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Lack of Alignment Between Labels: Its Implications for Patient Safety

A patient scrutinizes their bottle labelIn a recent article published, “Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety”, UBC’s Drs. Alexandra Thoenes, Luca Cariolato, and Alexis Pinçon examined the degree of difference between the labels of products from different marketing authorization holders, both generic and originator products, and analyzed the possible impact of these differences on patients’ health and the implications for risk mitigation.

“Label alignment” is a growing area of interest for the biopharmaceutical industry. Accuracy and synchronicity in safety/label writing are imperative to patient safety. In another communication that will be presented at the DIA annual meeting in June, Luca Cariolato has revisited this topic, this time to highlight the importance of developing the CCDS before local safety information.

The Importance of Developing a CCDS Before Local Safety Information

In drug safety, accurate labeling is crucial in serving as the reference source for health care professionals (HCPs) to understand the appropriate use of a drug and to minimize its known risks. In the postmarketing phase, the marketing authorization holders (MAHs) have to maintain a wide range of regional labeling for a single drug and ensure the labeling information is accurate. The first available product label is usually the one on which the drug is initially approved. Since pharmaceutical companies typically submit their first application in the European Union or the U.S.A., the Summary of Product Characteristics (SmPC) or the U.S. Package Insert (USPI) are in many instances the first labels available.

The Impact on Patient Safety and the Product Life Cycle When Local Label is Not Aligned to CCDS

Following the approval of the local label, the MAHs often prepare a Company Core Data Sheet (CCDS). This document is an internal reference and contains all data related to the characteristics of the drug and its safety profile. The CCDS is the gold standard for safety because it summarizes which adverse events are considered by the MAH to be related to the drug. The CCDS is also the reference tool to analyze and communicate the drug safety profile to appropriate stakeholders worldwide through various regulatory documents, including aggregate reports (PSURs, DSURs), risk management plans (RMP, REMS), and other local leaflets. The CCDS is much more comprehensive and up-to-date on safety issues related to the product. For this reason, it’s imperative that the local product label should be aligned with the CCDS. The lack of CCDS, or its lack of consistency with local labels, can represent a source of serious discrepancies between local leaflets, leading to misinterpretation and incorrect evaluation of safety information reported worldwide. As a result of these inconsistencies, HCPs could be misinformed by the different safety data published in various RSI causing situations that may create mistrust of the drug by stakeholders and subsequent negative evaluations by the regulatory authorities, and most importantly could cause harm to patients.

To ensure patient safety and trust, it is of the utmost importance to begin preparing the CCDS before the marketing authorization is submitted and to maintain synchronicity between local product labels and the CCDS.

At UBC, patient safety is our top priority. As such, we provide technology and services that encompass pre- and postmarketing safety/pharmacovigilance, risk management, signal detection, and assessment — as a comprehensive integrated program, or as standalone, targeted solutions. Our comprehensive technology-enabled solutions and expertise help collect and characterize safety events, identify possible signals, and understand their context efficiently and confidently. The management of the safety of products – including label alignment – requires extensive medical and regulatory knowledge and expertise.

To learn more about UBC’s pharmacovigilance and other safety-related capabilities, contact us.

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