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Impact of Prescription Medication shortages on healthcare in the United states

Impact of Prescription Medication shortages on healthcare in the United states. Erin M. Foley, DNAP, MSNA, CRNA.

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Impact of Prescription Medication shortages on healthcare in the United states

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  1. Impact of Prescription Medication shortages on healthcare in the United states Erin M. Foley, DNAP, MSNA, CRNA

  2. The Federal Drug Administration (FDA) defines a drug shortage as “a situation in which the totalsupply of all clinically interchangeable versions of a FDA-regulated drug is inadequate to meetthe current or projected demand at patient level”

  3. American Society of Health-System Pharmacists (ASHP) “ a supply issue that effects how the pharmacy prepares or dispenses a drug product or influences patientcare when prescribers must use an alternative agent” (Fox et al., 2014). • Based on these definitions, the ASHP reports more drug shortages than the FDA each year.

  4. The Path of medication to the patient

  5. Causes of Medication shortages • Quality Issues • Manufacturing Facility Closures • Rise in Demand • Generic Medications (71% of generic injectable meds are produced by 3 manufacturers) • Contamination • Supply Issues • FDA Demands

  6. Hurricane MAria

  7. Schweitzer’s perfect storm • Consolidating the market place for generic drugs resulted in a reduction of both buyers and manufacturers • The use of generic medications in the overall prescription medication marketplace increased. • Reliance on outsourced materials needed for drug production from foreign countries

  8. $4 Prescriptions: Good or Bad? • Wal-Mart’s Retail Prescription Program • Over 300 prescription medications • $4 for 30-day supply • $10 for a 90-day supply

  9. Incidence of Drug Shortages • The number of drug shortages had quadrupled from 61 reported drug shortages in 2005 to more than 250 in 2011 • The Government Accountability Office reported that nearly twelve hundred (1,200) medications were listed as being in a shortage between 2001 and 2011 • Average length of these shortages was 286 days • 80% of all shortages are sterile injectables

  10. National Drug Shortages from 2001-2019

  11. Frequently effected • Anesthetics • Antibiotics • Anti-Neoplastics • Fluid and Electrolytes • Chemotherapy

  12. University of Utah Drug Information ServiceContact: Erin.Fox@hsc.utah.edu, @foxerinr for more information.

  13. The Great Anesthesia Depression

  14. Propofol • Used in more than 50 million anesthetics annually • Shortage in 2009-2012 • Only 3 manufacturers in the US • Hep C outbreak • Hospira Facility Shutdown

  15. International influence

  16. Fentanyl

  17. Opioids

  18. Other Shortages • Other notable shortages indicated by respondents during the previous three months included the following: • Sterile water for injection (85.7%) • Potassium chloride premix bags (74.6%) • Emergency drugs used in cardiac arrest (65.6%) • Ketamine (59.8%) • Syringes, syringe caps, and other supplies (59.8%)

  19. Sodium Bicarbonate • FDA has taken two actions: • 1) It has approved the sourcing of sodium bicarbonate from an Australian medication manufacturer, a step that mirrors a prior action allowing the importation of normal saline solution from a Norwegian manufacturer in 2014; • 2) FDA has worked with a manufacturer to extend the expiration dates of some batches of three emergency medicines: atropine, dextrose and epinephrine.

  20. Does your hospital look like this? 98% of hospitals report being effected by drug shortages

  21. Still happening Today

  22. How do you find out about drug shortages • Download the FDA Drug Shortages APP • Check the website: • http://www.fda.gov/Drugs/DrugSafety/DrugShortages • http://www.ashp.org/shortages

  23. Out of meds??

  24. Norepinephrine Shortage

  25. Clinical Impact • Improper conversion between morphine and hydromorphone caused two deaths during a similar shortage in 2010. • adversely affecting choices for drug therapy • delaying medication therapies or treatments • escalating costs of product and resources to manage shortages • increasing risk for medication errors and untoward patient outcomes.

  26. Provider IMpact • emotional component to the drug shortages • frustration, anger, anxiety • mistrust that results in strained relationships

  27. Economic impact • $200-500 million per year in increased expenditure by hospitals • Average of 11% increase per medication • $216 million per year in increased labor costs

  28. What about the Patient? • Patients bear all the risk • Delay in care or even face death as a result of unavailability of medication. • 15 patients died as a result of a drug shortages in 2012 • Hsai et al : 76.2% of the 256 patients surveyed wanted “to be told by the anesthesia doctor about the neostigmine shortage” if there were “slight differences” in side effects between the drug combinations”

  29. “Medication shortages make us unwitting contestants in a bad episode of ‘Iron Chef,’ challenged to produce a tasty dish (a safe patient outcome) using a limited set of tools and ingredients … When should the unavailability of a desired medication lead us to postpone or cancel a scheduled case? … When the risk is significant, of course, we should include a discussion of these issues in our informed consent.” (Dutton and Cohen)

  30. What has the government done • 1999- Developed the Drug Shortage Program • 2011- President Obama issues an executive order: “As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines” • 2012- FDA Safety and Innovation Act • FDA averted a potential 195 shortages in 2012

  31. Drug Shortages prevented by the Food and Drug Administration

  32. Legislation • Bipartisan legislation from Senators Susan Collins (ME) and Claire McCaskill (MO) • Making Pharmaceutical Markets More Competitive Act (S. 1115) (H.R.2562) • Allow the Food and Drug Administration to give priority review to new drug applications for products where there are three or fewer approved drug alternatives. • Has been in committee since 2017

  33. Prevention is key • Group Purchasing Organizations • FDA SIA • Incentives for Manufacturers

  34. References • Dutton RP, Cohen JA. Medication shortages: are we the Iron Chefs or our own worst enemies? AnesthAnalg. 2011;113:1298–9. • ASHP. (2016). Drug shortages. Retrieved from http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm • Eban, K. (2014). Drug Shortages: The Scary Reality of a World Without Meds. Reader's Digest, June. • Executive Order 13588 -- Reducing Prescription Drug Shortages. (2011). Retrieved from https://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-13588-reducing-prescription-drug-shortages • FDA. (2015a). Drug Shortages Infographic. In FDA (Ed.). FDA.gov. • FDA. (2015b). Third Annual Report on Drug Shortages for Calendar Year 2015. Retrieved from http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM488353.pdf • FDA. (2016). Current and resolved drug shortages and discontinuations reported to FDA. Retrieved from http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

  35. References Continued • Fox, E. R., Sweet, B. V., & Jensen, V. (2014). Drug shortages: a complex health care crisis. Mayo ClinProc, 89(3), 361-373. doi:10.1016/j.mayocp.2013.11.014 • Fox, E. R., & Tyler, L. S. (2013). Call to action: finding solutions for the drug shortage crisis in the United States. ClinPharmacolTher, 93(2), 145-147. doi:10.1038/clpt.2012.225 • Hsia, I. K., Dexter, F., Logvinov, I., Tankosic, N., Ramakrishna, H., & Brull, S. J. (2015). Survey of the National Drug Shortage Effect on Anesthesia and Patient Safety: A Patient Perspective. AnesthAnalg, 121(2), 502-506. doi:10.1213/ane.0000000000000798 • Hvisdas, C., Lordan, A., Pizzi, L. T., & Thoma, B. N. (2013). US Propofol Drug Shortages: A Review of the Problem and Stakeholder Analysis. Am Health Drug Benefits, 6(4), 171-175. • Ladha, K. S., Nanji, K. C., Pierce, E., Poon, K. T., & Hyder, J. A. (2015). The Impact of a Shortage of Pharmacy-Prepared Ephedrine Syringes on Intraoperative Medication Use. AnesthAnalg, 121(2), 404-409. doi:10.1213/ane.0000000000000809

  36. References Continued • Landeiro, R. (2014). Possible influenza vaccine shortage by GSK. Retrieved from http://www.mobilehealth.net/possible-influenza-vaccine-shortage-gsk/ • Lazar, K. (2013). Closure of Ameridose, Westborough drug company, extended 6 weeks in meningitis probe. Boston Globe. Retrieved from http://archive.boston.com/whitecoatnotes/2013/01/03/closure-ameridose-westborough-drug-company-extended-weeks-meningitis-probe/i1ySx3qYTXiFbykdeUqbzK/story.html • Mazer-Amirshahi, M., Pourmand, A., Singer, S., Pines, J. M., & van den Anker, J. (2014). Critical drug shortages: implications for emergency medicine. AcadEmerg Med, 21(6), 704-711. doi:10.1111/acem.12389 • Rubenfire, A. (2015). Surmounting shortages. GPOs work creatively with manufacturers to avert drug shortfalls. Mod Healthc, 45(43), 16-18. • Schweitzer, S. O. (2013). How the US Food and Drug Administration can solve the prescription drug shortage problem. Am J Public Health, 103(5), e10-14. doi:10.2105/ajph.2013.301239

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