Background Spontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern. Method A questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR. Result Overall, 77.6% (208) of the 268 respondents had observed ADR; however, only 17.3% of the respondents had ever reported an ADR to the Ghana FDA. Health professionals who had average knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had good knowledge of spontaneous reporting of ADR. After adjustment on potential confounding variables (Knowledge, Feedback from FDA, Uncertainty about cause of ADR, Severity of ADR), Age (AOR = 2.26, 95%CI = 1.25–4.10), Fear of Legal Consequences (AOR = 0.15, 95%CI = 0.41–0.51), Time Constraint (AOR = 0.3, 95%CI = 0.10–0.91), Pharmacovigilance training (AOR = 18.78, 95%CI = 5.46–64.59) and Unavailability of Reporting form (AOR = 0.28, 95%CI = 0.09–0.88) were found to be significantly associated spontaneous reporting of ADR. Conclusion The proportion of health professionals in the Kpone- Katamanso District who spontaneously reported observed ADR was low though they had average knowledge about ADR reporting. This underscores the need for a policy to be implemented that makes spontaneous reporting of adverse drug reaction mandatory for health professionals.

Background Millions of praziquantel doses have been delivered in schistosomiasis endemic populations through preventive chemotherapy. However, no comprehensive assessment of short and long-term safety has been conducted. This systematic review assessed safety of praziquantel in persons with and without schistosome infections who received praziquantel treatment. Methods We identified relevant studies (published, unpublished, in press or preprint) that assessed safety of praziquantel without language restriction. We searched MEDLINE, EMBASE, CINAHL, and LILACS from 1978 to 31st October 2021, using well-formulated and piloted search strategy. We also searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2021), mRCT, Google Scholar, Hinari and Africa Journals Online. References of relevant studies were checked and experts were contacted for additional studies. One author searched and managed the search output. Two authors selected studies, extracted data and assessed quality of the included studies for risk of bias. Activities at all stages were checked independently by a third reviewer. Discrepancies were resolved through discussion among the authors. Data were analysed with RevMan v5.4 and STATA v17. Binary outcomes were reported as risk ratio using random-effects model and continuous outcomes as mean difference, all presented with their 95% confidence intervals. P-value was set at 0.05. Heterogeneity was assessed using I2-static and where possible sensitivity analysis was conducted. When pooling of data was not possible, we presented data in a narrative synthesis and as tables. Main results The search retrieved 3202 studies of which 134 met the inclusion criteria; 94 (70.1%) were conducted in Africa, 17 (12.7%) in Asia, 15 (11.2%) in the Americas (14 from Brazil), 4 (3.0%) in the Middle East and 3 (2.2%) in Europe. Praziquantel mostly resulted in mild-to-moderate and transient adverse events, however, majority of the included studies had design issues, including very short follow-up times (mostly few hours) for assessing incidence of adverse events. Less than <10% of the studies reported severe or serious adverse events. The subgroup analyses of twenty studies comparing school age children (SAC) and adults, and involved over one million participants found no difference in the nature of adverse events, but SAC experienced higher incidence than adults: headache (RR 3.07, 95% CI 2.32 to 4.06, twenty studies, I2 = 98%, p < 0.00001), dizziness (RR 1.80, 95% CI 1.36 to 2.37, p = 0.0001), vomiting (RR 2.43, 95% CI 1.87 to 3.14, I2 = 98%; p < 0.00001), four time for abdominal pain (RR 3.97, 95% CI 3.09 to 5.10, I2 = 96%, p < 0.00001), nausea (RR 1.67, 95% CI 1.32 to 2.12, I2 = 97%, p < 0.0001), general discomfort (RR 1.32, 95% CI 1.03 to 1.68, I2 = 97%, p < 0.00001), fever (RR 4.78, 95% CI 3.04 to 7.52, I2 = 98%, p < 0.00001), diarrhoea (RR 1.41, 95% CI 1.12 to 1.78, I2 = 92%, p < 0.00001), itching (RR 2.42, 95% CI 1.58 to 3.70, I2 = 93%, p <0.0001) and breathing difficulty (RR 2.46, 95% CI 1.41 to 4.29, I2 = 92%, p = 0.002). There was no statistically significant difference in incidence of swelling. Some of the studies that assessed safety in pregnant women reported serious events including miscarriages, foetal deaths and congenital anomalies, but the evidence is incoclusive given the limited numbers. Some studies reported praziquantel-related visual adverse events, but evidence is limited and remains inconclusive. There was paucity of data on long term adverse events, and events in co-morbidity, polypharmacy, co-infection with taeniasis. Generally, adverse events research in this area lacked methodological rigour. Conclusions The evidence generated from this review involving millions of people and millions of doses from different geographic locations with mostly mild-to-moderate and transient adverse events shows praziquantel is safe. However, given that the primary studies included in the review had design issues, including over 95% assessing adverse events over very short follow-up times, means serious long-term adverse events would have been missed. Also, the fact that some pregnant women who received praziquantel experienced serious events including miscarriages, foetal deaths and congenital anomalies calls for caution in the inclusion of pregnant women, particularly in their first trimester, in preventive chemotherapy campaigns. Additionally, the studies that reported severe visual adverse events raise safety concerns. Praziquantel is now offered repeatedly in endemic communities and the fact that in some settings up to 90% of those without infection could be offered the drug and the fact that there was no study that compared safety between infected and non-infected recipients, warrants further research. Evidence on safety in pregnant women and their foetuses, co-morbidity, polypharmacy, co-infection with taeniasis, as well as co-administration with drugs used in other preventive chemotherapy programmes, remain inconclusive and further research with long follow-up that should include blood chemistry analysis to provide additional evidence on long term safety, is warranted. This systematic review has exposed the lack of methodological rigour in adverse events studies and recommends future research should use robust and standardized design, methods, conduct and reporting.

Background: The shortage of oocyte donors in the face of increasing demand for infertility treatment globally has become a concern for stakeholders involved in assisted reproduction. Local research on oocyte donation is relatively limited in Ghana and tends to neglect female university students who constitute a large donor group for oocyte donation.Objective: This research sought to investigate the knowledge and attitude of female university students towards oocyte donation in assisted reproduction.Method: A questionnaire-based, cross sectional study was conducted among 295 female undergraduate students. The outcome variable was willingness to donate an oocyte or not. Factors investigated were socio-demographic characteristics, knowledge and attitude towards oocyte donation. Knowledge items were measured on a binary scale, where a correct response scored ‘1’ and an incorrect response scored ‘0’. Knowledge was rated as either high (score >3) or low (score £3). Attitude items were measured on a 5-point Likert scale and rated as positive (score >24) or negative (score £24). Descriptive and inferential statistics were computed with STATA version 15, assuming statistical significance at p<0.05.Results: Majority of the students, 278 (94.2%), were Christians and had a low level of knowledge about oocyte donation (61%). Fifty-two percent and 44% of students showed a positive attitude towards oocyte donation and were willing to donate oocytes respectively. Being a Christian [AOR = 0.24, 95% CI: 0.07-0.92], spending between GhC500-1000 a month [AOR = 2.47, 95% CI: 1.48-4.11] and having a positive attitude towards oocyte donation [AOR = 2.12, 95% CI: 1.30-3.34] were associated with willingness to donate oocytes.Conclusion: The low levels of knowledge among the female university students highlights the need for information regarding oocyte donation in assisted reproduction. Existing barriers can be addressed through further research, public education and by encouraging dialogue between health authorities, academia and religious leaders could be potentially beneficial in addressing the plight of infertile couples.

Background: Spontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern. Method: A questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR.Result: Overall, 77.6% (208) of the 268 respondents had witnessed ADR; however, only 17.3% of the respondents have ever reported an ADR to the FDA. Health professionals who had adequate knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had very good knowledge of spontaneous reporting of ADR. After statistical adjustment, Age (AOR=2.26, 95%CI= 1.25–4.10), Fear of Legal Consequences (AOR=0.15, 95%CI=0.41–0.51), Time Constraint (AOR=0.3, 95%CI=0.10–0.91), Pharmacovigilance training (AOR= 18.78, 95%CI= 5.46–64.59) and Unavailability of Reporting form (AOR=0.28, 95%CI=0.09– 0.88) were found to be significantly associated spontaneous reporting of ADR. Conclusion: The proportion of health professionals in the Kpone-Katamanso District who spontaneously report observed ADR is low. Our findings underscore the need for the FDA to intensify awareness through media sensitization and engage all relevant stakeholders on the need for the entire population to report ADR.