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

Author:

Fitsum Yodit1,Werede Azania2ORCID,Mahmud Saleh Abubeker3,Tesfamariam Eyasu H.4,Magombo Francis5,Misghina Freminatos1,Yemane Hermella1,Bahta Iyassu1,Abraham Liya1,Bahta Merhawi1ORCID,Debesai Merhawi1,Tesfagaber Meron1,Ghirmai Michael1,Tesfamariam Sirak1ORCID,Russom Mulugeta167ORCID

Affiliation:

1. National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea

2. Product Evaluation and Registration Unit, National Medicines and Food Administration, Ministry of Health, P.O.BOX 212 Asmara, Eritrea

3. Afabet Hospital, Ministry of Health, Afabet, Eritrea

4. Department of Statistics, Mai-Nefhi College of Science, Mai-Nefhi, Eritrea

5. WHO Country Office, Asmara, Eritrea

6. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands

7. European Programme for Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux, Bordeaux, France

Abstract

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.

Funder

WHO Country Office Asmara, Eritrea

Publisher

SAGE Publications

Subject

Pharmacology (medical)

Reference19 articles.

1. World Health Organization. A study on the public health and socioeconomic impact of substandard and falsified medical products, https://iris.who.int/bitstream/handle/10665/331690/9789241513432-eng.pdf?sequence=1

2. The global counterfeit drug trade: Patient safety and public health risks

3. Prevalence of Substandard and Falsified Essential Medicines

4. Bayer Global. Background information on counterfeit medicines, https://www.bayer.com/en/pharma/background-information-on-counterfeit-drugs (2022, accessed 17 May 2018).

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