AN ACT RELATING TO PRESCRIPTION DRUGS AND SUBSTANCE ABUSE
It is hereby enacted by the General Assembly of the State of Vermont:
Sec. 1. 18 V.S.A. chapter 84A is added to read:
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 provide for the 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.
§ 4282. DEFINITIONS
As used in this chapter:
(1) “Commissioner” means the commissioner of the department.
(2) “Department” means the Vermont department of health.
(3) “Trained law enforcement officer” shall include any officer designated by the department of public safety who has completed a training program established by rule by the department of health, which is designed to ensure that officers have the training necessary to responsibly and properly use information they receive from the electronic database for prescriptions created pursuant to this chapter.
§ 4283. ELECTRONIC DATABASE FOR PRESCRIPTIONS
(a) Contingent upon the receipt of funding, the department may establish an electronic 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 practitioner or pharmacist or dispensed to an address within the state by a pharmacy licensed by the Vermont board of pharmacy.
(b) A practitioner or a pharmacist shall not have to pay a fee or tax specifically dedicated to the operation of the system.
(c) Every dispenser who is licensed by the Vermont board of pharmacy shall report to the department the data required by this section for each controlled substance in Schedules II, III, and IV, as amended and as may be amended, dispensed to a patient within Vermont in a timely manner as prescribed by the department, except that reporting shall not be required for:
(1) a drug administered directly to a patient; or
(2) a drug dispensed by a practitioner 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.
(d) Data for each controlled substance that is dispensed shall include the following:
(1) patient identifier;
(2) drug dispensed;
(3) date of dispensing;
(4) quantity dispensed;
(5) prescriber; and
(e) The data shall be provided in the electronic format specified by the department unless a waiver has been granted by the department to an individual dispenser.
(f)(1) The data collected pursuant to this chapter shall be confidential and not subject to public records law except as provided in this chapter. The department shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained is not disclosed to persons except as provided in this section.
(2) The department shall be authorized to provide data to only the following persons:
(A) A designated representative of a board responsible for the licensure, regulation, or discipline of practitioners, pharmacists, or other persons who are authorized to prescribe, administer, or dispense controlled substances and who are involved in a bona fide specific investigation involving a designated person.
(B) A practitioner or pharmacist who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide current patient.
(C) A patient for whom a prescription is written, insofar as the information relates to that patient.
(D) Personnel or contractors, as necessary for establishing and maintaining the program’s electronic system.
(3) A person, other than a practitioner or pharmacist, who receives data or any report of the system from the department shall not provide it to any other person or entity except by order of a court of competent jurisdiction.
(4) A practitioner or pharmacist shall maintain or disclose data or reports received from the electronic database for prescriptions in the same manner as other individually identifiable health information is maintained or disclosed.
(5) The department shall purge all information that is more than six years old.
(6)(A) The commissioner may report any information that he or she reasonably suspects relates to fraudulent or illegal activity by a prescriber to the relevant occupational licensing or certification authority. The licensing or certification authority may report to a trained law enforcement officer.
(B) Notwithstanding subdivision (A) of this subdivision (6), the commissioner may report directly to an occupational licensing or certification authority or to a trained law enforcement officer, as permitted by and in a manner consistent with 42 C.F.R. Part 164, as amended and as may be amended, if the commissioner in good faith believes the disclosure is necessary to avert a serious and imminent threat to the health or safety of a person or the public, and the commissioner makes the report to a person the commissioner believes is reasonably able to prevent or lessen the threat.
(7) The commissioner shall offer practitioners and pharmacists training in the proper use of information they receive from the electronic database for prescriptions. Such training may be provided in collaboration with professional associations representing practitioners and pharmacists.
(g) A trained law enforcement officer who is entitled to receive information pursuant to this section shall not have access to the database except for information provided to the officer by the commissioner in accordance with subsection (f) of this section.
(h) The failure by a dispenser to transmit data to the department as required by subsection (c), (d), or (e) of this section shall be subject to discipline by the board of pharmacy or by the applicable professional licensing entity.
(i) Knowing disclosure of transmitted data to a person not authorized by subsection (f) 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.
§ 4284. ADVISORY COMMITTEE
(a) The commissioner shall establish an advisory committee to assist in the implementation and periodic evaluation of the electronic database for prescriptions. The advisory committee shall be chaired by the commissioner or his or her designee and shall include the following members:
(1) the deputy commissioner for alcohol and drug abuse programs;
(2) a representative from the Vermont medical society;
(3) a representative from the Vermont state nurses association;
(4) a representative from the Vermont board of medical practice;
(5) a representative from the Vermont board of pharmacy;
(6) an emergency room physician;
(7) a pharmacist;
(8) a representative of the Vermont state dental society;
(9) the commissioner of public safety;
(10) a representative of the Vermont attorney general;
(11) a representative of the Vermont substance abuse treatment providers association;
(12) a mental health provider or a certified alcohol and drug counselor;
(13) a consumer in recovery from prescription abuse; and
(14) any other member invited by the commissioner.
(b) The committee shall meet no less than quarterly in the first year, and no less than annually each following year, but may be convened at any time by the commissioner or the commissioner’s designee.
(c) The committee shall issue a report to the senate and house committees on judiciary, the senate committee on health and welfare, and the house committee on human services no later than January 15th in 2008, 2010, and 2012.
(d) This section shall sunset July 1, 2012 and thereafter the committee shall cease to exist.
§ 4285. RULEMAKING
The department shall adopt rules for the implementation of this chapter consistent with 45 C.F.R. Part 164, as amended and as may be amended, and that require the disclosure of no more than the minimum information necessary for purposes of this act and shall keep the senate and house committees on judiciary, the senate committee on health and welfare, and the house committee on human services advised of the substance and progress of initial rulemaking pursuant to this section.
Sec. 2. 18 V.S.A. § 4218 is amended to read:
§ 4218. ENFORCEMENT
(a) It is hereby made the duty of the department of public safety, its officers, agents, inspectors, and representatives, and pursuant to its specific authorization any other peace officer within the state, and of all state’s attorneys, to enforce all provisions of this chapter and of the rules and regulations of the board of health adopted under this chapter, except those otherwise specifically delegated, and to cooperate with all agencies charged with the enforcement of the federal drug laws, this chapter, and the laws of other states relating to regulated drugs.
(b) Such authorities and their specifically authorized agents shall have, at all times, access to all orders, prescriptions, and records kept or maintained under this chapter, as provided herein.
(c) A person who gives information to law enforcement officers, the drug rehabilitation commission, or professional boards as defined in section 4201 of this title and their specifically authorized agents, concerning the use of regulated drugs or the misuse by other persons of regulated drugs, shall not be subject to any civil, criminal, or administrative liability or penalty for giving such information.
(d) Nothing in this section shall authorize the department of public safety and other authorities described in subsection (a) of this section to have access to the electronic prescription database created pursuant to chapter 84A of this title, except as provided in that chapter.
The commissioner of health, the commissioner of public safety, the executive director of state’s attorney’s and sheriffs, the defender general, and the executive director of the Vermont chapter of the American civil liberties union shall report to the senate and house committees on judiciary, senate committee on health and welfare and the house committee on human services no later than December 15, 2006 regarding revisions to 18 V.S.A. § 4218 which will address medical record privacy concerns which may be raised by permitting law enforcement unfettered access to pharmacy records.
The Vermont General Assembly
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