RETROSPECTIVE ANALYSIS OF EMERGING DRUGS USE IN A QUEBEC WOMEN’S AND CHILDREN’S UNIVERSITY HOSPITAL AND PERSPECTIVES FOR SAFE AND OPTIMAL DRUG USE

Main Article Content

Jennifer Corny
Elaine Pelletier
Denis Lebel
Jean-François Bussières

Keywords

pediatrics, unlicensed, off-label, emerging drugs

Abstract

Background


Only few medicines are licensed for children. The use of emerging drugs (unmarketed drug, off-label drug with poorly documented use, and/or costly drugs) might represent an essential alternative for pediatric patients.


Objectives


The objective of the study was to assess emerging drug uses rate and profile in our women’s and children’s centre to support the implementation of an appropriate policy.


Methods


We identified retrospectively emerging drugs used between 2013-01-01 and 2014-02-28, using computerized pharmacist software extraction of drugs used. Conventional oncologic drugs were excluded. Retrospective analysis of medical charts for patients who received an emerging drug and literature review for each drug were performed to determine efficacy and safety endpoints. Median delays between first intention and final decision to use the drug and between final decision and first administration were calculated. Proportion of patients who experienced a positive evolution under treatment or a side effect possibly related to the drug was calculated.


Results


A total of 26 emerging drugs were identified (89 patients, 99 uses). Median treatment duration was 66 days [1-1435]. Median delay between first evocation and final decision to use the drug was 2 days [0-333] and 0 day [0-404] between final decision and first administration. 52/99 (53%) of patients experienced a positive evolution under treatment and 26/99 (26%) experienced a side effect possibly related to emerging drug use.


Conclusions


This study allowed us to describe emerging drug uses in a women and children tertiary hospital. It led to the implementation of a local emerging drug use policy ensuring optimal and safe use of these drugs. There is a significant number of emerging drugs used in pediatric which shows positive improvement in 56% of patients.

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References

1. Food and Drug Administration. Drug research and children. Silver Spring, MD: Author; 2011. Available at: http://www.fda.gov/Drugs/ResourcesForYou/Con - sumers/ucm143565.htm.
2. Food and Drug Administration. New pediatric labelling information database. Silver Spring, MD: Author; 2016. Available at: http://www.accessdata.fda.gov/scripts/sda/ sdNavigation.cfm?sd 5 labelingdatabase.
3. European Medicines Agency. Pediatric Committee (PDCO). London, UK: Author. Available at: http://www. ema.europa.eu/ema/index.jsp?curl 5 pages/about_us/ general/general_content_000265.jsp.
4. Health Canada. Paediatric Expert Advisory Committee. Ottawa: Author; 2012. Available at: http://www.hc-sc. gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/opi-bip/peac- cceip/index-eng.php.
5. Corny J, Lebel D, Bailey B, Bussières JF. Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. J Pediatr Pharmacol Ther 2015;20(4):316–28.
6. Health Canada. Drugs. Special Access Program. Ottawa: Author; 2015. Available at: http://www.hc-sc. gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php.
7. Orphanet. Homepage. 2016. Available at: http://www. orpha.net/national/CA-EN/index/homepage/.
8. Canadian Cancer Society. Homepage. Montreal, QC. Available at: http://www.cancer.ca/en/?region 5 qc.
9. Gillick MR. Controlling off-label medication use. Ann Intern Med 2009;150(5):344–7.
10. Memorial Sloan Kettering Cancer Center. Drug abacus. Available at: http://www.drugabacus.org/.
11. Institut national d’excellence en santé et services sociaux du Québec (INESSS). About the Institute. Available at: http://www.inesss.qc.ca/en/about-us/about-the-institut.html
12. Ansani N, Branch R, Fedutes-Henderson B, et al. United States medical practice summary: innovative off-label medication use. Am J Med Qual 2006;21(4):246–54.