Need for Higher Regulation of SGA Prescribing for BPSD

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  • 88.4% of the elderly use at least one prescription drug in comparison to 48.3% of those ages 20-59
  • In 2002, 3.4 million people in the U.S. had dementia Generation Antipsychotics (SGA) are typically used to treat schizophrenia or bipolar disorder (off-label use in dementia, anxiety disorder, and OCD)Associated with lower risk of EPS in comparison to FGAOff-Label Use - Practice of prescribing medications in a manner not approved by the FDA
  • 4 major drugs prescribed to elderlyPub Med – maintained by the US National Library of Medicine (NLM) at the National Institute of Health (NIH) – database for MEDline, science, biomed
  • Olanzapine shown to have a favorable QTc interval (from schizostudie)Limited QTc on aripiprazole – one study on young tourettespts showed it modified from baseline but values were not significant


  • 1. Caitlyn CardettiAdvisor: Dr. Dawn Albertson
  • 2. • Fastest growing age group.• Often excluded from clinical trials.• Most likely age group to useprescription drugs.1 2 3-4 5+Number of Prescription DrugsRisk of Polypharmacy with AgeAges 20-59 Age 60+
  • 3. • Symptoms include but are not limited to:• Agitation• Irritability• Anxiety• Commonly treated with off label use of secondgeneration antipsychotics (SGA)• FGA vs. SGA
  • 4. • Identify appropriateness of SGA as treatment for BPSD• Efficacy• Possible Adverse Drug Effects (ADE)• Specific issues concerning the elderly• Exacerbation of Age-Associated Diseases• Drug Interactions
  • 5. • Use of broad search terms in PubMed database• Preliminary search found only 3 of 9 SGA to be effectivefor treatment of BPSD• Olanzapine• Risperidone• Aripiprazole• Each drug individually searched inwith the following categories:• Adverse Drug Effects (ADE)• Age-Associated Diseases• Polypharmacy
  • 6. • Cardiovascular Disease• Olanzapine – favorable QTc profile• Risperidone – increased risk of stroke, possible risk of QTprolongation• Aripiprazole – possible risk of QT prolongation• Diabetes• Olanzapine – associated with increased glucose levels• Risperidone – associated with a few cases ofhyperglycemia• Aripiprazole – no data
  • 7. • Donezepil (Aricept)• Treatment for mild to moderate Alzheimer’s Disease• Possible indication of increased movement disorders witholanzapine• Antidiuretics• Drugs that limit formation of urine• No literature available• Beta Blockers• Drugs commonly prescribed for HTN• Olanzapine is inhibited by a common beta blocker• Statins• Medication that lowers cholesterol• Possible increased risk of muscle breakdownwhen used with SGA114%214%3-431%5+41%Polypharmacy in those Age60+
  • 8. • Increase resources available for doctors whenprescribing• Need for further studies in exacerbation of age-associateddiseases and drug interactionsOlanzapine Risperidone AripiprazoleDonezepil- ? ?Antidiuretics? ? ?BetaBlockers- ? ?Statins- - -Olanzapine Risperidone AripiprazoleCV Disease+ - -/?Diabetes- - ?
  • 9. • Update the Beers Criteria
  • 10. • Update the Beers Criteria
  • 11. • Create standard guidelines for prescribing• Assurance that non-pharmacological interventions were tried butfailed• Evaluations for drug profiles based on patient’s current healthcondition• Recommendations for follow-ups
  • 12. • Cerejeira, J., Largarto, L., & Mukaetova-Ladinska, E. B. (2012). Behavioral andpsychological symptoms of dementia. Frontiers of Neurology, 3(73), doi:10.3389/fneur.2012.00073.• Maher, A., Maglione, M., Bagley, S., Suttorp, M., Hu, J., Ewing, B., Wang, Z., Timmer, M., &Shekelle, P.G. (2011). Efficacy and comparative effectiveness of atypical antipsychoticmedications for off-label uses in adults: A systematic review and meta-analysis. Journal ofAmerican Medical Association, 306(12), 1359-69. Retrieved from• Department of Health and Human Services, Administration of Aging. (2011). Aging statistics.Retrieved from website:• Chen, Y., Briesacher, B., Field, T., Tjia, J., Lau, D., & Gurwitz, J. (2011). Unexplainedvariation across u.s. nursing homes in antipsychotc prescribing rates. Archives of InternalMedicine, 170(1), 89-95. doi: 10.1001/archinternmed.2009/469• Gu Q, Dillon CF, Burt VL. Prescription drug use continues to increase: U.S. prescriptiondrug data for 2007-2008. NCHS data brief, no 42. Hyattsville, MD: National Center forHealth Statistics. 2010.• Agency for Healthcare Research and Quality, Effective Health Care Program. (2011). Off-label use of atypical antipsychotics: An update. comparative effectiveness review no.43 (Publication No. 11-EHC087-EF). Retrieved from AHRQ Publication website:• Jeste M.D., D., Dolder, Pharm.D., C., Nayak M.A., G., & Salzman M.D., C. (2005). Atypicalantipsychotics in elderly patients with dementia or schizophrenia: Review of recentliterature. Harvard Review of Psychiatry, 13, 340-351. doi: 10.1080|10673220500433247
  • 13. • (2012). American geriatrics society updated beers criteria for potentially inappropriatemedication use in older adults. Journal of American Geriatrics Society, doi: 10.1111/j.1532-5415/2012.03923/x• De Deyn, P., Katz, I., Brodaty, H., Lyons, B., Greenspan, A., & Burns, A. (2005).Management of agitation, aggression, and psychosis associated with dementia: A pooledanalysis including three randomized, placebo-controlled double-blind trials in nursing homeresidents treated with risperidone. Journal of Clinical Neurology and Neurosurgery, doi:10.1016/j/clineuro.2005.03.013• McShane, R., Keene, J., Gedling, K., Fairburn, C., Jacoby, R., & Hope, T. (1997). Doneuroleptic drugs hasten cognitive decline in dementia? Prospective study with necropsyfollow up. British Medical Journal,315(7076), 266-270. Retrieved from• Ballard C, Lana MM, Theodoulou M, Douglas S, McShane R, et al. (2008) ARandomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or StoppingNeuroleptics (The DART-AD Trial) . PLoSMed 5(4): e76. doi:10.1371/journal.pmed.0050076Strait, J. B., & Lakatta, E. G. (2012).Aging-associated cardiovascular changes and their relationship to heart failure. HeartFailure Clinics, 8(1), 143-164. doi: 0.1016/j.hfc.2011.08.01• Glassman, A., & Bigger Jr., J. (2001). Antipsychotic drugs: prolonged qtc interval, torsade depointes, and sudden dath . American Journal of Psychiatry,158(11), 1774-82. Retrievedfrom• Lindborg, S., Beasley, C., Alaka, K., & Taylor, C. (2003). Effects of intramsucular olaznapinevs. haloperiodol and placebo on qtc intervals in acutely agitated patients. PsychiatryResearch Journal, 119(1-2), 113-23. Retrieved from
  • 14. • Gulisano, M., Cali, P., Cavanna, A., Eddy, C., Rickards, H., & Rizzo, R. (2011).Cardiovascular safety of aripiprazole and pimozide in young patients with tourettesnydrome. Journal of Neurological Sciences, 32(6), 1213-7. Retrieved from• tminan, M., Streiner, D., & Ronchon, P. (2003). Exploring the association between atypicalneuroleptic agents and diabetes mellitus in older adults.Pharmacotherapy, 23(11), 1411-5.Retrieved from• Kroner Pharm.D., B.C.P.S., B. (2002). Common drug pathways and interactions. DiabetesSpectrum, 15(4), 249-255. doi: 10.2337/diaspect.15.4.249• Nirogi, R., Bjyrapuneni, G., Kandikere, V., Benade, V., Muddana, N., Saralaya, R., Irappanavar, S., Ponnamaneni, R., & Mukkanti, K. (2012). Concurrent administration of atypicalantipsychotics and donepezil: drug interaction study in rats. European Journal of DrugMetabolism and Pharmacokinetics, Retrieved from• van den Heuvel, O., Bet, P., van Dam, E., & Eeckhout, A. (2006). The syndrome ofinappropriate antidiuretic hormone secretion (siadh) during treatment with the antipsychoticagents haloperidol and quetiapine.Ned Tijdschr Geneeskd, 150(35), 1944-8. Retrieved from• Atalay, A., Turnhan, N., & Aki, O. (2007). A challenging case of syndrome of inappropriatesecretion of antidiuretic hormone in an elderly patient secondary to quetiapine. SouthernMedical Journal, 100(8), 832-3. Retrieved from
  • 15. • Webber, M., Mahmud, W., Lightfoot, J., & Shekhar, A. (2004). Rhabdomyolysis andcompartment syndrome with coadministration of risperidone and simvastatin. Journal ofPsychopharmacology,18(3), 432-4. Retrieved from• Patier, J., Ferrere, F., Moreno-Cobo, M., & Echaniz, A. (2007). Rhabdomyolysis caused byassociation of simvastatin and risperidone. Medicina clinica ,129(11), 439. Retrieved from• Vivves, S., Batlle, M., Motane, E., & Ribera, J. (2008). Rhabdomyolysis and renal failuresecondary to interaction between simvastatin, ciclosporin a and risperidone in an allogeneicstem cell transplantation patient. Medicina clinica , 131(17), 676. Retrieved from• Walder, A., & Baumann, P. (2009). Mood stabilizer therapy and pravastatin: higher risk foradverse skin reactions?. Acta Medica, 52(1), 15-18. Retrieved from• Ohaski, K., Hamamura, T., Lee, Y., Fujiwara, Y., Suzuki, H., & Kuroda, S. (2000). Clozapine-and olanzapine-induced fos exression in the rat medial prefrontal cortex is mediated bybeta-adrenoceptors. Neuropsychopharmacology,23(2), 162-9. Retrieved from