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October 9, 2013
PHILADELPHIAThe Children's Hospital of Philadelphia (CHOP) has announced it is removing most dietary supplements from it Formulary, a list of medications approved for use, due to regulatory, safety and efficacy concerns. The hospital said FDA cannot guarantee the safety and efficacy of supplements, because the agency does not routinely review dietary supplement manufacturing. This is the first such official policy by a U.S. hospital.
In a scathing line of criticism often refuted by the supplement industry as inaccurate, Sarah Erush, PharmD, pharmacy clinical manager and a member of the hospital's Therapeutic Standards Committee, argued, "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. Administering these medicationsparticularly 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."
The hospital said it has made a list of very limited vitamins or nutrients that may be required in certain medical conditions, noting these listed supplements approved for use are proven to be safe and of high quality. In order to be included in CHOP's formulary, all products must follow similar guidelines as for FDA-approved medications. Among the requirements, a supplement must have adequate safety and efficacy data to support use for the requested indication, including data in pediatric patients, and there must be an available formulation with adequate quality assurance data.
In accordance with the new policy, parents or guardians will be asked upon admission whether the patient is taking any medication or supplements, and 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 contamination, mislabeling, interactions with medications, or potential unforeseen adverse effects. In order to use supplements not in the official CHOP Formulary, parent or guardians will required to sign a waiver 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."
Paul Offit, MD, Chair of the hospital's Therapeutic Standards Committee, said 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."
Offit is a longtime critic of alternative medicine and dietary supplements. Widespread media coverage of his book released earlier this year "Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine"which made several claims that the supplement industry is not regulated, drew a quick response from the American Herbal Products Association (AHPA). Michael McGuffin, president of AHPA, wrote a letter to the USA Today, detailing numerous regulations requiring supplement manufacturers' compliance and urging the news outlet to perform additional due diligence on future supplement-related stories and print more accurate and unbiased articles.
The Natural Products Association (NPA) responded to the CHOP news by sending a letter to Erush, expressing disappointment in the hospital's stance that dietary supplements are unregulated. "This inaccurate understanding of the supplement industry is doing a disservice to both the hospital and its patients," wrote John Shaw, executive director and CEO, and Cara Welch, Ph.D., senior VP of scientific and regulatory affairs for NPA.
In their letter, they explained to Erush that dietary supplements are regulated as a unique category of food by FDA, and under regulations specific to deitary supplements, manufacturers must:
Adhere to strict current Good Manufacturing Practices (cGMP), requiring identity, potency, and contaminant testing on all ingredients, with additional testing requirements for finished products.
Only use ingredients that are federally sanctioned.
Not add pharmaceutical ingredients, including steroids, to dietary supplements, as this effectively turns the product into an unapproved new drug.
Report to the FDA any information regarding serious adverse events that might be associated with the use of their product. Manufacturers must keep records of all adverse events, including non-serious events, for six years.
Register with the government, and give advance notification of raw materials imports.
"The FDA has been regularly inspecting facilities regarding their GMP compliance, and the rate of these inspections has almost doubled each year for the past few years," Shaw and Welch added. "Based on the regulations listed above and the number of inspections performed, we would dispute the hospitals impression that dietary supplements are 'essentially unregulated' and arent 'routinely reviewed' by the FDA." They further noted NPA agrees patients should consult with their healthcare providers about any supplement use, the trade group opposes the barriers CHOP has placed in front of patient use of supplements. They also stated CHOP's decision on supplements came as no surprise given Offit's involvement in thehospital. "Weve been responding to Dr. Offits misguided viewpoint of the dietary supplement industry for the past few months now," they wrote. Still, NPA itself as a resource for Erush and CHOP so that the hospital and patietns are receiving the most reliable information on dietary supplementation.
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