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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.
RESUMO
BACKGROUND: Relatively large number of false-negative malaria rapid diagnostic test (RDT) results for microscopically confirmed Plasmodium falciparum cases were reported from five of the six administrative regions of Eritrea in 2015. This activated the Ministry of Health to conduct an initial exploratory investigation. The main objective of the investigation was to confirm the sensitivity of the RDTs in the field in microscopically confirmed malaria cases, identify the possible causes of the failure and recommend further actions to be taken. METHODS: A team composed of the National Malaria Control Programme, National Medicines and Food Administration and Laboratory Unit of the Ministry of Health was established to confirm the sensitivity of the SD Bioline® RDTs. A 'Malaria RDT quality monitoring form' was prepared and distributed to 13 health facilities selected on availability of microscopy services, experienced laboratory personnel and malaria endemicity, to carry out preliminary investigation on the suspected RDT quality defect. In parallel, field visits to central and regional medical warehouses as well as selected health facilities were conducted to assess the storage conditions, handling and operator procedures. Furthermore, joint field assessment was conducted with the manufacturer, SD Bioline RDTs. During the time frame of 15 July 2015 to 19 January 2016, 65 microscopically confirmed patients were tested with Malaria RDTs SD Bioline Pf/Pv/Mixed Combo cassettes. RESULTS: A total of 65 blood specimens (50 P. falciparum, 13 Plasmodium vivax and 2 mixed) confirmed microscopically were tested against the available lots of malaria RDTs. Out of the 50 P. falciparum infected blood specimens, only 10 were confirmed positive with all the lots of PfHRP-2 detecting RDTs making the false negativity rate at 80% [41/51]. The false negative result for RDT targeting PfHRP2 antigen ranged from 65% [11/17] in Gash Barka region to 100% [12/12] in Northern Red Sea Region. In addition, supervisory visits undertaken by the study team have ruled out storage, handling and operator errors as causes of false negative results as the above parameter were found to be up to standards. CONCLUSION: The investigation confirmed high false-negativity rate in PfHRP-2 detecting RDTs and has ruled out quality of RDTs, storage, handling and operator error as causes of the reported problem. Therefore, molecular characterization of the P. falciparum is highly recommended to explore if parasite characteristics can be considered as causes of false negative results.
