M.G.L. c. 94C, §§ 7 and 9 and M.G.L. c. 112,
§§ 24B1/2 and 24B3/4 authorize pharmacists and physicians to engage
in collaborative drug therapy management (CDTM) in the Commonwealth pursuant to
collaborative practice agreements meeting the requirements of 247 CMR:
Board of Registration in Pharmacy and in Medicine. The Board
of Registration in Pharmacy has promulgated 247 CMR 16.00:
Collaborative Drug Therapy Management in accordance with
M.G.L. c. 112, §§ 24B1/2 and 24B3/4. 243 CMR 2.12 includes additional
definitions and requirements applicable to pharmacists and physicians entering
into collaborative practice agreements to practice CDTM in the
Commonwealth.
(1)
Definitions. Additional definitions applicable to the
practice of CDTM in the Commonwealth appear in 243 CMR
2.12 and in 247 CMR
2.00:
Definitions and 247 CMR
16.00:
Collaborative
Drug Therapy Management. As used in 243 CMR
2.12, all references to
"written" regarding collaborative practice agreement referrals, consents and
any other documents related to a collaborative practice agreement shall be:
(a) if paper based, written in ink, indelible
pencil or any other means; or
(b)
transmitted electronically in a format that maintains patient confidentiality
and can be read and stored in a retrievable and readable form. Collaborative
practice agreements and related referrals, consents and other documentation may
be transmitted electronically with the electronic signature(s) without
alteration of the information, provided the electronic transmission is in
accordance with the requirements of M.G.L. c. 94C, § 23(g); 105 CMR
721.00:
Standards for Prescription Format and Security in
Massachusetts;
247
CMR
9.01(19) and
9.07(1)(a).
As used in 243 CMR 2.12 and defined in M.G.L. c. 112, §
24B1/2(a), the following words shall have the following meanings:
Authorized Pharmacist means a
pharmacist who:
(a) is currently
registered by the Board of Registration in Pharmacy and is in good
standing;
(b) meets the
requirements of
247 CMR
16.02:
Pharmacist
Qualifications; and
(c) is
participating in drug therapy management with a supervising physician pursuant
to a written CDTM agreement with written protocols.
Board means the Board of
Registration in Medicine.
Collaborative Drug Therapy
Management or CDTM means the initiating,
monitoring, modifying and discontinuing of a patient's drug therapy by an
authorized pharmacist under the supervision of a physician in accordance with a
collaborative practice agreement. Collaborative drug therapy management may
include: collecting and reviewing patient histories; obtaining and checking
vital signs, including pulse, temperature, blood pressure and respiration; and,
under the supervision of, or in direct consultation with, a physician, ordering
and evaluating the results of laboratory tests directly related to drug therapy
when performed in accordance with approved protocols applicable to the practice
setting and when the evaluation does not include a diagnostic component.
Collaborative Practice Agreement or
CDTM Agreement means a written and signed agreement
between an authorized pharmacist with training and experience relevant to the
scope of the collaborative practice and a supervising physician that defines
the collaborative practice in which the authorized pharmacist and supervising
physician propose to practice. The collaborative practice must be within the
scope of the supervising physician's practice. In the community pharmacy
setting, the CDTM agreement shall include a written referral of an identified
patient from the supervising physician to an authorized pharmacist, and shall
include a written consent to the CDTM agreement by the named patient.
Community Pharmacy means a retail
drug business setting, licensed pursuant to M.G.L. c. 112, §§ 38 and
39. When there is a collaborative drug therapy management agreement between an
authorized pharmacist in a community pharmacy and a supervising physician, the
physician must obtain the informed consent of the patient in writing prior to
participating in CDTM.
License means a certificate of
registration which the board issues to a person pursuant to the requirements of
M.G.L. c. 112, §§ 2, 9 and 9B, and which authorizes the person to
engage in the practice of medicine.
Patient means, for the purposed of
243 CMR 2.12, a person who is referred to an authorized pharmacist by a
supervising physician for the purpose of receiving collaborative drug therapy
management services from the pharmacist. In the community pharmacy setting, the
patient must be notified of, and provide written consent to, the collaborative
drug therapy management services, and the supervising physician must provide
the patient with a copy of the referral to the authorized pharmacist and the
written consent to the referral provided by the patient.
Referral means the individual
patient referral by a supervising physician to an authorized pharmacist for the
purpose of receiving CDTM services in a community pharmacy setting. In all
other practice settings, Referral means the
consultation of a supervising physician and an authorized pharmacist about a
patient for the purpose of the patient's receiving CDTM services. In the
community pharmacy setting, the supervising physician shall execute a written
CDTM referral which shall include, but is not limited to, the patient's name
and address, the primary diagnosis for which CDTM services are authorized, the
diagnosis of any comorbid conditions for which CDTM services are authorized,
any known patient drug allergies, a statement that the patient has executed a
written consent to CDTM services, and any other specific instructions to the
authorized pharmacist.
Supervising Physician means a
physician who holds an active license to practice medicine in the Commonwealth
of Massachusetts. A supervising physician in a CDTM agreement may only delegate
to an authorized pharmacist pursuant to the written agreement and protocols
with the pharmacist.
(2)
Pharmacist Qualifications. In accordance with M.G.L.
c. 112, § 24B1/2(b), to qualify to enter into a collaborative practice
agreement, a pharmacist must:
(a) hold a
current unrestricted license in good standing to practice pharmacy in the
Commonwealth and currently be engaged in pharmacy practice in the
Commonwealth;
(b) agree to maintain
at least $1,000,000 (per occurrence) of professional liability insurance during
the term of the agreement which specifically covers drug therapy
management;
(c) have earned a
doctor of pharmacy degree or have completed five years of experience as a
licensed pharmacist;
(d) agree to
devote a portion of the practice to the defined drug therapy area that the
pharmacist shall co manage;
(e)
agree to complete, in each year of the term of the agreement, at least five
additional contact hours or 0.5 continuing education units (CEUs) of Board of
Registration in Pharmacy approved continuing education that address areas of
practice generally related to the particular collaborative practice agreement;
and
(f) if prescriptive practices
are included in the collaborative practice agreement, agree to maintain a
current controlled substance registration issued by the Department during the
term of the agreement, pursuant to M.G.L. c. 94C, §§ 7 and 9, and 105
CMR
700.000:
Implementation of M.G.L. c. 94C;
(g) Whenever an authorized pharmacist
participating in a CDTM agreement is disciplined by the Board of Registration
in Pharmacy, whether by consent agreement or by a final decision and order, or
otherwise subject to any practice restrictions, the authorized pharmacist must
provide written notification of such discipline or practice restriction to each
supervising physician.
(3)
Physician
Qualifications.
(a) To be
eligible to participate in a collaborative drug therapy management agreement, a
physician must possess an active license to practice medicine issued by the
Board, and must be actively engaged in the clinical practice of medicine and
the provision of patient care in the particular field of medicine in which the
collaborative drug therapy management is to take place.
(b) The physician is the supervisor in the
CDTM agreement and retains the ultimate responsibility for the care of the
patient. In a community pharmacy setting, a physician should enter into only as
many CDTM agreements setting as he or she can reasonably and safely supervise
at one time.
(c) The supervising
physician shall assess the patient and make a written referral of the
identified patient to the authorized pharmacist. The supervising physician's
written referral shall include a primary diagnosis and any co morbid conditions
that are included in the CDTM.
(d)
A physician is ineligible to participate in a CDTM if he or she is in a
Voluntary Agreement Not to Practice Medicine with the
Board, or has had his or her license to practice medicine temporarily suspended
or revoked by the Board. A physician shall be deemed ineligible to participate
in CDTM if he or she has voluntarily surrendered or has had suspended, revoked
or restricted his or her controlled substances license, permit or registration,
either state or federal. The Board may revoke a physician's right to
participate in a CDTM agreement for any of the grounds for discipline
enumerated in
243 CMR
1.03(5):
Grounds for
Complaint.
(e) Whenever
the Board enters into a Voluntary Agreement Not to Practice with a licensee, or
summarily suspends a physician's license, the Board may require that the
physician provide written notification to each authorized pharmacist with whom
the physician is in a CDTM agreement. Whenever the Board takes final
disciplinary action against a licensee, either by issuing a final decision and
order or by approving a consent agreement, the Board may require that the
physician provide written notification to each authorized pharmacist with whom
he or she is in a CDTM agreement.
(4)
Practice Setting
Requirements. In accordance with M.G.L. c. 112, § 24B1/2(c),
collaborative drug therapy management may be performed in the following
settings by pharmacists meeting the requirements of
247 CMR
16.02(1)
and authorized by a supervising physician
pursuant to a current collaborative practice agreement:
(a) Hospitals licensed pursuant to M.G.L. c.
111, § 51, subject to approval by the medical staff executive committee at
a licensed hospital or designee;
(b) Long term Care Facilities licensed
pursuant to M.G.L. c. 111, § 71, subject to approval by the long term care
facility medical director or designee;
(c) Inpatient or Outpatient Hospice Settings
licensed pursuant to M.G.L. c. 111, § 57D, subject to approval by the
hospice medical director or designee;
(d) Ambulatory Care Clinics licensed pursuant
to M.G.L. c. 111, § 51, with on-site supervision by the attending
physician and an authorized pharmacist, subject to approval by the ambulatory
care clinic medical staff executive committee or designee, or medical director
or designee;
(e) Community
Pharmacies (retail drug business settings) licensed by the Board of
Registration in Pharmacy pursuant to M.G.L. c. 112, § 39, subject to
restrictions listed below and pursuant to a current collaborative practice
agreement that includes the following requirements:
1.
Patient Age.
Patients must be 18 years of age or older;
2.
Vaccine
Administration. Pharmacists, as authorized pursuant to a
collaborative practice agreement, may administer vaccines;
3.
Patient Referral and
Consent. The collaborative practice agreement must provide that
the supervising physician will:
a. Provide a
written referral of the patient to the authorized pharmacist;
b. Specify the primary diagnosis for the
patient and any secondary diagnoses in a written referral or a subsequent
referral;
c. Provide a copy of the
written referral of the patient to the authorized pharmacist for CDTM services
to the patient; and
d. Obtain the
patient's written and informed consent to the collaboration and provide a copy
of the consent to the patient.
4. The patient's written consent form shall
include the following: "The pharmacist shall not replace the physician as the
principal medical decision maker."
5.
Record of Referral and
Consent. The authorized pharmacist and supervising physician must
maintain a written record of both the individual patient referral and the
patient's written informed consent to the collaboration in the patient's record
to be maintained by the authorized pharmacist and the supervising physician.
The supervising physician shall maintain the original patient consent to the
referral in the record in the custody of the supervising physician; transmit a
copy of the patient's consent to the authorized pharmacist within 24 hours; and
provide copies of the referral and consent to the patient in a timely
manner.
6.
Limited
Prescribing Authority. A pharmacist currently registered by the
Department, pursuant to M.G.L. c. 94C, §§ 7 and 9 and 105 CMR
700.00:
Implementation of M.G.L. c. 94C, to prescribe and possess
controlled substances, who practices in a community pharmacy pursuant to a
collaborative practice agreement that includes individually developed
prescriptive practice guidelines pursuant to which the supervising physician
has authorized the pharmacist to prescribe, may:
a. extend current drug therapy by 30 days for
not more than two 30 day periods or as may otherwise be specifically authorized
by the supervising physician in the referral of the patient and as provided in
the CDTM agreement;
b. initiate,
modify or discontinue dosages of medications prescribed by the supervising
physician for:
i. asthma;
ii. chronic obstructive pulmonary
disease;
iii. diabetes;
iv. hypertension;
v. hyperlipidemia;
vi. congestive heart failure;
vii. HIV or AIDS;
viii. osteoporosis; and
ix. comorbidities, listed in
243
CMR
2.12(4)(e)6.b.i. through
viii., and identified by the supervising physician along with the primary
diagnosis on the physician's referral of the patient.
c. The authorized pharmacist must provide a
copy of an initial prescription, a modification or a discontinuation of a
prescription to the supervising physician within 24 hours of its issuance,
unless more urgent notification is required under the circumstances and must
note the action taken in the patient's chart. A copy of all prescriptions must
be included in the patient's medical record in the custody of the supervising
physician.
7. No
authorized pharmacist in a community pharmacy may prescribe or be authorized to
prescribe Schedule II through V controlled substances, as defined in M.G.L. c.
94C, § 3(2) through (5).
8. An
authorized pharmacist in a community pharmacy may be authorized by a
supervising physician to issue prescriptions for Schedule VI controlled
substances, as defined in M.G.L. c. 94C, § 3(6), for the diagnoses
specified in the supervising physician's patient referral.
(5)
Collaborative Practice Agreements.
(a)
Required Agreement Terms for
All Practice Settings. In addition to specific practice setting
collaborative practice agreement requirements, pursuant to
247
CMR
16.03:
Practice Setting
Requirements, and in accordance with M.G.L. c. 112, §
24B¾, all collaborative practice agreements must also include:
1. the specific disease state(s) being co
managed, with each disease state identified as either primary or
comorbid;
2. the specific
pharmacist prescribing authority pursuant to the agreement;
3. detailed practice protocols;
4. the description of risk management
activities;
5. documentation of any
initiation, modification or discontinuation of a patient's medication in the
patient's medical record in the custody of the supervising physician;
6. the description of outcome
measurements;
7. detailed informed
consent procedures that are appropriate to the practice setting;
8. detailed procedures and periods by which
time any test results, copies of initial prescriptions, modifications or
discontinuances, copies of the patient consent and the CDTM agreement, and
other patient information will be forwarded from the authorized pharmacist to
the supervising physician, and a specific procedure for the pharmacist to
identify and transmit any urgent communications; and description of the nature
and form of the supervision of the authorized pharmacist by the supervising
physician, and a description of the procedure to follow when either the
authorized pharmacist or the supervising physician is unavailable or
absent;
9. the authorized
pharmacist's attestation of satisfaction of the qualifications listed in
247
CMR
16.02(1) for
participating in collaborative drug therapy management; and
10. the supervising physician's attestation
of satisfaction of the qualifications listed in
243
CMR
2.12 for participating in collaborative
drug therapy management.
(b)
Duties. A
collaborative practice agreement shall specify those duties of the authorized
pharmacist that may be delegated to other appropriately trained and authorized
staff and those duties under the agreement that shall not be delegated. A
collaborative practice agreement shall specify when and how a supervising
physician may delegate duties under the agreement, and the duration and scope
of the delegation.
(c)
Biennial Renewal. A collaborative practice agreement
must be reviewed and renewed by the authorized pharmacist and supervising
physician at least every two years.
(d)
Termination.
Prior to the termination or nonrenewal of a CDTM agreement, the supervising
physician and the authorized pharmacist shall arrange for an uninterrupted
continuation of the patient's drug therapy, in accordance with the terms of the
CDTM agreement. When a CDTM agreement is not renewed or CDTM is otherwise
terminated, the authorized pharmacist and the supervising physician shall
inform the patient in writing of the termination and of the procedures in place
for continuation of the patient's drug therapy, in accordance with the terms of
the CDTM agreement. The supervising physician has an ongoing responsibility for
patient care unless and until the physician patient relationship is
terminated.
(e)
Agreement to Be Filed in Primary Practice Setting. An
authorized pharmacist must maintain a copy of the current CDTM agreement,
including copies of the current patient referral and patient consent, in the
primary practice setting, readily retrievable at the request of the Board of
Registration in Medicine and the Board of Registration in Pharmacy. The
supervising physician must maintain the original of the current CDTM agreement,
including the original patient referral and patient consent, in the patient's
medical record in the custody of the supervising physician. The supervising
physician must maintain the patient's medical record in his or her custody and
make it available upon request during an investigation by the Board of
Registration in Medicine.
(f)
Employment Relationships. In accordance with M.G.L. c.
112, § 24B½(e):
1. A qualified
pharmacist may be hired by a physician or group of physicians for the purpose
of practicing collaborative drug therapy management under an agreement for the
benefit of the patient of that physician or physician group;
2. A community pharmacy may hire a physician
or licensed medical practitioner to conduct quality assurance reviews of
pharmacists engaged in collaborative drug therapy management; and
3. No community pharmacy may employ a
physician for the purpose of maintaining, establishing or entering into an
agreement.
