The US Food and Drug Administration (FDA) has issued a draft guidance for industry on the safety considerations for container labels and carton labeling design to minimize medication error. The industry was expected to provide its inputs before June 30,2013.
Pharma industry in the country sees the norms as a big advantage going by the rejections of products coming out of labeling errors. Labeling and design are integral to product marketing therefore we are relieved that such norms are going to be enforced, the industry said.
The purpose of this guidance is to help prescription drug and biologic product manufacturers focus on safety aspects of the container label and carton labeling design. It provides a set of principles and recommendations to ensure that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.
The guidance covers prescription drugs marketed under an approved new drug application (NDA) or abbreviated new drug application (ANDA). It will also include prescription drugs marketed without an approved NDA or ANDA. Further, biological products marketed under an approved biologics licensing application (BLA) are also included.
The guidance does not apply to over-the-counter (OTC) drug products. This is the second in a series of three guidance documents that the FDA is issuing to help minimize medication errors.
The focus is on minimizing risks associated with the design of the drug product and its container closure system. it also covers the best practices for the development and testing of proposed proprietary names to minimize risks associated with drug product nomenclature, such as proprietary names that look or sound like the name of another product.
Medication errors are a significant public health concern that account for an estimated 7,000 deaths annually in the United States. This urged FDA to address safety issues related to product labeling and nomenclature using the principles of cognitive and human factors engineering.
As part of the Prescription Drug User Fee Act (PDUFA IV) reauthorization, FDA committed to certain performance goals, including measures to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, designations, and error-prone labeling and packaging designs.
In June 2010, FDA held a public workshop and opened a public docket to receive comments on these topics.
The regulatory authority has now insisted that the format and content of prescription drug and biological product labels and labeling must comply with FDA regulations in 21 CFR part 201 for drugs and 21 CFR part 610 Subpart G- 80 Labeling Standards for biologics. Further, it should conform with all labeling requirements required by the United States Pharmacopeia (USP). Although this guidance refers to some aspects of those requirements as they relate to the prevention of medication errors, product sponsors should refer to the regulations and USP for the full requirements.
Product container labels and carton labeling should communicate information that is critical to the safe use of a medication from the initial prescription, to procurement, preparation and dispensing of the product to the time it is given to the patient.
Poor label design can contribute to medication errors by making it difficult for healthcare professionals, caregivers, and/or patients one to readily locate and understand critical safety information. Text is difficult to read because of font size or style, insufficient color contrast, or other design elements. There should be clear displays of warnings for critical information and expiry dates.