Northeastern University (Word 1MB)

							April 5, 2010


John Auerbach
Commissioner, Massachusetts Department of Public Health
250 Washington Street
Boston, MA 02108

Dear Mr. Auerbach:

I would like to thank the Department of Public Health, the Board of Registration in
Medicine and the Board of Registration in Pharmacy for their work on the new
regulations for Collaborative Drug Therapy Management 247 CMR 16.00, 243 CMR
2.12, and 105 CMR 700.000.

Northeastern University School of Pharmacy currently employs 19 clinical faculty with
practice sites in a variety of settings including hospitals and community health centers.
Our faculty look forward to the expanded opportunities to work with physicians in
accordance with the new regulations and to enhancing the education of the next
generation of pharmacists who will be providing these services.

In response to the request for comments on these regulations I would like to offer the
following;

   1.    In 243 CMR 212 (4)(d) “on-site supervision by the attending physician” may be
        interpreted as requiring that the attending physician be present for services to be
        provided by an authorized pharmacist. I recommend that “attending physician”
        be changed to “attending physicians affiliated with the ambulatory clinic”. This
        would allow for assistance from a physician without compromising the delivery
        of the service.

   2. In 247 CMR 16.04 (1)(g) “detailed informed consent procedures” are a required
      component of the collaborative practice agreement for all practice settings. I am
      not aware of any service that our clinical faculty currently provides that requires
      a separate informed consent. The current procedures for obtaining informed
      consent in these settings (all settings other than community pharmacy) should be
      sufficient and be viewed as implied informed consent for services performed by a
      collaborative practice agreement.
I am aware that many of the institutions where our faculty practice are interested in
engaging in collaborative drug therapy management activities. The site administrators
share concerns with the informed consent requirement described above. It is my
understanding that they too will be sending in written testimony regarding this issue.

I am also aware of the issues that the pharmacy associations in Massachusetts will be
identifying in their testimonies. Rather than duplicating them here I would like to state
that their requests are reasonable and I hope they also will be incorporated into the
revisions of the regulations.

Thank you for the opportunity to comment on these new regulations. If further
discussion of these concerns and suggestions would be helpful, please do not hesitate to
contact me.

Sincerely,




John Reynolds
Dean and Professor