AAGP Position Statement: Formulary Choices and Restrictions
Adopted by the AAGP Board of Directors, September 1997
Position 1: Optimal quality of medical care for geriatric patients requires access to the safest and most efficacious drugs for treatment of psychiatric disorders and syndromes. Drug formularies of health care organizations and facilities must therefore include a range of psychotherapeutic drugs for each indication that (1) ensures availability of the safest and the most efficacious agents for all geriatric patients, and (2) permits choices consistent with the most appropriate medical care and the most tolerable and effective treatment for each individual patient. Closed or restricted formularies discriminate against geriatric patients when they limit access to the most appropriate, individualized treatment.
Rationale: Individuals in the later stages of life have biologic and psychologic characteristics distinct from those of younger persons. Aging and disease are associated with changes in pharmacokinetics and pharmacodynamics that can alter both the therapeutic and adverse effects of drugs in geriatric patients. Geriatric patients are more vulnerable to the adverse effects of drugs. Therefore, restricting the choice of psychotherapeutic drugs may expose older adults to a disproportionate risk of adverse effects. There is also evidence that medically ill elderly patients have greater differences in their responsiveness to treatment with different psychotherapeutic drugs. Limiting the choice of psychotropic drugs based on claims of comparable efficacy in the general adult population therefore discriminates against older adults.
Formulary limitations may result in:
- the use of medications that fail to deliver maximal therapeutic effect, resulting in prolonged suffering, decreased social, occupational, emotional and physical functioning, an increase in morbidity, increased risk of mortality, and a potential increase in costs to both the individual and the community;
- delays in the initiation of treatment when non-formulary requests are required and the medication can not be obtained in a timely manner;
- the use of medications that, when prescribed for geriatric patients, have a profile of frequent or potentially serious adverse effects; and,
- changes to alternate medications that may result in withdrawal syndromes, relapse or other undesirable effects.
Position 2: Formulary choices should not be driven primarily be claims of comparable efficacy and lower product cost. Determinations of cost efficiency for the purpose of drug formulary decisions must emphasize considerations of safety and tolerability, as well as therapeutic efficacy and treatment effectiveness, and other factors that affect treatment compliance and outcomes in geriatric patients.
Rationale: Although different psychotherapeutic drugs may be similar in therapeutic efficacy, they often differ significantly in their side effect profiles. This has been demonstrated among drugs classified as antidepressants, anxiolytics, and antipsychotics. Compared to younger person, older adults have increased vulnerability tot he adverse side effects of these drugs, and the risks are even greater in those individuals with medical comorbidity and/or disability. Use of psychotherapeutic medications known to have a higher incidence of undesirable side effects in frail elderly patients may result in increased health care costs. The costs incurred from adverse drug effects in older adults commonly include the expense of treating medical complications (e.g. orthostatic hypotension, hyponatremia, urinary retention, adynamic ileus, and extrapyramidal signs and cardiac conduction and rhythm disturbances); psychiatric complications (e.g. delirium and depression); functional decline (e.g. diminished alertness, communication or swallowing dysfunction, bladder or bowel incontinence, gait disturbance); associated injuries and other adverse events (e.g. aspiration, falls, lacerations, and hip fractures) that may require emergency room visits or acute hospitalization. Furthermore, undesirable drug side effects may be more difficult for geriatric patients to tolerate, especially those patients with medical comorbidity and disability. Patients who experience distressing side effects are less likely to comply with prescribed treatment, and may have poor treatment outcomes, with prolonged illness and disability leading to increased health care costs. Therefore, determinations of cost efficiency must include consideration of safety and tolerability for older adults, in addition to treatment effectiveness and product cost. Drug formulary decisions that do not reflect safety and tolerability factors in geriatric patients are likely to diminish cost efficiency as well as quality of care and patientsí quality of life.