Posted 15 October 2014
By Alexander Gaffney, RAC
US drug regulators have long known that the physical attributes of a drug product can affect its safety and efficacy. Now the US Food and Drug Administration (FDA) wants to know exactly how a change in a drug's appearance affects patient adherence.
Since at least December 2013, FDA has been pushing generic drug companies to do more to take into account the size, shape and "other physical attributes" of their drug products.
In its guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules, the agency said companies will need to do more to ensure their products aren't just the same chemically, but also physically similar as well.
Take, for example, the size of a drug capsule. If the reference-listed drug is a small and easy-to-swallow capsule, but the generic drug is a large and cumbersome tablet, the end user may be unable to take the drug or even choke on it.
"[We] are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors," FDA wrote in its guidance. "We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates," FDA added.
The intended population for a drug—the very young, the very old or the very sick—might also impact what physical forms a drug product must take, FDA said. "Although not all patient factors can be addressed through pharmaceutical design and manufacture, the physical characteristics of a product can be," FDA explained.
FDA recommended other factors be considered as well, including film coatings, taste-enhancing excipients, and the smell, weight, surface area and shape of products.
Even the scoring of a drug tablet can be important, though FDA has said not so important as to merit delaying the entry of a generic product.
However, one prominent attribute didn't receive much attention in FDA's December 2013 guidance: color.
Historically, regulators haven't given all that much attention to the color of drugs, except perhaps when working to eliminate potential prescribing errors.
But now FDA says it's working to study the issue, saying that changes in drug color—especially when pharmacists substitute brand name drugs for their differently colored generic equivalents—could cause patient confusion and decrease drug regimen adherence.
Other changes in appearance, including in size and shape, can also have an impact.
"Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical appearances, leading to harmful clinical and public health consequences as well as increased health care costs from avoidable morbidity and mortality," FDA explained.
While that observation isn't necessarily new, FDA's deepening interest in it appears to be. The regulator says it plans to survey pharmacists and patients "about their perceptions about and experiences with generic drug product pill appearance change." The results of the survey will be used to "further [FDA's] understanding of the relationship between changes in pill appearance and non-adherence to prescribed therapeutic regimens," the agency wrote in a Federal Register notice.
FDA said it will ask pharmacists to describe how often they change suppliers for their generic drugs, what strategies they use to help patients transition between pills of different color/size/shape and how patients respond to changes in pill color and appearance.
Patients will also be polled. In one survey, FDA will focus on those older than 50 years of age with epilepsy, diabetes, hypertension, hyperlipidemia, depression, HIV or combinations of any of the six conditions. The second survey will draw from a database of commercially insured patients to find chronically ill patients who have experienced a change in pill appearance.
A comment period on the proposed survey is open for the next 60 days.
Federal Register Notice
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