the use of psychotropic medications such as tranquilizers and sedatives. For example, in a survey of 50 SNF patients in California, 50 percent of the drugs were prescribed with no substantiating diagnosis. These patients were exposed to risks of adverse drug reactions, particularly from anticholinergic drugs, sedative-hypnotics and major tranquilizers such as thioridazine and chlorpromazine. In a recent review of Medicaid prescriptions for 173 Tennessee nursing homes, researchers, found that 43 percent of residents received antipsychotic drugs and 9 percent were chronic recipients (received 365 daily doses per year). Although the nature of the study precluded analysis of the appropriateness of therapy, the authors were concerned over the extensive and long-term general use of these drugs in settings that were not devoted specifically to pyschiatric care. A California survey comparing Medicaid institutional and noninstitutional elderly found that psychotropic drug use was much higher in the institutions.

Much of the data collected in long-term care facilities have attempted only to document overuse and misuse of drugs. However, in a number of studies conducted by pharmacists, follow-up data after initiating routine drug regimen review procedures have demonstrated that these reviews can decrease inappropriate drug utilization.

One of the key objectives of monthly drug regimen reviews in SNFs is the reduction, subject to the approval of the attending physicians, of unwarranted or unnecessary drugs. Such reductions decrease patient exposure to unneeded drugs and therefore to unnecessary risks.

A study conducted in southern California on 517 nursing home patients showed that a pharmacist could appropriately reduce the average number of prescriptions per patient per month from 6.8 to 5.6. In Florida a pharmacist conducting monthly drug regimen reviewed reduced prescription rates from 7.6 to 6.7 per patient for 40 patients. A recently published report indicates a 42 percent decrease in prescription drug use and a 34 percent decrease in nonprescription drug use over an eight year period. In this case the authors concluded that pharmacists' activities were "catalytic in nature. Items such as workable stop-order policies, federally required SNF drug-regimen reviews, and elimination of drugs never used involved other members of the long-term care facility staff too."

Other published studies conducted in various parts of the country also indicate how drug utilization can be decreased due to pharmacist-conducted drug regimen review. 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.

In spite of this overwhelming evidence supporting the cost effectiveness of nondispensing pharmaceutical service, HHS policy, until recently, discouraged states from compensating pharmacists who provide such service (consulting services) when that same pharmacist also provides drug products for Medicare or Medicaid patients. The HHS view was that these pharmacists receive sufficient income from the dispensed prescription drug products and, consequently, that nondispensing service should be provided at no charge. This shortsighted policy was responsible for many state Medicaid agencies failing to recognize nondispensing pharmaceutical service as reimbursable even though other parts of the Medicare/Medicaid conditions of participation clearly indicated that it was such. While this policy has been largely eliminated, much of its effect remains and pharmacists in many states still experience difficulty in receiving Medicaid compensation for providing nondispensing service.

APhA has reviewed the proposed changes in the conditions of participation for Medicare and Medicaid skilled nursing facilities and intermediate care facilities. Generally, APhA supports most of the revisions that pertain to pharmaceutical service. The Association is especially pleased to note that the proposed conditions provide for pharmacist review of drug therapy in intermediate care facilities as well as skilled nursing facilities. If this proposed change is promulgated as a final rule, intermediate care patients will also benefit from pharmacist conducted drug therapy reviews.

Unlike the current conditions, the proposed rules establish outcome objectives which a pharmaceutical service program is to meet. This change will offer flexibility to facility administrators and pharmacists in designing service packages to meet the outcome objectives within constraints that might be unique to specific facilities.

HOME HEALTH CARE

Elderly patients cared for in the institutional setting have their drug therapy rigidly controlled. Any problems that result are usually the fault of the administrator, prescriber, nurse or pharmacist. On the other hand, additional variables are present in the home environment. Even if a patient is cared for by the best home health agency, much of that patient's drug therapy is controlled by the patient. Moreover, the patient is generally free to use nonprescription drugs and drugs provided by neighbors and relatives. Add to this scenario the known fact that patients often see other prescribers such as dentists and podiatrists and we have the ingredients for extremely dangerous, if not potentially fatal, drug problems.

Although federal programs have not attempted to collect national data on drug use by home health care patients, several individual agencies have reported on drug use and interventions to improve usage. A study of 55 patients of the home care department at Appalachian Regional Hospitals in eastern Kentucky indicated that 58.5 percent of patients misused their drugs and 63 percent had potential drug interactions. The average number of prescription drugs used were 5 per patient and 2 nonprescription drugs per patient. În a study conducted a number of years ago in New York, 62 percent of home care patients misused their drugs. The average number of drugs was 3.4 per patient and average patient age was 75 years. In southern California pharmacists who surveyed 23 home health patients found patients taking an average of 8.4 drugs concurrently. The average patient age was 71 years. Patients were prescribed inappropriate combinations or duplicate drugs; and many either overutilized or underutilized their medications. These studies indicate that many home health care patients are elderly and use numerous drugs concurrently with potential for complications and adverse drug reactions.

Several case reports illustrate how pharmacists help home health care patients. For example, at Appalachian Regional Hospitals a 55-year old female patient 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 three 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 future 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.

These examples show how home care patients can benefit from pharmacists' services. APhA has been encouraging home health agencies to avail themselves of the services of local pharmacists and has encouraged pharmacists to offer their talents to home health agencies. The Association's Academy of Pharmacy Practice Section on Long Term Care has adopted a statement (Attachment A) on home care, which describes the nature and scope of pharmaceutical service to home health agencies.

In the face of the desire of home health agencies to include pharmaceutical service in their programs, the desire of pharmacists to serve home health agencies, and the positive cost benefit of pharmaceutical service, it is ironic that current federal policy discourages home health agencies from acquiring the services of pharmacists.

Conditions of Participation for home health agencies in the Medicare program require:

Agency staff check all medicines a patient may be taking to identify possibly ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medications, and promptly report any problems to the physician."

Because many pharmacists provide services to home health agencies and the benefits that these patients receive are so important, APhA requested a ruling from

the Medicare Bureau several years ago to allow reimbursement to home health agencies for pharmacists' services. Medicare's response stated in part:

"Since the monitoring of drug therapy by a nurse . . . is considered a skilled nursing service, to the extent that a home health agency may engage a pharmacist to furnish needed advice and consultation or training to its nurses in connection with this skilled nursing service, the expenses incurred for such services may be included in its overhead as an indirect cost of furnishing covered services, i.e., skilled nursing services. However, the need for such services is expected to occur infrequently. . . .

APhA disagrees that drug therapy monitoring is solely a nursing function. Evidence clearly documents that pharmacists can provide effective service that complement those of nurses and other home health staff.

While this response has allowed home health agencies to obtain limited reimbursement for pharmacists' services, APhA believes that home health patients should have full access to pharmaceutical services including drug therapy monitoring and full participation by pharmacists on their health care team. The words of one home health agency administrator said it quite simply:

"One day a pharmacist knocked on my door and said 'You need me.' He was right. We did. He has been helping us with our elderly patients who have multiple doctors, visit multiple clinics, swap drugs and use OTC and prescribed drugs. His services have been invaluable and increased the quality of care we have been able to perform."

ADULT DAY CARE

Geriatric day care centers are attracting attention as a method of meeting the needs of elderly who are not capable of total independence but who do not require full-time professional care. Pharmacists working in a geriatric clinic in Arkansas found that patients were taking an average of 3.9 drugs per patient. In 120 patients observed during a 9-week study period, 43 drug interactions were documented and 25 percent of the patients complained of some untoward drug effect. By taking medication histories, monitoring drug therapy, consulting with patients and other health professionals, the pharmacists were able to identify, alleviate and prevent many medication-related problems.

INDEPENDENT LIVING

The vast majority of elderly people do not live in institutions. This group, which represents approximately 10 percent of the total U.S. population, spends about 25 percent of the total annual U.S. drugs expenditures. The average annual per capita expenditure on drugs by the elderly is almost 21⁄2 times the amount for the population as a whole. Drug therapy represents an important aspect in the lives of many elderly who live independently and also poses the greatest challenge for control and appropriate utilization.

A survey of 447 elderly Washington, D.C. residents revealed that 62 percent used prescription drugs. More than one-third used two to four prescription drugs and 5 percent used 5 to 9 prescriptions. Approximately 12 percent reported having experienced overdoses or side effects. Over two-thirds of this group used nonprescription drugs. A Minnesota study of 50 elderly people found an average of 3.4 prescription drugs and 2.9 nonprescription drugs taken per patient. Sixty-six percent of the drugs were taken with inadequate instructions and 25 percent were not being taken as labeled. A Michigan study of 338 senior citizens found that almost 25 percent of those interviewed were using four or more prescriptions at one time. This study also surveyed health providers who reported problems with noncompliance, sharing medications with others, and difficulty in following medication regimens.

These three studies are representative of findings of many studies that indicate a need for close monitoring of drug use in elderly patients and for patient education and use of other techniques to simplify drug regimens and increase compliance. Included with this testimony is a copy of the May 1980 issue of American Pharmacy which focuses on information on drug use by the elderly and the role of the pharmacist.

Mr. Chairman, the American Pharmaceutical Association has been encouraging pharmacists to take a more active professional interest in their elderly patients. For example, in 1978 former APhA President Jacob Miller suggested that pharmacists make house calls for those elderly patients who are in need of that type of service. Miller made that recommendation with the knowledge that some drug-related problems could be detected and resolved only when the pharmacist visited the patient in his or her home. Many pharmacists accepted Miller's suggestion and now offer home visits as one element of their service packages. How widely this practice

spreads depends on whether government, third-party payers, and patients recognize the potential value of this service and are willing to pay for pharmacist house calls. Pharmacists' activities for elderly outpatients can categorized as follows:

Drug therapy record keeping and monitoring.

Patient counseling and education.

Providing compliance aids, such as medication calendars and special packaging. Community health education programs.

The Association has developed a series of practice aids to assist the pharmacist in caring for elderly patients. Included in this series is a pharmacy health questionnaire, a diabetic monitoring checklist, a personal drug information checklist, and a home drug administration record (Attachment B). These aids are made available to pharmacists for their use in serving their elderly patients.

APhA is also aware that pharmacists require periodic refresher courses in order that they might continue to serve their patients competently. The Association pioneered in the development of drug monitoring continuing education workshops for pharmacists serving long-term care facilities. These same programs are pertinent for pharmacists' service to ambulatory patients as well and are currently being used for that purpose. APhA plans to devote a significant element of its 1981 Annual Meeting program in the various issues involved with serving the elderly population.

Although it is quite difficult to document directly how outpatient services affect compliance with drug therapy and numbers of drugs taken, the same effects that have been documented in institutional settings should apply. Ultimately, services that improve drug utilization decrease other health care costs because of decreases in adverse drug consequences.

SUMMARY AND CONCLUSION

In this statement I have outlined how pharmacists can promote rational drug therapy for elderly people in institutional, home and day care and independent living environments. APhA believes that pharmacists and government agencies can affect public health and promote proper drug use by encouraging more aggressive actions by pharmacists to:

Monitor drug therapy for all patients and follow-up actions when problems are detected.

Communicate with and educate other health professionals about drug-related problems and effects to affect drug prescribing practices.

Counsel and educate patients on a one-to-one basis.

Provide compliance aids for patients.

Provide community health education on appropriate drug use.

These actions will decrease unnecessary drug use, decrease the problems that occur from inappropriate drug use and thereby decrease the need for other health services. They will improve the quality of life of older people and increase independence for those using self-care by simplifying their treatment. All of these effects represent a savings to society.

The Association is encouraging development and continuation of these activities through its educational services and practice aids.

The government can and should also encourage those activities through education campaigns to the health professions, enacting laws and promulgating regulations to facilitate these activities. One of the best methods of accomplishing these goals is to provide a structure within the health financing system that gives financial incentives for health promotion activities.

Unfortunately, current government programs that include drug coverage consider only the cost of the drugs to be provided to patients. Payment programs should also include compensation for monitoring and other health promotion services.

Currently only the Medicare/Medicaid Skilled Nursing Facility regulations recognize the need for pharmacist-conducted monitoring drug therapy.

Even in these programs, pharmacists have had to fight for reimbursement for a service that was mandated and that provides overall savings to these programs. APhA hopes that this committee will be able to encourage recognition of the benefits of the services I have described, and the need for appropriate legal, regulatory and financial incentives for provision of these services to grow.