Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmaceutical Science,Pharmacology,Toxicology,Pharmacy
Link
http://link.springer.com/article/10.1007/s11096-018-0646-4/fulltext.html
Reference20 articles.
1. Lenk C, Duttge G. Ethical and legal framework and regulation for off-label use: European perspective. Ther Clin Risk Manag. 2014;10:537–46.
2. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000;8(320):79–82.
3. Spatz ES, Krumholz HM, Moulton BW. The new era of informed consent. Getting to a reasonable-patient standard through shared decision making. JAMA. 2016;315:2063–4.
4. European Medicines Agency. Evidence of harm from off-label or unlicensed medicines in children. 2004. http://www.ema.europa.eu/docs/en_GB/…/Other/…/WC500004021.pdf . Accessed 14 March 2018.
5. Aagaard L. Off-label and unlicensed prescribing of medicines in paediatric populations: occurrence and safety aspects. Basic Clin Pharmacol Toxicol. 2015;117:215–8.
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