Drug Administration Process Research Articles

Preventing Medication Errors with Antineoplastic Agents, Part 1

Goal — The goal of this program is to present practical ways to prevent medication errors with antineoplastic agents, identify common types of medication errors, and describe a system for reducing the incidence of medication errors and responding appropriately to antineoplastic medication errors. Objectives — At the completion of this program, the participant will be able to: 1. Describe the scope and impact of medication errors 2. Define common terms used in medication error literature. 3. List four common types of prescribing errors made with anti-neoplastic agents. 4. Identify steps where medication errors may occur during the drug ordering, preparation, and administration process. 5. Describe ways to prevent errors at each step of the medication use process. 6. Recommend a procedure for reporting and monitoring antineoplastic medication errors within the institution. 7. Describe a system for the non-punitive management of antineoplastic medication errors in health care systems.

Technology Assessment Status Evaluation Device Evaluation and the Food and Drug Administration Process, July 1994

Technology Assessment Status Evaluation Device Evaluation and the Food and Drug Administration Process, July 1994

Reply: Medicinal Uses of Marijuana

Letters15 December 1997Reply: Medicinal Uses of MarijuanaEric A. Voth, MD and Richard H. Schwartz, MDEric A. Voth, MDInternational Drug Strategy Institute; Topeka, KS 66606Search for more papers by this author and Richard H. Schwartz, MDInternational Drug Strategy Institute; Topeka, KS 66606Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-127-12-199712150-00035 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:The attitudes of Drs. Bayer and O'Connell are precisely why we undertook the project of sorting out emotion and passion from science and fact as they relate to the use of crude marijuana as a medicine. We found no compelling reason to abandon the Food and Drug Administration process of proving safety and efficacy and stepping back to the days of unproven and potentially toxic potions and tonics. That is the net effect of views represented by Drs. Bayer and O'Connell. Unlike the anecdotal diatribes that pervade support for the medicinal use of marijuana, our review was extensive ...

Determination of platinum in workroom air and in blood and urine from nursing staff attending patients receiving cisplatin chemotherapy.

The use of anti-neoplastic drugs is increasing and nursing staff are evidently concerned about the risk of hazardous exposure. General methods are available for measuring exposure to carcinogens. These methods, however, lack specificity. One group of anti-neoplastic drugs, based on cisplatin derivatives, contain platinum, which can be analysed at low concentrations with the use of adsorptive voltammetry. The aim of this study was to employ this technique for assessment of occupational exposure by selective determination of platinum in workroom air and in blood and urine samples from medical staff nursing cancer patients. The voltammetric method for determination of platinum has been further developed for analysis of blood, urine and air samples. The effects of different materials in crucibles and different acids for sample pre-treatment, and of the ashing temperature programme were investigated for optimum conditions for analysis of blood, urine and filter samples. Occupational exposure to cisplatin derivatives was also investigated among medical staff. Air sampling in the workroom, as well as analysis of blood and urine samples from the exposed subjects, was carried out during the process of drug preparation and administration and when attending treated patients. After development of the experimental method by the introduction of synthetic quartz crucibles and the optimization of acid composition, and of the temperature programme for sample pre-treatment, the recovery has been improved and the method has proved to be adequate for determination of platinum (Pt) in blood, urine and air-filter samples. Increased Pt blood levels were found in both graduate (2.2 +/- 1.7 ng ml-1) and staff nurses (3.8 +/- 4.0 ng ml-1), but not in pharmacists (0.47 +/- 0.31 ng ml-1), in comparison with unexposed subjects (1.2 +/- 0.69 ng ml-1). The variation was, however, high with CV > 50% for all groups. From the median values it can be seen that a few subjects with high values had a large impact on the mean values. The mean Pt level in urine samples was 126 +/- 92 ng l-1, which was found to be close to the pooled reference urine (110 ng l-1). No increased Pt air levels were found in any of the measurements. Moreover, the results showed difference in mean Pt blood level between staff at the investigated hospitals. The staff at hospital A had 1.2 +/- 0.53 ng ml-1, at hospital B 3.8 +/- 4.3 ng ml-1 and at hospital C 2.0 +/- 2.1 ng ml-1. The method has proved to be adequate for determination of platinum in blood, urine and air-filter samples. No increased airborne Pt levels were found. However, increased Pt blood levels were found. Staff nurses had a higher mean level than graduate nurses, which indicates that possible exposure occurs while attending treated patients rather than during the preparation and administration of drugs. There was a noticeable variations in the mean blood level for the investigated groups as a whole. This variation might reflect an actual difference in the exposure situation, but more probably depends on differences in skill and experience between the subjects. Routines and facilities for handling anti-neoplastic drugs vary between the clinics and this also probably has an impact on exposure.

Assessing Blunt Cannulae as Replacements for Hypodermic Needles During Intravenous Therapy Safety and Utility

Recently, blunt 18-gauge (ga) metal cannulae have become nationally commercially available as safety products. The ability of these blunt cannulae to prevent needlestick injury and to enable direct access of all standard latex ports and vial membranes, thus eliminating hypodermic needles entirely from the intravenous (i.v.) drug administration process, is assessed. In the laboratory setting, the needlestick injury potential of small-bore blunt cannulae versus hypodermic needles was studied using blinded and randomized methods. Insertion force requirements were studied for cannulae and needles. Metal 18-ga blunt cannulae were inserted into four brands of standard Y-ports and vial stoppers to assess postpuncture integrity and force requirements. Needlestick injury did not occur using small-bore blunt cannulae (P < .001; n = 51). Metal 18-ga cannulae passed into prepierced standard Y-ports as easily as hypodermic needles and without loss of Y-port integrity. Insertion of metal 18-ga cannulae without prior port puncture was possible, but was associated with substantial coring and loss of integrity of the port seal, except for IVAC brand ports (P < .03). Metal 18-ga cannulae can be inserted through virtually all intact standard rubber vial membranes or standard Y-ports to allow safe IV access. A single prepuncture of any standard latex membrane allows economical blunt metal cannula access equally efficiently as with expensive pre-slit membranes and without loss of membrane integrity.

Device evaluation and the food and drug administration process

Device evaluation and the food and drug administration process

Liquid chromatographic process identification using pulse testing techniques applications to column standardization and scale-up

Transfer functions have been obtained from frequency response analysis via liquid chromatographic pulse testing and Bode diagrams. The system order of the transfer function, within the range tested, is dependent on the anion-exchange gel characteristics, and not on packing height or pulse sample size. It is also observed that as the activity of the anion-exchange gel decreased, the system order of the transfer function decreased. This unique identification strategy could have great potential for the design of automatic control systems, and the standardization of chromatographic systems for Food and Drug Administration process validation. The ultimate goal, however, would be to verify phenomenological models to facilitate process scale-up for the commercialization of bioproducts.

Book Reviews

Book reviewed in this article:Current Clinical Neurophysiology: Update on EEG and Evoked Potentials, C. E. Henry (Ed).Epilepsy (Seminars in Neurology), Richard D. Walter (Ed).Epilepsy: A Clinical and Experimental Research (Monographs in Neural Sciences, Vol. 5), J. Majkowski (Ed). S. KargerEpilepsy, Pregnancy, and the Child, D. Janz, M. Dam, A. Richens, L. Bossi, H. Helge, and D. Schmidt (Eds).The Food and Drug Administration's Process for Approving New Drugs, Subcommittee on Science, Research and Technology. U.S.Immunological Aspects of Neurological Diseases (Monographs in Neural Sciences, Vol. 6), /. A. Aarli and O. Tonder (Eds).A Multidisciplinary Handbook of Epilepsy, B. P. Hermann (Ed). Charles C Thomas