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ROSEMONT, Ill. – Long Grove Pharmaceuticals, LLC, a generics company founded in 2019 by strategic healthcare investor Water Street Healthcare Partners, has announced its support for implementing critical changes to medication labels to enhance patient safety.
The company's initiative follows its sponsorship of a white paper by the Med Safety Board, which found that medication errors impact one in every 30 patients, with over a quarter of these cases leading to severe or life-threatening consequences. The Institute for Safe Medication Practices (ISMP) further reinforced these findings with a study analyzing 1,016 patient care reports, nearly half of which involved an error reaching a patient.
Alarmingly, more than 43 percent of the errors documented were linked to pharmaceutical manufacturer-related issues, such as missing or damaged barcodes, incomplete dosing information, misleading labeling, and confusing package designs.
“This level of adverse impact to patients is very disconcerting,” said Peter Karas, Chief Commercial Officer at Long Grove Pharmaceuticals. “Drug labels serve as a crucial means of conveying essential information about a product and this report proves that in the fast-paced healthcare environments where medications are administered, there is a significantly elevated risk for confusion.”
According to the Med Safety Board, medication mix-ups are often caused by lookalike labels, not just among different manufacturers but also within a single manufacturer’s product lines. This issue underscores the need for immediate action to revise label designs for better differentiation.
“There is a silver lining in the Med Safety Board’s findings,” Karas continued. “It is clear that simple design adjustments can help to dramatically reduce these rates. As manufacturers, we have the power to implement these subtle yet impactful changes immediately.”
While the FDA provides safe labeling design recommendations, it lacks definitive standards and rigorous evaluation processes. As a result, unclear label information continues to contribute to errors related to product name, dosage form and strength, concentration, and route of administration. Prominently displaying warnings and cautionary statements and thoughtful font size, style, and color contrast can help mitigate these risks.
Poorly oriented barcodes on vials can lead to scanning delays, and inadequate color differentiation can make it difficult for healthcare providers to distinguish between medications swiftly and accurately.
Amir Emamifar, PharmD, Managing Director at Pronexus Advisory, emphasized in a recent op-ed that patient safety is a shared responsibility across the pharmaceutical supply chain. However, manufacturers are uniquely positioned to preempt potential safety issues by proactively assessing their labels for confusion in real-world healthcare settings.
“Urgent and decisive action is necessary to ensure that patient safety is placed at the forefront,” added Karas. “Simple steps must be taken now to help stop these preventable errors before they occur.”
For a more comprehensive understanding of labeling and medication safety, please review the detailed white paper published by the Med Safety Board, supported by a grant from Long Grove Pharmaceuticals.
