About Me Amit Gupta R.Ph, Pharm.D, CCP, CGP • Owner of Amit Gupta Consulting, LLC • Pharmacy Consultant • 17 years of experience • Provide Consulting Pharmacy services to ASC, Dialysis, SNF, and ALF. Amit Gupta Consulting, LLC 5 Pelham Lane Bordentown NJ 08505 (908) 334-5437 firstname.lastname@example.org
Drug Diversion We all know the incidence of Drug Diversion is only increasing. The question is what do we do when it actually occurs?
CDS Discrepancy The DON/ Administrator will do the following fill out: DEA Form 106 initial and conduct a timely investigation NJ Division of Consumer Affairs, Department of Law and Public Safety, Drug Control Unit, Form DDC-52 Health Care Professional Responsibility and Reporting Enhancement Act Reporting form (only if division is done by a licensed provider) NJDOH HFSFO
CDS Discrepancy Legal Counsel • With the Center’s legal counsel, report to the healthcare specific state licensing board. • The Center’s legal counsel may report the diversion to the local police department. This report may be made regardless of whether the diversion occurred within the scope of the employee’s employment or training, or while the employee was a patient or visitor. Be careful when discussing the incidents with the accused.
CDS Discrepancy • The Center’s legal counsel and, if applicable, the drug diversion team/specialist will evaluate all incidents of drug diversion whether additional external reports should be made, such as to the NJDO Communicable Disease Service or FDA. • A police report will be filed. • If a CDS department exists in the state, that department will be notified • The Center will work with the Consultant Pharmacist to determine whether additional steps are required such as reporting to the local public health agency • The Center will consult their legal department to assist in all further action • The employee whom diverted will be reported to the authorities and released from employment
Policy • Free policy will be available on the SCC website • Feel free to adjust • Two version of policies
Power Outages Questions have been brought up during survey… What happens on the weekends to the fridge? What if you lose power for multiple hours? If a tree falls in the woods, but no one is there to hear, does it make a sound?
Refrigerator temperatures • What happens to the medications? • Succinylcholine - The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Meaning if exposed time at elevated temperatures for any amount of time, it will no longer be 14 days. • Rocuronium – The multi-dose vials are stable for up to 60 days at room temperature as long as not opened. • PPD – Must be stored in refrigerator. If improperly stored, may result in oxidation and degradation which may affect potency.
Refrigerator Thermometers New Data logging thermometers • Contain Bluetooth Connectivity – means it will notify you if the temperature is out of compliance • Ability to log temperatures for multiple days • Contain the ability to graph temperatures If the refrigerator is old, some do not fridges do not regulate temperature properly. (highs are too high, and the lows are too low)
Hazardous Drug in HealthCare/USP-800 A Brief Overview
NIOSH • The National Institute for Occupational Safety and Health • They have defined criteria for hazardous drugs • USP developed standards for handling these hazardous drugs to minimize the risk to public health. • The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs, and help reduce the risk posed to patients and the healthcare workforce.
Hazardous Drugs • Three classes of Hazardous Drugs (HD) • Antineoplastic (Megace, “cancer meds”, etc) • Non-antineoplastic (spironolactone, anti-psychotics, phenytoin) • Reproductive risk (VPA, fluconazole, clomiphene, oxytocin) • https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf • USP-800 describes the standards for handling HD to promote patient safety, work safety and environmental protection.
USP-800 • The NJ Board of Pharmacy has adopted USP 800 and the proposed effective date for pharmacies to meet the new requirements is the official date of General Chapter 800, which originally was July 1, 2018 and is now anticipated to be December 1, 2019. • USP standards are only legally enforceable when an entity with authority chooses to make elements of those chapters enforceable. • Even though the State may not immediately enforce the standards, Liability Insurance Carriers, and other Accrediting Organizations (JCAHO) may.
USP-800 • Federal Law requires that entities that handle HD must incorporate USP 800 standards: • Hazard Communication Program • Occupational Safety Program (OSHA) - Safety Data Sheets for HD • Centers must list HD used in the center, which must be reviewed annually, and updated whenever a new agent or dosage form is used.
The Long and Short • Hazardous Drugs are rarely, if ever, used in Surgical Centers, but when they are used: • You must use protective medical devices and techniques. • Do not have to use Personal Protective Equipment (PPE - gown) • Do not have to double glove • Spill training is required. • A standard operating procedure addressing the location of spill kit, clean up materials, PPE requires, and who is responsible.
Disposal • Unless your Center is producing more than 100 kg of hazardous or 1 kg of acute waste a month, you are exempt from having to follow Resource Conservation and Recovery Act (RCRA) • BUT Sewering prohibitions applies to all healthcare facilities, as does conditional exemption for hazardous waste that are also controlled substances. Cannot use kitty litter or putting the medication on chux. • Residue in Containers, IV bags and Syringes are not regulated as hazardous waste. Remaining medication in partially used vials can be disposed properly
Single vs. Multi-Dose Vials Multi-Dose Vial (MDV) • Although MDV's can be used for more than one patient when aseptic technique is followed, ideally even MDVs are used for only one patient. • A,MDV becomes a SDV when entering a patient care area (Anesthesia cart, operating room, etc) • A new needle and syringe every time • If in doubt, assume as a single dose vial • Rubber septum must be disinfected with alcohol wipe Single Dose Vial • Used for a single patient for a single procedure or injection • Discard after every use! • A new needle and syringe every time • Rubber septum must be disinfected with alcohol wipe
Thank You Amit Gupta R.Ph, Pharm.D, CGP, CCP email@example.com