Commissioner Monica Bharel
Re: Revised Drug Formulary Commission Regulation
December 22, 2016
Page 1
December 22, 2016
Dr. Monica Bharel
Commissioner, Department of Public Health
250 Washington Street, 2nd Floor
Boston, MA 02108
Dear Commissioner Bharel:
Thank you for the opportunity to comment on your Department’s proposed revision of 105 CMR 720: Drug Formulary Commission. When the Drug Formulary Commission began its work to implement Chapter 258 of the Acts of 2014, I thanked them for taking on this important work and encouraged them to be bold in demanding higher safety standards for opioid drugs. I renew my thanks to them and to you for this effort.
However, I will also emphasize that the intent of this law was to remove or restrict from use certain pills whose manufacturers ignore the severity of the opioid crisis – those who choose to produce pills without abuse deterrent properties. These draft regulations accomplish this, but I worry that they also go further, giving an imprimatur of safety to certain products unnecessarily. The intent of the legislation was to find some formulations which may be less dangerous than others, but not, by any means, to say that that any of these products are in fact completely safe.
The key mechanism by which the Commission can promote safety is through a reduction in the use of high-risk products. Identifying 2 products that can be substituted for 6 higher risk products is valuable to this goal. But these regulations also list 5 products that meet ADP efficacy criteria but that do not serve as substitutes for any HPHR product. By listing these, I worry we will create an undue sense of safety around certain opioids, without the benefit of having eliminated any more dangerous products.
We should not give such an impression of safety, and so I encourage you to revise these regulations to include only those ADF products that actually serve as substitutes for an HPHR product. Doing otherwise, I fear, may create an inappropriate endorsement and sense of safety around drugs that still present significant risks.
To support this I refer back to the language of the statute, which calls on the Commission not to identify and promote all ADF products, but more specifically to “prepare a drug formulary of chemically equivalent substitutions for drugs that… have a heightened level of public health risk” and to “include formulations of drugs that the commission has determined may be appropriately substituted” for an HPHR product.
Alternately, if the listing of these products seems, in the opinion of the Council and the Department, to be a necessary component of the regulations, I would suggest that the regulation also include clear, concise language alerting practitioners that a product’s listing in these regulations does not constitute an endorsement or suggestion about a product’s safety, only about its relative potential for harm as compared to other opioid products.
Thank you for your consideration of these comments and for your continued work in this area. Please let me know if you have any questions regarding this letter, or if I can be of any assistance to your Department.
Sincerely,
Senator John F. Keenan
Norfolk and Plymouth