Abstract
Pharmacovigilance is an essential part of the post-marketing surveillance of new biologicals. It not only requires a substantial investment of the marketing authorization holder but also of the clinical field to provide accurate safety information. Hence, does pharmacovigilance delivers value for money? This important question needs to be discussed in the light of regulatory requirements, value and cost.
Similar content being viewed by others
References
Bouvy JC, Ebbers HC, Schellekens H, Koopmanschap MA. The cost-effectiveness of periodic safety update reports for biologicals in Europe. Clin Pharmacol Ther. 2013;93(5):433–42.
European Commission. The rules governing medicinal products in the European Union Guidelines on pharmacovigilance for medicinal products for human use. [Homepage on the Internet]. https://ec.europa.eu/health/human-use/pharmacovigilance_en (2012). Accessed 21 May 2018.
Giezen TJ, Mantel-Teeuwisse AK, Meyboom RH, Straus SM, Leufkens HG, Egberts TC. Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database,VigiBase. Drug Saf. 2010;33(10):865–78. https://doi.org/10.2165/11538330-000000000-00000.
European Medicines Agency. Guidelines on good pharmacovigilance practices. EMA/529641/2016. 15 August 2016. [Homepage on the Internet]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211728.pdf (2016). Accessed 21 May 2018.
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the food and drug administration between 2001 and 2010. JAMA. 2017;317(18):1854–63.
Moorkens E, Jonker-Exler C, Huys I, Declerck P, Simoens S, Vulto AG. Overcoming -barriers to market access of biosimilars in the European Union: the case of biosimilar monoclonal antibodies. Front Pharmacol. 2016;7:193.
Klein K, Scholl J, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P. Traceability of biologics in the Netherlands: an analysis of information-recording systems in clinical practice and spontaneous ADR reports. Drug Saf. 2016;39(2):185–92.
Bauters T, Vandenbroucke J. Development of a flowchart for risk assessment and allocation of preparation of monoclonal antibodies. J Oncol Pharm Pract. 2017. https://doi.org/10.1177/1078155217743095.
Claus BO, Bauters T, Somers A. Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges. GaBI J. 2017;6(1):24–6.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.
Bouvy JC, De Huinink L, Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001–2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004–14.
Funding
None.
Conflicts of interest
None
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Claus, B. Is pharmacovigilance of biologicals cost-effective?. Int J Clin Pharm 40, 787–789 (2018). https://doi.org/10.1007/s11096-018-0695-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11096-018-0695-8