Mass. Gen. Laws ch. 112, sec. 12D — MA Code / Part I / Title XVI / Chapter 112 / Section 12D
Prescriptions of interchangeable drug products; notification of substitute for narrow therapeutic index immunosuppressant drug for treatment of organ or tissue transplant
Status: in_force

Section 12D. As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:— ''Department'', the department of public health. ''Interchangeable abuse deterrent drug product'', a drug with abuse deterrent properties identified by the drug formulary commission as an appropriate substitute for a drug that the commission has determined poses a heightened level of risk to the public due to the drug's potential for abuse and misuse pursuant to subsection (b) of section 13 of chapter 17. ''Interchangeable drug product'', a product containing a drug in the same amounts of the same active ingredients in the same dosage form as other products with the same generic or chemical name. ''Practitioner'', a physician, dentist, veterinarian, podiatrist, scientific investigator or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth. Every prescription issued in the commonwealth by a practitioner shall meet the standards for format established by the department. Only by signing the prescription in accordance with the standards shall the practitioner validate the prescription. The standards shall permit the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating ''no substitution''. The standards shall require that the indication of ''no substitution'' shall not be the default indication and further that the prescription indicate the ''Interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law''. Where the practitioner has so indicated ''no substitution'', the pharmacist shall dispense the exact drug product as indicated by the practitioner. Except in cases where the practitioner has indicated ''no substitution'', the pharmacist shall dispense: an interchangeable abuse deterrent product if one exists; or, if none exists, a less expensive, reasonably available, interchangeable drug product as allowed by the most current formulary or supplement thereof. The pharmacist shall also indicate on the label in the following manner the fact of the interchange: ''Interchange (name of exact drug product dispensed)'' In cases where the practitioner has instructed that no substitution be made, the pharmacist shall dispense the exact drug product as written by such practitioner. In the event of noncompliance by a pharmacist or a practitioner, the drug purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance. Said director shall refer the matter to the board of registration in pharmacy and, where appropriate, to the board of registration in medicine, for appropriate action. The provisions of this section shall not apply to prescriptions dispensed in a hospital licensed under section fifty-one of chapter one hundred and eleven; provided, however, that all outpatient prescriptions dispensed in a hospital shall be on prescription forms as required by this section; and provided further that no retail pharmacy, however organized, shall be exempted from the provisions of this section. If a patient covered by MassHealth pursuant to chapter 118E is prescribed a narrow therapeutic index immunosuppressant drug for the treatment of an organ or tissue transplant, the pharmacist shall notify the prescribing physician if a substitution to a narrow therapeutic index immunosuppressant drug for the treatment of an organ or tissue transplant is made. For the purposes of this paragraph, ''narrow therapeutic index immunosuppressant drug'' shall mean an immunosuppressant drug for the treatment of an organ or tissue transplant that has a narrow range in blood concentrations between efficacy and toxicity and requires therapeutic drug concentration or pharmacodynamic monitoring.

Section 12D. As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:—

''Department'', the department of public health.

''Interchangeable abuse deterrent drug product'', a drug with abuse deterrent properties identified by the drug formulary commission as an appropriate substitute for a drug that the commission has determined poses a heightened level of risk to the public due to the drug's potential for abuse and misuse pursuant to subsection (b) of section 13 of chapter 17.

''Interchangeable drug product'', a product containing a drug in the same amounts of the same active ingredients in the same dosage form as other products with the same generic or chemical name.

''Practitioner'', a physician, dentist, veterinarian, podiatrist, scientific investigator or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth.

Every prescription issued in the commonwealth by a practitioner shall meet the standards for format established by the department. Only by signing the prescription in accordance with the standards shall the practitioner validate the prescription.

The standards shall permit the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating ''no substitution''. The standards shall require that the indication of ''no substitution'' shall not be the default indication and further that the prescription indicate the ''Interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law''. Where the practitioner has so indicated ''no substitution'', the pharmacist shall dispense the exact drug product as indicated by the practitioner.

Except in cases where the practitioner has indicated ''no substitution'', the pharmacist shall dispense: an interchangeable abuse deterrent product if one exists; or, if none exists, a less expensive, reasonably available, interchangeable drug product as allowed by the most current formulary or supplement thereof. The pharmacist shall also indicate on the label in the following manner the fact of the interchange:

''Interchange (name of exact drug product dispensed)''

In cases where the practitioner has instructed that no substitution be made, the pharmacist shall dispense the exact drug product as written by such practitioner.

In the event of noncompliance by a pharmacist or a practitioner, the drug purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance. Said director shall refer the matter to the board of registration in pharmacy and, where appropriate, to the board of registration in medicine, for appropriate action.

The provisions of this section shall not apply to prescriptions dispensed in a hospital licensed under section fifty-one of chapter one hundred and eleven; provided, however, that all outpatient prescriptions dispensed in a hospital shall be on prescription forms as required by this section; and provided further that no retail pharmacy, however organized, shall be exempted from the provisions of this section.

If a patient covered by MassHealth pursuant to chapter 118E is prescribed a narrow therapeutic index immunosuppressant drug for the treatment of an organ or tissue transplant, the pharmacist shall notify the prescribing physician if a substitution to a narrow therapeutic index immunosuppressant drug for the treatment of an organ or tissue transplant is made. For the purposes of this paragraph, ''narrow therapeutic index immunosuppressant drug'' shall mean an immunosuppressant drug for the treatment of an organ or tissue transplant that has a narrow range in blood concentrations between efficacy and toxicity and requires therapeutic drug concentration or pharmacodynamic monitoring.