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Posted 11 October 2013 | By Alexander Gaffney, RAC,
At a fundamental level, the regulation of healthcare products is about trust.
Every time a drug, device, biologic or other product is prescribed by a doctor, dispensed by a pharmacist or taken by a patient, they do so with the basic understanding that a product is more likely than not to help alleviate symptoms or suffering.
While this doesn't seem like much, it's a far cry from the days of old when the trust one had in a product was based on faith or its marketing. Now, however, much of the same is based on the concept of "substantial evidence"-that is, preclinical data and clinical trials data substantiating a product's safety and efficacy, as well as evidence of its ability to be manufactured to quality standards.
But in the US, not every product taken for health reasons is subject to this paradigm, and in at least one instance the lack of supporting evidence has led to a collapse of trust in the broader category.
The product classification to which we are referring is dietary supplements. Under federal law, the US Food and Drug Administration (FDA) regulates these products not as drugs, but as food products thanks to the 1994 Dietary Supplement and Health Education Act (DSHEA).
As a result, these products don't need to go through the same regulatory reviews that their pharmaceutical counterparts do, and their sponsors need not submit safety, efficacy or quality data in support of applications so long as their ingredients are known to be (or shown to be in a new dietary ingredient application) generally regarded as safe (GRAS).
Whether or not a product is effective, however, is not established, as it is not intended to treat specific diseases or conditions-just nutritional deficiencies.
But even then, FDA's capacity to regulate dietary supplements is fairly limited. Some manufacturers introduce prescription drug products to their products without telling FDA; others manufacture their products to improper specifications; still others make borderline (if not outright) disingenuous claims.
And all that has eroded the confidence of one healthcare provider, the Children's Hospital of Philadelphia. On 8 October 2013, the hospital released a statement saying that it could ban most dietary supplements from its formulary of approved medications.
"[The] FDA does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness," the hospital wrote in a statement. The move would, it said, make it the first hospital in the country to actively discourage patients from using dietary supplements "as a matter of policy."
Calling them "essentially unregulated," a hospital official said they could not in good conscience prescribe them without knowing more about their adverse events, drug-drug interactions (DDIs) and proper dosing information.
"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," said Sarah Erush, pharmacy clinical manager and a member of the hospital's Therapeutic Standards Committee.
The hospital conceded that "certain medical conditions" might require the use of supplements such as vitamins or other nutrients, and said it would deal with these patients as the exception to its new rule. Those patients and others insisting on receiving supplements will be required to sign a liability waiver, they said.
In addition, all supplements left in the formulary will need to "follow similar guidelines as for FDA-approved medications," it explained. Specifically, the product will need to have adequate safety and efficacy information, as well as information about its quality.
Ultimately, CHOP may be an outlier. After all, the supplement regulations have been in place for decades, and little has been done to change them since then. But given the hospital's very public rebuke of the industry at large, we're left to wonder if others might follow in its footsteps. It is, as we said before, all a matter of trust.
Tags: Dietary Supplement, trust, Formulary, Latest News, regulation
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