J Lab Med Qual Assur.  2005 Jun;27(1):111-124.

Annual Report on External Quality Assessment in Therapeutic Drug Monitoring in Korea (2004)

• Kim JH
• Kim BK
• Lee SY
• Chun S
• Kwon GC
• Yoon Y
• Lim JB
• Shin DH
• Song KE
• Lee KR
• Suh SP
• Kim JQ

Abstract

Two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) Subcommittee of Korean Association of Quality Assurance for Clinical Pathology (KAQACP) were performed in 2004. Number of participating laboratories were increased to 89, by 11.3% increase comparing with the previous year. Response rates were 100.0% for both trials just like the previous year. Two kinds of control materials were requested to be tested in each trial so that each institution could know the possible systematic error. In both trials, 20 test items were responded at least from one laboratory. The average drug item was 6.8 per institution, which was elevated slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, phenytoin, carbamazepine, theophylline, and phenobarbital which were peformed in more than 71% of participating laboratories, followed by cyclosporine, lithium, tacrolimus, vancomycin, methotrexate, amikacin, gentamycin, salicylate, tobramycin, acetaminophen, primidone, free phenytoin, and amitryptyline. The most widely used TDM analyzer was Abbott TDx/TDxFLx (41.6%), followed by Roche Cobas Integra (21.3%), and Abbott AxSym (20.2%). The inter-laboratory coefficients of variations were not greatly improved comparing with previous years. We also determined cyclosporine and tacrolimus with reference method using liquid chromatography-tandem mass spectrometry. In conclusion, the TDM external quality assessment of 2004 showed grossly similar pattern comparing with those of previous year, except the 11.3% increase of participating laboratories.

Keyword

Quality assurance; External quality assessment; Therapeutic drug monitoring

MeSH Terms

Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Drug Monitoring*
Gentamicins
Korea*
Lithium
Mass Spectrometry
Methotrexate
Pathology, Clinical
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin
Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Gentamicins
Lithium
Methotrexate
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin