Take a Stake in Your Prescriptions - Part 2

Epilepsy News From: Wednesday, August 26, 2015

One of the most basic questions to ask, whether you are picking up a prescribed drug or purchasing an over-the-counter supplement is, “What is the quality of this product?” While it seems like a rather straight forward question, this is a bit more complex than it seems.

Over the past century, great strides have been made by regulators in the U.S. and globally to ensure the prescription medications we receive actually do what the manufacturers claim they will do, as well as provide the public with verification that the drug products contain what the label states and are of accepted purity and uniformity. Unfortunately, this very strict oversight does not always apply to products sold as supplements.

During the past several years, there has been increased interest by both patients and the medical community in the use of specific components of marijuana. While it is clear that cannabis contains a variety of molecules with distinct actions in the brain that might work to treat seizures, the question as to which specific components (or combination of components) and at what dose for specific seizure types, remains an open question. As with any prescription medication, these questions require clinical testing with a high quality, consistent product.

FDA Cannabidiol Warning

This past February, the Food and Drug Administration (FDA) issued warning letters to six different companies that were marketing a variety of products supposedly containing cannabidiol (CBD).

The FDA letters highlighted several very important issues.

  • First, these firms were making claims (both on their website and via social media) that these products could be used to treat a variety of both human and animal diseases, ranging from cancer, dementia, asthma, heart disease, and even Ebola! The FDA notes that NONE of these claims had been evaluated and verified. It is important to remember that the FDA approves drugs for specific diseases or disorders only after the sponsor of that product has submitted rigorous scientific evidence of both efficacy and patient safety. 
  • In addition, several of the products that claimed to contain CBD actually had none at all or only trace amounts.

What then are patients to do?

Ask questions.

If a particular product for sale claims to treat a condition, ask if this has been evaluated by the FDA. There is no such thing, however, as an “approved supplement.”

As for being assured that what you are buying contains what the product label states, look for a “USP” designation on the package. The USP, or U.S. Pharmacopeial Convention, is an independent verification service that has been instrumental in establishing federally recognized standards since 1820. These standards are critical for determining product and ingredient identity, strength, quality, and purity. These standards, in large part, help prevent the introduction of contaminants or other unwanted ingredients in the products we buy. Indeed, while today most people think of USP as the organization that sets standards for prescription medicines, the USP has been involved for almost two centuries with the standardization of botanicals and minerals used as medicinals or nutritional supplements.

Fortunately, several pharmaceutical companies are going through the process of testing and evaluating CBD. Hopefully, before long, we will begin to get some answers. Until then, ask questions!

Authored by

Barry Gidal PharmD

Reviewed Date

Wednesday, August 26, 2015

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