• Title/Summary/Keyword: causality assessment

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Hyperprolactinemia after taking Levosulpiride and its Causality Assessment: An Adverse Event Reported by a Community Pharmacy (Levosulpiride 복용 이후 발생한 고프로락틴혈증 및 그 인과성 분석: 지역약국에서 보고된 부작용 증례)

  • Lee, Heeyoung;Jo, Yu Jin;Yoon, Joong Sik;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.154-157
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    • 2018
  • Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as "possible" by the WHO-UMC and Naranjo scales, but as "probable" by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.

Causality Assessment of Adverse Events on Acupuncture (침의 유해사례 인과성 평가 연구)

  • Jung, Hee-Jung;Choi, Jun-Yong;Park, Ji-Eun;Kim, Kun-Hyung;Choi, Sun-Mi;Oh, Dal-Seok
    • Korean Journal of Acupuncture
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    • v.25 no.2
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    • pp.95-105
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    • 2008
  • Objectives : This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment. Methods : We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology. Results : In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall's tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale. Conclusion : A new algorithm which reflects acupuncture properties should be developed and elucidated.

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Visual Field Defect after Taking Atorvastatin/Ezetimibe, a Case Study (Atorvastatin/ezetimibe 복합제 복용 후 발생한 시야결손 부작용 사례보고)

  • Kim, Jiyoon;Lee, Kyunggyu;Kim, Junyoung;Lee, Jung-Min;Kim, Na-Young;Lee, Mo-Se;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.2
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    • pp.133-137
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    • 2019
  • Atorvastatin is one of the most widely prescribed medications for dyslipidemia treatment. In Korea, post combined therapy with ezetimibe, a 73-year-old woman was reported by a community pharmacy to have experienced visual field defect, which recovered after drug discontinuation. She had never experienced this symptom before, and several studies have reported an association between use of statins and visual disorders such as blurred vision, diplopia, and cataract. Blockage of cholesterol accumulation, oxidative stress, or myopathy is expected to be a cause of this symptom. Naranjo scale, Korean causality assessment algorithm (Ver.2), and World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria were the three tools used to determine causality between the visual disorder and atorvastatin. The results represent 'probable', 'certain', and 'probable/likely' causality, respectively. Our results, in combination with a review of literature, indicate that ocular adverse effects are highly likely related to atorvastatin.

A Case Report of Esophageal Ulceration after Taking Doxycycline (독시사이클린 복용 후 발생한 식도궤양형성 사례)

  • Kim, Ga Yeon;Lee, Chan Hee;Lee, Jeong Woo;Lee, Jung-Min;Lee, Mo-Se;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.3
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    • pp.209-214
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    • 2019
  • Doxycycline is frequently prescribed to treat urogenital infections or acne vulgaris. A 39-year-old man was prescribed doxycycline as a treatment for his skin infection. He took each tablet on an empty stomach in the morning, and just before going to bed with insufficient water. After taking the prescribed medication for approximately 3 weeks, he was diagnosed with esophageal ulcer. He had not experienced these symptoms before, and the drug label says that doxycycline rarely causes esophageal ulcer. After discontinuing the medication, the symptoms disappeared. Using the World Health Organization-Uppsala Monitoring Center criteria, the causality for doxycycline-induced esophageal ulcer was evaluated as "possible." Additionally, using the Naranjo scale and Korean causality assessment algorithm (Ver. 2), the causality was evaluated as "probable." Previous reports have stated that most patients who took doxycycline with insufficient water just before going to bed or in the supine position developed esophageal ulcer. Therefore, all patients taking doxycycline must be provided with detailed instructions about the appropriate administration methods.

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.

Psychiatric Symptoms after Taking Oseltamivir in a Child and Its Causality Assessment (Oseltamivir 복용 이후 소아에서 발생한 이상행동 및 그 인과성 평가)

  • Son, Pyoungwoo;Choi, Joonghyuk;Lee, Seungmin;Park, Seon Soon;Choi, Eunkyung;Yoo, Bong-Kyu;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.1
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    • pp.56-60
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    • 2019
  • Oseltamivir is an antiviral medication prescribed to prevent and treat influenza A and B. A case from a community pharmacy in Korea was reported for an adverse event associated with oseltamivir administration. A 20-month-old boy had psychiatric symptoms after receiving 2 doses of oseltamivir. Therefore, an evaluation of whether the psychiatric symptoms were caused by oseltamivir was required. To determine whether the adverse event resulted from the administrated medication or other factors, three tools were used: the Naranjo scale, the Korean causality assessment algorithm (Ver.2), and the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The psychiatric symptoms occurred after oseltamivir administration, and were attenuated after oseltamivir termination. A possible cause of the psychiatric symptoms is high fever, but information on the body temperature of the patient was not sufficient. Therefore, it was unclear whether there were other nonpharmacological causes of adverse drug reaction. For these reasons, in terms of causality, the results evaluated by the three tools represented, "possible", "probable", and "probable/likely", respectively.

Analysis of the Phillips Curve: An Assessment of Turkey

  • NAR, Mehmet
    • The Journal of Asian Finance, Economics and Business
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    • v.8 no.2
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    • pp.65-75
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    • 2021
  • This study analyzes the validity of the Phillips curve with regards to Turkey. The existence and direction of the causality relationship (reason-outcome relationship) between unemployment and inflation is investigated using inflation and unemployment data for the period 1980-2019. Unit root tests were utilized to evaluate the stationarity of the series. In line with the Zivot-Andrews unit root test, which was developed in response to the criticism of the failure of studies that presented macro-variables like inflation to consider traditional unit root tests, in this research, the Engle-Granger cointegration test was implemented to check whether the series could perform a joint action, and, finally, the Granger causality relationship was explored. According to the results of the analysis, over the relevant period there was a single directional causality relationship from inflation toward unemployment in Turkey. The importance of this relationship at the 10% significance level indicates the existence of many different factors that affect inflation and unemployment. Given the existence of a cointegration and causality relationship between inflation and unemployment, it can be said that, in Turkey, the Phillips curve is valid for the period 1980-2019 and that an increase of 1% in inflation will reduce the unemployment rate by 0.028%.

Effect of A Pharmacovigilance Practice Training Course for Future Doctors of Korean Medicine on Knowledge, Attitudes and Self Efficacy (약물감시 실습 교육이 한의과대학 학부생의 지식, 태도 및 자가 효능감에 미치는 효과)

  • Kim, Mikyung
    • The Journal of Korean Medicine
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    • v.41 no.1
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    • pp.21-44
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    • 2020
  • Objectives: This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum. Methods: Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education. Results: The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey. Conclusions: More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

Development of a Tele-Rehabilitation System for Outcome Evaluation of Physical Therapy

  • Park, Hyung-Soon;Lee, Jeong-Wan
    • Journal of Biomedical Engineering Research
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    • v.29 no.3
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    • pp.179-186
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    • 2008
  • This paper presents a portable tele-assessment system designed for remote evaluation of the hypertonic elbow joint of neurologically impaired patients. A patient's upper limb was securely strapped to a portable limb-stretching device which is connected through Internet to a portable haptic device by which a clinician remotely moved the patient's elbow joint and felt the resistance from the patient. Elbow flexion angle and joint torques were measured from both master and slave devices and bilaterally fed back to their counterparts. In order to overcome problems associated with the network latency, two different tele-operation schemes were proposed depending on relative speed of tasks compared to the amount of time delay. For slow movement tasks, the bilateral tele-operation was achieved in real-time by designing control architectures after causality analysis. For fast movement tasks, we used a semi-real-time tele-operation scheme which provided the clinicians with stable and transparent feeling. The tele-assessment system was verified experimentally on patients with stroke. The devices were made portable and low cost, which makes it potentially more accessible to patients in remote areas.