I Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

PRESCRIPTION DRUG USE 

IN NURSING HOMES 

Report 2 

An Inside View by Consultant Pharmacists 

JUNE GIBBS BROWN 

Inspector General 

NOVEMBER 1997 

OEI-06-96-0008 1 
EXECUTIVE SUMMARY 

PURPOSE 

To describe consultant pharmacists’ concerns about drug usage in nursing homes and their 

perceptions of their responsibilities for medication reviews for nursing home residents. 

BACKGROUND 

The primary goal of drug therapy for nursing home patients is to maintain and improve, to 

the extent possible, the patient’s functional capacity and quality of life. The Omnibus 

Budget Reconciliation Acts (OBRA) of 1987 and 1990, in recognition of this, require the 

regulation of certain drugs in nursing homes and the establishment of drug utilization 

review programs for nursing home residents. Provisions of the OBRA 1990, while not 

required for all nursing homes, also clearly establish Congress’ desire to involve 

pharmacists more actively in patient care. 

Broad oversight of the drug therapy requirements for the nursing homes is performed by 

consultant pharmacists hired to perform a monthly medication review for each resident. 

As such, these pharmacists are a valuable source of information. To take advantage of 

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

stratified random sample of the 17,000 nursing facilities. 

We undertook this inspection, using three different approaches, to provide insight into 

several issues related to prescription drug use in nursing homes. These issues are 

addressed in three reports, of which this is the second. This report presents the results of 

an in-depth, structured mail survey of these consultant pharmacists. 

The first report, “An Introduction Based on Texas” (OEI-06-96-00080), describes 

prescription drug use in nursing homes based on Texas data. The third report, “A 

Pharmaceutical Review and Inspection Recommendations” (OEI-06-96-00082), discusses 

results from an independent review of drugs and medical records for a sample of Texas 

nursing home patients. Recommendations addressing the issues and concerns raised 

collectively by all three reports are located in the third and final report of this inspection. 

FINDINGS 

Oualitv of Care Issues 

Overall, pharmacists tell us they and the nursing homes are complying with the law and 

regulations related to medication reviews of nursing home residents. However, problems 

and concerns raised by the consultant pharmacists indicate that legislative and regulatory 

intentions to assure high quality pharmaceutical care for nursing home residents are not 

yet fully realized. It is important to understand that reports of possible “inappropriate” 
use of medications are somewhat a matter of opinion. Ultimately, for nursing home 

patients, it is either the patient’s attending physician or the facility’s medical director who 

determines what is appropriate care. 

According to pharmacists, patients are experiencing numerous adverse reactions as a 

result of potentially inappropriate prescribing and inadequate administration or 

monitoring of the usage of medications. 

Adverse reactions reported by consultant pharmacists as occurring sometimes or often 

include constipation (reported by 81 percent); falls (66 percent); delirium (41 percent); 

depression (39 percent); and urinary incontinence (26 percent). 

Pharmacists have serious concerns about prescribing practices for antipsychotics, 

anxiolytics, sedatives/hypnotics, antidepressants, and other drugs. 

Because legislation prescribes certain limitations on antipsychotics, anxiolytics, and 

sedatives/hypnotics, there is concern that from 21 to 44 percent of pharmacists report 

some patients are receiving medically inappropriate prescriptions of these drugs. Other 

drugs, not necessarily legislated for scrutiny, which also seriously concern consultant 

pharmacists include H2 antagonists (reported by 65 percent); non-steroidal antiinflammatory drugs (47 percent); narcotics (46 percent); digoxin (40 percent); antibiotics 

and anti-infectives (39 percent); and gastrointestinals (36 percent). Moreover, according 

to 15 percent of the consultant pharmacists, some physicians are prescribing medically 

inappropriate antidepressants. One-third say antidepressants are sometimes prescribed 

without an appropriate diagnosis and that few or no physicians ensure their maintenance at 

appropriate levels. 

A number of medication administration problems which may put patients at risk also 

concern pharmacists. 

These include absence of specific usage directions; incomplete orders; failure to update 

medication administration records with dosage or schedule changes; physicians signing 

orders that are not current or correct; failure to include orders on the medication 

administration record; misplaced medications; and continuation of a medication in 

disregard of stop orders. Further, medications are sometimes administered by nursing 

staff at the wrong time, in non-optimal dosages, for inappropriate durations, or the 

medication may be inappropriately altered (crushing, dilution, etc.). 

Shortcomings of Medication Reviews 

While all consultant pharmacists report they conduct monthly drug regimen reviews, their 

responses indicate some serious shortcomings in the quality and thoroughness of reviews. 

ii 
Pharmacists conduct some reviews without consulting important medical records and 

without having patients’ diagnoses or laboratory reports. 

More than half of the reviews do not consider the resident’s assessment (65 percent) or 

plan of care (56 percent). Other records not consulted by pharmacists include facility 

incident and accident reports (20 percent) and specialists’ notes and nutritional plans (13 

percent). Fully one-third say they have difficulty obtaining a patient’s diagnosis and 

necessary lab reports. 

The results of drug regimen reviews often are not documented in records readily 

available to nursing home staff. 

While one-third of pharmacists say they document medication reviews and related contacts 

in the patients’ medical records or medication charts, many do not document their efforts 

in records most accessible to nursing home staff. 

There is an apparent need to strengthen pharmacists’ relationships with patients and 

direct care staff and also their performance of educational and counseling activities. 

Many pharmacists have no contact with patients or their families or with nurse aides in 

their conduct of drug regimen reviews. Also, over two-thirds report not providing 

education or training for either patients or their families or guardians; nearly half do not 

provide drug education for nurse aides or medication aides; and, despite the potentially 

critical interaction between diet and medications, most pharmacists have no contact with 

the facility dietitian. 

RECOMMENDATIONS 

Based on the concerns raised in this report, the Health Care Financing Administration 

(HCFA) should work with the States and other responsible entities to improve the 

effectiveness of medication reviews for patients in nursing homes. Recommendations to 

accomplish this are provided in the third and final report of this inspection, “A 

Pharmaceutical Review and Inspection Reports” (OEI-06-96-00082). 

COMMENTS ON THE DRAFT REPORT 

We solicited comments from agencies within the Department of Health and Human 

Services which have responsibilities for policies related to Medicare and Medicaid and 

long term care. We also requested input from several national organizations representing 

the interests of nursing homes, patients, or providers. We appreciate the time and efforts 

of those providing comments. 

Departmental Comments 

Within the Department, we received comments on the draft reports from the Health Care 

Financing Administration (HCFA) and the Assistant Secretary for Planning and Evaluation 

... 

111 
(ASPE). Both agencies concurred with the recommendations; HCFA emphasized the need 

for further studies to assess the extent of continued use of potentially inappropriate drugs, 

other avenues of possible cost savings related to drugs, and the need to determine and 

understand the potential sources of the escalating costs and claims for certain types of 

drugs used in nursing homes. The final reports reflect several clarifications or changes 

based on their suggestions. The full text of each agency’s comments is provided in the 

third and final report of this inspection, “A Pharmaceutical Review and Inspection 

Recommendations” (OEI-06-96-00082). 

Comments from External Organizations 

We also received comments from the following external organizations: American Health 

Care Association; American Association of Homes and Services for the Aging; American 

Medical Directors Association; American Society of Consultant Pharmacists; and National 

Association of Boards of Pharmacy. Most of the associations concurred with one or more 

of the recommendations within each of the inspection reports. All comrnentors support 

the need for better communication and coordination between nursing home staff and other 

healthcare providers, training nurse aides, and understanding the implications of nursing 

home medication services and associated costs. 

Several organizations questioned the methodology used in this inspection, particularly for 

the consultant pharmacist survey. However, as with any evaluation, there are always 

some limitations in how data and information can be obtained, given time and other 

resource constraints. Further, while we acknowledge that a survey of this nature 

introduces some bias and subjectivity, we also believe that the survey of consultant 

pharmacists provides us with an up-close view of what is happening with prescription drug 

use in nursing homes. Moreover, the results of the consultant pharmacist survey are 

consistent with our results from our two other methodologies. 

Some comments expressed concerns about the use of the term, “inappropriate.” As 

explained previously, use of this term in reporting concerns with a patient’s 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 physician’s role 

for nursing home patients’ medication regimens. We felt that further examination of this 

area is warranted before recommending changes which would impact so many entities 

involved in the process. 

In conclusion, we believe the three reports collectively, and each using a different 

approach, strongly indicate that the intent of the provisions of the OBRA Acts concerning 

iv 
prescription drug usage are not being clearly fulfilled. Further, HCFA has authority to 

correct and enhance quality of care for nursing home patients. The recommendations we 

present attempt to facilitate the initial steps of this effort, and to address some concerns 

evidenced in the reports and received comments. While we recognize that great strides 

have been made to meet the OBRA requirements, we believe further effort remains by all 

the players involved (HCFA, associations and their members, nursing homes, and 

residents and their families) to further improve quality of care for nursing home patients. 

The full text of each organization’s comments is provided in the third and final report of 

this inspection, “A Pharmaceutical Review and Inspection Recommendations” (OEI-06-96-

00082). 

V 
TABLE OF CONTENTS 

EXECUTIVE SUMMARY 

INTRODUCTION 

Regulation and control of prescription drugs in nursing homes 

Role of consultant pharmacists 

Physicians determine what is appropriate for patients 

Challenge of prescribing for the elderly 

SCOPE AND METHODOLOGY 

FINDINGS 

Quality of Care Issues 

Shortcomings of Medication Reviews 

RECOMMENDATIONS 

COMMENTS ABOUT DRAFT REPORTS 

ENDNOTES 

APPENDICES 

Inappropriate Medications for Elderly Persons 

1 

2 

3 

4 

5 

6 

9 

9 

14 

21 

22 

24 

A-l 

Consultant Pharmacists’ Assessment of Medication Problems (Weighted Data) B-l 

Additional Pharmacist Survey Weighted Data Tables C-l 
INTRODUCTION 

PURPOSE 

To describe consultant pharmacists’ concerns about drug usage in nursing homes and their 

perceptions of their responsibilities for medication reviews for nursing home residents. 

BACKGROUND 

Long Term Care and Prescription Medications 

Medicaid is the primary public program for long-term care assistance for the elderly and 

disabled. Long-term care is one of the largest and fastest growing needs of the elderly. 

Of the $39.8 billion in program expenditures for care of this population in fiscal year 

1995, 73 percent ($29.1 billion) went for nursing home stays. ’ 

Payments for prescription drugs represent a large portion of Medicaid’s expenditures for 

nursing facilities. Medicaid provided services for 1.7 million nursing home residents in 

fiscal year 1995 at an average cost per bed from $600 to $1000 per year.* This suggests 

that Medicaid paid between $1 billion and $1.7 billion to provide prescription drugs to 

residents of long term care facilities. This could be as much as 16 percent of total 

Medicaid prescription drug expenditures. 

Potential Health and Cost Problems 

Several recent studies suggest that inappropriate use of prescription drugs by the elderly 

creates the potential for serious health problems and the increased risk for wasted 

hundreds of millions of Federal dollars annually in medication and hospitalization costs. 

One study estimated that the percentage of hospitalizations of elderly patients due to 

adverse medication reactions to be 17 percent, almost 6 times greater than for the general 

population.3 Further, an expert panel of pharmacists estimates that the injuries resulting 

from failed drug therapy result in approximately 100,000 hospitalizations and a cost of 

$77 billion each year.4 

According to the Food and Drug Administration (FDA), the elderly, about 13 percent of 

the U. S. Population, account for over one-third of the “adverse drug experiences” 

reported by pharmacists, physicians, and other health professionals. These figures 

translate to 30,000 hospitalizations and $25 billion in costs among the elderly.’ Much of 

this cost is paid by the elderly population, but a large portion of it is borne by Federal 

health care programs including Medicare and Medicaid. Clearly, Federal programs as 

well as our senior citizens are paying the high cost of failed drug therapy.6 

Not only do the elderly use prescription drugs more than any other age population, they 

also tend to be taking several drugs at once, increasing the probability of adverse drug 

reactions.7v8 The elderly may also eliminate these medications from their system less 

I 
efficiently than those younger due to decreased bodily functions. Studies also suggest 

more subtle effects of inappropriate medication usage among the elderly, such as loss of 

cognitive or physical function and the potential for increased falls. Researchers have 

concluded that a number of prescription drugs used by the general population should not 

be prescribed for elderly patients (See Appendix A). Equally effective drugs which 

present fewer risks may be available.’ 

Regulation and Control of Prescription Drug Use in Nursing Homes 

Omnibus Budget Reconciliation Act of 1987 

As part of the Omnibus Budget Reconciliation Act of 1987 (OBRA 1987), Congress 

requires the regulation of certain drugs in nursing homes. On October 1, 1990, the 

Health Care Financing Administration (HCFA) implemented regulations which hold 

nursing homes accountable for monitoring medication usage. lo Significant requirements 

for pharmaceutical care of nursing home residents include provisions regarding Pharmacy 

Services (drug regimen review), Quality of Care (drug therapy), Resident Rights (selfadministration of drugs), Resident Assessment, and Infection Control. Additionally, 

physicians must justify the use of antipsychotic drugs based on specific diagnoses and 

observe specific parameters within which these drugs may be used. 

Nursing Home Patients, Medications, and OBRA 1987 

Each nursing home patient must receive necessary nursing, medical, and 

psychosocial services allowing him/her to attain and maintain the highest 

possible functional status. This status is defined by a comprehensive 

assessment and plan of care which each patient receives upon admission to 

the home and as “substantive” changes occur in the patient’s health status. 

To ensure each patient receives the necessary quality care, the law and 

subsequent regulations also recognize the value of medication therapy by 

defining certain limitations: 

1) patients must not receive unnecessary medications; 

2) patients cannot be prescribed antipsychotic drugs unless they are 

appropriate for a specific patient condition; 

3) patients prescribed antipsychotic drugs will receive gradual dose 

reductions, or behavioral programming in an effort to discontinue the 

drugs (unless clinically contraindicated); and 

4) the home must have no significant medication error rates and patients 

must also have no significant medication errors. 

To ensure these requirements are met, the States and HCFA are responsible for 

performing routine facility surveys. To guide these reviews, HCFA developed “Indicators 

for Surveyor Assessment of the Performance of Drug Regimen Reviews” and “Surveyor 

Methodology for Detecting Medication Errors. ” They also released revised interpretive 

guidelines relating to medication use in nursing facilities which provide tools for 

identifying medication errors, and even include a list of specific drug therapy 

circumstances which may constitute potential drug irregularities. Further, in July 1995, 

2 
HCFA implemented the final step in the implementation of OBRA 1987, new survey and 

enforcement procedures. Changes include the use of new quality of life guides for the 

patient, group, and family interviews; a protocol for non-interviewable residents; closer 

cooperation between the State survey agency and the ombudsmen programs; and better 

information for providers, including information to help them compare their patients to 

residents of other nursing facilities across the region, State, or nation. 

Omnibus Budget Reconciliation Act of 1990 

The provisions of Section 4401 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 

1990) clearly demonstrate Congress’ desire to involve pharmacists more actively in patient 

care by refocusing pharmacists from a product oriented role to one involving clinical 

practice responsibilities for reducing potential drug therapy problems. While not required 

for nursing homes in compliance with drug regimen review requirements (specified in 42 

CFR 483.60), practicing pharmacists are expected to: 

1) prospectively review the patient’s present drug therapy and medical condition with 

proposed drug therapy; 

2) appropriately intervene with the prescriber on the patient’s behalf when inappropriate 

drug therapy has been prescribed; and 

3) as an outcome of their review, counsel patients on the proper use and storage of 

medication and how to alleviate or prevent potential therapeutic problems related to 

medication usage. 

Under OBRA 1990, the State Medicaid plan must provide for a review of potential drug 

therapy problems due to therapeutic duplication; drug-disease contraindications; drug-drug 

interactions (including serious interactions with nonprescription or over-the-counter drugs); 

incorrect drug dosage or duration of drug treatment; drug-allergy interactions; and clinical 

misuse. Thus, OBRA 1990, in essence, requires a certain standard of practice for 

Medicaid patients. While this regulation and the statute at section 1927(g)(l)(D) of the 

Social Security Act preclude any Federal action to expand this law to apply directly to 

nursing home patients, most States have extended coverage to all patients, including those 

of health facilities. l1 One major camp onent of this law, patient counseling, has increased 

both the role and the responsibility of the pharmacist in patient healthcare understanding, 

planning, and outcomes, which, arguably, should be extended to all health care 

environments. 

Role of Consultant Pharmacists 

Pharmacists, through their education and training, should be able to identify any serious 

concerns related to medication prescribing and administration practices which, when 

corrected, yield a positive impact on the quality of life for nursing home patients. Each 

pharmacist’s relationship with nursing home patients requires their refocusing from a 

product orientation (distribution of medications) to that of a clinical practitioner 

responsible for reducing potential medication problems. Both our literature review and 

the consultant pharmacists themselves confirmed that moving to a patient-focused 

3 
orientation has required breaking with traditional dispensing roles and utilizing those 

clinical skills for which many pharmacists are now routinely being trained. This changing 

orientation within the industry helped strengthen the argument for using pharmacists in 

nursing homes to more effectively assist in medication changes which could positively 

impact a patient’s quality of care. 

To ensure compliance with the OBRA regulations, nursing facilities are expected to 

employ consultant pharmacists. These consultant pharmacists conduct monthly reviews of 

the drug regimen of each facility resident to determine whether the prescription drugs 

ordered for that individual are appropriate based on the OBRA guidelines. Consultant 

pharmacists are also required to: 

1) determine that drug records for each resident are in order; 

2) establish a system to record receipt and disposition of prescription drugs; 

3) offer advice and instruction in all other areas of pharmacy services; and 

4) report any irregularities they discover in a resident’s drug regimen to the attending 

physician and director of nursing. 

Some of the benefits potentially realized as a result of the consultant pharmacist role in 

nursing homes are the reduction of excessive medication usage, improvement in patient 

quality of care, and decreased cost for medication usage. Pharmacists may also help 

medical and nursing personnel significantly improve medication therapy for patients in 

nursing homes which, in turn, can help reduce total health care costs,r* particularly for 

those changes resulting from fewer medications being taken, more appropriate medication 

being prescribed, and fewer costly adverse reactions being experienced. 

In addition to detecting quality of care concerns associated with inappropriate medication 

usage, consultant pharmacists may detect potential waste and abuse which can increase 

costs to the programs. Duplicate prescriptions and the early renewal of maintenance 

prescriptions increase program costs in the form of additional dispensing fees and could be 

signs of possible diversion or resale of prescription drugs. The required destruction of 

numerous drugs upon the death, discharge, or change in treatment plan of a nursing home 

patient may also result in greater expenses than necessary. 

Physicians Determine What Is Appropriate For Each Patient 

Reports of possible “inappropriate” use of medications are somewhat a matter of medical 

opinion. Ultimately, for nursing home patients, it is either the patient’s attending 

physician or the facility’s medical director who determine what is appropriate care. This 

includes prescribing medications to meet patients’ needs. Once an individual is admitted 

to a nursing home, the attending physician routinely participates in the ongoing care of 

that patient, along with the other nursing home staff. The American Medical Association 

defines several functional responsibilities for physicians with patients in long term care 

facilities, including examining the patient upon admission; initiating, developing, and 

overseeing the implementation of a comprehensive plan of care; maintaining medical 

records; and participating in quality assurance reviews when possible.13 The physicians 

4 
are the primary persons to whom nursing staff look for identification and delineation of 

care for specific medical conditions, including prescribing of any necessary medications. 

Generally, the nursing home’s medical director is expected to participate in a foundation 

of activities relating to the care of nursing home patients. These include participating in 

the formulation and review of care policies, infection guidelines, and pharmacy protocols; 

provision of in-service education for staff; and attendance at a variety of facility 

committee meetings (e.g., quality assurance). This role includes coordinating visits to 

patients by other health care professionals, including attending physicians. Further, the 

medical director is expected to intervene if an attending physician is negligent in visiting 

patients or providing quality care. 

OBRA 1987 requires that the pharmacist report any identified irregularities to the 

attending physician of the patient and the director of nursing and that these reports be 

“acted upon. ” Yet, the regulations do not specify several important aspects of reporting 

any pharmacist’s 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 pharmacist’s 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 physician’s legal responsibility to order medication changes, not that of the director 

of nursing. We do not minimize the difficulties physicians encounter in meeting the 

medication needs of the most typical nursing home patient - the disabled or infirm elderly 

person. Much available literature details the complexities of diagnosing and the unique 

challenges of prescribing medications for the elderly. 

Challenges of Prescribing Medications for the Elderly14 

Some disorders, which occur in the general elderly population with characteristic 

symptoms and signs, present unusual features or, conversely, present without usual 

features. Problems usually restricted to the elderly include stroke, decubitus ulcers, 

metabolic bone disease, degenerative osteoarthritis, hip fracture, dementia syndrome, 

falling, Parkinsonism, and urinary incontinence. Further, the usual signs may be replaced 

with less specific ones, such as refusal to eat or drink, falling, incontinence, acute 

confusion, increasing dementia, weight loss, and failure to thrive. Multiple disorders in 

the elderly complicate and interfere with diagnosis and treatment of the presenting illness. 

Depression is probably the most common psychiatric disorder of persons over the age of 

65. Other conditions which become more common with age and which may present 

5 
themselves atypically include organic psychoses, paranoid states, hypochondriasis, and 

suicide. 

Aging changes bodily organs and systems, causing less efficient functioning, and thus, 

affecting the elderly person’s responses to medications. Any person over the age of 65 

has the potential for increased side effects, overdosage, and/or diminished efficacy for a 

minimum of 13 drug classes, such as antibiotics, antihypertensives, cardiac medications, 

psychiatric medications (antidepressants, tranquilizers, hypnotics, etc.), or pain relievers. 

Also, most clinical trials and studies on specific medications are usually performed using 

younger people; the result can be drug treatment standards often hazardous to the elderly. 

Thus, while the elderly may use the same drugs as younger persons, the effects can be far 

different. 

Research identifies many indicators relating to adverse medication outcomes, some of 

which more directly pertain to nursing home patients. These include a patient having five 

or more medications in their drug regimen, having 12 or more doses per day, having 

more than three concurrent disease states, and the presence of drugs requiring monitoring. 

Each of these are fairly common indicators for most nursing home patients. 

Thus, the typical elderly nursing home patient may require different care skills and 

knowledge of health care professionals than those required to treat the non-nursing home 

populations with acute care problems. The primary goal of drug therapy in chronic care 

is to maintain and improve, to the extent possible, the patient’s functional capacity and 

quality of life. 

SCOPE AND METHODOLOGY 

Focus of Report 

In 1996, the OIG undertook a project to assess the extent and appropriateness of drug use 

by Medicare and Medicaid residents of nursing facilities. This project, conducted in three 

phases, involved 1) a database analysis of the extent of prescription drug use by Texas 

nursing home residents eligible for both Medicare and Medicaid; 2) a national survey of 

consultant pharmacists to assess their role in identifying and reducing drug use problems 

in nursing facilities; and 3) a pharmaceutical review of a sample of residents to determine 

the appropriateness of prescription drugs utilized and to examine the extent of selected 

drug use problems. 

The first report, “An Introduction Based on Texas” (OEI-06-96-00080), provides specific 

information concerning actual drug expenditures and identifies the types of drugs being 

used in Texas nursing facilities. This report, focusing on the second component of the 

project, identifies problems and concerns raised by consultant pharmacists. The third 

report, “A Pharmaceutical Review and Inspection Recommendations” (OEI-06-96-00082), 

discusses results from an independent review of drugs and medical records for a sample of 

Texas nursing home patients. Recommendations addressing the issues and concerns raised 

collectively by all three reports are located in the third and final report of this inspection. 

6 
This inspection was initiated as part of Operation Restore Trust, an initiative involving 

multi-disciplinary teams of State and Federal personnel seeking to reduce fraud, waste, 

and abuse in nursing facilities and home health agencies, and by durable medical 

equipment suppliers. The initiative focused in five States (California, Florida, Illinois, 

New York, and Texas). 

Data analysis of prescription drug payments was purposely limited to Texas based on 1) 

the availability of Medicaid data and planned identification of the Medicare and Medicaid 

population in the State by HCFA and the Office of the Inspector General (OIG), 2) 

designation as a demonstration site for Operation Restore Trust, and 3) the large number 

of nursing facilities in Texas, approximately eight percent of long term care facilities in 

the nation. Texas also ranks third in the nation for total Medicaid spending. Such data 

was not readily available for other States. Thus, Texas was the selected site for the first 

and third phases of this inspection. While we recognize that State operations concerning 

nursing homes can vary greatly in their interpretation and enforcement of policies, we 

believe the concerns identified in Texas will be generally common to many States. 

Survey of Consultant Pharmacists 

Because consultant pharmacists are responsible for a monthly medication review of 

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

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

stratified random sample of the 17,000 nursing facilities. 

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

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

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

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

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

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

consulting pharmacist providing drug regimen reviews for the nursing home’s patients. 

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

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

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

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

Their responses were solicited with certain parameters: 

1) Pharmacists were asked to randomly select a single home for which they would provide 

information (this home was not necessarily the sample home from which we identified 

the pharmacists); 

2) We asked that they answer all questions throughout the survey with that one home in 

mind; 

3) Pharmacists were to have at least six month’s personal and continuous experience 

providing consultant pharmacy services to the nursing home about which they were 

responding; 

7 
4) The nursing home should include predominantly Medicare and Medicaid residents 

(some private pay as well); and 

5) The responses were to be reflective of their activities for the six month period prior to 

their receipt of the survey. 

Our original response rate for returned surveys mailed was 76 percent (682 of 900). 

However, in our decision to take a conservative approach, we dropped 221 returned 

surveys because some nursing facilities were determined to be duplicates as a result of 

name changes, misspellings, etc.; pharmacists being identified as servicing more than one 

sample facility; and some facilities closing subsequent to the review period. The 

remaining 461 surveys (75 percent ORT and 25 percent non-ORT) represent 51 percent of 

the original 900 and provide the basis for the findings of this report. 

Confidence levels were computed for selected variables using SUDAAN. At the 95 

percent level, confidence intervals were no greater than +8 percent for most survey 

responses. The data reported in our findings have been weighted to reflect responses 

received from pharmacists representing each ORT State or the other, non-ORT States. 

Assuming that the pharmacists did in fact randomly select the facility for which they 

provided information (including those pharmacists who were identified for more than one 

facility), we can generalize our findings to encompass all consultant pharmacists who have 

responsibilities for nursing home patients. 

This evaluation was conducted as part of ORT, an initiative involving multi-disciplinary 

teams of State and Federal personnel seeking to reduce fraud, waste, and abuse in nursing 

facilities and home health agencies, and by durable medical equipment suppliers. 

Our review was conducted in accordance with the Quality Standards for Inspections issued 

by the President’s Council on Integrity and Efficiency. 

8 
FINDINGS 

QUALITY OF CARE ISSUES 

Overall, pharmacists tell us that they and the nursing homes are complying with the law 

and regulations related to medication reviews of nursing home residents. However, the 

problems and concerns raised by the consultant pharmacists indicate that legislative and 

regulatory intentions to assure high quality pharmaceutical care for nursing home residents 

are not yet fully realized. 

Pharmacists believe that nursing home patients are experiencing numerous adverse 

medication reactions as a result of inadequate monitoring of medications and 

inappropriate prescribing practices. 

Consultant pharmacists, who advocated for and received increasingly responsible roles 

under OBRA 1987 and OBRA 1990, believed they could play a vital role in assuring 

quality care for nursing home patients. Arguably, pharmacists’ professional education 

gives them valuable expertise and clinical knowledge concerning pharmacotherapy. 

Critical to this expertise and extremely important for the nursing residents is monitoring 

the effects of medication usage, either for maintaining or improving a patient’s health 

status or to identify any effects of medications or disease which may undermine such 

improvement or maintenance. Many pharmacists report eight problems regarding 

monitoring of patients’ medications which sometimes occur: 

1) no lab testing to ensure continued need for the medication (61 percent); I5 

2) failure to chart drug usage (59 percent); 

3) medication to medication interactions not detected (57 percent); 

4) no lab testing to monitor potentially toxic drugs (51 percent); 

5) failure to adjust dosages for renal/hepatic function (50 percent); 

6) no monitoring for efficacy or side effects (50 percent); 

7) no physical functioning assessment of patient to check either for correct dosage or 

continued need for the medication (47 percent); and 

8) no physical assessments for routine monitoring of certain drugs (43 percent). 

Additionally, a large number of consultant pharmacists are concerned that medications 

being prescribed to patients contribute to patients’ constipation (reported by 81 percent of 

pharmacists); falls (66 percent); delirium (41 percent); depression (39 percent); and 

urinary incontinence (26 percent). l6 

Many drugs other than psychotropics are also psychoactive, in the sense that they may 

affect a patient’s cognition, balance, and motor coordination, as well as pulse and blood 

pressure. Unfortunately, elderly patients have an increased risk of falls if they experience 

a combination of several certain ailments or medications.17 One key to monitoring for 

these and other potential effects is the extent to which physicians have communicated their 

9 
expectations to conduct such monitoring, i.e., in their orders prescribing care for the 

patient or in progress notes, and the extent to which the nursing staff is able to accurately 

report the results of any such monitoring. 

Another factor directly linked to the effectiveness of such monitoring is the cooperation, 

coordination, and communication between all the key persons involved in the care of the 

patient. Cooperative healthcare team work requires routine interaction between the 

involved team members. In the case of the nursing home, it will at least require 

communication between medical, nursing, and pharmaceutical personnel and include the 

patient as well as other nursing home staff. However, it can be extremely difficult to get 

all the team members together routinely. This is complicated by the fact that such 

meetings are not required. Thus, the means and opportunity for communication (written 

or verbal) between the involved personnel becomes more critical. Written communication 

becomes even more necessary when at least two of the critical players (physician and 

consultant pharmacist) do not frequent the home regularly and rarely interact directly with 

each other. It becomes difficult to ensure that the necessary engagement between players 

occurs, and without clear communication, cooperation will be extremely hard to develop 

between these critical players, 

Many of the consultant pharmacists (40 percent) assess the extent of cooperation from 

residents’ personal physicians as only fair or poor. Consultant pharmacists are 

disturbed that some physicians do not take their concerns seriously or act promptly 

on their recommendations. 

Twenty-eight percent of the pharmacists report residents’ physicians only sometimes give 

serious consideration to their concerns. Similarly, 35 percent of consultant pharmacists 

say doctors only rarely or sometimes take prompt action on their recommendations about a 

specific resident’s prescriptions or medication regimen, although 65 percent say that those 

physicians who do take action do so promptly. Further, while 43 percent of consultant 

pharmacists say physicians act promptly on their recommendations about patterns in the 

physician s prescribing practice, many consultant pharmacists say they only do so 

sometimes (45 percent) or rarely (11 percent). By contrast, 99 percent of the consultant 

pharmacists say nurses seriously consider their concerns most to all the time. Further, 

over 90 percent of the pharmacists agree that bothpersonal physicians and nursing staff 

should routinely solicit their help regarding appropriate medications and dosages. 

A majority of pharmacists say personal physicians rarely or never seek their help 

regarding either the appropriate medications (reported by 68 percent) or proper dosages 

for medications (59 percent). In contrast, consultant pharmacists say nurses sometimes to 

often seek their help with medications (reported by 75 percent) or dosages (89 percent). 

For the most part, pharmacists report receiving very good to good cooperation from the 

nursing directors (95 percent), nursing staff (94 percent), and nursing home administrators 

(83 percent). However, they rate the cooperation of patients’ personal physicians and the 

facility medical directors somewhat lower, with only 57 percent and 72 percent, 

respectively, rated as good to very good. 

10 
According to many of the surveyed consultant pharmacists (55 percent), their medication 

reviews are more complicated because 50 percent or more of their patients are frail 

elderly (85 years or older). While 56 percent of the pharmacists say that physicians are 

adequately aware that certain medications are considered inappropriate for use by this age 

group, 29 percent state that physicians are not adequately aware of the special medication 

needs of these patients; another 15 percent did not know. As a result, pharmacists fault 

some physicians’ lack of awareness concerning the medication needs of elderly nursing 

home patients and the resulting consequences of prescribing without such awareness. 

Pharmacists have serious concerns about specific prescribing practices related to 

antipsychotics, anxiolytics, sedatives/hypnotics, antidepressants, as well as other 

prescription drugs.” 

The law specifies that patients have the right to be free from any medication imposed for 

the purposes of discipline or convenience, and not specifically required to treat medical 

symptoms. It also requires that any use of antipsychotic medications be based on a 

comprehensive assessment of the patient. In fact, some experts recommend that any 

patient using such drugs receive gradual dose reductions, have drug holidays (for which 

there are no Federal guidelines as to which drugs or for what dosages or durations), or 

receive behavioral programming in an effort to discontinue or reduce the dosage of these 

medications. Because legislation prescribes these and other limitations on antipsychotics, 

antianxiety medications, and sedatives/hypnotics, there is concern that from 21 to 44 

percent of pharmacists report some patients are receiving medically inappropriate 

prescriptions of these drugs. 

Further, consultant pharmacists report that of those physicians prescribing antidepressants, 

sedative/hypnotics, antianxiety agents, and antipsychotics, many are not attempting to 

achieve the lowest effective doses. Specifically, few physicians are attempting to achieve 

the lowest effective doses for antidepressants (reported by 42 percent of pharmacists); 

sedative/hypnotics (21 percent); anxiolytics (14 percent); and antipsychotics (10 percent). 

Important among the reasons pharmacists believe physicians are not limiting their 

prescribing of inappropriate medications, is the pressure to continue the medications from 

the patient’s family or guardian (28 percent), the patient (24 percent), and the facility staff 

(14 percent). Lack of physician knowledge (21 percent) or training (15 percent)‘are also 

noted by consultant pharmacists, along with perceived indifference by the physician 

responsible for ensuring the patient’s care (21 percent). 

11 
Table 1: Patients Receiving Inappropriate Medications 

Sedatives/ 

Antipsychotics Anxiolytics Hypnotics Antidepressants 1’ 

Patients Inappropriately 

Receiving 

% Consultant Pharmacists 

Reporting Yes 33 35 44 21 I 

% Consultant Pharmacists 

Reporting No 67 65 56 79 I’ 

We are aware that HCFA has committed to goals of decreasing patient usage of 

antipsychotics and antianxiety medications while increasing the use of antidepressants 

when appropriately necessary. Recent studies indicate that the OBRAs 1987 and 1990 

regulations may have helped to achieve such a reduction for antipsychotic drug use in this 

population. Preliminary data collected by HCFA on nursing homes in three test States 

indicate a shift in usage from antipsychotics to antidepressant medications. Specifically, 

the data illustrates an average decrease of 17 percent in the use of antipsychotics and an 

increase in antidepressant (77 percent) and hypnotic/sedative (27 percent) drug use. l9 

We should note that a considerable number of consultant pharmacists indicate appropriate 

prescribing practices for antipsychotics (46 percent); anxiolytics (44 percent); 

sedatives/hypnotics (38 percent); and antidepressants (57 percent). Yet, it is significant to 

note that from l-6 percent of the consultant pharmacists say these four drug categories are 

inappropriately prescribed by most or all physicians; an additional 9-17 percent say some 

physicians are inappropriately prescribing these medications to nursing home patients. 

Table 2 reflects how many physicians consultant pharmacists believe are inappropriately 

prescribing these categories of medications. 

Table 2: Percentage of Pharmacists Reporting Physicians 

Inappropriately Prescribing Medications 

Medication Type % None % Few % Some % Most % All 

Antipsychotics 46 42 10 2 1 

Anxiolytics 44 38 16 3 0 

Antidepressants 58 29 9 4 2 

Sedatives/Hypnotics 38 42 17 3 1 

In addition to the four drug categories discussed, consultant pharmacists also have serious 

concerns about patient usage of other medications including the following: 

12 
Medication Type 

1) H2 Antagonists 

2) Non-steroidal Anti-inflammatory 

3) Narcotics 

4) Digoxin 

5) Antibiotics and Anti-infectives 

6) Gastrointestinals 

drugs 

% Consultant Pharmacists 

Sometimes or Often Concerned 

6.5 

47 

46 

40 

39 

36 

According to 15 percent of the consultant pharmacists, some physicians are 

prescribing medically inappropriate antidepressants, and 33 percent indicate concern 

that antidepressants are prescribed without an appropriate diagnosis. 

Again, it is important to understand that “inappropriate” may also mean insu$fkient 

amounts rather than too much or a wrong type of medication. While 42 percent of 

consultant pharmacists report most or all physicians attempting to limit or reduce the 

dosage of these drugs, literature and research indicate that many physicians may be 

limiting antidepressants too much when a higher dosage would actually be more effective 

for depression. This was confirmed by consultant pharmacists reporting that when a 

diagnosis of “depression” is available, some (25 percent of pharmacists report) or most (6 

percent) physicians may be prescribing sedatives or hypnotics when antidepressants should 

be used in the treatment of depression.” 

Thirty-four percent of the consultant pharmacists express concern that physicians do 

not ensure the continued maintenance of appropriate levels of antidepressants. 

Treatment of depression must begin with a comprehensive evaluation of the older person. 

This assessment will rule out any associated medical or physical conditions which may 

present symptoms of depression or which may complicate the treatment of depression. 

This includes reviewing laboratory studies, including a complete blood cell count; liver 

function tests; serum albumin levels, thyroid function tests. Also, all current medications 

should be reviewed in light of any lab tests and symptoms being exhibited by the patient. 

Consultant pharmacists also expressed concerns 

medication usage by nursing home patients: 

Medication Issue 

1) Prolonged use of sleeping medicines 

2) Overutilization of drugs 

3) Use of “as needed” drugs for too long 

4) Use of antipsychotics without a diagnosis 

5) Use of contraindicated drug for patient’s 

existing diagnosis or disease 

about other potentially inappropriate 

% Consultant Pharmacists 

Sometimesor Often Concerned 

76 

62 

61 

45 

26 

13 
A number of medication administration issues are also problems according to 

consultant pharmacists. 

These include absence of specific usage directions (reported by 60 percent of 

pharmacists); incomplete orders (52 percent); failure to update the medication 

administration record with dosage or schedule changes (29 percent); physicians signing 

orders that are not current or correct (27 percent); and failure to include orders on the 

medication administration record (18 percent), These concerns may actually result in 

medications or treatment either occurring when unnecessary or being needed and not 

occurring at all (each of which may be grounds for citing immediate jeopardy for the 

patient not receiving the necessary care), Also, misplaced medications (22 percent) and 

continuation of a medication in disregard of stop orders (17 percent) also sometime 

concern consultant pharmacists. 

Approximately half of the surveyed consultant pharmacists state that medications are 

sometimes administered by nursing staff at the wrong time (reported by 59 percent), in 

non-optimal dosages (53 percent), for unsuitable durations (47 percent), or the medication 

may be improperly altered (crushing, dilution, etc.) (40 percent). Much less frequent 

administration concerns include administering the wrong medication (11 percent) or giving 

a medication to the wrong resident (4 percent). Any of these concerns can have 

potentially serious implications, both for the efficacy of the drug and a patient’s wellbeing. Yet, about 59 percent of pharmacists express concerns for their lack of authority 

to modify a resident’s drug regimen, order lab tests to assure an appropriate medication 

regimen (66 percent), or to ensure doctors are prescribing appropriately (62 percent). 

Consultant pharmacists are also concerned that doctors are not required to respond to their 

concerns (reported by 54 percent pharmacists) or may reject their recommendations (47 

percent), even though the consultant pharmacist is required to notify the physician and 

director of nursing of any problems. 

SHORTCOMINGS OF MEDICATION REVIEWS 

While all consultant pharmacists report they routinely conduct medication reviews, their 

responses indicate some serious shortcomings in the quality and thoroughness of reviews. 

Some consultant pharmacists say they do not routinely participate in comprehensive 

patient assessments or in reviews of each patient’s plan of care when opportunity 

allows. 

Section 483.20 of CFR 42 requires that nursing facilities conduct a comprehensive patient 

assessment at admission and promptly after a significant change in the patient’s condition. 

This assessment includes diagnosis(es), special treatment needs, recommended medication 

and nutritional therapy, cognitive, physical, behavioral, and psychosocial patterns, and 

other related health conditions. The assessment should occur at least once every 12 

months, and nursing facilities must perform a review of the assessment at least every 3 

months, and as appropriate, revise the patient’s assessment. This, in turn, could affect 

each patient’s plan of care. Also, OBRA 1987 Section 483.460(j)(5) states that “us 

14 
appropriate” the pharmacist must participate in the development, implementation, and 

review of each patient’s plan (either in writing or in person). 

More than half the consultant pharmacists state they do not routinely review a 

patient’s medication regimen against either the Resident Assessment (65 percent) or 

the Plan of Care (56 percent), although both are available. 

As discussed above, the patient’s assessment identifies critical information for the medical, 

nursing, and pharmaceutical healthcare team. The plan of care is prepared by an 

interdisciplinary team, which should include the attending physician, a registered nurse 

with responsibility for the patient, and “other appropriate staff in disciplines as determined 

by the resident’s needs, and, to the extent practicable, the participation of the resident, the 

resident’s family or the resident’s legal representative.” 

Further complicating the possible outcomes of the medication reviews, even though 

pharmacists indicate that most records necessary for conducting a medication review are 

readily available, some very important records are sometimes not available. Additionally, 

other important, available medical records may not be used by the consultant pharmacist. 

Most consultant pharmacists indicate no difficulty obtaining physician orders (reported by 

94 percent of pharmacists), medication administration records (89 percent), or physician 

progress notes (87 percent). 

Table 3: Performance of Drug Regimen Reviews 

I 

% Yes %No 1 

Against plan of care 44 56 

Against resident assessment 35 6.5 

Upon readmission from hospital 81 19 

Upon changes to doctor’s orders or resident’s plan of 75 25 

care 

Plans of care and patient assessments provide much of the necessary information for a 

pharmacist to identify any factors which may be negatively affecting a patient’s medication 

regimen. Yet 48 percent of the consultant pharrnwists report they have (at times) been 

prevented from performing a complete medication review because of lost or misplaced 

records. However, only 21 percent of the consultant pharmacists say that lack of 

complete, accurate medication records is a barrier to their ability to ensure an appropriate 

medication regimen for each patient. 

While 80 percent of consultant pharmacists have no difficulty in obtaining a facility’s 

incident or accident reports related to patients, 20 percent indicate they do not use them as 

part of the drug regimen review process. Such reports may be indicative of negative 

medication symptoms occurring and resulting in, for example, falls. Further, an analysis 

or summary monthly report by the facility might prove useful for identifying patterns of 

concern (e.g., patients on psychotropic drugs being the most prone to falls; falls occurring 

15 
more often during a late night shift; etc.). Further, approximately 13 percent of the 

consultant pharmacists indicate they do not use either specialists’ notes or nutritional plans 

to assist them in determining whether there may be a related contraindication or impact on 

the patient’s medication usage. 

More than one-third of consultant pharmacists indicate they have difficulty in 

obtaining the patient’s diagnosis. Additionally, 33 percent indicate difficulty 

obtaining any related laboratory reports, and some have problems getting hospital 

reports (30 percent) and patient discharge summaries (25 percent). 

It should be understood that pharmacists and nursing staff should have available at least 

one of the following three documents from which to obtain a patient’s diagnosis - the 

Minimum Data Set which identifies a patient’s chronic diagnostic conditions; the patient’s 

personal assessment; or the patient’s plan of care addressing any chronic or acute 

diagnoses. Without at least one of these records being available, complete, and accurate, 

consultant pharmacists will not have the necessary information for confirming existing 

conditions for each diagnosis, identifying subsequent medication regimen actions for 

treating a patient’s disease, or for continuing assessment of the patient’s health. Without 

this information, pharmacists can meet only a portion of their professional responsibility 

to the patients. 

With an incorrect diagnosis, or no available diagnosis, pharmacists are working in a void, 

one in which a wrong therapy may be initiated. For example, an older female patient 

may be exhibiting signs and symptoms of depression that may be caused by 

hypothyroidism. In this case, it would be improper to treat the symptoms with an 

antidepressant. Yet, without the required lab work, one may not realize the need for 

thyroid medication. Thus, in treating the symptom (depression) with an antidepressant 

instead of the cause (hypothyroidism) for the symptom, an incorrect or unnecessary 

therapy could be initiated, one which perpetuates the problem and may also cause 

additional perceived signs of senility (confusion, lapses in memory, difficulty 

communicating, etc.) 

While one-third of pharmacists say they document medication reviews and related 

contacts in the patients’ medical records or medication charts, many do not document 

their efforts in records most accessible to nursing home staff. 

Pharmacists have long understood and accepted the need to document any form of 

dialogue noting, at a minimum, the fact that the dialogue occurred, with whom, the date, 

and the issue discussed. Nursing facilities maintain many types of files related to patient 

care and related activities. As indicated below, many of the consultant pharmacists do not 

routinely document their contacts or meetings related to patients’ medication regimens in 

these records. 

16 
Table 4: Location of Consultant 

of Contact or Meetings Related 

Type Records Used for 

Consultant Pharmacist Documentation 

Daily Nursing Notes 

Medical Records 

Records of Dispensing Pharmacy 

Patient’s Plan of Care 

Patient’s Assessment 

Consultant Pharmacist (Own) Records 

Medication Chart 

Pharmacist Documentation 

to Patient Drug Problems 

% Yes 

5 95 

31 69 

32 68 

4 96 

4 96 

97 3 

34 66 

During a related review, we asked nursing facilities to provide certain necessary records 

for performing a desk review of a sample of patients’ medication regimens. Many of the 

facilities had difficulty providing the records of the pharmacy consultants because they 

were maintained by the pharmacists in another location. Regardless of the potential lack 

of documentation, explicitly required of facilities by HCFA, fully 98 percent of the 

consultant pharmacists having recommendations from their most recent reviews say they 

voiced those recommendations to the nursing staff or physicians. 

A complicating factor in conducting medication reviews is that pharmacists report 

most patients take six prescription medications on average. 

This supports what the literature stated, that nursing home patients receive more 

medication than non-institutionalized older persons. *’ Also the number of prescriptions 

can range to as many as twelve or more, resulting in extremely complex reviews. In 

addition to the prescribed medications, pharmacists report patients may also be scheduled 

or routinely taking an average of three PRN (“as needed”) medications. These PRN 

medications exceed 15 for some individuals. Thus, the average number of medications 

can range from 9 to beyond 20. This is important because the elderly use more 

prescription drugs than any other age group and are more likely to be taking multiple 

drugs, some of which may be inappropriate and result in particularly acute problems. 

This polypharmacy increases the probability of adverse drug reactions, creating a 

complicated regimen for pharmacists to review and understand, let alone communicate 

recommendations concerning such regimens. 

Yet, the American Society of Consultant Pharmacists, in which many of the nursing home 

consultant pharmacists have membership, indicates each consultant pharmacist completes 

from four to six patient reviews per hour. This time incorporates all other activities for 

which the consultant pharmacist is responsible in the nursing home, (e.g., meetings, 

training, etc.). Average review time may be somewhat longer for patients requiring 

skilled or hospice care or having a large number of medications.** Similarly, the 

consultant pharmacists in our survey indicated averaging four patient reviews per hour for 

monthly visits (this time is based on a 32 hour week, a 4.33 week month, and reported 

median numbers of patient reviews monthly). 

17 
It is also possible that not all medications a patient may be taking are included in the 

pharmacists’ medication reviews. 

The consultant pharmacists identified many barriers to their including non-prescribed 

medications in their medication reviews for each patient. Despite their importance as part 

of a patient’s overall health and drug regimen, consultant pharmacists say their review of 

such medications is limited by such factors as their nursing home contract not specifying 

these drugs as part of the review and non-prescribed medications not being included in 

either the assessment, plan of care, or the permanent medical record for each patient. 

Further, many consultant pharmacists say records on non-prescribed over-the-counter 

medications are usually insufficient or not available and that collecting data on their use 

from patients or guardians is too labor intensive (see Appendix B, table 10). 

A majority of the consultant pharmacists say they routinely maintain medication 

control, destruction, and quality records. 

Virtually all consultant pharmacists (96 percent) monitor for expired medications, proper 

storage, and integrity of packaging of medications received in the nursing home; 84 

percent maintain a system of records for medications received, administered, and 

destroyed. Fifty-four percent of the pharmacists also report they personally maintain or 

review a log of destroyed medications for each facility they serve. The primary reasons 

listed by consultant pharmacists for medications being returned for destruction include the 

patient’s death (83 percent); discontinuing therapy (40 percent); discharging the patient (24 

percent); and changing the medication (20 percent). Eight percent listed the expiration 

date of the medication; only 1 percent indicated the transfer of the patient as the primary 

reason for destroying. medications. Additionally, nearly 12 percent of the consultant 

pharmacists say they sometimes encounter overcharging for medications dispensed. 

It is interesting to note that fully 91 percent of the consultant pharmacists believe reusing 

medications would yield Federal and State savings (the primary exceptions are controlled 

drugs having Federal or State regulations that require destruction or medications in liquid 

form or vials contaminated by prior use). Even though some pharmacists indicated the 

savings may be offset by many potential administrative costs, 54 percent of the consultant 

pharmacists say unused, properly packaged medications could be returned to the-vendor 

pharmacy to redispense for use by others. 

Many consultant pharmacists (89 percent) do not participate in patient care planning 

committees. 

A majority of consultant pharmacists are participants of facility committees to ensure 

quality care (87 percent), pharmacy and therapeutics (74 percent), and infection control 

(67 percent). However, fully 89 percent do not participate in the facility’s patient care 

planning committee. Further, while most consultant pharmacists have routine contact with 

the medical professionals involved in patient care (facility nursing director, nursing staff, 

and patient’s personal physician), few routinely meet with the patient (18 percent), the 

primary individual for whom they are conducting the review. Only 12 percent contact a 

18 
patient when a problem with his/her medication regimen is encountered. Even fewer (five 

percent) report having routine contact with the patient’s family or guardian when a 

problem is encountered with a patient’s medication regimen. Also, despite the impact of 

diet on medications, less than half of the pharmacists routinely contact the facility dietitian 

(43 percent) and few consultant pharmacists have routine contact with either the nurse 

aides (18 percent) or other therapists (25 percent) regarding patients under review. Thus, 

there appears to be a need to strengthen pharmacists’ relationships with patients and direct 

care staff and also their performance of educational and counseling activities. 

Approximately 93 percent of the consultant pharmacists routinely participate in drug 

education and training of nursing staff, but many do not provide such training to 

patients, their families, or the nursing home’s aides. 

OBRA 1987 requires training of clients and staff in appropriate health and hygiene 

methods, “as needed. ” This includes, but is not limited to, training of direct care staff in 

the identification or detection of signs and symptoms of illness or dysfunction. Yet, over 

two-thirds of the consultant pharmacists do not provide education or training for either 

patients (73 percent) or their families or guardians (70 percent). And, nearly half the 

consultant pharmacists do not provide drug education for nurse aides (48 percent) or 

medication aides (50 percent). 

The law and regulations do not specifically require that such training include consultant 

pharmacist training to identify possible symptoms of contraindications, adverse reactions, 

or inappropriate responses to medications. However, it appears that such training would 

be an integral response to the health needs of nursing home patients. Aides should 

routinely be aware of the significance of patient complaints which may indicate potential 

medication problems. Patients complaining of light-headedness, dizziness, fainting, or 

acute weakness should signal the need for increased vigilance, not only for falls, but also 

for medication side effects. Such complaints could alert the pharmacist and nursing staff 

to the potential need for lab work, which could indicate drug-drug and drug-diet 

interactions. 

While most pharmacists are familiar with their enhanced responsibilities, significant 

numbers voice strong concerns about limitations on their professional authority to 

enforce OBRA drug-related provisions. 

As required, nursing facilities employ consultant pharmacists to conduct monthly reviews 

of each patient’s drug regimen to ensure that the prescription drugs ordered for that 

individual are appropriate based on the OBRA 1987 guidelines. These consultant 

pharmacists understand that they are required to 1) determine that drug records for each 

resident are in order, 2) establish a system to record receipt and disposition of 

prescription drugs, and 3) to offer advice and instruction in all other areas of pharmacy 

services. 

Pharmacists also realize they should report any concerns they may have about a resident’s 

medication regimen to the attending physician or director of nursing. Further, they know 

19 
that OBRA 1990 identifies pharmacists as key health care professionals with a potential 

role in improving therapeutic outcomes for Medicaid nursing home residents. However, 

32 percent of consultant pharmacists report they lack the authority to ensure either a 

facility’s or physician’s adherence to the OBRA drug-related provisions. 

As consultants, pharmacists can make recommendations and attempt persuasion to change, 

but they cannot force change. More specific indicators of lack of enforcement authority 

include 42 percent of the pharmacists saying they are unable to control the medications 

ordered and dispensed in the nursing home; 27 percent saying they cannot ensure the 

nursing staff appropriately monitor the clinical effects of medications on residents’ 

physical, mental, or emotional condition; and 24 percent saying they cannot guarantee the 

nursing staff will properly administer medications ordered. (See Appendix B, table 12.) 

It is important to note that, not withstanding their lack of authority to ensure appropriate 

medication regimens, most consultant pharmacists (84-90 percent) do not feel the statutory 

definition of their roles or their dual responsibilities to both nursing facilities and patients 

inhibit their ability to conduct appropriate medication reviews. This is borne out by the 

fact that all consultant pharmacists report they routinely conduct the required monthly 

drug regimen reviews for nursing home patients, and at least 75 percent say they perform 

a review when changes occur either to the physicians’ orders or to the resident’s plan of 

care. Nearly 93 percent of the consultant pharmacists indicate they routinely monitor each 

resident’s medication regimen to ensure it maintains or improves the patient’s functioning. 

Further, 95 percent of the consultant pharmacists perform the drug regimen review for a 

particular patient at least once a month with 31 percent of the consultant pharmacists 

visiting the nursing home weekly or more often. 

20 
RECOMMENDATIONS 

This report shares information concerning drug usage in nursing homes from the 

perspective of a nationally representative sample of consultant pharmacists. Pharmacists 

expressed concerns about their inability to always perform quality medication reviews, the 

role of the physician and nursing staff in appropriate medication usage by patients, and the 

problems of potentially inappropriate medication usage or maintenance. Collectively with 

the two other reports of this inspection, these concerns show a need for improvement and 

underscore the importance of strengthening the medication reviews and improving 

medication prescribing, administration, and monitoring practices in nursing homes. 

These concerns and those addressed in our first report, “An Introduction Based on Texas” 

(OEI-06-96-OOO80),indicate that HCFA should continue to work with the States and 

other responsible entities to improve and enforce existing requirements for more effective 

medication reviews for patients in nursing homes. Specific recommendations for HCFA 

to consider in this endeavor are provided in our third report of this inspection, “A 

Pharmaceutical Review and Inspection Recommendations” (OEI-06-96-00082). 

21 
COMMENTS ABOUT DRAFT REPORTS 

We solicited comments from agencies within the Department of Health and Human 

Services which have responsibilities for policies related to Medicare and Medicaid and 

long term care. We also requested input from several national organizations representing 

the interests of nursing homes, patients, or providers. We appreciate the time and efforts 

of those providing comments. 

Denartmental Comments 

Within the Department, we received comments on the draft reports from the Health Care 

Financing Administration (HCFA) and the Assistant Secretary for Planning and Evaluation 

(ASPE). Both agencies concurred with the recommendations; HCFA emphasized the need 

for further studies to assess the extent of continued use of potentially inappropriate drugs, 

other avenues of possible cost savings related to drugs, and the need to determine and 

understand the potential sources of the escalating costs and claims for certain types of 

drugs used in nursing homes. The final reports reflect several clarifications or changes 

based on their suggestions. The full text of each agency’s comments is provided in the 

third and final report of this inspection, “A Pharmaceutical Review and Inspection 

Recommendations” (OEI-06-96-00082). 

Comments from External Organizations 

We also received comments from the following external organizations: American Health 

Care Association; American Association of Homes and Services for the Aging; American 

Medical Directors Association; American Society of Consultant Pharmacists; and National 

Association of Boards of Pharmacy. Most of the associations concurred with one or more 

of the recommendations within each of the inspection reports. All commentors support 

the need for better communication and coordination between nursing home staff and other 

healthcare providers, training nurse aides, and understanding the implications of nursing 

home medication services and associated costs. 

Several organizations questioned the methodology used in this inspection, particularly for 

the consultant pharmacist survey. However, as with any evaluation, there are always 

some limitations in how data and information can be obtained, given time and other 

resource constraints. Further, while we acknowledge that a survey of this nature 

introduces some bias and subjectivity, we also believe that the survey of consultant 

pharmacists provides us with an up-close view of what is happening with prescription drug 

use in nursing homes. Moreover, the results of the consultant pharmacist survey are 

consistent with our results from our two other methodologies. 

Some comments expressed concerns about the use of the term, “inappropriate. ” As 

explained previously, use of this term in reporting concerns with a patient’s medication 

regimen are somewhat a matter of opinion. The evidence provided in these three reports 

does not prove that any one prescription was improper, but that closer examination is 

22 
warranted. Also, while the use of such a drug may be supported by physician orders in 

individual cases, use of the drug, in general, is likely to be considered inappropriate. 

Some comments addressed the implications of broadening Federal oversight. There is 

clear concern about the responsibility for medication issues being the responsibility of the 

physician, not the nursing home. Further, some organizations expressed concern that 

these particular issues did not result in direct recommendations about the physician’s role 

for nursing home patients’ medication regimens. We felt that further examination of this 

area is warranted before recommending changes which would impact so many entities 

involved in the process. 

In conclusion, we believe the three reports collectively, and each using a different 

approach, strongly indicate that the intent of the provisions of the OBRA Acts concerning 

prescription drug usage are not being clearly fulfilled. Further, HCFA has authority to 

correct and enhance quality of care for nursing home patients. The recommendations we 

present attempt to facilitate the initial steps of this effort, and to address some concerns 

evidenced in the reports and received comments. While we recognize that great strides 

have been made to meet the OBIL4 requirements, we believe further effort remains by all 

the players involved (HCFA, associations and their members, nursing homes, and 

residents and their families) to further improve quality of care for nursing home patients. 

The full text of each organization’s comments is provided in the third and final report of 

this inspection, “A Pharmaceutical Review and Inspection Recommendations” (OEI-06-96-

00082). 

23 
ENDNOTES 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

Health Care Financing Administration, BDMS, Division of Program Systems, 1996. 

Keitz, Todd. “10 Things You Should Know About the Long Term Care Market.” 

Medicinal Marketing and Media. 30(.5):42-46. May 1995. 

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. 

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. 

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. 

Knowlton, Calvin H. Statement before the Senate Special Committee on Aging, 

Hearing on Drugs and the Elderly, Washington, D. C. March 28, 1996. 

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. 

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. 

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. 

42 CFR Set 483.60. 

Perri, M., J. Kotzan, L. Pritchard, et al. “OBRA 90: The Impact on Pharmacists and 

Patients. ” American Pharmacy, February 1995, Vol. NS35, No. 2, pp. 24-28. 

Nelson, Arthur A. “The ‘Smoking Gun’ in OBRA 90. ” Pharmacy Times, February 

1993, pp. 49-58. 

Fanale, R. H., et al. “The Nursing Home Medical Director, ” Journal of the 

American Geriatrics Society, 1989, 37(4), pp. 371-373. 

24 
14. The Merck Manual, 15th edition, fourth printing. 

15. Government regulation and policies of third-party payors (insurance companies) 

have a direct impact on utilization, perhaps mostly by decreasing the number and 

types of laboratory tests routinely conducted in nursing homes. Medicare has 

changed its policy for payment of laboratory tests (i.e., no more orders for tests, 

especially multiple tests, without good clinical indications). Thus, one effect of 

this new policy may be less lab testing, particularly for those tests which cover a 

variety of possible physical effects of medication (i.e., Super Chemistry). 

16. According to research, there are at least four patterns of constipation found in 

infirm elderly nursing home patients which may often be due to secondary causes, 

such as physical immobility and medications (e.g., antidepressants and neuropletics 

with anticholinergic properties, calcium channel blockers, iron supplements, and 

narcotics). 

17. Elderly patients have an increased risk for falling when they experience a combination 

of any of the following: 

3) 

4) 

5) 

6) 

7) 

dementia, especially more advanced stages; 

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

antihypertensives and psychotropics as well as certain physical difficulties related to 

either urination or digestion; 

arthritis, particularly when the patient has limited mobility, may increase a patient’s 

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

usually inappropriately, for the pain; 

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

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

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

metabolic drug related causes include uncorrected hypothyroidism, hypoglycemia 

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

and dehydration (diuretics); and 

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

Also, some of the listed ailments or medications have their own potential for causing 

physical, mental, and emotional side effects for elderly persons. 

18. Both The MERCK Manual of Diagnosis and Theranv and the AARP Prescription 

Drug Handbook provide the most common reasons for usage and concerns related 

to the usage of these drugs: 

Antipsychotics (“major” tranquilizers also called neuroleptics) 

Are used to treat a variety of very severe emotional disorders, including severe anxiety, 

agitation, or psychosis. They should not be used to treat simple anxiety. Low doses of 

some of these may also be used to treat nausea and vomiting. The principle restriction 

while taking these drugs is related to the taking of any other drugs, including over-thecounter ones, because these drugs can negatively interact with blood pressure medication, 

antidepressants, antihistamines, barbiturates, narcotics, tranquilizers, cimetidine (medicine 

for ulcers), and antibiotics. Further, these drugs may disturb the ability of a patient’s 

body to regulate its temperature. 

25 
The most common side effects are sleepiness, sudden faintness or falling when getting up 

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

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

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

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

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

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

leukopenia, skin pigmentation). 

Antianxiety agents (“minor” tranquilizers also called anxiolytics) 

Anxiety neurosis is a neurotic disorder characterized by chronic, unrealistic anxiety often 

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

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

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

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

illness itself. 

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

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

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

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

myocardial infarction, depression). 

Benzodiazapines have largely supplanted other antianxiety drugs, including the 

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

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

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

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

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

these drugs tend to have a long half-life, and for some of the drugs in this category, halflives increase considerably with age (four- to sixfold at age go).] In the elderly, these 

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

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

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

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

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

Sedatives/Hypnotics 

These terms, as well as “antianxiety agent,” “minor tranquilizer,” and “anxiolytic” are 

ambiguous and often used interchangeably. A single one of these drugs is frequently 

useful in more than one therapeutic category, depending on the dosage. All available 

hypnotics involve some risk of overdose, habityation, over-tolerance, and addiction, as 

well as withdrawal symptoms that can include a temporary recurrence of sleeplessness. 

Ambulatory patients given these drugs should avoid activities requiring mental alertness, 

judgment, and physical coordination. They should particularly be used with extreme 

caution in patients with severe pulmonary insufficiency. The elderly may exhibit 

restlessness, excitement, or exacerbations of symptoms of organic brain disorders. Serum 

levels should routinely be checked for appropriate dosage levels when such symptoms are 

exhibited. 

19. Weekly Report for Week Ending January 17, 1997, Health Care Financing 

Administration, Health Standards and Quality Bureau. 

20. Ruegg et al presents three main types of depressive disorders in the elderly. These 

include: 

26 
1) the patient’s presentation of multiple somatic complaints (headache, 

gastrointestinal upset, fatigue) which, in effect, “mask” or hide the presence of 

depressive symptoms; 

2) the patient complains of difficulty concentrating or remembering, and withdraws 

from the environment, falsely mimicking dementia; and 

3) the patient experiences some form of delusion. (It should be noted that there are 

also some forms of medical illness with symptoms mimicking a delusional 

depression such as a tumor or stroke or Alzheimer’s disease.) 

21. Chrischilles E., D. Foley, R. Wallace, J. Let&e, T. Semla, J. Hanlon, et al. “Use 

of Medications by Persons 65 and Over: Data from the Established Populations for 

Epidemiologic Studies of the Elderly. ” Journal of Gerontology, 1992; 47 :M 137-44. 

22. Telephone conversations with Tom Clark, Director of Professional Affairs, subsequent 

to other conversations with Janice L. Feinberg, Director of Research and Education 

Foundation, both with the American Society of Consultant Pharmacists. 

27 
APPENDIX A 

20 Drugs Generally Considered 

Inappropriate for the Elderly 

The 20 drugs listed below were judged generally inappropriate for elderly patients by a panel of 

experts. The panel’s results and methodology, published in 1991, indicate that these drugs should 

normally not be used with elderly patients. However, they stress that there could be some medical 

situations in which use of these drugs would be appropriate. 

Medication 

Amitriptyline 

Carisoprodol 

Chlordiazepoxide 

Chlorpropamide 

Cyclandelate 

Use 

To treat 

depression 

To relieve severe 

pain caused by 

sprains and back 

pain 

As a (minor) tranquilizer 

or antianxiety 

medication 

To treat diabetes 

(a hypoglycemic agent) 

To improve blood 

circulation 

Comment 

Other antidepressant 

medications cause 

fewer side effects 

Minimally effective 

while causing 

toxicity; potential 

for toxic reaction 

is greater than 

potential benefit 

Shorter-acting 

benzodiazepines are 

safer alternatives 

Other oral medications 

have shorter half-lives 

and do not cause 

inappropriate 

antidiuretic hormone 

secretion 

Effectiveness is in 

doubt; no longer available 

in the U.S. 

A -1 
Medication 

Cyclobenzaprine 

Diazepam 

Dipyridamole 

Flurazepam 

Indomethacin 

Isoxsuprine 

Meprobamate 

Methocarbamol 

Use 

To relieve severe 

pain caused by 

sprains and back 

pain 

As a (minor) tranquilizer 

or antianxiety 

medication 

To reduce bloodclot formation 

As a sleeping pill 

(a hypnotic) 

To relieve the 

pain and 

inflammation of 

rheumatoid 

arthritis 

To improve blood 

circulation 

A (major) tranquilizer 

(used for anxiety) 

To relieve severe 

pain caused by 

sprains and back 

pain 

Comment 

Minimally effective 

while causing 

toxicity; potential 

for toxic reaction 

is greater than 

potential benefit 

Shorter-acting 

benzodiazepines are 

safer alternatives 

Effectiveness at low 

dosage is in doubt; 

toxic reaction is 

high at higher 

dosages; safer 

alternatives exist 

Shorter-acting 

benzodiazepines are 

safer alternatives 

Other nonsteroidal 

anti-inflammatory 

agents cause less 

toxic reactions 

Effectiveness is in 

doubt 

Shorter-acting I 

benzodiazepines are 

safer alternatives 

Minimally effective 

while causing 

toxicity; potential 

for toxic reaction 

is greater than 

potential benefit 

A -2 
Medication 

Orphenadrine 

Pentazocine 

Pentobarbital 

Phenylbutazone 

Propoxyphene 

Secobarbital 

Trimethobenzamide 

Source: 

Use 

To relieve severe 

pain caused by 

sprains and back 

pain 

To relieve 

moderate to severe 

pain 

As a sleeping pill 

and to reduce 

anxiety (hypnotic) 

To relieve the 

pain and 

inflammation of 

rheumatoid 

arthritis 

To relieve mild to 

moderate pain 

As a sleeping pill 

and to reduce 

anxiety (hypnotic) 

To relieve nausea 

and vomiting 

Comment 

Minimally effective 

while causing 

toxicity; potential 

for toxic reaction 

is greater than 

potential benefit 

Other narcotic 

medications are 

safer and more 

effective 

Safer sedativehypnotics are 

available 

Other nonsteroidal 

anti-inflammatory 

agents cause less 

toxic reactions 

Other analgesic 

medications are more 

effective and safer 

Safer sedativehypnotics are 

available 

Least effective of 

available 

antiemetics 

Beers, Mark, Joseph G. Ouslander, Irving Rollingher, et al. “Explicit Criteria for Determining 

Inappropriate Medication Use in Nursing Home Residents, ” Archives of Internal Medicine, Vol. 

lSl(Sept. 1991), pp. 1825-32. 

A -3 
APPENDIX B 

Consultant Pharmacists’ Assessments of 

Medication Problems in Nursing Homes 

(Weighted Data) 

Table 1: Concerns about Residents Using Certain Medications 

FREQUENCYOFOCCURRENCE 

(During Six-Month Period Prior to Survey) 

Medication Type 

% Often % Sometimes % Rarely % Never 

antibiotics or anti-infectives 3.2 35.8 48.4 12.6 

anesthetics 0.1 0.8 12.2 86.9 

antipsychotics 13.3 53.3 25.8 7.6 

antidepressants 6.9 31.4 47.7 14.0 

anxiolytics 14.6 46.0 32.4 7.0 

diuretic medications 2.6 26.3 48.8 22.2 

narcotics 6.5 39.3 35.8 18.4 

non-steroid anti-inflammatory 6.7 40.7 41.0 11.6 

sedatives or hypnotics 12.3 49.5 28.5 9.6 

steroids 2.6 11.7 53.3 32.3 

gastrointestinals 3.6 32.6 46.2 17.6 

ACE inhibitors 2.7 22.6 54.3 20.4 

calcium channel blockers 1.1 18.5 58.9 21.5 

H2 antagonists 17.7 47.6 26.8 7.9 

digoxin 3.5 36.5 49.2 10.8 

Source: Q30a-Q30o # 

B-l 
Table 2: Appropriateness of Prescribed Medication 

FREQUENCYOFOCCIRRENCE 

Problem Encountered % Often % Sometimes % Rarely % Never 

medication contraindicated by diagnosis or disease 1.7 24.2 66.7 7.5 

“as needed” medications administered too long 7.1 54.2 34.6 4.1 

unauthorized medication with no signed orders 0.7 7.6 41.0 50.7 

continuous use of sleeping medication for too long 26.5 49.6 22.1 2.1 

use of antipsychotic w/o diagnosis 6.0 38.6 42.7 12.7 

use of antidepressant w/o diagnosis 4.3 28.3 55.6 11.8 

overutilization 9.5 52.2 33.8 4.5 

underutilization 0.2 26.0 61.1 12.7 

use of more than one medication in same drug 4.2 35.9 53.9 6.0 

Source: Q311,Q31n-Q31u 

Table 3: Number of Physicians Inappropriately Prescribing Medications 

Medication Type 

Antipsychotics 

Anxiolytics 

Antidepressants 

Sedatives or Hypnotics 

Source: Q12a-Q12d 

% None % Few % Some % Most % All 

45.8 41.5 

43.8 37.6 

57.2 28.6 

37.8 41.9 

10.1 1.9 0.7 

16.0 2.6 0.0 

8.7 4.1 1.5 

17.0 2.6 0.7 

Inappropriate 

Elderly 

Percent Pharmacist 

Indicating 

14.9% 

21.0% 

20.5% 

27.8% 

23.6% 

14.3% 

Table 4: Why Doctors Don’t Limit 

Medications for the 

Reason 

Lack of training 

Lack of knowledge 

Indifference 

Pressure to continue medication 

from: 

b Family/guardian 

b Resident 

t Facility staff 

Source: Q19 

B-2 
Table 5: Administration of Medications 

Problem Encountered 

% Often 

incorrect dosage 2.2 

not optimal duration 2.0 

not optimal dosage 3.9 

administered at incorrect time 11.4 

administered to wrong resident 0.0 

inappropriate dosa e alteration 5.0 

(crush/no crush, dfiution, etc.) 

incorrect route of administration 0.1 

wrong medication Administered 0.0 

Source: Q31a-Q31g 

FREQUENCYOFOCCURRENCE 

% Sometimes % Rarely 

26.5 37.1 

44.4 44.1 

48.8 42.2 

47.6 36.9 

4.4 71.2 

35.0 51.3 

8.0 59.1 

10.9 76.5 

% Never 

3.4 

8.7 

5.1 

4.1 

24.3 

8.7 

32.8 

12.6 

% Never 

6.6 

9.6 

9.7 

15.4 

4.7 

8.3 

47.9 

15.7 

4.5 

14.2 

5.8 

9.1 

9.3 

Table 6: Monitoring of Medication Usage 

Problem Encountered 

failure to chart use 

l$:tTJIosage adjustment for renal/hepatic 

inappropriate for use by elderly 

duplicate prescriptions 

medication/medication interaction 

medication/diet interaction 

medication/gender interaction 

contraindicated by resident’s allergy history 

lack of lab testing to ensure continued need 

lack of monitoring for efficacy and side effects 

lack of lab testing for routine, on-going 

monitoring of toxics 

lack of physical assessment for continued need 

or appropriateness of dosage 

lack of physical assessment for routine, ongoing monitoring of certain medications 

Source: Qf31-Qr31 

FREQUENCYOFOCCURRENCE 

% Often % Sometimes % Rarely 

11.0 47.7 34.7 

6.0 44.2 40.2 

4.1 41.6 44.6 

0.9 28.1 55.1 

3.6 53.0 38.7 

1.8 32.6 57.3 

0.0 4.3 47.8 

0.8 19.7 63.8 

8.8 51.7 35.0 

11.0 38.6 36.2 

10.2 40.8 43.2 

9.1 37.5 44.3 

10.0 32.7 48.0 

B-3 
Table 7: Doctors Routinely Seeking Lowest Effective Dose for Select Drug Classes 

Antipsychotics Anxiolytics Sedatives/ Antidepressants 

Hypnotics 

Number of doctors routinely 

trying for lowest effective dose 

b All 

b Most 

b Some 

b Few 

b None 

Source: 414 

25.5% 

45.8% 

18.6% 

8.7% 

1.4% 

19.8% 21.9% 17.0% 

42.8% 41.4% 24.9% 

23.6% 15.6% 15.7% 

12.2% 19.1% 26.3% 

1.6% 1.9% 16.1% 

Table 8: Adverse Medication Reactions 

Problem Created 

contributed to urinary incontinence 

contributed to depression 

contributed to delirium 

contributed to falls 

contributed to constipation 

Source: Q31h-Q31m 

FREQUENCYOFOCCURRENCE 

% Often % Sometimes % Rarely % Never 

0.9 25.3 56.1 17.7 

1.1 38.1 50.4 10.4 

0.9 39.9 45.9 13.3 

6.1 60.2 27.1 6.7 

16.6 64.5 15.4 2.8 

B-4 

II 
Table 9: Quality Assurance and Quality Control Issues 

Problem Encountered 

medication order not on MAR 

medication listed on MAR w/o order 

MAR not updated to reflect new dose or schedule 

order sheets not current or correct when signed by MD 

lack specific directions for usage 

order incomplete 

medications not provided for periods away from nursing 

home 

theft of medications 

misplacement of medications 

medications found in trash can in resident’s room 

medications administered by inappropriate or unauthorized 

personnel 

medications administered in disregard of stop orders 

clinical abuse or misuse 

iource: Q311-Q319, Qa31-Qe31 

FREQUENCYOFOCCURRENCE 

% Often % Sometimes % Rarely % Never 

0.2 17.3 62.6 19.9 

0.1 6.7 47.8 45.4 

2.1 27.2 54.6 16.0 

4.6 22.0 54.5 18.8 

11.6 48.7 34.8 4.9 

5.8 46.5 40.2 7.5 

0.2 2.6 49.1 48.1 

0.1 5.1 49.1 45.8 

0.7 21.6 62.9 14.8 

0.0 3.3 31.8 64.9 

0.0 1.5 15.2 83.3 

0.3 17.0 60.3 22.4 

0.0 4.6 40.6 54.8 

Table 10: Barriers to Including Non-Prescribed Medications 

in Review of Residents’ Medication Regimens 

Possible Barriers 

Collecting data directly from residents or their guardians is too labor 

intensive 

Facility contract does not require pharmacist’s review of non-prescribed 

OTC medications 

Records of non-prescribed OTC medications not available 

Records of non-prescribed OTC medications insufficient 

Non-prescribed medications not included in resident’s plan of care 

Non-prescribed medications not part of resident’s assessment 

Non-prescribed medications not included in resident’s permanent medical 

record 

Facility staff do not routinely inspect residents’ rooms for non-prescribed 

medications 

Source: Q25a-Q25h 

% True % False 

63.9 36.1 

20.8 79.2 

34.1 65.9 

39.7 60.3 

61.6 38.4 

43.3 56.7 

48.8 51.2 

12.3 87.7 

B-5 
Table 11: Policy Barriers to Appropriate Reviews of Medication Regimens 

Possible Policy Barriers % True % False 

No clearly defined responsibilities.for pharmacists 10.2 89.8 

performing services in nursing facilities 

No clear separation between, responsibilities to the 11.6 88.4 

nursing home and to the restdents 

Primarily responsible to nursing home rather than to 15.7 84.3 

resident 

Lack of pharmacists’ enforcement authority to ensure facilities’ adherence to OBRA 

Source: QBa,J,k,p 

Table 12: Nursing home and Other Management 

to Appropriate Reviews of Medication 

Possible Management Issues as Barriers 

No control over medications ordered and dispensed 

in nursing home 

Insufficient access to records maintained by nursing 

home, e.g. assessment, plan of care 

No authority over nursing staff to ensure medications are administered as ordered 

No authority over nursin staff to ensure medically 

appro riate monitoring of resident’s physical 

condo.Pton as related to drug regimen 

No means of ensuring resident’s compliance with 

drug regimen 

No authority over dispensing pharmacy 

Source: Q29d,g,h,i,e,f 

Table 13: Professional Authority Issues 

to Appropriate Reviews of Medication 

Possible Professional Barriers 

Lack of authority to modify drug regimen 

Lack of authority to order lab tests to ensure appropriateness of drug regimen 

Insufficient authority to ensure doctors appropriately 

prescribe residents’ medications 

Doctors not required to respond to pharmacists’ concerns 

Doctors rejection of pharmacists’ recommendations 

Source: Q29b,c,l,m,n 

32.1 67.9 

Issues as Barriers 

Regimens 

% True % False 

42.4 57.6 

11.8 88.2 

23.7 76.3 

27.3 72.7 

17.4 82.6 

14.7 85.3 

as Barriers 

Regimens 

% True % False 

58.6 41.4 

65.5 34.5 

61.6 38.4 

54.4 45.6 

46.8 53.2 

B-6 
APPENDIX C 

Additional Pharmacist Survey Weighted Data 

Table 1: Routine Performance of Other Drug-Related Functions 

Consultant Pharmacist Functions % Yes % No 

Ensure MAR are complete and orderly 93.7 6.3 

Maintain records for medication receipt, administration, and 84.1 15.9 

destruction 

Monitpr medication records to ensure maintenance or improvement 92.9 7.1 

of resident’s functioning 

Monitor medications for expiration, proper storage, or packaging 96.0 4.0 

integrity 

Preparation of medication dispensing mechanisms, e.g. cart 67.2 32.8 

Periodical1 observe/evaluate medication passes to ensure accuracy 85.2 14.8 

of admims27ration 

Source: QlOe,p-t 

Table 2: Frequency of Routine Performance 

of Drug Education/Training and Committee Participation 

% Yes % No 

Drug education/training of: 

b nursing staff 93.0 7.0 

b nurse aides 52.0 48.0 

w medication aides 49.8 50.2 

t families/guardians 30.1 69.9 

w residents 27.1 72.9 

Participation in committees for: 

b pharmacy and therapy 73.6 26.4 

w quality assurance 86.5 13.5 

b infection control 67.3 32.7 

b care planning 10.9 89.1 

Source: QlOg-k,l-o I 

C-l 
Table 3: Difficulty in Obtaining Specific Patient-Related Records 

Patient Documents or Records % Yes 

Doctors’ orders 

Doctors’ progress notes 

Nurses’ progress notes 

Resident’s assessment 

Resident’s diagnosis(es) 

Resident’s plan of care 

Lab reports 

Resident’s nutritional plan 

Incident/accident reports 

Medication administration 

6.0 

12.7 

9.1 

11.0 

34.7 

3.4 

32.8 

needs 6.5 

19.8 

records 11.0 

Hospital discharge summary 25.5 

Specialists’ Notes (PT, OT, ST, etc.) 8.8 

Transfer reports 20.4 

Hospital/operation reports 30.1 

Source: Q28a-n 

Table 4: Routine Contacts 

for Medication Regimen Problems 

Who Contacted %Yes 

Medical Director 43.7 

Director of Nurses 93.7 

RNs/LVNs/PNs 96.4 

Resident 12.2 

Resident’s family/guardian 5.2 

Resident’s personal doctor 87.7 

Personal doctor’s PA/NP 54.9 

Appropriate nurse aide 17.8 

State certification agency 7.7 

Dietitian 42.5 

Therapist (e.g. occupational, 24.8 

physical , speech) 

Source: Q4la-k 

% No 

94.0 

87.3 

90.8 

89.0 

65.3 

96.6 

67.2 

93.5 

80.2 

89.0 

74.5 

91.2 

79.6 

69.9 

% No 

56.3 

6.2 

3.6 

87.8 

94.8 

11.5 

45.0 

82.2 

92.3 

57.5 

75.2 

c-2 
Table 5: Frequency of Contact with Residents 

Always Mostly Sometimes Rarely Never 

Routine1 meet with resident or 1.6 0.6 15.9 44.9 37.0 

family a7ter medication review 

Routinely ask resident or family 1.1 2.6 25.6 54.2 16.4 

preferences m certain prescribed 

medications 

Source: Q47,Q48 

Table 

Individual With Whom 

Consultant Pharmacist 

Communicates 

Nursing home Administrator 

Medical Director for Facility 

Director of Nursing for Facility 

Patient’s Personal Physician 

Immediate Nursing Staff (RN,LVN,PN) 

Nurse Aides 

Patient 

Patient’s Family or Guardian 

Source: Q6Oa-h 

6: Cooperation Between Pharmacists and Others 

Extent of Cooperation 

% Very Good % Good % Fair % Poor % No Contact 

51.6 31.1 8.9 1.7 6.7 

29.2 42.3 20.0 2.2 6.3 

73.4 21.1 2.3 1.7 1.5 

12.6 44.5 35.7 3.8 3.5 

60.6 33.5 5.0 0.9 0.0 

21.2 23.1 6.7 1.6 47.5 

11.8 19.7 9.3 1.4 57.9 

10.5 17.2 7.2 1.o 64.2 

c-3