Our regulatory assessment backed by our multi-step naming process ensures Cleaner, Safer, and Smarter results. Every time.
When you hear the term “POCA,” what do you think of? An eastern European folk dance? Dots? A band with a few hits from the late 1970s? That would be Polka or Poco — but in the world of creating brand names for pharmaceutical products, POCA is an acronym that stands for Phonetic and Orthographic Computerized Analysis. But why is this important when it comes to naming your asset? Success in determining an appropriate name for a drug product is rooted in uniqueness and creativity, while avoiding potential confusion – from both a trademark standpoint and a medication safety standpoint – to prevent medication errors. POCA plays a strong role in helping to identify potentially confusing drug names, and in turn, can help in the creation of names that avoid these pitfalls.
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 bodies as part of the overall drug approval process. Historically, regulatory name rejections left sponsors frustrated by a perceived lack of insight into these decisions. A series of public meetings in the early 2000s between the FDA and industry stakeholders uncovered a need for reproducibility and predictability. These discussions led to increased transparency and the eventual publishing of guidance documents outlining best practices.
The need for reproducibility is a likely reason why POCA was developed by the FDA: to help lend predictability to their process of reviewing and approving proposed drug names. Proven as a viable tool, POCA has been adopted to varying degrees by other worldwide regulatory authorities, including EMA, Health Canada and ANVISA (Brazil).
Before we get into the details of POCA, let’s take a brief look at the reason it exists: medication errors and their potential causes.
Medical errors, and medication errors specifically, cost the U.S. healthcare system more than 20 billion dollars annually and are a leading cause of morbidity and mortality. 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 health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.”
Typically, such errors have numerous causes that come together in a “perfect storm” that can reach a patient and result in patient harm. One potential cause of medication errors is inadvertently choosing an incorrect medication due to look-alike and/or sound-alike confusion between two drug names. In an effort to prevent such confusion, a lot of emphasis is placed on creating names that are not prone to confusability. To do that, we need to be able to predict names that are prone to medication errors. Cue: POCA.
POCA is a search engine embedded with linguistic equations that evaluate a proposed drug product name for orthographic (look-alike) and phonologic (sound-alike) similarity. When the POCA algorithm is run against a territory-specific database of drug names, it returns a list of drug names in that country or territory in descending order of score. To produce the score, POCA individually scores the orthographic and phonetic aspects of a name and then equally weighs the two to form a combined score. Ranging from 100 to zero, a higher score would mean greater similarity to the proposed name. Therefore, a score of 100 would mean the names are an exact match while a score of 45 would indicate lower similarity.
However, the algorithm is not a perfect predictor that a high similarity score will correlate to a medication error, nor can it stand on its own as a measure of name safety. Thus, POCA exerts its greatest utility when it is used as one tool in a risk assessment toolbox to predict whether a created name will be error-prone. Other tools used to assess the safety of a name include validation testing with healthcare practitioners who would come in contact with the product, expert evaluation using failure mode and effects analysis (FMEA) and other database searching to find potential look-alike or sound-alike names that may cause conflict.
Even though POCA is not the end-all-be-all, it’s beneficial because it’s reproducible and can be used as an objective and quantifiable measure of similarity between two names. But since it’s not foolproof, nor is it the last word on the viability of a potential name, it’s important to have a medication safety expert delve into the non-name characteristic citations that a POCA search returns. Similarities and differences in the “non-name criteria” (e.g., indication, dosage strength and dosage form) of the test product and a citation from the POCA search have a great effect on the overall risk of confusion and must be considered. Likewise, the harm that would occur if a cited medication were administered in place of the intended medication must also be considered. Often, there are names of products uncovered in a POCA search that have little to no impact on the safe existence of a created name due to the nature or availability of that product.
It’s only when POCA search results are coupled with expert analysis that the full potential of this tool can be realized. At Addison Whitney, we have on-staff pharmacists who understand medication errors and how they occur, as well as how the drug use process can vary by product type or clinical setting. Employing industry knowledge and extensive POCA experience, AW’s in-house pharmacists ensure your asset will go through an in-depth safety assessment during the name creation process.
This exhaustive vetting process, which is partly driven by POCA’s objectivity and partly driven by our expert analysis, increases the likelihood of your ultimate goal: regulatory approval. Our regulatory assessment backed by our multi-step naming process – including work from our Strategy, Trademark, Visual, Research and Verbal teams – ensures Cleaner, Safer, and Smarter results, every time.