Evaluation of a clinic-based quality structure for Special Access Programme medicines to treat parasitic infections
Publication: Official Journal of the Association of Medical Microbiology and Infectious Disease Canada
Volume 3, Number 3
Abstract
Abstract
Background: Frequently used drugs in our unit are only available through Health Canada’s Special Access Programme (SAP) or a compounding pharmacy. A tracking system was implemented to evaluate the turnaround time (TAT) and success rate of SAP applications for parasitic infections. Methods: We undertook a retrospective review of SAP logs from 2013 to 2015 inclusive, with outcomes of TAT and initial application success rates over time. Analyses were stratified by drug indication. Results: The mean TATs for all indications from 2013 to 2015 were 9.02 (SD 10.11) days, 7.04 (SD 7.6) days, and 7.25 (SD 8.97) days, respectively (p = 0.48). First-time success rates for ivermectin from 2013 to 2015 were 96%, 84%, and 71%, respectively. First-time success rates for albendazole from 2013 to 2015 were 74%, 60%, and 63%, respectively. In 2013, 14% (6/44) of initial SAP requests received an incomplete notification compared with 25% (14/57) and 32% (25/78) in 2014 and 2015, respectively (p = 0.08). Conclusions: Timely initiation of antihelminthic therapy is critical to reducing the risk of adverse clinical outcomes and a decreased quality of life from parasitic infections such as strongyloidiasis. Our findings document a prolonged TAT of non-formulary medications used to treat common helminthiases in Canada.
Résumé
Historique : De nombreux médicaments utilisés dans notre unité ne sont accessibles qu’auprès du Programme d’accès spécial (PAS) de Santé Canada ou d’une pharmacie spécialisée en préparations magistrales. Un système de suivi a été adopté pour évaluer le délai d’exécution (DÉ) des applications du PAS pour les infections parasitaires. Méthodologie : Les chercheurs ont entrepris une analyse rétrospective des journaux du PAS de 2013 à 2015 inclusivement, afin de recenser les DÉ et le taux de succès des applications initiales au fil du temps. Ils ont stratifié les analyses en fonction des indications thérapeutiques. Résultats : Les DÉ moyens pour toutes les indications entre 2013 et 2015 étaient de 9,02 ± 10,11 jours, 7,04 ± 7,6 jours et 7,25 ± 8,97 jours, respectivement (p = 0,48). De 2013 à 2015, les taux de réussite à la première demande d’ivermectine s’élevaient à 96 %, 84 %, et 71 %, respectivement, et ceux d’albendazole, à 74 %, 60 %, et 63 %, respectivement. En 2013, 14 % des demandes initiales de PAS (six sur 44) ont reçu une notification incomplète, par rapport à 25 % (14 sur 57) et à 32 % (25 sur 78) en 2014 et 2015, respectivement (p = 0,08). Conclusions : Il est essentiel d’entreprendre le traitement anthelminthique rapidement pour réduire le risque d’événements cliniques indésirables et de diminution de la qualité de vie causés par des infections parasitaires comme la strongyloïdiose. Les observations des chercheurs font état d’un DÉ prolongé avant d’obtenir les médicaments non inscrits utilisés pour le traitement des helminthiases communes au Canada.
Competing Interests:
The authors have nothing to disclose.
Registry and the Registration No. of the Study/Trial:
N/A
Animal Studies:
N/A
Funding:
No funding was received for this work.
Peer Review:
This article has been peer reviewed.
References
1. Government of Canada. Guidance document for industry and practitioners - Special Access Programme for drugs. [Internet]. Ottawa: Health Canada; 2013 [updated 2013 Dec 20; cited 2017 Mar 28]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs/guidance-industry-practitioners-special-access-programme-drugs-health-canada-2008.html.
2. Link K, Orenstein R. Bacterial complications of strongyloidiasis: Streptococcus bovis meningitis. South Med J. 1999;92(7):728–31. Medline:10414486
3. Boggild AK, Libman M, Greenaway C, et al; Committee to Advise on Tropical Medicine; Travel (CATMAT). CATMAT statement on disseminated strongyloidiasis: Prevention, assessment and management guidelines. Can Commun Dis Rep. 2016;42(1):12–9. Medline:29769976
4. Minuk L, Sibbald R, Peng J, et al. Access to thalidomide for the treatment of multiple myeloma in Canada: physician behaviours and ethical implications. Curr Oncol. 2010;17(4):11–9. Medline:20697510
5. Christie TKS, Harris M, Montaner JSG. Special access denied: A case study of Health Canada’s Special Access Program. Healthc Policy. 2006;2(2):27–34. Medline:19305701
6. Canadian Cancer Society. Cancer drug access for Canadians [Internet]. 2009 Sep 14 [cited 2017 Apr 6]. Available from: www.canceradvocacy.ca/ann/special.html/5917/Cancer+Drug+Access+Report+-+English.pdf.
7. Grant K. Why world-beating tropical drugs are so hard to get in Canada. Globe and Mail [Internet]. 2017 Jan 3 [cited 2017 Apr 6]:Health Care. Available from: https://www.theglobeandmail.com/news/national/why-world-beating-tropical-drugs-are-so-hard-to-get-incanada/article33469954/.
8. Kincaid L, Klowak M, Klowak S, et al. Management of imported cutaneous larva migrans: A case series and mini-review. Travel Med Infect Dis. 2015;13(5):382–7. Medline:26243366
9. Government of Canada. Food and Drug Regulations (C.R.C., c. 870) [Internet]. Ottawa: Minister of Justice; 2017 [updated 2018 May 17; cited 2017 Jun 20]. Divisions 1, 1A, 2, 8. Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/.
10. Schuster A, Lesshafft H, Talhari S, et al. Life quality impairment caused by hookworm-related cutaneous larva migrans in resource-poor communities in Manaus, Brazil. PLoS Negl Trop Dis. 2011;5(11):e1355. Medline:22087341
Information & Authors
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Published In
Official Journal of the Association of Medical Microbiology and Infectious Disease Canada
Volume 3 • Number 3 • September 2018
Pages: 131 - 136
Copyright
Copyright © 2018, Association of Medical Microbiology and Infectious Disease Canada (AMMI Canada). This article is free to read to all interested readers, immediately upon publication. For their own personal use, users may read, download, print, search, or link to the full text. Manuscripts published in the Official Journal of the Association of Medical Microbiology and Infectious Disease Canada are copyrighted to the Association of Medical Microbiology and Infectious Disease Canada (AMMI Canada). Requests for permission to reproduce this article should be made to the University of Toronto Press using the Permission Request Form: https://jammi.utpjournals.press/journal-policies#_copyright
History
Received: 10 September 2017
Accepted: 4 January 2018
Published ahead of print: 20 August 2018
Published online: 6 September 2018
Published in print: September 2018
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Authors
Contributors:
Conceptualization, AKB; Methodology, RM, SK, MK, AKB; Formal Analysis, RM CT, SP, AKB; Data Curation, RM, SK, MK, AKB; Writing – Original Draft, RM, CT, SP, AKB; Writing – Review & Editing, RM, CT, SP, AKB, SK, MK; Visualization RM; Supervision AKB; Project Administration, AKB. All authors critically appraised and approved the manuscript, and all serve as guarantors of the work.
Ethics Approval:
N/A
Informed Consent:
N/A
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Journal of the Association of Medical Microbiology and Infectious Disease Canada 2018 3:3, 131-136
Journal of the Association of Medical Microbiology and Infectious Disease Canada 2018 3:3, 131-136