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APPENDIX
PREPARED STATEMENT OF THE AMERICAN CALTH CARE ASSOCIATION,

WASHINGTON, D.C.

DRUGS IN NURSING HOMES Providers of long term care believe that drug therapy is the most significant, as well as the most frequent, treatment modality in nursing homes. Therefore, members of the American Health Care Association, representing 7500 long term care facilities, are vitally concerned with public initiatives to examine this important subject. We share the Committee's concern that the amount, type and effects of drugs given to nursing home patients are therapeutic, and that drugs promote, rather than detract from, the health of older people.

We wish to bring to the Committee's attention some problems related to drug utilization in nursing homes, to apprise the Committee of industry initiatives to improve drug usage and distribution, and to comment on the findings of the General Accounting Office on long term care drug programs.

The outstanding problem related to nursing home drug utilization is the paucity of knowledge available on the effects of medication in the aging body. Drug industry literature on their products reveals special dosage and cautions for infants, children, pregnant women and nursing mothers. Rarely is information available on the use of these drugs on older people. We are encouraged that the National Institute on Aging and the Food and Drug Administration are planning research in this field. We believe such research should be a major priority and should commence immediately.

A second problem deals with manpower. Nursing homes have developed viable systems for assuring proper drug therapy. Personal physicians order the medications. Complete drug profiles are reviewed by the dispensing and/or consulting pharmacist. The unit nurse monitors and records the effects that the drugs have on the patient.

To be successfully implemented, this system requires, (1) interested and knowledgeable physicians, (2) pharmacists who have clinical expertise, and (3) nurses with special training in the care of the elderly and the time to give needed individual attention.

For a variety of reasons, long term care facilities are experiencing qualitative and quantitative manpower problems. Some of these problems relate general disinterest in the care of the elderly on the part of professionals. Another factor is the disproportionately low remuneration for these health care practitioners because of public reimbursement policies.

However, long term care providers are working in a partnership with the scientific community, professional organizations and federal agencies to overcome these factors that impede proper drug utilization. Facilities themselves are developing innovative approaches to ensuring quality drug therapy programs. Some of the provider initiatives include:

Unit dose. -A growing number of long term care facilities are adopting unit dose drug distribution systems. In many instances these systems improve the accuracy and efficiency of drug distribution.

Drug review indicators. For the past six months this association has worked with the Health Care Financing Administration in the Department of Health and Human Services in its development of drug regimen review indicators, procedures to be used by surveyors in assessing the quality of pharmacy reviews. We believe that these guidelines will provide assistance to facilities and pharmacists as well as to surveyors in improving this essential long term care activity.

AHCA members have been active participants in the revision of the nursing home conditions of participation. We believe that it is through our efforts that the proposed rule will require pharmacist review of drug regimen of every intermediate care as well as skilled nursing facility patient. We believe that pharmacist review makes a difference in quality care and that this service is absolutely necessary.

Drug labeling.–For two years, the American Health Care Association has been a cosponsor of the U.S. Pharmacopeia's Drug/Product Problem Reporting System. Through this program, nursing homes are sent report forms three times a year on which to report such problems as unclear instructions and confusing labeling information. Last month, AHCA was given a special citation by the Food and Drug Administration for its contribution to this important program that is designed to protect the health of patients using drugs.

Patient/professional information.—We agree that additional drug information is necessary. We have submitted formal comments to the Food and Drug Administration endorsing the concept of a compendium of drug information relevant to the needs of patients and professionals alike being available in every long term care facility. However, as we mentioned earlier, little of this information is presently known and we believe this compendium will be only as valuable as the accuracy of its information.

Medication aides. In a few states, licensure laws permit development of medication courses for nurses aides. If the aides pass the course, they may accept assignments in administering oral medications. Facilities using these aides have discovered a lowering of the error rate, since this is the sole function of the aide who has been prepared to carry out this task. Additionally, facilities have found that professional nurses now have more time to conduct the individual assessments of patients and can more effectively monitor the effects of the drugs.

Finally, AHCA would like to comment on the General Accounting Office's recent report on drugs in nursing homes.

We were pleased that this investigation was undertaken and, in fact, cooperated with the GAO in explaining the study to long term care facilities in order to promote participation in the research. We believe that the study will add to the scarce body of knowledge about this key subject. The limitations of the research however, must be acknowledged. Only the drugs were studied and the study results relate to findings of a total of 58 facilities in five states.

Further, the research applied “screening criteria” for identifying problems in drugs usage. For example, the report cites as a problem the instance where a diuretic has been prescribed and electolyte tests are not taken every 59 days. In our experience, physicians are idiosyncratic in prescribing drugs and tests. Many physicians, especially those with long standing knowledge of individual patients, do not find the necessity in following the same arbitrary protocols developed by the GAO. Some physicians may request that their patients receive a banana a day and forego costly laboratory procedures. This may, in many situations, be good medical practice.

We remind the Committee of the first sentence in the Title XVIII of the Social Security Act:

"PROHIBITION AGAINST ANY FEDERAL INTERFERENCE” “Sec. 1801. Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency or person.”

We believe that the GAO application of screening criteria followed by a public announcement of poor care, approaches interference in the practice of medicine.

We agree with the GAO recommendation that screening criteria should be available and that valid criteria be shared among agencies, Professional Standards Review Organizations and practitioners. The screening nature, rather than a pass-fail connotation, must accompany the criteria. Professional judgment on the part of physicians, nurses and pharmacists must not be over-ridden by a government body's idea of how drugs should be monitored.

We disagree with the GAO recommendation that vendor and consultant pharmacy services be separated. This recommendation ignores the recent technological and procedural advances in long term care pharmacy. Computer and other systems permit vendor pharmacists to “plug in” new prescriptions to each patient's drug profile as the prescription is received. Such a system is an efficient and effective use of professional time.

We hope our comments have contributed to this discussion. In summary, we have suggested:

Immediate research on the effects of drugs on older patients.
Attention to the professional manpower needs of long term care facilities.
Drug reviews by pharmacists in all long term care facilities.

The development of additional screening criteria, with the caveat that the criteria be used only to screen, not to prescribe medical practice.

That facilities maintain the prerogative to contract with pharmacists, for drug purposes, who are judged to be most expert and efficient in carrying out this function.

PREPARED STATEMENT OF WESTERN STATES PHARMACY CONSULTANTS, LTD.

RATIONAL DRUG UTILIZATION IN LONG TERM CARE Mr. Chairman, I am Donald D. Coble, R.Ph., President of Western States Pharmacy Consultants, Ltd. I would like to express my gratitude for this opportunity to present the following testimony relating to drug utilization and rational drug therapy in long term care.

During the past decade, there has been much discussion among health care professionals, state and federal legislators, and educators on the problem of drug abuse or over-utilization among the elderly. Unfortunately, little headway has been made in this endeavor as is seen by the fact that even today the average nursing home patient, in this country, receives six to seven different medications ranging from eight to sixteen doses daily.

Western States Pharmacy Consultants, Ltd., has over the past three years made an attempt to develop the tools and skills necessary to not only identify those individual patients who are for one reason or another over-utilizing medications or are to some degree subject to being medicated in an irrational manner. We have been able to demonstrate, through extensive drug utilization review, educational programs, and implementation of drug acquisition protocol, that in fact not only are we able to significantly decrease overall drug utilization in any given long term care facility, but many of the “symptoms” manifested by various patients disappeared.

This second finding has had a reverse snowball effect in that as various complaints (side effects or adverse reactions to medications) subsided, even more drugs were discontinued.

The overall effects of such an approach to rational drug therapy as will be further described are:

(1) Improved long term health benefits;
(2) Decreased hospitalizations due to adverse or toxic drug reactions;
(3) Decreased drug acquisition costs;
(4) Decrease in medication duplication; and

(5) Decrease in nursing time spent doing clerical types of tasks such as ordering or inventorying of medications.

The following medical care evaluation study was performed from May, 1979, through October, 1979. This study was a combination of utilizing all of the effective tools and skills developed in the two years prior to this study.

The purpose of this study was to:
(1) Evaluate drug utilization patterns in a specific long term care facility.

(2) Demonstrate effective methods to significantly decrease overall drug utilization.

(3) Determine the cost savings involved in such a project.

(4) Identify those benefits gained by patients which a dollar value could not be determined.

Initial evaluation of drug utilization patterns were established through a computer-based patient profile system. At the outset of this study, the average number of different medications ordered was 10.50 per patient. At the conclusion of this study, drug utilization was reduced to 5.35 per patient. This reduction in overall drug utilization provided an estimated $85,000 savings in drug acquisition costs to the patient or facility. To achieve this change in drug utilization, required the cooperation of the clinical pharmacy consultant, nursing staff, occupational therapy, administration, social service, physical therapy, and the attending physicians. A multidisciplinary approach to patient review provided the pharmacy consultant with the information necessary to evaluate the total patient with respect to drug therapy.

A good example of how this review of the total patient is essential occurred as follows:

A 79-year old white male was being given physical therapy during recovery from a fractured hip was having difficulty with the walking parallel bars as the left hand would suddenly lose the ability to grip the bar. On review of medication, it was noted that the patient was receiving 50 mg of Diphenhydramine HCL, an antihistamine, three times a day for a since resolved dermatologic disorder. The pharmacy consultant informed the attending physician that this paradoxical loss of grip strength could be due to this particular medication and further recommended the discontinuance of this drug. The problem with this loss of gripping ability was eliminated and the patient responded well to physical therapy.

The actual protocol for this drug utilization study required extensive inservicing of nursing staff on the use of automatic stop order policies, limited quantity ordering of short term medications for the treatment of such ailments as coughs and colds or diarrhea. The attending physicians were educated as to the role of the clinical pharmacy consultant and the objectives of rational drug therapy. Finally, all other disciplines were informed as to the role of the total health care team and the need for open communication to ensure the most complete picture of any given patient.

With this type of open communication, the clinical pharmacy consultant was able to provide extensive evaluations on each patient's drug regimen, observing such factors as drug-diet, drug-disease, and drug-drug related problems. Along with these factors, communication to nursing staff and the attending physician was on a dayto-day basis. The following data was collected during this study:

The most frequently prescribed medications in this facility: Lanoxin, Lasix, Dilantin, Mellaril, DSS, Haldol, Hydrochlorthiazide, Milk of Magnesia, Aspirin, Tylenol, and Mylanta.

Change in drug utilization during this study:

May 1979

October 1979

Average orders per patient...
Average routine per patient
Average prn per patient.
Average Tx per patient

14.2
6.7
3.8
3.7

7.38 2.77 2.58 2.02

The facility was compared to 20 other facilities in the front range area of Colorado. At the beginning of the study, Ivy Manor was 19th highest in drug utilization and is presently the lowest of these 20 facilities.

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To summarize the results of this study, one must consider that although the dollar savings, with respect to drug acquisition costs, is significant, no attempt was made to determine the dollar value of overall improved health care, for the residents in this study, nor was the money saved in nursing time determined.

One factor that needs to be addressed at this point is the pharmacy vendor/ pharmacy consultant relationship. The clinical pharmacy consultants from Western States Pharmacy Consultants, Ltd., are contracted for consulting services exclusively by the long term care facilities. Each facility then obtains medications, biologicals, and supplies from the vendor pharmacies of their choice.

I would find it difficult if not impossible to believe that a consultant pharmacist employed by a vendor pharmacy could justify to the pharmacy for which he works an overall decrease in drug sales of greater than $85,000 in one facility in one year. There may exist a limited number of pharmacy consultants that in fact approach this type of cost effective drug utilization review, but it is obvious that there is little incentive to perform such a function. The analogy of the fox watching the chickens is similar to the vendor pharmacy/pharmacy consultant relationship.

I respectfully urge this committee to consider this obvious conflict of interest and for you to make recommendations and guidelines more stringent thus putting the pharmacy consultant in at least an arms length relationship with vendor pharmacies.

The roles of the vendor pharmacy and the pharmacy consultant are quite distinct and separate and should be mandated as such. Reasonable fees for service should be provided to the consultant pharmacist as they are for the pharmacy vendor.

Our experience has demonstrated that the patient-oriented, clinically-trained consulting pharmacist can provide improved health care as well as to decrease overall health care costs through rational drug utilization review.

PREPARED STATEMENT OF THE NATIONAL CITIZENS' COALITION FOR NURSING HOME

REFORM

RECOMMENDATIONS FOR IMPROVEMENTS OF PHARMACEUTICAL SERVICES IN NURSING

HOMES

Chairman Pepper and members of the Committee. My name is Susan Conner. I am employed by the National Citizens' Coalition for Nursing Home Reform. We appreciate this opportunity to present our views on drug therapy management in nursing homes. The Coalition is gravely concerned about the plight of those chronically ill nursing home residents who may suffer needlessly or even die as a result of the indiscriminate use and monitoring of drugs. Even legal drugs appropriately used by well-intentioned professionals can work untold mischief in the frail elderly. The inherent risks skyrocket in nursing homes, which have long been noted for poor prescribing, administration, and monitoring practices.

Congressional hearings have been held on this subject before, The incidence of drug misuse and abuse in nursing homes has been documented by both private and governmental sources. The General Accounting Office report which was issued here today only substantiates what most of us already knew or suspected. We believe it is time for a serious aggressive and coherent national program to end these practices.

The GAO has presented several recommendations of limited scope, but has failed to address the pharmacists drug review in the context of the entire nursing home system. Pharmacists provide only two of the four components of drug therapy: dispensing and monitoring. Of the remaining functions, prescribing is done by physicians and administration is carried out by nurses. Most day-to-day monitoring is also within the purview of nursing responsibilities. All of these functions are interdependent and cooperation among the professionals involved is necessary to ensure optimal results.

Physicians spend very little time in nursing homes. They may prescribe medications by phone or make only perfunctory visits to residents. Routine diagnostic procedures are often omitted. It is not uncommon to find duplicative or conflicting drugs in a resident's regimen. One drug may be ordered for a condition which is a side effect of another drug. Automatic stop orders may be neglected. The traditional paucity of geriatric research and of geriatric training in medical schools have certainly added to the general reluctance of physicians to treat elderly nursing home residents.

Drug administration and day-to-day monitoring often leave much to be desired. I have personally spent a total of three years working as a nurses aide-in facilities that were not considered “bad” by most standards. I observed and participated in many medication abuses, a few of which are enumerated here today. All the time, I was conscious of the tremendous potential for abuse which characterizes so many aspects of nursing home employment. Yet based on my many communications with other nurses aides around the country, I can reasonably say that my experiences were typical if not better than those of the majority of nursing home employees. Drugs are given either. by nurses who otherwise see little of the residents or by untrained aides such as I was who are familiar with the residents but who know nothing about drugs and their potential effects. The result is a remarkable rate of administration error and an environment in which the close monitoring necessary for geriatric polypharmacy is impossible. Adverse reactions, even if noted, may not

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