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Treating Elderly Patients Means More Questions Than Answers

Elderly patients use more psychiatric medications and have greater risks for adverse reactions than younger adults, but they are rarely represented in clinical trials.

American Association for Geriatric Psychiatry President Bruce Pollock, M.D., Ph.D., discusses the urgent need for more clinical evidence for geriatric psychopharmacotherapy at the association's annual meeting in March. Credit: AAGP

Elderly patients make up a large and growing portion of psychiatric medication users and suffer more adverse reactions than younger adults, yet research pays little attention to this unique population.

Geriatric psychopharmacology presents both serious challenges and vast opportunities to clinicians and academics. Bruce Pollock, M.D., Ph.D., president of the American Association for Geriatric Psychiatry (AAGP), discussed the paucity of clinical evidence to guide safe and effective treatment of elderly patients with mental illness in his plenary speech, "Medicine and Toxicity: Dose and Intent," at the AAGP annual meeting in March in Orlando.

Pollock is chair of neuropsychiatry and professor and head of the University of Toronto's Division of Geriatric Psychiatry. He emphasized that adverse drug reactions (ADRs) pose significantly higher risks to older patients, and as much as 20 percent of hospital admissions of people over age 70 have been blamed on ADRs. Of all the medications routinely taken by the elderly, psychoactive drugs and anticoagulants are the most commonly associated with preventable ADRs and result in millions of dollars in health care expenses and significant suffering, he noted.

Elderly patients are more sensitive to the side effects of many drugs because of physiological changes of aging, he added. The pharmacokinetics in elderly patients are more variable and unpredictable, sometimes resulting in dangerously high drug concentrations from "normal" adult doses of a medication.

In addition, elderly people often have more comorbid conditions that affect their organ systems and in turn their physiological response to psychoactive drugs than do other populations. They also tend to take more medications for thesse multiple illnesses, which greatly increases the risk of drug-drug interactions.

However, there is a dearth of high-quality clinical evidence on both efficacy and safety specifically clarifying the appropriate doses of pharmacotherapy in this vulnerable population. "It's a public-health scandal that medications are not adequately researched in the bulk of patients who will be taking them," Pollock said. He cited a U.S. Government Accountability Office report released in September 2007, which noted that the Food and Drug Administration (FDA) does not devote enough effort to evaluating drug applications for treatment in elderly patients.

Although the FDA's guidelines require pharmaceutical companies to include a "Geriatric Use" section in product labeling, this section is usually very short and often contains few patient data from clinical trials, Pollock commented. This is primarily because clinical trials designed to seek FDA approval often exclude a large subset of elderly patients who are sicker and more frail, have more comorbidities, and have lower socioeconomic status. Data are particularly thin on the very old, namely those above age 80. Physicians are often left with the trial-and-error approach to treating these patients whose care is the most complicated.

In addition, Pollock emphasized that clinicians must take a rational and careful approach to prescribing medications for geriatric patients. Because of the high risk of toxicity associated with most drugs in the frail elderly, it is crucial "to be very clear why we are giving a particular medicine and what we expect to happen," he told Psychiatric News in a subsequent interview. In other words, clinicians should avoid prescribing more and more drugs simply to treat the side effects caused by other drugs.

In his plenary speech, Pollock urged psychiatrists early in their careers to become involved in geriatric research. "The positive side is that there is such a huge deficit of information that almost any [research] we do in a systematic fashion will have a huge impact," he said.

He cited a study he cowrote with Charles Reynolds, M.D., and others on the effectiveness of maintenance antidepressants in older patients as an example.

"The study had only 116 subjects," he noted, "and it was published in the New England Journal of Medicine."

Pollock concluded that in his term as the AAGP president he would "continue the advocacy for expanding the evidence base, practice networks, and funding for late-life research from NIMH and other federal agencies, so that more older adults are included in clinical trials."

Pollock's other priorities include advocating for mental health parity legislation and securing additional incentives, such as student loan repayment legislation, to encourage more young practitioners and researchers to enter the geriatric psychiatry specialty.

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