Although thousands of scientific papers evaluate and compare new and established drugs each year, providing evidence to help doctors prescribe safe and effective doses, almost no studies focus on when or how to stop these medications, even late in life.
In a recent issue of the Archives of Internal Medicine, four University of Chicago physicians propose the first general framework for withholding or discontinuing medications, adding life expectancy, goals of care, treatment targets and time until benefit to the usual equation of drug plusses and minuses.
"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 where the medications were started," said geriatrician Holly Holmes, M.D., instructor of medicine at the University of Chicago and lead author of the study.
"We wanted to provide a road map," she said, "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."
The impetus for the guidelines came from some misguided advice. The authors care for patients at a nursing home. The pharmacy that supplies the nursing home monitors physician-prescribing practices and offers suggestions. After one review, the pharmacy sent a fax pointing out that, according to accepted guidelines, two patients at the nursing home ought to be taking a statin -- a cholesterol-lowering drug that can, over time, reduce the risk of heart attack.
"One of those patients was more than 100 years old, quite frail, with advanced cancer and multiple other medical problems," Holmes said. "The other one was dead. It made us wonder whether something wasn't missing from those guidelines."
There are well-tested algorithms for prescribing drugs and avoiding inappropriate medications in the elderly, but as the authors combed through them with their frail older patients in mind they noticed that none considered when medications that might have previously been appropriate should be discontinued.
"Most drug studies tell you how to treat the chart, how to treat the numbers," said co-author Caleb Alexander, M.D., assistant professor of medicine and a member of the Center for Clinical Medical Ethics at the University of Chicago, "but they don't always help you treat the patient. We set out to fill some of those gaps."
One of those gaps was prognosis. Drugs with long-term benefits, such as those for high blood pressure or elevated cholesterol, provide no immediate relief, are seldom entirely without side effects and can be quite expensive, especially for the elderly who often take many different drugs. Such medications may be appropriate for a 65-year old with mild heart disease but at some point in the next 25 years patient and physician may have to overcome what the authors refer to as "clinical inertia" and rethink that initial decision.
The authors suggest four criteria for doctors considering adding -- or subtracting -- a drug from an elderly patient's therapeutic arsenal. First is to calculate the patient's life expectancy, based on actuarial charts and modified by the patient's current health status and history. Second is to weigh the time to benefit. Pain relief may be immediate but some preventive medications, such as a statin, may not provide any benefit for years. Third is to work with the patient and family to determine the goals of care, a shifting balance of prevention, treatment and palliation. Fourth is to define treatment targets, such as relief of specific symptoms, that agree with the goals of care.
Even when it makes clinical sense to take patients off of a medicine, the authors note, it can be emotionally challenging. Sixty-five percent of all office visits end with the granting of a prescription. "It's often the closing moment of a caring interaction," Holmes said. "It seals the deal. It's not the same when you have to take it away."
Nonetheless, the authors say, it is necessary. "Medication discontinuation, when done right, can decrease costs, simplify prescription regimens, decrease adverse drug events and focus therapy for maximum benefit," Alexander said.
"Evidence-based medicine has changed the way physicians practice, but it seems to have had tunnel vision when it comes to withdrawing drugs," Holmes said. "The discontinuation of medications is a neglected science. It's not an area that the pharmaceutical companies are looking to fund."