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Drug shortages in developed countries—reasons, therapeutic consequences, and handling

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Abstract

Drug shortages in developed countries pose a serious public health problem and have far-reaching implications for healthcare providers and their patients. Given the current state of the market, with the limited number of manufacturers and the array of manufacturing quality issues, drug shortages have become a global concern, forcing regulatory authorities to explore and implement strategies to prevent and mitigate drug shortages.

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Notes

  1. Unapproved prescription drugs: drugs marketed in the United States that do not have required FDA approval http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm2007056.htm

  2. A Drug Shortage Website. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

  3. http://www.drugshortages.ca/drugshortagehome.asp

  4. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf

References

  1. Drug shortages 2014 (2014) A Premier healthcare alliance update. https://www.premierinc.com/wps/wcm/connect/bd794cb2-6f31-4ffb-ac85-30af42be7ef0/DrugShortage-Survey-White+Paper.pdf?MOD=AJPERES

  2. Drug shortages continue to pose patient safety risks and challenge providers, according to Premier, Inc. survey https://www.premierinc.com/wps/portal/premierinc/public/newsandevents/newsreleases/newsreleases/drug-shortages-continue-to-pose-patient-safety-risks-2-27-14

  3. International Society for Pharmaceutical Engineering (ISPE) Report on the ISPE Drug Shortages Survey (2013) http://www.ispe.org/drug-shortages-initiative/about-the-survey

  4. European Association of Hospital Pharmacists (AEHP). Medicines shortages. http://www.eahp.eu/practice-and-policy/medicines-shortages

  5. US Food and Drug Administration (2012) Center for Drug Evaluation and Research. Office of New Drugs, Drug Shortage Management. Manual of Policies and Procedures http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079936.pdf

  6. The multi-stakeholder steering committee on drug shortages in Canada protocol for the notification and communication of drug shortages http://www.drugshortages.ca/CMFiles/MSSC_Notification_Communication_Protocol_EN.pdf

  7. FDA drug shortage staff conversations with manufacturers.

  8. European patient organizations position paper. http://www.eahp.eu/sites/default/files/files/European%20patient%20organisations%20position%20on%20shortages%20medicinal%20products.pdf

  9. IMS health (2014) http://www.imshealth.com/portal/site/imshealth

  10. Information from FDA drug shortage staff.

  11. The multi-stakeholder steering committee on drug shortages in Canada multi-stakeholder toolkit; a toolkit for improved understanding and transparency of drug shortage response in Canada (2013) http://www.drugshortages.ca/CMFiles/MSSC_Multi-Stakeholder_Toolkit_EN.FINAL.pdf

  12. Conversations with FDA drug shortage staff

  13. McBride A, Holle LM, Westendorf C, Sidebottom M, Griffith N, Muller RJ, Hoffman JM (2013) Am J Health Syst Pharm 70(7):609–617. doi:10.2146/ajhp120563, National survey on the effect of oncology drug shortages on cancer care. http://www.ncbi.nlm.nih.gov/pubmed/23515514

    Article  PubMed  Google Scholar 

  14. Shortage of Caelyx, 09 September 2011, EMA/718827/2011

  15. The American Society of Health-System Pharmacists website http://www.ashp.org/menu/DrugShortages.aspx

  16. Food and Drug Administration Safety and Innovation Act (2012). http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf

  17. Strategic plan for preventing and mitigating drug shortages food and drug administration (2013) http://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf

  18. European medicine agency. What we do. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000091.jsp

  19. The European medicine agency shortages catalogue http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000376.jsp&mid=WC0b01ac05807477a

  20. European Medicines Agency (2013) An agency of the European Union Shortages of medicinal products due to manufacturing and quality problems http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/07/WC500146132.pdf

  21. European Medicines Agency (2012) Reflection paper on medicinal product supply shortages caused by manufacturing/good manufacturing practice compliance problems. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/11/WC500135113.pdf

  22. Government of Canada. Justice Laws Website Food and Drug Regulations, Part C Drugs, Division 1, (C.01.014.7). http://laws-lois.justice.gc.ca/Search/Search.aspx?txtS3archA11=C.01.014.7&txtT1tl3=%22Food+and+Drug+Regulations%22&h1ts0n1y=0&ddC0nt3ntTyp3=Regulations

  23. Canadian drug shortage database. Overview. http://www.drugshortages.ca/overview.asp

  24. Health Canada http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php

  25. Canadian drug shortage database http://www.drugshortages.ca/

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Authors and Affiliations

  1. US Food and Drug Administration, Silver Spring, MD, USA

    Susie Dill & Jin Ahn

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  1. Susie Dill
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  2. Jin Ahn
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Correspondence to Susie Dill.

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Dill, S., Ahn, J. Drug shortages in developed countries—reasons, therapeutic consequences, and handling. Eur J Clin Pharmacol 70, 1405–1412 (2014). https://doi.org/10.1007/s00228-014-1747-1

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  • DOI: https://doi.org/10.1007/s00228-014-1747-1

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