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Population Pharmacokinetics of Midazolam in Healthy Koreans: Effect of Cytochrome P450 3A-mediated Drug-drug Interaction.

Kwang Hee SHIN

Korean Journal of Clinical Pharmacy.2016;26(4):312-317.

OBJECTIVE: Midazolam is mainly metabolized by cytochrome P450 (CYP) 3A. Inhibition or induction of CYP3A can affect the pharmacological activity of midazolam. The aims of this study were to develop a population pharmacokinetic (PK) model and evaluate the effect of CYP3A-mediated interactions among ketoconazole, rifampicin, and midazolam. METHODS: Three-treatment, three-period, crossover study was conducted in 24 healthy male subjects. Each subject received 1 mg midazolam (control), 1 mg midazolam after pretreatment with 400 mg ketoconazole once daily for 4 days (CYP3A inhibition phase), and 2.5 mg midazolam after pretreatment with 600 mg rifampicin once daily for 10 days (CYP3A induction phase). The population PK analysis was performed using a nonlinear mixed effect model (NONMEM® 7.2) based on plasma midazolam concentrations. The PK model was developed, and the first-order conditional estimation with interaction was applied for the model run. A three-compartment model with first-order elimination described the PK. The influence of ketoconazole and rifampicin, CYP3A5 genotype, and demographic characteristics on PK parameters was examined. Goodness-of-fit (GOF) diagnostics and visual predictive checks, as well as bootstrap were used to evaluate the adequacy of the model fit and predictions. RESULTS: Twenty-four subjects contributed to 900 midazolam concentrations. The final parameter estimates (% relative standard error, RSE) were as follows; clearance (CL), 31.8 L/h (6.0%); inter-compartmental clearance (Q) 2, 36.4 L/h (9.7%); Q3, 7.37 L/h (12.0%), volume of distribution (V) 1, 70.7 L (3.6%), V2, 32.9 L (8.8%); and V3, 44.4 L (6.7%). The midazolam CL decreased and increased to 32.5 and 199.9% in the inhibition and induction phases, respectively, compared to that in control phase. CONCLUSION: A PK model for midazolam co-treatment with ketoconazole and rifampicin was developed using data of healthy volunteers, and the subject's CYP3A status influenced the midazolam PK parameters. Therefore, a population PK model with enzyme-mediated drug interactions may be useful for quantitatively predicting PK alterations.
Cross-Over Studies ; Cytochrome P-450 CYP3A ; Cytochrome P-450 Enzyme System* ; Cytochromes* ; Drug Interactions ; Genotype ; Healthy Volunteers ; Humans ; Ketoconazole ; Male ; Midazolam* ; Pharmacokinetics* ; Plasma ; Rifampin

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Effect of Voriconazole or Itraconazole on the Plasma Concentrations of Tacrolimus in Lung Transplant Recipients.

Yoo Jin JUNG ; Young Suk YI ; Ji Hyune AHN ; Eun Sun SON ; Min Soo PARK ; Jangik I LEE ; Min Jung CHANG

Korean Journal of Clinical Pharmacy.2016;26(4):306-311.

OBJECTIVE: This study was performed to compare the changes in the blood concentrations of tacrolimus when either itraconazole or voriconazole is together with tacrolimus to prevent or treat invasive aspergillus pneumonia (IAP) in patients with lung transplants. Therefore we can compare the degree of drug-drug interactions between tacrolimus and itraconazole against tacrolimus and voriconazole. METHODS: Patients who were admitted and had lung transplants in a territory referral hospital from September 2012 to May 2015 were analyzed retrospectively. The effects of itraconazole and voriconazole on the plasma concentrations of tacrolimus were analyzed. RESULTS: Mean tacrolimus concentrations was 10.49±2.35 ng/mL vs. 10.95±2.98 ng/mL (p=0.722), and mean concentration of tacrolimus over the dose of tacrolimus per day was 8.510±5.890 (ng/mL)/(mg/d) vs. 15.45±28.47 (ng/mL)/(mg/d) (p=0.947) in itraconazole vs. voriconazole group each. The ratio of the number of the results out of target tacrolimus concentrations to the total number of tacrolimus concentration results was 18.0±13.3% vs. 24.4±18.5% (p=0.185). CONCLUSION: There were no significant differences between itraconzaole and voriconazole to have influences on mean concentrations of tacrolimus over tacrolimus dose per weight per day. However voriconazole tended to raise tacrolimus plasma concentrations more than itraconazole. Safer and more effective drug management to prevent and treat fungal infections should be done by therapeutic drug monitoring not only of tacrolimus but of itraconazole and voriconazole in lung transplant patients.
Aspergillus ; Drug Interactions ; Drug Monitoring ; Humans ; Itraconazole* ; Lung* ; Plasma* ; Pneumonia ; Referral and Consultation ; Retrospective Studies ; Tacrolimus* ; Transplant Recipients* ; Voriconazole*

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Prescription Patterns and Factors Related to the Number of Medications in Chronic Obstructive Pulmonary Disease in Non-elderly Adults.

Chae won MOON ; Hyun O RA ; Sandy Jeong RHIE

Korean Journal of Clinical Pharmacy.2016;26(4):298-305.

BACKGROUND: This study is to investigate the prescription patterns and factors related to the number of medications treating chronic obstructive pulmonary disease (COPD) in patients under 65 years old according to GOLD guidelines. METHODS: We retrospectively analyzed the medical records of patients aged 40-64 years with a diagnosis of COPD from January to March 2016. Patients were classified by combined assessment of COPD (grades A, B, C, D) using spirometry, exacerbation history, mMRC, and/or CAT results. We analyzed prescribed medications, treatment options and factors related to the numbers of COPD medications. RESULTS: The total number of prescriptions were 251. About 35.5% of patients were classified as GOLD A, 34.2% as GOLD B, 17.1% as GOLD C and 13.2% as GOLD D. Inhaled bronchodilator was prescribed for 86.9% of patients and the most frequent COPD medication was long-acting muscarinic antagonist (LAMA) followed by inhaled corticosteroids/long acting beta agonist (ICS/LABA). The majority of low risk patients (GOLD A/B) were prescribed a monotherapy with LAMA or LABA. For high risk patients (GOLD C/D), combination treatment with ICS+LAMA+LABA was mostly prescribed. The 21.2% of patients in GOLD D received systemic corticosteroid. The average number of medications per prescription was 3.7, and this number increased with increasing COPD grade, COPD duration and lung function reduction (FEV₁, FEV₁/FVC). CONCLUSION: Generally high adherence to GOLD guideline recommendations was reported. Given the progressive nature of the disease, results suggest that closer attention to respiratory symptoms for early detection, diagnosis, and appropriate treatment of COPD is warranted.
Adult* ; Animals ; Cats ; Diagnosis ; Humans ; Lung ; Medical Records ; Prescriptions* ; Pulmonary Disease, Chronic Obstructive* ; Retrospective Studies ; Spirometry

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Educational Goals Extracted from Homepages of Pharmacy Schools in Korea.

Yu Cheol LIM ; Eunhee JI

Korean Journal of Clinical Pharmacy.2016;26(4):291-297.

BACKGROUND: The current educational goals and missions of pharmacy schools in Korea were analyzed to examine the current orientation and future direction of pharmaceutical education. METHODS: Educational mission statements were obtained from the homepages of 35 pharmacy schools and subjected to convert into codes. Themes and categories were induced using qualitative content-analysis from the codes and compared according to location of school (capital area versus province), public versus private, and date of initial enrollment (before versus in 2011). The themes and categories were compared with “the eight-star pharmacist” suggested by World Health Organization (WHO) and International Pharmaceutical Federation (FIP). RESULTS: Twelve themes, 44 categories, and 496 codes were identified. Themes included pharmaceutical expertise, professionalism, contribution to society, basic educational ideology, sphere of activity, leadership, research, dealing with future change, problem-solving ability, self-management and development, cooperation, and respect for life. Mission statements of schools that initially enrolled in 2011 cited humankind level contribution (p=0.011), patient-centered care (p=0.026), and globalization (p=0.018) more frequently than those enrolled before 2011. Most schools mentioned about care-giver, researcher, and decision-maker which were stated in “the eight-star pharmacist”. CONCLUSION: To meet the growing social requirements of a pharmacist's roles, wide-ranging active discussion on establishing educational goals should be made.
Education, Pharmacy ; Humans ; Internationality ; Korea* ; Leadership ; Patient-Centered Care ; Pharmacy* ; Professionalism ; Religious Missions ; Schools, Pharmacy* ; Self Care ; Value of Life ; World Health Organization

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Effective Teaching Skills in Pharmacy Practice Education.

Jeong Hyun YOON

Korean Journal of Clinical Pharmacy.2016;26(4):283-290.

Experiential education is a core curriculum of 6-year pharmacy education. Practicing pharmacists lie at the heart of experiential education serving as preceptors for undergraduate pharmacy students during experiential education. Preceptors are, however, confronted with a challenge of caring for patients and teaching students at the same time in a time-constrained environment. To improve the effectiveness and outcomes of experiential education, practicing pharmacists are required to demonstrate educational competence. Even small teaching moments can provide students with valuable learning opportunities that they could not have from on their own. Thus, it is vital to provide education and training for preceptors to advance their teaching skills. This article will describe practical and effective teaching skills that preceptors could adopt in the experiential education for pharmacy students. It is important that preceptors should use different teaching skills for different learners, according to their level of experience and knowledge, learning styles and needs, as well as the type of the practice. Therefore, possessing diverse teaching skills provides flexibility to adapt teaching to each student's learning levels and needs, and to the charateristics of the practice environment. Preceptors' level of confidence and comfort in using teaching skills can be enhanced through continuous practice and training, which consequently leads to the improved effectiveness of experiential education and student's satisfaction with the education.
Curriculum ; Education* ; Education, Pharmacy ; Heart ; Humans ; Learning ; Mental Competency ; Pharmacists ; Pharmacy* ; Pliability ; Students, Pharmacy

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Novel Oral Anticoagulants for the Treatment of Venous Thromboembolism in Cancer Patients.

Joo Hee KIM ; Hye Sun GWAK

Korean Journal of Clinical Pharmacy.2016;26(4):269-282.

Venous thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, has increased in cancer patients and adversely affects their prognosis. Low-molecular-weight heparins are recommended as efficacious and safe anticoagulation treatment in cancer patients. However, in practice, oral anticoagulation is preferred, especially if longterm or extended treatment is necessary. Novel oral anticoagulants have recently emerged as an alternative to the standard therapy owing to the ease of administration, predictable anticoagulation effect without the need of laboratory monitoring, and fewer drug interactions. These new agents have been shown as effective and safe for the management of cancer-associated thrombosis in ongoing head-to-head comparative trials. Here we review the advances and limitation of current anticoagulant therapies.
Anticoagulants* ; Drug Interactions ; Heparin, Low-Molecular-Weight ; Humans ; Prognosis ; Pulmonary Embolism ; Thrombosis ; Venous Thromboembolism* ; Venous Thrombosis

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Contributing Factors on Pharmacokinetic Variability in Critically Ill Neonates.

Sook Hee AN

Korean Journal of Clinical Pharmacy.2017;27(2):63-68. doi:10.24304/kjcp.2017.27.2.63

Neonates have large inter-individual variability in pharmacokinetic parameters of many drugs due to developmental differences. The aim of this study was to investigate the factors affecting the pharmacokinetic parameters of drugs, which are commonly used in critically ill neonates. Factors that reflect physiologic maturation such as gestational age, postnatal age, postconceptional age, birth weight, and current body weight were correlated with pharmacokinetic parameters in neonates, especially preterm infants. Comorbidity characteristics affecting pharmacokinetics in critically ill neonates were perinatal asphyxia, hypoxic ischemic encephalopathy, patent ductus arteriosus (PDA), and renal dysfunction. Administration of indomethacin or ibuprofen in neonates with PDA was associated with the reduced clearance of renally excreted drugs such as vancomycin and amikacin. Therapeutic hypothermia and extracoporeal membrane oxygenation were influencing factors on pharmacokinetic parameters in critically ill neonates. Dosing adjustment and careful monitoring according to the factors affecting pharmacokinetic variability is required for safe and effective pharmacotherapy in neonatal intensive care unit.
Amikacin ; Asphyxia ; Birth Weight ; Body Weight ; Comorbidity ; Critical Illness* ; Drug Therapy ; Ductus Arteriosus, Patent ; Gestational Age ; Humans ; Hypothermia, Induced ; Hypoxia-Ischemia, Brain ; Ibuprofen ; Indomethacin ; Infant, Newborn* ; Infant, Premature ; Intensive Care, Neonatal ; Membranes ; Oxygen ; Pharmacokinetics ; Vancomycin

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Providing Effective Feedback within Pharmacy Practice Education.

Jeong Hyun YOON

Korean Journal of Clinical Pharmacy.2017;27(2):55-62. doi:10.24304/kjcp.2017.27.2.55

Experiential education is a core curriculum of pharmacy education. In experiential education, formative feedback is an integral component of learning and teaching process. Feedback is defined as information provided by a preceptor regarding student's performance based on direct observation. With effective feedback, students can have opportunities to reinforce or correct behaviors and to acquire knowledge or skills. Students highly value and appreciate feedback. They rank provision of effective feedback as one of the most important qualities of preceptors. Preceptors, however, lack an understanding of feedback or practical skills necessary for providing effective feedback. As a result in reality, the feedback provided to students can be differentially effective in improving students' learning. This article describes a theoretical understanding of feedback including definition and value, as well as types of feedback. In addition, practical aspects in providing feedback, such as contents, timing, techniques, and models, are addressed. By understanding the value of feedback and mastering various feedback skills, preceptors will promote students' learning and enhance educational outcomes of experiential education.
Curriculum ; Education* ; Education, Pharmacy ; Formative Feedback ; Humans ; Learning ; Pharmacy* ; Students, Pharmacy

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Erratum: Current View of Orphan Drug Usage in Tertiary Hospital and Rare Incurable Disease Hospital.

Kyung Suk CHOI ; Young mi JEONG ; Yu Jeong KIM ; Yoon Hee KIM ; Hyunmin GU ; Byung Koo LEE ; Eunsook LEE ; Sandy Jeong RHIE

Korean Journal of Clinical Pharmacy.2016;26(3):267-267.

Erratum agreed to by all authors, editor in chief, publisher, and scientific society.

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Cold Medications Aggravated Rhabdomyolysis Symptoms Induced by Building Construction Work and Strenuous Exercise: a Case Report.

Hyonok YOON ; Yoon Jin JANG ; Si Nae PARK ; Eun Joo CHOI ; Soo Wan KIM

Korean Journal of Clinical Pharmacy.2016;26(3):264-266.

SUMMARY: A 21-year-old healthy Korean man worked on a building construction site every day for almost 2 months and exercised every day for 1 or 2 hours after working hard. He felt dizziness, nausea, and experienced vomiting and body aches immediately after exercise and immediately took cold medicines including acetaminophen, cimetidine, bepotastine, and Codenal? complex for the common cold symptoms for 2 days because he was scheduled to participate in navy training at that time. He complained of severe trapezius pain and aches in his left calf 3 days after joining the Navy training. Testing revealed creatine phosphokinase (CPK) 6260 U/L, myogloblin 176 mcg/L in the urine, liver enzymes increased, and oliguria, suggesting rhabdomyolysis. He recovered with intravenous fluids without any complications.
Acetaminophen ; Cimetidine ; Common Cold ; Creatine Kinase ; Dizziness ; Humans ; Liver ; Nausea ; Oliguria ; Rhabdomyolysis* ; Superficial Back Muscles ; Vomiting ; Young Adult

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