Formation and mission
The Drug Formulary Commission (“Commission”) is established by Massachusetts General Law Chapter 17, Section 13 and by regulation at 105 CMR 720.050. The Commission has been in existence for a number of years and its members are appointed by the Governor. Historically, the Commission’s main focus has been to develop a list of those drug products on the Massachusetts List of Interchangeable Drugs that are safely interchangeable (i.e., equivalent to each other in all significant respects).
In 2014, Chapter 258 of the Acts of 2014 was passed. This new law mandated the Commission to expand its responsibilities and tasked it with preparing a drug formulary of substitutions for Schedule II or III opiates that the Commission has determined have a heightened level of public health risk due to the drugs’ potential for abuse and misuse. Opioid abuse is a public health epidemic and this significant undertaking by the Commission will serve as an important tool aimed at preventing and treating addiction.
Summary of Definitions and Standards
The Drug Formulary Commission as authorized by M.G.L. c. 17, s. 13 and by regulation at 105 CMR 720.050 recommends whether drug products shall be placed on the Massachusetts Additional List of Interchangeable Drugs. According to statute and regulation, pharmaceutically equivalent drug products must meet one of two criteria in order to be considered by the Commission for addition to the list:
- Bioequivalence may be essential and has been established; or
- Bioequivalence is not essential.
Bioequivalence of drug products is defined at 105 CMR 720.021 as "drug products whose rate and extent of absorption do not show a significant difference when administered at the same molar dose of therapeutic moiety under similar conditions". Bioequivalence is considered essential when "bioinequivalence would have therapeutic significance i.e. use of different brands of the same drug product or different batches of the same drug would result in therapeutic failure or a hazard to the patient. This is most critical in drug products with a narrow therapeutic-toxicity range (i.e. the therapeutic and toxic concentrations of the drugs are similar) which requires careful patient titration and monitoring for safe and effective use".
Therapeutic equivalence of drug products is defined at 105 CMR 720.030 as drug products which
- Are pharmaceutically equivalent (same active ingredients, identical in strength, concentration, dosage form and route of administration);
- Meet applicable standards for strength, quality, purity and identity; and
- Are bioequivalent because (a) they present no known or potential bioequivalence problem and meet an acceptable in vitro standard; or (b) if they do present a known or potential bioequivalence problem, they are shown to meet an appropriate bioequivalence standard matching both rate and extent of absorption, are adequately labeled and are manufactured in compliance with current Good Manufacturing Practice regulations.
Factors for Consideration
To determine whether drug products are bioequivalent or therapeutically equivalent and should be interchangeable, the Commission should consider the following factors:
- Pertinent data
- USP and supplements
- Pertinent FDA listings
- Other state formularies
- Formularies of Massachusetts hospitals
- Data submitted by manufacturers
- Chemical and laboratory testing data
- Clinical evidence
Regulations at 105 CMR 720.060 specifically exclude the following categories of drugs from consideration by the DFC:
- Bioequivalence is essential but not established
- Subject of patent rights
- Single source