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appear on the chart. Communications in nursing homes are poor. There are three shifts, many part-time employees, and an alarming turnover of personnel at all levels. The ever increasing use of nursing pools is adding to the lack of continuity and communications. Short staffing and absenteeism are endemic. This hectic atmosphere is not conducive to careful observation, regular monitoring, and prompt reporting of changes in residents' conditions.

Pharmacists provide two very separate functions in the nursing home; they supply and dispense medications and they provide the monthly review to ensure that the drug regimen is appropriate for the resident. In most states, the nursing home serves as a financial middleman between the pharmacist and the state. This tends to cloud the direct accountability to the state which would enhance the consultant function. Instead dispensing pharmacists are paid by the nursing homes for prescriptions as they are filled. Consultant services are rendered by the same or subcontracted to another pharmacist and are billed separately also to the facility. The consulting role, being less quantifiable and less familiar to all concerned, may get short shrift in the heavy competition for the limited funds available under Medicaid. Yet the monthly review, if performed well, is the most effective known device for improving the quality of drug therapy in nursing homes.

The review, as anticipated by the Health Care Financing Administration in recent proposed regulations, should reveal errors in prescribing and administration of medications, oversights in monitoring, and should add the discretion of a specially trained professional to the care planning team. This will involve visiting and observing residents, talking to staff, and consulting with physicians where appropriate. The pharmacist can and should, by virtue of this special training, assume a leadership role in the management of drug therapy. However the pharmacist does not actually have direct responsibility for any of the three functions of prescribing, administration, and daily monitoring. He can only offer recommendations and education.

Unfortunately, the present reimbursement system severely limits and discourages the consultant function of pharmacists in nursing homes. The GAO, for example, notes a potential conflict of interest between the dispensing and consulting roles of nursing home pharmacists. This potential certainly exists, given that a reviewing pharmacist may face the practical dilemma of recommending the discontinuance of drugs whose sale is compensating that consulting time. Separating the roles might appear to be a logical solution to this problem. Yet the Department of Health and Human Resources admittedly intends that profits from dispensing offset somewhat the inadequate payment for consulting services.

At present, there is not evidence that the potential role conflict is indeed interfering with services provided to nursing home residents. Combining the roles offers some potential benefit in that a pharmacist familiar with the resident may catch some inappropriate medications or dosages before they are actually dispensed. Also an ideal consulting relationship would facilitate better instructions on administration and monitoring from the pharmacist to the staff. On the other hand, separation of the roles might result in further unnecessary fragmentation of services and impede efforts to develop a team approach.

There are models for pharmaceutical reimbursement which would decrease the tension between the consulting and dispensing roles. Massachusetts is experimenting with a reimbursement system which sets aside specific funds for consulting pharmacists services. This ensures that the state and not local nursing homes sets the rates for pharmacists' reimbursement. Since pharmacists have specific obligations under the regulations, they should have a direct fiscal relationship, as well.

Another reimbursement method which has shown great promise and has been proven widely acceptable is capitation reimbursement. The pharmacist is paid a set fee for both consultation and dispensing functions or is permitted minimal profit for dispensing medications and a set fee for consulting. Either way recognizes the consulting role as at least equal in importance to dispensing and lessens the incentive to dispense and approve unnecessary medications. California is now experimenting with such a system.

well-conceived reimbursement mechanism must encourage a thorough view of the drug regimen. Current regulations anticipate that this review should take around four hours per 100 residents per week. This comes to some nine-and-a-half minutes per resident per month. This is not enough time for a complete evaluation of the chart alone; it certainly would not cover such functions as patient observation and interview or staff and resident education. Yet these activities are vital to carrying out individual drug regimen reviews and to developing quality pharmaceutical services in the facility.

Reform must go beyond the clinical level to include research and professional education. Because drug therapy poses a greater risk in the old than in the young, we should look into other interventions which will achieve the same benefits without presenting such danger and requiring close monitoring. Then we need to ensure that new knowledge about geriatric pharmacotherapy and its alternatives make their way expeditiously through the educational system to the clinical level. One device is integrated programs such as the Veterans' Administration's system of Geriatric Research, Education and Clinical Centers. These facilities combine research, teaching, and clinical resources under one aegis, and encourage medical schools to develop geriatrics programs on their own in order to affiliate with the VA clinics. Another good strategy, advocated by Dr. Robert Butler of the Institute on Aging, would see medical students required to serve rotations in teaching nursing homes affiliated with their medical schools.

We also need more information about ways of involving residents and their surrogates in care planning. It is important to communicate information about medications and other treatments to residents so they can participate in decisions, given informed consent, and monitor their own therapy. The Food and Drug Administration has proposed that written information be distributed with prescriptions to consumers. But the regulatory scheme excludes institutionalized persons from those to receive this valuable information, reasoning that they are too ill and disabled to use the information and that it could be available to through staff or in a centrally located book. This ignores a long litany of grim realities in the nursing home setting. We urge you to push for research in communicating medical information to elderly residents and in involving them in decision-making.

Increased professionalism of nursing home employees would almost certainly cure some of the current ills of the system. Medical specialization is a trend which has not always served the best interests of patients. Nevertheless, we would like to see serious consideration of certification in long-term geriatric care for pharmacists, nurses, and aides in nursing homes. We have long advocated for training and certification of nurses aides. The American Society of Consultant Pharmacists argues for a similar requirement for pharmacists performing drug regimen reviews. Nurses may also need further specialized training. Their traditional

education has emphasized the delivery of direct, acute medical care. Supervisory skills, care of the chronically mentally and physically ill, and geriatrics, while part of general nursing curriculum, are not accorded high priority. Since nurses are not especially trained in the skills most needed in the nursing home, they tend to scorn this work as "geriatric babysitting.” Continuing education requirements would both professionalize and upgrade this challenging specialty area.

With all of the realities of staff turnover, shift coordination, and part-time employees in mind, perhaps we should consider the advisability of giving one staff person primary responsibility for coordinating the care of each resident. Rather than adding a burden to already overworked staff, this might reduce some of the confusion resulting from inconsistent and duplicative communications. This person would serve as primary liaison between the family, physician, pharmacists, and nursing staff. Because of the irregular schedules necessary in a facility operating around the clock, seven days a week, aides do not relate to the same supervising nurse every day. Patient care can vary dramatically depending on who is on duty. Many therapeutic programs fail because one shift or one part-time nurse is not cooperating with the care plan.

In some states, nurses aides have been trained to take over some of the responsibilities of drug administration. I have encountered mixed reactions to this policy from pharmacists and other professionals. A study of the value of such training and its impact on the quality of care should be undertaken and the common elements of successful programs determined and disseminated. Such factors as whether a unit dose system is utilized and who is responsible for developing and carrying out training should be considered. If the concept is truly feasible, medication aides could relieve nurses of the burdens of routine drug administration while enjoying some vertical job mobility themselves.

Despite the magnitude of the problems relating to drug therapy in nursing homes, we can point to several positive steps which may lead to eventual reforms in this area. Some of these, such as the interest in capitation reimbursement and the elimination of the nursing homes' middleman function between the state and pharmacist have been mentioned earlier. Some others relate to the growing responsiveness of professional associations and the federal government to this problem.

A growing voice for reform among pharmacists is the American Society of Consultant Pharmacists which represents practitioners serving over half of the nursing home residents in the country. The ASCP is pushing for changes which will ultimately expand and enhance the role of the pharmacist in long-term care. Significantly, the society is setting the standard for its members by encouraging greater professionalism. Members are required to complete annual continuing education requirements in clinical and geriatric pharmacy. Many of them in turn have developed progressive programs of drug monitoring and patient and staff education in their facilities.

The American Nurses Association has recently established a section for members working in nursing homes. Since nurses are so close to the problems of drug therapy, it is our hope that this group will actively and effectively advocate for better working conditions and more stringent qualifications for nurses in long-term care. Studies have indicated that geriatric nurse practitioners can perform a leadership role in nursing homes by upgrading both patient care and staff education. The services of these specially-trained professionals should be encouraged through the reimbursement system.

The Health Care Financing Administration is currently developing regulations which would clarify the expectations of the drug regimen review as it is evaluated during the survey process. This is encouraging and hopefully will lead to efforts to increase the reimbursable time for this inspection as well. Very importantly, HCFA is also proposing to extend the monthly pharmacist's review to intermediate care facilities just as it is currently required in skilled care. Present ICF regulations require only a quarterly nurse's review of drugs even though all of the problems of drug therapy management in SNFs appear to be duplicated at the lower level of

Finally, we were pleased to learn from Dr. Butler that the NIA and FDA are creating a joint work group to study problems relating to drug use in nursing homes. Dr. Butler is highly regarded in all quarters. He has effectively led his institute in advocating for research to improve the quality of life and health for our older citizens. This cooperative effort between a research institute and an agency with regulatory authority is a major step toward comprehensive, meaningful recommendations for future action.

We appreciate the opportunity to present our comments on this important issue.

care.

PREPARED STATEMENT OF THE NATIONAL COUNCIL OF HEALTH CENTERS,

WASHINGTON, D.C. Mr. Chairman, the National Council of Health Centers is pleased to have this opportunity to comment on several vital issues of concern to nursing homes.

The National Council is an association which represents investor-owned multifacility nursing home companies comprising over 110,000 beds in the United States and Canada. Our members are committed to providing high quality patient care at a reasonable cost and in addition to providing nursing and rehabilitative services, they are also involved in providing the total spectrum of care to the elderly, including congregate living arrangements, home health, adult day care, and meals on wheels. We are proud of the innovations that members of our association have brought to the field of aging and of the strides they have made in improving the quality of life for our nation's elderly.

We commend the House Committee on Aging for drawing attention to the many serious issues confronting the aged, and in particular those which we would like to address today, the problems in administering drugs in nursing homes. First, however, we would like to draw your attention to two other areas of concern, namely, current proposals to revise the survey and certification process for nursing homes and revisions in the SNF/ICF Conditions of Participation.

REVISIONS IN THE SURVEY/CERTIFICATION PROCESS During the past few months, the Department of Health and Human Services (HHS) held a series of ten hearings in each HHS region in order to solicit comments on certain issues involving the nursing home survey and certification process.

In our opinion, the issues raised, commonly known as Subpart S Revisions, were poorly developed and indeed, both the issues and the hearings seemed to generate universal criticism from providers and consumer advocates alike. We had several concerns regarding the hearings themselves, namely there was too little time provided to consult adequately with our membership, and then to prepare a thoughtful and intelligent response. The hearings seemed to be scheduled more as a convenience to Department staff and in an effort to "get them over with” than a legitimate attempt to elicit our comments and then later to evaluate them.

As if to support this conclusion, HHS officials seemed little interested in the testimony presented, nor did they seem inclined to ask questions or seek clarification of witnesses' statements. In point of fact, while delivering the testimony for the National Council our president was cut off because he had used his allotted fifteen

a

minutes, yet only minutes later, the meeting was adjourned an hour before lunch because of the lack of participants.

Mr. Chairman, we are frankly mystified at HHS's motives for holding these hearings. The Department was clearly not interested in hearing what participants had to say and if we had known that in advance, rather than participate in the hearings, we would have submitted a written statement for the record. Given the Department's reception, it would seem that the efforts of our president in journeying 600 miles were wasted.

As I mentioned earlier, the issues themselves were poorly conceived and described. To summarize in three or four_paragraphs a complicated issue and the proposed solution would seem ludicrous. Further, we believe that HHS already had decided where it stood with regard to the issues because even as the hearings were taking place, the Department was submitting to Congress those proposed issues which would require legislation. We are not satisfied with HHS's response to this, that legislation takes years to enact. Regardless of the length of time it takes to enact legislation, the point remains that the Department of Health and Human Services and Mrs. Harris have already decided that they want the changes and thus it is a futile exercise for us to debate them.

Apart from the manner in which these issues have been addressed by the Department of Health and Human Services, we are seriously concerned at the potential impact that they will have. When viewed in the context that beginning September 30, 1980, the Department will cut back its funding of the survey process from 100% to 75%, we are fearful that these proposals are designed more to save dollars than to improve the surveys. One need only observe the protests of the consumer advocates regarding Subpart S revisions to know that the onus would be placed on nursing homes, not HHS or the surveyors, if the new process were to fail.

We believe that the Department was much too premature in making these proposals and would have preferred instead, that the innovative efforts of a number of states such as Wisconsin, Massachusetts and West Virginia, be evaluated before undertaking a complete revamping of the current system.

Further, as we stated in our comments at the hearing, a genuine effort to upgrade the qualifications and training of surveyors is needed, because the effectiveness and value of the process is only as good as the people conducting the survey.

Finally, we are tired as an industry of shouldering all of the blame when there have been breakdowns in the survey process. We feel that if a poor nursing home is permitted to continue in business, it is not only the home's fault, but also that of the survey process and of the Department itself. It is not, however, the fault of the entire industry and that should be made perfectly clear. Until the Department is able to deal with the problems outlined, we feel these proposals are inappropriate and will in fact only exacerbate them.

SNF/ICF CONDITIONS OF PARTICIPATION While the Department has spent only a few months on the Subpart S Proposals, the revision in the SNF/ICF Conditions of Participation have taken literally years. Suddenly, however, we are faced with the prospect of having only sixty days to comment on the proposed rules, which could very significantly impact all certified nursing homes. Since we have all waited a number of years for these rules, we do not believe it is too much to ask that a 120-day public comment period be provided, as has been promised by HHS during the past. To date, HHS has ignored our vigorous protests regarding the 60-day comment period.

We have many serious reservations regarding the new Conditions of Participation, not the least of which, is that we do not believe that they can accomplish what they were set out to achieve, namely a reorientation of the survey so that it would be outcome-oriented. The National Council strongly supports efforts to focus on patient care and we would go a step further and advocate that the reimbursement system should build in incentives which would promote the patients' rehabilitation and improvement, rather than the opposite as is currently practiced.

It would seem that some of the HHS proposals regarding nursing home requirements were written in a vacuum, since they do not reflect the position of any interested party. For example, the patients funds regulations which are about to be promulgated require that nursing homes must begin to institute formal guardianship proceedings for patients who are incapable of managing their funds when no family is present. In the interim, the facility must manage the funds itself. Not only is this placing the facility in a role that neither the providers, patients, nor consumer advocates want, it is in contravention of some states' laws!

In a telegram and letter to HHS Secretary Harris, the National Council stated its concerns regarding the new Conditions, specifically the impact they will have on all nursing home patients, not just Medicare and Medicaid beneficiaries:

"It is simply not realistic to expect that the conditions will be applied to Medicare and Medicaid program patients and not expect the costs to private patients to increase as well

. This is especially true where states are presently paying facilities less than their actual costs . we respectfully submit that 60-days is simply not enough time to deal with such a comprehensive and important set of issues. It is illogical and unrealistic to give the public only 60 days to respond after it has taken the Department three years to develop its final proposal.'

We urge you, Mr. Pepper, and your Committee, to do whatever you can to assure a full 120-day public comment period for this very important set of regulations.

DRUG ADMINISTRATION IN NURSING HOMES

Much has been said and written about the problem of drug administration in nursing homes. Many of these comments deal with the over-medication and tranquilization of patients in order to make them more compliant and easier to manage.

We cannot condone the acts of any nursing home which goes beyond legal bounds. Those which do should not be permitted to continue providing services. We firmly believe, however, that the vast majority of nursing homes today are providing good care and do not wish to see the good homes castigated for the wrongdoings of the bad. Nor should we be blamed for the failure of federal and state agencies to do their job. There are more than enough regulations and inspections to ensure that quality care is delivered. We do not need a whole new set of rules such as the Department of Health and Human Services' revised Conditions of Participation for nursing homes. Rather, we need clear, objective criteria and better enforcement of existing rules.

Almost all of the criticism on drug administration has been directed towards nursing homes, with little attention given to the total process of drug prescription, administration, and review or of the various individuals involved in that process. Nor have critics attempted to go beyond the surface facts to seek the underlying causes of these problems and perhaps to propose some constructive solutions.

While the nursing homes themselves have improved, there has been little change in the public's perception of the homes. They are still often viewed as places where people go to die (but also where 40 percent of the patients could be cared for in the home). These are two misconceptions which need to be dispelled.

First, the majority of nursing home patients are discharged alive. Recent data from nearly 5,000 nursing home patients show that in one four-month period, one third of the patients were discharged, and of this number, 75 percent were discharged alive. Followup on these patients reveals that most were still living after six months.

Secondly, today's nursing home patient is much older and sicker than in the past. The combination of PSRO and utilization review as well as an acute shortage of nursing home beds with long waiting lists, have changed the population of nursing homes. The majority of nursing home residents are over 80 years old, most have two or more chronic disabilities, over half have some degree of senility; twenty percent have disturbed sleep, and 40 percent are agitated and nervous. Patients are in nursing homes because they are ill. It is unrealistic to expect them not to take medications, nor will looking only at the number of medications provide any useful data. This was pointed out by the Chief Medical Advisor of the General Accounting Office, Dr. Murray Grant, during testimony before your Committee.3

Dr. Grant stated that merely examining the number and amount of medications prescribed for a patient does not provide sufficient information to determine if he is being overmedicated. One must also look at the physical condition of the patient and the extent of his illness.

Nor should one compare the characteristics of nursing home patients and their medications needs with the non-institutionalized population of elderly, as a number of studies have attempted to do. One recent HCFA-funded study even went so far as to compare the records of ambulatory non-institutionalized Medicaid recipients with those of nursing home patients who had been in homes for a year or more, despite the fact that the average length of stay for a nursing home patient is only 270 days.

3

*Copy of telegram and letter attached.
1 Jan.-April, 1980 Data, National Health Corp., Murfreesboro, Tennessee.
2 1973–74 National Nursing Home Survey-NCHS.

*Murray Grant, M.D., Chief Medical Advisor, Human Resources Division of the General Accounting Office in responding to a question before the House Aging Committee hearings on “Drug Abuse in Nursing Homes,” June 25, 1980.

* "Ă Study of Antipsychotic Drug Use in Nursing Homes: Epidemiologic Evidence Suggesting Misuse,” American Journal of Public Health, May 1980.

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