Purpose: This study is a descriptive research intended to clarify the medication status of community-dwelling elders and to identify factors affecting their medication adherence. Methods: Data were collected using questionnaires and interviews from 101 subjects who had taken prescribed drugs for at least 7 days sampled among elderly people using home care nursing at a general hospital in Seoul. Results: According to the results of this study, medication adherence measured by pill counting was 88.3% and that measured by self-reporting was 94.6%. There were statistically significant differences in medication adherence according to major disease (p=.006), the number of admissions (p=.032), the number of drugs (p=.051), the frequency of medication (p=.026), and depression (r=-.205). In addition, depression was found to be a significant variable explaining the medication adherence with explanatory power 3.8% (p=.035). Conclusion: The presence of depression affected the elderly subjects' the medication adherence. Therefore, more concern and educational approaches are required to encourage elderly people to comply correctly with medication regimens particularly for elderly patients who have a malignant or long-lasting disease or who have to take multiple drugs or maintain a daily dosing frequency.
Appropriate drug classification is important fur rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers' ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, saff drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term Preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process fer reclassification application, are necessary.
In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.
An animal which is placed in a new environment displays a complex behavioral pattern consisting of locomotion, grooming and rearing. This behavioral pattern is influenced by endogenous and exogenous stimuli, such as hormonal secretion, level of neurohumoral transmitters, drugs and light. It is widely known that the most tranquilizers depressed spontaneous motor activity although their mechanisms of action were different, while antidepressants stimulated except imipramine which showed various action. Until the present time, the hole-board apparatus, which gives rather subjective data, has been used extensively to study the effects of drugs on general activity and exploratory behavior in mice. Recently a new apparatus for mobility measurements, called a 'Selective Activity Meter' has been introduced. This instrument supposedly produces more objective data on activity and behavior. The purpose of the present experiment was to study the influence of psychotropics on motor activity using the Selective Activity Meter. In the experiment, various psychotropic agents such as major tranquilizers(chlorpromazine, haloperidol); minor tranquilizers(meprobamate, diazepam); and antidepressants(amphetamine, imipramine) were used. In each experiment, the drug was administered to five mice and their activity was recorded. Each experiment was run five or more times and the results are based on the mean of each trial. The results are summarized as follows: 1. The group of mice treated with chlorpromazine showed markedly inhibited motor activity in comparison with controls and the inhibitory action of chlorpromazine was shown to be more intense than any of the other drugs used in the test. Haloperidol administration yielded similar results until 60 minutes, but mice showed less inhibition of motor activity than with chlorpromazine after 90 minutes. 2. In the group treated with diazepam, there was strong inhibition of motor activity until 30 minutes, but after 60 minutes the mice showed less inhibition than with chlorpromazine. In the meprobamate group, motor activity was inhibited in a manner similar to that of other tranquilizers, but the inhibition was less than that of diazepam. 3. In the group treated with imipramine, the inhibition developed gradually after ten minutes. 4. The effects of amphetamine did not appear until 30 minutes after administration, but then there was a significant increase in the motor activity.
Purpose: This study was done to investigate compliance with health behaviors among patients who are hypertensive. Method: The participants in this study were 121 outpatients with hypertension. Compliance with health behaviors was measured using a questionnaire developed by the researchers. Data were analyzed using t-test, ANOVA, Duncan's multiple range test and chi square test. Results: According to tile general characteristics of the participants, compliance with medication and diet was higher among women than men, among high school graduates than middle school graduates or those with lower academic qualifications, and among those who were unemployed compared to those who were employed. Compliance with alcohol abstinence or not smoking was higher among women than men, and among those who were unemployed compared to those who were employed. According to the risk factors of hypertension, compliance with health behaviors was significantly higher in those who had associated diseases. The participants in the group with a hypertension morbidity period longer than 10 years did exercise more than 3 times a week and regularly weighed themselves once or more a week. The item showing highest compliance concerning medication and diet was 'Take prescribed drugs regularly', while the one showing lowest was 'Take drugs with knowledge about their side effects'.
There are some reports about the influences of free fatty acids on the albumin binding of drugs. But they were concerned to the limited free fatty acids, mostly of azapropazone-warfarin bidning site bound drugs and determination of dissociation and association constants by stopped flow technique. These data were not enough to make conculsions for the general tendency of free fatty acid to albumin binding. Therefore the influence of various saturated fatty acids of $C_{10{\sim}20}$, oleic acid and linoleic acid as unsaturated fatty acids to albumin binding of warfarin and dansylsarcosine were studied by equilibrium dialysis. The concentration of free drug was determined by spectrophotometer according to the molar ratios of 0, 0.5, 1, 2 and 4 between free fatty acid and albumin. There were significant increasing in the free durg concentration of warfarin and dansylsarcosine when the molar ratio for capric acid, lauric acid and palmitic acid was 4. The free warfarin concentration was increased significantly at a molar ratio of 4 between oleic acid and albumin. Therefore the albumin binding of durgs can be variated significantly by increased free fatty acid of diabetics and cause to the pharmacokinetic variation between healthy and diabetics.
Thyrotropin binding inhibitory immunoglobulin (TBII) and thyroid stimulating antibody (TSAb) activities were measured in the thyroidal and peripheral venous blood samples at the time of subtotal thyroidectomy from twenty one patients with Graves' disease prepared for surgery with antithyroid drugs. There was no difference in TBII and TSAb activities between thyroidal and peripheral blood samples. These findings were regarded that while intrathyroidal lymphocytes are major site of thyrotropin receptor antibody (TRAb) production, similar levels are found in thyroidal and peripheral veins and that this in vivo study cannot exactly ascertain the TRAb producing site.
Purpose: This study was performed to identify effects of pneumoperitoneum on hemodynamic changes of hypertensive patients undergoing laparoscopic colectomy under general anesthesia. Methods: Data collection was done from January 2 to June 10, 2008. Seventy-six patients, including 38 hypertensive patients, who had taken antihypertensive drugs more than 1 month and 38 normotensive patients undergoing laparoscopic colectomy were enrolled in this study. The hemodynamic parameters were heart rate (HR), mean arterial pressure (MAP) and cardiac output (CO) which were measured 7 times from before induction of anesthesia to 5 min after deflation of the pneumoperitoneum. Collected data were analyzed using Repeated Measures ANOVA and Bonferroni comparison method. Results: HR in the hypertensive group was significantly decreased at deflation of the pneumoperitoneum and 5 min after deflation of the pneumoperitoneum (p=.012). MAP in the hypertensive group was not different from the normotensive group (p=.756). CO in hypertensive group was significantly lower than normotensive group (p<.001) from immediately after pneumoperitoneum to 5 min after deflation of the pneumoperitoneum. Conclusion: The results indicate that pneumoperitoneum during laparoscopic surgery does not lead to clinically negative hemodynamic changes in heart rate, mean arterial pressure or cardiac output of hypertensive patients, who have taken antihypertensive drugs for more than 1 month.
The purpose of this study is to assess the clinical efficacy and safety of NRM granules which were newly developed as a combination product containing antacids, digestive enzymes and herb drugs for the treatmet of various symptoms of upper gastrointestinal disorders taking SGN granules of similiar but different composition as a control. One hundred and twenty one patients were randomly allocated to receive one pack of either NRM granule(80 cases) or SGN granules(41 cases) three times a day after meal and undergone symptomatic, endoscopic and clinical laboratory assessment before and after two weeks of treatment. The results were as follows; 1. All symptoms except anorexia showed improvements in more than 90% of total cases with each symptom in the NRM group. 2. The general improvement rate was 97.5% in NRM group, and was superior to the(92.5%) of SGN group. 3. Two cases of NRM group and one case of SGN group developed mild nausea, and onecase of SGN group developed mild epigastric soreness. No cases of the two groups developed laboratory(blood, biochemical, urine) abnormalities. 4. The overall clinical efficacy rate was 95.0% in NRM group, 87.8% in SGN group. kccording to the result of this trial, it was concluded that NRM granule was an effective and safe drug and(but not statistically significant) was slightly more efficient than SGN for treatment of various symptoms in upper gastrointestinal disorders.
This study identified the actual conditions for safe anticancer drug management among nurses and the relationship between level of awareness and performance of anticancer drug safety regulations in terms of preparation, administration, and disposal. The respondents were 236 nurses working with chemotherapy in wards and outpatient clinics in five hospitals in and near Seoul. Safety regulations provided for the anticancer drug the Occupational Safety Health Administration (OSHA, 1999), as modified for an earlier study, were used. The results showed that the level of awareness and performance on the anticancer drug safety regulations indicate their preparation ($3.38{\pm}0.55$, $2.38{\pm}0.98$), administration ($3.52{\pm}0.46$, $3.17{\pm}0.70$), general handling and disposal ($3.33{\pm}0.54$, $2.42{\pm}0.90$) on a scale 0 to 5. Also, there were significant differences in job positions, work experience, type of preparation, and continuing education and a positive relationship between the level of awareness and nursing performance. Thus, nurses should receive continuing education on the handling of anticancer drugs to improve the level of performance following safety regulations.
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