Understanding, readiness, and response of healthcare professionals in combating falsified medical products in Eritrea: a population-based survey.

Background: The circulation of falsified medical products is a global threat and is expected to be higher in low- and middle-income countries. Objective: This study was conducted to assess the understanding, readiness, and response of Eritrea's healthcare professionals (HCPs), and identify potential areas of intervention to combat circulation of falsified medical products. Design: This was a nationwide population-based cross-sectional survey, conducted in December 2021. Methods: This study enrolled representative samples of HCPs working in public and private health facilities. Two-stage stratified cluster sampling was used to select study participants and data were collected through face-to-face interviews. Descriptive statistics, Mann-Whitney U test, Kruskal-Wallis test along with their post hoc tests, Jonckheere-Terpstra, and logistic regression analyses were performed as appropriate. Results: The study enrolled 707 HCPs, and 96.6% were successfully surveyed. The majority of the participants (62.5%) encountered products with suspected quality defects and 63.8% claimed that they had reported the incident(s) at least once. About 85% reported that complaints should be submitted to the Eritrean Pharmacovigilance Centre and 74.0% indicated that it should be reported at the earliest time possible even if the reporter lacks details. The standard reporting form for suspected product quality issues was correctly recognized by 13.8%. Overall, the median knowledge and attitude scores were found to be 9 out of 17 (interquartile range, IQR: 4.0) and 30 out of 35 (IQR: 4.0), respectively. Not knowing how to report (55.6%) and what to report (34.9%), no/delayed feedback from the regulatory authority (30.0%), and unavailability of reporting forms (29.0%) were the frequently reported barriers to reporting. In addition, profession (p = 0.027), no/delayed feedback (adjusted odds ratio [AOR]: 4.70; 95% CI: 2.17-10.18; p < 0.001), and not knowing how to report (AOR: 0.12; 95% CI: 0.05-0.28; p < 0.001) were found to be determinants of reporting suspected product quality defects. Conclusion: The readiness and response of Eritrea's HCPs in detecting and reporting falsified medical products seems promising, although a significant knowledge gap was observed.

What is the knowledge, attitude and practice of Eritrean healthcare professionals and their barriers to reporting? Background: Healthcare professionals (HCPs) play a key role in the fight against circulation of falsified medical products, a global threat. Therefore, they are expected to be knowledgeable, vigilant, and responsive enough toward early detection and reporting of suspected falsified medical products. This study was conducted to assess the understanding, readiness and response of Eritrea's HCPs in combating falsified medical products and identify potential areas of intervention. Methods: This was a nationwide population-based cross-sectional survey conducted in December 2021, and it enrolled representative samples of HCPs working in public and private health facilities. Data was collected through face-to-face interviews. Results: In this study, it is observed: that there is a significant association of knowledge and attitude with the level of education; those with low level of education had low knowledge and poor attitude.reporting a suspected product quality problem and hindering factors of reporting were found to be significantly associated with profession.three-fourth of the study participants indicated that cases should be reported at the earliest possible time even if the reporter lacks details.that the majority of the respondents could not recognize the standard reporting form for suspected product quality issues. Conclusions: The readiness and response of Eritrea's HCPs in detecting and reporting of falsified medical products seem promising even though a significant knowledge gap was observed. To enhance the ongoing efforts, in which essence massive sensitization is presumed to have paramount importance.

Tamsulosin and risk of priapism: A causality assessment using Austin Bradford Hill Criteria.

Tamsulosin hydrochloride, a selective alpha-adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC025  = 4.1; PRR025  = 19.9; ROR025  = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a 'sole suspect,' and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha-adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off-label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.

Knowledge, attitude and practice of antibiotics and their determinants in Eritrea: an urban population-based survey.

OBJECTIVE: To measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population. DESIGN: A population-based, nation-wide, cross-sectional study. SETTING: Urban settings of Eritrea. PARTICIPANTS: Members of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants. DATA COLLECTION AND ANALYSIS: Date were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant. PRIMARY AND SECONDARY OUTCOME MEASURES: Main outcome variables were knowledge, attitude and practice of antibiotics and ABR. Secondary outcome measure was the determinants of knowledge, attitude and practice. RESULTS: A total of 2477 adults were interviewed. The mean score of knowledge and attitude of antibiotics and ABR was 10.36/20 (SD=3.51, minimum=0 and maximum=20) and 22.34/30 (SD=3.59, minimum=6 and maximum=30), respectively. Of those who used antibiotics, the proportion of at least one inappropriate practice (use of antibiotics without prescription and/or discontinuation of prescribed antibiotics before completing the full course) was 23.8%. Young age <24 years (adjusted odds ratio (AOR)=1.61, 95% CI: 1.08 to 2.41), male sex (AOR=1.48, 95% CI: 1.14 to 1.91), higher level of education (AOR=1.76, 95% CI: 1.08 to 2.88), and negative attitude towards appropriate use of antibiotics (AOR=0.95, 95% CI: 0.92 to 0.97) were found to be the significant determinants of inappropriate practice of antibiotics. CONCLUSION: The gap in knowledge and inappropriate practice of antibiotics in the Eritrean urban population was widespread; requiring immediate attention from policy-makers and healthcare professionals.

Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database.

BACKGROUND: Diclofenac, a nonsteroidal anti-inflammatory drug, is not a documented cause of rhabdomyolysis in the Summaries of Product Characteristics held by major regulators. There are, however, eight published single case reports that associate rhabdomyolysis with diclofenac. OBJECTIVE: Triggered by a serious local case report, this study was conducted to evaluate the evidence for a causal association between diclofenac and rhabdomyolysis. PATIENTS AND METHODS: A descriptive analysis of rhabdomyolysis associated with diclofenac was conducted by mining data from the WHO Global Database of Individual Case Safety Reports, VigiBase, and published case reports. RESULTS: 70 eligible cases were retrieved from VigiBase. The median age was 56.5 years (range 1-90). Where reported precisely (26 reports), the median time to onset of rhabdomyolysis following administration of diclofenac was 3 days. In 20 cases, diclofenac was reported as a sole suspect and was solely administered in 14 of these. In 30 cases, rhabdomyolysis abated following withdrawal of diclofenac. Seven of these cases fulfilled the WHO-UMC case-causality assessment criteria for 'probable'. Diclofenac was probably an indirect cause in another five reports where rhabdomyolysis ensued from injection-site necrosis. There were eight fatalities and intramuscular administration was over-represented in this group. In 27 patients taking lipid-lowering agents, the incidence of acute kidney injury with rhabdomyolysis was 62.9% compared with 37.1% for the whole cohort. Off-label use of diclofenac for minor or undiagnosed conditions was reported. CONCLUSION: Currently available data suggests a causal link between diclofenac and rhabdomyolysis either directly or indirectly.

Hydrochlorothiazide and risk of hearing disorder: a case series.

BACKGROUND: Hydrochlorothiazide is not known to cause hearing disorder. The Eritrean Pharmacovigilance Centre, however, has received cases of hearing disorder, including irreversible deafness, associated with hydrochlorothiazide. The aim of this study is, therefore, to assess the causal relationship between hydrochlorothiazide and hearing disorder. METHODS: Data was retrieved from the WHO global adverse drug reaction database, VigiBase™. A search on VigiBase™ was made on August 6, 2017 using "hydrochlorothiazide" as drug substance, and "ototoxicity", "decreased hearing", and "vestibular disorder" as reaction terms. Cases were retrieved using VigiLyze™ and exported to an Excel spreadsheet for descriptive analysis. Causality was assessed using Austin Bradford-Hill criteria and labeledness of the reaction was evaluated through a thorough literature review including the summary of product characteristics. RESULTS: From 1972 to August 2017, 94 cases of hearing disorder associated with hydrochlorothiazide were submitted from 18 countries to VigiBase™. The median age was 64 years with almost equal male to female ratio. In 53.2% of the cases, hydrochlorothiazide was reported as the only suspected drug. Of these, 26 cases encountered hearing disorder following the sole intake of hydrochlorothiazide. Reaction was marked as "serious" in 36% of the cases and median time to reaction onset was 3 days. Outcome was reported as reversible in 66.7% of the cases. Reaction resolved in 17 cases following withdrawal of hydrochlorothiazide and recurred in one case after subsequent rechallenge with the product. Consistency of cases and a dose-response relationship was also observed in this case series. CONCLUSIONS: This case series assessment found a suggestive causal relationship between hydrochlorothiazide and hearing disorder. Taking the inherent limitations of this study into account, results should be interpreted with caution and further studies are required to validate the safety signal.