Therapeutic Drug Substitution Raises Consumer Concerns

Published January 1, 2009

Patients across the nation are concerned medical professionals may be engaging in a process known as “therapeutic substitution” of their medications, according to a study conducted by the National Consumers League.

“Therapeutic substitution” is the term for a pharmacist or doctor switching medications, straying from the original prescription and instead dispensing a chemically different drug that treats the same condition. It can happen without the knowledge of the patient or even the doctor who originally prescribed the medication.

Patients Often Not Consulted

The National Consumers League (NCL) study, which focused on patients’ opinions on therapeutic substitution, found most consumers don’t understand why therapeutic substitution is done, but they believe it happens frequently and do not react favorably to its practice.

“Nobody was really asking patients if this was acceptable to them,” said Sally Greenberg, NCL executive director. “We’re all about patient education and empowerment, and we wanted to get a feeling for it. There needs to be transparency involved. If a pharmacy or an insurance agency is going to make that switch, they really should let patients know.”

Greenberg said therapeutic substitution is most prevalent in the treatment of epilepsy, depression, and high cholesterol.

Potential Benefits

Therapeutic substitution isn’t bad in itself, explained Roueen Rafeyan, a psychiatrist and assistant professor of psychiatry at Rush University in Chicago. “Sometimes an alternative prescription is less expensive and equally effective,” he said, “which is a big plus for a patient with no health insurance or a high premium.”

A generic drug or a cheaper drug treating the same condition is probably better than no medication at all, Rafeyan noted.

Julie Urmie, a doctor and assistant professor of pharmacy at the University of Iowa, said such substitutions can be of great benefit to patients, “but only if the patients and their doctors are informed and agree.”

“This thing has to be done properly,” Urmie said.

Need to Know

Doctors and patients need to know about therapeutic substitution for several reasons, Rafeyan explained.

“Substituted medications can have different side effects than the original drug, they can mix differently with other medications a patient may be taking, and they can be less effective,” Rafeyan said. Also, substituted medications “might be a bad idea if the current treatment is working optimally.”

Urmie said doctors and patients need to know about substitutions so they can deal with the possible problems. “Patients should be monitored for any possible side effects or decreased effectiveness after switching medications,” she said.

Although some states have laws preventing therapeutic substitution without the doctor’s and patient’s permission, some in the medical community think more such laws should be created.

“At minimum, laws should be put into place to ensure therapeutic substitution doesn’t happen without the permission of both the doctor and the patient,” said Debbie Goss, president and CEO of the Epilepsy Foundation of Greater Chicago.

Pressure on Doctors

In September, the New York Medical Society released a therapeutic substitution study that found 90 percent of doctors felt pressured by insurance companies to alter the treatment of patients even if the doctor thought another method was better. They suggested more should be done to ensure patients receive the treatment their doctors think best suits their medical situation.

Moe Auster, a spokesman for the New York Medical Society, said insurers are a big contributor to the press for therapeutic substitution, and lawmakers are becoming more aware of this.

“I think there’s a growing recognition of the problem that health plans are economic behemoths able to dictate terms to the doctors and the patients,” Auster said.

Patient, Doctor Education

One of the best ways to prevent inappropriate therapeutic substitution is to educate patients, said Urmie. If a patient notices he has received a different medication than his prescription originally called for, he should ask questions and make sure his prescribing doctor approved it and can monitor his reaction to a new drug, she said.

Rafeyan said doctors also must work to keep therapeutic substitution under their control. They can do this, he said, by trying to prescribe medications that are both effective and less expensive.

“We all need to practice fiscal responsibility,” Rafeyan said. “If I can give the patient a medicine that is available more cheaply, but which has the same benefits, I should consider doing so.”

Doctors also can prevent inappropriate therapeutic substitution by being aware of their state’s laws regarding the practice, as some states have laws preventing pharmacists from substituting medications if doctors specify no change should be made to the original prescription.

Jillian Melchior ([email protected]) writes from Michigan.

For more information …

“Consumers’ Views on Therapeutic Substitution”:

“Insurance Carrier Rules Survey Results,” New York Medical Society: