Download - Key Facts about Drug Shortages
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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.
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Newly Identified Drug Shortages
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Drug Shortages by Primary Reason
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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.
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Drug Shortages by Administration Route
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Drug Shortages by Drug Class
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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
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What do we do?• Purchase off contract• Direct contact with our wholesaler to obtain the most up-to-
date 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
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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.integris-health.com/Facilities/Metro/Pharmacy/shortage/Forms/AllItems.aspx
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There is an App for That!
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Questions?• Please contact your pharmacy for any additional
information.