PROPOSAL
Maryland Register
Issue Date:  November 13, 2015
Volume 42 • Issue 23• Pages 1456—1458
 
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 34 BOARD OF PHARMACY
10.34.29 Drug Therapy Management
Authority: Health Occupations Article, §§12-6A-01, 12-6A-03—12-6A-08, and 12-6A-10, Annotated Code of Maryland
Notice of Proposed Action
[15-369-P]
The Secretary of Health and Mental Hygiene proposes to amend Regulations .01—.07 under COMAR 10.34.29 Drug Therapy Management.
This action was considered by:
(1) The Board of Pharmacy at a public meeting held June 17, 2015 notice of which was given by publication on the Board of Pharmacy website, http://dhmh.maryland.gov/pharmacy/SitePages/Home.aspx, from May 21, 2015 ― June 17, 2015, pursuant to the State Government Article, §10-506(c), Annotated Code of Maryland; and
(2) The Board of Physicians at a public meeting held July 29, 2015 notice of which was given by publication on the Board of Physician website, http://www.mbp.state.md.us/, from July 15, 2015 ― July 29, 2015, pursuant to the State Government Article, §10-506(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to add a new definition of “authorized prescriber” that includes “licensed podiatrist” and “certified advanced practice nurse with prescriptive authority.” The remainder of the other amendments throughout the proposal make multiple, but identical changes, to provide consistency with the new definition and the other health occupation boards that are now involved. The new statutory requirement under Health Occupations Article, §12-6A-06, Annotated Code of Maryland, authorizes a protocol by a licensed physician and licensed pharmacist to include initiation of drug therapy under a written, disease-state specific protocol.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. This proposal would have an indeterminable fiscal impact and operational impact on the Board of Pharmacy. The Board is required to promulgate regulations and has been reviewing the qualifications of pharmacists participating in Drug Therapy Management, which functions have been performed as a matter of course. The impact would be indeterminable depending on the increase in Drug Therapy Management applications. A minor increase could be absorbed with present staffing, however; a major increase may necessitate additional resources, including personnel.
 
 
Revenue (R+/R-)
 
II. Types of Economic Impact.
Expenditure (E+/E-)
Magnitude
 

 
 
 
 
 
A. On issuing agency:
(R+)
Indeterminable
B. On other State agencies:
NONE
 
C. On local governments:
NONE
 
 
 
Benefit (+)
Cost (-)
Magnitude
 

 
 
 
 
 
D. On regulated industries or trade groups:
(-)
Indeterminable
E. On other industries or trade groups:
NONE
 
F. Direct and indirect effects on public:
(+)
Indeterminable
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A. The Board of Pharmacy may receive additional revenue as more authorized prescribers and pharmacists apply.
D. A cost may incur for authorized prescribers that may decide to participate in Drug Therapy Management. The fee, if not shared with the pharmacist, has not changed and is intended for the review of the qualifications of pharmacists to participate in Drug Therapy Management.
F. The public will be positively affected by an increase in authorized prescribers and pharmacists that are available to participate in Drug Therapy Management. The revisions will have a positive impact on those patients with chronic diseases who require monitoring and modification of their medications providing those patients with more convenient access to care.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through December 14, 2015. A public hearing has not been scheduled.
.01 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) “Amendment” means a change to:
(a) A protocol or [physician-pharmacist] prescriber-pharmacist agreement; or
(b) The parties to the [physician-pharmacist] prescriber-pharmacist agreement.
(2) “Applicants” means physicians [and], pharmacists, podiatrists, or certified advanced practice nurses with prescriptive authority submitting a [physician-pharmacist] prescriber-pharmacist agreement and protocol to their respective Boards.
(2-1) “Authorized prescriber” means a licensed physician, licensed podiatrist, or certified advanced practice nurse with prescriptive authority under Health Occupations Article, §8-508, Annotated Code of Maryland.
(3) “Boards” means the Board of Physicians [and], the Board of Pharmacy, the Board of Podiatric Medical Examiners, and the Board of Nursing.
(4)—(5) (text unchanged)
.02 Content of Protocol.
A. A protocol shall:
(1) (text unchanged)
(2) Contain the following:
(a)—(c) (text unchanged)
(d) A list of circumstances requiring contact with the [physician or physicians] authorized prescriber or authorized prescribers who are a party to the [physician-pharmacist] prescriber-pharmacist agreement;
(e) A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the [physician] authorized prescriber unless permitted in the therapy management contract;
(f)—(i) (text unchanged)
B. A protocol may authorize:
(1) (text unchanged)
(2) The ordering of laboratory tests; [and]
(3) Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy[.]; and
(4) For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols.
C. A protocol may not authorize acts that exceed the scope of practice of the parties to the [physician-pharmacist] prescriber-pharmacist agreement.
D. (text unchanged)
.03 Content of [Physician-Pharmacist] Prescriber-Pharmacist Agreement.
A. The [physician-pharmacist] prescriber-pharmacist agreement shall contain the following:
(1) The names and signatures of the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists authorized to act under a therapy management contract;
(2) (text unchanged)
(3) The titles of the protocols to which the [physician-pharmacist] prescriber-pharmacist agreement pertains;
(4) The methods and time frames by which documentation and routine communication will occur between the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and the pharmacists, including the time frames in which the pharmacist will fully update the patient’s record in writing;
(5) The name, address, and telephone number of the party to the [physician-pharmacist] prescriber-pharmacist agreement who is to receive correspondence from the Boards related to the [physician-pharmacist] prescriber-pharmacist agreement;
(6) A statement that the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists shall comply with all State and federal laws relating to patient confidentiality; and
(7) A list of devices available to the pharmacists performing under the [physician-pharmacist] prescriber-pharmacist agreement, which are relevant to the disease-states or conditions to be managed.
B. Technical modifications to the [physician-pharmacist] prescriber-pharmacist agreement shall be registered with the Board of Pharmacy within 30 days of the technical modification.
C. The party designated as the contact person to receive correspondence from the Boards shall ensure that the parties to the [physician-pharmacist] prescriber-pharmacist agreement are notified in a timely manner of the information received from the Boards.
D. (text unchanged)
.04 Requirements for Participation in Drug Therapy Management.
A.—C. (text unchanged)
D. [A licensed physician] An authorized prescriber who has entered into a [physician-pharmacist] prescriber-pharmacist agreement shall submit to the [Board of Physicians] Boards that regulate the authorized prescriber a copy of:
(1) The [physician-pharmacist] prescriber-pharmacist agreement;
(2) Subsequent amendments made to the:
(a) [Physician-pharmacist] Prescriber-pharmacist agreement; or
(b) Protocols specified in the [physician-pharmacist] prescriber-pharmacist agreement; and
(3) Changes to participants of the:
(a) [Physician-pharmacist] Prescriber-pharmacist agreement; or
(b) Protocols specified in the [physician-pharmacist] prescriber-pharmacist agreement.
E. The [Board of Physicians] Boards that regulate the authorized prescriber shall notify the [physician] authorized prescriber of any additional information needed within 30 days of the receipt of the submitted information.
F. A licensed pharmacist who has entered into a [physician-pharmacist] prescriber-pharmacist agreement shall submit to the Board of Pharmacy a copy of:
(1) The [physician-pharmacist] prescriber-pharmacist agreement;
(2) Subsequent amendments made to the:
(a) [Physician-pharmacist] Prescriber-pharmacist agreement; or
(b) Protocols specified in the [physician-pharmacist] prescriber-pharmacist agreement; and
(3) Changes to participants of the:
(a) [Physician-pharmacist] Prescriber-pharmacist agreement; or
(b) Protocols specified in the [physician-pharmacist] prescriber-pharmacist agreement.
G.—H. (text unchanged)
.05 Guidelines for Use of Protocols.
A. On receipt of specific instructions from the [physician] authorized prescriber regarding a specific patient, the pharmacist may execute the [physician’s] authorized prescriber’s specific instructions even if the instructions deviate from the protocol.
B. (text unchanged)
C. Documentation of activities performed under a protocol or the [physician’s] authorized prescriber’s specific instructions shall be maintained in such a manner that it is accessible to the:
(1) [Physician] Authorized prescriber; and
(2) (text unchanged)
D. (text unchanged)
E. Oral communications between the [physician] authorized prescriber and pharmacist shall be summarized in the documentation maintained by the pharmacist and forwarded to the [physician] authorized prescriber.
F. Unless an alternative time period is stated in the [physician-pharmacist] prescriber-pharmacist agreement, the pharmacist shall inform the [physician] authorized prescriber within 48 hours if the pharmacist:
(1) Modifies the dose or agent under the therapy management contract; [or]
(2) Detects an abnormal result from an assessment activity[.]; or
(3) Initiates drug therapy under a written, disease-state specific protocol, for protocols by a licensed physician and pharmacist.
.06 Therapy Management Contracts.
A. A therapy management contract shall be signed by the:
(1) [Physician or physicians] Authorized prescriber or authorized prescribers involved in the management of the patient under a [physician-pharmacist] prescriber-pharmacist agreement;
(2) Pharmacist or pharmacists involved in the management of the patient under a [physician-pharmacist] prescriber-pharmacist agreement; and
(3) (text unchanged)
B. A therapy management contract shall contain:
(1) (text unchanged)
(2) A statement that:
(a) (text unchanged)
(b) The pharmacist shall notify the [physician] authorized prescriber under the terms of the [physician-pharmacist] prescriber-pharmacist agreement if the pharmacist:
(i)—(ii) (text unchanged)
(3) (text unchanged)
(4) A procedure for periodic review by the [physician] authorized prescriber of the drugs modified under the [physician-pharmacist] prescriber-pharmacist agreement or changed with the consent of the [physician] authorized prescriber;
(5)—(6) (text unchanged)
[C. The therapy management contract shall terminate 1 year from the date of signing unless renewed by the parties to the therapy management contract, including the patient.]
.07 Fees.
A. Scope. This regulation governs [physicians] authorized prescribers and pharmacists participating in drug therapy management or amendment of [physicians] authorized prescribers and pharmacists that participate in the [physician-pharmacist] prescriber-pharmacist agreements relating to drug therapy management.
B. Fees. The Board of Pharmacy requires a fee for the [physician-pharmacist] prescriber-pharmacist agreement and protocol application (which includes review of the qualifications of the pharmacist participants) of $100 per [physician-pharmacist] prescriber-pharmacist agreement.
VAN T. MITCHELL
Secretary of Health and Mental Hygiene
 
 

 Content Editor