What the regulation requires

• The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under agreement.
• Pharmaceutical services must include procedures that assure accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to meet each resident’s needs.
• The facility must employ or obtain a licensed pharmacist who (1) consults on all aspects of pharmacy services, (2) establishes a system of records of receipt and disposition of all controlled drugs in enough detail for accurate reconciliation, and (3) determines that drug records are in order and that all controlled drugs are accounted for and periodically reconciled.
• Unlicensed personnel may administer drugs only if State law permits, and only under the general supervision of a licensed nurse.

What the surveyor guidance says

• Timeliness is part of the requirement. Medications must be available when needed: new admission orders, first doses, after-hours and emergency needs, and refills before supply runs out. Delays that leave a resident without an ordered medication are investigated here.
• The pharmacist’s role is broad. Working with the facility and the medical director, the pharmacist helps develop and evaluate procedures for ordering, receiving, storing, labeling, administering, and disposing of medications; emergency supplies and automated dispensing; IV therapy; and staff education on recognizing adverse consequences.
• Administration procedures should address who is authorized to administer, timing of doses, correct technique (for example, medications that must not be crushed, and enteral tube administration), and documentation.
• Controlled medications: records must show receipt, access, usage, and disposition (including destruction, wastage, and return) in enough detail to reconcile. Reconciliation is periodic, as defined by facility procedure or whenever loss is identified, and should minimize the time between a loss and its detection. If diversion is suspected, reconciliation may need to be as frequent as daily. State or other federal requirements may set the frequency. Controlled drugs in the emergency supply must be reconciled too.
• Loss and diversion: discrepancies must be investigated and resolved, and suspected diversion acted on, including any required reporting. Diversion can also be cited as misappropriation of resident property.
• Disposal must follow State and federal requirements and prevent diversion and accidental exposure. The guidance singles out fentanyl patches because of their boxed warnings and the substantial amount of drug remaining after removal; facility policy should specify the disposal method.

What the regulation requires

• A licensed pharmacist must review each resident’s drug regimen at least once a month, and the review must include the medical chart.
• The pharmacist must report any irregularities to the attending physician, the medical director, and the director of nursing, and the reports must be acted upon. Irregularities include, but are not limited to, any drug that meets the unnecessary drug criteria in §483.45(d).
• Irregularities must be documented on a separate written report that lists, at a minimum, the resident’s name, the relevant drug, and the irregularity identified.
• The attending physician must document in the medical record that the irregularity was reviewed and what action, if any, was taken. If there is no change to the medication, the physician should document the rationale.
• The facility must have policies and procedures for the monthly review that include time frames for each step and the steps the pharmacist takes when an irregularity requires urgent action to protect the resident.

What the surveyor guidance says

• The medication regimen review (MRR) is a thorough evaluation of the regimen to promote positive outcomes and minimize adverse consequences, and medication-related problems must be considered whenever a resident has a change in condition.
• Monthly is the minimum. Some residents need review more often, even weekly, depending on condition. Policy should address residents expected to stay less than 30 days, and residents with an acute change of condition for whom an immediate review is requested.
• The pharmacist documents either that no irregularity was found (a signed and dated statement) or the nature of each irregularity, in a separate written report that may be paper or electronic. How fast the pharmacist notifies depends on the risk: immediate notification is expected for problems such as bleeding in a resident on an anticoagulant. The findings are part of the medical record and available to the resident or representative on request.
• The prescriber’s response must be in the resident’s record. The attending either accepts and acts on the recommendation or rejects it and documents why. The guidance states it is not acceptable to document only disagreement without giving a clinical basis.
• The facility should have a procedure for resolving situations where the attending does not concur with or does not act on an identified irregularity, and where the attending physician is also the medical director (see also F841, §483.70).
• When the attending has documented a valid clinical rationale for rejecting a recommendation, the pharmacist does not need to re-report the same irregularity each month unless a change in the resident’s condition or other circumstances warrants it.
• Surveyors investigate F756 together with F605 and F757 using one Critical Element Pathway (form CMS-20082), found in the Survey Resources download on the CMS Nursing Homes page.

What the regulation requires

Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug used (1) in excessive dose, including duplicate drug therapy; (2) for excessive duration; (3) without adequate monitoring; (4) without adequate indications for its use; (5) in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (6) any combination of these reasons.

What the surveyor guidance says

• Scope: F757 covers unnecessary medications excluding psychotropics. For concerns involving psychotropic medications, including the unnecessary-drug criteria as applied to them, surveyors are directed to F605.
• When to re-evaluate the regimen: at admission or re-admission, with any new or worsening change in condition, when the pharmacist identifies an irregularity, and after an emergency order once the acute problem has stabilized.
• Indication: the record should show why the resident is on each medication, consistent with the diagnosis, the resident’s goals and preferences, and accepted standards of practice. Non-drug approaches should be considered where appropriate.
• Dose and duplication: doses should reflect age, renal and hepatic function, and interactions. Two drugs of the same class or effect need a documented reason. The guidance points prescribers to the AGS Beers Criteria.
• Duration: medications started for a time-limited problem should have a stop date or a planned reassessment. Unnecessary antibiotic prescribing is cited at F757, and the same findings may also support F881 (antibiotic stewardship).
• Monitoring: the facility must monitor for effectiveness and for adverse consequences using the clinical and laboratory parameters appropriate to the drug, for example INR with warfarin, glucose with insulin, renal function and electrolytes with diuretics, and pain, sedation, and bowel function with opioids.
• Adverse consequences: when a resident has a new or worsening problem such as falls, confusion, anorexia, weight loss, lethargy, or bleeding, the team is expected to consider medications as a possible cause before adding another drug.
• Tapering: residents should be monitored and re-evaluated for adverse consequences and for the need to taper or stop a medication.
• Transitions: the risk of polypharmacy and duplicate therapy is highest at transitions of care. Medications started in the hospital or community without a clear documented indication call for a comprehensive evaluation of whether to continue them.

What the regulation requires

• §483.12(a)(2): the resident must be free from chemical restraints imposed for discipline or convenience and not required to treat medical symptoms.
• §483.45(c)(3): a psychotropic drug is any drug that affects brain activities associated with mental processes and behavior, including but not limited to antipsychotics, antidepressants, anti-anxiety drugs, and hypnotics.
• §483.45(e)(1): residents who have not used psychotropic drugs are not given them unless necessary to treat a specific condition that is diagnosed and documented in the clinical record.
• §483.45(e)(2): residents who use psychotropic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue the drugs.
• §483.45(e)(3): no PRN psychotropic unless necessary to treat a diagnosed specific condition documented in the clinical record.
• §483.45(e)(4): PRN orders for psychotropic drugs are limited to 14 days. If the prescriber believes a longer PRN order is appropriate, he or she should document the rationale in the medical record and indicate the duration.
• §483.45(e)(5): PRN orders for antipsychotic drugs are limited to 14 days and cannot be renewed unless the prescriber evaluates the resident for the appropriateness of that medication.
• The unnecessary drug criteria in §483.45(d) (dose, duration, monitoring, indication, adverse consequences) apply to psychotropics under this tag.

What the surveyor guidance says

• One tag for both problems. Because psychotropics can cause sedation that makes care more convenient for staff, CMS cites chemical restraint and unnecessary psychotropic use together at F605.
• Chemical restraint is judged by effect. “Convenience” means unnecessary administration of a medication that causes, intentionally or unintentionally, a change in behavior such as sedation, so that the resident is subdued or requires less effort from staff. “Discipline” means any action, including giving a medication, taken to punish or penalize a resident.
• Severity: if a medication has caused symptoms consistent with prolonged sedation that was not addressed (excessive sleeping, drowsiness, withdrawal, decreased participation in activities), noncompliance is cited at a minimum of severity level 3, actual harm.
• Signs surveyors look for: sleeping at times the resident would not ordinarily sleep, withdrawal from activities, confusion or cognitive decline, loss of function and greater ADL dependence, weight loss, skin breakdown, and new incontinence.
• Other drug classes count. Antihistamines, anticholinergics, and central nervous system agents used for conditions such as seizures, mood disorders, pseudobulbar affect, and muscle spasm are held to the psychotropic requirements when they are used in place of a psychotropic or for their effect on behavior or mental processes.
• Indication and diagnosis: without documentation that the practitioner has determined other treatments to be clinically contraindicated, the indication for a psychotropic is considered inadequate. Psychotropics started in the hospital or community without a clear documented indication, for example a history of schizophrenia without documentation supporting the diagnosis under DSM-5-TR, require a comprehensive evaluation of whether to continue.
• Unsupported diagnoses and prescriber referral: CMS states it is aware of residents given a schizophrenia diagnosis without sufficient supporting documentation. Where this causes actual harm or the likelihood of serious harm, or surveyors find a pattern (for example three or more) of the same practitioner prescribing antipsychotics for a new diagnosis lacking support, the survey team is told to consider referral to the State Medical Board or Board of Nursing.
• Non-pharmacological approaches first, unless clinically contraindicated, and continued alongside any medication. The care plan should name the target behavior or symptom and the person-centered approaches being used.
• Right to be informed: before a psychotropic is started or increased, the resident, family, or representative must be told the benefits, risks, and alternatives, including any boxed warning for antipsychotics, and may accept or decline. The record must document this; if it does not, F552 is cited (§483.10(c)).
• Gradual dose reduction: time frames must be consistent with standards of practice, with reductions in modest increments over adequate periods. The guidance gives this example of compliance: within the first year after a resident is admitted on a psychotropic or after one is started, the facility attempts a GDR in two separate quarters with at least one month between attempts, unless clinically contraindicated. The record should show the date of each attempt, the outcome, and the plan for future attempts.
• When GDR may be clinically contraindicated: reasons include, but are not limited to, (1) continued use is in accordance with current standards of practice and the physician has documented why a dose reduction would likely impair function or exacerbate an underlying medical or psychiatric disorder; or (2) target symptoms returned or worsened after the most recent GDR attempt in the facility and the physician has documented why a further attempt at that time would likely impair function, exacerbate the disorder, or increase distressed behavior. Residents with enduring, progressive, or terminal conditions such as chronic depression, Parkinson’s disease psychosis, or recurrent seizures may need these medications indefinitely.
• Monitoring: ongoing documentation of target symptoms, response, and adverse consequences such as sedation, falls, orthostasis, anticholinergic effects, movement disorders, and metabolic changes.
• PRN use without the indication: the guidance’s deficiency examples include staff giving a PRN anxiolytic nightly to help a resident sleep without a documented indication, and a PRN psychotropic order left in place beyond 14 days.

PRN psychotropic orders: the 14-day rules