A product’s Prescribing Information (PI) is a critical document for conveying a prescription brand’s efficacy, safety, and use. Yet, the creation of PIs often falls into a gap that neither internal art departments nor agencies of record can properly specialize in.
Franklyn Healthcom: We’re PI Specialists
We get you what you need—fast—and correct the first time. In fact, we have a 96% first-time approval rate for submitting to regulatory.
During Franklyn Healthcom’s years of expertise in helping pharmaceutical and life sciences companies successfully create and update PIs, we have seen 5 key errors that should and can be fixed.
1. Using automated proofreading or human proofreading
Automated proofreading is the default that many agencies and typesetters use when producing PIs. Automation is great for catching easily missed, minute details. But it takes a human eye to catch formatting inconsistencies, spacing errors, bad breaks, and table errors that can end up in your “final” PI.
Using one option without the other guarantees a certain percentage of errors. Make sure your PIs combine the competencies of technology and the human touch.
2. Choosing fit over size
Many regulations dictate PI formatting. Less experienced agencies and typesetters might reduce text size or compress text in order to fit a spec size. This can easily result in nonadherence to FDA regulations.
Make sure you are working with someone who understands the regulations that govern PIs and makes a commitment to size your PIs within those regulations—even if a printer or brand manager demands otherwise.
3. Treating PIs like branded collateral
If multiple agencies are producing PIs for your company, you risk confusion, errors, and FDA noncompliance. While your brand agencies may offer creative genius, they may not employ an in-house PI expert to oversee PI files. It’s best to have one expert supplier to produce PIs across all the brands in your organization. But at a minimum, make sure there is at least a PI expert within the agencies or printers that you currently work with. An agency or typesetter that is not completely versed in FDA requirements leaves you vulnerable to filing a PI that is not compliant.
4. Not having a master PI archive
It’s tempting to rely on your agencies or printers to manage your PI files. But what if they are not on top of the latest PI newsflash?
Consider this scenario: A printer has your latest PI just in from labeling, but the agency is not aware. This could easily lead to producing reflow sizes based on a now-outdated PI. In another scenario, the printer may have a PI that was sized from the original label before edits were made. Having a centralized hub for managing your PI files can greatly reduce the risk of these kinds of errors.
5. Not adhering to strict quality control practices
A PI is not a typical typesetting document. Certain phrases must be italicized. Certain words cannot be broken. Certain sections must be a specific size.
Best practices dictate that quality control and adherence to regulations must be ingrained into the production process—from Step 1 through completion—and not just in the final stages. Make sure your PI producers are experienced in all phases of the PI journey and that they use quality control measures to ensure a correct and compliant file.
To learn more about how best practice companies produce consistently flawless PIs, please contact:
Eric Knapp, Account Director, PI & Packaging, 25+ years of pharma and healthcare experience, with more than 20 years of exclusive focus on PI development and production, at eric.knapp@franklynhc.com.
PI Mistakes You Need to Fix Now
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