Section 3.0
Definitions.
3.1 "Abuse" means a maladaptive
pattern of drug use that results in harm or places the individual at risk of
harm. Abuse of a prescription medication involves its use in a manner that
deviates from approved medical, legal, and social standards, generally to
achieve a euphoric state ("high") or to sustain opioid dependence that is
opioid addiction or that is other than the purpose for which the medication was
prescribed. (Federation of State Medical Boards).
3.2 "Abuse-deterrent opioid" means an opioid
analgesic medicine determined by the U.S. Food and Drug Administration (FDA) to
be expected to result in a meaningful reduction in abuse. These properties may
be obtained by:
(i) Physical/Chemical
barriers that prevent chewing, crushing, cutting, grating, or grinding or
chemical barriers that resist extraction using common solvents like
water;
(ii) Antagonist/Agonist drugs
that interfere with, reduce, or defeat the euphoria associated with
abuse;
(iii) Aversion where
substances can be combined to produce an unpleasant effect if the dosage form
is manipulated prior to ingestion or a higher dosage than directed is used;
(iv) Delivery Systems where drug
release designs or the method of drug delivery can offer resistance to abuse;
(v) Prodrugs where a formulation
lacks opioid activity until transformed in the gastrointestinal system;
or
(vi) a combination of any of the
above methods.
3.3
"Administer" or "Administration" means the direct application of a drug by a
prescriber to the body of a patient or research subject by injection,
inhalation, ingestion, or any other means.
3.4 "Acute pain" means pain lasting fewer
than 90 days that is a normal and predicted physiological response to a
traumatic injury, surgical procedure, or specific disease.
3.5 "Addiction" means a primary, chronic,
neurobiologic disease, whose development and manifestations are influenced by
genetic, psychosocial, and environmental factors. Addiction often is said to be
characterized by behaviors that include impaired control over drug use,
craving, compulsive use, and continued use despite harm or risk of harm.
(Federation of State Medical Boards).
3.6 "Assisted living residence" means a
program which combines housing, health, and supportive services for the support
of resident independence and aging in place. Within a homelike setting,
assisted living units offer, at a minimum, a private bedroom, private bath,
living space, kitchen capacity, and a lockable door. Assisted living promotes
resident self-direction and active participation in decision-making while
emphasizing individuality, privacy, and dignity. Defined in
33 V.S.A.
§
7102(1).
3.7 "Chronic Pain" means pain caused by
various diseases or abnormal conditions and that continues longer than 90
consecutive days.
3.8 "Controlled
Substance" means a drug, other substance, or immediate precursor, included in
Schedules II, III, or IV of the federal Controlled Substances Act
(CSA).
3.9 "Controlled Substance
Treatment Agreement" means a document that is signed and agreed upon by both
the prescriber and the patient, acknowledging the rights and responsibilities
of being on and prescribing controlled substances, and the treatment
expectations.
3.10 "Diversion"
means the intentional transfer of a controlled substance from authorized to
unauthorized possession or channels of distribution including, but not limited
to, the sharing or purchasing of drugs between family and friends or individual
theft from family and friends. The federal Controlled Substances Act
(21 U.S.C. §§
801 et seq.) establishes a closed system of
distribution for drugs that are classified as controlled substances.
3.11 "Functional Examination" means an
examination used to describe an individual's ability to perform key daily
activities and to evaluate changes in the activities of everyday life. It
encompasses physical, social, and psychological domains, and covers outcomes
from baseline functions through death.
3.12 "Hospice Care" means a program of care
and support provided by a Medicare- certified hospice provider to help an
individual with a terminal condition to live comfortably by providing
palliative care, including effective pain and symptom management. Hospice care
may include services provided by an interdisciplinary team that are intended to
address the physical, emotional, psychosocial, and spiritual needs of the
individual and his or her family. As defined in 18 V.S.A. 9710(b)
3.13 "Hospice-eligible" means a person who is
terminally ill and qualifies to receive hospice services but is not enrolled in
a hospice program.
3.14 "High-Risk"
means a patient at increased risk for misuse, abuse, diversion, addiction,
overdose, or other aberrant behaviors as determined by the patient's history
and/or the risk assessment tool chosen by the provider.
3.15 "MME" means Morphine Milligram
Equivalent. The use of MME allows prescribers to equate the dosage of opioid in
a given medication. e.g. compare oxycodone with hydromorphone. A MME calculator
can be found on the Department of Health website.
3.16 "Misuse" means the use of a medication
(with therapeutic intent) other than as directed or as indicated whether
willful or unintentional, and whether harm results or not.
3.17 "Nursing home", means an institution or
distinct part of an institution which is in to its residents any of the
following:
3.17.1 skilled nursing care and
related services for residents who require medical or nursing care;
3.17.2 rehabilitation services for the
rehabilitation of persons who are injured, have a disability, or are
sick;
3.17.3 on a 24-hour basis,
health-related care and services to individuals who, because of their mental or
physical condition, require care, and services which can be made available to
them only through institutional care.
Defined in
33 V.S.A.
§
7102(7).
3.18 "OTP" means an Opioid
Treatment Program as defined and regulated by federal regulation 42 CFR, Part
8
and DEA regulations related to safe storage and dispensing of OTP's (1301.72).
OTP's are specialty addiction treatment programs for dispensing
opioid-replacement medication including methadone and buprenorphine under
carefully controlled and observed conditions. In Vermont, OTP's are sometimes
referred to as "Hubs."
3.19 "Opioid
naive" means a patient who has not used opioids for more than seven consecutive
days during the previous 30 days.
3.20 "Prescriber" means a licensed health
care professional with the authority to prescribe controlled
substances.
3.21 "Prescribe" means
an order for medication that is dispensed to or for an ultimate user but does
not include an order for medication that is dispensed for immediate
administration to the ultimate user (e.g., an order to dispense a drug to a bed
patient for immediate administration in a hospital is not a
prescription).
3.22 "Residential
care home" means a place, however named, excluding a licensed foster home,
which provides, for profit or otherwise, room, board, and personal care to
three or more residents unrelated to the home operator. Residential care homes
shall be divided into two groups, depending upon the level of care they
provide, as follows:
3.22.1 Level III, which
provides personal care, defined as assistance with meals, dressing, movement,
bathing, grooming, or other personal needs, or general supervision of physical
or mental well-being, including nursing overview and medication management as
defined by the licensing agency by rule, but not full-time nursing care;
and
3.22.2 Level IV, which provides
personal care, as described in subdivision (A) of this subdivision (10), or
general supervision of the physical or mental well-being of residents,
including medication management as defined by the licensing agency by rule, but
not other nursing care.
Defined in
33 V.S.A.
§
7102(10).
3.23"Risk Assessment" means a
process for predicting a patient's likelihood of misusing or abusing opioids in
order to develop and document a level of monitoring for that patient. An
example of a screening tool is the Screener and Opioid Assessment for Patients
with Pain (SOAPP), but prescribers can use any evidence-based screening tool.
Section 4.0 Universal
Precautions when Prescribing Opioids for Pain.
Prior to writing a prescription for an opioid Schedule II,
III, or IV Controlled Substance for the first time during a course of treatment
to any patient, providers shall adhere to the following universal precautions,
unless otherwise exempt by this rule.
4.1 Consider Non-Opioid and
Non-Pharmacological Treatment
Prescribers shall consider non-opioid and non-pharmacological
treatments for pain management and include any appropriate treatments in the
patient's medical record. Such treatments may include, but are not limited
to:
-- Nonsteroidal anti-inflammatory drugs (NSAIDs)
-- Acetaminophen
-- Acupuncture
-- Osteopathic manipulative treatment
-- Chiropractic
-- Physical therapy
4.2 Query the Vermont Prescription Monitoring
System according to the Vermont Prescription Monitoring System Rule.
4.3 Provide Patient Education and Informed
Consent
4.3.1 Discussion of Risks: Prior to
prescribing an opioid, a prescriber shall have an in-person discussion with the
patient regarding potential side effects, risks of dependence and overdose,
alternative treatments, appropriate tapering and safe storage and disposal. If
the patient is a minor, or lacks legal competence, then the in-person
discussion shall take place between the prescriber and the patient's parent,
guardian, or legal representative, unless otherwise provided for by
law.
4.3.2 Patient Education Sheet:
Prior to prescribing an opioid, the prescriber shall provide the patient with
the Department of Health patient education sheet published on the Department
website, or a written alternative provided that the sheet contains all of the
topics found in the Department-published sheet and is written in a fifth-grade
reading level or lower.
4.3.3
Informed Consent: Prior to prescribing an opioid, a prescriber shall receive a
signed informed consent from the patient. If the patient is a minor or lacks
the capacity to provide informed consent, then the patient's parent, guardian,
or legal representative may do so on the patient's behalf, unless otherwise
provided for by law.
4.3.3.1 The consent form
shall include: Information regarding the drug's potential for misuse, abuse,
diversion, and addiction; potential side effects; tolerance; the risks
associated with the drug for life-threatening respiratory depression;
potentially fatal overdose as a result of accidental exposure, especially in
children; neonatal opioid withdrawal syndrome; and potentially fatal overdose
when combining with alcohol and/or other psychoactive medication including but
not limited to benzodiazepines and barbiturates.
Section 5.0 Prescribing
Opioids for Acute Pain.
5.1 The purpose of
this section is to provide prescribers with a framework for prescribing opioids
in the smallest doses for the shortest periods of time to be effective in the
management of pain.
5.1.1 The limits found in
Figures 1.0 and 2.0 are maximums, not therapeutic recommendations.
5.1.2 The daily maximums found in Figure 1.0
and 2.0 are averages, not absolute daily limits. The average daily limit may
allow larger doses at the start of the prescription with smaller doses at the
end as the patient tapers.
5.2 The following limits apply to patients
who are opioid naive and are receiving their first prescriptions not
administered in a healthcare setting.
5.3 These limits do not prohibit a provider
from writing a second prescription (or renewal/refill prescription) for the
patient should that be necessary.
5.4 The framework provides four categories,
each with its own limits, shown in Figure 1.0 for adults ages 18 years old and
older and Figure 2.0 for children ages 0-17 years old. The pain category into
which a patient is placed is based on the medical judgment of the prescriber.
5.4.1 For adults ages 18 years old and older,
should a provider prescribe an average daily dose over 32 morphine milligram
equivalents, the reason must be justified in the medical record.
Figure 1.0 - Opioid Limits for Adults Ages 18 Years
Old or Older
|
Pain
|
Average Daily MME (allowing for
tapering)
|
Prescription TOTAL MME based on expected
duration of pain
|
Common average DAILY pill
counts
|
Commonly associated injuries, conditions and
surgeries
|
|
Minor pain
|
No Opioids
|
0 total MME
|
0 hydrocodone
0 oxycodone
0 hydromorphone
|
molar removal, sprains, non-specific low back pain,
headaches, fibromyalgia, un-diagnosed dental pain
|
|
Moderate pain
|
24 MME/day
|
0-3 days: 72 MME
1-5 days: 120 MME
|
4 hydrocodone 5mg or
3 oxycodone 5mg or
3 hydromorphone 2mg
|
non-compound bone fractures, most soft tissue
surgeries, most outpatient laparoscopic surgeries, shoulder arthroscopy
|
|
Severe pain
|
32 MME/day
|
0-3 days: 96 MME
1-5 days: 160 MME
|
6 hydrocodone 5mg or
4 oxycodone 5mg or
4 hydromorphone 2mg
|
many non-laparoscopic surgeries, maxillofacial
surgery, total joint replacement, compound fracture repair
|
|
For patients with severe pain and extreme
circumstance, the provider can make a clinical judgement to prescribe up to 7
days so long as the reason is documented in the medical record.
|
|
Extreme Pain
|
50 MME/day
|
7 day MAX: 350 MME
|
10 hydrocodone 5mg or
6 oxycodone 5mg or
6 hydromorphone 2mg
|
similar to the severe pain category but with
complications or other special circumstances
|
Figure 2.0 - Opioid Limits for Children Ages 0-17
Years
|
Pain
|
Average Daily MME (allowing for
tapering)
|
Prescription TOTAL MME based on expected
duration of pain
|
Common average DAILY pill
counts
|
Commonly associated injuries, conditions and
surgeries
|
|
Minor pain
|
No Opioids
|
0 total MME
|
0 hydrocodone
0 oxycodone
0 hydromorphone
|
molar removal, sprains, non-specific low back pain,
headaches, fibromyalgia, un-diagnosed dental pain
|
|
Moderate to Severe
pain
|
24 MME/day
|
0-3 days: 72 MME
|
4 hydrocodone 5mg or
3 oxycodone 5mg or
3 hydromorphone 2mg
|
non-compound bone fractures, most soft tissue
surgeries, most outpatient laparoscopic surgeries, shoulder arthroscopy
|
5.5 Extended-release/Long-acting Opioids
Long-acting opioids are not indicated for acute pain. Should
a provider need to use a long-acting opioid for acute pain for a specific
reason, that reason must be justified in the patient's medical
record.
5.6 Consultation and
Transfer of Patient Care
5.6.1 While treating
an adult patient for acute pain, and prior to ending a patient's care for acute
pain, a prescriber who is not the patient's primary care provider shall ensure
a safe transition of care by making a reasonable effort to communicate with the
patient's primary care provider with any relevant clinical information
concerning the patient's condition, diagnosis and treatment. A clear discharge
summary that includes expectations for ongoing pain treatment shall satisfy
this requirement.
5.6.2 Prior to
prescribing an opioid to a child in an Emergency Department, Urgent Care
setting or specialty care setting, prescribers shall make a reasonable effort
to consult with that child's primary care provider.
5.7 Exemptions
The following conditions, and those similar to them in the
medical judgment of the healthcare provider, are exempt from the limits found
in section 5.4:
-- Pain associated with significant or severe trauma
-- Pain associated with complex surgical interventions, such
as spinal surgery
-- Pain associated with prolonged inpatient care due to
post-operative complications
-- Medication-assisted treatment for substance use
disorders
-- Patients who are not opioid naive
-- Other circumstances as determined by the Commissioner of
Health
Section 6.0
Prescribing Opioids for Chronic Pain.
The following section outlines requirements for prescribing
Schedule II, III or IV opioids for chronic pain (pain lasting longer than 90
days). If the provider is prescribing to the patient for the first time during
a course of treatment, the Universal Precautions in Section 4.0 also apply. The
requirements in this section apply to patients who are receiving an opioid for
the treatment of chronic pain.
6.1
Screening, Evaluation, and Risk Assessment
6.1.1 The prescriber shall conduct and
document a thorough medical evaluation and physical examination as part of the
patient's medical record when prescribing opioids for chronic pain.
6.1.2 The prescriber shall document in the
patient's medical record any diagnoses which support the use of opioids for
relief of chronic pain.
6.1.3 The
prescriber shall evaluate and document benefits and relative risks, including
the risk for misuse, abuse, diversion, addiction, or overdose, for the
individual patient of the use of opioids prior to writing an opioid
prescription for chronic pain. The evaluation shall include but not be limited
to a Risk Assessment as defined in Section 3.0 of this rule.
6.1.4 Examples of risk assessment screening
tools are available on the Department of Health website.
6.2 Initiating an Opioid Prescription for
Chronic Pain
6.2.1 Prior to prescribing an
opioid for the treatment of chronic pain, the prescriber shall consider and
document in the patient's medical record:
6.2.1.1 Non-opioid alternatives up to a
maximum recommended by the FDA, including non-pharmacological treatments, have
been considered;
6.2.1.2 Trial use
of the opioid;
6.2.1.3 Any
applicable requirements to query the Vermont Prescription Monitoring
System;
6.2.1.4 That the prescriber
has asked the patient if he or she is currently, or has recently been,
dispensed methadone or buprenorphine or prescribed and taken any other
controlled substance. The prescriber shall explain that this information is
important for the patient's safety and that the patient is required by law to
disclose this information (18 V.S.A. §
4223);
6.2.1.5 Receive, and include in the patient's
medical record, a signed Controlled Substance Treatment Agreement from the
patient, or, if the patient lacks the capacity to provide informed consent,
from the patient's legal representative. This agreement must include functional
goals for treatment, dispensing pharmacy choice, and safe storage and disposal
of medication. It shall include other requirements as determined by the
prescriber, such as directly observed urine drug testing and pill counts to
reasonably and timely inform the prescriber if the patient is misusing the
prescribed substance.
6.2.2 For the duration of the patient's
treatment of chronic pain with opioids, the provider shall:
6.2.2.1 Schedule and undertake periodic
follow-up visits and evaluations at a frequency determined by the patient's
risk factors, the medication dose and other clinical indictors. Patients who
are stable in terms of the medication dose and its effectiveness in managing
chronic pain must be reevaluated no less than once every 90 days; and
6.2.2.2 Write the maximum daily dose or a
"not to exceed" equivalent on the prescription for the dispensing
pharmacy.
6.2.2.3 Examples of
informed consent documents and Controlled Substance Treatment Agreements shall
be made available on the Department of Health's website.
6.3 Referrals and Consultations
The prescriber shall consider referring a patient for a
consultation with an appropriate specialist (such as a pain specialist or
substance abuse specialist) when:
6.3.1
The patient is not meeting the goals of treatment despite escalating doses of
controlled substances for pain;
6.3.2 The patient is at high-risk for
substance misuse, abuse, diversion, addiction, or overdose as determined by the
patient's history or a screening undertaken pursuant to Section 1 of this
rule;
6.3.3 The prescriber has
reasonable grounds to believe, or confirms, a patient is misusing opioids or
other substances;
6.3.4 The patient
is seeing multiple prescribers and/or utilizing multiple pharmacies;
6.3.5 The patient has been prescribed
multiple controlled substances; or
6.3.6 The patient requests a
referral.
6.4
Reevaluation of Treatment
6.4.1 Controlled
Substance Treatment Agreements for people receiving treatment for chronic pain
shall be reviewed by the prescriber and patient no less frequently than once
every 365 days to reevaluate the patient. These reviews shall be documented in
the patient's medical record.
6.4.2
Prior to prescribing a dose of opioids, or a combination of opioids, that
exceeds a Morphine Milligram Equivalent Daily Dose of 90 the prescriber shall
document in the patient's medical record:
6.4.2.1 A reevaluation of the effectiveness
and safety of the patient's pain management plan, including an assessment of
the patient's adherence to the treatment regimen;
6.4.2.2 The potential for the use of
non-opioid and non-pharmacological alternatives for treating pain;
6.4.2.3 A functional examination of the
patient;
6.4.2.4 A review of the
patient's Controlled Substance Treatment Agreement and Informed Consent, making
any necessary revisions, including pill counts and directly observed urine
testing to monitor adherence and possible use of other substances;
6.4.2.5 An assessment of any co-morbid
conditions affected by treatment with opioids. This may be best conducted by a
mental health or addictions professional; and
6.4.2.6 Any other related actions by the
patient that may reasonably lead a prescriber to modify the pain management
regimen, including but not limited to aberrant behaviors, early refills of
controlled substances, or other known risks associated with misuse, abuse,
diversion, addiction, or overdose.
6.4.2.7 Prior to prescribing a patient an
average Morphine Milligram Equivalent Daily Dose of 90 or more, a prescriber
shall have an in-person discussion with the patient, regarding the increased
risk of fatal and non-fatal overdose, and any precautions the patient should
take. If the patient is a minor, or lacks legal competence, then this in-person
discussion shall take place between the prescriber and the patient's parent,
guardian, or legal representative, unless otherwise provided for by
law.
6.4.3 Based on the
reevaluation the prescriber shall determine and document:
6.4.3.1 Whether to continue the treatment of
pain with opioids or if there are available alternatives;
6.4.3.2 The possible need for a pain
management, substance abuse or pharmacological consultation to achieve
effective pain management, avoidance of dependence or addiction or taper from
the prescribed analgesics; and
6.4.3.3 Acknowledgement that a violation of
the agreement will result in a re-assessment of the patient's treatment plan
and alteration or institution of controls over medication prescribing and
dispensing, which may include tapering or discontinuing the prescription. This
may occur after consultation with an addictions specialist.
6.5 Exemptions
Patients experiencing chronic pain in the following
categories are exempt from the requirements found in this section:
-- Chronic pain associated with cancer or cancer
treatment
-- Patients in nursing homes
Section 8.0 Prescription of
Extended Release Hydrocodones and Oxycodones without Abuse Deterrent Opioid
Formulations.
Whereas, extended release hydrocodones and oxycodones that
are not manufactured as Abuse-deterrent Opioids are easily misused, abused,
diverted, and pose an increased threat to those who unintentionally ingest
them, this rule requires specific conditions for their prescription that are in
addition to provisions of Sections 4.0 through 7.0 of this rule.
8.1 Prior to prescribing an extended release
hydrocodone or oxycodone that is not an Abuse-deterrent Opioid, the prescriber
shall:
8.1.1 Conduct and document a thorough
medical evaluation and physical examination as part of the patient's medical
record;
8.1.2 Document in the
patient's medical record any diagnoses which support the use of an extended
release hydrocodone or oxycodone that is not an Abuse-deterrent Opioid for pain
relief;
8.1.3 Evaluate and document
benefits and relative risks, including the risk for misuse, abuse, diversion,
addiction, or overdose, for the individual patient of the use of extended
release hydrocodone or oxycodone that is not an Abuse-deterrent Opioid prior to
writing a prescription for such a substance. The evaluation shall include but
not be limited to a Risk Assessment as defined in Section 3.0 of this
rule;
8.1.4 Document in the
patient's medical record that the prescription of an extended release
hydrocodone or oxycodone that is not an Abuse-deterrent Opioid is required for
the management of pain severe enough to require daily, around-the-clock,
long-term, opioid treatment for which alternative treatment options, including
non-pharmacological treatments, are ineffective, not tolerated, or are
otherwise inadequate to provide sufficient management of pain;
8.1.5 Receive, and include in the patient's
medical record a signed Informed Consent from the patient, or, if the patient
lacks the capacity to provide informed consent, from the patient's legal
representative, that shall include information regarding the drug's potential
for misuse, abuse, diversion, and addiction; the risks associated with the drug
for life-threatening respiratory depression; potentially fatal overdose as a
result of accidental exposure, especially in children; neonatal opioid
withdrawal syndrome; and potentially fatal overdose when combining with
alcohol;
8.1.6 Receive, and include
in the patient's medical record, a signed Controlled Substance Treatment
Agreement from the patient, or if the patient lacks the capacity, from the
patient's legal representative. This agreement must include functional goals
for treatment, dispensing pharmacy choice, safe storage and disposal of
medication, and urine testing (no less frequently than annually with the actual
frequency to be determined by the clinician on the basis of the patient's risk
assessment and ongoing behavior). It shall include other requirements as
determined by the prescriber, such as directly observed urine drug testing and
pill counts to reasonably and timely inform the prescriber if the patient is
misusing the prescribed substance;
8.1.7 Query VPMS and document it in the
patient's medical record. The prescriber shall also document in the patient's
medical record:
8.1.7.1 A review of other
controlled substances prescribed to the patient prior to the first prescription
of an extended release hydrocodone or oxycodone that is not an Abuse-deterrent
Opioid;
8.1.7.2 A query no less
frequently than once every 120 days for any patient prescribed 40 mg or greater
of hydrocodone or 30 mg or greater of oxycodone per day of an extended release
hydrocodone or oxycodone that is not an Abuse-deterrent Opioid as long as the
patient possesses a valid prescription for that amount; and
8.1.7.3 A query no less frequently than as
described in the Vermont Prescription Monitoring System rule.
8.1.8 Determine and write a
maximum daily dose, or a "not to exceed value" for the prescription to be
transmitted; and
8.1.9 Write a
prescription that must be filled within seven (7) days of the date issued and
does not exceed a 30-day supply.
8.2 Prescribers subject to this section shall
schedule and undertake periodic follow-up visits and evaluations (no less
frequently than every 90 days), during which the following must be documented
in the patient's medical record:
8.2.1 Whether
to continue the treatment of pain with an extended release hydrocodone or
oxycodone that is not an Abuse-deterrent Opioid or if there are available
alternatives;
8.2.2 The possible
need for a pain management or substance abuse consultation; and
8.2.3 A provider explanation and a patient
acknowledgement that a violation of the agreement will result in a
re-assessment of the patient's treatment plan and alteration or institution of
controls over medication prescribing and dispensing, which may include tapering
or discontinuing the prescription. This may occur after consultation with an
addictions specialist.