June 24, e 24, 2017 2017 Ben Kesne ner RPh Executiv tive Directo tor Shelle ley Bagwell ll RPh PMP Directo tor CURRENT BOARD MEMBERS • Richard Mazzoni RPh Chairman NE • Amy Buesing RPh Hospital • Neal Dungan RPh SE • Joe Anderson RPh Central January 2017 • Teri Rolan RPh NW • Cathleen Wingert Public • Chris Woodul RPh SW • Michael Garringer Public • **Vacant** Public FEDERAL LAW 1
DEA Drug Take-Back Events Drug Disposal • Secure and Responsible Drug Disposal Act • Drug Take-Back events began in September • The goal of this Act is to allow for the collection 2010. • The DEA has sponsored 12 total take-back and disposal of Controlled Substances in a secure, convenient, and responsible manner events • Also reduces diversion and the introduction of • Most recently on October 22, 2016 some potentially harmful substances into the • October data not available environment • Record setting amount of 447 tons collected in April 2016 • Previous record 390 tons Current Drug Disposal Information DEA.gov Next National Take-Back • April 29, 2017 • Check back on DEA website to locate collection sites on April 1, 2017 • To find an authorized collector in your area call DEA Office at 800-882-9539 2
Syringe Disposal Controlled Substance Disposal safeneedledisposal.org Locations DEA.GOV 04-06-17 3
CONTACT INFO CONTACT INFO • DEA Office for Southern NM • DEA Office for Northern NM • 660 Mesa Hills Drive, Suite 2000 • 2660 Fritts Crossing SE El Paso, TX 79912 Albuquerque, NM 87106 • Las Cruces (575)526-0700 • Diversion Number: (505) 452-4500 • El Paso Diversion Fax: (505) 873-9921 (915)832-6000 MORE FROM DEA STILL MORE FROM DEA When is Significant? • DEA Updates the electronic 106 Form for According to the DEA . . . 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 .” 4
NMBoP Definition • Significant Loss: includes suspected • Update on Industry diversions, in-transit losses or any other Progress in Implementing unexplained loss and must be reported to Electronic Prescribing for the Board of Pharmacy within five (5) days of becoming aware of that loss Controlled Substances – May 17, 2013 E-PRESCRIBING UPDATE • All electronically transmitted controlled substance prescriptions are valid • Includes Schedule II • Please do not reject a C-II Rx because it is an E-prescription 5
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 (CS) prescription information to a pharmacy. The pharmacy via facsimile, or orally to a pharmacy on 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. 6
EMPLOYMENT NMCourts.gov SCREENING • According to DEA regulations: – A pharmacy registrant (i.e., the registrant or corporation which owns the pharmacy) must not employ in a position which allows access to controlled substances, anyone who has been convicted of a felony relating to controlled substances. . . C.F.R. Section 1301.76 Other security controls for practitioners. CIII-V Partial Refilling • Partial filling is allowed provided that: – Quantities are < prescribed – Total quantity on all partial refills does not exceed the total quantity prescribed – No dispensing occurs after 6 months from written date CFR 1306.23 Controlled Substance ER/LA OPIATE REMS Prescription Transfer • CFR 1306.25 Transfer between • AVAILABLE MARCH 1, 2013 pharmacies • NOT MANDATORY – (a) The transfer of original prescription • Assess patients for treatment information for a controlled substance listed in • Initiate therapy, modify dose, and discontinue Schedule III, IV, or V for the purpose of refill • Be knowledgeable about how to manage ongoing therapy. dispensing is permissible between pharmacies on • Counsel patients and caregivers about the safe use, proper a one-time basis only. However, pharmacies storage and disposal. • electronically sharing a real-time, online database Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics. may transfer up to the maximum refills permitted by law and the prescriber's authorization. 1306.25(a) 05-12-17 7
PHARMACY http://www.er-la-opioidrems.com COMPOUNDING • HR 3204 • The Drug Quality and Security Act • Became public law on November 27, 2013 The Drug Quality and The Drug Quality and Security Act (H.R. 3204) Security Act (H.R. 3204) • State pharmacy boards regulate traditional pharmacy • This legislation distinguishes compounding • FDA registration as an Outsourcing Facility compounders engaged in – Compounding of sterile drugs traditional pharmacy practice from – Elected to register as an outsourcing facility those making large volumes of – Not required to be a licensed pharmacy, but compounding must be done by or under direct supervision of a pharmacist compounded drugs without – May or may not obtain prescriptions for individual patients • Providers and patients would have the option of individual prescriptions. purchasing products from outsourcing facilities that comply with FDA quality standards. New Mexico Law & Board Activity 8
2017 Legislature Regulation Changes • HB 370 – Opioid Overdose Education • Partial Fill CII • HB 260 and SB 180 – Regulation of • Pharmacist Prescriptive Authority Biosimilar Products PHARMACY Reminders COMPOUNDING • MTP • A pharmacy may compound a patient- specific sterile preparation pursuant to a prescription or order for an individual 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. Compounded Sterile Non-Sterile Compounding Preparations • Must be compounded properly in • The wording allowing for office use accordance with all USP chapters compounding was removed from the • Currently USP <797> regulation. • A pharmacy may no longer compound • USP <800> effective on July 1, 2018 for a prescriber’s office use . – Hazardous compounding must be done in a negative pressure room – Can no longer have hazardous and non- hazardous compounding in the same room 16.19.36 06-13-14 16.19.30.9A(4) Removed 06-14-13 9
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