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Biomedical subjects

Michael R Cohen

Publications and source records attributed to Michael R Cohen.

At least 19 recordsLinked to original sources
PubMed2004

Reported medication errors associated with methotrexate.

PURPOSE: Medication errors reported to FDA as adverse events in which methotrexate was identified as a possible contributor were studied. METHODS: All adverse-event reports submitted to FDA between November 1997 and December 2001 indicating potential medication errors involving methotrexate were analyzed to determine the indication for use, the type of error, and the point in the medication-use process where the error occurred. RESULTS: A total of 106 cases of reported medication errors associated with methotrexate were identified, including errors resuiting in 25 deaths (24%) and 48 other serious outcomes (45%). The most common types of errors involved confusion about the once-weekly dosage schedule (30%) and other dosage errors (22%). The most frequently involved indication for use was rheumatoid arthritis (42%). Of the errors, 39 (37%) were attributable to the prescriber, 21 (20%) to the patient, 20 (19%) to dispensing, and 18 (17%) to administration by a health care professional. CONCLUSION: A review of medication errors involving methotrexate revealed that errors occurred during all phases of use, often resulted from confusion about dosage, and often caused death or other serious adverse effects.

Adult↗
PubMed2004

Reported adverse event cases of methemoglobinemia associated with benzocaine products.

BACKGROUND: Methemoglobinemia (MHb) is characterized by abnormal levels of oxidized hemoglobin that cannot bind and transport oxygen. When induced by benzocaine anesthetic spray and other chemicals, it can result in cyanosis and life-threatening complications. METHODS: From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we extracted every report for use of a benzocaine product. We classified each case by product type (eg, spray, gel, or solution), by whether MHb was involved, and by the dose given. RESULTS: Among 198 reported adverse events of all types associated with benzocaine, 132 cases (66.7%) involved definite or probable MHb. The MHb cases included 107 serious adverse events (81.1%) and 2 deaths (1.5%). In 123 cases (93.2%), the product was a spray; in 2 cases (1.5%), a benzocaine-containing lozenge; and 1 case, a gel. In the 69 cases that specified a dose, 37 (53.6%) indicated that a single spray was applied (approximately the recommended amount). CONCLUSIONS: Health professionals involved in endoscopy, intubation, bronchoscopy, or similar invasive procedures using benzocaine-containing sprays should know that (1) administration may cause MHb with potentially serious consequences, (2) identifying the reaction to benzocaine usually requires cooximetry (although it can be implied by symptoms), and (3) treatment involves immediate intravenous administration of 1 to 2 mg/kg of methylene blue.

Adult↗
PubMed2004

No bottoms up.

Explore the source record for details and available documents.

Drug Packaging↗
PubMed2004

Well...what'll it be?

Explore the source record for details and available documents.

Antidepressive Agents, Second-Generation↗
PubMed2003

Practical guide to bar coding for patient medication safety.

Bar coding for the medication administration step of the drug-use process is discussed. FDA will propose a rule in 2003 that would require bar-code labels on all human drugs and biologicals. Even with an FDA mandate, manufacturer procrastination and possible shifts in product availability are likely to slow progress. Such delays should not preclude health systems from adopting bar-code-enabled point-of-care (BPOC) systems to achieve gains in patient safety. Bar-code technology is a replacement for traditional keyboard data entry. The elements of bar coding are content, which determines the meaning; data format, which refers to the embedded data and symbology, which describes the "font" in which the machine-readable code is written. For a BPOC system to deliver an acceptable level of patient protection, the hospital must first establish reliable processes for a patient identification band, caregiver badge, and medication bar coding. Medications can have either drug-specific or patient-specific bar codes. Both varieties result in the desired code that supports patient's five rights of drug administration. When medications are not available from the manufacturer in immediate-container bar-coded packaging, other means of applying the bar code must be devised, including the use of repackaging equipment, overwrapping, manual bar coding, and outsourcing. Virtually all medications should be bar coded, the bar code on the label should be easily readable, and appropriate policies, procedures, and checks should be in place. Bar coding has the potential to be not only cost-effective but to produce a return on investment. By bar coding patient identification tags, caregiver badges, and immediate-container medications, health systems can substantially increase patient safety during medication administration.

Drug Labeling↗
PubMed2003

Findings from the ISMP Medication Safety Self-Assessment for hospitals.

BACKGROUND: Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. DESIGN: A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. METHOD: A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. RESULTS: The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. CONCLUSIONS: Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.

American Hospital Association↗
PubMed2003

Systems factors in the reporting of serious medication errors in hospitals.

Underreporting of medication errors poses a threat to quality improvement initiatives. Hospital risk management programs encourage medication error reporting for effective management of systems failures. This study involved a survey of 156 medical-surgical hospitals in the United States to evaluate systems factors associated with the reporting of serious medication errors. Prior to controlling for bed size, a multivariate logistic regression model showed increased reporting of medication errors in hospitals with 24-h pharmacy services, presumably because of better error reporting systems. When number of occupied beds was included, the final model demonstrated bed size to be the only statistically significant factor. Increased reporting rates for serious medication errors warrant further evaluation, but higher error reporting may paradoxically indicate improved error surveillance. Results suggest that increased availability of pharmacist services results in opportunities for more diligent systematic efforts in detecting and reporting medication errors, which should lead to improved patient safety.

Computer Systems↗
PubMed2003

Pain scales don't weigh every risk.

The risk of patients receiving opioids without adequate monitoring and resulting in adverse outcomes has been noted by the Institute for Safe Medication Practices. More aggressive opioid analgesia often is clinically indicated, but it is not without risk. Adverse drug events due to opioids have increased with the recent adoption of pain management standards by the Joint Commission on Accreditation of Healthcare Organizations. The implications of this are discussed and a specific safe practice recommendation is provided.

Analgesics, Opioid↗