South Plains Emergency Medical Services, Inc. P.O. Box Lubbock, Texas 79453
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1 South Plains Emergency Medical Services, Inc. P.O. Box Lubbock, Texas June 28, 2017 TO: SPEMS EMS Services SUBJECT: SPEMS PARAMEDIC PROTOCOL VARIANCE With the ongoing medication shortages, Epinephrine 1:10,000 pre-filled syringes may be unavailable. Please let this letter serve as your authority to utilize the variation described below until Epinephrine 1:10,000 is available from your supplier. The FDA has released a document allowing for extensions of expiration dates for Epinephrine 1:10,000. This document is attached to this variance. I will allow retention and use of these listed drugs until the extended expiration dates as listed and approved by this FDA document. If Epinephrine 1:10,000 is kept beyond the original expiration date as listed on the label, the FDA document must be present with this variance and the expiration date listed on the document will be considered the expiration date. No Epinephrine 1:10,000 may be kept beyond the extended expiration date that is listed on the FDA document. If Epinephrine 1:10,000 is unavailable, the following procedure will be followed: Epinephrine 1:10,000 can be obtained by utilizing Epinephrine 1:1,000 1mg/1mL vials or ampules. The Epinephrine 1:1,000 should be diluted with 9 additional ml s of NS. This will create Epinephrine 1:10,000 with a concentration of 1mg in 10mL; which is the same as the prefilled syringes. All doses will then be consistent with the SPEMS Protocols. This is a temporary variance and strictly to be used when Epinephrine 1:10,000 is unavailable from the supplier and you are in short supply. So long as the shortage continues, services may replace Epinephrine 1:10,000 with Epinephrine 1:1,000 vials or ampules. However, the minimum amount of Epinephrine 1:1,000 will be increased to satisfy requirements for Epinephrine 1:1,000 plus Epinephrine 1:10,000. Therefore, if Epinephrine 1:1,000 replaces all Epinephrine 1:10,000, then the minimum stock of Epinephrine 1:1,000 shall be increased to eight (8) as outlined in the SPEMS Protocols Equipment List. You will need to place a copy of this letter in each protocol book in each ambulance. Sincerely, Charles E. Addington II, D.O. Medical Director
2 Page 1 of 12 Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages [ ] Due to the ongoing critical shortages of injectable drugs used in critical care, FDA is alerting health care professionals and emergency responders of updated dates through which some of these injectable drugs, manufactured by Hospira Inc, a Pfizer company, may be used beyond the manufacturer s labeled expiration date. To help ensure patient safety, these products should have been and should continue to be stored as per labeled conditions. Hospitals that have the following lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. As data on additional emergency syringe products and lot numbers become available, this list can be expanded. Further information is found here (/Drugs/DrugSafety/ucm htm). Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov (drugshortages@fda.hhs.gov) with questions regarding these tables. Product and lot numbers of Atropine Sulfate Injection, Dextrose 50% Injection, and Epinephrine Injection products in ABBOJECT syringes eligible for use beyond the manufacturer s labeled expiration date (as of June 15, 2017). Atropine Sulfate Injection, USP 0.1 mg/ml; 5 ml ABBOJECT syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s original expiry date) 51013DK00 1-Mar Sep DK00 1-Apr Oct DK00 1-Jun Dec DK00 1-Jun Dec-2017
3 Page 2 of DK00 1-Jun Dec DK00 1-Oct Apr-2018 Atropine Sulfate Injection, USP 0.1 mg/ml; 10 ml ABBOJECT syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s original expiry date) 51475DK00 1-Mar Mar DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-May May DK00 1-May May DK00 1-May May DK00 1-May May DK00 1-May May DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun-2018
4 Page 3 of DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Aug Aug DK00 1-Sep Sep DK00 1-Sep Sep DK00 1-Sep Sep DK00 1-Sep Sep DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Nov Nov DK00 1-Nov Nov DK00 1-Nov Nov-2018
5 Page 4 of DK00 1-Nov Nov-2018 Dextrose 50% Injection, USP, 50 ml ABBOJECT Syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s original expiry date) 49368DK00 1-Jan Jan DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-May May DK00 1-May May DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jun Jun-2018
6 Page 5 of DK00 1-Jun Jun DK00 1-Jul Jul DK00 1-Jul Jul DK00 1-Aug Aug DK00 1-Aug Aug DK00 1-Aug Aug DK00 1-Oct Oct DK00 1-Nov Nov-2018 Epinephrine Injection, USP 0.1 mg/ml; 10 ml ABBOJECT syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s original expiry date) 52002DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct-2017
7 Page 6 of DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec-2017
8 Page 7 of DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan-2018
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11 Drug Shortages > Extended Use Dates Provided by Pfizer to Assist with Emergency Sy... Page 10 of DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Jul Apr DK00 1-Aug May DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug-2018
12 Drug Shortages > Extended Use Dates Provided by Pfizer to Assist with Emergency Sy... Page 11 of DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep-2018
13 Drug Shortages > Extended Use Dates Provided by Pfizer to Assist with Emergency Sy... Page 12 of DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep-2018 More in Drug Shortages (/Drugs/DrugSafety/DrugShortages/default.htm) Drug Shortages: Additional News and Information (/Drugs/DrugSafety/DrugShortages/ucm htm) Frequently Asked Questions about Drug Shortages (/Drugs/DrugSafety/DrugShortages/ucm htm)
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