# Presentation: 921008

## Drug Utilization for Selected Antidepressants Among Children & Adolescents in the U.S.

- Gianna C. Rigoni, Pharm.D., M.S.
- Epidemiologist
- Division of Surveillance, Research & Communication Support
- Office of Drug Safety, CDER, FDA
- February 2, 2004

## Objectives

- To describe the use of selected antidepressant products in 1-17 year olds in the U.S.
- To examine the physician specialties responsible for the prescribing of these products to 1-17 year olds
- To identify the primary diagnoses for which these products are used in 1-17 year olds

## PDAC Selected Antidepressants

- Fluoxetine HCl
- Prozac®,Prozac WeeklyTM, Sarafem®, & all generic manufacturers
- Bupropion HCl
- Wellbutrin®, Wellbutrin SRTM, Wellbutrin XLTM, & all generic manufacturers
- Sertraline HCl (Zoloft®)
- Paroxetine HCl
- Paxil®, Paxil CRTM, & all generic manufacturers
- Citalopram HBr (Celexa®)
- Escitalopram Oxalate (Lexapro®)
- Fluvoxamine Maleate
- Luvox® & all generic manufacturers
- Venlafaxine HCl (Effexor®, Effexor® XR)
- Nefazodone HCl (Serzone®)
- Mirtazapine
- Remeron®, Remeron SolTab®, & all generic manufacturer

## FDA Labeled Indications for Antidepressant Use in Pediatrics

- Pediatric major depressive disorder (MDD)
- Fluoxetine
- Pediatric obsessive-compulsive disorder (OCD)
- Fluoxetine
- Sertraline
- Fluvoxamine

## Methods

## Methods

- Data analyzed from January 1988 – December 2002
- Outpatient Drug Utilization Data Sources
- IMS Health, National Prescription Audit *Plus* (NPA *Plus**)*
- IMS Health, National Disease and Therapeutic Index (NDTI)

## National Prescription Audit Plus (NPA Plus)

- Measures the “retail outflow” of prescriptions from pharmacies to consumers
- Includes:  chain, independent, mass merchandisers, food stores with pharmacies, mail-order, and long-term care pharmacies
- Number of dispensed prescriptions is obtained from a sample of approximately 22,000 pharmacies in the U.S.
- Projected nationally

## National Disease and Therapeutic Index (NDTI)

- Collects data on drug products and diagnoses mentioned during _office-based_ physician visits
- Provides descriptive information on profiles and trends of diagnoses, patients, and treatment patterns occurring in _office-based_ practice
- Data are gathered from a _sample_ of 2,000-3,000 office-based physicians in the U.S.
- Projected nationally

## Results

## Total U.S. Prescriptions Dispensed* Annually for Selected Antidepressants, All Ages, 2002

- An estimated _157 million prescriptions_ dispensed in the U.S. in 2002
- Market Leaders
- Sertraline	(~ 20%)
- Paroxetine	(~ 19%)
- Fluoxetine	(~ 17%)
- Citalopram	(~ 14%)

-  Source: IMS Health, National Prescription Audit PlusTM, Year 1988 to 2002, Data Extracted January 2004.

## Total U.S. Prescriptions Dispensed* Annually for Selected Antidepressants, All Ages, 1988-2002

-  Source: IMS Health, National Prescription Audit PlusTM, Year 1988 to 2002, Data Extracted January 2004.

## Method for Estimating Use in 1-17 Year Olds from NPA Plus

- IMS Health NDTITM data
- _Proportion_ of office-based physician visits that involved the mention of one of the selected antidepressants to 1-17 year olds
- IMS Health NPA *Plus**TM* data
- Applied NDTI proportion to the total number of prescriptions dispensed in the U.S. for that year

- *   Source: IMS Health, National Prescription Audit PlusTM; National Disease and Therapeutic IndexTM ; Years 1988 to 2002, Data Extracted January 2004

## Top 5 Selected Antidepressants Dispensed* to 1-17 Year Olds, 2002

- *   Source: IMS Health, National Prescription Audit PlusTM; National Disease and Therapeutic IndexTM ; Years 1998 to 2002, Data Extracted January 2004

## Total U.S. Prescriptions Dispensed* Annually for Selected Antidepressants, Ages 1-17 Years,2002

- _Younger pediatric population_ (1-11 years)
- In 2002, an estimated 2.7 million prescriptions (~ 2% of total) dispensed
- Sertraline (31%), paroxetine (18%), fluoxetine (16%)
- _Adolescent population_ (12-17 years)
- In 2002, an estimated 8.1 million prescriptions (~ 5% of total) dispensed
- Sertraline (26%), paroxetine (22%), bupropion (13%)

- *   Source: IMS Health, National Prescription Audit PlusTM; National Disease and Therapeutic IndexTM ; Years 1998 to 2002, Data Extracted January 2004

## Top Office-Based Prescriber Specialties* Mentioning** Selected Antidepressants,Ages 1-17 Years, 1998-2002

- _Younger pediatric population_ (1-11 years)
- Top ranked physician specialties _have shifted slightly_ and relative proportions have also changed
**1998**     Psychiatry (66%); Family Practice (10%); and Pediatrics (8%)
**2002**     Psychiatry (64%); Pediatrics (17%); and Neurology (8%)
- _Adolescent population_ (12-17 years)
- Top ranked physician specialties _have remained constant_, but relative proportions have changed
**1998**     Psychiatry (67%); Pediatrics (10%); and Family Practice (9%)
**2002**     Psychiatry (65%); Pediatrics (17%); and Family Practice (9%)

- *   Source: IMS Health, National Disease and Therapeutic IndexTM , Years 1998 to 2002, Data Extracted January 2004
- ** A mention may result in a prescription written, refill authorized, sample given, drug administered in office, or any combination of these

## Diagnoses* Associated with the Use of Selected Antidepressants, Ages 1-11 and 12-17 Years, 2002

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 2002, Data Extracted January 2004

**59%**

**18%**

**8%**

**15%**

**26%**

**30%**

**18%**

**26%**

## Diagnoses* Associated with the Use of Selected Antidepressants, Ages 1-11 Years, 2002

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 2002, Data Extracted January 2004

## Diagnoses* Associated with the Use of Selected Antidepressants, Ages 12-17, 2002

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 2002, Data Extracted January 2004

## Diagnoses* Associated with the Use of Selected Antidepressants, Ages 1-17 Years, 1998-2002

- _Younger pediatric population_ (1-11 years)
- In 2002, **anxiety disorders** were the primary diagnoses (31% of total)
- In 1998, **mood disorders** were the primary diagnoses (47% of total in 2002 - data not shown)
- _Adolescent population_ (12-17 years)
- From 1998 - 2002,** mood disorders** have remained the primary diagnoses (59% of total in 2002)

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 2002, Data Extracted January 2004

## Limitations

- Outpatient Drug Use Data
- Data on dispensed prescriptions include prescriptions filled in the _outpatient_ pharmacy setting only
- Prescriptions dispensed for ages 1-17 years extrapolated from physician office visit data
- Data on prescriber specialties and indications
- Taken from a sample of 2,000-3,000 office-based physicians
- A mention of a product during a office visit may not result in a patient actually filling the prescription in a pharmacy

## Conclusions

- Antidepressant use among children & adolescents appears to be widespread
- Increasing annually since 1988
- _Psychiatrists_, _pediatricians_, and _primary care providers_ continue to be the primary prescribers
- Diagnoses for the outpatient use of _selected antidepressants_
- Ages 1-11 Years
- Anxiety disorders (31%), mood disorders (27%), attention-deficit disorder (17%)
- Ages 12-17 Years
- Mood disorders (59%), anxiety disorders (18%), attention-deficit disorder (8%)