MASSACHUSETTS - DRUGS

January 1, 2008

Massachusetts state laws and regulations that affect your medical practice

1. What findings are used to place controlled drugs into a particular schedule?

(1) Schedule I (listed in 21 CFR 1308.11):

(b) The drug or other substance has no currently accepted medical use in treatment in the United States.

( c ) There is a lack of accepted safety for use of the drug or other substance under medical supervision..

(2) Schedule II (listed in 21 CFR 1308.12):

(a) The drug or other substance has a high potential for abuse.

(b) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

( c ) Abuse of the drug or other substances may lead to severe psychological or physical dependence.

(3) Schedule III (listed in 21 CFR 1308.13):

(a) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.

(b) The drug or other substance has a currently accepted medical use in treatment in the United States.

( c ) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

(4) Schedule IV (listed in 21 CFR 1308.14):

(a) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.

(b) The drug or other substance has a currently accepted medical use in treatment in the United States.

( c ) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

(5) Schedule V (listed in 21 CFR 1308.15):

(a) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

(b) The drug or other substance has a currently accepted medical use in treatment in the United States.

( c ) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

(6) Schedule VI:

(a) The substance is a prescription drug; and

(b) Said prescription drug has not been included in Schedules I through V.

M.G.L.A. Chapter 94C (Controlled Substances Act)

2. What are the requirements for electronic prescriptions?

(1) A prescription may be transmitted electronically provided that:

(a) If said prescription is for a controlled substance in Schedules II through V, it is validated and authenticated pursuant to applicable regulations;

(b) If said prescription is for a controlled substance in Schedule VI it is validated in accordance with applicable regulations or by utilizing a system that includes:

(i) A combination of technical security measures, such as, but not necessarily limited to, those listed in Security Standards for the Protection of Electronic Protected Health Information (HIPAA), 45 CFR Part 164, Subpart C, s 164-312, to ensure a reasonable and appropriate level of:

1. Practitioner and dispenser authentication;

2. Technical non-repudiation;

3. Content integrity; and

4. Confidentiality.

(ii) An electronic signature that is:

1. Unique to an identified practitioner;

2. Originated solely by and under the ultimate control of the practitioner; and

3. Capable of verification.

(iii) Reasonable and appropriate security measures to invalidate a prescription if either the electronic signature or the prescription record to which it is attached or logically associated is altered or compromised; and

( c ) Said prescription meets any other generally applicable requirements of the federal Health Insurance Portability and Accountability Act (HIPAA) and related regulations.

(2) An electronic signature that meets these requirements shall have the full force and effect of a handwritten signature on a paper-based written prescription.

(3) A paper-based written prescription must be written and signed by the practitioner as set forth in the next paragraph.

105 MA ADC 721.030

3. What is the appropriate format for paper-based written prescriptions?

(1) Every prescription written in the Commonwealth of Massachusetts must be in a prescription format that conforms to the following requirements:

(a) A prescription must permit the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating "no substitution," provided that:

1. The indication of "no substitution" is not the default indication;

2. The prescription indicates that "interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law;" and

3. The indication of "no substitution" is a unique element in the prescription and shall not be satisfied by use of any other element, including the signature;

(b) If the prescription is paper-based, including but not limited to a prescription that is transmitted via facsimile or similar technology, or reduced to writing by a pharmacist, the prescription must be on a form that contains a signature line for the practitioner's signature on the lower portion of the form. Hospital and clinic prescription forms shall contain a line directly below the signature line for the practitioner to print or type his/her name. Below the signature line, or in the case of hospital and clinic prescription forms, below the line provided for the practitioner to print or type his/her name, there shall be a space in which the practitioner may indicate "no substitution." Below this space shall be printed the words "interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law;"

( c ) If the prescription is transmitted electronically, the practitioner shall generate and transmit the prescription in a format that can be read and stored by a pharmacy in a retrievable and readable form;

(d) The name and address of the practitioner shall be clearly indicated on the prescription. A hospital or clinic prescription shall have the name and address of the hospital or clinic clearly indicated on the prescription;

(e) The prescription shall contain the following information:

1. The registration number of the practitioner;

2. Date of issuance of the prescription;

3. Name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity of dosage units;

4. Name and address of the patient, except in a veterinary prescription;

5. Directions for use, including any cautionary statements required; and

6. A statement indicating the number of times to be refilled.

(2) Prescriptions for certified nurse midwifes, nurse practitioners, psychiatric nurses and physician assistants shall also contain the name of the supervising physician.

105 MA ADC 721.020

4. What are the procedures for prescribing more than one drug product?

Practitioners who wish to prescribe more than one drug product, with the same or different dispensing instructions, shall place each prescription on a separate prescription form or record. More than one drug product may be prescribed in the hospital setting on a single form or record provided, however, that the prescription provides clear directions for use and interchange of each drug product.

105 MA ADC 721.050

5. May physician assistants issue prescriptions?

(1) Any physician assistant who holds a full certificate of registration may issue written or oral prescriptions or medication orders for a patient, provided that he or she does so in accordance with all applicable state and federal regulations.

(2) A physician assistant who holds a temporary certificate of registration may prepare a written or oral prescription or medication order for a patient provided that:

(a) Any such written prescription or medication order is signed by his or her supervising physician, or by another licensed physician who has been designated to assume temporary supervisory responsibilities with respect to that physician assistant prior to the issuance of said prescription or medication order to the patient;

(b) Any such oral prescription or medication order is approved, in writing, by his or her supervising physician, or by another licensed physician who has been designated to assume temporary supervisory responsibilities with respect to that physician assistant prior to the issuance of that oral prescription or medication order; and

( c ) All such oral or written prescriptions or medication orders are issued in the name of the supervising physician, and are otherwise issued in accordance with all applicable state and federal laws and regulations.

(3) Any prescription or medication order issued by a physician assistant for a Schedule II controlled substance shall be reviewed by his or her supervising physician, or by a temporary supervising physician within 96 hours after its issuance.

(4) All physician assistants shall issue prescriptions or medication orders in accordance with written guidelines governing the prescription of medication which are mutually developed and agreed upon by the physician assistant and his or her supervising physicians.

(a) Such guidelines shall address, but need not be limited to, the following issues:

1. Identification of the supervising physicians for that work setting;

2. Frequency of medication reviews by the physician assistant and his or her supervising physician;

3. Types and classes of medications to be prescribed by the physician assistant;

4. The initiation and/or renewal of prescriptions for medications which are not within the ordinary scope of practice for the specific work setting in question, but which may be needed to provide appropriate medical care;

5. The quantity of any medication to be prescribed by a physician assistant, including initial dosage limits and refills;

6. The types and quantities of Schedule VI medications which may be ordered by the physician assistant from a drug wholesaler, manufacturer, laboratory or distributor for use in the practice setting in question;

7. Review of initial prescriptions or changes in medication; and

8. Procedures for initiating intravenous solutions.

(5) All prescriptions or medication orders issued by a physician assistant shall be issued in a manner which is consistent with the scope of practice of the physician assistant and accepted standards of good medical practice for licensed physicians with respect to prescription practices.

(6) At least four hours of the continuing medical education which a physician assistant is required to obtain as a condition for license renewal shall be in the field of pharmacology and/or pharmacokinetics.

(7) All prescriptions written by a physician assistant shall be written in accordance with Massachusetts regulations.

(8) A physician assistant may order only Schedule VI controlled substances from a drug wholesaler, manufacturer, distributor or laboratory and only in accordance with the written guidelines developed with the supervising physician, pursuant to 263 MA ADC 5.07(4). A physician assistant may sign only for sample Schedule VI controlled substances received by or sent to the practice setting by a pharmaceutical representative.

(9) The use of pre-signed prescription blanks or forms is prohibited.

(10) A physician assistant shall not prescribe controlled substances in Schedules II, III and IV for his or her own use. Except in an emergency, a physician assistant shall not prescribe Schedule II controlled substances for a member of his or her immediate family, including a parent, spouse or equivalent, child, sibling, parent-in-law, son/daughter-in-law, brother/sister-in-law, step-parent, step-child, step-sibling, or other relative permanently residing in the same residence as the physician assistant.

(11) The physician assistant and the supervising physician for that work setting shall be jointly responsible for all prescriptions or medication orders issued by the physician assistant in that work setting.

263 MA ADC 5.07

6. Does Massachusetts permit the prescription of interchangeable drug products?

Yes. Massachusetts has established a list of interchangeable drug products for use by physicians, other practitioners and pharmacists so that consumers of prescription drug products may realize cost savings by buying less expensive, safe drug products.

All prescriptions written by generic name can be interchanged if the drug is multi-source. To determine if a prescription written for a brand name drug product is interchangeable in Massachusetts:

(1) Look up the drug product by the brand name in the index of by generic name in the "Approved Drug Products with Therapeutic Equivalence Evaluations" ("Orange Book"). The drug products are arranged alphabetically.

(2) Compare the dosage form and strength of the drug product prescribed with the dosage form and strength of the same drug product in the "Orange Book."

(3) If the same drug product, dosage form and strength has been assigned an "A" rating by FDA and is not listed on the Exception List in 105 CMR 720.050, the drug product is interchangeable.

(4) If the drug product is not listed in the "Orange Book," refer to 105 CMR 720.050(b), the Massachusetts Additional List of Interchangeable Drugs.

(5) Copies of the "Approved Drug Products with Therapeutic Equivalence Evaluations" and its supplements ("Orange Book") are available from the:

U.S. Food and Drug Administration

Department of Health and Human Services

Government Printing Office

Washington, D.D. 20402-9371

and http://www.fda.gov/cder/drug/

Copies of the Massachusetts Additional List of Interchangeable Drug Products are available from:

The State House Bookstore

Room 116

Boston, MA 02133

and http://www.magnet.state.ma.us/dph/dcp/Drug Formulary/Drug Interchange/

105 MA ADC 720.200

(6) The Massachusetts List of Interchangeable Drug Products consists of:

(a) Drug products which are considered by the FDA to be therapeutically equivalent to other pharmaceutically equivalent products listed with the same generic or chemical name according to the most recent edition of "Approved Drug Products with Therapeutic Equivalence Evaluations" and its supplements as published by the U.S. Department of Health and Human Services.

(b) Drug products specified on a list established by the Department for which the Commission has determined that the bioequivalence is not essential, or if the Commission has determined that the bioequivalence may be essential, bioequivalence has been established. The list may include the following categories of drug products:

(i) Drug products which hold New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) approved by the FDA, which FDA does not consider to be therapeutically equivalent to other pharmaceutically equivalent products listed with the same generic or chemical name;

(ii) Drug products exempt from the Food, Drug and Cosmetic Act of 1962, and included in the Drug Efficacy Study Implementation (DESI) done by the National Academy of Sciences/National Research Council;

(iii) Frequently prescribed drug products which were manufactured prior to 1938 and meet the FDA Good Manufacturing Practices Requirements; and

(iv) Frequently prescribed over the counter drug products which contain the same amounts of active ingredients, in the same dosage forms, as other drug products with the same general or chemical name.

105 MA ADC 720.050

(7) The following categories of drug products are excluded from the list of interchangeable drug products:

(a) Drug products for which the Commonwealth has determined that bioequivalence may be essential, but for which bioequivalence has not been established;

(b) Drug products which are the subject matter of patent rights issued by the U.S. Patent Office, for which provision by other than the patent holder would violate the patent; and

( c ) Drug products available from only one manufacturer at one price.

105 MA ADC 720.060

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.