Black Widow Antivenin

Transcription

1 Drug Shortage information Action Plan Merck has low inventory of Antivenin Latrodectus Mactans. The company cannot estimate when regular distribution will resume. Merck announced that the expiration date for Antivenin lot H was extended to January 3, The packaged Antivenin lot H contains one vial of Antivenin lot , one vial of sterile diluent lot , and a 1 ml vial of horse serum for sensitivity testing. The expiration dating for the sterile diluent has not been extended. Discard the sterile diluent and reconstitute the Antivenin vial with 2.5 ml of sterile water for injection. Black Widow Antivenin Calcium Disodium Versenate Cefazolin In July 2013, Valeant transferred distribution of calcium disodium versenate to ASD Healthcare. Graceway Pharmaceuticals was purchased by Medicis in Medicis became a division of Valeant and the company has resumed manufacturing. FDA has allowed extended expiry on one lot of current available product. The 2.5 ml ampules (NDC , Lot #0503) have a labeled expiry of June 30, Shortage is due to manufacturing delays and increased demand. Memo created and sent to ED staff and pharmacy on process on how to obtain emergency supply through Merck. Merck (medical team) If after normal business hours, contact the same number and follow prompts Available through Medicis for active cases only. Will be sent overnight if needed. Call Plan approved at April P&T but has not been implemented at this time.

2 Cytarabine The shortage is due to manufacturing issues. Ben Venue stopped production in its plant and closed in early 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. D5W 1L bags Increased demand Encouraging practitioners to critically evaluate the need for IV fluids. D5W1/2NS Increased demand Encouraging practitioners to critically evaluate the need for IV fluids. This remains the preferred fluid for pharmacist therapeutic interchange for NS in adult patients. D5WNS Increased Demand Encouraging practitioners to critically evaluate the need for IV fluids. Daunorubicin Doxorubicin Droperidol Excel Bags (NS and D5W) The shortage is due to suspension of manufacturing and manufacturing issues. The shortage is due to manufacturing issues. Estimated release dates include late-august and late-september American Regent has on back order due to manufacturing delays. Hospira has droperidol on back order due to shortage of raw material. Unclear etiology, but may be due to production delays. 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. 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. Anesthesia preference is for ondansetron to be available as alternative (stocked on OR Omnicell already) Monitor. Pharmacy will prep amiodarone infusions in NS (non Excel) using a final concentration of 450 mg in 250 ml.

3 Famotidine Fosphenytoin Ben Venue closed its Bedford, Ohio production plant down. West-Ware states the shortage is due to manufacturing delays. Shortage is due to manufacturing delays and recalled lots contaminated with particulate matter. Encourage PO use when possible. Pharmacist encouraged to use P&T conversion of IV to PO famotidine. CPOE shortage alert encouraging prescriber to use po phenytoin if possible, or injectable phenytoin. Hydroxyzine inj Shortage is due to manufacturing issues. Promote alternatives such as diphenhydramine. CPOE shortage alert is active. 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. Lactated Ringers Increased demand Encouraging practitioners to critically evaluate the need for IV fluids. Memantine Multivitamin Oral Liquid Immediate release tablets have been discontinued from the manufacturer. Many of the extended release formulations are on backorder. Product currently not being produced. Pharmacy will continue to keep stock of immediate release tablets until supply depletes. There is no equivalent or comparable product currently available. Will continue to send the tablet to be crushed. NS and1/2 NS Fluids Pantoprazole Inj Shortage is due to manufacturing delays. Not yet listed as national shortage, but currently on intermittent backorder. Encouraging practitioners to critically evaluate the need for IV fluids. Encourage PO use when possible. Pharmacist encouraged to use P&T conversion of IV to PO pantoprazole.

4 Tamsulosin capsules The shortage is due to increased demand. Monitor. Thiotepa s Torsemide Ben Venue voluntarily entered into a consent decree with FDA in late-january, 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. Roche discontinued Demadex injection for business reasons. Demadex tablets are not affected by this shortage. Bedford has approval for torsemide injection, but has not yet launched the product. American Regent had temporarily suspended distribution of most drug products presentations in April, American Regent resumed manufacturing in Shirley, New York in early-may, 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). Encourage PO use when possible. Reference: ASHP s national current drug shortages list. Oct Recently added to list: Pantoprazole injection, tamsulosin capsules, memantine Recently removed from list: Trace elements, papaverine, vecuronium, metronidazole injection Where is information on drug shortages posted? On MOLLI>>drug information>>drug shortages. This includes a full report of all national shortages and the above abbreviated report

5 On Methodist MD>>Quality and Patient Safety>>Pharmacy and Therapeutics>>Drug Shortages and on Methodist MD under recent news This includes a full report of all national shortages and the above abbreviated report, and specific memos. Updated/new memos are posted under recent news. On System Pharmacy Sharepoint Page>> Shared documents>>drug shortages This includes the Excel tracking log used by the pharmacy drug shortage team of all shortages critical to Methodist. This also includes specific drug shortage memos