Introduced by Senator Sears of Bennington District and Senator Leddy of Chittenden District
Subject: Health; prescription drugs; controlled substances; monitoring; substance abuse
Statement of purpose: This bill proposes to establish a prescription drug monitoring program in order to promote the public health and welfare, detect and prevent substance abuse, and support the legitimate medical use of controlled substances.
AN ACT RELATING TO PRESCRIPTION DRUGS AND SUBSTANCE ABUSE
It is hereby enacted by the General Assembly of the State of Vermont:
Sec. 1. 33 V.S.A. chapter 48 is added to read:
CHAPTER 48. ELECTRONIC MONITORING OF PRESCRIPTIONS
§ 4801. ELECTRONIC DATABASE FOR PRESCRIPTIONS
(a) Contingent upon the receipt of funding, the Vermont department of health may establish an electronic system for monitoring Schedules II, III, and IV controlled substances 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 within the state of Vermont or who is licensed by the Vermont board of pharmacy shall report to the Vermont department of health the data required by this section in a timely manner as prescribed by the department of health, 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 Vermont department of health, 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, but not be limited to, 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 of health 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 section. The department of health 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 of health 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 who receives data or any report of the system from the department of health shall not provide it to any other person or entity except by order of a court of competent jurisdiction.
(4) The department shall purge all information that is more than six years old.
(g) The failure by a dispenser to transmit data to the department of health as required by subsections (c), (d), or (e) of this section shall be subject to discipline by the board of pharmacy or by the applicable professional licensing entity.
(h) Knowing disclosure of transmitted data to a person not authorized by subsection (f) of this section or by other state law, 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.
§ 4802. DEFINITIONS
As used in this chapter, the following definitions shall have the following meanings:
(1) “Patient identifier” means a patient’s:
(A) Full name;
(B) Address, including zip code;
(C) Date of birth; and
(D) Social Security number or an alternative identification number established pursuant to section 4806 of this title.
(2) “Pharmacy Universal Claim Form” means a form that:
(A) Is in the format of the “Pharmacy Universal Claim Form” incorporated by reference in section 4807 of this title; and
(B) Contains the information specified by section 4801 of this title.
(3) “Report” means a compilation of data concerning a patient, a dispenser, a practitioner, or a controlled substance.
§ 4803. DATA REPORTING
(a) A dispenser shall report all controlled substances dispensed after September 1, 2005.
(b) A dispenser of a Schedule II, III, or IV controlled substance shall transmit or provide the following data to the department of health or the department of health’s agent:
(1) The patient identifier;
(2) The national drug code of the drug dispensed;
(3) The metric quantity of the drug dispensed;
(4) The date of dispensing;
(5) The estimated days’ supply dispensed;
(6) The Drug Enforcement Administration registration number of the prescriber;
(7) The serial number assigned by the dispenser; and
(8) The Drug Enforcement Administration registration number of the dispenser.
(c)(1) The data shall be transmitted within 16 days of the date of dispensing unless the department of health grants an extension.
(2) An extension may be granted if a dispenser suffers a mechanical or electronic failure or cannot meet the deadline established by subdivision (1) of this subsection for other reasons beyond his or her control. A dispenser shall apply, in writing, for an extension. An application for an extension shall state the reason why an extension is required and the period of time for which the extension is required.
(3) An extension shall be granted to all dispensers if the department of health or its agent is unable to receive electronic reports.
(d) Except as provided in subsection (g) of this section, the data shall be transmitted by:
(1) An electronic device compatible with the receiving device of the department of health or its agent;
(2) A double-sided, high-density micro floppy disk; or
(3) A one-half inch nine-track 1600 or 6250 BPI magnetic tape.
(e) The data shall be transmitted in the format established by the “ASAP Telecommunications Format for Controlled Substances.”
(f) The department of health shall provide a toll-free telephone number for transmitting electronic reports by modem.
(g)(1) A dispenser who does not have an automated recordkeeping system capable of producing an electronic report in the format established by “ASAP Telecommunications Format for Controlled Substances” may request a waiver from electronic reporting. The request shall be made in writing to the department of health.
(2) A dispenser shall be granted a waiver if he or she agrees in writing to report the data by submitting a completed “Pharmacy Universal Claim Form.”
§ 4804. COMPLIANCE
(a) A dispenser shall be deemed to be the person who is registered with the U.S. Drug Enforcement Administration.
(b) A dispenser may presume that the patient identification information provided by the patient or the patient’s agent is correct.
§ 4805. REQUEST FOR REPORT
(a) A written request shall be filed with the department of health prior to the release of a report.
(b) A request for a report shall be made on a request form, except for a subpoena issued by a grand jury.
§ 4806. ALTERNATIVE PATIENT IDENTIFICATION NUMBER
(a) If a patient does not have a Social Security number or refuses to provide a Social Security number, the patient’s driver’s license number shall be used.
(b) If a patient does not have a Social Security number or a driver’s license number, the patient shall use a number designated by the Vermont department of health.
§ 4807. RULEMAKING
The department may adopt rules as necessary for the implementation of this chapter.
The Vermont General Assembly
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