Question A

Atypical antipsychotics has been approved by the FDA for the treatment of bipolar disorder and schizophrenia. Recently, it is being used off-label to treat behavioral and psychological symptoms of dementia (BPSD). This is after several trials indicated that it had the ability to produce the desired effects in this regard. “Atypical antipsychotics are not characterized by debilitating side effects that accompany conventional antipsychotics, such as extrapyramidal symptoms and tardive dyskinesia” (Desai et al., 2012). As a result, this has made atypical antipsychotics the preferred choice for controlling psychotic symptoms. This includes symptoms of dementia-like hallucinations and delusions. Atypical antipsychotics have also become useful in treating behavioral symptoms such as wandering, aggression and agitation. This due to the evidence of various controlled clinical trials showing its ability to work in this respect. However, in 2003, a warning was issued with regards to using risperidone; a class of the atypical antipsychotics. It was asserted that its increased usage puts patients under the risk of stroke. After a meta-analysis, in 2005, the FDA issued a warning of the increased risk of mortality with the usage of atypical antipsychotic. This is in comparison to the use of placebo. Use of atypical antipsychotics decreased as a result.

Question B

Acetylcholinesterase inhibitors are usually prescribed for patients suffering from mild to moderate Alzheimer’s dementia. The drugs achieve their effect by terminating impulse transmission through hydrolysis of the neurotransmitter acetylcholine. This takes place in both the peripheral and central nervous system. The drugs do not cure Alzheimer’s dementia. Available evidence indicates that they are only responsible for slowing down the damage that is being experienced. The drugs help the regions of the brain that have been damaged to function better. This aspect slows down the emergence of symptoms and helps improve the patient’s quality of life. Some patients do not seem to get any effect from the drugs while others are stabilized for a long time. Acetylcholinesterase inhibitors cannot be regarded as disease modifying. This is because they do not cure the disease. They only help to prevent or delay the onset of serious behavioral difficulties such as aggression, wandering, agitation, and anger. This helps to eliminate or reduce the need for antidepressants, anxiolytics, and antipsychotics.

Question C

FDA black box and MedWatch warnings have been effective in reducing the level of antipsychotics prescription to some extent. Before the warning years, atypical antipsychotic was mentioned in 12.5% of the doctor visits that involved dementia patients. “In the post warning years, the percentage had fallen to 11.5%” (Desai et al., 2012). This was an indication that some medical specialists had taken the warnings seriously. As a result, they did not mention this form of treatment to their patients. This had resulted in a 1% reduction in its mention. This was a significant step in reducing the treatment’s prescription given that it was very popular at the moment. “There were almost no mentions of conventional antipsychotics in any of the years” (Desai et al., 2012). This might also indicate the uncertainty of prescribers with this regard. Despite this decrease, there is no evidence for the substitution of atypical antipsychotics in relation to psychotropic medications. This was a clear indication that efficacy and safety of other drugs are considered to be controversial too.

The data should have shown some of the BPSD patients being switched to conventional antipsychotic in relation to the atypical antipsychotic warning, but it did not happen. This is an indication that the warning generally led to the reduction of antipsychotic prescriptions; be it atypical or conventional.

Question D

The warning resulted in the increased prescription of non-pharmacotherapies for patients with dementia. Between 2003 and 2004, percentage utilization of non-drug treatments was around 26%. There were changes in the following year when the FDA black box warning was issued. In 2005, the percentage utilization of non-pharmacotherapies was around 44%. This was an increase compared to the previous years. Given that this was the year when the warning was given, the response was quite significant. Utilization of non-drug treatments was high since people needed an alternative that would substitute atypical antipsychotics. Between 2006 and 2008, the percentage of patients that utilized non-drug treatments was around 34%. This was a decline compared to the year 2005. However, there was an increased utilization during this period compared to when the warning was not yet issued. As a result, it is safe to say that the warnings provided with regards to atypical antipsychotics worked in the favor of prescribing non-pharmacotherapies for psychological and behavioral symptoms of dementia.

Reference

Desai, V. C., Heaton, P. C., & Kelton, C. M. 2012, Impact of the Food and Drug Administration’s antipsychotic black box warning on psychotropic drug prescribing in elderly patients with dementia in outpatient and office-based settings. Alzheimer’s & Dementia, vol. 8, no. 5, pp. 453-457.

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