October 2009 - Page 2 of 5

Why Don’t Drug Labels Make the Actual Harms and Benefits Clear?

By Jacob Molyneux, blog editor/senior editor

How can we know if a drug really works? Gary Schwitzer, publisher of HealthNewsReview.org (an incisive Website that grades the quality of health news reporting) addresses this question on his blog this week by drawing attention to a recent perspective piece published in the New England Journal of Medicine (NEJM). It’s called “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians” and it states the problem clearly:

The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.

The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA.

One example given in the NEJM article is the sleeping pill Lunesta:

Clinicians who are interested in (Lunesta’s) efficacy cannot find efficacy information in […]

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Jacob Molyneux, senior editor/blog editor2016-11-21T13:21:34-05:00October 22nd, 2009|health care policy|0 Comments

Genomics, Technology, and Nursing: A “Focus on the Whole Person”

By Diana J. Mason, PhD, RN, editor-in-chief emeritus. Mason often writes for this blog about policy and research issues.

Last week, I attended the annual conference of CANS, the Council for the Advancement of Nursing Science, the “research-facilitation arm” of the American Academy of Nursing. The title of the conference was “Technology, Genetics and Beyond: Research Methodologies of the Future.”

‘Genomics’ vs. ‘genetics.’ I’m not a genomics researcher but I found the sessions enlightening in two ways. First, I admit to struggling with the terminology (and jargon) of the field. I was reminded today that the correct term for the field is “genomics,” since “genetics” refers to the study of single genes and thus limits the focus of study mostly to rare diseases. Genomics looks at associations among genes in the whole person—a shift in perspective that was enabled by the mapping of the human genome.

Targeted interventions. The second enlightenment came from keynote speaker and senior nurse researcher Christine Miaskowski, a dean and a professor of physiological nursing at the University of California at San Francisco School of Nursing. She noted that this shift to a focus on the whole person is what makes nurses and nursing research […]

Jacob Molyneux, senior editor/blog editor2016-11-21T13:21:36-05:00October 21st, 2009|nursing perspective, nursing research|0 Comments

TCAB: What’s Your Hospital Doing to Improve Care?

By Diana J. Mason, PhD, RN, AJN Editor-in-Chief Emeritus

What makes a “good hospital”? A patient might have the best surgeon in the world; but as any nurse will tell you, that patient will die unless the surgeon has a top-notch nursing staff to ensure that the patient is well prepared for the surgery and well supported during the recovery period. Too many hospitals have lost their understanding of what’s essential to ensure great clinical and financial outcomes. In such hospitals, nurses aren’t included in decision making, have little local authority, are penalized for identifying factors that lead to poor care, and can’t claim excellent team relationships.

The American Nurses Credentialing Center’s Magnet Recognition Program has helped to identify the factors that lead to excellence in nursing care, granting Magnet status to hospitals that provide such excellence. Now an initiative known as Transforming Care at the Bedside (TCAB) has provided the framework and tools for empowering bedside nurses to become agents for change. TCAB nurses work with other health care team members to improve care processes and effectiveness, focusing on four areas: the safety and reliability of care, teamwork and job satisfaction, patient and family satisfaction, and “value-added care.” (Increasing the amount of time […]

Jacob Molyneux, senior editor/blog editor2016-11-21T13:21:37-05:00October 20th, 2009|nursing perspective, nursing research|0 Comments

The eICU: Big Brother or Team Member?

By Peggy McDaniel, BSN, RN

There is an intriguing new technology available to hospital ICUs. It’s called an eICU. At Alegent Health in Omaha, Nebraska, the “software feeds real time data for roughly 100 patients, including vital signs, laboratory tests, cultures, and pharmacy data,” to nurses and a doctor monitoring the eICU from off site. Using the data, the software sets off alerts that are noted by the eICU staff and passed on to the bedside staff. The bedside clinicians have said that the extra help has allowed them to focus on bedside care.

About two years into its use, an interesting side benefit of this remote monitoring system was noted by the hospital’s director of infection control. She realized that the eICU allowed her to monitor and promote compliance to practice bundles as well as to compile data to promote better antimicrobial measures.

The article reports that the staff initially felt a bit concerned about being watched by “big brother.” However, the hospital promoted the idea of the eICU as a “part of the team” instead of an intrusion, an approach that appears to have been successful.

As a nurse who works to improve compliance to best practices that reduce hospital-acquired conditions, particularly bloodstream infections, I feel this presents an amazing opportunity to promote patient safety. For example, when I perform hospital audits, I see poor compliance to hand washing and the cleansing of IV access ports. These two practices are proven to help decrease the spread of […]

Jacob Molyneux, senior editor/blog editor2016-11-21T13:21:39-05:00October 19th, 2009|career, nursing perspective|4 Comments

Bring Back the House Call

But what about those who are not quite frail but are homebound due to less serious health problems? If not for the home visit, the condition of the patient described above would have declined to the point of requiring an ER visit or hospitalization. As the blogger KevinMD points out, “In-home visits could take the place of unnecessary and costly hospital stays and help prevent equally expensive re-admissions to the hospital.” Maybe it's time to bring back the house call.

Jacob Molyneux, senior editor/blog editor2016-11-21T13:21:41-05:00October 16th, 2009|Nursing|2 Comments