The Big Picture…

EMS – Not a drug free zone.
TETAF EMS Leadership Series
Ed Racht, MD
Chief Medical Officer
AMR Medicine
Who cares?
The impact of medication shortage on OOH practice
Today’s discussion…
Current state of the problem
Review of current national initiatives
Strategic options for EMS practices
Critical focus areas (hot topics)
The Big Picture…
• Extremely dynamic issue
• Significant regional variation
• Drug shortage reporting to the FDA is
• The majority of shortages are generics
The Big Picture…
• The U.S. pharmaceutical industry
generates $274B in revenue annually
• 3 Wholesalers account for 85% of
– AmerisourceBergen
– Cardinal Health
– McKesson
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)
Safety concerns
• 1800 pharmacists surveyed September
• 1000 adverse events related to shortage
– 25% medication errors
– 20% adverse drug reactions
(ASHP Survey 2011)
Aborting shortages
• 2011
195 shortages prevented
• 2012
12 shortages prevented
• Early notification of FDA noted to
be key in resolution
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%).
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.
EMS is a small piece of the puzzle
High impact specialties
Critical care
Anesthesia (out patient surgery)
Rheumatology / CT
Infectious disease*
Emergency medicine / EMS
The current state
of the problem.
Drug shortages by year
• Multifactorial
• Lack of market capacity
– Decreased production
– Production quality concerns
– Financial decisions
– Product discontinuations
– Alternative prescribing
Controlled substances quotas
The bottom line…
• Business Practices
• Regulatory Processes
Position papers
Stakeholder fora
(is that a word?)
Presidential Executive Order
The Food and Drug Administration
Safety and Innovation Act
“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”.
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.
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
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.
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.
A hospital 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.
Strategic options
for EMS.
Designate a drug shortage
(Think IMS)
Do not dispose of expired
medications – Store them
according to
recommendations and
label them clearly
(Consider physically
separate storage)
Review all protocols and
modify with appropriate
available alternatives
(Increase options of drugs)
Consider limiting use of
critical medications for
critical conditions
(Anxiety vs. Seizure)
Consider changing drug
deployment strategies
(Supervisors / Designated
Aggressively reinforce and
monitor appropriate drug
administration processes
(Different packaging,
concentrations, etc))
Hot topics…
Critical issues…
• Physician extension of expiration dates
– Efficacy (lot analysis)
– Safety
– Authority
Compounding pharmacies
State scope of practice
Public health emergency declaration
Foreign purchase
In summary…
This problem is here to stay
The solutions are complex, but doable
One size will not fit all
Pay close attention to patient safety
Pay attention to regulation and legislation
Keep an eye on changes
Share best practices…

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