• Title/Summary/Keyword: Adverse 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.

Late adverse reactions to iopromide (Ultravist®) diagnosed by the patch test: a case report (첩포검사로 진단된 Iopromide (Ultravist®)의 지연성 부작용 1예)

  • Lee, Soon Joo;Yang, Eun Mi;Choi, Woo Yeon;Song, Eun Song;Han, Dong Kyun;Cho, Young Kuk;Ma, Jae Sook
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.499-503
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    • 2009
  • Iodinated contrast media (CM) can cause immediate and late reactions. We treated a patient with a recurrent generalized maculopapular rash and a fever that occurred within two days of exposure to iodinated CM, iopromide ($Ultravist^{(R)}$), for chest computed tomography. We performed skin testing including prick tests, intradermal tests, and patch tests. Our findings indicated a late skin reaction to $Ultravist^{(R)}$in addition to cross-reactions to other iodinated CM such as ioversol ($Optiray^{(R)}$), iohexol ($Iobrix^{(R)}$), and iobitridol ($Xenetix^{(R)}$). In this study, we report the case of a patient diagnosed with a late adverse reaction to $Ultravist^{(R)}$in addition to cross-reactions to other iodinated CM.

Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS) (의약품부작용보고시스템을 이용한 메토클로프라미드의 이상사례 실마리정보 도출)

  • Min-Gyo Jang;Yeonghwa Lee;Hyunsuk Jeong;Kwang-Hee Shin
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.2
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    • pp.122-127
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    • 2023
  • Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

The Precaution Duty and the Product Liability for Adverse Reactions to the Contrast Media (조영제 부작용에 대한 주의의무와 제조물책임)

  • Kang, Yeong-Han
    • Journal of radiological science and technology
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    • v.30 no.4
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    • pp.305-311
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    • 2007
  • Contrast medium is a useful drug for radiological examinations and usability of it gradually increases while it has some inevitable adverse reaction and it is difficult to predict the occurrence and the degree of adverse reactions. Although the patient consented permission for the use of contrast media, the hospital could not be exempted from the responsibility for the adverse contrast media reaction. During radiological contrast media examination, the radiologist and the contrast media producer have the duty of precaution, prediction and avoid adverse results. In addition, they have reliabi lity of patient remedy for neglecting the duty. Since contrast medium are manufactured or processed as movable properties, the manufacturers are bound to the product liability if damages occur due to the defects in pharmaceuticals. In consideration of the characteristics of product liability, it is necessary to demand high degree of duty of care and diligence from producer or to reduce patient's burden of proof in a product liability lawsuit. For securing compensation ability and liability implementation, products compensation liability insurance is required for contrast medium manufacturers. In conclusion, contrast medium producer has legal liability for adverse reactions and the contract concluded with producer and hospital including legal liability will reduce liability of hospital and radiologist, patient.

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A Case of Non-small Cell Lung Cancer Patient Whose Dermatologic Adverse Reactions Associated with the Epidermal Growth Factor Receptor-inhibitors were Relieved with the Treatment of a Herbal medicine, Samultang-gagambang (비소세포폐암 환자의 표피성장인자 수용체 억제제 치료와 관련된 피부의 이상반응이 사물탕 가감방 투여로 호전된 1례)

  • Park, Hyeong-Jun;Chae, Jean;Lee, Jin-Soo;Jung, Hyun-Sik;Lee, Sang-Hun;Choi, Won-Cheol;Kim, Kyung-Suk
    • Journal of Korean Traditional Oncology
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    • v.16 no.1
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    • pp.55-61
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    • 2011
  • Objectives : Epidermal growth factor receptor-inhibitors have demonstrated improved overall survival in patients with non-small cell lung cancer, but their use is associated with dermatologic adverse reactions that often require symptomatic treatment. Methods : A 44-year-old woman, who started the chemotherapy of Iressa$^{(R)}$ on August 2010, developed cutaneous symptoms such as papulopustular rash, dry skin, and pruritus on her face and scalp after taking Iressa$^{(R)}$ for four weeks. The patient visited our clinic with such symptoms on March 2011 and underwent herebal remedy targeted to alleviate the skin reactions. The severity of dermatologic symptoms was evaluated with the numeric rating scale and the Common Terminology Criteria for Adverse Events version 4.0. Results : Noticeable changes on the skin lesion were observed after the two months of treatment, without any dose modification of the Iressa$^{(R)}$. The cutaneous symptoms as papulopustular rash, dry skin and pruritus were improved and there was no adverse event induced by the treatment with herbal medicine. Conclusions : This case report suggests that the treatment with a herbal medicine, Samultang-gagambang be considered as a useful treatment to relieve EGFR-inhibitor induced dermatologic adverse reactions.

A Case Report of Cyanopsia after Taking Sildenafil (실데나필 복용 이후 발생한 청색시증에 대한 사례)

  • Lee, Chan Hee;Yoon, Joong Sik;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.59-64
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    • 2020
  • The emergence of phosphodiesterase (PDE) 5 inhibitors gave rise to the solution for erectile dysfunction, starting with the development of sildenafil. Although their efficacy in treating erectile dysfunction has been shown, the side effects of PDE5 inhibitors, especially sildenafil, must be taken into consideration. A 64-year-old man received 100 mg of sildenafil and experienced blue vision in both eyes; however, after a day or so, his symptoms improved. The symptoms disappeared when he stopped administering sildenafil, but reappeared when the medication was re-administered. Therefore, he discontinued sildenafil treatment and was prescribed udenafil instead. After that, visual adverse events no longer occurred. Causality assessment showed that in this case, sildenafil-induced cyanopsia was "certain" under the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria and Korean causality assessment algorithm (Ver.2), and was "probable" according to the Naranjo scale. In addition, sildenafil also led to abnormal visual reactions in other cases. Sildenafil can also inhibit PDE6, which is present in retinal cells, unlike other PDE5 inhibitors. Thus, visual adverse reactions, such as blue vision, are the unique results of sildenafil, and other PDE5 inhibitors may be used to prevent them.

Usefulness of drug provocation tests in children with a history of adverse drug reaction

  • Na, Hye-Ran;Lee, Jeong-Min;Jung, Jo-Won;Lee, Soo-Young
    • Clinical and Experimental Pediatrics
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    • v.54 no.7
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    • pp.304-309
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    • 2011
  • Purpose: There are very few reports of adverse drug reactions (ADR) and almost no study of drug provocation test (DPT) in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods: We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009). With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results: There were 17 (23.9%) positive DPTs results out of 71 individual DPTs, and 11 patients (68.8%) from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%), Non-steroidal anti-inflammatory drugs in 4 (25%), penicillin in 3 (19%), cephalosporin in 2 (13%), and cotrimoxazole, macrolide and lactose in 1 each. Conclusion: DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.

Nurses' Monitoring Practice for Adverse Drug Reactions (약물 유해 반응에 대한 간호사의 모니터링 실천에 관한 연구)

  • Kim, Hyun-Jin;Lee, Seon-Hye
    • Journal of Korean Academy of Nursing Administration
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    • v.22 no.1
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    • pp.91-98
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    • 2016
  • Purpose: The aim of this study was to identify the relationship between nurses' knowledge of adverse drug reactions (ADR), attitudes, and monitoring practices and to establish an effective ADR reporting system and provide baseline data for its activation. Methods: The participants in this study were chosen by convenience sampling and included 182 nurses working at major general hospitals that operate a Regional Drug Safety Center. Data were collected from June 1 to 12, 2015 and analyzed using Cronbach's ${\alpha}$, descriptive statistics, independent t-test, one way ANOVA, Pearson correlation coefficient and stepwise regression with the SPSS program. Results: The nurses' average score for knowledge was 7.62 points, for attitude, 41.04 points and for monitoring practices, 34.22 points. ADR monitoring practices positively correlated with knowledge (r=.19, p=.011), attitude (r=.41, p<.001), drug performance competency (r=.54, p<.001), and drug education satisfaction (r=.54, p<.001). Drug performance competency, drug education satisfaction, and attitudes explained 42.0% of the ADR monitoring practices (Adj $R^2=.42$, F=43.95, p<.001). Conclusion: In order to facilitate and encourage nurses' voluntary monitoring practice of ADR, efforts must be made to create positive attitudes toward ADR, and to increase drug performance competency and drug education satisfaction.