Pharmaceuticals and Ambulatory Surgery Centers. Tom Simpleman

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1 Pharmaceuticals and Ambulatory Surgery Centers Tom Simpleman Consultant Pharmacist 2014 Rocky Mountain Ambulatory Surgery Center Educational Conference April 10, 2014

2 Pharmaceuticals and Ambulatory Surgery Centers Tom Simpleman Registered Pharmacist Board Certified Geriatric Pharmacist Fellow in the American Society of Consultant Pharmacists Certified Professional in Healthcare Quality Consultant Pharmacist Pharmaceuticals and Ambulatory Surgery Centers Review expectations, current findings from CMS DEA Colorado Board of Pharmacy USP 797 CDC One time One patient No fractionating Single Dose Vials Immediate use 1 hour Multiple Dose Vial Joint Commission Multi-dose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorter or longer). Manufacturers are only required by law to test the effectiveness of the bacteriostatic agent used in the multi-dose vial for a period of 28 days. Revised expiration date or BUD USP 797 Multiple Dose Vial CMS I. Multi-dose vials are dated when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Note: This is different from the expiration date for the vial. The multi-dose vial can be dated with either the date opened or the discard date as per ASC policies and procedures, so long as it is clear what the date represents and the same policy is used consistently throughout the ASC Multiple Dose Vial CMS J. Multi-dose medications used for more than one patient are stored and accessed away from the immediate areas where direct patient contact occurs.

3 Multiple Dose Vial Multipledose Vial CDC USP 797 If the vial is labeled as a multidose vial or container then the dating should not exceed 28 days UNLESS the manufacturer has data to support longer dating. Centers for Disease and Control (CDC) Multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices Should be dedicated to a single patient whenever possible. If a MDV must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. CDC Multi-dose vials Safe Practices for Medical Injections Q&A Large outbreaks in ASCs HBV and HCV Private Medical Practice Pain Clinic Endoscopy Clinic Hematology/oncology clinic CDC Primary Breaches Reinsertion of used needles/syringes into Multiple-dose Vials Single needle/syringe for IV drug to multiple patients CDC Outbreak Study Prevention Prevention prefer SDV vs. MDV CDC Outbreak Study Survey US healthcare workers Use same needle/syringe on multiple patients 1-3% Preparation of in same workspace where needle/syringes were dismantled?

4 CDC Outbreak Study Deficiencies identified in ASCs Lack of oversight of personnel Failure to follow-up on reported breaches in infection control Ensure workers understand and adhere to principles of infection control and aseptic technique Reinforce in training programs in incorporate into policies Monitor for adherence Multipledose Vial Centers for Disease and Control (CDC) Prevent inadvertent contamination Direct or indirect contact Contaminated surfaces or equipment CDC Multi-dose vials Safe Practices for Medical Injections Q&A Multipledose Vial Centers for Disease and Control (CDC) If vial enters immediate patient treatment area Dedicate to that patient only Discard after use CDC Multi-dose vials Safe Practices for Medical Injections Q&A Multipledose Vial CDC recommendations DEA Centers for Disease and Control (CDC) Immediate patient treatment area Patient rooms or bays and operating rooms CDC Multi-dose vials Safe Practices for Medical Injections Q&A Do not use bags or bottles of intravenous solution as a common source of supply for multiple patients Do not keep Multidose vials in immediate patient treatment area and store in accordance with manufacturer s recommendations CDC Practices to prevent transmission of infections to patients Bookeeping 222 forms Guide to show how to complete Store securely POA responsibilities When YOU receive a form (re-distributor)

5 DEA DEA DEA CSOS Controlled Substance Ordering System Diversion Occasional misplaced Track Significant amount Suspected controlled drug diversion Report Report ANY diversion to Colorado State Ephedrine Propofol Colorado Regulations Compounding Pharmacies Compounding Compounding Pharmacies Casual Sale Betamethasone suspension injection and a triamcinolone acetonide suspension injection challenges Prescriber Pharmacy - Patient Betamethasone suspension Triamcinolone Acetonide suspension Difficult to Sterilize Autoclave As temperature increases, some drug goes into solution Supersaturated solution starts crystallizing out» Ultrasound during cooling

6 Compounded Betamethasone suspension Triamcinolone Acetonide suspension Autoclaving Verify parameters Not verified and documented All vials may not be sterilize Verify time of sterilization begins after proper pressure and temperature Colorado Regulations Other Outlet Protocols Changes approved by board of pharmacy prior to implementation Detailed record keeping Inventory, controlled drugs, storage, dispensing Medical Waste Rules have been in place DEA trumps EPA Dan Goetz program Friday Earth friendly ingredients Closely replicate the human stomach function. Breaks down unwanted medications Non-digestible liquid Disposed of similar to common home garbage. Medical Waste Drug Buster Medical Waste Individuals can take unused drugs to various locations. Survey Challenges Expired drugs Anesthesia cart Cor Cart Any Kits Clean ports Infection control

7 IV solutions in boxes not on the floor IV solution hanging with no label, time opened not marked Warm IV solutions in blanket warmer no date Unmarked pre-drawn syringe Glucose meter date opened, verify operation per manufacturer guidelines or facility policy Occurrence reporting line Any non-explainable missing drug Call the health department for all incidents How people act when drugs are diverted Run PYXIS reports on a regular basis Report by the close of the next business day Expired meds Is the order cosigned Within the proper time period Crash cart Expiration dates Diverted drugs Deliberate Intended for the patient Did the patient report non relief 5 days to investigate Report trough the portal Assign tasks to be accomplished every day Verify the job gets done

8 References CDC Safe injection Practices to prevent transmission of infections to patients CDC Multi-dose vials Safe Practices for Medical Injections Q&A RxShortages References RxShortages References Epocrates THE FAWKS COMPANY Tom Simpleman Consultant Pharmacist Pharmaceuticals and Ambulatory Surgery Centers Q & A THE FAWKS COMPANY Tom Simpleman Consultant Pharmacist tsimpleman@fawks.com

9 THE FAWKS COMPANY Consulting is our profession Not a part time job