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1. The aging process

Elderly patients are exposed to increased risk of the misuse of drugs primarily because they are elderly. As people age, the number of developing chronic medical conditions and disabilities increases. For example, the average person over 65 years old suffers between one and three chronic medical conditions; many elderly have between five and nine chronic medical conditions.

The aging process causes decreased or impaired kidney function, muscle activity, heart function, and weakened immune and nervous systems. As a result, the elderly are more susceptible to disease. Also, recovery from disease in the elderly requires more time. Nearly two-thirds of the residents of nursing homes have three or more chronic medical conditions. Most of these chronic medical conditions are managed through the use of drugs.

It should be emphasized that most chronic medical conditions are managed through the use of drugs; most chronic medical conditions are not cured. In general, the greater the number of chronic medical conditions, the greater the number of drugs that are taken. With people living longer, the number of people on long-term medication therapy has increased dramatically. Many of the drugs of choice for the most common chronic conditions were not known two decades ago, and we do not know the medical implications of having patients on drug therapy for years or decades. 2. Inadequate medical supervision

Residents of nursing homes seldom see physicians. While statistics on the frequency of physician visits to residents in nursing homes is not available, federal regulations only require physicians to see nursing home residents once a month. Lack of supervision is not restricted solely to physicians. Studies indicate that consulting pharmacists practice less than five hours per week in two-thirds of the nursing homes.

In nursing homes, the vast majority of patient care is delivered by the nursing staffs. A majority of the nursing homes are proprietary, and studies indicate that the vast majority of nursing homes are staffed at or near the legal minimum. The paucity of nursing care was testified to before this Committee. To aggravate the paucity of staff is the typical allocation of responsibilities: the more highly trained staff tend to be occupied with administrative duties while the least trained staff are the most involved in patient care. What is a concerning potential is that when staff are spread thinly among many patients, the organizational imperative might demand that the patient be placed in a medical straight-jacket. Testimony before the Committee indicated that sacrificing the patient to drugs is more than a possibility. 3. Irrational drug therapy

When the conditions of multiple diseases and insufficient medical supervision are combined, the result is often irrational drug therapy. Irrational drug therapy has many faces-all can be frightening-some can be fatal.

(a) Insufficient drug regimen review.-Insufficient drug regimen review is one problem. More than 40 percent of nursing home residents receive seven or more medications per day. Additionally, residents in nursing homes may take various Over-the-Counter (OTC) products; OTC's are drugs. Although the elderly comprise 10 percent of the general population, the elderly consume 25 percent of all prescription drugs.

Without adequate drug regimen review, many patients continue on drugs that may no longer be appropriate. For example, between 60 and 80 percent of elderly patients taking digoxin may not need the drug. In 25 percent of nursing homes there is no process of stopping the automatic re-writing of prescriptions.

Of concern to many researchers is the widespread use of psychoactive drugs among nursing home residents. Over half the the residents of nursing homes take at least one psychoactive drug. Over half of these potent psychoactive drugs are prescribed on “as needed” basis (PRN). Studies indicate that up to 25 percent of the medications taken by institutionalized patients may be ineffective or unwarranted.

(6) Drug reactions/drug interactions.-Drug reactions and drug interactions threaten the health of all patients. The threat of drug reactions and drug interactions are more acute for residents of nursing homes. Residents of nursing homes are exposed to a greater number of drugs, their general health is poorer than other population groups, and medical supervision may be less.

One-fourth of nursing home residents receive medications with a potential for interaction. The elderly, in general, have a potential for adverse drug reactions that is 150 percent greater than the general population.

Adverse drug reactions and drug-drug interactions may account for 4-7 percent of all hospitalizations; the prevalence among the elderly is thought to be higher.

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Approximately 14 percent of all hospital patient days are accounted for by adverse drug reactions. Adverse drug reactions may be experienced by nearly one-third of hospitalized patients—and when an adverse drug reaction is experienced, the hospital stay is nearly doubled. Sadly, studies indicate that approximately 70-80 percent of adverse drug reactions are avoidable.

The vast majority of drug-drug interactions and adverse drug reactions could be prevented through pharmacists' intervention.

(c) Nutritional state. The importance of nutrition to the health status of the elderly has only recently been appreciated. The elderly take prescription and non

iption drugs for diagnosed medical conditions, relief from headaches and 1. vakness and for relief from other distress. In many instances these medications have adverse effects upon their nutritional state.

Drug therapy can influence body weight, contributing to underweight or obesity. Drug-induced nausea can directly imperil proper intake of adequate foodstuffs. Drugs can effect uptake of vitamins, certain drugs can also leach vitamins from the body. Equally important, several very common drugs can deplete necessary minerals from the system. Certain medications can interfere with the metabolism of food. These effects are more serious for older citizens who already may be suffering from subclinical nutritional deficiencies. Patient monitoring of diet and medications would prevent or improve these nutritional difficulties.

(d) Altered response to drugs.—Drugs are subject to rather rigorous review prior to clearance for public use. But, typically medications are tested upon adult populations aged between 21 and 60. Testing reveals the level of efficiency and safety for drugs and yields the appropriate clinical dosages. Unfortunately, the aging process itself has altered kidney function, heart activity, digestion, psychomotor function and metabolism. The result is that usual and normal doses of drugs may not be appropriate or safe in the elderly person.

Usual dosages of such drugs as the diuretics, antihypertensives, and the psychoactives are frequently inappropriate for the elderly, often causing drug-induced symptoms that mimic other medical conditions. Drug-induced symptoms are often interpreted as common conditions of the aging process—such as confusion, incontinence, dizziness and anorexia–when these symptoms are treated with additional, unnecessary drugs, the health of the patient is further threatened.

These problems can largely be obviated through routine patient review by a person trained in the actions of drugs on the body and the possible adverse effects: a pharmacist.

Irrational drug therapy has many faces-an over medicated patient, a patient who is not receiving a drug necessary to combat a disease, more frequent and more costly hospitalization, and lowered quality of life.

SUGGESTED SOLUTIONS

There is no workable solution to the problems of irrational drug therapy without pharmacy. As a profession, the nation's 130,000 pharmacists have the best knowledge of drugs and their actions upon the human body. In the recent past, pharmacy education has changed from emphasizing drug products to emphasizing the application of drug and disease knowledge to patient care.

During the decade of the seventies, pharmacy educators have attempted to respond to massive social and scientific changes affecting the practice of pharmacy. Students are afforded more opportunities to experience patient-centered learning and to work in close cooperative relationships with other health practitioners. Health care settings such as hospitals, clinics, nursing homes, and community pharmacies are increasingly used as settings for instructional programs. Societal responsibility and responsiveness to change characterize the current trends in pharmacy education.

The pharmacist must have a comprehensive knowledge of drugs that includes their composition and chemical and physicial properties, as well as their pharmacologic effects upon both healthy and ill patients. Pharmacists must be able to serve as prime sources of drug and health information for patients and other health professionals. They must also become familiar with the physiological, pathophysiological, and socioeconomic characteristics of patients and the influence of these characteristics on drug action and drug-taking behavior. Particularly in the field of geriatric pharmacy, pharmacists must learn about toxicities of drugs in greater detail

. Whereas drug-drug interactions have already been studied and taught in schools of pharmacy, now it is also necessary to teach drug-food interactions, druglaboratory test value interactions, and particularly for the elderly, who are faced with multiple pathology and polypharmacy, drug-disease interactions. Pharmacists can then assist in the initiation and monitoring of rational drug therapy and in the provision of other services where their expertise can contribute to the well-being of society.

Four contemporary pharmacy concepts play a critical role in reducing the problems of drug use in the elderly: drug utilization review, increased patient monitoring, patient education, and direct consumer education.

If we wish to reduce the number of drug interactions, drug duplication, medication errors, and costs, we need drug utilization review by pharmacists.

Increased ongoing-patient-monitoring by pharmacists allows detection of adverse drug reactions, unnecessary or unwarranted medications, drug-induced symptoms, over or underutilization of medications, excessive duration of drug therapy, or withholding of an appropriate drug of choice for therapy.

Patients have a right and responsibility to understand and be involved in their care. Pharmacists are uniquely qualified to counsel patients about their own therapies, nonprescription drugs, prescription drugs, home remedies, alternatives or supplements to drug use, diet-drug interactions, and the do's and don't's of drug use. Increasingly, pharmacists are being trained to communicate with the elderly, who may have impaired hearing and vision, a confused state of mind, and reluctance to report symptoms.

An increased number of pharmacists are participating in direct consumer education about the wise use of drugs at eating-together places, churches, senior citizen apartments, and similar sites.

LEGISLATIVE DIRECTIONS

I have described some problems and have demonstrated the ability to respond. The responsibility now rests with the Congress to create legislation to implement the solutions we have outlined. Given the authority and incentives, pharmacy will respond. In the design of future legislation, I urge the Congress to consider the following legislative objectives:

(1) Mandate review and monitoring procedures to address the many drug-related problems the elderly encounter, and provide the economic and professional incentives for implementation.

(2) Provide adequate funds for research to increase the body of scientific knowledge related to drug use in the elderly.

(3) Support educational programs to bring this new knowledge to the nation's health students and practitioners, and to consumers.

Mr. Chairman, on behalf of pharmacy education, I thank you for this opportunity to make a statement on a pressing health need.

FLORIDA PHARMACY ASSOCIATION,

Tallahassee, Fla., July 9, 1980. Congressman CLAUDE PEPPER, Federal Building, Miami, Fla.

DEAR CONGRESSMAN PEPPER: I know your extreme interest in the health care of the elderly of our nation and particularly the needs of those requiring nursing home services.

I have been following the media coverage regarding your Aging Committee hearings and report.

There was one question that seems to appear every time government discusses nursing home problems which is, should the same pharmacist perform the consulting and dispensing services? To me, the answer is very simple and logical. It does not matter! What matters is who is paying for the service and is the patient receiving the benefits of the service.

The Florida Pharmacy Association has gone on record on numerous occasions and at every level on this matter. Here is our position.

First, the current system requires that the N.H. pay the pharmacist for these services. That in itself breeds a bad situation, because the N.H. administrator may not care about the patients needs, and therefore, could negotiate with the pharmacist to only provide superficial services or a part of a total contract. The N.H. administrator can bill government for the full services, collect that amount and pay the pharmacist less or nothing for the services that were not performed anyway. This is the problem that concerns me—the patient is being overlooked.

By the same token, if you were to require the government to contract with the pharmacist for the services and pay him directly, we then have the situation where the N.H. administrator will be more inclined to make certain that the pharmacist performs these services he is being reimbursed for. Under this proposal, we no longer have the fox watching the chicken house situation. Also, because the pharmacist is being paid for his services, he will then perform them regardless of the N.H. administrator.

The second question deals with whether the pharmacist providing the service should also be the consultant or not. We maintain that again under our proposal, it would make no difference because we have a different set of checks and balances regarding the delivery of services. Another point is that you could just as well have an unscrupulous consultant who would direct the business to a friend, and this again circumvents the check and balance system we have proposed by a direct payment by government for the pharmacy consultant services.

How can government expect the level of services they wish for patients when they pay someone else and don't require that these monies be paid directly to the provider of the services? I don't believe government would like to have to obtain monies due them from me through a third party that had no obligation to the government. This is exactly what they are asking pharmacists to do.

The Florida Pharmacy Association agrees with the testimony of APhA and ASCP as they related to the proper utilization of the pharmacist as a professional and the implementation of a capitation payment system for drug products dispensed to a N.H. patient.

In closing, I was sorry to read where you "expressed skepticism about pharmacist deciding whether nursing home patients receive proper medication.” Congressman Pepper, I can assure you that the pharmacist trained as a consultant and clinical practitioner is the best health care provider to make this determination. The pharmacist is the watchdog over the prescribing habits of the physician, and the administering procedures of the nurse. His involvement is critical to the health care of the N.H. patient.

I certainly hope that our comments and observations concerning the services of the consultant pharmacist and how payment is made for these services will be fully reviewed and studied, for we believe it is the only logical and practical solution to fulfilling the needs of the N.H. patient.

Thank you for representing the State of Florida. We are very proud of you and your achievements. Please call upon us if we can be of service to you. Respectfully yours,

J. B. POWERS, Executive Director.

CALIFORNIA ASSOCIATION OF HEALTH FACILITIES,

Sacramento, Calif., July 16, 1980. Hon. CLAUDE PEPPER, House Office Building, Washington, D.C.

DEAR REPRESENTATIVE PEPPER: Those of us in the long term care profession appreciate your concerns over quality care of nursing home residents. We take pride in the good care given to residents in our member facilities. A part of our regular program is a concept of peer review and an open invitation to the public to visit our facilities on a regular basis.

We were concerned, however, over the news reports on your recent House Select Committee on Aging hearing and the publicity which came out of it. One article distributed by Associated Press, quoted Esther Stanley of Santa Cruz, California, relative to her being overdrugged by a nursing home. We have investigated this particular incident and found that Mrs. Stanley was a resident of a Santa Cruz facility in 1974. The news article does not give a date, but rather infers that this was a situation which might have occurred last week. There is no question that Mrs. Stanley was given strong medication at that time and, fortunately, it was corrected.

What disturbs us is that the nursing home is blamed for her being sedated. Nowhere is there any mention of the fact that Mrs. Stanley, or any other nursing home patient, is not given drugs by the facility. All drugs are given at the direction of the patient's doctor. The facility staff, by law, must follow the orders of the doctor in giving out medication. Should the facility fail to give medication to a patient as directed, they are subject to a severe penalty, including fine and possible jail sentence. On many occasions, such as the one in Santa Cruz, professional staff members will call to the attention of the patient's doctor that the medicine is causing a reaction, etc. It is still up to the doctor to change the medication.

We are aware that in 1974 and prior years there were some facilities here in California, as well as other parts of the country, which did not do a good job of caring for the aged and the chronically ill. Fortunately today most of these types of operators have been forced out of the business either through peer review or through legal means.

It is unfair that the 99 percent of the good nursing homes must get a “black eye,” from those few bad ones. It is not very often that the news media prints the good things that take place in long term care everyday. Nor does the media take the time to tell about the totally inadequate funding provided under the Medi-Cal and Medicare programs. All too often the public forgets that there are those within our community who require financial support for their care. We can spend billions on defense and refugees, yet we don't spend enough to care for those citizens who have given years of their life to their country and now must be cared for under a subsidized program of health care.

You might be interested to know that during this past year, residents and staff members of California's nursing homes have raised over $90,000 for the California Heart Association through a spring program called Rock 'N Roll Jamboree. This program nationwide via the American Health Care Association, will raise over 142 million dollars for the Heart Association.

With the help of the California Legislature, two years ago we instituted an educational program upgrading nurse aides to the status of "certified nurse assistant." This program is working very well and is, of course, helping to provide better care for the resident. This too has required additional funding in order to provide a higher wage upon completion of training.

We would be honored to have you visit California nursing home members of our Association and let us show you that “we care.” Our nearly 900 members statewide represent more than 80,000 long term care reisdents and over 65,000 professional employees. Sincerely,

BRUCE YARWOOD, Executive Vice President.

AMERICAN PHARMACEUTICAL ASSOCIATION,

Washington, D.C., July 31, 1980. Hon. CLAUDE PEPPER, Chairman, Select Committee on Aging, U.S. House of Representatives, Washington, D.C.

DEAR SIR: Thank you for the opportunity of presenting the American Pharmaceutical Association's views on drug abuse in nursing homes before the Select Committee on Aging on June 25. As you recall, time constraints prevented me from presenting orally my entire statement and I request that the written statement furnished by the Association be included in the hearing record. Moreover, several questions were asked during the course of the hearing which bear on the Association's testimony, and I should like to take this opportunity to offer the Association's comments on those questions.

The first question deals with the role of the pharmacist and the nurse in monitoring drug therapy of long-term care patients. APhA believes that the issue is not whether nurses or pharmacists are better suited to monitor therapy. Clearly, pharmacists have more extensive education and training with regard to drug therapy, but nurses have more extensive education and training regarding patient care activities including caring for patients in whom drugs are being used. The best results are obtained when pharmacists and nurses work as teams in caring for patients in long-term care facilities. Indeed, it has been the Association's experience that the best drug therapy monitoring occurs when pharmacists and nurses share a mutual respect for each other's contribution and work cooperatively in assuring the best drug therapy in patients.

APha recognizes, however, that in many cases nursing staff is comprised primarily of nurses aides and other lesser trained individuals. The Association has developed a training guide entitled “The Right Drug to the Right Patient,” which assists pharmacists in training nursing staff in specific areas involving drug therapy. Inservice training is one of the major contributions pharmacists make in long-term care settings and the “Right Drug to the Right Patient” has been an invaluable tool in accomplishing that goal.

You asked all witnesses their views concerning the revised conditions for participation for skilled nursing facilities in intermediate care facilities. Time did not permit me to address that issue. APhA has worked very closely with officials in the Department of Health and Human Services in revising the conditions to assure that pharmaceutical service provided to patients in these facilities is of high quality. One major positive change in the revised conditions is that they provide for pharmacists to review drug therapy for patients in intermediate care facilities as well as patients

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