Current Status of Guidelines for Therapeutic Drug Monitoring:An Evidence-based Evaluation_Chinese Journal of Evidence-Based Medicine

Authors：

 HUANGLiang ^1,2 ,  ZHANGLing-li ^1,2 ,  LIYou-ping ³ , ZENGLi-nan ^1,2 , HUZhi-qiang ^1,2,4 , LIUDan ^1,2 , CHENMin ^1,2

1. Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, China;
2. Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University), Ministry of Education, Chengdu 610041, China;
3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
4. West China School of Pharmacy, Sichuan University, Chengdu 610041, China;

Corresponding author：

ZHANGLing-li, Email: zhlingli@sina.com; LIYou-ping, Email: yzmylab@hotmail.com

Keywords：

Therapeutic drug monitoring; Guideline; Evidence-based evaluation

DOI：

10.7507/1672-2531.20160069

Video：

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Objective To investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring (TDM) guidelines, so as to provide references for the development of TDM guidelines in China. Methods Guidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang Data, NGC (National Guideline Clearinghouse ), GIN (Guidelines International Network), World Health Organization (WHO) guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. Results A total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that: for the integrity of reporting items of guidelines, three (75%) management guidelines ranked grade A, but only 1 (3.13%) technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows: standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. Conclusion There is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.

Citation： HUANGLiang, ZHANGLing-li, LIYou-ping, ZENGLi-nan, HUZhi-qiang, LIUDan, CHENMin. Current Status of Guidelines for Therapeutic Drug Monitoring:An Evidence-based Evaluation. Chinese Journal of Evidence-Based Medicine, 2016, 16(4): 451-459. doi: 10.7507/1672-2531.20160069 Copy

1.	中华医学会儿科学分会临床药理学组. 儿童治疗性药物监测专家共识. 中华儿科杂志, 2015, 53(9):650-659.
2.	Lim W, Arnold DM, Bachanova V, et al. Evidence-based guidelines-an introduction. ASH Education Program Book, 2008, 28(1):26-30.
3.	国家卫生计生委个体化医学检测技术专家委员会. 药物代谢酶和药物作用靶点基因检测技术指南(试行). 2015. Available at:http://www.moh.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.
4.	国家卫生计生委个体化医学检测技术专家委员会. 肿瘤个体化治疗检测技术指南(试行). 2015. Available at:http://www.moh.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.
5.	Practice guidelines for pharmacotherapy specialists. The accp clinical practice affairs committee, subcommittee b, 1998-1999. American college of clinical pharmacy. Pharmacotherapy, 2000, 20(4):487-490.
6.	Valdes R, Payne DA, Linder MW. Laboratory analysis and application of pharmacogenetics to clinical practice. American Association for Clinical Chemistry, 2010. Available at:http://www.aacc.org/members/nacb/LMPG/Pages/default.aspx.
7.	Patsalos PN, Berry DJ, Bourgeois BFD, et al. Antiepileptic drugs-best practice guidelines for therapeutic drug monitoring:A position paper by the subcommission on therapeutic drug monitoring, ilae commission on therapeutic strategies. Epilepsia, 2008, 49(7):1239-1276.
8.	Holt DW, Armstrong VW, Griesmacher A, et al. International federation of clinical chemistry/international association of therapeutic drug monitoring and clinical toxicology working group on immunosuppressive drug monitoring. Ther Drug Monit, 2002, 24(1):59-67.
9.	Caudle KE, Rettie AE, Whirl-Carrillo M, et al. Clinical pharmacogenetics implementation consortium guidelines for cyp2c9 and hla-b genotypes and phenytoin dosing. Clin Pharmacol Ther, 2014, 96(5):542-548.
10.	Hicks J, Swen J, Thorn C, et al. Clinical pharmacogenetics implementation consortium guideline for cyp2d6 and cyp2c19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther, 2013, 93(5):402-408.
11.	Rybak MJ, Lomaestro BM, Rotschafer JC, et al. Vancomycin therapeutic guidelines:A summary of consensus recommendations from the infectious diseases society of america, the american society of health-system pharmacists, and the society of infectious diseases pharmacists. Clin Infect Dis, 2009, 49(3):325-327.
12.	Acosta EP, Gerber JG, Morse G, et al. Position paper on therapeutic drug monitoring of antiretroviral agents. Aids Res Hum Retrov, 2002, 18(12):825-834.
13.	Charles DeBattista AFS. 2003 psychotropic dosing and monitoring guidelines. Primary Psychiatry, 2003, 10(7):80-84,87-96.
14.	Hammett-Stabler CA, Johns T. Laboratory guidelines for monitoring of antimicrobial drugs. National academy of clinical biochemistry. Clin Chem, 1998, 44(5):1129-1140.
15.	Shaw K, Amstutz U, Kim RB, et al. Clinical practice recommendations on genetic testing of cyp2c9 and vkorc1 variants in warfarin therapy. Ther Drug Monit, 2015, 37(4):428-436.
16.	Khanna R, Sattin BD, Afif W, et al. Review article:A clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease. Aliment Pharm Therap, 2013, 38(5):447-459.
17.	Higgins N, Tseng A, Sheehan NL, et al. Antiretroviral therapeutic drug monitoring in canada:Current status and recommendations for clinical practice. Can J Hosp Pharm, 2009, 62(6):500-509.
18.	Yatscoff RW, Boeckx R, Holt DW, et al. Consensus guidelines for therapeutic drug monitoring of rapamycin:Report of the consensus panel. Ther Drug Monit, 1995, 17(6):676-680.
19.	NICE. Fluorouracil chemotherapy the my5-fu assay for guiding dose adjustment. 2014. Available at:http://www.nice.org.uk/guidance/dg16.
20.	Ashbee HR, Barnes RA, Johnson EM, et al. Therapeutic drug monitoring (tdm) of antifungal agents:Guidelines from the british society for medical mycology. J Antimicrob Chemoth, 2014, 69(5):1162-1176.
21.	Cantarovich M, Brown NW, Ensom MH, et al. Mycophenolate monitoring in liver, thoracic, pancreas, and small bowel transplantation:A consensus report. Transplant Rev (Orlando), 2011, 25(2):65-77.
22.	Richards M, Williams M, Chalmers E, et al. A united kingdom haemophilia centre doctors' organization guideline approved by the british committee for standards in haematology:Guideline on the use of prophylactic factor viii concentrate in children and adults with severe haemophilia a. Br J Haematol, 2010, 149(4):498-507.
23.	Hiemke C, Baumann P, Bergemann N, et al. Agnp consensus guidelines for therapeutic drug monitoring in psychiatry:Update 2011. Pharmacopsychiatry, 2011, 44(6):195-235.
24.	Baumann P, Ulrich S, Eckermann G, et al. The agnp-tdm expert group consensus guidelines:Focus on therapeutic monitoring of antidepressants. Dialogues Clin Neurosci, 2005, 7(3):231-247.
25.	Oellerich M, Armstrong VW, Schutz E, et al. Therapeutic drug monitoring of cyclosporine and tacrolimus. Clin Biochem, 1998, 31(5):309-316.
26.	Agence francaise de securite s, des produits de s. Update on good use of injectable aminoglycosides, gentamycin, tobramycin, netilmycin, amikacin. Pharmacological properties, indications, dosage, and mode of administration, treatment monitoring. Med Maladies Infect, 2012, 42(7):301-308.
27.	Yu H, Steeghs N, Nijenhuis CM, et al. Practical guidelines for therapeutic drug monitoring of anticancer tyrosine kinase inhibitors:Focus on the pharmacokinetic targets. Clin Pharmacokinet, 2014, 53(4):305-325.
28.	Boffito M, Acosta E, Burger D, et al. Therapeutic drug monitoring and drug-drug interactions involving antiretroviral drugs. Antivir Ther, 2005, 10(4):469-477.
29.	Licht RW, Vestergaard P, Kessing LV, et al. Psychopharmacological treatment with lithium and antiepileptic drugs:Suggested guidelines from the danish psychiatric association and the child and adolescent psychiatric association in denmark. Acta Psychiat Scand, 2003, Supplementum.(419):1-22.
30.	Chau MM, Kong DC, van Hal SJ, et al. Consensus guidelines for optimising antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haematological malignancy, 2014. Intern Med J, 2014, 44(12b):1364-1388.
31.	Ng F, Mammen OK, Wilting I, et al. The international society for bipolar disorders (isbd) consensus guidelines for the safety monitoring of bipolar disorder treatments. Bipolar Disorders, 2009, 11(6):559-595.
32.	Trevillian P. The cari guidelines. Calcineurin inhibitors in renal transplantation:Therapeutic drug monitoring. Nephrology (Carlton), 2007, 12(Suppl 1):S57-65.
33.	Morris RG, Ilett KF, Tett SE, et al. Cyclosporin monitoring in australasia:2002 update of consensus guidelines. Ther Drug Monit, 2002, 24(6):677-688.
34.	陈耀龙, 陈恳, 叶志康, 等. 中国万古霉素治疗药物监测指南的制定. 中国偱证医学杂志,2015, 15(2):236-239.
35.	广东省药学会. 万古霉素个体化给药临床药师指引. 2015. Available at:http://www.sinopharmacy.com.cn/notification/681.html.
36.	Okada K, Kimura T, Mikamo H, et al. Clinical practice guidelines for therapeutic drug monitoring of arbekacin:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2014, 20(1):1-5.
37.	Hamada Y, Tokimatsu I, Mikamo H, et al. Practice guidelines for therapeutic drug monitoring of voriconazole:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2013, 19(3):381-392.
38.	Matsumoto K, Takesue Y, Ohmagari N, et al. Practice guidelines for therapeutic drug monitoring of vancomycin:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2013, 19(3):365-380.
39.	International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Definitions of tdm & ct. 2013, 2015(Oct 5). Available at:https://www.iatdmct.org/about-us/about-association/about-definitions-tdm-ct.html.
40.	张相林. 中国药理学会治疗药物监测研究专业委员会学会简介. 2012. Available at:http://www.tdmchina.org/portal.php?mod=view&aid=5.

1. 中华医学会儿科学分会临床药理学组. 儿童治疗性药物监测专家共识. 中华儿科杂志, 2015, 53(9):650-659.
2. Lim W, Arnold DM, Bachanova V, et al. Evidence-based guidelines-an introduction. ASH Education Program Book, 2008, 28(1):26-30.
3. 国家卫生计生委个体化医学检测技术专家委员会. 药物代谢酶和药物作用靶点基因检测技术指南(试行). 2015. Available at:http://www.moh.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.
4. 国家卫生计生委个体化医学检测技术专家委员会. 肿瘤个体化治疗检测技术指南(试行). 2015. Available at:http://www.moh.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.
5. Practice guidelines for pharmacotherapy specialists. The accp clinical practice affairs committee, subcommittee b, 1998-1999. American college of clinical pharmacy. Pharmacotherapy, 2000, 20(4):487-490.
6. Valdes R, Payne DA, Linder MW. Laboratory analysis and application of pharmacogenetics to clinical practice. American Association for Clinical Chemistry, 2010. Available at:http://www.aacc.org/members/nacb/LMPG/Pages/default.aspx.
7. Patsalos PN, Berry DJ, Bourgeois BFD, et al. Antiepileptic drugs-best practice guidelines for therapeutic drug monitoring:A position paper by the subcommission on therapeutic drug monitoring, ilae commission on therapeutic strategies. Epilepsia, 2008, 49(7):1239-1276.
8. Holt DW, Armstrong VW, Griesmacher A, et al. International federation of clinical chemistry/international association of therapeutic drug monitoring and clinical toxicology working group on immunosuppressive drug monitoring. Ther Drug Monit, 2002, 24(1):59-67.
9. Caudle KE, Rettie AE, Whirl-Carrillo M, et al. Clinical pharmacogenetics implementation consortium guidelines for cyp2c9 and hla-b genotypes and phenytoin dosing. Clin Pharmacol Ther, 2014, 96(5):542-548.
10. Hicks J, Swen J, Thorn C, et al. Clinical pharmacogenetics implementation consortium guideline for cyp2d6 and cyp2c19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther, 2013, 93(5):402-408.
11. Rybak MJ, Lomaestro BM, Rotschafer JC, et al. Vancomycin therapeutic guidelines:A summary of consensus recommendations from the infectious diseases society of america, the american society of health-system pharmacists, and the society of infectious diseases pharmacists. Clin Infect Dis, 2009, 49(3):325-327.
12. Acosta EP, Gerber JG, Morse G, et al. Position paper on therapeutic drug monitoring of antiretroviral agents. Aids Res Hum Retrov, 2002, 18(12):825-834.
13. Charles DeBattista AFS. 2003 psychotropic dosing and monitoring guidelines. Primary Psychiatry, 2003, 10(7):80-84,87-96.
14. Hammett-Stabler CA, Johns T. Laboratory guidelines for monitoring of antimicrobial drugs. National academy of clinical biochemistry. Clin Chem, 1998, 44(5):1129-1140.
15. Shaw K, Amstutz U, Kim RB, et al. Clinical practice recommendations on genetic testing of cyp2c9 and vkorc1 variants in warfarin therapy. Ther Drug Monit, 2015, 37(4):428-436.
16. Khanna R, Sattin BD, Afif W, et al. Review article:A clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease. Aliment Pharm Therap, 2013, 38(5):447-459.
17. Higgins N, Tseng A, Sheehan NL, et al. Antiretroviral therapeutic drug monitoring in canada:Current status and recommendations for clinical practice. Can J Hosp Pharm, 2009, 62(6):500-509.
18. Yatscoff RW, Boeckx R, Holt DW, et al. Consensus guidelines for therapeutic drug monitoring of rapamycin:Report of the consensus panel. Ther Drug Monit, 1995, 17(6):676-680.
19. NICE. Fluorouracil chemotherapy the my5-fu assay for guiding dose adjustment. 2014. Available at:http://www.nice.org.uk/guidance/dg16.
20. Ashbee HR, Barnes RA, Johnson EM, et al. Therapeutic drug monitoring (tdm) of antifungal agents:Guidelines from the british society for medical mycology. J Antimicrob Chemoth, 2014, 69(5):1162-1176.
21. Cantarovich M, Brown NW, Ensom MH, et al. Mycophenolate monitoring in liver, thoracic, pancreas, and small bowel transplantation:A consensus report. Transplant Rev (Orlando), 2011, 25(2):65-77.
22. Richards M, Williams M, Chalmers E, et al. A united kingdom haemophilia centre doctors' organization guideline approved by the british committee for standards in haematology:Guideline on the use of prophylactic factor viii concentrate in children and adults with severe haemophilia a. Br J Haematol, 2010, 149(4):498-507.
23. Hiemke C, Baumann P, Bergemann N, et al. Agnp consensus guidelines for therapeutic drug monitoring in psychiatry:Update 2011. Pharmacopsychiatry, 2011, 44(6):195-235.
24. Baumann P, Ulrich S, Eckermann G, et al. The agnp-tdm expert group consensus guidelines:Focus on therapeutic monitoring of antidepressants. Dialogues Clin Neurosci, 2005, 7(3):231-247.
25. Oellerich M, Armstrong VW, Schutz E, et al. Therapeutic drug monitoring of cyclosporine and tacrolimus. Clin Biochem, 1998, 31(5):309-316.
26. Agence francaise de securite s, des produits de s. Update on good use of injectable aminoglycosides, gentamycin, tobramycin, netilmycin, amikacin. Pharmacological properties, indications, dosage, and mode of administration, treatment monitoring. Med Maladies Infect, 2012, 42(7):301-308.
27. Yu H, Steeghs N, Nijenhuis CM, et al. Practical guidelines for therapeutic drug monitoring of anticancer tyrosine kinase inhibitors:Focus on the pharmacokinetic targets. Clin Pharmacokinet, 2014, 53(4):305-325.
28. Boffito M, Acosta E, Burger D, et al. Therapeutic drug monitoring and drug-drug interactions involving antiretroviral drugs. Antivir Ther, 2005, 10(4):469-477.
29. Licht RW, Vestergaard P, Kessing LV, et al. Psychopharmacological treatment with lithium and antiepileptic drugs:Suggested guidelines from the danish psychiatric association and the child and adolescent psychiatric association in denmark. Acta Psychiat Scand, 2003, Supplementum.(419):1-22.
30. Chau MM, Kong DC, van Hal SJ, et al. Consensus guidelines for optimising antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haematological malignancy, 2014. Intern Med J, 2014, 44(12b):1364-1388.
31. Ng F, Mammen OK, Wilting I, et al. The international society for bipolar disorders (isbd) consensus guidelines for the safety monitoring of bipolar disorder treatments. Bipolar Disorders, 2009, 11(6):559-595.
32. Trevillian P. The cari guidelines. Calcineurin inhibitors in renal transplantation:Therapeutic drug monitoring. Nephrology (Carlton), 2007, 12(Suppl 1):S57-65.
33. Morris RG, Ilett KF, Tett SE, et al. Cyclosporin monitoring in australasia:2002 update of consensus guidelines. Ther Drug Monit, 2002, 24(6):677-688.
34. 陈耀龙, 陈恳, 叶志康, 等. 中国万古霉素治疗药物监测指南的制定. 中国偱证医学杂志,2015, 15(2):236-239.
35. 广东省药学会. 万古霉素个体化给药临床药师指引. 2015. Available at:http://www.sinopharmacy.com.cn/notification/681.html.
36. Okada K, Kimura T, Mikamo H, et al. Clinical practice guidelines for therapeutic drug monitoring of arbekacin:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2014, 20(1):1-5.
37. Hamada Y, Tokimatsu I, Mikamo H, et al. Practice guidelines for therapeutic drug monitoring of voriconazole:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2013, 19(3):381-392.
38. Matsumoto K, Takesue Y, Ohmagari N, et al. Practice guidelines for therapeutic drug monitoring of vancomycin:A consensus review of the japanese society of chemotherapy and the japanese society of therapeutic drug monitoring. J Infect Chemother, 2013, 19(3):365-380.
39. International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Definitions of tdm & ct. 2013, 2015(Oct 5). Available at:https://www.iatdmct.org/about-us/about-association/about-definitions-tdm-ct.html.
40. 张相林. 中国药理学会治疗药物监测研究专业委员会学会简介. 2012. Available at:http://www.tdmchina.org/portal.php?mod=view&aid=5.

Chinese Journal of Evidence-Based Medicine

Current Status of Guidelines for Therapeutic Drug Monitoring:An Evidence-based Evaluation

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