Key Facts about Drug Shortages

1. 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.

2. Newly Identified Drug Shortages

3. Drug Shortages by Primary Reason

4. 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.

5. Drug Shortages by Administration Route

6. Drug Shortages by Drug Class

7. 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

8. 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

9. 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

10. There is an App for That!

12. Questions? • Please contact your pharmacy for any additional information.