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15187
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1. Global HIV/AIDS Initiative Nigeria (GHAIN). Pharmacovigilance for Antiretroviral Drugs, Training of Health Care Professionals, Participant’s Manual, 2009. 2. Sim SC, Kacevska Mand Ingelman-Sundberg M. Pharmacogenomics of drug-metabolizing enzymes: a recent update on clinical implimentations and endogenous effects. The Pharmacogenomic Journal.13; 2013:1-11. Available from: http://www.nature.com/tpj/journal/v13/n1/pdf/tpj201245a.pdf 3. Daly AK. Pharmacogenomics of adverse drug reactions. Genome medicine. 5(5); 2013: 1-12. Available from: URL: http://genomemedicine.com/content/pdf/gm409.pdf 4. U.S. Department of Health and Human Services (USDHHS). Guidance for Industry. Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labelling. 2013. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegu latoryInformation/Guidances/UCM337169.pdf 5. Bannur Z, Rahaman, Salleh MZ and Teh LK. Pharmacogenomics Based Practice in Malaysia: The Attitude, Knowledge and Adoption by the Healthcare Professionals. IMJM. 13(1); 2014: 41-50. Available from URL: http://iiumedic.net/imjm/v1/download/Volume%2013%20No%2 01/IMJM%20Vol%2013%20No%201%20p41-50.pdf 6. Kitzmiller JP, Groen DK, Phelps MAand Sadee W. Pharmacogenomic testing: Relevance in medical practice: Why drugs work in some patients but not in others. Cleve Clin J Med. 78(4);2011: 243–257. doi:10.3949/ccjm.78a.10145. Available from: URL: http://www.ccjm.org/content/78/4/243.full.pdf+html 7. Djordjevic N and Jankovic S. Pharmacogenetics – The Future of the Drug Therapy. Acta Medica Medianae.46(2); 2007:56-60. Available from: URL: http://publisher.medfak.ni.ac.rs/2007- html/3-broj/PHARMACOGENETICS%20....pdf 8. Abubakar AR, Simbak NB and Haque M. Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment. Research J Pharm Tech. 7(9); 2014: 1091-1098. 9. U.S. Department of Health and Human Services Food and Drug Administration. 2008. Guidance for Industr-E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegu latoryInformation/Guidances/ucm073162.pdf 10. Strimbu K and Tavel JA. What are Biomarkers? Curr Opin HIV AIDS.5(6); 2010: 463–466. Available from: URL: doi:10.1097/COH.0b013e32833ed177: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078627/pdf/nih ms259967.pdf 11. Novelli G, Ciccacci C, Borgiani P, Amati MP and Abadie E. Genetic test and genomic biomarkers qualification and validation. Clin Cases Miner Bone Metab.5 (2);2008: 149-154. Available from URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2781197/pdf/Clin icalCases-5-0149.pdf 12. World Health Organization (WHO). The importance of Pharmacovigilance. Safety Monitoring of medicinal product.UK, 2002. Available from: URL: http://whqlibdoc.who.int/hq/2002/a75646.pdf 13. Lee A and Thomas SHL. Adverse drug reactions. In: Walker R and Edward C. Clinical Pharmacy and Therapeutics, Edited by Roger Walker.Churchill Livingstone, New York US. 2003; 3rd ed: pp. 33-46. 14. Lazarou J, Pomeranz BH and Corey PN. Incidence of adverse drug reactions in hospitalized patients - A meta-analysis of prospective studies. JAMA. 279(15); 1998: 1200-5. Available from: URL: http://jama.jamanetwork.com/article.aspx?articleid=187436 15. Uppsala Reports. For everyone concerned with the issues of Pharmacovigilance. The Uppsala monitoring Centre. 2013. Available from: URL: http://www.whoumc.org/graphics/27880.pdf 16. Stausberg J. International prevalence of adverse drug events in hospitals: an analysis of routine data from England, Germany, and the USA. BMC Health Serv Res. 14(125); 2014: 1-9. doi:10.1186/1472-6963-14-125 Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3984698/pdf/147 2-6963-14-125.pdf 17. Health Canada. Prescription Pharmaceuticals in Canada: Post Approval Monitoring of Safety and Effectiveness. Extract from the Journals of the Senate. 2011. Available from: URL:http://www.parl.gc.ca/Content/SEN/Committee/411/soci/re p/rep20mar13-e.pdf 18. Carleton B. Linking Pharmacovigilance and Pharmacogenomics. WHO- The Uppsala Monitoring Centre: Graphics. 2014. Available from: URL: http://www.whoumc.org/graphics/28152.pdf 19. World Health Organization (WHO). Area of works Pharmacovigilance, Geneva, Switzerland, 2013. Available from URL: www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/ (Accessed on 20/9/2014) 20. Giezen TJ, Mantel-Teeuwisse AK andLeufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf.32(10); 2009: 811-7.doi: 10.2165/11316550- 000000000-00000. Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/19722725 21. Lopez-Gonzalez E, Herdeiro MT and Figueiras A. Determinants of Under-Reporting of Adverse Drug Reactions. Drug Saf. 32(1); 2009: 19-31. 0114-5916/09/0001-0019/$49.95/0. Available from URL: http://www.rima.org/web/medline_pdf/DeterminantsofUnderRep orting.pdf 22. Aziz Z, Siang TC and Badarudin NS.Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 16(2); 2007: 223-8. Available from URL: http://onlinelibrary.wiley.com/doi/10.1002/pds.1313/pdf 23. Bakhouche H and Slanař O. Pharmacogenetics in Clinical Practice. Prague Medical Report. 113 (4); 2012: 251–261. Available from URL: http://pmr.cuni.cz/file/5637/PMR2012A0026.pdf (Accessed on 20/9/2014) 24. Sivadasan S, Yuong NY, Chyi NW, ChingALS, Ali AN, Veerasamy R, Marimuthub K andArumugama DS. Knowledge and Perception towards Pharmacovigilance and adverse drug reaction reporting among medicine and pharmacy students. World Jour Pharm Pharm Sc. 3(3); 2014: 1652-1676. Available from: URL: http://www.wjpps.com/download/article/1396446337.pdf 25. Upadhyaya P, Seth V, Moghe VV, Sharma M and Ahmed M. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college. Ther Clin Risk Manag. 8(19);2012: 307-12.doi: 10.2147/TCRM.S31482. Available from URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3387833/ 26. Hazell L and Shakir SAW. Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Saf. 29(5); 2006: 385- 396. Available from: URL:http://www.eecs.berkeley.edu/ ~daw/teaching/c79-s13/readings/AdverseDrugReactions.pdf 27. Sardas S. Pharmacogenovigilance – An Idea whose time has come. Current Pharmacogenomics and Personalized Medicine.8(1); 2010:1-3. Available from: URL:http://www.farmakovijilansdernegi.org/UserFiles/File/Pharmacogenovigilance.pdf 28. Sadee, W. Genomics and personalized medicine. Int J Pharm. 4(15); (2011):2–4. Available from: URL: http://www.sciencedirect.com/science/article/pii/S0378517311003759 29. USA Food and Drug Administration(FDA). Drugs, Science and Research (Drug).Additional research Area. Genomics.Table of Pharmacogenomic Biomarkers in Drug Labelling. 2014. Available fromhttp://www.fda.gov/drugs/scienceresearch/researchareas/pha rmacogenetics/ucm083378.htm 30. Clark DW, Donnelly E, Coulter DM, Roberts RL and Kennedy MA. Linking Pharmacovigilance with Pharmacogenetics. Drug Saf. 27(15); 2004:1172-1174. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15588114 31. Salleh MZ, Teh LK, Lee LS, Ismet RI, Patowary A , Joshi K, Pasha A, Ahmed AZ, Janor RM, Hamzah AS, Adam A, Yusoff K, Hoh BP, Hatta FHM, Ismail MI , Scaria V and Sivasubbu S. Systematic Pharmacogenomics Analysis of a Malay Whole Genome: Proof of Concept for Personalized Medicine. PLoS One. 8(8); 2013:1-10: DOI: 10.1371/journal.pone.0071554. Available from: URL: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjour nal.pone.0071554 32. Ma Q and Lu AY. Pharmacogenetics, Pharmacogenomics, and Individualized Medicine. Pharmacol Rev. 2011; 63 (2): 437-457. Available from URL: http://ec.europa.eu/digitalagenda/futurium/sites/futurium/files/futurium/library/Ma,%20Lu%20%202011%20%20Pharmacogenetic s,%20pharmacogenomics,%20and%20individualized%20medicin e.pdf 33. Li J, Zhang L, Zhou H, Stoneking M and Tang K. Global patterns of genetic diversity and signals of natural selection for human ADME genes. Hum Mol Genet.20(3); 2011: 528-540. doi: 10.1093/hmg/ddq498. Available from URL: http://hmg.oxfordjournals.org/content/20/3/528.full.pdf+html 34. Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E and Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 360(4); 2009: 354-62. doi: 10.1056/NEJMoa0809171 522. Available from: URL: http://www.nejm.org/doi/full/10.1056/NEJMoa0809171#t=article 35. Kaniwa N and Saito Y. Pharmacogenomics of severe cutaneous adverse reactions and drug-induced liver injury. J Hum Genet.58 (6); 2013: 317–326.doi:10.1038/jhg.2013.37. Available from: URL: http://www.nature.com/jhg/journal/v58/n6/pdf/jhg201337a.pdf 36. Johansson Iand Ingelman-Sundberg M. Genetic Polymorphism and Toxicology—With Emphasis on Cytochrome P450.Toxicol Sciences.120(1); 2011: 1–13. doi:10.1093/toxsci/kfq374. Available from: URL: http://toxsci.oxfordjournals.org/content/120/1/1.full.pdf+html 37. Ventola CL. Role of Pharmacogenomic Biomarkers in Predicting and Improving Drug Response Part 1: The Clinical Significance of Pharmacogenetic Variants.PT. 2013; 38(9): 545-560. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828931/pdf/ptj3 809545.pdf 38. Ma MK, Woo MH and McLeod HL. Genetic Basis of Drug Metabolism. Am J Health-Syst Pharm. 59 (21); 2002: 2061- 2069. 39. Pirmohamed M, Burnside G, Eriksson N, Jorgensen AJ, Cheng HT, Nicholson T, Kesteven P, Christersson C, Wahlström B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Anke H, Maitland-van der Zee, Williamson RP, Daly AK, Avery P, Kamali F, and Wadelius M. Randomized Trial of Genotype-Guided Dosing of Warfarin. N Engl J Med. 369(24); 2013: 2294-2303. Available from URL: http://www.nejm.org/doi/full/10.1056/NEJMoa1311386 40. Otsuka S, Yamamoto M, Kasuya S, Ohtomo H, Yamamoto Y, Yoshida TO and AkazaT. HLA antigens in patients with unexplained hepatitis following halothane anaesthesia. Acta Anaesthesiol Scand. 29(5); 1985:497-501. Available from URL: http://onlinelibrary.wiley.com/doi/10.1111/j.1399- 6576.1985.tb02242.x/article 41. Berson A, Freneaux E, Larrey D, Lepage V, Douay C, Mallet C, Fromentry B, Benhamou JP and Pessayre D. Possible role of HLA in hepatotoxicity – anexploratory-study in 71 patients with drug-induced idiosyncratic hepatitis. J Hepatol. 20(3); 1994:336- 342. Available from URL: http://www.journal-ofhepatology.eu/article/S0168-8278%2894%2980004-9/pdf 42. Stricker BH, Van den Broek JW, Keuning J, Eberhardt W, Houben HG, JohnsonM and Blok AP. Cholestatic hepatitis due to antibacterial combination of amoxicillin and clavulanic acid (augmentin). Dig Dis Sci. 34(10); 1989:1576-1580. Available from:URL: http://www.ncbi.nlm.nih.gov/pubmed/2791808 43. Chung WH, Hung SI, Hong HS, Hsih MS, Yang LC, Ho HC, Wu JY and Chen YT. Medical genetics: a marker for Stevens-Johnson syndrome. Nature. 428(6982); 2004: 486. Available from: URL: http://www.nature.com/nature/journal/v428/n6982/full/428486a.html 44. US Food and Drug Administration (FDA): Information for Healthcare Professionals. Dangerous or Even Fatal Skin Reactions - Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics). 2013. Available from URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketdrugsafetyinformationforPatientsandProviders/ucm124718.htm
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15187 https://intelek.unisza.edu.my/intelek/pages/view.php?ref=15187 https://intelek.unisza.edu.my/intelek/pages/search.php?search=!collection407072 Restricted Document Article Journal application/pdf Adobe Acrobat Pro DC 20 Paper Capture Plug-in with ClearScan 8 1.7 2024-08-30 10:09:24 5664-01-FH02-FP-15-03090.pdf UniSZA Private Access Pharmacogenovigilance: A Potential Tool in Pharmacovigilance Research Journal of Pharmacy and Technology Pharmacogenovigilance is a program which can be developed by integrating pharmacogenomics into a pharmacovigilance studies. The fact that genes play a vital role in variability in response to medicines makes pharmacogenomic of adverse drug reactions (ADRs) very essential program. Genetic variations have significantly affected the drug action in many patients, and a time predisposes patient to uncommon ADRs that are not seen in other patients. Pharmacogenetics provides greener path to individualized use of medicines, drug safety and efficacy studies due to genetic polymorphism. In order to explore these potential benefits, integration of pharmacogenovigilance in to clinical practice and public health system has become necessary. It is imperative for every medical practitioner to consider genetic factors in order to prescribe the best medication to his patients. Literature search using terms genetic biomarkers, application of pharmacogenetics and pharmacogenomics, and influence of pharmacogenetics on pharmacovigilance was done using PubMed, PhamaKG, US FDA and WHO websites. Several challenges facing drug safety and pharmacovigilance were highlighted and proposed pharmacogenomics approaches in solving them. The purpose of this article is to justify pharmacogenovigilance as an essential tool for drug safety and efficacy while providing the most feasible way for its successful integration in to the cycle of patients care. In conclusion, considerable progresses have been recorded on the potentials of pharmacogenovigilance in drug safety and efficacy study during post-marketing surveillance, and based on the provided evidences, the right time for pharmacogenovigilance is now. 7 12 1476-1482 1. Global HIV/AIDS Initiative Nigeria (GHAIN). Pharmacovigilance for Antiretroviral Drugs, Training of Health Care Professionals, Participant’s Manual, 2009. 2. Sim SC, Kacevska Mand Ingelman-Sundberg M. Pharmacogenomics of drug-metabolizing enzymes: a recent update on clinical implimentations and endogenous effects. The Pharmacogenomic Journal.13; 2013:1-11. Available from: http://www.nature.com/tpj/journal/v13/n1/pdf/tpj201245a.pdf 3. Daly AK. Pharmacogenomics of adverse drug reactions. Genome medicine. 5(5); 2013: 1-12. Available from: URL: http://genomemedicine.com/content/pdf/gm409.pdf 4. U.S. Department of Health and Human Services (USDHHS). Guidance for Industry. Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labelling. 2013. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegu latoryInformation/Guidances/UCM337169.pdf 5. Bannur Z, Rahaman, Salleh MZ and Teh LK. Pharmacogenomics Based Practice in Malaysia: The Attitude, Knowledge and Adoption by the Healthcare Professionals. IMJM. 13(1); 2014: 41-50. Available from URL: http://iiumedic.net/imjm/v1/download/Volume%2013%20No%2 01/IMJM%20Vol%2013%20No%201%20p41-50.pdf 6. Kitzmiller JP, Groen DK, Phelps MAand Sadee W. Pharmacogenomic testing: Relevance in medical practice: Why drugs work in some patients but not in others. Cleve Clin J Med. 78(4);2011: 243–257. doi:10.3949/ccjm.78a.10145. Available from: URL: http://www.ccjm.org/content/78/4/243.full.pdf+html 7. Djordjevic N and Jankovic S. Pharmacogenetics – The Future of the Drug Therapy. Acta Medica Medianae.46(2); 2007:56-60. Available from: URL: http://publisher.medfak.ni.ac.rs/2007- html/3-broj/PHARMACOGENETICS%20....pdf 8. Abubakar AR, Simbak NB and Haque M. Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment. Research J Pharm Tech. 7(9); 2014: 1091-1098. 9. U.S. Department of Health and Human Services Food and Drug Administration. 2008. Guidance for Industr-E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegu latoryInformation/Guidances/ucm073162.pdf 10. Strimbu K and Tavel JA. What are Biomarkers? Curr Opin HIV AIDS.5(6); 2010: 463–466. Available from: URL: doi:10.1097/COH.0b013e32833ed177: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078627/pdf/nih ms259967.pdf 11. Novelli G, Ciccacci C, Borgiani P, Amati MP and Abadie E. Genetic test and genomic biomarkers qualification and validation. Clin Cases Miner Bone Metab.5 (2);2008: 149-154. Available from URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2781197/pdf/Clin icalCases-5-0149.pdf 12. World Health Organization (WHO). The importance of Pharmacovigilance. Safety Monitoring of medicinal product.UK, 2002. Available from: URL: http://whqlibdoc.who.int/hq/2002/a75646.pdf 13. Lee A and Thomas SHL. Adverse drug reactions. In: Walker R and Edward C. Clinical Pharmacy and Therapeutics, Edited by Roger Walker.Churchill Livingstone, New York US. 2003; 3rd ed: pp. 33-46. 14. Lazarou J, Pomeranz BH and Corey PN. Incidence of adverse drug reactions in hospitalized patients - A meta-analysis of prospective studies. JAMA. 279(15); 1998: 1200-5. Available from: URL: http://jama.jamanetwork.com/article.aspx?articleid=187436 15. Uppsala Reports. For everyone concerned with the issues of Pharmacovigilance. The Uppsala monitoring Centre. 2013. Available from: URL: http://www.whoumc.org/graphics/27880.pdf 16. Stausberg J. International prevalence of adverse drug events in hospitals: an analysis of routine data from England, Germany, and the USA. BMC Health Serv Res. 14(125); 2014: 1-9. doi:10.1186/1472-6963-14-125 Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3984698/pdf/147 2-6963-14-125.pdf 17. Health Canada. Prescription Pharmaceuticals in Canada: Post Approval Monitoring of Safety and Effectiveness. Extract from the Journals of the Senate. 2011. Available from: URL:http://www.parl.gc.ca/Content/SEN/Committee/411/soci/re p/rep20mar13-e.pdf 18. Carleton B. Linking Pharmacovigilance and Pharmacogenomics. WHO- The Uppsala Monitoring Centre: Graphics. 2014. Available from: URL: http://www.whoumc.org/graphics/28152.pdf 19. World Health Organization (WHO). Area of works Pharmacovigilance, Geneva, Switzerland, 2013. Available from URL: www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/ (Accessed on 20/9/2014) 20. Giezen TJ, Mantel-Teeuwisse AK andLeufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf.32(10); 2009: 811-7.doi: 10.2165/11316550- 000000000-00000. Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/19722725 21. Lopez-Gonzalez E, Herdeiro MT and Figueiras A. Determinants of Under-Reporting of Adverse Drug Reactions. Drug Saf. 32(1); 2009: 19-31. 0114-5916/09/0001-0019/$49.95/0. Available from URL: http://www.rima.org/web/medline_pdf/DeterminantsofUnderRep orting.pdf 22. Aziz Z, Siang TC and Badarudin NS.Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 16(2); 2007: 223-8. Available from URL: http://onlinelibrary.wiley.com/doi/10.1002/pds.1313/pdf 23. Bakhouche H and Slanař O. Pharmacogenetics in Clinical Practice. Prague Medical Report. 113 (4); 2012: 251–261. Available from URL: http://pmr.cuni.cz/file/5637/PMR2012A0026.pdf (Accessed on 20/9/2014) 24. Sivadasan S, Yuong NY, Chyi NW, ChingALS, Ali AN, Veerasamy R, Marimuthub K andArumugama DS. Knowledge and Perception towards Pharmacovigilance and adverse drug reaction reporting among medicine and pharmacy students. World Jour Pharm Pharm Sc. 3(3); 2014: 1652-1676. Available from: URL: http://www.wjpps.com/download/article/1396446337.pdf 25. Upadhyaya P, Seth V, Moghe VV, Sharma M and Ahmed M. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college. Ther Clin Risk Manag. 8(19);2012: 307-12.doi: 10.2147/TCRM.S31482. Available from URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3387833/ 26. Hazell L and Shakir SAW. Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Saf. 29(5); 2006: 385- 396. Available from: URL:http://www.eecs.berkeley.edu/ ~daw/teaching/c79-s13/readings/AdverseDrugReactions.pdf 27. Sardas S. Pharmacogenovigilance – An Idea whose time has come. Current Pharmacogenomics and Personalized Medicine.8(1); 2010:1-3. Available from: URL:http://www.farmakovijilansdernegi.org/UserFiles/File/Pharmacogenovigilance.pdf 28. Sadee, W. Genomics and personalized medicine. Int J Pharm. 4(15); (2011):2–4. Available from: URL: http://www.sciencedirect.com/science/article/pii/S0378517311003759 29. USA Food and Drug Administration(FDA). Drugs, Science and Research (Drug).Additional research Area. Genomics.Table of Pharmacogenomic Biomarkers in Drug Labelling. 2014. Available fromhttp://www.fda.gov/drugs/scienceresearch/researchareas/pha rmacogenetics/ucm083378.htm 30. Clark DW, Donnelly E, Coulter DM, Roberts RL and Kennedy MA. Linking Pharmacovigilance with Pharmacogenetics. Drug Saf. 27(15); 2004:1172-1174. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15588114 31. Salleh MZ, Teh LK, Lee LS, Ismet RI, Patowary A , Joshi K, Pasha A, Ahmed AZ, Janor RM, Hamzah AS, Adam A, Yusoff K, Hoh BP, Hatta FHM, Ismail MI , Scaria V and Sivasubbu S. Systematic Pharmacogenomics Analysis of a Malay Whole Genome: Proof of Concept for Personalized Medicine. PLoS One. 8(8); 2013:1-10: DOI: 10.1371/journal.pone.0071554. Available from: URL: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjour nal.pone.0071554 32. Ma Q and Lu AY. Pharmacogenetics, Pharmacogenomics, and Individualized Medicine. Pharmacol Rev. 2011; 63 (2): 437-457. Available from URL: http://ec.europa.eu/digitalagenda/futurium/sites/futurium/files/futurium/library/Ma,%20Lu%20%202011%20%20Pharmacogenetic s,%20pharmacogenomics,%20and%20individualized%20medicin e.pdf 33. Li J, Zhang L, Zhou H, Stoneking M and Tang K. Global patterns of genetic diversity and signals of natural selection for human ADME genes. Hum Mol Genet.20(3); 2011: 528-540. doi: 10.1093/hmg/ddq498. Available from URL: http://hmg.oxfordjournals.org/content/20/3/528.full.pdf+html 34. Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E and Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 360(4); 2009: 354-62. doi: 10.1056/NEJMoa0809171 522. Available from: URL: http://www.nejm.org/doi/full/10.1056/NEJMoa0809171#t=article 35. Kaniwa N and Saito Y. Pharmacogenomics of severe cutaneous adverse reactions and drug-induced liver injury. J Hum Genet.58 (6); 2013: 317–326.doi:10.1038/jhg.2013.37. Available from: URL: http://www.nature.com/jhg/journal/v58/n6/pdf/jhg201337a.pdf 36. Johansson Iand Ingelman-Sundberg M. Genetic Polymorphism and Toxicology—With Emphasis on Cytochrome P450.Toxicol Sciences.120(1); 2011: 1–13. doi:10.1093/toxsci/kfq374. Available from: URL: http://toxsci.oxfordjournals.org/content/120/1/1.full.pdf+html 37. Ventola CL. Role of Pharmacogenomic Biomarkers in Predicting and Improving Drug Response Part 1: The Clinical Significance of Pharmacogenetic Variants.PT. 2013; 38(9): 545-560. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828931/pdf/ptj3 809545.pdf 38. Ma MK, Woo MH and McLeod HL. Genetic Basis of Drug Metabolism. Am J Health-Syst Pharm. 59 (21); 2002: 2061- 2069. 39. Pirmohamed M, Burnside G, Eriksson N, Jorgensen AJ, Cheng HT, Nicholson T, Kesteven P, Christersson C, Wahlström B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Anke H, Maitland-van der Zee, Williamson RP, Daly AK, Avery P, Kamali F, and Wadelius M. Randomized Trial of Genotype-Guided Dosing of Warfarin. N Engl J Med. 369(24); 2013: 2294-2303. Available from URL: http://www.nejm.org/doi/full/10.1056/NEJMoa1311386 40. Otsuka S, Yamamoto M, Kasuya S, Ohtomo H, Yamamoto Y, Yoshida TO and AkazaT. HLA antigens in patients with unexplained hepatitis following halothane anaesthesia. Acta Anaesthesiol Scand. 29(5); 1985:497-501. Available from URL: http://onlinelibrary.wiley.com/doi/10.1111/j.1399- 6576.1985.tb02242.x/article 41. Berson A, Freneaux E, Larrey D, Lepage V, Douay C, Mallet C, Fromentry B, Benhamou JP and Pessayre D. Possible role of HLA in hepatotoxicity – anexploratory-study in 71 patients with drug-induced idiosyncratic hepatitis. J Hepatol. 20(3); 1994:336- 342. Available from URL: http://www.journal-ofhepatology.eu/article/S0168-8278%2894%2980004-9/pdf 42. Stricker BH, Van den Broek JW, Keuning J, Eberhardt W, Houben HG, JohnsonM and Blok AP. Cholestatic hepatitis due to antibacterial combination of amoxicillin and clavulanic acid (augmentin). Dig Dis Sci. 34(10); 1989:1576-1580. Available from:URL: http://www.ncbi.nlm.nih.gov/pubmed/2791808 43. Chung WH, Hung SI, Hong HS, Hsih MS, Yang LC, Ho HC, Wu JY and Chen YT. Medical genetics: a marker for Stevens-Johnson syndrome. Nature. 428(6982); 2004: 486. 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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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Pharmacogenovigilance is a program which can be developed by integrating pharmacogenomics into a pharmacovigilance studies. The fact that genes play a vital role in variability in response to medicines makes pharmacogenomic of adverse drug reactions (ADRs) very essential program. Genetic variations have significantly affected the drug action in many patients, and a time predisposes patient to uncommon ADRs that are not seen in other patients. Pharmacogenetics provides greener path to individualized use of medicines, drug safety and efficacy studies due to genetic polymorphism. In order to explore these potential benefits, integration of pharmacogenovigilance in to clinical practice and public health system has become necessary. It is imperative for every medical practitioner to consider genetic factors in order to prescribe the best medication to his patients. Literature search using terms genetic biomarkers, application of pharmacogenetics and pharmacogenomics, and influence of pharmacogenetics on pharmacovigilance was done using PubMed, PhamaKG, US FDA and WHO websites. Several challenges facing drug safety and pharmacovigilance were highlighted and proposed pharmacogenomics approaches in solving them. The purpose of this article is to justify pharmacogenovigilance as an essential tool for drug safety and efficacy while providing the most feasible way for its successful integration in to the cycle of patients care. In conclusion, considerable progresses have been recorded on the potentials of pharmacogenovigilance in drug safety and efficacy study during post-marketing surveillance, and based on the provided evidences, the right time for pharmacogenovigilance is now.
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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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Pharmacogenovigilance: A Potential Tool in Pharmacovigilance
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pharmacogenovigilance: a potential tool in pharmacovigilance
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