"Off label" is used whenever a medicine is used in a manner that isn't Food and Drug Administration (FDA) approved. Does this mean the medication is experimental? No, no way. This means simply that no research has been listed in the FDA for approval of the medication for that particular use. It doesn't mean that no studies have been done.
Many studies may not have been submitted or may have been submitted and approved by European governments. It does not mean that the medicine is not widely prescribed for a use apart from what the FDA approved. It doesn't mean that doses under or over the recommended range authorized by the FDA are neither effective nor safe. It doesn't mean that the medicine is unsafe in age groups younger or over the age of what the FDA approved.
It merely means that once the company submitted the medication for approval to the FDA it submitted studies that specified a diagnosis, a dosage range, as well as an age group that their study subjects reflected. Drug research and development have a fascinating history. Psychiatric drugs are often discovered serendipitously.
Most drugs have multiple effects on the body, and focusing on one particular action towards the exclusion of some other is as much dependent on marketing because it is drug action. For instance, the first antipsychotic medication originated and tested by a trauma surgeon who was specifically interested in getting a medication that could prevent surgical shock, an ailment having a high mortality rate at the time. It was only through clinical observation that it had been discovered to possess antipsychotic effects as well as a variety of other effects on the body.
The company that originally introduced it towards the Usa did not believe that there would be considered a marketplace for it as being an antipsychotic and therefore released it to the public as an antiemetic. Only through multiple physician-driven lectures were psychiatrists in the United States comfortable enough to test it on patients suffering from schizophrenia. Maybe even odder is the fact that the first antidepressant effects were observed in medications developed to deal with tuberculosis.
Only later was it discovered that these medications inhibited, or blocked, monoamine oxidase, an enzyme that breaks down norepinephrine, serotonin, and dopamine in the synaptic cleft. To call any particular medication an antihypertensive, an antipsychotic, an antidepressant, or an anticonvulsant is actually a misnomer and really reflects the prospective population that a particular medication is geared toward when released to the public, and not the broad range of results of which the medicine is capable. It also reflects the cost that the companies go through in order to obtain FDA approval.
The FDA requires that each medication target a specific diagnosis in order to get approval. This is a hugely expensive enterprise for one diagnosis, that is exponentially greater for multiple diagnoses. Therefore, it is unlikely drug companies will submit studies for approval for more than one or two diagnoses, unless they can see some return on investment. Consequently, clinical practice is usually quite different from what are the Physicians' Desk Reference (a typical reference of all FDA approved prescription drugs) publishes. Clinical practice moves at a much faster pace than clinical trials and publications will keep track of.
Although clinical trials are thought to become the definitive proof of any particular medication's efficacy, astute clinical observations are what brought the largest drug discoveries towards the world and cannot be discounted simply because no study has yet to be published. There are two broad explanations why off-label use makes sense in psychiatry. First, psychiatric diagnoses don't fit into the neat little categories that the DSM-IV-TR tries to define. They generally have numerous overlapping symptoms.
For example, anhedonia, or loss of interest, can be seen in numerous conditions that include depression, schizophrenia, and frontal lobe damage. Many psychiatrists believe that medications should be prescribed to target the specific neurochemicals underlying such specific symptoms regardless of the DSM diagnosis. Off-label use is practiced with a clear rationale for another reason as well.
Human nature defies categories. Although there may be broad similarities between two individuals struggling with depression, it's doubtful that any one person is suffering in exactly the same way as another from both a biochemical standpoint along with a psychological standpoint.
Thus, one may respond to one particular therapy or antidepressant and not another, and the reasons result from the therapies' and antidepressants' biochemical differences, not their similarities. Therefore, off-label use in psychiatry is more the rule compared to exception.
Hospitalization is the highest degree of treatment. It is reserved for the most severe types of depression (as well as other mental disorders). One criterion used for determining the necessity of hospitalization may be the presence of suicidality. Having suicidal ideation does not automatically dictate a a hospital stay but prompts an inquiry into the patient's level of risk to harm oneself (varieties).
Hospitalization can also be indicated if a person's functional impairment is so poor that they're unable to care adequately for themselves (e.g., not able to get out of bed and not eating). Usually, depressed folks are willing to be hospitalized if recommended and therefore do so voluntarily. Situations exist, however, once the physician believes hospitalization is essential however the patient refuses. The doctor then needs to decide if the person should be admitted involuntarily.
Criteria for involuntary admission differs from state to state, but it is generally not easy to admit someone against his or her will. Most states have mental hygiene laws in place to protect patient's rights. Typically, dangerousness to self varieties is the criterion necessary to commit someone. Usually an appeal process is available to this type of patient as well.
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