Clinical Guidance Applicable to All Medications
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- The prescribing physician needs to have
- Competence and confidence in diagnosing common psychiatric disorders
- Knowledge of available psychosocial treatments
- Knowledge of medications prescribed
- Procedures for monitoring medication effects and adherence
- The disorder for which medication is prescribed needs to be
- Sufficiently common to be seen regularly by a pediatric PCC
- Efficiently and accurately diagnosable by a pediatric PCC
- The medication needs to
- Have demonstrated efficacy for the disorder
- Be relatively safe, as assessed by several parameters
- Have adverse effects that are reasonably predictable, readily detected, and readily managed
- The dosing and monitoring of the medication need to
- Generally follow FDA or AAP/AACAP guidelines
- The system of care needs to provide
- Access to pediatric psychopharmacology expertise for consultation on issues beyond the expertise of the pediatric PCC
- Adequate payment for services rendered
- Minimal administrative and regulatory barriers
- The prescribing physician needs to have
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- Due to the impact of the patient’s and family’s ideas, concerns, and expectations about mental disorders and medication, the process of obtaining informed consent from the parent or guardian and assent from the patient can be more complicated and difficult for psychotropic medications than other medications
- Consent is usually an ongoing process that unfolds over time as the patient and caregiver(s) develop new questions and concerns about medication(s)
- When prescribing medications for non-FDA-approved indications, and especially when prescribing a medication that has no indication for any psychiatric disorder in children, carefully justify and document the rationale in the medical record.
- 2 aspects:
- Medicolegal consent documentation
- Clinical consent process
- Clinical consent process covers (see Box 4-1 for full details):
- 1. Preparation
- 2. Take the patient's and family's pulse
- 3. Evidence supporting short-term efficacy and effectiveness
- 4. Alternative or additional treatments
- 5. Adverse effects and potential effects during pregnancy
- 6. Potential long-term adverse effects
- 7.Pharmacokinetic issues
- 8. Adherence
- 9. Cost
- 10. Family preferences and questions
- Bottom line: Your opinion about benefit-to-risk ratio for this patient
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- Provide information about adherence and non-adherence in a nonjudgmental manner before prescribing a medication
- Emphasize the importance of "tracking" medication adherence rather than emphasizing actual adherence
- Before making decisions about dose increases, it is critically important to assess adherence, which may include consulting the pharmacist who filled the prescription(s)
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- Medication treatment is often initiated during an acute clinical crisis when the child's symptoms are at their worst, thus doses that are used in the acute phase may be higher than are needed later during subacute or maintenance treatment
- On the other hand, over the longer term, doses may need to be increased in response to growth and maturation
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- Among stimulants and selective serotonin reuptake inhibitor (SSRIs), the most commonly prescribed psychotropic medications for youth, there is 1 boxed warning for SSRIs and 1 for stimulants (see book for details).
- SSRIs: Concerns about Suicidal Thoughts and Behaviors
- Stimulants: Concerns About Abuse and Dependence
- It is important to keep in mind that all adverse effects described in these boxed warnings occur infrequently and may never be seen by an individual pediatric PCC.
- Among stimulants and selective serotonin reuptake inhibitor (SSRIs), the most commonly prescribed psychotropic medications for youth, there is 1 boxed warning for SSRIs and 1 for stimulants (see book for details).