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  • Stephen Boulanger

Phase Two CMS Pharmacy Requirements: Part Two

Are you ready for the next roll out of CMS updates?

Mark your calendars for November 28th. This is when Phase 2 of the regulation changes go in to affect. To help you prepare, we will be highlighting any changes that impact the way medications are handled, documented, on stored etc. Some of the new information surround medications is easy to locate, like §438.45 Pharmacy Services, but other guidelines are co-mingled within different sections and can be overlooked.

FTag 554 §483.10 (c)(7) The right to self-administer medications if the interdisciplinary team, as defined by §483.21(b)(2)(ii), has determined that this practice is clinically appropriate.

GUIDANCE §483.10(c)(7)

If a resident requests to self-administer medication(s), it is the responsibility of the interdisciplinary team (IDT) (as defined in §483.21(b), F657, Comprehensive Care Plans) to determine that it is safe before the resident exercises that right. A resident may only self-administer medications after the IDT has determined which medications may be self-administered.

When determining if self-administration is clinically appropriate for a resident, the IDT should at a minimum consider the following:

The medications appropriate and safe for self-administration;

The resident’s physical capacity to swallow without difficulty and to open medication bottles;

The resident’s cognitive status, including their ability to correctly name their medications what conditions they are taken for;

The resident’s capability to follow directions and tell time to know when medications need to be taken;

The resident’s comprehension of instructions for the medications they are taking, including the dose, timing, and signs of side effects, and when to report to facility staff.

The resident’s ability to understand what refusal of medication is, and appropriate steps taken by staff to educate when this occurs.

The resident’s ability to ensure that medication is stored safely and securely.

Appropriate notation of these determinations must be documented in the resident’s medical record and care plan. If a resident is self-administering medication, review the resident’s record to verify that this decision was made by the IDT, including the resident. The decision that a resident has the ability to self-administer medication is subject to periodic assessment by the IDT, based on changes in the resident’s medical and decision-making status. If self-administration is determined not to be safe, the IDT should consider, based on the assessment of the resident’s abilities, options that allow the resident to actively participate in the administration of their medications to the extent that is safe (i.e., the resident may be assessed as not able to self-administer their medications because they are not able to manage a locked box in their room, but they may be able to get the medications from the nurse at a designated location and then safely self-administer them).

Medication errors occurring with residents who self-administer should not be counted in the facility’s medication error rate and should not be cited at §483.45(f)(1) F759 and §483.45(f)(2) F760, Medication Errors. However, this may call into question the judgment of facility staff in allowing self-administration of medication for that resident.


Determine that facility staff have a process to demonstrate that the resident has taken the self-administered medication.

Ask residents if they requested to self-administer medications and if they received a response.

How do staff determine if a resident is able to safely self-administer medications?

If the interdisciplinary team has determined that the resident can safely self-administer medications, was this request honored?

If the interdisciplinary team was not involved in determining whether the self-administration of medications was clinically appropriate, cite here at F554. If other concerns related to care planning are identified, see guidance at §483.21, Comprehensive Person-Centered Care Planning.


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