Drugs/Medical Archive

Understanding Preemption in Plain English

March 5th, 2010. By Kristine B

Over the last year or so, there’s been some discussion in the media about “preemption.” So, I thought I’d take this opportunity to explain preemption and why it’s important (specifically, why and how it affects you). 

In legal-speak, preemption is based on the Supremacy Clause of the US Constitution. That clause states that some matters are of national importance rather than local importance. In those matters, national (federal) law must take precedence over state laws. Furthermore, states cannot pass laws that are inconsistent with the federal law. Preemption extends downwards as well, so that state law takes precedence over community law. 

Ok—let’s give a completely unrealistic and ridiculous example to simplify things here. Let’s say our friends in Washington DC decide that Wednesdays should be “Wear Red” day—kind of a “have heart” or weekly AIDS Awareness thing. Now let’s also suppose that some state actually bans wearing red on Wednesdays. Whoops—would seem to be a problem here, right? Ahh, but with preemption, federal law could “preempt” state law and you could look forward to viewing a sea of red every Wednesday. 

Now, this happens where the matter is of national importance. Not every law is subject to preemption. Also, there are situations in which state and federal laws are similar and do not entirely contradict each other, leaving questions about which laws should be followed. 

For example, not all states have the same employment laws. There’s a federal law, called the Fair Labor Standards Act (FLSA) that sets out employee wages and hours worked. However, many states have laws that overlap with the FLSA and also set out wage and hour regulations. In those situations, it is not Read the rest of this entry »

Tags: Pleading Ignorance, Preemption
Posted in Drugs/Medical, Pleading Ignorance | 3 Comments »

Parents: Is your Kid on Isotretinoin? (aka Accutane)

March 3rd, 2010. By AbiK

Yes, Roche stopped selling acne drug Accutane back in June 2009. But that was a decision made by that company—not the FDA. And, that decision was made (insert raised eyebrow here) for “business reasons”—not for any safety issues. Ahh, but here’s the thing… those “business reasons” included competition from generics. And guess what? You can still get those generics. Other than Accutane, isotretinoin is sold as Sotret, Claravis and Amnesteem.

I imagine a number of parents of acne-ridden teens breathed a sigh of relief when Roche stopped marketing Accutane. After all, what parent wants to consider putting their teenage daughter on some form of guaranteed contraception in order to be put on a drug proven to cause birth defects just so they can clear up their zits? Beyond that, reports of depression, suicidal thoughts, possible gastrointestinal problems—and labelling that also warns of a potential sudden decrease in night vision (mom, can I have the keys to the car?)—don’t exactly add up to a drug you want your child on.

But let’s face it, internet-savvy teens have no problem beating the system and finding ways to order isotretinoin online—particularly when the promise of clear skin in on the line. Enter a recent study published in the Journal of American Academy of Dermatology (January 2010) titled Availability of Oral Isotretinoin and Terbinafine on the Internet.

The study, by Jason P. Lott and Carrie L. Kovarik, MD, looks at the proliferation of websites that sell certain medications without a prescription—specifically dermatologic medications. In their study of websites readily found via Google search, they categorized the websites into four groups: Illicit Commercial (those that offered purchase without a prescription); Legitimate Commercial (US licensed pharmacies requiring prescriptions); Informational (those offering only information, not sale); and Other for those not fitting into the other above categories.

What did they find? For their search on “no prescription Accutane”, 66% of the sites returned on search were categorized as Illicit Commercial. Translation: you could buy Accutane from them without a prescription.

Lott and Kovarik state that they did not go through and actually purchase any oral isotretinoin via the sites they studied—so it’s not certain that the medications would actually be received or if they would be authentic. That said, the authors of the study indicate that the US Government Accounting Office (GAO) reports that 94% of all online opioid purchases result in delivery of the drugs as advertised.

If the GAO report is true, I’d be checking my kid’s backpack.

Tags: Accutane, Acne Medication, Amnesteem, Claravis, Isotretinoin, Sotret
Posted in Drugs/Medical, Emerging Issues | No Comments »

US Troops: The Bomb was Real–maybe the Injury was, too

March 3rd, 2010. By AbiK

Ever wonder what happens to soldiers who’ve been targeted in a roadside bombing in Iraq or Afghanistan?—and by that question I’m referring to those soldiers who live. Apparently not much happens unless there is an obvious injury. Or so one would be led to believe given the news today of a new medical policy coming from the Pentagon.

As reported at cnn.com, US troops who’ve been targeted in roadside bombings will now be pulled from duty for a 24-hour period to be monitored for headaches, memory or concentration loss, ringing ears and blurred vision—the signs of a concussion. If the soldier scores low for any of these symptoms he or she will be kept out of combat until their condition improves.

So why is this new medical policy—expected to be signed into effect within two to three weeks—happening now? Well, for one thing, a traumatic brain injury (TBI) that’s been sustained due to simply being near (definition of “near” is withing 55 yards of a blast according to the cnn.com article) a roadside bomb can go undetected only to surface months or years later. (Sound familiar to anyone with PTSD? or Gulf War Syndrome?)

If you think there aren’t too many soldiers affected by roadside bombs, think again. According to NATO’s International Security Assistance Force statistics, around 80 roadside bombs have exploded EACH WEEK in Afghanistan since June, 2009. Additionally, a 2008 RAND study indicated that as many as 300,000 US troops who’ve returned home from Iraq and Afghanistan could be suffering from traumatic brain injuries.

Pentagon officials estimate the number of troops that could be removed from duty under the new policy is about two percent.

Tags: Afghanistan, Brain Injury, Iraq, PTSD, TBI, Veterans
Posted in Drugs/Medical, Veterans | No Comments »

Should Hospitals have Limits in how Green they go?

March 2nd, 2010. By AbiK

Some things were just meant to be used once and one time only. Dixie® cups. Band-Aids®. Drinking straws. Envelopes you lick, to name a few. But how about laparoscopic ports, surgical scissors and pulse oximeters?

Seems some hospitals—in both an effort to be “green” as well as to introduce some cost controls—are recycling some surgical items labeled for one-time use (aka, “single-use devices” or SUDs). According to an article in the Baltimore Sun (2/25/10), the number of hospitals doing the recycling is growing; in fact, the article quotes Dr. Martin A. Makary of Johns Hopkins University School of Medicine as stating that about a “quarter of the nation’s hospitals now do some reprocessing”.

There are proponents on both sides of the hospital recycling debate. On the one hand, you’ve got those who argue that certain implements have historically been collected after use and sent back to the manufacturer where they were reprocessed—not necessarily under any regulatory watchful eye—and repackaged for re-use. The argument would then go: wouldn’t you rather reprocess them yourself and have more control over things?

And you’ve also got the January 2008 report from the US Government Accountability Office (GAO) titled Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk. The conclusion of that report, as written about in an article at the Journal of the Association of American Medical Colleges (March, 2010), is that “although available FDA data fail to allow for rigorous in-depth comparisons, reprocessed SUDs do not present an increased health risk when compared with new nonreprocessed devices. Of the 434 adverse events reported to the FDA between 2003 and 2006 in which reprocessed SUDs were identified, only 65 actually did involve a reprocessed device, and all adverse events were similar to those reported for new devices.” 

Ok. My faith (or lack thereof) in the FDA’s oversight of all things medical notwithstanding, the obvious question is does anyone really want recycled surgical tools to be used on them without their knowledge and consent? There’s just something a little…discomforting…about lying on that chilly operating table, bright lights aglow, feeling that IV starting to flow and wondering whether that anesthesia conduction needle has been thoroughly disinfected. I’d prefer to have my thoughts on other things at that moment.

Tags: Green Hospitals, Single Use Device Reprocessing
Posted in Drugs/Medical | No Comments »

Pelvic Exams without Consent: Medical Malpractice Suit?

March 1st, 2010. By janem

Imagine you’re unconscious and several men insert objects into your vagina. Many women would consider this gang rape. At the very least, sexual assault. Guess what, it may have happened to you—without your knowledge!

How would you react if you underwent surgery such as a routine hysterectomy and found out that right after you were anesthetized, a team of medical students performed pelvic exams—without your consent? I believe that is a violation of our basic rights, to say the least. Where’s the respect? 

I know what I’d do: file a medical malpractice suit, pronto.  As a matter of fact, I’m actually scheduled for routine surgery in a few months—at a university hospital—and that rang my alarm bell. I called my gynecologist and spoke with her receptionist. “Under no circumstances do I want a student poking around my private parts,” I said, or probably yelled. She replied that I had to take that up with my gynecologist, who of course is never available for a phone call. 

So does uninformed consent qualify for a medical malpractice suit? Well, not quite, but then again, I haven’t spoken with a medical malpractice attorney…What I did discover online is that “A medical practitioner may also be legally liable if a patient does not give “informed consent” to a medical procedure that results in harm to the patient, even if the procedure is performed properly.” In my opinion, psychological harm fits the bill. 

In Canada, you aren’t even asked for consent, unlike the UK and the US—or so Americans and Brits were led to believe. Some ethical medical students have been asked to perform pelvic exams in Canada (and in British and American hospitals) without the patient’s knowledge, and they have refused. And that’s how the public knows about Read the rest of this entry »

Tags: medical malpractice, Pelvic Exam
Posted in Drugs/Medical, Emerging Issues | 18 Comments »