PMID- 32770586
OWN - NLM
STAT- MEDLINE
DCOM- 20210702
LR  - 20210702
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 29
IP  - 9
DP  - 2020 Sep
TI  - Tuberculosis drug safety and pharmacovigilance in health system of Kosova: A 
      cross-sectional analysis.
PG  - 1037-1045
LID - 10.1002/pds.5076 [doi]
AB  - 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, secondary and tertiary health care levels in 
      Kosova. We included 930 registered tuberculosis 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 collected 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 comprehensible 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.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Krasniqi, Shaip
AU  - Krasniqi S
AD  - Institute of Pharmacology and Toxicology and Clinical Pharmacology, Faculty of 
      Medicine, University of Prishtina "Hasan Prishtina", Prishtina, Kosovo.
FAU - Neziri, Burim
AU  - Neziri B
AUID- ORCID: 0000-0002-4515-8640
AD  - Institute of Clinical Physiology, Faculty of Medicine, University of Prishtina 
      "Hasan Prishtina", Prishtina, Kosovo.
FAU - Jakupi, Arianit
AU  - Jakupi A
AD  - Health Agency for Development - HAD, Prishtina, Kosovo.
FAU - Shurdhaj, Ismajl
AU  - Shurdhaj I
AD  - Health Agency for Development - HAD, Prishtina, Kosovo.
FAU - Daci, Armond
AU  - Daci A
AD  - Department of Pharmacy, Faculty of Medicine, University of Prishtina "Hasan 
      Prishtina", Prishtina, Kosovo.
FAU - Jupolli-Krasniqi, Nora
AU  - Jupolli-Krasniqi N
AD  - Health Agency for Development - HAD, Prishtina, Kosovo.
FAU - Pira, Mimoza
AU  - Pira M
AD  - Health Agency for Development - HAD, Prishtina, Kosovo.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200807
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antitubercular Agents)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Antitubercular Agents/*adverse effects
MH  - Central Nervous System Diseases/chemically induced/*epidemiology
MH  - Cross-Sectional Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Gastrointestinal Diseases/chemically induced/*epidemiology
MH  - Humans
MH  - Incidence
MH  - Kosovo/epidemiology
MH  - Male
MH  - Middle Aged
MH  - National Health Programs/organization & administration/statistics & numerical 
      data
MH  - Pharmacoepidemiology/*organization & administration/statistics & numerical data
MH  - Pharmacovigilance
MH  - Registries/statistics & numerical data
MH  - Risk Factors
MH  - Sex Factors
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Tuberculosis, Pulmonary/*drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - TB inpatients
OT  - TB outpatients
OT  - adverse effects
OT  - pharmacoepidemiology
OT  - tuberculosis
EDAT- 2020/08/10 06:00
MHDA- 2021/07/03 06:00
CRDT- 2020/08/10 06:00
PHST- 2019/04/26 00:00 [received]
PHST- 2020/06/04 00:00 [revised]
PHST- 2020/06/18 00:00 [accepted]
PHST- 2020/08/10 06:00 [pubmed]
PHST- 2021/07/03 06:00 [medline]
PHST- 2020/08/10 06:00 [entrez]
AID - 10.1002/pds.5076 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2020 Sep;29(9):1037-1045. doi: 10.1002/pds.5076. Epub 
      2020 Aug 7.