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2017 Maine Pharmacy Association Spring Convention Pharmacy Law Update Husson University April 1, 2017 Greg Cameron, R.Ph (NO APRIL FOOLS) 1 G. Cameron 2017 2017 Maine Pharmacy Association Spring Convention • Dental Hygienists and Fluoride Dispensing • Opioid Law and Regulations Update • Drug Quality and Security Act 2013 • Comprehensive Addiction & Recovery Act 2016 • Technician & Intern Duties • Recent Board of Pharmacy Actions 2 OBJECTIVES G. Cameron 2017 2017 Maine Pharmacy Association Spring Convention • Public Law 114–198, 114th Congress • Comprehensive Addiction and Recovery Act of 2016 • (696 PAGES) • REASON: To authorize the Attorney General and Secretary of Health and Human Services to award grants to address the prescription opioid abuse and heroin use crisis, and for other purposes 3 • Comprehensive Addiction and Recovery Act of 2016 G. Cameron 2017 2017 Maine Pharmacy Association Spring Convention • Parts of this LAW: TITLE I—PREVENTION AND EDUCATION TITLE II—LAW ENFORCEMENT AND TREATMENT TITLE III—TREATMENT AND RECOVERY TITLE IV—ADDRESSING COLLATERAL CONSEQUENCES TITLE V—ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, AND VETERANS TITLE VI—INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS PRESCRIPTION OPIOID ABUSE TITLE VII—MISCELLANEOUS Sec. 702. Partial fills of schedule II controlled substances 4 • Comprehensive Addiction and Recovery Act of 2016 G. Cameron 2017 2017 Maine Pharmacy Association Spring Convention SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES 1. Partial Fills - A prescription for a controlled substance in schedule II may be partially filled if— a) it is not prohibited by State law b) the prescription is written and filled in accordance with this title, regulations prescribed by the Attorney General, and State law c) the partial fill is requested by the patient or the practitioner that wrote the prescription; and d) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed 5 G. Cameron 2017 • Comprehensive Addiction and Recovery Act of 2016 2017 Maine Pharmacy Association Spring Convention SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES 2. REMAINING PORTIONS.— a) IN GENERAL.—Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II— i. may be filled; and ii. shall be filled not later than 30 days after the date on which the prescription is written b) EMERGENCY SITUATIONS.—In emergency situations, the remaining portions of a partially filled prescription for a controlled substance in schedule II— i. may be filled; and ii. shall be filled not later than 72 hours after the prescription is issued G. Cameron 2017 • Comprehensive Addiction and Recovery Act of 2016 6 2017 Maine Pharmacy Association Spring Convention SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES 3. CURRENTLY LAWFUL PARTIAL FILLS.— a) Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before the date of enactment of this subsection, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled 7 G. Cameron 2017 • Comprehensive Addiction and Recovery Act of 2016 2017 Maine Pharmacy Association Spring Convention SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES 4. RULE OF CONSTRUCTION.— a) Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled 8 G. Cameron 2017 • Comprehensive Addiction and Recovery Act of 2016 2017 Maine Pharmacy Association Spring Convention Compounding Quality Act Title I of the Drug Quality and Security Act of 2013 On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. 9 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention H.R.3204 — 113th Congress (2013-2014) Public Law No: 113-54 (11/27/2013) • Drug Quality and Security Act - Title I: Drug Compounding - Compounding Quality Act • (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs 10 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • Exempts compounded drugs from: new drug requirements labeling requirements track and trace requirements • IF, the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements 11 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention G. Cameron 2017 • Establishes annual registration requirement for any outsourcing facility • Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports • Subjects such facilities to a risk-based inspection schedule Drug Quality and Security Act of 2013 (Compounding Quality Act) 12 2017 Maine Pharmacy Association Spring Convention • Requires the Secretary to: Assess an annual establishment fee on each outsourcing facility A re-inspection fee, as necessary 13 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • Prohibits the resale of a compounded drug labeled “not for resale” or the intentional falsification of a prescription for a compounded drug • Deems a compounded drug to be misbranded if its advertising or promotion is false or misleading 14 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • State Boards of Pharmacy are required to send reports: 1. Describing any disciplinary actions taken against compounding pharmacies 2. Any recall of a compounded drug 3. Any concerns that a compounding pharmacy may be violating the FFDCA 15 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • Revises compounding pharmacy requirements: 1. Repeals prohibitions on advertising and promotion of compounded drugs 2. Repeals the requirement that prescriptions filled by a compounding pharmacy be unsolicited 16 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • LABELING OF DRUGS. A. LABEL.—The label of the drug includes— i. the statement ‘This is a compounded drug.’ or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug ii. the name, address, and phone number of the applicable outsourcing facility 17 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • LABELING OF DRUGS. A. LABEL.—The label of the drug includes— iii. with respect to the drug— 1) the lot or batch number; 2) the established name of the drug 3) the dosage form and strength 4) the statement of quantity or volume, as appropriate 5) the date that the drug was compounded 6) the expiration date 18 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • LABELING OF DRUGS. A. LABEL.—The label of the drug includes— iii. with respect to the drug— (CONTINUED) 7) storage and handling instructions 8) the National Drug Code number, if available 9) the statement ‘Not for resale’, and 10) if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement ‘Office Use Only’ 11) a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient. (If it doesn’t fit on the label , see container requirement). G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 19 2017 Maine Pharmacy Association Spring Convention • Labeling of the CONTAINER— A. The container from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include— i. a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient ii. information to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800– FDA–1088 iii. directions for use, including, as appropriate, dosage and administration 20 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES A. ANNUAL REGISTRATION i. Upon electing and in order to become an outsourcing facility, shall register with the Secretary its name, place of business, a point contact email address, and unique facility identifier ii. shall indicate whether the outsourcing facility intends to compound a drug that appears on the list in effect under section 506E during the subsequent calendar year 21 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES B. AVAILABILITY OF REGISTRATION FOR INSPECTION LIST i. The Secretary shall make available for inspection, to any person so requesting, any registration filed or facility registered as an outsourcing facility ii. State in which each such facility is located iii. whether the facility compounds from bulk drug substances, and iv. whether any such compounding from bulk drug substances is for sterile or non-sterile drugs 22 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES (Continued) C. DRUG REPORTING BY OUTSOURCING FACILITIES i. Report due once during the month of June, and once during the month of December of each year a) identifying the drugs compounded during the previous 6-month period and ii. with respect to each drug identified providing the active ingredient, the source of such active ingredient, the NDC of the source drug or bulk active ingredient, if available, the strength of the active ingredient per unit, the dosage form and route of administration, the package description, the number of individual units produced, and the National Drug Code number of the final product, if assigned 23 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES D. RISK-BASED INSPECTION FREQUENCY i. Outsourcing facilities 1) shall be subject to inspection E. RISK-BASED SCHEDULE.—The Secretary, acting through one or more officers or employees duly designated shall inspect outsourcing facilities in accordance with a risk-based schedule established by the Secretary’ 24 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES F. RISK FACTORS.—shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities, which shall be based on the following factors i. The compliance history of the outsourcing facility ii. The record, history, and nature of recalls linked to the outsourcing facility iii. The inherent risk of the drugs compounded at the outsourcing facility iv. The inspection frequency and history of the outsourcing facility v. Whether the outsourcing facility has registered 25 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES G. ADVERSE EVENT REPORTING.—Outsourcing facilities shall submit adverse event reports to the Secretary H. INTERIM LIST.— the Secretary may designate drugs, categories of drugs, or conditions I. UPDATES.—The Secretary shall review, and update as necessary, the regulations containing the lists of drugs, categories of drugs, or conditions regularly, but not less than once every 4 years 26 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES J. DEFINITIONS 1) The term ‘compounding’ includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug 27 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES J. DEFINITIONS 2) The term ‘essentially a copy of an approved drug’ means i. a drug that is identical or nearly identical to an approved drug, or a marketed drug ii. a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug 28 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES J. DEFINITIONS 3) The term ‘approved drug’ means a drug that is approved and does not appear on the list of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective 29 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES J. DEFINITIONS 4) The term ‘outsourcing facility’ means a facility at one geographic location or address that— G. Cameron 2017 a) is engaged in the compounding of sterile drugs b) has elected to register as an outsourcing facility and c) complies with all of the requirements of this section d) is not required to be a licensed pharmacy e) may or may not obtain prescriptions for identified individual patients Drug Quality and Security Act of 2013 (Compounding Quality Act) 30 2017 Maine Pharmacy Association Spring Convention • REGISTRATION OF OUTSOURCING FACILITIES K. DEFINITIONS 5) The term ‘sterile drug’ means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.’’ 31 G. Cameron 2017 Drug Quality and Security Act of 2013 (Compounding Quality Act) 2017 Maine Pharmacy Association Spring Convention 32 G. Cameron 2017 2017 Maine Pharmacy Association Spring Convention • An Act To Allow Dental Hygienists To Prescribe Fluoride Dentifrice And Antibacterial Rinse • Apply topical antimicrobials, excluding antibiotics, including fluoride, for the purposes of bacterial reduction, caries control and desensitization in the oral cavity • The independent practice dental hygienist shall follow current manufacturer’s instructions in the use of these medicaments 33 G. Cameron 2017 Dental Hygienists 2017 Maine Pharmacy Association Spring Convention • Prescribe, dispense, or administer anticavity toothpastes or topical gels with 1.1% or LESS sodium fluoride and oral rinses with 0.05%, 0.2%, 0.44%, or 0.5% sodium fluoride and: • Prescribe, dispense, or administer chlorhexidine gluconate oral rinse 34 G. Cameron 2017 Dental Hygienists 2017 Maine Pharmacy Association Spring Convention Effective 7/1/2017 • Total MMEs are not to exceed 100mg / day unless an exception • Pharmacists may dispense a lesser quantity than is prescribed if requested by the patient Pharmacist must notify the prescriber within 7 days Remaining quantity is void (different then new Federal Law) • All opioid medications must be prescribed electronically, or prescribers must request a waiver from DHHS 35 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention • PMP for the pharmacists (when to check) o Applies to Opioids and Benzodiazepines Patient is not a Maine Resident Rx is written by an out of state prescriber Patient has not received a prescription for Opioids or Benzodiazepine within the previous 12 months Patient pays cash when the actually have insurance Pharmacists may be fined $250 per violation / $5,000 per year for failure to report to the PMP 36 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention • PMP Dispensers Must Review: # of pharmacies filling controlled substances for this patient # of prescribers prescribing controlled substances for this patient Aggregate MME Notify the PMP Office Coordinator and decline filling the prescription until you can contact the prescriber if you suspect the prescription is fraudulent or may be duplication of therapy 37 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention • Days Supply o Indication of acute pain 7 days o Indication of chronic pain 30 days • Early Refills 38 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention Regulations • Definitions a) Acute Pain – pain that is the normal, predicted physiological response to noxious chemical, thermal, or mechanical stimulus. This pain is typically associated with invasive procedures, trauma, and disease and is usually time-limited b) Chronic Pain – pain that persists beyond the usual course of an acute disease or healing and may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years 39 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention Code Exemption A Pain associated with active and aftercare cancer treatment. Providers must document in the medical record that pain is directly related to cancer or cancer treatment. An exemption for aftercare may be claimed up to 6 months post-remission B Palliative care in conjunction with serious illness C End-of-life and hospice care D Medication assisted treatment for SUD E Pregnant individual with pre-existing prescription for >100MMEs (only applies during pregnancy F Acute pain for the patient with pre-existing opioid prescription for chronic pain. The acute pain must be new or onset or postoperative, 7day limit applies G Individuals pursuing an active taper of opioid medications with a maximum taper period of 6 months after which the opioid limitations will apply unless the patient meets additional exceptions 40 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention • Diagnosis code: ICD-10 code must be included on any (aggregate) prescription that exceeds 100 MMEs Not required on veterinary prescriptions • Exemption code: Must be included if claiming exemption from the 100 MME aggregate daily limit 41 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention • Requirement that Dispensers Report Information to the PMP by Electronic Means • No later than the close of business on the next business day after dispensing a controlled substance, dispensers must report: Dispenser identification number Dates prescription was filled and delivered (issued) Prescription number Whether the prescription is new or a refill National drug code (NDC) of the drug dispensed Quantity dispensed, Dosage Patient ID number, name, address, and date of birth Date prescription was issued by the prescriber Exemption code and ICD-10 code if aggregate >100 MMEs If prescription is for animal use G. Cameron 2017 Opiate Law Update LD 1646 42 2017 Maine Pharmacy Association Spring Convention Calculating Total Daily Dose of Opioids For Safer Dosage - CDC https://www.cdc.gov/drugoverdose/pdf/calculating_total_da ily_dose-a.pdf Opioid Comparison Table http://www.agencymeddirectors.wa.gov/Calculator/DoseCalc ulator.htm 43 G. Cameron 2017 Opiate Law Update LD 1646 2017 Maine Pharmacy Association Spring Convention §13834. Prohibited acts 1. Delegate authority. A pharmacist may not delegate the pharmacist's authority to administer drugs or vaccines; except that a pharmacist licensed under this chapter who has obtained a certificate of administration pursuant to section 13832 may delegate the authority to administer drugs and vaccines to a pharmacy intern who is under that pharmacist's direct supervision and who has obtained drug administration training pursuant to section 13832, subsection 3. A pharmacy intern may administer drugs and vaccines only to a person 18 years of age or older. [ 2013, c. 98, §1 (AMD) .] 44 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Pharmacy Technicians - A pharmacy technician or pharmacy intern working under the direct supervision of a pharmacist may: 1. Accept delivery of prescription medication to be loaded into a dispensing machine at a point of care location 2. Stock a dispensing machine at a point of care location 3. Remove drugs from a dispensing machine at a point of care location for quality assurance purposes or to carry out a change in formulary; and 4. Perform other functions related to an automated pharmacy system except for the removal of drugs from a dispensing machine at a point of care location for purposes of administration or dispensing to patients. G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 45 2017 Maine Pharmacy Association Spring Convention • No person with access to a dispensing machine may remove more drugs than necessary to fill a prescription or meet the immediate needs of a patient in a hospital or institution. 46 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Telephone Prescription Drug Orders A pharmacist or pharmacy intern may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the practitioner A pharmacy technician may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the practitioner to the extent authorized by the pharmacist on duty. • Facsimile Prescription Drug Orders A pharmacist, pharmacy intern or pharmacy technician may accept a prescription drug order transmitted by facsimile machine or facsimile computer software directly to a pharmacy. 47 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Generally + The pharmacist in charge or the pharmacy shall determine the duties of pharmacy technicians based upon the needs of the pharmacy + Pharmacy technicians are limited to performing tasks in the dispensing of prescription legend drugs and nonjudgmental support services • Automated Pharmacy Systems + A pharmacy technician on duty at an institutional pharmacy may perform the duties relating to an automated pharmacy system under the direct supervision of a pharmacist 48 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Limitations A pharmacy technician may not perform any of the following tasks: + Clinically evaluate a patient profile relative to drugs that have or will be dispensed; + Perform patient counseling; + Make decisions that require the education and professional training of a pharmacist; or + Sign any federally-required controlled substance or inventory form 49 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Verification of Status The pharmacist in charge shall ensure that each pharmacy technician employed at the pharmacy for which the pharmacist in charge is responsible is licensed with the board A pharmacy technician shall carry the wallet-sized license card issued by the board at all times the technician is on duty and shall produce the card upon request of the pharmacist in charge, a pharmacist on duty or an agent of the board No pharmacist in charge or pharmacist on duty shall permit a person who is not licensed pursuant to the terms of this chapter to perform the duties of a pharmacy technician 50 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Notice of Employment and Non-Employment of Pharmacy Technicians The pharmacist in charge shall notify the board via letter, fax, email or on line within 10 days after the commencement or cessation of employment of any pharmacy technician at a pharmacy for which the pharmacist in charge is responsible 51 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention • Notice of Termination of Employment For Drug-Related Reasons or Theft The pharmacist in charge or a designee of the pharmacist in charge shall notify the board via letter, fax, email or on line of the termination of employment of a pharmacy technician for any of the following reasons and shall include in the notice the reason for the termination. Notice shall be provided within 7 days after the termination Any drug-related reason, including but not limited to adulteration, abuse, theft or diversion; Theft of non-drug merchandise; or Theft of cash or credit/debit card data. 52 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns 2017 Maine Pharmacy Association Spring Convention Discipline • Pharmacy technicians are subject to the disciplinary provisions of 10 MRSA §8003(5-A), 32 MRSA §§ 13742-A and 13743 and Chapters 30, 31 and 32 of the board's rules. 53 G. Cameron 2017 Pharmacy Technicians & Pharmacy Interns