Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
Psychotropic Drug Use 
in Nursing Homes 
JANET REHNQUIST 
Inspector General 
NOVEMber 2001 
OEI-02-00-00490  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 
protect the integrity of the Department of Health and Human Services programs as well as the 
health and welfare of beneficiaries served by them.  This statutory mission is carried out through a 
nationwide program of audits, investigations, inspections, sanctions, and fraud alerts.  The 
Inspector General informs the Secretary of program and management problems and recommends 
legislative, regulatory, and operational approaches to correct them. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 
Inspector General.  It conducts short-term management and program evaluations (called 
inspections) that focus on issues of concern to the Department, the Congress, and the public.  The 
inspection reports provide findings and recommendations on the efficiency, vulnerability, and 
effectiveness of departmental programs. 
OEI's New York regional office prepared this report under the direction of John I. Molnar, 
Regional Inspector General, and Renee C. Dunn, Deputy Regional Inspector General.  Principal 
OEI staff included: 
REGION  HEADQUARTERS 
Demetra Arapakos, Project Leader
 Brian Ritchie, Director, Technical Support Staff

Patricia Banta, Lead Analyst
 Bambi Straw, Program Specialist

Miriam Gareau, Program Analyst
 Barbara Tedesco, Mathematical Statistician

Thomas Zimmerman, Program Analyst

Robert Gibbons, Region IX

.

To obtain copies of this report, please call the New York Regional Office at (212) 264-2000. 
Reports are also available on the World Wide Web at our home page address: 
http://www.hhs.gov/oig/oei  E X E C U T I V E  S U M M A R Y  
PURPOSE 
To assess the extent and nature of inappropriate psychotropic drug use in nursing homes 
and how it relates to chemical restraints. 
BACKGROUND 
The Senate Special Committee on Aging requested that the Office of Inspector General 
look at the extent to which psychotropic drugs in nursing homes are being used as 
inappropriate chemical restraints.  Usage rates for these drugs have been increasing since 
1995.  A chemical restraint is the use of a drug to control an individuals behavior and is 
legally appropriate only if used to ensure the physical safety of residents or other 
individuals. 
Psychotropic medications 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 medications.  The Centers for Medicare & Medicaid 
Services established guidelines for the appropriate use of these drugs in nursing homes. 
Several programs exist to monitor the quality of care in nursing homes, including the 
appropriate use of psychotropic drugs.  These include the nursing home survey and 
certification process and the State Long Term Care Ombudsman program. 
We combined five methods for this inspection: 1) a medical record review of 485 nursing 
home residents taking psychotropic drugs; 2) an analysis of survey and certification and 
ombudsman program data; 3) an assessment of 135 nursing home Drug Regimen Reviews; 
4) on-site visits to 10 nursing homes; and 5) a telephone survey of 20 survey and 
certification and ombudsmen staff.  We excluded anti-depressants from our review. 
FINDINGS 
Psychotropic drug use in nursing homes is generally appropriate 
Eighty-five percent of residents psychotropic drugs use is medically appropriate.  Nearly 
all have the potential to benefit functionally from their drug therapy and are using the 
drugs within Medicare guidelines for appropriate use. 
Another 8 percent of residents are using psychotropic drugs inappropriately. These drugs 
are inappropriate for one or more of the following reasons: the dose is too high because 
i 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  appropriate dose reductions are not followed; there is unjustified chronic use of the drug; 
there is no documented benefit to the resident; the wrong type of drug is being given for a 
particular diagnosis; and there is unnecessary duplicate drug therapy.  The use of 
psychotropic drugs as an inappropriate chemical restraint does not appear to be 
widespread; our medical record reviewers could not conclusively determine that any of the 
inappropriate drug use was a chemical restraint.  Finally, for 7 percent of residents, 
reviewers could not determine the appropriateness of their psychotropic drug use due to 
insufficient medical record documentation. 
Data from survey and certification and ombudsman programs support the 
findings of the medical record review 
Deficiencies from the Online Survey Certification Reporting System that directly cite the 
misuse of chemical restraints and psychotropic drugs are not common.  Deficiency tag 
F222, (inappropriate chemical restraints) comprises 0.08 percent of all deficiencies in the 
current survey and has decreased slightly over the past four surveys.  Further, tag F329 
(unnecessary psychotropic drugs) comprises 2 percent of all deficiencies in the current 
survey and has remained constant.  Also, most surveyors in our sample States concur that 
inappropriate chemical restraints are not common. 
Similarly, Ombudsman complaints specific to the inappropriate use of chemical restraints 
and psychotropic drugs are not prevalent.  In 1999, complaints about physical and 
chemical restraints accounted for 1 percent of all nursing home complaints, while those 
about the use of psychoactive drugs comprised just 0.25 percent of the total. 
A growth in the proportion of nursing home residents with mental disorders may 
contribute to increasing psychotropic drug rates 
Data from the Online Survey Certification Reporting System show that from 1995 to 1999 
the overall national drug usage rate for anti-psychotics grew from 16 to 19.4 percent. 
During this time period, anti-anxiety drug rates increased from 14.3 to 15.7 percent.  At 
the same time, data from this system show that over the last four surveys the proportion of 
residents with a documented psychiatric disorder, excluding dementia, increased from 13 
to 16 percent and the proportion with behavioral symptoms grew from 29 to 31 percent. 
Further, numerous articles have linked the increasing prevalence of mental disorders 
among nursing home residents to higher psychotropic drug rates. 
CONCLUSION 
In response to concerns expressed by the Senate Special Committee on Aging about the 
use of psychotropic drugs as inappropriate chemical restraints in nursing homes, this 
report finds that these drugs are generally being used appropriately.  While drug usage 
ii 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  rates for anti-psychotic and anti-anxiety medications have been rising, most psychotropic 
drug use in nursing homes is medically appropriate.  Where it is inappropriate, the 
problems do not appear to be related to inappropriate chemical restraints but rather to 
inappropriate dosage, chronic use, a lack of documented benefit to the resident, and 
inappropriate duplicate drug therapy.  We do note, however, that lack of adequate 
documentation for residents psychotropic drug use is of some concern.  The Centers for 
Medicare & Medicaid Services may consider educating providers to better document the 
appropriate use of these drugs. 
AGENCY COMMENTS 
We received comments on the draft report from the Centers for Medicare & Medicaid 
Services.  They believe that the report will contribute to a better understanding of 
psychotropic drug use in nursing homes and in identifying areas for further focus.  The 
CMS also notes that training related to psychotropic drug use and related documentation 
issues is already underway or planned. 
iii 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  T A B L E   O F   C O N T E N T S  
PAGE

EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  i 

INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

FINDINGS

Nursing home psychotropic drug use generally appropriate  . . . . . . . . . . . . . . . . . . . . . . 8

Survey and certification and ombudsman data support medical record review . . . . . . . .  10

Growth in resident mental disorders may contribute to increasing drug rates . . . . . . . . .  11

CONCLUSION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14

APPENDIX

A:  Confidence intervals for key medical record review findings . . . . . . . . . . . . . . . . . .  15

B:  Agency Comments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

iv 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  I N T R O D U C T I O N  
PURPOSE 
To assess the extent and nature of inappropriate psychotropic drug use in nursing homes 
and how it relates to chemical restraints. 
BACKGROUND 
The Senate Special Committee on Aging requested that the Office of Inspector General 
look at the extent to which psychotropic drugs in nursing homes are being used as 
inappropriate chemical restraints.  Usage rates for these drugs have been increasing since 
1995.  A chemical restraint is the use of a drug to control an individuals behavior and is 
legally appropriate only if used to ensure the physical safety of residents or other 
individuals. 
We are also releasing a companion report entitled Psychotropic Drug Use in Nursing 
Homes Supplental Information - 10 Case Studies, OEI-02-00-00491, which presents 
information from on-site visits to ten nursing homes. 
Psychotropic Medications 
Psycho-pharmacologic medications are drugs that affect brain activities associated with 
mental processes and behavior.  These drugs are also called psychoactive or 
psychotherapeutic medications.  For clarity, we will refer to this class of drugs 
throughout our study as psychotropics.  Psychotropic medications are divided into four 
broad categories: anti-psychotic; anti-depressant; anti-anxiety; and hypnotic medications. 
Anti-psychotic Drugs.  Anti-psychotic medications are used to treat various psychoses 
and neurologic conditions.  These include schizophrenia, schizoaffective disorder, 
delusional disorder, psychotic mood disorder, acute psychotic episode, Tourettes 
syndrome, and Huntingtons disease.  Other indications for long-term anti-psychotic use in 
the elderly are organic mental syndromes (including dementia with associated psychotic 
and/or agitated features defined by certain behaviors that are harmful to self or others) 
and mood disorders with psychotic features. 
Anti-psychotics are classified as either conventional or atypical.  Conventional anti-
psychotics have several serious side effects.  These side effects prompted the development 
of newer drugs called atypical anti-psychotics, which came onto the market 
1 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  in the mid 1990s.  Clinical trials have demonstrated their effectiveness for a variety of 
disorders in the elderly, including schizophrenia and other psychoses.  Although atypical 
anti-psychotics elicit fewer adverse reactions, other characteristics of these drugs, such as 
the effects on residents cognition, have not been thoroughly tested.1 
Anti-depressant Drugs.  Anti-depressant drugs are usually used in the treatment of 
depression and agitation.  Anti-depressants in low dosages are also used to treat insomnia. 
Side effects include excessive sedation, anti-cholinergic effects (dry mouth, constipation, 
urinary retention, blurred near vision, rapid heart rate, confusion, and disorientation), 
orthostatic hypotension (which can predispose a resident to falls), and electro 
cardiographic changes.  Most anti-depressants have a long enough half-life that the 
elderly, who have lower tolerance levels for most drugs, require smaller and less frequent 
doses. 
Anti-anxiety and Hypnotic Drugs.  Anti-anxiety drugs are used for the short-term 
management of anxiety and insomnia.  Hypnotics are medications used for short-term 
sleep aids.  However, even lower dosages of these two categories of drugs in the elderly 
population are associated with impairment of daytime functioning and may in some cases 
increase confusion and disorientation, which may in turn exacerbate problem behaviors.2 
Omnibus Budget Reconciliation Act of 1987 
On December 22, 1987, Congress enacted comprehensive nursing home reform with the 
Omnibus Budget Reconciliation Act (OBRA) of 1987 (P.L. 100-203).  As part of OBRA 
1987, Congress passed the comprehensive Nursing Home Reform Act (NHRA).  This Act 
mandates that residents be free from physical or chemical restraints imposed for the 
purposes of discipline or convenience.  It also states that restraints may only be imposed 
to ensure the physical safety of the resident or other residents and only upon the written 
order of a physician that specifies the duration and circumstances under which the 
restraints are to be used.  Further, NHRA limits the use of as needed (P.R.N.) orders 
and requires efforts to withdraw the drug or decrease dosage be made for residents who 
are receiving psychotropic drugs. 
Additionally, the Omnibus Budget Reconciliation Act (OBRA) of 1990 requires the 
regulation of certain drugs in nursing homes and the establishment of Drug Regimen 
Reviews for nursing home residents.  The provisions of Section 4401 of OBRA 1990 
1  Cohen, Lawrence, J., Burke, William, J. (1999) Appropriate Use of Anti-psychotics for 
Residents with Dementia in the Long-Term Care Setting, Consultant Pharmacist 14, (2). 
2 Stimmel, Glen (1996) Use of Sedation in Patients with Behavioral Disturbances of Dementia, 
Consultant Pharmacist 11, (Supplement D): 9-11. 
2 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  involve pharmacists more actively in patient care by refocusing pharmacists from a 
product oriented role to one involving clinical practice responsibilities for reducing 
potential drug therapy problems. 
The Centers for Medicare and Medicaid Services Regulations 
To implement the requirements of OBRA 1987, on February 2, 1989, the Center for 
Medicare & Medicaid Services (CMS), formerly known as the Health Care Financing 
Administration, finalized regulations (42 C.F.R 483.25(1)) on anti-psychotic medications 
and unnecessary drugs.  These regulations were further refined in 1991.  The CMS 
regulations state that each residents drug regimen must be free from unnecessary drugs 
and define what is considered an unnecessary drug.  An unnecessary drug is any drug 
used: 
C  in excessive dose; 

C  for excessive duration; 

C  without adequate monitoring or without adequate indications for its use; 

C  in the presence of adverse consequences, which indicate the dosage should

be reduced or discontinued; or 
C  without specific target symptoms. 
In addition, the CMS regulations state that 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, the regulation mandates that residents who use anti-psychotic drugs receive 
gradual dose reductions and behavioral interventions, unless clinically contraindicated, in 
an effort to discontinue these drugs. 
In July 1995, the CMS completed the final step in the implementation of OBRA 1987 by 
introducing new tasks into the nursing home survey process.  Further refinements to 
survey procedures and interpretive guidelines were implemented on July 1, 1999.  Some of 
these are specific to psychotropic drug therapy, including: new investigative protocols and 
the incorporation of quality indicators (QIs) based on the Minimum Data Set (MDS) into 
the off-site survey process;  an update to the list of anti-psychotic drugs that can be cited 
as unnecessary or misused under tag number F329; the addition of drug therapy 
guidelines; and a revised definition of medication error.  Additionally, the updated CMS 
regulations change some anti-psychotic dosing restrictions and list medications considered 
potentially hazardous to the elderly. 
Nursing Home Monitoring Programs 
Several programs exist to monitor the quality of care in nursing homes.  These programs 
can act as a safeguard against the use of psychotropic drugs as inappropriate chemical 
3 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  restraints and provide a venue for receiving and handling complaints about such misuse. 
Nursing Home Survey and Certification.  All Medicare and/or Medicaid participating 
nursing homes must be certified in meeting certain Federal requirements.  Nursing home 
certification is achieved through routine surveys.  The CMS contracts with States to 
perform these surveys for Medicare and dually-eligible nursing homes.  All nursing homes 
are subject to an unannounced standard survey no later than 15 months after the date of 
the previous standard survey.  If during the standard survey a nursing home is found to 
have provided substandard quality of care, an additional extended survey will be 
conducted within 2 weeks.  During either type of survey, a surveyor may cite the nursing 
home for a deficiency if that facility fails to meet specific requirements. 
Survey deficiencies are categorized, collected, and reported in the Online Survey 
Certification and Reporting System (OSCAR).  Several deficiencies relate directly to 
pyschotropic drug misuse.  For example, tag number F329 is cited for all unnecessary 
drugs including: anti-anxiety, anti-depressant, anti-psychotic, and hypnotic drug use.  Tag 
number F330 is specific to anti-psychotic drug use in residents who do not have a specific 
condition as diagnosed and documented in the medical record, and tag number F222 is 
cited for inappropriate chemical restraints.  In addition, other tags that address quality of 
care, residents rights, and drug regimen reviews also indirectly relate to the misuse of 
psychotropic drugs. 
Ombudsman Program.  The State Long Term Care Ombudsman program was 
established in 1978 by the Older Americans Act to ensure quality of care and advocacy on 
behalf of long term care residents.  It requires that each State have an Ombudsman 
program, which are run by States and local communities and use both paid and volunteer 
staff.  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 systematically collect and report data relating to their Ombudsman 
Program under the National Ombudsman Reporting System (NORS).  Two of the 
complaint categories in NORS specifically relate to the use of psychotropic drugs - one for 
chemical and physical restraints and the other for psychotropic drug assessment, use, and 
evaluation.  Other categories indirectly address this problem, such as weight loss, 
assistance in eating, and functionality. 
METHODOLOGY 
We combined five methods for this inspection: 1) a medical record review of residents 
taking psychotropic drugs; 2) an analysis of nursing home survey and certification and 
4 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  ombudsman program data; 3) an assessment of nursing home Drug Regimen Reviews; 4) 
on-site visits to 10 nursing homes; and  5) a telephone survey of State survey and 
certification and ombudsmen staff.  The findings of the on-site visits are presented in a 
companion report, Psychotropic Drug Use in Nursing Homes Supplemental Information -
10 Case Studies, OEI-02-00-00491. 
We excluded anti-depressants from our review because depression in nursing home 
residents has historically been under-diagnosed and under-treated.  Therefore, the increase 
in anti-depressant use is generally considered to be appropriate. 
Nursing home and resident sample 
We used a two-stage cluster sample for this inspection.  In the first stage of sampling, we 
used the OSCAR current survey file to select a random sample of 203 nursing homes. 
For each of the nursing homes in our sample, we requested their enrollment census for the 
month of November 2000.  From this census, we asked the nursing homes to identify 
which residents received a psychotropic drug and what type (anti-psychotic, anti-anxiety, 
hypnotics, and/or anti-depressants) they received.  We obtained a response from 196 of 
the 203 nursing homes, for an overall response rate of 97 percent. 
In the second stage of sampling, we selected a random sample of 587 nursing home 
residents.  From each of the 196 nursing home enrollment lists we randomly selected 3 
residents who received either an anti-psychotic, anti-anxiety, and/or a hypnotic during 
November 2000 (we excluded residents solely on anti-depressants).  One nursing home 
had only two residents who met these criteria and we sampled both residents. 
Medical record review 
For each of the residents in our sample, we requested their complete clinical records for 
May 2000 through November 2000.  Among the documentation we requested were 
admission sheets, plans of care, nurses and physicians notes, medication administration 
records, psychiatric and neurological assessments, behavior management records, and 
physician orders. 
We received 574 of the 587 medical records that we requested, for a medical record 
response rate of 98 percent.  If we had obtained a response from all 203 nursing homes in 
our first stage of sampling and had sampled 3 residents from each one, our overall 
response rate for medical records would have been 94 percent.  Of the 574 medical 
records we did receive, we sent 485 for medical record review.  The other 89 residents did 
not meet our sampling criteria and were excluded from the medical record review.  While 
they were identified by their nursing home as having received a psychotropic drug in 
November 2000, their record showed no evidence that they had actually used the drug. 
Many of these residents had PRN (as necessary) orders that were not administered in 
November.  Other residents were taking these drugs for non-psychiatric reasons. 
5 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  We used an independent contractor to conduct the medical record review.  First, together 
with the contractor, we developed a screening instrument to review the residents records. 
The screening instrument was based on the CMS guidelines for the appropriate use of 
psychotropic drugs.  We also obtained input on this instrument from the American 
Association of Geriatric Psychiatrists and the American Medical Directors Association. 
Nurse screeners with geriatric experience initially reviewed all the records; the cases that 
did not pass this initial screening were passed on for second level review. 
Both a geriatric psychiatrist and a consultant pharmacist conducted the second level 
review.  These reviewers determined a drug to be inappropriate if, based on the clinical 
documentation in the medical record, the drug was not medically necessary or reasonable. 
See Appendix A for confidence intervals on key findings of the medical record review. 
Analysis of nursing home survey and certification and ombudsman program data 
We examined data from both the OSCAR and NORS.  In OSCAR, we looked at nursing 
home deficiencies for chemical restraints (F222), unnecessary psychotropic drugs (F329), 
and psychotropic drug use in the absence of a documented diagnosis (F330).  In NORS, 
we looked at complaints made to Ombudsman about physical and chemical restraints 
(H60) and psychoactive drugs (H62).  For both sets of data, we looked at both the 
prevalence of and changes over time for each of the specific deficiencies and complaints. 
Assessment of Drug Regimen Reviews 
From the 196 nursing homes that responded to our request for an enrollment list, we 
requested 6 months of drug regimen reviews (DRRs).  Overall, 135 nursing homes 
submitted these DRRs.  We did not follow-up with the other 61 nursing homes.  We 
reviewed a selection of these DRRs to determine how they assure that psychotropic drugs 
are being used appropriately. 
Site visits 
We selected a purposive sub-sample of 10 nursing homes in different States to visit on-
site.  These 10 nursing homes were selected based on five criteria: 1)  geographical 
location, 2) number of residents in November 2000, 3) drug usage rate, 4) urban/rural 
location, and 5) ownership status.  We chose nursing homes in California, Florida, Idaho, 
Maryland, Massachusetts, Missouri, New York, Ohio, Texas, and Wisconsin.  Five of the 
facilities were large (more than 100 residents), four were medium (61-99 residents), and 
one was small (less than 60 residents).  Also, four of the homes had a high psychotropic 
drug usage rate (greater than 34 percent), four had a moderate rate (18 to 34 percent), 
and two had rates of less than 18 percent.  Lastly, eight of the nursing homes were located 
in an urban area while two were rural, and nine were for-profit while one was non-profit. 
While on-site at these 10 facilities, we interviewed both administrative as well as direct 
care staff.  Our administrative interviews included discussions with nursing home 
6 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  administrators, directors of nursing, medical directors, consultant pharmacists, 
psychiatrists, social workers, and psychologists.  We spoke with these respondents about 
how psychotropic drugs are being used and monitored in their facility. 
We also interviewed nurses and certified nurse aides in each facility separately from 
administrative staff about how they care for and monitor residents on psychotropic drugs 
and handle aggressive residents.  Lastly, while on-site we spoke with and observed the 
residents in our sample and toured the facility, including observing at least one structured 
activity and meal time. 
Telephone interviews with State surveyors and ombudsmen 
For the States represented in our purposive sub-sample, we conducted two structured 
telephone interviews - one with the State ombudsman and the other with the State survey 
and certification director or other manager.  During these interviews, we discussed with 
respondents how pyschotropic drugs are being used by nursing homes in their State, the 
nature and extent of inappropriate chemical restraints, and the processes that their State 
has in place to handle such complaints. 
Limitations 
Our methodology has two main limitations.  First, we assessed the appropriateness of 
psychotropic drugs based solely on a medical record review and not on in-person clinical 
assessments of the residents in our sample.  For example, our reviewers state that they 
could not conclusively determine if any inappropriate drug use was an inappropriate 
chemical restraint without a physical examination of the resident.  Second, the nursing 
homes in our sample self-identified the residents that were receiving psychotropic drugs in 
November 2000. 
This inspection was conducted in accordance with the Quality Standards for 
Inspections issued by the Presidents Council on Integrity and Efficiency. 
7 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  F I N D I N G S  
Psychotropic drug use in nursing homes is generally appropriate 
Our medical record review shows that 85 percent of nursing home residents who take 
psychotropic drugs are taking drugs that are medically appropriate.  Another eight percent 
are using psychotropic drugs inappropriately, and for seven percent our reviewers could 
not determine the appropriateness of their psychotropic drug therapy due to insufficient 
medical record documentation.  See Graph 1 below. 
Graph 1 
Nursing Home Residents Psychotropic Drug Use 
Source: Medical Record Screening Instrument, 2001 
Eighty-five percent of residents psychotropic drug use is medically appropriate 
Most nursing home residents taking psychotropic drugs are taking drugs that are medically 
appropriate.  Nearly all of these residents have the potential to benefit functionally from 
their drug therapy and there is evidence that, for most, their therapeutic goal has been or 
can be achieved.  Also, in accordance with the CMS guidelines, in most cases the 
psychotropic drugs are being used at appropriate dosages and duration and not as 
inappropriate duplicate therapy.  The drugs are also generally being used with adequate 
indications and monitoring and without adverse consequences. 
8 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  Nearly all residents taking anti-psychotic drugs (95 percent) or anti-anxiety drugs (93 
percent) have a documented diagnosis of mental illness.  More specifically, among 
residents on anti-psychotic drugs, the most common diagnosis is dementia with associated 
psychotic or agitated behaviors (71 percent), while 14 percent have a diagnosis of 
schizophrenia.  Close to half of residents taking anti-anxiety drugs (43 percent) have a 
diagnosis of dementia of the Alzheimers type with behavioral disturbance.  For the few 
residents with no documented mental health diagnosis, most are appropriately taking an 
anti-psychotic or anti-anxiety drug due to an acute problematic behavior. 
We noted several features of nursing homes Drug Regimen Reviews (DRRs) that may 
help to assure that psychotropic drugs are used appropriately.  These DRRs are conducted 
on a monthly basis by pharmacists to assess residents drug treatment plans.  Many of the 
DRRs we reviewed include the pharmacists recommendation to change a medication in 
order to improve the management of a residents behavioral symptoms, as well as a 
recommendation to re-evaluate or discontinue PRN (when necessary) drug orders.  The 
DRRs also commonly include a suggestion to decrease dosage, a reminder that reduction 
attempts are past due, or an identification of medication errors, such as when 
inappropriate duplicate drugs are being given.  In many cases, the residents physician 
concurs with the pharmacists recommendation and indicates this agreement on the DRR. 
Eight percent of residents are using psychotropic drugs inappropriately 
Eight percent of residents who take psychotropic drugs are using these drugs 
inappropriately. These drugs are inappropriate for one or more of the following reasons: 
the dose is too high because appropriate dose reductions are not followed; there is 
unjustified chronic use of the drug; there is no documented benefit to the resident; the 
wrong type of drug is being given for a particular diagnosis; and there is inappropriate 
duplicate drug therapy.  For example, in a few cases an additional anti-psychotic drug is 
being given to treat symptoms without dose adjusting on the first drug to a level that 
would effectively treat the resident.  In many instances there is no clear documentation to 
support continued need for duplicate or triplicate drug therapy.  Residents on more than 
one psychotropic drug are more likely than residents on just one psychotropic drug to be 
taking a medication inappropriately. 
There do not appear to be any nursing home characteristics associated with inappropriate 
use.  Neither ownership type nor urban or rural setting are linked with inappropriate use of 
these drugs.  Also, nursing homes with higher psychotropic drug usage rates are not more 
likely than homes with medium and low rates to inappropriately use these drugs. 
However, nearly all nursing home surveyors and some ombudsmen we interviewed say 
that inadequate nursing home staffing ratios, training, and experience may be associated 
with a greater likelihood of inappropriate drug use. 
Inappropriate chemical restraints do not appear to be widespread.  Our medical record 
reviewers could not conclusively determine that any of the inappropriate drug use was an 
inappropriate chemical restraint.  In follow-up discussions with reviewers, all agree that 
9 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  based on their medical record review, the use of psychotropic drugs as inappropriate 
chemical restraints, solely for the convenience of staff, does not appear to be common. 
Seven percent of residents medical records lack sufficient documentation to 
determine the appropriateness of their psychotropic drug use 
Seven percent of residents we sampled have such inadequate records that our medical 
record reviewers are unable to determine if their drug use is appropriate.  Some of these 
residents records lack information about their mental health history, while others lack 
physician notes on the medical rationale for why the drug is being used.  For example, 
several residents were taking hypnotic drugs without any note of sleeping problems in 
their records.  However, based on their clinical judgement and other documentation in the 
record, our reviewers believed that these drugs may have been appropriate. 
There are two other ways in which nursing home documentation for these drugs is 
insufficient.  Of the records that went for second level review, there was not always 
adequate documentation to explain why residents were taking psychotropic drugs outside 
of the CMS dosage guidelines (even though the medical reviewers determined that the 
dosage was appropriate).  Also, some records do not have adequate documentation to 
support the duration of time the resident has been receiving the drug.  In fact, our medical 
reviewers cite this as one of the biggest documentation problems.  They state that 
documentation to justify the appropriateness of chronic use of pyschotropic drugs is often 
lacking since residents records commonly lack physician notes to support ongoing drug 
therapy. 
Data from survey and certification and ombudsman programs support 
the findings of the medical record review 
The OSCAR deficiencies that directly cite inappropriate psychotropic drugs and chemical 
restraints are not common.  Deficiency tag F222, cited for inappropriate chemical 
restraints, comprises 0.08 percent of all deficiencies in the current survey, and the number 
of these deficiencies has been decreasing slightly over the past three surveys.  Further, tag 
F329, cited for unnecessary psychotropic drugs, comprises 2 percent of all deficiencies in 
the current survey; the number of these deficiencies has remained constant.  Lastly, tag 
F330, cited for the use of a psychotropic drug in the absence of a documented diagnosis, 
accounts for 0.13 percent of all deficiencies; these deficiencies have also seen a small 
decrease.  It should be noted that other deficiencies, such as pressure sores and weight 
loss, may indicate that psychotropic drugs are being used as inappropriate chemical 
restraints. 
Similarly, ombudsman complaints specific to the inappropriate use of psychotropic drugs 
and chemical restraints are not prevalent.  In 1999, complaints about physical and chemical 
restraints accounted for 1 percent of all nursing home complaints, while those about the 
use of psychoactive drugs comprised just 0.25 percent of the total. 
10 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  Furthermore, the number of these complaints, while increasing slightly from 1996 to 1998, 
have decreased from 1998 to 1999. 
Also, most surveyors and some ombudsmen in our sample States concur that 
inappropriate chemical restraints are not common.  Most of the 10 surveyors we 
interviewed say that use of psychotropic drugs as inappropriate chemical restraints is 
uncommon.  While fewer ombudsmen agree, most say that only a small number of nursing 
homes are using the drugs inappropriately.  Further, a majority of both surveyors and 
ombudsmen in our sample report that over the past three years, the inappropriate use of 
these drugs as inappropriate chemical restraints has decreased or remained the same. 
Several respondents in our sample States say that chronic drug use may be more of a 
problem.  One surveyor says:  The decision to use the drug might be right but [nursing 
homes] might not handle it correctly as [they] go along.  An ombudsman agrees: [It] 
may have been appropriate to use the drug at the start, but not keep the resident on the 
drug for 5 years. 
A growth in the proportion of nursing home residents with mental 
disorders may contribute to increasing psychotropic drug rates 
More residents are taking psychotropic drugs 
Since 1995, nursing home psychotropic drug usage rates have increased.  This increase 
occurred after initial drops in usage rates following the implementation of OBRA 87.  The 
largest increase has occurred with the use of anti-psychotics.  Based on OSCAR data, 
from 1995 to 1999 the national rate for anti-psychotics grew from 16 percent to 19.4 
percent, and anti-anxiety drug rates increased from 14.3 percent  to 15.7 percent.3 
However, hypnotic drug rates have remained relatively steady at 5 percent for this time 
period. 
Based on our sample, which excluded residents taking only anti-depressants, anti-
psychotics appear to be the most prevalent of the different groups of psychotropic drugs. 
Sixty-seven percent of residents on psychotropic drugs are taking an anti-psychotic 
medication, while 42 percent are taking an anti-anxiety drug, and far fewer (17 percent) 
are taking a hypnotic medication.  Overall, more than half of these residents are taking two 
or more psychotropic drugs. 
Nursing homes have a higher proportion of residents with mental disorders 
The population of residents with mental disorders in nursing homes has also been growing. 
Data from OSCAR show that the proportion of all residents with a documented 
3 American Society of Consultant Pharmacists Fact Sheet, September (2000). 
11 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  psychiatric disorder, excluding dementia, increased from 13 percent to 16 percent over the 
last four surveys.  Also, the proportion of all residents with behavioral symptoms grew 
from 29 percent to 31 percent over the same period.  Further, in our telephone interviews 
two ombudsmen  say they are seeing more problem behavior and dementia among nursing 
home residents in their States.  Lastly, one of our medical record reviewers, a geriatric 
psychiatrist, mentions that nursing homes are different now than they were when OBRA 
87 was first implemented, due to the higher proportion of  psychiatric residents. 
Numerous articles have also documented the increasing prevalence of mental disorders 
among nursing home residents.  In one article examining the effects of OBRA 87 on 
psychotropic prescribing rates, the authors argue that the prevalence of psychiatric 
disorders in long-term care facilities is formidable, and nursing homes have become 
defacto mental health facilities.4  When discussing the impact this has had on 
psychotropic drug use, they caution against trends that equate low utilization ... with 
high-quality care, without considering other factors such as improvements in the quality of 
life associated with appropriate use of psychotropic medications.5  In another article from 
the Consultant Pharmacist, the authors state that the small but meaningful increase in 
usage seen in several categories ... may be explained by an increase in [behavioral] acuity 
of patients.6 
Lastly, nursing homes appear to be accepting more residents with a history of 
psychotropic drug use.  At least one third of the residents in our sample entered the 
nursing home already on their medication.  Several of our medical record reviewers point 
out that hospitals common use of these drugs results in new nursing home admissions 
who already have a prior history of taking psychotropic medications.  Finally, a few of the 
administrators at the nursing homes we visited say that they try to reduce drug levels for 
residents entering the home already taking high dosages. 
Four of the 10 nursing homes we visited are actively seeking out psychiatric 
patients 
Four of the 10 nursing homes we visited specifically target psychiatric patients.  All four 
have psychotropic drug usage rates that are above the national average.  These nursing 
homes actively seek out such patients because they have developed the expertise and 
staffing structure necessary to care for residents with a mental illness.  Some 
4 Lantz, Melinda, Giambanco, Vincent, and Buchalter, Eric. (1996) A Ten-Year Review of the 
Effect of OBRA-87 on Psychotropic Prescribing Practices in an Academic Nursing Home, Psychiatric 
Services. 
5 Lantz, (1996). 
6 Tobias, Dianne and Pulliam, Charles. (1997) General and Psychotherapeutic Medication Use in 
878 Nursing Facilities: A 1997 National Survey, Consultant Pharmacist. 
12 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  administrators mention that in order to remain financially viable, they need to target this 
segment of the nursing home population; residents with lesser care needs or with less 
advanced dementia or Alzheimers disease are increasingly going to other long term care 
settings, such as assisted living centers. 
13 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  C O N C L U S I O N  
In response to concerns expressed by the Senate Special Committee on Aging about the 
use of psychotropic drugs as inappropriate chemical restraints in nursing homes, this 
report finds that these drugs are generally being used appropriately.  While drug usage 
rates for anti-psychotic and anti-anxiety medications have been rising, most psychotropic 
drug use in nursing homes is medically appropriate.  Where it is inappropriate, the 
problems do not appear to be related to inappropriate chemical restraints but rather to 
inappropriate dosage, chronic use, a lack of documented benefit to the resident, and 
inappropriate duplicate drug therapy.  We do note, 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. 
AGENCY COMMENTS 
We received comments on the draft report from the Centers for Medicare & Medicaid 
Services.  They believe that the report will contribute to a better understanding of 
psychotropic drug use in nursing homes and in identifying areas for further focus.  The 
CMS also notes that training related to psychotropic drug use and related documentation 
issues is already underway or planned. 
14 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  APPENDIX A 
Confidence Intervals for Key Medical Record Review Findings 
We calculated confidence intervals for the medical record review key findings.  The point 
estimate and 95% confidence intervals are given for each of the following: 
POINT  CONFIDENCE 
KEY FINDINGS 
ESTIMATE*  INTERVAL 
Nursing home residents who are taking 
psychotropic drugs that are medically 
appropriate  85 %  81 % - 89% 
Nursing home residents who are taking 
psychotropic drugs that are medically 
inappropriate  8%  5 % - 11% 
Nursing home residents whose medical records 
lack sufficient documentation to determine the 
appropriateness of their psychotropic drug use  7 %  4 % - 10 % 
* N = 485 
15 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  APPENDIX B 
Comments on the Draft Report 
In this appendix, we present in full the comments from the Centers for Medicare & 
Medicaid Services. 
16 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  17 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490  18 
Psychotropic Drug Use in Nursing Homes  OEI 02-00-00490