2015 Rich Mazzoni, R.Ph. Santa Fe LuGina Mendez-Harper, R.Ph. - PDF document

Octobe ctober 5, 2015 r 5, 2015 Ben Ben Kesn Kesner er Executive ve Director or CURRENT BOARD MEMBERS • Joe R. Anderson, R.Ph. Albuquerque • Amy Buesing, R.Ph. La Mesa • Danny Cross, R.Ph. Carlsbad 2015 • Rich Mazzoni, R.Ph. Santa Fe • LuGina Mendez-Harper, R.Ph. Peralta • Buffie Saavedra Albuquerque • Anise Yarbrough Corrales • Chris Woodul, R.Ph. Ruidoso • Cathleen Wingert Santa Fe DRUG DISPOSAL • “Secure and Responsible Drug Disposal Act” Signed Into Law FEDERAL LAW • October 12, 2010 • Requires DEA and US Attorney General promulgate regulations for return of unused prescription drugs for disposal. 1

Disposal of Controlled Substances Disposal of Controlled Substances • Final Rule published • This rule proposes requirements to govern • Federal Register / Vol. 79, No. 174 / the secure disposal of controlled Tuesday, September 9, 2014 substances by both DEA registrants and ultimate users. – Pages 53520 - 53570 • Effective Date October 9, 2014 DEA Drug Take-Back Events • Drug Take-Back events began in September 2010. • The DEA has sponsored 9 take-back days. • 309 tons collected on September 27, 2014 • Collected more than 4.8 million pounds (over 2,411 tons) of medication at over 6,000 sites manned by law enforcement partners throughout all 50 states, the District of Columbia, and several U.S. territories. MORE FROM DEA • DEA FIELD DIVISION OFFICE FOR N.M. • 2660 FRITTS CROSSING SE ALBUQUERQUE, NM 87106 • Diversion Number: (505) 452-4500 Diversion Fax: (505) 873-9921 2

Rescheduling of Hydrocodone STILL MORE FROM DEA • DEA Updates Form for Reporting Theft or • Effective October 6, 2014 Loss of Controlled Substances • Federal Register / Vol. 79, No. 163 / Aug 29, • DEA has an updated electronic version of the 2014. Pages 49661 - 49682 DEA Form 106 • Schedule III to a Schedule II • DEA Form 106 requires registrants to include the NDC which will help to accurately track • Required inventory of all hydrocodone controlled substances reported as stolen or containing products lost • All Schedule II regulations will apply • The paper version of DEA Form 106 is obsolete as of October 28, 2008. STILL MORE FROM DEA E-PRESCRIBING UPDATE • New DEA Number Series • All electronically transmitted • Effective December 6, 2013 , DOD personal service controlled substance prescriptions contractors will be issued a new DEA registration number that begins with the letter "G" are valid • Registrant type (first letter of DEA Number): – A/B/F/G – Hospital/Clinic/Practitioner/Teaching • Includes Schedule II Institution/Pharmacy – M – Mid-Level Practitioner (NP/PA/OD/ET, etc.) • Please do not reject a C-II Rx – P/R – Manufacturer/Distributor/Researcher/Analytical because it is an E-prescription Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program – X – Buprenorphine (Suboxone) physician 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 duly authorized agent of a DEA-registered individual • For a Schedule III–V drug, an authorized agent may 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 statement, published October 6, 2010, in the Federal behalf of the practitioner. 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 SCREENING CIII-IV REFILLING • 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. Controlled Substance TIRF REMS (?) Prescriptions • Transmucosal Immediate • Expirations Release Fentanyl – Schedule II • No expiration date – Schedule III-IV • Risk Evaluation & Mitigation • 6 months Strategies – Non-Controlled • 12 months from the date written TIRF REMS TIRF REMS • FDA-required program • https://www.tirfremsaccess. • You must enroll in the TIRF com/TirfUI/rems/home.action REMS Access program to prescribe, dispense, or distribute TIRF medicines. 4

NABP Issues Rogue Online Pharmacy Public ER/LA OPIATE REMS Health Alert – July, 2013 • AVAILABLE MARCH 1, 2013 • 10,533 internet drug outlets ranked as Not • NOT MANDATORY Recommended by NABP • Assess patients for treatment • 97% out of 10,181 sites reviewed by the NABP • Initiate therapy, modify dose, and discontinue • Be knowledgeable about how to manage ongoing therapy. were found to be out of compliance with pharmacy laws and practice standards established in the • Counsel patients and caregivers about the safe use, proper storage and disposal. United States to protect the public health. • Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics. PHARMACY NABP Issues Rogue Online Pharmacy Public Health Alert – July, 2013 COMPOUNDING • Of these Not Recommended sites: • HR 3204 • 2,372 have a physical address located outside of the US • The Drug Quality and Security Act • 8,961 do not require a valid prescription • 6,129 issue prescriptions per online consultation or • Became public law on November questionnaire only 27, 2013 • 4,935 offer foreign or non-FDA approved drugs • 1,614 do not have secure sites • 4,144 have server locations in foreign countries • 1,181 dispense controlled substances 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 compounders engaged in traditional pharmacy practice from • FDA registers pharmacy “outsourcing facilities” making large volumes of compounded drugs without those making large volumes of individual prescriptions. compounded drugs without individual prescriptions. • Providers and patients would have the option of purchasing products from outsourcing facilities that comply with FDA quality standards. 5

Prescription Transfers • A pharmacy may not refuse to transfer New Mexico Law original prescription information to another pharmacy who is acting on behalf of a & patient and who is making a request for this information Board Activity 3-22-15 April 24, 2014 April 24, 2014 • NEW REGULATION • New compounded sterile • 16.29.36 COMPOUNDED STERILE product rule incorporates PRODUCTS USP <797> directly. • New Mexico Register June 13, 2014 • EFFECTIVE: June 29, 2014 PHARMACY COMPOUNDING April 18, 2013 • A pharmacy may compound a patient- • 16.19.30.9 NMAC – COMPOUNDING OF specific sterile product pursuant to a NON-STERILE PHARMACEUTICALS prescription or order for an individual • The wording allowing for office use patient. compounding was removed from the • Preparation of non-patient specific regulation. compounded sterile product for sale is • A pharmacy may no longer considered manufacturing, and requires compound for a prescriber’s office registration with the FDA and the NM Board of Pharmacy as a wholesaler/distributor. use. 6

BOP NEWSLETTER June 14, 2013 • Drug, Device & Cosmetic Act • The NM Board of Pharmacy is now utilizing an electronic version of its newsletter published by the – 26-1-16 J. NABP. • Pharmacists may combine refills up • To subscribe, please send an e-mail from the e-mail address you wish to use with the word SUBSCRIBE to a 90-day supply. in the subject line of the e-mail to: • No controlled substances. • Practitioner can specify no • NewMexicoBOPNewsletter@nabp.net combining of refills on prescription. CPE Requirements PROTECTED HEALTH INFORMATION • PHI ITEMS MUST BE • REG PART 4 – PHARMACIST SHRED OR OTHERWISE ALTERED SO THAT • Effective January 1, 2013, pharmacist CONFIDENTIAL PATIENT and pharmacist clinician renewal INFORMATION DOES NOT applications shall document: END UP DISCARDED UNALTERED. CPE Requirements CPE Requirements • REG PART 4 – PHARMACIST • REG PART 4 – PHARMACIST • 3. A minimum of 0.2 CEU (2 contact • 1. A MINIMUM of 10 hours hours) per renewal period shall be in (EXCLUDING LAW CE) shall be the area of PATIENT SAFETY as obtained thru “Live Programs” applicable to the practice of • 2. ACPE, ACCME OR BOARD pharmacy APPROVED 7