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  • PART I ADMINISTRATION OF THE GOVERNMENT
  • TITLE II EXECUTIVE AND ADMINISTRATIVE OFFICERS
    OF THE COMMONWEALTH
  • CHAPTER 17 DEPARTMENT OF PUBLIC HEALTH
  • Section 13 Drug formulary commission

[ First paragraph effective until August 6, 2014. For text effective August 6, 2014, see below.]

  Section 13. There shall be in the department a drug formulary commission consisting of nine members appointed by the governor. The membership shall include a clinical pharmacist, a pharmaceutical chemist, a clinical pharmacologist, a retail pharmacist, a person with experience in pharmaceutical manufacturing, two practicing physicians and two persons not involved in the delivery of health services who shall be representatives of the public. One of the two public appointees by reason of age, training, experience and affiliation shall represent the interests of the elderly. None of the members may be employed by any pharmaceutical manufacturing company.

[ First paragraph as amended by 2014, 258, Sec. 2 effective August 6, 2014. For text effective until August 6, 2014, see above.]

  (a) There shall be in the department a drug formulary commission consisting of 16 members. The commission shall include: the commissioner of public health or a designee, who shall serve as the chair of the commission; the director of Medicaid or a designee; the commissioner of insurance or a designee; and 10 members appointed by the governor, which shall include: a clinical pharmacist; a pharmaceutical chemist; a clinical pharmacologist; a retail pharmacist; a person with experience in insurance pharmacy benefit design; 2 persons with experience in pharmaceutical manufacturing, 1 of whom shall have experience with biologics; 4 practicing physicians, 1 of whom shall specialize in addiction medicine and 1 of whom shall specialize in the treatment of chronic pain; and 2 persons who are not involved in the delivery of health services who shall be representatives of the public. One of the 2 public appointees by reason of age, training, experience and affiliation shall represent the interests of the elderly. None of the members may be employed by a pharmaceutical manufacturing company or private insurer. Members shall serve for a term of 3 years, but a person appointed to fill a vacancy shall serve only for the unexpired term.

[ Second paragraph effective until August 6, 2014. Deleted by 2014, 258, Sec. 2.

  Members shall serve for a term of three years. Of the first appointments under this section, three shall be appointed for a term of three years; three shall be appointed for a term of two years; and three shall be appointed for a term of one year. As the term of a member expires, his successor shall be appointed to serve for a term of three years.

[ Third paragraph effective until August 6, 2014. For text effective August 6, 2014, see below.]

  The commission shall prepare a drug formulary of interchangeable drug products which shall be adopted by regulations of the department. Said formulary shall be based on assessment and evaluation of the United States Pharmacopeia and its supplements, additional pertinent listings of the Department of Health, Education, and Welfare, Food and Drug Administration, other state formularies, formularies of various hospitals of the commonwealth, as well as data submitted by manufacturers. The commission shall assess and evaluate chemical and laboratory testing data, clinical proof of bioequivalence, and therapeutic equivalence where available. The commission shall also adopt for inclusion in said formulary the list of drugs determined by the regulation of the Food and Drug Administration to be therapeutically equivalent and interchangeable when said list becomes available.

[ Third paragraph as amended by 2014, 258, Sec. 3 effective August 6, 2014. For text effective until August 6, 2014, see above.]

  (b) The commission shall prepare a drug formulary of interchangeable drug products which shall be adopted by regulations of the department. Said formulary shall be based on assessment and evaluation of the United States Pharmacopeia and its supplements, additional pertinent listings of the Department of Health, Education, and Welfare, Food and Drug Administration, other state formularies, formularies of various hospitals of the commonwealth, as well as data submitted by manufacturers. The commission shall assess and evaluate chemical and laboratory testing data, clinical proof of bioequivalence, and therapeutic equivalence where available. The commission shall also adopt for inclusion in said formulary the list of drugs determined by the regulation of the Food and Drug Administration to be therapeutically equivalent and interchangeable when said list becomes available.

[ Two paragraphs inserted following third paragraph by 2014, 258, Sec. 4 effective August 6, 2014.]

  The commission shall also prepare a drug formulary of chemically equivalent substitutions for drugs that are opiates, as defined in section 1 of chapter 94C, and contained in schedule II or III of section 3 of said chapter 94C that the commission has determined have a heightened level of public health risk due to the drugs' potential for abuse and misuse. The department shall adopt this drug formulary, as prepared by the commission, by regulation. The formulary shall include formulations of drugs that the commission has determined may be appropriately substituted and that incorporate any of the following abuse deterrent properties:

  (1) a physical or chemical barrier that (i) prevents chewing, crushing, cutting, grating, grinding, melting or other physical manipulations that enable abuse or (ii) resists extraction of the opioid by common solvents such as water, alcohol or other organic solvents;

  (2) an agonist or antagonist combination that interferes with, reduces or defeats the euphoria associated with abuse;

  (3) an aversion quality that produces an unpleasant effect if the dosage form is manipulated or altered or a higher dose than directed is used;

  (4) a delivery system that, under United States Food and Drug Administration guidance, offers resistance to abuse;

  (5) a prodrug technique that limits opioid activity until transformed in the gastrointestinal tract; or

  (6) any other technique, as may be identified or recommended by the United States Food and Drug Administration, that offers significant abuse deterrence.

  In preparing the formulary, the commission shall consider information contained in drug applications approved by the United States Food and Drug Administration and other regulatory and guidance documents distributed by the United States Food and Drug Administration. A determination of substitution between 2 drug products shall not require that both products incorporate the same methods of abuse deterrence. Inclusion of a drug on the formulary shall not be the basis for a labeling or marketing claim of abuse deterrence potential, unless the United States Food and Drug Administration authorizes such a claim. In considering whether a drug is a chemically equivalent substitution the commission shall consider: the accessibility of the drug and its proposed substitute; whether the drug's substitute is cost prohibitive; the effectiveness of the substitution; and whether, based upon the current patterns of abuse and misuse, the drug's substitute incorporates abuse deterrent technology that will be an effective deterrent to such abuse and misuse. In conducting its analysis, the commission may request an insurance benefit review by the center for health information and analysis.

[ Fourth through sixth paragraphs effective until August 6, 2014. For text effective August 6, 2014, see below.]

  Said formulary shall not include drugs which are the subject matter of patent rights issued by the United States Patent Office nor shall it include those drug products for which bioequivalence is considered essential, but for which bioequivalence has not been established by the Food and Drug Administration.

  The commission shall provide for distribution copies of such formulary and revisions thereto amongst physicians and pharmacists licensed to practice within the commonwealth and to other appropriate individuals and shall supply a copy to any person on request upon payment of the cost of printing.

  Said formulary shall be revised from time to time but in no event less frequently than once a year so as to include new pertinent information on drugs approved for inclusion or drugs to be deleted and to reflect current information as to the therapeutic efficacy of drugs and pharmaceuticals.

[ Fourth through sixth paragraphs as amended by 2014, 258, Sec. 5 effective August 6, 2014. For text effective until August 6, 2014, see above.]

  Said formularies shall not include drugs which are the subject matter of patent rights issued by the United States Patent Office nor shall it include those drug products for which bioequivalence is considered essential, but for which bioequivalence has not been established by the Food and Drug Administration.

  The commission shall provide for distribution copies of such formularies and revisions thereto amongst physicians and pharmacists licensed to practice within the commonwealth and to other appropriate individuals and shall supply a copy to any person on request upon payment of the cost of printing.

  Said formularies shall be revised from time to time but in no event less frequently than once a year so as to include new pertinent information on drugs approved for inclusion or drugs to be deleted and to reflect current information as to the therapeutic efficacy of drugs and pharmaceuticals.

[ Seventh paragraph effective until August 6, 2014. For text effective August 6, 2014, see below.]

  The department, in cooperation with the commission, shall promulgate rules and regulations to insure public education regarding the provisions of this section.

[ Seventh paragraph as amended by 2014, 258, Sec. 6 effective August 6, 2014. For text effective until August 6, 2014, see above.]

  (c) The department, in cooperation with the commission, shall promulgate rules and regulations to insure public education regarding the provisions of this section.

  Any person or party in interest aggrieved by a finding or report of the commission shall be entitled to a judicial review thereof as provided in section fourteen of chapter thirty A.

[ Subsection (d) added following the eighth paragraph by 2014, 258, Sec. 7 effective August 6, 2014.]

  (d) For purposes of this subsection, the term "extended release long-acting opioids'' shall mean a drug that is subject to the United States Food and Drug Administration's risk evaluation and mitigation strategy for extended release and long-acting opioid analgesics and the term "non-abuse deterrent opioid'' shall mean an opioid drug product that is approved for medical use but does not meet the requirements for listing as a chemically equivalent substitute pursuant to this section. The commission shall also identify drugs that are extended release long-acting opioids and non-abuse deterrent opioids, contained in schedule II or III of section 3 of chapter 94C, that the commission has determined have a heightened level of public health risk due to the drugs' potential for abuse and misuse for which no adequate chemically equivalent substitute is available and shall notify the commissioner of public health that such drugs pose a threat to the public's health.

Any person or party in interest aggrieved by a finding or report of the commission shall be entitled to a judicial review thereof as provided in section fourteen of chapter thirty A.