EMS – Not a drug free zone. TETAF EMS Leadership Series Ed Racht, MD Chief Medical Officer AMR Medicine

3. EMS – Not a drug free zone.TETAF EMS Leadership SeriesEd Racht, MDChief Medical OfficerAMR Medicine

4. Who cares?

6. The impact of medication shortage on OOH practice

7. Today’s discussion… • Current state of the problem • Review of current national initiatives • Strategic options for EMS practices • Critical focus areas (hot topics)

9. The Big Picture… • Extremely dynamic issue • Significant regional variation • Drug shortage reporting to the FDA is voluntary • The majority of shortages are generics

10. The Big Picture… • The U.S. pharmaceutical industry generates $274B in revenue annually • 3 Wholesalers account for 85% of revenue • AmerisourceBergen • Cardinal Health • McKesson

12. The Big Picture… • The cost of purchasing alternative therapies approaches $200M • Hospital pharmacists are spending an additional 8-12 hours per week dealing with shortages • $216M additional annual labor cost to deal with shortages (ASHP 2012)

13. Safety concerns • 1800 pharmacists surveyed September 2011 • 1000 adverse events related to shortage • 25% medication errors • 20% adverse drug reactions (ASHP Survey 2011)

14. Aborting shortages • 2011 195 shortages prevented • 2012 12 shortages prevented • Early notification of FDA noted to be key in resolution

15. Top 3 FDA actions to avert shortages • Asking other firms to increase production (31%) • Working with manufacturers to identify ways to mitigate quality issues, i.e. flexibility through regulatory discretion (28%) • Expediting review of regulatory submissions (26%).

16. The challenge… Under current law and regulation, manufacturers are not required to report to FDA when they experience an interruption in the production of their products, unless that drug is “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition.” The same holds true when manufacturers choose to discontinue a product.

17. EMS is a small piece of the puzzle

19. High impact specialties • Critical care • Anesthesia (out patient surgery) • Oncology • Rheumatology / CT • Infectious disease* • Emergency medicine / EMS

21. The current state of the problem.

23. Drug shortages by year

26. Why? • Multifactorial • Lack of market capacity • Decreased production • Production quality concerns • Financial decisions • Product discontinuations • Alternative prescribing

27. Controlled substances quotas

30. Why?The bottom line… • Business Practices • Regulatory Processes

31. Current National Initiatives.

32. Position papers

33. Stakeholder fora(is that a word?)

34. www.fda.gov/drugs

35. www.ashp.org/shortages

40. Legislation.

41. Presidential Executive Order13588

42. The Food and Drug Administration Safety and Innovation Act

43. “The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions in the legislation, which also reauthorizes funding for the Prescription Drug User Fee Act”.

44. What the FDASIA does • Broadens the scope of the early notification requirement by requiring all manufacturers of covered drugs to notify FDA of potential discontinuances.  • Manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or temporarily • Enables FDA to require mandatory reporting of shortages of biological products.  • Makes clear that the notification requirement applies to drugs that are used in emergency medical care or during surgery (if they are intended for use in the prevention of a debilitating disease or condition). • Requires FDA to issue a non-compliance letter to manufacturers who fail to comply with the drug shortage notification requirements and to make the letter and the company’s response to the letter available to the public.

45. What the FDASIA does Requires FDA to submit an annual report to Congress on drug shortages and FDA’s efforts to address shortages.  Requires FDA to establish a task force to develop and implement a strategic plan for enhancing our response to drug shortages.  The strategic plan must be published and submitted to Congress within one year after enactment of FDASIA. Requires that, prior to taking any enforcement action or issuing any warning letter that reasonably could be anticipated to lead to a disruption in supply, appropriate offices within FDA communicate about the action and evaluate the relative risks and benefits to patients from the shortage and enforcement action or warning letter. Expressly states that FDA may expedite review of certain applications and expedite inspections that could help to mitigate or prevent a shortage.

46. What the FDASIA does Requires FDA to maintain a publicly available, up-to-date list of drugs in shortage, including the cause and estimated duration of the shortage. If a shortage involves a controlled substance, FDA must notify the Drug Enforcement Administration (DEA) of the shortage and request that DEA increase the quota of the product to alleviate the shortage. Ahospital is not required to register with FDA as a manufacturer solely because the hospital repackages drugs declared to be in shortage for use within hospitals within the same health system and if done in response to the shortage to extend the hospital system’s supply of the product. Requires a GAO report examining the causes of drug shortages and formulating recommendations to prevent or alleviate shortages.

47. Strategic options for EMS.

48. Designate a drug shortage team(Think IMS)

49. Do not dispose of expired medications – Store them according to manufacturers recommendations and label them clearly(Consider physically separate storage)

50. Review all protocols and modify with appropriate available alternatives(Increase options of drugs)