Framework developed for "unprescribing" drugs

Washington -- Physicians always can turn to research papers, guidelines and pharmaceutical companies for help in determining who should be prescribed a drug, but they often are on their own when deciding whether it's time to call a halt.

Four University of Chicago physicians decided to address this gap and have developed a framework to help with the decision-making, particularly for elderly patients, about when a medication is no longer necessary.

They propose adding factors such as life expectancy, goals of care, treatment targets and the time until a benefit is expected to the usual equation of risks versus benefits. Their work appears in the March 27 Archives of Internal Medicine.

Prescribing for elderly patients long has been a cause for concern. Because they often are being treated for several chronic diseases, such patients might be at risk for deleterious drug-drug interactions. But ignoring a treatable condition is not an option.

Treatment guidelines might add to the conundrum. As physicians move into the era of evidence-based medicine, these directives might be dictating which drug should be prescribed for which patients regardless of whether that individual might be better served by not taking it.

"Our framework was designed to help patients and physicians decide when to stop taking even safe and effective drugs in situations that are often radically different from those that existed when the medications were started," said Holly Holmes, MD, instructor of medicine at the University of Chicago and the study's lead author. "We wanted to provide a road map that would steer people away from the prescribing cascade that is common for patients late in life and guide them past the barriers that prevent removal of treatments that may no longer be effective."

That approach is attracting interest. "Attention now is on identifying the risk-benefit for individuals," said Ilene Zuckerman, PharmD, PhD, director of studies in medication appropriateness at the University of Maryland's Peter Lamy Center for Drug Therapy and Aging in Baltimore. But there are many different factors to balance, she added. "I think, on the research side, we are focusing more on 'optimal prescribing.' "

Expanding the framework

A presentation of the Chicago model at the annual meeting in February of the American Academy of Hospice and Palliative Medicine garnered much interest, Dr. Holmes said. "Doctors, nurses, social workers and others have been needing a framework in which to make these decisions."

The paradigm also can work for younger patients, she said. "This is the type of approach to medication use that could help all people."

For example, the expense of medications hits everyone and the elimination of those that are unnecessary could help reduce those costs, said Dr. Holmes.

There are other important reasons why a drug should be stopped, said Caleb Alexander, MD, an internist and assistant professor of medicine at the University of Chicago. He was a co-author on the study.

"Stopping a medicine may be the only way to know whether it's still needed," he said. "Many people get better in spite of the medications they are on rather than because of them."

Prioritization also might become more important as the number of prescriptions increases.

"The patient may be on 17 other medicines that all look important in isolation," Dr. Alexander said. "But we need to treat patients and consider the entirety of the patients' prescription regimen and not one medicine at a time."

He is amazed at how many patients fail to heed the "as needed" designation and instead take medicines constantly.

Drugs for arthritis, mild heartburn, constipation and headaches are examples of drugs that might be needed only occasionally.

Of course, the more complicated the prescribing instructions, the more time is needed by physicians to communicate with patients. Some medications absolutely must be taken for the long term, such as diabetes drugs, note the framework's authors.

Goal-setting also might pose a challenge, the researchers write. Patients and family members might have difficulty making decisions about complex clinical situations such as whether palliative care alone should be provided or if life-prolonging care is called for. Physicians might find it difficult to provide information needed to make those decisions -- especially regarding medication use among the elderly, a group not typically represented in clinical trials.

Nonetheless, the development of the framework constitutes important and needed work on the road to individualizing medication use, said Donna Fick, RN, PhD, associate professor of nursing at Pennsylvania State University and lead author of a 2003 study that updated the Beers Criteria used to determine which drugs might pose a particular risk for older patients.

But the nation's medical system might not be set up to carry out such a framework, she cautioned.

"It would be an ideal world if we could have this thoughtfulness and degree of information and communication of goal-setting with the patient and family," she said. The lack of time and even knowledge as to which medications a patient is taking could prove to be obstacles. "There might be another specialist prescribing something the primary care physician doesn't know about.

Plus, these conversations are difficult, she added. "They are thoughtful communications. They don't happen in a hallway."

But Dr. Holmes said she uses the framework everyday. "I frame a conversation with a patient with whether I think the medication is likely to be a benefit given the patient's overall clinical status, age, function and medication problems and discuss with them their goals of care and how the medications they are taking fit in with those goals and which should be continued or stopped."