Code of Vermont Rules › Agency 13 - AGENCY OF HUMAN SERVICES › Sub-Agency 140 - DEPARTMENT OF HEALTH › Chapter 069 - PRESCRIPTION MONITORING SYSTEM › Section 13 140 069 - PRESCRIPTION MONITORING SYSTEM

Current through June, 2024
Section 1.0
				Authority
This rule is adopted pursuant to
				  18 V.S.A. §§
											4287 and 289 and Section 2a of Act 173
				  (2016).
Section 2.0 Purpose
This rule implements the Vermont Prescription Monitoring
				  System (VPMS) created by 18 V.S.A. chapter 84A, that requires the Department of
				  Health to establish an electronic database and reporting system for monitoring
				  dispensed prescriptions of controlled substances. The intent is to promote
				  public health through enhanced opportunities to prevent, detect and treat
				  misuse of controlled substances, without interfering with the legitimate
				  medical use of those substances. The use of VPMS in treating patients in
				  hospice care, and other end-of-life care is not required. In the event of
				  electronic or technological failure, the requirements for registering with,
				  uploading to and querying the VPMS are waived.
Section 3.0 Definitions
3.1 "Administered" means direct application
				of a drug to the body of a patient by means of injection, inhalation, ingestion
				or any other means.
3.2 "Chronic
				Pain" means pain caused by various diseases or abnormal conditions and that
				continues longer than 90 days.
3.3
				"Commissioner" means the Commissioner of Health.
3.4 "Controlled substance" means a substance
				listed on the Federal Drug Enforcement Administration's Schedules II, III or IV
				as defined in 21 C.F.R. Part 1308.
3.5 "DEA" means the Federal Drug Enforcement
				Administration.
3.6 "Delegates" are
				individuals employed by prescribers, pharmacists, or the Vermont Chief Medical
				Examiner who are authorized by these entities to access the VPMS database
				related to the clinical care of bona fide current patients of the authorizing
				health care prescriber or dispenser or related to a bona fide investigation or
				inquiry into an individual's death by the Chief Medical Examiner.
3.7 "Department" means the Vermont Department
				of Health.
3.8 "Dispensed" means a
				Schedule II, III, or IV controlled substance given to a patient by a pharmacy
				or prescriber pursuant to an order by a prescriber.
3.9 "Dispenser" means a pharmacy or
				prescriber that prepares and delivers a Schedule II, III, or IV controlled
				substance for a patient pursuant to an order by a prescriber.
3.10 "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 offered or designated by the Department of Health designed to ensure
				that officers have the training necessary to use responsibly and properly any
				information that he or she receives from the VPMS.
3.11 "OBOT" means Office Based Opioid
				Treatment physician practice for prescribing buprenorphine as established by
				the Drug Abuse and Treatment Act of 2000. In Vermont, OBOTs are often referred
				to as "Spokes". An OBOT may be a preferred provider, an individual physician
				practice or several physicians practicing as a group.
3.12 "OTP" means an Opioid Treatment Program
				as defined and regulated by federal regulation 42 R, Part 8 and DEA regulations
				related to safe storage and dispensing at OTPs ( § 1301.72 ). OTPs are
				specialty addiction treatment programs for dispensing opioid-replacement
				medication including methadone and buprenorphine under carefully controlled and
				observed conditions. OTPs offer onsite ancillary services. In Vermont, OTPs are
				sometimes referred to as "Hubs".
3.13 "Palliative care" as defined in
				18 V.S.A. section
				2(6) means interdisciplinary
				care given to improve the quality of life of patients and their families facing
				the problems associated with a serious medical condition,
3.14 "Pharmacist" means a health care
				professional licensed to dispense Schedule II, III or IV controlled substances
				as defined by the Vermont Administrative Rules of the Board of Pharmacy.
				3.15
3.15 "Pharmacy" means an
				entity that dispenses Controlled Substances, or provides pharmaceutical care,
				as defined by the Vermont Administrative Rules of the Board of
				Pharmacy.
3.16 "Prescriber" means a
				health care professional licensed to prescribe Schedule II, III or IV
				controlled substances.3.17
3.17
				"Query" means the action of accessing a Prescription Drug Monitoring Program
				and retrieving information from it regarding controlled substance(s) prescribed
				or dispensed to a patient.
3.18
				"Reciprocal Agreements" means a written agreement that provides for the
				exchange of information requests and responses of Prescription Drug Monitoring
				Program data between state data-sharing partners if access under such agreement
				is consistent with the privacy, security, and disclosure protections under the
				statute and these regulations.
3.19
				"Replacement prescription" means an unscheduled prescription request in the
				event that the document on which a patient's prescription was written has been
				lost or stolen, or the patient's prescribed medication is reported to the
				prescriber as having been lost or stolen.
3.20 "Report of Controlled Substances
				Dispensed" means the report format used by pharmacies for submitting required
				data to the VPMS pursuant to this rule.
3.21 "Reportable prescription" means each
				controlled substance dispensed from any Vermont-licensed pharmacy.
3.22 Unsolicited Report" is a notification
				sent to a patient's provider when clinical thresholds established by the
				Department have been met or exceeded.
3.23 "Vermont Prescription Monitoring System"
				(VPMS) means the statewide database that collects data on Schedule II, III, or
				IV controlled substances dispensed by a Vermont-licensed pharmacy.