Pharmacovigilance Practice Among Pediatric Neurologists from Poland and Germany

Overview

Journal BMC Med Educ

Publisher Biomed Central

Specialty Medical Education

Date 2023 Aug 1

PMID 37528387

Authors

Dorota Kopciuch

Krzysztof Kus

Izabela Niskiewicz

Jedrzej Flicinski

Tomasz Zaprutko

Piotr Ratajczak

Elzbieta Nowakowska

Karolina Hoffmann

Agnieszka Koligat-Seitz

Wieslaw Bryl

Anna Paczkowska

Affiliations

Soon will be listed here.

Abstract

Objectives: To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany.

Methods: The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany.

Results: The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work.

Conclusion: There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.

References

Neininger M, Jeschke S, Kiesel L, Bertsche T, Bertsche A . Physicians' perspectives on adverse drug reactions in pediatric routine care: a survey. World J Pediatr. 2021; 18(1):50-58. PMC: 8761136. DOI: 10.1007/s12519-021-00478-1. View

John L, Arifulla M, Cheriathu J, Sreedharan J . Reporting of adverse drug reactions: an exploratory study among nurses in a teaching hospital, Ajman, United Arab Emirates. Daru. 2013; 20(1):44. PMC: 3555921. DOI: 10.1186/2008-2231-20-44. View

Wu W, Pantaleo N . Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm. 2003; 60(3):253-9. DOI: 10.1093/ajhp/60.3.253. View

Sanghavi D, Dhande P, Pandit V . Perception of pharmacovigilance among doctors in a tertiary care hospital: influence of an interventional lecture. Int J Risk Saf Med. 2013; 25(4):197-204. DOI: 10.3233/JRS-130598. View

Bisht M, Singh S, Dhasmana D . Effect of educational intervention on adverse drug reporting by physicians: a cross-sectional study. ISRN Pharmacol. 2014; 2014:259476. PMC: 3977536. DOI: 10.1155/2014/259476. View

Androsova G, Krause R, Borghei M, Wassenaar M, Auce P, Avbersek A . Comparative effectiveness of antiepileptic drugs in patients with mesial temporal lobe epilepsy with hippocampal sclerosis. Epilepsia. 2017; 58(10):1734-1741. DOI: 10.1111/epi.13871. View

Paveliu M, Bengea-Luculescu S, Toma M, Paveliu S . Perception on adverse drug reaction reporting by physicians working in southern romania. Maedica (Bucur). 2013; 8(1):17-25. PMC: 3749755. View

Agarwal R, Daher A, Ismail N . Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from klang valley in malaysia. Malays J Med Sci. 2013; 20(2):52-61. PMC: 3744000. View

Hardeep , Bajaj J, Rakesh K . A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in northern India. J Clin Diagn Res. 2013; 7(1):97-9. PMC: 3576761. DOI: 10.7860/JCDR/2012/4883.2680. View

10.

Chatterjee S, Lyle N, Ghosh S . A survey of the knowledge, attitude and practice of adverse drug reaction reporting by clinicians in eastern India. Drug Saf. 2006; 29(7):641-2. DOI: 10.2165/00002018-200629070-00009. View

11.

Awodele O, Akinyede A, Adeyemi O, Awodele D . Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med. 2011; 23(4):217-26. DOI: 10.3233/JRS-2011-0541. View

12.

Tomson T, Battino D, Bonizzoni E, Craig J, Lindhout D, Perucca E . Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol. 2018; 17(6):530-538. DOI: 10.1016/S1474-4422(18)30107-8. View

13.

Kopciuch D, Zaprutko T, Paczkowska A, Ratajczak P, Zielinska-Tomczak L, Kus K . Safety of medicines-Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Pharmacoepidemiol Drug Saf. 2019; 28(12):1543-1551. DOI: 10.1002/pds.4792. View

14.

Braillon A, Bewley S . Prescribing in pregnancy shows the weaknesses in pharmacovigilance. BMJ. 2018; 361:k2334. DOI: 10.1136/bmj.k2334. View

15.

Kopciuch D, Kamal N, Kamal N, Hamdy N, Paczkowska A, Zaprutko T . Neurologists' Knowledge, Practice, and Attitudes towards Pharmacovigilance and Adverse Drug Reactions Reporting Process in Epileptic Patients-Comparative Analysis from Poland and Egypt. Int J Environ Res Public Health. 2022; 19(7). PMC: 8998900. DOI: 10.3390/ijerph19074169. View

16.

Backstrom M, Mjorndal T . A small economic inducement to stimulate increased reporting of adverse drug reactions--a way of dealing with an old problem?. Eur J Clin Pharmacol. 2006; 62(5):381-5. DOI: 10.1007/s00228-005-0072-0. View

17.

Ahmad A, Patel I, Balkrishnan R, Mohanta G, Manna P . An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study. Perspect Clin Res. 2013; 4(4):204-10. PMC: 3835963. DOI: 10.4103/2229-3485.120168. View

18.

Ganesan S, Sandhiya S, Reddy K, Subrahmanyam D, Adithan C . The Impact of the Educational Intervention on Knowledge, Attitude, and Practice of Pharmacovigilance toward Adverse Drug Reactions Reporting among Health-care Professionals in a Tertiary Care Hospital in South India. J Nat Sci Biol Med. 2017; 8(2):203-209. PMC: 5523529. DOI: 10.4103/0976-9668.210014. View

19.

Kongkaew C, Noyce P, Ashcroft D . Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008; 42(7):1017-25. DOI: 10.1345/aph.1L037. View

20.

Farha R, Hammour K, Rizik M, Aljanabi R, Alsakran L . Effect of educational intervention on healthcare providers knowledge and perception towards pharmacovigilance: A tertiary teaching hospital experience. Saudi Pharm J. 2018; 26(5):611-616. PMC: 6035326. DOI: 10.1016/j.jsps.2018.03.002. View