Md. Code Regs. 10.34.35.01

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.35.01 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Alternate site care environment" means the location where the patient is receiving infusion therapy other than an inpatient hospital setting.

(2) "Compounding worksheet" means a document or electronic record which:

(a) Specifies instructions for a specific compounded parenteral medication;

(b) Documents the manufacturer's:

(i) Ingredients;

(ii) Lot numbers; and

(iii) Expiration dates; and

(c) Includes a copy of the prescription label.

(3) Delegated Pharmacy Act.

(a) "Delegated pharmacy act" means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.

(b) "Delegated pharmacy act" does not include:

(i) An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Title 12, Subtitle 6A, Annotated Code of Maryland;

(ii) The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or Health Occupations Article, Title 12, Annotated Code of Maryland;

(iii) The delegation of a pharmacy act by a pharmacy technician, pharmacy student, or pharmacy technician trainee;

(iv) A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland;

(v) A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months; or

(vi) The performance of other functions prohibited in regulations adopted by the Board.

(4) "End of therapy" means the conclusion of parenteral infusion therapy as ordered by the prescriber.

(5) "Infusion nurse" means a registered nurse providing infusion therapy as defined in COMAR 10.27.20.02BB in an alternate site environment.

(6) "Infusion pharmacy" means a pharmacy that provides pharmaceutical care to patients receiving parenteral therapy in an alternate site care environment.

(7) "Licensed authorized prescriber of record" means an individual with the authority to prescribe and monitor a patient's parenteral infusion therapy for the duration of the patient's infusion therapy.

(8) "Parenteral infusion access device" means, but is not limited to, intravenous, subcutaneous, intrathecal, epidural, or peripheral nerve catheter device through which parenteral medications may be administered.

(9) "Patient care plan" means an individualized care plan that reflects the patient's parenteral infusion therapy pharmaceutical monitoring plan aimed at optimizing the outcome of therapy while minimizing untoward effects from the medication.

(10) "Patient triage form" means a written or electronic tool used by a clinician or by a registered pharmacy technician when communicating with a patient, a patient's caregiver, or an infusion nurse to document the patient's current status, including but not limited to, the patient's response to therapy, medication changes or adverse reactions, and pain level.

(11) "Permit holder" means a person, corporation, or other legal entity authorized by the Board to establish and operate a pharmacy.

(12) "Pharmacy technician" means an individual who is registered with the Board to perform delegated pharmacy acts.

(13) "Pharmacist" means an individual who is licensed to practice pharmacy.

(14) "Supervision" means the on-site provision of management, direction, oversight and review of tasks assigned to personnel.

Md. Code Regs. 10.34.35.01