2016 Dr. Douglas H. Kay CPE Symposium

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1 GREGORY CAMERON, R.Ph ASSISTANT PROFESSOR OF PHARMACY PRACTICE FIELD COORDINATOR COMMUNITY SITES HUSSON UNIVERSITY SCHOOL OF PHARMACY November 5, 2016 Please Silence All Electronic Equipment

2 OBJECTIVES FOR TODAY Board of Pharmacy Recent Action Updates New Federal Addiction Laws Maine s Opioid Law- Update

3 EXPERIENCE Licensed pharmacist for MANY, MANY years 15 years as State Senior Pharmacy Inspector Currently teaching pharmacy law and P1 Skills Husson Interests: 22 caliber, 9mm, 357 mag. TRAINS

4 Maine Board of Pharmacy Actions Background Peers & protect the public They do not look out for the pharmaciststhat is the Association s job Governor appoints Hold your ability to work and earn an income

5 LD1646 An Act To Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program? Affects Many Statues and Regulations

6 Some of the affected Sections (NOT ALL) 22 MRSA 7246, sub- 1-A, 1-B and 1-C 22 MRSA 7246, sub- 5, 22 MRSA 7249, sub- 4, 22 MRSA 7250, sub- 4, 22 MRSA 7251, sub MRSA 7253 and MRSA 2105-A, sub- 2, H 32 MRSA MRSA 2591-A, sub- 2, M 32 MRSA 2600-C 32 MRSA 3282-A, sub- 2, Q and R,

7 1-A. Acute pain. "Acute pain" means pain that is the normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus "Acute pain" typically is associated with invasive procedures, trauma and disease and is usually time-limited.

8 1-C. Chronic pain. "Chronic pain" means pain that persists beyond the usual course of an acute disease or healing of an injury. "Chronic pain" may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

9 5. Prescriber. "Prescriber" means a licensed health care professional with authority to prescribe controlled substances and a veterinarian licensed under Title 32, chapter 71-A with authority to prescribe controlled substances.

10 4. Immunity from liability. A dispenser or prescriber is immune from liability for disclosure of information if the disclosure was made pursuant to and in accordance with this chapter.

11 1. Failure to submit information. a) A dispenser who knowingly fails to submit prescription monitoring information to the department as required by this chapter commits a civil violation for which a fine of $250 per incident, not to exceed $5,000 per calendar year b) May be adjudged and is subject to discipline by the Maine Board of Pharmacy or by the applicable professional licensing entity.

12 7253. Prescribers and dispensers required to check prescription monitoring information 1. Prescribers. a) On or after January 1, 2017 b) Upon initial prescription of a benzodiazepine or an opioid medication to a person c) And every 90 days for as long as that prescription is renewed

13 2. Dispensers. a) On or after January 1, 2017, a dispenser shall check prescription monitoring information prior to dispensing a benzodiazepine or an opioid medication to a person under any of the following circumstances:

14 Under any of the following circumstances: A. The person is not a resident of this State; B. The prescription is from a prescriber with an address outside of this State; C. The person is paying cash when the person has prescription insurance on file; or D. According to the pharmacy prescription record, the person has not had a prescription for a benzodiazepine or an opioid medication in the previous 12-month period.

15 A dispenser shall notify the program and withhold a prescription until the dispenser is able to contact the prescriber of that prescription if the dispenser has reason to believe that the prescription is fraudulent or duplicative.

16 3. Exception; hospital setting and facilities A. When a licensed or certified health care professional directly orders or administers a benzodiazepine or opioid medication to i. a person in an emergency room setting ii. an inpatient hospital setting iii. a long-term care facility or a residential care facility The requirements to check prescription monitoring information established in this section do not apply

17 4. Violation. A person who violates this section commits a civil violation for which a fine of $250 per incident, not to exceed $5,000 per calendar year, may be adjudged 5. Rulemaking. Notwithstanding section 7252, the department may adopt routine technical rules as defined in Title 5, chapter 375, subchapter 2-A to implement this section.

18 7254. Exemption from opioid medication limits until January 2017; rulemaking a) Exemption until January In addition to the exceptions established (And Other Titles) 1) a licensed health care professional may prescribe opioid medication in an amount greater than the morphine milligram equivalents limited and as long as it is medically necessary and 2) the need is documented in the patient's chart

19 7254. Exemption from opioid medication limits until January 2017; rulemaking This subsection is repealed January 1, 2017 or on the effective date of the rules establishing exceptions to prescriber limits as provided in subsection 2, whichever is later. All will be notified when this effective date of the new rules is determined.

20 2. Rulemaking. a) Notwithstanding section 7252, no later than January 1, 2017, the department shall adopt routine technical rules to establish reasonable exceptions to prescriber limits, including for chronic pain and acute pain b) The rules must take into account clinically appropriate exceptions c) Include prescribers in the rule-making process including the drafting of draft rules and changes after the public hearing process

21 2210. Requirements regarding prescription of opioid medication 1. Limits on opioid medication prescribing: A. Except as provided in subsection 2 (EXCEPTIONS) an individual licensed whose scope of practice includes prescribing opioid medication may not prescribe:

22 2210. Requirements regarding prescription of opioid medication 1. Limits on opioid medication prescribing (cont.) A. To a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day;

23 2210. Requirements regarding prescription of opioid medication 1. Limits on opioid medication prescribing (cont.) B. To a patient who has an active prescription for opioid medication in excess of 100 morphine milligram equivalents of an opioid medication per day or

24 2210. Requirements regarding prescription of opioid medication 1. Limits on opioid medication prescribing (cont.) C. an opioid medication in an amount that would cause that patient's total amount of opioid medication to exceed 300 morphine milligram equivalents of opioid medication per day; except that, on or after July 1, 2017, the aggregate amount of opioid medication prescribed may not be in excess of 100 morphine milligram equivalents of opioid medication per day

25 2210. Requirements regarding prescription of opioid medication 1. Limits on opioid medication prescribing (cont.) D. On or after January 1, 2017 i. more than a 30-day supply of an opioid medication to a patient under treatment for chronic pain. "Chronic pain ii. more than a 7-day supply of an opioid medication to a patient under treatment for acute pain. "Acute pain"

26 2. Exceptions. A. An individual licensed whose practice includes prescribing opioid medication is exempt from the limits on opioid medication when prescribing opioid medication to a patient for: i. Pain associated with active and aftercare cancer treatment; ii. Palliative care in conjunction with a serious illness iii. End-of-life and hospice care; iv. Medication-assisted treatment for substance use disorder; or

27 2. Exceptions. A. An individual licensed whose practice includes prescribing opioid medication is exempt from the limits on opioid medication when prescribing opioid medication to a patient for: v. Other circumstances determined by DHHS vi. When directly ordering or administering a benzodiazepine or opioid medication to a person in an emergency room setting, an inpatient hospital setting, a long-term care facility or a residential care facility

28 3. Electronic prescribing A. An individual licensed whose scope of practice includes prescribing opioid medication and who has the capability to electronically prescribe shall prescribe all opioid medication electronically by July 1, 2017 B. An individual who does not have the capability to electronically prescribe must request a waiver from the Commissioner of DHHS C. Stating the reasons for this waiver request

29 4. Continuing education By December 31, 2017, an individual licensed under this chapter must successfully complete 3 hours of continuing education every 2 years on the prescription of opioid medication as a condition of prescribing opioid medication. The board shall adopt rules to implement this

30 Comprehensive Addiction and Recovery Act of 2016.

31 Comprehensive Addiction and Recovery Act of Different Titles Affects Controlled Substance Prescription Filling VA State Prescription Opioid Abuse

32 Comprehensive Addiction and Recovery Act of SEC PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES. (a) IN GENERAL. Section 309 of the Controlled Substances Act (21 U.S.C. 829) is amended by adding at the end the following: (f) PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES. (1) PARTIAL FILLS

33 Comprehensive Addiction and Recovery Act of SEC 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 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

34 Comprehensive Addiction and Recovery Act of Remaining portions of a partially filled prescription for a Schedule II A. May be filled; B. Shall be filled not later than 30 days after the date on which the prescription is written.

35 Comprehensive Addiction and Recovery Act of Remaining portions of a partially filled prescription for a Schedule II EMERGENCY SITUATIONS In emergency situations, the remaining portions of a partially filled prescription for a controlled substance in schedule II: 1. May be filled; and 2. Shall be filled not later than 72 hours after the prescription is issued

36 Comprehensive Addiction and Recovery Act of Remaining portions of a partially filled prescription for a Schedule II CURRENTLY LAWFUL PARTIAL FILLS (b) RULE OF CONSTRUCTION. 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

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