• Title/Summary/Keyword: adverse drug reactions

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Pharmacoeconomics Evaluation of Morphine, MS Contin and Oxycodone in the Treatment of Cancer Pain

  • Zhang, Wen-Zhou;Yu, Wei-Jiang;Zhao, Xiu-Li;He, Bao-Xia
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.20
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    • pp.8797-8800
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    • 2014
  • Objective: To analyze cost-effectiveness of morphine, MS contin and oxycodone in the treatment of cancer pain, providing guidance for rational drug use in the clinic. Methods: Confirmed by histology, a total of 171 patients with various cancers who required analgesic treatment were selected and divided into 3 groups, 57 cases for each group, given morphine, MS contin and oxycodone, respectively. If there appeared a poor short-term effect or aggravated sudden pain during the treatment, a short-acting morphine injection was given and adverse reactions were processed by symptomatic treatment. The pain relief rate and adverse reactions of groups were observed and pharmacoeconomics evaluation was undertaken. Results: The pain relief rates with morphine, MS contin and oxycodone were 89.5%(51/57), 91.2%(52/57) and 93.0%(53/57), respectively, with no difference samong groups (${\chi}^2=4.4489$, P=0.6162). The occurrence rates of adverse reactions were 59.7%(34/57), 54.4%(31/57) and 43.9%(25/57), again with no significant variation (P>0.05). The ratios of cost-effectiveness (C/E) for the 3 groups were $14.6{\pm}7.21$, $15.0{\pm}7.44$ and $16.1{\pm}8.10$. When the price of 3 kinds of analgesics was reduced by 10%, the ratios of cost-effectiveness were $12.2{\pm}6.53$, ($13.4{\pm}6.08$ and $14.5{\pm}6.74$ but there was no differences when compared with before the price adjustment (t=1.86, P=0.0651; t=1.30, P=0.1948; t=1.17, P=0.2453). Conclusion: Morphine, MS contin and oxycodone give similar pain relief and adverse reaction rates but of all, morphine is the preferred drug for the treatment of cancer pain from the perspective of pharmacoeconomics.

A Case of Skin Eruption Occurred after Switching Formulation of Quetiapine Fumarate (Quetiapine Fumarate의 제형 변경 후 발생한 피부 발진 1예)

  • Kwon, Yong-Seok;Lim, Se-Won
    • Korean Journal of Biological Psychiatry
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    • v.16 no.4
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    • pp.266-270
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    • 2009
  • Adverse drug reactions are very common in clinical practice, and skin is one of the most frequent organs for adverse drug reactions. We report a case of a 71-year-old male patient who developed skin eruptions after switching formulation of quetiapine immediate release(IR) to quetiapine extended release(XR). He had been taking quetiapine IR(400mg/day) for treatment of manic episode which was developed one year ago. The patient showed great improvement of symptoms after taking quetiapine IR for about one year, thus dosage of medication was reduced to 50mg/day on the average. Unfortunately dose reduction has tended to worsen symptoms, so dose of quetiapine was increased again to 200mg/day with formulation changes to XR. Two days after he took new formulation, erythematous papules were occurred over his anterior neck and ventral side of left wrist. As he stopped quetiapine XR, the skin lesions gradually subsided. And he was successfully treated with readministration of quetiapine IR without any skin lesions.

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The Surveillance of Adverse Drug Reactions (ADR) Reported in Samsung Medical Center (삼성서울병원에서 보고된 의약품 부작용의 현황 조사)

  • Cho, Jeong Ah;Lee, Hu Kyung;Sohn, Kie Ho;Choi, Kyung Eub
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.30-37
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    • 2000
  • Adverse drug reactions (ADR) may result in increased hospital admissions, morbidity and mortality, adding extra cost to healthcare expenditures. Thus, it is critical to activate ADR monitoring and reporting program in tertiary hospitals in developing countries such as Korea. This study was performed to identify the types of ADR being reported in a tertiary hospital, Samsung Medical Center, and to find out the ways to improve current ADR monitoring system. Of 464 ADR reports submitted to the pharmacy department during the 6-month survey period, $97.8\%$ of the reports were from out patient and $48.5\%$ were from patients aged between 50 and 60. The medical department with the highest frequency in ADR reporting was Internal Medicines $(35.6\%)$. The most common ADR manifestations were gastrointestinal complaints $(43.4\%)\;and\;75\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $32.8\%$. In terms of causality assessment, $85.1\%$ of the reports were probable cases by WHO causality assessment criteria. In regards to sources of report, $75.6\%$ of ADR were reported by physicians and $24.4\%$ by nurses. There were no ADR reported by pharmacists. In conclusion, there is an urgent need to improve ADR monitoring system for inpatient and to motivate pharmacist involvement in ADR monitoring and reporting in Korea.

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Measuring the Seriousness of Adverse Drug Reactions : Comparisons between Korean Experts and WHO Working Group Members (의약품 부작용의 심각도 조사 비교분석)

  • Rhee, Jin-Nie;Park, Se-Young;Heo, Ji-Haeng;Park, Mi-Hae;Ha, Ji-Hye;Lee, Eui-Kyung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.3
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    • pp.237-242
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    • 2011
  • This study measures seriousness of adverse drug reactions (ADRs) among Korean physicians and pharmacists using two times surveys based on Delphi technique. Each participant scored 20 ADR terms on a scale of one to ten (10 being the most serious). We repeated the exercise for the 49 first survey respondents and 32 re-evaluated score. We compared the results of our survey with those of WHO CIOMS (Council for International Organization of Medical Sciences) working groups members conducted in 1995. The overall mean ADR seriousness score was 6.49 for Koreans and 5.12 for WHO CIOMS members, presenting Korean experts perceived more seriously for each ADR. Mean score changes for the same respondents showed similar trends regardless of access to the first survey results. There were no statistically significant score differences between the physicians and the pharmacists. The high consensus of seriousness for each ADR between the Korean experts and the WHO CIOMS members implies that the similar results are reproducible, suggesting the possibility of developing standardized tools for measuring the seriousness of individual ADRs in the future.

Initiation of Pharmaceutical Care Service in Medical Intensive Care Unit with Drug Interaction Monitoring Program (내과계 중환자실 약료 서비스 도입과 약물상호작용 모니터링)

  • Choi, Jae Hee;Choi, Kyung Sook;Lee, Kwang Seup;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.138-144
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    • 2015
  • Objective: It is to evaluate the drug interaction monitoring program as a pilot project to develop a pharmaceutical care model in a medical intensive care unit and to analyze the influencing factors of drug interactions. Method: Electronic medical records were retrospectively investigated for 116 patients who had been hospitalized in a medical intensive care unit from October to December in 2014. The prevalence of adverse reaction with risk rating higher than 'D' was investigated by Lexi-$Comp^{(R)}$ Online database. The factors related with potential drug interaction and with treatment outcomes were analyzed. Results: The number of patients with a potential interaction of drug combination was 92 (79.3%). Average ages, the length of stay in the intensive care unit and the numbers of prescription drugs showed significant differences between drug interaction group and non-drug interaction group. Opioids (14.4%), antibiotics (7.2%), and diuretics (7.2%) were most responsible drug classes for drug interactions and the individual medications included furosemide (6.4%), tramadol (4.9%), and remifentanil (4.5%). There were 950 cases with a risk rating of 'C' (84.6%), 142 cases with a risk rating of 'D' (12.6%), and 31 cases with a risk rating of 'X' (avoid combination) (2.8%). The factors affecting drug interactions were the number of drugs prescribed (p < 0.0001) and the length of stay at intensive care unit (p < 0.01). The patients in intensive care unit showed a high incidence of adverse reactions related to potential drug interaction. Therefore, drug interaction monitoring program as a one of pharmaceutical care services was successfully piloted and it showed to prevent adverse reaction and to improve therapeutic outcomes. Conclusion: Active participation of a pharmacist in the drug management at the intensive care unit should be considered.

Studies of the side effects on using the contrast media: It's characteristic and management (조영제를 사용하는 환자의 부작용: 특성과 관리에 관한 연구)

  • Seon, Jong-Ryoul;Yoo, Se-Jong
    • Journal of the Korea Safety Management & Science
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    • v.16 no.4
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    • pp.427-431
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    • 2014
  • The purpose of this study is to monitor the current adverse reactions in administering CT contrast agents at general hospitals and also to suggest the practical guidelines to minimize the risk and to show the successful patient management. At four Dajeon city general hospitals, the contrast agents were administered in 646,828 cases and the overall prevalence of adverse reactions was 4,110 cases from January 2010 to December 2013. However, we excluded the two hospitals' 3,658 cases because the patients' data was inadequate. Consequently, the case surveys on the rest of 452 cases have been studied and submitted. After comparing the patients with a control group, we evaluated that the key factors of the adverse reactions were the gender and age difference of the patients, the examination period, the examination method, the quantity and administrating speed of the contrast agents. Even though the four general hospitals have their own management systems on adverse reactions, but their systems were not satisfying. To improve the quality of the management systems and to investigate further cases, some hospital administration procedures on the subject should be systemized and general hospitals should follow the recommended procedures. Moreover, the existing three-year-term evaluation should not only judge the adverse reaction management but also conclude some details on the sub criteria of the evaluation. The details on the sub criteria include the contrast agent characters, the quantity and administrating speed of the drug, the incidents' occurred time, an anamnesis; a case history, the medical history of the patients and the reaction occurring body parts, and the examination title. The details of the medical examiners are also added to the sub criteria.

Toxic epidermal necrolysis induced by lamotrigine treatment in a child

  • Yi, Youngsuk;Lee, Jeong Ho;Suh, Eun Sook
    • Clinical and Experimental Pediatrics
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    • v.57 no.3
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    • pp.153-156
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    • 2014
  • Toxic epidermal necrolysis is an unpredictable and severe adverse drug reaction. In toxic epidermal necrolysis, epidermal damage appears to result from keratinocyte apoptosis. This condition is triggered by many factors, principally drugs such as antiepileptic medications, antibiotics (particularly sulfonamide), nonsteroidal anti-inflammatory drugs, allopurinol, and nevirapine. Lamotrigine has been reported potentially cause serious cutaneous reactions, and concomitant use of valproic acid with lamotrigine significantly increases this risk. We describe a case of an 11-year-old girl with tic and major depressive disorders who developed toxic epidermal necrolysis after treatment with lamotrigine, and who was diagnosed both clinically and pathologically. Children are more susceptible to lamotrigine-induced rash than adults, and risk of serious rash can be lessened by strict adherence to dosing guidelines. Unfortunately, in our case, the patient was administered a higher dose than the required regimen. Therefore, clinicians should strictly adhere to the dose regimen when using lamotrigine, especially in children.

Effect of Triple Compared to Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Percutaneous Coronary Intervention (관상동맥 약물 용출 스텐트 삽입 후 항혈소판제제 3제요법과 2제요법의 임상적 효과 비교)

  • Ye, Kyong-Nam;Kim, Jeong-Tae;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.2
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    • pp.113-122
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    • 2012
  • ACC/AHA/SCAI Guideline recommends for administration dual antiplatelet therapy after drug-eluting stent (DES) to prevent restenosis and stent thrombosis in patients with percutaneous coronary intervention (PCI). Recently triple antiplatelet therapy including cilostazol is known to reduce restenosis and stent thrombosis significantly after DES implantation. However, there is lack of data providing the efficacy of triple antiplatelet therapy. The purpose of this study is to evaluate the clinical effects of the triple therapy after DES implantation compared with the dual therapy. This retrospective study collected data from medical charts of 251 patients who received DES implantation between Jul 2006 and Jun 2008. They received either dual antiplatelet therapy (N = 154 clopidogrel and aspirin; Dual group) or triple antiplatelet therapy (N = 97 cliostazol, clopidogrel and aspirin; Triple group). Major adverse cardiac event rates (MACE, included total death, myocardial infarction, target lesion revascularization) at 12 months, 24 months, stent thrombosis, rates of bleeding complications and adverse drug reactions were compared between these two groups. Compared with the dual group, the triple group had a similar incidence of the MACE rates at 24months (12.3% vs. 12.4%, p = 0.99). There is no difference in overall stent thrombosis between two groups (Dual group 2.6% vs. Triple group 4.1%, p = 0.5). Subgroup analysis showed that diabetic patients got more benefit in reducing MACE rates but, there is no statistical difference. Bleeding complications and adverse drug effects were not different significantly. As compared with dual antiplatelet therapy, triple antiplatelet therapy did not reduce the 12-months, 24-months MACE rates and stent thrombosis. Bleeding complications and adverse drug effects were not different.

Pharmacogenomics in Relation to Tailor-made Drugs

  • Satoh, Tetsuo
    • Biomolecules & Therapeutics
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    • v.14 no.4
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    • pp.183-188
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    • 2006
  • The field of cytochrome P450 pharmacogenomics has progressed rapidly during the past 25 years. Recently, conjugating enzymes including sulfotransferase, acetyltransferase, glucuronosyltransferase and glutathione transferase have been also extensively studied. All the major human drug-metabolizing P450 enzymes and some conjugating enzymes have been identified and cloned, and the major gene variants that cause inter-individual variability in drug response and are related to adverse drug reactions have been identified. This information now provides the basis for the use of predictive pharmacogenomics to yield drug therapies that are more efficient and safer. Today, we understand which drugs warrant dosing based on pharmacogenomics to improve drug treatment. It is anticipated that genotyping could be used to personalize drug treatment for vast numbers of subjects, decreasing the cost of drug treatment and increasing the efficacy of drugs and health in general. It is assumed that such personalized P450 gene-based treatment which is so-called tailor(order)-made drug therapy would be relevant for 10-20% of all drug therapy in the future.

Allopurinol-induced severe cutaneous adverse reactions: A report of three cases with the HLA-B58:01 allele who underwent lymphocyte activation test

  • Kim, Eun-Young;Seol, Jung Eun;Choi, Jae-Hyeog;Kim, Na-Yul;Shin, Jae-Gook
    • Translational and Clinical Pharmacology
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    • v.25 no.2
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    • pp.63-66
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    • 2017
  • Allopurinol-induced severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome are reportedly associated with the $HLA-B^{\star}58:01$ genotype. Three patients who developed SCARs after allopurinol administration were subjected to HLA-B genotyping and lymphocyte activation test (LAT) to evaluate genetic risk and to detect the causative agent, respectively. All three patients given allopurinol to treat gout were diagnosed with DRESS syndrome. Symptom onset commenced 7-24 days after drug exposure; the patients took allopurinol (100-200 mg/d) for 2-30 days. HLA-B genotyping was performed using a polymerase chain reaction (PCR)-sequence-based typing (SBT) method. All patients had a single $HLA-B^{\star}58:01$ allele: $HLA-B^{\star}13:02/^{\star}58:01$ (a 63-year-old male), $HLA-B^{\star}48:01/^{\star}58:01$ (a 71-year-old female), and $HLA-B^{\star}44:03/^{\star}58:01$ (a 22-year-old male). Only the last patient yielded a positive LAT result, confirming that allopurinol was the causative agent. These findings suggest that patients with $HLA-B^{\star}58:01$ may develop SCARs upon allopurinol administration. Therefore, HLA-B genotyping could be helpful in preventing serious problems attributable to allopurinol treatment, although PCR-SBT HLA-B genotyping is time consuming. A simple genotyping test is required in practice. LAT may help to identify a causative agent.