Transcript Maine Law Update

Maine Pharmacy Law Update:
September 2016
S e pt e m b e r 1 1 , 2 0 1 6
J e s s i c a B a te s , P h a r m D
Objectives
1.
Discuss the future of electronic prescribing of opioids
2.
Review partial fills of opioids
3.
Review goals of Prescription Monitoring Program (PMP)
4.
Discuss the role of the pharmacist regarding naloxone
5.
Define Collaborative Practice Agreement (CPA)
6.
State qualifications necessary to provide care
7.
Outline the CPA laws
Legislative Document 1646 (Public Law 488) Timeline
July 29, 2016
• Limit MMEs to
<300 mg/day
for preexisting Rx or
<100 mg/day
for new Rx
• 3 hours of
CME for
prescribers
every 2 years
• Pharmacists
able to shortfill opioid
prescriptions
January 1, 2017
• Limit 7 day
supply for
acute pain
• Limit 30 day
supply for
chronic pain
• PMP
requirements
• Fines in effect
July 1, 2017
• Limit MMEs to
<100 mg/day
• All opioid
prescriptions
must be
electronic
(unless waiver
from DHHS)
Exceptions can be made, please refer to exceptions slide in this presentation
December 31, 2017
• Deadline for first
3 hours of CME
for providers
LD 1646 (Public Law 488)
Requirements Effective 7/29/16
Total MMEs not to exceed 300 mg/day (see exceptions)
Prescribers must complete 3 hours of CMEs regarding opioid prescribing every 2 years (first
deadline 12/31/17)
Pharmacists may dispense a lesser quantity than the quantity indicated on the prescription if
requested by the patient
◦ Remaining quantity is void
◦ Pharmacist must notify prescriber within 7 days
LD 1646 (Public Law 488)
Suggestions for Compliance (7/29/16 – 1/1/17)
For patients on multiple opioids, the total daily MME includes the sum of MMEs for all
opioid medications
Document “medically necessary” or “exception” on all opioid prescriptions exceeding 100
MME/day
Document plan for taper on all opioid prescriptions exceeding 100 MME/day (if no
exception)
For patients taking less than 300 MME/day:
Taper to less than 100 MME/day by 1/1/17
For patients taking more than or equal to 300 MME/day:
Taper to less than 100 MME/day by 7/1/17
LD 1646 (Public Law 488)
Requirements Effective 1/1/17
Limit to 7 day supply of opioid medication for the indication of acute pain
Limit to 30 day supply of opioid medication for the indication of chronic pain
PMP requirements for pharmacists (applies to opioids and benzodiazepines):
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◦
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◦
Patient is not a Maine resident
Prescription from an out-of-state provider
Patient pays cash when they have insurance on file
Patient has not received prescription for benzodiazepine or opioid within previous 12 months
PMP requirements for prescribers:
◦ Initial prescription of opioid or benzodiazepine
◦ Every 90 days as long as prescription is renewed
Pharmacists and prescribers may be fined $250 per violation up to $5,000 per year for failure to
report to the PMP
LD 1646 (Public Law 488); Ch. 22, Sect. 9, 7253 & 7254
Enhancements to the PMP
Requires DHHS to include enhancements to the PMP:
◦
◦
◦
◦
◦
A calculator/chart to convert dosages to and from MMEs
Transmittal of peer data on an actual basis to prescribers
Authority of staff members to view data
Improvement to speed and tailor to workflow
Veterinarian information that differentiates animals from people
LD 1646 (Public Law 488); Ch. 22, Sect. 9, 7253 & 7254
Suggestions for Compliance (1/1/17 – 7/1/17)
Document “medically necessary” or “exception” on all opioid prescriptions exceeding 100
MME/day
◦ Rules and regulations, including “medically necessary” definition, to be e-published by 1/1/17
Document plan for taper on all opioid prescriptions exceeding 100 MME/day (if no exception)
Day supply limits:
◦ Pharmacists can fill opioid prescriptions for acute pain for a lesser quantity if that prescription exceeds a
7 day supply
◦ Pharmacists can fill opioid prescriptions for chronic pain for a lesser quantity if that prescription exceeds
a 30 day supply
LD 1646 (Public Law 488)
Requirements Effective 7/1/17
Total MMEs not to exceed 100 mg/day (exceptions)
All opioid medications must be prescribed electronically, or prescribers must request a waiver
from DHHS
LD 1646 (Public Law 488)
Suggestions for Compliance 7/1/17 – Forward
Document “medically necessary” or “exception” on all opioid prescriptions exceeding 100
MME/day
Document plan for taper on all opioid prescriptions exceeding 100 MME/day (if no exception)
Do not accept hard copy opioid prescriptions unless a waiver is obtained
LD 1646 (Public Law 488)
Requirements Effective 12/31/17
Deadline for first three hours of required CME for providers
LD 1646 (Public Law 488)
Exceptions
Exceptions
Limits on opioid prescribing do not apply to:
PMP check is not required for benzodiazepine or
opioid prescription directly administered in*:
• Circumstances under which greater amounts are
medically necessary and the need is
documented in the patient’s chart
• Active and aftercare cancer treatment
• Palliative care
• End-of-life or hospice care
• Medication-assisted treatment for substance use
disorder
•
•
•
•
Emergency room
Inpatient hospital
Long-term care facility
Residential care facility
*PMP check is required in these settings if the prescription is for later use
LD 1646 (Public Law 488)
100 MME Opioid Comparison Table
Opioid Medication
Dose Equivalent to 100 MMEs
Morphine
100 mg
Fentanyl
~41 mcg
Hydrocodone
100 mg
Hydromorphone
25 mg
Methadone
~20 mg
Oxycodone
~66 mg
Oxymorphone
~33 mg
Tapentadol
250 mg
Tramadol
1000 mg
http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm
LD 1646 (Public Law 488)
Caveats
Does not apply to methadone/Suboxone for substance use disorder
Rules and regulations are being developed
No current method for enforcement
Fines only apply to failure to report to the PMP
Decision-making still in progress:
◦ Dispensing acute-on-chronic opioid prescriptions (i.e., 5 day supply of Tussionex in a patient on a chronic
opioid that would put them over 100 MMEs/day)
◦ PMP updates
LD 1646 (Public Law 488)
Knowledge Check
Starting January 1, 2017, what is the maximum day supply for an acute pain
opioid prescription?
a.
b.
c.
d.
e.
5
7
10
14
As much as is “medically necessary”
LD 1646 (Public Law 488)
Knowledge Check
Which of the following is NOT an exception for limitations prescribing opioid
medication?
a.
b.
c.
d.
Hospice patient
Chemotherapy patient
Chronic pain patient
Substance use disorder
Opioid Tapering
Techniques
Re a sons fo r ta p e ring
Co mp a ss ionate ta p ering
M et h adon e ta p er p ro tocol ( P CHC)
Why Taper?
High Dose Opioid and Overdose Risk
12
Adjusted Hazard Ratio
10
8
6
4
2
0
1-19 mg
20-49 mg
50-99 mg
MME per day
Overdose: death, hospitalization, unconsciousness, or respiratory failure
>100 mg
Key Points from the CDC Opioid
Prescribing Guideline
Number needed to kill for all doses:
550
Number needed to kill for doses >200 MME/day:
32
Median time to opioid-related death:
2.6 years
Reducing Exceptionally High Prescribing
Rates in Maine
From PMP data:
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16,000 Mainers on >100 MME/day
1,200 Mainers on >300 MME/day
60 opioid pills per person per year prescribed
Nation’s highest rate of prescribing long-acting opioids
Accelerating opioid deaths (both prescription and illicit)
Compassionate Opioid Tapering
Keep in mind:
◦ The patient did not prescribe opioids to themselves
◦ Someone told them that they need this medication
◦ Pain = fear
Difficult conversations:
◦ Frame the conversation around the patient and their safety, using phrases like:
◦ “I am concerned for your safety because…” or “I will always work with you and your doctor to find a more effective
treatment for your pain…”
◦ DO NOT frame the conversation around statements such as “I am not comfortable…” or “the
law says…”
◦ Acknowledge that tapering can be difficult
Developing a Taper Plan
Side effects of tapering:
◦ Anxiety, insomnia, achiness
Reasonable taper plan*:
◦ A 10% reduction every week or every other week is reasonable
◦ More rapid tapers (10-20%) every week may be appropriate for emergent
safety issues
◦ Slowing the taper when a patient gets to 10-20% of the starting daily dose is
appropriate
◦ Begin reducing by 5-10% every 2-4 weeks as tolerated
*Does not apply to methadone tapers
Methadone MME
1200
MME (mg)
1000
800
Methadone
Oxycodone
Morphine
600
400
200
0
5
15
25
35
45
55
65
75
85
95 Dose (mg)
Methadone Taper Algorithm
MME
greater
than 200
mg/day?
Yes
No
↓ by 20% every
2 weeks until 25
mg/day reached
Switch to longacting opioid at
50% MME
Maintain for 2
months
↓ by 20% of original
dose every 2 weeks
until 20% remains
↓ by 10% of original
dose for 2 weeks,
then stop
Knowledge Check
What is the purpose of the 2 month plateau during a
methadone taper when switching from 20 mg per day of
methadone to a long-acting opioid at 50% of the MME?
a. To extend the taper to avoid causing the patient to go into
opioid withdrawal
b. The 2 month plateau is not really necessary, it is just a
compassionate way to allow patients to remain on opioids for
as long as possible
c. To allow patients to reach a new steady state while methadone
is being eliminated from the system due to its long half-life
d. LD 1646 mandates that all patients must be tapered off of
methadone within 2 months
Dispensing Intranasal
Naloxone
Pharmacist ’s role in providing intranasal naloxone
Possibilities for the future
Public Law 508; Ch. 11-A
Obtaining Intranasal Naloxone
By prescription
◦ Pharmacists can serve as patient advocates by recommending prescription naloxone for
patients on high-dose opioids
By collaborative practice agreement
By protocol
◦ Rules not yet in place by Board of Pharmacy
Public Law 508; Ch. 11-A
Pharmacists Can:
Dispense to an individual at risk of experiencing an
opioid-related drug overdose
Dispense to an immediate family member
Dispense to a friend or another person in a position
to assist the individual if the individual is at risk of
experiencing an opioid-related drug overdose
Public Law 508; Ch. 11-A
Immunity
Healthcare professionals and pharmacists are immune from criminal and civil
liability and are not subject to professional disciplinary action for:
◦ Storing naloxone
◦ Dispensing naloxone
◦ Prescribing naloxone
Public Law 508; Ch. 11-A
Knowledge Check
Who can a pharmacist dispense intranasal naloxone to?
a.
b.
c.
d.
An immediate family member
A friend
The patient
All of the above
Public Law 508; Ch. 11-A
Collaborative Practice
Agreements
Def i n it ion
Qu a l if icat ions a n d s co p e o f p ra c ti ce fo r p h a rm acist s
A gre ement ex p ec tat ions
Title 32, Ch. 117, Subsect. 13841
Collaborative Practice Agreement
Written and signed agreement between a pharmacist with training and
experience relevant to the scope of collaborative practice and a practitioner that
supervises and provides direct consultation to the pharmacist providing care
◦ Scope allowed
◦ Start and end dates
◦ Specific guidelines for the prescriptive practice of the pharmacist
Title 32, Ch. 117, Subsect. 13841
Scope of Authority
Collect and review patient’s history
Obtain and check vital signs
Order and evaluate laboratory tests
◦ Not including a diagnostic component
◦ MUST be related to the drug therapy
Initiate, monitor, modify, or discontinue drug therapy
◦ Must be reported to practitioner in a timely manner
Title 32, Ch. 117, Subsect. 13841
Necessary Qualifications
License must be valid and unrestricted
Possess certification from the Board of Pharmacy Specialties or completed an accredited
pharmacy residency or one of the following:
◦ If the residency is not in the area of practice in the agreement, requires 15 hours of CE in each clinical
area covered by the agreement
◦ Graduated with a PharmD from an accredited college, 2 years of experience, and 15 hours of CE in each
clinical area
◦ BS Pharm, 3 years of experience, 15 hours of CE in each clinical area
Title 32, Ch. 117, Subsect. 13841
What Can be Managed?
Examples:
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Anticoagulation
Asthma
Diabetes
Dyslipidemia
Hyperlipidemia
Hypertension
Infectious disease
Cancer
Thyroid disorder
What is specified in the agreement
Exceptions:
◦ Hospital pharmacists handling inpatient care is
not limited in this chapter
◦ This is prohibited from clinical or investigational
trials
Title 32, Ch. 117, Subsect. 13841
CPA Rules
Relate to the law that was intact
Gives examples of disease states (but does not limit to those listed)
Definition of unrestricted license
CE requirement must be met before signing the agreement
Application must be submitted to the board of pharmacy and the licensing board of the
practitioner
Title 32, Ch. 117, Subsect. 13841
Agreement Contents
3 month start-up period
Site and setting
Who is in the agreement
Qualifications of the participants
How to cancel the agreement with written
notification
What disease, drugs, and drug categories are
allowed
◦ Terminate if the pharmacist no longer holds an
unrestricted license
◦ Death of pharmacist/practitioner
◦ How continuity of care should be handled if
agreement is suddenly terminated
Treatment protocols
How patients are referred
◦ No payment for referrals and practitioners are
not obligated to refer to the pharmacist
Proof of liability insurance
Treatment protocol
Title 32, Ch. 117, Subsect. 13841
Treatment Protocol: Authorized Pharmacist
Activities
Informed consent procedure
◦ Patient signed waiver agreeing shared medical
record
Scope of practice
Communication procedures with practitioner
◦ Defines time period to relay information after
results obtained
Practitioner can override any decision made by
the pharmacist
Documentation
Pharmacist and practitioner must have
periodic reviews
Title 32, Ch. 117, Subsect. 13841
Changes to the Agreement
If changes are made to the CPA:
◦ 10 days to report to both boards
◦ Modifications must be signed and dated by both parties
◦ Any amendments to the protocol need to include a new copy of the amended treatment protocol sent
to both boards
◦ Any changes in the liability insurance includes policy certificate
Title 32, Ch. 117, Subsect. 13841
Documentation is Key
Adhere to board’s rules in Chapter 24
Complaints are fielded and investigated by both boards
Any disciplinary action to the CPA must be reported within 10 days to the other participant
Title 32, Ch. 117, Subsect. 13841
Knowledge Check
What qualifications does the pharmacist need to have to be
able to partake in a CPA?
a. Possess certification from the Board of Pharmacy Specialties or
completed an accredited pharmacy residency
b. If the residency is not in the area of practice in the agreement, check
with the provider to see if they are comfortable with your knowledge
without additional training
c. Graduated with a PharmD from an accredited college with 15 hours of
CE in each clinical area
d. BS Pharm, 1 year of experience, and 15 hours of CE in each clinical area
Title 32, Ch. 117, Subsect. 13841
Knowledge Check
Which of the following is NOT part of the CPA?
a.
b.
c.
d.
e.
Treatment protocols
Site and setting
The initial 2 month limit
Qualifications of the participants
Which diseases, drugs, and drug categories are allowed
Title 32, Ch. 117, Subsect. 13841
Questions?
Email:
[email protected]