Common Pharmaceutical Labeling Issues

With the looming threat of litigation, counterfeit drugs lost shipments, and expiring products; labels continue to play a critical role in the pharmaceutical industry. The more companies strive to follow ever-changing compliance regulations, the more important it becomes to manage labels effectively. Incorrectly handled labels can result in failed compliance, significant fines, or worse.

Challenges in Pharmaceutical Product Labeling

The biggest challenge for healthcare stakeholders is to make sure that consumers take their medicines as prescribed by doctors. Improper label comprehension and non-adherence can result in a higher incidence of serious issues like heart attacks, strokes, diabetes, and cancer. Mislabelling in the pharmaceutical industry also results in a waste of money in terms of unnecessary medical bills, emergency room visits, hospitalization, etc. 

According to EMA, 80 percent of patients fail to understand drug labels due to complex language or a lack of instruction as to how and when they should be administered. To help solve this issue, the FDA has issued revised draft Guidance on Consumer Medication Information Labels. A number of other countries including Australia, Canada, and the United Kingdom have already revised their rules based on ICH guidelines. 

Today’s healthcare providers are too busy taking care of patients to ensure that medications are properly labeled. They might even hand over pill bottles without bothering to confirm their content’s accuracy or clarity. In such cases, pharmacists can only do what they think is best. Not only does this affect medication compliance but also opens doors for abuse. Inadequate labeling may give rise to poor health outcomes and even life-threatening situations if directions like timing (day vs night), dosage frequency (number of tablets per day), or formulation mix-ups (oral vs IV) occur among patients.

Moreover, there is no uniform way to communicate patient-focused educational materials in real-time. Pharmaceutical companies face increased risk of penalties, fines, and possible regulatory actions related to inappropriate or inadequate drug labeling. Labels help drive decision-making processes for both caregivers & patients which directly impacts adherence rates & clinical outcomes. 

Product life cycle management that encompasses point of sale, supply chain, physician offices, hospitals, and pharmacies remains critical for ensuring patients get appropriate information in real-time. 

Pharmaceutical Issues

• Compliance Issues

Ensuring compliance with regulations is essential for all companies in any industry, but for those in the pharmaceutical industry, it’s a matter of life and death. There are hundreds of regulations that need to be followed when working with drugs, from marketing materials to label requirements and storage standards.

• Need to update Labels

Often, manufacturers need to update their labels for a variety of reasons. This can be a change in ingredients or how the medicine is to be administered. Whatever the case, each company needs to have its own set of processes to go through when updating labeling for new or existing drugs.

• Non-Compliance

Risks directly associated with compliance vary depending on a number of factors, but often include manufacturing delays, product recalls, and even FDA investigations. Companies need to continuously work with legal teams to ensure they’re in compliance at all times or face serious consequences. These companies also need to comply with pharmaceutical regulations in other regions throughout their supply chain.

• Standard Labeling

The labels that pharmaceutical companies are required to put on their products can vary greatly from one region to another. The US is one of the most stringent regions when it comes to standards for drug labeling, and nearly all of a product’s label needs to be in English. Other countries, like Japan and China, for example, can have entirely different labeling requirements. 

• Maintaining safety standards

It’s no secret that pharmaceutical labeling can be a complicated process. By working with a partner that specializes in these services though, you can ensure that your company remains compliant at all times. You can also avoid risks and save time and money by outsourcing labeling requirements to an experienced service provider. 

• Common Packaging Concerns with Pharmaceuticals

The pharmaceutical industry involves a wide range of products, from over-the-counter painkillers to prescription and over-the-counter medicines. Packaging for these products is also quite varied. This means that manufacturers need to understand their options when it comes to packaging as well as meet regional standards for labeling requirements for each region where they sell their products. 

Key Takeaways

Label management means different things to people in different industries. The FDA offers one definition of label management: the art and science of ensuring that drug product labeling remains relevant, accessible, and compliant to provide patients with safe and effective use information. In practice, however, it’s more often about resolving concerns about safety or adverse events than anything else. How do you manage your labels?