Published online July 1, 2005
PEDIATRICS
Vol. 116
No. 1
July 2005, pp.
233-235
(doi:10.1542/peds.2005-0928)
Pediatricians and Antidepressant Medications: Black Box or Black Hole?
Lynn Mowbray Wegner, MD
Learning and Development Associates
Morrisville, NC 27560
Abbreviations: AAP, American Academy of Pediatrics • FDA, US Food and Drug Administration • AACAP, American Academy of Child and Adolescent Psychiatry
The intent of this commentary on the article by Leslie and colleagues1 is to describe ongoing efforts by the American Academy of Pediatrics (AAP) and other pediatric professional organizations to support pediatricians and other pediatric clinicians as they attempt to provide care for their patients who have mental health disorders.
The article by Leslie et al is extremely important to primary pediatric medical providers and provides an important framework for this commentary for several reasons.
- Although there have been periodic short articles published (eg, ref 2), this article responds to requests from pediatricians for a more comprehensive summary of information describing the US Food and Drug Administration (FDA) review of antidepressant use in US children.
- The authors provided the background information of the uneven published evidence of children’s responses and observed adverse effects of antidepressants.
- Progressive regulatory steps were described, most of which have occurred in the past 10 years.
- The need for additional research is raised. Kelleher and Greenhouse’s commentary3 expands the discussion. The studies advocated by Kelleher and Greenhouse are essential to the "do-no-harm" dictum guiding the pediatrician’s daily work.
- The authors grappled with the thorny issue of "off-label" prescribing of antidepressants and proposed future activities needed to establish the safe and appropriate prescribing patterns pediatricians want to follow.
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THE PRIMARY CARE PROVIDER ON THE FRONT LINE
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The AAP recognizes the critical importance of providing pediatricians with assistance in the pharmacological management of children and adolescents with mental health disorders. The FDA Pediatric Advisory Committee’s vote in September 2004 to advise the FDA to require a "black-box warning" sounded an alarm extending from the examination rooms of tertiary child psychiatry clinics in Boston, Massachusetts, to solo primary care providers in the Oklahoma panhandle and rural Montana. Pediatricians were left wondering what to do about their patients already taking antidepressants (for a variety of conditions, as Leslie and her colleagues note). Many of these children had dramatic improvement in the quality of their daily life experiences and showed no evidence of suicidal thinking, let alone self-destructive actions. Would it be more "harmful" to withdraw the medications from their treatment programs than it would be to continue prescribing these black-box medications? What discussions should ensue between the physicians and the parents of these children? Additionally, should these medications be prescribed as part of a newly identified mental health condition? Were there new expectations for informed consent and monitoring? What would be the future implications for other psychotropic medications prescribed for children (eg, the stimulant medications)?
Now, 8 months later, pediatricians grapple with these and additional issues. In an unusual step, the FDA has released suggested practice parameters for monitoring youth taking antidepressants and raised concerns about medico-legal implications of care provision. The suggestion to limit the use of psychotropic medications in the United States solely to mental health subspecialists (eg, child and adult psychiatrists, pediatric subspecialists with postresidency training in mental health diagnosis, management, and psychotropic medications) is untenable, given the projected increase in incidence of the disorders and the concomitant static numbers of child psychiatrists.4
Leadership of national pediatric medical organizations recognizes improved access to mental health care must involve children’s medical primary providers. We now have a situation in the United States in which screening is encouraged in primary care settings to identify children and adolescents with needs for developmental and/or emotional/behavioral assessment and to provide possible intervention.5 What steps are the AAP and other pediatric organization taking to assist the primary care front line?
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CURRENT AAP ACTIVITIES RESPONDING TO THE BLACK BOX
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Leslie and her co-authors articulated important areas for development. At this time, the following are in place:
Coordinated Activities Within the AAP Regarding the Black-Box Warning
When the FDA announcement was made last fall, the leadership of the AAP Section on Developmental and Behavioral Pediatrics, Committee/Section for Children With Disabilities, Committee on Drugs, Committee on Psychosocial Aspects of Child and Family Health, Committee on Medical Liability, AAP Federal Affairs Office, and several AAP members attending the FDA hearings began an ad hoc group: the "black-box committee." Regular conference calls were established immediately after the FDA announcement. Since then, antidepressant use as well as other emerging psychotropic medication issues (eg, the Drug Enforcement Agency announcement regarding schedule II drugs–refill practice, the Canadian government’s announcement of the prohibition against prescribing long-acting amphetamine salt medications) have been discussed. The black-box committee is in the midst of finalizing suggestions to help primary medical providers. These suggestions will be forthcoming in the next 2 months (possibly sooner) and will provide interim guidance between the 2004 FDA decision and the future development of a set of consensus-supported practice guidelines.
Development of Materials for Use With Families in Primary Care Settings
In late December, the joint American Academy of Child and Adolescent Psychiatry (AACAP)/American Psychiatry Association sent their preliminary guidelines and proposed a "family fact sheet"6 to the AAP (among other organizations) for review and anticipated endorsement. The AAP board felt that a separate family fact sheet endorsed by the AAP would better meet the needs of primary pediatricians. The AACAP statement to psychiatrists and the family fact sheet were subsequently published in February 2005 on the AACAP Web site and a Web site directed at the lay public. The black-box committee is revising this statement so that it is more appropriate for use in primary care settings. The explanatory statement for families, the "AAP Family Fact Sheet," should be released by the black-box committee in the next several months. AAP membership will be alerted on the AAP Web site and other AAP-sponsored periodicals such as the AAP News. This fact sheet will not be identical to the AACAP family information sheet.
Improved Partnerships With Child Psychiatry at the National Level
Two national organizations, the AAP and AACAP, are combining forces to create the support permitting primary providers to function as the "front line." Carol Berkowitz, MD, FAAP, and Richard Sarles, MD, both current presidents and representing the leadership of the AAP and AACAP, respectively, met in January 2005 and jointly endorsed future collaborations between pediatrics and child psychiatry to enhance access to and quality of children’s mental health care. Efforts at increasing AAP/AACAP collaboration have continued. Drs Berkowitz and Sarles sent a joint letter to a national behavioral health company endorsing modification of allowable physician visits for medication monitoring in light of the FDA decision. There have been official AACAP representatives on AAP projects, and new relationships are being established. For example, an AAP liaison to the AACAP Committee on Healthcare, Access, and Economics was created to specifically collaborate on access areas through identifying effective collaborations between primary care physicians and child psychiatrists as well as improving financial factors. The AAP and AACAP are also addressing access-to-care issues in the areas of reimbursement, mental health "carve outs," accurate coding for mental health issues, and novel collaborative working relationships to extend the limited US child psychiatry workforce.
Development of Continuing Education Modules for the Primary Care Provider
AAP continuing medical education meetings are being developed to provide sessions describing evidence-based care and consensus positions on the diagnosis and management of children’s and adolescents’ mental health disorders. Articles in AAP-sponsored publications will continue to expand the knowledge base for primary providers for children. The evidence supporting intervention (both pharmacologic and nonpharmacologic) will be clearly identified in all continuing medical education activities. The AAP will continue to require full disclosure of pharmaceutical industry relationships for those presenting programs at these meetings and writing these articles. In addition, the Section on Developmental and Behavioral Pediatrics will continue to host 4-day-long continuing medical education training in developmental and behavioral diagnosis and management on an every-other-year basis.
Advocacy for Research on Pediatric Use of Psychotropic Medications
AAP members of FDA panels will continue to advocate for additional studies of the long-term effects of psychotropic medications and children’s exposure to existing medications. Improved understanding of the metabolism of these medicines is essential to completely understanding children’s responses to them.
Support for the Primary Care Provision of Children’s Mental Health Care in General
The AAP Board established the Task Force on Mental Health in 2004 with representation from many areas of the AAP (including AAP board representation) and liaisons from the AACAP, American Psychological Association, National Association of Social Workers, National Association of Mentally Ill, Child and Adolescent Action Center, Child Neurology Society, and the Society for Adolescent Medicine. The Task Force on Mental Health has initial 2-year funding (with grant applications pending for additional years) to develop a practical consensus-based approach for the primary care provider to identify and establish an initial treatment program for children and adolescents in their practice. Establishing collaborative community-based relationships with other mental health providers will be a very important component.
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WHAT THE PRIMARY PROVIDER CAN DO TODAY
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Although the proposed documents described above are being developed, primary health providers have a responsibility to heed the recommendations by Leslie et al: - Pediatricians must know the published evidence for those mental health conditions in children showing positive response to medications.
- Local community resources should be identified to provide appropriate nonpharmacologic treatment (eg, family therapy, cognitive behavioral therapy, interpersonal therapy).
- Diagnostic assessments should include standardized rating scales supporting the appropriate Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis. (For examples of scales, see www.brightfutures.org/mentalhealth and the Center for Epidemiologic Studies Depression Scale for Children [CES-DC], and the Pediatric Symptom Checklist [PSC, Y-PSC] at www.dbpeds.org.)
- Regular monitoring of efficacy and adverse effects must be part of the comprehensive plan. Standardized rating scales may be a useful part of this efficacy surveillance. The individual patient’s condition will indicate the need for the specific combination of telephone and face-to-face contacts. The prescribing physician needs to pay particular attention to the initiation, titration, and discontinuation periods with respect to medication management.
Parents depend on pediatricians to advise treatment based on knowledge, and pediatricians expect the AAP to provide informed guidance. Both needs can, and will, be met.
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FOOTNOTES
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Accepted Apr 26, 2005.
Address correspondence to Lynn Mowbray Wegner, MD, Learning and Development Associates, 3500 Gateway Centre Blvd, Suite 140, Morrisville, NC 27560. E-mail: lwegner{at}learningfirst.com
No conflict of interest declared.
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REFERENCES
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- Leslie L, Newman TB, Chesney PJ, Perrin JM. The food and drug administration’s deliberations on antidepressant use in pediatric patients.
Pediatrics. 2005;116
:195
–204[Abstract/Free Full Text]
- Wegner L. Advice for treating children with antidepressants.
AAP News. 2004;25
:289[Free Full Text]
- Kelleher KJ, Greenhouse JB. Thinking outside the (black) box: antidepressants, suicidality, and research synthesis.
Pediatrics. 2005;116
:231
–233[Free Full Text]
- American Academy of Child and Adolescent Psychiatry. AACAP work force data sheet. Available at: www.aacap.org/training/workforce.htm. Accessed April 15, 2005
- Rezet B, Risko W, Blaschke GS; Dyson Community Pediatrics Training Initiative Curriculum Committee. Competency in community pediatrics: consensus statement of the Dyson Initiative Curriculum Committee.
Pediatrics. 2005;115(4 suppl)
:1172
–1183
- American Academy of Child and Adolescent Psychiatry. Facts for families. Available at: www.aacap.org/publications/factsfam/index.htm. Accessed April 15, 2005
PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics
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