The Children’s Hospital of Philadelphia, referred to as CHOP, has just become the first American hospital to set guidelines for the use of dietary supplements. We know many adults take supplements, but it’s uncertain how many children are being given dietary supplements by their parents. The National Institutes of Health (NIH) estimates “nearly 12 percent of children (about 1 in 9) in the United States are using some form of complementary health product or practice, such as dietary or herbal supplements.”
The doctors and health care practitioners at CHOP found that many parents do not consider dietary supplements to be ‘drugs’ so they fail to report what their children are taking. In many cases the ingredients of these supplements can cause an adverse reaction when combined with certain prescribed medications.
Dietary supplements are unregulated; the F.D.A. can suggest that manufacturers follow “good manufacturing practice” (GMP) conditions but they cannot enforce that recommendation. Ingredients that may be unsafe for adults can be dangerous when taken by children. Earlier this year a Canadian group of scientists studied herbal supplements like St. Johns’ Wort, Echinacea and other popular products. They found that 1/3 of the supplements tested had no trace of the plant ingredient advertised and some contained ingredients that could be potentially unsafe.
According to the New York Times op-ed, Skip The Supplements, by Paul A Offit, chief of infectious disease, and Sarah Erush, clinical manger in pharmacy department, at the Children’s Hospital of Philadelphia, the hospital is asking more questions of parents. CHOP has established guidelines for administering dietary supplements, requiring “that the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (GMP) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.”
“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, 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.”
The hospital is contacting dietary supplement manufacturers, in a good faith effort to help parents who feel strongly about giving supplements to their children. But the manufacturers are not showing the same level of commitment to consumer safety. Offit and Erush report that roughly 90% of companies contacted for verification fail to respond. Others have refused to provide the required papers that could authenticate their products. Some lied, claiming they were in compliance with the GMP standards, though the FDA had identified them as being in violation. And, some actually admitted that their products did not meet standards.
The hospital has to take a delicate position in this matter. Parents have the right to give their children supplements. And, the hospital has to do its best to treat illness and prevent unnecessary complications. This new plan provides safeguards for the hospital and ultimately, for patients. The hospital requires parents who insist on continuing dietary supplements to sign a waiver stating that they understand the supplement may be dangerous. The waiver states, “Use of an agent for which there are no reliable data on toxicity and drug interactions, makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”
CHOP is the first hospital in the nation to set polices for use of drug supplements. Hopefully this will set a precedent and encourage other medical facilities to adopt similar standards. Until the FDA has the legal authority to regulate the manufacturing process for herbal and dietary supplements it is up to other agencies and individuals to figure out what is safe and what is not. The best course of action for individuals may be to simply eat a more balanced diet and avoid supplements all together. Given the negative information coming to light over the past several years, this writer has eliminated nearly all supplement intake, fearing either a harmful side-effect or just being taken advantage of by an unscrupulous manufacturer, or both.
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