Drug Shortage information Action Plan - …

1 drug Shortage information Action plan Aminocaproic Acid Shortage is due to manufacturing issues. Guidelines on using tranexamic acid have been reviewed by P&T and distributed to surgery areas. Aminophylline inj Shortage is due to manufacturing issues. Looking into alternatives and current use. Atropine Inj Manufacturers have suspended the production leading to delays. Using vials for EH carts and trays. Black Widow Antivenin Merck has low inventory of Antivenin Latrodectus Mactans. The company cannot estimate when regular distribution will resume. Memo created and sent to ED staff and pharmacy on process on how to obtain emergency supply through Merck. Merck (medical team) 1-800-672-6372 If after normal business hours, contact the same number and follow promptsCalcium chloride and calcium gluconate Shortage is due to manufacturing problems Conservation to minimum amount in adult TPN solutions, with the intent to keep ionized calcium within low normal range.

2 (1 mmoles/L) See conservation plan for further details. Calcium gluconate For boluses, premix bags are available 1 gram calcium gluconate in 50 mL NS Calcium chloride Have been removed from Emery House carts and placed in RSI kits at University. Cytarabine The Shortage is due to manufacturing issues. Some products are available. Alternatives: For AML, use Mitoxantrone+Etoposide. For ALL, use alternative regimens or omit Cytarabine. See Chemo Action plan for plans on select critical chemo shortages-approved by P&T. Daunorubicin The Shortage is due to suspension of manufacturing and manufacturing issues. A communication letter has been sent to oncologists/hematologists to notify them of the Shortage . Use alternative anthracycline or an alternative regimen for lymphomas, metastatic breast cancer, or sarcomas.

3 Dextrose 50% Shortage is due to increased demand and manufacturing delays. Reduced stock in crash carts from 2 to 1 syringe. Drawing up vials on demand for use on floors. Watching stock closely. May consider stocking D10 bags in the Omnicells on floors for emergent hypoglycemia, if necessary. Doxorubicin The Shortage is due to manufacturing issues. The duration of the Shortage is unknown. A communication letter has been sent to oncologists/hematologists to notify them of the Shortage . Use alternative anthracycline or an alternative regimen for lymphomas, metastatic breast cancer, or sarcomas. Fosphenytoin Akorn and American Regent no longer manufacture. Hospira had a voluntary recall. Other manufacturers reason unknown. Have been able to order Stock very low in the system. There is a CPOE order alert active, asking prescribers to utilize alternatives: Alternative injectables include (adult dosing): Phenytoin injection (use same dose and frequency as fosphenytoin) Levetiracetam (Keppra) 20mg/kg load; 1000 mg bid for prophylaxis/maintenance dose Valproate sodium 20mg/kg load; 10-15 mg/kg/day divided q8-12 hours maintenance dose Phenobarbital 20mg/kg load; 50-100 mg BID or TID maintenance dose Hydroxyzine inj Shortage is due to manufacturing issues.

4 Promote alternatives such as diphenhydramine. Labetalol The Shortage is due to manufacturing delays. Carpujects available as of 3-21 will be bringing these back in. Leucovorin inj The Shortage is due to increased demand and manufacturing issues. P&T approved pharmacist interchange from leucovorin to levoleucovorin if needed. Leucovorin tablets are currently available and are not affected by the Shortage . A communication letter has been sent to oncologists/hematologists to notify them of the Shortage . Mannitol The Shortage is due to increased demand and manufacturing delays. The expected duration of the Shortage is unknown. Can order from Hospira. Shortage starting to stabilize. Currently, concentrated sodium chloride remains available in Neuro ICU Omnicell with safety steps in place. Nitroglycerin Drips The Shortage is due to manufacturing delays and the companies cannot estimate a release date.

5 Shortage plan approved Dec P&T. For non-ACS patients, encourage IV Nicardipine, IV Sodium Nitroprusside We have been able to obtain vials and have placed these back in the cath lab. Nitroglycerin ointment There is no reason provided for the Shortage . Unit dose has become available Some is still available for ordering. Assessing plan to destock from omnicell to centralize stock. Unit dose has become available, and we are monitoring supply Papaverine inj The Shortage is due to suspended production by the sole manufacturer. Vascular surgery will defer use to CV surgery. Exploring other options and alternatives, including verapamil. Perflutren lipid microspheres The Shortage is due to manufacturing delays and another manufacturer voluntarily suspending production. The expected duration of the Shortage is unknown.

6 plan approved at August P&T to allow for non-formulary use of Optison during Shortage . plan implemented on August 3, 2012 due to no stock of Definity in the system. Memo created for Definity and sent to pharmacy/ECHO techs-cardiology. Phosphate injections Both sodium phosphate and potassium phosphate injections are short. No known resolution date. Shortage plan in place. Recently have opened up use for sodium phosphate in TPN. For boluses, automatic interchanges to PO are in place if patient meets specific criteria. Utilize potassium phosphate for bolusing. See Shortage plan for further details. Have established a contract with People s Pharmacy to supply sodium phosphate for use in TPN. plan was taken to P&T to be able to order product from Norway if needed (to be determined by drug Shortage team). Rabies Vaccine No products are fully available.

7 RabAvert available but there is a delay in getting orders as the company fulfills current orders. Email distributed to pharmacy staff on how to obtain: Novartis: a. Pre-exposure- representative said look at CDC website ( ) b. Post-exposure- will allow distribution via their customer service (877-683-4732) or local distributor. Sanofi-Pasteur: a. Pre-exposure- None Post-exposure- will allow overnight distribution, physician must fill out form and fax to company ) Sodium Bicarbonate The Shortage is due to manufacturing delays and increased demand for product. Intermittently receiving syringes. Vial stock has stabilized. FDA has approved temporary importation of sodium bicarbonate injection from Australia. P&T approved ordering of this product if needed. EH cart par reduced from 2 to 1; Broselow cart par reduce from 3 to 1 on adult presentation and from 4 to 2 on pediatric presentation.

8 Reduce in cardiac boxes from 6 to 4. Once syringe stock has stabilized, pharmacy will increase par back to normal. Sodium Chloride APP has sodium chloride concentrated solution on Shortage due to increased demand. APP discontinued sodium chloride 20 mL vials in February 2013 All adult hospitals have switched to and sets in CPOE/PharmNet have been corrected. Will continue to watch supply of Sodium thiosulfate inj American Regent-temporarily d/c of manufacturing. American Regent-on backorder with no release date for the 100 mg/mL 10 mL vial presentation; American Regent and Hope Pharmaceutical have 250 mg/mL 50 mL vial available. There is severely limited stock within the entire system and we will probably exhaust our supply at current usage. A minimal supply must be kept in reserve for emergent known cyanide toxicity situations.

9 During the Shortage of sodium thiosulfate, nitroprusside infusions will be sent without any sodium thiosulfate added. Pharmacy is notified when a nitroprusside infusion stays on a patient s profile for greater than 48 hours. Thiotepa Injections Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue. FDA has permitted importation of Italian product. This was taken to P&T and approved if needed in May (to be determined by drug Shortage team).

10 Tuberculin Sanofi Pasteur states the Shortage is due to supply and demand issues. JHP states the Shortage is due to increased demand for the product. Estimated release date is late May 2013. Currently, Employee Health is granting temporary clearance for annual TB skin testing. Testing is being continued on new hires. Trace elements Shortage is due to the sole manufacturer having manufacturing problems. Conservation plan is in place. Patients on long-term TPN will receive trace elements on MWF. Please see plan for further details. plan has gone to P&T and was approved to order product from Norway if needed (to be determined by drug Shortage team). Verapamil Hospira states the Shortage is due to manufacturing delays. Hospira is the sole supplier of verapamil injection. Monitoring supply closely. Reduction to the EH cart may be needed in the near future.