Drug Utilization for Selected Antidepressants Among Children

1
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

2
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

3
PDAC Selected Antidepressants

• Fluoxetine HCl
• Prozac,Prozac Weekly, Sarafem, all generic
  manufacturers
• Bupropion HCl
• Wellbutrin, Wellbutrin SR, Wellbutrin XL,
  all generic manufacturers
• Sertraline HCl (Zoloft)
• Paroxetine HCl
• Paxil, Paxil CR, 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

4
FDA Labeled Indications for Antidepressant Use in
Pediatrics

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

5
Methods
6
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?)

7
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

8
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

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Results
10
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.

11
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.

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

• IMS Health NDTI 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 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
13
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
14
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
15
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
16
Diagnoses Associated with the Use of Selected
Antidepressants, Ages 1-11 and 12-17 Years, 2002
15
8
18
59
26
18
30
26
Source IMS Health, National Disease and
Therapeutic IndexTM , Year 2002, Data Extracted
January 2004
17
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
18
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
19
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
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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

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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)