United States General Accounting Office

GAO Testimony

Before the Special Committee on Aging, U.S. Senate

For Release on Delivery

Expected at 9:30 a.m.

Thursday, March 28, 1996

PRESCRIPTION DRUGS

AND THE ELDERLY

Many Still Receive

Potentially Harmful Drugs

Despite Recent

Improvements

Statement of Sarah F. Jaggar, Director

Health Financing and Public Health Issues

Health, Education, and Human Services Division

G O A

years

1921 - 1996

GAO/T-HEHS-96-114

Mr. Chairman and Members of the Committee:

We are pleased to be here today to discuss a significant problem that

affects the health of millions of elderly Americans—the inappropriate use

of prescription drugs. According to gerontology experts, the inappropriate

use of prescription drugs may cause adverse drug reactions that may lead

to subtle deterioration of function or precipitate medical crises, resulting

in hospitalization or death. These problems also contribute to the

expenditure of billions of dollars in higher medical costs borne in part by

either Medicare or Medicaid.

Last July, we issued a report on the extent of this problem, its causes, and

emerging trends in health care delivery that may affect drug prescribing

for the elderly.1

 Our study was based on a literature review and documents

obtained from leading researchers in the fields of gerontology and elderly

clinical pharmacology. We interviewed these individuals and

representatives of the Food and Drug Administration (FDA), the Health

Care Financing Administration (HCFA), state Medicaid programs, industry

trade associations, senior citizen and consumer advocacy groups, and

medical associations who are knowledgeable in the use of prescription

drugs for the elderly. We also analyzed data on prescription drug use from

HCFA’s 1992 Medicare Current Beneficiary Survey.

Today I would like to focus my remarks on the factors that contribute to

inappropriate use of prescription drugs among the elderly and their

potential health and economic consequences. I also would like to highlight

practices used and the health care industry’s role in reducing

inappropriate drug use among the elderly.

In summary, our analysis of 1992 data found that about 17.5 percent of

almost 30 million Medicare recipients were still prescribed drugs that were

generally unsuitable for their age group. While this is an improvement over

the almost 25 percent reported for 1987 data, the inappropriate use of

prescription drugs remains a significant health problem for the elderly.

Insufficient coordination of patient drug therapies and weaknesses in

communication among providers, pharmacists, and patients have

compounded this problem. Inappropriate prescribing practices and the

ensuing drug use have caused many elderly persons to suffer adverse

effects that, according to FDA, have resulted in $20 billion in

hospitalizations each year. These costs are covered in part by Medicare

1

Prescription Drugs and the Elderly: Many Still Receive Potentially Harmful Drugs Despite Recent

Improvements (GAO-HEHS-95-152, July 24, 1995).

Page 1 GAO/T-HEHS-96-114
and Medicaid. States, advocacy groups, and physician and pharmacy

organizations have, however, taken a number of measures to reduce the

incidence of inappropriate drug use. In addition, managed care, pharmacy

benefit management, and other coordinated health care systems have

features that have the potential to reduce inappropriate use of prescription

drugs among the elderly.

Several Factors

Contribute to the

Inappropriate Use of

Drugs

The factors leading to the inappropriate use of prescription drugs are

multifaceted and interconnected. They can reflect the behavior of the

physician, pharmacist, and patient, either collectively or individually.

From the time a drug is prescribed to the time when the drug is taken,

many possible interrelated events can result in an adverse drug reaction or

other serious effects.

The inappropriate use of prescription drugs can take several different

forms. These range from potentially life-threatening drug-drug interactions

to unnecessary therapeutic duplication—that is, using two or more similar

drugs to treat the same problem. These inappropriate uses yield few

benefits at increased costs. For example, an elderly woman who was

taking hypertension medication visited her doctor after she began

experiencing chest pain and tingling in the hands. The doctor prescribed

four additional medications to treat these symptoms. When she took the

prescriptions to be filled, her pharmacist identified the symptoms as side

effects of the hypertension medication she was taking. The pharmacist

contacted the physician, who prescribed a different hypertension

medication.

Compounding the problem of insufficient coordination are incomplete

physician and pharmacy records of patient conditions, allergies, and

current therapeutic regimens. In addition, physicians may prescribe

incorrect dosages, pharmacists may not recognize possible drug-drug or

allergic reactions, and patients may not take medications as prescribed.

Another complicating factor may be a lack of relevant guidelines for

prescribing drugs to the elderly. The elderly generally cannot tolerate adult

dosages because they are more sensitive to the effects of drugs and less

capable of systemically eliminating them. In 1989, FDA issued voluntary

guidelines for testing new drugs for elderly patients; however, several

experts believe that clinical trials performed under these guidelines are

not representative of the elderly as a whole.

Page 2 GAO/T-HEHS-96-114
Inappropriate Use of

Prescription Drugs

Has Major Health and

Economic

Implications

We found that many elderly persons have been prescribed drugs

inappropriately, putting them at risk. In 1992, more than one in six

noninstitutionalized Medicare recipients 65 or older were prescribed at

least one drug that was potentially unsuitable for this age group.

Additionally, because the elderly tend to suffer from multiple health

problems, they are more vulnerable to other inappropriate uses of

prescription drugs. This misuse can range from adverse drug combinations

to prescribing several drugs to treat one condition. For example, a woman

in her eighties with severe arthritis pain was prescribed a medication that

caused stomach problems. To combat the stomach discomfort, she was

prescribed a second medication, which triggered a urinary tract infection.

When a third drug was added to treat the urinary infection, the woman

began having terrifying hallucinations. Ultimately, the woman’s therapy

was switched to nonpharmaceutical treatment that controlled her arthritis

pain.

Inappropriate uses of prescription drugs can have a number of health and

economic consequences. One study we reviewed estimated that 17 percent

of hospitalizations of persons 65 or older were directly related to adverse

drug reactions.2

 According to FDA, these hospitalizations cost about

$20 billion annually. Other studies reported that less severe

reactions—which can go unnoticed or be discounted as effects of

aging—have indirectly resulted in numerous injuries. One study estimated

that each year, 32,000 elderly persons suffer hip fractures in falls caused

by adverse drug reactions, such as loss of coordination.3

 Another study

concluded that about 16,000 car accidents that result in injury each year

can be attributed to adverse drug reactions that elderly drivers

experienced.4

Several Measures May

Help Minimize

Inappropriate Use of

Prescription Drugs

A number of recent measures may help minimize the inappropriate use of

prescription drugs that can cause adverse effects in the elderly, including

monitoring drug use and educating physicians and patients on possible

misuses. All states are required to monitor the use of Medicaid

prescription drugs through prospective and retrospective reviews.5

2

Nananda Col and others, “The Role of Medication Noncompliance and Adverse Drug Reactions in

Hospitalizations of the Elderly,” Archives of Internal Medicine, Vol. 150, No. 4 (Apr. 1990), pp. 841-45.

3

Wayne A. Ray and others, “Psychotropic Drug Use and the Risk of Hip Fractures,” The New England

Journal of Medicine, Vol. 316, No. 7 (Feb. 12, 1987), pp. 363-69.

4

Wayne A. Ray and others, “Psychoactive Drugs and the Risk of Injurious Motor Vehicle Crashes in

Elderly Drivers,” American Journal of Epidemiology, Vol. 136, No. 7 (Oct. 1, 1992), pp. 873-83.

5

This is a requirement of the Omnibus Budget Reconciliation Act of 1990 (P.L. 101-508).

Page 3 GAO/T-HEHS-96-114
Prospective reviews are intended to detect problems before a pharmacist

fills a prescription. Automated systems linked to statewide Medicaid data

bases have shown promise in alerting pharmacists to possible drug

utilization problems, such as adverse drug-drug interactions or a

drug-disease contraindication.6

 Retrospective reviews are intended to

detect prescribing patterns that indicate inappropriate or unnecessary

medical treatment, as well as fraud or abuse. Retrospective drug utilization

reviews can also be used to help ensure that patients follow their

prescribed drug therapies.

Inappropriate use of prescription drugs also can be minimized through

physician education in geriatrics and elderly clinical pharmacology.

However, these areas of study have only recently been emphasized in

medical school curricula, which means that many experienced, practicing

doctors may have had little formal training in these areas. Several experts

we interviewed stressed the need for improved continuing education to

help ensure that doctors are knowledgeable about issues relating to

prescription drugs and the elderly. They also believe that doctors should

rely more on the expertise of pharmacists to decide the most appropriate

drug therapy to prescribe.

Increasing patient understanding of prescription drugs also can help

minimize the incidence of inappropriate drug use. Particularly important is

physician or pharmacist counseling on the correct use of a prescription

drug and the drug’s characteristics, such as subtle side effects that should

not be ignored. However, a recent study found that about 26 percent of

patients interviewed had not been counseled by a physician about their

drug therapies.7

Public advocacy groups have encouraged the elderly to take an active role

in learning about the drugs they are prescribed. In addition, state and local

agencies have developed several initiatives that alert elderly consumers to

the dangers of inappropriate drug use. For example, the Massachusetts

Department of Public Health sponsors seminars where pharmacists

inventory the prescription drugs of those who attend. At these seminars,

expired and no longer used drugs are eliminated, and the remaining drugs

are catalogued in a “Medicine Passport” that can be shown to doctors and

pharmacists as new or additional drugs are prescribed.

6

See Prescription Drugs: Automated Prospective Review Systems Offer Potential Benefits for Medicaid

(GAO/AIMD-94-130, Aug. 5, 1994).

7

“How Is Your Doctor Treating You?” Consumer Reports, Feb. 1995, pp. 81-88.

Page 4 GAO/T-HEHS-96-114
Managed Care and

Pharmacy Benefit

Management Have the

Potential to Reduce

Inappropriate Use of

Prescription Drugs

Managed care plans and pharmacy benefit management firms, known as

PBMs, as well as other coordinated health care systems can play an

important role in reducing the incidence of prescription drug misuse.

Experts in gerontology and elderly clinical pharmacology believe that the

most effective way to minimize inappropriate prescription drug use is to

improve the coordination of care. Although plans vary, a basic tenet of

managed care is to control utilization—often through one physician, or

“gatekeeper,” who coordinates patient care, including overseeing various

treatments and drug regimens.

The patient data that managed care plans collect also enable plans to

monitor the drug therapies patients receive and the prescribing patterns of

physicians. One health maintenance organization (HMO) that we visited

periodically compared the drug-prescribing habits of its doctors to the

HMO’s standards and provided its doctors with these analyses. In addition,

the HMO used these analyses to identify doctors who may need additional

training or counseling in prescribing drugs for their elderly patients.

PBMs manage prescription drug benefits on behalf of managed care plans

and other health plan sponsors.8

 Typically the services provided by a PBM

include drug utilization reviews that have the potential to identify and

reduce inappropriate drug use. For example, PCS Health Systems

conducted a drug utilization review in 1994 that generated almost

25 million alerts. Of these alerts, 25 percent involved drug-age

contraindications and excessive daily dosages—two misuses that are

prevalent among the elderly.

Through monitoring, PBMs can also detect lapses in prescription refills for

persistent medical conditions, such as high blood pressure, and alert a

patient’s doctor, if required. In addition, PBMs are developing data bases on

patient characteristics, medical conditions, and drug therapies. With this

information, PBMs are beginning to research the relative effectiveness of

varying treatments from both a therapeutic and a cost perspective. Results

of this research should enable doctors, patients, and payers to make more

informed health care decisions.

It is too early to understand the full impact that managed care and PBMs

may have on inappropriate drug use among the elderly. Several experts

believe that these systems have the potential to improve coordination of

patient care and thereby increase the detection of possible misuse.

8

For more information on PBMs, see Pharmacy Benefit Managers: Early Results on Ventures With Drug

Manufacturers (GAO/HEHS-96-45, Nov. 9, 1995).

Page 5 GAO/T-HEHS-96-114
However, they cautioned that improved coordination also depends on the

quality of patient care, which has varied widely among managed care

plans. One expert further cautioned that improved coordination of care

could be compromised by pressures to contain costs or increase profits.

Still, the health and financial costs associated with adverse effects create a

strong incentive for managed care plans to seek and implement measures

that could minimize the inappropriate use of prescription drugs among the

elderly.

Conclusions The results of our study indicate that the number of elderly patients

receiving drugs identified as generally unsuitable for their use has declined

somewhat in recent years. However, the inappropriate use of prescription

drugs among the elderly and the resultant adverse effects remain

significant health problems. Improving physician, pharmacist, and patient

communication and understanding about inappropriate use can further

reduce the incidence of prescription drug misuse among the elderly.

Effective use of managed care and PBMs also holds the potential to reduce

inappropriate prescription drug use and, thus, the impact drug misuse has

on our nation’s health care costs.

Mr. Chairman, this concludes my prepared statement. I will be happy to

answer any questions that you or other Members of the Committee may

have.

GAO Contact For more information on this testimony, please call John Hansen,

Assistant Director, at (202) 512-7105.

(108272) Page 6 GAO/T-HEHS-96-114
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