Medicationsafety, Policy, Allergies, Medication Safety

Medicationsafety, Policy

What\u2019s in Your Medicine May Surprise You \u2013 a Call for Greater Transparency About Inactive Ingredients

The ingredients listed on the bottle only tell half the story. Here's what you need to know.

9/16/2020 4:27:00 PM

The ingredients listed on the bottle only tell half the story. Here's what you need to know. medicationsafety

The ingredients listed on the bottle only tell half the story. Here's what you need to know.

. Manufacturers are now required to report disruptions in the manufacturing of an active pharmaceutical ingredient – the part of the medicine that produces the intended therapeutic benefit.But the CARES Act doesn't include excipients - the “inactive" ingredients that make up the bulk of a final medicine. It also doesn't include the materials needed to package and distribute medical products, such as vials and other containers, packaging, and labels. While the CARES Act improves the flow of information and may signal potential drug shortages, it is intended to support regulators (like the FDA) in their public health responsibilities. It does not increase transparency to consumers of medicines.

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As a trained pharmacist and researcher interested in uncovering risks to medicine quality, I believe patients and clinicians would benefit from having more information about all the ingredients in medicine. But for this to happen additional measures are needed to

for all components of a medicine, including excipients.Product labeling for ‘inactive’ ingredientsAs the so-called “inactive" ingredients in medicines, excipients are often mistaken as being free from potential harm. But the evidence suggests otherwise. Between 2015 to 2019, health-care professionals, patients, and manufacturers filed nearly

2,500 reports to the FDAabout an adverse reaction to an excipient.While excipients are listed on packaging or package insert for over-the-counter and prescription drugs, this information can be difficult to find. Furthermore, patients often switch from brand name to generic versions, or the pharmacist substitutes one manufacturer for another. While the active pharmaceutical ingredient remains the same, excipients may be different, and even seemingly slight differences can significantly impact patient safety. For example, a patient may be allergic to an excipient in the newly refilled medicine with a different manufacturer.

Excipients are critical materials and serve a broad variety of functions. They serve as fillers, help the body to absorb the medicine, and add flavor or color to drugs. In fact, some are often found in food products, such as lactose, peanut oil, and starch. In the United States, excipients are approved by the FDA as part of the review process for the finished medicine; they are considered by the regulatory agency as generally recognized as safe or “GRAS." However, a complete picture of their clinical effect remains unclear.


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