Opioid prescriptions increased 300 percent from 1999 to 2010, and there was a 400 percent increase in deaths related to drug overdose during the same period. To combat the national prescription drug abuse epidemic, CVS Caremark has created a program that will monitor practices of clinicians who prescribe highly addictive drugs.
Reported in the New England Journal of Medicine, CVS Caremark evaluated its pharmacy submission records on 42 physicians with extreme and apparently unjustifiable practices of prescribing hydrocodone, oxycodone, alprazolam, or methadone. The clinicians were asked to provide additional information about their prescription patterns.
Only six identified legitimate reasons for their unusual prescribing practices; the rest failed to respond or gave insufficient reasoning for their actions. As a result, CVS Caremark suspended controlled substance dispensing for 36 providers.
“While this program is not a comprehensive solution to prescription drug abuse, it is an important first step that is in line with the ethical duty pharmacists have to ensure that a prescription for a controlled substance is appropriate,” said Mitch Betses, R.Ph., CVS’s senior vice president of pharmacy services and a coauthor of the report. “We know there are many ways to fight prescription drug abuse, and we are committed to continuing to identify solutions to stop the improper use of controlled substances.”
Betses M, Brennan T. “Abusive Prescribing of Controlled Substances—A Pharmacy View.” 2013. NEJM. Aug 21 [Epub ahead of print] http://www.nejm.org/doi/full/10.1056/NEJMp1308222.
Study Assesses Mortality Risk of Numerous Psychotropics
There has been much debate on whether pharmacologic interventions increase mortality risk in patients with severe psychiatric illness. A study in JAMA Psychiatry attempted to clarify the issue.
Lead author Arif Khan, M.D., of the Northwest Clinical Research Center in Bellevue, Wash., and colleagues analyzed mortality rates of nearly 100,000 adults with mental illness who participated in 28 drug clinical trials submitted to the FDA from 1990 to 2011. The study examined mortality rates of individuals with or without mental illness and those receiving antipsychotics or placebo.
The results showed that patients with schizophrenia, depression, or bipolar disorder had the highest risk for mortality among individuals with psychiatric illnesses and those without psychiatric illness. In addition, the study found that administration of atypical antipsychotics, selective serotonin reuptake inhibitors, and selective serotonin-norepinephrine reuptake inhibitors did not increase risk of mortality when compared with placebo, whereas heterocyclic antidepressants, such as imipramine and amitryptiline, did. Suicide accounted for 41 percent of the deaths.
The authors said that “the FDA may have data on more than 20,000 patients for individual psychotropic agents, but the SBA [Summary Basis of Approval] reports in general include data on approximately 3,000 to 5,000 patients, with even fewer data in supplemental new drug applications. Further detailed analysis of the clinical trial data by the FDA or the pharmaceutical companies is required before any firm conclusions can be drawn.”
Khan A, Faucett J, Morrison S, Brown WA. “Comparative Mortality Risk in Adult Patients With Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, and Attention-Deficit/Hyperactivity Disorder Participating in Psychopharmacology Clinical Trials.” 2013. JAMA Psychiatry. Aug 28. [Epub ahead of print] http://archpsyc.jamanetwork.com/article.aspx?doi=10.1001/jamapsychiatry.2013.149.
In August Mylan Inc. confirmed that it received Food and Drug Administration (FDA) approval of its bioequivalence study of 300 mg bupropion hydrocholoride (HCl) extended-release (ER) tablets. Bupropion HCl ER tablets are the generic form of Wellbutrin and are used to treat depression.
Mylan submitted the study results in April in response to an FDA request for all generic drug companies marketing bupropion ER tablets to conduct a fasting-state comparison study with Wellbutrin. Mylan’s bupropion HCl tablets were introduced to the United States market in 2010.
Schizophrenia Bulletin published a study evaluating the impact of dose reductions of the atypical antipsychotics risperidone and olanzapine in 61 individuals with stable schizophrenia. The patients were divided into two groups: those receiving 50 percent less of their initial dose of risperidone or olanzapine, and those who maintained a constant dose. Cognitive decline was assessed with the Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS).
At the six-month follow-up, the reduction group showed significantly greater improvement in total RBANS and DIEPSS scores than the constant-dose group.
According to the researchers, it was the first study to show how dose reduction of antipsychotics can be beneficial in improving cognitive function in patients with stable psychosis.
Takeuchi H, Suzuki T, Remington G, et al. “Effects of Risperidone and Olanzapine Dose Reduction on Cognitive Function in Stable Patients With Schizophrenia….” 2013 Schizophr Bull.;39(5):993-8. http://schizophreniabulletin.oxfordjournals.org/content/39/5/993.long. ■