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PERIODIC SURVEY OF FELLOWS
American Academy of Pediatrics
Division of Health Services Research
EXECUTIVE SUMMARY
Periodic Survey #62
Issues Surrounding Pediatric Drug Labeling
This survey was initiated by the Committee on Drugs (COD) as part
of a contract awarded to the AAP by the U.S. Food and Drug Administration
(FDA), to provide a list of drugs in need of additional study for
use in the pediatric population. The survey addressed pediatricians'
practices regarding drug utilization and opinions on the need for
additional drug labeling. Pediatricians' needs for education and technical
assistance, and preferred sources of information about pediatric dosing
and labeling were also explored. Partial funding for this survey was
provided by the FDA grant, "The Priority Drugs and Pediatric
Labeling Education Project" (AAP/FDA contract solicitation number
223-02-3007/Requisition/Purchase No. D17612).
Findings from this survey will be used (in combination with a Delphi
study of pediatric subspecialists and Academy leadership) to assist
the FDA in identifying and prioritizing drugs requiring additional
pediatric study, as well as to develop educational programs and resources
to provide new or enhanced information on pediatric labeling.
Periodic Survey #62 was an eight-page self-administered
questionnaire sent to 2,067 non-retired United States members of the
AAP. An original mailing and six follow-up mailings to recontact nonrespondents
were conducted from April through September 2005; 991 questionnaires
were received for a response rate of 48%. Analysis was limited to
respondents who provide direct patient care (n=925, or 93% of all
respondents).
Drug Utilization and Information Needs
- Nearly all pediatricians (>90%) report prescribing analgesics,
antibacterials, dermatologic agents, gastrointestinal and
respiratory tract medications. Most pediatricians prescribe
antiviral (85%) and mental health (66%) medications, while
47% say they prescribe sedatives/hypnotics and only 34% prescribe
cardiovascular medications.
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Pediatricians say they have about the right amount of
information for most classes of drugs. However, 67% of pediatricians
say they do not have enough information on cardiovascular
medications, 56% lack information on mental health medications
and 46% say they have too little information on sedatives/hypnotics.
- One-half of pediatricians (50%) think it is most important
to have additional information on mental health medications,
while 20% say information on cardiovascular medications
is most important. Less than 10% named another class of
drugs as most important to have additional information.
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Nearly all pediatricians (>90%) say they currently prescribe
ibuprofen and inhaled steroids, 83% prescribe polyethylene
glycol and 63% prescribe quinolones. About one-half prescribe
atomoxetine (54%) and sumatriptans (50%), 43% prescribe
SSRIs, and 19% prescribe atypical antipsychotics. Less than
10% each prescribe buspirone, isotretinonin or propofol.
- Most pediatricians think they have sufficient information
on ibuprofen (92%), inhaled steroids (87%), polyethylene glycol
(72%), quinolones (61%), isotretinonin (57%), and atomoxetine
(53%). However, most pediatricians say they have do not have
enough information regarding dosing, efficacy or safety on
atypical antipsychotics (80%), buspirone (75%), propofol (70%),
sumatriptans (64%) and SSRIs (60%).
- There was no consensus on which drug was most important
to have additional information: 35% named SSRIs, 20% named
atypical antipsychotics, and 10% said sumitriptans. Less
than 10% each named any other drug.
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Availability of Drug Therapies
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A large majority of pediatricians think there
are enough effective therapeutic choices currently available for
otitis media (90%) and asthma (80%); about two-thirds think there
are enough therapeutic choices for GERD (67%) and ADHD (61%).
Opinion on therapies for headaches and depression is divided:
regarding headaches, 48% say there are enough therapies and 40%
say not enough; similarly, for depression, 37% of pediatricians
say there are sufficient choices while 34% say there are not.
However, more than half of pediatricians (57%) think there are
not enough effective therapeutic choices for bronchiolitis.
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About one-fourth of pediatricians each think
it is most important to have more effective therapeutic choices
available for bronchiolitis and depression (27%, 24%), and 16%
named headaches as the priority condition in need of more effective
therapies.
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Methods of Receiving Drug Labeling Information
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- Eight out of ten pediatricians currently receive new information
about clinically important pediatric drug labeling from a
pediatric dosage book (85%) and from Pediatrics (78%); 74%
named AAP News as a source, 64% named other journals and 61%
say they get their information from drug representatives.
Other sources are less frequently used: PDA-based databases
(39%), news media (29%), nonFDA Web sites (27%), PediaLink
(16%), and FDA Web sites (15%).
- About 30% of pediatricians say receiving drug labeling
information via a pediatric dosage book is most likely to
influence a change in their prescribing behavior; 17% say
information in Pediatrics and 16% say AAP News is most likely
to influence them to change prescribing behavior.
- A majority of pediatricians say they often or sometimes
use general search engines (29% often, 38% sometimes), online
drug databases (26%, 34%) and disease-specific Web sites (7%,
44%) to search for information on new pediatric drug labeling.
Most pediatricians never use the Web sites of patient or advocacy
organizations (77%, 72%, respectively) or FDA Web sites (55%)
to search for drug labeling information.
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| AAP Pediatric Drug Labeling Resources |
- Forty-five percent of those who read the Pediatric Drug
Labeling Update say its information has influenced them to
change their prescribing practice for a specific drug, while
38% say they can't recall this ever happening.
- About one-third of pediatricians (32%) say they would be
very likely to participate in an AAP-sponsored program on
new pediatric drug labeling; 47% say they would be somewhat
likely.
- The preferred formats for such a program are: computerized
course (38%), written self-instructional material such
as PREP or PIR (34%), in-person CME course with a lecture
and question/answer session (11%), and CME with a straight
lecture/presentation (7%).
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American Academy of Pediatrics, Division of Health Services Research
Periodic Survey #62: Executive Summary
"Issues Surrounding Pediatric Drug Labeling", January
2006
Not for citation or quotation without permission
of the author
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