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.