Archive for the ‘Product Safety’ Category

Skin Cancer Prevention: Will new FDA Rules Help?

Wednesday, June 29th, 2011

In yesterday’s post, I examined the various types of skin cancer and their prevalence in the US. Melanoma is the most deadly form of skin cancer and its incidence is on the rise. In that post, I examined some of the ways to protect yourself from the types of UV radiation that cause skin damage and cancer. One of these protection methods is the use of sunscreen. Sunscreen matters because the data is clear that sun exposure is what is causing deadly skin cancers:

  • About 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) radiation from the sun.
  • The vast majority of mutations found in melanoma are caused by ultraviolet radiation.
  • About 65 percent of melanoma cases can be attributed to ultraviolet (UV) radiation from the sun.
  • One or more blistering sunburns in childhood or adolescence more than double a person’s chances of developing melanoma later in life.
  • A person’s risk for melanoma doubles if he or she has had more than five sunburns at any age.

Statistics from the Skin Cancer Foundation website

However, up until now, there has been very little regulation of the marketing of different sunscreens. It has been very difficult for the American public to know whether the sunscreen they were choosing was going to be effective in protecting them from both UVA and UVB rays.  There was also little way to know how much protection you were really receiving and whether the claims like “waterproof” and “sunblock” were just marketing or really claims with research behind them. Why does this matter? Check out this video from the FDA:

How the New FDA Rules Will Help

Well, some of this is going to change next summer. Last week, the FDA announced new regulations of sunscreen. If sunscreens meet the new legal standards, they can use certain marketing phrases so that consumers know what level of protection will be provided by the product. For example, “[u]nder the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Image from FDA.gov

Image from FDA.gov

The FDA explains the impact of the new regulations with the following:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

Information from the FDA

So what does this all mean? It means that if you want a sunscreen that will provide protection against both UVA and UVB, you need to choose one that says “broad spectrum” AND has a minimum SPF of 15. You also need to look for a time limit on the water resistance of the sunscreen. In the future, other regulations may take effect, including limiting the SPF claims to 50 since there is no evidence that a higher SPF offers greater protection. The impact of the current rules should be an easier way for consumers to know that they are getting the greatest possible protection from the sunscreen they buy.

The New Regulations Do Not Address the Safety of Ingredients

So, while the new sunscreens will make it clearer whether the sunscreen protects against both UVA and UVB rays and how long the sunscreen will remain water resistant, the regulations do not regulate the ingredients that comprise the sunscreens. The ingredients in the sunscreens have not been tested for safety. Dr. Len has written a blog on the American Cancer Society website that touches on this issue:

Many of the ingredients of sunscreens have been used for years, however the FDA acknowledged today that they have not been tested for safety using modern techniques. They did emphasize that the benefits of sunscreens containing these ingredients far outweigh the risks given their longstanding safety profile.

Nanoparticles present in sunscreen-especially those containing zinc and titanium oxides-have been another source of concern.  It is the use of “nanotechnology” that has made these effective sunscreens more acceptable since they don’t leave you with that white, pasty look that inhibited their use in the past.

Although it appeared during a news conference this morning that the FDA is satisfied at this time that products containing nanoparticles such as zinc and titanium oxides are safe when used as directed based on scientific evidence, another representative seemed a bit more cautious in his comments at second briefing held a couple of hours later by stating that nanoparticles are still being evaluated for safety.

The FDA did say they will continue to examine the science and the data regarding sunscreen ingredients, and will advise consumers promptly should they find evidence to the contrary regarding their safety profile.

One interesting outcome of the FDA’s announcement was their statement that they will be seeking further information from manufacturers and others on the safety and effectiveness of aerosol sunscreens.  The FDA apparently is concerned about inhalation risks as well as effectiveness in real-life use.  This is a sunscreen delivery method that many of us (including me) use often because of ease and convenience, and the questions regarding safety and effectiveness are certain to get some notice.

As more and more people are educated and aware of the risks of skin cancer, the use of sunscreens will presumably rise. Does it worry you that the new regulations deal more with marketing issues and confirming that the sunscreens do work effectively to minimize exposure to UVA and UVB rays than with the safety of the ingredients that provide that protection? Do you agree that since the risk of skin cancer outweighs the potential risks caused by the ingredients?

Personally, I use sunscreen and put it on my children daily. However, I also go out of the way to try to use ones that seem to have the “safest” record in terms of the chemicals involved. I also choose to use sun-shirts and other protective clothing as much as possible when at the pool or beach to minimize the amount skin I have to cover with sunscreen. Okay – honestly – it is also to minimize the amount of sunscreen smearing that I have to do every day. In order to work effectively, you are really supposed to use a lot of sunscreen all over exposed skin. As much as possible, we try to spend out time outside during the early morning and late afternoon/evening to minimize the direct exposure.

What steps do you take to protect yourself from sun exposure? What about the idea that a certain amount of sun exposure is good for Vitamin D production? What about the new FDA regulations, do they may sense? Will you shop for sunscreen differently?

Related Posts:

Skin Cancer: Types, Causes and How to Protect Yourself

Newest Word on Crib Safety: Ban the Bumpers?

Tuesday, June 14th, 2011

Which crib bedding would you choose? Aesthetic or safe?

In the newest topic regarding crib safety, Maryland is considering regulations to ban the sale of crib bumpers. For many years, more and more emphasis has been placed on infants sleeping in safe cribs without any additional “stuff” in them. This has included the elimination of lots of former nursery staples. Baby blankets, stuffed animals, pillows and other loose items have been banned from the crib by safety experts for years. As requirements for cribs have required slats that are closer together, the utility of using a bumper to help a child from getting stuck between crib slats has been eliminated. More recently, the Consumer Product Safety Commission has developed even newer crib safety standards, including eliminating the use of drop-sides, and warned against the use of sleep positioners. Yet, despite the advice to put babies to sleep only on their backs in cribs empty of everything except a well fitting mattress and fitted sheet, many parents and caregivers persist in using other items in cribs. Now, with an increasing number of deaths associated with crib bumpers, Maryland is considering a stronger stance.

Danger of Crib Bumpers

The concern about crib bumpers is that there have been infant deaths associated with suffocation or strangulation and the use of crib bumpers. Some of the deaths are directly attributable to the bumpers (for instance a child found with their head wrapped in the ties of the bumper or their face pressed into the side of the bumper), while others are only potentially related to the bumper use but not definitively so (for instance, children whose death are classified as SIDS, but where bumpers were in use in the crib at the time of death and may have been a contributing factor in the death). This makes the discussion of the dangers muddy – with manufacturers claiming that bumpers are safe and advocates warning against their use to protect against suffocation.

Potential Ban on Sale of Bumpers

When the Baltimore Sun reported on the potential regulations, they mentioned something that gave me pause. They explained that if Dr. Sharfstein, secretary of the state Department of Health and Mental Hygiene, does decide to regulate this issue, the regulations will impact only the sale, not the use of the bumpers. While this makes sense from a policy perspective, the goal is not to punish parents who may not be aware of the safety risks, and from a enforceability perspective, the state cannot possibly enforce a regulation that requires knowledge of whether bumpers are being used in individual homes, the regulation of the sale of the item is going to have some drawbacks.

Will a State Ban Save Lives?

So here are my questions. Will regulations against the sale of these bumpers in Maryland make any difference in saving lives? In this day of internet shopping and wide availability of items through catalogues and easy interstate travel, are Maryland families going to forgo the crib bumper because they cannot be purchased in the local baby store, or are they still going to be buying the bumper with a set of nursery items on Amazon or through a national baby store? Will Internet or national companies without a store presence in Maryland be punished for selling a bumper to a person with a Maryland address? If so, then perhaps the word will get out that these items are dangerous and should not be used. If not, will parents even realize that the goal of the regulation is actually to curb the use of the bumpers. Either way, I guess that by decreasing the number of bumpers in Maryland homes, safety will be increased and perhaps over time, awareness will be increased and other states may follow suit.

Getting the Word Out

My other concern is that if there are parents who are still using bumpers, blankets or other items in their babies’ cribs, is the issue one of parent education? Perhaps the real emphasis needs to be on wider parental awareness of the safety issue. There are lots of great resources available to learn how to put infants to sleep safely:

httpv://www.youtube.com/watch?v=VNekf5P9_Yg&feature=youtu.be

Since the early 1990s, the emphasis has been on having infants sleep on their backs. This has lead to a dramatic decrease in SIDS deaths since that time. The “Back to Sleep” campaign began in 1994 and continues to this day.  However, when reading a 2005 paper from the AAP, I was surprised to read that SIDS deaths are more likely to occur when a baby who is used to sleeping on their back is placed to sleep on their stomach. This suggests that education needs to be of all potential caregivers since an occasional babysitter, grandparent or child care provider who is unfamiliar with the recommendations and the child’s normal sleep position may place the child to sleep on their stomach and cause real risk.

AAP has made many recommendations since 2005 including that children sleep in cribs with only a fitted sheet and without any additional soft bedding. These recommendations have varied somewhat over time on the use of bumpers and sleep positioners. However, the overall advice seems to remain the same – eliminate all soft bedding items. Despite these recommendations, there are still images in popular media of nurseries complete with cribs with soft bedding.

What changes are still needed?

What changes are needed to get the word out? Do you think that there needs to be a stronger effort to change the marketing images for infant products? Do you think that a ban on the sale of bumpers will have a significant impact on child safety? What about an education campaign focusing on caregivers, grandparents and day care providers?

Related Posts:

Over Two Million Cribs Recalled…What About Yours?

Infant Safety – drop-down crib hazard; CPSC issues recall

Generation 2 Worldwide and “ChildESIGNS” Drop Side Crib Brands Recalled; Three Infant Deaths Reported

Consumer Product Safety Commission vows to crack down on defective cribs – washingtonpost.com

 

Images from: sidscenter.org, potterybarnkids.com

Children’s Medications: Coming Changes and Tips to Avoid Overdose

Tuesday, May 24th, 2011

We all know that a little over-the-counter (OTC) pain medication can be just what the doctor ordered for minor aches, pains or to help combat the symptoms of a nasty flu. Most adults, however, also realize that medications can be dangerous. No, I am not talking about the blast from the past news stories about medications that have been tampered with (…though it is weird that the Unabomber, Ted Kaczynski, is back in the news as one possible suspect in the Tylenol poisonings that killed people in the Chicago area in 1982). My focus today is on the danger involved with overdoses of commonly used pain medication. In particular, the risk of accidentally overdosing children on OTC pain relievers such as Tylenol.

Image from www.tylenol.com

There has been quite a bit of focus recently on the possible changes to Tylenol and other acetaminophen containing drugs for children. These are not formula changes and they have nothing to do with the myriad of Tylenol recalls over the past couple of years. Currently, the basic concern is that overdoses of this common medication accounts for a fairly sizeable number of poisoning cases, which can be very serious since overdose can cause liver damage to children. An AP article reports that:

Dosing errors with children’s acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

These overdose situations most often occur in children under 2 years old.

Chart provided on www.tylenol.com

When I read this, I was not surprised. Currently acetaminophen for children, Tylenol and other brands, come in two different concentrations.  Most commonly one is labeled “Children’s” and the other “Infant’s.” Each of these medications include on the outside packaging a confusing little matrix that details the correct dosage for a child of a particular age or weight range. The correct dosing for your child’s age and weight may not be the same if you have a child that is particularly large or small for their age. Additionally, if you have both children’s and infant’s acetaminophen products in your home, you must be careful to provide the correct dosing for the correct concentration. This does not even get into the differences in dosing between the liquid medicine and the tablets. Finally, the box does not provide dosing information for children less than two years of age. The dosing instruction for children under 24 months is “ask your doctor.” So, how many of you are going to make that phone call?

The harsh realities of parenting and sick kids

My children are both young; the youngest is now a little past her second birthday. In the last few years, we have had both infant and children medication in the house, liquid and tablets, and I have been very careful to make sure to double-check myself if I ever have to medicate either child to make sure that I am reading the correct dosing matrix for the correct concentration and for the correct child. More often than not, I have found that children need medication when their parents are tired. As parents know – children frequently get sick in the middle of the night and when children in the house are sick nobody in the household sleeps well. I always try to take this into account to avoid dosing errors. However, this can be confusing particularly when children are little.

When my children were very little, I used to ask the doctor at each appointment what would be the correct Tylenol dose for their current weight. I did not foresee having to use that information, but I wanted to make sure that I knew the correct amount in case I was caught with a sick child in the middle of the night. If it had been a while since my child was weighed, I would sometimes have to call for dosing information. Additionally, I found that it was nearly impossible to dose a child properly using the little cups included with the medication. However, the medicine packaging clearly states that you are only to dose using the enclosed cup. I found that my ability to dose the correct amount of medication was much improved when I used a syringe style dropper.

The FDA steps in – finally!

Well, apparently, I have not been alone in my concerns. The FDA panel that met last week, has made some recommendations that may improve some of these problems in the future and lessen the chances that children will receive too much medication. According to the AP article, the following recommendations have been voted on and will be recommended to the FDA:

  • Dosing instructions should be added for children younger than 2 years old
  • Dosing instructions should be provided based on a child’s weight (rather than the focus being on a child’s age)
  • Limiting cup measurements to milliliters  (rather than both teaspoons and milliliters…one of many things that make the current measurement cups confusing)
  • Mandating a single dosage for children’s solid acetaminophen tablets

Infant Tylenol (and other acetaminophen products) a thing of the past

Relatedly, the article mentioned that the Consumer Healthcare Products Association, which includes the makers of Tylenol and many other acetaminophen producers, agreed to voluntarily stop producing infant drops. This decision means that a day may be coming soon when there would only be one concentration available of children’s acetaminophen.

Some tips and tricks to avoid overdosing your child

If infant acetaminophen is eliminated and children’s acetaminophen is sold with the changed dosing instructions, I think that parents and other caregivers will find it much easier to provide children with the correct amount of medication. However, I would still recommend taking the following steps to protect your children:

  • Keep all medications, including children’s acetaminophen, in a locked closet or other locked secure location away from children.
  • Do not forget to re-secure medication, even when children are sick, so that children are not accidentally able to overdose (when using medicine frequently the temptation to leave it accessible should not overcome the safety element of keeping it away from little hands).
  • Keep a list of the current weight of each child in the house available with the medications so that a caregiver (or tired parent) knows the weight of each child to be able to refer to the dosing chart when needed.
  • Use a clearly marked cup or syringe that is specifically for medicine to dose your child – do not use a household spoon or other imprecise measuring tool.
  • If in doubt on dosing, call the pediatrician to be sure – do not guess!
  • When multiple people will be caring for a sick child (or if you are tired), make sure that you note down the time of each dose of medication to ensure proper timing between doses to avoid accidental overdose.
  • Read the ingredients on any medication carefully to ensure that you do not give your child multiple medications containing the same ingredient – acetaminophen is sometimes added to other medications in combination drugs.

The best advice

Obviously, since I am not a doctor, you should check with your pediatrician if you have any questions about what the correct method is for providing medication to your child, but these tips will hopefully help eliminate some of the more common medication errors in your home.

Your take?

Do you have other tips to share? What about the recommended changes, do you think that additional changes are needed? Do you use fever-reducing medications in your child if your child is not displaying other symptoms, or do you allow the fever to do its work its way out?

UPDATE: Window Blinds: Why are children still dying?

Wednesday, April 27th, 2011

UPDATE – October 20, 2011:

A few months ago, this blog highlighted the issue of dangerous window treatments. In the original article, I discussed how difficult it was for parents to know whether the window treatments in their home were safe and the relatively small cost it would take for manufacturers to make kids safer. So the unfortunate reality is that despite the ongoing safety concerns and injuries and even deaths due to window blind cords, manufacturers persist in making and selling dangerous blinds and shades that have cords that are accessible to children. This week, the Consumer Product Safety Commission has announced another recall of so-called Roman shades and roll-up blinds. These products have cords that allow a child to become strangled if they get their neck caught between the cord and the fabric or if the child accidentally wraps the cord around their neck. While the recall says that injuries have not yet been reported based on this product, these products are of the same type as many where injuries and deaths have been previously reported. It leaves me to wonder at what point the government or some external force will provide enough pressure on the manufacturers to stop creating and marketing dangerous blinds to the public? As my original post explained the cost savings in manufacturing blinds this way is not extreme, but the costs are huge to families when children are hurt. Furthermore, these products are being sold, at least in this case, at discount stores to families who are likely buying what blinds they can afford without any knowledge of the potential danger.

 

Photo: www.flickr.com/photos/stvcr/

For several years, there have been periodic news reports about major recalls involving window blinds. Window blind manufacturers have also provided a number of different types of safety elements on their blinds. These have included breakaway plastic pieces on the bottoms of the cords and other sorts of “safer” ways to deal with the cords involved in the use of the blinds. How many of you believed that these recalls and changes meant that new blinds or blinds that had not been subject to any recalls were safe?

As a parent, I thought that I was fairly up-to-date about this issue.  I had replaced all of the Roman style blinds in one room in my home with cordless blinds before my daughter was born. I had purchased another type of cordless blind system for the playroom. In the one remaining area with older style blinds, I had carefully checked to make sure that the cords were not tied into a loop and that they were cleated-up high so that no additional cord was accessible at child-height. Then, I basically went on living my life without thinking too much more about it.

Well, a recent New York Times article changed that for me. The article details the injuries and deaths of several children. These children were all severely injured or killed by window blind cords. The disturbing part to me, however, was that many of the parents had taken what I would have considered to be major precautions. They had baby-proofed their homes. They had tied-up the extra cords. Yet still, the boys and girls mentioned were hurt or killed by either the interior cords of the blinds and/or by climbing up and getting tangled in the supposedly secured/safe blind cords.

What a disturbing wake-up call. I certainly walked around my house last night with a different idea of child safety. But, as I mentioned, I know that a cordless type of blind exists.  So, why is this not the safety standard?

The New York Times article explains:

Now, prodded by a Missouri mother whose daughter was strangled in a window blind, the Consumer Product Safety Commission has asked manufacturers to devise a way to eliminate the risks from window cords or perhaps face mandatory regulations. Critics of the industry complain that manufacturers have dragged their feet on addressing safety hazards for decades, making minor tweaks or putting the onus on parents to shorten cords or buy tie-down devices. Until recently, regulators have done little to crack down, they say.

In response to the commission’s latest push, the industry, working with a task force of regulators and consumer advocates, says it will come up with a fix by the fall.

But the negotiations have gotten off to a rocky start. Like some other regulatory battles that involve consumer safety, this one comes down to a sobering question: how much should manufacturers, and ultimately consumers, be required to pay to prevent the maiming or death of a child?

When I read this, I imagined that it came down to this question because the cost of making all window blinds cordless was prohibitive.  The article even states that “… cordless blinds are more difficult to manufacture than corded blinds and can cost considerably more in stores, by some estimates, twice as much.” However, when you examine further, it seems that the cost of cordless blinds might not really be much more and certainly not prohibitively expensive.

The article goes on to say that James G. Onder, a St. Louis lawyer who represents parents whose children have been injured or killed by blinds, “…said manufacturers have repeatedly testified in depositions that the additional cost of making a cordless blind is $1 to $2.” If this is accurate and cordless blinds can be made for $1-2 more per blind, then why are children dying?

The Consumer Product Safety Commission (CPSC) issued a press release in March 2011 that said that:

About half of the deaths of children who strangle in window cords have not been reported, according to an article in this week’s Journal of the American Medical Association and co-authored by a staff member of the U.S. Consumer Product Safety Commission (CPSC).

The study found that 49 percent of the total number of window cord strangulations in the United States were not being reported to the CPSC. The study estimates that total number from 1981 to 1995 was 359. These figures mean that nearly one child is strangling in window cords every two weeks. Almost all of these deaths (93 percent) are children three years old and under.

What does it say if window blind manufacturers are selling cordless blinds for twice as much in stores, when they only cost an additional $1 or $2 additional dollars to make? What does that say about the cost of safety? What message does that send to the parents of the child who dies approximately every 2 weeks from window cord strangulation?

If the window blind manufacturers are not going to make safer blinds of their own, should they be regulated? What about the continued marketing of a product that proclaims to have safety features but is not as safe as it can be for children? Is it worth the risk?

Meningitis & Your Baby: Three Things To Think About

Tuesday, April 26th, 2011

A quick story.  I remember opening the piece of mail. It was a quick note from a school official informing the student population that there was a suspected incidence of meningitis at another local university. The long and short of it was that if, as a residential student, I didnt want to move back home with my parents, I wanted to continue to live on campus, I would need to sign a waiver or be vaccinated.

Too many years have gone by, and  I can no longer remember what I chose, but the thought of meningitis made me think very carefully about whether I wanted to be vaccinated. At the time I didn’t know much about meningitis, but with the stern warning I received in the form of that letter, I researched and learned that the effects of bacterial meningitis (commonly caused by Neisseria meningitides) can be devastating. My choice notwithstanding, the choice of “to vaccinate or not” has recently been extended to that parents of infants and toddlers.

1. The signs of meningitis

The classic symptoms of meningitis are a high fever, headache and stiff neck. Detection of these symptoms, particularly headache and stiff neck are certainly difficult to detect in infants and toddlers. According to the Centers for Disease Control and Prevention, infants with meningitis may appear slow or inactive, have vomiting, be irritable, or be feeding poorly. Seizures are also a possibility.

2. An Ounce of Prevention: A vaccine is available

I was fortunate; I had the choice. I was a young adult, and I had access to a vaccine. Until recently, however, parents could not make a similar choice for their small children. The Food and Drug Administration (FDA) has recently approved a vaccine to prevent meningitis in babies and toddlers. Specifically, the FDA has approved the vaccine Menactra for usage in babies and toddlers. Menactra has been frequently used to vaccinate non-toddlers and non-elderly (ages 2 to 55). For now, the FDA has approved the usage of Menactra in babies as young as 9 months.

3. Is it safe to give to your child?

The FDA has ushered Menactra into the great debate of “to vaccinate or not to vaccinate.” I’ve read the literature and opinions of others on the topic. Each position has its passionate advocates. Putting the debate aside, the potential harm created by meningitis is well documented. Even though rates of meningitis are low in the United States, infants and toddlers are particularly vulnerable.  Meningitis can develop rapidly; in a matter of hours or days.  Even with proper care, the FDA says up to 15% of people who develop meningitis die from the infection. Of the people that contract meningitis, one in four will suffer complications such as brain damage or hearing loss. A scary number for any parent to consider. So, no matter what side of the debate you stand on, at least you now have a choice for your baby.

It doesn’t say “leave a response” down below for nothing. Feel free to let us know…

QUESTION:  What choice will you make?  Is vaccinating with Menactra a choice you will make?

 

Medical Technology and Patient Safety – Part II – EMR’s (electronic medical records)

Saturday, April 9th, 2011

Let’s begin the discussion about whether or not medical technology is truly advancing the efficient and safe delivery of patient care with the topic of electronic medical records (EMR’s). Much has already been written on this subject; however, a recap of some of the arguments being made – pro and con – for EMR’s will set the stage for what I believe is the major problem with this technological advance.

If you have ever had to review old-fashioned hand-written records relating to a patient’s care, which I’ve been doing now for almost four decades, you were thrilled – at least initially - when you heard about the advent of this new, eye-strain-saving project. Not only was I counting on cutting down the number of times I would have to increase the strength of my prescription eyeglasses, I figured I might now be able to actually read what the healthcare provider learned by history, found on examination, thought was the more likely diagnoses causing the patient’s presenting complaint and what the doctor’s plans were to address the medical problem confronting that healthcare provider. What a bonus! No more guessing! Too good to be true?

Now with EMR’s, when you request medical records from a healthcare provider, you could expect to receive – presumably with the push of a “print” button, not papyrus-like records filled with hieroglyphics, but a formatted, easily readable comprehensive rendition of what happened in the course of patient care. Well, not so fast, I quickly learned.

With the arrival of EMR’s, I became mired in a world of radio buttons, drop down menus, cryptic narratives that didn’t really match the fill-in-the-blanks charting, and a world of metadata to find out the story-behind-the-story (like who accessed the EMR, what they were looking at and when they saw it).

Now let’s be real – I sincerely doubt that the medical profession and the computer and software vendors had lawyers in mind when they created and rolled-out this new marvel. As the medical profession is so quick to point out to us lawyers, lawyers are not the ones in the trenches trying to make people better and save lives. We’re the bottom feeders (oh yeah – that’s their description so many times), who do nothing but second guess for our personal monetary gain the medical community’s valiant efforts. That discussion is for another day!

Turns out, however, that it is not only my kind screaming about how this modern medical technology has flaw upon flaw associated with it; the medical profession has serious, second thoughts about just how wonderful EMR’s are.

The Concepts Behind EMR’s

Just do a search in your favorite search engine on the topic of EMR’s – add the word “controversy” or get really ingenious and pose the question: “What are the pro’s and con’s of EMR’s?” While you’re combing through page after page of search results, take note of who is writing about why EMR’s are not the next best thing to sliced bread. I’ll save you the task; it’s the medical profession. That’s right, the very people who hailed the advent of EMR’s and extolled the many intended virtues of this technology.

The Pro’s of EMR’s:

Here are some of intended benefits of EMR’s:

  • improve the quality of patient healthcare through instant, universal access to patient data (at the click of a mouse or push of a button)
  • avoid, if not eradicate, the “unreadability” (interpretation: I can’t read your handwriting; what are you telling me?) of hand-written chart entries.
  • improve patient safety through better detection of adverse events. The intended goal is premised on EMR’s having a central database of patient information, decision-making, outcomes (including adverse events) and other key epidemiological data available and accessible for analysis.
  • enhanced quality of care through immediate access of all pertinent patient information (e.g. testing, radiological studies, medications, vital signs, laboratory studies, etc.) so that caregivers can make better, faster and more informed decisions about continuing plans of care.
  • making healthcare more cost efficient by reducing unnecessary redundancy of testing (due to inability to locate prior paper-based information), digital access to key points of patient data rather than the waste incurred through manual search of past records from various healthcare provider sources, copying, faxing, etc.
  • keeping records safe: with proper digital storage measures, there can be avoidance of destruction, misplacement and the like.
  • overcoming inaccurate past medical history (PMH) information since care providers would have access to a patient’s “true and accurate” medical history by accessing stored medical data. Healthcare providers would no longer be relying on ofttimes faulty patient memory of PMH.
  • improved coordination and information exchange between healthcare providers. Studies have shown that the communication and transfer of information between primary care physicians and hospital-based physicians has been less than optimal.
  • improved, accessible and faster surveillance capabilities for wide scale events such as epidemics, catastrophic natural disasters (e.g. Katrina) and even bioterrorism.

I have absolutely no doubt that there are a host of other EMR pro’s. Yet even though the concept of EMR’s has apparently been the topic of discussion for about forty years and there are so many potential benefits inherent in their use, one must wonder – why did it take so long to implement EMR’s and why are they not being fervently embraced throughout the medical profession?

Some Con’s

As with many great modern marvels, once the allure of the new toy wears-off and implementation begins, some of the flaws begin to surface. ERM’s clearly have their share of warts.

  • privacy concerns – do EMR’s have the ability to turn the sacrosanct confidential communications between physician and patient on their ear? Some scream a resounding “yes.” Some have expressed deep-seated concerns that such accessible data will be used against a patient when they apply for jobs, health insurance, or – I’ve seen said – even a college scholarship. The potential inclusion of genetic data in EMR’s and the accessibility by researchers or others who don’t fit the need-to-know category also has privacy advocates screaming “foul.”
  • loss of the benefit of provider narratives (which were the norm in hand-written charts) so as to better appreciate the subtleties and thought processes of medical care. It is often said that medicine is an art, not a science. The ability to appreciate the art of medicine, some fear, has been lost when all that you can glean is pre-formatted information from drop-down menus and radio buttons. There’s no longer an ability to appreciate the true thinking process of the caregiver. Some refer to these problems as blind and meaningless use of short-cuts, templates and pre-fills, which don’t allow subsequent caregivers relying on EMR charts to get a true and accurate picture of a prior caregiver’s true thoughts. Apparently, quicker and easier input does not always translate into better or more accurate information.

Think I’m making this one up? Here’s what one internist at Harvard Medical School had to say about EMR’s:

Harvard Medical School internist and entrepreneur Dr. Rushika Fernandopulle says that many EMRs are designed to improve coding and maximize reimbursements, often at the expense of clinician functionality. “When you’re trying to read the notes of your colleague [in an EMR], it’s almost impossible to figure out what happened to the patient,” Fernandopulle tells the Journal. “You have to read through two pages of all this junk that’s put in to increase billing.”

  • Notwithstanding the claims of EMR advocates, many in healthcare and related fields firmly believe that EMR’s are not safe and secure. They point out that despite encryption and restricted access through log-in’s via usernames and passwords, there are numerous and disturbing instances of hackers gaining access to private patient information.

• November 26, 2007, Canada. Hackers accessed medical information on HIV and hepatitis from a Canadian health agency computer.
• September 22, 2008, UK. The National Health Service (NHS) reported the loss of 4 CDs in the mail containing information on 17,990 employees.
• September 30, 2008, US. The company Blue Cross and Blue Shield of Louisiana confirmed breach of personal data, including Social Security numbers, phone numbers and addresses of about 1,700 brokers. The data was accidentally attached to a general email.

(source: The HWN Team @ HealthWorldNet.com)

  • computer-driven healthcare is potentially hazardous to one’s health. Rather than paraphrase, let me share one comment I found on a blog extolling the virtues of EMR’s:

Try telling that to a computer: I am on medication that I take every three days. So, a normal 30 day supply last[s] me 90 days. However, the computer at my pharmacy automatically renews the prescription and I get a phone call every month asking me to come pick it up. I now have a year’s worth of pills on hand and they’ll expire before I can take them (which means I should not take them as they may not be effective). So, I called on Friday to tell them that I wanted to opt out of the system. The nice person informed me that I had been removed from the system. 9:01 AM Today (Monday) I got a call, telling me that my prescription is ready to be picked up. This is what happens when people cede thinking and into the ‘computer said it so it must be true’ mindset that we’ve all experienced from time to time to maddening effect.

  • way too much information, a lot of which is purely redundant and distracting. From my perspective as a lawyer, this is a major problem with EMR’s. A click of a radio button or a selection from a drop-down menu often generates duplicate entry data in a host of other fields across the system. As you try working your way through the jungle of screens or paper generated by EMR’s, you say to yourself, “Didn’t I just read that same thing somewhere else?” Now put yourself in the shoes of a healthcare provider. You have a number of patients to see, orders to give, reports on patients to share, calls from your pager to answer – and all you want to know when checking a patient’s EMR is some key information so you can do what needs to be done and move on. What do you find? More information than your ever wanted or needed and at times conflicting information. Frustration mounts and you yearn for the days of color-coded, hand-written charts.
  • How fast can you type? Simple but real issue for apparently many in the medical profession. EMR’s are meant to save time – perhaps not!
  • How fast do the records load? Some have become frustrated when using internet portals for records with very slow loading time of EMR’s when using over-utilized internet connections during peak usage hours.
  • those developing the EMR software failed to consult with practitioners before rolling out their product leading to templates, care strategies and selection choices that have no practical use for actual caregivers.

Just as is the case with the pro’s, there are many more con’s being voiced throughout the internet by medical care providers. That being said, I am of the firm belief that one of the biggest flaws is the manner in which EMR’s were and continue to be implemented – rolled out for use – in our medical institutions and physician offices. This can range from lack of training, lack of quality control, lack of system-wide coordination – you name it. In the rush to purchase, upload and put in use EMR’s, too little thought seems to have been given too many times to such projects before implementation. After the implementation, many problems started to rear their ugly heads.

Here are but a few examples of poor implementation voiced by a nurse, Kaye, in a comment she posted to the first installment of this series. Make sure to take particular note of Kaye’s fourth point!

1. Facilities are not getting input from the potential users before purchasing. Cost and JC compliance is more important than usability. “Here is your new system. Make it work.”
2. Seasoned nurses and ancillary staff are not given the considerations derserving of the huge technological changes. It’s a whole other language. A COW (Computer On Wheels) stands in the field.
3. A culture clash has developed between nursing and the IT department who cannot appreciate the urgency of correcting problems.
4. At my facility, there are 3 different systems. They don’t ‘talk’ to each other. Whose idea was that?

I could go on; but you get the point.

In my next installment, I will share with you with more real-life examples of just how misleading, inaccurate and unsafe EMR’s can be. Just to give you a tease – how about the case of a woman who was paralyzed following an epidural for labor and post-childbirth pain relief. Hours after she was diagnosed by a neurologist as having suffered injury to her spinal cord leaving her with significant, devastating motor deficits and sensory loss, she was noted by a nurse in the EMR to be “ambulating [i.e. walking] x 2″? I wonder if that would have happened if the nurse had to hand-write that entry and not just click on a drop down menu choice. There will be plenty more examples of such just how effective and safe EMR’s have turned out to be. Stay tuned and tune in to Part III coming next week.

Related Posts: Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Part I.

 

Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Blog Series – Part I

Monday, March 28th, 2011

Medical Technology - source: Siemens.com

This is the first installment of a series of posts on issues relating to new advances in medical technology and how they may affect patient health and safety – not always for the good. Unless you live in a cave or just don’t care, you must have noticed news reports about how the medical industry is awash in the creation and implementation of new technologies. Presumably these new medical tech toys and gadgets are intended to advance the timely, enhanced, cost-effective delivery of healthcare with the end point being improved patient care and patient safety. The question is – do they always do that or can they, in fact, be tools the lead to patient injuries and – at times -even death?

I recently came across a posting by Dr. William L. Roper, MPH, CEO of the University of North Carolina Health Care System, which was in essence a transcript of a speech he gave at the Agency for Healthcare Research and Quality (AHRQ) in Washington, D.C. on March 23, 2011. Among his other vast accomplishments, in the spring of 1986, he was nominated by President Reagan and confirmed by the Senate for the position of administrator of the federal Health Care Financing Administration, with responsibility for the Medicare and Medicaid programs nationally. For the previous three years, he served on the White House domestic policy staff.

I bring Dr. Roper’s recent remarks to your attention since they are the inspiration for this series of blogs. While Dr. Roper’s address did not specifically address topics such as EMR’s, COW’s (still wondering how a cow fits into this topic? Stay tuned!), and the like, the following selected excerpts are the seeds of thought for the present series:

I have the job of leading an academic medical enterprise, and am challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.

The Institute of Medicine, under Sam Their’s and then Ken Shine’s leadership, played a very important role across the decade of the 1990s, defining “quality” in health care, and pointing to problems in quality and patient safety. Bill Richardson led a multi-year IOM initiative that included the groundbreaking report, To Err is Human in 2000, and then Crossing the Quality Chasm in 2001.

These reports were a clarion call for action – especially making the point that a systems approach was required to deal effectively with these issues.

While Dr. Roper’s speech was, in large part, an historical analysis of progress in the Medicare healthcare delivery system, it is also a well-versed commentary on the so-called advances in medicine for patient care and safety. Why else have so many toiled for so long in trying to find system-failures and methodologies for eradicating those failures and thereby improving the delivery of safe, efficient and effective healthcare?

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level . . . [W]e are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

What has technology done to improve healthcare?

The answer, in short, is – some amazing things and some not so amazing things have taken place in terms of technological advances in healthcare. Unfortunately, as we will explore in this series, some of these technological advances have led to some catastrophic results for patients. One need look no further than how the medical institutions rushed to implement the newest, shiniest and “best” radiology machines and through their haste left in their wake scores of maimed and dead patients. We reported on this investigation by NY Times reporter, Walt Bogdanich  in Eye Opener, over a year ago.

Just over the course of the last year or so, our firm has been involved in case after case in which this issue of medical technology and patient care/safety keeps rearing its ugly and devastating head. We will share with you (leaving identifying information obscured as we are required to do) tales of just how medical technology can impact – positively and (unfortunately) negatively patient health and safety. We’ll analyze and discuss our views on just how well medical technology and its implementation (more the latter) have, in our view, negatively impacted – all too often – patient health and safety. We invite you to follow along as we consider the good, the bad and the ugly of medical technology such as EMR’s, COW’s, iPads and the like. Please join us and share your comments along the way.

Some related posts to get you started:

The Radiation Boom – Radiation Offers New Cures and Ways to Do Harm

FDA Unveils Initiative To Reduce Unnecessary Radiation Exposure from Medical Imaging

At Hearing on Radiation, Calls for Better Oversight

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The Story of How a New York Times Reporter – Walt Bogdanich – Has Made a Real Difference in Medical Device Radiation Safety

The Week in Review: did you miss last week’s posts on health, safety, medicine, law and healthcare? A sneak preview of the week ahead.

Saturday, March 26th, 2011

Eye Opener - Nash & Associates Blog

This week we are starting a weekly posting of our blogs of this past week, some key blogs of interest to our more than 6,500 monthly readers, and a sneak preview of what’s coming next week. We would really like for you to join our community of readers, so don’t forget to hit the RSS Feedburner button or subscribe to our blog, Eye Opener. We share with you our thoughts, insights and analysis of what’s new in the law, the world of law and medicine, health, patient and consumer safety as well as a host of other topics that we deal with as lawyers on a daily basis in trying to serve the needs of our clients.

For those of you on Twitter, Facebook and LinkedIn, we have a vibrant presence on those social networks as well. Hit the icon(s) of your choice and become part of our ever-growing social network community. Share your thoughts, share our posts, give us your feedback on what YOU would like to hear about.

This Past Week

Birth Defect Updates: Warnings About Opioid Use Before and During Pregnancy In this post, Sarah Keogh, explored a new report which is vital information for women who are pregnant or thinking about becoming pregnant. Opiods, narcotic pain killers such as morphine, codeine, hydrocodone and oxycodone, are a valuable part of a physician’s drug armamentarium, but they can have significant implications for a fetus if taken during pregnancy or even just before a woman become pregnant. Read Sarah’s important piece, be informed and learn why you should discuss the use of any such drugs with your obstetrician/gynecologist before taking them.

 

Doctors Disciplined by Their Own Hospitals Escape Actions by Licensing Boards. Who’s at Fault? Brian Nash, founder of the firm, writes about a serious problem with this country’s medical licensing boards, who have failed, at an alarming rate, to take disciplinary action against physicians, who have had their hospital privileges revoked, suspended or curtailed for issues such as sub-standard care, moral transgressions and the like. Public Citizen brought this story to light; we analyze the issue and share our thoughts on this serious patient health and safety issue.

Decreasing Obesity Risks in Children: Another Benefit of Breastfeeding A mom herself and an advocate for public health childhood obesityand safety throughout her legal career, Sarah Keogh reports on a recent study covered by the Baltimore Sun about the long-term benefits of breastfeeding for at least six months. The issue for many, however, is – how can a family of two income earners afford to do this? Does our society and the workplace really lend itself to this practice? Read Sarah’s compelling piece and share your experience and thoughts.

The Week Ahead

Sneak preview of what’s ahead during the week of March 28, 2011:

medical technology

Brian Nash begins a series on the issue of medical technology and patient health/safety. Is the medical community being properly trained in the proper and safe use of all the new medical devices that are hitting our hospitals, clinics and medical offices? Is the rush to have the newest, shiniest and “best” new medical device really advancing the safe and effective delivery of healthcare in our country? Here’s a sneak preview…

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a much better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

Some top posts you may have missed

What happens when your surgeon has been up all night and you are being wheeled into the operating room to be his or her next surgical case? We looked at an article from The New England Journal of Medicine that addressed this patient safety issue and made recommendations for change.  See our posting entitled A Surgeon’s Sleep Deprivation and Elective Surgery-Not a good (or safe) combination.

Dr. Kevin Pho, who is the well known editor and contributor of KevinMD.com, wrote a piece in which he espoused his belief that medical malpractice cases really do not improve patient safety. Having read this piece and finding that this was just too much to digest, Brian Nash wrote a counter-piece entitled Malpractice System Doesn’t Improve Patient Safety – Oh Really? What this led to was cross-posting by Dr. Kevin Pho on our blog, Eye Opener, and our posting on his blog. Our blog post (as best I can tell) led to one of the all-time highest postings of comments by readers of KevinMD. One thing all participants in the “debate” learned – we are both passionate about our positions. Read what led to this firestorm.

 

Why do so many patients die when their in-hospital alarms go unheard or unheeded?

Thursday, February 17th, 2011

ICU alarm monitor

Sunday’s edition (February 13, 2011) of the the Boston Globe online (boston.com) tells a chilling story of how many times the alarms used to monitor patients go unheard and unheeded by medical staff leading to death or catastrophic injuries for patients throughout this country. The story, which was a two part series (for the second installment, see For nurses, it’s a constant dash to respond to alarms) by Globe reporter Liz Kowalczyk, narrates numerous incidents in which alarms simply went unnoticed, ignored or unmonitored. Numerous other issues such as lack of education of hospital staff as to how to properly connect the devices, failures to realize the batteries had gone dead, turning the alarms so low in volume they could not be heard, taping over amplification systems to avoid the “annoyance” of the alarms and the like are also chronicled in this series. While it is documented by an analysis of the FDA’s database of adverse events involving medical devices that 216 patients died nationwide between 2005 and mid-2010, it is also certain that this number of alarm-related deaths is probably much higher. The ECRI Institute, which was hired by the Globe to analyze the FDA database, believes that the health care industry under-reports these cases to the FDA.

Some examples of alarm-related deaths

Since links to the Globe’s original articles are provided above, I will not go into the level of detail that is otherwise available through reading the original reports. Here is a sampling of the types of “alarm failures” leading to patient deaths:

  • staff misprogrammed complicated monitors
  • staff had forgotten to turn the monitors on
  • batteries had gone dead leading and failed to function (one instance where a man had a “flat line” for more than two hours that went undetected)
  • defective wires or connections on the monitors
  • malfunction or design flaws in the monitoring devices
  • staff ignored the device warnings because of “alarm fatigure

Alarm Fatigue

According to one computation at Johns Hopkins Hospital in one 15 bed unit as to how often alarms go off during the course of day, it was documented that there were 942 alarms per day – “about 1 critical alarm every 90 seconds.” There is no doubt that the number of alarms and the clinical settings in which they are used have increased over the years. As Ms. Kowalczyk noted, “[W]ith the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses can become desensitized – sometimes leaving patients to die without anyone rushing to their bedside.”

In some cases, busy nurses have not heard or ignored alarms warning of failing batteries or other problems not considered life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, can go unheeded. At one undisclosed US hospital last year, manufacturer Philips Healthcare, based in Andover, found that one of its cardiac monitors blared at least 19 dangerous-arrhythmia alarms over nearly two hours but that staff, for unexplained reasons, temporarily silenced them at the central nursing station without “providing therapy warranted for this patient.’’ The patient died, according to Philips’s report to federal officials.

Keep in mind that many of these alarms are not only audible in the patient rooms; they also sound at the central nurse’s station. In some instances, hospitals have put up hallway speakers for nurses to hear the alarms more readily. In other facilities, in addition to audible alarms, various pieces of critical data information (e.g. heart rhythm, heart rate) are visible on displays at nurses stations and in some places, it is reported, “on brightly colored scrolling signs in corridors.”

The article quotes one nurse at Boston Medical Center, who addresses some of the issues at the heart of this “alarm fatigue” phenomenon.

Everyone who walks through the door gets a monitor. We have 17 [types of alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes...background

False Alarms - the cry wolf issue

It is well known that some alarms can go off when a patient sits up, coughs, turns or makes other normal movements. According to the Globe report, "'[s]ome studies have found that more than 85 percent of the alarms are false.” I have no idea how this statistic was compiled, but even if it is accurate (which is debatable), that still leaves dozens if not hundreds (if not thousands) of alarms going off daily in every hospital throughout this country that are an indication of a patient in need of rapid response life-saving care.

Another nurse is quoted by the Globe in expressing both the frustration and the need for attentiveness when the alarm goes off. “You have to respond to the alarm[, b]ut there are some days when you feel you’re just running from alarm to alarm. It can be exasperating.”

The Fix

The short answer appears to be: there is no easy, quick fix. Here are some of the measures institutions have taken to address this problem:

  • working with engineers at prestigious institutions (e.g. MIT’s work with Boston’s Children’s Hospital) to develop more sophisticated monitors to identify true crisis alarms.
  • hiring of dedicated monitor technicians and/or nurses, who man the central nurses’ station to triage alarms.
  • specialized education programs to avoid misprogramming or connection mistakes due to lack of knowledge by staff
  • establishing tighter standards of which patients should be connected to alarmed monitors – to cut down on the “background noise” of alarms.
  • replacement of old equipment for more advanced, accurate alarm/monitor systems
  • implementation of new programs in-hospital to require bioengineers to check the monitors daily to make sure they are working properly.
  • implementation of standardized settings on machines so that alarms are not turned so low they are non longer audible. (One case of a patient death was attributed to staff turning the the “vexatious” alarm down to a 40% of full volume – no one responded to an arrhythmia alarm for 40 minutes because no one heard the reduced volume alarm during that time.)
  • changing batteries every day in monitors to make sure they are, in fact, charged and working

The Blame Game

As you might suspect, the finger-pointing that takes place after a patient is found dead or severely injured is rampant. As the Globe reports, “Initially, hospitals almost always blame the monitor’s alarm for not sounding when it should have, according to reports. But the company investigations show the assertion is often false.”

In 40 of the cases reviewed by the Globe, the alarms did not sound, usually because the staff had not properly programmed or turned on the machines.; in only eight cases was there a malfunction or design flaw.

[I]n nearly 100 cases, manufacturers ere unable to determine exactly what went wrong, often because they didn’t have enough information, or they told federal regulators they still were reviewing the death.

Where to from here?

While I certainly don’t have to contend with the incessant noise of alarms going off all day long, nor am I required to jump away from what I’m doing to respond to a false alarm, I can’t help but think that in a health industry as advanced as ours allegedly is, there must be some steps that can readily be taken so that others don’t die because some nurse has “alarm fatigue,” or a battery died, or the volume was turned down too low to avoid the annoyance of the alarm or some other ill-conceived and unacceptable reason.

What suggestions do you have for the healthcare industry to deal with this problem? Have you ever worked in a setting where this is a problem? If so, how did you and/or your institution deal with this issue? There are a lot of smart people in bioengineering and in our health institutions; why is this still such a problem in a country that claims to be so advanced?

Image by ectopicinteractive.com

DARVON AND DARVOCET WITHDRAWN FROM U.S. MARKET – WHAT SHOULD YOU DO IF YOU ARE TAKING THESE MEDICATIONS?

Tuesday, November 23rd, 2010

Last week, the manufacturer of Darvon and Darvocet, Xanodyne Pharmaceuticals, agreed to withdraw these drugs from the market in response to FDA requests.  The FDA has also requested that generic drug manufacturers also stop marketing propoxyphene-based pain killers like Darvon and Darvocet. These drugs were withdrawn from the U.K. market almost six years ago. About a year and a half ago, the European drug agency also placed a ban on propoxyphene-based pain killers. An estimated 10 million Americans are taking propoxyphene-based drugs.

Although propoxyphene was always associated with a number of complications, the FDA’s request was prompted by new studies revealing the drug’s serious cardiovascular side-effects. The FDA was petitioned on a number of occasions to pull propoxyphene off the market. The latest petition came from the public interest group Public Citizen in 2006.  The FDA submitted the petition to an expert advisory committee that voted in favor of withdrawing the medication in 2009 (14 to 12 ).

The FDA did not request that the medication be removed from  the U.S. market in 2009. Instead, it requested that the manufacturer of the drug, Xanodyne Pharmaceuticals, Inc., conduct research to study the effects of the drug on the heart. This new research revealed that people taking propoxyphene (Darvon, Darvocet and  the like) can develop abnormal or fatal heart rhythm.  These findings prompted the FDA to request the withdrawal of the medication. Propoxyphene is also associated with the following cardiovascular complications:

  • Tachycardia
  • Cardiac/respiratory arrest
  • Congestive heart failure
  • Myocardial infarction
  • Hypotension

Some other side effects include:

  • Drug overdose/toxicity
  • Drug dependence/withdrawal
  • Anxiety
  • Nausea
  • Vomiting
  • Drowsiness/ dizziness
  • Hives
  • Difficulty breathing
  • Chest tightness
  • Swelling of the face, mouth, lips or tongue

The Public Citizen group has claimed that about 2000 people in the U.S. have died as a result of propoxyphene in the last six years. The good news for those taking Darvon, Darvocet or a similar drug is that the cardiovascular side effects of these drugs are not cumulative. Therefore,  the risk of developing cardiovascular problems should go away once the drug is stopped.

If you are taking Darvon or Darvocet, DO NOT stop taking the drug until you talk to your doctor. Sudden interruption of the medication can lead to serious withdrawal symptoms.  If you are taking propoxyphene-based medications, contact your doctor immediately so that you may be transitioned to a safer pain killer.

Photo: pharmer.org