Preparation for Child Psych PRITE and Boards
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| − | == | + | ==FDA's Role== |
| + | '''Food and Drug Administration oversees the pharmaceutical industry''', which includes manufacture, marketing, and sale of medications. Clinical practice by prescribers is NOT regulated by the FDA. | ||
| + | The '''Pediatric Research Equity Act''' of 2013 allowed FDA to mandate the pharm. companies to research pediatric safety and efficacy of certain medications. Prior to that, labeling for pediatric use was often extrapolated from adult data. | ||
| + | *For example, '''haloperidol''' and '''chlorpromazine''' carry extrapolated "FDA approval" for psychosis for children as young as 3 and 1 y.o., respectively, while actual research amounts to only moderate and low quality of evidence for these drugs, respectively. | ||
| + | |||
| + | ==Terms== | ||
'''Indication''' is an illness or condition for which a drug or device is helpful, or "indicated." | '''Indication''' is an illness or condition for which a drug or device is helpful, or "indicated." | ||
| − | The Food and Drug Administration (FDA) classifies indications for drugs in the United States. Indications for drugs can be classified in two categories: | + | The Food and Drug Administration (FDA) classifies indications for '''marketing''' of drugs in the United States. Indications for drugs can be classified in two categories: |
* FDA-approved, also called labeled indications | * FDA-approved, also called labeled indications | ||
| − | * Non FDA-approved, also called off-label indications | + | * Non FDA-approved, also called off-label indications. "off-label" does not mean "inappropriate" for clinical use. |
| + | ** This means that FDA did not approrve medication's use for marketing, either because it denied the company's request, or, more often, because approval for specific marketing was never requested. (1) | ||
==Bipolar Disorder in Adults== | ==Bipolar Disorder in Adults== | ||
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|} | |} | ||
| + | ==References== | ||
| + | |||
| + | (1) Lorberg B., et. al Pediatric Psychopharmocology. JACAAP 2014; 53:7 | ||
{{stub}} | {{stub}} | ||
[[Category:Concepts]] | [[Category:Concepts]] | ||
Revision as of 22:14, 6 August 2015
FDA's Role
Food and Drug Administration oversees the pharmaceutical industry, which includes manufacture, marketing, and sale of medications. Clinical practice by prescribers is NOT regulated by the FDA. The Pediatric Research Equity Act of 2013 allowed FDA to mandate the pharm. companies to research pediatric safety and efficacy of certain medications. Prior to that, labeling for pediatric use was often extrapolated from adult data.
- For example, haloperidol and chlorpromazine carry extrapolated "FDA approval" for psychosis for children as young as 3 and 1 y.o., respectively, while actual research amounts to only moderate and low quality of evidence for these drugs, respectively.
Terms
Indication is an illness or condition for which a drug or device is helpful, or "indicated." The Food and Drug Administration (FDA) classifies indications for marketing of drugs in the United States. Indications for drugs can be classified in two categories:
- FDA-approved, also called labeled indications
- Non FDA-approved, also called off-label indications. "off-label" does not mean "inappropriate" for clinical use.
- This means that FDA did not approrve medication's use for marketing, either because it denied the company's request, or, more often, because approval for specific marketing was never requested. (1)
Bipolar Disorder in Adults
| FDA Approval | Acute Mania (alone) | Acute Mania (w Li+ or VPA) | Acute Depression | Maintenance Alone | Maintenance w Li+ or VPA |
| Li+ | + | + | |||
| Carbamazepine | + | + | |||
| Lamotrigine | + | + with VPA | |||
| Valproic Acid | + | + | |||
| Seroquel | + | + | + | + | |
| Zyprexa | + | + | + | ||
| Risperdone | + | + | + | + | |
| Abilify, Geodon | + | + | |||
| Zyprexa + Prozac (Symbyax) | + |
References
(1) Lorberg B., et. al Pediatric Psychopharmocology. JACAAP 2014; 53:7