CMS SOM App. PP, Tag F757

Each resident’s drug regimen must be free from unnecessary drugs. An

unnecessary drug is any drug when used—

§483.45(d)(1) In excessive dose (including duplicate drug therapy); or

§483.45(d)(2) For excessive duration; or

§483.45(d)(3) Without adequate monitoring; or

§483.45(d)(4) Without adequate indications for its use; or

§483.45(d)(5) In the presence of adverse consequences which indicate the dose

should be reduced or discontinued; or

§483.45(d)(6) Any combinations of the reasons stated in paragraphs (d)(1) through

(5) of this section.

INTENT

The intent of these requirements is to ensure each resident’s entire drug/medication

regimen is managed and monitored to promote or maintain the resident’s highest

practicable mental, physical, and psychosocial well-being.

NOTE:

• For concerns related to psychotropic medications only, including the

unnecessary medication requirements, surveyors should assess compliance

with §483.10(e), §483.12(a), and §§483.45(c) and (e), F605.

• This guidance uses the terms “medications,” and, “drugs,” interchangeably.

• For purposes of this guidance, references to “the pharmacist” mean the

facility’s licensed pharmacist, whether employed directly by the facility or

under arrangement.

The regulations and guidance are not intended to supplant the judgment of a practitioner

in consultation with facility staff, the resident, and his/her representatives and in

accordance with professional standards of practice. However, surveyors are expected to

investigate the basis for decisions and interventions affecting residents. For example, a

resident’s medical record should contain documentation that demonstrates how the

practitioner arrived at their decision(s) in accordance with the professional standards of

practice.

DEFINITIONS

“Adequate Indications for use” refers to the identified, documented clinical rationale

for administering a medication that is based upon an assessment of the resident’s

condition and therapeutic goals, and after any safer treatments have been deemed

clinically contraindicated. Also, adequate indication for use means that the medication

administered is consistent with manufacturer’s recommendations and/or clinical practice

guidelines, clinical standards of practice, medication references, clinical studies or

evidence-based review articles that are published in medical and/or pharmacy journals.

“Adverse consequence” refers to unwanted, unintended, or dangerous effects that a drug

may have, such as impairment or decline in an individual’s mental or physical condition

or functional or psychosocial status. It may include various types of adverse drug

reactions and interactions (e.g., medication-medication, medication-food, and

medication-disease) (adapted from The Merck Manual Professional Version,

http://www.merckmanuals.com/professional/clinical-pharmacology/adverse-drug-reactions/adverse-drug-reactions.)

NOTE: Adverse drug reaction (ADR) is a form of adverse consequences. It may be

either a secondary effect of a medication that is usually undesirable and different from the

therapeutic effect of the medication or any response to a medication that is noxious and

unintended and occurs in doses for prophylaxis, diagnosis, or treatment. The term “side

effect” is often used interchangeably with ADR; however, side effects are but one of five

ADR categories, the others being hypersensitivity, idiosyncratic response, toxic reactions,

and adverse medication interactions. A side effect is an expected, well-known reaction

that occurs with a predictable frequency and may or may not constitute an adverse

consequence.

“Anticholinergic side effect” refers to an effect of a medication that opposes or inhibits

the activity of the parasympathetic (cholinergic) nervous system to the point of causing

symptoms such as dry mouth, blurred vision, tachycardia, urinary retention, constipation,

confusion, delirium, hallucinations, flushing, and increased blood pressure. Types of

medications that may produce anticholinergic side effects include:

• Antihistamines, antidepressants, anti-psychotics, antiemetics, muscle relaxants;

and

• Certain medications used to treat cardiovascular conditions, Parkinson’s disease,

urinary incontinence, gastrointestinal issues and vertigo.

“Neuroleptic Malignant Syndrome (NMS)” refers to a syndrome related to the use of

medications, that typically presents with a sudden onset of diffuse muscle rigidity, high

fever, labile blood pressure, tremor, and notable cognitive dysfunction. It is potentially

fatal if not treated immediately, including stopping the offending medications.

“Serotonin Syndrome” refers to a potentially serious clinical condition resulting from

overstimulation of serotonin receptors. It is commonly related to the use of multiple

serotonin-stimulating medications (e.g., SSRIs, SNRIs, triptans, certain

antibiotics). Symptoms may include restlessness, hallucinations, confusion, loss of

coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature,

overactive reflexes, nausea, vomiting and diarrhea.

GUIDANCE

Medications are an integral part of the care provided to residents of nursing facilities.

They are administered to try to achieve various outcomes, such as curing an illness,

arresting or slowing a disease process, reducing or eliminating symptoms, or as part of

diagnosing or preventing a disease or symptom.

Comprehensive Assessment

The indications for initiating, maintaining, or discontinuing medication(s) are determined

by evaluating the resident’s physical, behavioral, mental, and psychosocial signs and

symptoms in order to identify and rule out any underlying medical conditions, including

the assessment of relative benefits and risks, and the preferences and goals for treatment.

The resident’s medical record should include documentation of this evaluation and the

rationale for chosen treatment options.

Additionally, the facility should ensure that the initiation or change in a medication is

not:

• Due to a medical condition or problem (e.g., pain, fluid or electrolyte imbalance,

infection, obstipation, medication side effect or polypharmacy) that can be

expected to improve or resolve as the underlying condition is treated or the

offending medication(s) are discontinued;

• Due to environmental stressors alone, that can be addressed to improve the

symptoms; and

• Due to psychological stressors alone, that can be expected to improve or resolve

as the situation is addressed.

Circumstances that warrant evaluation of a resident’s underlying medical condition and

medication(s) include:

• Admission or re-admission: Some residents may be admitted to the facility on

medications that were started in the hospital or the community without a clear

documented indication for why the medication was begun or should be continued.

The prescribing practitioner and the IDT should subsequently determine if

continuing the medication is justified by conducting a comprehensive evaluation;

• A new or worsening change in condition/status;

• An irregularity identified in the pharmacist’s medication regimen review. See

F756 for guidance related to the medication regimen review; and

• New medication order as an emergency measure – When a resident is

experiencing an acute medical problem or emergency and the acute phase has

stabilized, the staff and prescriber should consider whether medications are still

relevant.

Determining the Necessity for use of Medications

Proper medication selection and prescribing (including dose, duration, and type of

medication(s)) may help stabilize or improve a resident’s outcome, quality of life and

functional capacity. Any medication or combination of medications—or the use of a

medication without adequate indications, in excessive dose, for an excessive duration, or

without adequate monitoring—may have serious side effects, such as changes in vital

signs/lab values, confusion, immobility, falls, and hip fractures, which can be especially

dangerous for elderly residents, in addition to an increased risk of death. American

Geriatrics Society 2023 updated AGS Beers Criteria® for Potentially Inappropriate

Medication Use in Older Adults provides information on safely prescribing medications

for older adults, https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.18372.

NOTE: Instances of prescribing antibiotics unnecessarily should be cited at §483.45(d),

F757. The findings may support citing F881 as well, in which case the surveyor must also

show that the facility is not implementing part or all of the Antibiotic Stewardship

Program (e.g., antibiotic use protocols that utilize an infection assessment tool,

monitoring of antibiotic use, or feedback and education to prescribing providers).

Resident’s Right to be Informed

In accordance with the requirements at §483.10(c), residents have the right to be

informed of and participate in their treatment. Prior to initiating or increasing a

medication, the resident, family, and/or resident representative must be informed of the

benefits, risks, and alternatives for the medication, in advance of such initatiation or

increase. The resident has the right to accept or decline the initiation or increase of a

medication. To demonstrate compliance, the resident’s medical record must include

documentation that the resident or resident representative was informed in advance of the

risks and benefits of the proposed care, the treatment alternatives or other options and

was able to choose the option he or she preferred. A written consent form may serve as

evidence of a resident’s consent to medication, but other types of documentation are also

acceptable. If a medication has been initiated or increased, and there is not

documentation demonstrating compliance with the resident’s right to be informed and

participate in their treatment, noncompliance with §483.10(c) exists and F552 must be

cited.

Dose and Duration

The dose and duration of medications, in accordance with §483.45(d)(1) and (d)(2), are

based on a variety of factors, including the resident’s diagnoses, signs and symptoms,

current condition, age, coexisting medication regimen, review of lab and other test

results, input from the Interdisciplinary Team (IDT) about the resident, including the

resident’s preferences and goals, the type of medication(s), and therapeutic goals being

considered or used.

Dose refers to the total amount/strength/concentration of a medication given at one time

or over a period of time. The individual dose is the amount/strength/concentration

received at each administration. The amount received over a 24-hour period may be

referred to as the daily dose.

Polypharmacy refers to the use of five or more medications for an individual which can

increase the risk of adverse outcomes such as falls, frailty, disability, and mortality in

older adults. Polypharmacy also increases the possibility of prescribing cascades when

additional drugs are prescribed to treat the adverse effects of one of the current

medications.

Duplicate therapy refers to two or more medications of the same pharmacological

class/category without a clear distinction of when one medication should be administered

over another. Duplicate therapy is generally not indicated, unless current clinical

standards of practice and documented clinical rationale confirm the benefits of multiple

medications from the same class or with similar therapeutic effects. Some examples of

potentially problematic duplicate therapy include use of more than one medication

containing the same ingredient, use of more than one drugs within the same class, or

medications from different therapeutic categories with similar effects or properties.

The risk for polypharmacy and duplicate therapy is particularly high during transitions of

care, especially if medications are not tracked closely between locations or within the

care settings. Documentation is necessary to clarify the rationale for each medication and

the approach to monitor the benefits and any adverse consequences.

Excessive dose refers to the total amount of any medication (including duplicate therapy)

given at one time or over a period of time that is greater than the amount recommended

by the manufacturer’s label, package insert, and accepted standards of practice for a

resident’s age and condition.

NOTE: If the resident’s condition has not responded to treatment or has declined despite

treatment, it is important to evaluate both the medication and the dose..

The clinical rationale for continued use of a medication(s) should be documented in the

medical record. Examples of inappropriate duration that should be cited for noncompliance may include:

• A medication was initiated because of a time-limited condition (for example,

delirium, pain, infection, nausea and vomiting, cold and cough symptoms, or

itching). However, failure to review whether the underlying cause has resolved

led to excessive duration, because the medication was not discontinued when the

condition resolved or there was no documentation indicating why continued use

was still relevant.

• A medication was administered beyond the stop date established by the

prescriber, without evidence of clinical indication for continued use of the

medication.

Monitoring and Adverse Consequences

Medication management is based in the care process and includes recognition or

identification of the problem/need, assessment, diagnosis/cause identification,

management/treatment, monitoring, and revising interventions, in accordance with

§483.45(d)(3) and (d)(5), as well as documenting medication management steps.

Monitoring and accurate documentation of the resident’s response to any treatment (such

as, lab results, vital signs, progress notes, behavior flow sheets, medication administration

records and the consultant pharmacist’s drug regimen review) is essential to evaluate the

ongoing effectiveness, benefits as well as risks of medications.

Note: The facility’s pharmacist is a valuable source of information about medications.

The pharmacist and attending physician must adhere to the requirements for reporting

and responding to identified irregularities (See F756 Drug Regimen Review).

When there are multiple prescribers, the continuation of a medication needs to be

evaluated to determine if the medication is still warranted in the context of the resident’s

other medications and comorbidities. Medications prescribed by a specialist or begun in

another care setting, such as the hospital, need to be clinically indicated and documented

in the resident’s medical record. If it is determined through monitoring that changes in

the resident’s treatment plan need to be made, surveyors must review the medical record

to determine whether the prescribing practitioner provided a rationale for continued use

or discontinuation. Without a rationale, the use of the medication(s) may be unnecessary

and therefore, noncompliant.

The surveyor must review documentation to confirm that residents are being adequately

monitored and re-evaluated for adverse consequences and the need for tapering. Adverse

consequences related to medications are common enough to warrant serious attention and

close monitoring, and can range from minimal harm to functional decline, hospitalization,

permanent injury, and death.

One of the existing mechanisms to warn prescribers about risks associated with

medications is the Food and Drug Administration (FDA) requirement that manufacturers

include warnings about adverse reactions and potential safety hazards identified both

before and after approval of a medication, and what to do if they occur (Visit:

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-

reporting-program or search for “FDA Safety Alerts for Human Medical Products.”

Manufacturers are required to place statements about serious problems or

contraindications in a prominently displayed box (“black box”) in the medication

labelling. The boxed warning is reserved for prescription drugs that pose a significant risk

of serious or life-threatening adverse effects, based on medical studies. Use of a tool,

such as the CMS Adverse Drug Event Trigger Tool, may assist in identifying resident

risk factors and triggers for adverse drug events as well as in determining whether a

facility has systems and processes in place to minimize risk factors and mitigate harm to

residents. This tool and other resources are available on the CMS Adverse Events in

Nursing Homes website, https://www.cms.gov/Medicare/Provider-E

nrollment-and-

Certification/QAPI/Adverse-Events-NHs. Additionally, as part of a facility’s QAPI

program, a facility may track its use of certain classes of medications through reports

from the long-term care pharmacist which could identify trends and reduce adverse

events.

INVESTIGATIVE PROCEDURES

Use the Unnecessary Medications, Chemical Restraints/Psychotropic Medications, and

Medication Regimen Review Critical Element (CE) Pathway, along with the above

interpretive guidance, when determining if the facility meets the requirements or when

investigating concerns.

Review the medications (prescription, over-the-counter medications, and nutritional

supplements such as herbal products) currently ordered and/or discontinued by the

prescriber at least back to the most recent signed recapitulation of all medications.

Obtain a copy of the current orders if necessary. Gather information regarding the

resident’s mental, physical, functional, and psychosocial status and the medication-related therapeutic goals identified in the care plan as the basis for further review.

Use the table below to guide observations, record review, and interviews with the

resident or representative and relevant staff. Symptoms and signs described in the table

may also be related to a resident’s condition or disease. The surveyor may seek

clarification about the basis of specific signs and symptoms from the attending physician

and/or pharmacist.

SYMPTOMS, SIGNS, AND CONDITIONS

THAT MAY BE ASSOCIATED WITH

MEDICATIONS

REVIEW FOR HOW THE IDT

MANAGED MEDICATIONS FOR

THE RESIDENT

Determine if the resident has been transferred to

acute care since the last survey and/or has recently

(e.g., the previous 3 months) experienced a change

in condition or currently has signs and symptoms,

such as:

• Anorexia and/or unplanned weight loss, or

weight gain

• Apathy

• Behavioral changes, unusual patterns

(including increased expressions or

indications of distress, social isolation or

withdrawal)

• Bleeding or bruising, spontaneous or

unexplained

• Bowel dysfunction including diarrhea,

constipation and impaction

• Dehydration, fluid/electrolyte imbalance

• Depression, mood disturbance

• Dysphagia, swallowing difficulty

• Falls, dizziness, or evidence of impaired

coordination

• Gastrointestinal bleeding

• Headaches, muscle pain, generalized or

nonspecific aching or pain

• Lethargy

• Mental status changes, (e.g., new or

worsening confusion, new cognitive decline,

worsening of dementia (including delirium),

inability to concentrate)

• Psychomotor agitation (e.g., restlessness,

inability to sit still, pacing, hand-wringing,

or pulling or rubbing of the skin, clothing,

or other objects).

• Psychomotor retardation (e.g., slowed

speech, thinking, and body movements)

• Rash, pruritus

• Respiratory difficulty or changes

• Sedation (excessive), insomnia, or sleep

disturbance

• Seizure activity

• Urinary retention or incontinence

Review the record (including the care

plan, comprehensive assessment, and

other parts of the record as appropriate) to

determine whether it reflects the following

elements related to medication

management for the resident:

• Clinical indications for use of the

medication

• Implementation of person-centered, non-pharmacological

approaches to care

• Dose, including excessive dose and

duplicate therapy

• Duration, including excessive

duration

• Consideration of potential for

tapering/GDR or rationale for

clinical contraindication

• Monitoring for and reporting of:

o Response to medications and

progress toward therapeutic

goals and resident’s goals

o Emergence of medication-related adverse

consequences

• Adverse consequences, if present

and potentially medication-related,

note if there was:

o Recognition, evaluation,

reporting, and management

by the IDT

o Physician action regarding

potential medication-related

adverse consequences

• The resident’s goals and

preferences for medications

and treatments

SYMPTOMS, SIGNS, AND CONDITIONS

THAT MAY BE ASSOCIATED WITH

MEDICATIONS

REVIEW FOR HOW THE IDT

MANAGED MEDICATIONS FOR

THE RESIDENT

If observations or record review indicate symptoms

or changes in condition that may be related to

medications, determine whether the facility

considered medications as a potential cause of the

change or symptom.

Interview the resident, his or her family, and representative(s) and the IDT, as needed to

gather information about use of medications and any possible side effects in the facility.

Evaluate if the resident may have experienced psychosocial harm related to side effects

of medications.

For a resident who is unable to communicate psychosocial outcomes related to

medication side effects, the surveyor should consider how a reasonable person in the

resident’s condition would experience the changes caused by medication side effects as

explained in the Psychosocial Outcome Severity Guide, on the CMS Nursing Homes

Survey Resources website.

The surveyor is not expected to prove that an adverse consequence was directly caused

by a medication or combination of medications, but rather that there was a failure in the

care process related to considering and acting upon such possibilities.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

• F552, Right to be Informed/Make Treatment Decisions

• F553, Right to Participate Planning Care

• F580, Notification of Changes

• F656, Develop/Implement Comprehensive Care Plan

• F710, Physician Supervision

• F756, Drug Regimen Review

• F841, Medical Director

• F881, Antibiotic Stewardship Program

DEFICIENCY CATEGORIZATION

Examples of Level 4, immediate jeopardy to resident health and safety include, but

are not limited to:

• Facility failure to take appropriate action (e.g., suspending administration of the

anticoagulant) in response to an elevated International Normalized Ratio (INR)

for a resident who is receiving warfarin, resulting in either the potential or actual

need to transfuse or hospitalize the resident.

• Failure to respond appropriately to an INR level that is above or below the target

range for treatment of atrial fibrillation, prevention of deep vein thrombosis

(DVT) or pulmonary embolus, or other documented indication.

• Failure to recognize developing serotonin syndrome (e.g., confusion, motor

restlessness, tremor) in a resident receiving a SSRI antidepressant, leading to the

addition of medications with additive serotonin effect or medication to suppress

the symptoms.

• Failure to recognize and respond to signs and symptoms of neuroleptic malignant

syndrome (NMS).

• In the presence of initial gastrointestinal bleeding, i.e. blood in stool, the failure to

recognize medication therapies (such as NSAIDs or COX-2 inhibitors,

bisphosphonates) as potentially causing or contributing to the gastrointestinal

bleed, resulting in the continued administration of the medication, until the

resident required hospitalization for severe bleeding.

Examples of Level 3, actual harm that are not immediate jeopardy include, but are

not limited to:

• The facility failed to monitor the side effects of a resident’s new medication

regimen as the source of a resident’s recent nausea. Instead of adjusting the

current regimen, the prescriber added a medication to treat the nausea, which

caused agitation and insomnia.

• A resident had been sick and taking in less fluids. Staff failed to monitor the

resident’s blood pressure when the resident mentioned feeling lightheaded. The

resident continued to receive prescribed blood pressure medications without

adequate monitoring which led to a low blood pressure causing the resident to fall

and sustain a serious injury.

Examples of Level 2, no actual harm, with potential for more than minimal harm,

that is not immediate jeopardy, include but are not limited to:

• Facility failure to identify and act upon minor symptoms of allergic response to

medications, such as a rash with mild itching to the abdomen and no other

symptoms, causing minimal discomfort.

• Facility failure to monitor for response or for the emergence or presence of

adverse consequences for a resident who has not yet experienced an adverse

consequence or decline in function, such as by monitoring hydration status and

basic metabolic profile for a resident receiving diuretics or ACE inhibitors.

Severity Level 1:

Severity Level 1 does not apply for this regulatory requirement because the failure of the

facility to provide appropriate care and services to manage the resident’s medication

regimen to avoid unnecessary medications and minimize negative outcome places

residents at risk for more than minimal harm.

RESOURCES AND TOOLS

The following resources and tools provide information on medications including box

warnings, appropriate dosing, medication categories, drug interactions, and medication

safety information. Some of these resources also assist in identifying the correct class of a

medication. Additionally, the list includes some of the recognized clinical resources

available for understanding the overall treatment and management of medical problems,

symptoms and medication consequences and precautions.

• U.S. Department of Health and Human Services, National Institute of Mental

Health Web site, which includes publications and clinical research information,

www.nimh.nih.gov

• MedlinePlus, https://www.nlm.nih.gov/medlineplus/druginformation.html

• National Library of Medicine Drug Information Portal,

http://druginfo.nlm.nih.gov/drugportal/drug/categories

(medication class

information).

• The Food and Drug Administration (FDA) webpage, Medwatch: The FDA Safety

Information and Adverse Event Reporting Program,

http://www.fda.gov/Safety/MedWatch/default.htm

• Post-Acute and Long-Term Care Medical Association, https://paltmed.org/

• American Society of Consultant Pharmacists, https://www.ascp.com/

This list is not all-inclusive. CMS is not responsible for the content or accessibility of

pages found at these sites. URL addresses were current as of the date of this publication.

References to non-CMS sources do not constitute or imply endorsement of these

organizations or their programs by CMS or the U.S. Department of Health and Human

Services and were current as of the date of this publication.