2013 CE & SNOW

2016 Dr. Douglas H. Kay CPE Symposium

GREGORY CAMERON, R.Ph

ASSISTANT PROFESSOR OF PHARMACY PRACTICE FIELD COORDINATOR COMMUNITY SITES

HUSSON UNIVERSITY SCHOOL OF PHARMACY

Please Silence All Electronic Equipment

November 5, 2016

G. Cameron 2016


G. Cameron 2016

OBJECTIVES FOR TODAY

• Board of Pharmacy Recent Action Updates

• New Federal Addiction Laws

• Maine’s Opioid Law- Update


G. Cameron 2016

EXPERIENCE • Licensed pharmacist for MANY, MANY years

• 15 years as State Senior Pharmacy Inspector

• Currently teaching pharmacy law and P1 Skills lab @ Husson

• Interests: 22 caliber, 9mm, 357 mag.

• TRAINS


G. Cameron 2016

Maine Board of Pharmacy Actions

• Background

Peers & protect the public

They do not look out for the pharmacists- that is the Association’s job

Governor appoints

Hold your ability to work and earn an income


G. Cameron 2016

LD1646 An Act To Prevent Opiate Abuse by

Strengthening the Controlled Substances Prescription Monitoring Program?

• Affects Many Statues and Regulations

Presenter

Presentation Notes


G. Cameron 2016

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-§1 • 22 MRSA §§7253 and 7254 • 32 MRSA §2105-A, sub-§2, ¶H • 32 MRSA §2210 • 32 MRSA §2591-A, sub-§2, ¶M • 32 MRSA §2600-C • 32 MRSA §3282-A, sub-§2, ¶¶Q and R,

Presenter

Presentation Notes


G. Cameron 2016

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.

LD1646 (cont.)


G. Cameron 2016

LD1646 (cont.)

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.


G. Cameron 2016

LD1646 (cont.)

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.


G. Cameron 2016

LD1646 (cont.)

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.


G. Cameron 2016

LD1646 (cont.)

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.


G. Cameron 2016

§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

LD1646 (cont.)


G. Cameron 2016

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:

LD1646 (cont.)


G. Cameron 2016

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.

LD1646 (cont.)


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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.

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


G. Cameron 2016

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.

LD1646 (cont.)


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§7254. Exemption from opioid medication limits until January 2017; rulemaking

a) Exemption until January 2017. 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

LD1646 (cont.)


G. Cameron 2016

§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.

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


G. Cameron 2016

§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:

LD1646 (cont.)


G. Cameron 2016


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;

LD1646 (cont.)


G. Cameron 2016



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

LD1646 (cont.)


G. Cameron 2016



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

LD1646 (cont.)


G. Cameron 2016


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"

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


G. Cameron 2016

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

LD1646 (cont.)


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“Comprehensive Addiction and Recovery Act of 2016’’.


G. Cameron 2016


9 Different Titles

Affects Controlled Substance Prescription Filling

VA

State Prescription Opioid Abuse


G. Cameron 2016


SEC. 702. 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


G. Cameron 2016


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 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


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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.


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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


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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


G. Cameron 2016


G. Cameron 2016

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2013 CE & SNOW