Adverse drug reaction reporting--proposal to implement a revised system.
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Biomedical subjects
Publications and source records attributed to J A Linkewich.
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The preparation of guidelines that address antineoplastic drug administration is described. Vesicant drugs are identified, and specific techniques to avoid extravasation and tissue injury are included as are specific treatment recommendations for extravasation injury. The guidelines were developed by a multidisciplinary ad hoc task force that focused on a major objective of permitting particular treatments to be initiated immediately after extravasation is noted.
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Since previously reviewed in the Journal (Vol. 12, No. 2), metoclopramide has been confirmed as an effective drug in treating and preventing various types of vomiting and as a useful agent in oesophageal reflux disease, gastroparesis, dyspepsia, and in a variety of functional gastrointestinal disorders. Of considerable importance is the recent evidence of its efficacy when administered intravenously in high dosages in preventing severe vomiting associated with cisplatin. Good results have been achieved in patients not previously treated with cisplatin, but further studies are needed to determine its level of efficacy in patients who have experienced severe vomiting during earlier courses of cytotoxic therapy. Side effects consisting of mild sedation, diarrhoea and reversible extrapyramidal reactions have occurred, but are tolerated by many patients.
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A case of timolol-associated heart failure in a 73-year old white man is reported. The patient, with a history of cardiovascular disease and glaucoma, was admitted to the hospital because of complaints of shortness of breath, orthopnea, and reduced exercise tolerance. Chest roentgenogram showed interstitial congestive failure, and an EKG demonstrated sinus bradycardia. The patient's medications before admission included quinidine, isosorbide dinitrate, dipyridamole, aspirin, pilocarpine eyedrops 4%, timolol eyedrops 0.5%, and nitroglycerin ointment and sublingual tablets. On the second day of hospitalization, it was noted that the patient's dyspnea and sinus bradycardia could be related to a recent increase in his timolol dosage. The timolol was discontinued, and the patient's heart rate increased. As the patient's pulse rate increased, the symptoms of congestive heart failure disappeared. This case demonstrated the importance of obtaining complete drug histories from patients. The potential for adverse system reactions resulting from topical medications should be considered.
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The medical and nursing staffs of two affiliated hospitals were surveyed on their frequency and purpose of use of their hospital's formulary manual. A numerical rating of the perceived educational value of the manuals was also requested. Twenty-two per cent (141/650) of those surveyed completed their questionnaires. Ninety-six per cent of the respondents indicated use of the formulary manuals at least once a month; 62% used the manuals at least once a week. The frequency and character of use of various sections of the formulary manuals are presented. The perceived educational value of the manuals was rated 3 or greater on a scale of 1 (no value) to 5 (greatest value) by 80% of the respondents. The hospitals' formulary manuals are frequently referred to for various types of drug information. The professional staffs perceive the formulary manuals to be educationally valuable sources of drug information. Reasons for the low rate of response to the survey are presented. A plan of how to increase the response rate in a planned future survey is also presented.
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A study was conducted at a university hospital to determine the patterns of clindamycin prescribing, to assess the appropriateness of clindamycin usage and to quantitate the drug's toxic reactions. Three evaluators (two pharmacists and a physician) reviewed clindamycin usage data for 65 patients who received 67 courses of clindamycin therapy during the period January 1, 1975, through March 20, 1975. Forty-eight courses were parenteral, three oral, and 16 a combination of parenteral and oral. Fifty-four courses were intended for therapeutic use rather than prophylactic use. Of these 54 therapeutic courses, 23 were considered rational and 26 irrational; insufficient data existed to make a judgment in five cases. Three adverse reactions (diarrhea in each case) were observed. The time relationship of this study with the changing clinical status of clindamycin is discussed. Identification of clindamycin's toxicity appears to have reduced oral use at the study hospital, but parenteral usage of the drug remains high.
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