Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice.

Abstract

To assess the PREEMPT protocol modifications that have developed in clinical practice over time. The United States Food and Drug Administration approved the 155-unit fixed-dose, fixed-site PREEMPT protocol of onabotulinumtoxinA (BoNT-A) injections for migraine prevention 9 years ago. This is an anonymous survey with free text response options of Headache Medicine clinicians. Out of the 878 contacted Headache Medicine clinicians, 182 (20.7%) completed the survey. Of the 182 respondents, 141 (77.5%) reported that they did not always follow the PREEMPT protocol. Of the 182 respondents, 128 (70%) changed the number of injections, 115 (63%) changed the total units of BoNT-A injected, 105 (57.7%) altered the location of injection sites (58%); 101 (55.5%) do not aspirate to ensure the absence of blood return; 22 (12.1%) changed the dilution; and 4 (2.2%) added lidocaine. The main reported reasons for changes in number, dose, and location of injections included adapting to the patients' pain, anatomy, and preferences. The wide inter- and intra-personal variations in BoNT-A injections for chronic migraine prevention seen in this survey raise concerns about the standardization of the procedure and suggest that an advisory protocol containing more evidence and discussion of the reasoning behind the recommendations might be more helpful than the current prescriptive protocol.