Patient safety is at the heart of drug development and licensing processes. But the duty of care does not stop at launch. Manufacturers must satisfy strict regulatory demands throughout a product’s lifecycle, including re-labeling. How can they ensure current safety information at a reasonable cost?
Although the way the pharmaceutical industry operates is changing, its duty of care towards patients and consumers remains paramount. There are emergency mechanisms in place to recall or rapidly re-label products in the rare instances that an urgent Safety Label Change (SLC) is required, but any other need to communicate new dosage regimes or side effects are the responsibility of the manufacturer. Outdated labels can compromise patient safety, harm the organization’s reputation and add significant costs of destroying excessive quantities of old packaging.
KPMG’s recent report Investing in patient safety explores practices and attitudes to label updates in the pharmaceutical industry. Benchmarking provides insights and perspectives for organizations as they strive to meet their duty of care while managing the financial aspects of SLCs.