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1. Farcas A, Bojita M. Adverse drug reactions in clinical practice: a causality assessment of a case of drug-induced pancreatitis. Journal of Gastrointestin Liver Dis. 18(3); 2009: 353-358 Available from: URL: http://www.ncbi.nlm.nih.gov /pubmed/19795031 2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. A meta-analysis of prospective studies. Journal of American Medical Association. 279(15); 1998: 1200- 1205 Available from: URL: http://www.ncbi.nlm. nih.gov/pubmed/9555760 3. Morimoto T, Gandhi TK, Fiskio JM, Seger AC, So JW, Cook EF. Development and validation of a clinical prediction rule for angiotensin-converting enzyme inhibitor induced cough. J. Gen. Intern. Med. 19 (6); 2004: 684–691. Available from: URL: http://www.citeulike.org/group/1012/article/563972 4. Andrade RJ, Robles M, Fernández-Castañer A, López-Ortega S, López-Vega MC, Lucena MI. Assessment of drug-induced hepatotoxicity in clinical practice: a challenge for gastroenterologists. World J Gastroenterol. 13 (3); 2007: 329– 340. Available from: URL:http://www.wjgnet.com/1007- 9327/pdf/v13/i3/329.pdf 5. Pirmohamed M, Kevin B, Kitteringham NR. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective. Chem. Res. Toxicol. 11 (9); 1998: 969–988. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC1884203/pdf/bcp0055-0486.pdf 6. WHO Definitions. WHO International Drug Monitoring: The role of national centers: Tech Rep Ser.1972 no. 498 Available from: URL: http://www.who.int/medicines/areas/quality_safety/ safety_efficacy/trainingcourses/definitions.pdf 7. Edward IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet. 356; 2000: 1255-1259. Available from: URL: http://www.scribd.com/doc/22293073/ Adverse-Drug-Reactions-Definitions-Diagnosis-And-Management 8. Lindquist M. The need for definitions in pharmacovigilance. Drug Saf. 30; 2007: 825-830. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3689877/ 9. Kachhadiya R, Kumar A, Bhatia RK. Prevalence of medication errors across the world. International Journal of Pharmaceutical Research. 1(3); 2009:21-34. Available from: URL: http://www.ijpronline.com/ViewArticleDetail.aspx?ID=36 10. Rockville Md. Taxonomy of Medication Errors. National Coordinating Council on Medication Error Reporting and Prevention. 1998. Available from: URL: http://www.nccmerp.org/medErrorTaxonomy.html 11. Rao KS, Mohanta GP, Manna PK, Kumar RV. Pharmacogenetics and Pharmacogenomics- A potential tool for individualization of drug therapy. International Journal of Pharmaceutical Research. 4(1); 2012: 1-4. Available from: URL: http://www.ijpronline.com/ViewArticleDetail.aspx?ID=152 12. Alomar MJ. Factors affecting the development of Adverse Drug Reactions. Saudi Pharmaceutical Journal. 2014; 22; 83-94. Available from: URL: http://ac.elscdn.com/S1319016413000170/1-s2.0-S1319016413000170- main.pdf?_tid=89627982-2049-11e4-811f 00000aacb35fandacdnat=1407646273_e571a8a3d975a6c975113 2977c8ba981 13. Bushardt RL, Massey EB, Simpson TW, Ariail JC, Simpson KN. Polypharmacy: misleading, but manageable. Clin Interv Aging. 3 (2); 2008: 383–389. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555477/pdf/hjm ph7201_0015.pdf 14. Chang Y, Huang SK, Tao P, Chien CW. Population based study on the association between acute renal failure (ARF) and the duration of polypharmacy. BMC Nephrol. 13 (96); 2012: 1-7. Available from: URL: http://www.biomedcentral.com/1471- 2369/13/96 15. Routledge PA, O’mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. BJCP. 57 (2); 2003: 121–126. Available from: URL: http://onlinelibrary.wiley.com/ doi/10.1046/j.1365-2125.2003.01875.x/full 16. Rochon PA, Gurwitz JH. Optimising drug treatment for elderly people: the prescribing cascade. BMJ. 315 (7115); 1997: 1096– 1099. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2127690/pdf/9366745.pdf 17. Buetow S, Elwyn G. Patient Safety and Patient Error. Lancet. 369 (9556); 2007:158-161. Available from: URL: http://www.thelancet.com/journals/lancet/article/PIIS0140- 6736%2807%2960077-4/fulltext?version=printerFriendly 18. Campbell JDA, Thompson M. Patient Safety Rounds: Description of an Inexpensive but Important Strategy to Improve the Safety Culture. American Journal of Medical Quality. 22(1); 2007:26-4. Available from: URL:http://ajm.sagepub.com/ content/22/1/26.full.pdf+html 19. Debellis K, Field TS, Gurwitz JH, Harrold LR, Rothschild J, Seger AC. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 289 (9); 2003: 1107–1116. Available from: URL: http://www.patientsafetyresearch.org/journal%20articles/Incindence_Preventability.pdf 20. Bates DW, Clapp MD, Federico F, Goldmann DA, Kaushal R, Landrigan C. Medication errors and adverse drug events in paediatric inpatients. JAMA. 285 (16); 2001: 1107–1116. Available from: URL:http://patientsafetyresearch.org/journal %20articles/Original%20267.pdf 21. Patel A, Ganguly B. Analysis of dose calculation of medicines prescribed in paediatric age group. International Journal of Pharmaceutical Research. 2(4); 2010: 21-25 22. Jimmy J, Padma GMR. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. Available from: URL: 54 (3); 2006: 226–233. http://www.sciencedirect.com/science/article/pii/ S1319016413000170 23. El-Eraky H, Thomas SHL. Effects of sex on the pharmacokinetic and pharmacodynamic properties of quinidine. Br. J. Clin. Pharmacol. 56 (2); 2003: 198–204. Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/12895193pdf 24. Ensom MH. Gender-based differences and menstrual cyclerelated changes in specific diseases: implications for pharmacotherapy. Pharmacotherapy. 20 (5); 2000: 523–539. Available from: http://onlinelibrary.wiley.com/doi/10.1592/ phco.20.6.523.35161/pdfURL: 25. Singh NP, Uppal M, Anuradha S, Agarwal A, Rizvi SN. Angiotensin converting enzyme inhibitors and cough-a north Indian study. J. Assoc. Physicians India 46 (5); 1998: 448–451 Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/ 11273288pdf 26. Rajani S, Subba RB, Bhawana S. Incidence of Hepatotoxicity Due to Anti-tubercular Medicines and Assessment of Risk Factors. The Ann. Pharmacother. 38 (6); 2004: 1074–1079. Available from: URL: http://aop.sagepub.com/content/38/6/1074. full.pdf+html 27. Mitchell SC, Smith RL, Waring RH. The menstrual cycle and drug metabolism. Curr. Drug Metab. 10 (5); 2009: 499–507. Available from: URL: http://www.eurekaselect.com/69794/article 28. Duncombe D, Wertheim EH, Skouteris H, Paxton SJ, Kelly L. How well do women adapt to changes in their body size and shape across the course of pregnancy. J. Health Psychol. 13 (4); 2008: 503–515. Available from: URL: https://www.researchgate.net/publication/5431464_How_well_do _women_adapt_to_changes_in_their_body_size_and_shape_acro ss_the_course_of_pregnancy 29. Pack AM, Davis AR, Kritzer J, Yoon A, Camus A. Antiepileptic drugs: are women aware of interactions with oral contraceptives and potential teratogenicity. Epilepsy Behav. 14(4), 2009.640– 644. Available from: URL: http://www.sciencedirect.com/ science/article/pii/S152550500900050X 30. Brundage SC. Preconception health care. Am Fam Physician. 65(12); 2002: 2507–2514. 31. Holmes LB, Harvey EA, Coull BA, Huntington KB, Khoshbin S, Hayes AM. The teratogenicity of anticonvulsant drugs. N Engl J Med. 344; 2001: 1132–1138. Available from: URL: http://www.nejm.org/doi/pdf/10.1056/NEJM200104123441504 32. Meloni P, D’Angeli I, Piazze J, Cerekya A, Simari T, Pala A. First trimester PAPP-A levels associated with early prediction of pregnancy induced hypertension. Hypertens Pregnancy. 28(4); 2009: 361–368. Available from: URL: https://www.researchgate.net/publication/38023994_First_trimester_PAPP-A_levels_associated_with_early_ prediction_of_pregnancy_induced_hypertension 33. Yuan R, Venitz J. Effect of chronic renal failure on the disposition of highly hepatically metabolized drugs. Int J Clin Pharmacol Ther. 38 (5); 2000: 245–253. 34. Chung CH, Mirakhur B, Chan E. Cetuximab-induced anaphylaxis and IgE specific for galactose-a-1,3-galactose. N Engl J Med. 358 (11); 2008: 1109–1117. Available from: URL: http://www.nejm.org/doi/pdf/10.1056/NEJMoa074943 35. Harboe T, Johansson SG, Florvaag E, Oman H. Pholcodine exposure raises serum IgE in patients with previous anaphylaxis to neuromuscular blocking agents. Allergy. 62 (12); 2007: 1445– 1450. Available from: URL: http://onlinelibrary.wiley.com/doi/ 10.1111/j.1398-9995.2007.01554.x/pdf 36. Benseler V, McCaughan GW, Schlitt HJ, Bishop GA, Bowen DG, Bertolino P. 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15183 https://intelek.unisza.edu.my/intelek/pages/view.php?ref=15183 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 9 1.7 2024-08-30 10:02:45 5651-01-FH02-FP-15-03031.pdf UniSZA Private Access Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment Research J. Pharm. and Tech Several factors predispose patient to develop adverse drug reactions (ADRs), some of these factors are drug related, patient related, disease related, social and adverse drug related. The contributions of these factors to development of ADRs are very crucial and are well documented in medical literature. It has become necessary for every medical practitioner to consider these factors in order to prescribe the best medication to his patients. The current classification of ADRs is only based on drug known pharmacology and dose dependent of its action. In order to give comprehensive classification, the time course of its appearance and its severity as well as patient susceptibility are taken into consideration. Knowledge of causality assessment enables the medical practitioners to clarify the likelihood that the suspected adverse drug reaction is actually due to the medicine. This requires careful patient monitoring because adverse drug reaction can be difficult and a times impossible to distinguish from patient disease condition. The purpose of this article is to review the factors affecting the development of ADRs, its broader classification and to assess causal relationship between the suspected drug and appearance of ADRs. 7 9 1091-1098 1. Farcas A, Bojita M. Adverse drug reactions in clinical practice: a causality assessment of a case of drug-induced pancreatitis. Journal of Gastrointestin Liver Dis. 18(3); 2009: 353-358 Available from: URL: http://www.ncbi.nlm.nih.gov /pubmed/19795031 2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. A meta-analysis of prospective studies. Journal of American Medical Association. 279(15); 1998: 1200- 1205 Available from: URL: http://www.ncbi.nlm. nih.gov/pubmed/9555760 3. Morimoto T, Gandhi TK, Fiskio JM, Seger AC, So JW, Cook EF. Development and validation of a clinical prediction rule for angiotensin-converting enzyme inhibitor induced cough. J. Gen. Intern. Med. 19 (6); 2004: 684–691. Available from: URL: http://www.citeulike.org/group/1012/article/563972 4. Andrade RJ, Robles M, Fernández-Castañer A, López-Ortega S, López-Vega MC, Lucena MI. Assessment of drug-induced hepatotoxicity in clinical practice: a challenge for gastroenterologists. World J Gastroenterol. 13 (3); 2007: 329– 340. Available from: URL:http://www.wjgnet.com/1007- 9327/pdf/v13/i3/329.pdf 5. Pirmohamed M, Kevin B, Kitteringham NR. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective. Chem. Res. Toxicol. 11 (9); 1998: 969–988. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC1884203/pdf/bcp0055-0486.pdf 6. WHO Definitions. WHO International Drug Monitoring: The role of national centers: Tech Rep Ser.1972 no. 498 Available from: URL: http://www.who.int/medicines/areas/quality_safety/ safety_efficacy/trainingcourses/definitions.pdf 7. Edward IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet. 356; 2000: 1255-1259. Available from: URL: http://www.scribd.com/doc/22293073/ Adverse-Drug-Reactions-Definitions-Diagnosis-And-Management 8. Lindquist M. The need for definitions in pharmacovigilance. Drug Saf. 30; 2007: 825-830. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3689877/ 9. Kachhadiya R, Kumar A, Bhatia RK. Prevalence of medication errors across the world. International Journal of Pharmaceutical Research. 1(3); 2009:21-34. Available from: URL: http://www.ijpronline.com/ViewArticleDetail.aspx?ID=36 10. Rockville Md. Taxonomy of Medication Errors. National Coordinating Council on Medication Error Reporting and Prevention. 1998. Available from: URL: http://www.nccmerp.org/medErrorTaxonomy.html 11. Rao KS, Mohanta GP, Manna PK, Kumar RV. Pharmacogenetics and Pharmacogenomics- A potential tool for individualization of drug therapy. International Journal of Pharmaceutical Research. 4(1); 2012: 1-4. Available from: URL: http://www.ijpronline.com/ViewArticleDetail.aspx?ID=152 12. Alomar MJ. Factors affecting the development of Adverse Drug Reactions. Saudi Pharmaceutical Journal. 2014; 22; 83-94. Available from: URL: http://ac.elscdn.com/S1319016413000170/1-s2.0-S1319016413000170- main.pdf?_tid=89627982-2049-11e4-811f 00000aacb35fandacdnat=1407646273_e571a8a3d975a6c975113 2977c8ba981 13. Bushardt RL, Massey EB, Simpson TW, Ariail JC, Simpson KN. Polypharmacy: misleading, but manageable. Clin Interv Aging. 3 (2); 2008: 383–389. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555477/pdf/hjm ph7201_0015.pdf 14. Chang Y, Huang SK, Tao P, Chien CW. Population based study on the association between acute renal failure (ARF) and the duration of polypharmacy. BMC Nephrol. 13 (96); 2012: 1-7. Available from: URL: http://www.biomedcentral.com/1471- 2369/13/96 15. Routledge PA, O’mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. BJCP. 57 (2); 2003: 121–126. Available from: URL: http://onlinelibrary.wiley.com/ doi/10.1046/j.1365-2125.2003.01875.x/full 16. Rochon PA, Gurwitz JH. Optimising drug treatment for elderly people: the prescribing cascade. BMJ. 315 (7115); 1997: 1096– 1099. Available from: URL: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2127690/pdf/9366745.pdf 17. Buetow S, Elwyn G. Patient Safety and Patient Error. Lancet. 369 (9556); 2007:158-161. Available from: URL: http://www.thelancet.com/journals/lancet/article/PIIS0140- 6736%2807%2960077-4/fulltext?version=printerFriendly 18. Campbell JDA, Thompson M. Patient Safety Rounds: Description of an Inexpensive but Important Strategy to Improve the Safety Culture. American Journal of Medical Quality. 22(1); 2007:26-4. Available from: URL:http://ajm.sagepub.com/ content/22/1/26.full.pdf+html 19. Debellis K, Field TS, Gurwitz JH, Harrold LR, Rothschild J, Seger AC. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 289 (9); 2003: 1107–1116. Available from: URL: http://www.patientsafetyresearch.org/journal%20articles/Incindence_Preventability.pdf 20. Bates DW, Clapp MD, Federico F, Goldmann DA, Kaushal R, Landrigan C. Medication errors and adverse drug events in paediatric inpatients. JAMA. 285 (16); 2001: 1107–1116. Available from: URL:http://patientsafetyresearch.org/journal %20articles/Original%20267.pdf 21. Patel A, Ganguly B. Analysis of dose calculation of medicines prescribed in paediatric age group. International Journal of Pharmaceutical Research. 2(4); 2010: 21-25 22. Jimmy J, Padma GMR. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. Available from: URL: 54 (3); 2006: 226–233. http://www.sciencedirect.com/science/article/pii/ S1319016413000170 23. El-Eraky H, Thomas SHL. Effects of sex on the pharmacokinetic and pharmacodynamic properties of quinidine. Br. J. Clin. Pharmacol. 56 (2); 2003: 198–204. Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/12895193pdf 24. Ensom MH. Gender-based differences and menstrual cyclerelated changes in specific diseases: implications for pharmacotherapy. Pharmacotherapy. 20 (5); 2000: 523–539. Available from: http://onlinelibrary.wiley.com/doi/10.1592/ phco.20.6.523.35161/pdfURL: 25. Singh NP, Uppal M, Anuradha S, Agarwal A, Rizvi SN. Angiotensin converting enzyme inhibitors and cough-a north Indian study. J. Assoc. Physicians India 46 (5); 1998: 448–451 Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/ 11273288pdf 26. Rajani S, Subba RB, Bhawana S. Incidence of Hepatotoxicity Due to Anti-tubercular Medicines and Assessment of Risk Factors. The Ann. Pharmacother. 38 (6); 2004: 1074–1079. Available from: URL: http://aop.sagepub.com/content/38/6/1074. full.pdf+html 27. Mitchell SC, Smith RL, Waring RH. The menstrual cycle and drug metabolism. Curr. Drug Metab. 10 (5); 2009: 499–507. Available from: URL: http://www.eurekaselect.com/69794/article 28. Duncombe D, Wertheim EH, Skouteris H, Paxton SJ, Kelly L. How well do women adapt to changes in their body size and shape across the course of pregnancy. J. Health Psychol. 13 (4); 2008: 503–515. Available from: URL: https://www.researchgate.net/publication/5431464_How_well_do _women_adapt_to_changes_in_their_body_size_and_shape_acro ss_the_course_of_pregnancy 29. Pack AM, Davis AR, Kritzer J, Yoon A, Camus A. Antiepileptic drugs: are women aware of interactions with oral contraceptives and potential teratogenicity. Epilepsy Behav. 14(4), 2009.640– 644. Available from: URL: http://www.sciencedirect.com/ science/article/pii/S152550500900050X 30. Brundage SC. Preconception health care. Am Fam Physician. 65(12); 2002: 2507–2514. 31. Holmes LB, Harvey EA, Coull BA, Huntington KB, Khoshbin S, Hayes AM. The teratogenicity of anticonvulsant drugs. N Engl J Med. 344; 2001: 1132–1138. Available from: URL: http://www.nejm.org/doi/pdf/10.1056/NEJM200104123441504 32. Meloni P, D’Angeli I, Piazze J, Cerekya A, Simari T, Pala A. First trimester PAPP-A levels associated with early prediction of pregnancy induced hypertension. 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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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Several factors predispose patient to develop adverse drug reactions (ADRs), some of these factors are drug related, patient related, disease related, social and adverse drug related. The contributions of these factors to development of ADRs are very crucial and are well documented in medical literature. It has become necessary for every medical practitioner to consider these factors in order to prescribe the best medication to his patients. The current classification of ADRs is only based on drug known pharmacology and dose dependent of its action. In order to give comprehensive classification, the time course of its appearance and its severity as well as patient susceptibility are taken into consideration. Knowledge of causality assessment enables the medical practitioners to clarify the likelihood that the suspected adverse drug reaction is actually due to the medicine. This requires careful patient monitoring because adverse drug reaction can be difficult and a times impossible to distinguish from patient disease condition. The purpose of this article is to review the factors affecting the development of ADRs, its broader classification and to assess causal relationship between the suspected drug and appearance of ADRs.
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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
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adverse drug reactions: predisposing factors, modern classifications and causality assessment
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