should have been deleted, rather than increased. This case is not unusual, and the complications can be fatal. What clearly is needed are people intimately familiar with the therapeutic and the toxic effects of the drug.

The CHAIRMAN. It is almost frightening to hear you give those examples. What is a patient to do if a doctor, who is the one person the patient relies on, does not realize these consequences and the patient takes it, and sometimes I am afraid some of these results you describe here are fatal.

What is the poor patient to do? Is every patient supposed to have at least three doctors?

I know doctors make mistakes. What can anybody do? It looks like that kind of thing should be detected.

Dr. LAMY. One thing the patient can do is what we are doing right now with elderly people, we go into the community, into churches and meeting places and tell them how to react to a physician and the pharmacist, what questions to ask, to write down the problem, to ask whether they still need the drug.

The patient must assume certain responsibility. Nobody else is doing it for the patient right now and I think the patient will and can assume the responsibility and say to the doctor, do I still need this drug? I have been on it half a year. We find a very good response among elderly citizens.

The CHAIRMAN. I know my late and beloved wife was that way. She would insist the doctor tell her what the medicine was and what it was supposed to do but ordinarily doctors don't like that very much. Maybe I misjudge them and maybe they don't mind it but I just have a feeling that a lot of times they feel like saying: What would you know about it if I tell you?

Dr. LAMY. They may not like it but one should ask what the effects are and how long must I take it.

We have a list of about 10 or 12 drugs which we list where the patient should ask not only about prescription drugs but nonprescription drugs such as aspirin.

The CHAIRMAN. Thank you very much. Go right ahead.

Dr. LAMY. The final test I can attest to from my own family is my mother-in-law. She is an 82-year-old, white female, with circulation problems. She underwent surgery, and at the site of the surgical incision, an infection developed. This was treated with an oral dosage form of penicillin. I called the surgeon, and suggested that an oral dosage form would not be sufficient, the patient would not and could not develop a sufficient blood level to fight the infection. The drug was needed in injection form-it was the right drug in the wrong dosage form-the surgeon refused.

After 2 months, I checked the patient out of the hospital. The patient was my mother-in-law, and while she was ambulant and living independently before the surgery, she has now bounced back and forth between hospitals and nursing homes. She is now unable to walk, and is in poor condition. The prognosis is poor.

Mr. Chairman, we have outlined some horrible problems for an increasing segment of our society. They are horrible because they exist, and even more horrible because they need not exist. We have the means presently and widely available to solve these problems. Pharmacy is prepared to respond.

As a private individual I do not think the regulations as formulated help the quality of drug usage in nursing homes.

The CHAIRMAN. Thank you, Dr. Lamy. I am afraid we need to finish the panel. I am just advised that we are borrowing another committee's room here. They will require us to vacate the room shortly for another hearing. So we will have to abbreviate our presentation.

Dr. Penna.

STATEMENT OF DR. RICHARD PENNA, DIRECTOR OF PROFESSIONAL AFFAIRS, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, D.C.; ACCOMPANIED BY DENA CAIN, LLB, DIRECTOR OF PUBLIC AFFAIRS, AND CYRELLE GERSON, SPECIALIST IN LONG-TERM CARE.

Dr. PENNA. I will abbreviate my abbreviation, Mr. Chairman. I am pleased to be here and pleased to represent the American Pharmaceutical Association—APhA. I am accompanied by Deena Cain, director of public affairs; and Cyrelle K. Gerson, director of special projects.

APhA is the national professional society of pharmacists in the United States. The association's 55,000 membership is composed of practitioners from all environments of care-community/ambulatory, acute care, and long-term care-students, educators, research scientists and others.

The association is pleased to have the opportunity of discussing with the Select Committee on Aging how pharmacists' services in the form of monitoring drug therapy and patient counseling can achieve rational drug therapy in the elderly.

Some of the factors that contribute to drug misuse and the potential for increased drug problems in the elderly population are: Adverse drug reactions or interactions due to multiple drug use; acute and chronic disease states; poor eyesight; difficulty in opening prescription containers; confusion regarding the array of medicines they must take; seeing more than one physician or other prescribers; uninformed self medication; saving and reuse of previously prescribed medication; comparing symptoms and exchanging drug products among friends and family.

Fifteen years ago, the pharmacy profession recognized its responsibility to insure rational drug therapy in patients and set about the enormous task of doing something about it.

Pharmacy defines rational drug therapy as assuring that the right drug is administered to the right patient at the right time, in the right amount, in the right dosage form, via the right route of administration, to bring about the right response, all with due consideration of costs.

Violation of any of these rights-whether by the prescriber, the nurse, the pharmacist or the patient-constitutes drug misuse.

The extent of drug misuse and its effects have been studied by a number of investigators for elderly patients living in long-term care facilities, home health care, adult day care or independently at home.

Almost without exception, when pharmacists have been given the authority and have exercised their responsibility to review

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drug therapy of elderly patients in these settings, positive, cost effective patient benefits have ensued.

Mr. Chairman, we go on in our statement to discuss the various environments of care. I am not going to discuss those in any great depth due to the press of time.

would like to merely state that published studies conducted in various parts of the country indicate how drug utilization can be decreased due to pharmacist-conducted drug regimen reviews.

These studies showed decreases of 0.9 to 2.44 prescriptions per patient per month, with about 1.5 prescriptions as the most frequent reduction. Using these figures and medicare/medicaid data, a recent review concluded that drug regimen reviews could save these programs $3.2 to $37.2 million per year in SNF's.

If the drug regimen review requirement were extended to intermediate care facilities, an additional net savings of $3.5 to $40.9 million might be realized.

These savings do not consider the additional patient benefits that result from rational drug therapy, such as decreases in adverse drug reactions and decreased hospitalizations.

One of the key objectives of any drug regimen is the reduction of unwarranted or unnecessary drugs subject to the approval of the attending physician. Such reductions decrease patient's exposure to unneeded drugs and, therefore, to unnecessary risk.

Mr. Chairman, since you expressed your concern for patients caring for themselves in the home, I should like to give you two case studies of pharmacists who have been able to work with home care agencies for patients.

One occurred in Appalachia where a pharmacist is involved in a home care program. It involves a 55-year-old female patient who was visited in her home by the pharmacist, who identified 10 prescription drugs the patient was taking.

The patient reported total overutilization of many of her drugs in that she was taking all drugs five times a day rather than two, three or four times a day as prescribed.

Some of her medication was not recorded in her home health record since it was prescribed by a physician 3 years prior to referral to the agency.

On further investigation the pharmacist found that she was taking many nonprescription vitamin preparations that were adversely affecting her arthritis. He found a large unplugged refrigerator completely full of nonprescription medications.

The pharmacist initiated patient education, recommended lab tests, and discussed the patient with the physician. The visiting nurse reinforced the pharmacist's instructions. The result was a decrease in the dose of some of the patient's medications and elimination of others with a vast improvement of her condition. In some cases a relatively minor change in the dosage form of the drug can avert potential problems. For example, a pharmacist consulting with a home health agency in southern California discovered during a routine drug regimen review that an 81-year-old hypertensive female patient on a 2-gram low-sodium diet had been advised to take two packets of Metamucil daily. Each packet contains 250 mg of sodium, thus accounting for 25 percent of her recommended daily sodium intake. The pharmacist suggested a

change to the bulk form of the product which contains only 7 mg of sodium per dose.

You mentioned the problem of patients caring for themselves in their homes. I would like to inform you of a project on which we are currently working, to develop a Home Drug Administration Record. This is a record the pharmacist will fill out for the patient which will allow the patient in his or her own home to keep track of their medications.

One of the things you will notice is the large printing. Our advisers tell us that elderly patients need large printing in order to be able to read instructions properly.

The CHAIRMAN. Do all pharmacists have those forms?

Dr. PENNA. This is still under development. We are field testing it now. We will revise the form appropriately and then all pharmacists will be advised that it is available for their use.

Another activity is a project with the American Red Cross. They teach courses for people who have ill relatives or friends at home. These courses are oriented to teaching these people how to better care for these individuals.

In cooperation with the Red Cross, we have developed a personal drug information checklist which is like a diary, which the pharmacist fills out for the individual giving him complete instructions. This is attached to our statement.

You will notice there are clock faces where the pharmacist circles the time of day the drug should be administered.

Lastly, I should like to state that the association was very pleased to have cooperated with GAO in its report. We met with GAO officials at the initial stages of their study, and provided them with a great deal of information, as a matter of fact, all of the information we had on the role of pharmacists serving long-term care patients.

We also were privileged to review a draft of that report and our comments on the draft are published in the appendix of that report and express very clearly our views of the report. Generally, I think I can say the association endorses the recommendations.

We have problems with the last recommendation. I am sure we will get into that with the questions and answers.

Mr. Chairman, that concludes our remarks.

[The prepared statement of Dr. Penna follows:]

STATEMENT OF THE AMERICAN PHARMACEUTICAL ASSOCIATION

Mr. Chairman, I am Dr. Richard P. Penna, Director of Professional Affairs of the American Pharmaceutical Association (APHA). I am accompanied by Dena Cain, Director of Public Affairs and Cyrelle K. Gerson, Director of Special Projects. APhA is the national professional society of pharmacists in the United States. The Association's 55,000 membership is composed of practitioners from all environments of care (community/ambulatory, acute care, and long-term care), students, educators, research scientists, and others.

One of the most important responsibilities of the pharmacy profession is to assure rational drug therapy. APhA has invested considerable resources to assist pharmacists in fulfilling that responsibility. The Association is pleased to have the opportunity of discussing with the Select Committee on Aging how pharmacists' services in the form of monitoring drug therapy and patient counseling can achieve rational drug therapy in the elderly.

Drug therapy over the years has been like the health profession's stepchild. Health professionals have supported it to the extent that they have recognized that drug therapy serves a valid purpose, but when it came to refining it to provide for

optimum patient care, drug therapy has suffered from benign neglect. This attitude has affected patients of all age categories, but none so dramatically as the elderly, The following factors contribute to drug misuse and the potential for increased drug problems in the elderly population:

The more drugs a patient takes, the more prone he or she is to experiencing an adverse drug reaction or interaction.

The aging process affects the way the body handles drugs. As a result older people are more sensitive to the adverse effects of many drugs.

Acute and chronic disease states may affect a patient's response to drugs. A patient with several chronic conditions—not uncommon in the elderly population— may be especially vulnerable.

Many elderly people have poor eyesight. Hence they cannot read prescription labels easily and often take their medication at the wrong time or not at all. Many elderly have difficulty in opening prescription containers, particularly those that have child-resistant caps. Many elderly simply stop taking their medication or leave containers opened to be exposed to oxygen, heat, and moisture, which may hasten drug decomposition.

Many elderly become confused regarding the array of medicines they must take. This is perhaps the most frequent problem encountered by pharmacists. For example, digoxin, a potent cardiac drug is confused with quinidine, another potent cardiac drug. Digoxin is usually taken once daily, while quinidine is usually taken three times daily.

Many elderly patients see more than one physician and other prescribers such as dentists and podiatrists. As a result there is a very real potential that prescribers may place a patient on similar or interacting medication.

Self-medication is a way of life. People usually try to treat a disease first with nonprescription drugs before consulting a physician. This practice can be hazardous among the elderly if they are taking prescribed medication or have a disease which is contraindicated with nonprescription medication. Advertising especially for arthritis remedies, laxatives and vitamins are directed toward the elderly population "market."

Because drugs can be expensive there is a tendency among the elderly to save their medication in the event the symptoms recur. This can be a dangerous practice. It encourages self-medication with potent drugs.

It has become common practice to compare symptoms and exchange drug products. The result is that medication prescribed for patient A is taken by patient B who may be allergic to it or be on other medication that is contraindicated.

Fifteen years ago, the pharmacy profession recognized its responsibility to ensure rational drug therapy in patients and set about the enormous task of doing something about it. I should like to relate for the Committee the profession's progress, its accomplishments, its frustrations and some of the impediments that we have had to face in making certain that elderly patients receive the best in drug therapy. Pharmacy defines rational drug therapy as assuring that the right drug is administered to the right patient, at the right time, in the right amount, in the right dosage form, via the right route of administration, to bring about the right response, all with due consideration of costs. Violation of any of these rights-whether by the prescriber, the nurse, the pharmacist or the patient-constitutes drug misuse.

The extent of drug misuse and its effects have been studied by a number of investigators for elderly patients living in long-term care facilities, home health care, adult day care or independently at home. Almost without exception, when pharmacists have been given the authority and responsibility to review drug therapy of elderly patients in these settings, positive, cost effective patients benefits have ensued.

LONG-TERM CARE FACILITIES

According to surveys by the National Center for National Statistics conducted in 1973-74 and in 1977, approximately 5 percent of the population 65 and over reside in nursing homes. Results from the 1973-1974 survey indicated that almost 90 percent of nursing home residents were 65 or over and that 96 percent of nursing home residents were treated with one or more categories of drugs. The drug categories used most frequently were tranquilizers (used by 48 percent of residents), vitamins and iron (38 percent), analgesics (37 percent), stool softeners (35 percent) and sedative hypnotics (34 percent). A 1976 survey of Skilled Nursing Facilities conducted by the Office of Long Term Care in the Public Health Service found an average of 6.1 prescriptions per patient. In the Skilled Nursing Facility (SNF) survey a range of 0 to 23 drugs were prescribed per patient.

Long-term care professionals have expressed concern over the number of drugs taken concurrently by long-term care patients. Concern has focused particularly on