Lubna Merchant, M.S., Pharm.D., Deputy Director of the Division of Medication Error Prevention and Analysis, discusses the agency’s role in preventing medication errors caused by proprietary (brand) name confusion.
About medication errors
FDA uses a definition of medication error from the National Coordinating Council for Medication Error Reporting and Prevention. That is, a medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm. These errors can occur while the medication is in the control of the health care professional, patient, or consumer.
Medication errors can occur at any time in the medication use process, including during prescribing, dispensing, administering, and monitoring. A medication error can result in patients getting the wrong formulation, strength, dose, frequency, or even the wrong drug. Approximately 54,000 suspected U.S. medication error cases were submitted to FDA in 2014.
Drug name confusion can cause medication errors
There are many ways in which drug name confusion can cause medication errors, such as similarity in spelling and pronunciation that result in prescribing or dispensing of the wrong medication. In addition, analysis of name confusion errors has shown that other factors, such as shared strength or dose between products, may also contribute to name confusion and has led to errors involving drugs with similar names. However, this is not always the case as errors have also been reported despite differences in product strength.
Another contributing factor that can lead to drug name confusion is confirmation bias, the tendency to search for, interpret, or recall information in a way that confirms one's beliefs or hypotheses. When a product has been on the market for some time and has name recognition, familiarity with the drug name has been known to cause confirmation bias.
Efforts to avoid drug name confusion before approval
FDA’s safety review of a proposed proprietary name focuses on the prevention of medication errors. We recommend that sponsors submit their requests for FDA’s review of their proposed proprietary name as soon as they have the recommended supporting information described in the “Contents of a Complete Submission for the Evaluation of Proprietary Names” guidance.
When FDA reviews a proposed proprietary name for either a new brand name drug or new generic drug application, we look for error-prone naming attributes and potential sources for error, including the spelling and pronunciation of the name as well as its appearance when scripted. We also perform prescription simulation studies with FDA health care professionals by asking them to interpret a proposed proprietary name in simulated real-world use conditions. The results of these studies are analyzed carefully to identify the vulnerability of the proposed name to be misinterpreted by health care professionals.
Further, we evaluate the similarity of names by using FDA’s Phonetic and Orthographic Computer Analysis (POCA) program to identify names that look or sound like the proposed proprietary name. After identifying potential look-alike/sound-alike names, proposed proprietary names are analyzed further using the principles of failure modes and effects analysis (FMEA), a systematic tool that helps us to determine where failures might occur in the medication-use system with the proposed product.
We also evaluate the proposed proprietary name to make sure it is not misleading by misrepresenting the product’s safety or efficacy.
Reporting medication errors to FDA
Even with our thorough pre-marketing drug name review process, the potential for unexpected confusion still exists. We strongly encourage all reports of medication errors in the United States to be reported to FDA through MedWatch, the agency’s adverse event reporting system. We evaluate reports from pharmaceutical companies, health care professionals, and patients that we receive through this system. We also review reports from other sources including the Institute for Safe Medication Practices. With this information, we are able to apply the “lessons learned” to improve our drug name review process.
Addressing name confusion errors and informing the public
When we receive a medication error report, we evaluate it to understand the root cause of the error and review pertinent information, such as labeling and packaging. Once an error is identified, FDA may recommend that the sponsor make changes to the labeling and packaging of the product. Changes have been made to the presentation of the drug name on the container label and/or carton labeling by incorporation of mixed case letters, different font size, layout, and color.
In rare cases, we’ve worked with sponsors to change a proprietary name to resolve medication errors resulting from name confusion. FDA may also employ drug safety communications, consumer updates, or scientific publications to inform the public about medication errors. In addition, the sponsor may conduct outreach to the public about medication errors through mass mailings of letters, emails, educating drug representatives, and reaching out directly to pharmacies and wholesalers.
Help combat drug name confusion errors
In order to help reduce drug name confusion errors, we encourage health care professionals to be aware of drug names that look and sound alike, and identify drug names that may be problematic. Pharmacists and nurses should match the drug’s indication to the patient’s condition before dispensing or administering the product. It is also important for patients to always double-check their medications and ask their health care provider or pharmacist about medications that look or sound different than expected.
The future of reducing the risk of drug name confusion errors
Last year, FDA published the draft guidance for industry – “Best Practices in Developing Proprietary Names for Drugs.” This guidance is intended to help sponsors of drugs and biologic products develop proprietary names that do not cause or contribute to medication errors or misbrand a drug. As we go forward, we continue to diligently evaluate proposed proprietary names and post-marketing error reports to minimize the potential for drug name confusion and prevent medication errors.
- Contents of a Complete Submission for the Evaluation of Proprietary Names â Guidance for Industry
- Best Practices in Developing Proprietary Names for Drugs â Guidance for Industry
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- OSE Procedures for Handling Requests for Proprietary Name Review