Code of Vermont Rules › Agency 13 - AGENCY OF HUMAN SERVICES › Sub-Agency 140 - DEPARTMENT OF HEALTH › Chapter 076 - PRESCRIBING OF OPIOIDS FOR PAIN › Section 13 140 076 - PRESCRIBING OF OPIOIDS FOR PAIN

Current through June, 2024
Section 1.0 Authority.
This rule is adopted pursuant to
				  18 V.S.A.
				  §
											4289 (e), Section
				  14(e) of Act 75 (2013) and Section 2a of Act 173 (2016).
Section 2.0 Purpose.
This rule provides legal requirements for the appropriate use
				  of opioids in treating pain in order to minimize opportunities for misuse,
				  abuse, and diversion, and optimize prevention of addiction and overdose. The
				  prescription limits for acute pain only apply to the first prescription written
				  for a given course of treatment, and do not apply to renewals or refills. This
				  rule only applies to Schedule II, III, or IV Controlled
				  Substances.
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.