When medications are prescribed for patients, the intent is to improve the patient’s quality of life by curing a disease, reducing or eliminating the symptoms of a disease, arresting or slowing a disease process, or preventing a disease or its symptoms from appearing in the first place (Hepler and Strand, 1990).
But a medication is a two-edged sword; it can cut both ways. The same dose of a medication given to two different people may cure one and harm the other. In recent years there has been a growing recognition in clinical literature, in the popular press, and in health policy circles that misuse of medications is creating serious health problems, disabilities, and death at an alarming rate. This "silent epidemic" can appear in a variety of situations – when a person is prescribed the wrong medication for his or her medical condition or age, the right medication in the wrong dose, or two or more medications that interact with dangerous, unintended side effects. Eight general categories of medication-related problems have been identified (Table 1). The resulting physical and mental effects can make people feel worse instead of better, less functional, more confused, and less able to care for themselves. Medication-related problems occur most often in older people and are generally more severe.
UNTREATED INDICATION: Patient has medical problem that requires drug therapy but is not receiving medication for that indication
IMPROPER DRUG SELECTION: Patient has medical problem that requires drug therapy but is taking the wrong medication
SUBTHERAPEUTIC DOSAGE: Patient has medical problem that is being treated with an inadequate dose of the correct medication
FAILURE TO RECEIVE DRUGS: Patient has a medical problem that is the result of not receiving a drug (e.g., for pharmaceutical, psychological, sociological, or economic reasons)
OVERDOSAGE: Patient has medical problem that is being treated with too much of the correct drug
INVERSE DRUG REACTION: Patient has medical problem that is the result of an unintended and detrimental adverse drug effect
DRUG INTERACTION: Patient has medical problem that is the result of a drug–drug, drug–food, or drug–laboratory interaction
DRUG USE WITHOUT INDICATION: Patient is taking a drug without a valid medical reason Source:
(Hepler and Strand, 1990).
However, there is a substantial body of literature that indicates that most medication-related problems are predictable and thus preventable. Steps can be taken to avoid preventable problems that result from the lack of knowledge about the appropriate use of medication in the older population; inadequate provider, patient, and care-giver education; and deficiencies in medication information tracking.
Studies have been conducted that examine the costs of medication-related problems in different settings, including nursing homes, hospitals, and in the community. However, surprisingly little research has been done to assess the full extent of the costs, both economic and human, of medication-related problems specifically in the older population. Research is also needed to devise better care delivery and information systems to reduce the risk of medication-related problems. More research is also needed to guide the development of national policies to address all of the interrelated issues of appropriate prescribing in the elderly. Without more information, medication-related problems in the elderly population will only increase.
Medication-related problems are a serious public health concern affecting people of all ages, costing the United States billions of dollars and thousands of lives. The human toll of medication-related problems is staggering. In an April 1998 issue of the Journal of the American Medical Association, a meta-analysis of 39 prospective studies was done to estimate the number of adverse drug reactions and deaths due to medications. Although the study did not specifically focus on older people, it found that in a single year approximately 2,216,000 hospitalized patients had serious adverse drug reactions and 106,000 died as a consequence of their medication.
Even when the outcome is not death, medication-related problems decrease quality of life by affecting the mind’s and body’s ability to function normally. The economic costs attributable to medication-related problems, in nursing homes, hospitals, and the community, are enormous as well, totaling nearly $85 billion annually (figure 1). (Johnson and Bootman, 1995; Harrison and Cox, 1997; Bates, 1997) This economic cost rivals that of cancer, Alzheimer’s disease, diabetes, and other major diseases and conditions commonly affecting the elderly population (figure 2).
Source: (Johnson and Bootman 1995; Bootman, Harrison and Cox, 1997; Bates, Spell and Cullen, 1997).
Sources: Alzheimer’s Disease Foundation and Referral (ADEAR) Center; National Cancer Institute; American Diabetes Association; Arthritis Foundation; National Center for Health Statistics, 1994; National Parkinson Foundation; National Stroke Foundation
Researchers have begun studying the reasons why things go awry – and at what frequency and cost to society. Several studies have been conducted that examine the economic cost of medication-related problems in different settings.
Medication-Related Problems in the Ambulatory and Hospital Populations
In a landmark study, Drug-Related Morbidity and Mortality: A Cost-of-Illness Model, researchers developed an economic model to estimate the cost of medication-related problems in the ambulatory population. The researchers took the perspective of a third-party payer, looking at various positive and negative outcomes associated with medication therapy. The costs of medication-related illness and death were estimated at $76.6 billion annually. Hospitalizations accounted for the majority of costs, some $47 billion; while admissions to long-term care facilities were the second largest cost component, at $14 billion. (Johnson and Bootman, 1995) Since the total amount of money spent on medications for ambulatory patients is about $80 billion per year, for every dollar spent on medications, another dollar is spent to treat new health problems caused by the medications.
A study from Boston’s Brigham and Women’s Hospital and Massachusetts General determined the direct hospital costs attributable to adverse drug events in hospitalized patients. When projected nationally, the direct costs of treating adverse drug events in hospitalized patients were conservatively estimated at $4 billion annually (Bates, Spell and Cullen, 1997). If the costs associated with outpatient treatment and disability were included, the total direct medical costs of adverse drug events in hospitalized patients could be up to 10 times greater (Classen, Pestonik, Evans, Lloyd and Burke, 1997).
Medication-Related Problems in U.S. Nursing Home Facilities
In a 1997 study, The Health Care Cost of Drug-Related Morbidity and Mortality in Nursing Facilities, researchers applied a pharmoeconomic model to determine the cost of medication-related problems in U.S. nursing facilities. Using decision-analysis techniques, the study estimated the cost of medication-related problems and the impact of federally-mandated retrospective drug regimen review on those costs. The study found that consultant pharmacist-conducted drug regimen review saves as much as $3.6 billion annually in costs associated with medication-related problems. In spite of this, medication-related problems in nursing facilities still account for $4 billion in costs. Approximately $3 billion is spent annually for medications in nursing facilities; therefore, for every dollar spent on medications, $1.33 is spent to treat medication-related problems. (Bootman, Harrison and Cox, 1997)
Aging as a Risk Factor
The consequences of medication-related problems are a potential health problem that is particularly acute for the elderly population. One study estimated the percentage of hospitalizations of older patients due to adverse medication reactions to be 17%, almost six times greater than for the general population (Nanada, Fanale and Cronholm, 1990). Adverse medication effects in older persons – such as drowsiness, loss of coordination, and confusion – can result in serious injury due to falls or automobile accidents, or less catastrophic yet equally debilitating outcomes, such as loss of functional ability and memory impairment. (General Accounting Office, 1996)
Older people are especially at risk for several reasons. First, the physiological changes of aging increase the risk for medication problems in the elderly population. Experts agree that medication effects in older people are often different than in younger people, because age-related changes in the human body cause differences in the way that the body responds to medications. Older patients often lack the ability to eliminate medications from their systems as efficiently as younger patients do because of decreased liver and kidney function. They are also more sensitive to the effects of medications and are, thus, not able to tolerate usual adult dosages. (General Accounting Office, 1996) Further, there are pronounced differences even among the 65–75 ("young old"), 75–85 ("older old"), and 85 and older ("oldest old") age groups.
As a group, older people are more likely to suffer from multiple chronic diseases, requiring several different medications at one time. The average older person uses 4.5 prescription medications concurrently and an additional two over the counter medications. As the number of prescriptions and non-prescription medications increases, so does the potential for problems caused by drug interactions or drug-disease contraindications (General Accounting Office, 1996).
The increasing use of over-the-counter (OTC) medications by older people constitutes an added risk for medication-related problems. Older Americans use at least 25% of all OTC medications for many common conditions, including arthritis, insomnia, and pain control. Until recently, many of these OTC medications were available only by prescription, and the number of medications making the switch from prescription to non-prescription is growing rapidly.Yet, no information or labeling exists on OTC medications to let older people who wish to self-medicate know how these products may interact with other prescription medications they may be taking, how dosage levels may affect them differently with age, or how the medication itself may act on an older body. For example, an older man with an enlarged prostate could develop acute urinary retention – becoming unable to urinate – if he takes an antihistamine such as diphenhydramine or a decongestant such as pseudoephedrine. Information of this type included with OTC medications could help older people make more informed choices about their self-care and help prevent medication-related problems.
Despite recent improvements in the study of new medications in the older population, under-representation of people over age 65 – and particularly those over age 75 – in clinical trials has resulted in a lack of specific knowledge about dosage levels and the effects of different medications in the very population that uses them the most. To help health care professionals take better care of their patients, more information is needed about the use of medications in this population. As noted by Dr. Jerry Avorn, of Harvard’s Brigham and Women’s Hospital, "The use of drugs by the elderly and their clinical outcomes have not been prominent research or programmatic priorities for the federal government, philanthropic, or corporate grantmakers."
Other factors that place older people at risk include cognitive impairments that make it difficult or impossible to follow appropriately prescribed medication regimens; lack of a primary care-giver to help with taking medications; financial considerations that impact the purchase and regular use of medications; and problems with vision that can make it difficult to read labels or patient inserts and to follow directions correctly.
There is also a high incidence of inappropriate medication prescribing in the elderly. The General Accounting Office report found that 17.5% of the nearly 30 million Medicare recipients were prescribed medications generally unsuitable for their age group. (General Accounting Office, 1996) Another report issued in November 1997 by the Department of Health and Human Services Office of Inspector General found that a similarly high number of Texas nursing home residents received at least one of 20 medications considered by medical experts to be inappropriate for use by older people. (Office of Inspector General, 1997)
Explicit criteria for determining potentially inappropriate medication use in older people were developed for nursing facility residents by a team of researchers in geriatrics at the University of California at Los Angeles in 1991. The criteria include specific medications or classes of medications that should be avoided in frail, elderly nursing home residents except under unusual clinical circumstances. The criteria also provide information on doses, frequencies of administration, or duration of medication therapy that generally should not be exceeded in these patients. (Beers, Ouslander, Rollingher, Reuben, Brooks and Beck 1991) These criteria have been recently updated and expanded to help identify inappropriate use of medications in all people over the age of 65 (Beers, 1997).
Such criteria provide a valuable tool for assessing the quality of prescribing in older persons as well as identifying the potential risks for medication-related problems.
A Shortage of Trained Professionals
While a great deal of knowledge exists about appropriate medical care for the geriatric population, the overwhelming majority of older people are cared for by health professionals with no formal education or training in geriatrics. In fact, geriatric-specific coursework – and geriatric pharmacotherapy in particular – is inadequate in the curricula of our health professional schools. Only two full departments of geriatrics exist in the United States today, and only 11 of our country’s 126 medical schools require courses devoted solely to geriatrics. Although 53 U.S. medical schools offered geriatrics as an elective, less than 3% of medical school graduates surveyed reported taking those courses. This is an alarming short fall in American medical education given that older people will constitute approximately 50% of physician visits in the first few decades of the new century. (Alliance for Aging Research, 1996)
There is also a need to emphasize geriatrics in the training of pharmacists, nurses, physician assistants, and others that care for older people. If a greater number of health care professionals in all disciplines had a better understanding of medications and their effects in older persons, many medication-related problems could be avoided.
The United States also suffers from a lack of an adequate system for collecting, processing, and analyzing data about medication effects, especially after medications are approved for marketing by the Food and Drug Administration (FDA). Although the FDA’s MedWatch program collects spontaneous reports of suspected adverse effects in the general population, these reports rely on voluntary accounts and are not adequate to develop a database that can be used to extract general information about medication-related problems. The absence of focus on medication-related problems, along with funding constraints, has resulted in a lack of data on medication-related effects (Ray, Griffen and Avorn, 1993).
There is a potential source of extensive data on medication use and outcomes in frail elderly persons available through the federally-mandated resident assessment requirements for nursing facilities participating in Medicare and Medicaid. The Resident Assessment Instrument provides a comprehensive, standardized reproducible, assessment of each nursing facility resident’s medical, functional, and psychological needs through the use of a Minimum Data Set (MDS) of core elements relating to 16 areas of resident status.
The Health Care Financing Administration (HCFA), which oversees the Medicare and Medicaid programs, requires that the MDS be automated for electronic submission to the states, and will ultimately create a national database as a repository of this clinical data for all nursing facility residents. The MDS will be used as the basis for Medicare’s prospective payment system for skilled nursing facilities beginning July 1, 1998.
Although HCFA has specified a section of the MDS (Section U) to document a resident’s medication regimen, the use of this section is currently not mandated. Requiring incorporation of medication use information into the resident assessment process would provide important data to relate medication use to resident outcomes, track changes in patterns of medication use over time, develop and apply quality indicators to identify patterns of potentially inappropriate medication use, and conduct research to identify ways to improve resident outcomes through appropriate medication use. This information could fill a substantial information gap, providing a much needed source of data on medication use and outcomes in the frail, elderly nursing facility population.
In this report, the Alliance for Aging Research has set out to define the scope of medication problems in older people. We now identify strategies needed to address and alleviate the effects of these problems on our older population. Based on a careful review of medication-related problems in the elderly population and the potential solutions, the expert panel recommends the following:
1. Compile and disseminate a list of medications considered potentially inappropriate for use in older persons and mandate that the list be used as a screening tool.
The Secretary of Health and Human Services should compile a list of medications that are potentially inappropriate for use in older persons based on work already done and a separate list of "red alert" medications (those that should rarely, if ever, be used for older people). The lists should include prescription and over-the-counter medications, and where possible herbal and alternative remedies. Periodically, the lists and criteria for inclusion of the medications should be reviewed and updated. Research should evaluate the adverse outcomes of these medications to help better define the lists in the future. Health professionals should be educated and informed about these lists to ensure their appropriate and widespread use. The lists should also be disseminated to the lay public.
Where Congress has the authority, it should mandate, and in other situations encourage, that the list be used for screening medications that are prescribed to the elderly. Screening should also evaluate medications that, although safe in many older persons, pose a hazard when certain diagnoses are present. This screening tool should be included as part of prospective drug-utilization review (DUR) programs in health care settings, including all pharmacies. Data collected by states and managed care organizations should be analyzed to assess the extent of continued use of these medications in the older population. These data should be appropriately disseminated to patients and health care providers.
2. Provide geriatrics-relevant labeling information for over-the-counter medications.
The Food and Drug Administration (FDA) should require a new subsection, titled "For Use By Older Persons," in the "Warnings" or "Precautions" section of the labeling for all over-the-counter (OTC) medications. This OTC subsection would be analogous to the new FDA-mandated "Geriatric Use" subsection within the "Precautions" section of prescription drug labeling. In this subsection, manufacturers should be required to describe available information pertinent to this class of medications in older consumers, including specific effects of the medication in older persons, special dosing considerations, any limitations, possible adverse effects, side effects, or monitoring needs associated with their use. This information should be easy to read and understand in order to promote safe and effective use of nonprescription medicines among older persons. Medications known to pose a high risk for older persons should be marked prominently with a universally recognizable symbol.
3. Fund and encourage research on medication-related problems in older persons to determine which medications are most troublesome and which patients are most at risk.
Studies should be funded by the Agency for Health Care Policy and Research, the National Institutes of Health, and other appropriate entities to determine the factors that place older persons at high risk for medication-related problems. Developing a scientific base is essential to provide the information health care professionals need to better identify those older persons who are most vulnerable to medication-related problems and take preventive action, thereby saving lives and health care dollars. The scientific base must include longitudinal studies, integrated databases, and consensus-based and evidence-based screening tools.
4. Provide incentives to pharmaceutical manufacturers to better study medication effects in the frail elderly and oldest old in pre- and post-marketing clinical trials.
Recruiting frail and vulnerable older people as participants in clinical trials can be a complex and difficult task. Nonetheless, the FDA should encourage that additional Phase IIIB studies be conducted by pharmaceutical companies to identify actual and potential medication-related problems and limitations of medications that will be used frequently by older persons, particularly the oldest old and persons residing in long-term care facilities. Clinical trials should include identification of outcomes that can be particularly relevant to the elderly population, such as effects on cognition, mood, or gait stability. It is important to include frail and vulnerable older persons as well as women and ethnic and racial minorities so that medications to be used by these groups will have been tested on people like themselves. As an incentive, pharmaceutical companies that conduct these studies might receive an extension of their medication patent for the product being studied, similar to the patent extension under consideration for medications used in the pediatric population.
5. Establish mechanisms for data collection, monitoring, and analysis of medication-related problems by age group.
Existing systems, such as the FDA’s MedWatch, need to be adapted to better analyze and disseminate the data that are already collected to determine trends in medication use and medication-related problems in older persons. Data should be reported in 10-year age bands over age 65.
The Health Care Financing Administration should mandate the integration of medication-use information into the resident assessment process by incorporating Section U into the Minimum Data Set (MDS) for all nursing facilities. The incorporation of the Section U medication use information into the resident assessment process will provide valuable data to enable improvement in care for nursing facility residents. As researchers identify correlations between medication use and outcomes, the dissemination of this information will lead to improved medication therapy for nursing facility residents.
In addition, a greater number of post-marketing (Phase IV) surveillance studies focusing on elderly persons, especially those with multiple co-morbidities, should be conducted and supported, particularly if the medication will be used frequently in this population.
Regardless of source, data on medication-related problems should be reported, not only by medication, but also by age group to determine medication use and effects across age groups. Data should be made available to both health care professionals and the general public order to improve prescribing and use of medications, especially in older adults.
6. Encourage health care professionals’ competency in geriatric pharmacotherapy.
Most health care professionals need to be formally trained and knowledgeable about geriatrics and the clinical use of medications in the elderly population. As the U.S. population continues to age, health care professionals will spend much of their time caring for patients over 65 years old. They should have special instruction about this age group, beginning in school and throughout their careers.
Postgraduate training programs in geriatrics, continuing education, and opportunities for certification of health care professionals in geriatric pharmacotherapy need to be provided to meet the demand for qualified health care professionals. Geriatric Education Centers could provide such training. Increased competency in geriatric pharmacotherapy will be invaluable in providing better care, creating better outcomes, and controlling health care costs in this growing population.
Credentialing organizations, health professional schools, professional associations, and health care providers should establish criteria for competency in geriatric pharmacotherapy within their fields.
7. Direct Medicare Graduate Medical Education dollars to training in geriatric pharmacotherapy.
The Health Care Financing Administration should require that a specific portion of the nearly $7 billion Medicare Graduate Medical Education budget distributed to teaching hospitals be directed to training physicians, nurses, pharmacists, and other health care professionals in geriatric pharmacotherapy. This initiative will train health care professionals to provide informed care to older Americans and help address the shortage of health care professionals trained in geriatrics by targeting existing resources to an area where there is a great national need. Incentives should be offered to encourage hospitals to provide interdisciplinary education and staff in the area of geriatrics.
8. Fund and provide education and resources for caregivers providing medication assistance to older people.
Many older people receive care – including assistance with medications – from persons who have no formal training in managing medications. These services are often provided by home health agencies, assisted living facilities, senior centers, or by other community-based providers. Education, training, and resources on the proper, safe, and effective use of medications are needed by caregivers who provide any oversight or assistance with medications.
Minimum education, training requirements, and standards of practice should be developed by appropriate professional associations in cooperation with specialty groups caring for older persons to ensure proper care, especially when medication assistance is provided.
Modern medications provide us with extraordinarily powerful therapeutic interventions, and for elderly patients with multiple diseases, properly managed, medication therapy is often the best hope for longer and better lives. And yet, we come face-to-face with the many problems that can result from their misuse. The elderly population is especially vulnerable to medication-related problems due to their physiological make-up; a lack of knowledge and training among health professionals and care-givers about the special health problems of older people; a deficiency of research about the effects of medications in this population, especially the oldest old; and the lack of a comprehensive system for collecting, processing, and analyzing data on medication effects.
Many studies have been conducted and much literature has been published to demonstrate that medication-related problems are an important issue in the population overall, both in terms of cost and lives lost. However, little research has been done to show what proportion of the problem relates specifically to older people, and even less work has been done to investigate the effects of many common medications in this population. We need a major national commitment to better understanding the effects of medication in the older population. Until we do a better job of managing what are ultimately preventable problems, we will continue to be hampered in our goal of achieving healthy aging.
Like so many problems faced by modern society, reducing the economic and human toll of medication-related problems will require much public and private effort, as well as new ways of thinking about medications and diseases. But if nothing is done, the scope of the problem, large as it is today, will be far worse for future generations. In this report, the panel assembled by the Alliance for Aging Research recommends specific actions that can be taken immediately. Now is the time to take on this daunting task and we urge action in all sectors of society related to health.