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Last Updated: 1/30/2014

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Safe Medication Use as an Essential Component of Wellness among People with Mental Health Problems

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Challenge

Tens of millions of people in the United States use prescription and over-the-counter (OTC) medications. As many as 3 billion prescriptions are written annually1 with an estimated 10 million adults (5.5 percent) reporting psychotropic medication use during a 1-month period.2

Too many people, however, suffer unnecessary discomfort, injuries, and even death as a result of preventable errors from all types of medications.3 Each year, adverse events from drug use result in more than 4 million visits to emergency departments, doctors' offices, or other outpatient settings,4 and 117,000 hospitalizations.5

Between 11 percent6 and 50 percent7 of injuries associated with pharmaceutical use could be prevented with currently available knowledge. The Institute of Medicine (IOM) estimates that at least 1.5 million preventable adverse drug events occur within the healthcare system each year at a cost in excess of $4 billion.8 The amount of preventable harm from OTC medication use is not known.

Few published studies have examined medication errors related specifically to psychotropic medication use, though one review of the charts of 31 patients in a state psychiatric hospital detected 2,194 medication errors during the patients' collective 1,448 inpatient days. Of those errors, 58 percent were judged to have the potential to cause severe harm.9

Change in body weight is a possible adverse effect of a number of psychotropic drugs10,11 and second generation antipsychotic medications are especially associated with weight gain, dyslipidemia, insulin resistance, and the metabolic syndrome.12 Weight gain in turn increases the risk of developing diabetes mellitus, coronary artery disease, and other health problems.13,14 Medications with sedative properties may alter metabolism, compounding the problem. Moreover, patients who are receiving treatment may eat more as their appetite and well-being improve. Additionally, psychotropic medications may mask or contribute to symptoms of medical illness15 and reduce pain sensitivity.16 These effects are an important consideration in the selection of pharmacological therapy.17

Polypharmacy—the use of multiple antipsychotic agents—is a common practice that requires consideration of its safety and efficacy as a mode of treatment for persons with psychiatric disorders. It is associated with several inherent negative consequences, including increased risk for medication-related adverse events and drug interactions. The long-term effects remain largely unknown.18 And the issue of potential adverse results from polypharmacy may be exacerbated by a lack of coordinated care among various healthcare providers, leading to unintended drug interactions. While polypharmacy may be effective in some cases, prescribing must focus on helping the consumer as a whole, rather than on simply treating symptoms. Consumer involvement in the assessment of risks and benefits when making medication decisions helps balance the desire for symptom resolution against the risk of increased medication burden.19

The many potentially avoidable injuries and deaths resulting from medication errors, unintentional exposures, drug-drug interactions, drug abuse, misuse, or self-harm represent a collective failure to adequately manage medication risks. Some known side effects are avoidable. Many times a known side effect can be prevented by more judicious prescribing, better consumer-provider communication, or optimal monitoring.20

Improving knowledge, safety, and quality in the medication-use system requires a shift toward a patient-centered model of care based on consumer-provider partnerships and communication. One of the most effective ways to reduce medication errors is to move toward a model of health care where there is more of a partnership between consumers and health care providers21 and where consumers are aware of and consider medication alongside alternative types of wellness interventions.

As the U.S. Food and Drug Administration (FDA) and other stakeholders work to improve how the healthcare system manages medication risks in the United States, it is recognized that more needs to be done to protect the public from preventable harm from medication use. And all participants in the healthcare community—consumers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, FDA, and other Federal agencies—have a role to play.22 The FDA believes that many drug?related risks can be managed, reducing the incidence of preventable injury. This type of harm is the target of the Safe Use Initiative, which is bringing together various parts of the healthcare system to develop interventions that measurably reduce preventable harm from medications. The Safe Use Initiative is designed to combat medication misuse and errors.

Goals

Participants will:

  • understand FDA's approach to the management of drug-related risks, harm reduction, and the reduction of medication misuse and errors through the Safe Use Initiative;
  • become familiar with the trade-offs to be considered in making informed decisions about medication use; and
  • be aware of various tools and resources to support consumer-provider dialogue around medication and other treatment options.

Target Audiences

  • Consumers, survivors, current and past recipients of mental health services, peers, family members, and mental health organizations
  • Mental health providers
  • Primary care providers

Presenters

Karen D. Weiss, M.D., M.P.H., is the lead for the Safe Use Initiative in the FDA's Center for Drug Evaluation and Research. Under this initiative, FDA will create partnerships with the healthcare community to improve the safe use of marketed prescription and non-prescription medicines. In her 20 years at FDA, Dr. Weiss has been involved in a variety of activities, including regulation of therapeutic biologicals, pediatric drug development, oncology drug development, and now, drug safety. She received her undergraduate and medical degrees at The Ohio State University, completed a pediatric residency in Grand Rapids, MI, and a Pediatric Hematology-Oncology fellowship at St. Jude Children's Research Hospital. She was an assistant professor at Georgetown University before she joined FDA, and earned her M.P.H. from Johns Hopkins University.

Gerald "Jerry" Overman, PharmD., B.C.P.P., is the clinical pharmacy specialist for the National Institute of Mental Health, part of the National Institutes of Health (NIH). He received his Doctor of Pharmacy Degree from the University of Arizona and completed 3 years of postdoctoral residency and fellowship training at the University of Texas College of Pharmacy and the University of Texas Health Science Center at San Antonio. He became Board Certified in Psychiatric Pharmacy Practice in 1996. Dr. Overman worked for 5 years as the clinical pharmacy specialist in psychiatry/substance abuse at The South Texas Veterans Health Care System and clinical assistant professor at the University of Texas Health Science Center and the University of Texas at Austin College of Pharmacy. Prior to joining the NIH, he held a clinical faculty position at the University of Illinois within the Departments of Pharmacy Practice and Psychiatry in the areas of neuropsychiatry and addiction. His areas of interest include the pharmacological management of psychotic, mood, and substance use disorders and the deleterious effect of substance use disorders on other major psychiatric disorders (dual diagnosis).

Mark Davis, M.A., has used his experiences and skills to promote social inclusion, inspire others in similar circumstances, and effect change in both the health and behavioral health systems. He is a proud gay man who is recovering from addictions and living with a mental illness, hearing loss, and HIV. He is a leader in several communities including mental health consumers/survivors, suicide attempt survivors, individuals with disabilities, and those representing sexual and gender minorities. Mr. Davis has inspired the development of more than 75 peer-run groups and cross-system collaborations. He also has affected the development of culturally competent research, funding, data collection, and services for lesbian, gay, bisexual, transgender, intersex, and questioning citizens, as well as those receiving mental health services and people living with HIV/AIDS. He is the founding president of the Pennsylvania Mental Health Consumers' Association and facilitates Pink & Blues, a Depression and Bipolar Support Alliance peer-run recovery, support, and advocacy group for persons living with a mental illness who identify as LGBTIQ.


1 U.S. Department of Health and Human Services, Food and Drug Administration (2009). FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.

2 Palouse-Ram, R., Jonas, B.S., Orwig, D., and Safran, M.A. (2004). Prescription psychotropic medication use among the U.S. adult population: results from the third National Health and Nutrition Examination Survey, 1988-1994. Journal of Clinical Epidemiology. 57(3): 309-317.

3 U.S. Department of Health and Human Services, Food and Drug Administration (2009). FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.

4 Zhan, C., Arispe, I., Kelley, E., et al. (2005). Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Joint Commission Journal on Quality and Patient Safety. 31(7): 372.

5 Budnitz, D.A., Pollock, D.A., Weidenback, K.N., et al. (2006). National surveillance of emergency department visits for outpatient adverse drug events. Journal of the American Medical Association. 296(15): 1858.

6 Gandhi, T.K., Weingart, S.N., Borus, J., et al. (2003). Adverse drug events in ambulatory care. The New England Journal of Medicine. 348(16): 1556.

7 Gurwitz, J.H., Field, T.S., Avorn, J., et al. (2000). Incidence and preventability of adverse drug events in nursing homes. The American Journal of Medicine. 109: 87.

8 Committee on Identifying and Preventing Medication Errors, Aspden, P., Wolcott, J.A., Bootman, J.L., Cronenwett, L.R. eds. (2007). Preventing Medication Errors. Washington, DC: The National Academies Press.

9 Grasso, B.C., Genest, R., Jordan, C.W., Bates, D.W. (2003). Use of chart and record reviews to detect medication errors in a state psychiatric hospital. Psychiatric Services. 54(5): 677-681.

10 Vanina, Y., Podolskaya, A., Sedky, K., Shahab, H., Siddiqui, A., Munshi, F., and Lippmann, S. (2002). Body weight changes associated with psychopharmacology. Psychiatric Services. 53:842-847.

11 Berken, G., Weinstein, D., Stern, W. (1984). Weight gain: a side effect of tricyclic antidepressants. Journal of Affective Disorders. 7:133-138.

12 Parks, J., Svendsen, D., Singer, P., and Foti, M.E. eds. (2006). Morbidity and Mortality in People with Serious Mental Illness. Alexandria, VA: National Association of State Mental Health Program Directors.

13 Umbricht, D., Kane, J. (1996). Medical complications of new antipsychotic drugs. Schizophrenia Bulletin. 22:475-483.

14 Kawachi, I. (1999). Health consequences of weight gain. Therapeutic Advances in Psychoses. 7:1-3.

15 Parks, J., Svendsen, D., Singer, P., and Foti, M.E. eds. (2006). Morbidity and Mortality in People with Serious Mental Illness. Alexandria, VA: National Association of State Mental Health Program Directors.

16 Ibid.

17 Holden, J., Holden, U. (1970). Weight changes with schizophrenic psychosis and psychotropic drug therapy. Psychosomatics. 9:551-561.

18 NASMHPD Medical Directors Council (2001). NASMHPD Medical Directors' Technical Report on Psychiatric Polypharmacy. Alexandria, VA: National Association of State Mental Health Program Directors.

19 Ibid.

20 U.S. Department of Health and Human Services, Food and Drug Administration (2009). FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.

21 Committee on Identifying and Preventing Medication Errors, Aspden, P., Wolcott, J.A., Bootman, J.L., Cronenwett, L.R. eds. (2007). Preventing Medication Errors. Washington, DC: The National Academies Press.

22 U.S. Department of Health and Human Services, Food and Drug Administration (2009). FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.

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