ACMT Position Statement: Addressing the Rising Cost of Prescription Antidotes
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Antidotal therapy is an essential component of poisoning management. In recent years, there have been unprecedented increases in the costs of antidotes. The American College of Medical Toxicology calls upon providers, hospitals, formularies pharmaceutical industry, government, insurance companies, and pharmacy benefit managers to adopt practices to ensure that antidotes are available to our patients and price are based on value and cost.
Thank you to Dr. Mary Ann Howland and St. John’s Doctor of Pharmacy students, whose research produced the table of antidote prices. ACMT would like to acknowledge the Members of the Position Statement and Guidelines Committee for contributions to this statement: Jeffrey Brent, Howard Greller, Thomas Kurt, Silas Smith, and Brandon Warrick.
Compliance with Ethical Standards
While individual practitioners may differ, these are the positions of the American College of Medical Toxicology (ACMT) at the time written, after a review of the issue and pertinent literature.
Conflicts of Interest
- 1.Dart RC, Goldfrank LR, Chyka PA, Lotzer D, Woolf AD, McNally J, et al. Combined evidence-based literature analysis and consensus guidelines for stocking of emergency antidotes in the United States. Ann Emerg Med. 2000;36(2):126–32. https://doi.org/10.1067/mem.2000.108182.CrossRefPubMedGoogle Scholar
- 3.FDA. Frequently asked questions about patents and exclusivity. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm. Accessed October 21, 2016.
- 6.Tufts Center for the Study of Drug Development. Costs to develop and win marketing approval for a new drug is $2.6 billion. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study. Accessed October 21, 2016.
- 8.Reference for prices of new drugs are higher in the US Hirschler B. Exclusive—transatlantic divide: how US pays three times more for drugs. Reuters. http://www.reuters.com/article/us-pharmaceuticals-usa-comparison-idUSKCN0S61KU20151012. Published October 12, 2015. Accessed July 26, 2017.
- 9.Kanavos P, Ferraio A, Vandoros S, Anderson GF. Higher U.S. branded drug prices and spending compared to other countries may stem partly from quick uptake of new drugs. Heath Aff. 32:753–61.Google Scholar
- 10.National Institute for Health Care and Excellence (NICE). https://www.nice.org.uk. Accessed October 26, 2016.
- 11.Qualifying for pediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act: Frequently asked questions on pediatric exclusivity (505A), the pediatric “Rule,” and their interaction. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm077915.htm. Accessed October 21, 2016.
- 12.BTG settles CroFab patent litigation with Bioclon and RDT. https://www.thepharmaletter.com/article/btg-settles-crofab-patent-litigation-with-bioclon-and-rdt. Accessed August 26, 2017.
- 14.O’Brien E. Why drug prices remain insanely high and 6 things you can do to save. http://www.marketwatch.com/story/six-tips-for-fighting-rising-prescription-drug-costs-2015-09-15. Accessed July 26, 2017.
- 15.Red Book Online® [database online]. Greenwood Village, Colorado: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed 1/23/2016.Google Scholar
- 17.STAT. Doctors have toxic reaction to Valent pricing for a lead poisoning drug. https://www.statnews.com/pharmalot/2016/10/11/valeant-drug-prices-lead-poisoning/. Accessed October 21, 2016.
- 18.The Washington Post. This $153,000 rattlesnake bite is everything wrong with American healthcare. https://www.washingtonpost.com/news/wonk/wp/2015/07/20/this-153000-rattlesnake-bite-is-everything-wrong-with-american-health-care/. Accessed October 26, 2016.
- 19.Red Book Online® [database online]. Greenwood Village, Colorado: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed November 15, 2012. Courtesy Dr. Mary Ann Howland.Google Scholar
- 20.Red Book Online® [database online]. Greenwood Village, Colorado: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed March 8, 2016. Courtesy Dr. Mary Ann Howland.Google Scholar
- 21.Red Book Online® [database online]. Greenwood Village, Colorado: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed June 20, 2017. Courtesy Dr. Mary Ann Howland.Google Scholar
- 22.NPR. Price soars for key weapon against heroin overdoses. http://www.npr.org/sections/health-shots/2015/09/10/439219409/naloxone-price-soars-key-weapon-against-heroin-overdoses. Accessed October 21, 2016.