The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.
The new guide starts with the recommendation that manufacturers undertake fundamental research to avoid the mistakes below, which may lead the patient or even the medical professionals to error:
The new guide subsequently lists what it identifies as additional good practices for evaluating a proposed proprietary name:
The guide then focuses on the discussion of proprietary names, in whole or in part, that intentionally mislead, such as, for example, a medicine that has the word cure, in its name, when its effect is only palliative. Such non-conformities include confusion caused by the pronunciation of one or more words.
After that, the guide begins to assess the recommended methods for assessing risks arising from medication errors due to the similarity of a proprietary name in relation to other names, suggesting the following:
Finally, in addition to a glossary, the guide ends with very interesting and useful attachments:
(i) Appendix A - Examples of previously used modifiers and their 205 commonly understood meanings,
(ii) Appendix B - Methodology of research to conduct a review of inappropriate adoption of trademarks,
(iii) Annex C - Considerations on research methodology for conducting name simulation studies,
(iv) Annex D - Checklist of highly similar name pairs,
(v ) Annex E - Checklist of moderately similar name pairs and
(vi) Annex F - Low similarity name pairs.