Merck redesigns drug labels for clarity
pharmafile | June 14, 2011 | News story | Manufacturing and Production | FDA, Labelling, Merck & Co
The FDA has approved a major overhaul of labelling for a range of Merck & Co products, paving the way for a new standardised format that improves readability and should cut the risk of medication errors.
The redesign affects a number of Merck’s solid oral drug products, including cholesterol-lowerer Zocor (simvastatin), Propecia (finasteride) for hair loss, diabetes treatment Januvia (sitagliptin) and Singulair (montelukast) for asthma, among others.
The Label Standardisation Project was a major exercise for Merck, and involved evaluating the proposed label content and layout, selecting new packaging design, and obtaining regulatory approval to implement it. All told the project affects 34 container labels for 16 products.
The National Coordinating Council for Medication Error Reporting and Prevention estimates that around 1.3 million people are harmed across the US every year because of medication errors, often because improper dosages are given to patients. Merck’s labelling is designed to provide better information on product and strength differentiation.
Merck said the changes came off the back of “comprehensive research conducted directly with pharmacists and pharmacy technicians” to understand how label changes could help support the accuracy of medication dispensing within the pharmacy.
The changes required feedback and review from all of CDER’s eight clinical divisions, said the FDA.
“We commend Merck for their efforts,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This was no small undertaking, and we are hopeful that Merck’s new standardised labels will aid in reducing pharmacy selection errors.”
Phil Taylor
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