Important Information

Mental Health and Pharmacogenetics

  • A FD. U.S. Food and Drug Administration. Table of Pharmacogenomic Biomarkers in Drug Labeling n.d. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm.
  • Hicks JK, Swen JJ, Thorn CF, Sangkuhl K, Kharasch ED, Ellingrod VL, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Tricyclic Antidepressants. Clin Pharmacol Ther 2013;93:402–8. doi:10.1038/clpt.2013.2.
  • Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther 2015;98:127–34. doi:10.1002/cpt.147.
  • Han C, Wang S-M, Bahk W-M, Lee S-J, Patkar AA, Masand PS, et al. A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci 2018;16:469–80. doi:10.9758/CPN.2018.16.1.469.
  • Hall-Flavin DK, Winner JG, Allen JD, Jordan JJ, Nesheim RS, Snyder KA, et al. Using a pharmacogenomic algorithm to guide the treatment of depression. Transl Psychiatry 2012;2:e172. doi:10.1038/tp.2012.99.
  • Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, et al. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics 2013;23:535–48. doi:10.1097/FPC.0b013e3283649b9a.
  • Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med 2013;16:219–27.
  • Espadaler J, Tuson M, Lopez-Ibor JM, Lopez-Ibor F, Lopez-Ibor MI. Pharmacogenetic testing for the guidance of psychiatric treatment: a multicenter retrospective analysis. CNS Spectr 2016:1–10. Apr 21 [Epub ahead of print]. doi:10.1017/S1092852915000711.
  • Perez V, Salavert A, Espadaler J, Tuson M, Saiz-Ruiz J, Saez-Navarro C, et al. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry 2017;17:250. doi:10.1186/s12888-017-1412-1.
  • Tadić A, Helmreich I, Mergl R, Hautzinger M, Kohnen R, Henkel V, et al. Early improvement is a predictor of treatment outcome in patients with mild major, minor or subsyndromal depression. J Affect Disord 2010;120:86–93. doi:10.1016/J.JAD.2009.04.014.
  • van Calker D, Zobel I, Dykierek P, Deimel CM, Kech S, Lieb K, et al. Time course of response to antidepressants: Predictive value of early improvement and effect of additional psychotherapy. J Affect Disord 2009;114:243–53. doi:10.1016/J.JAD.2008.07.023.
  • Winner JG, Carhart JM, Altar CA, Goldfarb S, Allen JD, Lavezzari G, et al. Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation. Curr Med Res Opin 2015:1–11. doi:10.1185/03007995.2015.1063483.
  • Espadaler J, Carcedo D, Pérez-Mitru A, Menchón J, Saiz-Ruiz J, Bobes J, et al. Cost-Consequence Analysis of Using Neurofarmagen In The Decision-Making Process During The Treatment of Patients With Depression In The US. Value Heal 2017;20:A713.
  • Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pr 2006;12:71–9.

What is Pharmacogenomics (PGx)?

Pharmacogenomics is the study of genetic differences in metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects.

Why PGx (Pharmacogenomic) testing?

  1. Adverse Drug Reactions are on the rise in the US. There are over 100,000 deaths and 2 Million adverse drug events in the US annually. Many of these could be prevented if the physician knew the patient could not tolerate certain medicationsADR’s are now the 4th leading cause of death in the US
  2. Most physicians are not familiar with RAW genetic results – PGx testing and results enable the physician to determine which
    medications to prescribe based on the individual
  3. Enhancing Patient Outcomes through molecular screening
    1. The average post-acute care nursing home patient is on 15.2 medications.
    2. The costs have become unsustainable
    3. Many of the drugs are offsetting side effects not targeting clinical efficacy
    4. Over-prescribing is a band-aid approach to eliminate readmissions to the hospitals
  4. Physicians are under intense pressure to act responsibly and often conservatively

How do you determine who should be tested?

Evidence-based protocols based on medical necessity assist and guide physicians to determine which patients to test based on the following criteria:

Patient Type Criteria
New Patients No treatment history for the condition/medication
All Patients History of medication sensitivity or ADEs to current meds.
All Patients Failure of previous medications to provide therapeutic value
All Patients On multiple medications
All Patients Experiencing unpleasant or intolerable side effects of current meds
All Patients Suspected of abusing or diverting medication

How does PGx testing benefit the patient?

  • Not everyone responds to a drug or medication in the same way
  • Each individual has their own unique genetic makeup, which affects the way their bodies respond to a disease and treatment
  • PGx uses information about a person’s genetic make up to choose the drugs and drug doses that are likely to work best for that person as well as determining the proper drug-to-drug combinations

How does PGx testing benefit the physician?

  1. Improve & revolutionize patient care though PGx testing
  2. Actionable data at the point of care
  3. Tools to follow medical necessity protocols and track outcomes
  4. Incorporating personalized medicine techniques is a competitive advantage
  5. Provides ancillary revenue source for your practice (Precision Genetics LCS Model)

What gene panels do we offer? (See attached PGx panel list)

  1. Pain
  2. Psych
  3. Cardio
  4. Comprehensive

YOUR MEDICINES SHOULD WORK, RIGHT?

They should but they may not. Your unique genetics means your medicine may not be working right…or not working at all. Let Precision Genetics help your healthcare provider identify the best plan for your prescription medication.