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The Risks of Poor Pharmaceutical Labeling and Packaging

August 6, 2019

Effective product labeling is essential regardless of your industry or the item being marketed. But for those operating in the pharmaceutical sphere, superior label design isn't merely a means to showcase your product on the shelf; it's also required to keep consumers safe and healthy. Certain types of packaging, like tamper evident packaging, will also be used for these purposes.

When pharmaceuticals aren't packaged and labeled with best practices and industry regulations in mind, manufacturers and distributors end up taking a huge risk. If you fail to determine the best types of pharmaceutical labels for your product and ensure all packaging and labeling aligns with FDA standards, your inattention to detail could come with colossal costs. Here are just a few of the potential dangers you might face if you do not pursue product labeling and packaging that adheres to regulations.

Compromised Consumer Safety

One of the biggest risks you'll take with subpar product labeling and packaging is the potential for consumer harm. According to the World Alliance for Patient Safety, an estimated 7,000 people die every year due to inappropriately dispensed drugs. If a product's packaging and labeling fails to adequately provide essential information to pharmacists and end consumers, it's possible that this drug could cause harm to patients. Unintended side effects or even long-term health concerns could easily come into play. Unless your business feels comfortable with the idea of playing with patient health and well-being, you'll need to carefully consider the necessary regulations for packaging and labeling before signing off on the final design. One small error or omission could make all the difference.

Non-Compliance Costs

Whether or not harm comes to consumers who use your product, you may also have to contend with the costs associated with poor packaging and labeling decisions. For failing to comply with FDA regulations, your business could be subject to fines, including those associated with a potential product recall. If it can be determined that your drug is dangerous, ineffective, or does not otherwise comply with FDA packaging and labeling guidelines, you will be responsible for paying any fees that come as a result. What's more, you'll have to spend additional time and money correcting these errors if you want your drug to continue to be stocked on store shelves. It's also possible that your organization could face litigation as a result of any harm that comes to a consumer due to improper labeling. Considering the substantial costs that accompany recalls, lawsuits, and error correction, it's essential that you ensure all regulations are met before your product ever becomes commercially available.

Reputational Damage

Another risk you might take with improper pharmaceutical product labeling is the damage it might do to your brand. While customer loyalty may not be what it once was, most consumers tend to be loyal to a medication -- until the medication fails to meet their standards. If your brand's reputation has somehow been tarnished due to a recall or negative media coverage, you'll have a hard time earning back consumer trust. Even when a manufacturer does everything right and a medication becomes tainted in other ways (like when containers of Tylenol in Chicago pharmacies were poisoned with cyanide in the 1980s), a brand has to work overtime in order to rise above the fallout. While many of those operating in the pharmaceutical industry do have a fair amount of resources at their disposal, you may have a difficult time making a comeback after extensive damage has been done to your brand's reputation. Rather than taking that chance, you'll want to ensure that your labeling protects both customers and your company from harm.

Clearly, the importance of clear and compliant labeling cannot be overstated. To learn more about how we can improve your pharmaceutical packaging and labeling to mitigate these risks, please contact us today.

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