DPH Issues Emergency Order Requiring Use of PMP for Each Prescription of Hydrocodone-only Medication
Thursday, April 24, 2014
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Please read the following important prescribing notice issued by the Massachusetts Department of Public Health - Bureau of Health Care Safety and Quality
TO:
Massachusetts
Controlled Substance Registration Participants
FROM:
Deborah Allwes, BS, BSN, MPH, Director of the Bureau of Health Care
Safety and Quality
DATE:
April 24, 2014
RE:
Emergency Order Regarding Prescription
Monitoring Program prior to Prescribing of Hydrocodone-only medications Introduction:
On April 15, 2014 a federal
district court judge enjoined Commissioner Bartlett's ban on the prescribing
and dispensing of hydrocodone-only medications. However; an emergency continues
to exist which is detrimental to the public health with respect to the number
of opiate-related overdoses and amount of opiate abuse and addiction in the
Commonwealth.
Emergency order
regarding Prescription Monitoring Program
The Commissioner has
issued an order, effective immediately, pursuant to the Governor's declaration
of a public health emergency, requiring registered individual prescribers to
utilize the Prescription Monitoring Program (PMP) to evaluate a patient's
prescription history prior to each instance of issuing a prescription for
hydrocodone-only extended release medication that is not in an abuse deterrent
formulation.
[1]
In Massachusetts,
prescriptions for controlled substances in Schedules II and III can be written
for no more a 30-day supply (MGL c. 94C, § 23(d)), so this order will require
the prescriber to check the patient's PMP record, at a minimum, every 30 days
while he or she is being prescribed this medication.
The Commissioner issues this order pursuant
to the March 27, 2014 vote by the Public Health Council (PHC), permitting the
Commissioner to take other actions as necessary to respond to the declared
public health emergency.
The
Commissioner will update the PHC at the regular monthly meeting as to the
action she took
.
Best Practices
for Prescribing
On April 22, 2014,
the Board of Registration in Medicine (BORIM) promulgated emergency regulations
requiring licensees, prior to prescribing hydrocodone-only extended release
medication that is not in an abuse deterrent form to 1) conduct a risk
assessment for a patient, including an evaluation of the patient's risk
factors, substance abuse history, presenting conditions, current medications,
and PMP data; 2) discuss the risks and benefits of the medication with the
patient; 3) enter into a pain management treatment agreement with the patient;
supply a letter of medical necessity for the pharmacy that will fill the
prescription; and 4) document this information in the patient's medical
records.
The Department
recommends that other prescribers' professional licensing boards promulgate
regulations that follow BORIM's lead. Regulation by BORIM will directly or
indirectly affect the prescribing by approximately 95% of the prescribers of
controlled substances in Massachusetts.
Physicians represent almost 75% of such prescribers.
Prescribers who are physician assistants and
advanced practice registered nurses represent another nearly 20% of
prescribers.
These practitioners, except
nurse midwives, can only practice under the supervision of a physician pursuant
to mutually agreed-upon guidelines including prescriptive practice.
The Commissioner recommends
registered individual prescribers document both a risk assessment and
controlled substance treatment agreement for each patient for whom they
prescribe hydrocodone-only extended release medication that is not in an abuse
deterrent formulation.
Specifically:
1.
Prescribers must evaluate and document in the
patient's medical record the risks and benefits for the individual patient of
the use of extended release hydrocodone-only medication without abuse
deterrents prior to writing a prescription for such a medication; and
2.
Prescribers must use a validated tool(s) to
screen for risky alcohol and drug use, such as the single item alcohol
and drug screen questions shown below (AUDIT-C and the Single-item drug screen)
; and
3.
Prescribers must place in the patient's file
a Pain Management Treatment Agreement signed by the patient that shall include
such requirements as drug screening, pill counts, safe storage and disposal,
and other conditions as appropriate in the prescriber's judgment, based on the
patient's history, as shown below.
Question: I am a
prescriber and have a patient that I want to write three 30-day prescriptions
for. Is this okay?
Answer:
No. You must go into the PMP and review a
patient's prescription history prior to each prescription.
Question: How do
I enroll in the PMP?
Answer: Go to the
MA Drug Control Program's website and fill out an enrollment application.
Follow the instructions on the screen: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/ma-online-prescription-monitoring-program/
Question: I am
already enrolled in the PMP, what else do I need to do?
Answer: As long
as you have a current MCSR and are enrolled in the PMP, there is nothing more
you need to do for enrollment.
Question:
I am an advance practice registered nurse (APRN) or a physician
assistant (PA). Can I enroll in the PMP?
Answer:
The MA Drug Control Program encourages all prescribers to enroll in the
PMP.
Question:
How do I get more information on validated screening tools?
Answer:
The Department has published a Screening Brief Intervention and
Referral to Treatment (SBIRT) Guide.
The
SBIRT Guide includes additional information on validated screening tools.
The Guide is available free of charge and can
be ordered online at
www.mass.gov/maclearinghouse
Question:
How can I learn
more about integrating SBIRT into my practice?
Answer:
MASBIRT Training and Technical Assistance
(MASBIRT TTA) provides free training, coaching, and consultations on
implementation for healthcare and public health professionals statewide; equips
providers to identify and address patients' unhealthy substance use, including
prescription drug misuse; and helps organizations build linkages with specialty
substance abuse treatment.
T
rainings can help you: Develop clinical
protocols; enhance motivation through effective communication; negotiate goal
setting; and build linkages with specialty substance abuse treatment.
MASBIRT TTA can be reached during regular
business hours by calling 617-414-3749 or through
www.masbirt.org
Question:
How do I access
services for a patient who has a problem with drugs and alcohol?
Answer:
The Massachusetts Substance
Abuse Information and Education Helpline provides free and confidential
information and referrals for alcohol and other drug abuse problems and related
concerns. Staff members are available to answer questions and provide
referrals by telephone Monday through Friday from 8:00 am to 10:00 pm and on
Saturday and Sunday from 9:00 am to 5:00 pm. Language interpreters are
available; additionally, information and referrals can be accessed at any time
via the website at
http://www.helpline-online.com/
If you have any
questions about this letter, please contact:
Prescription Monitoring and
Drug Control Program
Bureau of Health Care Safety
and Quality
Massachusetts Department of Public
Health
99 Chauncy Street
Boston, MA 02111
phone: 617-983-6700
email:
dcp.dph@state.ma.us
website:
www.mass.gov/dph/dcp
________________________________________________________________
Validated Single- Item Alcohol and Drug Screen
Questions
ALCOHOL:
How many times in
the past year have you had X or more drinks in a day?
X is 5 for men and 4
for women
A response of
greater than one is considered positive.
[2]
DRUGS:
How many times in
the past year have you used an illegal drug or used a prescription medication
for non-medical reasons?
If asked to clarify
the meaning of "non-medical reasons” you can say "for instance, because of the
experience or feeling it caused”
A response of at
least one time was considered positive for drug use.
[3]
[1]
The regulation would not impose specific criteria which would require a
prescriber to refuse to write a prescription: prescribers are expected to
review the information in the PMP for use as a clinical decision-making tool.
[2]
Smith PC, Schmidt
SM, Allensworth-Davies D, Saitz R. Primary Care Validation of a Single-Question
Alcohol Screening Test. J Gen Intern Med. 2009; 24(7): 783-788.
[3]
Smith PC,
Schmidt SM, Allensworth-Davies D, Saitz R. A single-question screening test for
drug use in primary care. Arch Intern Med. 2010; 170(13): 1155-1160.
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