Pharmacovigilance and Ranitidine Withdrawal Awareness among Libyan Private Pharmacies (Gharyan): A Cross-Sectional Study

INTRODUCTION. Pharmacovigilance ensures drug safety through continuous monitoring, yet awareness remains limited in low-resource settings. Ranitidine, a widely used antacid, was withdrawn globally in 2020 due to contamination with N-nitrosodimethylamine (NDMA), a suspected carcinogen. Despite an official withdrawal from drug circulation, ranitidine is still at risk of being used unreasonably; the conditions given make it a relevant goal to assess professional awareness of pharmaceutical employees.

AIM. This study aimed to detect pharmacovigilance challenges among Lybian pharmacies and explore the new growth vectors using awareness of ranitidine withdrawal reasons and safety issues among pharmacy employees as an example.

MATERIALS AND METHODS. A cross-sectional study was conducted engaging 130 pharmacy employees of Gharyan city, Libya, in January-March 2023. A structured questionnaire with three sections was used, including: 1) demo graphics (age, gender, education, and experience); 2) basic pharmacovigilance knowledge of participants (six questions with Yes/No answers); 3) awareness of ranitidine withdrawal (six questions with Yes/No answers). Data were analysed using descriptive statistics.

RESULTS. The survey showed that almost a third of participants (36.2%) were not familiar with the term “pharmacovigilance”; more than two-thirds (63.8%) did not know that Libya’s national pharmacovigilance centre existed. This contradicts the responses regarding pharmacovigilance measures: 78.5% stated they were trained in pharmacovigilance; 81.5% knew about special report forms to be filled out for any adverse drug reactions, while 16.2% previously made reports on adverse reactions. 55.4% of participants were familiar with the cases where drugs were withdrawn due to related risks. At the same time, 79.2% thought that ranitidine was still dispensed from the pharmacies; and 30.8% misclassified ranitidine, a Н2-blocker, as an antihistamine. 61.5% of participants thought carcinogenic impurities were caused by manufacturing contamination; moreover, only another 36.1% associated the impurities also with the improper storage.

CONCLUSIONS. The identified critical gaps in pharmacovigilance knowledge and ranitidine safety highlight the need for targeted educational interventions among Gharyan pharmacy employees and regulatory enforcement of drug withdrawals from the circulation.

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