CONTENTS:
- Perspective: Money doesn’t buy health
- Wyeth v. Levine: FDA approval does not protect against lawsuits.
- More on stroke
- A comedy of (not funny) errors… Read what happened to nearly kill a patient
Perspective: Money doesn’t buy health
A recent report indicates that the cost-benefit of healthcare in the US falls behind leading economic competitors. The Business Roundtable concludes that “America’s healthcare system has become a liability in a global economy.” Spending on healthcare per person is about 2 ½ times more than any other advanced country such as Canada, Japan, Germany, the United Kingdom and France, where government involvement in health care is greater than in the US. Somewhat surprisingly, what we get in benefits for what we pay reveals an even greater discrepancy when the US is compared with developing countries like China, India and Brazil. Bottom line: “other countries spend less on healthcare and their workers are relatively healthier.” Next ->
Wyeth v. Levine: FDA approval does not protect against lawsuits.
When Diana Levine lost an arm due to an intra-arterial injection of Wyeth’s drug Phenergan (promethazine), she sued the manufacturer. Wyeth claimed immunity from suit in state court because the feds, through the FDA, approved the labeling of the drug. Unlike the court’s prior ruling regarding medical devices, Riegel v. Medtronic, the labeling of a drug was deemed not to protect the manufacturer. The Supreme Court ruled that Wyeth could not hide behind FDA approval in defending itself against misuse of the drug. FDA approved labeling was deemed to be the “minimum” warning required to be published. (if the link fails, paste this URL into your browser http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf ) The Wall Street Journal argues that this ruling will significantly reduce the availability of new, and possibly even older, drugs with serious potential side effects. The Supreme Court felt that a stronger label urging an IV drip route rather than IV push could have prevented the damages caused by the intra-arterial injection.
Perhaps.
[Editor’s note: Was the problem not the result of improper administration (into an artery instead of a vein)? Is this really the drug’s fault?]
A news summary of the matter is available at MedpageToday.com.
More on stroke
- “Silent strokes” may be more common than full-blown strokes in people under 65
- Risk of misdiagnosis of a stroke may be linked to patient age.
- Patients who arrive at hospital within one hour after stroke more likely to receive tPA.
- Informed consent important when treating or not treating stroke with tPA
A comedy of (not funny) errors. Here’s what happened…
• The doctor writes an order for a very dangerous, paralyzing, ICU-only drug… on the wrong patient and one who is on a non-monitored unit.
• An inexperienced resident pharmacist prepares drug infusion, correctly labeling the drug as highly dangerous and sends it to the patient’s medical unit.
• A pharmacy tech delivers the drug to the medical unit.
• Per protocol, two medical unit nurses verify the correct drug, dosage, patient, and infusion rate… not noting that it is only for ICU use.
• Infusion is begun on this wrong patient.
• The patient gets up to go to the bathroom and collapses, being able to yell out for help as he goes down. Is resuscitated, fortunately with no apparent ill effects.
It’s hard to believe that at least 5 separate clinicians missed this error.