Overview
During our audit, we found that 8 out of the 40 (20%) children in our maximum dosage sample received psychotropic medications in dosages that exceeded the US Food and Drug Administration’s (FDA’s) recommendations. Amounts and dosages of medications that exceed the FDA’s recommended guidelines may be appropriate under some circumstances, and while we are not questioning prescribers’ medical expertise, there should be more state oversight for children in protective custody receiving these higher amounts and dosages. The Department of Children and Families (DCF) currently does not have any oversight policies or procedures for children prescribed psychotropic medications, especially for situations when the dosages exceed the FDA’s recommendations.
According to the American Academy of Child and Adolescent Psychiatry’s 2005 “Position Statement on Oversight of Psychotropic Medication Use for Children in State Custody: A Best Principles Guideline,”
State child welfare agencies, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications, in consultation with child and adolescent psychiatrist, should design and implement effective oversight procedures that:
- Establish guidelines for the use of psychotropic medications for youth in state custody. . . .
For example, the State of California has adopted the Los Angeles Department of Mental Health’s “Parameters 3.8 For Use of Psychotropic Medication for Children and Adolescents” guidelines. These guidelines state, “Treatment provided outside the parametric elements in this guide requires special justification or consultation and subsequent documentation in medical record.”
We recommend that DCF implement maximum dosage guidelines for psychotropic medications and that DCF provide additional oversight and authorization when children in its protective custody are prescribed psychotropic medications that exceed the FDA’s recommended maximum dosage. For example, DCF should contact the prescriber to ensure the safety and necessity of the dosage in question and then clearly document the reasons given by the prescriber in iFamilyNet (iFN). Given the documentation weaknesses we have described previously in this audit report, we believe this step is particularly appropriate, as the absence of psychosocial treatment in many instances, and the lack of documentation regarding medication and other treatments, may hinder treatment with these higher-than-recommended dosages.
As our audit was nearing completion, additional areas of concern that were outside the scope of our objectives came to our attention. Given the high-risk nature of these areas, we looked into them, and the results are documented below.
Auditee’s Response
[The Office of the State Auditor (OSA)] indicates that in 8 cases children received dosages that were above FDA guidelines. DCF acknowledges cases exceeding FDA guidelines but emphasizes that these guidelines are not the standard for most child psychiatrists. In Massachusetts and throughout the country, nationally accepted literature-based recommended maximum dosages prevail. Using these standards, there was one case that exceeded both FDA and literature-based recommendations (16 year old on 40 mg escitalopram- Lexapro), which was an error.
These literature-based maximums are presented in the Texas Psychotropic Medication Utilization Parameters and the [Los Angeles Department of Mental Health] Parameters for Psychotropic Medication Use (cited by the OSA above), both of which provide guidance to the DCF medical team and to pediatric mental health professionals nationally. In addition to these tools from other states utilized by the DCF medical team, DCF also follows guidance from the MassHealth Pediatric Behavioral Health Medication Initiative (“PBHMI”), that defines what is considered high risk psychotropic prescribing in pediatrics in MA. Youth who are identified as high-risk and have concerns for inappropriate use of a medication will require a Doc-to-Doc review with the DCF child psychiatrist.
DCF disagrees that exceeding FDA maximums guidelines always necessitates prescriber follow-up. Literature-based maximums, even when surpassing FDA recommendations, are accepted practice with proper justification. We appreciate the OSA’s consideration of the national standard methods being used, and note that DCF consults prescribers when concerns arise about inappropriate dosing or when dosing falls outside literature-based parameters.
Auditor’s Reply
Based on DCF’s response, it believes that only 1 child was prescribed psychotropic medication over the FDA-recommended maximum dosage. We verified that the number is 8 children out of the sample of 40 (see the “Maximum Dosages” section). We would still recommend that more oversight be outlined for children who are prescribed psychotropic medications over the FDA-recommended maximum dosages, even if only one child was involved.
We did not state in our audit that children cannot be prescribed psychotropic medications over the FDA‑recommended maximum dosages but rather that children who are prescribed these higher dosages should also receive more oversight from DCF. We found that, of those 8 cases where children were prescribed psychotropic medications over the FDA-recommended maximum dosages, there were no notes related to the higher dosage, and iFN did not have up-to-date, accurate medication information.
We commend DCF for seeking consultation with psychotropic medication prescribers and participating in other oversight programs. However, this oversight is not documented. We recommend that DCF document all reasons/recommendations for children in its protective custody who are prescribed psychotropic medications at dosages higher than FDA-recommended maximum dosages, or literature‑based maximums as mentioned in DCF’s reply, so that all individuals involved in the child’s mental health treatment are informed and provide proper care.
| Date published: | November 7, 2024 |
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