Department of Health and Human Services 
I 
OFFICE  OF 

INSPECTOR  GENERAL 

PRESCRIPTION  DRUG  USE 

IN  NURSING  HOMES 

Report  2 
An  Inside  View  by  Consultant  Pharmacists 
JUNE  GIBBS  BROWN 
Inspector  General 
NOVEMBER  1997 
OEI-06-96-0008 1  EXECUTIVE  SUMMARY 

PURPOSE 
To describe  consultant  pharmacists  concerns  about drug usage in nursing homes and their 
perceptions  of their  responsibilities  for medication  reviews  for nursing  home residents. 
BACKGROUND 
The primary  goal of drug therapy  for nursing  home patients  is to maintain  and improve,  to 
the extent possible,  the patients  functional  capacity  and quality  of life.  The Omnibus 
Budget Reconciliation  Acts (OBRA) of  1987 and 1990, in recognition  of this,  require  the 
regulation  of certain  drugs in nursing  homes and the establishment  of drug utilization 
review  programs  for nursing  home residents.  Provisions  of the OBRA 1990, while not 
required  for all nursing  homes,  also clearly  establish  Congress  desire to involve 
pharmacists  more actively  in patient  care. 
Broad oversight  of the drug therapy  requirements  for the nursing homes is performed  by 
consultant  pharmacists  hired to perform  a monthly  medication  review for each resident. 
As such, these pharmacists  are a valuable  source of information.  To take advantage  of 
their experience,  we surveyed  a statistically  valid sample of pharmacists  drawn from a 
stratified  random  sample of the  17,000 nursing  facilities. 
We undertook  this inspection,  using three  different  approaches,  to provide  insight  into 
several  issues related  to prescription  drug use in nursing  homes.  These issues are 
addressed  in three  reports,  of which this is the second.  This report presents  the results of 
an in-depth,  structured  mail survey  of these consultant  pharmacists. 
The first report,  An Introduction  Based on Texas (OEI-06-96-00080),  describes 
prescription  drug use in nursing homes based on Texas data.  The third  report,  A 
Pharmaceutical  Review and Inspection  Recommendations  (OEI-06-96-00082),  discusses 
results from an independent  review  of drugs and medical  records  for a sample of Texas 
nursing  home patients.  Recommendations  addressing  the issues and concerns  raised 
collectively  by all three reports  are located  in the third and final report  of this inspection. 
FINDINGS 
Oualitv of Care Issues 
Overall,  pharmacists  tell us they and the nursing homes are complying  with the law and 
regulations  related  to medication  reviews  of nursing home residents.  However,  problems 
and concerns  raised by the consultant  pharmacists  indicate  that legislative  and regulatory 
intentions  to assure high quality  pharmaceutical  care for nursing  home residents  are not 
yet fully  realized.  It is important  to understand  that reports  of possible  inappropriate  use of medications  are somewhat  a matter of opinion.  Ultimately,  for nursing  home 
patients,  it is either  the patients  attending  physician  or the facilitys  medical  director  who 
determines  what is appropriate  care. 
According  to pharmacists,  patients are experiencing  numerous  adverse reactions as a 
result of potentially  inappropriate  prescribing  and inadequate  administration  or 
monitoring  of the usage of medications. 
Adverse  reactions  reported  by consultant  pharmacists  as occurring  sometimes  or often 
include  constipation  (reported  by 81 percent);  falls (66 percent);  delirium  (41 percent); 
depression  (39 percent);  and urinary  incontinence  (26 percent). 
Pharmacists have serious concerns  about prescribing  practices for antipsychotics, 
anxiolytics,  sedatives/hypnotics,  antidepressants,  and other drugs. 
Because legislation  prescribes  certain  limitations  on antipsychotics,  anxiolytics,  and 
sedatives/hypnotics,  there  is concern  that from 21 to 44 percent  of pharmacists  report 
some patients  are receiving  medically  inappropriate  prescriptions  of these drugs.  Other 
drugs,  not necessarily  legislated  for scrutiny,  which also seriously  concern  consultant 
pharmacists  include H2 antagonists  (reported  by 65 percent);  non-steroidal  anti-
inflammatory  drugs (47 percent);  narcotics  (46 percent);  digoxin  (40 percent);  antibiotics 
and anti-infectives  (39 percent);  and gastrointestinals  (36 percent).  Moreover,  according 
to 15 percent  of the consultant  pharmacists,  some physicians  are prescribing  medically 
inappropriate  antidepressants.  One-third  say antidepressants  are sometimes  prescribed 
without an appropriate  diagnosis  and that few or no physicians  ensure their  maintenance  at 
appropriate  levels. 
A number of medication administration  problems which may put patients at risk also 
concern  pharmacists. 
These include absence of specific usage directions;  incomplete  orders;  failure  to update 
medication  administration  records  with dosage or schedule changes;  physicians  signing 
orders  that are not current  or correct;  failure  to include  orders  on the medication 
administration  record;  misplaced  medications;  and continuation  of a medication  in 
disregard  of stop orders.  Further,  medications  are sometimes  administered  by nursing 
staff at the wrong time,  in non-optimal  dosages,  for inappropriate  durations,  or the 
medication  may be inappropriately  altered  (crushing,  dilution,  etc.). 
Shortcomings  of Medication  Reviews 
While  all consultant  pharmacists  report  they conduct  monthly  drug regimen  reviews,  their 
responses  indicate  some serious  shortcomings  in the quality  and thoroughness  of reviews. 
ii  Pharmacists  conduct some reviews without consulting  important medical records and 
without  having patients diagnoses or laboratory reports. 
More than half of the reviews  do not consider  the residents  assessment  (65 percent)  or 
plan of care  (56 percent).  Other records  not consulted  by pharmacists  include  facility 
incident  and accident  reports  (20 percent)  and specialists  notes and nutritional  plans (13 
percent).  Fully  one-third  say they have difficulty  obtaining  a patients  diagnosis  and 
necessary  lab reports. 
The results of drug regimen reviews often are not documented in records readily 
available to nursing home staff. 
While  one-third  of pharmacists  say they document  medication  reviews  and related contacts 
in the patients  medical  records  or medication  charts,  many do not document  their efforts 
in records  most accessible  to nursing  home  staff. 
There is an apparent need to strengthen  pharmacists relationships  with patients and 
direct care staff and also their performance  of educational  and counseling  activities. 
Many pharmacists  have no contact  with patients  or their families  or with nurse aides in 
their conduct  of drug regimen  reviews.  Also,  over two-thirds  report  not providing 
education  or training  for either  patients  or their families  or guardians;  nearly  half do not 
provide  drug education  for nurse aides or medication  aides;  and, despite the potentially 
critical  interaction  between diet and medications,  most pharmacists  have no contact with 
the facility  dietitian. 
RECOMMENDATIONS 
Based on the concerns  raised in this report,  the Health  Care Financing  Administration 
(HCFA)  should work with the States and other responsible  entities  to improve  the 
effectiveness  of medication  reviews  for patients  in nursing homes.  Recommendations  to 
accomplish  this are provided  in the third  and final  report  of this inspection,  A 
Pharmaceutical  Review and Inspection  Reports  (OEI-06-96-00082). 
COMMENTS  ON THE DRAFT REPORT 
We solicited  comments  from agencies  within  the Department  of Health  and Human 
Services which have responsibilities  for policies  related  to Medicare  and Medicaid  and 
long term care.  We also requested  input from  several national  organizations  representing 
the interests  of nursing homes,  patients,  or providers.  We appreciate  the time and efforts 
of those providing  comments. 
Departmental  Comments 
Within  the Department,  we received  comments  on the draft  reports  from the Health Care 
Financing  Administration  (HCFA)  and the Assistant  Secretary  for Planning  and Evaluation 
... 
111  (ASPE).  Both agencies  concurred  with the recommendations;  HCFA emphasized  the need 
for further  studies to assess the extent of continued  use of potentially  inappropriate  drugs, 
other avenues  of possible  cost savings related  to drugs,  and the need to determine  and 
understand  the potential  sources of the escalating  costs and claims for certain  types of 
drugs used in nursing  homes.  The final reports  reflect  several clarifications  or changes 
based on their  suggestions.  The full text of each agencys comments  is provided  in the 
third and final report  of this inspection,  A Pharmaceutical  Review and Inspection 
Recommendations  (OEI-06-96-00082). 
Comments  from External  Organizations 
We also received  comments  from the following  external  organizations:  American  Health 
Care Association;  American  Association  of Homes and Services for the Aging;  American 
Medical  Directors  Association;  American  Society  of Consultant  Pharmacists;  and National 
Association  of Boards of Pharmacy.  Most of the associations  concurred  with one or more 
of the recommendations  within each of the inspection  reports.  All comrnentors  support 
the need for better communication  and coordination  between nursing home staff and other 
healthcare  providers,  training  nurse aides,  and understanding  the implications  of nursing 
home medication  services  and associated  costs. 
Several organizations  questioned  the methodology  used in this inspection,  particularly  for 
the consultant  pharmacist  survey.  However,  as with any evaluation,  there  are always 
some limitations  in how data and information  can be obtained,  given time and other 
resource  constraints.  Further,  while we acknowledge  that a survey of this nature 
introduces  some bias and subjectivity,  we also believe  that the survey of consultant 
pharmacists  provides  us with an up-close  view of what is happening  with prescription  drug 
use in nursing  homes.  Moreover,  the results of the consultant  pharmacist  survey are 
consistent  with our results from our two other methodologies. 
Some comments  expressed  concerns  about the use of the term,  inappropriate.  As 
explained  previously,  use of this term in reporting  concerns  with a patients  medication 
regimen  are somewhat  a matter of opinion.  The evidence  provided  in these three reports 
does not prove that any one prescription  was improper,  but that closer examination  is 
warranted.  Also,  while the use of such a drug may be supported by physician  orders in 
individual  cases, use of the drug,  in general,  is likely  to be considered  inappropriate. 
Some comments  addressed  the implications  of broadening  Federal  oversight.  There  is 
clear concern  about the responsibility  for medication  issues being the responsibility  of the 
physician,  not the nursing  home.  Further,  some organizations  expressed  concern  that 
these particular  issues did not result in direct  recommendations  about the physicians  role 
for nursing  home patients  medication  regimens.  We felt that further  examination  of this 
area is warranted  before  recommending  changes  which would impact so many entities 
involved  in the process. 
In conclusion,  we believe  the three reports  collectively,  and each using a different 
approach,  strongly  indicate  that the intent  of the provisions  of the OBRA Acts concerning 
iv  prescription  drug usage are not being clearly  fulfilled.  Further,  HCFA  has authority  to 
correct  and enhance  quality  of care for nursing  home patients.  The recommendations  we 
present  attempt  to facilitate  the initial  steps of this effort,  and to address some concerns 
evidenced  in the reports  and received  comments.  While  we recognize  that great strides 
have been made to meet the OBRA requirements,  we believe  further  effort  remains  by all 
the players  involved  (HCFA,  associations  and their  members,  nursing homes,  and 
residents  and their families)  to further  improve  quality  of care for nursing home patients. 
The full text of each organizations  comments  is provided  in the third and final report of 
this inspection,  A Pharmaceutical  Review and Inspection  Recommendations  (OEI-06-96-
00082). 
V  TABLE  OF  CONTENTS 
EXECUTIVE  SUMMARY 
INTRODUCTION 
 1 
Regulation  and control  of prescription  drugs in nursing  homes 
 2 
Role of consultant  pharmacists 
 3 
Physicians  determine  what is appropriate  for patients 
 4 
Challenge  of prescribing  for the elderly 
 5 
SCOPE  AND METHODOLOGY 
 6 
FINDINGS 
 9 
Quality of Care Issues 
 9 
Shortcomings  of Medication  Reviews 
 14 
RECOMMENDATIONS 
 21 
COMMENTS  ABOUT  DRAFT  REPORTS 
 22 
ENDNOTES 
 24 
APPENDICES 
Inappropriate  Medications  for Elderly  Persons  A-l 
Consultant  Pharmacists  Assessment  of Medication  Problems  (Weighted Data)  B-l 
Additional  Pharmacist  Survey Weighted  Data Tables  C-l  INTRODUCTION 
PURPOSE 
To describe  consultant  pharmacists  concerns  about drug usage in nursing homes and their 
perceptions  of their responsibilities  for medication  reviews for nursing home residents. 
BACKGROUND 
Long Term Care and Prescription  Medications 
Medicaid  is the primary  public program  for long-term  care assistance  for the elderly  and 
disabled.  Long-term  care is one of the largest and fastest growing  needs of the elderly. 
Of the $39.8 billion  in program  expenditures  for care of this population  in fiscal year 
1995, 73 percent  ($29.1 billion)  went for nursing  home stays.  
Payments  for prescription  drugs represent  a large portion  of Medicaids  expenditures  for 
nursing  facilities.  Medicaid  provided  services  for  1.7 million  nursing home residents  in 
fiscal year  1995 at an average cost per bed from $600 to $1000 per year.*  This suggests 
that Medicaid paid between $1 billion  and $1.7 billion  to provide  prescription  drugs to 
residents  of long term care facilities.  This could be as much as 16 percent  of total 
Medicaid prescription  drug expenditures. 
Potential Health and Cost Problems 
Several recent  studies suggest that inappropriate  use of prescription  drugs by the elderly 
creates the potential  for serious health problems  and the increased  risk for wasted 
hundreds  of millions  of Federal  dollars  annually  in medication  and hospitalization  costs. 
One study estimated that the percentage  of hospitalizations  of elderly  patients due to 
adverse medication  reactions  to be 17 percent,  almost 6 times greater  than for the general 
population.3  Further,  an expert panel of pharmacists  estimates that the injuries  resulting 
from failed drug therapy  result  in approximately  100,000 hospitalizations  and a cost of 
$77 billion  each year.4 
According  to the Food and Drug Administration  (FDA),  the elderly,  about  13 percent  of 
the U. S. Population,  account  for over one-third  of the adverse  drug experiences 
reported  by pharmacists,  physicians,  and other health professionals.  These figures 
translate  to 30,000 hospitalizations  and $25 billion  in costs among the elderly.  Much of 
this cost is paid by the elderly  population,  but a large portion  of it is borne by Federal 
health  care programs  including  Medicare  and Medicaid.  Clearly,  Federal  programs  as 
well as our senior citizens  are paying  the  high  cost  of failed  drug  therapy.6 
Not only  do the elderly  use prescription  drugs more than any other age population,  they 
also tend to be taking  several  drugs at once,  increasing  the probability  of adverse drug 
reactions.7v8 The elderly  may also eliminate  these medications  from their  system less 
I  efficiently  than those younger  due to decreased  bodily  functions.  Studies also suggest 
more  subtle effects  of inappropriate  medication  usage among the elderly,  such as loss of 
cognitive  or physical  function  and the potential  for increased  falls.  Researchers  have 
concluded  that a number of prescription  drugs used by the general  population  should not 
be prescribed  for elderly  patients  (See Appendix  A).  Equally  effective  drugs which 
present  fewer risks may be available. 
Regulation  and Control of Prescription  Drug Use in Nursing Homes 
Omnibus Budget Reconciliation  Act of  1987 
As part of the Omnibus Budget Reconciliation  Act of  1987 (OBRA 1987), Congress 
requires  the regulation  of certain  drugs  in nursing  homes.  On October  1, 1990, the 
Health Care Financing  Administration  (HCFA)  implemented  regulations  which hold 
nursing homes accountable  for monitoring  medication  usage. lo Significant  requirements 
for pharmaceutical  care of nursing home  residents  include provisions  regarding  Pharmacy 
Services (drug regimen  review),  Quality  of Care (drug therapy),  Resident  Rights (self-
administration  of drugs),  Resident  Assessment,  and Infection  Control.  Additionally, 
physicians  must justify  the use of antipsychotic  drugs based on specific  diagnoses  and 
observe  specific parameters  within  which  these drugs may be used. 
Nursing  Home  Patients,  Medications,  and  OBRA  1987 
Each nursing home patient must receive  necessary  nursing, medical,  and 
psychosocial  services allowing him/her  to attain and maintain the highest 
possible functional status.  This status is defined by a comprehensive 
assessment and plan of care which each patient receives upon admission to 
the home and as substantive changes occur  in the patients health status. 
To ensure each patient receives  the necessary  quality care, the law and 
subsequent regulations also recognize  the value of medication therapy by 
defining certain limitations: 
1)  patients must not receive  unnecessary  medications; 
2) 	 patients cannot be prescribed  antipsychotic  drugs unless they are 
appropriate  for a specific patient condition; 
3) 	 patients prescribed  antipsychotic  drugs will receive  gradual dose 
reductions,  or behavioral  programming  in an effort  to discontinue the 
drugs (unless clinically contraindicated);  and 
4) 	 the home must have no significant medication error  rates and patients 
must also have no significant medication errors. 
To ensure these requirements  are met,  the States and HCFA  are responsible  for 
performing  routine  facility  surveys.  To guide these reviews,  HCFA  developed  Indicators 
for Surveyor  Assessment  of the Performance  of Drug Regimen  Reviews  and Surveyor 
Methodology  for Detecting  Medication  Errors.   They  also released  revised  interpretive 
guidelines  relating  to medication  use in nursing  facilities  which provide  tools for 
identifying  medication  errors,  and even  include  a list of specific drug therapy 
circumstances  which may constitute  potential  drug irregularities.  Further,  in July  1995, 
2  HCFA  implemented  the final step in the implementation  of OBRA  1987, new survey  and 
enforcement  procedures.  Changes  include  the use of new quality  of life guides for the 
patient,  group,  and family  interviews;  a protocol  for non-interviewable  residents;  closer 
cooperation  between the State survey  agency  and the ombudsmen  programs;  and better 
information  for providers,  including  information  to help them compare  their patients  to 
residents  of other  nursing  facilities  across the region,  State, or nation. 
Omnibus Budget Reconciliation  Act of  1990 
The provisions  of Section 4401 of the Omnibus  Budget Reconciliation  Act of  1990 (OBRA 
1990) clearly  demonstrate  Congress  desire  to 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.  While  not required 
for nursing  homes  in compliance  with drug regimen  review  requirements  (specified  in 42 
CFR 483.60),  practicing  pharmacists  are expected  to: 
1) 	prospectively review the patients present drug therapy and medical condition with 
proposed drug therapy; 
2) 	 appropriately intervene with the prescriber on the patients behalf when inappropriate 
drug therapy has been prescribed; and 
3) 	 as an outcome of their review, counsel patients on the proper use and storage of 
medication and how to alleviate or prevent potential therapeutic problems related to 
medication usage. 
Under OBRA 1990, the State Medicaid  plan must provide  for a review  of potential  drug 
therapy  problems  due to therapeutic  duplication;  drug-disease  contraindications;  drug-drug 
interactions  (including  serious interactions  with nonprescription  or over-the-counter  drugs); 
incorrect  drug dosage or duration  of drug treatment;  drug-allergy  interactions;  and clinical 
misuse.  Thus,  OBRA 1990, in essence,  requires  a certain  standard of practice  for 
Medicaid  patients.  While  this regulation  and the statute at section  1927(g)(l)(D)  of the 
Social Security  Act preclude  any Federal  action  to expand this law to apply directly  to 
nursing  home patients,  most States have extended  coverage  to all patients,  including  those 
of health  facilities. l1 One major  camp onent  of this law, patient  counseling,  has increased 
both the role and the responsibility  of the pharmacist  in patient  healthcare  understanding, 
planning,  and outcomes,  which,  arguably,  should be extended to all health  care 
environments. 
Role of Consultant  Pharmacists 
Pharmacists,  through  their education  and training,  should be able to identify  any serious 
concerns  related  to medication  prescribing  and administration  practices  which,  when 
corrected,  yield  a positive  impact on the quality  of life for nursing  home patients.  Each 
pharmacists  relationship  with nursing  home patients  requires  their  refocusing  from a 
product  orientation  (distribution  of medications)  to that of a clinical  practitioner 
responsible  for reducing  potential  medication  problems.  Both our literature  review  and 
the consultant  pharmacists  themselves  confirmed  that moving  to a patient-focused 
3  orientation  has required  breaking  with traditional  dispensing  roles and utilizing  those 
clinical  skills for which  many pharmacists  are now routinely  being trained.  This changing 
orientation  within  the industry  helped  strengthen  the argument  for using pharmacists  in 
nursing  homes to more  effectively  assist in medication  changes  which could positively 
impact a patients  quality  of care. 
To ensure compliance  with the OBRA regulations,  nursing  facilities  are expected to 
employ  consultant  pharmacists.  These consultant  pharmacists  conduct monthly  reviews of 
the drug regimen  of each facility  resident  to determine  whether  the prescription  drugs 
ordered  for that individual  are appropriate  based on the OBRA guidelines.  Consultant 
pharmacists  are also required  to: 
1) determine that drug records for each resident are in order; 
2)  establish a system to record receipt and disposition of prescription drugs; 
3)  offer advice and instruction in all other areas of pharmacy services; and 
4) 	 report any irregularities they discover in a residents drug regimen to the attending 
physician and director of nursing. 
Some of the benefits  potentially  realized  as a result of the consultant  pharmacist  role in 
nursing homes are the reduction  of excessive  medication  usage,  improvement  in patient 
quality of care,  and decreased  cost for medication  usage.  Pharmacists  may also help 
medical  and nursing  personnel  significantly  improve  medication  therapy  for patients  in 
nursing homes which,  in turn,  can help reduce total health care costs,r* particularly  for 
those changes resulting  from fewer medications  being taken,  more appropriate  medication 
being prescribed,  and fewer costly  adverse reactions  being experienced. 
In addition  to detecting  quality  of care concerns  associated  with inappropriate  medication 
usage,  consultant  pharmacists  may detect potential  waste and abuse which can increase 
costs to the programs.  Duplicate  prescriptions  and the early  renewal  of maintenance 
prescriptions  increase  program  costs in the form of additional  dispensing  fees and could be 
signs of possible  diversion  or resale of prescription  drugs.  The required  destruction  of 
numerous  drugs upon the death,  discharge,  or change  in treatment  plan of a nursing  home 
patient may also result  in greater  expenses than necessary. 
Physicians Determine  What Is Appropriate For Each Patient 
Reports  of possible  inappropriate  use of medications  are somewhat a matter of medical 
opinion.  Ultimately,  for nursing  home patients,  it is either  the patients  attending 
physician  or the facilitys  medical  director  who determine  what is appropriate  care.  This 
includes prescribing  medications  to meet patients  needs.  Once an individual  is admitted 
to a nursing  home,  the attending physician  routinely  participates  in the ongoing  care of 
that patient,  along  with the other  nursing  home staff.  The American  Medical  Association 
defines  several  functional  responsibilities  for physicians  with patients  in long term care 
facilities,  including  examining  the patient  upon admission;  initiating,  developing,  and 
overseeing  the implementation  of a comprehensive  plan of care;  maintaining  medical 
records;  and participating  in quality  assurance  reviews  when possible.13  The physicians 
4  are the primary  persons  to whom nursing  staff look for identification  and delineation  of 
care for specific medical  conditions,  including  prescribing  of any necessary  medications. 
Generally,  the nursing  homes medical director  is expected to participate  in a foundation 
of activities  relating  to the care of nursing  home patients.  These include participating  in 
the formulation  and review  of care policies,  infection  guidelines,  and pharmacy protocols; 
provision  of in-service  education  for staff;  and attendance  at a variety  of facility 
committee  meetings  (e.g.,  quality  assurance).  This role includes coordinating  visits to 
patients  by other health care professionals,  including  attending  physicians.  Further,  the 
medical  director  is expected to intervene  if an attending  physician  is negligent  in visiting 
patients  or providing  quality  care. 
OBRA 1987 requires  that the pharmacist  report  any identified  irregularities  to the 
attending  physician  of the patient  and the director  of nursing  and that these reports  be 
acted upon.   Yet, the regulations  do not specify  several  important  aspects of reporting 
any pharmacists  concerns: 
1. 	how  (i.e.,  in what format or in which patient records, such notification will be 
provided); 
2. 	 whether the medical and nursing personnel are required to provide an explanation for 
acceptance or rejection of the pharmacists concerns; 
3. 	 guidance to medical, nursing, or pharmaceutical staff as to what constitutes acting on 
reported concerns or irregularities;  and 
4. 	 no specified format or record location for acceptance or rejection of pharmacists 
concerns by medical or nursing personnel. 
It should be noted that regardless  of any reported  concerns  by the consultant  pharmacist,  it 
is the physicians  legal responsibility  to order  medication  changes,  not that of the director 
of nursing.  We do not minimize  the difficulties  physicians  encounter  in meeting  the 
medication  needs of the most typical  nursing  home patient  - the disabled or infirm elderly 
person.  Much available  literature  details the complexities  of diagnosing  and the unique 
challenges  of prescribing  medications  for the elderly. 
Challenges of Prescribing  Medications  for the Elderly14 
Some disorders,  which occur  in the general  elderly  population  with characteristic 
symptoms and signs,  present  unusual features  or,  conversely,  present  without usual 
features.  Problems  usually  restricted  to the elderly  include  stroke,  decubitus ulcers, 
metabolic  bone disease,  degenerative  osteoarthritis,  hip fracture,  dementia  syndrome, 
falling,  Parkinsonism,  and urinary  incontinence.  Further,  the usual signs may be replaced 
with less specific ones,  such as refusal  to eat or drink,  falling,  incontinence,  acute 
confusion,  increasing  dementia,  weight loss,  and failure  to thrive.  Multiple  disorders  in 
the elderly  complicate  and interfere  with diagnosis  and treatment  of the presenting  illness. 
Depression  is probably  the most common  psychiatric  disorder  of persons  over the age of 
65.  Other conditions  which become more common  with age and which may present 
5  themselves  atypically  include organic  psychoses,  paranoid  states,  hypochondriasis,  and 
suicide. 
Aging changes bodily  organs  and systems,  causing  less efficient  functioning,  and thus, 
affecting  the elderly  persons  responses  to medications.  Any person  over the age of 65 
has the potential  for increased  side effects,  overdosage,  and/or  diminished  efficacy  for a 
minimum  of  13 drug classes,  such as antibiotics,  antihypertensives,  cardiac  medications, 
psychiatric  medications  (antidepressants,  tranquilizers,  hypnotics,  etc.),  or pain relievers. 
Also,  most clinical  trials and studies on specific medications  are usually  performed  using 
younger  people;  the result can be drug treatment  standards  often hazardous  to the elderly. 
Thus,  while the elderly  may use the same drugs as younger  persons,  the effects can be far 
different. 
Research  identifies  many  indicators  relating  to adverse  medication  outcomes,  some of 
which more directly  pertain  to nursing  home patients.  These  include a patient  having  five 
or more medications  in their drug regimen,  having  12 or more doses per day,  having 
more than three concurrent  disease states, and the presence  of drugs requiring  monitoring. 
Each of these are fairly  common  indicators  for most nursing  home patients. 
Thus,  the typical  elderly  nursing  home patient  may require  different  care skills and 
knowledge  of health care professionals  than those required  to treat the non-nursing  home 
populations  with acute care problems.  The primary  goal of drug therapy  in chronic  care 
is to maintain  and improve,  to the extent possible,  the patients  functional  capacity  and 
quality  of life. 
SCOPE AND METHODOLOGY 
Focus of Report 
In  1996, the OIG undertook  a project  to assess the extent and appropriateness  of drug use 
by Medicare  and Medicaid  residents  of nursing  facilities.  This project,  conducted  in three 
phases,  involved  1) a database analysis  of the extent of prescription  drug use by Texas 
nursing  home residents  eligible  for both Medicare  and Medicaid;  2) a national  survey of 
consultant  pharmacists  to assess their  role in identifying  and reducing  drug use problems 
in nursing  facilities;  and 3) a pharmaceutical  review  of a sample of residents  to determine 
the appropriateness  of prescription  drugs utilized  and to examine  the extent of selected 
drug use problems. 
The first report,  An Introduction  Based on Texas  (OEI-06-96-00080),  provides  specific 
information  concerning  actual drug expenditures  and identifies  the types of drugs being 
used in Texas nursing facilities.  This report,  focusing  on the second component  of the 
project,  identifies  problems  and concerns  raised by consultant  pharmacists.  The third 
report,  A Pharmaceutical  Review and Inspection  Recommendations  (OEI-06-96-00082), 
discusses  results from an independent  review  of drugs and medical  records  for a sample of 
Texas nursing  home patients.  Recommendations  addressing  the issues and concerns  raised 
collectively  by all three reports  are located  in the third  and final report  of this inspection. 
6  This  inspection  was initiated  as part of Operation  Restore  Trust,  an initiative  involving 
multi-disciplinary  teams of State and Federal  personnel  seeking to reduce  fraud,  waste, 
and abuse in nursing  facilities  and home health  agencies,  and by durable  medical 
equipment  suppliers.  The initiative  focused  in five States (California,  Florida,  Illinois, 
New York,  and Texas). 
Data analysis  of prescription  drug payments  was purposely  limited to Texas based on  1) 
the availability  of Medicaid  data and planned  identification  of the Medicare  and Medicaid 
population  in the State by HCFA and the Office of the Inspector  General  (OIG), 2) 
designation  as a demonstration  site for Operation  Restore Trust,  and 3) the large number 
of nursing  facilities  in Texas,  approximately  eight percent  of long term care facilities  in 
the nation.  Texas also ranks third in the nation  for total Medicaid  spending.  Such data 
was not readily  available  for other States.  Thus,  Texas was the selected site for the first 
and third phases of this inspection.  While  we recognize  that State operations  concerning 
nursing homes can vary greatly  in their  interpretation  and enforcement  of policies,  we 
believe  the concerns  identified  in Texas will be generally  common to many  States. 
Survey of Consultant Pharmacists 
Because consultant  pharmacists  are responsible  for a monthly  medication  review of 

nursing home patients,  they serve as a valuable  source of information.  To take advantage 

of their experience,  we surveyed  a statistically  valid sample of pharmacists  drawn from a 

stratified  random  sample of the 17,000 nursing  facilities. 

In order  to be able to discuss issues related  to the Presidential  initiative,  Operation  Restore 

Trust (ORT),  stratification  was based on whether  the nursing  home is in an ORT State. 

This resulted  in six strata - one for each of the five ORT States (California,  Florida, 

Illinois,  New York,  Texas) and one for non-ORT  States.  We randomly  selected  150 

nursing homes for each of the six strata resulting  in a sample of 900 facilities.  Each of 

the 900 nursing  facilities  sampled was contacted  directly  to obtain the name of its current 

consulting  pharmacist  providing  drug regimen  reviews  for the nursing  homes patients. 

A structured,  in-depth mail survey asked pharmacists  to provide  sufficient  information  to 

determine  1) whether and to what extent drug regimen  reviews are being conducted,  2) 

other  services  which pharmacists  may be providing,  3) constraints  of the review process, 

and 4) their  views about medication  use problems  in nursing facilities. 

Their  responses  were solicited  with certain  parameters: 

1) 	Pharmacists were asked to randomly select a single home for which they would provide 
information (this home was not necessarily the sample home from which we identified 
the pharmacists); 
2) 	 We asked that they answer all questions throughout the survey with that one home in 
mind; 
3) 	 Pharmacists were to have at least six months personal and continuous experience 
providing consultant pharmacy services to the nursing home about which they were 
responding; 
7  4) 	 The  nursing  home  should  include  predominantly  Medicare  and Medicaid  residents 
(some  private  pay  as well);  and 
5) 	 The  responses  were  to be reflective  of their  activities  for the six month  period  prior  to 
their  receipt  of the survey. 
Our original  response  rate for returned  surveys  mailed  was 76 percent  (682 of 900). 
However,  in our decision  to take a conservative  approach,  we dropped 221 returned 
surveys because some nursing  facilities  were determined  to be duplicates  as a result of 
name changes,  misspellings,  etc.;  pharmacists  being identified  as servicing  more than one 
sample facility;  and some facilities  closing  subsequent to the review period.  The 
remaining  461 surveys  (75 percent  ORT and 25 percent  non-ORT)  represent  51 percent  of 
the  original  900 and provide  the basis for the findings  of this report. 
Confidence  levels were computed  for selected variables  using SUDAAN.  At the  95 
percent  level,  confidence  intervals  were no greater  than +8  percent  for most survey 
responses.  The data reported  in our findings  have been weighted to reflect  responses 
received  from pharmacists  representing  each ORT State or the other,  non-ORT  States. 
Assuming that the pharmacists  did in fact randomly  select the facility  for which they 
provided  information  (including  those pharmacists  who were identified  for more than one 
facility),  we can generalize  our findings  to encompass  all consultant  pharmacists  who have 
responsibilities  for nursing  home patients. 
This evaluation  was conducted  as part of ORT, an initiative  involving  multi-disciplinary 
teams of State and Federal  personnel  seeking to reduce fraud,  waste, and abuse in nursing 
facilities  and home health  agencies,  and by durable medical equipment  suppliers. 
Our review  was conducted  in accordance  with the Quality Standards for  Inspections issued 
by the Presidents  Council  on Integrity  and Efficiency. 
8  FINDINGS 
QUALITY OF CARE ISSUES 
Overall,  pharmacists  tell us that they and the nursing homes are complying  with the law 
and regulations  related  to medication  reviews  of nursing  home residents.  However,  the 
problems  and concerns  raised by the consultant  pharmacists  indicate that legislative  and 
regulatory  intentions  to assure high quality  pharmaceutical  care for nursing home residents 
are not yet fully  realized. 
Pharmacists believe that nursing home patients are experiencing  numerous adverse 
medication reactions as a result of inadequate monitoring  of medications and 
inappropriate prescribing  practices. 
Consultant  pharmacists,  who advocated  for and received  increasingly  responsible  roles 
under OBRA 1987 and OBRA 1990, believed  they could play a vital role in assuring 
quality care for nursing  home patients.  Arguably,  pharmacists  professional  education 
gives them valuable  expertise  and clinical  knowledge  concerning  pharmacotherapy. 
Critical  to this expertise  and extremely  important  for the nursing  residents  is monitoring 
the effects of medication  usage,  either  for maintaining  or improving  a patients  health 
status or to identify  any effects of medications  or disease which may undermine  such 
improvement  or maintenance.  Many pharmacists  report eight problems  regarding 
monitoring  of patients  medications  which  sometimes occur: 
1)  no lab testing to ensure continued need for the medication (61 percent); I5 
failure to chart drug usage (59 percent); 
2) 
3)  medication to medication interactions not detected (57 percent); 
4)  no lab testing to monitor potentially toxic drugs (51 percent); 
5)  failure to adjust dosages for renal/hepatic function (50 percent); 
no monitoring for efficacy or side effects (50 percent); 
6) 
7) 	 no physical functioning assessment of patient to check either for correct dosage or 
continued need for the medication (47 percent); and 
8)  no physical assessments for routine monitoring of certain drugs (43 percent). 
Additionally,  a large number  of consultant  pharmacists  are concerned  that medications 
being prescribed  to patients  contribute  to patients  constipation  (reported  by 81 percent  of 
pharmacists);  falls (66 percent);  delirium  (41 percent);  depression  (39 percent);  and 
urinary  incontinence  (26 percent). l6 
Many drugs other than psychotropics  are also psychoactive,  in the sense that they may 
affect a patients  cognition,  balance,  and motor  coordination,  as well as pulse and blood 
pressure.  Unfortunately,  elderly  patients  have an increased  risk of falls if they experience 
a combination  of several  certain  ailments  or medications.17  One key to monitoring  for 
these and other potential  effects  is the extent to which physicians  have communicated  their 
9  expectations  to conduct  such monitoring,  i.e.,  in their orders prescribing  care for the 
patient  or in progress  notes,  and the extent to which the nursing  staff is able to accurately 
report  the results of any such monitoring. 
Another  factor directly  linked  to the effectiveness  of such monitoring  is the cooperation, 
coordination,  and communication  between all the key persons  involved  in the care of the 
patient.  Cooperative  healthcare  team work requires  routine  interaction  between the 
involved  team members.  In the case of the nursing  home,  it will at least require 
communication  between medical,  nursing,  and pharmaceutical  personnel  and include the 
patient as well as other nursing home staff.  However,  it can be extremely  difficult  to get 
all the team members together  routinely.  This is complicated  by the fact that such 
meetings are not required.  Thus,  the means and opportunity  for communication  (written 
or verbal) between the involved  personnel  becomes more critical.  Written  communication 
becomes even more necessary  when at least two of the critical  players  (physician  and 
consultant  pharmacist)  do not frequent  the home regularly  and rarely  interact  directly  with 
each other.  It becomes difficult  to ensure that the necessary  engagement  between players 
occurs,  and without clear communication,  cooperation  will be extremely  hard to develop 
between these critical  players, 
Many of the consultant pharmacists (40 percent) assess the extent of cooperation  from 
residents personal physicians as only fair or poor.  Consultant pharmacists are 
disturbed that some physicians  do not take their concerns  seriously or act promptly 
on their recommendations. 
Twenty-eight  percent of the pharmacists  report  residents  physicians  only  sometimes give 
serious consideration  to their concerns.  Similarly,  35 percent  of consultant  pharmacists 
say doctors  only rarely  or sometimes take prompt  action  on their  recommendations  about a 
specific residents prescriptions  or medication regimen,  although  65 percent  say that those 
physicians  who do take action do so promptly.  Further,  while 43 percent  of consultant 
pharmacists  say physicians  act promptly  on their recommendations  about patterns in the 
physician s prescribing  practice,  many consultant  pharmacists  say they only do so 
sometimes  (45 percent)  or rarely  (11 percent).  By contrast,  99 percent  of the consultant 
pharmacists  say nurses seriously  consider  their concerns  most to all the time.  Further, 
over 90 percent  of the pharmacists  agree that bothpersonal  physicians  and nursing  staff 
should routinely  solicit their help regarding  appropriate  medications  and dosages. 
A majority  of pharmacists  say personal  physicians  rarely  or never  seek their help 
regarding  either the appropriate  medications  (reported  by 68 percent)  or proper  dosages 
for medications  (59 percent).  In contrast,  consultant  pharmacists  say nurses sometimes to 
often seek their help with medications  (reported  by 75 percent)  or dosages (89 percent). 
For the most part,  pharmacists  report  receiving  very good to good cooperation  from the 
nursing  directors  (95 percent),  nursing  staff (94 percent),  and nursing  home administrators 
(83 percent).  However,  they rate the cooperation  of patients  personal  physicians  and the 
facility  medical  directors  somewhat  lower,  with only  57 percent  and 72 percent, 
respectively,  rated as good to very good. 
10 
 According  to many of the surveyed  consultant  pharmacists  (55 percent),  their medication 
reviews  are more complicated  because 50 percent  or more of their patients  are frail 
elderly  (85 years or older).  While  56 percent  of the pharmacists  say that physicians  are 
adequately  aware that certain  medications  are considered  inappropriate  for use by this age 
group,  29 percent  state that physicians  are not adequately  aware of the special medication 
needs of these patients;  another  15 percent  did not know.  As a result,  pharmacists  fault 
some physicians  lack of awareness concerning  the medication  needs of elderly  nursing 
home patients  and the resulting  consequences  of prescribing  without such awareness. 
Pharmacists  have serious concerns about specific prescribing practices related to 
antipsychotics,  anxiolytics,  sedatives/hypnotics,  antidepressants,  as well as other 
prescription  drugs. 
The law specifies  that patients have the right to be free from any medication  imposed for 
the purposes  of discipline  or convenience,  and not specifically  required  to treat medical 
symptoms.  It also requires  that any use of antipsychotic  medications  be based on a 
comprehensive  assessment of the patient.  In fact,  some experts recommend  that any 
patient using such drugs receive  gradual  dose reductions,  have drug holidays  (for which 
there are no Federal  guidelines  as to which drugs or for what dosages or durations),  or 
receive  behavioral  programming  in an effort  to discontinue  or reduce the dosage of these 
medications.  Because legislation  prescribes  these and other limitations  on antipsychotics, 
antianxiety  medications,  and sedatives/hypnotics,  there  is concern  that from 21 to 44 
percent  of pharmacists  report  some patients  are receiving  medically  inappropriate 
prescriptions  of these drugs. 
Further,  consultant  pharmacists  report  that of those physicians  prescribing  antidepressants, 
sedative/hypnotics,  antianxiety  agents,  and antipsychotics,  many are not attempting  to 
achieve  the lowest effective  doses.  Specifically,  few physicians  are attempting  to achieve 
the lowest effective  doses for antidepressants  (reported by 42 percent  of pharmacists); 
sedative/hypnotics  (21 percent);  anxiolytics  (14 percent);  and antipsychotics  (10 percent). 
Important  among the reasons pharmacists  believe  physicians  are not limiting  their 
prescribing  of inappropriate  medications,  is the pressure  to continue  the medications  from 
the patients  family  or guardian  (28 percent),  the patient  (24 percent),  and the facility  staff 
(14 percent).  Lack of physician  knowledge  (21 percent)  or training  (15 percent)are  also 
noted by consultant  pharmacists,  along with perceived  indifference  by the physician 
responsible  for ensuring  the patients  care (21 percent). 
11  Table  1:  Patients  Receiving  Inappropriate  Medications 
Sedatives/ 
Antipsychotics  Anxiolytics  Hypnotics  Antidepressants  1 
Patients  Inappropriately 
Receiving 
% Consultant Pharmacists 
Reporting Yes  33  35  44  21  I 
% Consultant Pharmacists 
Reporting No  67  65  56  79  I 
We are aware that HCFA  has committed  to goals of decreasing  patient usage of 
antipsychotics  and antianxiety  medications  while  increasing  the use of antidepressants 
when appropriately  necessary.  Recent studies indicate  that the OBRAs 1987 and 1990 
regulations  may have helped to achieve  such a reduction  for antipsychotic  drug use in this 
population.  Preliminary  data collected  by HCFA  on nursing  homes in three test States 
indicate a shift in usage from antipsychotics  to antidepressant  medications.  Specifically, 
the data illustrates  an average decrease  of  17 percent  in the use of antipsychotics  and an 
increase  in antidepressant  (77 percent)  and hypnotic/sedative  (27 percent) drug use. l9 
We should note that a considerable  number of consultant  pharmacists  indicate  appropriate 
prescribing  practices  for antipsychotics  (46 percent);  anxiolytics  (44 percent); 
sedatives/hypnotics  (38 percent);  and antidepressants  (57 percent).  Yet,  it is significant  to 
note that from  l-6  percent  of the consultant  pharmacists  say these four drug categories  are 
inappropriately  prescribed  by most or all physicians;  an additional  9-17 percent  say some 
physicians  are inappropriately  prescribing  these medications  to nursing home patients. 
Table 2 reflects  how many physicians  consultant  pharmacists  believe  are inappropriately 
prescribing  these categories  of medications. 
Table  2: Percentage  of Pharmacists  Reporting  Physicians 
Inappropriately  Prescribing  Medications 
Medication  Type  % None  % Few  % Some  % Most  % All 
Antipsychotics  46  42  10  2  1 
Anxiolytics  44  38  16  3  0 
Antidepressants  58  29  9  4  2 
Sedatives/Hypnotics  38  42  17  3  1 
In addition  to the four drug categories  discussed,  consultant  pharmacists  also have serious 
concerns  about patient  usage of other medications  including  the following: 
12  % Consultant  Pharmacists 
Medication  Type  Sometimes  or Often Concerned 
1) H2 Antagonists  6.5 
2) Non-steroidal  Anti-inflammatory  drugs  47 
3) Narcotics  46 
4) Digoxin  40 
5) Antibiotics  and Anti-infectives  39 
6) Gastrointestinals  36 
According to 15 percent of the consultant  pharmacists,  some physicians are 
prescribing medically inappropriate  antidepressants,  and 33 percent indicate concern 
that antidepressants  are prescribed without an appropriate diagnosis. 
Again,  it is important  to understand  that  inappropriate  may also mean insu$fkient 
amounts rather  than too much or a wrong type of medication.  While 42 percent  of 
consultant  pharmacists  report  most or all physicians  attempting  to limit or reduce the 
dosage of these drugs,  literature  and research  indicate that many physicians  may be 
limiting  antidepressants  too much when a higher  dosage would actually  be more effective 
for depression.  This was confirmed  by consultant  pharmacists  reporting  that when a 
diagnosis of depression  is available,  some (25 percent  of pharmacists  report) or most (6 
percent) physicians  may be prescribing  sedatives or hypnotics  when antidepressants  should 
be used in the treatment  of depression. 
Thirty-four percent of the consultant pharmacists express concern that physicians do 
not ensure the continued maintenance  of appropriate levels of antidepressants. 
Treatment  of depression  must begin with a comprehensive  evaluation  of the older person. 
This assessment will rule out any associated  medical or physical  conditions  which may 
present  symptoms of depression  or which may complicate  the treatment  of depression. 
This includes reviewing  laboratory  studies,  including  a complete  blood cell count;  liver 
function  tests; serum albumin  levels,  thyroid  function  tests.  Also,  all current  medications 
should be reviewed  in light of any lab tests and symptoms being exhibited  by the patient. 
Consultant pharmacists also expressed concerns about other potentially inappropriate 
medication usage by nursing home patients: 
% Consultant Pharmacists 
Medication Issue  Sometimesor Often Concerned 
1)  Prolonged use of sleeping medicines  76 
2)  Overutilization of drugs  62 
3)  Use of as needed drugs for too long  61 
4)  Use of antipsychotics without a diagnosis  45 
5) 	 Use of contraindicated drug for patients  26 
existing diagnosis or disease 
13 
 A number of medication administration  issues are also problems according to 
consultant  pharmacists. 
These  include  absence of specific usage directions  (reported  by 60 percent  of 
pharmacists);  incomplete  orders  (52 percent);  failure  to update the medication 
administration  record  with dosage or schedule changes  (29 percent);  physicians  signing 
orders that are not current  or correct  (27 percent);  and failure  to include orders on the 
medication  administration  record  (18 percent),  These concerns  may actually  result in 
medications  or treatment  either  occurring  when unnecessary  or being needed and not 
occurring  at all (each of which may be grounds  for citing  immediate jeopardy  for the 
patient  not receiving  the necessary  care),  Also,  misplaced  medications  (22 percent) and 
continuation  of a medication  in disregard  of stop orders  (17 percent)  also sometime 
concern  consultant  pharmacists. 
Approximately  half of the surveyed  consultant  pharmacists  state that medications  are 
sometimes administered  by nursing  staff at the wrong time (reported  by 59 percent),  in 
non-optimal  dosages (53 percent),  for unsuitable  durations  (47 percent),  or the medication 
may be improperly  altered  (crushing,  dilution,  etc.)  (40 percent).  Much less frequent 
administration  concerns  include administering  the wrong medication  (11 percent) or giving 
a medication  to the wrong resident  (4 percent).  Any of these concerns  can have 
potentially  serious implications,  both for the efficacy  of the drug and a patients  well-
being.  Yet, about 59 percent  of pharmacists  express concerns  for their  lack of authority 
to modify  a residents  drug regimen,  order  lab tests to assure an appropriate  medication 
regimen  (66 percent),  or to ensure doctors  are prescribing  appropriately  (62 percent). 
Consultant  pharmacists  are also concerned  that doctors  are not required  to respond to their 
concerns  (reported by 54 percent  pharmacists)  or may reject their recommendations  (47 
percent),  even though the consultant  pharmacist  is required  to notify  the physician  and 
director  of nursing of any problems. 
SHORTCOMINGS  OF  MEDICATION  REVIEWS 
While all consultant  pharmacists  report  they routinely  conduct medication  reviews,  their 
responses  indicate  some serious shortcomings  in the quality  and thoroughness  of reviews. 
Some consultant pharmacists  say they do not routinely  participate in comprehensive 
patient assessments or in reviews of each patients plan of care when opportunity 
allows. 
Section 483.20  of CFR 42 requires  that nursing  facilities  conduct a comprehensive  patient 
assessment at admission  and promptly  after a significant  change  in the patients  condition. 
This assessment  includes diagnosis(es),  special treatment  needs,  recommended  medication 
and nutritional  therapy,  cognitive,  physical,  behavioral,  and psychosocial  patterns,  and 
other related health  conditions.  The assessment  should occur at least once every  12 
months,  and nursing  facilities  must perform  a review of the assessment  at least every  3 
months,  and as appropriate,  revise  the patients  assessment.  This,  in turn,  could affect 
each patients  plan of care.  Also,  OBRA 1987 Section 483.460(j)(5)  states that  us 
14  appropriate  the pharmacist  must participate  in the development,  implementation,  and 
review  of each patients  plan (either  in writing  or in person). 
More than half the consultant  pharmacists state they do not routinely  review a 
patients medication  regimen against either the Resident Assessment (65 percent) or 
the Plan of Care (56 percent),  although  both are available. 
As discussed above,  the patients  assessment  identifies  critical  information  for the medical, 
nursing,  and pharmaceutical  healthcare  team.  The plan of care is prepared  by an 
interdisciplinary  team,  which should  include  the attending  physician,  a registered  nurse 
with responsibility  for the patient,  and  other appropriate  staff in disciplines  as determined 
by the residents  needs,  and,  to the extent practicable,  the participation  of the resident,  the 
residents  family  or the residents  legal representative. 
Further  complicating  the possible  outcomes  of the medication  reviews,  even though 
pharmacists  indicate that most records  necessary  for conducting  a medication  review  are 
readily  available,  some very  important  records  are sometimes  not available.  Additionally, 
other  important,  available  medical  records  may not be used by the consultant  pharmacist. 
Most consultant  pharmacists  indicate  no difficulty  obtaining  physician  orders  (reported by 
94 percent  of pharmacists),  medication  administration  records  (89 percent),  or physician 
progress  notes (87 percent). 
Table  3:  Performance  of Drug  Regimen  Reviews 
I 
% Yes  %No  1 
Against plan of care  44  56 
Against resident assessment  35  6.5 
Upon readmission from hospital  81  19 
Upon changes to doctors orders or residents plan of  75  25 
care 
Plans of care and patient  assessments provide  much of the necessary  information  for a 
pharmacist  to identify  any factors  which may be negatively  affecting  a patients  medication 
regimen.  Yet 48 percent  of the consultant  pharrnwists  report  they have (at times) been 
prevented  from performing  a complete  medication  review because of lost or misplaced 
records.  However,  only  21 percent  of the consultant  pharmacists  say that lack of 
complete,  accurate  medication  records  is a barrier  to their  ability  to ensure an appropriate 
medication  regimen  for each patient. 
While  80 percent  of consultant  pharmacists  have no difficulty  in obtaining  a facilitys 
incident  or accident  reports  related  to patients,  20 percent  indicate they do not use them as 
part of the drug regimen  review  process.  Such reports may be indicative  of negative 
medication  symptoms  occurring  and resulting  in, for example,  falls.  Further,  an analysis 
or summary  monthly  report by the facility  might prove useful  for identifying  patterns  of 
concern  (e.g.,  patients  on psychotropic  drugs being the most prone to falls;  falls occurring 
15 
 more often during  a late night shift; etc.).  Further,  approximately  13 percent  of the 
consultant  pharmacists  indicate they do not use either  specialists  notes or nutritional  plans 
to assist them  in determining  whether there  may be a related contraindication  or impact on 
the patients  medication  usage. 
More than one-third  of consultant pharmacists indicate they have difficulty  in 
obtaining the patients diagnosis.  Additionally,  33 percent indicate difficulty 
obtaining  any related laboratory reports,  and some have problems getting hospital 
reports (30 percent) and patient discharge summaries (25 percent). 
It should be understood  that pharmacists  and nursing  staff should have available  at least 
one of the following  three documents  from which to obtain a patients  diagnosis  - the 
Minimum  Data Set which identifies  a patients  chronic  diagnostic  conditions;  the patients 
personal  assessment;  or the patients plan of care addressing  any chronic  or acute 
diagnoses.  Without  at least one of these records being available,  complete,  and accurate, 
consultant  pharmacists  will not have the necessary  information  for confirming  existing 
conditions  for each diagnosis,  identifying  subsequent medication  regimen  actions for 
treating  a patients  disease,  or for continuing  assessment of the patients  health.  Without 
this information,  pharmacists  can meet only  a portion  of their professional  responsibility 
to the patients. 
With an incorrect  diagnosis,  or no available  diagnosis,  pharmacists  are working  in a void, 
one in which a wrong therapy may be initiated.  For example,  an older  female patient 
may be exhibiting  signs and symptoms of depression  that may be caused by 
hypothyroidism.  In this case,  it would be improper  to treat the symptoms  with an 
antidepressant.  Yet, without the required  lab work,  one may not realize  the need for 
thyroid  medication.  Thus,  in treating  the symptom  (depression)  with an antidepressant 
instead of the cause (hypothyroidism)  for the symptom,  an incorrect  or unnecessary 
therapy  could be initiated,  one which perpetuates  the problem  and may also cause 
additional  perceived  signs of senility  (confusion,  lapses in memory,  difficulty 
communicating,  etc.) 
While one-third of pharmacists say they document medication reviews and related 
contacts in the patients medical records or medication charts,  many do not document 
their efforts in records most accessible to nursing home staff. 
Pharmacists  have long understood  and accepted the need to document  any form of 
dialogue  noting,  at a minimum,  the fact that the dialogue  occurred,  with whom,  the date, 
and the issue discussed.  Nursing  facilities  maintain  many types of files related  to patient 
care and related  activities.  As indicated below,  many of the consultant  pharmacists  do not 
routinely document  their contacts  or meetings  related  to patients  medication  regimens  in 
these records. 
16 
 Table  4:  Location  of Consultant  Pharmacist  Documentation 
of Contact  or Meetings  Related  to Patient  Drug  Problems 
Type  Records  Used  for  % Yes 
Consultant  Pharmacist  Documentation 
Daily Nursing Notes 
 5  95 
Medical Records 
 31  69 
Records of Dispensing Pharmacy 
 32  68 
Patients Plan of Care 
 4  96 
Patients Assessment 
 4  96 
Consultant Pharmacist (Own) Records 
 97  3 
Medication Chart 
 34  66 
During a related  review,  we asked nursing  facilities  to provide  certain  necessary  records 
for performing  a desk review  of a sample of patients  medication  regimens.  Many of the 
facilities  had difficulty  providing  the records  of the pharmacy  consultants  because they 
were maintained  by the pharmacists  in another  location.  Regardless  of the potential  lack 
of documentation,  explicitly  required  of facilities  by HCFA,  fully 98 percent  of the 
consultant  pharmacists  having  recommendations  from their most recent reviews  say they 
voiced those recommendations  to the nursing  staff or physicians. 
A complicating factor in conducting  medication reviews is that pharmacists report 
most patients take six prescription medications on average. 
This supports what the literature  stated, that nursing  home patients receive  more 
medication  than non-institutionalized  older persons. * Also  the number of prescriptions 
can range to as many  as twelve or more,  resulting  in extremely  complex  reviews.  In 
addition to the prescribed  medications,  pharmacists  report  patients may also be scheduled 
or routinely  taking  an average  of three PRN (as needed)  medications.  These PRN 
medications  exceed  15 for some individuals.  Thus,  the average number of medications 
can range from 9 to beyond  20.  This is important  because the elderly  use more 
prescription  drugs than any other  age group and are more likely  to be taking  multiple 
drugs,  some of which may be inappropriate  and result  in particularly  acute problems. 
This polypharmacy  increases  the probability  of adverse drug reactions,  creating  a 
complicated  regimen  for pharmacists  to review  and understand,  let alone communicate 
recommendations  concerning  such regimens. 
Yet, the American  Society  of Consultant  Pharmacists,  in which many of the nursing  home 
consultant  pharmacists  have membership,  indicates  each consultant  pharmacist  completes 
from four to six patient  reviews  per hour.  This time  incorporates  all other activities  for 
which the consultant  pharmacist  is responsible  in the nursing  home,  (e.g.,  meetings, 
training,  etc.).  Average  review  time may be somewhat longer  for patients  requiring 
skilled or hospice  care or having  a large number of medications.**  Similarly,  the 
consultant  pharmacists  in our survey  indicated  averaging  four patient  reviews per hour for 
monthly  visits  (this time is based on a 32 hour week,  a 4.33 week month,  and reported 
median  numbers  of patient  reviews  monthly). 
17  It is also possible that not all medications  a patient may be taking are included in the 
pharmacists medication  reviews. 
The consultant  pharmacists  identified  many  barriers  to their  including  non-prescribed 
medications  in their medication  reviews  for each patient.  Despite their  importance  as part 
of a patients  overall  health  and drug regimen,  consultant  pharmacists  say their review  of 
such medications  is limited  by such factors  as their nursing  home contract  not specifying 
these drugs as part of the review  and non-prescribed  medications  not being included  in 
either the assessment,  plan of care,  or the permanent  medical  record  for each patient. 
Further,  many consultant  pharmacists  say records  on non-prescribed  over-the-counter 
medications  are usually  insufficient  or not available  and that collecting  data on their use 
from patients  or guardians  is too labor intensive  (see Appendix  B, table  10). 
A majority of the consultant  pharmacists say they routinely maintain medication 
control,  destruction,  and quality records. 
Virtually  all consultant  pharmacists  (96 percent)  monitor  for expired  medications,  proper 
storage,  and integrity  of packaging  of medications  received  in the nursing  home;  84 
percent  maintain  a system of records  for medications  received,  administered,  and 
destroyed.  Fifty-four  percent  of the pharmacists  also report  they personally  maintain  or 
review  a log of destroyed  medications  for each facility  they serve.  The primary  reasons 
listed by consultant  pharmacists  for medications  being returned  for destruction  include the 
patients death (83 percent);  discontinuing  therapy  (40 percent);  discharging  the patient  (24 
percent);  and changing  the medication  (20 percent).  Eight percent  listed the expiration 
date of the medication;  only  1 percent  indicated  the transfer  of the patient  as the primary 
reason for destroying. medications.  Additionally,  nearly  12 percent  of the consultant 
pharmacists  say they sometimes  encounter  overcharging  for medications  dispensed. 
It is interesting  to note that fully 91 percent  of the consultant  pharmacists  believe  reusing 
medications  would yield  Federal  and State savings  (the primary  exceptions  are controlled 
drugs having  Federal  or State regulations  that require  destruction  or medications  in liquid 
form or vials contaminated  by prior  use).  Even though some pharmacists  indicated  the 
savings may be offset by many potential  administrative  costs,  54 percent  of the consultant 
pharmacists  say unused,  properly  packaged medications  could be returned  to the-vendor 
pharmacy  to redispense  for use by others. 
Many consultant  pharmacists  (89 percent) do not participate  in patient care planning 
committees. 
A majority  of consultant  pharmacists  are participants  of facility  committees  to ensure 
quality  care (87 percent),  pharmacy  and therapeutics  (74 percent),  and infection  control 
(67 percent).  However,  fully  89 percent  do not participate  in the facilitys  patient  care 
planning  committee.  Further,  while most consultant  pharmacists  have routine  contact  with 
the medical professionals  involved  in patient  care (facility  nursing  director,  nursing  staff, 
and patients  personal  physician),  few routinely  meet with the patient  (18 percent),  the 
primary  individual  for whom they are conducting  the review.  Only  12 percent  contact  a 
18 
 patient  when a problem  with his/her  medication  regimen  is encountered.  Even fewer (five 
percent)  report  having  routine  contact  with the patients  family  or guardian  when a 
problem  is encountered  with a patients  medication  regimen.  Also,  despite the impact of 
diet on medications,  less than half of the pharmacists  routinely  contact  the facility  dietitian 
(43 percent)  and few consultant  pharmacists  have routine  contact  with either  the nurse 
aides (18 percent)  or other therapists  (25 percent)  regarding  patients under review.  Thus, 
there  appears to be a need to strengthen  pharmacists  relationships  with patients  and direct 
care staff and also their performance  of educational  and counseling  activities. 
Approximately 93 percent of the consultant  pharmacists routinely participate in drug 
education  and training of nursing staff,  but many do not provide such training to 
patients, their families,  or the nursing homes aides. 
OBRA 1987 requires  training  of clients  and staff in appropriate  health and hygiene 
methods,  as needed.   This includes,  but is not limited to, training  of direct care staff in 
the identification  or detection  of signs and symptoms of illness or dysfunction.  Yet, over 
two-thirds  of the consultant  pharmacists  do not provide  education  or training  for either 
patients  (73 percent)  or their  families  or guardians  (70 percent).  And,  nearly  half the 
consultant  pharmacists  do not provide  drug education  for nurse aides (48 percent)  or 
medication  aides (50 percent). 
The law and regulations  do not specifically  require  that such training  include consultant 
pharmacist  training  to identify  possible  symptoms of contraindications,  adverse reactions, 
or inappropriate  responses  to medications.  However,  it appears that such training  would 
be an integral  response to the health  needs of nursing home patients.  Aides should 
routinely  be aware of the significance  of patient complaints  which may indicate potential 
medication  problems.  Patients  complaining  of light-headedness,  dizziness,  fainting,  or 
acute weakness  should signal the need for increased  vigilance,  not only  for falls,  but also 
for medication  side effects.  Such complaints  could alert the pharmacist  and nursing  staff 
to the potential  need for lab work,  which could indicate drug-drug  and drug-diet 
interactions. 
While most pharmacists are familiar with their enhanced  responsibilities,  significant 
numbers voice strong concerns  about limitations on their professional  authority to 
enforce OBRA drug-related  provisions. 
As required,  nursing  facilities  employ  consultant  pharmacists  to conduct monthly  reviews 
of each patients  drug regimen  to ensure that the prescription  drugs ordered  for that 
individual  are appropriate  based on the OBRA 1987 guidelines.  These consultant 
pharmacists  understand  that they are required  to 1) determine  that drug records  for each 
resident  are in order,  2) establish  a system to record  receipt  and disposition  of 
prescription  drugs,  and 3) to offer  advice and instruction  in all other areas of pharmacy 
services. 
Pharmacists  also realize  they  should report  any concerns  they may have about a residents 
medication  regimen  to the attending  physician  or director  of nursing.  Further,  they know 
19 
 that OBRA  1990 identifies  pharmacists  as key health  care professionals  with a potential 
role in improving  therapeutic  outcomes  for Medicaid  nursing home residents.  However, 
32 percent  of consultant  pharmacists  report  they lack the authority  to ensure either  a 
facilitys  or physicians  adherence  to the OBRA drug-related  provisions. 
As consultants,  pharmacists  can make recommendations  and attempt persuasion  to change, 
but they cannot  force change.  More specific  indicators  of lack of enforcement  authority 
include 42 percent  of the pharmacists  saying they are unable to control  the medications 
ordered  and dispensed  in the nursing home;  27 percent  saying they cannot  ensure the 
nursing  staff appropriately  monitor  the clinical  effects of medications  on residents 
physical,  mental,  or emotional  condition;  and 24 percent  saying they cannot  guarantee  the 
nursing  staff will properly  administer  medications  ordered.  (See Appendix  B, table  12.) 
It is important  to note that,  not withstanding  their lack of authority  to ensure appropriate 
medication  regimens,  most consultant  pharmacists  (84-90 percent)  do not feel the statutory 
definition  of their  roles or their dual responsibilities  to both nursing  facilities  and patients 
inhibit  their  ability  to conduct appropriate  medication  reviews.  This  is borne out by the 
fact that all consultant  pharmacists  report  they routinely  conduct the required  monthly 
drug regimen  reviews  for nursing home patients,  and at least 75 percent  say they perform 
a review when changes occur either  to the physicians  orders or to the residents  plan of 
care.  Nearly  93 percent  of the consultant  pharmacists  indicate they routinely  monitor  each 
residents  medication  regimen to ensure  it maintains  or improves  the patients  functioning. 
Further,  95 percent  of the consultant  pharmacists  perform  the drug regimen  review  for a 
particular  patient  at least once a month with 31 percent  of the consultant  pharmacists 
visiting  the nursing home weekly or more often. 
20 
 RECOMMENDATIONS 
This report  shares information  concerning  drug usage in nursing homes  from the 
perspective  of a nationally  representative  sample of consultant  pharmacists.  Pharmacists 
expressed concerns  about their inability  to always perform  quality  medication  reviews,  the 
role of the physician  and nursing  staff in appropriate  medication  usage by patients,  and the 
problems  of potentially  inappropriate  medication  usage or maintenance.  Collectively  with 
the two other reports  of this inspection,  these concerns  show a need for improvement  and 
underscore  the importance  of strengthening  the medication  reviews and improving 
medication  prescribing,  administration,  and monitoring  practices  in nursing  homes. 
These concerns  and those addressed  in our first report,  An Introduction  Based on Texas 
(OEI-06-96-OOO80),indicate  that HCFA  should continue  to work with the States and 
other responsible  entities  to improve  and enforce  existing  requirements  for more effective 
medication  reviews  for patients  in nursing  homes.  Specific recommendations  for HCFA 
to consider  in this endeavor  are provided  in our third  report  of this inspection,  A 
Pharmaceutical  Review and Inspection  Recommendations  (OEI-06-96-00082). 
21 
 COMMENTS  ABOUT  DRAFT  REPORTS 
We solicited  comments  from agencies  within the Department  of Health and Human 
Services  which have responsibilities  for policies  related  to Medicare  and Medicaid  and 
long term care.  We also requested  input from several  national  organizations  representing 
the interests  of nursing  homes,  patients,  or providers.  We appreciate  the time and efforts 
of those providing  comments. 
Denartmental  Comments 
Within the Department,  we received  comments  on the draft reports  from the Health Care 
Financing  Administration  (HCFA)  and the Assistant  Secretary  for Planning  and Evaluation 
(ASPE).  Both agencies  concurred  with the recommendations;  HCFA emphasized  the need 
for further  studies to assess the extent of continued  use of potentially  inappropriate  drugs, 
other avenues of possible  cost savings related to drugs,  and the need to determine  and 
understand  the potential  sources of the escalating  costs and claims for certain  types of 
drugs used in nursing  homes.  The final reports  reflect  several clarifications  or changes 
based on their  suggestions.  The full text of each agencys  comments  is provided  in the 
third and final report  of this inspection,  A Pharmaceutical  Review and Inspection 
Recommendations  (OEI-06-96-00082). 
Comments  from External  Organizations 
We also received  comments  from the following  external  organizations:  American  Health 
Care Association;  American  Association  of Homes and Services  for the Aging;  American 
Medical  Directors  Association;  American  Society of Consultant  Pharmacists;  and National 
Association  of Boards of Pharmacy.  Most of the associations  concurred  with one or more 
of the recommendations  within each of the inspection  reports.  All commentors  support 
the need for better communication  and coordination  between nursing home staff and other 
healthcare  providers,  training  nurse aides,  and understanding  the implications  of nursing 
home medication  services  and associated  costs. 
Several organizations  questioned  the methodology  used in this inspection,  particularly  for 
the consultant  pharmacist  survey.  However,  as with any evaluation,  there are always 
some limitations  in how data and information  can be obtained,  given time and other 
resource  constraints.  Further,  while we acknowledge  that a survey of this nature 
introduces  some bias and subjectivity,  we also believe  that the survey of consultant 
pharmacists  provides  us with an up-close  view of what is happening  with prescription  drug 
use in nursing  homes.  Moreover,  the results of the consultant  pharmacist  survey  are 
consistent  with our results  from our two other methodologies. 
Some comments  expressed  concerns  about the use of the term,  inappropriate.   As 
explained  previously,  use of this term in reporting  concerns  with a patients  medication 
regimen  are somewhat  a matter  of opinion.  The evidence  provided  in these three reports 
does not prove that any one prescription  was improper,  but that closer examination  is 
22  warranted.  Also,  while the use of such a drug may be supported by physician  orders  in 
individual  cases, use of the drug,  in general,  is likely  to be considered  inappropriate. 
Some comments  addressed  the implications  of broadening  Federal  oversight.  There  is 
clear concern  about the responsibility  for medication  issues being the responsibility  of the 
physician,  not the nursing  home.  Further,  some organizations  expressed  concern  that 
these particular  issues did not result  in direct recommendations  about the physicians  role 
for nursing home patients  medication  regimens.  We felt that further  examination  of this 
area is warranted  before  recommending  changes which would impact so many entities 
involved  in the process. 
In conclusion,  we believe  the three reports  collectively,  and each using a different 
approach,  strongly  indicate  that the intent of the provisions  of the OBRA Acts concerning 
prescription  drug usage are not being clearly  fulfilled.  Further,  HCFA  has authority  to 
correct  and enhance  quality  of care for nursing  home patients.  The recommendations  we 
present attempt to facilitate  the initial  steps of this effort,  and to address some concerns 
evidenced  in the reports  and received  comments.  While  we recognize  that great strides 
have been made to meet the OBIL4 requirements,  we believe  further  effort  remains by all 
the players  involved  (HCFA,  associations  and their members,  nursing  homes,  and 
residents and their families)  to further  improve  quality  of care for nursing home patients. 
The full text of each organizations  comments  is provided  in the third  and final report of 
this inspection,  A Pharmaceutical  Review and Inspection  Recommendations  (OEI-06-96-
00082). 
23 
 ENDNOTES 

1.  Health Care Financing  Administration,  BDMS, Division  of Program  Systems,  1996. 
2.  Keitz,  Todd.  10 Things  You Should Know  About  the  Long Term  Care  Market. 
Medicinal Marketing and Media.  30(.5):42-46.  May  1995. 
3.  Beard,  Keith.  Adverse Reactions  as a Cause of Hospital  Admission  in the Aged, 
Drugs  & Aging,  Vol.  2, No.  4 (July/Aug.  1992), pp. 356-67. 
4.  Published  October  9,  1995,  in  the Archives  of Internal Medicine,  the data  further 
illustrates  that while spending one dollar  to purchase prescription  drugs,  Federal and 
State governments  also spend another dollar to correct the problems caused by misuse 
of those drugs. 
5.  General Accounting  Office.  Prescription  Drugs and the Elderly:  Many Still Receive 
Potentially  Harmful  Drugs  Despite  Improvements.  Letter  Report  GAO/HHES-95-
152. July 24,  1995. 
6.  Knowlton,  Calvin  H.  Statement  before  the  Senate  Special  Committee  on  Aging, 
Hearing  on Drugs and the Elderly,  Washington,  D. C.  March 28,  1996. 
7.  Inappropriate  use of medications  can take a number of the following  forms: 
drug-drug  interaction;  drug-age contraindication;  drug-allergy  contraindication; 
drug-disease  contraindication;  incorrect  drug dosage;  incorrect  duration  of drug 
therapy;  and less effective  drug therapy. 
8.  Spore,  Diana L.,  P. Larrat,  et al.  Inappropriate  Drug Prescriptions  for Elderly 
Residents of Board and Care Facilities.   American Journal  of Public Health, 
March  1997, Vol.  87, No.  3, pp. 404-409. 
9.  Beers, Mark,  Joseph G. Ouslander,  Irving  Rollingher,  et al.  Explicit Criteria  for 
Determining  Inappropriate  Medication  Use in Nursing facility  Residents.  Archives 
of Internal Medicine,  Vol.  lSl(Sept.  1991), pp.  1825-32. 
10.  42 CFR Set 483.60. 
11.  Perri,  M., J. Kotzan, L. Pritchard,  et al.  OBRA 90: The Impact on Pharmacists and 
Patients.   American Pharmacy,  February  1995, Vol.  NS35, No. 2, pp. 24-28. 
12.  Nelson,  Arthur  A.  The Smoking Gun in OBRA 90.   Pharmacy Times, February 
1993, pp. 49-58. 
13.  Fanale,  R. H.,  et al.  The Nursing  Home Medical  Director,  Journal  of the 
American  Geriatrics Society,  1989, 37(4), pp. 371-373. 
24 
 14.  The  Merck  Manual,  15th edition,  fourth  printing. 
15. 	 Government  regulation  and  policies  of third-party  payors  (insurance  companies) 
have  a direct  impact  on utilization,  perhaps  mostly  by decreasing  the  number  and 
types  of  laboratory  tests  routinely  conducted  in nursing  homes.  Medicare  has 
changed  its policy  for  payment  of  laboratory  tests  (i.e.,  no  more  orders  for  tests, 
especially  multiple  tests,  without  good  clinical  indications).  Thus,  one  effect  of 
this  new  policy  may  be  less  lab testing,  particularly  for  those  tests  which  cover  a 
variety  of possible  physical  effects  of medication  (i.e.,  Super  Chemistry). 
16. 	 According  to research,  there  are  at least  four  patterns  of constipation  found  in 
infirm  elderly  nursing  home  patients  which  may  often  be due  to secondary  causes, 
such  as physical  immobility  and  medications  (e.g.,  antidepressants  and  neuropletics 
with  anticholinergic  properties,  calcium  channel  blockers,  iron  supplements,  and 
narcotics). 
17. 	 Elderly  patients  have  an increased  risk  for falling  when  they  experience  a combination 
of  any  of the  following: 
dementia,  especially more advanced stages; 

orthostasis,  a  fall  in  systolic  blood  pressure,  may  be  enhanced  by  certain 

antihypertensives  and psychotropics  as well as certain physical  difficulties  related to 

either urination  or digestion; 

3)  arthritis,  particularly  when the patient has limited mobility,  may increase a patients 

tendency  to fall or to experience  confusion when certain narcotic analgesics are used, 

usually inappropriately,  for the pain; 

4)  incontinence  of urine or bowel,  past stroke,  or abnormal balance or gait, seizures; 

5)  age-related  decreases  in sight,  hearing,  reaction time,  sensory  awareness  or the use 

of anticonvulsants  which may increase the possibility of falls for ambulatory patients; 

6)  metabolic  drug  related  causes  include  uncorrected  hypothyroidism,  hypoglycemia 

(insulin and oral antidiabetics),  anemia (NSAIDS), low serum sodium and potassium, 

and dehydration  (diuretics);  and 

7)  the inability to recognize  environmental  risks (e.g.,  unlocked  bed wheels). 

Also,  some  of the listed  ailments  or medications  have  their  own  potential  for causing 
physical,  mental,  and  emotional  side  effects  for  elderly  persons. 
18. 	 Both  The  MERCK  Manual  of Diagnosis  and  Theranv  and  the  AARP  Prescription 
Drug  Handbook  provide  the  most  common  reasons  for  usage  and  concerns  related 
to the  usage  of these  drugs: 
Antipsychotics (major tranquilizers also called neuroleptics) 
Are used to treat a variety of very severe emotional  disorders,  including  severe anxiety, 
agitation,  or psychosis.  They should not be used to treat simple anxiety.  Low doses of 
some of these may also be used to treat nausea and vomiting.  The principle  restriction 
while taking these drugs is related to the taking of any other drugs,  including  over-the-
counter  ones, because these drugs can negatively  interact with blood pressure  medication, 
antidepressants,  antihistamines,  barbiturates,  narcotics,  tranquilizers,  cimetidine  (medicine 
for ulcers),  and antibiotics.  Further,  these drugs may disturb the ability of a patients 
body to regulate  its temperature. 
25 
 The most common  side effects are sleepiness,  sudden  faintness or falling when getting up 

from a reclining  or sitting position,  muscle  stiffness,  and slowness of movement  (each of 

which may be treated symptomatically  by other medications  which may negatively  interact 

with antipsychotics).  Certain examples  should clearly be avoided  for medical  reasons such 

as thioridazine  in patients with heart disease.  Elderly patients who use these drugs are 

more prone  to extrapyramidal  side effects,  tardive dyskinesia,  and hypotension. 

Occurrences  of other rare side effects can also be increased  in the elderly  (e.g., 

leukopenia,  skin pigmentation). 

Antianxiety agents  (minor tranquilizers also called anxiolytics) 
Anxiety neurosis  is a neurotic  disorder  characterized  by chronic,  unrealistic  anxiety often 

punctuated  by acute attacks of anxiety or panic.  It afflicts only 5 percent  of the 

population,  is characteristically  among  young adults,  and affects women twice as often as 

men.  Anxiety symptoms  often become  less severe and troublesome  with middle  age.  The 

risk is that many elderly persons  being treated for anxiety may not actually be suffering  the 

illness itself. 

Both physiologic  and psychologic  facts cause anxiety neurosis,  and there is evidence that a 

genetic propensity  may also exist.  Physical examinations  and laboratory  studies usually 

can establish whether  the patient is truly suffering  anxiety or another  illness which may 

manifest  itself with symptoms  similar to those of anxiety (e.g.,  Graves disease, 

myocardial  infarction,  depression). 

Benzodiazapines  have largely supplanted  other antianxiety drugs,  including  the 

barbiturates,  meprobamate,  and hydroxyzine.  While phenothiazines  (e.g.,  thioridazine)  are 

occasionally  used as antianxiety agents,  their side effects make them ill-suited for 

ambulatory  patients without marked  anxiety,  or for patients who do not respond  or tend to 

become dependent  with the use of benzodiazepines.  [The degree of central nervous  system 

depression  produced  by most anxiolytics  is dose-dependent  and can be severe.  Further, 

these drugs tend to have a long half-life,  and for some of the drugs  in this category,  half-

lives increase considerably  with age (four- to sixfold at age go).]  In the elderly,  these 

drugs are often associated with over sedation,  ataxia, confusion,  reduced  energy  levels , 

and paradoxical  excitement  and delirium.  Physiologic  changes common  to elderly persons 

may explain any unusual responses to the drugs.  These drugs can actually worsen the 

conditions  of patients suffering  dementia  or depression  and, occasionally,  induce florid 

delirium.  In the elderly,  these drugs should be used for short-term  treatment  only. 

Sedatives/Hypnotics 
These terms,  as well as antianxiety agent,  minor tranquilizer,  and anxiolytic  are 
ambiguous  and often used interchangeably.  A single one of these drugs is frequently 
useful in more than one therapeutic  category,  depending  on the dosage.  All available 
hypnotics  involve some risk of overdose,  habityation,  over-tolerance,  and addiction,  as 
well as withdrawal  symptoms  that can include a temporary  recurrence  of sleeplessness. 
Ambulatory  patients given these drugs should avoid activities requiring  mental alertness, 
judgment,  and physical coordination.  They should particularly  be used with extreme 
caution in patients with severe pulmonary  insufficiency.  The elderly may exhibit 
restlessness,  excitement,  or exacerbations  of symptoms  of organic brain disorders.  Serum 
levels should routinely  be checked  for appropriate  dosage levels when such symptoms  are 
exhibited. 
19. 	 Weekly  Report  for Week Ending  January  17, 1997, Health Care Financing 
Administration,  Health  Standards and Quality  Bureau. 
20. 	 Ruegg et al presents three  main types of depressive  disorders  in the elderly.  These 
include: 
26 
 1) 	 the patients presentation  of  multiple  somatic complaints  (headache, 
gastrointestinal  upset,  fatigue) which,  in effect,  mask  or hide the presence  of 
depressive  symptoms; 
the patient complains  of difficulty  concentrating  or remembering,  and withdraws 
2) 	
from the environment,  falsely mimicking  dementia;  and 
3) 	 the patient experiences  some form of delusion.  (It should be noted that there are 
also some forms of medical illness with symptoms  mimicking  a delusional 
depression  such as a tumor or stroke or Alzheimers  disease.) 
21. 	 Chrischilles  E.,  D.  Foley,  R.  Wallace,  J. Let&e,  T.  Semla,  J. Hanlon,  et al.  Use 
of  Medications  by  Persons  65 and  Over:  Data  from  the  Established  Populations  for 
Epidemiologic  Studies  of the  Elderly.    Journal of Gerontology,  1992; 47 :M 137-44. 
22. 	 Telephone  conversations  with Tom  Clark,  Director  of Professional  Affairs,  subsequent 
to other  conversations  with  Janice  L.  Feinberg,  Director  of Research  and  Education 
Foundation,  both  with  the  American  Society  of  Consultant  Pharmacists. 
27 
 APPENDIX  A 

20 Drugs Generally  Considered 
Inappropriate  for the Elderly 
The 20 drugs listed below were judged  generally  inappropriate  for elderly  patients by a panel of 
experts.  The panels  results and methodology,  published  in 1991, indicate that these drugs should 
normally  not be used with elderly  patients.  However,  they stress that there could be some medical 
situations  in which use of these drugs would be appropriate. 
Medication  Use  Comment 
Amitriptyline  To treat 
 Other antidepressant 
depression 
 medications  cause 
fewer side effects 
Carisoprodol  To relieve  severe 
 Minimally  effective 
pain caused by 
 while causing 
sprains and back 
 toxicity;  potential 
pain 
 for toxic reaction 
is greater  than 
potential  benefit 
Chlordiazepoxide  As a (minor)  tranquilizer 
 Shorter-acting 
or antianxiety 
 benzodiazepines  are 
medication 
 safer alternatives 
Chlorpropamide  To treat diabetes 
 Other oral medications 
(a hypoglycemic  agent) 
 have shorter  half-lives 
and do not cause 
inappropriate 
antidiuretic  hormone 
secretion 
Cyclandelate  To improve  blood 
 Effectiveness  is in 
circulation 
 doubt;  no longer  available 
in the U.S. 
A -1 
 Medication  Use  Comment 
Cyclobenzaprine  To relieve  severe 
 Minimally  effective 
pain caused by 
 while causing 
sprains and back 
 toxicity;  potential 
pain 
 for toxic reaction 
is greater  than 
potential  benefit 
Diazepam  As a (minor)  tranquilizer 
 Shorter-acting 
or antianxiety 
 benzodiazepines  are 
medication 
 safer alternatives 
Dipyridamole  To reduce blood-
 Effectiveness  at low 
clot formation 
 dosage is in doubt; 
toxic reaction  is 
high at higher 
dosages;  safer 
alternatives  exist 
Flurazepam  As a sleeping pill 
 Shorter-acting 
(a hypnotic) 
 benzodiazepines  are 
safer alternatives 
Indomethacin  To relieve  the 
 Other nonsteroidal 
pain and 
 anti-inflammatory 
inflammation  of 
 agents cause less 
rheumatoid 
 toxic reactions 
arthritis 

Isoxsuprine  To improve  blood 
 Effectiveness  is in 
circulation 
 doubt 
Meprobamate  A (major) tranquilizer 
 Shorter-acting I 
(used for anxiety) 
 benzodiazepines  are 
safer alternatives 
Methocarbamol  To relieve  severe 
 Minimally  effective 
pain caused by 
 while causing 
sprains and back 
 toxicity;  potential 
pain 
 for toxic reaction 
is greater  than 
potential  benefit 
A -2 
 Medication  Use  Comment 
Orphenadrine  To relieve  severe  Minimally  effective 
pain caused by  while causing 
sprains  and back  toxicity;  potential 
pain  for toxic reaction 
is greater  than 
potential  benefit 
Pentazocine  To relieve  Other narcotic 
moderate  to severe  medications  are 
pain  safer and more 
effective 
Pentobarbital  As a sleeping pill  Safer sedative-
and to reduce  hypnotics  are 
anxiety  (hypnotic)  available 
Phenylbutazone  To relieve  the  Other nonsteroidal 
pain and  anti-inflammatory 
inflammation  of  agents cause less 
rheumatoid  toxic reactions 
arthritis 
Propoxyphene  To relieve  mild to  Other analgesic 
moderate  pain  medications  are more 
effective  and safer 
Secobarbital  As a sleeping pill  Safer sedative-
and to reduce  hypnotics  are 
anxiety  (hypnotic)  available 
Trimethobenzamide  To relieve  nausea  Least effective  of 
and vomiting  available 
antiemetics 
Source: 
Beers,  Mark,  Joseph  G.  Ouslander,  Irving  Rollingher,  et  al.  Explicit  Criteria  for  Determining 
Inappropriate  Medication  Use  in  Nursing  Home  Residents,  Archives  of  Internal  Medicine,  Vol. 
lSl(Sept.  1991), pp.  1825-32. 
A -3 
 APPENDIX  B 

Consultant Pharmacists  Assessments of 
Medication  Problems in Nursing Homes 
(Weighted Data) 
Table  1:  Concerns  about  Residents  Using  Certain  Medications 
FREQUENCYOFOCCURRENCE 
(During  Six-Month  Period  Prior  to Survey) 
Medication  Type 
% Often  % Sometimes  % Rarely  % Never 
antibiotics  or anti-infectives  3.2  35.8  48.4  12.6 
anesthetics  0.1  0.8  12.2  86.9 
antipsychotics  13.3  53.3  25.8  7.6 
antidepressants  6.9  31.4  47.7  14.0 
anxiolytics  14.6  46.0  32.4  7.0 
diuretic  medications  2.6  26.3  48.8  22.2 
narcotics  6.5  39.3  35.8  18.4 
non-steroid  anti-inflammatory  6.7  40.7  41.0  11.6 
sedatives  or hypnotics  12.3  49.5  28.5  9.6 
steroids  2.6  11.7  53.3  32.3 
gastrointestinals  3.6  32.6  46.2  17.6 
ACE  inhibitors  2.7  22.6  54.3  20.4 
calcium  channel  blockers  1.1  18.5  58.9  21.5 
H2 antagonists  17.7  47.6  26.8  7.9 
digoxin  3.5  36.5  49.2  10.8 
Source:  Q30a-Q30o  # 
B-l  Table  2:  Appropriateness  of Prescribed  Medication 
FREQUENCYOFOCCIRRENCE 
Problem  Encountered  % Often  % Sometimes  % Rarely  % Never 
medication  contraindicated  by diagnosis  or disease  1.7  24.2  66.7  7.5 
as  needed  medications  administered  too long  7.1  54.2  34.6  4.1 
unauthorized  medication  with  no  signed  orders  0.7  7.6  41.0  50.7 
continuous  use of sleeping  medication  for too long  26.5  49.6  22.1  2.1 
use of antipsychotic  w/o  diagnosis  6.0  38.6  42.7  12.7 
use of antidepressant  w/o  diagnosis  4.3  28.3  55.6  11.8 
overutilization  9.5  52.2  33.8  4.5 
underutilization  0.2  26.0  61.1  12.7 
use of more  than  one  medication  in same  drug  4.2  35.9  53.9  6.0 
Source:  Q311,Q31n-Q31u 
Table  3:  Number  of Physicians  Inappropriately  Prescribing  Medications 
Medication  Type  % None  % Few  % Some  % Most  % All 
Antipsychotics  45.8  41.5  10.1  1.9  0.7 
Anxiolytics  43.8  37.6  16.0  2.6  0.0 
Antidepressants  57.2  28.6  8.7  4.1  1.5 
Sedatives  or Hypnotics  37.8  41.9  17.0  2.6  0.7 
Source:  Q12a-Q12d 
Table  4:  Why 	 Doctors  Dont  Limit  Inappropriate 
Medications  for the  Elderly 
Reason  Percent  Pharmacist 
Indicating 
Lack  of training  14.9% 
Lack  of knowledge  21.0% 
Indifference  20.5% 
Pressure  to continue  medication 
from: 
b  Family/guardian  27.8% 
b  Resident  23.6% 
t  Facility  staff  14.3% 
Source:  Q19 
B-2 
 Table  5:  Administration  of Medications 
FREQUENCYOFOCCURRENCE 
Problem  Encountered 
% Often  % Sometimes  % Rarely  % Never 
incorrect  dosage  2.2  26.5  37.1  3.4 
not  optimal  duration  2.0  44.4  44.1  8.7 
not  optimal  dosage  3.9  48.8  42.2  5.1 
administered  at incorrect  time  11.4  47.6  36.9  4.1 
administered  to wrong  resident  0.0  4.4  71.2  24.3 
inappropriate  dosa  e alteration  5.0  35.0  51.3  8.7 
(crush/no  crush,  dfiution,  etc.) 
incorrect  route  of administration  0.1  8.0  59.1  32.8 
wrong  medication  Administered  0.0  10.9  76.5  12.6 
Source:  Q31a-Q31g 
Table  6:  Monitoring  of Medication  Usage 
FREQUENCYOFOCCURRENCE 
Problem  Encountered 
% Often  % Sometimes  % Rarely  % Never 
failure  to chart  use 
 11.0  47.7  34.7  6.6 
l$:tTJIosage  adjustment  for renal/hepatic 
 6.0  44.2  40.2  9.6 
inappropriate  for use by elderly 
 4.1  41.6  44.6  9.7 
duplicate  prescriptions 
 0.9  28.1  55.1  15.4 
medication/medication  interaction 
 3.6  53.0  38.7  4.7 
medication/diet  interaction 
 1.8  32.6  57.3  8.3 
medication/gender  interaction 
 0.0  4.3  47.8  47.9 
contraindicated  by  residents  allergy  history 
 0.8  19.7  63.8  15.7 
lack  of lab  testing  to ensure  continued  need 
 8.8  51.7  35.0  4.5 
lack  of monitoring  for efficacy  and  side  effects 
 11.0  38.6  36.2  14.2 
lack  of lab  testing  for routine,  on-going  10.2  40.8  43.2  5.8 
monitoring  of toxics 
lack  of physical  assessment  for continued  need  9.1  37.5  44.3  9.1 
or appropriateness  of dosage 
lack  of physical  assessment  for routine,  on- 10.0  32.7  48.0  9.3 
going  monitoring  of certain  medications 
Source:  Qf31-Qr31 
B-3  Table  7: Doctors  Routinely  Seeking  Lowest  Effective  Dose  for  Select  Drug  Classes 
Antipsychotics  Anxiolytics 	 Sedatives/  Antidepressants 
Hypnotics 
Number  of doctors  routinely 
trying  for  lowest  effective  dose 
b  All 
25.5%  19.8%  21.9%  17.0% 
b  Most 
45.8%  42.8%  41.4%  24.9% 
b  Some 
18.6%  23.6%  15.6%  15.7% 
b  Few 
8.7%  12.2%  19.1%  26.3% 
b  None 
1.4%  1.6%  1.9%  16.1% 
Source:  414 
II 
Table  8:  Adverse  Medication  Reactions 
FREQUENCYOFOCCURRENCE 
Problem  Created 
% Often  % Sometimes  % Rarely  % Never 
contributed  to urinary  incontinence 
 0.9  25.3  56.1  17.7 
contributed  to depression 
 1.1  38.1  50.4  10.4 
contributed  to delirium 
 0.9  39.9  45.9  13.3 
contributed  to falls 
 6.1  60.2  27.1  6.7 
contributed  to constipation 
 16.6  64.5  15.4  2.8 
Source:  Q31h-Q31m 
B-4  Table  9:  Quality  Assurance  and  Quality  Control  Issues 
FREQUENCYOFOCCURRENCE 
Problem  Encountered 
% Often  % Sometimes  % Rarely  % Never 
medication  order  not  on  MAR  0.2  17.3  62.6  19.9 
medication  listed  on  MAR  w/o  order  0.1  6.7  47.8  45.4 
MAR  not  updated  to reflect  new  dose  or schedule  2.1  27.2  54.6  16.0 
order  sheets  not  current  or correct  when  signed  by  MD  4.6  22.0  54.5  18.8 
lack  specific  directions  for usage  11.6  48.7  34.8  4.9 
order  incomplete  5.8  46.5  40.2  7.5 
medications  not  provided  for periods  away  from  nursing  0.2  2.6  49.1  48.1 
home 
theft  of medications  0.1  5.1  49.1  45.8 
misplacement  of medications  0.7  21.6  62.9  14.8 
medications  found  in trash  can  in residents  room  0.0  3.3  31.8  64.9 
medications  administered  by  inappropriate  or unauthorized  0.0  1.5  15.2  83.3 
personnel 
medications  administered  in disregard  of stop orders  0.3  17.0  60.3  22.4 
clinical  abuse  or misuse  0.0  4.6  40.6  54.8 
iource:  Q311-Q319,  Qa31-Qe31 
Table  10:  Barriers  to Including  Non-Prescribed  Medications 
in Review  of Residents  Medication  Regimens 
Possible  Barriers  % True  % False 
Collecting  data  directly  from  residents  or their  guardians  is too labor  63.9  36.1 
intensive 
Facility  contract  does  not  require  pharmacists  review  of non-prescribed  20.8  79.2 
OTC  medications 
Records  of non-prescribed  OTC  medications  not  available  34.1  65.9 
Records  of non-prescribed  OTC  medications  insufficient  39.7  60.3 
Non-prescribed  medications  not  included  in residents  plan  of care  61.6  38.4 
Non-prescribed  medications  not  part  of residents  assessment  43.3  56.7 
Non-prescribed  medications  not  included  in residents  permanent  medical  48.8  51.2 
record 
Facility  staff  do not  routinely  inspect  residents  rooms  for non-prescribed  12.3  87.7 
medications 
Source:  Q25a-Q25h 
B-5 
 Table  11:  Policy  Barriers  to Appropriate  Reviews  of Medication  Regimens 
Possible  Policy  Barriers  % True  % False 
No clearly  defined  responsibilities.for  pharmacists  10.2  89.8 
performing  services  in nursing  facilities 
No clear  separation  between,  responsibilities  to the  11.6  88.4 
nursing  home  and  to the restdents 
Primarily  responsible  to nursing  home  rather  than  to  15.7  84.3 
resident 

Lack  of pharmacists  enforcement  authority  to 
 32.1  67.9 
ensure  facilities  adherence  to OBRA 

Source:  QBa,J,k,p 
Table  12:  Nursing  home  and  Other  Management  Issues  as Barriers 
to Appropriate  Reviews  of Medication  Regimens 
Possible  Management  Issues  as Barriers  % True  % False 
No control  over  medications  ordered  and  dispensed  42.4  57.6 
in nursing  home 
Insufficient  access  to records  maintained  by nursing  11.8  88.2 
home,  e.g.  assessment,  plan  of care 
No authority  over  nursing  staff  to ensure  23.7  76.3 
medications  are  administered  as ordered 
No authority  over  nursin  staff  to ensure  medically  27.3  72.7 
appro  riate  monitoring  of residents  physical 
condo.Pton as related  to drug  regimen 
No means  of ensuring  residents  compliance  with  17.4  82.6 
drug  regimen 
No authority  over  dispensing  pharmacy  14.7  85.3 
Source:  Q29d,g,h,i,e,f 
Table  13:  Professional  Authority  Issues  as Barriers 
to Appropriate  Reviews  of Medication  Regimens 
Possible  Professional  Barriers  % True  % False 
Lack  of authority  to modify  drug  regimen  58.6  41.4 
Lack  of authority  to order  lab tests  to ensure  65.5  34.5 
appropriateness  of drug  regimen 
Insufficient  authority  to ensure  doctors  appropriately  61.6  38.4 
prescribe  residents  medications 
Doctors  not  required  to respond  to pharmacists  54.4  45.6 
concerns 
Doctors  rejection  of pharmacists  recommendations  46.8  53.2 
Source:  Q29b,c,l,m,n 
B-6  APPENDIX  C 

Additional Pharmacist Survey Weighted  Data 
Table  1:  Routine  Performance  of Other  Drug-Related  Functions 
Consultant  Pharmacist  Functions  % Yes  % No 
Ensure  MAR  are complete  and  orderly  93.7  6.3 
Maintain  records  for medication  receipt,  administration,  and  84.1  15.9 
destruction 
Monitpr  medication  records  to ensure  maintenance  or improvement  92.9  7.1 
of residents  functioning 
Monitor  medications  for expiration,  proper  storage,  or packaging  96.0  4.0 
integrity 
Preparation  of medication  dispensing  mechanisms,  e.g.  cart  67.2  32.8 
Periodical1  observe/evaluate  medication  passes  to ensure  accuracy  85.2  14.8 
of admims27ration 
Source:  QlOe,p-t 
Table  2:  Frequency  of Routine  Performance 
of Drug  Education/Training  and  Committee  Participation 
% Yes  % No 
Drug  education/training  of: 
b  nursing  staff  93.0  7.0 
b  nurse  aides  52.0  48.0 
w  medication  aides  49.8  50.2 
t  families/guardians  30.1  69.9 
w  residents  27.1  72.9 
Participation  in committees  for: 
b  pharmacy  and  therapy  73.6  26.4 
w  quality  assurance  86.5  13.5 
b  infection  control  67.3  32.7 
b  care  planning  10.9  89.1 
Source:  QlOg-k,l-o  I 
C-l  Table  3:  Difficulty  in Obtaining  Specific  Patient-Related  Records 
Patient  Documents  or Records  % Yes  % No 
Doctors  orders  6.0  94.0 
Doctors  progress  notes  12.7  87.3 
Nurses  progress  notes  9.1  90.8 
Residents  assessment  11.0  89.0 
Residents  diagnosis(es)  34.7  65.3 
Residents  plan  of care  3.4  96.6 
Lab reports 
 32.8  67.2 
Residents  nutritional  plan 
 needs  6.5  93.5 
Incident/accident  reports 
 19.8  80.2 
Medication  administration 
 records  11.0  89.0 
Hospital  discharge  summary  25.5  74.5 
Specialists  Notes  (PT,  OT,  ST,  etc.)  8.8  91.2 
Transfer  reports  20.4  79.6 
Hospital/operation  reports  30.1  69.9 
Source:  Q28a-n 
Table  4: Routine  Contacts 
for Medication  Regimen  Problems 
Who  Contacted  %Yes  % No 
Medical  Director  43.7  56.3 
Director  of Nurses  93.7  6.2 
RNs/LVNs/PNs  96.4  3.6 
Resident  12.2  87.8 
Residents  family/guardian  5.2  94.8 
Residents  personal  doctor  87.7  11.5 
Personal  doctors  PA/NP  54.9  45.0 
Appropriate  nurse  aide  17.8  82.2 
State  certification  agency  7.7  92.3 
Dietitian  42.5  57.5 
Therapist  (e.g.  occupational,  24.8  75.2 
physical  , speech) 
Source:  Q4la-k 
c-2  Table  5: Frequency  of Contact  with  Residents 
Always  Mostly  Sometimes  Rarely  Never 
Routine1  meet  with  resident  or  1.6  0.6  15.9  44.9  37.0 
family  a7ter  medication  review 
Routinely  ask resident  or family  1.1  2.6  25.6  54.2  16.4 
preferences  m certain  prescribed 
medications 
Source:  Q47,Q48 
Table  6: Cooperation  Between  Pharmacists  and  Others 
Extent  of Cooperation 

Individual  With  Whom  % Very  Good  % Good  % Fair  % Poor  % No Contact 

Consultant  Pharmacist 
Communicates 
Nursing  home
Administrator  51.6  31.1  8.9  1.7  6.7 
Medical  Director  for
Facility  29.2  42.3  20.0  2.2  6.3 
Director  of Nursing  for
Facility  73.4  21.1  2.3  1.7  1.5 
Patients  Personal
Physician  12.6  44.5  35.7  3.8  3.5 
Immediate  Nursing  Staff
(RN,LVN,PN)  60.6  33.5  5.0  0.9  0.0 
Nurse  Aides 
 21.2  23.1  6.7  1.6  47.5 
Patient 
 11.8  19.7  9.3  1.4  57.9 
Patients  Family  or 

Guardian 
 10.5  17.2  7.2  1.o  64.2 
Source:  Q6Oa-h 
c-3