October 2018 Adela Padilla RPh State Drug Inspector Kris Mossberg PharmD State Drug Inspector CURRENT BOARD MEMBERS • Richard Mazzoni RPh Chairman NE • Bill Lord RPh Hospital • Neal Dungan RPh SE April 2018 • Joe Anderson RPh Central • 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 2010. • The goal of this Act is to allow for the collection and disposal of Controlled Substances in a secure, • The DEA has sponsored 15 total take-back convenient, and responsible manner events • Also reduces diversion and the introduction of • Most recently on April 28, 2018 some potentially harmful substances into the • October 28, 2017 environment • Record setting amount of 456 tons collected • Previous record 450 tons in April 2017 • Total collection of 9,015,668 pounds Current Drug Disposal Information DEA.gov 2
Controlled Substance Disposal Next National Take-Back Locations • Late September to October 2018 • Check back on DEA website to locate collection sites starting September 1, 2018 • To find an authorized collector in your area call DEA Office at 800-882-9539 DEA.GOV 12-01-17 3
Syringe Disposal safeneedledisposal.org CONTACT INFO • DEA Office for Northern NM • 2660 Fritts Crossing SE Albuquerque, NM 87106 • Diversion Number: (505) 452-4500 Diversion Fax: (505) 873-9921 MORE FROM DEA CONTACT INFO • DEA Office for Southern NM • 660 Mesa Hills Drive, Suite 2000 El Paso, TX 79912 • Las Cruces (575)526-0700 • El Paso (915)832-6000 4
STILL MORE FROM DEA • DEA Updates the electronic 106 Form for Reporting Theft or Loss of Controlled Substances • Requires registrants to include the NDC which will help to accurately track controlled substances reported as stolen or lost • Required to report a “Significant Loss” What is Significant? NMBOP Definition According to the DEA . . . • Significant Loss: includes suspected • What constitutes a significant loss for one diversions, in-transit losses or any other registrant may be construed as insignificant for unexplained loss and must be reported to another the Board of Pharmacy within five (5) days • “. . . the repeated loss of small quantities of of becoming aware of that loss controlled substances over a period of time may indicate a significant aggregate problem that must be reported to DEA, even though the individual quantity of each occurrence is not significant.” 16.19.20.36B DEA Issues Policy Statement on Role of E-PRESCRIBING UPDATE Agents in Communicating CS Prescriptions Drug Enforcement Administration (DEA) issued a • All electronically transmitted statement of policy that clarifies the proper role of a controlled substance prescriptions duly authorized agent of a DEA-registered individual practitioner in communicating controlled substance are valid (CS) prescription information to a pharmacy. The • Includes Schedule II statement, published October 6, 2010, in the Federal Register, reminds health care providers that a • Please do not reject a C-II Rx prescription for a CS medication must be issued by a DEA-registered practitioner acting in the usual course because it is an E-prescription of professional practice. 5
EMPLOYMENT DEA Issues Policy Statement on Role of Agents in Communicating CS Prescriptions SCREENING • An authorized agent may prepare the prescription. . . • According to DEA regulations: for the signature of that DEA-registered practitioner. – A pharmacy registrant (i.e., the registrant or • For a Schedule III–V drug, an authorized agent may corporation which owns the pharmacy) must not transmit a practitioner-signed prescription to a employ in a position which allows access to pharmacy via facsimile, or orally to a pharmacy on controlled substances, anyone who has been behalf of the practitioner. convicted of a felony relating to controlled • An authorized agent may transmit by facsimile a substances. . . practitioner-signed Schedule II prescription for a patient in a hospice or long-term care facility (LTCF) C.F.R. on behalf of the practitioner. Section 1301.76 Other security controls for practitioners. NMCourts.gov Controlled Substance CIII-V Partial Refilling Prescription Transfer • Partial filling is allowed provided that: • CFR 1306.25 Transfer between pharmacies – Quantities are < prescribed – (a) The transfer of original prescription – Total quantity on all partial refills does information for a controlled substance listed in not exceed the total quantity prescribed Schedule III, IV, or V for the purpose of refill – No dispensing occurs after 6 months from dispensing is permissible between pharmacies on written date a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization. CFR 1306.23 1306.25(a) 05-12-17 6
Controlled Substance CARA ACT 2016 Prescription Transfer • The Comprehensive Addiction and Recovery Act (CARA) • An unfilled original EPCS prescription can • Signed into law by President Obama on July 22, be forwarded from one DEA registered 2016 retail pharmacy to another DEA registered • First major federal addiction legislation in 40 retail pharmacy, and this includes Schedule years and the most comprehensive effort to II controlled substances address the opioid epidemic. Added 02-19-18 CARA ACT 2016 CARA ACT 2016 • Summary of Provisions of CARA • Title VII: Sec. 702 of the CARA ACT of 2016 • Expand prevention and educational efforts—particularly aimed at teens, parents and other caretakers, and aging – Partial Fills of Schedule II Controlled Substances : Amends the populations—to prevent the abuse of methamphetamines, opioids and heroin, and to promote treatment and Controlled Substances Act by allowing schedule II substances to recovery. be partially filled if certain conditions and restrictions are met. • Expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. • Title VIII: Sec. 303 of the CARA ACT of 2016 • Expand resources to identify and treat incarcerated individuals suffering from addiction disorders promptly by collaborating with criminal justice stakeholders and by providing evidence-based treatment. – Medication-assisted treatment for recovery from addition : NPs • Expand disposal sites for unwanted prescription medications to keep them out of the hands of our children and and PAs who have completed 24 hours of required training may adolescents. seek a DATA 2000 waiver for up to 30 patients to prescribe • Launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country. BUPRENORPHINE. • Launch a medication-assisted treatment and intervention demonstration program. • Complete bill language available at • Strengthen prescription drug monitoring programs to help states monitor and track prescription drug diversion and to help at-risk individuals access services. https://www.congress.gov/114/plaws/publ198/PLAW- 114publ198.pdf 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. 7
The Drug Quality and Security Act (H.R. 3204) • State pharmacy boards regulate traditional pharmacy compounding • 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 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. PHARMACY COMPOUNDING • A pharmacy may compound a patient- New Mexico Law specific sterile preparation pursuant to a prescription or order for an individual & patient. • Preparation of non-patient specific Board Activity 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 Repackaging and Distribution by Preparations a Pharmacy • Must be compounded properly in accordance with all USP chapters • Pharmacy licensed by the board may repackage • Currently USP <797> under the following conditions: – By a managing pharmacy for use in an automated drug • USP <800> effective on December 1, 2019 distribution system of a licensed health care facility – Hazardous compounding must be done in a – To a clinic under the same ownership as the pharmacy negative pressure room – Must be repackaged into a sealed unit-dosed container – Can no longer have hazardous and non-hazardous with appropriate BUD, and properly labeled compounding in the same room 16.19.36 16.19.6.30 11-28-17 8
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