Children’s hospital removes supplements from formulary

The Children’s Hospital of Philadelphia (CHOP) recently became the first U.S. hospital to disallow most dietary supplements in its formulary.

The hospital said it made the decision because the FDA does not routinely review the manufacturing of dietary supplements. “Because vitamins and dietary supplements are essentially unregulated, there is no sound information about adverse side effects, drug interactions, or even standard dosing for the vast majority of them,” said Sarah Erush, PharmD, BCPS, pharmacy clinical manager and a member of the hospital’s Therapeutic Standards Committee.

“Administering these medications – particularly to children with serious health complications – is unethical when the risks are unknown, and when there are alternative treatments that have been proven in clinical trials to be safe and effective,” Erush added.

However, because there are certain medical conditions that may require supplementation of vitamins or nutrients, the hospital has determined “a very limited and carefully selected list of acceptable products that are proven to be of high quality and safe,” according to a CHOP statement.

With CHOP’s new policy, parents or guardians will be asked upon admission whether the patient is taking any medication or supplements. If so, the attending nurse or physician will review the hospital’s policy discouraging the use of supplements and inform parents or guardians of the potential risks associated with the supplement such as contamination, mislabeling, interactions with medications, or potential unforeseen adverse effects.

If the parent or guardian insists still wants to give their child a dietary supplement that is not on the CHOP formulary, they must sign a hospital waiver stating that they agree to be responsible for providing the product.

“Educating families is one of the most important reasons for implementing this new policy. Most people assume that supplements they buy at the health food store or online are strictly monitored or are safe because they are ‘all natural’. But supplements are only subject to FDA review if an adverse event is reported, so there are many for which we have no reliable data,” Erush said.