Unknown amount of time for reporting to ARCOS Drug shortages may prevent preparation of certain products Implementation timeline: Meet with DEA to determine security needs Security install: Update packaging center space to accommodate new totes, secure glass window, secure door to substance space” install badge reader and security cameras. “controlled Submit DEA license applications for approval Develop policies & procedures Develop training materials Hire technicians Purchase of capital equipment and storage SOP for each individual product will be prepared Validate workflow process with technicians Technicians trained/validated Validation for Outside Testing Labs sterility testing will be conducted Communication plan between sites needs to be identified and developed Once products have been validated and are ready for preparation, will begin with two products, in addition to midazolam and norepinephrine that SLMC will be producing for a total of four products. Once process is developed, begin to incorporate 1-2 products per month, until fully operational. Month Labor (FTE) # of products Products Year 1 % Savings realized for added product Month 0-3 1 tech 2 products Midazolam, 100% savings 1 pharmacist norepinephrine Months 4-5 2 techs +2 products (4 total) Midazolam, 75% savings 0.5 pharmacist norepinephrine magnesium 2gm, fentanyl Month 2 techs + 2 products (6 total) magnesium 1gm 50% savings 0.5 pharmacist hydromorphone PCA, Month 2 techs + 2 product (8 total) phenylephrine syringe 42% savings 0.5 pharmacist Morphine PCA Month 8 2 techs +1 products (9 total) Succinylcholine 33% savings 0.5 pharmacist syringes Month 9 2 techs + 1 product (10 total) Ropivacaine 0.2% 250 25% savings 0.2 pharmacist ml
Unknown amount of time for reporting to ARCOS Drug shortages may prevent preparation of certain products Implementation timeline: Meet with DEA to determine security needs Security install: Update packaging center space to accommodate new totes, secure glass window, secure door to “controlled substance space” install badge reader and security cameras. Submit DEA license applications for approval Develop policies & procedures Develop training materials Hire technicians Purchase of capital equipment and storage SOP for each individual product will be prepared Validate workflow process with technicians Technicians trained/validated Validation for Outside Testing Labs sterility testing will be conducted Communication plan between sites needs to be identified and developed Once products have been validated and are ready for preparation, will begin with two products, in addition to midazolam and norepinephrine that SLMC will be producing for a total of four products. Once process is developed, begin to incorporate 1-2 products per month, until fully operational. Month Labor (FTE) # of products Products Year 1 % Savings realized for added product Month 0-3 1 tech 1 pharmacist 2 products Midazolam, norepinephrine 100% savings Months 4-5 2 techs 0.5 pharmacist +2 products (4 total) Midazolam, norepinephrine magnesium 2gm, fentanyl 75% savings Month 2 techs 0.5 pharmacist + 2 products (6 total) magnesium 1gm hydromorphone PCA, 50% savings Month 2 techs 0.5 pharmacist + 2 product (8 total) phenylephrine syringe Morphine PCA 42% savings Month 8 2 techs 0.5 pharmacist +1 products (9 total) Succinylcholine syringes 33% savings Month 9 2 techs 0.2 pharmacist + 1 product (10 total) Ropivacaine 0.2% 250 ml 25% savings
Centralized%20Sterile%20Product%20Preparation%20Business%20Proposal.docx