Md. Code Regs. 10.07.02.26

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

Section 10.07.02.26 - Pharmaceutical Services

A. Definition. In this regulation, the term committee means the pharmaceutical services committee.

B. Duties of the Nursing Home.

(1) The nursing home shall provide appropriate methods and procedures for administering drugs and biologicals to the nursing home's residents.

(2) The nursing home shall provide pharmaceutical services in accordance with accepted professional standards and related federal, State, and local laws.

C. Duties of the Pharmaceutical Services Committee.

(1) A pharmaceutical services committee, or its equivalent, shall develop written policies and procedures for safe and effective drug therapy, distribution, control, and use.

(2) The composition of the committee shall include at least:

(a) The licensed pharmacist;

(b) The director of nursing;

(c) The consultant dietitian-nutritionist;

(d) One physician; and

(e) The administrator.

(3) The committee shall meet at least quarterly to establish policies and procedures.

(4) There shall be an agenda to guide meeting participants.

(5) All members of the committee shall review revisions of policies and procedures before implementing any changes.

(6) The pharmaceutical services committee may not develop policies and procedures that prohibit or restrict a resident from receiving medications from the pharmacy of the resident's choice.

(7) In cases where the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the nursing home has contracted with to provide pharmaceutical services, the resident shall be responsible for the additional amount.

(8) The committee may not require the pharmacy to provide drugs by way of a specific drug distribution system such as unit dose or use of a particular packaging system.

(9) The committee shall establish the contents of sealed emergency drug kits.

(10) The committee shall oversee the accuracy and adequacy of pharmaceutical services to the nursing home.

(11) The committee shall make recommendations for improvements to pharmaceutical services.

(12) The committee shall document its actions and recommendations.

D. Labeling.

(1) Medications shall be accurately and plainly labeled. Except for those over-the-counter medications that the Department may list as suitable for purchasing in bulk and dispensing as needed, the labels for all medications shall bear at least:

(a) The resident's full name;

(b) The name of the drug;

(c) Strength;

(d) Original filling date and date refilled, if applicable;

(e) Name of authorized prescriber;

(f) Expiration date of medication (month, year);

(g) Any special handling and storage instructions;

(h) Name and address of dispensing pharmacy;

(i) Prescription number;

(j) Number of tablets or capsules; and

(k) Accessory federal labels.

(2) A nurse may not package, repackage, bottle, or label any medication, in whole or in part, or alter any labeled medication in any way.

E. Storage.

(1) The nursing home shall store medications in a locked medication storage area that:

(a) Is well lighted;

(b) Is located where personnel preparing drugs for administration will not be interrupted;

(c) Is spacious enough to allow separate storage of external and internal medications;

(d) Is kept in a clean, orderly and uncluttered manner; and

(e) Contains a refrigerator to be used for medication storage only.

(2) The nursing home shall keep poisons and medications marked for external use only separate from general medications and Schedule II drugs.

F. Schedule II-IV Drugs.

(1) Schedule II drugs shall be kept in separately locked, securely fixed boxes or drawers in the storage area, under two locks. The lock on the door of a medication room shall be counted as one of the two locks.

(2) A nurse and a second staff member who is a nurse or an administrator may destroy controlled dangerous substances in Schedules II-V on the premises of the nursing home.

(3) If a controlled dangerous substance is destroyed on the nursing home premises in accordance with §F(2) of this regulation:

(a) A record of the disposal, in addition to any other required records, shall be maintained in the nursing home; and

(b) A copy of the record of disposal shall be forwarded to the Office of Controlled Substances Administration.

(4) A nursing home, whether or not operating a licensed pharmacy, shall maintain a signed record of a Schedule II count at each change of shift.

(5) A nursing home that administers Schedule II drugs shall maintain a drug record that documents:

(a) The name of the resident;

(b) The date, time, kind, dosage, and method of administration of all Schedule II drugs; and

(c) The name of the authorized prescriber who prescribed the medication.

Md. Code Regs. 10.07.02.26

Regulations .26F amended and .26G_H repealed effective January 17, 1983 (10:1 Md. R. 28)
Regulation .26EE amended effective October 25, 1982 (9:21 Md. R. 2106); September 16, 2002 (29:18 Md. R. 1442); amended effective 46:12 Md. R. 541, eff. 6/17/2019