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HCFA Releases Draft Guidelines on Chemical Restraints
by Diane B. Crutchfield, D.Ph., C.G.P.
Geriatric Times May/June 2001 Vol. II Issue 3
Federal regulations for long-term care facilities continue to expand. Although their sheer volume can seem overwhelming, the intent of these regulations is to ensure the safety, welfare and best possible care for the elderly population residing in nursing homes.Health care professionals working in the long-term care environment are all too familiar with the challenge of meeting the complexities of the federal regulations. In this article I will share some of the concerns with the most recent release of draft guidelines related to chemical restraints and medication use. An implementation date for these guidelines has not been determined as of yet. In addition, a number of changes to these guidelines are probable before they are eventually implemented.
Last December, the Health Care Financing Administration (HCFA) released draft guidelines on the use of chemical restraints. The guidelines are based on the Omnibus Budget Reconciliation Act of 1987 language that stated that a resident has the right to be free from chemical or physical restraints that are used for disciplinary purposes or staff convenience and that are not required to treat a resident's medical condition. Although the draft has been expected for several years, the re-emergence at this time may be due, in part, to the increased national focus on nursing homes and on the use and misuse of medications in the elderly.
Several concerns are raised with the basic definitions provided in the draft. For example, chemical restraint is defined as "any drug that is used for discipline or convenience and not required to treat medical symptoms." Note the term any. In the same section, the guidelines state, "If the resident needs emergency care, restraints may be used for brief periods to permit medical treatment." No definition of "brief period" is provided. The initial interpretation is that chemical restraints may never be used; however, a later guideline provides for their use in (undefined) emergencies.
Procedures in the guidance to surveyors at section 483.13(a) state that residents should be included in the survey sample if they "appear to be possibly chemically restrained." The instructions to the surveyors further suggest that symptoms indicative of the use of chemical restraint include dry mouth, sedation or constipation. However, these are also common side effects of many medications and are not related to the intended use of the drug.
The same section defines medical symptoms and specifically states the facility's responsibility to assure that an appropriate medical condition is documented: "While there must be a physician's order reflecting the presence of a medical symptom, HCFA will hold the facility ultimately accountable for the appropriateness of that determination."
Clearly, there are valid and significant concerns regarding the implementation of these guidelines as they are currently written. The American Society of Consultant Pharmacists (ASCP) and the American Geriatrics Society (AGS) have jointly sent comments to HCFA addressing these concerns. One of their initial recommendations is to delete the use of the term "chemical restraint" and use the description of psychopharmacological medications. The inappropriate and appropriate use of the medications also must be clearly defined.
Strict interpretation of the regulations as they are currently drafted may lead to the underuse of needed medications for fear of reprimand during state surveys.
Changes were also drafted to the unnecessary drug regulation at Tag F329. Current regulations for "long-term use of antipsychotic medications (or medications used as alternatives for antipsychotics)" state, "Antipsychotic medications…should not be used for the long-term treatment of cognitive or behavioral symptoms unless the clinical record documents that the resident has one or more of the following 'specific conditions.'" A definition for "long-term use" is not provided. Residents with hallucinations or delusions have likely already received antipsychotic medications chronically, and it would not be appropriate to discontinue them and risk a significant change in the resident's mental status.
Alternative medications listed in the draft include anti-seizure medications. However, other medications are also used as psychopharmacological interventions. The decision will be left to the surveyor to determine the appropriate use of the medication. These alternatives should not be grouped with traditional antipsychotics, as their use, side effects and monitoring are much different.
The acute use of antipsychotics, or alternatives, is described, but there are medications other than those defined by HCFA that are frequently used in acute situations, such as lorazepam (Ativan). The length of time that a medication can be utilized for an acute situation is not defined.
Changes recommended by ASCP and AGS include creating a section for the emergency use of psychopharmacological medications and defining these as medications used with the intent of changing mood, mental status or behavior.
Mood stabilizers do not require dose reductions according to these regulations, but the term is not defined. Olanzapine (Zyprexa) is one example of an antipsychotic that is also approved for use as a mood stabilizer, thus leading to possible confusion for a surveyor focused on dose reductions.
Monitoring for side effects of antipsychotic medications has been included in the regulations for several years. The new draft now adds monitoring for dizziness and alteration in level of consciousness. Elderly residents frequently suffer from vertigo that is unrelated to any medication use. Altered level of consciousness may refer to lethargy, but again this is not clearly delineated.
A statement to surveyors that facilities should not be urged to use behavioral monitoring records for antidepressant medications was deleted in the most recent draft. The concern is that antidepressant utilization may decline if this routine monitoring is required. It is also difficult to accurately measure many of the symptoms of depression on such a record.
There are some positive points in the draft regulation that should be noted. There is a focus on the nonpharmacological treatment of behavioral problems that is emphasized by the interdisciplinary approach referred to in the draft. All staff are to be trained in identifying behaviors and successful interventions. More training will be required, as the phrase "all staff" implies any person employed at the long-term care facility. A challenge will be how to educate all staff on the use of psychopharmacological medications, as is also required in the regulation.
Again, the reader must note that this is currently only a draft guideline. Physicians, consultant pharmacists and directors of nursing homes are encouraged to read and have an understanding of the draft as well as its application. Further clarification will hopefully be forthcoming before the guidelines are finalized.
This summary provides only a snapshot view of the changes that are proposed. The reader is encouraged to visit the ASCP Web site at <www.ascp.com/public/pr/hcfadraftchem.shtml> to read the entire draft and the comments that were sent to HCFA from ASCP and AGS.
Dr. Crutchfield is president of Pharmacy Consulting Care, an independent consultant pharmacy practice located in Knoxville, Tenn.
