Scriptability In Pharmaceutical Name Approval

Posted June 12, 2017 by
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Awash with regulatory, legal, and naming restrictions, the naming of a pharmaceutical compound has no shortage of challenges. One of the more complex facets facing companies and their naming agency is the often-under-acknowledged aspect of scriptability.

Defined by the FDA as the “appearance of the name when scripted throughout the medication use system (e.g., prescribing, dispensing, administering)” the aspect of a pharmaceutical name’s scriptability is something that seems out-of-date in today’s rapidly digitizing healthcare space. Referred to as “e-prescribing” or “e-Rx,” a study done by Office of the National Coordinator for Health Information Technology showed that from 2008 to 2012 alone, the number of physicians “e-prescribing” climbed from 7% all the way to 48%.

Despite this dramatic trend towards a much more uniform state of prescribing medications, the FDA still places a tremendous amount of emphasis on the scripability of a new name submission. As such, pharmaceutical companies and their naming agencies will have to be aware of it as a restriction and incorporate a methodology that accounts for it as part of the naming and safety testing process.

Even if creating pharmaceutical name candidates that met the various other criteria was a simple task, something as subjective as scriptability would still present a unique challenge. In the simplest of terms, judging if two different pharmaceutical Brand names appear similar enough to warrant a reasonable chance of misprescription when it is written out in physical handwriting is difficult to say the least. The more obvious red flags like two names beginning and ending with the same letter or string of letters seems easy enough to avoid, but what about determining if two names have similar “upstroke letters” and “downstroke letters” in similar places in their structure? How dramatically could things like this change from handwriting to handwriting? Are there “tall man letters” or “short man letters” in similar places? The chances for confusion and ultimately name rejection because of these factors are extremely varied.

As Senior Vice President at brandsymbol, Doug Rand, reflects on his over two decades experience in pharmaceutical branding he says, “Scriptability is certainly one of the more common reasons for drug name rejection, and only through testing – preferably robust prescription simulation testing– and safety expert analysis can any reasonable level of certainty be achieved that new name will be able to pass FDA scrutiny when it comes to potential scriptability issues.”

Tags:

Branding | Healthcare | Pharmaceutical Naming | Regulatory | Safety

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