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Psychotropic Drug Use in Nursing Homes
By Edna H. Travis, Esq.
March
2005 It is well-recognized that the number of nursing
home residents with some variation of psychiatric illness continues to
grow. (The Mental Health Challenge In Long -Term Care, April 2005 issue Caring
for the Ages, Kathleen K. Frampton). Best estimates indicate that up
to 80% of nursing home residents have a mental disorder, such as Alzheimer's
disease, depression, and anxiety and psychotic disorders. Indeed, it has
been suggested that nursing homes are becoming de facto, "largely
forgotten psychiatric hospitals" a phrase attributed to William Reichman,
MD, former President of the American Association for Geriatric Psychiatry
(The
Mental Health Challenge In Long -Term Care, April 2005 issue Caring for
the Ages, Kathleen K. Frampton).
As a result, many health professionals are becoming concerned about the
adequacy and availability of resources to address this growing need. While
these concerns can be addressed through increased use of mental health
professionals and careful and sensitive evaluations of individual
patients, medications designed to combat these disorders can also provide
some relief. However, while pharmacotherapy can play an important role in
the management of psychiatric illnesses in the elderly, these drugs can be
very difficult to administer and cannot and should not be seen as a
panacea. First, a recent study published in February in JAMA documents
that many of the traditionally used psychoactive drugs were not nearly as
effective as had been previously thought. (Sink, KM, Holden, KF, Yaffe K. Pharmacological treatment of neuropsychiatric symptoms of
dementia, a review of the evidence, Journal of the American Medical
Association, jama.ama-assn.org Feb.
2, 2005). Second, even assuming that such drugs can be extremely helpful
in ensuring the psychological well-being of patients, they are easily
subject to abuse and are known to contribute to preventable and adverse
drug events including falls. (Falls
in the Nursing Home, Annals of Internal Medicine, September 1994; Falls
Among Older People: Relationship to Medication Use and Orthostatic
Hypotension, Journal of the American Geriatrics Society, 1995)
Laurence Z. Rubenstein; Karen R. Josephson; and Alan S. Robbins As a
result their use must be carefully monitored. Friends and family members
often question whether a resident has been improperly medicated and wonder
how best to inquire of the staff without fear of retribution.
BACKGROUND/LAW
The Older Americans Act and the State Ombudsman Programs The
Older Americans Act established the State Long Term Care Ombudsman program
in 1978 to ensure quality of care and advocacy on behalf of long term care
residents. It requires that each state have an ombudsman program, run by
state and local communities. The programs have multiple functions,
including identifying, investigating, and resolving complaints made on
behalf of residents, protecting the legal rights of residents, and
providing information and consultation to residents and families. All of
the states collect and report data relating to their Ombudsman programs.
(For information on the ombudsman program see the
National Long Term Care Ombudsman Center
web site, and the Administration
on Aging's
website.)
OBRA 1987 and implementing regulations
The Nursing Home Reform Act, part of the Omnibus Budget Reconciliation Act of 1987, established standards for nursing homes around the country. It provided for a state survey and certification process to enforce these standards, which include periodic assessments for each resident, a comprehensive care plan for each resident, medically related social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident, and pharmaceutical services, which include procedures to ensure that all drugs and biologicals are accurately acquired, received, dispensed and
administered. (For an overview of the Act, see AARP article The 1987 Nursing Home Reform
Act) Residents' Rights The Act and the regulations
identify a number of residents' rights. These include the right to be free from any physical or chemical restraints imposed for the purposes of discipline or convenience and not required to treat a patient's medical
condition." The Act stated that such restraints were to be used "only" where there is a threat to "physical safety."
[Nursing Home Reform
Act; Sec.
1395i-3]. Resident's Drug Regimen/Unnecessary Drugs Each resident's drug regimen must be free from unnecessary drugs, defined as any drug used in excessive dose, for excessive duration, without adequate monitoring, without adequate indication for its use, or in the presence of adverse consequences, which indicate the dosage should be reduced, or discontinued.
The Centers for Medicare and Medicaid Services has issued a state operations manual that includes a section providing guidance on
"unnecessary drugs" (pages 191-214, section 483.25(1))
use. This also includes a section with "interpretive guidelines" on the use of specific psychotropic drugs. See also
the article Appropriate
Use of Psychotropic Drugs in Nursing Homes, American Family Physician,
2000) Nursing Home Survey and Certification/Compare Database All nursing homes participating in Medicare and Medicaid must receive certification for compliance with federal requirements. This is achieved through routine surveys that use deficiency-based measures of performance, known as deficiency tags.
(Report on Comparing Nursing Home Quality and Performance by the American Health Care
Association). The deficiency tags are themselves categorized as nursing home health deficiencies (f-tags) and life-safety deficiencies (k-tags). These survey deficiencies are categorized, collected and reported in the Online Survey Certification and Reporting system (OSCAR), which provides the underlying data for the
Nursing Home Compare
Database. The CMS Nursing Home Compare database includes scores on quality indicators (QI) which
are based on Minimum Data Sets (MDS) developed
to capture potential problems in performance that would highlight certain facilities for additional review. These appear on Nursing Home Compare as "quality measures." This database is available on line to the public and provides information on individual nursing
homes. Pharmacy Review System The Act also established a pharmacy review system. Each nursing home must employ an outside consulting pharmacist who is responsible for the quality of pharmaceutical services, including ensuring that all drugs are accurately dispensed and administered in the
facility. In particular, the pharmacist must conduct a drug regimen review for each patient at least once a month.
The American Society of Pharmacy Consultants is an active professional organization providing support to pharmacy consultants and information to the public. Their web site, which includes general guidelines on the use of psychotherapeutic drugs in older adults and a policy statement on the separation of pharmacy providers, can be found at
www.ascp.com.
REGULATION OF PSYCHOTROPIC MEDICATIONS Psychotropic medications, also described as
"psycho-pharmacologic medications,"
"psychoactive" or "psychotherapeutic" medication, are drugs that affect brain activities associated with mental processes and behavior. They are divided into four broad categories; anti-psychotic, anti-depressant, anti-anxiety, and hypnotic.
Where these medications are used, when less aggressive treatment could be effective, they are considered to be "chemical
restraints" (Generally, chemical restraints can be described as the use of a drug to control behavior (such as pacing, restlessness, uncooperativeness) and they are legally appropriate only if used to ensure the physical safety of residents or others.)
In addition to prohibiting the use of unnecessary drugs, the regulations specifically address the use of
anti-psychotic drugs. Residents who have not previously used anti-psychotic drugs should not be given these drugs unless anti-psychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record. Further, residents who use anti-psychotic drugs must receive gradual dose reductions and behavioral interventions, unless clinically contradicted, in an effort to discontinue
their use.
Several of the deficiencies identified in the Nursing Home Surveys relate directly to psychotropic drug use: Tag number F222 (inappropriate chemical restraints), Tag number F329 (unnecessary psychotropic drugs); and Tag number F330 (specific to anti-psychotic drug use in residents who do not have a specific condition as diagnosed and documented in the medical record).
(Report on Psychotropic Drug Use)
Some of the quality indicators are specific to psychotropic drug therapy (#19: prevalence of antipsychotic use in absence of psychotic or related conditions (risk adjusted: low and high risks); #20 prevalence of antianxiety/hypnotic use; and #21 prevalence of hypnotic use more than two times in last week. There are also quality indicators for prevalence of symptoms of depression (#4) and prevalence of symptoms of depression without antidepressant therapy (#5).
(Caring for the Ages, "A Practical Way to Use the Quality Indicators in Long Term
Care, May 2003).
1998 study and 2001 Report In 1997, the
US Senate Committee on Aging called attention to reports of continued problems with the well-being of patients in nursing homes due to inadequate care.
The use pf psychotropic drugs to control behavior was one of the issues
raised. Noting that usage rate for psychotropic drugs had been increasing since 1995, the Committee expressed concerns about whether they were being used as inappropriate chemical restraints.
In November, 2001, at the request of the Committee, the Office of the Inspector General reviewed the use of psychotropic drugs in nursing homes and published a report of its study, entitled Psychotropic Drug Use in Nursing Homes. The Report concluded that the use of psychotropic drugs in nursing homes was generally appropriate. According to the Report, eighty five percent of residents' drug use was medically appropriate, with 8 percent using psychotropic drugs inappropriately because the dose was too high due to (1) failure to follow appropriate drug dose reductions, (2) unjustified chronic use of the drug, (3) lack of a documented benefit to the resident, (4) giving the wrong type of drug for a particular diagnosis, or (5) unnecessary duplicate therapy. The report also concluded that a growth in the proportion of nursing home residents with mental disorders may contribute to the increase in psychotropic drug
use. The authors noted however "that lack of adequate documentation for residents' psychotropic drug use is of some concern. The Centers for Medicare and Medicaid Services may consider educating providers to better document the appropriate use of these drugs."
The Agency commented that it believed that the report would contribute to a better understanding of psychotropic drug use in nursing homes and identifying areas for further focus. It also noted that training related to psychotropic drug use and related documentation issues was already underway or planned.
(Psychotropic Drug Use in Nursing Homes)
ENFORCEMENT OF THE ACT
Nursing homes receive Medicaid and Medicare payments for long term care only if they are certified by the state as being in substantial compliance with the requirements of the Act.
If the survey reveals that a nursing home is out of compliance, the government regulator is authorized to begin enforcement. The severity of the remedy depends on whether the deficiency puts a resident in immediate jeopardy and whether the deficiency is an isolated incident, part of a pattern, or widespread throughout the facility. A wide range of sanctions can be imposed, such as directed in-service staff training, imposing a directed plan of correction, state monitoring, civil monetary penalties, denial of payment of all new Medicare or Medicaid admissions, denial of payment for all Medicaid and Medicare patients, temporary management, and termination of the provider agreement.
(Federal
and State Enforcement of the 1987 Nursing Home Reform Act, AARP February 2001, Bernadette Wright). (
42 CFR
488, Enforcement provisions begin at 488.320) The Act cannot be enforced by individuals, although other forms of recourse are available to them.
Recently, questions are beginning to emerge about the adequacy of federal and state enforcement. In a recent study (May 2005,) AARP reported on that there have been weaknesses in state and federal monitoring and enforcement activities. It concluded that inadequate enforcement has seriously limited the effectiveness of the Act, and that although quality has improved in some areas, more work is needed to improve the quality of both care and life in nursing
homes ( Enforcement of Quality Standards in Nursing Homes,
AARP, May 2005; see also, New York said to be Lax Inspecting Nursing
Homes, discussing study by the Long Term Care Community Coalition, New
York Times, May 16, 2005).
CURRENT ISSUES/WHAT'S HAPPENING NOW? Many older adults benefit from new and improved medicines. However, for many reasons, they are also more likely to be at risk for adverse reactions to drugs, negative drug interactions, or drug overdoses. Elderly people metabolize drugs slowly.
Indeed it is well-documented that the elderly are particularly susceptible to having dangerous and inappropriate drug regimens prescribed for them.
Psychotropic drugs, which calm and combat depression and are often prescribed to alleviate anxiety, angry behavior, screaming, delusions and paranoia, are among the drugs that can often benefit older adults. However, they are often associated with preventable and adverse drug related events such as oversedation, confusion, hallucinations and falls.
(Falls
in the Nursing Home, Annals of Internal Medicine, September 1994; Falls
Among Older People: Relationship to Medication Use and Orthostatic
Hypotension, Journal of the American Geriatrics Society, 1995). Because these drugs are easily subject to abuse, their use in nursing homes is specifically regulated to ensure that they are not used inappropriately to address issues such as restraint, falls, or restlessness.
This issue has a strong emotional component. Visiting families expect to find their relatives alert and responsive and become concerned if they
see them as unduly sedated. On the other hand, visitors hope and expect to find a pleasant and peaceful environment and can become distressed if
a resident is agitated, or is surrounded by other agitated and noisy patients.
It is well known that families are often reluctant to raise questions or complain
out of fear that staff or management will find a way to retaliate against the friend or relative.
Beyond the evaluation of the prescribing physician, the most direct control imposed by the federal
regulations may well lie in the hands of the consulting pharmacist who is responsible for monitoring the use of medication. The
American Society of Consultant Pharmacists, also provides guidance to pharmacists and to the public.
ASCP has general guidelines on the use of psychotherapeutic
medications in older adults and a
policy statement on the separation of pharmacy providers (dispensers) and
consultants.
The role is not without its conflicts, however. The consulting pharmacist is employed by the nursing facility itself and the pharmacist's review is subject to obstacles, human error, and time constraints. The pharmacist depends on access to medical records, diagnoses and lab reports, and other patient records, which are sometimes
incomplete. In a 1997 U.S. Department of Health and Human Service Report "Prescription Drug Use in Nursing Homes," based on a Texas Nursing Home study, it was found that on average the pharmacist spent 15 to 20 minutes on an initial patient review and 5 to 10
minutes per month on subsequent reviews. One third of pharmacists conducting reviews said they had difficulty obtaining a patient's diagnosis and necessary lab reports. Likewise, in a
Massachusetts study, investigators said that the drug orders by health care providers and failure to adequately monitor residents were observed to be the most frequent causes of preventable adverse drug events.
Most commonly, doctors and staff made ordering errors, gave wrong doses,
ordered drugs with harmful interactions, and made wrong choices of drugs. (Inside View by Consultant Pharmacists
(AARP: AgeLine Record with Abstract).
www.seniorcarepharmacist.com and the American Medical Directors'
Association, provide information on their web sites about the effectiveness of the consulting
pharmacist.)
WHAT CAN YOU DO?
Individuals have no independent right to enforce the statute and regulations, but there are other recourses available to them
(www.medicare.gov/NHCompare/home.asp); AARP Bulletin (Checklist:
What to Look for in a Nursing
Home, April 2002)
2. Check out the Ombudsman program in your state; an independent third party may be able to help where a family member feels uncomfortable
or may fear retaliation.
3. Look for these symptoms of overmedication
4. See if your facility has a Family
Council. The federal government allows family members to advocate for residents as part of a family council.
The government requires nursing homes to allow family members to use space for meetings without staff
members. Several states also require that nursing homes establish family councils. New York recently passed a Family Council Law, as did Massachusetts. New York regulations are located at Title 10, sec. 415.5 ( c ). These regulations require that a facility staff member listen to the views and act upon the grievances of residents and families.
4. Locate a state organization that will advocate on your behalf. Although the Ombudsman Programs are
intended to intervene on behalf of
patients themselves, other groups provide support to the families and friends of nursing homes patients.
The Friends and Relatives of Institutionalized Aged
(FRIA) is one such organization, based in New York. FRIA's goal is to assist families
in ensuring that nursing home residents receive proper care. It helps relatives become effective advocates of the needs of their loved ones. The
FRIA website has information on identifying overmedications, in addition to many other articles and publications. OTHER RESOURCES AARP Article
(If Nursing Home Problems
Occur)
Book entitled Drug Related Problems in Geriatric Nursing Home
Patients, 1991.
And a 2001 report entitled
Psychotropic Drug Use in Nursing
Homes.
Article in Journal of Applied Gerontology, Vol. 18, No. 1 March 1999 entitled
"Changes in resident and facility risk factors for psychotropic drug use in nursing homes since the Nursing Home Reform
Act."
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