = .02) were the significant risk factors for HBV infection among the study participants. The study showed a low prevalence of HBV infection in the Sunyani West District of Ghana using HBsAg as a serum marker to diagnose the infection. Keywords: Hepatitis, prevalence, risk factors, Sunyani Wes

Ectopic pregnancies in low resource setting: a retrospective review of cases in Kumasi, Ghana

Background: Ectopic pregnancy remains a public health threat for women in reproductive age, and a major cause of maternal mortalities in the first trimester of pregnancy. Past studies in Ghana on the burden of Ectopic Pregnancy (EP) have focused on major referral health facilities with little consideration of primary health facilities. This study was set out to determine the prevalence of Ectopic Pregnancy, demographic characteristics involved and the various types of Ectopic Pregnancy seen in primary health settings in Kumasi, Ghana.Methods: A retrospective descriptive cross-sectional study was conducted at the Suntreso Government and Tafo Government Hospitals in the Kumasi metropolitan area from 2007 to 2017. A review of 28,600 obstetric cases recorded in registers of the two facilities was done using electronic data extraction form. The data were exported into STATA/IC 14.0 for statistical analysis.Results: A prevalence of 0.76% EP was recorded over the study period of 10 years. 61.75% of the women diagnosed with EP were between the ages of 21-30 years with a mean age and standard deviation of 27.61 and 5.91 respectively. Tubal (fallopian tubes) EP was seen in 76.96% of the women diagnosed with EP. 10.18% and 7.19% of the tubal EP occurred in the cornual and fimbriae respectively. Ruptured EP was seen in 58.99% of the cases.Conclusions: The study reported EP in about one in a hundred cases. The commonest EP that emerged from this study was tubal (fallopian tube) EP. Among the tubal EP, cornual and fimbria were the commonest EP that occurred in the fallopian tube. Although cases of tubo-ovarian and ovarian EP are rare, a significant percentage were observed in this study. Early reporting and diagnosis of EP should be of great importance to prevent ruptured EP and any associated complications

Snakebites and Antisnake Venom Utilization in Ghana’s Oti Region: A 6-Year Retrospective Study

Background: Snakebite is a global environmental and occupational hazard and a significant public health threat. In rural areas, snakebite cases often go unreported and undocumented due to the lack of access to well-structured healthcare facilities/infrastructure. In some cases, the need for antisnake venom (ASV) far outstrips supply, negatively affecting treatment outcomes. This study, therefore, assessed the epidemiological characteristics of snakebite cases, their management, and how antivenoms are utilised at the selected hospital in the Jasikan District Hospital. Methods: A 6-year retrospective study using secondary data from antivenom return forms (pharmacy records), clinical records (patient folders), the District Health Information Management System-2 (DHIMS-2) database, and consulting room registers was carried out in selected hospitals in the Jasikan District, Oti, Ghana. Results: The predominant symptom of snakebite was localised pain (71.4%). The snakebite commonly occurred at home (19%) and on farms (18%). Of the 98 snakebite cases, ASV was administered to 73 (74.5%) cases. Supportive treatment applied included prophylactic antitetanus immunoglobulin (ATS) (80.6%), prophylactic antibiotics (63%), corticosteroids (80.6%), and analgesics (63%). 95% (n=94) of complete recoveries were recorded; three were discharged against medical advice, and one was mortality. The supply and use of antivenom were erratic throughout the months of high incidence, partly due to inconsistent availability at the Regional Medical Stores. The average ASV vials and hospital stay duration were 1.23±0.86 vials and 2.67±1.97 days, respectively. Although the peak of snakebites occurs in April, May, and June, the demand for antivenom in April and May exceeded supply. Conclusion: The outcome of most snakebite case management was appropriate, irrespective of inadequate ASV supply in certain months. The erratic antivenom supply should be aligned with seasonal and facility-use patterns to enhance regional snakebite management

Vitamin A status and body pool size of infants before and after consuming fortified home-based complementary foods.

BACKGROUND: Home fortification using sachets of micronutrient powder (e.g. "Sprinkles") is a food-based approach offering an alternative to high dose vitamin A (VA) supplements for infants. The primary objective was to investigate the impact of VA-home fortification on infant VA pool size. The secondary objective was to compare VA status of infants assessed by the modified relative dose response (MRDR) test before and the (13)C-retinol isotope dilution ((13)C-RID) test in the same infants after vitamin A supplementation. METHODS: A randomized-controlled trial was conducted in 7-9 month old infants in Ghana. Eligible children were randomly allocated to receive a daily sachet of "Sprinkles" with or without VA for 5 months added to complementary foods. The MRDR test indirectly determined VA liver reserves at baseline and the (13)C-RID determined VA body pool at follow-up in the same cohort of children. RESULTS: At baseline, the MRDR values (95 % CI) for infants were comparable in the intervention and control groups: normal at 0·032 (SD 0·018) (0·025-0·038) and 0·031 (SD 0·018) (0·024-0·038), respectively. After intervention, total body stores (TBS) and liver retinol concentrations did not differ between intervention and control groups; TBS were 436 (SD 303) and 434 (SD 186) μmol, respectively, and estimated liver concentrations were 0·82 (SD 0·53) and 0·79 (SD 0·36) μmol/g liver, indicating adequate reserves in all children. CONCLUSIONS: Both the MRDR and (3)C-RID tests confirmed that the infants had adequate VA status before and after home fortification of their complementary foods. These tests offered more information than serum retinol concentrations alone, which predicted VA deficiency using current suggested cutoffs not corrected for inflammation status

Characteristics of Inpatient Hypertension Cases and Factors Associated with Admission Outcomes in Ashanti Region, Ghana: An Analytic Cross-Sectional Study

Background. Hypertension remains a cause of morbidity and mortality in the Ashanti Region of Ghana. It has been featured in the top ten causes of OPD attendance, admissions, and deaths since 2012. We investigated the sociodemographic characteristics and spatial distribution of inpatient hypertensives and factors associated with their admission outcomes. Methods. A 2014 line list of 1715 inpatient HPT cases aged ≥25 years was used for the cross-sectional analytic study. Accounting for clustering, all analyses were performed using the “svy” command in Stata. Frequencies, Chi-square test, and logistic regression analysis were used in the analysis. Arc view Geographic Information System (ArcGIS) was used to map the density of cases by place of residence and reporting hospital. Results. Mean age of cases was 58 (S.D 0.0068). Females constituted 67.6% of the cases. Age, gender, and NHIS status were significantly associated with admission outcomes. Cases were clustered in the regional capital and bordering districts. However, low case densities were recorded in the latter. Conclusion. Increasing NHIS access can potentially impact positively on hypertension admission outcomes. Health educational campaigns targeting men are recommended to address hypertension-related issues

Family Planning Awareness, Perceptions and Practice among Community Members in the Kintampo Districts of Ghana

Family planning is known to prevent maternal deaths, but some social norms, limited supplies and inconsistent use makes this difficult to achieve in most low- and middle-income countries. In spite of the high fertility levels in most sub-Saharan African countries and the potential economic benefits of family planning, its patronage remains very low in the sub-region. This study was with the objective of identifying the levels of awareness, utilization, access to and perceptions about family planning and contraception. A cross-sectional study design was used for the study, with data collected from multiple sources using both quantitative and qualitative approaches. Relevant findings included a marked disconnect between family planning/contraceptive knowledge and use. The pills and injectables were the most frequently used, but females in the study population poorly patronised emergency contraception. Supplies of most family planning methods were found to be health facility based, requiring clients to have to necessarily go there for services. Some respondents harboured perceptions that family planning was the responsibility of females alone and that it fuelled promiscuity among female users. Recommendations made include ensuring that health facilities had adequate staff and expertise to provide facility-based family planning services and also to disabuse the minds of community members of the negative perceptions towards family planning

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

Online instructional experiences in an unchartered field-The challenges of student-teachers of a Ghanaian College of Education

Student satisfaction is the pinnacle upon which any effective online learning hinges. It is for that reason, educators design course activities that allow students to effectively practice, work together on relevant projects to personalize their learning. In emerging institutions like the Colleges of Education in Ghana that are traditionally inclined toward teachers’ professional development through conventional face-to-face interaction, online education became the medium of interaction for the first time to promote social distancing in response to COVID-19 pandemic while enhancing access and continuous professional development of the human resources for the education sector. This basic qualitative study examined the conduct of online teaching in a traditional face-to-face educational system in Ghana. The analysis of the semi-structured interviews revealed that the basic infrastructure for online teaching and learning is absent. Specifically, student trainees are saddled by poor internet connectivity, high cost of data in an emergency remote teaching environment. Due to these challenges, a significant proportion of the participating student-teachers wouldn’t choose online learning for their work and professional development. In view of this, the study recommends policy makers to institutionalize online education into the curricula of all professional institutions of higher education in Ghana