By safety labels, we refer to the cartons, packaging materials, prescribing information, reference safety information or even the patient information leaflet or consumer information guide, which may contain relevant safety information. The associated safety text gets updated whenever there is any update to the safety profile of the product. The prescribers, pharmacists, nurses, care-givers, or even the patients may refer to these labels and hence it is essential these are updated at all times. In some countries there is a concept of Urgent Safety Restrictions, where the marketing authorization holder (MAH) is expected to address the label change in 24-48 hours,

Outdated product information

The prescriber may be unaware of the new adverse events, warnings, and contraindications. E.g., the medicine that was recommended for use during pregnancy is now contraindicated.

Incorrect Information

Due to oversight, incorrect information may get printed onto the product labels. Also, the important information may be missed to get included. Either scenarios can have an impact on the patient. E.g., gelatin capsule may unacceptable to a vegan patient, and hence it is essential to state this. One more example is the non-disclosure of the medicine ingredients, especially when the patient is allergic to certain ingredients.

Reasons

1. Lack of awareness: The manufacturing department is unaware of the labelling update and continues to print the old labels. The supply chain team may be clueless as the regulatory team has not communicated. The chain of events may lead to non-compliance.
2. Cost-Saving: The company has already printed the erstwhile artworks and labels in bulk and invested a lot of money in this procedure. The management is unwilling to discard the old labels due to budget constraints. This is perhaps one of the most typical reasons the Pharmacovigilance department may be unaware of this non-compliance. Other costs that may impact this, are those associated with the filing of regulatory variations.
3. Public health reasons: When the product administration is a priority, e.g., vaccine administration during the pandemic, when the reference safety information gets updated but the prescribers are unaware.

Potential Impact

Incorrect or outdated product labels can have a direct impact on the risk to the public health. It is essential that the company personnel (including the management) are aware of this. Any non-compliance identified during an audit or a regulatory inspection may be classified as major observation, if not critical. Hence it is essential to maintain the updated product labels at all the times, rather than waiting for the regulatory agency to revoke the licence!