Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

PRESCRIPTION DRUG USE 

IN NURSING HOMES 

Report 3 

A Pharmaceutical Review 

and 

Inspection Recommendations 

JUNE GIBBS BROWN 

Inspector General 

NOVEMBER 1997 

OEI-06-96-00082 
EXECUTIVE SUMMARY 

PURPOSE 

To assess the extent and appropriateness of pharmaceutical use by selected Texas nursing 

home residents and to describe pharmacists’ concerns about drug use. 

BACKGROUND 

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

the extent possible, the 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. Yet, several recent studies 

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

high health care costs in the elderly population. It is important to understand that reports 

of possible “inappropriate” use of medications are somewhat a matter of opinion. 

Ultimately, for nursing home patients, it is either the patient’s attending physician or the 

facility’s medical director who determine what is appropriate care. This includes 

prescribing medications to meet patients’ needs. 

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

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

addressed in three reports, of which this is the third. The first report describes 

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

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

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

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

nursing home patients. Additionally, this final report presents recommendations 

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

this coordinated inspection. 

FINDINGS 

Overall, contracted pharmacists’ reviews consistently identified the same problems and 

concerns for patients as were raised by our analysis of Texas data and the national survey 

of consultant pharmacists. This finding underscores the need for strengthening medication 

reviews and improving medication prescribing, administration, and monitoring practices in 

nursing homes. 
Oualitv of Care Issues 

Contracted medication reviews revealed potentially serious concerns with residents’ 

drug regimens. 

20 percent of the reviewed patient records identified patients receiving at least one drug 

judged inappropriate for their diagnoses. Additionally, patients’ records indicated some 

residents were taking medications potentially contraindicated by their diet requirements, 

plans of care, or assessments. 

16 percent of patients were receiving, without a prescription in their records, drugs for 

which prescriptions are generally required. Further, 23 percent of the patients were 

prescribed medications for which the records showed no orders or receipts to indicate the 

patient actually received the medication. 

Approximately 20 percent of residents received at least one drug considered by experts to 

be inappropriate for use by the elderly. 

Some patients’ records indicate they may be experiencing unnecessary adverse medication 

reactions as a result of inadequate monitoring. 

21 percent of patients were receiving drugs which may sometimes negatively interact with 

other drugs in their regimen. 

Nearly one-third of patients were receiving more than one drug from the same class, 

sometimes a potential hazard. Drugs from the same class may produce similar side effects 

which can be additive and need to be carefully managed. Yet, 19 percent of all records 

indicate no monitoring for efficacy. 

ShortcominPs of Medication Reviews 

Resident medication records are often incomplete, making it difficult or impossible to 

identify or confirm potential drug regimen problems. 

31 percent of patients’ records were not sufficientlq complete to allow contract 

pharmacists to make determinations concerning the appropriateness of medications 

prescribed for patients’ diagnoses. 

Contract pharmacists identified several patients whose prescribed medications may have 

contributed to falls, depression, and constipation. However, due to insufficient records, 

they were unable to pinpoint or eliminate the patient’s drug regimen as the cause. 

Often the contract pharmacists were unable to determine whether a patient had received a 

monthly drug regimen review during the sampled time period. 

ii 
Thorough contracted medication reviews required much more time than the usual 

review times reported by nursing home consultant pharmacists. Allotting more time 

for conducting reviews appears to help in detecting more medication concerns. 

Contract pharmacists’ reviews averaged 50 minutes, which is considerably longer than the 

times consultant pharmacists expend doing medication reviews (averaged 5-10 minutes per 

monthly review with initial reviews taking 15-20 minutes). 

The contract pharmacists identified medication problems or concerns for 20 percent of the 

patients which had not been identified by the nursing home consultant pharmacists’ 

reviews. 

RECOMMENDATIONS 

Medication problems and concerns raised collectively by the three coordinated reports 

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

enforcement of existing regulations and required reviews of medication usage in 

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

Administration: 

Continue to monitor and encourage reductions in the use of potentially inappropriate 

prescription drugs in the elderly nursing home population; 

Work with other Federal and State agencies to identify and analyze reasons for the 

rapid escalation in costs and claims for certain types of drugs used in nursing homes 

(i.e., gastrointestinal, psychotherapeutic, cardiac, cardiovascular, and anti-infectives); 

Strengthen the effectiveness and impact of medication reviews conducted by consultant 

pharmacists in nursing homes; 

Require nursing homes to ensure that the curriculum for required on-going, in-service 

training for personal care staff (nurse aides) includes information on how to recognize 

and report signs of possible contraindications, adverse reactions, or inappropriate 

responses to medications; 

Strengthen and enforce coordination and communication among the involved healthcare 

team members in nursing homes; and 

More vigorously pursue enforcement of resident health outcomes. 

COMMENTS ON THE DRAFT REPORT 

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

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

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

... 

111 
the interests of nursing homes, patients, or providers. We appreciate the time and efforts 

of those providing comments. 

Departmental Comments 

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

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

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

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

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

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

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

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

Appendix D. 

Comments from External Organizations 

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

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

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

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

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

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

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

home medication services and associated costs. 

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

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

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

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

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

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

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

consistent with our results from our two other methodologies. 

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

explained previously, use of this term in reporting concerns with a 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 

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

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

involved in the process. 

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

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

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

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

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

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

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

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

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

The full text of each organization’s comments is provided in Appendix E. 

V 
TABLE OF CONTENTS 

EXECUTIVE SUMMARY 

INTRODUCTION 

METHODOLOGY 

FINDINGS 

Quality of Care Issues 

Shortcomings of Medication Reviews 

RECOMMENDATIONS 

COMMENTS ABOUT DRAFT REPORTS 

ENDNOTES 

APPENDICES 

Inappropriate Medications for Elderly Persons 

Nursing Home Patient Records Requested 

Pharmaceutical Desk Review Form 

Departmental Comments About Inspection Draft Reports

4 

Comments by External Organizations About Inspection Draft Reports 

1 

7 

9 

9 

11 

14 

16 

18 

A-l 

B-l 

C-l 

D-l 

E-l 
INTRODUCTION 

PURPOSE 

To assess the extent and appropriateness of pharmaceutical use by selected Texas nursing 

home residents and to describe pharmacists’ concerns about drug use. 

BACKGROUND 

Long-Term Care and Prescription Medications 

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

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

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

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

Payments for prescription drugs represent a large portion of 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.2 This suggests 

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

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

Medicaid prescription drug expenditures. 

Potential Health and Cost Problems 

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

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

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

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

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

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

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

$77 billion each year.4 

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

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

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

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

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

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

well as our senior citizens are paying the high cost of failed drug therapy.6 Not only do 

the elderly use prescription drugs more than any other age population, they also tend to be 

taking several drugs at once, increasing the probability of adverse drug reactions.‘,* The 

elderly may also eliminate these medications from their system less efficiently than those 

younger due to decreased bodily functions. 

1 
Studies also suggest more subtle effects of inappropriate medication usage among the 

elderly, such as loss of cognitive or physical function and the potential for increased falls. 

Researchers have concluded that a number of prescription drugs used by the general 

population should not be prescribed for elderly patients (see Appendix A). Yet, the 

General Accounting Office reported that the Health Care Financing Administration’s 

(HCFA) Office of the Actuary in 1992 found 17.5 percent of the 30 million senior citizens 

receiving Medicare benefits had received at least one medication inappropriate for use by 

the elderly. Today, many equally effective drugs are available which present fewer risks 

for elderly patients.’ 

Regulation and Control of Prescription Drug Use in Nursing Facilities 

Omnibus Budget Reconciliation Act of 1987 

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

required the regulation of certain drugs in nursing facilities. On October 1, 1990, HCFA 

implemented regulations which hold nursing facilities accountable for monitoring 

medication usage. lo Significant requirements for pharmaceutical care of nursing home 

residents include provisions regarding Pharmacy Services (drug regimen review), Quality 

of Care (drug therapy), Resident Rights (self-administration of drugs), Resident 

Assessment, and Infection Control. Additionally, physicians must justify the use of 

antipsychotic drugs based on specific diagnoses and observe specific parameters within 

which these drugs may be used. 

~ 

II Nursing Home Patients, Medications, and OBRA 1987 

/I 

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

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

I possible functional status. This status is defined by a comprehensive 

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

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

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

subsequent regulations also recognize the valueof medication therapy by 

defining certain limitations: 

1) patients must not receive unnecessary medications; 

2) patients cannot be prescribed antipsychotic drugs unless they are 

appropriate for a specific patient condition; 

3) patients prescribed antipsychotic drugs will receive gradual dose 

reductions, or behavioral programming in an effort to discontinue the 

drugs (unless clinically contraindicated); and 

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

must also have no significant medication errors. 

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

performing routine facility surveys. To guide the medication-related part of these 

reviews, HCFA developed “Indicators for Surveyor Assessment of the Performance of 

Drug Regimen Reviews, ” standards to assist in assessing the quality of drug regimen 

2 
reviews and for enforcing performance, and “Surveyor Methodology for Detecting 

Medication Errors,” provides the surveyor with a mechanism to evaluate the outcome of 

the entire medication distribution system and to ensure the facility error rate is less than 

five percent and that residents are free of risk from significant medication errors. Several 

States have proven the five percent error rate to be a target figure now more easily 

obtained and, additionally, HCFA is considering lowering this target rate for hospitals to 

two percent. The HCFA also released revised interpretive guidelines relating to 

medication usage in nursing facilities which provide tools for identifying medication 

errors, and even include a list of specific drug therapy circumstances which may constitute 

potential drug irregularities. None of these standards is routinely shared by HCFA with 

consultant pharmacists who conduct the nursing home pharmaceutical reviews. 

As a final step in the implementation of OBRA 1987, in July 1995 HCFA released new 

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

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

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

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

to residents of other nursing facilities across the region, State, or nation. Again, none of 

these potentially useful changes were disseminated to consultant pharmacists. 

Omnibus Budget Reconciliation Act of 1990 

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

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

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

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

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

CFR 483.60), practicing pharmacists are expected to: 

1) prospectively review the 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 

3 
both the role and the responsibility of the pharmacist in patient healthcare understanding, 

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

environments. 

Role of Consultant Pharmacists 

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

concerns related to medication prescribing and administration practices which, when 

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

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

consultant pharmacists. These consultant pharmacists are supposed to conduct monthly 

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

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

Consultant pharmacists are also required to: 

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

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

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

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

physician and director of nursing. 

Some of the potential benefits of the consultant pharmacist role in nursing homes are the 

reduction of excessive medication usage, improvement in patient quality of care, and 

decreased cost for medication usage. Pharmacists may also help medical and nursing 

personnel significantly improve medication therapy for patients in nursing homes which, 

in turn, can help reduce total health care costs,12 particularly for those changes resulting 

from fewer medications being taken, more appropriate medications being prescribed, and 

fewer costly adverse reactions being experienced. Yet, there are no standards for either 

drug regimen reviews or drug utilization reviews provided by HCFA to consultant 

pharmacists. There are only minimal conduct requirements for medication reviews and no 

standardized process, common definitions, administration, or quality assurance process for 

this requirement. Thus, there is no acceptable means for comparing reviews, findings, or 

patient outcomes between nursing homes or consultant pharmacists, let alone between 

States. 

Patient Assessment and Plan of Care 

As part of the nursing home’s assessment process for each patient entering the facility, the 

required Resident Assessment Instrument provides a standardized process for reviewing 

each patient’s functional capacity. This, in turn, leads to the individual Plan of Care 

specific to that patient’s identified needs. These two documents could be of considerable 

help to consultant pharmacists in monitoring patient medication for desired care outcomes. 

However, many consultant pharmacists reported in the prior phase of this inspection that 

resident assessments and care plans are not routinely used as part of their medication 

reviews. l3 

4 
The Resident Assessment Instrument includes tools which could facilitate a pharmacist’s 

medication review for a nursing home patient. One collects a minimum amount of 

information needed to evaluate each patient (the Minimum Data Set); the other identifies 

any conditions that may require further assessment (“triggers” from the Resident 

Assessment Protocols). As part of the assessment, section 0 reviews patient medications. 

The HCFA developed a drug class reference list of specific drugs to ensure that 

categorization and identification of patient drugs is standardized for surveyors and other 

personnel using the Resident Assessment Instrument (to ensure everyone is defining a drug 

in the same class). Again, these tools are not routinely shared with consultant pharmacists 

nor are they required for use in conducting patient medication reviews. 

The Minimum Data Set Drug Class Index groups specific drugs a patient may be taking 

into the four OBRA categories (antianxiety drugs, antidepressants, antipsychotics, and 

hypnotics) and adds diuretics. The HCFA list also identifies which specific drugs in the 

five categories are inappropriate for the elderly. It should be noted that the Beers list 

(Appendix A) includes the same drugs as the HCFA list. However, the Beers list is more 

extensive and includes drugs of other types which are also inappropriate for the elderly 

(i.e., certain pain medications, medications for blood circulation or blood pressure, etc.). 

Yet, neither the HCFA list nor the Beers list are required or suggested for use by 

consultant pharmacists as part of their medication review process. 

Physicians Determine What Is Appropriate For Each Patient 

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

opinion. Ultimately, for nursing home patients, it is either the 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.14 The physicians 

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

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

Generally, the nursing 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 pharmucy protocols; 

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

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

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

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

patients or providing quality care. 

5 
OBRA 1987 requires that the pharmacist report any identified irregularities to the 

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

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

any 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 Elderly15 

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

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

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

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

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

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

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

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

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

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

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

suicide. 

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

affecting the elderly 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. 

6 
Research identifies many indicators relating to adverse medication outcomes, some of 

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

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

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

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

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

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

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

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

quality of life. 

METHODOLOGY 

Focus of Our Series of Reports 

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

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

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

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

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

in nursing facilities; and 3) a pharmaceutical review of patients’ records to determine the 

extent and appropriateness of prescription drugs utilized by a random sample of Texas 

nursing home residents. 

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

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

used in Texas nursing facilities. The second report, “An Inside View by Consultant 

Pharmacists” (OEI-06-96-00081), focuses on the problems and concerns raised by 

consultant pharmacists based on a national mail survey. The third phase of this inspection 

involved a pharmaceutical desk review of the medical records of a sample of Texas 

nursing home residents, the results of which are included in this report. 

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

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

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

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

New York, and Texas). 

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

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

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

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

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

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

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

7 
and third phases of this inspection. While we recognize that State operations concerning 

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

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

Focus and Methodology of This Report 

Through consultation with pharmacists and nursing surveyors from the Health Care 

Financing Administration and with representatives of the American Society of Consultant 

Pharmacists, we identified nursing home records (administrative and medical) pertinent to 

conducting a desk review for a patient’s pharmaceutical regimen. We selected for review 

254 nursing home patients residing in Texas nursing homes during the period January 1 to 

July 1, 1995. The nursing homes provided each patient’s most recent assessment and plan 

of care, as well as their drug regimen, payment records, and medical records. Any 

additional records to assist in a patient’s medication review were also requested from the 

nursing home. Appendix B identifies both the letter of request to the nursing home and 

the specific records requested for each selected patient. 

We contracted with Integrated Healthcare Auditing and Services, Inc. (IHAS) to provide 

pharmacists experienced in performing patient medication reviews for nursing home 

patients. While there are many methods of performing a medication review for nursing 

home patients, we asked pharmacists to conduct both a general review (an overview of 

each patient’s drug therapy) and a problem-oriented review (focused on each patient’s 

medical problems and their individual responses to their drug therapy). Essentially, these 

pharmacists assessed the appropriateness and impact of each patient’s drug regimen. 

As no standardized tool is available for the conduct of individual patient medication 

reviews, we developed one with help from experts to facilitate the process of recording 

findings for each patient under review (see Appendix C). Additionally, for any patient 

review involving medical concerns beyond the pharmacist’s expertise, a physician having 

geriatric and pharmacological experience was contracted by IHAS to make final medical 

determinations. We do not generalize the contract pharmacists’ findings to encompass all 

Texas nursing home patients, choosing instead to present the findings only in relation to 

the 254 patients reviewed. 

This review was conducted in accordance with ths Quality Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

8 
FINDINGS 

QUALITY OF CARE ISSUES 

Overall, contracted pharmacists consistently identified the same problems and concerns for 

patients as those raised by our analysis of Texas data and the national survey of consultant 

pharmacists. Medication problems and concerns raised collectively by the three 

coordinated reports of this inspection demonstrate the need for stronger monitoring and 

more positive enforcement of existing regulations and required reviews of medication 

usage in nursing homes. 

Medication reviews reveal potentially serious concerns with residents’ drug regimens. 

�  20 percent of residents received at least one drug judged inappropriate for the 

diagnoses in their records. Of these, 32 percent received three or more inappropriate 

drugs, and five percent had seven or more. For some, the inappropriate drugs are 

rather benign, such as acetaminophen or milk of magnesia. However, others received 

psychoactive drugs such as diazepam and Prozac or drugs normally used to treat 

cardiac or cardiovascular problems and which are likely to pose greater dangers when 

inappropriate for a patient’s condition. Additionally, based on available patient 

records, contract pharmacists identified patients taking medications potentially 

inappropriate according to the patients’ diet requirements (17 percent), plans of care (8 

percent), or by the resident assessments (6 percent). 

�  16 percent of residents had no prescription in their records to support one or more of 

the drugs in their regimen for which a prescription is generally required. This finding 

reflects those drugs identified in the medical records, including the medication 

administration records, provided by the nursing homes. At a minimum, this finding 

shows a problem with incomplete nursing home records. In the worst case, it shows 

that patients are receiving drugs not ordered. 

The drugs represent nearly 8 percent of the total drugs identified through this review 

and range in type from gastrointestinal preparations and laxatives to antianxiety drugs 

and antidepressants. Additionally, 14 percent of residents are taking over-the-counter 

medications without physician orders. Most of these were for pain control or 

gastrointestinal problems (acetaminophen, Zantac) which may interact with other 

prescribed medications being taken. Further, 23 percent of the patient records 

indicated patients having been prescribed medications for which the records showed no 

orders or receipts to indicate the patient actually received the medication. 

�  Contract pharmacists identified 20 percent of residents whose records indicated use of 

at least one drug considered generally to be inappropriate for the elderly. These 

inappropriate drugs were identified by matching drugs identified in each patient’s 

9 
records against a list of 20 drugs generally considered inappropriate for elderly 

patients by a panel of experts (see Appendix A). Some of these drugs are 

inappropriate because of being outdated and having been replaced by more efficacious 

and less risky alternatives as well as their unique effects on the elderly. As with any 

medication, one should be aware that some medical situations might warrant the use of 

these drugs. Of the patients identified, 21 percent had two or more such possibly 

inappropriate drugs. This confirms findings of the first report of this seriesI in 

which a comparison of Texas drug records with the list found that 20 percent of 

residents received one or more of the listed drugs. 

There are many challenges to prescribing and monitoring medications for elderly nursing 

home patients. Multiple disorders in the elderly combined with patients having five or 

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

than three concurrent disease states, and taking medications which require monitoring 

greatly complicate identification of possible adverse effects of a patient’s medication 

regimen. This complex picture is further compounded by the need to balance what could 

be inappropriate medications against the benefits of relieving or treating diseases which 

warrant such usage for the enhancement or maintenance of an individual’s quality of life. 

Arguably, pharmacists’ professional education gives them valuable expertise and clinical 

knowledge concerning pharmacotherapy. Critical to this expertise and extremely 

important for the nursing home residents is monitoring the effects of medication usage, 

either for maintaining or improving a patient’s health status or to identify any effects of 

medications or disease which may undermine such improvement or maintenance. 

�  Findings of the contract pharmacists indicate that some patients may be experiencing 

unnecessary adverse medication reactions as a result of inadequate monitoring of 

medications. Some of the patients’ records identified medications which possibly 

contributed to their constipation (14 percent), falls (8 percent), or depression (5 

percent). For 9 percent of the patients, their records indicated other adverse effects 

possibly caused by medications. Patients’ records indicated a potentially serious lack 

of necessary monitoring: 

- 19 percent of the patients’ records gave no indication of monitoring for 

medication side effects when required; 

- 23 percent of the records had no indication that required lab testing had been 

performed; 

- 19 percent of the records did not indicate that necessary physical assessments 

had been conducted. 

�  According to available records, 21 percent of residents received medications which 

may sometimes interact negatively with other drugs included in their medication 

regimens. For example, if a patient received both glyburide (oral antidiabetic agent) 

and levothyroid medications, the glyburide may decrease the necessary effects of the 

10 
thyroid medication. However, some negative interactions can be expected when a 

patient has a complex diagnostic picture. Yet, medication interactions may sometimes 

be so severe as to be absolutely contraindicated; medications may represent poor 

therapeutic choices if other therapy choices are available; or the risk of a negative 

interaction may be justified when there are no other treatment options available. 

�  Nearly one-third of residents received more than one drug from the same class, 

sometimes considered a potential hazard unless the drug regimen requires this 

combination for efficacy or to meet the multiple demands and needs of multiple 

disease states for which a patient may be diagnosed. Drugs from the same class may 

produce similar side effects which can be additive, in which case they definitely need 

to be carefully managed. Yet, 19 percent of the records indicate no monitoring for 

appropriate efficacy when warranted. 

Several examples illustrate the concern raised by the contract pharmacists about 

patients taking multiple drugs with additive side effects that require monitoring. One 

example is a patient concurrently receiving nortriptyline (tricyclic antidepressant), 

Prozac (fluoxetine, for treatment of major depression, obsessive-compulsive disorder, 

etc.), and haloperidol (haldol, antipsychotic agent). Another example was a patient 

taking three medications all of which can cause sedation, lorazepam (anti-anxiety agent 

also used for insomnia), cyproheptadine (antihistamine), and perphenazine 

(antipsychotic agent). Another patient was taking two forms of salicylates (aspirin) 

which may result in toxicity; one taking cimetidine (H2-receptor antagonist used for 

treatment of upper gastrointestinal problems such as an ulcer) which may decrease 

absorption of iron salts or increase the effects of temazepam (sleep aide) also required 

by the patient; and another was taking both haldol and amitriptyline for insomnia. 

SHORTCOMINGS OF MEDICATION REVIEWS 

Resident medication records are often incomplete, making it difficult or impossible to 

identify or confirm potential drug regimen problems. 

In many of the reviewed cases, there were a number of records in which our contracted 

pharmacists were unable to find sufficient supporting information to make any definitive 

determination. 

�  As previously stated, 20 percent of residents had clearly documented use of drugs 

inappropriate for the recorded diagnoses. However, another 31 percent of patients’ 

records were insufficiently complete to allow the pharmacists to make determinations 

concerning the appropriateness of prescribed medications for indicated diagnoses. An 

incorrect diagnosis, or no easily available diagnosis, forces pharmacists to work in a 

void. Incomplete records could cause drug regimen problems to be significantly 

understated. 

Nursing homes are required to maintain each patient’s most recent assessment, plan of 

care, and the doctor’s orders which provide much of the necessary information for a 

11 
pharmacist to identify any factors which may negatively affect a patient’s medication 

regimen. Thus, between these three documents, pharmacists should be able to make a 

determination. However, the contracted pharmacists often were unable to make a 

decisive determination because of insufficient records. 

�  Also previously discussed, the contractors identified several patients for whom 

prescribed medications may have contributed to constipation, falls, or depression. 

These situations are often attributable to inappropriate use or dosages of certain drugs. 

However, the contract pharmacists were unable to link these events directly to adverse 

drug reactions because of incomplete resident records (i.e., daily nursing notes were 

not requested, unavailable individual patient drug reviews, lack of orders, etc.). For 

the same reason, they were unable to rule out a resident’s drug regimen as the cause 

of these conditions. 

It should be noted that consultant pharmacists may find themselves in a similar situation of 

not having all the necessary records to fully conduct their reviews. Additionally, by not 

being in the nursing home on a routine basis, they may lack familiarity with the location 

of critical information in a facility’s files. 

Often, contract pharmacists were unable to determine whether a patient had received 

a monthly drug regimen review during the sampled time period. 

Nursing homes did not provide copies of patient’s monthly drug regimen reviews. 

Reasons cited included: 

1) not being able to obtain the individual report from the facility’s consultant 

pharmacist. Most consultant pharmacists provide services to more than one facility 

and their drug regimen review records may be kept at home or in the contracted 

company’s office, rather than at the nursing home. 

2) administrative changes in personnel and multiple record locations. New employees 

are sometimes uncertain as to where certain patient reports are maintained. 

Because there is no requirement to file the drug regimen reports in each patient’s 

clinical record in the facility, reports may beI maintained in numerous possible 

locations. 

3) nursing homes sometimes only maintain a summary report of concerns. The 

facility may not require their consultant pharmacist to provide individual patient 

reports, choosing instead to have a summary report which only identifies patients 

for whom the consultant pharmacist has some concern. 

4) drug regimen reviews were not conducted as required. 

12 
Our contracted medication reviews required much more time than the usual review 

times reported by nursing home consultant pharmacists. Allotting more time for 

conducting reviews can help detect more medication concerns. 

As previously discussed, medication reviews for nursing home patients can be extremely 

complex due to the number of primary and secondary diagnoses patients may have as well 

as the number of medications being prescribed. Contract pharmacists reported patients 

having an average of three primary and three secondary diagnoses and receiving an 

average of ten medications. They reported completing each patient’s medication review in 

an average time of 50 minutes (a few reviews took as little as 20 minutes). Yet, direct 

responses from consultant pharmacists indicated they spend an average of 5-10 minutes on 

each patient’s monthly drug regimen review, with most initial reviews taking 15-20 

minutes. 

The contract pharmacists’ lengthier, more in-depth record reviews identified medication 

problems or concerns for 20 percent of the patients which had not been previously 

identified by the nursing home consultant pharmacists. Their concerns included lack of 

monitoring for efficacy; drugs which were clearly inappropriate for use by elderly 

individuals; inappropriate method of administration (i.e., crushing of sustained action 

drugs); medications inappropriate for diagnoses; medications being received on schedule 

with a duplicate available “as needed” (PRN); some PRN medications not having 

prescriptions; extending duration of drug use beyond the timeframe ordered; providing 

medications for which the patient has allergies; and medications being ordered for dosages 

other than those the patient received. 

Further complicating regular medication reviews can be the number of over-the-counter 

medications being used by the nursing home patients. This record review indicates most 

patients (82 percent) use over-the-counter drugs and nearly 17 percent of these are being 

used without physician orders. Our previous report found that a serious weakness in 

medication reviews is that many consultant pharmacists said they do not review use of 

over-the-counter (OTC) drugs. l7 The principal reasons stated for such non-review are 

that nursing homes do not allow OTC drugs without prescriptions, that nursing staff check 

patients’ rooms for any non-prescribed medications, and that the pharmacists do not have 

sufficient time to do the reviews and therefore are unable to discuss medication regimens 

with patients. 

13 
RECOMMENDATIONS 

Based on the collective concerns raised in this report and the two other reports resulting 

from this inspection, “An Introduction Based on Texas” (OEI-06-96-00080) and “An 

Inside View by Consultant Pharmacists” (OEI-06-96-00081). we recommend that HCFA 

work with the States and others to improve the quality of prescription drug care in nursing 

homes. To accomplish this objective, HCFA should: 

1. Continue to monitor and encourage reduction in the use of potentially 

inappropriate prescription medications by the elderly nursing home population.18 

2. Work with other interested government entities, such as the Assistant Secretary 

for Planning and Evaluation and the Agency for Health Care Policy and 

Research, to: 

a. Identify and analyze reasons for and the appropriateness of cost escalation for 

certain types of drugs used in nursing homes (i.e., gastrointestinal, 

psychotherapeutic, cardiac, cardiovascular, and anti-infectives)” and 

b. Examine resident and facility-specific characteristics and drug utilization data to 

better understand the factors contributing to the differences between nursing homes 

in the costs of prescription medications used by patients. 

3. Strengthen the effectiveness and impact of medication reviews conducted by 

pharmacists in nursing homes by: 

a. Providing guidance to medical, nursing, and pharmaceutical personnel on handling 

notifications about medication concems;20 

b. Requiring pharmacists to consult patient assessments and plans of care in the 

conduct of their medication reviews; 

c. Reviewing and updating routinely Appendix N of the Survey/Certification protocol; 

the Drug Class Index of the Minimum Data Set, Section 0; Appendix P, guidelines 

for psychopharmacologic medications used in long term care facilities; and any 

other related medication policy and procedureszl and ensure that consultant 

pharmacists routinely conduct drug regimen reviews using these protocols as one 

set of available tools for improving their reviews but also for helping to ensure 

they conduct reasonably complete reviews. It may be that HCFA could require 

nursing homes hiring or contracting with pharmacists to provide these tools; and 

d. Encouraging prescribing physicians to provide clinical outcome expectations for 

medications prescribed and requiring pharmacists to monitor for these 

expectations. 22 

14 
4. Enforce and enhance HCFA’s training requirement of personal care staff (nurse 

aides) (i.e., aides’ training curriculum should include information on how to 

recognize and report behavioral signals or signs of possible contraindications, 

adverse reactions, or inappropriate responses to medications).23 

5. Strengthen and enforce coordination, communication, and patient documentation 

in nursing homes by: 

a. Exploring the feasibility of requiring nursing facilities to maintain in one central 

location all records pertinent to a patient’s medical care; 

b. Requiring consultant pharmacists to document each patient’s medication review and 

resulting actions; and 

c. Requiring that pharmacists’ concerns always be reported to the attending physicians 

and nursing home medical directors, as well as to the Directors of Nursing. 

6. More vigorously pursue enforcement of positive resident health outcomes. As 

part of this pursuit, HCFA should require pharmacist’s direct input to achieving 

optimal clinical outcomes for residents (i.e., fewer falls or pressure sores as well 

as less frequent urinary incontinence, which can all be exacerbated by certain 

psychopharmacological, cardiovascular, and other drug therapies).U Options for 

HCFA to consider: 

a. Encouraging consultant pharmacists, nursing home medical staff, and physicians to 

become more familiar with HCFA’s defined quality of care indicators which are 

related to pharmacy services and which may enhance pharmaceutical patient 

outcomes; 

b. Encouraging consultant pharmacists to interact with (counsel and inform) patients 

as part of their medication reviews; and 

c. Including in State and Federal surveys, process-focused reviews of pharmacists’ 

recommendations and subsequent actions by appropriate medical and nursing 

personnel, and the resulting clinical outcomes for the patients. 

15 
COMMENTS ABOUT DRAFT REPORTS 

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

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

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

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

of those providing comments. 

Departmental Comments 

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

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

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

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

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

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

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

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

Appendix D. 

Comments from External Organizations . 

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

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

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

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

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

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

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

home medication services and associated costs. 

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

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

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

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

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

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

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

consistent with our results from our two other methodologies. 

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

explained previously, use of this term in reporting concerns with a 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 

16 
warranted. Also, while the use of such a drug may be supported by physician orders in 

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

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

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

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

these particular issues did not result in direct recommendations about the 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 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 Appendix E. 

17 
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 Phamzacy, 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. 

Office of Inspector General, Office of Evaluation and Inspections, “Prescription 

Drug Use in Nursing Facilities: An Inside View by Consultant Pharmacists” (OEI06-96-0008 1)) November 1997. 

18 
14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

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

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

Merck Manual, 15th edition. 

Office of Inspector General, Office of Evaluation and Inspections, “Prescription 

Drug Use in Nursing Facilities: An Introduction Based on Texas” (OEI-06-96-

OOOSO),November 1997. 

Office of Inspector General, Office of Evaluation and Inspections, “Prescription 

Drug Use in Nursing Facilities: An Inside View by Consultant Pharmacists” (OEI06-96-0008 l), November 1997. 

This can be accomplished at the State level by assuring the inclusion of nursing 

home residents in the automated prospective drug utilization review programs 

already in place. At the nursing home level, State and Federal surveyors, 

consultant pharmacists employed as a requirement of OBRA 1987, and physicians 

serving as medical directors or primary care physicians should be reminded of the 

dangers associated with these drugs and directed to continue to actively pursue a 

reduction in their use. Finally, similar analysis of data from additional States 

should be undertaken to further assess the extent of the continued use of these 

contraindicated drugs. 

We understand that new and more effective products may be more costly and may 

be the most appropriate for certain patients’ diagnoses. However, this may be only 

one reason for an increase in certain drug costs. In light of concerns expressed in 

the medical literature, further investigation is warranted to determine whether some 

of these drugs are medically necessary. 

This should include defining what constitutes both “acting on” concerns of any 

healthcare team member, including pharmacists, and “documentation of actions 

taken” in records readily accessible to nursing home and other State/Federal staff 

(i.e., in the patient’s clinical record). 

Include both drugs about which there are utilization concerns (H2 antagonists, nonsteroidal anti-inflammatories, narcotics, antibiotics and anti-infectives, and 

gastrointestinals) and drugs which in many instances may be inappropriate for use 

by elderly persons. 

We recognize that most clinical expectations are clearly indicated by the prescribed 

medication, it may not be reasonable to expect that those outcomes have been 

clarified for the remaining members of the healthcare team. 

While we do not believe nurse aides should be able to identify specific probable 

causes for changes they observe, they should be sufficiently aware that those 

changes may be reflective of possible clinical problems. As part of HCFA’s 

required on-going training of personal care staff (nurse aides), and as pharmacists 

19 
are either directly or indirectly currently employed by the nursing homes to 

perform drug regimen reviews, pharmacists could provide the necessary in-service 

training on the recognition of possible behavioral signals or signs of potential 

contraindications, adverse reactions, or inappropriate responses to medications. 

However, HCFA could explore cost-effective alternatives to pharmacists providing 

this training. 

24. Nursing homes, like physicians, have a major responsibility for resident quality of 

care. This includes efforts to ensure, promote, and encourage necessary 

communication and corrective actions for health concerns raised by any healthcare 

team member. Clearly, pharmacists performing medication review services, either 

as nursing home employees or contractors, are an integral part of the healthcare 

team. 

4 

20 
APPENDIX A 

20 Drugs Experts Consider 

Inappropriate for the Elderly 

The 20 drugs listed below were judged generally inappropriate for elderly patients by a panel of 

experts. The panel’s results and methodology, published in 1991 and used consistently since that 

time, indicate that these drugs should normally not be used with elderly patients. However, they 

stress that there could be some medical situations in which use of these drugs would be appropriate. 

Further, it should be noted that this list constitutes a minimum of drugs not considered appropriate 

for the elderly and could be revised to include others. 

Medication 

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 

benzodiazepines are 

safer alternatives 

Minimally effective 

while causing 

toxicity; potential 

for toxic reaction 

is greater than 

potential benefit 

A -2 
Medication Use 

Orphenadrine To relieve severe 

pain caused by 

sprains and back 

pain 

Pentazocine To relieve 

moderate to severe 

pain 

Pentobarbital As a sleeping pill 

and to reduce 

anxiety (hypnotic) 

Phenylbutazone To relieve the 

pain and 

inflammation of 

rheumatoid 

arthritis 

Propoxyphene To relieve mild to 

moderate pain 

Secobarbital As a sleeping pill 

and to reduce 

anxiety (hypnotic) 

Trimethobenzamide To relieve nausea 

and vomiting 

Source : 

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 

Nursing Home Patient Records Requested 

For an identified review period, nursing homes for the selected 254 patients were asked to provide 

any patient record, including the initial Patient Assessment and Plan of Care, related to the initial 

admit of the patient to the facility. For the time period related to each patient’s indicated stay 

period in the nursing home, nursing homes were also asked to provide any subsequent changes as 

well as the following items specific to the time period under review: 

Patient Assessment/Evaluation(s) 

Plan(s) of Care 

Medication Administration Records 

Physician Prescriber Orders 

Physician Prescriber Progress Notes 

Behavioral Monitoring Sheets 

Laboratory Orders 

Laboratory Reports 

Incident or Accident Reports 

Nursing Monthly Summary Progress Report(s) 

Nursing Quarterly Summary Report(s) 

Drug Regimen Review(s) 

Consultant Pharmacist Review and Remarks Sheet(s) 

Consultant Pharmacist Quarterly Report(s) 

Consultant Pharmacist Correspondence (related to patient reviews) 

Facilities were also asked to provide any additional documentation including assessments by other 

providers which may impact medication therapy (i.e., diet, therapists, etc.). 

The table below provides a sample of the letter sent to the nursing homes for the required records. 

B-l 
Letter to Nursing Homes for Required Records 

) Dear Nursing Home Admimsrraror: 

The Office of Evaluatton and Inspecuons.pan of rhe Office of Inspector General. conductsnational program eraluar~ons. Although orher InspectorGeneral offices 

conduct fraud invesngationsand audits. our function IS IO provide policy makers and managerswnh analysisand recommrndarionsfor improving:programs. 

policies. and regularionsmvolvmg Medxare and Lledicaid We are currenrly involved in an evaluarionto assessthe extem and appropnatenessof drug use b! 

patlen& m nursing homes. 

Your facility has been randomly selected for our review of medicationusage in Texas nursinghomes. Under aurhorlrygrarxed 10 the Office of InspectorGenrral. 

‘, by 42 CFR Section 3525. we are requesrmg rhaf you provide panent records for one or a few randomly seiecred resldenrs Thesr resldeno are ,Wei~~ve rl~yrhle 

‘~ benejicmrres for w/Km Medmwf pardfor rhe srqs in !our/ncr/in durrng 1995 AtrachmentA idennfies the resldenror residents(by name. their Hcakh Insurance 

! Claim Number (HICN) number. and rhe stay date(s)) for whom we require copies of applicableparlent records 

To ensure that we have sufticienr information to conductour review. copies of the nursinghome records should mclude any records rrlared to rhr parirnr’s stay as 

indicatedon the attached list (generally. a 3.month period). Additionally. we need any patient specific record for rhe firsu’initialadmisslonto your facrlity. The 

, following records are requestedfor each resident: 

1. Pamien* m for the first/initial admission fo your facility 

2. Patimt ~sEv&&km4s1 for fhe period specified in Attachment A (hereafter referred to as the “stay1 

3. R3n of Crs for the first/initial admission to your facility 

4. l%~Itl of Crs for the period related to stay 

. . . 5. AdmsbWm Ibawds (MARI for the period related to stay 

6. Phy&h~ - olda for the period related to stay 

7. R@tim Rgcrba Roqsrr NCROS for the period related to sfay 

. . a. Mmtamg Sbets for the period related to stay 

9. IAS adas for et.9 pertod related to stay 

10. Id F@ats for the period related to stay 

11. Wa Q Accklmt lbpaa for the period related to stay 

12. Mus@j ManMy Smmq Rogsn Rapm for the period related to stay 

13. m Qmfuiy Summy Rapat for the period related to stay 

14. Drup w kpat to m for each month for the period related to stay 

15. Ihug UtSzdm Raort for the period related fo stay 

16. c -ttRpmrcht-rd- Sheaf for each specified patient for the period related to stay 

17. phamvirt w Rport for the period related 10 stay 

18. Rpmrcirt canrpmdacs to/from physicianlsl. Director of Nursing, or other regarding patient’s medication therapy or 

associated issues including lab issues related fo medicationlsl for the period related to stay 

19. m pm&t avln(mnr conducted by other professional personnel impacting medication therapy (e.g.. Dietary Evaluation. 

PsychiatrWPsychologic evaluation. Social Evaluation. Dental, etc.1 for the period related 10 stay /’If you determine that other information would be valuable to our assessment of drug usage, please provide this information, as well. 

I Instructions 

. All copies must be complete, clear, and legible. 

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

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

Sheet for October, etc.) Thts is to ensure that the medical consultants performmg the review will be able to easily identify the type of 

information they are reviewing. 

. The attached form Mttachment B1 must be filled out as a summary sheet for each patient for each stay indicating which forms you have 

copied in relation to the indicated stay and are sending to this office. In a few cases this might necessitate duplicate copying Of some 

records. However, it is very important that all records associated with each patient’s stay be a complete, stand alone package. 

. If forms are unavailable, indicate this in the space provided, giving the reason for not provtding that form (e.g.. not maintamed in / 

this facility; unable to locate; etc.). II 

I, 

. If additional or other types of records are provided, but not listed on the attached form, add the type to the list under the I: 

category “Other.” I/ 

. Please mail the requested information to this office by November 18 using first class or overnight mail. (1 

If you have any questions regarding this request, or if you will be unable to provide the requested records by November 18, please contact Leah 11 Bostick or Kevin Golladay at 11800-848-8960. Thank you very much for your assistance and prompt response. 1, 

I

[Appendix B to the letter is not included.] -

B-2 
APPENDIX C 

Pharmaceutical Desk Review Form 

Medical Review Screening and Certification 

Patient Name: 

Patient Sample #: 

Medicare Number: 

Nursing Facility: 

Medical Record #: 

Sample Stay Period: 

NURSING FACILITY PATIENT DIAGNOSES 

Primary Diagnosis 

1. 

DOB: 

Gender: M/F 

To (3 months, generally) 

Secondary or Co-Morbidities 

CONTINUE WITH MEDICATION SUMMARY SHEETS 

COMPLETE MEDICAL REVIEW SCREENING AND CERTIFICATION 

C-l 
---..- _.. __--- __- -.. 

1- ---. .-..- “.--_l_--..-.---.~- -- 
PAGE I OF 4 2 3 4 $5 6a 6b *I 8 9 IO II I2 

NDC X FOR MED ON NDC LIST MED IN MED RX Rx SPECIFIES M.D. ORDERS ORDERS MI> OKDLRS PRN 0RDI:RED OTC 

MEDICATION BUT NOT IN RECORDS INAPPROPRIATE AVAILABLE NO GENERIC INCOMPLETE IIAVE (‘OKKI,(‘l’, 

MEDICATION NAME RECORDS BUT NOT ON FOR DIAGNOSIS SUBSTITUTION SPECI1.K (‘IJKKI;NI 

NDC LIST DIKECTIONS WIII:N 

FOR USAGt SIGN1.I) 

I 

2 

3 

4 

5 

6 

I 

8 

9 

IO 

II 

I2 

13 

14 

I5 

CODE: 

PATIENT LAST NAME MEDICATION SUMMARY SHEET PATIENT SAMPLE # 

PAGE I OF 4 2 3 4 $5 6a 6b *I 8 9 IO II I2 

NDC X FOR MED ON NDC LIST MED IN MED RX Rx SPECIFIES M.D. ORDERS ORDEKS MI> OKDLRS PRN 0RDI:RED OTC 

MEDICATION BUT NOT IN RECORDS INAPPROPRIATE AVAILABLE NO GENERIC INCOMPLETE IIAVE (‘OKKI,(‘l’, 

MEDICATION NAME RECORDS BUT NOT ON FOR DIAGNOSIS SUBSTITUTION SPEC1I.K (‘IJKKI;NI 

NDC LIST DIKECTIONS WIII:N 

FOR USAGt SIGN1.I) 

I 

2 

3 

4 

5 

6 

I 

8 

9 

IO 

II 

I2 

13 

14 

15 

CODE: 

“Y” FOR YES “IN” CODE FOR INSUFFICIENT INFORMATION TO MAKE DETERMINATIONS 

“N” FOR NO “NA” FOR NOT APPLICABLE 

“DN” FOR DON’T KNOW 

IF “Y”, Use Remarks Section ‘to explain potential or actual problem __~ 

COMPLETED BY: NAME & TITLE DATE: 

c-2 
PAGE 2 OF 4 ‘13 I4 I5 16 I7 ‘IX 19 20 ‘?I 22 

MED DOSAGE WITHIN DOSE DOSE DOSE NOT DOSAGE OPIYMAL DURATION DIIRATION MEDICAL/MD 

INAPPROPRIATE APPROPRIATE EXCESSIVE INSUFFICIENT ADJUSTED TO INAPPKOPRIATE DURATION INSUFI~I(‘II:N’I I:X(‘i:SSIVE JUSTIFICA’~ION 

MEDICATION NAME FOR ELDERLY SUGGESTED COMPENSATE FOR FORELDERLY (I.ONGI:K ‘I-IIAN AVAII.ABl.li 

RANGE REDUCED AI’I’KOPKIATL) FOK LONGI:K 

RENALItIEPATIC I)lIKATION 

FUNCTION 

I 

2 

3 

4 

5 

6 

I 

8 

9 

I 0 

II 

I2 

13 

I4 

I5 

CODE: 

--- 

PATIENT LAST NAME MEDICATION SUMMARY SHEET PATIENT SAMPLE # 

PAGE 2 OF 4 ‘13 I4 I5 16 I7 ‘IX 19 20 ‘?I 22 

MED DOSAGE WITHIN DOSE DOSE DOSE NOT DOSAGE OPIYMAL DURATION DIIRATION MEDICAL/MD 

INAPPROPRIATE APPROPRIATE EXCESSIVE INSUFFICIENT ADJUSTED TO INAPPKOPRIATE DURATION INSUFI~I(‘II:N’I I:X(‘i:SSIVE JUSTIFICA’~ION 

MEDICATION NAME FOR ELDERLY SUGGESTED COMPENSATE FOR FORELDERLY (I.ONGI:K ‘I-IIAN AVAII.ABl.li 

RANGE REDUCED AI’I’KOPKIATL) FOK LONGI:K 

RENALItIEPATIC I)lIKATION 

FUNCTION 

I 

2 

3 

4 

5 

6 

I 

8 

9 

I 0 

II 

I2 

13 

I4 

I5 

CODE: 

I

“Y” FOR YES “IN” CODE FOR INSUFFICIENT INFORMATION TO MAKE DETERMINATIONS 

“N” FOR NO “NA” FOR NOT APPLICABLE 

“DN” FOR DON’T KNOW 

IF “Y”, Use Remarks Section to explain ___~~~.~ potential or actual problem .___.~ - ~~~~~.~ ~-

COMPLETED BY: NAME & TITLE DATE: 

c-3 
PATIENT LAST NAME MEDICATION SUMMARY SHEET PATIENT SAMPLE # 

PAGE 3 OF 4 23 *25 ‘26 21 28 29 30 31 32 ‘33 

APPROPRIATE & CORRECTROUTE MEDICATION IS OF NEGATIVELY MAR NECESSARY MONITORING GI:NDL:R AI.LERGY NftiATlVLLY 

ACCURATE OF SAME DRUG CLASS INTERACTS REFLECTS LAB TESTING FOR SIDE CONTRA- (‘ONTRA- INTERACTS 

MEDICATION NAME ADMINISTRATION ADMINISTRATION AS OTHER ME0 WITH OTHER DOSE AS FOR ROUTINE. EFFECTS INDl(‘ATlON INDICATION wrrtl 

TECHNIQUE BEING TAKEN MEDS BEING PRESCRIBED ON-GONG DIIiT/I~00D 

(SPECIFY OTHER TAKEN (SPECIFY MONITORING 

DRUG8 OTHER DRUG#) 

I 

2 

3 

4 

5 

6 

L

“Y” FOR YES “IN” CODE FOR lNSUFFlClENT INFORMATION TO MAKE DETERMINATIONS 

“N” FOR NO “NA” FOR NOT APPLICABLE 

“DN” FOR DON’T KNOW 

IF “Y”, Use Remarks Section to explain potential or actual problem 

p-------. .-__--~~ ~~~~- ___~ ~_=~..~~~_~~~. 

COMPLETED BY: NAME & TITLE DATE: 

c-4 
PATIENT LAST NAME MEDICATION SUMMARY SHEET PATIENT SAMPLE # 

PAGE 4 OF 4 34 35 36 *37 38 39 40 41 42 43 44 45 45 

CONTRlauTtD CONTRlWTED CONTRIBUTED CONTRlBUTED rxmTRlB”TED MLD Mm PHYSICAL 

CODE: 

“Y” FOR YES “IN” CODE FOR INSUFFICIENT INFORMATION TO MAKE DETERMINATIONS 

“N” FOR NO “NA” FOR NOT APPLICABLE 

“DN” FOR DON’T KNOW 

IF “Y”, Use Remarks Section to explain potentialor actual problem 

COMPLETED BY: NAME & TITLE DATE: 

C-5 
Remarks Section 

Use this page for additional information related to medication concerns marked in columns 

MEDS# COLUMN # REVIEWER’S NOTES 

Attach additional page[s], if needed 

C-6 
Medical Review Screening and Certification 

After completing the Medication Summary Sheet for this patient, answer the following questions. 

1. Did the consultant pharmacist for the nursin home identif the same concerns as you did? 

zI - I- .x-a- OI.D..x.“x*.lx..l.-x..l*O.101 Cl10IrcRIDIrr11011x. Y i 1011xIexr .x1.L ?

If NO, which medication(s) and questions(s) were not identified? (Use numbers from the 

Medication Summarv Sheet form to identify.) [ #reflects medication & reflects column 

number] 

# Q-’ Comment 

# Q-’ Comment 

# Q-’ Comment 

# Q-’ Comment 

REFER TO IHAS PHYSICIAN FOR CERTIFICATION. m if you feel necessary to confirm 

your findings. 

2. Did the consultant/pharmacist for the nursing home relay the concerns to the appropriate 

medical personnel?” 

- YES - NO

If NO, which medication(s) and question(s) did they not relay (use numbers from the 

Medication Summary Sheet form to identify. [#reflects medication & Q reflects column 

number] 

# Q 7Comment 

# Q 7Comment 

# Q.-w, Comment 

# Q-7 Comment 

REFER TO IHAS PHYSICIAN FOR DOCUMENTATION. m if you feel necessary to 

confirm your findings. 

3. Was there follow-up action taken to correct the concerns of the nursing home’s consultant 

pharmacists? 

- YES - NO - NA

4. Was the action appropriate to correct the concerns you identified? 

- YES- NO NA

If NO, what should have been done (that wasn’t)? 
--- 

-- -- -- -- -- -- 

--- 

Drug Use by Texas Nursing Home Patients 

M.D. Referral/Decision Form 

Patient Name: Referral Date / / 

Patient Sample Number: 

Medicare Number: 

REASONS FOR REFERRAL: 

1. Pharmacist questions the following numbered items on the Medication Summary Sheet form: 

[#reflects me#dicat$ & Q#reflcts col;mn rmber] 

# Q #Q #Q 

2. Incomplete File 

3. Pharmacist unfamiliar with a particular medication 

4. Other 

Pharmacist Requesting Referral 

Print Name 

TO BE COMPLETED BY M.D. 

(M.D. Decision) 

Agree with IHAS Pharmacist’s Determination 

Disagree with IHAS Pharmacist’s Determination 

(Note: If the MD agrees or disagrees only in part, s/he must be specific as to each question raised 

by the pharmacist above). 

Reason(s) for Disagree 

M.D. Comments 

Print M.D. Name M .D . Signature 

Date Review Completed I / Amount of time for review by 

(Minut$* 

C-8 
APPENDIX D 

Departmental Comments About Inspection Draft Reports 

DATE: SEP 2 3 1997 

TO: June Gibbs Brown 

InspectorGeneral 

FROM: Nancy-Am Min DeParle N & 

Deputy Administrator 

SUBJEXT: Office of Inspector General (OK?) Draft Report: “Prescription Drug Use in 

Nursing Facilities: An IntroductionBasedon Texas,” (OEI-06-96-00080) 

We reviewedthe above-referencedreport that describesthe extent and appropriatenessof 

drug use by Medicareand Medicaid residents of Texas r~ursing homes. 

Paymentsfor prescription drugs representa largeportion of Medicaid’sexpendituresfor 

nursing homes. In fiscal year 1995, Medicaid payments for prescriptiondrugsreached 

$9.8billion. Medicaidprovided servicesfor 1.7million nursinghome residentsiu the 

sameyear. Prescriptiondrug costs are estimatedto rangefrom $600to $1000per 

resident. This implies that between$1 billion and $1.7billion of those paymentswent 

for prescription drugsin nursing facilities. Additionally,severalrecent studies suggest 

that the use of inappropriate or contraindicateddrugsis a contributingfactor to the high 

health Carecosts in the elderly population. 

To assessthe extent of prescription druguse by dually-eligibleresidents, OIG obtained 

Medicaid data for nursing home r&dents in Texas for calendar years 1992-94 and the 

first 6 months of 1995. This data collection and extractioneffort was a part of OK’s 

joint Texas DatabaseProject. 

The Health Care Financing Administration(HCF’A)concurswith all of OIG’s 

recommendations, Our detailed commentsare as follows: 

OIG Recowdation 1 

HCFA should continue to monitor and encouragereductioniu the use of contraindk~ed 

prescription drugs in the elderly population. 

D-l 
HCFA ResDonse 

We concur. This cambe accomplished at the state level However, states are not required 

to ixIude nursing facility (NF) residents in the automated prospective drug utilization 

review (DUR) programs unless the NF is not in compliance with drug regimen review 

requirements specified in 42 CFR 483.60. This regulation, and the statute at 

section 1927(g)(l)(D) of the Social Security Act, preclude any Federal action to require 

DUR for drugs dispensed by NFs that are in compliance with Federal requirements. The 

requirements specify that states are not required to ‘perform additional drug use reviews 

with respect to drugs dispensed to residents of nursing facilities which are in compliance 

with drug regimen review procedures , , t , ” HCFA will continue to monitor data from 

states that included this population in the automated prospective DUR programs. 

At the facility level, state and Federal surveyors, consultant pharmacists employed as a 

requirement of the Omnibus Budget Reconciliation Act of 1987,and physicians should 

be reminded of the dangers associated with these drugs and directed to continue to 

actively pursue a reduction in their use. 

Most state Medicaid agencies distribute newsletters that relate concerns regarding drug 

problems, such as drug contraindications in the elderly population, to pharmacists and 

physicians in the state. Also, information sharing among state Medicaid agencies in 

forums such as the annual DWRsymposium keeps state and Federal surveyors, consultant 

pharmacists, and physicians abreast of the dangers associated with cmtraindicatedtigs 

andthe elderly, 

HCFAagreesthat similaranalysis of data from more states should be undertaken to 

further assess the extent of continued use of contraindicated drugs. HCFA will ~~~tifm~ 

to act as a clearinghouse by collecting data reported by states in the IXJR aunual reports 

on this subject, and disseminating the information to f&lit&e data sharing among slates. 

IIIaddition,we encourage states that have included NF residents in their DUR prognuns 

to establish relationships with local colleges of pharmacy that may be interestedin 

assessing the extent of the continued use of contraindicated drugs in the elderly 

population. 

OIG Recommendation 2 

HCFA and others should be aware of the significant increases in tie number of claims, 

as well as the rapidly escalating costs for certain types of drugs (especially 

ga~troinmid, psychotherapeutic, cardiac, cwdiovascular, and anti-infectives)used in 

le. 

D-2 
HCFA Response 

We concur. HCFA is aware of the significant increases iu the number of claims, and the 

escalating costs for certain drugs used in NFs in those states that report such information 

in DUR annual repom. HCFA will play a more active role in making state Medicaid 

agencies aware of trends in this area via the HCFA DUR Newsletter, scheduled for 

quarterly publication. The newsletter will share information we receive regarding the 

increase in the use of these drugs in NFs and other information refevant to DUR. We will 

strongly encourage states to share such information with consultant pharmacists, 

physicians, and all providers responsible for ensuring quality care in NY&. 

In addition, HCFA would like OIG to report the extent of possible cost satigs, whether 

they come km cheaper alternative drugs, or from the fact that drugs may not be 

necessary. HCFA would like to know whether the safer and more effective alternatives 

cost less than those drugs presently used. 

PIG Recommendation 3 

Further study should be undertaken, examining data about resident conditions, types of 

specialized care, and other facility-speciSc characteristics, along with drug expenditure 

and usage data, to better understand the factors contributing to the differences between 

NFs in the costs of prescription drugs used by residents. 

HCFA Response 

We concur. Anther study in this area should be undertaken, and HCFA wonld like to 

solicit the help of organizations such as the Agency for Health Care Policy and Research 

to further examine this issue. 

D-3 
OCT 13 1997 

TO: June Gibbs Brown 

Inspector General 

FROM: Nancy-Ann Min DeParIe r\) fl D 

Deputy Administrator 

SUBJECT: Office of inspector General (OIG) Draft Report: “Prescription Drug Use in 

Nursing Facilities: An Inside View by Consultant Pharmacists,” 

(OEI-06-96-00081) 

We reviewed the above-referenced report that describes consultant pharmacists’ concerns 

about drug usage in nursing homes and their perceptions of their responsibilities for 

medication reviews for nursing home residents. 

The Omnibus Budget Reconciliation Act of 1987and subsequent regulations define 

certain limibtions related to drug therapy, Among these, (1) patients must not receive 

unnecessary medications; (2) patients cannot be prescribed antipsychotic drugs unless 

they are appropriate for a specific patient’s condition; and (3) prescribed a&psychotic 

drugs will receive gradual dose reductions or behavioral programming in an effort to 

discontinue the drugs (unless clinically contraindicated). Also, nursing homes must have 

no sign&-ant medication error rates and patients should have no significant medication 

errors. Oversight in the nursing homes for these requirements is performed by consultant 

pharmacists hired to perform a monthly medication review for each resident. As such, 

these pharmacists are a valuable source of information. To take advantage of their 

experience, OIG surveyed a StatisticaJlyvalid sample of pharmacists drawn from a 

stratified random sample of the 17,000nursing facilities. The report represents the results 

of an indepth, structured mail survey of these consultant pharmacists. 

The OIG report suggests that the Health Care Financing Administration (HCFA) work. 

with the states and other responsible entities to impr6ve the effectiveness of medication 

review for patients in nursing homes. HCFA is o&&g the following comments to 

OIG’s suggestions for improvement: 

Informing and Jhcumentinp 

HCFA will explore ways to enhance each of these suggestions to improve communication 

between the pharmacist and physician, but we must point out that facilities have always 

been required to maintain records of the pharmacist review in the facility. The January 

1982 State Operations Manual transmittal which first introduced the Appendix N 

D-4 
guidelines stated, “A record of drug reviews must be maintained in the facility in order to 

demonstrate that such reviews have been performed.” 

The purpose of drug regimen review was to introduce current drug information into the 

facility and to share that information. relative to specific patients, with the medical and 

nursing staffs. HCFA never expected that some pharmacists would keep this information 

to themselves, as is apparently the case in the example OIG described on page 16 in 

which many facilities had trouble providing drug regimen review records because the 

pharmacist “had them in a different location.” 

State and Federal Survey and Certification 

We have been endeavoring to review and update Appendix N for some time and will 

continue to do so in the future. We have devoted considerable time and effort (including 

time in obtaining physician and pharmacist input) to guidelines for psychopharmacologic 

medications for Appendix P (applies to long texmcare (LTC) facilities), and to guidelines 

for intermediate care facilities for the mentally retarded. 

Since Appendix N was adopted, Medicare has changed its policy for payment of 

laboratory tests (i.e., no more orders for tests, especially multiple tests, without good 

clinical indications). This means any laboratory tests referred to in the revision will have 

to address a multitude of “clinical justified conditions,” instead of time periods (in the 

current Appendix N) which are less difficult to define and to reach consensus. 

OIG suggests that HCFA should ensure that consult&t pharmacists routineIy conduct 

drug regimen reviews according to Appendix N pro&c&. Appendix N comes nowhere 

near the scope of the pharmacology that potentially occurs in LTC facilities. Appendix N 

was developed to give surveyors enough information to make a reasonable judgment as to 

whether the pharmacist had conducted a reasonably completejob of drug regimen review. 

Its purpose was never intended for use by pharmacists. Unfortunately, it has been 

per,ceivedby some pharmacists as the entire drug regimen ,reviewrequirement. 

-

D-5 
DATE: 

TO: 

FROM: 

SUBJECT: 

OCT I 4 199-i’ 

June Gibbs Brown 

Iuspector General 

Nancy-Ann Mm DeParle 0 w m 

Deputy Administrator 

Office of Inspector General (OK?)DraIt Report: “Prescription Drug Use m 

Nursing Facilities: A Pharmaceutical Review of Selected Texas Patients,” 

(OEI-06-96-00082) 

We reviewed the above-referenced report that examines the extent and appropriateness of 

pharmaceutical use by selected Texas nursing home (NH) residents and describes 

pharmacists concerns about drug use. This is the third in a series of OIG reports and 

underscores the need to strengthen medication reviews and improve medication 

prescribing, administration, and monitoring practices in NHs. 

The Omnibus Budget Reconciliation Act of 1987(OBRA 1987)and subsequent 

regulations define certain limitations related to drug therapy. Among these are: 

1) patients must not receive unnecessary medications; 2) patients cannot be prescribed 

antipsychotic drugs unless they are appropriate for a specific patient condition; 3) patients 

prescribed antipsychotic drugs will receive gradual dose reductions or behavioral 

programming in an effort to discontinue the drugs (unless clinically contraindicated); and 

4) the NH must have no significant medication error rates. NHs often engage conSultant 

pharmacists to help them comply with these requirements. 

The Health Care Financing Administration (HCFA)concurs with the intent of the report 

recommendations. Our detailed comments are: 

PIG. Recommendation #l 

HCFA should continue to monitor and encourage reduction in the use of comaindic~ed 

prescription drugs in the elderly NH population. 

D-6 
HCFA Resoonse 

We concur. This recommendation refers to a paper by Beers. M.H.. et al., entitled 

“Explicit Criteria for Determining Inappropriate Medication Use in Nursing Home 

Residents,” and published in the Archive of Internal Medicine, September 1991. 

Adoption of these criteria as Medicare gu.ideIineshas been proposed at the staff level in 

HCFA. 

OIG Recommendation #2 

HCFA should identif) and analyze reasons for the rapid escalation in costs and claims for 

certain types of drugs used in NHs (i.e., gastrointestinal, psychotherapeutic, cardiac, 

cardiovascular, and anti-infectives). 

HCFA Resuonse 

We concur. We must detexminethe potential source of this escalation. One potential 

reason for increased costs is the decrease in the use of antipsychotic drugs and the 

increase in the use of antidepressant drugs that are used in long-tetm care facilities. 

HCFA has been encouraging the diagnosis and treatment of depression and the more 

conservative use of antipsychotic drugs since the early 1990s. Since most autipsychotic 

drugs are off-patent and generically available (thus less expensive) and the 

antidepressants being used are not, cost escalations could be occurring because of these 

factors. 

OIG Recommendation #3 

HCFA should strengthen the effectiveness and impact of medication reviews conducted 

by consultant pharmacists in NHs. 

HCFA Response 

We partially concur. Pharmacists have been required to conduct drug regimen reviews in 

Nl-ls since 1974. Appendix N was primarily written for surveyors, but it also serves the 

purpose of defining, for pharmacists, what,is involved in a drug regimen review. 

Appendix N was updated in March of 1985 and again in SepteIubw 1990. Appendix P, 

which contains extensive psychopharmacological drug therapy guidelines, was written in 

D-7 
September 1989 as part of the OBRA 1987initiatives. These guidelines were updated in 

April of 1992, and again in June of 1995. In short, consultant pharmacists have extensive 

government guidance as to what is expected of the drug regimen review. 

We would be willing to more vigorously pursue enforcement of positive resident 

“outcomes” which would require the pharmacist’s input in achieving. For example: falls, 

pressure sores, and urimuy incontinence can be exacerbated by psychoparmacological, 

cardiovascular, and other drug therapy. The pharmacist can be helpful to the nurse and 

physician in mini&&g risk to the resident, which would be a better use of resources 

than investing time in finther Federal regulation of the drug regimen review. 

OIG Recommendation #4 

HCFA should require NHs to provide ongoing, in-service training for personal care staff 

(nurse aides) on how to recognize behavioral signals and symptoms of contraindications, 

adverse reactions, or inappropriate responses to medications. 

HCFA ResDonse 

We concur. However, we believe our current regulations are adequate to cover this type 

of course material. It is important for care givers to recognize these behavioral signs. 42 

CFR section 483.152@)(2)(i) states that the ctic@rn of the nurse aide training program 

must include taking and recording vital signs, and 42 CFR 

section 483.152(b)(Z)(iv)requires the training program to include recognizing abnormal 

changes in body functioning and the importance of reporting such changes to a 

supervisor. While these requirements do not relate specifUly to possible 

contrain&cation~, adverse reactions, or inappropriate responses to medications, we do not 

believe the nurse aides need to be able to identify the probable causes for the changes 

they obsm. Rather, they need to recognize the changes,and report them, promptly, to 

someone who is trained to intervene clinicaIly. Therefore, we do not believe any related 

changes to our regulatim or accompanying guidelines are necessary. 

OIG Recommendation #5 

HCFA should explore the feasibility of requiring NFs to maintain all records pertinent to 

a patient’s care in one location in the NF. 

D-8 
HCFA Resoonse 

We concur and will explore the feasibility of the above recommendation. 

Technical Comments 

Page 12 - We note that of the problems and concerns found by the independent 

pharmacists (called contract pharmacists in the report), 20 percent were not identified by 

the facility’s contract pharmacist. Among the contract pharmacists’ concerns were the 

follow-ing: 

0 lack of monitoring (drug therapy) for efficacy 

0 drugs which were clearly inappropriate for use by elderly individuals 

0 inappropriate method of administration, i.e., crushing of sustained action 

drugs 

0 medications inappropriate for diagnosis 

0 medications being received on schedule when a duplicate order was 

available 

(Note: Duplicate dispensing may be one reason for high drug expenditures 

in Texas.) 

0 some medications not having orders 

0 providing medications for which the patient had allergies 

0 medication being ordered for dosages’otherthan those the patient received 

(Note: These are probably medication errors.) 

Also, we are interested in two questions in the context of the above findings: To what 

degree has the Texas state survey agency identified these problems in the last regular 

survey, and if the Texas state agency did identify these problems, what remedy did it 

prescribe? 

D-9 
--- 

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary 

Washington. D.C. 20201 

TO: June Giblk?Brown 

Inspector General 

FROM: Da\id F. Garrison Mw 

Principal Deputy Assistant Secret&$ 

for Planning and Evaluation 

SUBJECT: OIG Draft Report: “Prescription Drug Use in Nursing Facilities: An Inside View 

By Consultant Pharmacists” Concur with Comment 

We have reviewed the draft OIG report entitled “Prescription Drug Use in Nursing Facilities: An 

Inside View By Consultant Pharmacists” and concur with the following comments on this report. 

I appreciate the OIG’s findings that some pharmacists are having difficulty carrying out their 

responsibilities to assure accurate and adequate administration of prescription drugs in nursing 

facilities. Heartening, however, is the information included in this report that pharmacists 

contracted by the OIG for this study report that nursing homes are complying ‘withthe required 

medication reviews for nursing home residents. Particularly encouraging were the cooperative 

relationships that many pharmacists reported having with physicians, nurses, and administrators 

in these facilities. I believe that the information presented in this report underscores the 

effectiveness of the pharmacists’ reviews -- precisely the result sought by enacting the OBRA 

‘87 provisions. As the IG notes, there is still room for improvement. 

Executive Surnma~~, The body of the report correctly highlights that it isphysician~ who 

determine what is appropriate drug use for nursing home patients. However, the Executive 

Summary o+y references this critical role when recommending that pharmacists inform 

physicians of their medication concerns. We recommend the Executive Summary emphasize 

that prescribing and monitoring medications is the responsibility of the nursing home resident’s 

physician and that many of the problems and concerns raised in this report are not the result of .d 

.poor nursing home practices. 

Pecommendations. Among the “opportunities for improvement” suggested by the OIG are the 

recommendations that Appendix N of the Survey and Certification protocol be reviewed and 

updated, and a list of inappropriate drugs for the elderly be developed. We agree. We 

understand that there are several provisions in Appendix N that are no longer current and that 

recent advances in drug therapy for the elderly have identified several drugs that should never (or 

with rare exception) be used by the elderly. We recommend HCFA implement these 

recommendations. 

D - 10 
Yagb 2 - Jute Gibbs Brown 

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

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

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

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

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

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

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

pharmacists providing this training. 

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

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

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

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

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

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

types of facilities that were the subject of this report. 

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

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

this discussion could be eliminated from the report. 

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

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

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

statement be reconciled. 

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

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

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

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

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

D- 11 
APPENDIX E 

Comments by External Organizations About Inspection Draft Reports 

AMERICAN 6OCIElY OF CONSULTANT PHARMKISTS -

September 29,1997 

June Gibbs Brown 

Inspector Genera1 

Office of Inspector General 

Department of Health and Human Services 

Washington, DC 20201 

RE: Draft reports - prescription drug use in nursing homes 

Dear Ms. Brown: 

The American Society of Consultant Pharmacists is pleased to comment on 

the draft inspection reports related to prescription drug use in nursing homes. 

ASCP is the national professional association representing more than 6,300 

pharmacists who provide medication distribution and consultant services to 

manage and improve drug therapy outcomes of individuals residing in longterm care environments. ASCP members serve the full spectrum of long 

term care settings, including nursing homes, subacute care and assisted living 

facilities, psychiatric hospitals, facilities for the mentally retarded, correctional 

institutions, hospice, and home, care. 

We have reviewed each of the three draft reports and our comments are 

shown below. 

ASCPs Overall Observations 

1. Medications that are generally considered inappropriate for use in the 

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

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

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

justified. ASCP suggests using the term “potentially inappropriate” instead of 

“contraindicated.” 

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

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

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

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

-

ljpl Duke c&eel 

Al-, VA 99314-3563 

703/739-1300 

7034739-1391fax 

inlo8axp.can

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

E-l 
_( . 

I June Gibbs Brown 

Sept. 20. 1997 ragI- 2 

strongly emphasized the rights of indlviduai residents to choose their own 

pharmacy provider, over the rights of the nursing facility. As a result, it is 

common for Texas nursing facilities to be served by five, ten or more 

pharmacy providers, each with only a few patients. 

In this environment, where pharmacy providers serve only a few nursing 

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

geriatric pharmacotherapy and knowledge of nursing facility regulations. As 

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

where nursing facilities are served by one or two primary pharmacy 

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

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

an important complement to the retrospective drug regimen review 

performed by the consultant pharmacist. 

ASCP recognizes the need for expanded knowledge of geriatric 

pharmacotherapy by both physicians and pharmacists. In order to recognize 

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

pharmacists to develop expertise, ASCP created an independent commission 

to certify pharmacists in geriatric pharmacy practice. The first certification 

examination in geriatric pharmacy practice will be administered by the 

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

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

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

patients. 

An Introduction Based on Texas 

3. ASCP’s Overall Observations 

The first report combines information about appropriateness of drug use (e.g., 

medicines not generally considered appropriate for use in the elderly) and 

cost of medicines for nursing home residents. These are two separate issues. 

ASCP suggests presenting this information in two separate sections .to 

highlight the difference. 

Just because the cost of a particular drug category is increasing does not mean 

that medication use in this category is inappropriate. Newer (and more 

expensive) medications often have fewer side effects, especially in the frail 

elderly, and are more effective than older medications. For example, all the 

medications on the list of twenty drugs not considered appropriate for use in 

E-2 
June GibbsBrown 

Sept 29, 1997 

Pap 3 

the elderly are multisource generic products. As patients are switched off 

these products, they are often placed on newer, more expensive medications. 

In the category of antidepressants, amitriptyline is an older tricyclic 

antidepressant with many adverse effects in the elderly, such as urinary 

retention, constipation, and dry mouth. Many nursing home residents have 

been placed on newer agents such as fluoxetine (Prozac) or sertraline (Zoloft). 

These newer agents are better tolerated by the elderly, but are more expensive. 

In the antipsychotic drug category, residents are being switched from older 

agents such as haloperidol (Haldol) and thioridazine (Mellarii) to newer 

agents such as risperidone (Risperdal) and olanzapine (Zyprexa). These 

newer agents are less ljkeiy to produce serious side effects such as tarclive 

dyskinesia and extrapyramida1 symptoms. 

In the cardiovascular category, there is increasing use of ACE inhibitors, such 

as enaIapril (Vasotec) and iisinopril (Zestril), due to recent evidence of benefit 

from these agents in treatment of heart failure and prevention of renal 

dysfunction in diabetic patients. 

4. Page i, Findings, third bullet 

“In 7994 almost 20 vercent, more than 16,600, of Texas’ dually-entitled 

beneficiaries received at Ieast one of twenty drugs considered by medical 

experts to be inappropriate for elderly use due to side effects or other 

consequences. U 

As noted in our introductory comments, prospective drug regimen review 

can be an effective means of preventing or correcting drug-related problems. 

As an example of this, one large long-term care pharmacy provider collected 

data in 1997 on 12,000 nursing facility residents across numerous states and 

found that only 12.9% of residents were receiving a medication on the list of 

twenty drugs identified in the OIG report as not appropriate for the elderly. 

Of these medication orders, 67% were for propoxyphene. 

Increasingly, long-term care pharmacy providers are using tools such as 

formularies, or preferred drug lists, and therapeutic interchange as part of the 

prospective drug regimen review process. When properly applied, these tools 

can enhance efforts to improve drug therapy outcomes in nursing facility 

residents. Please see the attached Ascp Statement on Formula&s in 

Nursing Facilities, ASCP Guidelines for the Development of Formulary 

Systems in Nursing Facilities, and ASCP Guidelines for Implementing 

Therapeutic Interchange in Long-Term Care. 

E-3 
Jme Gibbs Bmwm 

Sept. 29, 1907 

Page 4 

5. Page iii, third recommendation 

“Further stltdy should be rtnderfaken, exmining data about resident 

condifions, types of speclallzed care and other facility-specific characteristics 

along with drlcg expenditure and usage data, tu better understand tfre factors 

contributing to the wide diff erences between nming facilities in the costs of 

prescription drugs med by residents. n 

ASCP strongly agrees with this recommendation. Because of the planned 

impIementation of the Prospective Payment System (PPS) for nursing 

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

variations in costs. ASCP suggests including this recommendation in the 

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

An Inside View by Consultant Pharmacists 

6. Page ii, “Shortcomings of Medication Reviews” 

ASCP suggests changing the title of this section to “Obstacles to Adequate 

Medication Reviews.” The current title implies that inadequate reviews are 

the fault of the consultant pharmacist. In fact, the material presented in this 

section is primarily focused on factors that are beyond the control of the 

consultant pharmacist. 

7. Page ii, fifth paragraph 

“Phnrmacists conduct some reviews without consulting important medical 

records and without having patients diagnoses or laboratory reporfs.” 

The explanatory information makes clear that this information is frequently 

unavailable for review. ASCP suggests changing this wording to 

“Pharmacists conduct some reviews without access to important medical 

records, including patients’ diagnoses and laboratory reports.” 

8. Page ii, sixth paragraph 

“‘illore than half of the reviews do not consider the resident’s assessment (65 

percent) or pkm of care (56 percent).” 

ASCP recommends that consultant pharmacists participate in the assessment 

and care planning process, and use these documents to facilitate the drug 

E-4 
June Gibbs Brown 

Sept. 29,199: 

Page 5 

regimen review. Please see the attached ASCP Statement on the Role of the 

Consultant Pharmacist in Resident Assessment and Care Pianning. 

9. Page iii, item 3 under “Informing and Documenting” 

“Explore the feasibility of requiring nursing facilities to maintain all records 

pertinent to II patient’s care in one location in the nursrng juciiity.” 

AS0 agrees with this suggestion. However, there may be a few appropriate 

exceptions to this requirement. For example, the current Medication 

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

notebook with the medication cart for convenience in distributing 

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

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

10. Page iii, “State and Federal Survey and Certification,” number 1 

“To enhance bofh surveys (Federal or State) of medication usage and monthly 

drug reginzen reviews by consultant pharmacists, HCFA should review and 

update Appendix N of the Survy/Certificntion protocol and any related 

medication policy and procedures.” 

ASCP agrees that Appendix N is obsolete, and we suggest that Appendix N be 

deleted. In its present form, these survey indicators are actually 

counterproductive. What often happens is that surveyors, and even some 

consultant pharmacists, become narrowly focused on these indicators and 

miss other significant findings that would be more important. 

A!XP is planning to coordinate development of a new set of indicators for 

conducting drug rqimen reviews. These indicators will include the list of 

twenty medications considered inappropriate for use in the elderly. We will 

begin with a literature search and seek input and consensus from a broad 

group of consultant pharmacists, geriatric pharmacotherapists, physicians and 

others. These indicatvrs will be updated periodically, and can be used by 

consultant pharmacists, surveyors, and others to evaluate appropriateness of 

drug therapy. ASCP will forward a copy of our new drug regimen revjew 

indicators to HCFA upon completion, no later than July, 1998. 

11. Page iii, “Training of Aides” 

“As part 

pharmacists should provide in-service training on the recognition of signals 

E-5 
JuneGibbsBrown 

Sept. 29, 1997 

Page6 

and possible symptoms of contraindicatrons, adverse reactions, 01 

Inappropriate ;esponses to medications.” 

Nurse aides are currently required to have a minimum of welve hours of 

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

guidelines. ASCP agrees with the recommendation for specific training for 

nurse aides regarding identification of medication side effects. ASCI’ suggesb 

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

training related to detection of medication side effects be recommended for 

nurse aides. 

12 Page 17, fifth paragraph 

“If is inferesfing to note that fully 91 percent of the cons&ant pharmacists 

believe reusing medicafions would yield Federal and State savings (the 

primary exceptions are controlled drugs having Federal or State regulations 

that require destruction or medications in liquid form or vials contaminated 

by prior use). Even though some pkarmacisfs indicated the savings may be 

offsef by many potential administrative costs, 54 percent of the consuitanf 

pharmacists say unused, properly packaged medications could be returned to 

the vendor pharmacy to yedispense for use by others.” 

The issue of return and reuse of medications by nursing facilities is complex. 

ASCP has developed a position statement which explores the various facets of 

this issue. Please see the attached ASCP Statement on Return and Reuse of 

Medications in Long-Term Care Facilities. 

A Pharmaceutical Review of Selected Texas Patients 

13. Page ii, first paragraph 

“22 percent of patients were receiving, without a prescription in their records, 

drugs fir which prescriptions are generally required. Further, 23 percent of 

the patients were prescribed medications for which the records showed no 

orders or receipts to indicate tke patient actually received the medication.” 

This is a high proportion of such orders, and these results are inconsistent 

with the findings in Part II of this report, which showed that 83% of 

consultant pharmacists in the nationa survey rarely or never found a 

medication order not on the MAR. The remainder of the respondents found 

this problem “sometimes.” Ninety-three percent of consultant pharmacists 

rarely or never find a medication listed on the MAR without an order. 

E-6 
June Gibbs Brown 

Sept 29, 1997 

Page 7 

14. Page ii, last paragraph 

“The contract pharmacists idenfijed medicafiotz problems or concerns for 20 

percent of the pntienfs which hud not been identified by the nursrng home 

consultant pharmacists’ reviews.” 

It would be more accurate to say “The contract pharmacists identified 

medication problems or concerns in 20 percent of the patients where there 

was no documentation that these problems had been identified by the 

nursing home consultant pharmacists’ reviews.” Elsewhere in the OIG 

report, it is noted that consultant pharmacists in Texas frequently provide 

some of their findings to the facility in verbal reports or in documents that 

are not a part of their official report. 

15. Page iii, “Recommendations” 

In the final list of recommendations, please include the third 

recommendation from the first report: 

“Further study should be undertaken, examining data about resident 

conditions, types of specialized care and other facility-specific characteristics 

along with drug expenditure and usage data, to better undeqtand the factors 

contributing to the wide differences between nursing facilities in the costs of 

prescription drugs used by residents.” 

16. Page iii, “Recommendations” 

ASCP suggests adding a recommendation that HCFA require consultant 

pharmacist recommendations to be made a part of the resident’s clinical 

record. This recommendation is supported by findings from the national 

survey of consultant pharmacists (see Table 4 and discussion, page 16 of full 

report). Consultant pharmacists document their findings and 

recommendations in the clinical record only about one-third of the time. 

This lack of documentation in the clinical record decreases the ability of the 

consultant pharmacist to cummunicate significant information to the 

interdisciplinary team and nursing facility staff. 

ASCP has long suppotied the documentation of wnsultant pharmacist 

findings and recommendations in the clinical rec&cl. See the attached ASCP 

Guidelines for Documenting Consultant Pharmacists’ Activities in the 

Medical Record. 

E-7 
June Gibbs Eravm 

Sept. 20, 1997 

Page 8 

The American Society of Consultant Pharmacists is pleased to provide these 

comments on the draft report and we hope that these comments will be 

useful in your review and preparation of the final version of this report. If 

you have any questions about our comments, or if additional information is 

needed, please contact Thomas Clark, ASCP Director of Professional Affairs, at 

703739-1316, x123. 

Sincerely, 

R. Timothy Webster 

Executive Director 

enc.: ASCP Statement on Pharmaceutical Care 

ASCP Statement on Formularies in Nursing Facilities 

ASCP Guidelines for the Development of Formulary 

Systems in Nursing Facilities 

ASCP Guidelines for Implementing Therapeutic 

Interchange in Long-Term Care 

ASCP Statement on the Role of the Consultant 

Pharmacist in Resident Assessment and Care Planning 

ASCP Statement on Return and Reuse of Medications in 

Long-Term Care Facilities 

A!XP Guidelines for Documenting Consultant 

Pharmacists’ Activities in the Medical Record 

E-8 
National Association of Boards of Pharrnacyb 

700 BUSSP H’ghway . ParkR:dge /L 60066 

Tel: 847/69&S-727 * Fax b-47/698-0124 

October 1997 

June Gibbs Brown 

Inspector General 

Department of Health &Human Services 

Office of Inspector General 

Washington. DC 2020 1 

Dear Ms. Brown: 

Thank you for the opportunity to comment on rhe draft xqection reports 

describing,the results of the inspections of the issues related to prescription 

chug use in nursing homes. 

We concur with the general findings of the reports calling for strengthening 

medication reviews, improving medication prescribing, administration, and 

monitoring practices in nursing homes. We strongly support increased use of 

the pharmacist in the medication retiew and patient care processes and 

access to critical patient data. 

rther assistance, please do not hesitate to contact me. 

&en A. C&zone, MS, FtPh 

becuttve Director/Secretary f 

.! 

CClmwg 

NABP Executive Committee 

Fxecutive Officers - State Bcurds of Pharmacy 

E-9 

cc 
fkmxkan HCSMIbrekkssochtiotl I:.; L sweet, NW. Washington, DC 20005 4014 

FAX: 202.842-3860 

October 2. 1997 

June Brown 

Inspector 

Department of and Human 

330 Independence Avenue, S. W., Room 5657 

Washington, DC 20201 

Dear Ms. Gibbs: 

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

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

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

this letter. 

We have reviewed all three reports! An Inside J&w by Consultant Pharmacists; An 

Introduction Based on Texas; and A Pharmaceutical Review ofSelecred Texas Putients. 

Although our comments rererence primarily the national document, An View by 

Pharmacists, they applicable to areas of Texas-related drafts. 

Texas stale afliliate member, the Texas Health Care Association, has also 

reviewed the reports and provided comments to us. Those comments are incorporated 

our Icttcr. 

American Health Association is a federation of 50 state health care 

organizations, together representing more than 11,000 non-profit and for-profit assisted 

living, nursing facility, and subacute care providers that care for one million elderly and 

disabled individuals nationally. To be Medicare and Medicaid certified, nursing facilities 

must be in substantial compliance with all requirements of participation at 42 CFR 483 

Subpart B, These requirementi include regulations governing unnecessary drugs, 

antipsychotic drugs, medication errors and pharmacy services, including those related to 

consultant pharmacists and drug regimen review. 

Our comments address four key areas. They are not necessarily all-inclusive but are 

provided to illustrate the problems we found in the dran document discussion and 

recommendations. 

E- 10 
pharmacists asked hrobd and sometimes vague questions. Nevertheless, on the basis 

of responses to these broad questions, the Office of Inspector Gcncrnl Is drawing 

specific conclusions and making extensive recommendaHoas. 

�  Terms such as “concerns” and “inappropriate” are used in se\-eral significant areas of 

the text These are broad terms which need to be broken do\\n into specifics to limit 

variations in their interpretations. The concerns should be specifically described. For 

example, since inappropria/e can be over-use, under-use, wrong drug for condilion. 

or other factors, it should be specifically identified, and the percentage of occurrence 

of that descriptor provided. With more specific terms, the meaning of some of the 

findings would be clearer, and the relevance of some of the solu~io~~s to the rrported 

problems would be more apparent. To assist the reader in understanding the problems 

and recommendations, we also recommend that a copy of the survey instrument be 

included in the final report. 

2. The reports raise valid concerns about physicians’ prescribing practices, lack of 

knowledge or training regarding appropriate medications for the elderly, and 

unresponsiveness to consultant pharmacists’ recommendations. However, our 

reviews found that several recommendations which are made in the drafts either do 

not address these issues or they are targeted toward areas which will not solve the 

problems. They also place the burden of correction on the nursing facility, 

expecting facility’s administration or nursing staff to manage a process over which 

they do not have complete control. 

Page i of the Executive Summary of the hide View draft contains this statement: 

“Pharmacists have serious concerns about prescribing practices for antipsychotics, 

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

The opening paragraph on page two of the Inside View draft states: “It should be 

noted that regardless of any reported concerns by the consultant pharmacist, it is the 

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

nursing.” 

Page 9 of the Inside View draft states: “Many of the consultant pharmacists (40 

percent) assess the extent of cooperation t?om residents’ personal physicians as only 

fair or poor. Consultant pharmacists arc disturbed thnt some physicians do not take 

their concems seriously or act promptly on their rccommcndations...” It goes on to 

state that 63 percent of respondents report that physicians rarely or only sometimes 

seriously consider their recommendations. Page 9 also states: “By contrast, 99 

percentof Iheconsultantpharmacistssay nursesseriouslyconsidertheir concerns 

mostto all the time.” 

In spite of the above-noted statements, the draft recommendation which addresses these 

issuesis directedat the nursing facility, as noted on page20 of the Iwide View: “State 

2 

E- 11 
and Federal survey and certificati.,n programs could Include process focused reviews of 

pharmacists’ recommendations and subsequent actions by appropriate medical and 

nursing personnel as part of their on-going suncys.” The AHCA belicvcs that this 

recommendation would penalize nursing facilities for physicians’ prescribing practices 

and lack of responsiveness to the consultant pharmacis(s recommendations, even if 

facilities have attempted, without success, to “educate” the physician about fcdcral long 

term care regulations. This recommendation also contradicts the Health Care Financing 

Administration’s emphasis on resident “outcome orienled” survey procedures for nursing 

facilities. 

3. The reports contain internal inconsistencies. For example, the draft indicates 

that consultant pharmacists’ responses to the survey show serious shortcomings in 

the quality and thoroughness of the pharmacists’ drug regimen reviews. The draft 

further states that pharmacists conduct some reviews without consulting important 

medical records and without having patients’ diagnoses or laboratory reports. 

Nevertheless, the consultant pharmacists responding to the OIG’s survey draw 

conclusions about the “appropriateness” of residents’ medications. 

�  Page ii of the draft Inside View contains these statements: “Pharmacists conduct 

some reviews without consulting important medica records and without having 

patients’ diagnoses or laboratory reports. Many pharmacists have no contact with 

patients or their families or with nurse aides in their conduct of drug regimen 

reviews.” 

In spite of these significant findings, the draft emphasizes consultant pharmacists’ 

conclusions and concerns. These responses should raise questions to the reader about 

how the pharmacists arrived at these conclusions without thorough knowledge of the 

resident’ assessments, care plans, and the rationale For the use of a particular medication 

or dosage. For example, the chart on page 12 of the draft illustrates pharmacists’ 

“concerns.” The reader should ask how the pharmacists would know about such issues as 

overutilizatioa of drugs, use of antipsychotics without a diagnosis, or use of 

contraindicated drugs for patients’ existing diagnosis or disease given their admissions 

that they conduct their reviews without consulting important medical records or having 

the rcsidcnts’ diagnoses. 

4. The drafts report that consultrnt pharmacists bave serious concerns about the 

USPof prescription drup in nunimgfacilitia, and the OIGsuggeststhat legislative 

and regulatory iateutions related to the quality of these services are not being fully 

realized. However, according to Halth Cart Finan&ng Administration data, the 

rates of nursing facilities’ noncompliance with key requirements of participation 

governing quality of care aspects of prescription drug use and the adminlstration of 

pharmacy services, including those of consultant pharmacists, are not as high as the 

reports suggest, 

E- 12 
-- 

-- 

-- 

-- 

-- 

. In the OIG survey, consuftan: phstmacists reporteti that, in general. nursing faciltties 

and consultant pharmacists are complying with the law and regulations related to 

medicafion reviews of nursing home residents. However, the “concerns” that 

consultant pharmacists repott in the OlG survey suggest that nursing facilities arc not 

complying with many other federal requirements rclatcd to prescriptton drug use. A 

review of the data resulting from inspections of nursing facilities’ compliance with 

these requirements does not support all of these concerns. For euamplc, page I2 

contains a chart which shows the percentage of consultant pharmacists who reported 

that they are “sometimes or often” concerned about: prolonged USCof sleeping 

medicines (67%); overutilizadon of drugs (62%): use of “as needed” drugs for too 

long (61%); use of antipsychotics without a diagnosis (45%); and use of 

contraindicated drugs for a patient’s existing diagnosis or disease (26%). The 

national rates of noncompliance cited at federal regulations related to these areas for 

10,692 surveys of nursing facilities between July, 1996 and April, 1997 were: 

�  42 CFR 48325(1)(l) Unnecessary drugs (in excessive dose; for excessive 

duration; without adequate indications for use; in the presence of adverse 

reactions; or a combination of the preceding) -- Noncompliance rate: 9.9 

percent. 

�  42 CFR 483.25(1)(2)(i) If antipsychotic drugs were not previously used, 

they are not used unless necessary to treat a specific diagnosed and 

documented condition Noncompliance rate: 1 2 percent. 

�  42 CFR 483.25(1)(2)(B) Residents who use antipsychotic drugs receive 

gradual dose reductions, behavioral interventions, unless clinically 

contraindicated -- Noncompliance rate: I .2 percent. 

�  42 CFR 483.25(m)(l) - The facility ensures that it is free of medication error 

rates of five percent or greater -- Noncompliance rate: 4.8 

�  42 CFR 483.25(m)(2) The facility ensures that residents are free of any 

significant medication errors -- Noncompliance rate: 2.3 percent 

�  The facilities surveyed during the above-noted time period were found to have 

national compliance rates of 0.8, 1.8, and 1.2, respectively, for the federal 

requirements at 42 CFR 483.60, including those governing drug regimen review, 

reporting irregulanides to the attending physician and director of nursing, and acting 

on reports. 

In addition, please note the following general comments. 

�  The findiig that a 20 percent increase in drug costs has occurred in a short period of 

time may not be unusual. Most new and more effective products that have come on 

E- 13 
the market in the last IO year; are expensive. Their a\*erage cost is $ I .OO10 %1.50 per 

dose. If new, more effective drug.\ <ce now available, why should thry not hc used for 

nursing facility residents in place of the 10 ;J 20-year-old drug thcrapres? The 

availability of these drugs, too. is an important factor in delivering qua/icy of care. 

Conducting drug regimen reviews on a routme basis and/or conducting reyicws for 

the OIG’s research without physically being present in the nursing facihty or seeing 

residents produces questionable results. This practice may explain some of the 

pharmacists’ concerns about prescription drug use in nursing facilities. If the 

consultant pharmacist is actually in the facility, the likelihood is increased that needed 

information will be obtained with the help of facility staff. Therefore, wc recommend 

that further research be conducted before any conclusions are reached regarding the 

survey of pharmacists. 

We recommend that the final reports note that many of the concerns such as proper 

monitoring and physician prescribing practices for the elderly which are identified in 

these drafts III-Znot limited to elderly individuals in nursing facilities. They also relale 

to those who are at home and in hospitals. 

We recommend that health professionals and the public continue to be educated 

about, and further research be conducted on, the use of drugs and the elderly. In 

addition, it is imporknt that consultant pharmacists clinical orientation be increased, 

especially through training in geriatric pharmacology. 

We recommend removal of the recommendations that require pharmacy review notes 

be placed in a particular location in the facility and to promote that a common drug 

category list be used during drug regimen reviews and medication pass reviews. 

Facilities need flexibility to file their pharmacy review notes where they can best be 

utilized by the individual facility staff. A common drug category list is not 

compatible with the growing younger populations in the nation’s nursing facilities, in 

particular with the advent of subacute care. 

We would be pleased to discuss these recommendations further if needed. 

Sincerely, 

-Janet A. Myder, 

Director of Regulatory Systems 

a\rcg\Jml\canmentrbipe3bdoe 

cc:few HealthCareAssociation 

5 

E - 14 
October 14. 1997 

The Honorable June Gibbs Brown 

Office of the Inspector General 

330 Independence Avenue 

Washington, DC 2020 I 

Dear Ms. Brown: 

Thank you very much for this opportunity to comment on the droftreports on 

prescription drug use in nursing homes: “Prescription Drug Use in Nursing 

Facilities: An Introduction Based on Texas, OEI - 06-964X0X”; “An Inside View by 

Consultant Pharmacists, OEf -06-964081”; and “A Pharmaceutical Review of 

Selected Texas Patients, OEI -06-96-OKX32”. This letter includes our general 

comments on the reports and we have attached speciRc and technical 

comments, also. 

AAHSA represents not-for-profit organizations dedicated to providing highquatity health care, housing and services to the nation’s elderly. Our 

membership consists of over 5,ooOnot-for-profit nursing homes, continuing care 

retirement communities, senior housing facilities, assisted living and communitybased service organizations. With our broad range of facilities and services. 

AAHSA serves more than one million older persons daily. We have a long history 

and consequently, significant experience in meeting the needs of the elderly. 

We recognize the important role that the Medicare and Medicaid programs 

have played in ensuring that the health care needs of older Americans are 

adequately met. 

AAHSA nursing facifity members are committed to providing quality health care 

to all their residents. Prescription drugs are an important element in the medical 

care of residents and the findings of the OIG studies are of great interest. Some 

of the findings and recommendations of the reports indicate the need for 

further studies and could be helpful in improving the quality of medical care 

given residents in nursing facilities. However, we are concerned with some of 

the methodologies used in the study, the limited nature of the findings and the 

recommendations for new program reauirements that are&justified by the 

studies. 

E-
The Honorable June Gibbs Brown 

October 14, 1997 

Page 2 

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

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

problems, and the “appropriate” use of pharmaceutical resources available to 

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

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

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

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

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

solutions can be identified. targeted education and voluntary compliance 

might be the most cost effective approach. 

Better communications among the physicians, patients, consultant pharmacists, 

and nursing facilities’ staffs could eliminate some of the problems highlighted 

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

of any problems identiCed by a consultant pharmacist’s monthly review. But it is 

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

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

with and responsibilities to the patient. Increased requirements for selected 

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

be the mosf appropriafe focus. Greater understanding by and communication 

among gJ portiis should be the goal. 

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

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

interpreted in a broader context, including payment methodologies. increased 

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

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

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

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

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

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

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

the listed are or dangerous uninfofmed 

In the of certain of as or 

may misleading unique can 

their Nonetheless, is to the of drugs time 

E- 16 
The Honorable June GiDbs Brown 

October 14, 1997 

Page 3 

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

period. 

AAHSA agrees with the recommendation that HCFA contkue to monitor and 

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

prospective drug utilization review programs are not thoroughly analyzed and 

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

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

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

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

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

for understanding fhe situation and designing possible changes to ameliorate 

perceived problems. 

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

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

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

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

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

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

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

and responsibilities, diierent perspectives, and debatable interpretations. 

Nonetheless, some of the problems indicated by the consultant pharmacists 

deserve closer examination, pariiiularty those indicating communications 

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

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

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

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

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

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

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

potential problems that warrant further examination before major program 

changes are suggested For national implementation. Therefore, AAHSA supports 

its recommendations that HCFA monitor and enkourage reduction of certain 

prescription medications and identify and analyze reasons for rapidly increasing 

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

the effectiveness of the medication reviews through guidance to involved 

E - 17 
The Honorable June Gibbs Brown 

October 1A, 1997 

?age 4 

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

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

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

prescribing physicians and nursing staffs concerning “appropriate” drug use for 

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

and payment method. The last recommendation concerning the placement of 

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

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

no difkulty obtaining a patient’s assessment and 97% report no problem 

getting the patient’s plan of care. 

Our specific comments and recommendations are attached. AAHSA 

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

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

and HCFA and solutions are developed. 

Z,&v 

President 

Enclosure 

E- 18 
AAHSA / 

October 1997 

Page I 

Detailed Comments of the Association Homes jervices the 

on Reports 

Prescription Use Nursing 

An Based Texas, 

. 20% in drug per is rapid 

troubling, noi New have available the 

for of common of elderly, genetic 

are yet and often a higher tag. 

some the drugs a health with 

side Some the costs also attributed better 

care patient Also to rapid 

in is rapid of drug relative 

the Price and other components it. 

�  Because the study only looks at one state and does not appear to examine 

the Medicaid payment methodologies fur prescription drugs, it is impossible 

to determine how much of that increase might be due to administrative rules 

and procedures under the control of the state’s Medicaid program. 

. The study found that 17% of the state’s prescription drug payments were for 

the dually-ellglble paputattan in nursing facilities (NFs). The dually-eligible 

population tends to have greater medical care needs than the average 

Medicaid or Medicare patient. Without further analysis of the study 

population selected compared to the dualiy eligible population in the 

community and to other segments of the TX Medicaid population and 

compared to similar populations in other states, it is impossible to assess 

whether that proportion may be “out- of-line”. Patient acuity measures 

would be crucial for any such analysis. 

�  The finding that some NF r&dents rece’ke inappropriate cf unnecessary 

drugs is of grave concern. Given the high number of prescriptions per 

patient, that risk becomes more dangerous. We are well aware of the 

health hazards and costs associated with such treatments, partk~~l~~ty for the 

elderty. Because the elderly, espe&Aty those poor and in nursing homes, 

tend to have multiple health problems, the prescription problems may seem 

more extreme. But problems of drug use are ndther unkque to the elderly 

E- 19 
AAHSA / 

October 14, 1997 

Page 2 

nor to nursing home residents. This study has focused on a narow segment 

of the population, but the problem is much more widesixecd. Sea the 

enclosed cartoon for a commentary on OVI drug-criented socieb. 

�  There are, however, some prescripticn problems related particularly to the 

oge of NF potients. The elderly body does not process drugs as efficiently OS 

it did when it was younger and it is more sensitive to the effects of many 

drugs. For those reasons, among others, there are certainly some drugs and 

some treatment regimens that should generally not be recommended for 

elderly patients. However, it is important to be cautious about labeling any 

list of such drugs as “inappropriate” of “contraindicated”. Those terms have 

specific medical meaning. Appropriate use of a drug can be a debatable 

matter of judgment. The list of 20 drugs used in the study was constructed by 

a small group of experts using Delphi methods and was controversial at the 

time it was published. But rnme importantly, it must be recognized that, for 

some cases. it could be appropriate and necessary to use one of the drugs 

on the list. Based on a physician’s clinical knowledge of a particular patient, 

the doctor could knowingly choose one of the proscribed drugs as the best 

option in the given circumstances. (Such use could appopriately trigger a 

discussion or comment from the consultant pharmacist during the monthly 

review, to determIne whether or not it were, in fact, an “appropriate” use.) 

�  Despite the concerns expressed above about the drug list and how it is 

labeled, we are encouraged by the reduced percentage of beneficiaries 

receiving drugs from the list over the time petiod of the study. While the 

study notes that the percentage “shifted downward slightly” from 1992 to 

the first half of 1995, it is actualty a MX reduction in the rate. In part, that 

may reflect Ihe growing impact of OBRA ‘87. In part, it may reflect the time 

lag frequently noted far scientific literature to have an impact on daih/ 

medical practice. 

�  The study shows a need for more education about drug use for the elderly 

that includes physicians, their patients and ail caregivers, regardless of 

setting. Particular attention could be targeted on the five drug categories 

that represent rapidly growing costs to the TX Medicaid program and. within 

those categories, focus should be on drugs p&enting the greatest risks to 

elderly patients. The costs of such education and who pays them need to 

be considered in any policy recommendations. 

E - 20 
AAHSA Comments / Recommendations 

October 14. 1997 

Page 3 

�  On page i!, some of the findings about the .5drug categoties and 

gastrointestinal ������������� make comparisons to “all Medicaid prescn’ptiordrug paymenk” and it is unclear whether that refers to just the payments fcr 

the study population or the total ,Medica!d program. 

. The finding that gastrointestinal drugs average nearly $38.5 annually per 

beneficiary would mean $1.05 per day not $1 SO. 

�  The finding that average presctiption drug payments per beneficiary varied 

so widely among NFs may reflect, in part, the vafiotions In practice patterns 

that are found throughout medical practice. However, it calls foefurther 

analysis that takes into account average case mix or patient acuity, special 

characteristics of NFs that may be relevant, as well as an examination of the 

distribution of those costs and a closer look at the outlien. 

�  Table 6 and the discussion above it on p.9 are a bit confusing. If the facility 

with the lowest total drug payment averaged $0.17 per (patient?) day and 

had at least 6 beneficiaries during 1994, the patients must have had very 

short stays if the ����� facility payment was less than $10.00. (The bottom row 

of the table multiplied by 365 does not equal the top row.) Perhaps more 

extreme cases need to be excluded or slightly different comparisons are 

necessary to be dear and meaningful. 

�  AAHSA agrees with the recommendations in bold type on p. 10. However, 

AAHSA has reservations about the inclusion of NF residents in the automated 

prospective drug utiliiation review programs already in place, without some 

evidence that those programs are operating smoothly in each state, reviews 

are timely and cost effective and that they have the capacjty and expertise 

to handle the nursing facility population. There is no diius-sion of this 

utliiiation review program in the reports and no justiiation to support the 

recommendation. AAHSA supports the recommendation for further study, 

but does not believe that the survey of consultant pharmacists provides 

useful insights. 

An Inside View bv Consultant Pharmoc*ists. OEI-O6-9&00081 

�  The methodology of this survey and its written repart are basically flawed 

and would b-emisleading if published. The data represents personal opinions 

o? consultant pharmacists rather than accurate reports of activities within 

E - 21 
AAHSA Comments / Recommendations 

cktober 14. I997 

Page 4 

nursing fccilities. It does not present a realistic picture on which to base 

policy considerations. 

1. While the selection of pharmacists may have been random, it is not 

likely that the pharmacist’s selection of a facility on which to base 

responses could have been random in any statistical sense. As 

noted on page 7, you can generalize the findings, “Assuming that 

the pharmacists did in fact randomly select the facility for which 

they provided information...“. Without seeing the survey instructions 

and questionnaire, there is absolutely no basis for making that ,, 

crucial assumption and putting any faith in the findings, 

2. Even if the study could document a totally random selection of NFs 

by consultant pharmacists, the fact that their responses are based 

solely on personal recall of activities over a 6 month period with no 

documents or records for reference to improve the accuracy of 

their responses and no advance warning at the beginning of the 6 

month period, means that the responses are merety impressionistic. 

not accurate reports of actual actiities. 

3. Many of the responses reflect the frequency of a particular action 

(“of-ten, sometimes rarely, never,” or “none, few, some, most, all”), 

but there are no definitions in the write-up or the tables in the back 

explaining in numerical term what those words mean. Does that 

mean that there were no definitions given the respondents. either? 

That makes the response even more impressionistic and less useful 

for defining any realtty. What is a rare occurrence to one 

pharmacist may be considered a “sometimes” event by another, or 

both may be weighing their answer based on the number of 

consultant revFews they conducted (or remembered) during the 

tlme period or by the number of dually eligible involved. 

4. Because the study represents only one perspective on the 

situation, it may identify problems and solutions that would be of 

dubious merit. For example, same of the consultant pharmacists 

cite lack of drug monitoring through lab tests. However, this issue is 

open to dispute. Some physicians feel that clinical and physiologic 

indicators are more useful. incur less pain and cost for the patient 

and that lab tests are necessary when there is a change in the 

patient’s condition or treatment plan. rather than on a se? 

calendar schedule. Regardless of the merits of the case on either 

side, the ‘dentification of polii problems and solutions would be 

enhanced by such a debate among al involved parties. 

E - 22 
AAHSA Comments / Recommendations 

October 14. 1997 

Page 5 

. Given the above criticisms of the study, it is hardly necessary tc comment on 

tne substance of the report. Nevertheless. It is lmootiant to Dolnt out some of 

the hazards with the current write-up of the report. 

1. P.8: Such general statements as, “Pharmacists believe that 

nursing home patients are experiencing numerous adverse 

medication reactions as a result of inadequate monitoring of 

medications...” are dangerous because they reflect penonal 

opinion only, do not state what percent of pharmacists actually 

believe that. whether they think that statement applies to 100% of 

NF patients or some lesser amount, and draw conclusions about 

relationships that are not supported by data. A pharmacist would 

likely see cases of urinary incontinence, depression, delirium, falls 

and constlpaiiin among nursing facility residents as she would 

among a comparably aged population living in the community. 

These conditions occur relatively frequently in the elderly, 

regardless of drug regimen. There are many contributing facton. 

This particular study provides no basis for concluding a cause and 

effect relationship with drug prescribing and monitoring as the sole 

(or major) causaiive factor. 

2. P.8: The percentages following the 8 problem statements reflect 

the percentage of pharmacists that thJ& the problem occurs 

sometimes or often, not the frequency of cases where the problem 

actualfy occurs, but that is not clear in the Wteup. 

3. Throughout this report there are statements typed in bold, “...the 

consultant pharmacists express concern....“, “....are also problems 

according to consultant pharmacists”, “Pharmacists have serious 

concerns about...“. but it Is unclear what percentage of 

respondents reported a problem or how frequently they observed 

a problem. Citing the specific questions asked and the 

percentages of responses might help clarify these points. Far some 

issues, it might be reasonable to expect that each and every 

pharmacist that observed even one Event X ought to be 

concerned, but otherevents/issues might not be that critical. 

. Because AAHSA concludes that thii survey has no value beyond vague 

impressions and opinions, we do support further, data-based study of some of 

fhe issues discussed because they do raise questions about quality of care 

and the need for better communications among involved parties. Also. the 

E - 23 
AAHSA Commenrs / Recommendations 

October 14. 1997 

Page 6 

study ought to reflect the roles apd activities of the various parties involved ir: 

the caring process as well as those of the consultant pharmacists, since there 

are legally defined roles, responsibilities and relationships that are involved 

and must be considered to get a full perspective of the situailon. 

. AAHSA does not believe this survey provides an accurate basis for 

consideration of policy changes or new regulatory requirements. 

A Pharmaceutical Review of Selected Texas Patients, OEI-06-OQWQ 

�  This report does not explain how the sample of 254 nursing home patients 

was selected for a desk review of their pharmaceutical regimen, and the 

report states that, “We do not generalize the contract pharmacists’ findings 

to encompass all Texas nursing home patients, choosing instead to present 

the findings only in relation to the 254 patients reviewed.” AAHSA agrees that 

the findings apply only to the sample of 25.4 residents and questions why the 

OIG then uses this study as the basis for making policy recommendations for 

regulatory and programmatic changes on a national basis for an assumed 

national problem. There would be significant costs nationally associated with 

some of the recommendations, but the costs could hardly be justified by 

problems identiied in a nonrepresentative sample of 254 TX patients. 

�  This repoft is valuable, however, because it includes some of the cautionary 

language and qualifications necessary, but lacking in the previous two 

reports. These subtle distinctions are cruc*~ll because they highlight the 

uncertainties of practicing medicine and prescribing drugs for the elderly 

and the need for direct clinical involvement and medical judgments on a 

case-by-case basis in order to provide the most appropriate care for each 

patient. For example, 

1. P.8 “As with any medication, one should be aware that some medical 

situotiins might warant the use of these [Iii of 20 drugs geneKllly 

considered inappropriate for elder!y patients by a panel of experts] 

drugs.” 

2. P.8 “...contract pharmacists identified patients taking medications 

potentiallv contraindicated.......” [Emphasis added.] 

3. P.9 “...the need to balance what could be inappropriate medications 

against the benefits of relieving or treating diieoses which warrant such 

E - 24 
hAiiSA Comments / Recommendations 

October 14, 1997 

Page 7 

usage For ?he enhancement or maintenance of an individual’s q~rolity of 

Ilfe.” 

4. P.9 “-records indicated other adverse effects possibly caused by 

medications.” [Emphasis added.] 

. Despite the limitations of this study, it does raise concerns and potential 

problems about the consultant pharmacists’ reviews and their relationship 

with the full patient care iearn. including physicians, nurses and aides. 

AAHSA suppork the essence of the firxt recommendations on p. 13. with 

emphasis on further study, education and approaches to encourage better 

communications and better practices within the NF, rather than the 

imposition of new requirements. Regarding recommendation #5, there is 

insufficient data to support the need to maintain all patient care records in 

one spot in the NF. The opinion poll shows 89% of consultant pharmacists 

have no difficulty obtaining a patient’s assessment and 97% report no 

problem getting the patient’s plan of care. 

1. Any further discussion of the issue should include a multi-disciplinary team 

of all care givers having any role in using the records in order to balance all 

needs appropriately. 

2. These studies provide no justification for imposing new, national 

regulations- the nature of the problems are not thoroughly understood. all 

part&s involved in the NF should be involved in the analytical process, and 

the costs and benefk of alternative policy options have not been analyzed. 

E - 25 
E - 26 
an increased use in ardiac ad cardio=nculardmgs as well. ~+~&on i3 also mope aggnxsively 

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

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

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

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

hospital setting wha al immuncnt infbajon slim. 

E - 27 
~DDl’TlONAL COMMENTS OF ‘lXL%MEnIC~ MEDJQ$L DIRJXfORS 

&%OCIATION ON OK -m ON FRESBRTON DRUG USEM 

mm 

October6,1997 

OIC RQQolf 4 - u cri tie D 

37htrodu ‘on il8saI 0 

AS noted in Dr. L.awtrOrm’scover later, AMDA is extremely wttaxned about 

inappropriatewe ofprcscxiption drugsthat result in poor patientoutcomes and 

hospirstintian. Ad an ofgattitatioa, wt enck8wr to f&c the 6tadard of practice in longtam cam settingl by eduation prognnrs tlut are devutedto rippru+ate w use, as well 

as xrticla in ourjournul,&&&%xnc Modkine.nK_Anlulo~Tsrm C!ML Ws 

also provkie instru&n on mtc drugUK in our m to c&ify long-term cart 

mcdiiol dii~. In addition, ni&y of’our40 state chptere kvc provided eduatiorul 

pgt3m on appropriatedrug ust in the elderly. We arc well aware ofthc unktunate 

outmmci that may result barn tbc use of drugs that are inappropri8tcor not mediclily 

nccwMq. 

Wt a~, tier, mindfid that the cornerstoneof nursingfiwility mform is individualized 

are plmnin(l ad tmdmeut ofacb individual ruidcnt While drug guiddinea are very 

useful. in individual circumstancesphysicians may prwxibe drugregimens that vary 

6om the guidelines but are, in N, the optimal drugtbaapy fw that indkidual patient. 

You may wish to ‘mdudc in yuur diissian of OBRA the fact that the Resident 

h~SSft5~t InsbumMt/Midtnum D8ta set (RAI/MDS) tqWWats OBRA ‘87’s focus on 

e~sufhtg that every toting facility rwidcnt’s individualneeds are met. Futthamon, 

0BR.A ‘87 requiresthat mu&g facilities provide servicerto ensurethat acb resident 

�chicva bir or bu “highest pradiable phyaioal, mental, snd psyohosocial wdf-being.” 

Tht mquirtmaIts br iodivldlmlii cart plans as well as cue and savicu to achim the 

raidcnt’s highest pmctiab!t well being may all k&a&e the cowse of drug thwapy in 

wliystwsnaydeviwehrIlr%mltkama”rpgroach. 

E - 28 
Residents.” Archives ojInremlMedicine, Vol. 151 (Sepr ;;;I), pp. 1825-32 It should 

be noted that although the drugs listed in Appendix A include many that most 

goriatrickns would avoid in tmxtiag elderly patients, then was some contmvemy in the 

medical community about the a&k, particularly about the Delphi method used in 

rraching its conclusions. A review of wmmenta and Iettm to the editor following 

publications of the articlecould provide some context for the contmversy. The list of 

inappropriatemedications in nursingfacilities should be made with a broaderumsensus 

and revisited paiodically. 

Findiaru: 

�  LOtcthe OIG, AhIDA is ctmcarnedthat prescriptiondrug payments for dually 

eligible Texas nursing home rcsidantshave increasedrapidly, rising by 20 percent 

from 1992 to 1994. 7he data fktn Texas is consistent with rqwtts &om managed 

m c~niplni~ ho&a& and patienta. The cost of drugs has clearly risen rapidly, 

Pndm~ynew,vny~edrugrhPveoamtonthtmsrhIntheputfourtotivc 

ytam Conmrttntly, with the dwtd emphasis and attentionon providing the highest 

pncticable &n&onal IevcIand quality of Ii&,the typical nursing facility taidcnt is 

ndving much ma medical attention and msbnart th8ninlJlcpt” 

�  Regarding increased drugusa, M noted in Dr. L&mme’s l&a. it is nut unexpected 

that an inctuae in the use of cardiacand ca&ovasadu drugs would occur in the 

nursing hcllity setting Thereir nowgoodevidence that more qgrcwive tmaiment 

of amgutive heart failure(CHF) anhtnces @ii of life and deaesw tpitodts of 

acute aacebuion of congesriw haastMurc, therebydeacasing cpiaodca of 

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

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

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

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

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

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

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

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

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

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

MtiOgWhUlint- i&c&m date. Pltrthermare,in tight ofOBRA ‘87’s 

rquiremm to ptwkk etavices to achicw the resident’shighest pmctkable wellkin&physiciMHouldhve~diftlcultyinlimiting~gtknpi~t 

ultiinftctives. ardiac linlgi$ 8od 8tltacpalus ifthey an lncdidly qpfqb. 

‘Iheaarhstrmrll~ddnrg~~forM~ingmqjoriCyof 

pfwdptb~ittitoousinmoattratdtduitmtdicint,nfl~~ww 

tkrapiet. high demand, end high prtdanw of gstroinbcrtinJ. tiiovssFul~. ai 

pychiatric problasnain tk nufsing fMlhy poplhdon. 

E - 29 
3 

“inappropriateness” is subject to considerable &erp~tation. See comments above 

regarding the lead article apparently relied upon to detmine appropriateness 

�  &garding drug costs, we note with intere.st Table 5, which reflects the percent 

change in tots1 Ixnefkian‘e~ receiving prescription drugs and total payment for five 

drug dassifications. Clearly there is a vast discmpnncy when the percent of 

btneficiaries rccciving gamointestimd prepamtio~ haS inaeased 1S.J%, while the 

CoSt ha9 f&n 93.5%; or witen the percent ofreSidentS receiving psychotherapeutic 

dfuga has incrcascd nearly 1OTTbut the coat has inwed nearly 92% The other 

categories ofdrugs show similar, although slightfy ksa chmric, trends. This vaat 

incmae in drug payments raise, ~hc question of what stab may be doing to amVol 

the cox of there drugs. 

�  The draft report ootes that total prescxiption drug payments, average paymsntr per 

day, and average payments per beneficiary vary widely by Texas nursing hility 

AhIDA canam with 010 on the Mcd to fiuther analyze variables such aa size of 

facSty, Qoility type, severity of illness, types and mmbsre of ocher actvices. We 

recommend epecific focus on patient aarity. which we believs has incrased in recent 

years. We note that varinttonr have been observed in medical treatments, procedures. 

end prescribing throughout many EMS of he&h care services, e.g., TVRPs and 

hystertctomies. Ongoing efforts to u&rat&d and address thiq variability are highly 

desirable. 

RoMQjm&#&& 

- AMDAcrgrceewiththe rewmatanjation that HCFA should wntinuc to monitor and 

tneotnage rcductiw in the us0 of inapprc#ats ot poorly &+ctive prescription drugs 

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

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

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

amcut that eimilar anaIyais of data 6um additional states shouhi be undertaken to 

furthe assess the extant oft&. contimted use ofthese contraindicated drugs. We do, 

however, we ravotmtnd that a fwma definition of 07G use of the terms 

QmtnindicataY er(d ‘incff&ivt” be adopted, in orda to fbcilitate uniform rcvicw. 

It is important to note that inappropriate and oontraindiuted art not rrynonymv~~ 

turns in medicine. Wedsu suggest that the list of inrpprophtt drugs should be 

stratifled with emphasis on drugs that IUCthe most likely “offendeN and have 

rtuonablc olternadvt tmrmm. We temtnmtnd mllrbontion behwen HCFA and 

pro&a&ma1 organizationa to publish informatios whisb AMDA codd publish and 

disseminate. 

�  ���  significant increase iadmgcostsisofunivcrwlintecewfbrpati~~ 

physicians; it should be reviewed as an &pervasive iwe, not as peculiar to n~rrin8 

facitititi. Consiiaation of chug we and coats in mxsiug facilities done porcr the 

danger of enating an inf&,pturdird ofprescribing fbr nursit@ hcifi patients. We 

do qpreci~e the01%‘~ oollcern &r inudng Me&aid costs, but UI appropriate 

appmaeh may be fm tba Mediaid -to fmur the diqnv@iMute increaSe in 

E -30 
4 

their cotis beyond what is explainedby increased use. increase in beneficiary use 

would szem IO warrant. We do not believe it is necesauy tu single out certainrypcs of 

drugs for review as to medical rIecesrity. It is AMDA’6 position that all mcdicationz 

ordered should be medically necessary. 

�  We agree with the OIG that iiutha study should examine data about resident 

conditions (pwticulsrIy severity of illness. IISnoted above), types of specialized are 

and o&ex facility-specific chnnderitics, along with drug usage end expendituredata, 

to better undentmd the factors contributii M wriationr between nursing fkeilities in 

the costs of prcwiptian drugs by rcridents. We rlso suggest analysis of resident 

essessments to pin fxtter unda-stsnding of the individual f&ton that may influence 

mediation choicq CIHIanalysis ofwiwthti, in the case ofquestionable mediation 

regimens, othermoir traditionalregimens had been prcscn’bcdand then diaarded as 

not efTdw in a pticuhu patient. 

Qpnaents on OIG Reuort - “PrescdpQiOPPLYP Use M 

Omnibus I3UdgetRccaaciiiation Ad of 1987; This section should include (Ldiscussion of 

OBR4 37’s fodts on individualized assessmans and cwz plan requirements,as well as 

its rquitwnents to meet the nsident’t highest pm&able well-being, as disatssed above, 

due to the possible impact those rqukements may have on drugtherapy. 

Oronibw Budget ReconcilictiofiAct of 199@T?u summuy in the OK reportdoes not 

mention that the OBRA ‘90 8mendmentr8pociFythat the phmnrCiStmust offa to 

cotJm?elpatklrt QrtheiraradYa% (eqhllsis ad&d) on dimctiornand pwautions fbr 

Prcpupias~-~-; eommenadme&dsmdthecrpeutic 

compliations, properstonge, ete We amme that for mrning facility patient+ 

“~~3’ would efkr to the Rining &of the nwsing facility. 

physicians Dutermiaekhnt is Approprirrtc fir Ex41 Petkt: AMDA is plused to see

010 mccgnition otthe fist thatit is the patlent’sattatding physician or the facilit$s 

medial dllor do dotumirie ti is appropriatecue, including prewiiing 

mediations to meet paiems’ needs. 

E-31 
J 

When con&ant pharmtins have decided to i&rm the medics1direaor of 

irregularities,medical directorshave not found problemswith the Brmat in which such 

repmts arc made We feel that it would be burdensomefor physicians to be requiredto 

include with their ordersa medical outcome equtation for each prescribed medication 

For most drups. the expectationsJhould be quite clear fromthe petient record. For 

example, a paient with taminal cancer who is raeking a MC analgesic patch for 

pain contrvfwill p&ably need mcdic&ms for amsripation and nause.zt,common side 

cfTe35 of the anal+2 regimen. Anotk common exam& is the usu8l need for 

potassium supplemsntutionfbr pati- receiving loop diuretics. 

Regarding notice of rccepuncc or rejectionofconuultm phannacist’t concems, WI: 

expect that would be addressedin the notes from the next regularphysician’s visit to the 

patient. Careshould be taken not to create an additionalpaperworkburden for medieal 

and ntthng st&Tin respondingco those con-6 

&&I&& 

Qudity ofcarehua: �  ��  notedin the report,the pclwrlenecof signs and symptoms of various diseasea and 

gdtric uypdtomw present in this pop&ion are easily confused with adverse dnzg 

redCti0mt.It ropuircrthe diqn08ir 8ndj&ma6 cf 8 physician to di&nntiate 8 

cause and dfca dationship utd advise I patient on the risk/bcacf~ of any treatment. 

This entire subject should not be addnaeed without physician input. 

�  Apppropriuause and monitoringof medication in a nursing facility population is and 

aluayswillbeimportmt8dditRcuk lkbestproce36forthisicacyet 

undiscovered. A combiacd e&t amongthe interdisciplinarytwm, including the 

physician and medical dir&or, scans ideal. This, howwer, rcquireearpanded roles 

and finding far this wurk, 

E - 32 
6 

less likely to create a need for inves”:atif$ possible abnormallab results, which may 

be very expensive and wonisome and yet produce no real benefit to the patient. 

Shortcombs of &&atiQn8evicws: 

�  ��  note that thatwell-unX~edand’organizedmedical recordsoverlapbetween sites of 

service and present a majorchallenge in every a~ of health care. 

�  Regardhg the OK’s findinga that residentmedication recordsare often incomplete, 

making it difficult or impossible to dearly ideMy or co&inn potential drug regimen 

problems, AMDA obaer~ thatthis is a 00mple.xproblem. Many patient8have 

problems thu evade precise diagnosir and me problemsthat fit into many 

ategoriea, and those tdtdd be noted in the progr~ notw. In nuny other aspects. 

the 010 finding@r-sent a systems problem that is beyond the control of either 

medical direc&xsor attendingphysicians. 

a AMDA~thatHCFA&uldcaainuetomonitorand F)IEOW(B~ reduction in rho

use of codmindiated presa+m hs in the cldaly nursingfacility population. 

We reiteratemu requestthat the terms “amtraindiatcd” and“inappropriate”be 

defined, in orderto enrun unifizm interpretation 

�  AMDA rgrew stronglythat HCFA should identify and analyze the reasons for rapid 

escalation in costs and claims for cdc(riatypes ofdnlgs used in nursing facilitiw. 

While the increawd use ofdltqp amo@ reSidCNsnuy be simply the re3ultOf 

incrrucd acuity of r&de* ewe mix (e.g. in the ase of4odinfectives), or 

improTentr io diagnosis and treatments(as in the ca.~ ofantideprtssants), and may 

be entiretyappmpriat~ the weaih in drug prices aeenlad@CQOdOoO~Cto 

the iacrease in drugw, and chuukl be fevicwsd. ltatds in nursing ticility 

prescriptiondrug UJC#ho&dbe comprrcd arithnational&a on praaibing and coats. 

E - 33 
� 

+bcd, and requiringphmacim to tttomturL. .:.ese apcctations.” AS noted 

above, general clinical e~pcctations will be ckar in the cue of most medications. If 

a physician is using a drug tn treat a condition other than that for which the drug is 

normally pmcribed. it is reasonableto expect that the physician should clarify the 

condition that the drug is expected to treat. 

AMDA sgrccrrwith the recommendationto requirenursiq facilities to provideongoin& in-&cc training for personal csre aaff(CNAs) on recognizing behavioral 

JY?f@Omr Of Cotmhldi~rIS, EdverselemSioo6, or inappropriatetcsponscs to 

mediations. C’P& ure the fiunt-line of nutaing home carq and their &stance in 

recognizing aymptams of medication pmbkms could gra%lyenhance the qualii of 

rwkient care. Fimt, howaver, there should incrwad fund+ for rtlffrnd continuing 

educltioa dfbrts to enhanoaiqtaaaions betw~~ the physicians, pharmacists.and 

facility StafE tt would not be prudentto trainnurseaides to look for medication side 

~saschrtPehardtodisMlradi~evar.fortnincdpfryridansmd . phamlaa&without ifd pmasa andstntc&e to ~WUCthat physicians and 

pharm8cistsueaiready wnuhuade among tkriudvw about these issues. To 

train nrrx &a withuut hn(:easuriag that the physloian-pharmacistiii Is wrking 

ffbctidy would be disrupti~ to patient cate and okall oonfidence in a nursing 

ZWlity. 

w Rqaiding the recummettd&n concexning medicA records,AMDA believes that 

! medical recordorg+mtion and availabili should be drivenby patient care needs 

and net convenience. Moatmending phyddana have faced exactly the same issue: 

ready awus to the entiremalical rexxm%However, we rsagnk that goad and 

acceaaible patient care is at rtake This pbblems wuuld need to be addressedby a 

collaborative efftxt ofmmdng futility tia medical directors,artendingphysicians. 

andph8tmaciSta. 

. Cornmeats on OKGRwort - YPrcs&Hion w 

~adlities: AJI Inside View bv CousultantPbrn&&” (CN2~&XJ81~ 

h&d&~&: This tidy qpan to be a totaNyaubjectiw survey thu is not bnsaI on 

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

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

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

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

punulth~furraportbyaFedadrgaacy. Pu~tbisrepottcarldcrrrtca 

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

commission a reporton how they might betterMfiU their statutorynzipowibifhier. 

E - 34 
8 

on generalized impressions and not on actual data or actual chart review, it is difficult 

to respond to them munh@blly 

- Notwithstanding the non-factual basis of the survey, we observe that respondents 

noted a wed for geater monitoring of cwttinued nml fbr medications, and 

monitoring of potenblly toxic drugs. Any focus on increasedlaboratorymonitoting 

should be coordinatedwith PartB carrias, to ensure cwcrage of appropriatetests. 

�  We note that a numberof con&ant pharmacist8assessed the extent of coopaalion 

6um tridents panonal physicians as only t%ror povr. One aspee of this feeling of 

������  appear& tv be that w~ltant pitumrci~ wefe disturbedthat some 

physicians do nvt take their cv-l Kliourly 01 avt prvmptlyon their 

rmommendstions. Many pharmtiDtr colnpl&ed that phy$icians only or never 

seek their help rqarding appmprirtemedicuions vr properdosages. physicirns in 

long&um care settings use wnsukant phartnacb as ����������� That is, physicirns 

cdl on wnsult~nt phunucists when ph+ians want additivnal infbrmrtivnon 

medications. Mast of the time, phyaiciaaado not need such wnsultant serkes. 

Cleariy. cwpwatioq with appropriatewuwtmettdadona ftom wnsultant pharmacists 

ia imqmtmt, and the mwriug ftility medicaJdkctvr is in the best position to secure 

that tmvptdm. AMDA’s wnvlusivn seems to bc bornevut by Table 6, which 

shorn that 7 I .4% of tmpvndents consideredthe -on bawem the consulting 

pharmacist md medical directorto be gvod vr vay gwd. 010 should rewmmcnd 

that HCFA clvsc tbs fbedbackloop in wnNtant nursingfrelity drug tevkwo by 

ma&ting tbrt the me&ad dimctvr nvt vniy be informedof conema and 

rewmmcnduians, but tJmttk medical dinxtor vwxscc the rcvi~s by tic wnrttltant 

pharmadst Such a change would rliow the medicA dirstar (0 mort etktivsly 

monitor the medidpractke of attendingphysicians as well as coordinate resident 

oare. 

Shvttcomings of Medication Reviews: 

Once rgain, given the anecdotal nature vfti ~cvcy, it is diicuk to hwe sufficient 

infvmmiivtt on whiob tv haso cutnmamx Fopuamplq 33%of -tits indicated 

thattJwyhnddiffiadtyinvln8iithcprtirpt’8diagnoais. SinwtbcOIOrrport 

wmctly vbsma that in&muttivn on dinprir should be in the patknt’r rccard in at 

last Mn of three places (the MDS, the p&llt’n pemonal aaae4ameJlt,or the plan of 

are). it seems edmacly udiily that a diagmsir would not be found in at Icast one 

of thvr places. iRaf CalIsinto quesliva the validity of the rrpars 0Tat best. makes 

interpntdton vf its f&dings exucmely epecuJatiw. 

E - 35 

0 
9 

�  Same respondents voiced “strong mwxma” about limitations on their professional 

authority to enforce OBRA provisions, F&ral and State survey and ������������� 

agcnci~ have been charged with enforcement rwponsibiliriss, not consulfanl 

pharmacists. It is cxtremaly unrezalistic for consultant pharmacist to imagine that they 

could �� should be able to mrmre a Facility’s or physicians’ adherence to OBRA 

provisions. or guarantee that the nursing staff properly administer medications 

demonstrates a lack of comprehension of the appropriate roles of various members of 

the intexdisciplinary team 

y 

�  &DA strongly endorses the Oft’s recmmendation that medical directors should 

always be informed when pharmacists have patient me&&on concertx. Such notice 

to the medical diior is not currently required by HCFA regulatiorw. ti nowf 

above, WA bclim th81 notice to the medica! direc%or w&l improve 

complima with appropriate phatmaciats recormne&atioos. 

E - 36