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F329 (Rev. 22, Issued: 12-15-06, Effective/Implementation: 12-18-06)

§483.25(l) Unnecessary Drugs

  1. General. Each resident’s drug regimen must be free from unnecessary drugs.  An unnecessary drug is any drug when used:
    1. In excessive dose (including duplicate therapy); or
    2. For excessive duration; or
    3. Without adequate monitoring; or
    4. Without adequate indications for its use; or
    5. In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
    6. Any combinations of the reasons above.
  2. Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that:
    1. Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and
    2. Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

INTENT: §483.25(l) Unnecessary drugs

The intent of this requirement is that each resident’s entire drug/medication regimen be managed and monitored to achieve the following goals:

  • The medication regimen helps promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being, as identified by the resident and/or representative(s) in collaboration with the attending physician and facility staff;
  • Each resident receives only those medications, in doses and for the duration clinically indicated to treat the resident’s assessed condition(s);
  • Non-pharmacological interventions (such as behavioral interventions) are considered and used when indicated, instead of, or in addition to, medication;
  • Clinically significant adverse consequences are minimized; and • The potential contribution of the medication regimen to an unanticipated decline or newly emerging or worsening symptom is recognized and evaluated, and the regimen is modified when appropriate.

NOTE: This guidance applies to all categories of medications including antipsychotic medications.

Although the regulatory language refers to “drugs,” the guidance in this document generally will refer to “medications,” except in those situations where the term “drug” has become part of an established pharmaceutical term (e.g., adverse drug event, and adverse drug reaction or consequence).

For purposes of this guidance, references to “the pharmacist” mean the facility’s licensed pharmacist, whether employed directly by the facility or through arrangement.

The surveyor’s review of medication use is not intended to constitute the practice of medicine. However, surveyors are expected to investigate the basis for decisions and interventions affecting residents.

Definitions are provided to clarify terminology related to medications and to the evaluation and treatment of residents.

  • “Adverse consequence” is an unpleasant symptom or event that is due to or associated with a medication, 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., medicationmedication, medication-food, and medication-disease).

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” is 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, or hallucinations.​​
  • “Behavioral interventions” are individualized non-pharmacological approaches (including direct care and activities) that are provided as part of a supportive physical and psychosocial environment, and are directed toward preventing, relieving, and/or accommodating a resident’s distressed behavior.
  • “Clinically significant” refers to effects, results, or consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status.
  • “Distressed behavior” is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.
  • “Dose” is 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.
    • “Excessive dose” means 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, current standards of practice for a resident’s age and condition, or clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals and that lacks evidence of:

– A review for the continued necessity of the dose;

– Attempts at, or consideration of the possibility of, tapering a medication; and

– A documented clinical rationale for the benefit of, or necessity for, the dose or for the use of multiple medications from the same pharmacological class.

  • “Duplicate therapy” refers to multiple medications of the same pharmacological class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking.
  • “Duration” is the total length of time the medication is being received.
    • “Excessive Duration” means the medication is administered beyond the manufacturer’s recommended time frames or facility-established stop order policies, beyond the length of time advised by current standards of practice, clinical practice guidelines, clinical studies or evidence-based review articles, and/or without either evidence of additional therapeutic benefit for the resident or clinical evidence that would warrant the continued use of the medication.
  • “Extrapyramidal symptoms (EPS)” are neurological side effects that can occur at any time from the first few days of treatment to years later. EPS includes various syndromes such as:
    • Akathisia, which refers to a distressing feeling of internal restlessness that may appear as constant motion, the inability to sit still, fidgeting, pacing, or rocking.
    • Medication-induced Parkinsonism, which refers to a syndrome of Parkinson-like symptoms including tremors, shuffling gait, slowness of movement, expressionless face, drooling, postural unsteadiness and rigidity of muscles in the limbs, neck and trunk.
    • Dystonia, which refers to an acute, painful, spastic contraction of muscle groups (commonly the neck, eyes and trunk) that often occurs soon after initiating treatment and is more common in younger individuals.
  • “Gradual Dose Reduction (GDR)” is the stepwise tapering of a dose to determine if symptoms, conditions, or risks can be managed by a lower dose or if the dose or medication can be discontinued.
  • “Indications for use” is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and 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.
  • “Insomnia” is the inability to sleep characterized by difficulty falling asleep, difficulty staying asleep, early waking, or non-restorative sleep, which may result in impaired physical, social, or cognitive function.
  • “Medication Interaction” is the impact of another substance (such as another medication, nutritional supplement including herbal products, food, or substances used in diagnostic studies) upon a medication. The interactions may alter absorption, distribution, metabolism, or elimination. These interactions may decrease the effectiveness of the medication or increase the potential for adverse consequences.
  • “Medication Regimen Review” (MRR) is a thorough evaluation of the medication regimen by a pharmacist, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medication. The review includes preventing, identifying, reporting, and resolving medication-related problems, medication errors, or other irregularities in collaboration with other members of the interdisciplinary team.51
  • “Monitoring” is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to:
    • Ascertain the individual’s response to treatment and care, including progress or lack of progress toward a therapeutic goal;
    • Detect any complications or adverse consequences of the condition or of the treatments; and
    • Support decisions about modifying, discontinuing, or continuing any interventions.
  • “Neuroleptic Malignant Syndrome” (NMS) is a syndrome related to the use of medications, mainly antipsychotics, 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.
  • “Non-pharmacological interventions” refers to approaches to care that do not involve medications, generally directed towards stabilizing or improving a resident’s mental, physical or psychosocial well-being.
  • “Psychopharmacological medication” is any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.
  • “Serotonin Syndrome” is a potentially serious clinical condition resulting from over stimulation 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 heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea.
  • “Tardive dyskinesia” refers to abnormal, recurrent, involuntary movements that may be irreversible and typically present as lateral movements of the tongue or jaw, tongue thrusting, chewing, frequent blinking, brow arching, grimacing, and lip smacking, although the trunk or other parts of the body may also be affected.

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