Chapter 41. Administration of a Maintenance Injectable Medication
Regulation .01 Scope.LinkCopy Citation
This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.
Regulation .02 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Authorized prescriber” means a practitioner licensed and authorized under Health Occupations Article, Annotated Code of Maryland, to prescribe prescription drugs.
(2)
“Board” means the Maryland Board of Pharmacy.
(3)
Maintenance Injectable Medication.
(a)
“Maintenance injectable medication” means a medication that:
(i)
Is administered by injection other than intravenously;
(ii)
Except as authorized for a self-administered drug pursuant to Health Occupations Article, §12-509, Annotated Code of Maryland, is not a biological product; and
(iii)
Treats a chronic need, condition, or disorder.
(b)
“Maintenance injectable medication” includes, but is not limited to, a medication for:
(i)
The treatment of a psychiatric disorder;
(ii)
The treatment of a substance use disorder;
(iii)
Contraception; and
(iv)
Vitamins.
(4)
“Pharmacist” means an individual who practices pharmacy under Health Occupations Article, §12-101, Annotated Code of Maryland.
(5)
“Practicing pharmacy” has the meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland.
(6)
“Primary care practitioner” means a licensed health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual.
Regulation .03 Requirements to Administer a Maintenance Injectable Medication — Pharmacist’s Responsibilities.LinkCopy Citation
A.
Upon completion of all requirements established by the Board in this chapter, and after review of all relevant information, a pharmacist may administer a maintenance injectable medication.
B.
In order to administer a maintenance injectable medication, a pharmacist shall:
(1)
Utilize and follow the Board-approved procedure set forth in Regulation .07 of this chapter to administer a maintenance injectable medication;
(2)
Refer a patient for additional care to the patient’s primary care practitioner or the authorized prescriber, if necessary;
(3)
Provide the patient and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered;
(4)
Document the encounter and maintain records pursuant to Regulation .05 of this chapter; and
(5)
Notify the authorized prescriber that the medication was administered to the specific patient and any relevant information about the patient’s condition.
C.
A pharmacist shall:
(1)
Obtain written approval from the patient’s authorized prescriber prior to administering an initial dose of a maintenance injectable medication; and
(2)
Notify the patient of all fees that the patient is required to pay before administering a maintenance injectable medication.
Regulation .04 Training Program Requirements.LinkCopy Citation
A.
Except as provided in §C of this regulation, a pharmacist shall successfully complete a Board-approved training program for the administration of injectable maintenance medications prior to administering injectable maintenance medications.
B.
At a minimum, a Board-approved training program consists of the following elements:
(1)
Administration of a maintenance injectable medication;
(2)
Management of the patient populations served by a pharmacist;
(3)
Knowledge of the specific maintenance injectable medications that a pharmacist may administer; and
(4)
Current guidelines relating to the specific patient populations served by a pharmacist and the specific maintenance injectable medications that a pharmacist may administer, if applicable.
C.
The training program requirement set forth in §A of this regulation is waived for a pharmacist who has undergone the training as part of a formal education program.
D.
A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, who has successfully completed a Board-approved certification course under Health Occupations Article, §12-508, Annotated Code of Maryland, may administer a maintenance injectable medication under the direct supervision of a licensed pharmacist who meets the requirements set forth in Regulation .03 of this chapter.
Regulation .05 Record Keeping.LinkCopy Citation
A.
A pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain the records of a minor patient, including the information listed in §B of this regulation, until the minor patient attains the age of majority plus 3 years or for 5 years after the record was made, whichever is later.
B.
For a minimum of 5 years, except for records related to minors, a pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain documentation, in electronic or other form, including:
(1)
The type and dose of maintenance injectable medication administered;
(2)
The name, address, and date of birth of the patient;
(3)
The name of the pharmacist who administered the maintenance injectable medication;
(4)
The date that the maintenance injectable medication was administered;
(5)
A copy of the patient’s visit summary, including any pertinent details about the patient’s condition; and
(6)
The name and address of the authorized prescriber of the maintenance injectable medication.
C.
A pharmacist who administers an injectable maintenance medication as an independent provider at a location that is not a pharmacy shall maintain records as required by §§A and B of this regulation.
Regulation .06 Patient Information and Consent.LinkCopy Citation
A.
A pharmacist that administers a maintenance injectable medication shall:
(1)
Obtain a paper or electronic consent form signed by the patient, or the patient’s legal guardian, that authorizes the pharmacist to administer the maintenance injectable medication;
(2)
Provide the patient, or the patient’s legal guardian, with a copy of the consent form for future reference upon request;
(3)
Provide the patient, or the patient’s legal guardian, and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered; and
(4)
Notify the patient of the need to attend any upcoming appointments the patient has scheduled with the prescriber for additional care.
B.
The administering pharmacist shall:
(1)
Disclose their credentials on the consent form; and
(2)
Provide every patient with notification of the fee for service prior to administration.
Regulation .07 Standard Procedures.LinkCopy Citation
A.
Before a pharmacist administers a maintenance injectable medication, a pharmacist shall have and maintain a written procedure for any maintenance injectable medication that may be administered.
B.
A pharmacist shall administer a maintenance injectable medication in accordance with the written procedure, including:
(1)
Recording and maintaining the prescription files in accordance with Regulation .05 of this chapter;
(2)
Reviewing and screening for the following:
(a)
Indications;
(b)
Precautions;
(c)
Contraindications; and
(d)
Allergies;
(3)
Reviewing the process for handling adverse reactions, including but not limited to:
(a)
Acute anaphylactic reactions; and
(b)
Other acute emergencies;
(4)
Following injection or administration procedures;
(5)
Advising the patient of post-administration procedures, including waiting requirements; and
(6)
Documenting and maintaining a maintenance injectable medication record, including:
(a)
Patient’s:
(i)
Name;
(ii)
Date of birth;
(iii)
Address;
(iv)
Consent form;
(v)
Authorized prescriber; and
(vi)
Administering pharmacist’s name and license number;
(b)
Administration:
(i)
Date;
(ii)
Dose;
(iii)
Site; and
(iv)
Route;
(c)
Maintenance injectable medication:
(i)
Name, generic or brand;
(ii)
Manufacturer;
(iii)
Lot number; and
(iv)
Expiration date;
(d)
Notification to the authorized prescriber that the patient received a specific maintenance injectable medication; and
(e)
Verification that the prescription is:
(i)
Not for the patient’s initial dose, if applicable; or
(ii)
For the patient’s initial dose and the patient’s record contains documented approval from the authorized prescriber.
C.
The pharmacist shall:
(1)
Sign and date the standard procedure at least annually;
(2)
Make the standard procedure available for inspection by the Board upon request; and
(3)
Review and update the standard procedure as necessary.
Chapter annotations
Authority: Health-Occupations Article, §§12-101(o-1) and 12-509, Annotated Code of Maryland
History: Effective date: June 13, 2022 (49:12 Md. R. 640)