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AAMC Critical Drug Shortages – August 28, 2015 (Updated monthly, if not more often) Dear Colleagues, Due to a variety of reasons, AAMC is currently faced with multiple medication shortages. Manufacturing delays and increased demand have resulted in a nationwide critical shortage. An alphabetical listing of medications experiencing imminent or ongoing sporadic, supply issues is summarized on the next pages. The most urgent concerns to highlight are listed below. Ampicillin/Sulbactam (Unasyn) Cefotaxime vial [all sizes] Dextrose 50% vials ONLY Epinephrine emergency cardiac syringe Methylene blue Recommendations for restricted use and/or alternative therapies are provided in this memo. Additional details regarding the status of medication availability is provided through alternative alerts in Epic, on the AAMC Pharmacy Drug Shortage site (http://www.aahs.org/medstaff/?page_id=3269), and on the American Society of Health-System Pharmacy (ASHP) drug shortage site (www.ashp.org/DrugShortages/Current). Medications out of stock include – ammonium chloride, droperidol vials, epinephrine preservative free ampules, fomepizole injection, hydroxyzine injection, indigo carmine injection, L-cysteine, methyldopa injection, nitroglycerine SDV IV vial, and pancuronium injection. New shortage products – ampicillin/sulbactam (Unasyn), cefotaxime vials, dextrose 50% vials ONLY, epinephrine preservative free ampules, and fomepizole vials Medications discontinued by manufacture – phentolamine, pralidoxime injection sodium Resolved drug shortages – caffeine benzoate IV (allow 24-48 hours if needed), edrophonium injection, pipercillin/Tazobactam injection (Zosyn), and vecuronium For additional information or therapeutic considerations, please contact the Pharmacist on Duty, or myself, Jared S. Calish, PharmD, Pharmacy Clinical Coordinator via e-mail: [email protected]. We appreciate your understanding as we strive to treat our patients during drug shortages. Page 1 of 4 AAMC Critical Drug Shortages – August 28, 2015 (Updated monthly, if not more often) 1. 2. Ammonium chloride vials a. Long term back order since March 2011, out of stock. b. Little historical use, primarily used for treatment of hypochloremia or hypochloremic metabolic alkalosis for patients who cannot receive sodium chloride and in end-stage renal disease. Consider other standard methods for alkalosis reversal (bicarbonate drips, dialysis). Ampicillin/Sulbactam (Unasyn) [all sizes] a. Currently little to none available due to shortage from all manufactures. b. Below is a table for suggested empiric alternatives for adults on or in need of Unasyn. An EPIC alternative alert has been built to help guide providers. With any antimicrobial therapy you want to simplify/target therapy once know pathogen is recognized. Indication (Empiric) Gynecological Intra-abdominal Skin and Soft tissue (empiric) 3. 4. 5. 6. 7. 8. Antibiotic to change to Cefoxitin OR ceftriaxone + metronidazole Cefoxitin OR levofloxacin + metronidazole OR ceftriaxone + metronidazole Cefazolin OR levofloxacin + clindamycin NICU Contact Dr. Clance for alternatives in these patient populations Caffeine benzoate IV vials a. Now available. If needed, please allow 24-48 hours to obtain since it is not kept on the shelf due to its inactivity for the past 3 years. Please note this medication has not been available from 8/2012 – 8/2015. b. Primarily used to treat emergency respiratory failure associated with CAN depressant overdoses. It has off-label uses for treatment in the overdose of CNS depressant agents; although no longer the preferred agent for this indication. Caffeine benzoate was more commonly used for postdural puncture headache and in combination of ECT to prolong seizure duration. The Caffeine citrate formulation is used for neonates for apnea. Cefotaxime vials [all sizes] a. Shortage is due to reduction in number of manufactures from 3 to 2, causing a decrease in supply th on the market. Best guess of when product is to be released is 4 quarter 2015. b. AAMC has cefotaxime restricted to pediatrics and Infectious Disease. This medication is used very sparingly by both services; an alternative would be ceftriaxone or pipercillin/tazobactam (Zosyn). Dextrose 50% vials a. Out of stock and not available from wholesaler or from any manufacture at this time. b. AAMC does have plenty of prefilled syringes on hand and currently swapping out vials for syringe as needed when ordered and within the Pyxis machines. Droperidol a. American Regent sole manufacture and currently not making for various manufacturing reasons. Pharmacy is out of stock since November 2012. b. There are other antiemetic alternatives to consider: ondansetron, metoclopramide, promethazine, and prochlorperazine (IV limited availability). Most of these medications are available as an injection, oral, and rectal formulations. Epinephrine Emergency Cardiac Syringe a. Wholesaler currently out of stock and only able to obtain direct orders from manufactures when available at this time. b. This item is almost exclusively found on the emergency code cart. In the interim Pharmacy will be placing in prepackage bags a standard epinephrine emergency syringe with an 18 gauge 3 ½ inch needle that can be attached to the epinephrine syringe if needed. Epinephrine preservative free ampules a. Manufacturing currently not producing. Pharmacy is out of stock since November 2012, returned briefly in July 2015 and now out of stock again. b. The preservative free vials primarily used in the operating room. Regular non-preservative free vials are appropriate to use based on the package insert. An alternative is the regular Page 2 of 4 AAMC Critical Drug Shortages – August 28, 2015 (Updated monthly, if not more often) 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. epinephrine vials or ampules. These vials contain 0.1% sodium bisulfate which is compatible for ophthalmic use. Fomepizole vials a. FDA recall caused the shortage of this product earlier in 2015 and now the manufacture reports another FDA recall. b. Primarily used to treat antifreeze overdose. Recommend discuss with Maryland Poison Center first (1-800-222-1222). There is an alternative regimen but obtaining the appropriate ethanol concentrations are difficult to come by. Hydroxyzine IV a. All sizes are not available from wholesaler and Pharmacy is out of stock of this medication since 3/2013. Manufacturer estimated time to release has been updated to April 2015. b. Alternatives include but not limited to diphenhydramine or cetirizine for urticaria/atopic dermatitis/pruritus. Indigo carmine injection a. Currently only one manufactured left supplying the market limiting supply. Pharmacy has zero vials on hand. Shortage originated 3/2014. b. There is no single dye that can replace indigo carmine. Potential options include methylene blue and indocyanine green. Choice of alternative agent will depend on type of procedure and prescriber discretion, as well as product availability. Many of the marker dyes are on back-order. See “Dye Agent Alternatives” on the drug shortage site for more information. L-Cysteine a. Out of stock at the wholesaler since 1/2015. b. Our parenteral nutrition company CAPS also out of stock. NICU providers have been alerted. No alternative identified at this time. Additional information on how to conserve can be found at ASPEN’s web site: http://www.nutritioncare.org/Guidelines_and_Clinical_Practice/Clinical_Practice_Library/Parent eral_Nutrition_Cysteine_Product_Shortage_Considerations/ Methyldopa IV a. Sole manufacture, American Regent had recalled the product in 2011. None currently available. b. Consider alternatives: IV hydralyzine or IV labetolol. Methylene blue a. Reason for shortage manufacturing shortage unknown. Started 4/2015. Akorn estimates release in summer 2015 and American Regent cannot provide an estimate release b. Used primarily for GI fistula and other GI diagnostic procedure. Also used for methemoglobinemia treatment. Many of the marker dyes are on back-order. See “Dye Agent Alternatives” on the drug shortage site for more information. Morphine PF injection a. Out of stock at wholesaler of the 25mg/mL and 50mg/mL concentration. Limited amount left in nd AAMC. Expected release now changed to 2 quarter 2015. b. Conserve preservative free morphine as much as needed. May need to purchase other concentrations to help out usage. Oxycodone/acetaminophen 5/325 solution (Roxicet) a. Manufactures are validating new source of raw materials thus causing the delay. Update, now no release date. Main Pharmacy is out and Clatanoff Pharmacy has limited amount on hand. b. An alternative alert is currently directing prescriber to acetaminophen/oxycodone individual components as liquids or hydrocodone elixir. Pancuronium IV a. Long term backorder with manufacture (6/2012), no estimated release date. Out of stock. Alternatives include succinylcholine, cisatracurium, and/or vecuronium. Phentolamine mesylate injection a. Out of stock at wholesaler and both manufactures have stopped making for now. Unknown if they will resume. Pharmacy has ZERO vials on hand. Manufacture discontinued this product. b. An alternative for use for extravasations includes terbutaline as a ratio of 1:9 with saline as the base solution. IV Therapy is aware and this alternative was approved by P&T in 2012. Page 3 of 4 AAMC Critical Drug Shortages – August 28, 2015 (Updated monthly, if not more often) 19. Phytonadione syringes a. Single dose phytonadione syringes are on backorder. June 2015. b. Clatanoff Pharmacy is stocking up on glass ampoules of phytonadione with a filter needle. 20. Pralidoxime chloride (Protopam) a. All stock expired and manufactured have stopped making. None available at AAMC. b. Use in conjunction to treat organophosphate insecticide toxicity and cholinesterase inhibitor toxicity. Alternatives include using Mark-1 auto-injector. AAMC Emergency Management Director has already been notified 6/2014. 21. Scopolamine injection a. No longer being manufactured. Pharmacy is currently out of stock of this item since 3/2015. See web site for more information: http://www.fresenius-kabi.us/images/documents/ourproducts/Scopolamine_Supply_Letter_Feb_2015_vF.pdf b. Alternatives atropine and glycopyrrolate injection can be used in place of. Anesthesia has been notified in separate communication already. Page 4 of 4