Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
PRESCRIPTION  DRUG  USE 

IN  NURSING  HOMES 

Report  3 
A  Pharmaceutical  Review 
and 
Inspection  Recommendations 
JUNE  GIBBS  BROWN 
Inspector  General 
NOVEMBER  1997 
OEI-06-96-00082  EXECUTIVE  SUMMARY 
PURPOSE 
To assess the extent and appropriateness  of pharmaceutical  use by selected Texas nursing 
home residents  and to describe  pharmacists  concerns  about drug use. 
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.  Yet, several  recent  studies 

suggest that the use of inappropriate  or contraindicated  drugs is a contributing  factor to the 

high health care costs in the elderly  population.  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 determine  what is appropriate  care.  This includes 

prescribing  medications  to meet patients  needs. 

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 third.  The first report describes 

prescription  drug use in Texas nursing  facilities;  the second report  discusses medication 

use concerns  expressed  by a nationally  representative  sample of consultant  pharmacists. 

This third report  provides  the results of a pharmaceutical  review  (conducted  by 

independent  pharmacists  with whom we contracted  for this purpose)  of 254 sampled Texas 

nursing home patients.  Additionally,  this final report  presents  recommendations 

addressing  the issues and concerns  raised collectively  by all three  reports  issued as part of 

this coordinated  inspection. 

FINDINGS 
Overall,  contracted  pharmacists  reviews consistently  identified  the same problems  and 
concerns  for patients  as were raised by our analysis  of Texas data and the national  survey 
of consultant  pharmacists.  This finding  underscores  the need for strengthening  medication 
reviews  and improving  medication  prescribing,  administration,  and monitoring  practices  in 
nursing  homes.  Oualitv  of Care Issues 
Contracted  medication  reviews  revealed  potentially serious concerns  with residents 
drug regimens. 
20 percent  of the reviewed  patient  records  identified  patients  receiving  at least one drug 
judged  inappropriate  for their diagnoses.  Additionally,  patients  records  indicated  some 
residents  were taking  medications  potentially  contraindicated  by their diet requirements, 
plans of care,  or assessments. 
16 percent  of patients  were receiving,  without a prescription  in their records,  drugs for 
which prescriptions  are generally  required.  Further,  23 percent  of the patients  were 
prescribed  medications  for which the records  showed no orders  or receipts to indicate the 
patient  actually  received  the medication. 
Approximately  20 percent  of residents  received  at least one drug considered  by experts to 
be inappropriate  for use by the elderly. 
Some patients  records  indicate  they may be experiencing  unnecessary  adverse medication 
reactions  as a result of inadequate  monitoring. 
21 percent  of patients  were receiving  drugs which may sometimes  negatively  interact with 
other drugs in their regimen. 
Nearly  one-third  of patients  were receiving  more than one drug from the same class, 
sometimes  a potential  hazard.  Drugs from the same class may produce  similar  side effects 
which can be additive  and need to be carefully  managed.  Yet,  19 percent  of all records 
indicate  no monitoring  for efficacy. 
ShortcominPs of Medication  Reviews 
Resident medication records are often incomplete,  making it difficult  or impossible to 
identify or confirm potential drug regimen problems. 
31 percent  of patients  records  were not sufficientlq  complete  to allow contract 
pharmacists  to make determinations  concerning  the appropriateness  of medications 
prescribed  for patients  diagnoses. 
Contract  pharmacists  identified  several patients whose prescribed  medications  may have 
contributed  to falls,  depression,  and constipation.  However,  due to insufficient  records, 
they were unable to pinpoint  or eliminate  the patients  drug regimen  as the cause. 
Often the contract  pharmacists  were unable  to determine  whether  a patient  had received  a 
monthly  drug regimen  review  during  the sampled time period. 
ii  Thorough  contracted  medication reviews required much more time than the usual 
review times reported by nursing home consultant  pharmacists.  Allotting more time 
for conducting  reviews appears to help in detecting more medication  concerns. 
Contract  pharmacists  reviews  averaged  50 minutes,  which is considerably  longer than the 
times consultant  pharmacists  expend doing medication  reviews  (averaged  5-10 minutes per 
monthly  review  with initial  reviews  taking  15-20 minutes). 
The contract  pharmacists  identified  medication  problems  or concerns  for 20 percent  of the 
patients  which had not been identified  by the nursing home consultant  pharmacists 
reviews. 
RECOMMENDATIONS 

Medication  problems and concerns raised collectively  by the three coordinated  reports 

of this inspection  demonstrate the need for stronger monitoring and more positive 

enforcement  of existing regulations  and required reviews of medication  usage in 

nursing homes.  Therefore,  we recommend  that the Health Care Financing 

Administration: 

Continue  to monitor  and encourage  reductions  in the use of potentially  inappropriate 
prescription  drugs in the elderly  nursing  home population; 
Work with other Federal  and State agencies to identify  and analyze  reasons  for the 
rapid escalation  in costs and claims  for certain  types of drugs used in nursing  homes 
(i.e.,  gastrointestinal,  psychotherapeutic,  cardiac,  cardiovascular,  and anti-infectives); 
Strengthen  the effectiveness  and impact of medication  reviews conducted  by consultant 
pharmacists  in nursing homes; 
Require  nursing homes to ensure that the curriculum  for required  on-going,  in-service 
training  for personal  care staff (nurse aides) includes information  on how to recognize 
and report  signs of possible contraindications,  adverse reactions,  or inappropriate 
responses  to medications; 
Strengthen  and enforce  coordination  and communication  among the involved  healthcare 
team members  in nursing homes;  and 
More  vigorously  pursue enforcement  of resident  health outcomes. 
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 
... 
111  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 
(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 
Appendix  D. 
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 
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 
iv  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 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 Appendix  E. 
V  TABLE  OF  CONTENTS 

EXECUTIVE SUMMARY 
INTRODUCTION 
 1 
METHODOLOGY 
 7 
FINDINGS 
 9 
Quality  of Care Issues 
 9 
Shortcomings  of Medication  Reviews 
 11 
RECOMMENDATIONS 
 14 
COMMENTS ABOUT DRAFT REPORTS 
 16 
ENDNOTES 
 18 
APPENDICES 

Inappropriate  Medications  for Elderly  Persons 
 A-l 
Nursing  Home Patient  Records Requested 
 B-l 
Pharmaceutical  Desk Review  Form 
 C-l 
Departmental  Comments  About Inspection  Draft Reports
 D-l 
4 

Comments  by External  Organizations  About Inspection  Draft Reports 
 E-l  INTRODUCTION 
PURPOSE 
To assess the extent and appropriateness  of pharmaceutical  use by selected Texas nursing 
home residents  and to describe  pharmacists  concerns  about drug use. 
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.2  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.,*  The 
elderly  may also eliminate  these medications  from their  system less efficiently  than those 
younger  due to decreased  bodily  functions. 
1  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).  Yet, the 
General  Accounting  Office reported  that the Health Care Financing  Administrations 
(HCFA)  Office of the Actuary  in 1992 found  17.5 percent  of the 30 million  senior citizens 
receiving  Medicare  benefits  had received  at least one medication  inappropriate  for use by 
the elderly.  Today,  many equally  effective  drugs are available  which present  fewer risks 
for elderly  patients. 
Regulation  and Control of Prescription  Drug Use in Nursing Facilities 
Omnibus Budget Reconciliation  Act of  1987 
As part of the Omnibus Budget Reconciliation  Act of  1987 (OBRA 1987), Congress 
required  the regulation  of certain  drugs in nursing  facilities.  On October  1, 1990, HCFA 
implemented  regulations  which hold nursing  facilities  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. 
~ 
II  Nursing  Home  Patients,  Medications,  and  OBRA  1987 
/I 
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 
I 
assessment and plan of care which each patient receives upon admission to 
the home and as substantive changes occur in the patients health status. 
I 
To ensure each patient receives  the necessary  quality care, the law and 
/I 
subsequent  regulations also recognize  the valueof 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 the medication-related  part of these 
reviews,  HCFA developed  Indicators  for Surveyor  Assessment  of the Performance  of 
Drug Regimen  Reviews,  standards to assist in assessing the quality  of drug regimen 
2  reviews  and for enforcing  performance,  and  Surveyor  Methodology  for Detecting 
Medication  Errors,  provides  the surveyor  with a mechanism  to evaluate  the outcome  of 
the entire  medication  distribution  system and to ensure the facility  error  rate is less than 
five percent  and that residents  are free of risk from  significant  medication  errors.  Several 
States have proven  the five percent  error  rate to be a target figure  now more easily 
obtained  and,  additionally,  HCFA  is considering  lowering  this target rate for hospitals  to 
two percent.  The HCFA also released  revised  interpretive  guidelines  relating  to 
medication  usage 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.  None of these standards  is routinely  shared by HCFA  with 
consultant  pharmacists  who conduct the nursing  home pharmaceutical  reviews. 
As a final step in the implementation  of OBRA  1987, in July  1995 HCFA  released  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.  Again,  none of 
these potentially  useful changes were disseminated  to consultant  pharmacists. 
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 
3  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.  To 
ensure compliance  with the OBRA regulations,  nursing  facilities  are expected to employ 
consultant  pharmacists.  These consultant  pharmacists  are supposed to 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 potential  benefits  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,12 particularly  for those changes  resulting 
from fewer medications  being taken,  more appropriate  medications  being prescribed,  and 
fewer costly  adverse  reactions  being experienced.  Yet, there are no standards for either 
drug regimen  reviews  or drug utilization  reviews provided  by HCFA to consultant 
pharmacists.  There  are only minimal  conduct  requirements  for medication  reviews and no 
standardized  process,  common  definitions,  administration,  or quality  assurance  process for 
this requirement.  Thus,  there  is no acceptable  means for comparing  reviews,  findings,  or 
patient  outcomes between  nursing  homes or consultant  pharmacists,  let alone between 
States. 
Patient Assessment and Plan of Care 
As part of the nursing  homes  assessment process for each patient entering  the facility,  the 
required  Resident  Assessment  Instrument  provides  a standardized  process for reviewing 
each patients  functional  capacity.  This,  in turn,  leads to the individual  Plan of Care 
specific to that patients  identified  needs.  These two documents  could be of considerable 
help to consultant  pharmacists  in monitoring  patient  medication  for desired care outcomes. 
However,  many consultant  pharmacists  reported  in the prior  phase of this inspection  that 
resident  assessments  and care plans are not routinely  used as part of their medication 
reviews. l3 
4  The Resident  Assessment  Instrument  includes tools which could  facilitate  a pharmacists 
medication  review  for a nursing  home patient.  One collects  a minimum  amount of 
information  needed to evaluate  each patient  (the Minimum  Data Set); the other  identifies 
any conditions  that may require  further  assessment  (triggers  from the Resident 
Assessment  Protocols).  As part of the assessment,  section 0  reviews patient  medications. 
The HCFA developed  a drug class reference  list of specific drugs to ensure that 
categorization  and identification  of patient  drugs is standardized  for surveyors  and other 
personnel  using the Resident  Assessment  Instrument  (to ensure everyone  is defining  a drug 
in the same class).  Again,  these tools are not routinely  shared with consultant  pharmacists 
nor are they required  for use in conducting  patient  medication  reviews. 
The Minimum  Data Set Drug Class Index groups  specific drugs a patient may be taking 
into the four OBRA categories  (antianxiety  drugs,  antidepressants,  antipsychotics,  and 
hypnotics)  and adds diuretics.  The HCFA  list also identifies  which specific drugs in the 
five categories  are inappropriate  for the elderly.  It should be noted that the Beers list 
(Appendix A) includes the same drugs as the HCFA  list.  However,  the Beers list is more 
extensive  and includes drugs of other types which are also inappropriate  for the elderly 
(i.e.,  certain  pain medications,  medications  for blood circulation  or blood pressure,  etc.). 
Yet, neither  the HCFA  list nor the Beers list are required  or suggested for use by 
consultant  pharmacists  as part of their medication  review process. 
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.14  The physicians 
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 pharmucy 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. 
5  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 Elderly15 
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 
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. 
6 
 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. 
METHODOLOGY 
Focus of Our Series of Reports 
In 1996, we 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 patients  records to determine  the 
extent and appropriateness  of prescription  drugs utilized  by a random  sample of Texas 
nursing home residents. 
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.  The second report,  An Inside View by Consultant 
Pharmacists  (OEI-06-96-00081),  focuses on the problems  and concerns  raised by 
consultant  pharmacists  based on a national  mail survey.  The third phase of this inspection 
involved  a pharmaceutical  desk review  of the medical  records  of a sample of Texas 
nursing home residents,  the results of which are included  in this report. 
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 
7  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. 
Focus and Methodology  of This Report 
Through  consultation  with pharmacists  and nursing  surveyors  from the Health  Care 
Financing  Administration  and with representatives  of the American  Society  of Consultant 
Pharmacists,  we identified  nursing  home records  (administrative  and medical)  pertinent  to 
conducting  a desk review  for a patients  pharmaceutical  regimen.  We selected  for review 
254 nursing  home patients  residing  in Texas nursing  homes during the period January  1 to 
July  1, 1995.  The nursing  homes provided  each patients  most recent assessment  and plan 
of care,  as well as their drug regimen,  payment  records,  and medical  records.  Any 
additional  records  to assist in a patients  medication  review  were also requested  from the 
nursing home.  Appendix  B identifies  both the letter of request to the nursing  home and 
the specific  records  requested  for each selected patient. 
We contracted  with Integrated  Healthcare  Auditing  and Services,  Inc.  (IHAS) to provide 
pharmacists  experienced  in performing  patient  medication  reviews  for nursing  home 
patients.  While  there  are many methods of performing  a medication  review  for nursing 
home patients,  we asked pharmacists  to conduct both a general  review  (an overview  of 
each patients  drug therapy)  and a problem-oriented  review  (focused on each patients 
medical problems  and their  individual  responses  to their drug therapy).  Essentially,  these 
pharmacists  assessed the appropriateness  and impact of each patients drug regimen. 
As no standardized  tool  is available  for the conduct  of individual  patient  medication 
reviews,  we developed  one with help from experts to facilitate  the process of recording 
findings  for each patient under review  (see Appendix  C).  Additionally,  for any patient 
review  involving  medical  concerns  beyond  the pharmacists  expertise,  a physician  having 
geriatric  and pharmacological  experience  was contracted  by IHAS to make final medical 
determinations.  We do not generalize  the contract  pharmacists  findings  to encompass  all 
Texas nursing  home patients,  choosing  instead to present  the findings  only  in relation  to 
the 254 patients  reviewed. 
This review  was conducted  in accordance  with ths  Quality Standards for  Inspections 
issued by the Presidents  Council  on Integrity  and Efficiency. 
8 
 FINDINGS 

QUALITY  OF  CARE  ISSUES 
Overall,  contracted  pharmacists  consistently  identified  the same problems  and concerns  for 
patients  as those raised  by our analysis  of Texas data and the national  survey  of consultant 
pharmacists.  Medication  problems  and concerns  raised collectively  by the three 
coordinated  reports  of this inspection  demonstrate  the need for stronger  monitoring  and 
more positive  enforcement  of existing  regulations  and required  reviews of medication 
usage in nursing  homes. 
Medication  reviews reveal potentially serious concerns  with residents drug regimens. 
 	 20 percent  of residents  received  at least one drug judged  inappropriate for  the 
diagnoses in their records.  Of these,  32 percent  received  three or more inappropriate 
drugs,  and five percent  had seven or more.  For some,  the inappropriate  drugs are 
rather benign,  such as acetaminophen  or milk of magnesia.  However,  others  received 
psychoactive  drugs such as diazepam and Prozac or drugs normally  used to treat 
cardiac  or cardiovascular  problems  and which are likely  to pose greater dangers  when 
inappropriate  for a patients  condition.  Additionally,  based on available  patient 
records,  contract  pharmacists  identified  patients taking  medications  potentially 
inappropriate  according  to the patients diet requirements  (17 percent),  plans of care (8 
percent),  or by the resident  assessments (6 percent). 
 	 16 percent  of residents  had no prescription  in their records  to support one or more of 
the drugs in their  regimen  for which a prescription  is generally  required.  This finding 
reflects  those drugs  identified  in the medical records,  including  the medication 
administration  records,  provided  by the nursing  homes.  At a minimum,  this finding 
shows a problem  with incomplete  nursing  home records.  In the worst case,  it shows 
that patients  are receiving  drugs not ordered. 
The drugs represent  nearly  8 percent  of the total drugs identified  through  this review 
and range  in type from  gastrointestinal  preparations  and laxatives to antianxiety  drugs 
and antidepressants.  Additionally,  14 percent  of residents  are taking over-the-counter 
medications  without  physician  orders.  Most of these were for pain control  or 
gastrointestinal  problems  (acetaminophen,  Zantac) which may interact  with other 
prescribed  medications  being taken.  Further,  23 percent  of the patient  records 
indicated patients  having  been prescribed  medications  for which the records  showed no 
orders or receipts  to indicate  the patient actually  received  the medication. 
Contract  pharmacists  identified  20 percent  of residents  whose records  indicated  use of 
 	
at least one drug considered  generally  to be inappropriate for  the elderly.  These 
inappropriate  drugs were identified  by matching  drugs identified  in each patients 
9 
 records  against a list of 20 drugs generally  considered  inappropriate  for elderly 
patients  by a panel of experts  (see Appendix  A).  Some of these drugs are 
inappropriate  because of being outdated  and having  been replaced  by more efficacious 
and less risky  alternatives  as well as their unique effects on the elderly.  As with any 
medication,  one should be aware that some medical  situations  might warrant the use of 
these drugs.  Of the patients  identified,  21 percent  had two or more such possibly 
inappropriate  drugs.  This confirms  findings  of the first report  of this seriesI  in 
which a comparison  of Texas drug records  with the list found that 20 percent  of 
residents  received  one or more of the listed drugs. 
There  are many challenges  to prescribing  and monitoring  medications  for elderly  nursing 
home patients.  Multiple  disorders  in the elderly  combined  with patients  having  five or 
more medications  in their drug regimen,  having  12 or more doses per day,  having more 
than three concurrent  disease states, and taking medications  which require  monitoring 
greatly  complicate  identification  of possible  adverse effects of a patients  medication 
regimen.  This complex  picture  is further  compounded  by the need to balance  what could 
be inappropriate  medications  against the benefits  of relieving  or treating  diseases which 
warrant  such usage for the enhancement  or maintenance  of an individuals  quality  of life. 
Arguably,  pharmacists  professional  education  gives them valuable  expertise  and clinical 
knowledge  concerning  pharmacotherapy.  Critical  to this expertise  and extremely 
important  for the nursing home 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. 
Findings  of the contract  pharmacists  indicate that some patients  may be experiencing 
 	
unnecessary adverse medication reactions as a result of inadequate monitoring of 
medications.  Some of the patients  records  identified  medications  which possibly 
contributed  to their constipation  (14 percent),  falls (8 percent),  or depression  (5 
percent).  For 9 percent  of the patients,  their records  indicated  other  adverse effects 
possibly  caused by medications.  Patients  records  indicated  a potentially  serious lack 
of necessary  monitoring: 
-	 19 percent  of the patients  records  gave no indication  of monitoring  for 
medication  side effects when required; 
-	 23 percent  of the records  had no indication  that required  lab testing had been 
performed; 
-	 19 percent  of the records  did not indicate that necessary  physical  assessments 
had been conducted. 
According  to available  records,  21 percent  of residents  received  medications which 
 	
may sometimes interact negatively with other drugs  included  in their  medication 
regimens.  For example,  if a patient  received  both glyburide  (oral antidiabetic  agent) 
and levothyroid  medications,  the glyburide  may decrease  the necessary  effects of the 
10  thyroid  medication.  However,  some negative  interactions  can be expected  when a 
patient  has a complex  diagnostic  picture.  Yet, medication  interactions  may sometimes 
be so severe as to be absolutely  contraindicated;  medications  may represent  poor 
therapeutic  choices  if other therapy  choices  are available;  or the risk of a negative 
interaction  may be justified  when there  are no other treatment  options  available. 
 	 Nearly  one-third  of residents  received  more than one drug from  the same class, 
sometimes  considered  a potential  hazard unless the drug regimen  requires  this 
combination  for efficacy  or to meet the multiple  demands  and needs of multiple 
disease  states for which a patient  may be diagnosed.  Drugs from the same class may 
produce  similar  side effects which can be additive,  in which case they definitely  need 
to be carefully  managed.  Yet,  19 percent  of the records  indicate  no monitoring  for 
appropriate  efficacy  when warranted. 
Several examples  illustrate  the concern  raised by the contract  pharmacists  about 
patients  taking multiple  drugs with additive  side effects that require  monitoring.  One 
example  is a patient concurrently  receiving  nortriptyline  (tricyclic  antidepressant), 
Prozac (fluoxetine,  for treatment  of major depression,  obsessive-compulsive  disorder, 
etc.),  and haloperidol  (haldol,  antipsychotic  agent).  Another  example  was a patient 
taking three medications  all of which can cause sedation,  lorazepam  (anti-anxiety  agent 
also used for insomnia),  cyproheptadine  (antihistamine),  and perphenazine 
(antipsychotic  agent).  Another  patient  was taking  two forms of salicylates  (aspirin) 
which may result  in toxicity;  one taking  cimetidine  (H2-receptor  antagonist  used for 
treatment  of upper gastrointestinal  problems  such as an ulcer)  which may decrease 
absorption  of iron salts or increase  the effects  of temazepam  (sleep aide) also required 
by the patient;  and another  was taking both haldol  and amitriptyline  for insomnia. 
SHORTCOMINGS  OF MEDICATION  REVIEWS 
Resident medication records are often incomplete,  making it difficult or impossible to 
identify or confirm potential drug regimen problems. 
In many of the reviewed  cases,  there  were a number of records  in which  our contracted 
pharmacists  were unable  to find sufficient  supporting  information  to make any definitive 
determination. 
As previously  stated, 20 percent  of residents  had clearly  documented  use of drugs 
 	
inappropriate  for the recorded  diagnoses.  However,  another  31 percent  of patients 
records  were insufficiently  complete  to allow the pharmacists  to make determinations 
concerning  the appropriateness  of prescribed  medications  for indicated  diagnoses.  An 
incorrect  diagnosis,  or no easily  available  diagnosis,  forces pharmacists  to work in a 
void.  Incomplete  records could cause drug regimen  problems  to be significantly 
understated. 
Nursing  homes are required  to maintain  each patients  most recent  assessment,  plan of 
care,  and the doctors  orders  which provide  much of the necessary  information  for a 
11  pharmacist  to identify  any factors  which may negatively  affect  a patients  medication 
regimen.  Thus,  between these three  documents,  pharmacists  should be able to make a 
determination.  However,  the contracted  pharmacists  often were unable  to make a 
decisive  determination  because of insufficient  records. 
Also previously  discussed,  the contractors  identified  several patients  for whom 
 	
prescribed  medications  may have contributed  to constipation,  falls,  or depression. 
These situations  are often attributable  to inappropriate  use or dosages of certain  drugs. 
However,  the contract  pharmacists  were unable  to link these events directly  to adverse 
drug reactions  because of incomplete  resident  records  (i.e.,  daily  nursing  notes were 
not requested,  unavailable  individual  patient  drug reviews,  lack of orders,  etc.).  For 
the same reason,  they were unable to rule out a residents  drug regimen  as the cause 
of these conditions. 
It should be noted that consultant  pharmacists  may find themselves  in a similar  situation  of 
not having  all the necessary  records  to fully  conduct  their reviews.  Additionally,  by not 
being  in the nursing home on a routine  basis,  they may lack familiarity  with the location 
of critical  information  in a facilitys  files. 
Often,  contract pharmacists were unable to determine whether a patient had received 
a monthly drug regimen review during the sampled time period. 
Nursing homes did not provide  copies of patients  monthly  drug regimen  reviews. 
Reasons cited included: 
1) 	 not being able to obtain the individual  report  from the facilitys  consultant 
pharmacist.  Most consultant  pharmacists  provide  services to more than one facility 
and their drug regimen  review  records  may be kept at home or in the contracted 
companys  office,  rather  than at the nursing  home. 
2) 	 administrative  changes  in personnel  and multiple  record  locations.  New employees 
are sometimes uncertain  as to where certain  patient  reports  are maintained. 
Because there  is no requirement  to file the drug regimen  reports  in each patients 
clinical  record  in the facility,  reports  may be maintained  in numerous  possible 
I 
locations. 
3) 	 nursing  homes  sometimes only  maintain  a summary  report  of concerns.  The 
facility  may not require  their consultant  pharmacist  to provide  individual  patient 
reports,  choosing  instead to have a summary  report  which only  identifies  patients 
for whom the consultant  pharmacist  has some concern. 
4)  drug regimen  reviews  were not conducted  as required. 
12  Our contracted  medication  reviews required much more time than the usual review 
times reported  by nursing  home consultant  pharmacists.  Allotting more time for 
conducting  reviews can help detect more medication concerns. 
As previously  discussed,  medication  reviews  for nursing  home patients  can be extremely 
complex  due to the number  of primary  and secondary  diagnoses  patients  may have as well 
as the number of medications  being prescribed.  Contract  pharmacists  reported  patients 
having  an average  of three primary  and three  secondary  diagnoses  and receiving  an 
average  of ten medications.  They reported  completing  each patients medication  review  in 
an average time of 50 minutes (a few reviews  took as little as 20 minutes).  Yet, direct 
responses  from consultant  pharmacists  indicated  they spend an average  of  5-10  minutes  on 
each patients  monthly  drug regimen  review,  with most initial  reviews taking  15-20 
minutes. 
The contract  pharmacists  lengthier,  more  in-depth record  reviews  identified  medication 
problems  or concerns  for 20 percent  of the patients  which had not been previously 
identified  by the nursing  home consultant  pharmacists.  Their  concerns  included  lack of 
monitoring  for efficacy;  drugs which were clearly  inappropriate  for use by elderly 
individuals;  inappropriate  method of administration  (i.e.,  crushing  of sustained  action 
drugs); medications  inappropriate  for diagnoses;  medications  being received  on schedule 
with a duplicate  available  as needed  (PRN);  some PRN medications  not having 
prescriptions;  extending  duration  of drug use beyond  the timeframe  ordered;  providing 
medications  for which the patient  has allergies;  and medications  being ordered  for dosages 
other than those the patient  received. 
Further  complicating  regular  medication  reviews  can be the number of over-the-counter 
medications  being used by the nursing home patients.  This record  review  indicates most 
patients  (82 percent)  use over-the-counter  drugs and nearly  17 percent  of these are being 
used without physician  orders.  Our previous  report  found that a serious weakness  in 
medication  reviews  is that many consultant  pharmacists  said they do not review use of 
over-the-counter  (OTC) drugs. l7 The principal  reasons  stated for such non-review  are 
that nursing homes do not allow OTC drugs without prescriptions,  that nursing  staff check 
patients  rooms for any non-prescribed  medications,  and that the pharmacists  do not have 
sufficient  time to do the reviews and therefore  are unable to discuss medication  regimens 
with patients. 
13 
 RECOMMENDATIONS 
Based on the collective  concerns  raised in this report  and the two other  reports resulting 
from this inspection,  An Introduction  Based on Texas  (OEI-06-96-00080)  and An 
Inside  View by Consultant  Pharmacists  (OEI-06-96-00081).  we recommend  that HCFA 
work with the States and others  to improve  the quality  of prescription  drug care in nursing 
homes.  To accomplish  this objective,  HCFA  should: 
1. 	 Continue to monitor and encourage  reduction  in the use of potentially 
inappropriate  prescription  medications by the elderly nursing home population.18 
2. 	 Work with other interested  government entities,  such as the Assistant Secretary 
for Planning  and Evaluation  and the Agency for Health Care Policy and 
Research,  to: 
a. 	 Identify  and analyze  reasons for and the appropriateness  of cost escalation  for 
certain  types of drugs used in nursing homes (i.e.,  gastrointestinal, 
psychotherapeutic,  cardiac,  cardiovascular,  and anti-infectives)  and 
b. 	 Examine  resident  and facility-specific  characteristics  and drug utilization  data to 
better understand  the factors  contributing  to the differences  between nursing homes 
in the costs of prescription  medications  used by patients. 
3. 	 Strengthen the effectiveness  and impact of medication reviews conducted by 
pharmacists in nursing homes by: 
a. 	 Providing  guidance  to medical,  nursing,  and pharmaceutical  personnel  on handling 
notifications  about medication  concems;20 
b. 	 Requiring  pharmacists  to consult patient assessments and plans of care in the 
conduct of their medication  reviews; 
c. 	 Reviewing  and updating  routinely  Appendix  N of the Survey/Certification  protocol; 
the Drug Class Index of the Minimum  Data Set, Section 0;  Appendix  P, guidelines 
for psychopharmacologic  medications  used in long term care facilities;  and any 
other related  medication  policy  and procedureszl and ensure that consultant 
pharmacists  routinely  conduct drug regimen  reviews using these protocols  as one 
set of available  tools for improving  their reviews but also for helping  to ensure 
they conduct reasonably  complete  reviews.  It may be that HCFA could require 
nursing homes hiring  or contracting  with pharmacists  to provide  these tools;  and 
d. 	 Encouraging  prescribing  physicians  to provide  clinical  outcome  expectations  for 
medications  prescribed  and requiring  pharmacists  to monitor  for these 
expectations. 22 
14 
 4. 	 Enforce  and enhance  HCFAs training  requirement  of personal care staff (nurse 
aides) (i.e.,  aides training  curriculum  should include information  on how to 
recognize  and report behavioral  signals or signs of possible contraindications, 
adverse reactions,  or inappropriate  responses to medications).23 
5. 	 Strengthen  and enforce  coordination,  communication,  and patient documentation 
in nursing homes by: 
a. 	 Exploring  the feasibility  of requiring  nursing  facilities  to maintain  in one central 
location  all records pertinent  to a patients  medical  care; 
b. 	 Requiring  consultant  pharmacists  to document  each patients  medication  review and 
resulting  actions;  and 
c. 	 Requiring  that pharmacists  concerns  always be reported  to the attending  physicians 
and nursing home medical  directors,  as well as to the Directors  of Nursing. 
6. 	 More vigorously pursue enforcement  of positive resident health outcomes.  As 
part of this pursuit,  HCFA should require pharmacists direct input to achieving 
optimal clinical outcomes for residents (i.e.,  fewer falls or pressure sores as well 
as less frequent urinary incontinence,  which can all be exacerbated  by certain 
psychopharmacological,  cardiovascular,  and other drug therapies).U  Options for 
HCFA to consider: 
a. 	 Encouraging  consultant  pharmacists,  nursing home medical  staff,  and physicians  to 
become more familiar  with HCFAs  defined  quality  of care indicators  which are 
related to pharmacy  services  and which may enhance  pharmaceutical  patient 
outcomes; 
b. 	 Encouraging  consultant  pharmacists  to interact  with (counsel and inform)  patients 
as part of their medication  reviews;  and 
c. 	 Including  in State and Federal  surveys,  process-focused  reviews  of pharmacists 
recommendations  and subsequent  actions by appropriate  medical  and nursing 
personnel,  and the resulting  clinical  outcomes  for the patients. 
15 
 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. 
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 
(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 
Appendix  D. 
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  cab 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 
16 
 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 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 Appendix  E. 
17 
 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  Phamzacy, 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.  Office of Inspector  General,  Office of Evaluation  and Inspections,  Prescription 
Drug Use in Nursing  Facilities:  An Inside View by Consultant  Pharmacists  (OEI-
06-96-0008 1)) November  1997. 
18 
 14.  Fanale,  R. H.,  et al.  The Nursing  Home Medical  Director,  Journal  of the 
American  Geriatrics Society,  1989, 37(4), pp. 371-373. 
15.  Merck Manual,  15th edition. 
16.  Office of Inspector  General,  Office of Evaluation  and Inspections,  Prescription 
Drug Use in Nursing  Facilities:  An Introduction  Based on Texas (OEI-06-96-
OOOSO)N, ovember  1997. 
17.  Office of Inspector  General,  Office of Evaluation  and Inspections,  Prescription 
Drug Use in Nursing  Facilities:  An Inside View by Consultant  Pharmacists  (OEI-
06-96-0008 l),  November  1997. 
18.  This can be accomplished  at the State level by assuring  the inclusion  of nursing 
home residents  in the automated  prospective  drug utilization  review  programs 
already  in place.  At the nursing  home level,  State and Federal  surveyors, 
consultant  pharmacists  employed  as a requirement  of OBRA 1987, and physicians 
serving  as medical  directors  or primary  care physicians  should be reminded  of the 
dangers associated  with these drugs and directed  to continue  to actively  pursue a 
reduction  in their use.  Finally,  similar  analysis  of data from additional  States 
should be undertaken  to further  assess the extent of the continued  use of these 
contraindicated  drugs. 
19.  We understand  that new and more effective  products  may be more costly  and may 
be the most appropriate  for certain  patients diagnoses.  However,  this may be only 
one reason for an increase  in certain  drug costs.  In light of concerns  expressed  in 
the medical  literature,  further  investigation  is warranted  to determine  whether  some 
of these drugs are medically  necessary. 
20.  This should include defining  what constitutes  both  acting on concerns  of any 
healthcare  team member,  including  pharmacists,  and  documentation  of actions 
taken  in records readily  accessible  to nursing  home and other  State/Federal  staff 
(i.e.,  in the patients  clinical  record). 
21.  Include both drugs about which there are utilization  concerns  (H2 antagonists,  non-
steroidal  anti-inflammatories,  narcotics,  antibiotics  and anti-infectives,  and 
gastrointestinals)  and drugs which in many  instances may be inappropriate  for use 
by elderly  persons. 
22.  We recognize  that most clinical  expectations  are clearly  indicated  by the prescribed 
medication,  it may not be reasonable  to expect that those outcomes  have been 
clarified  for the remaining  members  of the healthcare  team. 
23.  While  we do not believe  nurse aides should be able to identify  specific probable 
causes for changes  they observe,  they should be sufficiently  aware that those 
changes may be reflective  of possible clinical  problems.  As part of HCFAs 
required  on-going  training  of personal  care staff (nurse aides),  and as pharmacists 
19 
 are either  directly  or indirectly  currently  employed  by the nursing  homes to 
perform  drug regimen  reviews,  pharmacists  could provide  the necessary  in-service 
training  on the recognition  of possible  behavioral  signals or signs of potential 
contraindications,  adverse reactions,  or inappropriate  responses  to medications. 
However,  HCFA could explore  cost-effective  alternatives  to pharmacists  providing 
this training. 
24. 	 Nursing  homes,  like physicians,  have a major  responsibility  for resident  quality  of 
care.  This includes efforts  to ensure,  promote,  and encourage  necessary 
communication  and corrective  actions  for health concerns  raised by any healthcare 
team member.  Clearly,  pharmacists  performing  medication  review  services,  either 
as nursing  home employees  or contractors,  are an integral  part of the healthcare 
team. 
4 
20 
 APPENDIX  A 
20 Drugs Experts Consider 
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 and used consistently  since that 
time,  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. 
Further,  it should be noted that this list constitutes  a minimum  of drugs not considered  appropriate 
for the elderly  and could be revised  to include  others. 
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 
(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 
Nursing Home Patient Records Requested 
For an identified  review period,  nursing  homes for the selected 254 patients  were asked to provide 
any patient  record,  including  the initial  Patient  Assessment and Plan of Care,  related  to the initial 
admit of the patient  to the facility.  For the time period  related  to each patients  indicated  stay 
period  in the nursing  home,  nursing  homes were also asked to provide  any subsequent changes as 
well as the following  items specific to the time period  under review: 
Patient Assessment/Evaluation(s) 

Plan(s) of Care 

Medication  Administration  Records 

Physician  Prescriber  Orders 

Physician  Prescriber  Progress  Notes 

Behavioral  Monitoring  Sheets 

Laboratory  Orders 

Laboratory  Reports 

Incident  or Accident  Reports 

Nursing Monthly  Summary Progress  Report(s) 

Nursing Quarterly  Summary Report(s) 

Drug Regimen Review(s) 

Consultant  Pharmacist  Review and Remarks  Sheet(s) 

Consultant  Pharmacist  Quarterly  Report(s) 

Consultant  Pharmacist  Correspondence  (related to patient  reviews) 

Facilities  were also asked to provide  any additional  documentation  including  assessments by other 
providers  which may impact medication  therapy  (i.e.,  diet,  therapists,  etc.). 
The table below provides  a sample of the letter sent to the nursing homes for the required  records. 
B-l  Letter  to Nursing  Homes for Required  Records 
) Dear Nursing Home Admimsrraror: 
The Office of Evaluatton and Inspecuons.pan of rhe Office of Inspector General. conductsnational program eraluar~ons. Although orher InspectorGeneral offices 
conduct fraud invesngationsand audits. our function IS IO provide policy makers and managerswnh analysisand recommrndarionsfor improving:programs. 
policies. and regularionsmvolvmg Medxare and Lledicaid  We are currenrly involved in an evaluarionto assessthe extem and appropnatenessof drug use b! 
patlen& m nursing homes. 
Your facility has been randomly selected for our review of medicationusage in Texas nursinghomes. Under aurhorlrygrarxed 10 the Office of InspectorGenrral. 
, by 42 CFR Section 3525. we are requesrmg  rhaf you provide panent records for one or  a few randomly  seiecred  resldenrs  Thesr resldeno  are  ,Wei~~ve  rl~yrhle 
~ benejicmrres for w/Km Medmwf pardfor  rhe srqs in !our/ncr/in  durrng 1995  AtrachmentA idennfies the resldenror residents(by name. their Hcakh Insurance 
! Claim Number (HICN)  number. and rhe stay date(s)) for whom we require copies of applicableparlent records 
To ensure that we have sufticienr information to conductour review. copies of the nursinghome records should mclude any records rrlared to rhr parirnrs stay as 
indicatedon the attached list (generally. a 3.month period).  Additionally. we need any patient specific record for rhe firsuinitialadmisslonto your facrlity. The 
, following records are requestedfor each resident: 
1.  Pamien*  m  for the first/initial admission fo your facility 
2.  Patimt ~sEv&&km4s1  for fhe period specified in Attachment A (hereafter  referred  to as the  stay1 
3.  R3n of Crs  for the first/initial admission to your facility 
4. 	 l%~Itl  of Crs  for the period  related  to stay 
. .  .
5.  AdmsbWm  Ibawds  (MARI  for the period  related  to stay 
6.  Phy&h~  - olda  for the period  related  to stay 
7. 	 R@tim  Rgcrba  Roqsrr  NCROS for the period  related  to sfay 
.  . 
a.  Mmtamg  Sbets  for the period  related  to stay 
9.  IAS  adas  for et.9 pertod  related  to stay 
10.  Id  F@ats  for the period related to stay 
11.  Wa  Q Accklmt  lbpaa  for the period  related  to stay 
12.  Mus@j  ManMy  Smmq  Rogsn  Rapm  for the period  related  to stay 
13.  m  Qmfuiy  Summy  Rapat  for the period  related  to stay 
14.  Drup w  kpat  to m  for each month for the period  related  to stay 
15.  Ihug  UtSzdm  Raort  for the period  related  fo stay 
16.  c  -ttRpmrcht-rd- Sheaf for each specified patient for the period related to stay 
17.  phamvirt  w  Rport  for the period related 10 stay 
18. 	 Rpmrcirt  canrpmdacs  to/from physicianlsl. Director of Nursing, or other regarding patients medication therapy or 
associated issues including lab issues related fo medicationlsl for the period related to stay 
19. 	 m  pm&t  avln(mnr  conducted by other professional personnel impacting medication therapy (e.g.. Dietary Evaluation. 
PsychiatrWPsychologic evaluation. Social Evaluation. Dental, etc.1 for the period related 10 stay
/
If you determine  that other information  would be valuable to our assessment  of drug usage,  please provide this information,  as well. 
I 
Instructions 
.  All copies must be complete,  clear, and legible. 

.  All copies should clearly indicate the name or Medicare  Health Insurance  Number (HICN) at the top left corner of each page. 

.  All copies should indicate,  at the top left corner of each page, the type of document  you are providing (e.g.,  DUR Page 1 of 4. CP Review 

Sheet for October,  etc.)  Thts is to ensure that the medical consultants  performmg the review  will be able to easily identify the type of 
information  they are reviewing. 
. 	 The attached  form Mttachment  B1 must be filled out as a summary  sheet for each patient  for  each stay indicating which forms you have 
copied in relation to the indicated  stay and are sending to this office.  In a few  cases this might necessitate  duplicate copying Of some 
records.  However,  it is very important  that all records associated  with each patients  stay be a complete,  stand alone package. 
.  If forms are unavailable,  indicate this in the space provided,  giving the reason for not provtding that form (e.g..  not maintamed  in  / 
this facility; unable to locate; etc.).  II 
I, 
. 	 If additional or other types  of records are provided,  but not listed on the attached  form, add the type to the list under the  I: 
category  Other. 
I/ 
.  Please mail the requested  information  to this office by November  18 using first class or overnight  mail.  (1 
If you have any questions  regarding this request,  or if you will be unable to provide the requested  records by November  18,  please contact  Leah 
11
Bostick or Kevin Golladay at 11800-848-8960.  Thank you very much for your assistance  and prompt response. 
1, 
I
[Appendix  B to  the  letter  is not  included.] 
-
B-2 
 APPENDIX  C 
Pharmaceutical  Desk Review Form 
Medical Review Screening  and Certification 
Patient  Name:  DOB: 
Patient  Sample #:  Gender: M/F 
Medicare  Number: 
Nursing Facility: 
Medical Record #: 
Sample Stay Period:  To  (3 months,  generally) 
NURSING FACILITY  PATIENT  DIAGNOSES 
Primary  Diagnosis  Secondary  or Co-Morbidities 
1. 
CONTINUE  WITH MEDICATION  SUMMARY SHEETS 

COMPLETE  MEDICAL  REVIEW  SCREENING  AND CERTIFICATION 

C-l  ---..- _.. __--- __- -.. 1- ---.  .-..- .--_l_--..-.---.~- --  PATIENT  LAST  NAME  MEDICATION  SUMMARY  SHEET  PATIENT  SAMPLE  # 
PPAAGGEE  II  OOFF  44   22   33   44   $$55   66aa   66bb   **II   88   99   IIOO   IIII   II22  
NNDDCC  XX  FFOORR   MMEEDD   OONN  NNDDCC   LLIISSTT   MMEEDD   IINN   MMEEDD   RRXX   RRxx  SSPPEECCIIFFIIEESS   MM..DD..   OORRDDEERRSS   OORRDDEEKRSS   MMII>>  OOKKDDLLRRSS   PPRRNN   00RRDDII::RREEDD   OOTTCC  
MMEEDDIICCAATTIIOONN   BBUUTT  NNOOTT   IINN   RREECCOORRDDSS   IINNAAPPPPRROOPPRRIIAATTEE   AAVVAAIILLAABBLLEE   NNOO  GGEENNEERRIICC   IINNCCOOMMPPLLEETTEE   IIIIAAVVEE   ((OOKKKKII,,((ll,,  
MMEEDDIICCAATTIIOONN   NNAAMMEE   RREECCOORRDDSS   BBUUTT  NNOOTT  OONN   FFOORR  DDIIAAGGNNOOSSIISS   SSUUBBSSTTIITTUUTTIIOONN   SSPPEECC1I1I..KK   ((IIJJKKKKII;;NNII  
NNDDCC  LLIISSTT   DDIIKKEECCTTIIOONNSS   WWIIIIII::NN  
FFOORR  UUSSAAGGtt   SSIIGGNN11..II))  
II  

22  

33  

44  

55  

66  

II  

88  

99  

IIOO  

IIII  

II22  

1133  

1144  

I155  

CCOODDEE::  
Y FOR YES  IN  CODE  FOR  INSUFFICIENT  INFORMATION  TO  MAKE  DETERMINATIONS 
N  FOR  NO  NA  FOR  NOT  APPLICABLE 
DN  FOR  DONT  KNOW 
IF Y,  Use  Remarks  Section  to explain  potential  or actual  problem
__~ 
COMPLETED  BY:  NAME  & TITLE  DATE: 
c-2  PATIENT  LAST  NAME  MEDICATION  SUMMARY  SHEET  PATIENT  SAMPLE  # 
PPAAGGEE  22  OOFF  44   1133   II44   II55   1166   II77   IIXX   1199   2200   ??II   2222  
MMEEDD   DDOOSSAAGGEE   WWIITTHHIINN   DDOOSSEE   DDOOSSEE   DDOOSSEE  NNOOTT   DDOOSSAAGGEE   OOPPIIYYMMAALL   DDUURRAATTIIOONN   DDIIIIRRAATTIIOONN   MMEEDDIICCAALL//MMDD  
IINNAAPPPPRROOPPRRIIAATTEE   AAPPPPRROOPPRRIIAATTEE   EEXXCCEESSSSIIVVEE   IINNSSUUFFFFIICCIIEENNTT   AADDJJUUSSTTEEDD   TTOO   IINNAAPPPPKKOOPPRRIIAATTEE   DDUURRAATTIIOONN   IINNSSUUFFII~~II((IIII::NNII   II::XX((ii::SSSSIIVVEE   JJUUSSTTIIFFIICCAA~~IIOONN  
MMEEDDIICCAATTIIOONN   NNAAMMEE   FFOORR  EELLDDEERRLLYY   SSUUGGGGEESSTTEEDD   CCOOMMPPEENNSSAATTEE   FFOORR   FFOORREELLDDEERRLLYY   ((II..OONNGGII::KK   II--IIIIAANN   AAVVAAIIII..AABBll..llii  
RRAANNGGEE   RREEDDUUCCEEDD   AAIIIIKKOOPPKKIIAATTLL))   FFOOKK  LLOONNGGII::KK  
RREENNAALLIIttIIEEPPAATTIICC   II))llIIKKAATTIIOONN  
FFUUNNCCTTIIOONN  
II  
22  
33  
44  
55  
66  
II  
88  
99  
II  00  
IIII  
II22  
1133  
II44  
II55  
CCOODDEE::  
I
Y FOR YES  IN CODE FOR INSUFFICIENT  INFORMATION  TO MAKE  DETERMINATIONS 
N FOR NO  NA FOR NOT APPLICABLE 
DN  FOR DONT  KNOW 
IF  Y,  Use  Remarks  Section  to explain potential  or actual  problem
___~~~.~  .___.~  - ~~~~~.~  ---  ~-
COMPLETED  BY:  NAME  & TITLE  DATE: 
c-3  PATIENT  LAST  NAME  MEDICATION  SUMMARY  SHEET  PATIENT  SAMPLE  # 
PAGE 3 OF 4  23  *25  26  21  28  29  30  31  32  33 
APPROPRIATE  &  CORRECTROUTE  MEDICATION  IS OF  NEGATIVELY  MAR  NECESSARY  MONITORING  GI:NDL:R  AI.LERGY  NftiATlVLLY 
ACCURATE  OF  SAME  DRUG  CLASS  INTERACTS  REFLECTS  LAB TESTING  FOR SIDE  CONTRA- (ONTRA- INTERACTS 
MEDICATION  NAME  ADMINISTRATION  ADMINISTRATION  AS OTHER  ME0  WITH  OTHER  DOSE AS  FOR ROUTINE.  EFFECTS  INDl(ATlON  INDICATION  wrrtl 
TECHNIQUE  BEING  TAKEN  MEDS  BEING  PRESCRIBED  ON-GONG  DIIiT/I~00D 
(SPECIFY  OTHER  TAKEN  (SPECIFY  MONITORING 
DRUG8  OTHER  DRUG#) 
I 
2 
3 
4 
5 
6 
L
Y FOR YES  IN  CODE  FOR  lNSUFFlClENT  INFORMATION  TO  MAKE  DETERMINATIONS 
N  FOR  NO  NA  FOR  NOT  APPLICABLE 
DN  FOR  DONT  KNOW 
IF  Y,  Use  Remarks  Section  to explain  potential  or actual  problem 
p-------.  .-__--~~  ~~~~- ___~  ~_=~..~~~_~~~. 
COMPLETED  BY:  NAME  & TITLE  DATE: 
c-4  PATIENT  LAST  NAME  MEDICATION  SUMMARY  SHEET  PATIENT  SAMPLE  # 
PAGE 4 OF 4  34  35  36  *37  38  39  40  41  42  43  44  45  45 
CONTRlauTtD  CONTRlWTED  CONTRIBUTED  CONTRlBUTED  rxmTRlBTED  MLD  Mm  PHYSICAL 
CODE: 
Y FOR YES  IN CODE FOR INSUFFICIENT  INFORMATION  TO MAKE DETERMINATIONS 
N FOR NO  NA FOR NOT APPLICABLE 
DN FOR DONT  KNOW 
IF Y,  Use Remarks Section to explain potentialor actual problem 
COMPLETED  BY:  NAME  & TITLE  DATE: 
C-5  Remarks  Section 
Use this page for additional  information  related to medication  concerns  marked  in columns 
MEDS#  COLUMN  #  REVIEWERS  NOTES 
Attach additional  page[s],  if needed 
C-6  Medical  Review Screening  and Certification 
After completing  the Medication  Summary  Sheet for this patient,  answer the following  questions. 
1.  Did the consultant  pharmacist  for the nursin  home identif  the same concerns  as you did? 
zI  - I- .x-a-OI.D..x.x*l.x..l.-x..l*O1.01 Cl10IrcRIDiI r1r1011x1.0 11xIYex .rx 1.L  ?
If NO,  which medication(s)  and questions(s)  were not identified?  (Use numbers  from the 
Medication  Summarv Sheet form to identify.)  [ #reflects  medication  & reflects  column 
number] 
#  Q-  Comment 
#  Q-  Comment 
#  Q-  Comment 
#  Q-  Comment 
REFER  TO IHAS PHYSICIAN  FOR  CERTIFICATION.  m  if you feel necessary  to confirm 
your findings. 
2. 	 Did the consultant/pharmacist  for the nursing home relay the concerns  to the appropriate 
medical  personnel? 
YES  NO
- -
If NO,  which medication(s)  and question(s) did they not relay  (use numbers from the 
Medication  Summary Sheet form to identify.  [#reflects medication  & Q reflects  column 
number] 
#  Q  7Comment 
#  Q  7Comment 
#  Q.-w, Comment 
#  Q-7  Comment 
REFER  TO IHAS  PHYSICIAN  FOR  DOCUMENTATION.  m  if you feel necessary  to 
confirm  your findings. 
3. 	 Was there follow-up  action taken to correct  the concerns  of the nursing  homes consultant 
pharmacists? 
YES  NO  NA
- - -
4.  Was the action appropriate  to correct  the concerns  you identified? 
YES NO  NA
- -
If NO,  what should have been done (that wasnt)?  Drug Use by Texas Nursing Home Patients 
M.D.  Referral/Decision  Form 
Patient Name:  Referral  Date  /  / 
--- 
Patient  Sample Number: 
Medicare  Number: 
REASONS  FOR  REFERRAL: 
1. Pharmacist  questions the following  numbered  items on the Medication  Summary  Sheet form: 
[#reflects me#dicat$  & Q#reflcts  col;mn  rmber] 
# --  Q  --  --  --  #-Q-   #-Q-  
2. Incomplete  File 
3. Pharmacist  unfamiliar  with a particular  medication 
4. Other 
Pharmacist  Requesting Referral 
Print  Name 
TO BE COMPLETED  BY M.D. 
(M.D.  Decision) 
Agree with IHAS Pharmacists  Determination 
Disagree with IHAS Pharmacists  Determination 
(Note: If the MD agrees or disagrees  only  in part,  s/he must be specific as to each question raised 
by the pharmacist  above). 
Reason(s) for Disagree 
M.D.  Comments 
Print  M.D.  Name  M .D . Signature 
Date Review Completed  I  /  Amount of time for review  by 
--- 
(Minut$* 
C-8 
 APPENDIX  D 

Departmental  Comments  About  Inspection  Draft  Reports 
DATE: 
SEP 2 3 1997 
TO: 	 June Gibbs Brown 
InspectorGeneral 
FROM: 	 Nancy-Am  Min DeParle  N  & 
Deputy Administrator 
SUBJEXT: 	 Office of Inspector General (OK?) Draft Report: Prescription Drug Use in 
Nursing Facilities: An IntroductionBasedon Texas, (OEI-06-96-00080) 
We reviewedthe above-referencedreport that describesthe extent and appropriatenessof 
drug use by Medicareand Medicaid  residents  of Texas  r~ursing homes. 
Paymentsfor prescription drugs representa largeportion of Medicaidsexpendituresfor 
nursing  homes.  In fiscal  year  1995, Medicaid  payments  for prescriptiondrugsreached 
$9.8billion. Medicaidprovided servicesfor 1.7million nursinghome residentsiu the 
sameyear. Prescriptiondrug costs are estimatedto rangefrom $600to $1000per 
resident. This implies that between$1 billion and $1.7billion of those paymentswent 
for prescription drugsin nursing facilities. Additionally,severalrecent studies suggest 
that the use of inappropriate or contraindicateddrugsis a contributingfactor to the high 
health Carecosts in the elderly population. 
To assessthe extent of prescription druguse by dually-eligibleresidents, OIG obtained 
Medicaid data for nursing home r&dents in Texas  for calendar  years  1992-94  and 
the 
first 6 months of 1995. This data collection and extractioneffort was a part of OKs 
joint Texas DatabaseProject. 
The Health Care Financing Administration(HCFAc)oncurswith all of OIGs 
recommendations, Our detailed commentsare as follows: 
OIG Recowdation  1 
HCFA should continue to monitor and encouragereductioniu the use of contraindk~ed 
prescription drugs in the elderly population. 
D-l  HCFA ResDonse 
We concur.  This cambe accomplished at the state level  However, states are not required 
to ixIude  nursing facility (NF) residents in the automated prospective drug utilization 
review (DUR) programs unless the NF is not in compliance with drug regimen review 
requirements specified in 42 CFR 483.60.  This regulation, and the statute at 
section 1927(g)(l)(D) of the Social Security Act, preclude any Federal action to require 
DUR for drugs dispensed by NFs that are in compliance with Federal requirements.  The 
requirements specify that states are not required to perform additional drug use reviews 
with respect to drugs dispensed to residents of nursing facilities which are in compliance 
with drug regimen review procedures , , t ,   HCFA will continue to monitor data from 
states that included this population in the automated prospective DUR programs. 
At the facility level, state and Federal surveyors, consultant pharmacists employed as a 
requirement of the Omnibus Budget Reconciliation Act of 1987,and physicians should 
be reminded of the dangers associated with these drugs and directed to continue to 
actively pursue a reduction in their use. 
Most state Medicaid agencies distribute newsletters that relate concerns regarding drug 
problems, such as drug contraindications in the elderly population, to pharmacists and 
physicians in the state. Also, information sharing among state Medicaid agencies in 
forums such as the annual DWRsymposium keeps state and Federal surveyors, consultant 
pharmacists, and physicians abreast of the dangers associated with cmtraindicatedtigs 
andthe elderly, 
HCFAagreesthat similaranalysis of data from more states should be undertaken to 
further assess the extent of continued use of contraindicated drugs. HCFA will ~~~tifm~ 
to act as a clearinghouse by collecting data reported by states in the IXJR aunual reports 
on this subject, and disseminating the information to f&lit&e  data sharing among slates. 
IIIaddition,we encourage states that have included NF residents in their DUR prognuns 
to establish relationships with local colleges of pharmacy that may be interestedin 
assessing the extent of the continued use of contraindicated drugs in the elderly 
population. 
OIG Recommendation 2 
HCFA and others should be aware of the significant increases in tie number of claims, 
as well as the rapidly escalating costs for certain types of drugs (especially 
ga~troinmid,  psychotherapeutic, cardiac, cwdiovascular, and anti-infectives)used in 
le. 
D-2 
 HCFA Response 
We concur.  HCFA is aware of the significant increases iu the number of claims, and the 
escalating costs for certain drugs used in NFs in those states that report such information 
in DUR annual repom.  HCFA will play a more active role in making state Medicaid 
agencies aware of trends in this area via the HCFA DUR Newsletter, scheduled for 
quarterly publication.  The newsletter will share information we receive regarding the 
increase in the use of these drugs in NFs and other information refevant to DUR. We will 
strongly encourage states to share such information with consultant pharmacists, 
physicians, and all providers responsible for ensuring quality care in NY&. 
In addition, HCFA would like OIG to report the extent of possible cost satigs,  whether 
they come km  cheaper alternative drugs, or from the fact that drugs may not be 
necessary.  HCFA would like to know whether the safer and more effective alternatives 
cost less than those drugs presently used. 
PIG Recommendation 3 
Further study should be undertaken, examining data about resident conditions, types of 
specialized care, and other facility-speciSc characteristics, along with drug expenditure 
and usage data, to better understand the factors contributing to the differences between 
NFs in the costs of prescription drugs used by residents. 
HCFA Response 
We concur.  Anther study in this area should be undertaken, and HCFA wonld like to 
solicit the help of organizations such as the Agency for Health Care Policy and Research 
to further examine this issue. 
D-3 
 OCT 13 1997 
TO: 	 June Gibbs Brown 
Inspector General 
FROM: 	 Nancy-Ann Min DeParIe  r\)  fl  D 
Deputy Administrator 
SUBJECT: 	 Office of inspector General (OIG) Draft Report: Prescription Drug Use in 
Nursing Facilities: An Inside View by Consultant Pharmacists, 
(OEI-06-96-00081) 
We reviewed the above-referenced report that describes consultant pharmacists concerns 
about drug usage in nursing homes and their perceptions of their responsibilities for 
medication reviews for nursing home residents. 
The Omnibus Budget Reconciliation Act of 1987and subsequent regulations define 
certain limibtions  related to drug therapy,  Among these,  (1) patients must not receive 
unnecessary medications; (2) patients cannot be prescribed antipsychotic drugs unless 
they are appropriate for a specific patients condition; and (3) prescribed a&psychotic 
drugs will receive gradual dose reductions or behavioral programming in an effort to 
discontinue the drugs (unless clinically contraindicated). Also, nursing homes must have 
no sign&-ant medication error rates and patients should have no significant medication 
errors. Oversight in the nursing homes for these requirements 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, OIG surveyed a StatisticaJlyvalid sample of pharmacists drawn from a 
stratified random sample of the 17,000nursing facilities.  The report represents the results 
of an indepth,  structured mail survey of these consultant pharmacists. 
The OIG report suggests that the Health Care Financing Administration (HCFA) work. 
with the states and other responsible entities to impr6ve the effectiveness of medication 
review for patients in nursing homes.  HCFA is o&&g  the following comments to 
OIGs suggestions for improvement: 
Informing  and Jhcumentinp 
HCFA will explore ways to enhance each of these suggestions to improve communication 
between the pharmacist and physician, but we must point out that facilities have always 
been required to maintain records of the pharmacist review in the facility.  The January 
1982  State Operations Manual transmittal which first introduced the Appendix N 
D-4  guidelines stated, A record of drug reviews must be maintained in the facility in order to 
demonstrate that such reviews have been performed. 
The purpose of drug regimen  review  was  to introduce current drug information into the 
facility and to share that information. relative to specific patients, with the medical and 
nursing staffs.  HCFA never expected that some pharmacists would keep this information 
to themselves,  as is apparently  the case  in the example  OIG  described  on page  16 in 
which many facilities had trouble providing drug regimen review records because the 
pharmacist had them in a different location. 
State and Federal  Survey and Certification 
We have been endeavoring to review and update Appendix N for some time and will 
continue to do so in the future. We have devoted considerable time and effort (including 
time in obtaining physician and pharmacist input) to guidelines for psychopharmacologic 
medications for Appendix P (applies to long texmcare (LTC) facilities), and to guidelines 
for intermediate care facilities for the mentally retarded. 
Since Appendix N was adopted, Medicare has changed its policy for payment of 
laboratory tests (i.e., no more orders for tests, especially multiple tests, without good 
clinical indications).  This means any laboratory tests referred to in the revision will have 
to address a multitude of clinical justified conditions, instead of time periods (in the 
current Appendix N) which are less difficult to define and to reach consensus. 
OIG suggests that HCFA should ensure that consult&t pharmacists routineIy conduct 
drug regimen reviews according to Appendix N pro&c&.  Appendix N comes nowhere 
near the scope of the pharmacology that potentially occurs in LTC facilities.  Appendix N 
was developed to give surveyors enough information to make a reasonable judgment as to 
whether the pharmacist had conducted a reasonably completejob of drug regimen review. 
Its purpose was never intended for use by pharmacists. Unfortunately, it has been 
per,ceivedby some pharmacists as the entire drug regimen ,reviewrequirement. 
-
D-5  DATE: 
OCT  I  4 199-i 
TO:  June Gibbs Brown 
Iuspector General 
FROM:  Nancy-Ann Mm DeParle  0  w  m 
Deputy Administrator 
SUBJECT:  Office of Inspector General (OK?)DraIt Report: Prescription Drug Use m 
Nursing Facilities: A Pharmaceutical Review of Selected Texas Patients, 
(OEI-06-96-00082) 
We reviewed the above-referenced report that examines the extent and appropriateness of 
pharmaceutical use by selected Texas nursing home (NH) residents and describes 
pharmacists  concerns about drug use. This is the third in a series of OIG reports and 
underscores the need to strengthen medication reviews and improve medication 
prescribing, administration, and monitoring practices in NHs. 
The Omnibus Budget Reconciliation Act of 1987(OBRA 1987)and subsequent 
regulations define certain limitations related to drug therapy. Among these are: 
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 NH must have no significant medication error rates. NHs often engage conSultant 
pharmacists to help them comply with these requirements. 
The Health Care Financing Administration (HCFA)concurs with the intent of the report 
recommendations.  Our detailed comments are: 
PIG. Recommendation #l 
HCFA should continue to monitor and encourage reduction in the use of comaindic~ed 
prescription drugs in the elderly NH population. 
D-6 
 HCFA Resoonse 
We concur.  This recommendation refers to a paper by Beers. M.H.. et al., entitled 
Explicit Criteria for Determining Inappropriate Medication Use in Nursing Home 
Residents, and published in the Archive of Internal Medicine, September 1991. 
Adoption of these criteria as Medicare gu.ideIineshas been proposed at the staff level in 
HCFA. 
OIG Recommendation #2 
HCFA should identif) and analyze reasons for the rapid escalation in costs and claims for 
certain types of drugs used in NHs (i.e., gastrointestinal, psychotherapeutic, cardiac, 
cardiovascular, and anti-infectives). 
HCFA Resuonse 
We concur. We must detexminethe potential source of this escalation. One potential 
reason for increased costs is the decrease in the use of antipsychotic drugs and the 
increase in the use of antidepressant drugs that are used in long-tetm care facilities. 
HCFA has been encouraging the diagnosis and treatment of depression and the more 
conservative use of antipsychotic drugs since the early 1990s. Since most autipsychotic 
drugs are off-patent and generically available (thus less expensive) and the 
antidepressants being used are not, cost escalations could be occurring because of these 
factors. 
OIG Recommendation #3 
HCFA should strengthen the effectiveness and impact of medication reviews conducted 
by consultant pharmacists in NHs. 
HCFA Response 
We partially concur.  Pharmacists have been required to conduct drug regimen reviews in 
Nl-ls since 1974. Appendix N was primarily written for surveyors, but it also serves the 
purpose of defining, for pharmacists, what,is involved in a drug regimen review. 
Appendix N was updated in March of 1985 and again in SepteIubw 1990. Appendix P, 
which contains extensive psychopharmacological drug therapy guidelines, was written in 
D-7 
 September 1989 as part  of the OBRA 1987initiatives.  These guidelines were updated in 
April of 1992, and again in June of 1995. In short, consultant pharmacists have extensive 
government guidance as to what is expected of the drug regimen review. 
We would be willing to more vigorously pursue enforcement of positive resident 
outcomes which would require the pharmacists input in achieving.  For example: falls, 
pressure sores, and urimuy incontinence can be exacerbated by psychoparmacological, 
cardiovascular, and other drug therapy.  The pharmacist can be helpful to the nurse and 
physician in mini&&g  risk to the resident, which would be a better use of  resources 
than investing time in finther Federal regulation of the drug regimen review. 
OIG Recommendation #4 
HCFA should require NHs to provide ongoing, in-service training for personal care staff 
(nurse aides) on how to recognize behavioral signals and symptoms of contraindications, 
adverse reactions, or inappropriate responses to medications. 
HCFA ResDonse 
We concur.  However, we believe our current regulations are adequate to cover this type 
of course material.  It is important for care givers to recognize these behavioral signs.  42 
CFR section 483.152@)(2)(i) states that the ctic@rn  of the nurse aide training program 
must include taking and recording vital signs, and 42 CFR 
section 483.152(b)(Z)(iv)requires the training program to include recognizing abnormal 
changes in body functioning and the importance of reporting such changes to a 
supervisor. While these requirements do not relate specifUly  to possible 
contrain&cation~, adverse reactions, or inappropriate responses to medications, we do not 
believe the nurse aides need to be able to identify the probable causes for the changes 
they obsm.  Rather, they need to recognize the changes,and report them, promptly, to 
someone who is trained to intervene clinicaIly.  Therefore, we do not believe any related 
changes to our regulatim  or accompanying guidelines are necessary. 
OIG Recommendation #5 
HCFA should explore the feasibility of requiring NFs to maintain all records pertinent to 
a patients care in one location in the NF. 
D-8 
 HCFA Resoonse 
We concur and will explore the feasibility of the above recommendation. 
Technical Comments 
Page 12 -We note that of the problems and concerns found by the independent 
pharmacists (called contract pharmacists in the report), 20 percent were not identified by 
the facilitys contract pharmacist. Among the contract pharmacists concerns were the 
follow-ing: 
0  lack of monitoring (drug therapy) for efficacy 
0  drugs which were clearly inappropriate for use by elderly individuals 
0  inappropriate method of administration, i.e., crushing of sustained action 
drugs 
0  medications inappropriate for diagnosis 
0  medications being received on schedule when a duplicate order was 
available 
(Note: Duplicate dispensing may be one reason for high drug expenditures 
in Texas.) 
0  some medications not having orders 
0  providing medications for which the patient had allergies 
0  medication  being ordered for dosagesotherthan those the patient received 
(Note: These are probably medication errors.) 
Also, we are interested in two questions in the context of the above findings:  To what 
degree has the Texas state survey agency identified these problems in the last regular 
survey, and if the Texas state agency did identify these problems, what remedy did it 
prescribe? 
D-9  DEPARTMENT  OF HEALTH  & HUMAN SERVICES  Office  of the  Secretary 
Washington.  D.C.  20201 
TO:  June Giblk?Brown 
Inspector General 
FROM:  Da\id F. Garrison  Mw 
Principal Deputy Assistant Secret&$ 
for Planning and Evaluation 
SUBJECT: 	 OIG Draft Report: Prescription Drug Use in Nursing Facilities: An Inside View 
By Consultant Pharmacists --- Concur  with  Comment 
We have reviewed the draft OIG report entitled Prescription Drug Use in Nursing Facilities: An 
Inside View By Consultant Pharmacists and concur with the following comments on this report. 
I appreciate the OIGs findings that some pharmacists are having difficulty carrying out their 
responsibilities to assure accurate and adequate administration of prescription drugs in nursing 
facilities.  Heartening, however, is the information included in this report that pharmacists 
contracted by the OIG for this study report that nursing homes are complying withthe required 
medication reviews for nursing home residents.  Particularly encouraging were the cooperative 
relationships that many pharmacists reported having with physicians, nurses, and administrators 
in these facilities.  I believe that the information presented in this report underscores the 
effectiveness of the pharmacists reviews --precisely the result sought by enacting the OBRA 
87 provisions.  As the IG notes, there is still room for improvement. 
Executive Surnma~~, The body of the report correctly highlights that it isphysician~ who 
determine what is appropriate drug use for nursing home patients.  However, the Executive 
Summary o+y references this critical role when recommending that pharmacists inform 
physicians of their medication concerns.  We recommend the Executive Summary emphasize 
that prescribing and monitoring medications is the responsibility of the nursing home residents 
physician and that many of the problems and concerns raised in this report are not the result of
.d 
.poor nursing home practices. 
Pecommendations.  Among the opportunities for improvement suggested by the OIG are the 
recommendations  that Appendix N of the Survey and Certification protocol be reviewed and 
updated, and a list of inappropriate drugs for the elderly be developed.  We agree.  We 
understand that there are several provisions in Appendix N that are no longer current and that 
recent advances in drug therapy for the elderly have identified several drugs that should never (or 
with rare exception) be used by the elderly.  We recommend HCFA implement these 
recommendations. 
D - 10 
 Yagb 2 -Jute  Gibbs Brown 

Another  recommendation  advanced  by the OIG is, [a]s part of the on-going  training of personal 

care staff (nurse aides), pharmacists  should provide  in-service  training on the recognition  of 

signals and possible  symptoms  of contraindications,  adverse reactions,  or inappropriate  responses 

to medications.  We believe that such training would  be highly desirable.  We recommend 

HCFA consider  modifying  the nurse aide training program  to include training on recognizing 

symptoms  of contraindications,  adverse reactions,  and inappropriate  responses  to medications. 

In addition,  we recommend  HCFA explore whether there are cost-effective  alternatives  to 

pharmacists  providing  this training. 

fiand  e  On a more technical  note, we recommend  the report clarify that 

the OBRA 87 legislative  changes and subsequent  regulations  apply to Medicare skilled nursing 

facilities as well as Medicaid NFs.  Similarly,  we note the report indicates that nursing 

facilities  were the facilities that were the subject of the pharmacists  responses  (as opposed  to 

Medicare  SNFs or dually-certified  facilities).  In addition,  the findings  and recommendations  are 

described  in terms of nursing homes and nursing facilities.  We recommend  clarifying  the 

types of facilities that were the subject of this report. 

As written, the report incorrectly  implies that the OBRA 90 drug provisions  are applicable  to 

nursing homes.  We recommend  that the scope of these provisions  be clarified.  Alternatively, 

this discussion  could be eliminated  from the report. 

The report states,  . , . from l-6 percent of the consultant  pharmacists  say these four drug 

categories  are inappropriately  prescribed  by most or all physicians  . . .  (p. 11). This statement 

is inconsistent  with the percentages  reflected in Table 2.  We recommend  the table and the 

statement  be reconciled. 

Finally, we recommend the OIG identify any next steps that should be pursued  as a result of this 

study.  For example, your office  may want to consider  administering  a similar questionnaire  to 

nursing home physicians and nurses to obtain their perspectives  on the effectiveness  of 

pharmacists drug regimen reviews. In addition, you may wish to recommend additional 

research that HCFA or ASPE should consider to fkthef  our understanding  in this area. 

D- 11 
 APPENDIX  E 
Comments  by External  Organizations  About  Inspection  Draft  Reports 
AMERICAN 6OCIElY OF 	CONSULTANT  PHARMKISTS 
-
September  29,1997 

June  Gibbs  Brown 

Inspector  Genera1 

Office of Inspector General 

Department  of Health  and  Human  Services 

Washington,  DC  20201 

RE:  Draft reports  -prescription  drug  use in nursing homes 
Dear Ms. Brown: 
The American  Society  of Consultant  Pharmacists  is pleased  to comment  on 
the draft  inspection  reports  related  to prescription  drug  use in nursing  homes. 
ASCP is the national  professional  association  representing  more  than  6,300 
pharmacists  who  provide  medication  distribution  and  consultant  services  to 
manage  and  improve  drug  therapy  outcomes  of individuals  residing  in long-
term  care environments.  ASCP members  serve  the full spectrum  of long 
term  care settings,  including  nursing  homes,  subacute  care and  assisted  living 
facilities,  psychiatric  hospitals,  facilities  for the mentally  retarded,  correctional 
institutions,  hospice,  and  home, care. 
We have  reviewed  each of the three  draft  reports  and  our comments  are 
shown  below. 
ASCPs  Overall  Observations 
1.  Medications  that  are generally  considered  inappropriate  for use in the 

elderly  are referred  to in the draft  reporta  as contraindicated.  However,  this 

is not  the correct  term  to use  for these medications~  In some  specific 

situations,  the use of one of these  medications  in the elderly  could  be 

justified.  ASCP suggests  using  the term  potentially  inappropriate  instead  of 

contraindicated. 

2. 	 Parts  1 and  3 of this three  part  report  focus on medication  use and 

consultant  pharmacy  practice  in Texas nursing  facilities.  It should  be noted 

that Texas may  not be representative  of the rest of the nation  with  regard  to 

long-term  care pharmacy  practice.  One  significant  difference  is that Texas has 

-
ljpl  Duke c&eel 
Al-,  VA 99314-3563 
703/739-1300 

7034739-1391fax 

inlo8axp.can

b...- II...  .,,*.--e  -n-r 

E-l  _(  . 
I  June Gibbs  Brown 
Sreapt. g20I. -1997
2 
strongly  emphasized  the  rights  of indlviduai  residents  to choose  their  own 
pharmacy  provider,  over  the  rights  of the  nursing  facility.  As a result,  it is 
common  for  Texas  nursing  facilities  to be served  by  five,  ten  or more 
pharmacy  providers,  each  with  only  a few  patients. 
In this  environment,  where  pharmacy  providers  serve  only  a few  nursing 

facility  patients,  it is difficult  for  dispensing  pharmacists  to have  expertise  in 

geriatric  pharmacotherapy  and  knowledge  of nursing  facility  regulations.  As 

a result,  the  task  of the  consultant  pharmacist  is made  more  difficult.  In states 

where  nursing  facilities  are served  by one  or two  primary  pharmacy 

providers,  many  medication  problems  are detected  and  corrected  at the time 

of dispensing.  This is referred  to as prospective  drug  regimen  review,  and  is 

an important  complement  to the  retrospective  drug  regimen  review 

performed  by the consultant  pharmacist. 

ASCP recognizes  the need  for expanded  knowledge  of geriatric 

pharmacotherapy  by both  physicians  and pharmacists.  In order  to recognize 

those pharmacists  who  have  developed  this expertise,  and  to encourage  other 

pharmacists  to develop  expertise,  ASCP created  an independent  commission 

to certify  pharmacists  in geriatric  pharmacy  practice.  The first certification 

examination  in geriatric  pharmacy  practice  will be administered  by the 

Commission  for Certification  in Geriatric  Pharmacy  on November  12,1997. 

ASCP has also developed  a Statement  on Pharmaceutical  Care, which  is 

designed  to assist  our  members  in improving  drug  therapy  outcomes  for their 

patients. 

An Introduction  Based on Texas 

3.  ASCPs Overall  Observations 
The first report  combines  information  about  appropriateness  of drug  use (e.g., 
medicines  not  generally  considered  appropriate  for use in the elderly)  and 
cost of medicines  for nursing  home  residents.  These are two separate  issues. 
ASCP suggests  presenting  this information  in two separate  sections  .to 
highlight  the  difference. 
Just because  the cost of a particular  drug  category  is increasing  does not mean 
that  medication  use in this category  is inappropriate.  Newer  (and  more 
expensive)  medications  often  have  fewer side effects, especially  in the frail 
elderly,  and  are more effective than older medications.  For example,  all the 
medications  on the list of twenty  drugs  not considered  appropriate  for use in 
E-2  June GibbsBrown 
Sept 29,  1997 
Pap  3 
the  elderly  are  multisource  generic  products.  As patients  are  switched  off 
these  products,  they  are  often  placed  on  newer,  more  expensive  medications. 
In the  category  of antidepressants,  amitriptyline  is an older  tricyclic 
antidepressant  with  many  adverse  effects  in the  elderly,  such  as urinary 
retention,  constipation,  and  dry  mouth.  Many  nursing  home  residents  have 
been  placed  on newer  agents  such  as fluoxetine  (Prozac)  or sertraline  (Zoloft). 
These  newer  agents  are  better  tolerated  by  the  elderly,  but  are  more  expensive. 
In the antipsychotic  drug  category,  residents  are being  switched  from older 
agents  such  as haloperidol  (Haldol)  and  thioridazine  (Mellarii)  to newer 
agents  such  as risperidone  (Risperdal)  and  olanzapine  (Zyprexa).  These 
newer  agents  are less ljkeiy  to produce  serious  side effects such  as tarclive 
dyskinesia  and  extrapyramida1  symptoms. 
In the cardiovascular  category,  there  is increasing  use of ACE inhibitors,  such 
as enaIapril  (Vasotec)  and  iisinopril  (Zestril),  due  to recent  evidence  of benefit 
from  these  agents  in treatment  of heart  failure  and  prevention  of renal 
dysfunction  in diabetic  patients. 
4.  Page i, Findings,  third  bullet 
In 7994 almost  20  vercent,  more  than  16,600,  of Texas  dually-entitled 
beneficiaries  received  at  Ieast  one  of  twenty  drugs  considered  by  medical 
experts  to  be  inappropriate  for  elderly  use  due  to side  effects  or  other 
consequences.  U 
As noted  in our  introductory  comments,  prospective  drug  regimen  review 
can be an effective  means  of preventing  or correcting  drug-related  problems. 
As an example  of  this, one large  long-term  care pharmacy  provider  collected 
data in 1997 on  12,000 nursing  facility  residents  across numerous  states  and 
found  that  only  12.9% of residents  were  receiving  a medication  on the list of 
twenty  drugs  identified  in the OIG report  as not appropriate  for the elderly. 
Of these medication  orders,  67% were  for propoxyphene. 
Increasingly,  long-term  care pharmacy  providers  are using  tools such  as 
formularies,  or preferred  drug  lists, and  therapeutic  interchange  as part  of the 
prospective  drug  regimen  review  process.  When  properly  applied,  these  tools 
can enhance  efforts  to improve  drug  therapy  outcomes  in nursing  facility 
residents.  Please  see the attached  Ascp  Statement  on Formula&s  in 
Nursing  Facilities,  ASCP  Guidelines  for the Development  of Formulary 
Systems  in Nursing  Facilities,  and  ASCP Guidelines  for Implementing 
Therapeutic  Interchange  in  Long-Term  Care. 
E-3  Jme Gibbs Bmwm 
Sept. 29, 1907 
Page 4 
5.  Page  iii,  third  recommendation 
Further  stltdy  should  be  rtnderfaken,  exmining  data  about  resident 
condifions,  types  of  speclallzed  care  and  other  facility-specific  characteristics 
along  with  drlcg  expenditure  and  usage  data,  tu better  understand  tfre factors 
contributing  to  the  wide  diff erences  between  nming  facilities  in  the  costs  of 
prescription  drugs  med  by  residents.  n 
ASCP  strongly  agrees  with  this  recommendation.  Because  of the  planned 

impIementation  of the  Prospective  Payment  System  (PPS)  for  nursing 

facilities  in 1998, more  research  is essential  to explore  the  reasons  for  these 

variations  in costs.  ASCP  suggests  including  this  recommendation  in the 

comprehensive  list  of recommendations  at the  conclusion  of  the  third  report. 

An  Inside  View by Consultant  Pharmacists 
6.  Page  ii, Shortcomings  of Medication  Reviews 
ASCP  suggests  changing  the  title  of this  section  to  Obstacles  to Adequate 
Medication  Reviews.  The  current  title  implies  that  inadequate  reviews  are 
the  fault  of the  consultant  pharmacist.  In fact,  the  material  presented  in this 
section  is primarily  focused  on  factors  that  are  beyond  the  control  of the 
consultant  pharmacist. 
7.  Page  ii, fifth  paragraph 
Phnrmacists  conduct  some  reviews  without  consulting  important  medical 
records  and  without  having  patients  diagnoses  or  laboratory  reporfs. 
The  explanatory  information  makes  clear that  this  information  is frequently 
unavailable  for review.  ASCP suggests  changing  this wording  to 
Pharmacists  conduct  some  reviews  without  access to important  medical 
records,  including  patients  diagnoses  and  laboratory  reports. 
8.  Page  ii, sixth  paragraph 
illore  than  half  of  the  reviews  do not  consider  the residents  assessment  (65 
percent)  or  pkm  of care  (56  percent). 
ASCP recommends  that  consultant  pharmacists  participate  in the  assessment 
and  care planning  process,  and  use these documents  to facilitate  the drug 
E-4  June Gibbs Brown 
Sept. 29,199: 
Page 5 
regimen  review.  Please  see  the  attached  ASCP  Statement  on  the  Role  of the 
Consultant  Pharmacist  in  Resident  Assessment  and  Care  Pianning. 
9.  Page  iii, item  3 under  Informing  and  Documenting 
Explore  the feasibility  of requiring  nursing  facilities  to  maintain  all  records 
pertinent  to  II patients  care  in  one  location  in  the  nursrng  juciiity. 
AS0  agrees  with  this  suggestion.  However,  there  may  be a few  appropriate 

exceptions  to this requirement.  For example,  the current  Medication 

Administration  Records  (MARS) for all patients  are commonly  kept  in a 

notebook  with  the medication  cart  for convenience  in distributing 

medications  to the residents.  ASCP  suggests  that the OIG  report  include  a list 

of pertinent  patient  records  that should  be kept in one location  in the facility. 

10.  Page iii, State and  Federal  Survey  and  Certification,  number  1 
To  enhance  bofh  surveys  (Federal  or  State)  of  medication  usage  and monthly 
drug  reginzen  reviews  by  consultant  pharmacists,  HCFA  should  review  and 
update  Appendix  N  of the  Survy/Certificntion  protocol  and  any  related 
medication  policy  and  procedures. 
ASCP agrees that Appendix  N is obsolete,  and we suggest  that Appendix  N be 
deleted.  In its present  form,  these survey  indicators  are actually 
counterproductive.  What  often  happens  is that  surveyors,  and  even  some 
consultant  pharmacists,  become  narrowly  focused  on these  indicators  and 
miss  other  significant  findings  that  would  be more  important. 
A!XP  is planning  to coordinate  development  of a new  set of indicators  for 
conducting  drug  rqimen  reviews.  These  indicators  will include  the list of 
twenty  medications  considered  inappropriate  for use in the elderly.  We will 
begin  with  a literature  search  and  seek input  and  consensus  from a broad 
group  of consultant  pharmacists,  geriatric  pharmacotherapists,  physicians  and 
others.  These indicatvrs  will be updated  periodically,  and can be used  by 
consultant  pharmacists,  surveyors,  and  others  to evaluate  appropriateness  of 
drug  therapy.  ASCP will forward  a copy of our new drug  regimen  revjew 
indicators  to HCFA  upon  completion,  no later  than  July,  1998. 
11.  Page  iii, Training  of Aides 
As part 
pharmacists  should  provide  in-service  training  on  the  recognition  of signals 
E-5  JuneGibbsBrown 
Sept. 29, 1997 
Page6 
and  possible  symptoms  of  contraindicatrons,  adverse  reactions,  01 
Inappropriate  ;esponses  to  medications. 
Nurse  aides  are  currently  required  to have  a minimum  of welve  hours  of 

inservice  training  per  year,  according  tv tag  F497 of the  interpretive 

guidelines.  ASCP agrees  with  the  recommendation  for specific  training  for 

nurse  aides  regarding  identification  of medication  side  effects.  ASCI suggesb 

that a requirement  for four hours  per year  (or one  hour  per  quarter)  of 

training  related  to detection  of medication  side effects be recommended  for 

nurse  aides. 

12  Page  17, fifth paragraph 
If  is inferesfing  to note  that fully  91 percent  of  the cons&ant  pharmacists 
believe  reusing  medicafions  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  pkarmacisfs  indicated  the  savings  may  be 
offsef  by  many  potential  administrative  costs,  54  percent  of  the  consuitanf 
pharmacists  say  unused,  properly  packaged  medications  could  be  returned  to 
the  vendor  pharmacy  to  yedispense  for  use  by  others. 
The issue  of return  and  reuse  of medications  by nursing  facilities  is complex. 
ASCP has developed  a position  statement  which  explores  the various  facets of 
this issue.  Please  see the attached  ASCP Statement  on  Return  and  Reuse of 
Medications  in Long-Term  Care Facilities. 
A Pharmaceutical  Review  of Selected  Texas Patients 
13.  Page ii, first paragraph 
22 percent  of  patients  were  receiving,  without  a prescription  in  their  records, 
drugs  fir  which  prescriptions  are  generally  required.  Further,  23 percent  of 
the  patients  were  prescribed  medications  for  which  the  records  showed  no 
orders  or  receipts  to  indicate  tke  patient  actually  received  the  medication. 
This  is a high  proportion  of such  orders,  and  these results  are inconsistent 
with  the findings  in Part II of this report,  which  showed  that 83% of 
consultant  pharmacists  in  the nationa  survey  rarely  or never  found  a 
medication  order  not  on the MAR.  The remainder  of the respondents  found 
this  problem  sometimes.  Ninety-three  percent  of consultant  pharmacists 
rarely  or never  find  a medication  listed  on the MAR without  an order. 
E-6  June Gibbs Brown 
Sept  29, 1997 
Page 7 
14.  Page  ii, last paragraph 
The  contract  pharmacists  idenfijed  medicafiotz  problems  or  concerns  for  20 
percent  of the  pntienfs  which  hud  not  been  identified  by  the  nursrng  home 
consultant  pharmacists  reviews. 
It would  be more  accurate  to say  The  contract  pharmacists  identified 
medication  problems  or concerns  in 20 percent  of the  patients  where  there 
was  no documentation  that  these  problems  had  been  identified  by  the 
nursing  home  consultant  pharmacists  reviews.  Elsewhere  in  the  OIG 
report,  it is noted  that consultant  pharmacists  in  Texas  frequently  provide 
some  of their  findings  to the  facility  in verbal  reports  or in documents  that 
are not a part  of their  official  report. 
15.  Page  iii,  Recommendations 
In the  final  list  of recommendations,  please  include  the  third 
recommendation  from  the  first  report: 
Further  study  should  be  undertaken,  examining  data  about  resident 
conditions,  types  of  specialized  care  and  other  facility-specific  characteristics 
along  with  drug  expenditure  and  usage  data,  to  better  undeqtand  the factors 
contributing  to  the  wide  differences  between  nursing  facilities  in  the costs of 
prescription  drugs  used  by  residents. 
16.  Page  iii,  Recommendations 
ASCP  suggests  adding  a recommendation  that  HCFA  require  consultant 
pharmacist  recommendations  to be made  a part  of the  residents  clinical 
record.  This  recommendation  is supported  by  findings  from  the  national 
survey  of consultant  pharmacists  (see Table  4 and  discussion,  page  16 of full 
report).  Consultant  pharmacists  document  their  findings  and 
recommendations  in the clinical  record  only  about  one-third  of the time. 
This lack of documentation  in the clinical  record  decreases  the  ability  of the 
consultant  pharmacist  to cummunicate  significant  information  to the 
interdisciplinary  team  and  nursing  facility  staff. 
ASCP has  long  suppotied  the documentation  of wnsultant  pharmacist 
findings  and  recommendations  in the clinical  rec&cl.  See the attached  ASCP 
Guidelines  for Documenting  Consultant  Pharmacists  Activities  in the 
Medical  Record. 
E-7  June Gibbs Eravm 
Sept. 20, 1997 
Page 8 
The  American  Society  of Consultant  Pharmacists  is pleased  to provide  these 
comments  on  the  draft  report  and  we  hope  that  these  comments  will  be 
useful  in your  review  and  preparation  of the  final  version  of this  report.  If 
you  have  any  questions  about  our  comments,  or if additional  information  is 
needed,  please  contact  Thomas  Clark,  ASCP  Director  of Professional  Affairs,  at 
703739-1316,  x123. 
Sincerely, 
R. Timothy  Webster 
Executive  Director 
enc.:  ASCP  Statement  on Pharmaceutical  Care 
ASCP Statement  on  Formularies  in Nursing  Facilities 
ASCP Guidelines  for the Development  of Formulary 
Systems  in Nursing  Facilities 
ASCP Guidelines  for Implementing  Therapeutic 
Interchange  in Long-Term  Care 
ASCP Statement  on the Role of the Consultant 
Pharmacist  in Resident  Assessment  and  Care Planning 
ASCP Statement  on Return  and  Reuse  of Medications  in 
Long-Term  Care  Facilities 
A!XP  Guidelines  for Documenting  Consultant 
Pharmacists  Activities  in the Medical  Record 
E-8  National  Association  of  Boards  of  Pharrnacyb 
700  BUSSP  Hghway  .  ParkR:dge  /L 60066 
Tel:  847/69&S-727  *  Fax  b-47/698-0124 
October  1997 
June Gibbs  Brown 

Inspector  General 

Department  of  Health  &Human  Services 

Office of Inspector  General 

Washington.  DC  2020 1 

Dear Ms. Brown: 
Thank you for the opportunity  to comment  on rhe draft xqection  reports 
describing,the  results  of the inspections  of the issues  related  to prescription 
chug use in nursing  homes. 
We concur  with the general  findings  of the reports  calling  for strengthening 
medication  reviews,  improving  medication  prescribing,  administration,  and 
monitoring  practices  in nursing  homes.  We strongly  support  increased  use of 
the pharmacist  in the medication  retiew  and  patient  care  processes  and 
access  to critical  patient  data. 
rther assistance,  please  do not hesitate  to contact  me. 
&en  A. C&zone,  MS, FtPh 

becuttve  Director/Secretary 
f 

.! 
CClmwg 
cc  NABP Executive  Committee 

Fxecutive  Officers -State Bcurds of Pharmacy 

E-9  fkmxkan  HCSMIbrekkssochtiotl 	 I:.;  L sweet,  NW. Washington,  DC 20005 4014 
FAX: 202.842-3860 
October  2. 1997 
June  Brown 

Inspector 

Department  of  and Human 

330 Independence  Avenue,  S. W., Room 5657 

Washington,  DC 20201 

Dear Ms. Gibbs: 

The American  Health Care Association  (AHCA)  is pleased  to respond  to your request  for 

review  and submission  of comments  on the draft inspection  reports  regarding  issues 

related  to prescription  drug use in nursing  facilities.  Our comments  are incorporated  into 

this letter. 

We have reviewed  all three reports! An Inside  J&w by Consultant Pharmacists;  An 
Introduction  Based on Texas; and A Pharmaceutical  Review ofSelecred  Texas Putients. 
Although  our comments  rererence  primarily  the national document,  An  View by 
Pharmacists,  they  applicable  to  areas of  Texas-related  drafts. 
Texas stale afliliate  member,  the Texas Health Care Association,  has also 
reviewed  the reports  and provided  comments  to us. Those comments  are incorporated 
our Icttcr. 
American  Health  Association  is a federation  of 50 state health care 
organizations,  together  representing  more than 11,000 non-profit  and for-profit  assisted 
living, nursing  facility,  and subacute  care providers  that care for one million  elderly  and 
disabled  individuals  nationally.  To be Medicare  and Medicaid  certified,  nursing  facilities 
must be in substantial  compliance  with all requirements  of participation  at 42 CFR 483 
Subpart B,  These requirementi  include regulations  governing  unnecessary  drugs, 
antipsychotic  drugs, medication  errors and pharmacy  services,  including  those related  to 
consultant  pharmacists  and drug regimen  review. 
Our comments  address  four key areas.  They are not necessarily  all-inclusive  but are 
provided  to illustrate  the problems  we found in the dran document  discussion  and 
recommendations. 
E- 10  pharmacists  asked hrobd and sometimes  vague questions.  Nevertheless,  on the basis 
of responses  to these broad questions,  the Office of Inspector Gcncrnl Is drawing 
specific conclusions  and making  extensive  recommendaHoas. 
 	 Terms such as concerns  and inappropriate  are used in se\-eral significant  areas of 
the text  These are broad terms which need to be broken do\\n  into specifics  to limit 
variations  in their interpretations.  The concerns  should be specifically  described.  For 
example,  since inappropria/e  can be over-use,  under-use,  wrong drug for condilion. 
or other factors,  it should be specifically  identified,  and the percentage  of occurrence 
of that descriptor  provided.  With more specific  terms, the meaning  of some of the 
findings  would be clearer, and the relevance  of some of the solu~io~~s  to  the rrported 
problems  would be more apparent.  To assist the reader in understanding  the problems 
and recommendations,  we also recommend  that a copy of the survey instrument  be 
included  in the final report. 
2.  The reports raise valid concerns about physicians  prescribing  practices,  lack of 
knowledge  or training  regarding  appropriate  medications  for the elderly,  and 
unresponsiveness  to consultant  pharmacists  recommendations.  However,  our 
reviews  found that several recommendations  which are made in the drafts either do 
not address these issues or they are targeted toward areas which will not solve the 
problems.  They also place the burden of correction on the nursing  facility, 
expecting  facilitys  administration  or nursing staff to manage a process over which 
they do not have complete  control. 
Page i of the Executive  Summary  of the hide  View draft contains  this statement: 
Pharmacists  have serious concerns  about prescribing  practices  for antipsychotics, 
anxiolytics,  sedatives/hypnotics,  antidepressants,  and other drugs. 
The opening  paragraph  on page two of the Inside View draft states:  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 the director  of 
nursing. 
Page 9 of the Inside  View draft states:  Many of the consultant  pharmacists  (40 
percent)  assess  the extent of cooperation  t?om residents  personal  physicians  as only 
fair or poor.  Consultant  pharmacists  arc disturbed  thnt some physicians  do not take 
their concems  seriously  or act promptly  on their rccommcndations...  It goes on to 
state that 63 percent  of respondents  report that physicians  rarely or only sometimes 
seriously  consider  their recommendations.  Page 9 also states:  By contrast,  99 
percentof Iheconsultantpharmacistssay nursesseriouslyconsidertheir concerns 
mostto all the time. 
In spite of the above-noted  statements,  the draft recommendation  which addresses  these 
issuesis directedat the nursing  facility, as noted on page20 of the Iwide View:  State 
2 
E- 11  and Federal  survey  and certificati.,n  programs  could Include process  focused  reviews  of 
pharmacists  recommendations  and subsequent  actions  by appropriate  medical  and 
nursing  personnel  as part of their on-going  suncys.  The AHCA belicvcs  that this 
recommendation  would penalize  nursing  facilities  for physicians  prescribing  practices 
and lack of responsiveness  to the consultant  pharmacis(s  recommendations,  even if 
facilities  have attempted,  without  success,  to educate  the physician  about fcdcral  long 
term care regulations.  This recommendation  also contradicts  the Health Care Financing 
Administrations  emphasis  on resident  outcome  orienled  survey procedures  for nursing 
facilities. 
3.  The reports contain  internal  inconsistencies.  For example,  the draft indicates 
that consultant  pharmacists  responses to the survey show serious shortcomings  in 
the quality  and thoroughness  of the pharmacists  drug regimen reviews.  The draft 
further states that pharmacists  conduct some reviews without  consulting  important 
medical records and without  having patients  diagnoses  or laboratory  reports. 
Nevertheless,  the consultant  pharmacists  responding  to the OIGs survey draw 
conclusions  about the appropriateness  of residents  medications. 
Page ii of the draft Inside View contains these statements:  Pharmacists  conduct 
 	
some reviews  without  consulting  important  medica  records  and without  having 
patients  diagnoses  or laboratory  reports.  Many pharmacists  have no contact  with 
patients  or their families  or with nurse aides in their conduct  of drug regimen 
reviews. 
In spite of these significant  findings,  the draft emphasizes  consultant  pharmacists 
conclusions  and concerns.  These responses  should raise questions  to the reader about 
how the pharmacists  arrived at these conclusions  without  thorough  knowledge  of the 
resident  assessments,  care plans, and the rationale  For the use of a particular  medication 
or dosage.  For example,  the chart on page 12 of the draft illustrates  pharmacists 
concerns.  The reader should ask how the pharmacists  would know about such issues  as 
overutilizatioa  of drugs, use of antipsychotics  without  a diagnosis,  or use of 
contraindicated  drugs for patients  existing  diagnosis  or disease  given their admissions 
that they conduct  their reviews  without consulting  important  medical  records or having 
the rcsidcnts  diagnoses. 
4.  The drafts report that consultrnt  pharmacists  bave serious concerns  about the 
USPof prescription  drup in nunimgfacilitia, and the OIGsuggeststhat legislative 
and regulatory  iateutions  related to the quality of these services are not being fully 
realized.  However,  according  to Halth  Cart  Finan&ng Administration  data, the 
rates of nursing  facilities  noncompliance  with key requirements  of participation 
governing  quality  of care aspects of prescription  drug use and the adminlstration  of 
pharmacy  services, including  those of consultant  pharmacists,  are not as high as the 
reports suggest, 
E- 12  . 	 In the OIG survey,  consuftan:  phstmacists  reporteti that, in general.  nursing  faciltties 
and consultant  pharmacists  are complying  with the law and regulations  related to 
medicafion  reviews  of nursing  home residents.  However,  the concerns  that 
consultant  pharmacists  repott  in the OlG survey suggest  that nursing  facilities  arc not 
complying  with many other federal requirements  rclatcd to prescriptton  drug use.  A 
review  of the data resulting  from inspections  of nursing  facilities  compliance  with 
these requirements  does not support all of these concerns.  For euamplc,  page  I2 
contains  a chart which  shows the percentage  of consultant  pharmacists  who reported 
that they are sometimes  or often concerned  about: prolonged  USCof sleeping 
medicines  (67%); overutilizadon  of drugs (62%): use of as needed  drugs for too 
long (61%); use of antipsychotics  without a diagnosis  (45%); and use of 
contraindicated  drugs for a patients  existing  diagnosis  or disease  (26%).  The 
national  rates of noncompliance  cited at federal regulations  related to these areas for 
10,692 surveys  of nursing  facilities  between  July, 1996 and April,  1997 were: 
 	 42 CFR 48325(1)(l)  -- Unnecessary  drugs (in excessive  dose; for excessive 
duration;  without  adequate indications  for use; in the presence  of adverse 
reactions;  or a combination  of the preceding)  --Noncompliance  rate:  9.9 
percent. 
 	 42 CFR 483.25(1)(2)(i) -- If antipsychotic  drugs were not previously  used, 
they are not used unless necessary  to treat a specific  diagnosed  and 
documented  condition  -- Noncompliance  rate:  1 2 percent. 
 	 42 CFR 483.25(1)(2)(B) -- Residents  who use antipsychotic  drugs receive 
gradual dose reductions,  behavioral  interventions,  unless clinically 
contraindicated  --Noncompliance  rate:  I .2 percent. 
 	 42 CFR 483.25(m)(l)  - The facility ensures  that it is free of medication  error 
rates of five percent  or greater --Noncompliance  rate:  4.8 
 	 42 CFR 483.25(m)(2)  -- The facility ensures  that residents  are free of any 
significant  medication  errors --Noncompliance  rate:  2.3 percent 
 	 The facilities  surveyed  during the above-noted  time period were found to have 
national  compliance  rates of 0.8, 1.8, and 1.2, respectively,  for the federal 
requirements  at 42 CFR 483.60, including  those governing  drug regimen  review, 
reporting  irregulanides  to the attending  physician  and director  of nursing,  and acting 
on reports. 
In addition,  please note the following  general comments. 
 	 The findiig  that a 20 percent  increase  in drug costs has occurred  in a short period of 
time may not be unusual.  Most new and more effective  products  that have come on 
E- 13  the market in the last IO year; are expensive.  Their a\*erage cost is $ I .OO10 %1.50 per 
dose.  If new, more effective  drug.\ <ce now available,  why should thry not hc used for 
nursing  facility  residents  in place of the 10 ;J 20-year-old  drug thcrapres?  The 
availability  of these drugs, too. is an important  factor in delivering  qua/icy of care. 
Conducting  drug regimen  reviews  on a routme basis and/or conducting  reyicws  for 
the OIGs research  without physically  being present  in the nursing  facihty  or seeing 
residents  produces  questionable  results.  This practice  may explain  some of the 
pharmacists  concerns  about prescription  drug use in nursing  facilities.  If the 
consultant  pharmacist  is actually in the facility, the likelihood  is increased  that needed 
information  will be obtained  with the help of facility staff.  Therefore,  wc recommend 
that further  research be conducted  before any conclusions  are reached  regarding  the 
survey of pharmacists. 
We recommend  that the final reports note that many of the concerns  such as proper 
monitoring  and physician  prescribing  practices  for the elderly which  are identified  in 
these drafts III-Znot limited to elderly individuals  in nursing facilities.  They also relale 
to those who are at home and in hospitals. 
We recommend  that health professionals  and the public continue  to be educated 
about, and further research  be conducted  on, the use of drugs and the elderly.  In 
addition,  it is imporknt  that consultant  pharmacists  clinical  orientation  be increased, 
especially  through  training  in geriatric pharmacology. 
We recommend  removal  of the recommendations  that require pharmacy  review  notes 
be placed  in a particular  location  in the facility and to promote  that a common  drug 
category  list be used during drug regimen  reviews  and medication  pass reviews. 
Facilities  need flexibility  to file their pharmacy  review notes where they can best be 
utilized  by the individual  facility staff.  A common  drug category  list is not 
compatible  with the growing  younger  populations  in the nations  nursing  facilities,  in 
particular  with the advent of subacute care. 
We would be pleased  to discuss  these recommendations  further if needed. 
Sincerely, 
-Janet  A. Myder, 
Director  of Regulatory  Systems 
a\rcg\Jml\canmentrbipe3bdoe 
cc:few  HealthCareAssociation 
5 
E - 14  October  14. 1997 
The Honorable  June Gibbs Brown 
Office of the Inspector  General 
330 Independence  Avenue 
Washington,  DC 2020 I 
Dear Ms. Brown: 
Thank you very much for this opportunity  to comment  on the droftreports  on 
prescription  drug use in nursing homes:  Prescription  Drug Use in Nursing 
Facilities: An Introduction  Based on Texas, OEI -06-964X0X;  An Inside View by 
Consultant  Pharmacists,  OEf -06-964081;  and A Pharmaceutical  Review of 
Selected  Texas Patients, OEI -06-96-OKX32.  This letter includes our general 
comments  on the reports and we have attached  speciRc and technical 
comments,  also. 
AAHSA represents  not-for-profit  organizations  dedicated  to providing high
quatity health  care, housing and services to the nations elderly.  Our 
membership  consists of over 5,ooOnot-for-profit  nursing homes, continuing  care 
retirement  communities,  senior housing facilities, assisted living and community-
based service organizations.  With our broad range of facilities and services. 
AAHSA serves more than one million older persons daily.  We have a long history 
and consequently,  significant  experience  in meeting  the needs of the elderly. 
We recognize  the important  role that the Medicare and Medicaid programs 
have played in ensuring  that the health care needs of older Americans  are 
adequately  met. 
AAHSA nursing facifity members  are committed  to providing quality  health  care 
to all their residents.  Prescription  drugs are an important  element  in the medical 
care of residents  and the findings of the OIG studies are of great interest.  Some 
of the findings and recommendations  of the reports indicate  the need for 
further studies and could be helpful in improving the quality of medical  care 
given residents  in nursing facilities.  However, we are concerned  with some of 
the methodologies  used in the study, the limited nature of the findings and the 
recommendations  for new program reauirements  that are&justified  by the 
studies. 
E- The Honorable  June Gibbs Brown 

October  14, 1997 

Page 2 

AAHSA agrees  that there is room for greater  understanding  of the medical 

needs of the elderly,  particularly  those with chronic conditions  and multiple 

problems,  and the appropriate  use of pharmaceutical  resources  available  to 

help them.  We al50  reCoCJniZ5  the potential  benefits  that more geriatric 

education  of physicians,  pharmacists,  nursing staff, residents  and their famiiies 

could have on patient outcomes.  However, there is a great reluctance  to 

endorse  more federal regulations  or requirements  for nursing facilities, one of the 

most over-regulated  industries in the country.  Once srxcific  problems  and 

solutions  can be identified.  targeted  education  and voluntary  compliance 

might be the most cost effective  approach. 

Better communications  among the physicians, patients, consultant  pharmacists, 

and nursing facilities staffs could eliminate  some of the problems  highlighted 

by the reports.  In particular. it makes sense for the medical  diiector  to be aware 

of any problems  identiCed by a consultant  pharmacists  monthly  review.  But it is 

also important  to recognize  that each of the caregiving  parties has a specific 

role to play dictated,  in part, by state professional  licensure  and relationships 

with and responsibilities  to the patient.  Increased  requirements  for selected 

providers and the nursing facility, the place where  the parties interact,  may not 

be the mosf appropriafe  focus.  Greater  understanding  by and communication 

among gJ portiis  should be the goal. 

The analysis of TX Medicaid claims for prescription  drugs (0EI-W96m) 

Indicates problems  because of rlslng program costs, but the data needs to be 

interpreted  in a broader context,  including  payment  methodologies.  increased 

use of certain  more expensive  drugs, such as those that treat cardiovascular 

disease or depression,  may very well represent  better  patient diagnosis and 

care. rather than prescription  misuse.  OBRA 87 has mandated  the provision of 

NF care to bring the patient to the highest practicable  physical,  mental.  and 

psycho-social  well-being  and that sometimes  requires expensive  drug 

treatments.  In addition, prescribing drugs for elderly  patients is a complex 

process unique to each case.  One can not  that  the  associated 

the  listed  are  or  dangerous  uninfofmed 
In  the  of  certain  of  as  or 
may  misleading  unique  can 
their  Nonetheless,  is  to  the  of  drugs  time 
E- 16  The Honorable  June GiDbs Brown 

October  14, 1997 

Page 3 

and it is encouraging  to see a 20% drop in such use over the course of the study 

period. 

AAHSA agrees with the recommendation  that HCFA contkue  to monitor and 

encourage  reduction  of the use of certain drugs, though  changes  in the 

prospective  drug utilization review programs  are not thoroughly  analyzed  and 

justified.  AAHSA OISOagrees that HCFA should focus attention  and further study 

on the five categories  raisins  costs and medical concerns  in the NF.  The lost 

recommendation,  for further  study of factors  (which should include  patient 

acuity measures)  affecting  the wide differences  among  nursing facilities in the 

costs of pfestiption  drugs used by residents  is partiiulariy  important  as a basis 

for understanding  fhe situation and designing  possible changes  to ameliorate 

perceived  problems. 

The report on consultant  pharmacists  views (OEMX-96-KQ81  )is impossible  to 

interpret  because  of the constraints  of the methodology  and lack of a detailed 

explanation  of it.  The selected  consultant  pharmacists  were asked to recall 

experiences  in a particular  facility over a 6 month  period, without records and 

data reflecting  all relevant  actiiities  and without guidance  on how to define 

the frequency  of remembered  occunences.  It is an impressionistic  opinion poll 

of views from one set of players in a complex  process with legally  defined roles 

and responsibilities,  diierent  perspectives,  and debatable  interpretations. 

Nonetheless,  some of the problems  indicated  by the consultant  pharmacists 

deserve  closer examination,  pariiiularty  those indicating communications 

problems-inadequate  records documentation,  lack of referral  to the records 

when conducting  drug reviews, lack of reporting  of monthly  reviews to the 

medical director,  etc.  To better understand  the nature and extent  of these 

problems  and possible solutions,  all parties should be involved in study design, 

analysis, and recommendations,  including the medical directors nursing staff. 

The third report  (O&06-9&00082),  based on contract  pharmacists  reviews of 

medical records in a small. nonrandom  sample of cases, highlights  other 

potential  problems  that warrant further examination  before major program 

changes  are suggested  For national implementation.  Therefore,  AAHSA supports 

its recommendations  that HCFA monitor and enkourage  reduction  of certain 

prescription  medications  and identify and analyze reasons for rapidly increasing 

costs of certain  drugs.  We also support the third recommendation  to strengthen 

the effectiveness  of the medication  reviews through  guidance  to involved 

E  - 17  The Honorable  June Gibbs Brown 

October  1A, 1997 

?age 4 

parties.  Additional  changes  and new reauirements  on a national  level are not 

justified, given the limited information  In these TIX studies.  We agree with the 

neea for more education  and training for all involved parties, including 

prescribing  physicians  and nursing staffs concerning  appropriate  drug use for 

the elderly,  but it is uncleor  how that might best be provided, where,  by whom. 

and payment  method.  The last recommendation  concerning  the placement  of 

all patient  care records in one location within the nursing facility is premature 

and unJustlfled. since the opinion poll shows 89% of consultant  pharmacists  have 

no difkulty  obtaining a patients  assessment  and 97% report no problem 

getting  the patients  plan of care. 

Our specific comments  and recommendations  are attached.  AAHSA 

appreciates  this opportunity  to comment  on these draft reports and would be 

happy to continue  the dialog OSthe issues are explored  further within your office 

and HCFA and solutions are developed. 

Z,&v 
President 
Enclosure 
E- 18  AAHSA  / 
October  1997 
Page  I 
Detailed  Comments  of the  Association  Homes  jervices  the 
on  Reports 
Prescription  Use  Nursing 
An  Based  Texas, 
.  20%  in  drug  per  is  rapid 
troubling,  noi  New  have  available  the 
for  of  common  of  elderly,  genetic 
are  yet  and  often  a  higher  tag. 
some  the  drugs  a  health  with 
side  Some  the  costs  also  attributed  better 
care  patient  Also  to  rapid 
in  is  rapid  of  drug  relative 
the  Price  and  other  components  it. 
 	 Because  the study only looks at one state and does not appear to examine 
the Medicaid payment  methodologies  fur prescription  drugs, it is impossible 
to determine  how much of that increase  might be due to administrative  rules 
and procedures  under the control  of the states  Medicaid program. 
. 	 The study found that  17% of the states  prescription  drug payments  were for 
the dually-ellglble  paputattan in nursing facilities  (NFs).  The dually-eligible 
population  tends to have greater  medical  care needs than the average 
Medicaid or Medicare  patient.  Without  further  analysis of the study 
population  selected  compared  to the dualiy eligible  population  in the 
community  and to other  segments  of the TX Medicaid population  and 
compared  to similar populations  in other states, it is impossible  to assess 
whether  that proportion  may be out- of-line.  Patient acuity measures 
would be crucial for any such analysis. 
 	 The finding that some NF r&dents  receke inappropriate  cf unnecessary 
drugs is of grave concern.  Given the high number of prescriptions  per 
patient, that risk becomes  more dangerous.  We are well aware of  the 
health  hazards and costs associated  with such treatments,  partk~~l~~ty for the 
elderty.  Because  the elderly,  espe&Aty  those poor and in nursing homes, 
tend to have multiple  health  problems,  the prescription  problems  may seem 
more extreme.  But problems  of drug use are ndther  unkque to the elderly 
E- 19  AAHSA  / 
October  14, 1997 
Page  2 
nor to nursing  home  residents.  This study  has  focused  on a narow  segment 
of the population,  but the problem  is much more widesixecd.  Sea the 
enclosed  cartoon  for a commentary  on OVI drug-criented  socieb. 
  There are, however,  some prescripticn  problems  related  particularly  to the 
oge  of NF potients.  The elderly  body  does  not  process  drugs  as efficiently  OS 
it did when it was younger  and it is more sensitive  to the effects  of many 
drugs.  For those reasons, among  others, there are certainly  some drugs and 
some treatment  regimens  that should generally  not be recommended  for 
elderly  patients.  However, it is important  to be cautious about labeling  any 
list of such drugs as inappropriate  of contraindicated.  Those terms  have 
specific medical  meaning.  Appropriate  use of a drug can be a debatable 
matter  of judgment.  The list of 20 drugs used in the study was constructed  by 
a small group of experts  using Delphi methods  and was controversial  at the 
time it was published.  But rnme importantly,  it must  be recognized  that, for 
some cases. it could be appropriate  and necessary  to use one of the drugs 
on the list.  Based on a physicians clinical knowledge  of a particular  patient, 
the doctor could knowingly  choose one of the proscribed drugs as the best 
option in the given circumstances.  (Such use could appopriately  trigger a 
discussion or comment  from the consultant  pharmacist  during the monthly 
review, to determIne  whether  or not it were, in fact, an appropriate  use.) 
 	 Despite the concerns  expressed  above about the drug list and how it is 
labeled,  we are encouraged  by the reduced  percentage  of beneficiaries 
receiving  drugs from the  list over the time petiod of the study.  While the 
study notes that the percentage  shifted downward  slightly  from  1992 to 
the first half of 1995, it is actualty a MX  reduction  in the rate.  In part, that 
may reflect  Ihe growing impact of OBRA 87.  In part, it may reflect  the time 
lag frequently  noted far scientific literature  to have an impact on daih/ 
medical  practice. 
 	 The study shows a need for more education  about drug use for the elderly 
that includes  physicians, their patients and ail caregivers,  regardless  of 
setting.  Particular attention  could be targeted  on the five drug categories 
that represent  rapidly growing costs to the TX Medicaid program  and. within 
those categories,  focus should be on drugs p&enting  the greatest  risks to 
elderly  patients.  The costs of such education  and who pays them  need to 
be considered  in any policy recommendations. 
E - 20  AAHSA  Comments  / Recommendations 

October  14. 1997 

Page 3 

 	 On page i!, some of the findings about the .5drug categoties  and 
gastrointestinal   make comparisons  to all Medicaid prescnptior
drug paymenk  and it is unclear whether  that refers to just the payments  fcr 
the study population  or the total ,Medica!d program. 
. 	 The finding that gastrointestinal  drugs average  nearly $38.5 annually  per 
beneficiary  would mean $1.05 per day not $1 SO. 
 	 The finding that average  presctiption  drug payments  per beneficiary  varied 
so widely among  NFs may reflect,  in part, the vafiotions In practice  patterns 
that are found throughout  medical  practice.  However,  it calls foefurther 
analysis  that takes into account  average  case mix or patient acuity, special 
characteristics  of NFs that may be relevant,  as well as an examination  of the 
distribution  of those costs and a closer look at the outlien. 
 	 Table 6 and the discussion above it on p.9 are a bit confusing.  If the facility 
with the lowest total drug payment  averaged  $0.17  per (patient?) day and 
had at least 6 beneficiaries  during 1994, the patients  must have had very 
short stays if the  facility  payment  was less than $10.00.  (The bottom  row 
of the table multiplied  by 365 does not equal the top row.)  Perhaps more 
extreme  cases need to be excluded  or slightly  different  comparisons  are 
necessary  to be dear  and meaningful. 
 	 AAHSA agrees with the recommendations  in bold type on p. 10. However, 
AAHSA has reservations  about the inclusion of NF residents in the automated 
prospective  drug utiliiation  review programs already  in place, without  some 
evidence  that those programs  are operating  smoothly  in each state, reviews 
are timely  and cost effective  and that they have the capacjty  and expertise 
to handle  the nursing facility population.  There is no diius-sion  of this 
utliiiation  review program in the reports and no justiiation  to support the 
recommendation.  AAHSA supports the recommendation  for further  study, 
but does not believe that the survey of consultant  pharmacists  provides 
useful insights. 
An Inside  View bv Consultant  Pharmoc*ists. OEI-O6-9&00081 
 	 The methodology  of this survey and its written  repart are basically  flawed 
and would  b-emisleading  if published.  The data represents  personal  opinions 
o? consultant  pharmacists  rather than accurate reports of activities within 
E - 21  AAHSA  Comments  / Recommendations 

cktober  14. I997 

Page 4 

nursing fccilities.  It does not present a realistic  picture on which to base 
policy considerations. 
1.  While the selection  of pharmacists  may have been random,  it is not 
likely that the pharmacists  selection  of a facility on which to base 
responses  could have been random in any statistical  sense.  As 
noted on page 7, you can generalize  the findings, Assuming  that 
the pharmacists  did in fact randomly  select the facility for which 
they provided information....  Without  seeing the survey instructions 
and questionnaire,  there is absolutely  no basis for making that  ,, 
crucial assumption  and putting any faith in the findings, 
2. 	 Even if the study could document  a totally random selection  of NFs 
by consultant  pharmacists,  the fact that their responses  are based 
solely  on personal recall of activities over a 6 month period with no 
documents  or records for reference  to improve the accuracy  of 
their responses  and no advance warning at the beginning  of the 6 
month  period, means that the responses are merety impressionistic. 
not accurate  reports of actual actiities. 
3. 	 Many of the responses  reflect  the frequency  of a particular action 
(of-ten, sometimes  rarely, never, or none, few, some, most, all), 
but there are no definitions  in the write-up or the tables in the back 
explaining  in numerical  term what those words mean.  Does that 
mean that there were no definitions  given the respondents.  either? 
That makes the response  even more impressionistic  and less useful 
for defining any realtty.  What is a rare occurrence  to one 
pharmacist  may be considered  a sometimes  event by another,  or 
both may be weighing  their answer based on the number of 
consultant  revFews they conducted  (or remembered)  during the 
tlme period or by the number of dually eligible involved. 
4. 	 Because the study represents  only one perspective  on the 
situation,  it may identify problems  and solutions that would be of 
dubious merit.  For example,  same of the consultant  pharmacists 
cite lack of drug monitoring  through  lab tests.  However,  this issue is 
open to dispute. Some physicians feel that clinical and physiologic 
indicators  are more useful. incur less pain and cost for the patient 
and that lab tests are necessary when there is a change  in the 
patients  condition or treatment  plan. rather than on a se? 
calendar  schedule.  Regardless  of the merits of the case on either 
side, the dentification  of polii  problems  and solutions would  be 
enhanced  by such a debate among al  involved  parties. 
E - 22  AAHSA  Comments  / Recommendations 

October  14. 1997 

Page 5 

. 	 Given the above criticisms of the study, it is hardly necessary  tc comment  on 
tne substance  of the report.  Nevertheless.  It is lmootiant  to Dolnt out some of 
the hazards with the current write-up of the report. 
1. 	 P.8:  Such general  statements  as, Pharmacists  believe  that 
nursing  home  patients  are experiencing  numerous  adverse 
medication  reactions  as a result  of inadequate  monitoring  of 
medications...  are dangerous  because they reflect  penonal 
opinion only, do not state what percent  of pharmacists  actually 
believe  that. whether  they think that statement  applies to 100% of 
NF patients  or some lesser amount,  and draw conclusions  about 
relationships  that are not supported  by data.  A pharmacist  would 
likely see cases of urinary incontinence,  depression,  delirium,  falls 
and constlpaiiin  among  nursing facility residents  as she would 
among a comparably  aged population  living in the community. 
These conditions  occur relatively  frequently  in the elderly, 
regardless  of drug regimen.  There are many contributing  facton. 
This particular study provides no basis for concluding  a cause and 
effect  relationship  with drug prescribing and monitoring  as the sole 
(or major) causaiive  factor. 
2. 	 P.8: The percentages  following  the 8 problem  statements  reflect 
the percentage  of pharmacists  that thJ& the problem  occurs 
sometimes  or often,  not the frequency  of cases where  the problem 
actualfy occurs, but that is not clear in the Wteup. 
3. 	 Throughout  this report there are statements  typed in bold, ...the 
consultant  pharmacists  express concern....,  ....are also problems 
according  to consultant  pharmacists,  Pharmacists  have serious 
concerns  about.... but it Is unclear what percentage  of 
respondents  reported  a problem or how frequently  they observed 
a problem.  Citing the specific questions asked and the 
percentages  of responses  might help clarify these points.  Far some 
issues, it might be reasonable  to expect  that each and every 
pharmacist  that observed  even one Event X ought to be 
concerned,  but otherevents/issues  might not be that critical. 
. 	 Because  AAHSA concludes  that thii survey has no value beyond vague 
impressions  and opinions, we do support further, data-based  study of some of 
fhe issues discussed  because they do raise questions  about quality  of care 
and the need for better communications  among involved  parties.  Also. the 
E - 23  AAHSA Commenrs  / Recommendations 

October  14. 1997 

Page 6 

study ought to reflect  the roles apd activities of the various parties involved  ir: 
the caring process as well as those of the consultant  pharmacists,  since there 
are legally  defined roles, responsibilities  and relationships  that are involved 
and must be considered  to get a full perspective  of the situailon. 
. 	 AAHSA does not believe  this survey provides an accurate  basis for 
consideration  of policy changes  or new regulatory  requirements. 
A Pharmaceutical  Review  of Selected  Texas  Patients,  OEI-06-OQWQ 
 	 This report does not explain how the sample  of 254 nursing home patients 
was selected  for a desk review of their pharmaceutical  regimen,  and the 
report states that, We do not generalize  the contract  pharmacists  findings 
to encompass  all Texas nursing home patients, choosing  instead to present 
the findings only in relation  to the 254 patients reviewed.  AAHSA agrees  that 
the findings apply only to the sample  of 25.4 residents  and questions  why the 
OIG then uses this study as the basis for making policy recommendations  for 
regulatory  and programmatic  changes  on a national basis for an assumed 
national problem.  There would be significant  costs nationally  associated  with 
some of the recommendations,  but the costs could hardly be justified by 
problems  identiied  in a nonrepresentative  sample of 254 TX patients. 
 	 This repoft is valuable,  however,  because it includes some of the cautionary 
language  and qualifications  necessary,  but lacking in the previous two 
reports.  These subtle distinctions  are cruc*~ll because  they highlight  the 
uncertainties  of practicing  medicine and prescribing drugs for the elderly 
and the need for direct clinical involvement  and medical judgments  on a 
case-by-case  basis in order to provide the most appropriate  care for each 
patient.  For example, 
1. P.8 As with any medication,  one should be aware that some medical 
situotiins  might warant  the use of these [Iii  of 20 drugs geneKllly 
considered  inappropriate  for elder!y patients by a panel of experts] 
drugs. 
2.  P.8 ...contract  pharmacists  identified  patients taking medications 
potentiallv  contraindicated.......  [Emphasis added.] 
3.  P.9 ...the need to balance what could be inappropriate  medications 
against the benefits of relieving  or treating  diieoses  which warrant  such 
E - 24  hAiiSA  Comments  / Recommendations 

October  14,  1997 

Page  7 

usage  For ?he enhancement  or maintenance  of an individuals  q~rolity  of 
Ilfe. 
4.  P.9  -records  indicated  other  adverse  effects  possibly  caused  by 
medications.  [Emphasis  added.] 
. 	 Despite  the  limitations  of this study,  it does  raise  concerns  and  potential 
problems  about the  consultant  pharmacists  reviews and their relationship 
with the full patient care iearn. including  physicians,  nurses and aides. 
AAHSA suppork  the essence  of the firxt recommendations  on p. 13. with 
emphasis  on further study, education  and approaches  to encourage  better 
communications  and better practices within the NF, rather than the 
imposition  of new requirements.  Regarding  recommendation  #5, there is 
insufficient  data to support the need to maintain all patient care records  in 
one  spot  in the  NF.  The  opinion  poll  shows  89%  of consultant  pharmacists 
have no difficulty  obtaining  a patients assessment  and 97% report no 
problem  getting  the patients  plan of care. 
1. Any further  discussion of the issue should include a multi-disciplinary  team 
of all care givers having any role in using the records in order to balance  all 
needs appropriately. 
2.  These studies provide no justification  for imposing new, national 
regulations- the nature of the problems  are not thoroughly  understood.  all 
part&s  involved in the NF should be involved in the analytical  process, and 
the costs and benefk  of alternative  policy options have not been analyzed. 
E - 25  E - 26 
 an increased  use in ardiac  ad  cardio=nculardmgs  as well.  ~+~&on  i3 also mope aggnxsively 

identified,  diagnosed,  and @cated in the musing home ting  The cower and S&X entidcp-ts 

are clwrly  aIs0 much mm  expcnsiw.  Wi  mgad  b itions,  more patkots  ae  t2anrfkvd  f?om 

acutm hoepitai stays into the long term setting who rquire  atibiotios,  cad, additionally,  residcntr  may 

bcmo~~~bctnrtedfori~eestioabin~cl~PrrmseetingnthuQnk~sfenodtothc.wu(c 

hospital setting wha  al immuncnt  infbajon  slim. 

E - 27  ~DDlTlONAL  COMMENTS OF lXL%MEnIC~  MEDJQ$L DIRJXfORS 
&%OCIATION ON OK  -m  ON FRESBRTON  DRUG USEM 
mm 
October6,1997 
OIC  RQQ4olf - u  cri  tie  D 
3h7trodu  on il8saI 0 
AS noted in Dr. L.awtrOrmcsover later, AMDA is extremely wttaxned  about 
inappropriatewe ofprcscxiption drugsthat result in poor patientoutcomes and 
hospirstintian.  Ad an ofgattitatioa, wt enck8wr to f&c the 6tadard of practice in long-
tam cam settingl by eduation prognnrs tlut are devutedto rippru+ate w  use, as well 
as xrticla in ourjournul,&&&%xnc  Modkine.nK_Anlulo~Tsrm  C!ML Ws 
also provkie instru&n  on mtc  drugUK in our m  to c&ify long-term cart 
mcdiiol dii~.  In addition, ni&y ofour40 state chptere  kvc  provided  eduatiorul 
pgt3m  on appropriatedrug ust in the elderly. We arc well aware ofthc unktunate 
outmmci that may result barn tbc use of drugs that are inappropri8tcor not mediclily 
nccwMq. 
Wt a~, tier,  mindfid that the cornerstoneof nursingfiwility mform is individualized 
are plmnin(l ad  tmdmeut ofacb  individual ruidcnt  While drug guiddinea  are very 
useful. in individual circumstancesphysicians may prwxibe drugregimens that vary 
6om the guidelines but are, in N,  the optimal drugtbaapy fw that indkidual patient. 
You may wish to mdudc in yuur diissian  of OBRA the fact that the Resident 
h~SSft5~t  InsbumMt/Midtnum D8ta set (RAI/MDS) tqWWats OBRA 87s focus on 
e~sufhtg that every toting  facility rwidcnts individualneeds are met. Futthamon, 
0BR.A  87 requiresthat mu&g facilities provide servicerto ensurethat acb  resident 
chicva bir or bu highest pradiable  phyaioal, mental, snd psyohosocial wdf-being. 
Tht mquirtmaIts br iodivldlmlii  cart plans as well as cue and savicu  to achim  the 
raidcnts highest pmctiab!t  well being may all k&a&e  the cowse of drug  thwapy in 
wliystwsnaydeviwehrIlr%mltkamarpgroach. 
E - 28  Residents. Archives  ojInremlMedicine,  Vol.  151 (Sepr  ;;;I),  pp.  1825-32  It should 
be noted  that  although  the drugs  listed in Appendix  A include  many  that  most 
goriatrickns would avoid  in tmxtiag  elderly  patients,  then  was some  contmvemy  in the 
medical community about  the a&k,  particularly  about the Delphi  method used in 
rraching its conclusions.  A review  of wmmenta  and Iettm  to the editor  following 
publications of the articlecould provide  some  context  for the contmversy.  The list of 
inappropriatemedications in nursingfacilities should be made with  a broaderumsensus 
and revisited paiodically. 
Findiaru: 
 	 LOtcthe OIG, AhIDA is ctmcarnedthat prescriptiondrug payments for dually 
eligible Texas nursing home rcsidantshave increasedrapidly, rising by 20 percent 
from 1992 to 1994. 7he data fktn Texas is consistent with rqwtts &om managed 
m  c~niplni~  ho&a&  and patienta.  The cost of drugs has clearly risen rapidly, 
Pndm~ynew,vny~edrugrhPveoamtonthtmsrhIntheputfourtotivc 
ytam  Conmrttntly, with the dwtd  emphasis and attentionon providing the highest 
pncticable &n&onal IevcIand quality of Ii&,the typical nursing facility taidcnt  is 
ndving  much ma  medical attention and msbnart th8ninlJlcpt 
 	 Regarding increased drugusa, M noted in Dr. L&mmes  l&a.  it is nut unexpected 
that  an inctuae in the use of cardiacand ca&ovasadu  drugs would occur in the 
nursing hcllity setting Thereir nowgoodevidence that more qgrcwive  tmaiment 
of amgutive  heart failure(CHF) anhtnces @ii  of life and deaesw  tpitodts of 

acute aacebuion  of congesriw haastMurc, therebydeacasing cpiaodca of 

hospitalization. A comstont ofCHF is ACE inhibiin,  rquiring a relatively 

upcnsive  class of hugs.  In tdditlon the canplicrrioM nswciatcd with isolated 

systolic hypertansid in tba ddcdy may bo rcducul by more ag@%siYt(rertmeat of 

tltvatd praaams, the&y  accwnting for m imxaascd UK in cardiac and 

cardiovasashu drugs as well. Dapression.is aiao being more aggnkvcly  identified. 

diagno4,andtr~adinthamxai~homeMtin&tk~and&k 

antidcprrJ#atr UC clcatiy much more qensive.  W& regardto infkctio~  morn 

patients who M - &canuuta bmpitti ttayr into the long-tam cart terrings 

rquke8M+Xkd.  Add&nally,reskk&maynowbemoreapttobCtPat0dfo~ 

infbai~~~~~~cm~cbma,betrrpidimdtothc~cbolpitll 

MtiOgWhUlint- i&c&m  date.  Pltrthermare,in tight ofOBRA 87s 
rquiremm  to ptwkk  etavices to achicw the residentshighest pmctkable well
kin&physiciMHouldhve~diftlcultyinlimiting~gtknpi~t 
ultiinftctives.  ardiac linlgi$ 8od 8tltacpalus  ifthey an lncdidly  qpfqb. 
Iheaarhstrmrll~ddnrg~~forM~ingmqjoriCyof 
pfwdptb~ittitoousinmoattratdtduitmtdicint,nfl~~ww 
tkrapiet.  high demand, end high prtdanw  of gstroinbcrtinJ. tiiovssFul~.  ai 
pychiatric problasnain tk  nufsing fMlhy poplhdon. 
E - 29  3 
inappropriateness  is subject to considerable &erp~tation.  See comments  above 
regarding the lead article apparently relied upon to detmine  appropriateness 
 	 &garding  drug costs, we note with intere.st Table 5, which reflects the percent 
change in tots1 Ixnefkiane~ receiving prescription drugs and total payment  for five 
drug dassifications.  Clearly there is a vast discmpnncy when the percent of 
btneficiaries  rccciving  gamointestimd  prepamtio~  haS inaeased  1S.J%, while  the 
CoSt ha9 f&n  93.5%; or witen the percent ofreSidentS  receiving  psychotherapeutic 
dfuga has incrcascd nearly 1OTTbut the coat has inwed  nearly 92%  The other 
categories  ofdrugs  show similar,  although  slightfy  ksa chmric,  trends.  This vaat 
incmae  in drug payments raise, ~hc question of what stab  may be doing to amVol 
the cox of there drugs. 
The draft report ootes that total prescxiption drug payments, average paymsntr  per 
 	
day, and average payments per beneficiary vary widely by Texas nursing hility 
AhIDA canam  with 010 on the Mcd to fiuther analyze variables such aa size of 
facSty,  Qoility type, severity of illness,  types and mmbsre  of ocher actvices.  We 
recommend  epecific focus on patient aarity. which we believs has incrased  in recent 
years.  We note that varinttonr have been observed in medical treatments,  procedures. 
end prescribing  throughout many EMS of he&h  care services, e.g., TVRPs and 
hystertctomies.  Ongoing efforts to u&rat&d  and address thiq variability are highly 
desirable. 
RoMQjm&#&& 
- AMDAcrgrceewiththe  rewmatanjation  that HCFA should wntinuc  to monitor  and 
tneotnage  rcductiw  in the us0 of inapprc#ats  ot poorly &+ctive  prescription  drugs 

in the eldaly  population  We also agree that at the facilii  kvcl, survey~n, 

consultant  pharmaoi~ts,  and physicians  should be reminded of the d-s  associated 

with such drugs and dirccted to aaively ve  a rtduetion in their use.  We also 

amcut  that  eimilar anaIyais of data 6um additional states shouhi be undertaken to 
furthe  assess the extant oft&. contimted use ofthese  contraindicated  drugs.  We do, 
however, we ravotmtnd that a fwma  definition of 07G use of the terms 
QmtnindicataY  er(d incff&ivt  be adopted, in orda  to fbcilitate uniform rcvicw. 
It is important to note that inappropriate and oontraindiuted  art not rrynonymv~~ 
turns  in medicine.  Wedsu suggest that the list of inrpprophtt  drugs should be 
stratifled with emphasis on drugs that IUCthe most likely offendeN  and have 
rtuonablc  olternadvt  tmrmm.  We temtnmtnd mllrbontion  behwen  HCFA and 
pro&a&ma1 organizationa to publish informatios  whisb AMDA codd  publish and 
disseminate. 
significant  increase iadmgcostsisofunivcrwlintecewfbrpati~~ 
 	  
physicians;  it should be reviewed as an &pervasive  iwe,  not as peculiar to n~rrin8 
facitititi.  Consiiaation  of chug we and coats in mxsiug facilities done porcr the 
danger of enating  an inf&,pturdird  ofprescribing  fbr nursit@ hcifi  patients.  We 
do qpreci~e  the01%~ oollcern &r inudng  Me&aid  costs, but UI appropriate 
appmaeh  may be fm tba Mediaid  -to  fmur  the diqnv@iMute  increaSe in 
E -30 
 4 
their cotis  beyond  what  is explainedby increased  use. increase  in beneficiary  use 
would  szem  IO warrant.  We do not believe it is necesauy tu single out certainrypcs of 
drugs  for review  as to medical  rIecesrity.  It is AMDA6  position  that  all mcdicationz 
ordered  should  be medically  necessary. 
 	 We agree  with the OIG that iiutha  study should  examine  data  about  resident 
conditions (pwticulsrIy severity of illness. IISnoted above), types of specialized  are 
and o&ex facility-specific  chnnderitics,  along with  drug  usage  end expendituredata, 
to better  undentmd  the factors contributii  M wriationr  between  nursing fkeilities  in 
the costs of prcwiptian drugs by rcridents. We rlso suggest analysis of resident 
essessments to pin  fxtter unda-stsnding of the individual f&ton that may influence 
mediation  choicq CIHaInalysis ofwiwthti,  in the case ofquestionable  mediation 
regimens, othermoir traditionalregimens had been prcscnbcdand then diaarded as 
not efTdw  in a pticuhu  patient. 
Qpnaents  on OIG Reuort - PrescdpQiOPPLYP Use M 
Omnibus I3UdgetRccaaciiiation Ad of 1987; This section should include (Ldiscussion of 
OBR4 37s fodts on individualized assessmans and cwz plan requirements,as well as 
its rquitwnents to meet the nsidentt highest pm&able  well-being, as disatssed above, 
due to the possible impact those rqukements may have on drugtherapy. 
Oronibw Budget ReconcilictiofiAct of 199@T?u summuy in the OK reportdoes not 
mention that the OBRA 90 8mendmentr8pociFythat the phmnrCiStmust offa to 
cotJm?eplatklrt QrtheiraradYa% (eqhllsis  ad&d) on dimctiornand pwautions  fbr 
Prcpupias~-~-;  eommenadme&dsmdthecrpeutic 
compliations,  properstonge, ete We amme  that for mrning facility patient+ 
~~3  would efkr to the Rining &of  the nwsing facility. 
physicians Dutermiaekhnt is Approprirrtfci r
 Ex41 Petkt:  AMDA is plused to see
010 mccgnition otthe fist thatit is the patlentsattatding physician or the facilit$s 

medial  dllor  do  dotumirie ti  is appropriatecue, including prewiiing 

mediations  to meet paiems needs. 

E-31  J 
When con&ant  pharmtins  have decided to i&rm  the medics1direaor of 
irregularities,medical directorshave not found problemswith the Brmat in which such 
repmts arc made  We feel that it would be burdensomefor physicians to be requiredto 
include with their ordersa medical outcome equtation  for each prescribed medication 
For most drups. the expectationsJhould be quite clear fromthe petient record. For 
example, a paient with taminal cancer who is raeking  a MC  analgesic patch for 
pain contrvfwill p&ably  need mcdic&ms  for amsripation and nause.ztc,ommon side 
cfTe35 of the anal+2  regimen. Anotk  common exam&  is the usu8l need for 
potassium supplemsntutionfbr pati- receiving loop diuretics. 
Regarding notice of rccepuncc or rejectionofconuultm  phannacistt concems, WI: 
expect that would be addressedin the notes from the next regularphysicians visit to the 
patient. Careshould be taken not to create an additionalpaperworkburden for medieal 
and ntthng st&Tin respondingco those con-6 
&&I&& 
Qudity ofcarehua: 
   notedin the report,the pclwrlenecof signs and symptoms of various diseasea and 
gdtric  uypdtomw present in this pop&ion  are easily confused with adverse dnzg 
redCti0mt.It ropuircrthe diqn08ir 8ndj&ma6  cf 8 physician to di&nntiate  8 
cause and dfca  dationship utd advise I patient on the risk/bcacf~ of any treatment. 
This entire subject should not be addnaeed without physician input. 
  Apppropriuause and monitoringof medication in a nursing facility population is and 
aluayswillbeimportmt8dditRcuk  lkbestproce36forthisicacyet 
undiscovered. A combiacd e&t  amongthe interdisciplinarytwm, including the 
physician and medical dir&or, scans ideal. This, howwer, rcquireearpanded roles 
and finding far this wurk, 
E - 32  6 
less likely to create a need for inves:atif$ possible abnormallab results, which may 
be very expensive and wonisome and yet produce no real benefit to the patient. 
Shortcombs  of &&atiQn8evicws: 
   note that thatwell-unX~edandorganizedmedical recordsoverlapbetween sites of 
service and present a majorchallenge in every a~  of health care. 
 	 Regardhg the OKs findinga that residentmedication recordsare often incomplete, 
making it difficult or impossible to dearly ideMy  or co&inn potential drug regimen 
problems, AMDA obaer~  thatthis is a 00mple.xproblem. Many patient8have 
problems thu evade precise diagnosir and me  problemsthat fit into many 
ategoriea, and those tdtdd  be noted in the progr~  notw.  In nuny other aspects. 
the 010 finding@r-sent  a systems problem that is beyond the control of either 
medical direc&xsor attendingphysicians. 
a 	 AMDA~thatHCFA&uldcaainuetomonitorand  F)IEOW(Br~e duction in rho
use of codmindiated  presa+m  hs  in the cldaly nursingfacility population. 
We reiteratemu requestthat the terms amtraindiatcd andinappropriatebe 
defined, in orderto enrun unifizm interpretation 
 	 AMDA rgrew stronglythat HCFA should identify and analyze the reasons for rapid 
escalation in costs and claims for cdc(riatypes ofdnlgs used in nursing facilitiw. 
While the increawd use ofdltqp amo@ reSidCNsnuy be simply the re3ultOf 
incrrucd acuity of r&de*  ewe mix (e.g. in the ase  of4odinfectives), or 
improTentr  io diagnosis and treatments(as in the ca.~ ofantideprtssants), and may 
be entiretyappmpriat~ the weaih  in drug prices aeenlad@CQOdOoO~Cto 
the iacrease in drugw,  and chuukl be fevicwsd.  ltatds  in nursing ticility 
prescriptiondrug UJC#ho&dbe comprrcd arithnational&a  on praaibing  and coats. 
E - 33  +bcd,  and requiringphmacim  to tttomturL.  .:.ese apcctations.  AS noted 
above,  general  clinical  e~pcctations  will be ckar  in the cue  of most medications.  If 
a physician is using a drug tn treat a condition other than that for which  the drug  is 
normally  pmcribed.  it is reasonableto expect  that the physician  should  clarify  the 
condition that the drug is expected to treat. 
AMDA sgrccrrwith the recommendationto requirenursiq  facilities to provideon
goin& in-&cc  training for personal csre aaff(CNAs)  on recognizing behavioral 
JY?f@Omr  Of Cotmhldi~rIS,  EdverselemSioo6, or inappropriatetcsponscs to 
mediations.  CP& ure the fiunt-line of nutaing home carq and their &stance  in 
recognizing aymptams of medication pmbkms could gra%lyenhance the qualii  of 
rwkient care. Fimt, howaver, there should incrwad  fund+  for rtlffrnd continuing 
educltioa dfbrts to enhanoaiqtaaaions  betw~~ the physicians, pharmacists.and 
facility StafE tt would not be prudentto trainnurseaides to look for medication side 
~saschrtPehardtodisMlradi~evar.fortnincdpfryridansmd
.
phamlaa&without  ifd  pmasa andstntc&e to ~WUCthat physicians and 
pharm8cistsueaiready wnuhuade  among tkriudvw  about these issues. To 
train nrrx &a  withuut hn(:easuriag that the physloian-pharmacistiii  Is wrking 
ffb ctidy  would  be disrupti~  to patient cate and okall  oonfidence in a nursing 
ZWlity. 
w  Rqaiding  the recummettd&n concexning medicA records,AMDA  believes that 
! 	 medical recordorg+mtion  and availabili  should be drivenby patient care needs 
and net convenience. Moatmending phyddana have faced exactly the same issue: 
ready awus  to the entiremalical rexxm%However, we rsagnk  that goad and 
acceaaible patient care is at rtake  This pbblems wuuld need to be addressedby a 
collaborative efftxt ofmmdng futility tia  medical directors,artendingphysicians. 
andph8tmaciSta. 
.
Cornmeats  on OKGRwort  - YPrcs&Hion  w 
~adlities:  AJI Inside  View bv CousultantPbrn&&  (CN2~&XJ81~ 
h&d&~&:  This tidy  qpan  to be a totaNyaubjectiw survey thu is not bnsaI on 

ehwtnvinv or say otherevidanc~baseddmu For that tuoq  WCqwtion  the weight 

that8houldbc&8nt0thkmp0tt.  WCwommcnd  that the OIG not publish this rrport 

but rdy inrtaadon the evidenc&mxd  repat hy mated  pkmaokt  reviewers. The 

fmdiad, of tbia su~dy are itttarr(ifig. but may be more rpproprirtefor a pharmacists 

punulth~furraportbyaFedadrgaacy.  Pu~tbisrepottcarldcrrrtca 

pnccdcnctbrta*a)lgroppothahhclte~onalsm~~ondre~~cntto 

commission a reporton how they might betterMfiU their statutorynzipowibifhier. 

E - 34  8 
on generalized  impressions  and not on actual  data  or actual  chart  review,  it is difficult 
to respond to them munh@blly 
-	 Notwithstanding the non-factual  basis  of the survey,  we observe  that respondents 
noted  a wed  for geater  monitoring  of cwttinued  nml  fbr medications,  and 
monitoring of potenblly  toxic drugs. Any focus on increasedlaboratorymonitoting 
should be coordinatedwith PartB carrias, to ensure cwcrage of appropriatetests. 
 	 We note that a numberof con&ant  pharmacist8assessed the extent of coopaalion 
6um  tridents  panonal physicians as only t%ror povr. One aspee of this feeling  of 
  appear& tv be that w~ltant  pitumrci~  wefe disturbedthat some 
physicians do nvt take their cv-l  Kliourly 01 avt prvmptlyon their 
rmommendstions.  Many pharmtiDtr colnpl&ed  that phy$icians only  or never 
seek their help rqarding appmprirtemedicuions vr properdosages. physicirns in 
long&um care settings use wnsukant phartnacb  as  That is, physicirns 
cdl on wnsult~nt phunucists when ph+ians  want additivnal infbrmrtivnon 
medications. Mast of the time, phyaiciaaado not need such wnsultant serkes. 
Cleariy. cwpwatioq  with appropriatewuwtmettdadona ftom wnsultant pharmacists 
ia imqmtmt, and the mwriug ftility  medicaJdkctvr  is in the best position to secure 
that tmvptdm.  AMDAs wnvlusivn seems to bc bornevut by Table 6, which 
shorn  that 7 I .4% of tmpvndents consideredthe -on  bawem  the consulting 
pharmacist md medical directorto be gvod vr vay gwd. 010 should rewmmcnd 
that HCFA clvsc tbs fbedbackloop in wnNtant  nursingfrelity drug tevkwo by 
ma&ting  tbrt the me&ad dimctvr nvt vniy be informedof conema  and 
rewmmcnduians,  but tJmttk medical dinxtor vwxscc the rcvi~s  by tic wnrttltant 
pharmadst  Such a change would rliow the medicA dirstar (0 mort etktivsly 
monitor the medidpractke  of attendingphysicians as well as coordinate resident 
oare. 
Shvttcomings of Medication Reviews: 
0  Once  rgain,  given  the anecdotal  nature  vfti  ~cvcy,  it is diicuk  to hwe  sufficient 
infvmmiivtt on whiob tv haso cutnmamx Fopuamplq  33%of -tits  indicated 
thattJwyhnddiffiadtyinvln8iithcprtirpt8diagnoais.  SinwtbcOIOrrport 
wmctly  vbsma  that in&muttivn on dinprir  should be in the patkntr rccard in at 
last  Mn of three places (the MDS, the p&lltn  pemonal aaae4ameJlto,r the plan of 
are).  it seems edmacly  udiily  that a diagmsir would not be found in at Icast one 
of thvr  places. iRaf CalIsinto quesliva the validity of the rrpars 0Tat best. makes 
interpntdton vf its f&dings exucmely epecuJatiw. 
E - 35  9 
  Same  respondents  voiced  strong  mwxma  about  limitations  on their  professional 
authority  to enforce  OBRA  provisions,  F&ral  and State survey  and   
agcnci~  have  been  charged  with  enforcement  rwponsibiliriss,  not consulfanl 
pharmacists.  It is cxtremaly  unrezalistic  for consultant  pharmacist  to imagine  that they 
could   should  be able to mrmre  a Facilitys  or physicians  adherence  to OBRA 
provisions.  or  guarantee  that the nursing  staff properly  administer  medications 
demonstrates  a lack of comprehension  of the appropriate  roles of various  members  of 
the intexdisciplinary  team 
y 
 	 &DA  strongly  endorses  the Ofts  recmmendation  that medical  directors  should 
always  be informed  when  pharmacists  have patient  me&&on  concertx.  Such  notice 
to the medical  diior  is not currently  required  by HCFA  regulatiorw.  ti  nowf 
above, WA  bclim  th81 notice to the medica!  direc%or w&l  improve 
complima  with  appropriate  phatmaciats  recormne&atioos. 
E - 36