January y 27, 27, 2018 2018 Adela Padilla RPh State Drug Inspe pecto tor Peter Ryba RPh PMP Directo tor CURRENT BOARD MEMBERS • Richard Mazzoni RPh Chairman NE • Bill Lord RPh Hospital • Neal Dungan RPh SE • Joe Anderson RPh Central October 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 14 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 28, 2017 some potentially harmful substances into the • Record setting amount of 456 tons collected environment • Previous record 450 tons in April 2017 • Total collection of 912,305 pounds Current Drug Disposal Information DEA.gov Next National Take-Back • April 28, 2018 • Check back on DEA website to locate collection sites on April 1, 2018 • To find an authorized collector in your area call DEA Office at 800-882-9539 2
Syringe Disposal safeneedledisposal.org 3
Syringe Disposal Continued Controlled Substance Disposal https://www.cabq.gov/fire/household- Locations pharmaceutical-disposal DEA.GOV 12-01-17 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 4
STILL MORE FROM DEA What 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 .” NMBOP Definition E-PRESCRIBING UPDATE • Significant Loss: includes suspected • All electronically transmitted diversions, in-transit losses or any other controlled substance prescriptions unexplained loss and must be reported to are valid the Board of Pharmacy within five (5) days • Includes Schedule II of becoming aware of that loss • Please do not reject a C-II Rx because it is an E-prescription 16.19.20.36B • Update on Industry Progress in Implementing Electronic Prescribing for Controlled Substances – May 17, 2013 5
DEA Issues Policy Statement on Role of Agents in Communicating CS Prescriptions Drug Enforcement Administration (DEA) issued a statement of policy that clarifies the proper role of a duly authorized agent of a DEA-registered individual practitioner in communicating controlled substance (CS) prescription information to a pharmacy. The statement, published October 6, 2010, in the Federal Register, reminds health care providers that a prescription for a CS medication must be issued by a DEA-registered practitioner acting in the usual course of professional practice. DEA Issues Policy Statement on Role of EMPLOYMENT 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. 6
NMCourts.gov Controlled Substance CIII-V Partial Refilling Prescription Transfer • Partial filling is allowed provided that: • CFR 1306.25 Transfer between – Quantities are < prescribed pharmacies – (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 CARA ACT 2016 CARA ACT 2016 • The Comprehensive Addiction and Recovery Act • Summary of Provisions of CARA • Expand prevention and educational efforts — particularly aimed at teens, parents and other caretakers, and aging (CARA) populations — to prevent the abuse of methamphetamines, opioids and heroin, and to promote treatment and recovery. • Signed into law by President Obama on July 22, • Expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. 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. • First major federal addiction legislation in 40 • Expand disposal sites for unwanted prescription medications to keep them out of the hands of our children and adolescents. years and the most comprehensive effort to • Launch an evidence-based opioid and heroin treatment and intervention program to expand best practices address the opioid epidemic. throughout the country. • Launch a medication-assisted treatment and intervention demonstration program. • Strengthen prescription drug monitoring programs to help states monitor and track prescription drug diversion and to help at-risk individuals access services. 7
PHARMACY CARA ACT 2016 COMPOUNDING • Title VII: Sec. 702 of the CARA ACT of 2016 • HR 3204 – Partial Fills of Schedule II Controlled Substances : Amends the • The Drug Quality and Security Act Controlled Substances Act by allowing schedule II substances to be partially filled if certain conditions and restrictions are met. • Became public law on November • Title VIII: Sec. 303 of the CARA ACT of 2016 – Medication-assisted treatment for recovery from addition : NPs 27, 2013 and PAs who have completed 24 hours of required training may seek a DATA 2000 waiver for up to 30 patients to prescribe BUPRENORPHINE. • Complete bill language available at https://www.congress.gov/114/plaws/publ198/PLAW- 114publ198.pdf 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
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