Association between education in EOL care and variability in EOL practice: a survey of ICU physicians

This study investigated the association between physician education in EOL and variability in EOL practice, as well as the differences between beliefs and practices regarding EOL in the ICU. Physicians from 11 ICUs at a university hospital completed a survey presenting a patient in a vegetative state with no family or advance directives. Questions addressed approaches to EOL care, as well physicians' personal, professional and EOL educational characteristics. The response rate was 89%, with 105 questionnaires analyzed. Mean age was 38 +/- A 8 years, with a mean of 14 +/- A 7 years since graduation. Physicians who did not apply do-not-resuscitate (DNR) orders were less likely to have attended EOL classes than those who applied written DNR orders [0/7 vs. 31/47, OR = 0.549 (0.356-0.848), P = 0.001]. Physicians who involved nurses in the decision-making process were more likely to be ICU specialists [17/22 vs. 46/83, OR = 4.1959 (1.271-13.845), P = 0.013] than physicians who made such decisions among themselves or referred to ethical or judicial committees. Physicians who would apply "full code" had less often read about EOL [3/22 vs. 11/20, OR = 0.0939 (0.012-0.710), P = 0.012] and had less interest in discussing EOL [17/22 vs. 20/20, OR = 0.210 (0.122-0.361), P < 0.001], than physicians who would withdraw life-sustaining therapies. Forty-four percent of respondents would not do what they believed was best for their patient, with 98% of them believing a less aggressive attitude preferable. Legal concerns were the leading cause for this dichotomy. Physician education about EOL is associated with variability in EOL decisions in the ICU. Moreover, actual practice may differ from what physicians believe is best for the patient.

US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins

Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic biological agent with a unique chemical, biochemical, biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles. As a result, LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety. Previously, the US Food and Drug Administration (FDA) cautioned against using various LMWHs interchangeably, however recently, the FDA approved generic versions of LMWH that have not been tested in large clinical trials. This paper highlights the bio-chemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes, and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical use.