Laws on unnecessary drugs and gradual dose reduction


USC – United States Code

CFR – Code of Federal Regulations

H&S – Code California Health and Safety Code

Laws on unnecessary drugs and gradual dose reduction:

  • 42 CFR §483.25(l)
  • 42 USC §1396r(c)(1)(D)
  • Note: The excerpt of the following regulation contains pertinent provisions on the prohibition of unnecessary drugs but excludes other parts of the regulation.

    Code of Federal Regulations, Title 42, Section 483.25(1)

    Quality of care.

    Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance

    with the comprehensive assessment and plan of care.

    (l) Unnecessary drugs–(1) General. Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:

    (i) In excessive dose (including duplicate drug therapy); or

    (ii) For excessive duration; or

    (iii) Without adequate monitoring; or

    (iv) Without adequate indications for its use; or

    (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or

    (vi) Any combinations of the reasons above.

    (2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that–

    (i) 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

    (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

    Additional Information on Unnecessary Drug Standards: The federal Centers for Medicare and Medicaid Services (CMS), the federal agency that oversees nursing homes, has published extensive guidelines interpreting the above regulation on unnecessary drugs. The guidelines, consisting of about 82 pages, provide direction on when antipsychotic drug use is considered inappropriate. CMS publishes the guidelines at F-329 in Appendix PP (Guidance to Surveyors for Long Term Care Facilities) to its State Operation Manual:

    United States Code, Title 42, Section 1396r(c)(1)(D)

    (D) Use of psychopharmacologic drugs

    Psychopharmacologic drugs may be administered only on the orders of a physician and only as part of a plan (included in the written plan of care described in paragraph (2)) designed to eliminate or modify the symptoms for which the drugs are prescribed and only if, at least annually, an independent, external consultant reviews the appropriateness of the drug plan of each resident receiving such drugs. In determining whether such a consultant is qualified to conduct reviews under the preceding sentence, the Secretary shall take into account the needs of nursing facilities under this subchapter to have access to the services of such a consultant on a timely basis.

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