Pharmacy Law Update Presented by New Mexico Board

Pharmacy Law Update Presented by New Mexico Board of Pharmacy June 22, 2019 Kris Mossberg State Drug Inspector Adela Padilla RPh State Drug Inspector


Richard Mazzoni RPh Bill Lord RPh Neal Dungan RPh Dale McCleskey RPh Teri Rolan RPh

Cathleen Wingert Chris Woodul RPh Michael Garringer Gwen Griscom Chairman NE Hospital SE Central NW

Public SW Public Public FEDERAL LAW Current Drug Disposal Information

Controlled Substance Public Disposal Locations APD Disposal Locations 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, convenient, and

responsible manner Also reduces diversion and the introduction of some potentially harmful substances into the environment DEA Drug Take-Back Events Began September 2010. The DEA has sponsored 16 total take-back events On October 27, 2018

Collected 457 tons (914,236 pounds) Record setting amount of 474.5 tons previously collected in April 2018 Total collection of 5,439 tons (10,878,950 pounds) Next National Take-Back Late April 2019 Check back on DEA website to

locate collection sites starting in early April Take Back Collection Sites Syringe Disposal CONTACT INFO DEA Office for Northern NM

2660 Fritts Crossing SE Albuquerque, NM 87106 Diversion Number: (505) 452-4500 Diversion Fax: (505) 873-9921 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 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? According to the DEA . . . What constitutes a significant loss for one registrant may be construed as insignificant for another . . . the repeated loss of small quantities of 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. NMBOP Definition Significant Loss: includes suspected diversions, in-transit losses or any other unexplained loss and must be reported to the Board of Pharmacy

within five (5) days of becoming aware of that loss STILL MORE FROM DEA Registrant type (first letter of DEA Number): A/B/F/G Hospital/Clinic/Practitioner/Teaching 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, PA, NP E-PRESCRIBING UPDATE Controlled substances in schedules II V can be electronically prescribed. Please do not reject a C-II Rx

because it is an E-prescription 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. CFR 1306.04 DEA Issues Policy Statement on Role of Agents in Communicating CS Prescriptions

An authorized agent may prepare the prescription. . . for the signature of that DEA-registered practitioner. For a Schedule IIIV drug, an authorized agent may transmit a practitioner-signed prescription to a pharmacy via facsimile; or orally to a pharmacy on behalf of the practitioner. An authorized agent may transmit by facsimile a practitioner-signed Schedule II prescription for a patient in a hospice or long-term care facility (LTCF) on behalf of the practitioner.

Controlled Substance Prescription Transfer CFR 1306.25 Transfer between pharmacies (a) The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on 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. 1306.25(a) 05-12-17 CIII-V Rx Transferring for refill purposes Once the original Rx is filled, the transfer

must be communicated directly between two licensed pharmacists Document pursuant to 1306.25 (b) (3) (4) Unfilled Electronically Prescribed controlled substance(EPCS) An unfilled original EPCS prescription can be FORWARDED from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances

(73 FR 36722) Addressed in a guidance letter by Loren Miller (DEA), available from the BOP website (FAQ transfer of controlled substance prescriptions) For questions about system requirements to electronically transfer an EPCS, please contact the DEA. Added 02-19-18 EMPLOYMENT SCREENING

According to DEA regulations: The registrant shall not employ, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause

CFR 1301.76 CARA 2016 The Comprehensive Addiction and Recovery Act (CARA) Signed into law by President Obama on July 22, 2016 First major federal addiction legislation in 40

years and the most comprehensive effort to address the opioid epidemic. CARA 2016 Summary of Provisions of CARA Prevention and Educational Expand the availability of naloxone Treat incarcerated individuals Expand disposal sites for unwanted prescription medications

Expand evidence-based opioid and heroin treatment and intervention program Strengthen prescription drug monitoring programs CARA 2016

Title VII: Sec. 702 of the CARA ACT of 2016 Partial Fills of Schedule II Controlled Substances: Amends the Controlled Substances Act by allowing schedule II substances to be partially filled if certain conditions and restrictions are met. Title VIII: Sec. 303 of the CARA ACT of 2016 Medication-assisted treatment for recovery from addition: NPs 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 The Drug Quality and Security Act (H.R. 3204) Differentiates compounders engaged in traditional pharmacy practice (503A, a licensed pharmacy) from those making

large volumes of sterile compounded drugs without individual prescriptions (503B, an FDA-registered outsourcing facility). November 2013 Outsourcing Facility licensure in NM Any outsourcing facility, that

distributes or causes to be distributed, compounded sterile drugs into New Mexico shall be registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act and be licensed by the NMBOP as an outsourcing facility NMAC Outsourcing Facility

Current FDA registration as an Outsourcing Facility Licensed by NMBOP as an outsourcing facility Providers may purchase non patientspecific compounded sterile product, for administration, from an outsourcing facility. FDA Section 503A: Compounding Drugs That Are Commercially Available

To qualify for the 503A exemptions: Compounder cannot compound regularly or in an inordinate amount any drug products that are essentially copies of a commercially available drug product Not considered a copy if there is a change made for an individual patient, which produces for that patient a significant difference from the commercially available drug, as determined by the prescriber, FDA Guidance for Compounding

Essentially a copy of a commercially available drug product if: Same Active Pharmaceutical Ingredients (API) as a commercially available drug product API have same, similar (within 10%), or an easily substitutable dosage strength Commercially available drug product can be used by the same route of administration Combination of more than one commercially available drug is still a copy, even if the

combination is not commercially available. Essentially a copy Documented prescriber determination: No particular format needed but must be a clear change and significant difference for the patient for example No Dye X, patient allergy Liquid form, patient cant swallow tablet

6mg, patient needs higher dose 503A FDA does not intend to take action if the: - compounder fills 4 or fewer Rxs for the relevant compounded drug product in a calendar month (intended for emergencies); - documented prescriber determination (significant difference for an individual patient); - drug product is currently in shortage under

506E Unprofessional Conduct If compound regularly or in an inordinate amount any drug products that are essentially copies of commercial products. New Mexico Law &

Board Activity PHARMACY COMPOUNDING A pharmacy may compound a patientspecific 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 Preparations Must be compounded properly in accordance with all applicable USP chapters numbered less than <1000> Currently USP <797> USP <800> effective on December 1, 2019

Hazardous compounding must be done in a negative pressure room Can no longer have hazardous and nonhazardous compounding in the same room 16.19.36 Non-Sterile Compounding The wording allowing for office use compounding was removed from the regulation. A pharmacy may no longer compound

for a prescribers office use. Removed 06-14-13 Repackaging and Distribution by a Pharmacy for Administration Pharmacy licensed by the board may repackage under the following conditions:

By a managing pharmacy for use in an automated drug distribution system of a licensed health care facility (for administration) To a clinic under the same ownership as the pharmacy, for administration to clinic patients (not dispensing) Must be repackaged into a sealed unit-dosed container with appropriate BUD, and properly labeled

11-28-17 Automated Drug Distribution Systems (Pyxis type) A managing pharmacy may use an automated drug distribution system to supply medications for patients of a health care facility licensed under 16.19.11 or inpatient hospice facility The system may be located in a health care facility that

is not at the same location as the managing pharmacy Considered an extension of the managing pharmacy. If the system contains controlled substances for routine dosing, the managing pharmacy must submit and maintain a separate registration with the DEA 08-28-15 Emergency drug supply for a

licensed custodial care facility E-Kit- emergency drug supply Accessed only by licensed personnel on duty Controlled substances only if 24-hour/365 days per year on-site nurse Can be an automated drug distribution system These do not require separate registration with the DEA (because not used for routine dosing)

Prescription Synchronization Prescription drug or device benefit shall allow an insured to fill or refill a prescription for less than a thirty-day supply of the prescription drug, AND apply a prorated daily copayment or coinsurance for the fill or refill, if Prescribing practitioner or the pharmacist determines it to be in the best interest of the insured The insured requests or agrees to receive less than a thirty-day supply of the prescription drug; and The reduced fill or refill is made for the purpose of

synchronizing the insured's prescription drug fills. 2015 HB 274 Legislature Prescription Synchronization The insurer shall allow a pharmacy to override any denial indicating that a prescription is being refilled too soon for the purposes of medication synchronization; and prorate a dispensing fee to a pharmacy that fills a prescription with less

than a thirty-day supply 2015 HB 274 Legislature Drug, Device & Cosmetic Act Pharmacists may combine refills up to a 90 day supply. No controlled substances. Practitioner can specify no combining of refills on prescription.

26-1-16J 06-14-13 Conscientious Objection 24-7A-7 NMSA

A pharmacist who declines to fill a prescription for reasons of conscience shall personally: (1) promptly so inform the patient, if possible, and any person then authorized to make health-care decisions for the patient; (2) provide continuing care to the patient until a transfer can be effected; and

(3) unless the patient or person then authorized to make healthcare decisions for the patient refuses assistance, immediately make all reasonable efforts to assist in the transfer of the patient to another health-care practitioner or health-care institution that is willing to comply with the individual instruction or decision. Electronic Prescribed Controlled Substances by January 1, 2021 The SUPPORT for Patients and

Communities Act, which Congress passed and President Trump signed into law in October 2018, mandates the use of electronic prescribing of controlled substances (EPCS) for all controlled substances under Medicare Part D by January 1, 2021. CII Partial Filling A prescription for a Schedule II may be

partially filled if the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. Remaining portions shall be filled not later than 30 days after the date on which the prescription is written. 03-29-17

CII Partial Filling A CII initially filled more than 30 days from date written may be partially filled if: (1) the pharmacist is unable to dispense the total quantity prescribed; (2) the partial fill amount is recorded on the written prescription or in the electronic prescription record; (3) the remaining portion is filled within 72 hours of the partial filling; and

(4) the pharmacist notifies the prescribing physician if the remaining portion cannot be filled within the 72 hour period. No further quantity may be supplied beyond 72 hours without a new prescription. 06-26-18 CII RX LTCF/terminal patient

Partial filling of a CII RX for Hospice or LTCF patients, 60 day allowance is unchanged NMAC D CIII-V Partial Filling Partial filling is allowed provided that: Total quantity of all partial fills does not exceed the total quantity prescribed

No dispensing occurs after 6 months from written date CFR 1306.23, NMAC C 24-2D-1 PAIN RELIEF ACT (2019 amended) Relating to Opioid Overdose Requires health care providers under

certain circumstances, to advise patients on the risks of overdose an opioid overdose reversal medication and to co-prescribe an opioid antagonists Section 3A (new section of the Pain Relief Act) First-time prescribed Inform patients the

risk of overdose Inform patients the availability of an opioid antagonist Previous prescribed Each calendar year Advise patients on the risks of overdose Inform the patients

the availability of an opioid antagonist Section 3B (new section of the Pain Relief Act) At least 5-day supply: Co-prescribe an opioid antagonist Provide written information regarding the temporary effects of the opioid antagonist and techniques for administration

Written information shall contain a warning that a person administering the opioid antagonist should call 911 immediately after administering the opioid antagonist Controlled Substance Prescriptions Expiration Dates All CS prescriptions expire 6 months from the date written,B Effective 10-16-16 Prescription Requirements Shall verify the identity of the patient or representative who is receiving any prescription for a CS before it is released Current govt issued photo identification required,

and the documentation of: Name Number Identification Type (DL, ID card, passport) State (If applicable) 10-16-16 Prescription Transfers

A pharmacy may not refuse to transfer original prescription information to another pharmacy who is acting on behalf of a patient and who is making a request for this information In the case of a hard copy unfilled CS Rx, the patient can pick it up and take to another pharmacy

03-22-15 Controlled Substance Refills PRESCRIPTION REFILL REQUIREMENTS: (1) Controlled substance prescriptions dispensed directly to a patient shall not be refilled before 75% of the prescription days supply has passed, unless the practitioner authorizes the early refill, which must be

documented by the pharmacist. Controlled Substance Refills PRESCRIPTION REFILL REQUIREMENTS: (2) Controlled substance prescriptions delivered to a patient indirectly (as in mail order) to a patient shall not be refilled before 66% of a 90 day supply has passed or 50% of a 30 day supply has passed, unless the

practitioner authorizes the early refill, which must be documented by the pharmacist. Controlled Substance Inventory Records Document date, time, and open or close of business Initial Inventory Annual Inventory Actual inventory within 4 days of annual inventory date (May 1st, or alternate set date on record with board)

Inventory when there is a CS schedule change Inventory required for change of PIC Must be taken within 72 hours by the new PIC Upon transfer of ownership of a pharmacy 10-16-16 Optometrist Prescribing

An Optometrist: May prescribe hydrocodone and hydrocodone combination medications; Shall not prescribe any other controlled substance classified in Schedule I or II pursuant to the CS Act 2015 SB 367 Cannabidiol (CBD)

Epidiolex Manufactured by GW Pharmaceuticals Treatment of seizures associated with LennoxGastaut syndrome or Dravet syndrome in patients 2 years of age and older. 1st CBD product approved by FDA In September of 2018- DEA classified Epidiolex as a schedule 5 controlled substance FDA approval (June 2018) & no more than

0.1% THC Examination Repeats A candidate who fails either the NAPLEX or MPJE may repeat that examination upon submittal of the proper application and fee. A candidate may not take either the NAPLEX or MPJE more than five consecutive times without passing. Failure to finish an examination is counted as an attempt. Candidates who fail or do not complete the NAPLEX shall wait a period of at least 45

days prior to retaking the examination. Candidates who fail or do not complete the MPJE shall wait a period of at least 30 days prior to retaking the examination. 06-23-17 Pharmacist ACTIVE STATUS

Any pharmacist who maintains competency through the development and maintenance of knowledge, skill and aptitude, to ensure continuing competence as a pharmacy professional, and is able to demonstrate to the board said competence in the practice of pharmacy shall be issued an active license. CPE Requirements

Pharmacist Continuing Education Requirements Live CPEs A minimum of 10 contact hours excluding the law requirement, shall be obtained through live programs Must be ACPE, ACCME, or board approved programs

CPE Requirements Live Programs Live programs means CPE activities that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences, workshops, etc. (Definitions)

CPE Requirements Patient Safety A minimum of 0.2 CEU (2 contact hours) per renewal period shall be in the area of PATIENT SAFETY as applicable to the practice of pharmacy CPE Requirements

Pharmacy Law A minimum of 0.2 CEU ( 2 contact hours) per renewal period shall be in the subject area pharmacy law offered by the N.M. board of pharmacy CPE Requirements Safe and appropriate use of opioids

A minimum of 0.2 CEU (two contact hours) per renewal period shall be in the area of safe and appropriate use of opioids. FDA Opioid REMS CE available CPE Requirements 30 Total Hours Required

10 Hours of Live Programs 2 Hours Patient Safety (Applicable to Pharmacy) 2 Hours Pharmacy Law 2 Hours Safe and Appropriate Use of Opioids ------------ CEs obtained for Immunization Certification, Smoking Cessation, Naloxone etc. are in addition to the 30 hour requirement (16.19.26 NMAC) ACPE UNIVERSAL ACTIVITY NUMBER B: Both Pharmacist Prescriptive Authority Renewal

CPE Requirements (16.19.26 NMAC) Continuing education shall be in addition to requirements in NMAC. Naloxone DOH Standing Order CPE Requirements Pharmacist Clinician Pharmacist Clinician (PhC) renewal

in addition to 20 hours live CE ACPE or ACCME A PhC with a controlled substance registration to prescribe Schedule II or III shall complete a minimum of 2 contact hours per renewal period in the subject area of responsible opioid prescribing practices. (B) (3) (d) CPE Requirements

Pharmacist Clinician Educational programs approved by the New Mexico Medical Board in the subject area of opioid prescribing shall meet the requirements of this section. CPE Requirements Pharmacist Allows CPE programs that are approved by other state boards of

pharmacy to count toward your New Mexico pharmacist renewal CPE Requirements Pharmacists and pharmacist clinicians without sufficient documentation of completion of CPE requirements shall:

CPE Requirements Be subject to a fine of not less than $1,000 Be required to complete the deficient CPE in a satisfactory time period as determined by the board

Pharmacist Clinician Prohibit prescribing for themselves or immediate family members, except under emergency situations. Does not apply to meds under 16.19.26 (Vaccines, tobacco cessation, naloxone, TB testing) Prohibited from referring a patient for the use of medical cannabis 04-18-13 Pharmacist Clinician: PMP (With Prescriptive Authority for CS) Shall register with the PMP May authorize delegate(s) but is solely responsible for reviewing PMP and

documentation of medical record 1st rx written for over a 4 day supply for a CII, III, IV require PMP review OR if there is a gap in prescribing the CS for 30 days or more. Other regs for utilizing PMP reports for continuous use of CS 10-14-16

Pharmacy Technicians Non-Certified Technician Registration expires after 1 year Cannot be renewed Exception: Technician that is enrolled in a board recognized technician training program. Pharmacy Technicians

MUST be registered PRIOR to working as a pharmacy technician Pharmacy Techs that are being allowed to work after their registration has expired may result in disciplinary action against the supervising pharmacist as well as the pharmacist-in-charge, and the pharmacy Professional Judgment

only by a RPh Pharmacy technician cannot perform tasks that require professional judgment. Professional judgment means a cognitive process, by a licensed professional, that takes education, experience, current primary literature and current standards of practice into consideration when drawing conclusions and reaching decisions.

Professional Judgement Professional judgment means a cognitive process, by a licensed professional, that takes education, experience, current primary literature and current standards of practice into consideration when drawing conclusions and reaching decisions. Improper Activities of

Pharmacy Technicians Perform the RPH final check and supervise Receipt of all new verbal prescription orders and reduction to writing; Professional judgment Consult a patient or his agent regarding a prescription or over-the-counter Patient Counseling Professional consultation with the prescriber

PTCB Renewal Changes Any CE hours earned by a CPhT will need to be pharmacy technician specific in order to qualify toward recertification PTCB will be reducing the number of allowable in-service CE hours from 10 to 5 Pharmacy Technicians

The permissible ratio of pharmacy technicians to pharmacists on duty is to be determined by the Pharmacist-InCharge Support Personnel Support personnel (who are not pharmacy technicians) may NOT: Process and fill prescriptions

Stock prescription drugs in sites that do not utilize barcode verification or similar electronic verification process to ensure correct selection of medication Perform duties restricted to a pharmacist, intern or technician Pseudoephedrine and Ephedrine

OTC Sales Submit sales information reports electronically every seven (7) days New Mexico Methamphetamine Special Information System (NMMSIS-Brian Sallee) NMMSIS is the Board-authorized contract for collection of data in a Board-defined format Pharmacies may petition the executive director of the board for an alternative method for the


CS prescriptions must be reported within one business day of a prescription being filled 03-22-15 Pharmacist Prospective Drug Review: Prior to dispensing any

prescription, a pharmacist shall review the patient profile for the purpose of identifying: (a) clinical abuse/misuse; (b) therapeutic duplication; (c) drug-disease contraindications; (d) drug-drug interactions; (e) incorrect drug dosage; (f) incorrect duration of drug treatment; (g) drug-allergy interactions; (h) appropriate medication indication 05-11-12 Pharmacist (2) Upon recognizing any of the above, a pharmacist, using professional judgment, shall take appropriate steps to avoid or resolve the potential problem. These steps may include requesting and reviewing a controlled substance Prescription

Monitoring report or another state's report if applicable and available, and/or consulting with the prescriber and/or counseling the patient. The pharmacist shall document steps taken to resolve the potential problem 05-11-12 PMP Facts

16.19.29 NMAC Only an authorized account holder can access the NM PMP. Sharing login information is a violation of both federal and state regulations. Pharmacist delegate must be a certified pharmacy technician or a registered intern. Only for pharmacist dispensing or providing pharmaceutical care as defined by law. Pharmacist is responsible for reviewing and

documenting. Dispensers and the PMP All dispensers (clinics, urgent care or emergency care, dispensing practitioners) must report within one business day if more than 12 doses or 72 hour supply was dispensed (whichever is less) If a pharmacy did not dispense any controlled substances during an operating business day, a zero report must be submitted within one business day.

If a dispenser becomes aware of an data entry error, the correction must be submitted to the PMP within five (5) business days. Board of Pharmacy Newsletter Only utilizing an electronic version published by the NABP To subscribe, please go to

Boards of Pharmacy New Mexico Click on link to subscribe Enter email, first and last name Protected Health Information PHI items must be shredded or otherwise altered so that confidential patient information does not end up discarded unaltered


DRUG STORAGE Controlled Room Temp 68 to 77 degrees F Cold 36 to 46 degrees F Freezer -13 to 14 degrees F

Automated Filling Systems Pharmacist shall inspect and verify accuracy of final contents, and label prior to dispensing the prescription unless: AFS is maintained and operated according to policies and procedures, and verification criteria per regulation Completed and sealed prescription ready to be dispensed to patient Proper loading, quality assurance, and security are pharmacists responsibility

No CII 05-29-15 TIRF REMS Trans-mucosal Immediate Release Fentanyl Risk Evaluation & Mitigation Strategies

FDA-required program You must enroll in the TIRF REMS Access program to prescribe, dispense, or distribute TIRF medicines. Health Care Work Force Data Collection, Analysis and Policy Act 24-14C-5. HEALTH CARE WORK FORCE DATA COLLECTION BY BOARDS

B. A board shall not approve a subsequent application for a license or renewal of a license until the applicant provides the information pursuant to Subsection C of this section. C. A board shall adopt rules regarding the manner, form and content of reporting data; the consistency of data entry fields used; and the information that an applicant, pursuant to Subsection A of this section, shall provide to a board.

Health Care Work Force Data Collection, Analysis and Policy Act ISSUANCE OR RENEWAL OF PHARMACIST LICENSE (Adopted October 18, 2013) The Board shall not approve the application for a pharmacist license or renewal of a pharmacist license until the applicant provides the data

required by the Health Care Work Force Data Collection, Analysis and Policy Act.

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