I wouldn’t want to be a nurse administering heparin and I wouldn’t be surprised if seasoned nurses are reluctant to inject their patients with the blood thinner.
Most everyone is familiar with the incident that happened with actor Dennis Quaid’s twins: in 2007 a nurse picked up the wrong bottles of Heparin and the newborns were given an overdose that almost killed them. The “tired” nurse was blamed, and now Quaid has launched a campaign for better bottle-labeling systems. Wouldn’t better labeling be the responsibility of the drug manufacturer?
In October, US officials announced that heparin’s potency will be reduced by about 10 percent. So some patients will receive a higher-than-usual dose or number of units of heparin. (Sounds like good news for the manufacturer-unless the price of heparin drops by 10 percent. ) According to the FDA, recommended doses of heparin described in the drug’s label have not changed, and it does not recommend that clinicians increase a patient’s heparin dose to compensate for the reduced potency. Does that mean a patient has a higher risk of blood clots?
Researchers at the University of Oxford say that the risk of having a potentially fatal blood clot after surgery is higher and lasts for longer than had previously been thought. What if a patient isn’t given enough of the low-dosage heparin?
It’s very confusing.
According to HealthDay News, the decrease in potency will make it easier to spot impurities. The new lots will be identified by either the letter “N” placed next to the lot number or expiration date (three manufacturers) or a numeric code (one manufacturer). Got that?
Officials say that the correct dosing of heparin “has always been highly individualized and requires intense monitoring, which is a protocol that will remain in effect.” Dr. Dwaine Rieves, director of the FDA’s Center for Drug Evaluation and Research Division of Medical Imaging and Hematology Products, said, ”The use of heparin is closely tied into monitoring and doses adjusted based on that.” If I were a nurse, I’d be thinking about Quaid’s twins who were given too much heparin; I’d be thinking about amputee James Bradley, who was given too much.
This past September Hospira was approved for a heparin product that features, according to its web site, an ‘enhanced label design.’ Among the features of the label design are, “vibrant label colors to each strength, simplified text and increased font for dosing information, and differentiated warning labels”.
Sounds pretty basic. A hospital is a high-stress environment. Decisions have to be made quickly and accurately with split-second timing. Often there are parents, or loved ones in the room panicking. And while doctors and nurses are trained to focus on the task at hand and resist becoming distracted by any outside force that may take away from the direct relationship between practitioner and patient, the fact remains that people are human and things can get confusing.
Thus, the labeling of medication in such an obvious fashion as to ensure that the wrong medication, or strength is not fed to the wrong individual seems pretty obvious. In a quiet room without distraction a practitioner has the opportunity to carefully size up the vial and the label before injecting the substance into his patient.
However hospitals—and especially the ER—are far from quiet. There are a thousand-and-one things going on at once as you reach for that vial. Did I check the label? Oh, I’m sure I did. This is the right stuff…
For Kimberly and Dennis Quaid, it turned out to be the wrong stuff. Read the rest of this entry »
Pleading Ignorance recently posted about what a “Statute of Limitations” means. And while each state has its own guidelines for when the amount of tme to file a lawsuit runs out, the bottom line is that, well no, you can’t just file whenever you feel like it.
So keep in mind, if you’ve been affected by adverse effects from either Heparin or Avandia, you can still file–but you need to be mindful of filing deadlines.
We recently posted a blog about filing for Heparin; and an article for filing for Avandia.
If you wish to consult with a lawyer on either case, click here for Heparin and click here for Avandia. It’s free. And remember, while deadlines are in place, a lawyer ideally needs about a month in advance of that deadline to ensure he has time to review your individual situation and to pull together any necessary paperwork. So the clock’s ticking…
Between November 2007 and February 2008 reports of adverse health effects linked to heparin started to flood the media. By February 2008, the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) had managed to identify the initial source of the problem, and consequently announced a recall of certain heparin products produced by Baxter Healthcare.
Heparin is used in a variety of medical applications, including cardiac procedures, dialysis and flush catheters. Because possible routes of exposure include injections, pre-filled syringes or IV bags, the potential for hundreds if not thousands of people to have been exposed to the potentially lethal product was enormous. And the numbers give some indication of that. Read the rest of this entry »
Have you thought of contaminated heparin lately? It’s kind of drifted off people’s radar, but it’s still a current topic on YouTube. Deep in the bowels of YouTube you will find an FDA video, which YouTube shows as being 3 months old, that recaps the reasons why heparin was recalled and precautions you should take, in case there’s more contaminated blood thinner still “at large.”
The video itself is dated July, 2008. It’s interesting that it followed a heavily viewed video from Reuters on heparin contamination titled, “FDA feels the heat over heparin”. So it would appear that the FDA, in a belated abundance of caution, chose to finally advise consumers to keep their eyes and ears open for any possible future heparin recalls. That someone chose to post the video only 3 months ago hints at reports that the FDA is apparently still receiving word of adverse events, which may or may not be due to contaminated product. Read the rest of this entry »