One of the nation's largest and oldest children's hospitals is cracking down on parents who bring their kids herbs, extracts or other dietary supplements.
In what it describes as a break from other hospitals, the Children's Hospital of Philadelphia, or CHOP, last month removed most dietary supplements from its list of approved medicines, and established new policies for administering them.
Dr. Paul Offit, chief of infectious diseases at CHOP, tells The Salt the move comes after a "growing level of frustration" over the years. Offit, who chairs the board which approved the new policy, says supplements often aren't what they claim to be. The Food and Drug Administration, or FDA, treats them as food, not pharmaceuticals.
"The problem has been that we can't even get from most companies that certificate of analysis, that shows the product was independently tested and what's on the label is in the bottle," Offit says, pointing to a recent problems like in Hawaii, where a fat-burning supplement was linked to liver failure.
Under CHOP's old policy, dietary supplements were treated as home medications. If a family brought them in, an attending doctor or nurse was obliged to evaluate them as best they could and administer them along with hospital-sanctioned meds during the patient's admission. If the supplements ran out, the provider would order more through the hospital pharmacy. Now, families are entirely responsible – they have to obtain and administer the unapproved supplements themselves, notify a doctor when that happens, and sign a waiver form. The hospital is also distributing additional explainers to families.
Not so surprisingly, CHOP's move has drawn criticism from a leading dietary supplement trade group, the Natural Products Association, which described the decision as "unfortunate" and "misguided." In a letter to the hospital, NPA director John Shaw said that companies must adhere to strict manufacturing practices and that the FDA has been ramping up its inspections of them.
Dietary supplements are generally defined as vitamins, minerals, herbs and extracts that may come in tablets, capsules or powders. They're regulated as a unique category of food by the FDA.
While Offit's aim is to discourage families from using most supplements, the hospital isn't banning all of them. It's developing a list of about three dozen exceptions, which must be verified by the U.S. Pharmacopeial Convention and confirmed through the hospital's own lab work. Offit views the move as "finally trying to do something that the FDA should have done long ago."
CHOP's list of exceptions provides comfort to doctors like Daniel Monti, director of Thomas Jefferson University's Myrna Brind Center of Integrative Medicine. Monti doesn't think CHOP is being overly restrictive, "so much as safe for children." All hospitals have formularies with some restrictions, he explains, though CHOP is "being as conservative as you can get." In that regard, he hopes CHOP's policy doesn't "limit options for care" or potentially beneficial treatments.
A 2008 study of 109 children's hospitals found that hospitals rarely include herbs and supplements on its formulary. But less than half had any written policies, while seventy percent directed health professionals to store and administer as patients' home supply.
John Neely, a professor of pediatrics at Penn State's College of Medicine and director an integrative medicine program at the Milton S. Hershey Medical Center, wonders whether CHOP's stricter policy could backfire, leading families to hide important health information about supplement use from doctors.
"What I find is patients are acutely aware if physicians are really opposed to herbal medicines and supplements," Neely tells The Salt. "When I start to negatively ask patients about them, people just don't divulge, they are so afraid physicians will be angry with them."
Offit, with CHOP, stresses the intent is to improve dialogue with families, and have a better way to track everything patients are taking and how it's affecting them. "I think frankly for the first time we can understand the level of usage in our hospital," he says.