1. All staff who administer medications to residents shall have completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing.
  2. 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.
  3. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11.
  4. [An assisted living manager shall ensure that the resident’s initial assessment process identifies whether a resident:] Self-Administration.

 (1) A manager shall ensure that the resident’s initial assessment by the delegating nurse/case manager identifies whether a resident:

[(1)] (a) Is capable of self-administration of medication;

[(2)] (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

[(3)] (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 §F 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[(2)] (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. Spousal Administration. While residing in the same assisted living facility 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 provider 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 Review Upon Admission.

(1) [The assisted living manager shall consult within 14 days of a resident’s admission with the individuals set forth in §G(2) of this regulation to review a new resident’s medication regime.] The manager shall ensure that within 14 days of a new resident’s admission, a medication regimen review is conducted by a:

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

(a) Primary care physician;

(b) Certified registered nurse practitioner;

(c) Certified registered nurse-midwife;

(c) Registered nurse, who may be the delegating nurse or case manager; or

(d)  Licensed pharmacist.

(2) The purpose of the medication regimen review [required by §G of this regulation] is to review with the [assisted living] manager or designee:

(a) A resident’s current medication profile, including all prescription and nonprescription medications and tube feedings;

(b) The potential that current medications have to act as chemical restraints;

(c) The potential for any adverse drug interactions, including potential side effects from the medications; and

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

(3) The [assisted living] manager, or designee, shall ensure that the regimen review [required by §G of this regulation is documented in the resident’s records], including any recommendations are given by the reviewer, is documented in the resident’s records..

G. Pharmacy Review.

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

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

(a) The program is in compliance with the 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) Based on available information, the desired effect of each medication is achieved, and, if not, that the appropriately 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 appropriately 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 drug use without current indication in the resident’s records of a medical condition that warrants the use of the drug;

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

(i) Current medication selections result in inappropriate drug 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) The resident records need to be reviewed to assure that periodic, Periodic diagnostic monitoring required by certain medications have been performed; and

(n) The resident’s medication regimens need to be reviewed to determine if more 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] .14 of this chapter.

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

L. 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 days. The delegating nurse shall make appropriate recommendations to the appropriately authorized prescriber, and the assisted living manager or designee.]

I.  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 residents:] Medications are labeled with the following:

(a) Name of the resident;

(b) Name of the medication;

(c) Reason for the medication;

(d) Dose;

(e) Physician’s or authorized prescriber’s name;

(f) Date of issuance;

(g) Expiration date;

(h) Refill limits; [and]

(i) Directions for use[.] ;

(j) Frequency; and

(k) Route.

  1. A program may not have interim medications.
  2. Medical orders shall be updated at least annually with the Resident Assessment Tool, or sooner as needed

[N.] L. Medications and treatments shall be administered consistent with current signed medical orders and using professional standards of practice.

  1. Staff shall chart on the medication administration record each time staff administer, or assist in the administration of, a medication.
  2. Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy.
  3. [Required Documentation.] Controlled Dangerous Substances.

(1) A staff member shall count and record the documentation required under §M 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 §M 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 physician or other authorized health care practitioner.

  1. Accounting for Narcotic and Controlled Drugs.

(1) Staff shall count and record [controlled drugs, such as narcotics,] Schedule II through V controlled substances before the close of every shift.

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

(3) All Schedule II and III narcotics shall be maintained under a double lock system.

(4) The manager shall obtain a Controlled Dangerous Substances registration certificate from the Maryland Division of Drug Control.

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

(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 program and their destruction shall be:

(a) Conducted by two members of the staff, one of whom must be a licensed practitioner, pharmacist, or a nurse; 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 days of destruction

  1. All staff who administer medications to residents shall have completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing.
  2. 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.
  3. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11.
  4. [An assisted living manager shall ensure that the resident’s initial assessment process identifies whether a resident:] Self-Administration.

 (1) A manager shall ensure that the resident’s initial assessment by the delegating nurse/case manager identifies whether a resident:

[(1)] (a) Is capable of self-administration of medication;

[(2)] (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

[(3)] (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 §F 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[(2)] (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. Spousal Administration. While residing in the same assisted living facility 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 provider 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 Review Upon Admission.

(1) [The assisted living manager shall consult within 14 days of a resident’s admission with the individuals set forth in §G(2) of this regulation to review a new resident’s medication regime.] The manager shall ensure that within 14 days of a new resident’s admission, a medication regimen review is conducted by a:

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

(a) Primary care physician;

(b) Certified registered nurse practitioner;

[(c) Certified registered nurse-midwife;]

(c) Registered nurse, who may be the delegating nurse or case manager; or

(d)  Licensed pharmacist.

(2) The purpose of the medication regimen review [required by §G of this regulation] is to review with the [assisted living] manager or designee:

(a) A resident’s current medication profile, including all prescription and nonprescription medications and tube feedings;

(b) The potential that current medications have to act as chemical restraints;

(c) The potential for any adverse drug interactions, including potential side effects from the medications; and

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

(3) The [assisted living] manager, or designee, shall ensure that the regimen review [required by §G of this regulation is documented in the resident’s records], including any recommendations given by the reviewer is documented in the resident’s records..

G. Pharmacy Review.

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

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

(a) The program is in compliance with the 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) Based on available information, the desired effect of each medication is achieved, and, if not, that the appropriately 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 appropriately authorized prescriber;

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

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

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

(i) Current medication selections result in inappropriate drug 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) [The resident records need to be reviewed to assure that periodic]   Periodic diagnostic monitoring required by certain medications have been performed; and

(n) [The resident’s medication regimens need to be reviewed to determine if more] 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] .14 of this chapter.

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

L. 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 days. The delegating nurse shall make appropriate recommendations to the appropriately authorized prescriber, and the assisted living manager or designee.]

I.  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 residents:] Medications are labeled with the following:

(a) Name of the resident;

(b) Name of the medication;

(c) Reason for the medication;

(d) Dose;

(e) Physician’s or authorized prescriber’s name;

(f) Date of issuance;

(g) Expiration date;

(h) Refill limits; [and]

(i) Directions for use[.] ;

(j) Frequency; and

(k) Route.

  1. A program may not have interim medications.
  2. Medical orders shall be updated at least annually with the Resident Assessment Tool, or sooner as needed

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

  1. Staff shall chart on the medication administration record each time staff administer, or assist in the administration of, a medication.
  2. Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy.
  3. [Required Documentation.] Controlled Dangerous Substances.

(1) A staff member shall count and record the documentation required under §M 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 §M 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 physician or other authorized health care practitioner.

  1. Accounting for Narcotic and Controlled Drugs.

(1) Staff shall count and record [controlled drugs, such as narcotics,] Schedule II through V controlled substances before the close of every shift.

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

(3) All Schedule II and III narcotics shall be maintained under a double lock system.

(4) The manager shall obtain a Controlled Dangerous Substances registration certificate from the Maryland Division of Drug Control.

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

(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 program and their destruction shall be:

(a) Conducted by two members of the staff, one of whom must be a licensed practitioner, pharmacist, or a nurse; 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 days of destruction

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