October 8, 2013 — The Children’s Hospital of Philadelphia (CHOP) announced today that its Formulary — the list of medications approved for use — will no longer include most dietary supplements. The hospital said the action was being taken because the Food and Drug Administration (FDA) does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness. The move makes CHOP the first hospital in the United States to discourage patients from using these products without a doctor’s provision as a matter of policy.
Dietary supplements essentially unregulated, no sound information about adverse side effects
“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.”
Dietary supplements are defined as vitamins, minerals, herbs, botanicals, amino acids, enzymes and animal extracts meant to “supplement” the diet and are not intended to replace a healthy diet or to treat, diagnose, prevent, or cure diseases. Melatonin, Echinacea, chondroitin sulfate, glucosamine, CoEnzyme Q10, milk thistle, and probiotics are some of the most commonly used supplements.
The hospital’s updated policy acknowledges that there are certain medical conditions that may require supplementation of vitamins or nutrients. To that end, the hospital has determined a very limited and carefully selected list of acceptable products that are proven to be of high quality and safe.
Parents to be educated about new policy, must sign waiver to continue use of dietary supplements not in CHOP Formulary
Under the hospital’s updated 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. Potential risks include contamination, mislabeling, interactions with medications, or potential unforeseen adverse effects.
If, after receiving this information, a parent or guardian insists on continuing 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’,” said Erush. “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. We’d much rather treat children with what we know works than provide them with a substance that may at best do nothing, or at worst, cause harm.”
Products that meet regulatory guidelines may be included in CHOP Formulary
In order to be included in CHOP’s formulary, all products must follow similar guidelines as for FDA-approved medications. If able to meet these criteria, pharmacy will stock and dispense as a formulary medication, avoiding the need for a waiver:
- The product must have adequate safety and efficacy data to support use for the requested indication, including data in pediatric patients
- There must be an available formulation with adequate quality assurance data
“CHOP has long embraced its responsibility to advance patient safety as the cornerstone to improving children’s health.” said Paul Offit, MD, chair of the hospital’s Therapeutic Standards Committee. “Patients with chronic diseases use dietary supplements more frequently than the general population and are at greater risk for adverse events and interactions. Better monitoring and regulating the way we distribute these products is one more step we can take to make sure that we’re providing the best possible medical care for our children.”