Md. Code Regs. 10.07.14.31 - Medication Management and Administration

A. All unlicensed staff who will administer medications to residents shall have first completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing to teach the certified medication technician course.

B. The assisted living manager shall document completion of the medication technician training and certification as a medication technician by the Maryland Board of Nursing per COMAR 10.39.04 in the personnel file or other readily available record of each unlicensed staff member who administers medications.

C. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11.

D. Self-Administration of Medication.

(1) An assisted living manager shall ensure that the resident's initial assessment process identifies whether a resident:

(a) Is capable of self-administration of medication;

(b) Is capable of self-administration of medication, but requires a reminder to take medications or physical assistance with opening and removing medications from the container, or both; or

(c) Requires that medications be administered by the assisted living program staff or by a spouse or domestic partner of the resident in accordance with §E of this regulation.

(2) For a resident who is capable of self-administration or, although capable, requires a reminder or physical assistance, as stated in §D(1)(b) of this regulation, the assisted living manager shall ensure that the resident is reassessed by the delegating nurse quarterly for the ability to safely self-administer medications with or without assistance.

E. Administration of Medication by a Spouse or Domestic Partner. While residing in the same assisted living program as their spouse or domestic partner, a resident may administer medications to their spouse or domestic partner providing the following documentation is maintained in the resident's record:

(1) An initial assessment by their health care practitioner documenting the resident's competency and ability to safely administer medications to their spouse or domestic partner;

(2) Quarterly assessments by the delegating nurse documenting the resident's continued ability to safely administer medications to their spouse or domestic partner; and

(3) Current signed medical orders.

F. Medication Regimen Review Upon Admission.

(1) The assisted living manager shall consult within 14 calendar days of a resident's admission with the individuals set forth in §F(2) of this regulation to review a new resident's medication regime.

(2) The medication review may be conducted by a:

(a) Health care practitioner;

(b) Registered nurse, who may be the delegating nurse; or

(c) Licensed pharmacist.

G. The purpose of the medication regimen review required by §F of this regulation is to review with the assisted living manager or designee:

(1) A resident's current medication profile, including all prescription and nonprescription over-the-counter medications and tube feedings;

(2) The potential that current medications have to act as a chemical restraint;

(3) The potential for any side effects;

(4) The potential for adverse drug interactions; and

(5) Any medication errors that have occurred since admission.

H. The assisted living manager, or designee, shall ensure that the medication regimen review required by §F of this regulation is documented in the resident's records, including any recommendations given by the reviewer.

I. Pharmacy Review.

(1) The assisted living manager shall arrange for a licensed pharmacist to conduct an on-site review of health care practitioner prescriptions, health care practitioner orders, and resident records at least every 6 months for any resident receiving nine or more medications, including over-the-counter and as needed (PRN) medications.

(2) The pharmacist's review shall include, but is not limited to, whether:

(a) The assisted living program is in compliance with Board of Pharmacy's requirements for packaging of medications;

(b) Each resident's medications are properly stored and maintained;

(c) Each resident receives the medications that have been specifically prescribed for that resident in the manner that has been ordered;

(d) The desired effectiveness of each medication is achieved based on available information, and, if not, that the appropriate authorized prescriber is so informed;

(e) Any undesired side effects, potential and actual adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber;

(f) The resident has a medical condition as documented in the resident's records that is not currently being treated by medication;

(g) There is medication use without current indication in the resident's records of a medical condition that warrants the use of the medication;

(h) There is medication overuse that is causing side effects as documented in the resident records;

(i) Current medication selections result in inappropriate medication dosage;

(j) The resident may be experiencing drug interactions;

(k) The resident is receiving medication, either prescribed or over-the-counter medications, as well as herbal remedies that could result in drug-drug, drug-food, or drug-laboratory test interactions;

(l) Administration times of medication need to be modified to address drug interactions or meal times, or both;

(m) Periodic diagnostic monitoring required by certain medications have been performed; and

(n) More cost-effective medications are available to treat current medical conditions.

(3) The pharmacist shall document the pharmacy review as required under this section in each resident's chart and this documentation shall be reviewed every 6 months as part of the assisted living program's quality assurance activities as required in Regulation .13 of this chapter.

J. The person conducting the on-site review under §F or G of this regulation shall recommend changes, as appropriate, to the appropriate authorized prescriber and the assisted living manager or designee.

K. If a resident requires that staff administer medications as defined in Regulation .02B(3) of this chapter, and the administration of medications has been delegated to an unlicensed staff person pursuant to COMAR 10.27.11, the assisted living manager shall comply with COMAR 10.27.11 by arranging for an on-site review by the delegating registered nurse at least every 45 calendar days. The delegating nurse shall make appropriate recommendations to the appropriate authorized prescriber, and the assisted living manager or designee.

L. Safe Storage of Medication. The assisted living manager, or designee, shall ensure that:

(1) Medications are stored in the original dispensed container;

(2) Medications are stored in a secure location, at the proper temperature; and

(3) The following documentation is maintained for all prescription and over-the-counter medications prescribed to residents:

(a) Name of the resident;

(b) Name of the medication;

(c) Reason for the medication;

(d) Dose;

(e) Frequency;

(f) Route;

(g) Authorized prescriber's name;

(h) Date of issuance;

(i) Expiration date;

(j) Refill limits; and

(k) Directions for use.

M. Medications and treatments shall be administered consistent with current signed medical orders and using professional standards of practice.

N. Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy.

O. Required Documentation.

(1) A staff member shall record the documentation required under §L of this regulation for all residents for whom medications are administered, or who receive assistance in taking their medications, as defined by Regulation .02B(3)(b) of this chapter, at the time that the resident takes or receives medications.

(2) A staff member shall record the documentation required under §L of this regulation for residents who self-administer:

(a) Upon admission; or

(b) When changes in the resident's medication regimen are ordered by a health care practitioner.

P. Accounting for Narcotic and Controlled Substances.

(1) A qualified staff member and a witness shall count and record Schedule II through V controlled substances before the close of every shift.

(2) The daily record shall account for all controlled substances documented as administered on the medication administration record.

(3) All Schedule II through V controlled substances shall be maintained under a double lock system.

(4) As required, the assisted living program shall obtain a Controlled Dangerous Substances registration certificate from the Department's Office of Controlled Substances Administration.

(5) The assisted living manager shall develop written policies and procedures to guard against theft and diversion of controlled substances, that include:

(a) Proper storage;

(b) Accountability;

(c) Access;

(d) Destruction; and

(e) Reporting procedures.

(6) Controlled substances may not be returned to the pharmacy.

(7) Controlled substances in need of disposal shall be destroyed on-site at the assisted living program and their destruction shall be:

(a) Conducted by two members of the staff, one of whom shall be a licensed practitioner, licensed pharmacist, registered nurse, licensed practical nurse, certified medication technician, or licensed assisted living manager; and

(b) Recorded on a form supplied by the Division of Drug Control, a copy of which shall be forwarded to the Division within 10 calendar days of destruction.

Notes

Md. Code Regs. 10.07.14.31

Regulations .31 adopted effective December 29, 2008 (35:26 Md. R. 2249); adopted effective 52:8 Md. R. 357, eff. 4/28/2025.