Winter 2010

Tough Decisions About Medications
By Thomas R. Clark, RPh, MHS, CGP
Aging Well
Vol. 3 No. 1 P. 8

What do you do when a blood pressure medication also increases fall risk?

Medication use always involves consideration of the potential benefits vs. the potential risks or harm. This deliberation is especially important in older adults, even though the evidence base is notably lacking for this population. Older adults, especially those over the age of 75, are often excluded from clinical trials. Clinicians who lack training or expertise in older adult care frequently assume that the results of clinical trials can be extrapolated to elders and that the benefits and risks of medicines are similar for these individuals.

In fact, drug therapy decision making is more complex for older adults. One reason for this is the presence of multiple morbidities and risk factors. For instance, treating hypertension in older adults decreases the risk of cardiovascular events by approximately the same amount as in younger adults but it but increases the risk of serious fall injuries. So in an elder with hypertension and fall risk, is it better to treat the hypertension to reduce cardiovascular risk, or is it better to allow the elevated blood pressure to avoid medication-related adverse effects and the increased risk of fall injury?

One study posed this question to 123 community-dwelling individuals aged 70 and older with hypertension and fall risk. The goal was to determine what the patient would want in this situation. The startling conclusion is that study participants were divided evenly with respect to their treatment preferences, with one half placing greater importance on reducing the risk of cardiovascular events and one half placing greater importance on reducing the risk of fall injuries and side effects.

Another study explored the preferences of older adults with type 2 diabetes mellitus concerning treatment intensity. The benefits of intensive glucose control may take seven or more years to accrue, whereas medications for diabetes may have adverse effects and decrease quality of life. This study found that older patients’ preferences for intensity of diabetes treatment varied widely and were not closely associated with vulnerability. Therefore, it is critical to involve older adults in the decisions about the treatment of diabetes mellitus, irrespective of clinical status.

These studies teach that clinicians should not make assumptions about patient preferences but instead should discuss potential benefits and risks with patients. Elders’ treatment goals and values may not be consistent with what the clinician expects.

Clinical Practice Guidelines
Patient preferences, values, and goals may also differ from what is assumed in most clinical practice guidelines on which clinicians rely. These guidelines are usually focused on a single disease or condition and are intended to reduce adverse outcomes associated with that disease. Extending life for as long as possible is often assumed to be desirable, even if not explicitly stated in the guideline.

To the frail elder patient, outcomes related to quality of life and functional status may be more important than prolonging life to the maximum extent possible. Since some medications can impair functional status and reduce quality of life, discussions about these potential adverse outcomes are important. The patient may choose to forego medications that may not support particular goals and desired outcomes. It is important for the clinician to respect the decision of the patient and caregiver and tailor medication use to help achieve patient goals.

In many cases, clinical practice guidelines do not emphasize or address the importance of integrating patient preferences and values into decisions about drug therapy. For some clinicians, the decision to prescribe or recommend medications is triggered when a blood pressure or laboratory value exceeds that suggested in a guideline. In fact, these end points should trigger a discussion with the patient to understand patient goals and values so that appropriate decisions about initiating or withholding drug therapy can be made.

Hypertension is a good example. Clinical practice guidelines for hypertension focus on achieving target blood pressure goals to reduce cardiovascular events. We know some older adults will likely have other goals or priorities and may accept higher blood pressure in exchange for fewer medication-adverse effects or a lower risk of falls.

Pay for Performance
One recent trend in healthcare payment is the concept of value-based purchasing, or pay for performance. The idea is that healthcare organizations or health professionals should be paid in correspondence to outcomes achieved. Payment is increased when certain outcomes are achieved or decreased when certain outcomes are not achieved.

The criteria used to evaluate so-called quality care are generally derived from clinical practice guidelines. The usual approach is to aggregate all the patients of a certain physician, hospital, etc and then calculate the percentage of patients who achieve the selected outcomes.

Sticking with the hypertension example, a payer may determine what percentage of a physician’s patients with hypertension have blood pressures below a certain target goal. Payment for that physician may be impacted according to how that physician compares with peers on this measure.

Under this payment scheme, a physician who truly provides patient-centered care and treats patients according to their values and priorities could be financially penalized. The payer defines quality care according to whether the patient achieves predetermined disease-based outcome measures. What is good for the disease, however, is not always in the patient’s best interest. One consequence of this payment scheme, if not properly designed, is introducing perverse incentives for clinicians to advocate or provide treatments that are counter to patients’ desires and values.

Reevaluating Drug Therapy at the End of Life
The benefit vs. risk calculation for medication use may change as a person ages and the end of life approaches. One proposed model for appropriate prescribing for patients later in life includes consideration of a patient’s remaining life expectancy, the time to achieve benefit from the medication, and the goals of care and treatment targets related to the medication.

The authors of this model state that “regardless of standards of care, practice guidelines, and other clinical pathways, shared decision making among physicians, patients, and families about goals of care is important when deciding whether to stop, start, or continue therapy with a medicine for a patient late in life. As disease progresses and it is clearer that cure is not realistic, an individualized approach to a patient’s treatment may become increasingly palliative.”

Patients with advanced cancer often choose to enroll in hospice, which emphasizes palliative care, including the relief of pain and other symptoms as the end of life approaches. In this context, preventive medicines (eg, statins, antihypertensives) are often discontinued because the risks and adverse effects are considered to outweigh the potential benefit.

Advanced dementia is increasingly being recognized as a terminal illness. Although the time of death may be somewhat less predictable than with cancer, a palliative approach to care may often be more appropriate than aggressive interventions that can reduce quality of life and functional status. In this context, treatment options should be discussed with family members, and patient and family preferences should be considered in decisions to continue or withdraw medications.

— Thomas R. Clark, RPh, MHS, CGP, is the director of clinical affairs for the American Society of Consultant Pharmacists in Alexandria, Va.