Transcript Drug Shortages

Key Facts about Drug Shortages
• Newly identified drug shortages have tripled from 61 in 2005 to 178 in
2010. By December 2011 they had already topped 200.
• Of the 127 studied drug shortages in 2010‐11, sterile injectables
accounted for the majority (80%). The major therapeutic classes
included oncology drugs (28%), antibiotics (13%), and
electrolyte/nutrition drugs (11%).
• The leading primary reasons for the shortages reported to FDA were
problems at the manufacturing facility (43%), delays in manufacturing
or shipping (15%), and active ingredient shortages (10%).
• Manufacturing quality problems that have resulted in shortages can
be serious, including findings of glass shards, metal filings, and fungal
or other contamination in products meant for injection into patients.
Newly Identified Drug Shortages
Drug Shortages by Primary Reason
Unique Manufacturing and Market Features
of Sterile Injectables
• Manufacturing such products is complex and can easily lead to problems
that affect safety.
• Dedicated manufacturing lines are often required.
• The top three generic injectable manufacturers hold 71% of the market
by volume.
• Most sterile injectables have one manufacturer that produces at least
90% of the drug (innovator and generic combined).
• “Just in time” manufacturing and inventorying practices leave little margin
for error.
• Together, these factors make shortages of sterile injectables more likely
to occur and harder to prevent or mitigate.
Drug Shortages by Administration Route
Drug Shortages by Drug Class
A Few Examples of Ongoing Injectable
Shortages
• Benzodiazepines: midazolam, lorazepam, diazepam
• Nutritional: amino acids, sodium acetate, sodium chloride
(concentrate), magnesium sulfate, selenium, MVI (two
years of short supply), and many more
• Pain meds: morphine, fentanyl, hydromorphone, empty
sterile PCA vials
• Other: vitamin K, dopamine, heparin drips, magnesium
sulfate, oxytocin, ondansetron, famotidine,
metoclopramide
What do we do?
• Purchase off contract
• Direct contact with our wholesaler to obtain the most up-to-date
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information
Checking availability with other wholesalers
Buying products from our surrounding facilities
Buying products directly from a manufacturer
Compounding the item within the pharmacy
Increased purchasing of available therapeutic alternatives
Outsourcing an item for compounding to reputable sources
Limit remaining supply to patients with no viable alternative
(with P&T collaboration)
Stockpiling when possible
Purchasing from other hospitals
Text Messaging when flagged item become available
Resources
• Detailed information about shortages can be found on the
ASHP (American Society of Health System Pharmacists)
website at http://www.ashp.org/shortages
• Information about how we are handling a specific shortage
is under the “Shortage” link on the Metro Pharmacy
website.
-Go to the Inside page, Clinical Hotspots, IBMC Pharmacy (right
side), shortages (left menu bar).
https://insideintegris.corp.integrishealth.com/Facilities/Metro/Pharmacy/shortage/Forms/AllItems.aspx
There is an App for That!
Questions?
• Please contact your pharmacy for any additional
information.