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

BACKGROUND: Migraines, 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. OBJECTIVE: To Investigate The Prevalence And Pattern Of Off-Label Prescribing For Children With Migraines. METHODS: A 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. RESULTS: Of 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. CONCLUSIONS: This 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.

Healthcare Disparities in Hispanic Diabetes Care: A Propensity Score-Matched Study.

Hispanics represent the largest minority group in the US. Research has shown that the ethnic minority especially Hispanics have a disproportionate burden of illness associated with diabetes mellitus. However, many have been focused on small sample sizes with potential selection bias. This study aims to examine the ethnicity disparity in health care utilization and expenditures between Hispanic and non-Hispanics after controlling for confounding variables. Cross-sectional with propensity score-matched design. The study revealed that Hispanics with diabetes had higher poverty rates, lower education, less physical activity, and less health care utilization/expenditures than did non-Hispanics. The assessment of ethnicity differences in health care is challenging because of the potential biases that require careful adjustment. This study successfully identified and controlled for confounding bias and concluded the Hispanics disparity in health care utilization still exists.

Prevalence and factors associated with off-label antidepressant prescriptions for insomnia.

BACKGROUND: The primary objective of our study was to investigate the prevalence of off-label antidepressant drug use in insomnia. The secondary objective was to compare prescribing patterns between off-label antidepressants vs hypnotics approved by the US Food and Drug Administration for insomnia, with particular emphasis on socioeconomic characteristics of patients and physicians. METHODS: We undertook a secondary data analysis using the national longitudinal database from the 2006 National Ambulatory Medical Care Survey. Subjects were identified from outpatient visits in which at least one insomnia drug was prescribed. A series of weighted Chi-squared statistics was used to compare drug use for insomnia across various patient and physician characteristics. Multivariate logistic regression was conducted to identify factors associated with off-label antidepressant drug use. RESULTS: Among 901.95 million outpatient visits that took place in the US in 2006, an estimated 30.43 million visits included at least one drug prescription for insomnia. Off-label antidepressants were prescribed significantly more frequently (45.1%) than nonbenzodiazepine z-hypnotics (43.2%) and benzodiazepines (11.7%). Insomnia prescribing patterns were significantly influenced by physician specialty and physician office settings. Pediatricians (odds ratio [OR]: 65.892; 95% confidence interval [CI]: 5.536-810.564) and neurologists (OR: 4.784; 95% CI: 2.044-11.201) were more likely to prescribe off-label antidepressants than psychiatrists. Self-paying patients were more likely to receive off-label antidepressants as treatment for insomnia than patients with private insurance (OR 2.594; 95% CI: 1.128-5.967). CONCLUSION: Our findings indicate significant socioeconomic disparities in the use of off-label antidepressants. Future studies might explore interventional and educational strategies to ensure well informed clinical decisions that can withstand pharmaceutical marketing strategies and diagnostic uncertainties regarding the treatment of insomnia.

Community pharmacy-based hypertension disease-management program in a Latino/Hispanic-American population.

OBJECTIVE: To evaluate if the community, pharmacy-based hypertension disease-management (DM) program significantly improved patient's clinical outcomes and health-related quality of life (HRQOL) in a Latino/Hispanic-American community. DESIGN: Quasi-experimental time-series study. SETTINGS: The study was implemented at two primary-care clinics in health maintenance organizations and two community pharmacy settings located in South Florida. PARTICIPANTS: Patients who have a long-term history of uncontrolled hypertension were identified and referred by their primary care physicians. INTERVENTION: A nine-month, community pharmacy-based hypertension disease-management program. MAIN OUTCOME MEASURES: HRQOL was assessed via SF-12 questionnaire and analyzed by norm-based scoring methods. Wilcoxon signed rank tests with 0.05 alpha levels were used to compare the differences in systolic blood pressure (SBP)/diastolic BP (DBP), medication compliance, and frequency of BP screenings between baseline and endpoint of the intervention. RESULTS: A total of 53 patients (50.5%) completed the program. SBP/DBP significantly declined from 150.5/95.5 mmHg to 133.8/83.3 mmHg on the second month and remained consistent throughout the study period. Quality of life and mental component summary/physical component summary scores slightly increased from 48.58/46.68 to 50.39/51.51. The number of patients monitoring BP at home and medication compliance also significantly increased after nine months of intervention. CONCLUSIONS: The key factor in accomplishing this DM program is meeting the health care needs of a unique population-the Hispanic-American community. Clinicians, administrators, and public health officials should note that understanding the broad parameters of a culture is essential to providing quality care to individuals, families, and communities.