Off-Label Prescribing for Children with Migraines in U.S. Ambulatory Care Settings.

backgroundMigraines, Which Affect About 10% Of School-Age Children In The United States, Can Significantly Impair Quality Of Life. Despite Potential Disability, Many Children Do Not Receive Treatment Or Prophylaxis, Since Medications Specifically Approved For Children Are Significantly Less Than For Adults. There Is Also Controversy Surrounding The Apparent Widespread Practice Of Prescribing Off-Label Medications For Children With Migraines. However, Little Research Has Been Done To Identify Physician-Prescribing Patterns Of Migraine Medication For Children.

objectiveTo Investigate The Prevalence And Pattern Of Off-Label Prescribing For Children With Migraines.

methodsA Secondary Data Analysis Was Conducted Using The Pooled National Ambulatory Medical Care Survey (Namcs) 2011 And 2012. Patients Aged 17 Years Or Younger With A Migraine Diagnosis Were Included. A Series Of Weighted Descriptive Analyses Were Used To Estimate The Prevalence Of Migraine Drugs Prescribed During Pediatric Office Visits. A Weighted Logistic Regression Was Constructed To Compare The Prescribing Patterns Between Off-Label And Fda-Approved Medications. Analyses Used Sas 9.4 Methodology And Incorporated Sample Weights To Adjust For The Complex Sampling Design Employed By Namcs.

resultsOf The 12.9 Million Outpatient Visits With A Migraine Diagnosis That Took Place Between 2010 And 2012, 1.2 Million Were Pediatric Visits. Females Accounted For Nearly Twice The Number Of Migraine Visits Than Males (66% Vs. 34%). Children Aged 12-17 Years Accounted For The Highest Frequency Of Visits (84%), Compared With Those Aged Under 12 Years (16%). 66.7% Of These Pediatric Patients Received At Least 1 Migraine Drug. Of These, Off-Label Medications Were Prescribed 1.5 Times More Than Fda-Approved Medications For Children (60.34% Vs. 39.65%). The Results Of Logistic Regression Showed A Significant Likelihood Of Prescribing Off-Label Medications Based On Physician Specialty, Patient Race, And Reason For Visit. Neurologists (Or = 0.028, P < 0.05) And Pediatricians (Or = 0.095, P < 0.05) Were Less Likely To Prescribe Off-Label Drugs Than General And Family Practitioners. Visits For Preventive Care (Or = 5.8, P < 0.05) And Flare-Ups From Chronic Migraines (Or = 5.0, P < 0.05) Were More Likely To Result In Off-Label Drug Prescriptions Than Visits For New Migraine Incidence.

conclusionsThis Study Provides Significant Real-World Evidence Of The Widespread Practice Of Prescribing Off-Label Drugs To Children With Migraines. Although Medical Literature Shows That Off-Label Prescribing May Not Be Harmful, There Is A Dearth Of Research And Practice Guidelines To Help Practitioners Uphold Safety Standards And Ensure The Prescription Of Age-Appropriate Medications To Children. DISCLOSURES: No outside funding supported this study. The authors report no potential conflicts of interest relevant to this research. Lai and Ting contributed to study concept and design and collected the data, along with the other authors. Data interpretation was performed by Lai, Koh, Obi, Ho, and Ting. The manuscript was written and revised by Lai, Koh, and Ho, with assistance from Ting and Obi.