§ 4281. Legislative intent
The General Assembly recognizes the important public health benefits of the legal
medical use of controlled substances and also the significant risk to public health
that can arise due to the abuse of those substances. It is the intent of this chapter
to create the Vermont Prescription Monitoring System, which will provide an electronic
database and reporting system for electronic monitoring of prescriptions for Schedules
II, III, and IV controlled substances, as defined in 21 C.F.R. Part 1308, as amended and as may be amended, to promote the public health through enhanced
opportunities for treatment for and prevention of abuse of controlled substances,
without interfering with the legal medical use of those substances. (Added 2005, No. 205 (Adj. Sess.), § 1.)
§ 4282. Definitions
As used in this chapter:
(1) “Dispenser” means any person who “dispenses” or engages in “dispensing” as those terms
are defined in 26 V.S.A. § 2022(5).
(2) “Health care provider” means an individual licensed, certified, or authorized by law
to provide professional health care service in this State to an individual during
that individual’s medical or dental care, treatment, or confinement.
(3) “VPMS” means the Vermont Prescription Monitoring System established under this chapter.
(4) “Delegate” means an individual employed by a health care provider or pharmacy or in
the Office of the Chief Medical Examiner and authorized by a health care provider
or dispenser or by the Chief Medical Examiner to request information from the VPMS
relating to a bona fide current patient of the health care provider or dispenser or
to a bona fide investigation or inquiry into an individual’s death.
(5) “Department” means the Department of Health.
(6) “Drug diversion investigator” means an employee of the Department of Public Safety
whose primary duties include investigations involving violations of laws regarding
prescription drugs or the diversion of prescribed controlled substances and who has
completed a training program established by the Department of Health by rule that
is designed to ensure that officers have the training necessary to use responsibly
and properly any information that they receive from the VPMS.
(7) “Evidence-based” means based on criteria and guidelines that reflect high-quality,
cost-effective care. The methodology used to determine such guidelines shall meet
recognized standards for systematic evaluation of all available research and shall
be free from conflicts of interest. Consideration of the best available scientific
evidence does not preclude consideration of experimental or investigational treatment
or services under a clinical investigation approved by an institutional review board. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 6; 2017, No. 113 (Adj. Sess.), § 85.)
§ 4283. Creation; implementation
(a) The Department shall maintain an electronic database and reporting system for monitoring
Schedules II, III, and IV controlled substances, as defined in 21 C.F.R. Part 1308, as amended and as may be amended, that are dispensed within the State of Vermont
by a health care provider or dispenser or dispensed to an address within the State
by a pharmacy licensed by the Vermont Board of Pharmacy.
(b) As required by the Department, every dispenser who is licensed by the Vermont Board
of Pharmacy shall report to the Department in a timely manner data for each controlled
substance in Schedules II, III, and IV, as amended and as may be amended, dispensed
to a patient within Vermont. Reporting shall not be required for:
(1) a drug administered directly to a patient; or
(2) a drug dispensed by a health care provider at a facility licensed by the Department,
provided that the quantity dispensed is limited to an amount adequate to treat the
patient for a maximum of 48 hours.
(c) Data for each controlled substance that is dispensed shall include the following:
(1) patient identifier, which may include the patient’s name and date of birth;
(2) drug dispensed;
(3) date of dispensing;
(4) quantity and dosage dispensed;
(5) the number of days’ supply;
(6) health care provider; and
(7) dispenser.
(d) The data shall be provided in the electronic format defined by the Department. To
the extent possible, the format shall not require data entry in excess of that required
in the regular course of business. Electronic transmission is not required if a waiver
has been granted by the Department to an individual dispenser. The Department shall
strive to create VPMS in a manner that will enable real-time transmittal to VPMS and
real-time retrieval of information stored in VPMS.
(e) It is not the intention of the Department that a health care provider or a dispenser
shall have to pay a fee or tax or purchase hardware or proprietary software required
by the Department specifically for the use, establishment, maintenance, or transmission
of the data. The Department shall seek grant funds and take any other action within
its financial capability to minimize any cost impact to health care providers and
dispensers.
(f) The Department shall purge from VPMS all data that are more than six years old.
(g) The Commissioner shall develop and provide advisory notices, which shall make clear
that all prescriptions for controlled drugs in Schedules II, III, and IV are entered
into a statewide database in order to protect the public. The notices shall be distributed
at no cost to dispensers and health care providers who are subject to this chapter.
(h) A dispenser shall be subject to discipline by the Board of Pharmacy or by the applicable
licensing entity if the dispenser intentionally fails to comply with the requirements
of subsection (b), (c), or (d) of this section. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 7.)
§ 4284. Protection and disclosure of information
(a) The data collected pursuant to this chapter and all related information and records
shall be confidential, except as provided in this chapter, and shall not be subject
to the Public Records Act. The Department shall maintain procedures to protect patient
privacy; ensure the confidentiality of patient information collected, recorded, transmitted,
and maintained; and ensure that information is not disclosed to any person except
as provided in this section.
(b)(1) The Department shall provide only the following persons with access to query the VPMS:
(A) a health care provider, dispenser, or delegate who is registered with the VPMS and
certifies that the requested information is for the purpose of providing medical or
pharmaceutical treatment to a bona fide current patient;
(B) personnel or contractors, as necessary for establishing and maintaining the VPMS;
(C) the Medical Director of the Department of Vermont Health Access and the Director’s
designee, for the purposes of Medicaid quality assurance, utilization, and federal
monitoring requirements with respect to Medicaid recipients for whom a Medicaid claim
for a Schedule II, III, or IV controlled substance has been submitted;
(D) a medical examiner or delegate from the Office of the Chief Medical Examiner, for
the purpose of conducting an investigation or inquiry into the cause, manner, and
circumstances of an individual’s death; and
(E) a health care provider or medical examiner licensed to practice in another state,
to the extent necessary to provide appropriate medical care to a Vermont resident
or to investigate the death of a Vermont resident.
(2) The Department shall provide reports of data available to the Department through the
VPMS only to the following persons:
(A) A patient or that person’s health care provider, or both, when VPMS reveals that a
patient may be receiving more than a therapeutic amount of one or more controlled
substances.
(B) A designated representative of a board responsible for the licensure, regulation,
or discipline of health care providers or dispensers pursuant to a bona fide specific
investigation.
(C) A patient for whom a prescription is written, insofar as the information relates to
that patient.
(D) The relevant occupational licensing or certification authority if the Commissioner
reasonably suspects fraudulent or illegal activity by a health care provider. The
licensing or certification authority may report the data that are the evidence for
the suspected fraudulent or illegal activity to a drug diversion investigator.
(E)(i) The Commissioner of Public Safety, personally, or the Deputy Commissioner of Public
Safety, personally, if the Commissioner of Health, personally, or a Deputy Commissioner
of Health, personally, makes the disclosure and has consulted with at least one of
the patient’s health care providers, when the disclosure is necessary to avert a serious
and imminent threat to a person or the public.
(ii) The Commissioner of Public Safety, personally, or the Deputy Commissioner of Public
Safety, personally, when he or she requests data from the Commissioner of Health,
and the Commissioner of Health believes, after consultation with at least one of the
patient’s health care providers, that disclosure is necessary to avert a serious and
imminent threat to a person or the public.
(iii) The Commissioner or Deputy Commissioner of Public Safety may disclose such data received
pursuant to this subdivision (E) as is necessary, in his or her discretion, to avert
the serious and imminent threat.
(F) A prescription monitoring system or similar entity in another state pursuant to a
reciprocal agreement to share prescription monitoring information with the Vermont
Department of Health as described in section 4288 of this title.
(G) The Commissioner of Health or the Commissioner’s designee in order to identify patients
who filled prescriptions written pursuant to chapter 113 of this title.
(c) A person who receives data or a report from VPMS or from the Department shall not
share that data or report with any other person or entity not eligible to receive
that data pursuant to subsection (b) of this section, except as necessary and consistent
with the purpose of the disclosure and in the normal course of business. Nothing shall
restrict the right of a patient to share his or her own data.
(d) The Commissioner shall offer health care providers and dispensers training in the
proper use of information they may receive from VPMS. Training may be provided in
collaboration with professional associations representing health care providers and
dispensers.
(e) A drug diversion investigator who may receive information pursuant to this section
shall not have access to VPMS except for information provided to the officer by the
licensing or certification authority.
(f) The Department is authorized to use information from VPMS for research, trend analysis,
and other public health promotion purposes, provided that data are aggregated or otherwise
de-identified. The Department shall post the results of trend analyses on its website
for use by health care providers, dispensers, and the general public. When appropriate,
the Department shall send alerts relating to identified trends to health care providers
and dispensers by electronic mail.
(g) Following consultation with the Vermont Prescription Drug Advisory Council and an
opportunity for input from stakeholders, the Department shall develop a policy that
will enable it to use information from VPMS to determine if individual prescribers
and dispensers are using VPMS appropriately.
(h) Following consultation with the Vermont Prescription Drug Advisory Council and an
opportunity for input from stakeholders, the Department shall develop a policy that
will enable it to evaluate the prescription of regulated drugs by prescribers.
(i) Knowing disclosure of transmitted data to a person not authorized by subsection (b)
of this section, or obtaining information under this section not relating to a bona
fide specific investigation, shall be punishable by imprisonment for not more than
one year or a fine of not more than $1,000.00, or both, in addition to any penalties
under federal law.
(j) All information and correspondence relating to the disclosure of information by the
Commissioner to a patient’s health care provider pursuant to subdivision (b)(2)(A)
of this section shall be confidential and privileged, exempt from public inspection
and copying under the Public Records Act, immune from subpoena or other disclosure,
and not subject to discovery or introduction into evidence.
(k) Each request for disclosure of data pursuant to subdivision (b)(2)(B) of this section
shall document a bona fide specific investigation and shall specify the case number
of the investigation. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 8, eff. Oct. 1, 2013; 2015, No. 27, § 3, eff. May 20, 2015; 2015, No. 173 (Adj. Sess.), § 1; 2019, No. 82, § 7; 2023, No. 6, § 148, eff. July 1, 2023; 2023, No. 51, § 3, eff. July 1, 2023.)
§ 4285. Immunity
A dispenser or health care provider shall be immune from civil, criminal, or administrative
liability as a result of any action made in good faith pursuant to and in accordance
with this chapter, but nothing in this section shall be construed to establish immunity
for the failure to follow standards of professional conduct or the failure to exercise
due care in the provision of services. (Added 2005, No. 205 (Adj. Sess.), § 1.)
§ 4286. Repealed. 2005, No. 205 (Adj. Sess.), § 1.
§ 4287. Rulemaking
The Department shall adopt rules for the implementation of VPMS as defined in this
chapter consistent with 45 C.F.R. Part 164, as amended and as may be amended, that limit the disclosure to the minimum information
necessary for purposes of this chapter. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 9.)
§ 4288. Reciprocal agreements
The Department of Health may enter into reciprocal agreements with other states that
have prescription monitoring programs so long as access under such agreement is consistent
with the privacy, security, and disclosure protections in this chapter. (Added 2013, No. 75, § 10, eff. Oct. 1, 2013.)
§ 4289. Standards and guidelines for health care providers and dispensers
(a) Each professional licensing authority for health care providers shall develop evidence-based
standards to guide health care providers in the appropriate prescription of Schedules
II, III, and IV controlled substances for treatment of acute pain, chronic pain, and
for other medical conditions to be determined by the licensing authority. The standards
developed by the licensing authorities shall be consistent with rules adopted by the
Department of Health. The licensing authorities shall submit their standards to the
Commissioner of Health, who shall review for consistency across health care providers
and notify the applicable licensing authority of any inconsistencies identified.
(b)(1) Each health care provider who prescribes any Schedule II, III, or IV controlled substances
shall register with the VPMS by November 15, 2013.
(2) If the VPMS shows that a patient has filled a prescription for a controlled substance
written by a health care provider who is not a registered user of VPMS, the Commissioner
of Health shall notify the applicable licensing authority and the provider by mail
of the provider’s registration requirement pursuant to subdivision (1) of this subsection.
(3) The Commissioner of Health shall develop additional procedures to ensure that all
health care providers who prescribe controlled substances are registered in compliance
with subdivision (1) of this subsection.
(c) Except in the event of electronic or technological failure, health care providers
shall query the VPMS with respect to an individual patient in the following circumstances:
(1) at least annually for patients who are receiving ongoing treatment with an opioid
Schedule II, III, or IV controlled substance;
(2) when starting a patient on a Schedule II, III, or IV controlled substance for nonpalliative
long-term pain therapy of 90 days or more;
(3) the first time the provider prescribes an opioid Schedule II, III, or IV controlled
substance written to treat chronic pain; and
(4) prior to writing a replacement prescription for a Schedule II, III, or IV controlled
substance pursuant to section 4290 of this title.
(d)(1) Each dispenser who dispenses any Schedule II, III, or IV controlled substances shall
register with the VPMS.
(2) Except in the event of electronic or technological failure, dispensers shall query
the VPMS in accordance with rules adopted by the Commissioner of Health.
(3) Pharmacies and other dispensers shall report each dispensed prescription for a Schedule
II, III, or IV controlled substance to the VPMS within 24 hours or one business day
after dispensing.
(e) The Commissioner of Health shall, after consultation with the Vermont Prescription
Drug Advisory Council, adopt rules necessary to effect the purposes of this section.
The Commissioner and the Council shall consider additional circumstances under which
health care providers should be required to query the VPMS, including whether health
care providers should be required to query the VPMS prior to writing a prescription
for any opioid Schedule II, III, or IV controlled substance or when a patient requests
renewal of a prescription for an opioid Schedule II, III, or IV controlled substance
written to treat acute pain, and the Commissioner may adopt rules accordingly.
(f) Each professional licensing authority for health care providers and dispensers shall
consider the statutory requirements, rules, and standards adopted pursuant to this
section in disciplinary proceedings when determining whether a licensee has complied
with the applicable standard of care. (Added 2013, No. 75, § 11; amended 2015, No. 173 (Adj. Sess.), § 2; 2019, No. 82, § 8.)
§ 4290. Replacement prescriptions and medications
(a) As used in this section, “replacement prescription” means an unscheduled prescription
request in the event that the document on which a patient’s prescription was written
or the patient’s prescribed medication is reported to the prescriber as having been
lost or stolen.
(b) When a patient or a patient’s parent or guardian requests a replacement prescription
for a Schedule II, III, or IV controlled substance, the patient’s health care provider
shall query the VPMS prior to writing the replacement prescription to determine whether
the patient may be receiving more than a therapeutic dosage of the controlled substance.
(c) When a health care provider writes a replacement prescription pursuant to this section,
the provider shall clearly indicate as much by writing the word “REPLACEMENT” on the
face of the prescription. The health care provider shall document the writing of the
replacement prescription in the patient’s medical record. (Added 2013, No. 75, § 12, eff. Oct. 1, 2013.)