ORIGINAL REPORT Tuberculosis drug safety and pharmacovigilance in health system of Kosova: A cross-sectional analysis Shaip Krasniqi 1 | Burim Neziri 2 | Arianit Jakupi 3 | Ismajl Shurdhaj 3 | Armond Daci 4 | Nora Jupolli-Krasniqi 3 | Mimoza Pira 3 1 Institute of Pharmacology and Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Prishtina “Hasan Prishtina”, Prishtina, Kosovo 2 Institute of Clinical Physiology, Faculty of Medicine, University of Prishtina “Hasan Prishtina”, Prishtina, Kosovo 3 Health Agency for Development - HAD, Prishtina, Kosovo 4 Department of Pharmacy, Faculty of Medicine, University of Prishtina “Hasan Prishtina”, Prishtina, Kosovo Correspondence Burim Neziri, Institute of Clinical Physiology, Faculty of Medicine, University of Prishtina “Hasan Prishtina”, Rrethi i Spitalit, p.n., 10000 Prishtina, Kosovo. Email: burim.neziri@uni-pr.edu Funding information Global Fund to Fight AIDS, Tuberculosis, and Malaria, within the Project for Kosovo “Maintaining and Scaling Up Tuberculosis Prevention and Treatment Activities in Kosovo”, Grant/Award Number: KOS- 911-G05-T Abstract Background: Tuberculosis (TB) remains a significant worldwide social and life- threatening epidemiological problem. Because this disease requires multiple drug treatment and prolonged therapy for several months, followed by a high probability of adverse effects (AEs), we assessed AE monitoring for anti-TB drugs in the Health Care System of Kosova. Methods: This survey was a cross-sectional analysis performed at the primary, sec- ondary and tertiary health care levels in Kosova. We included 930 registered tuber- culosis patients within three levels of this health system in our study. Furthermore, we interviewed 62 physicians and 71 nurses at TB health facilities. Data were col- lected from official TB registers and personal contact with patients for 12 months. Results: The representative age group was 19 to 29 years (30.49%), followed by a group of patients aged >60 years (23.23%). Among 930 patients treated with TB drugs, the total incidence of adverse AEs was 29.03%. Female TB patients had a higher rate of AEs than did male patients (33.56% vs 28.84%, respectively). The highest incidence of registered AEs was recorded in the gastrointestinal system (270, 80.83%), followed by the central nervous system (CNS, 7.50%) and was lower in other organ systems. The reporting of anti-TB drug effects by medical staff (TB medical doctor and TB medical nurse) at different levels of TB medical settings occurred among 62.90% of medical doctors and 81.69% of nurses. Only 53.23% of medical doctors and 46.48% of nurses completed pharmacovigilance training. Conclusion: The pharmacovigilance approach in Health System of Kosova is not com- prehensible and not systematic. The relatively low incidence of AEs among TB patients is due under reporting of these by medical staff. The knowledge, attitudes, and adherence of medical staff reveal low awareness for pharmacovigilance activities, and this concern should be addressed to reinforce this important issue for the safe treatment of TB patients. KEYWORDS adverse effects, pharmacoepidemiology, TB inpatients, TB outpatients, tuberculosis Received: 26 April 2019 Revised: 4 June 2020 Accepted: 18 June 2020 DOI: 10.1002/pds.5076 Pharmacoepidemiol Drug Saf. 2020;1–9. wileyonlinelibrary.com/journal/pds © 2020 John Wiley & Sons Ltd 1