Development and implementation of a pharmacist-managed clinical pharmacogenetics service.

PURPOSE The development and implementation of a pharmacist-managed clinical pharmacogenetics service are described. SUMMARY A pharmacist-managed clinical pharmacogenetics service was designed and implemented at an academic specialty hospital to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in the hospital's patients. A series of accredited educational seminars were conducted for our pharmacists to establish competencies in providing pharmacogenetic consults for the genes to be tested by the clinical pharmacogenetics service. The service was modeled after and integrated with an already-established clinical pharmacokinetics service. A steering committee was formed to evaluate the use of available tests, new evidence for implementation of additional tests, and other service quality metrics. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consultation. The consultation includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed. The service has been met with positive clinician feedback. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care. CONCLUSION The development of and experience with a pharmacist-managed clinical pharmacogenetics service are described. The program's success has depended on collaboration between the clinical laboratory and pharmacists, and pharmacists' pharmacogenetic recommendations have been well accepted by prescribers.

[1]  G. Koren,et al.  Codeine, ultrarapid-metabolism genotype, and postoperative death. , 2009, The New England journal of medicine.

[2]  Philip J Schneider,et al.  ASHP national survey of pharmacy practice in hospital settings: dispensing and administration--2008. , 2009, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[3]  M. Relling,et al.  Genetic Polymorphism of Inosine Triphosphate Pyrophosphatase Is a Determinant of Mercaptopurine Metabolism and Toxicity During Treatment for Acute Lymphoblastic Leukemia , 2009, Clinical pharmacology and therapeutics.

[4]  Shashi Amur,et al.  Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use , 2008, Pharmacotherapy.

[5]  J. Panetta,et al.  UGT1A1 promoter genotype correlates with SN-38 pharmacokinetics, but not severe toxicity in patients receiving low-dose irinotecan. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  Andrew A Somogyi,et al.  Pharmacogenetics of Opioids , 2007, Clinical pharmacology and therapeutics.

[7]  S. Amur,et al.  The Experience with Voluntary Genomic Data Submissions at the FDA and a Vision for the Future of the Voluntary Data Submission Program , 2007, Clinical pharmacology and therapeutics.

[8]  M. Relling,et al.  Thiopurine methyltransferase in acute lymphoblastic leukemia. , 2006, Blood.

[9]  Invader UGT1A1 molecular assay for irinotecan toxicity. A genetic test for an increased risk of toxicity from the cancer chemotherapy drug irinotecan (Camptosar). , 2006, The Medical letter on drugs and therapeutics.

[10]  M. Dubinsky,et al.  A Cost-Effectiveness Analysis of Alternative Disease Management Strategies in Patients with Crohn's Disease Treated with Azathioprine or 6-Mercaptopurine , 2005, The American Journal of Gastroenterology.

[11]  C. Raehl,et al.  Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy. , 2005, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[12]  B. Meshkin,et al.  Pharmacogenetic testing: proofs of principle and pharmacoeconomic implications. , 2005, Mutation research.

[13]  M. Schrappe,et al.  Thiopurine methyltransferase (TPMT) genotype and early treatment response to mercaptopurine in childhood acute lymphoblastic leukemia. , 2005, JAMA.

[14]  M. Pirmohamed,et al.  Cost-effectiveness analysis of HLA B*5701 genotyping in preventing abacavir hypersensitivity. , 2004, Pharmacogenetics.

[15]  Soma Das,et al.  Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[16]  M. Weinstein,et al.  HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[17]  S. Bae,et al.  Pharmacoeconomic analysis of thiopurine methyltransferase polymorphism screening by polymerase chain reaction for treatment with azathioprine in Korea. , 2003, Rheumatology.

[18]  J. Medicis,et al.  Polymorphisms and the Pocketbook: The Cost‐Effectiveness of Cytochrome P450 2C19 Genotyping in the Eradication of Helicobacter pylori Infection Associated with Duodenal Ulcer , 2003, Journal of clinical pharmacology.

[19]  B. Arondekar,et al.  Evidence of the Economic Benefit of Clinical Pharmacy Services: 1996–2000 , 2003, Pharmacotherapy.

[20]  J. Esdaile,et al.  Practical pharmacogenetics: the cost effectiveness of screening for thiopurine s-methyltransferase polymorphisms in patients with rheumatological conditions treated with azathioprine. , 2002, The Journal of rheumatology.

[21]  C. Heng,et al.  Thiopurine Methyltransferase Polymorphisms in a Multiracial Asian Population and Children With Acute Lymphoblastic Leukemia , 2002, Journal of pediatric hematology/oncology.

[22]  E. Oren,et al.  Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. , 2001, JAMA.

[23]  N. Peet,et al.  Pharmacogenomics: challenges and opportunities. , 2001, Drug discovery today.

[24]  M. Relling,et al.  Preponderance of thiopurine S-methyltransferase deficiency and heterozygosity among patients intolerant to mercaptopurine or azathioprine. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[25]  C. Destache,et al.  Individualized Pharmacokinetic Monitoring Results in Less Aminoglycoside‐Associated Nephrotoxicity and Fewer Associated Costs , 2001, Pharmacotherapy.

[26]  M. H. Ensom,et al.  Pharmacogenetics , 2001, Clinical pharmacokinetics.

[27]  M. Relling,et al.  Mercaptopurine therapy intolerance and heterozygosity at the thiopurine S-methyltransferase gene locus. , 1999, Journal of the National Cancer Institute.

[28]  H. McLeod,et al.  Thiopurine Methyltransferase Genotype Predicts Therapy-Limiting Severe Toxicity from Azathioprine , 1998, Annals of Internal Medicine.

[29]  W. Evans,et al.  Pharmacogenetics of cancer therapy: getting personal. , 1998, American journal of human genetics.

[30]  B. A. Bush,et al.  Collaboration between Pharmacy and Laboratory: Defining Total Allowable Error Limits for Therapeutically Monitored Drugs , 1998, The Annals of pharmacotherapy.

[31]  G. Lurcott,et al.  The effects of the genetic absence and inhibition of CYP2D6 on the metabolism of codeine and its derivatives, hydrocodone and oxycodone. , 1998, Anesthesia progress.

[32]  ASHP statement on the pharmacist's role in clinical pharmacokinetic monitoring. , 1998, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[33]  R. Weinshilboum,et al.  Human thiopurine methyltransferase pharmacogenetics: Gene sequence polymorphisms , 1997, Clinical pharmacology and therapeutics.

[34]  Ching-Hon Pui,et al.  Molecular Diagnosis of Thiopurine S-Methyltransferase Deficiency: Genetic Basis for Azathioprine and Mercaptopurine Intolerance , 1997, Annals of Internal Medicine.

[35]  J. Sheller,et al.  Pharmacogenetic determination of the effects of codeine and prediction of drug interactions. , 1996, The Journal of pharmacology and experimental therapeutics.

[36]  W. Evans,et al.  Azathioprine-induced myelosuppression in thiopurine methyltransferase deficient heart transplant recipient , 1993, The Lancet.

[37]  W. Evans,et al.  Altered mercaptopurine metabolism, toxic effects, and dosage requirement in a thiopurine methyltransferase-deficient child with acute lymphocytic leukemia. , 1991, The Journal of pediatrics.

[38]  R. Weinshilboum,et al.  Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukaemia , 1990, The Lancet.