Prescription Drugs and the Elderly: Many Still Receive Potentially Harmful Drugs Despite Recent Improvements
Published: 1995-07-24T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Pursuant to a congressional request, GAO examined the elderly's inappropriate use of prescription drugs, focusing on: (1) whether the inappropriate use of prescription drugs by the elderly is widely viewed as a serious health problem; (2) the ways prescription drugs are used inappropriately and why these situations occur; (3) how public knowledge of prescription drugs can be improved; and (4) how emerging trends in health care delivery affect drug prescribing for the elderly.
section_title: What GAO Found
paragraphs: GAO found that: (1) the inappropriate prescription drug use is a serious health risk for the elderly, since they take more prescription drugs than other age groups, they often take several drugs at once, resulting in adverse drug reactions, and they do not efficiently eliminate drugs from their systems due to decreased body function; (2) the percentage of Medicare recipients over 65 using unsuitable prescription drugs dropped from 25 percent in 1987 to 17.5 percent in 1992; (3) inappropriate prescription drug use results from physicians using outdated prescribing practices, pharmacists not performing drug utilization reviews, and patients not informing their physician and pharmacist of all the drugs they are taking; (4) to address the problem of inappropriate prescription drug use, the government is working to disseminate information on the effect of prescription drugs on the elderly, the medical community is working to increase physicians' knowledge of geriatrics, and patients are increasingly seeking information about their drug therapies; and (5) enrollment in managed care plans has grown rapidly, particularly among senior citizens, allowing for the potential to improve the coordination of drug therapies for newly enrolled elderly patients.

section_title: Letter
paragraphs: A recent study concluded that, in 1987, nearly one of four noninstitutionalized elderly patients were taking prescription drugs that many experts regard as generally unsuitable for their age group because alternative drugs provide the same therapeutic benefit with fewer side effects. According to gerontology experts, the percentage of elderly patients affected by the inappropriate use of prescription drugs would be even greater if other situations, such as potentially dangerous drug interactions or incorrect dosages, were taken into account. The inappropriate use of prescription drugs may cause unnecessary adverse drug reactions that may lead to subtle deterioration of function or precipitate medical crises resulting in hospitalization or death. They also contribute to higher medical costs borne in part by either Medicare or Medicaid. The Food and Drug Administration (FDA) estimates that the annual cost of hospitalizations due to inappropriate prescription drug use is $20 billion.
Concerned that the inappropriate use of prescription drugs harms the health and quality of life of the elderly, you asked us to determine if the inappropriate use of prescription drugs among the elderly is widely viewed as a serious health problem; identify the ways prescription drugs are inappropriately used and why these situations occur; identify how physicians, pharmacists, and patients receive information on prescription drugs and how their knowledge of prescription drugs and drug therapies could be improved; and provide information on how emerging trends in health care delivery affect drug prescribing for the elderly.
To address these issues, we conducted a literature review and obtained documents from leading researchers in the fields of gerontology and elderly clinical pharmacology. We interviewed these individuals as well as representatives of 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 analyzed data on prescription drug use from HCFA’s 1992 Medicare Current Beneficiary Survey. We conducted our study from October 1994 to May 1995 in accordance with generally accepted government auditing standards. (See app. I for details on our scope and methodology.)
subsections: section_title: Inappropriate Use of Prescription Drugs Is a Major Health Problem for the Elderly
paragraphs: The inappropriate use of prescription drugs is a problem that is particularly acute for the elderly. The elderly use more prescription drugs than any other age group and are more likely to be taking multiple prescription drugs, which increases the probability of adverse drug reactions. Furthermore, the elderly are more susceptible to adverse drug reactions because of the aging process. As a result, many experts believe that some drugs are generally inappropriate for the elderly because equally effective and safer alternative drugs exist. Additionally, other drugs though appropriate should be used at reduced dosage levels to accommodate elderly physiology.
subsections: section_title: Inappropriate Prescription Drug Use Is Widespread Among the Elderly
paragraphs: Based on 1987 data from the National Medical Expenditure Survey, a research study published in July 1994 concluded that almost 25 percent of the noninstitutionalized elderly 65 or older used prescription drugs at least once during the year that are generally considered unsuitable for their age group. The study used a list of 20 drugs, based on criteria published in 1991, that generally should not be used by elderly patients.
A second study published in October 1994 reinforced the findings of the earlier study. In this study, the researchers interviewed a sample of community residents, 75 or older living in Santa Monica, California, during 1989 and 1990 about their use of prescription drugs, over-the-counter medications, and home remedies within the 4 weeks prior to the interview. The researchers used primarily the same criteria as the July 1994 study, but only looked at drug usage over a 1-month period rather than the entire year. This study concluded that 14 percent of those interviewed used at least one of the drugs generally identified as not suitable for elderly patients.
Several experts we interviewed expressed reservations about the appropriateness of using 1991 criteria to evaluate prescription drug use in years before the criteria were developed. However, these experts did not disagree with the criteria themselves. To determine if there was much change in prescribing patterns after 1991, we analyzed data from the Medicare Current Beneficiary Survey conducted by HCFA’s Office of the Actuary to see what percentage of noninstitutionalized Medicare beneficiaries in 1992 used any of the 20 drugs. Our analysis showed that an estimated 17.5 percent of the almost 30 million senior citizens in the survey used at least one of these drugs in 1992. Although this represented an improvement over the 1987 data, more than one out of six elderly patients were still using prescription drugs generally considered unsuitable for their age group.
Many health care practitioners questioned whether the use of these drugs should always be characterized as inappropriate. They maintained that, under certain circumstances, their use would be perfectly acceptable. For example, if a patient was already using a particular drug and doing well, there would be little medical justification for switching to another drug. Still, none of these practitioners said that this rationale would account for the high percentage of elderly patients using drugs deemed inappropriate. All the experts we interviewed agreed that the inappropriate use of prescription drugs continues to be a significant health problem.
Several experts also pointed out that these research studies only looked at one type of the inappropriate use of prescription drugs. In their opinion, when other examples are considered such as potentially dangerous drug interactions or incorrect dosages, the percentage of senior citizens affected by the inappropriate use of prescription drugs would be even greater than the estimates provided in those studies.
section_title: The Elderly Are Particularly Vulnerable to Inappropriate Prescription Drug Use
paragraphs: The elderly are more likely than other segments of the population to be affected by the inappropriate use of prescription drugs. As a group, the elderly are more likely to suffer from more than one disease or chronic condition concurrently, which means that they may take several different drugs at one time. As the number of prescriptions increases, so does the potential for adverse drug reactions caused by drug interactions or drug-disease contraindications. The physiological changes of aging are a major reason drugs have the potential to cause problems in the elderly. Elderly patients often lack the ability to eliminate drugs from their systems as efficiently as younger patients do because of decreased liver and kidney function. In addition, they are more sensitive to the effects of drugs. Thus, they are not able to accommodate the normal adult dosage.
The inappropriate use of prescription drugs is a major cause of adverse drug reactions that, if severe enough, can result in hospitalization or death. Since the elderly are more vulnerable to the effects of the inappropriate prescription drug use, they are at greater risk from adverse drug reactions than other segments of the population. Studies indicate that about 3 percent of all hospital admissions are caused by adverse drug reactions.However, the percentage is much higher for the elderly. One study estimated the percentage of hospitalizations of elderly patients due to adverse drug reactions to be 17 percent, almost 6 times greater than for the general population. Applying an average unit cost to the proportion of hospital admissions that are drug-related, FDA estimates that hospitalizations due to inappropriate prescription drug use cost about $20 billion annually.
Less severe adverse drug reactions may go unnoticed or be discounted by both health practitioners and the elderly as the normal effects of the aging process. However, these side effects, such as drowsiness, loss of coordination, and confusion, can result in falls or car accidents. A study estimated that 32,000 senior citizens annually suffer hip fractures as a result of falls caused by adverse drug reactions. Another study concluded that about 16,000 car accidents resulting in injuries each year can be attributed to adverse drug reactions experienced by elderly drivers. Even if no serious bodily injury occurs, adverse drug reactions decrease the general quality of life for patients because of drug-induced mental impairment, loss of coordination, or addiction.
section_title: Many Factors Contribute to the Inappropriate Use of Prescription Drugs
paragraphs: The factors leading to the inappropriate use of prescription drugs are multifaceted and interconnected, according to experts we interviewed. These factors reflect the behavior of the physician, pharmacist, and patient, either collectively or individually. From the time a drug is prescribed to the point where the drug is taken, many possible events, often interconnected with each other, can lead to an adverse drug reaction or other serious results.
The inappropriate use of prescription drugs can take several different forms, ranging from potentially life-threatening drug-drug interactions to therapeutic duplication (using two or more similar drugs to treat the same problem), which yields little benefit at increased cost. Other examples of the inappropriate use of prescription drugs include drug-age contraindication, drug-allergy contraindication, drug-disease contraindication, incorrect drug dosage, incorrect duration of drug therapy, and less effective drug therapy.
A physician, a pharmacist, or a patient may take or omit actions that can produce an adverse drug reaction. For example, a drug-drug interaction could be due to a physician not recognizing that a prescribed drug interacts badly with another prescribed medication or over-the-counter drug used by the patient. (See fig. 1.) The pharmacist may contribute to the situation by not detecting the negative interaction or by failing to determine which drugs the elderly patient is taking. The elderly patient may not give the doctor and pharmacist a complete list of all the medications, including over-the-counter drugs, that he or she is taking. Thus, all three parties may contribute to a drug-drug interaction, with potentially serious consequences to the patient.
Health care professionals noted that the overuse and underuse of drug therapies may also contribute to the inappropriate use of prescription drugs. Drug overuse occurs when a medication is prescribed but either no medication was needed or an alternative treatment approach existed. For example, changes in diet and lifestyle may be more appropriate than drug therapy. More controversial is the selection of drug therapy over counseling to treat psychological conditions such as anxiety or depression. Drug underuse occurs when an appropriate medication either is not prescribed or is underprescribed. For example, one study reported that patients with advanced cancer were at risk of receiving less than adequate pain medication.
section_title: Better Information and Communication Can Help Prevent Inappropriate Drug Use
paragraphs: According to several experts we interviewed, lowering the elderly’s risk of adverse drug reactions requires that more detailed information on the impact of drug therapies on the elderly be developed and disseminated to health practitioners. Furthermore, many health practitioners agreed that physicians, pharmacists, and patients should all participate in the drug therapy decision-making process. Increased communication between and among physicians, pharmacists, and patients is vital to ensuring that this process is effective.
subsections: section_title: FDA Has Improved Drug Guidelines for the Elderly
paragraphs: One difficulty in prescribing drugs for the elderly has been the lack of specific information on dosage levels established for the elderly through clinical tests. Recognizing the need for additional information on the effects of drugs on the elderly, FDA issued voluntary guidelines in 1989 governing the testing of new drugs intended for elderly patients. These guidelines call for the inclusion of elderly patients during the drug’s testing process. The intent of these guidelines is to develop better information for both physicians and pharmacists on dosage standards for new drugs intended for elderly patients as well as to identify side effects that are more pronounced in the elderly than in the general population. FDA’s Director of Drug Policy and Evaluation stated that he believed that pharmaceutical manufacturers have complied with these guidelines. However, several experts said that clinical trials performed under these guidelines are not representative of the elderly population as a whole. For example, they believe that elderly patients over 75 are underrepresented.
section_title: Better Physician Education Can Improve Poor Prescribing Practices
paragraphs: The medical community has only recently started to emphasize the study of geriatrics and elderly clinical pharmacology. For example, board certification in geriatrics was offered for the first time in 1988. Recognizing the aging of the population, most medical schools now offer courses in geriatrics, though only 12 schools require courses devoted solely to geriatrics. Experts we interviewed agreed that medical schools could improve how they train doctors in geriatrics. Moreover, several experts stressed the need to improve the quality of continuing education in geriatrics, because a large portion of the education doctors receive in medical school becomes outdated during their careers. Since medical schools have only recently introduced geriatric training in their curricula, many doctors in practice today have had little formal training in that area. Two experts also pointed out a similar need for an emphasis on geriatrics in the training of pharmacists, both in pharmacy school and through continuing education.
While preclinical training in pharmacology is routinely provided in medical school, several experts said that improvements are needed in the teaching of clinical pharmacology, which trains doctors in the use of drug therapies to treat disease. Doctors obtain their clinical pharmacology training during their residencies. Physicians’ clinical knowledge of the unique aspects of elderly pharmacology depends on their exposure to elderly patients. Several experts believe that the real expertise in pharmacology rests with the pharmacists and that doctors need to use this expertise in deciding the most appropriate drug therapy to prescribe.
section_title: Drug Utilization Review Programs Offer Safeguards Against Inappropriate Use of Prescription Drugs
paragraphs: One strategy that is increasingly used to identify and minimize the inappropriate use of prescription drugs involves drug utilization reviews. Drug utilization reviews are intended to screen drug therapies for potential problems, such as drug-drug interactions, drug-disease contraindications, incorrect dosages, or improper duration of treatment. These reviews can be done either prospectively or retrospectively. Prospective drug utilization reviews are designed to detect potential problems before a prescription is filled by the pharmacist. Retrospective drug utilization reviews occur after the prescription is filled and are intended to detect prescribing patterns that indicate inappropriate or unnecessary medical treatment as well as fraud or abuse. The Omnibus Budget Reconciliation Act of 1990 requires all states to conduct ongoing retrospective reviews of Medicaid prescription drug claims and prospective reviews before each prescription is filled. Most states have expanded that requirement to mandate drug utilization review of all prescriptions. While several experts acknowledged the potential benefits of drug utilization review systems, two experts cautioned that these benefits have not been thoroughly documented to date.
A prospective drug utilization review system allows point-of-sale vendors such as pharmacies to check a prescription and a patient’s history against a central database. This database can alert a pharmacist to possible drug-drug interactions or a drug-disease contraindication. Our study of prospective Medicaid drug utilization review systems in five states during fiscal year 1993 found that pharmacies’ use of automated drug utilization review systems linked to statewide Medicaid databases provided a more thorough prospective review than a manual or localized system. This type of automated review can reduce the risk of inappropriate drug therapy and increase patient safety, though we recognized the need for these benefits to be demonstrated conclusively and recommended that HCFA take steps to do so. We also recommended that HCFA develop guidance for the development of these systems to ensure standard implementation of effective drug utilization review systems.
New York State’s Elderly Pharmaceutical Insurance Coverage program provides prescription drug insurance coverage for low-income senior citizens not eligible for Medicaid. This program uses a retrospective drug utilization review system for its therapeutic drug monitoring program. This review system monitors each client’s prescriptions, using data from prescription claims submitted for payment by pharmacies, to detect potential problems such as overutilization of a drug or a drug-drug interaction. Once a potential problem is detected, a program official notifies the prescribing physician. The alert is informational only and provides the doctor with a history of the patient’s prescription drug usage, the suspected problem, its effect and severity, and recommendations for resolving the problem. No action is required, but the doctor is asked to respond. In one analysis conducted by program staff, 38.4 percent of the patients whose doctors received letters alerting them to a potential problem subsequently had their drug therapy changed.
The Massachusetts Medicaid program also uses its retrospective drug utilization review system to detect questionable prescribing practices affecting any of its recipients. For example, if a patient is prescribed a nonsteroidal anti-inflammatory drug commonly used to relieve the symptoms of arthritis, the system will monitor that patient for potential side effects of this type of medication, such as stomach or intestinal bleeding. If the patient later begins to take antiulcer medications, the system will issue an alert to the prescribing doctor that the usage of the first drug may be the cause of the ulcers. This allows the doctor to evaluate the situation and, if warranted, alter the patient’s drug therapy.
A retrospective drug utilization review system can also monitor patient compliance with a prescribed drug therapy. For example, a patient may discontinue his or her blood pressure medication when the symptoms disappear. Despite the lack of symptoms, the causes remain, leaving the patient still at risk. A retrospective drug utilization review can detect the patient’s failure to refill a prescription and alert the patient’s doctor to the situation for further action.
section_title: Improved Patient Counseling Can Reduce the Risk of Adverse Drug Reactions
paragraphs: One way to lower the potential of adverse drug reactions is to ensure that patients are counseled by either their doctor or pharmacist on the usage and characteristics of a prescription drug. Often, subtle side effects of drugs are ignored by patients and not reported back to the doctor or pharmacist. Unless alerted that the patient is experiencing side effects, a doctor would not be likely to change drug therapies. Counseling not only improves the information received by the patient but also that obtained from the patient. This improved communication between doctor or pharmacist and the patient may prompt a question that leads to the discovery of a drug-drug interaction or drug-allergy interaction.
Although effective counseling by doctors and pharmacists can help reduce the likelihood of an adverse drug reaction, two studies have found that many patients do not receive this counseling. A Consumer Reports study of 70,000 people published in 1995 found that about 26 percent had not been counseled by a physician about their drug therapies. A 1989 study by the American Association of Retired Persons (AARP) found that more than one out of three patients reported that they were not counseled by their doctors on their drug therapies. Time pressures on both doctors and pharmacists may also be an obstacle to effective counseling.
Recognizing the importance of counseling, the Omnibus Budget Reconciliation Act of 1990 mandated that pharmacists counsel Medicaid patients when they receive prescription drugs. A majority of states have expanded this requirement to include all patients. Officials of the American Pharmaceutical Association and the American Society of Consultant Pharmacists, two professional associations that represent pharmacists, stressed the importance of counseling but noted that the current system of compensation for pharmacists is based on dispensing drugs and lacks meaningful incentives for counseling. For example, a pharmacist may detect a potential problem with a prescription and, after consultation with the doctor and patient, cancel the prescription. If another drug is not substituted and no drug is dispensed, the pharmacist receives no reimbursement for the professional services rendered.
section_title: Patients Can Protect Themselves From Adverse Drug Reactions
paragraphs: Patients who seek information about their drug therapies can reduce their likelihood of experiencing adverse drug reactions. Besides requesting counseling from both the doctor and pharmacist, public advocacy groups urge individuals to develop their own knowledge of drugs. To achieve this objective, AARP encourages the development of package product inserts in large type that are easy for the elderly to read and understand. Public Citizen Health Research Group, a public advocacy group, has also published a consumer guidebook for prescription drugs. Moreover, pharmaceutical manufacturers have begun to make information available directly to consumers. Increased understanding of their drugs, dosage requirements, and possible side effects makes patients more likely to avoid the inappropriate use of drugs.
State and local agencies have developed several initiatives to alert consumers to the dangers of inappropriately using prescription drugs. For example, the Massachusetts Department of Public Health sponsors brown bag seminars at senior citizen or community centers. At these seminars, elderly patients are encouraged to bring in all their medicines for review by pharmacists. The goal is to inventory all the medications a senior citizen has and eliminate those that are for conditions no longer being treated or which have expired. The remaining drugs are cataloged in what is called a “medicine passport” that can be shown to doctors and pharmacists as new or additional drugs are prescribed. This record allows health practitioners to quickly review what other medications the person is taking and why.
section_title: Managed Care Has the Potential to Reduce the Inappropriate Use of Prescription Drugs
paragraphs: Recent changes in the health care delivery system have implications for the use of prescription drugs. The growing emphasis on controlling health care costs creates a strong incentive to reduce the inappropriate use of prescription drugs and the physical and financial costs associated with adverse drug reactions. Likewise, the increasing importance of cost containment has helped spur the emergence of managed care as a major form of health care delivery. The number of people covered by managed care plans has increased dramatically from 10 million in 1980 to almost 90 million in 1992. Moreover, many managed care plans have recently initiated major marketing efforts to enroll elderly patients. Similarly, the number of people whose prescriptions are filled by pharmacy benefit management companies has also increased. While it is too early to understand the full impact these changes may have on reducing inappropriate drug use—in general, and among the elderly in particular—several experts we interviewed stated that these changes have the potential to improve the coordination of care and to increase the ability to detect inappropriate use of drugs. However, one expert cautioned that the achievement of these goals might be adversely affected by pressures to contain costs or increase profits.
subsections: section_title: Improved Coordination of Care Is a Goal of Managed Care
paragraphs: Many elderly patients are under the care of several specialists as well as their primary care physician. At times, these doctors may prescribe several drugs to treat various ailments. Unless these various drug therapies are coordinated, adverse drug reactions pose a serious risk. Experts in gerontology and elderly clinical pharmacology that we spoke to stated that the most effective way to deal with the inappropriate use of prescription drugs was to improve the coordination of care. Ideally, this role should fall to the patient’s primary physician.
Proponents of managed care have stressed improved coordination of care as a major goal. Though there are several variations of managed care such as health maintenance organizations (HMO) or preferred provider organizations, a basic characteristic of managed care is control over utilization. Often, this is done through a gatekeeper. A gatekeeper is usually the patient’s designated primary doctor who oversees the individual’s care, referring the patient to specialists as needed. This allows one doctor to coordinate various treatments, including drug regimens. Several experts agreed that such coordination could help lower the risk of adverse drug reactions posed by inappropriate drug therapy or a patient receiving multiple prescriptions from different doctors. However, they cautioned that the improved coordination of care is dependent on the quality of patient care, which varies widely among managed care plans.
Managed care plans also have the potential to use formularies to reduce the inappropriate use of prescription drugs. A formulary lists the preferred drugs used to treat certain diseases or conditions. Typically, the formulary is developed by a committee of doctors and pharmacists associated with the managed care plan, who seek to identify the most effective drug therapies at the lowest cost to the plan. For example, if two drug therapies are deemed equally effective, then the plan will recommend the less costly of the two as the preferred treatment. However, several experts expressed the concern that cost concerns rather than effectiveness may be the primary driving force in selecting which drugs to place on a managed care plan’s formulary.
A managed care plan can change its formulary to reflect new drug therapies. This has an impact on the prescribing behavior of a plan’s doctors who may have to seek an exception if they wish to prescribe a drug not designated by the plan’s formulary. However, two experts said that few managed care plans have used their formularies to improve prescribing practices for elderly patients though the experts acknowledged this potential exists.
Another potential advantage of managed care is the data collected on patients. This gives managed care plans the information needed to monitor both the drug therapies patients receive and the prescribing patterns of physicians. One HMO we visited provided its doctors with periodic analyses of their drug-prescribing habits as compared with standards developed by the HMO. This comparison allows the HMO to identify doctors who may need additional training or counseling in prescribing drugs for their patients, particularly the elderly.
section_title: Increasing Number of People Obtain Prescriptions From Pharmacy Benefit Management Firms
paragraphs: Over the past few years, the number of people who receive their prescription drugs through pharmacy benefit management firms has increased dramatically from fewer than 60 million in 1989 to 100 million in 1993. Pharmacy benefit management firms manage prescription drug benefits on behalf of health plan sponsors, including self-insured employers, insurance companies, and managed care plans.
The initial attraction of pharmacy benefit management firms is their ability to reduce administrative costs and obtain discounts on prescriptions drugs through volume buying. However, these firms can also provide formulary management and drug utilization review services with the potential to reduce inappropriate drug use. For example, the drug utilization review done by one pharmacy benefit management firm, PCS Health Systems, generated almost 25 million alerts in 1994. Of these alerts, 25 percent dealt with drug-age contraindications and excessive daily dosages, two types of inappropriate drug use prevalent among the elderly. Likewise, by monitoring patient prescription drug use, pharmacy benefit management firms can detect a patient’s failure to refill a prescription for a persistent medical condition such as high blood pressure. The firm can then alert the patient’s doctor to this situation for further action if required.
Pharmacy benefit management firms can also develop initiatives to address the inappropriate use of drugs among the elderly. For example, Medco has instituted an educational program called “Partners for Healthy Aging.” This program provides specialized information to doctors, pharmacists, and patients to alert them to potential concerns in the use of prescription drugs among the elderly.
As the number of patients served by these firms has increased so has the information gathered on patients. With the accumulation of data on patient characteristics, medical conditions, and drug therapies, pharmacy benefit management firms are developing the necessary database for engaging in outcomes research. Such research allows companies to demonstrate the effectiveness of different courses of treatment for a disease from both a therapeutic and cost perspective. This would permit doctors, patients, and payers to make both financially and clinically informed health care decisions.
A draft of this report was reviewed and commented on by five leading experts in the field of elderly clinical pharmacology. Where appropriate, the report was changed to reflect their comments.
As agreed with your office, unless you publicly announce its contents earlier, we plan no further distribution of this report until 30 days after its issue date. At that time, we will make copies available upon request.
This report was prepared by John C. Hansen, Assistant Director, Frank Putallaz, and Tom Taydus. Please call Mr. Hansen at (202) 512-7105 if you or your staff have any questions about this report.
section_title: Scope and Methodology
paragraphs: To determine the significance of the inappropriate use of prescription drugs among the elderly, we conducted a literature review and obtained documents and testimonial evidence from leading researchers in the fields of gerontology and elderly clinical pharmacology. Additionally, we interviewed other knowledgeable professionals concerning the issues related to the use of prescription drugs by the elderly. Included among these professionals were representatives of FDA, HCFA, senior citizen and consumer advocacy groups, the American Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, the American Medical Association, the American Society of Consultant Pharmacists, and the American Association of Medical Colleges.
We interviewed state officials in Massachusetts, New York, and Vermont to see how state and federal health programs deal with the inappropriate use of prescription drugs among the elderly. Massachusetts was selected because of the number of prominent researchers in the areas of elderly clinical pharmacology located there. New York was selected because the state administers the Elderly Pharmaceutical Insurance Coverage program, which provides prescription drug coverage to low-income senior citizens. Vermont, a rural state in contrast to Massachusetts and New York, was selected because it was one of only eight states that had implemented a statewide automated prospective drug utilization review system for Medicaid prior to 1994. In each state, we obtained information on the operation of Medicaid drug utilization review systems as well as various state initiatives to help senior citizens avoid adverse drug reactions.
To update the results from earlier research studies, we analyzed data from HCFA’s 1992 Medicare Current Beneficiary Survey, the most recently available data. According to HCFA, this survey is designed to provide reliable baseline data to project Medicare costs and is representative of the Medicare population as a whole.
To determine what causes the inappropriate use of prescription drugs, we reviewed the literature and interviewed the leading experts previously cited. We also obtained information on physician gerontology education and questioned state officials about the implementation of drug utilization review programs and their effect on the causes of the inappropriate use of prescription drugs.
To determine how physicians, pharmacists, and patients receive information on drug therapies, we identified actions that drug manufacturers and FDA have taken to provide better dosage information for elderly patients as well as changes in how drug manufacturers disseminate information to physicians, pharmacists, and patients. We also obtained information on efforts by state agencies, senior citizen advocacy groups, pharmacy groups, and medical organizations to improve communication between and among physicians, pharmacists, and patients.
To identify emerging trends in the health care delivery system and their potential effects on the inappropriate use of prescription drugs, we obtained information on how managed care plans develop formularies, train their staff on new drug therapies, and track both patient and physician use of prescription drugs. To assess the effect of the growth of pharmacy benefit management firms, we obtained information on how these plans coordinate and monitor drug therapies.
section_title: Medicare Current Beneficiary Survey
paragraphs: The Medicare Current Beneficiary Survey is a continuous, multipurpose survey of a representative sample of the Medicare population. It is administered by HCFA’s Office of the Actuary and began gathering data in 1991. The survey generates data on issues of prime importance to the management of the Medicare program and the development of health care policy. Focusing on health care use and expenditures, the survey generates data to (1) allow HCFA to monitor the financial effects of changes in the Medicare program; (2) develop reliable and current information on the use and cost of services not covered by Medicare such as prescription drugs and long-term care; and (3) obtain information on the sources of payments for costs of covered services not assumed by Medicare. Although its focus is on the financing of health care, the survey collects a variety of information about the Medicare population, including demographic characteristics, health status, insurance coverage, financial resources, and family support.
The survey is based on a sample of Medicare recipients drawn from the Medicare enrollment file. The sample is representative of the Medicare population as a whole. Since the survey is a longitudinal study, those selected for participation are interviewed three times a year for several years to form a continuous profile of their health care. Initial participants who completed the first round of interviews numbered 12,677. Of these, 942 resided in an institutional setting and 11,735 were community-based. The sample is adjusted annually for attrition and for newly eligible persons.
The initial interview gathers baseline data on demographic characteristics, health status, insurance coverage, financial resources, and family support. Subsequent interviews gather details of the participants’ health care use since the last interview emphasizing the type of health care used and the source for paying for it. This includes information on the prescription drugs a participant is using even though Medicare does not provide reimbursement for their cost.
Information collected is edited for consistency, documented, and organized into files. Later, these files are merged with HCFA claims payment records. Also, administrative data such as Medicaid buy-in status and capitated plan membership are added to the file. All personal identifying information is removed.
section_title: 20 Drugs Generally Considered Inappropriate for the Elderly
paragraphs: Table III.1 lists the 20 drugs deemed generally inappropriate for elderly patients by a panel of experts. The reasons given by this panel for judging a drug inappropriate are also provided as is the purpose of these drugs. The panel’s results and methodology were published in 1991. Though the goal of this panel was to identify drugs inappropriate for the elderly living in a nursing home setting, a later examination of these drugs by another panel of experts also judged these drugs as generally inappropriate for elderly patients living in a community-based setting. Several of the experts we interviewed agreed that these drugs should normally not be used with elderly patients though they stressed that there would be some medical situations where the use of these drugs would be appropriate. One expert noted the need for research studies based on patient-related outcomes data to confirm the views of the expert panelists.
Shorter-acting benzodiazepines are safer alternatives.
Shorter-acting benzodiazepines are safer alternatives.
Shorter-acting benzodiazepines are safer alternatives.
Shorter-acting benzodiazepines are safer alternatives.
Safer sedative-hypnotics are available.
Safer sedative-hypnotics are available.
Other antidepressant medications cause fewer side effects.
Other nonsteroidal anti-inflammatory agents cause less toxic reactions.
Other nonsteroidal anti-inflammatory agents cause less toxic reactions. (continued)
Other oral hypoglycemic medications have shorter half-lives and do not cause inappropriate antidiuretic hormone secretion.
Other analgesic medications are more effective and safer.
Other narcotic medications are safer and more effective.
To improve blood circulation Effectiveness is in doubt.
To improve blood circulation Effectiveness is in doubt.
This drug is no longer available in the U.S.
Effectiveness at low dosage is in doubt. Toxic reaction is high at higher dosages. Safer alternatives exist.
Minimally effective while causing toxicity. Potential for toxic reaction is greater than potential benefit.
Minimally effective while causing toxicity. Potential for toxic reaction is greater than potential benefit.
Minimally effective while causing toxicity. Potential for toxic reaction is greater than potential benefit.
Minimally effective while causing toxicity. Potential for toxic reaction is greater than potential benefit.
Least effective of available antiemetics.
section_title: Use of Drugs Considered Generally Inappropriate for the Elderly
paragraphs: At our request, HCFA’s Office of the Actuary used data from the Medicare Current Beneficiary Survey to determine the percentage of community-based elderly who used at least 1 of the 20 drugs identified in appendix III as generally inappropriate for their age group. The most current compiled data are for 1992. The first step was to identify survey participants who were 65 or older and who were noninstitutionalized. Of their survey population, 9,182 participants met these criteria. This group represented 29,862,854 Medicare beneficiaries nationwide according to HCFA’s Office of the Actuary. The next step was to determine which of these participants used at least 1 of the 20 drugs sometime during 1992 and project that use to the national population. The results indicated that an estimated 17.5 percent or 5,219,811 noninstitutionalized Medicare beneficiaries 65 or older used at least 1 of those drugs during 1992.
These results are displayed in table IV.1. Specifically, the table lists the percentages of noninstitutionalized elderly found to be using each of the 20 drugs. The middle column details the results based on research using data from the 1987 National Medical Expenditure Survey covering noninstitutionalized residents 65 or older. The right-hand column presents the results of the analysis described above. We did not include the research results based on interviews conducted during 1989 and 1990 of a sample of noninstitutionalized elderly 75 or older residing in Santa Monica, California. This was because the participants in this study represented one community rather than a national sample and belonged to a different age group than the other two studies. In addition, their use of the 20 drugs was measured during a period of 1 month versus 1 year in the other 2 analyses.
section_title: Glossary
subsections: section_title: Drug-Age Contraindication
paragraphs: Use of a drug not recommended for the age group of a patient.
section_title: Drug-Drug Interaction
paragraphs: The potential for, or the occurrence of, an adverse drug reaction as a result of the use of two or more drugs together.
section_title: Drug-Allergy Interaction
paragraphs: The potential for, or the occurrence of, an allergic reaction as a result of drug therapy.
section_title: Drug-Disease Contraindication
paragraphs: The potential for, or occurrence of, an undesirable alteration of the therapeutic effect of a given prescription because of the presence, in the patient for whom it is prescribed, of an additional disease condition. Also, the potential for, or the occurrence of, an adverse effect of the drug on the patient’s disease condition.
section_title: Incorrect Drug Dosage
paragraphs: A dosage that lies outside the daily recommended dosage range as specified in predetermined standards as necessary to achieve therapeutic benefit.
section_title: Incorrect Duration of Drug Therapy
paragraphs: The number of days of prescribed therapy exceeds or falls short of the recommendations contained in the predetermined standards.
section_title: Therapeutic Duplication
paragraphs: The prescribing and dispensing of two or more drugs from the same therapeutic class such that the combined daily dose puts the patient at risk of an adverse drug reaction or yields no additional therapeutic benefit.
section_title: Less Effective Drug Therapy
paragraphs: Use of a drug therapy that is less desirable than other alternatives because of factors such as therapeutic effectiveness, presence of side effects, ease of use, or cost.
section_title: Bibliography
paragraphs: Avorn, Jerry. “Grant Watch—Medication Use and the Elderly: Current Status and Opportunities.” Health Affairs (Spring 1995), pp. 276-86.
Beard, Keith. “Adverse Reactions as a Cause of Hospital Admission in the Aged.” Drugs & Aging, Vol. 2, No. 4 (July/Aug. 1992), pp. 356-67.
Beers, Mark, Joseph G. Ouslander, Irving Rollingher, and others. “Explicit Criteria for Determining Inappropriate Medication Use in Nursing Home Residents.” Archives of Internal Medicine, Vol. 151 (Sept. 1991), pp. 1825-32.
Beers, Mark, Jerry Avorn, Stephen B. Soumerai, and others. “Psychoactive Medication Use in Intermediate-Care Facility Residents.” Journal of the American Medical Association, Vol. 260, No. 20 (Nov. 25, 1988), pp. 3016-20.
Beers, Mark, Michele Storrie, and Genell Lee. “Potential Adverse Drug Interactions in the Emergency Room.” Annals of Internal Medicine, Vol. 112, No. 1 (Jan. 1, 1990), pp. 61-64.
Bero, Lisa A., Helene L. Lipton, and Joyce Adair Bird. “Characterization of Geriatric Drug-Related Hospital Readmissions.” Medical Care, Vol. 29, No. 10 (Oct. 1991), pp. 989-1000.
Cleeland, Charles, Rene Gonin, Alan K. Hatfield, and others. “Pain and Its Treatment in Outpatients with Metastatic Cancer.”  New England Journal of Medicine, Vol. 330, No. 9 (Mar. 3, 1994), pp. 592-96.
Col, Nananda, James E. Fanale, and Penelope Kronholm. “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.
Colt, Henri G., and Alvin P. Shapiro. “Drug-Induced Illness as a Cause of Admission to a Community Hospital.” Journal of the American Geriatrics Society, Vol. 37, No. 4 (Apr. 1989), pp. 323-26.
Gurwitz, Jerry H., “Suboptimal Medication Use in the Elderly: The Tip of the Iceberg.” Journal of the American Medical Association, Vol. 272, No. 4 (July 27, 1994), pp. 316-17.
Kane, Robert L., and Judith Garrard. “Changing Physician Prescribing Practices: Regulation vs. Education.” Journal of the American Medical Association, Vol. 271, No. 5 (Feb. 2, 1994), pp. 393-94.
Lurie, Peter, and Philip R. Lee. “Fifteen Solutions to the Problems of Prescription Drug Abuse.” Journal of Psychoactive Drugs, Vol. 23, No. 4 (Oct.-Dec. 1991), pp. 349-57.
Manasse, Henri R. Jr. “Medication Use in an Imperfect World: Drug Misadventuring as an Issue of Public Policy, Part 1.” American Journal of Hospital Pharmacy, Vol. 46 (May 1989), pp. 929-44.
Manasse, Henri R. Jr. “Medication Use in an Imperfect World: Drug Misadventuring as an Issue of Public Policy, Part 2.” American Journal of Hospital Pharmacy, Vol. 46 (June 1989), pp. 1141-52.
Ray, Wayne A., Marie R. Griffin, and Ronald I. Shorr. “Adverse Drug Reactions and the Elderly.” Health Affairs, Vol. 9, No. 3 (Fall 1990), pp. 114-22.
Ray, Wayne A., Randy L. Fought, Michael D. Decker. “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.
Ray, Wayne A., Marie R. Griffin, William Schaffner, and others. “Psychotropic Drug Use and the Risk of Hip Fracture.” New England Journal of Medicine, Vol. 316, No. 7 (Feb. 12, 1987), pp. 363-69.
Soumerai, Stephen B., and Helene L. Lipton. “Sounding Board—Computer-Based Drug-Utilization Review—Risk, Benefit, or Boondoggle.” New England Journal of Medicine, Vol. 332, No. 24 (June 15, 1995), pp. 1641-45.
Stuck, Andreas E., Mark Beers, Andrea Steiner, and others. “Inappropriate Medication Use in Community-Residing Older Persons.” Archives of Internal Medicine, Vol. 154 (Oct. 10, 1994), pp. 2195-2200.
Sullivan, Sean D., David H. Kreling, and Thomas K. Hazlet. “Noncompliance With Medication Regimens and Subsequent Hospitalization: A Literature Analysis and Cost of Hospitalization Estimate.” Journal of Research in Pharmaceutical Economics, Vol. 2, No. 2 (1990), pp. 19-33.
Wilcox, Sharon M., David U. Himmelstein, and Steffie Woolhandler. “Inappropriate Drug Prescribing for the Community-Dwelling Elderly.” Journal of the American Medical Association, Vol. 272, No. 4 (July 27, 1994), pp. 292-96.
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subsections: section_title: Address Correction Requested