Preserving Patient Safety: Understanding the Risks of Look-Alike and Sound-Alike Drug Names

Patient safety is a critical aspect of the Healthcare Industry that involves protecting patients from harm and ensuring that they receive quality care. One of the risks to patient safety is the occurrence of errors related to look-alike and sound-alike medication names. These errors can happen when a healthcare provider mistakenly prescribes or administers the wrong medication or product due to its similarity to another drug.

Look-alike medications refer to drugs that have similar packaging, appearance, or labeling as another medication. Sound-alike medications, on the other hand, are names that sound similar to other marketed products. These similarities can lead to confusion among healthcare providers, which can result in medication errors.

Medication safety is a subset of patient safety. According to the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP), a medication error is defined as: “…any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.”

The responsibility of medication error prevention is shared among patients, healthcare practitioners, regulatory bodies, and the pharmaceutical industry.

Regulatory bodies, such as the FDA, EMA, and Health Canada, can reject a name or proposed container label if they feel either may lead to confusion or a medication error. Therefore, if the pharmaceutical industry and branding agencies fail to prioritize patient safety throughout the processes, the brand will more than likely be rejected in the name of patient safety.

In the world of product branding, drug names are held to a higher standard than the names of other types of products, and as such, need to be approved by the regulatory agencies as part of the overall drug approval process.

To address the risks associated with look-alike and sound-alike confusion between drug names, drug naming agencies such as Brand Institute and its regulatory affiliate, Drug Safety Institute, can play a crucial role in this process by:

  • Conducting research, e.g., name simulation studies to address name similarities. This research can help pharmaceutical companies understand potential risks associated with their brand name candidates.
  • Developing prevention strategies, e.g., working with a team of experts, such as those at Drug Safety Institute, comprised of former regulators from global agencies (including EMA, FDA, and Health Canada) to develop strategies to prevent medication errors.

Brand Institute and Drug Safety Institute have the experience to navigate the regulatory challenges of branding and brand name development.

By Cristina Milesi