Abstract
Purpose
The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum.
Method
A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants.
Results
The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula.
Conclusion
This study gave a good general impression in current educational activities and the respondents’ needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.
Similar content being viewed by others
References
World Health Organisation (2002) The importance of pharmacovigilance—safety monitoring of medicinal products. WHO. http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf. Accessed 22 October 2016
CIOMS Working group VIII (2010) Practical aspects of signal detection in pharmacovigilanc: report of CIOMS working group VIII. CIOMS, Geneva
Pacurariu AC, Coloma PM, van Haren A, Genov G, Sturkenboom MC, Straus SM (2014) A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee. Drug Saf 37(12):1059–1066
Lester J, Neyarapally GA, Lipowski E, Graham CF, Hall M, Dal PG (2013) Evaluation of FDA safety-related drug label changes in 2010. Pharmacoepidemiol Drug Saf 22(3):302–305
Inman WH (1996) Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 41(5):434–435
Pedros C, Vallano A, Cereza G, Mendoza-Aran G, Agusti A, Aguilera C, Danes I, Vidal X, Arnau JM (2009) An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians: a time series analysis in Spain. Drug Saf 32(1):77–83
Figueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ (2006) An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 296(9):1086–1093
Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A (2008) Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal. Drug Saf 31(4):335–344
Gerritsen R, Faddegon H, Dijkers F, van GK, van PE (2011) Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods. Drug Saf 34(9):755–762
Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ, Edwards BD, Edwards IR, Hartigan-Go K, Lindquist M, McEwen J, Moride Y, Olsson S, Pal SN, Soulaymani-Bencheikh R, Tuccori M, Vaca CP, Wong IC (2014) Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf 37(10):743–759
Nundy S (2008) Adverse events: learning the science behind the art. Acad Med 83(12):1164
Alper E, Rosenberg EI, O'Brien KE, Fischer M, Durning SJ (2009) Patient safety education at U.S. and Canadian medical schools: results from the 2006 Clerkship Directors in Internal Medicine survey. Acad Med 84(12):1672–1676
Gwee MC (2009) Teaching of medical pharmacology: the need to nurture the early development of desired attitudes for safe and rational drug prescribing. Med Teach 31(9):847–854
Maeda S, Kamishiraki E, Starkey J (2012) Patient safety education at Japanese medical schools: results of a nationwide survey. BMC Res Notes 5:226
Nie Y, Li L, Duan Y, Chen P, Barraclough BH, Zhang M, Li J (2011) Patient safety education for undergraduate medical students: a systematic review. BMC Med Educ 11:33
Dal Pan GJ (2014) Ongoing challenges in pharmacovigilance. Drug Saf 37(1):1–8
SurveyMonkey Inc. SurveyMonkey: free online survey software & questionnaire tool. http://www.surveymonkey.com. Accessed between August 2014–July 2015.
Heckathorn D (2011) Snowball versus respondent-driven sampling. Sociol Methodol 41(1):355–366
Goodman LA (1961) Snowball sampling. Ann Math Stat 32(1):148–170
Morgan DL (2008) The SAGE encyclopedia of qualitative research methods. SAGE Publications, Los Angeles, pp 816–817
McDonald J, Dominquez L (2005) Moving from content knowledge to engagement. J Coll Sci Teach 35(3):18–22
Acknowledgements
We want to thank all the respondents who filled out the questionnaire, without whom, we would have never obtained a global view on this subject.
Contributions of authors
JH is responsible for the questionnaire setup, planning, and analysis of the data. LH and EP are responsible for the acquisition of respondents. JH, LH, and EP are responsible for the drafting and the revision of the manuscript.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
No funding source.
Conflict of interest
The authors declare that they have no competing interests.
Electronic supplementary material
ESM 1
(DOCX 17 kb)
Rights and permissions
About this article
Cite this article
Hartman, J., Härmark, L. & van Puijenbroek, E. A global view of undergraduate education in pharmacovigilance. Eur J Clin Pharmacol 73, 891–899 (2017). https://doi.org/10.1007/s00228-017-2237-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00228-017-2237-z