FEDERAL LAW convenient, and responsible manner Also reduces - PDF document

• Richard Mazzoni RPh Chariman NE • Amy Buesing RPh Hospital • LuGina Mendez RPh NW • Joe Anderson RPh Central • Neal Dungan RPh SE • Chris Woodul RPh SW • Buffie Saavedra Public • Cathleen Wingert Public • Vacant Public Drug Disposal • Secure and Responsible Drug Disposal Act • The goal of this Act is to allow for the collection and disposal of Controlled Substances in a secure, FEDERAL LAW convenient, and responsible manner • Also reduces diversion and the introduction of some potentially harmful substances into the environment DEA Drug Take-Back Events Disposal of Controlled Substances • Final Rule published • Drug Take-Back events began in September 2010. • Federal Register / Vol. 79, No. 174 / • The DEA has sponsored 11 total take-back Tuesday, September 9, 2014 events – Pages 53520 - 53570 • Most recently on April 30, 2016 • Effective Date October 9, 2014 • Record setting amount of 447 tons collected • Previous record 390 tons 1

DEA Drug Take-Back Events CONTACT INFO • Next scheduled for October 22, 2016 • DEA Office for Northern NM – 10:00 AM to 2:00 PM • 2660 Fritts Crossing SE • “Got Drugs?” Handouts are not available on Albuquerque, NM 87106 DEA website as of today • Diversion Number: (505) 452-4500 • Check back on DEA website to locate Diversion Fax: (505) 873-9921 collection sites CONTACT INFO Rescheduling of Hydrocodone • DEA Office for Southern NM • Effective October 6, 2014 • Federal Register / Vol. 79, No. 163 / Aug 29, • 660 Mesa Hills Drive, Suite 2000 2014. Pages 49661 - 49682 El Paso, TX 79912 • Schedule III to a Schedule II • Las Cruces (575)526-0700 • Required inventory of all hydrocodone containing products • El Paso (915)832-6000 • All Schedule II regulations will apply When is Significant? STILL MORE FROM DEA According to the DEA . . . • DEA Updates the electronic 106 Form for Reporting Theft or Loss of Controlled • What constitutes a significant loss for one Substances registrant may be construed as insignificant for • Requires registrants to include the NDC another which will help to accurately track controlled • “. . . the repeated loss of small quantities of substances reported as stolen or lost controlled substances over a period of time may • Required to report a “Significant Loss” indicate a significant aggregate problem that must be reported to DEA, even though the individual quantity of each occurrence is not significant.” 2

NMBoP Definition STILL MORE FROM DEA • New DEA Number Series • Significant Loss: includes suspected • Effective December 6, 2013 , DOD personal service diversions, in-transit losses or any other contractors will be issued a new DEA registration number unexplained loss and must be reported to that begins with the letter "G" • Registrant type (first letter of DEA Number): the Board of Pharmacy within five (5) days – A/B/F/G – Hospital/Clinic/Practitioner/Teaching of becoming aware of that loss Institution/Pharmacy – M – Mid-Level Practitioner (NP/PA/OD/ET, etc.) – P/R – Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program – X – Buprenorphine (Suboxone) physician E-PRESCRIBING UPDATE • All electronically transmitted • Update on Industry controlled substance prescriptions Progress in Implementing are valid Electronic Prescribing for • Includes Schedule II Controlled Substances • Please do not reject a C-II Rx – May 17, 2013 because it is an E-prescription DEA Issues Policy Statement on Role of DEA Issues Policy Statement on Role of Agents in Communicating CS Prescriptions Agents in Communicating CS Prescriptions • An authorized agent may prepare the prescription. . . Drug Enforcement Administration (DEA) issued a for the signature of that DEA-registered practitioner. statement of policy that clarifies the proper role of a • For a Schedule III–V drug, an authorized agent may duly authorized agent of a DEA-registered individual transmit a practitioner-signed prescription to a practitioner in communicating controlled substance pharmacy via facsimile, or orally to a pharmacy on (CS) prescription information to a pharmacy. The behalf of the practitioner. statement, published October 6, 2010, in the Federal Register, reminds health care providers that a • An authorized agent may transmit by facsimile a prescription for a CS medication must be issued by a practitioner-signed Schedule II prescription for a DEA-registered practitioner acting in the usual course patient in a hospice or long-term care facility (LTCF) of professional practice. on behalf of the practitioner. 3

EMPLOYMENT CIII-V REFILLING SCREENING • According to DEA regulations: • May partially refill >5 times if: – A pharmacy registrant (i.e., the registrant or – Quantities are < prescribed corporation which owns the pharmacy) must not employ in a position which allows access to – Total quantity on all refills does not controlled substances, anyone who has been exceed amount prescribed convicted of a felony relating to controlled – All partial refills are within 6 months of substances. . . the written date C.F.R. Section 1301.76 Other security controls for practitioners. TIRF REMS (?) TIRF REMS • Transmucosal Immediate • FDA-required program Release Fentanyl • You must enroll in the TIRF REMS Access program to prescribe, dispense, or • Risk Evaluation & Mitigation distribute TIRF medicines. Strategies ER/LA OPIATE REMS TIRF REMS • AVAILABLE MARCH 1, 2013 • https://www.tirfremsaccess. • NOT MANDATORY • Assess patients for treatment com/TirfUI/rems/home.action • Initiate therapy, modify dose, and discontinue • Be knowledgeable about how to manage ongoing therapy. • Counsel patients and caregivers about the safe use, proper storage and disposal. • Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics. 4

PHARMACY The Drug Quality and COMPOUNDING Security Act (H.R. 3204) • HR 3204 • This legislation distinguishes • The Drug Quality and Security Act compounders engaged in traditional pharmacy practice from • Became public law on November those making large volumes of 27, 2013 compounded drugs without individual prescriptions. The Drug Quality and Security Act (H.R. 3204) • State pharmacy boards regulate traditional pharmacy compounding New Mexico Law • FDA registration as an Outsourcing Facility – Compounding of sterile drugs & – Elected to register as an outsourcing facility – Not required to be a licensed pharmacy, but compounding Board Activity must be done by or under direct supervision of a pharmacist – May or may not obtain prescriptions for individual patients • Providers and patients would have the option of purchasing products from outsourcing facilities that comply with FDA quality standards. Controlled Substance Prescription Requirements Prescriptions • Shall verify the identity of the person who is • Expirations receiving any rx for a CS – Schedule II • Current govt issued photo identification required, and the documentation of: • No expiration date – Schedule II-V – Name • 6 months – Number – Non-Controlled – Identification Type (DL, ID card, passport) • 12 months from the date written – State (If applicable) 16.19.20.45A,B Effective mid Sept 16.19.20.42G Effective mid Sept 5

Automated Drug Distribution Automated Filling Systems Systems • Pharmacist shall inspect and verify accuracy of final • A managing pharmacy may use an automated drug contents, and label prior to dispensing the prescription distribution system to supply medications for patients unless: of a health care facility • AFS is maintained and operated according to policies • The system may be located in a health care facility that and procedures, and verification criteria per regulation is not at the same location as the managing pharmacy • Completed and sealed prescription ready to be dispensed • Considered an extension of the managing pharmacy. to patient • If the system contains controlled substances, the • Proper loading, quality assurance, and security are pharmacist’s responsibility managing pharmacy must submit and maintain a separate registration with the DEA • No CII prescriptions 16.19.6.27 08-28-15 16.19.6.28 05-29-15 Prescription Transfers April 24, 2014 • A pharmacy may not refuse to transfer • NEW REGULATION original prescription information to another • 16.19.36 COMPOUNDED STERILE pharmacy who is acting on behalf of a PREPARATIONS patient and who is making a request for this • New Mexico Register June 13, 2014 information • EFFECTIVE: June 29, 2014 16.19.6.23D 03-22-15 PHARMACY April 24, 2014 COMPOUNDING • A pharmacy may compound a patient- • New compounded sterile specific sterile preparation pursuant to a preparation rule incorporates prescription or order for an individual USP <797> directly. patient. • Preparation of non-patient specific compounded sterile product for sale is considered manufacturing, and requires registration with the FDA and the NM Board of Pharmacy as an outsourcing facility. 6