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.

Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned.

Establishing a mature pharmacovigilance system in a low-income country is a challenge. Nevertheless, Eritrea, one such low-income country, was able to achieve a fully fledged pharmacovigilance system within a period of almost 9 years. In the last five years (2014-2019), the Eritrean Pharmacovigilance Centre has submitted, on average, 646 individual case safety reports (ICSRs) per million inhabitants per year to the World Health Organization (WHO) global database of ICSRs. As a result, Eritrea has been rated among the top reporting countries in Africa. The center has detected about 30 safety signals, achieved maturity level three on the WHO rapid benchmarking assessment, and gained huge political commitment. In the last few years, monitoring of product quality through the pharmacovigilance system found approximately 55 medical products that were either substandard or falsified and were subsequently recalled from the Eritrean market by the National Medicines and Food Administration. The aim of this article is to describe Eritrea's success stories, key strategies for success, challenges encountered, and lessons learned to share them with the international pharmacovigilance community and beyond.

Intravenous ranitidine injection and risk of cardiac arrest: Medication errors.

BACKGROUND: Ranitidine injection is not well-known to cause cardiac arrest except in few published case reports. The Eritrean Pharmacovigilance Centre received four cases of cardiac arrest associated with ranitidine injection. OBJECTIVE: To assess the causal relationship between cardiac arrest and ranitidine, and to identify possible risk factors. METHODS: This is a descriptive case series assessment of cardiac arrest associated with ranitidine and data was mined to supplement the cases from the WHO global database of individual case safety reports. RESULTS: In all cases, ranitidine injection was administered fast IV bolus without proper dilution and the outcome was fatal in three. All patients encountered cardiac arrest within 20 minutes of intravenous use. Causality was found to be probable in two cases and possible in the other two. Cardiac arrest could have been prevented in all cases. On top of this, from the WHO global database, 185 cases of cardiac arrest and cardio-pulmonary arrest associated with ranitidine were retrieved and 49.7% were fatal. In 40% of the cases, ranitidine was reported as a single suspect. In 36 cases, cardiac arrest resolved following withdrawal of ranitidine and reaction recurred in one case after re-introduction of the product. CONCLUSION: There appears a causal link between ranitidine and cardiac arrest, possibly related to medication errors that warrants immediate attention from healthcare professionals.

Praziquantel and risk of visual disorders: Case series assessment.

INTRODUCTION: Praziquantel has been in use by helminthiasis and schistosomiasis control programs for about 30 years. Although deemed to be safe with regard to its adverse drug reaction profile in reference to the product information of Biltricide, the Eritrean Pharmacovigilance Center received reports of visual abnormalities related to the drug. This is a case series assessment of unusual cases of visual abnormalities associated with praziquantel. METHODS: Search was made in VigiBase by setting praziquantel as a drug substance, Eritrea as the reporting country and all eye disorders, high level term (HLT) to capture all visual disorders associated with Praziquantel. The retrieved dataset was exported into an Excel spreadsheet for descriptive analysis and causality was assessed using Austin Bradford-Hill criteria. RESULTS: There are a total of 2579 Individual Case Safety Reports (ICSRs) of various Adverse Drug Reactions (ADRs) of praziquantel reported from Eritrea in VigiBase. The 61 reports of visual abnormalities that arose within the first 24 hours of praziquantel administration are of note. With a strong association as evidenced by the positive IC025 value, the association of praziquantel and blurred vision was consistently reported from different health facilities over a period of three years. It is a specific association in terms of both the exposure (only praziquantel) and the outcome (blurred vision) as reported in majority of the cases. However, experimental evidences for the association are lacking, the underweight profile of the Eritrean population suggests overdosing as a possible risk factor for the occurrence of these reactions. CONCLUSION: The strength, temporal plausibility, consistency and specificity of the association are suggestive of a causal association between praziquantel and visual disorders.

Risk Factors of Gout in MDR-TB Patients in Eritrea: A Case-Control Study.

Though the incidence of gout in general population is less than 5% (globally), a study conducted in Eritrea among patients with multidrug resistant tuberculosis (MDR-TB) revealed a higher incidence (25%). Other similar studies conducted elsewhere, however, did not report gout as an adverse effect. It is unknown why a higher incidence of gout is being reported in Eritrea compared to similar studies from other countries. The objective of this study is therefore to explore risk factors for the increased risk of incident gout among MDR-TB patients in Eritrea. A case-control study was conducted in Merhano MDR-TB National Referral Hospital in Eritrea. All MDR-TB patients diagnosed with gout between June 2011 and June 2018 were considered as cases. Controls matched by age, sex, and cumulative drug exposure time were selected from the same study population (1:1 ratio). A total of 84 MDR-TB patients, 42 cases and 42 controls, were included in this study. No patient from the control group has comorbidities, while six patients from the case group have diabetes (χ2 = 6.46, df=1, p=0.026). Patients having tachycardia (OR=3.26, 95% CI=1.28, 8.27), alopecia (OR=3.11, 95% CI=1.00, 9.67), and gastrointestinal upset (OR=3.17, 95% CI=1.26, 7.96) as adverse effects and being on prolonged use of propranolol (OR=3.26, 95% CI=1.28, 8.27) were found to be more likely to develop incident gout compared to their controls. In conclusion, MDR-TB patients with diabetes mellitus, tachycardia, alopecia, and gastrointestinal upset and on prolonged use of propranolol tablet had increased risk of incident gout.

Serious hepatotoxicity following use of isoniazid preventive therapy in HIV patients in Eritrea.

WHO information note indicates that isoniazid preventive therapy (IPT) is generally safe with little risk of hepatotoxicity. However, when the policy of IPT for HIV patients was introduced in Eritrea, frequent IPT-associated hepatotoxicity and fatality have been reported to the Pharmacovigilance Centre. The aim of the study is to assess the causal association of IPT and hepatotoxicity and identify possible risk factors in patients on Highly Active Anti-retroviral Therapy (HAART). This is a case series assessment of spontaneously reported cases to the Eritrean Pharmacovigilance Centre. Data extracted from VigiFlow (reported between 2014 and 2016) were exported to excel spread sheet for descriptive and qualitative analysis. Naranjo probability scale and Austin Bradford-Hill criteria were used to assess causality. The P-Method was used to assess preventability. A total of 31 of cases of hepatotoxicity related to IPT were retrieved. Majority (80.6%) of the cases were marked as "serious" due to life-threatening situation (n = 15), hospitalization (n = 6), and death (n = 4). Baseline liver function test was normal in 61.3% and hepatitis B and C infections were ruled out in 77.4%. IPT was discontinued in 26 cases and reaction abated in 22 of them. Causality assessment using Austin Bradford-Hill criteria found that the association was strong, consistent and specific with a plausible temporal relationship and biological mechanism. IPT-associated hepatotoxicity that led to treatment interruption and death was observed in patients on HAART in Eritrea. Hence, close laboratory monitoring of patients is recommended to minimize the risk.