Archive for the ‘medications’ Category

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?

Week in Review (April 23 – 29, 2011): The Eye Opener Health and Law Blog

Saturday, April 30th, 2011

From the Editor:

Last week was a busy but productive week for our firm’s blawgers – 6 posts – and we actually practiced law a lot! My personal thanks to our writers for taking the time to post some important pieces on health, safety, medicine and law. To our readers, my continued and sincere thanks as well. While it’s great to pull-out our soapbox and write about stuff we do and are passionate about, it’s incredibly rewarding to have you, our readers, take the time to read what we write. To those who left comments, a special thanks. We really enjoy interacting with you!

Now on to the business at hand. What did we write about that you may find interesting? Here you go.

My Pet Peeves About the New Age Mediation Process

Having been inspired by a fellow blawger from New York, Scott Greenfield, who chided legal bloggers (thus the name “blawgers”) for simply rehashing news and not taking a stand on issues, I wrote a piece called Mediation of Lawsuits: The 5 Top Things that Tick Me Off!

Having recently been through a number of mediations that were enough to pull your hair out because of the silliness that people engage in when they claim they are mediating to get cases resolved, I decided that it was time to take a stand and post a personal rant. While perhaps best understood by lawyers, claims adjusters and mediators, this blawg was not intended just for them. I’ve seen what impact foolish approaches and conduct by the participants to mediation can have on my clients, the injured parties. It was time to sound-off; so that’s what I did. I once again invite anyone who has been a party to a lawsuit mediation to do your own personal sound-off and tell us what it was like for you. It’s your turn to tell us just how much you enjoyed the process and what can be done to make it better. Read the horror story told in our Comments section by one of our Canada readers when she went through a domestic mediation process. Share your thoughts and stories as well.

Health Care: Who’s “Voiceless” When It Comes to Being Heard on Capitol Hill

Guess I had too much time on my hands at the beginning of this week (not really!). I couldn’t help but be inspired by a piece Jason Penn had done last week about how families were so adversely affected by the budget cuts that were made when the government shutdown was looming a few weeks ago. As I was going through my Google Reader early this past week, I came across an Op Ed by a doctor, who was complaining or at least suggesting that the president and congress need to hear more what doctors had to say about health care reform. Having read that, Jason’s piece jumped into my mind and the result was my blawg entitled Health Reform: What voice does the patient have in the debate.

The post brings to light the amount of money being spent by the healthcare industry in its lobbying efforts on health care reform. ObamaCare‘s raison d’etre is explored as well since it is ironic, if not sad, how the story behind all this money, lobbying and legislation seems to have been lost in the rhetoric. More affordable, better and available health care for our citizens? Then why were the most needy among us the victims of back room wheeling and dealing when the time came for budget cuts to save the federal government from closing its doors? I ask the question – who’s voice is being heard – but more important – who’s is not?

FDA approves use of “meningitis drug,” Menactra, for younger children

Hopefully you’ll never need to use this information, but if you do, Jason Penn reported on a condition – meningitis – that can affect not only adults and older children, but infants and toddlers as well. Meningitis is generally defined as an inflammation of the protective membranes covering the brain and spinal cord. Prior to a recent change in position by the FDA, there wasn’t a vaccine available for children under the age of 2. Now, with the FDA’s recent approval, Menactra can be used to vaccinate children from the age of 9 months to age 2.

In addition to this news release, Jason tells parents about the signs and symptoms they should be aware of to spot this condition.

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.

To learn more about this important topic, read his piece Meningitis & Your Baby: Three Things to Think About.

Why are children still dying because of venetian blinds?

Sarah Keogh wrote what I believe is a very important piece for parents, grandparents or anyone who has a baby in the house. Years ago we all heard about the horror of parents finding their babies dead from strangulation when their necks became entangled in venetian blinds. Years have passed since those stories made the front page. Well, an update on just how well manufacturers and parents have been doing to avoid such tragedies was recently posted in The New York Times.

In her blawg entitled Window Blinds: Why are Children Still Dying, Sarah tells us the sad truth that these deaths and injuries still continue in our country. Find out what you as a caregiver of a young child need to realize about this product. Maybe you’ve put the cords up high and out-of-reach for your baby. Maybe you’ve taken other steps to avoid such a nightmarish event ever happening in your home and in your life. Unfortunately, many who have done so have still suffered this tragedy. Why? What is being done by manufacturers and the government to prevent these injuries and deaths ? Read Sarah’s piece for the answers and some practical advice you can take to make your home safer for your child.

Hospitals Reporting Methods for “Adverse Events”

We all know by now that if you want to look good to the public, all you have to do is “play with the numbers.” Well, it seems like hospitals have a penchant for doing just that. One of the key “numbers” that advocates of patient health and safety look at is how many “adverse events” take place in any given hospital. An “adverse event,” as you may already know, is – simply put – any harm to a patient as a result of medical care.

In his post this past week, Jason Penn compares some interesting adverse event bookkeeping by hospitals throughout our country. His blawg, The New Enron? Are Hospitals Cooking the Books?, brings to light serious flaws in the way that our medical institutions “count” the number of so-called adverse events taking place within their walls. His research for this piece reveals…

[M]edical errors occur 10 times more than previously thought.Maybe that wasn’t hard hitting enough. Let me try again. How about this: mistakes occur in one out of every three hospital admissions!

Frankly, that strikes me as an astounding and very concerning number. Are the numbers being reported reflecting this? The simple answer is no. Why not? Read Jason’s post and see what reporting systems are in place – or not in place as the case may be. We all remember Enron. Is this the medical version of “making the numbers look good” when they simply are not!

Surgeons and Booze – an Obvious Bad Combination – Who’s Protecting Us?

It doesn’t take a genius to realize that surgeons should not be under the influence when we as patients are “under the knife” What’s not so obvious is just how prevalent this may be in the operating rooms of our country (and throughout the world).

Wondering what the studies have been done by the medical profession to examine this problem? Have any idea what regulations are in place by hospitals to guard against the problem of “hungover surgeons”?

Wonder no more. Jon Stefanuca’s blog this past week, Hungover Surgeons: Watch Out! There’s Nothing Between You and Their Scalpel!,will tell you all you need to know. Jon queries: “Should hospitals regulate for patient safety?” What do you think? Share your comments.

A “Sneak Peak” of the week ahead

Some more good advice is on the way for parents of special needs children. We all know about what a wonderful aide dogs are for the blind. Mike Sanders will share what he’s learned how these canine wonders are being used for kids in need. Suffering from asthma or know someone who is? Jon Stefanuca will be sharing with  you some valuable information on this topic next week. A number of our clients or their now-deceased family members have suffered from this condition. Jon will share a story or two (without revealing protected confidential information) to bring to light just how this medical condition needs to be better recognized and treated by our health care providers before its too late. We all know what a difficult job nursing can be. That being said, Sarah Keogh will be telling us about some very concerning “trends” that are coming to light in this wonderful profession. Stay tuned for this important piece.

We’ll start next week off with a new blawg by our in-house medical specialist, Theresa Neumann. Her post on how important it can be to get a second opinion before you sign-up for a surgery, procedure or test is sitting in the queue just waiting to hit the pages of The Eye Opener – Views and Opinions from the Nash Community.

One Final Note: I wrote in last weekend’s Week In Review that we intended to post a new White Paper by Marian Hogan on a very important topic relating to Patient Controlled Analgesia (PCA). It didn’t happen – because of “my Bad.” I fouled-up and sent the wrong draft of Marian’ s piece to our graphic designer. He did a wonderful job – as usual – of getting it ready – it just wasn’t the right version. The problem is fixed, but my mistake will delay the posting of this important White Paper for another week. Public apology: Sorry, Marian! We’ll make it right soon.


Makena: Drug to fight prematurity leads to major firestorm.

Thursday, April 7th, 2011

Last week, I started following a still emerging story about a drug that I had never heard of before called Makena. The medication is a synthetic form of progesterone that is used for women who have a high risk of prematurely delivering a baby based on having had a premature delivery in the past. The drug must be injected by these women weekly for 18-20 weeks of their pregnancy.

According to the Baltimore Sun, the controversy surrounding this drug began when the “…K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.” This was possible because originally the medication was created by a compounding pharmacy mixing it together for patient use. Then in February, the FDA granted K-V Pharmaceutical Co. the exclusive rights to manufacture the medication for seven years.

If raising the cost of the medication 75 times its original cost (from $10-20/dose to $1,500/dose) were not enough, the Baltimore Sun reports that the company then went on to “sen[d] letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug.”  However, the FDA, amid a loud outcry of complaints, has “…declared it would do no such thing.  In its statement, the FDA noted that the drug was important and K-V ‘received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.’”

What has been so interesting are the implications of this story and the reactions to it. Clearly, the original decision by the pharmaceutical company to raise the cost of the drug 75 times the old cost is an attempt to make money from their exclusive rights. I can hardly imagine that there is any reason other than profit creation for this move given that they did not have costs associated with research and development or any other clearly identifiable costs. So, aside from my initial reaction of disgust that this might make it harder for women who need this medication to protect their children, I also thought about the bigger implications.

First of all, the cost issue is not so simple as it first appears.  As another article from the Baltimore Sun mentioned, “[t]he burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.” The increased costs of drugs impact many Americans directly – those without insurance or those for whom even co-pays are a major budgetary struggle. However, the costs here also reach all of us. If the costs associated with the company’s increased profit are borne by the insurance companies and Medicaid, it also means that the costs are going to be felt by all of us who pay for health insurance or whose companies pay for health insurance and yes, by all of us, who pay taxes.

Secondly, for those women who do not realize that they could still go to a compounding pharmacy for this prescription and for whom it is not covered by insurance, the increased cost may mean that some woman will go without these injections. The Baltimore Sun article reports that:

About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.

The implications here deal with both the health and safety of the unborn child who is now at risk of premature birth. But, unfortunately, they also have an associated monetary cost. The cost of a baby being born prematurely is also going to weigh on the insurance companies and is, therefore, going to be shared by all in the form of potentially increased premiums.

Given the intense criticism in the news, K-V Pharmaceutical Company moderately changed course in the last few days, according to Medical News Today and said they would bring the cost of Makena down to $690 per dose from the originally announced price of $1,500 per dose. While this is lower, this is hardly a significant adjustment given that the compounded version costs between $10-20 per dose. The March of Dimes, which originally backed FDA approval of the drug and was allowing the pharmaceutical company’s use of its name and logo, is apparently embarrassed by KV Pharmaceutical’s decisions. According to an article on the nonprofitquarterly.org, “…the March of Dimes is backing out of a sponsorship deal with the [pharmaceutical] company that sells [Makena]. Last Friday, the nation’s leading nonprofit focused on the health of pregnant women and babies said it would no longer allow St. Louis-based, KV Pharmaceutical Co. to use its name or logo in any of the drug company’s promotions.”

The response from the March of Dimes is not KV Pharmaceutical Co.’s only trouble as the Wall Street Journal is reporting that after the FDA announcement that it will not take action against pharmacies that compound the drug, and the company subsequently announced that it would cut the cost, the company’s shares fell 5.2%.  Reuter’s is reporting that this represents a drop of more than 20 percent.  Congress is also in an uproar about this issue.  The Reuter’s article says that elected officials are creating pressure for more to do be done on this issue.

What do you think should be done about KV Pharmaceutical Co.? Are they really any different from any of the other pharmaceutical companies? Is it relevant to consider that this is a so-called orphan drug and that the company has exclusive rights because of this? Do you think that allowing compounding pharmacies to create the drug for woman separate from the FDA approved drug is a sufficient solution? What about the bigger question of companies creating inflated prices for their products and having insurance (and all of us) foot the bill?

 

Follow-up Blog: Important questions and answers on Pradaxa

Monday, January 10th, 2011

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Therapeutic Switching: Who is Really Ordering Your Medications?

Wednesday, December 8th, 2010

The Simple Life

Once upon a time, in a little town called Mayberry, all things were good.  No one really became ill, but if he did, the local town doctor would prescribe a medicine that was promptly filled by the “Ma & Pa” Pharmacy.  The patient got better because of the doctor’s expertise and the prompt response of the pharmacy to deliver the prescribed medicine to the ailing individual.

If “Mayberry” ever really existed, it certainly does not today.  How many times have you been to the doctor for an ailment and the medicine prescribed by that trained and licensed practitioner was denied by your insurance company once you took that prescription to the pharmacy?  Two, three, maybe even 7 days later, after much haggling with the insurance company, you finally get your medication.  Or, when you pick up your prescription from the pharmacy, after doing a little shopping to occupy your time while the prescription is being filled, the pharmacy technician notifies you that your insurance company would not cover the prescribed medication, switching it instead for a cheaper version (not even generic version of the same drug)!  Believe it or not, sometimes the patient is not even notified of the switch!  And this is acceptable practice?!?

What Role Does Your Health Insurer Play?

In April of 2010, Maryland MedChi, the Maryland State Medical Society sponsored a survey for its members titled, “Impact of Patient Health Insurance Protocols on the Maryland Physician’s Ability to Provide Care.” This survey assessed the distribution of perceived problems across the state of Maryland and the impact of insurer protocols on patient care, physician practice management and physician professional satisfaction.  An essentially universal frustration amongst respondents (95%) was the negative impact of insurance carrier requirements on regarding what physicians can prescribe or order on behalf of their patients.  Depending on the insurer, there were pre-approval protocols, step-therapy protocols, therapeutic switching and others that significantly affected the physician’s ability to treat his or her patient.  The problems related to time spent “haggling” with the insurer, communicating with patients to explain the problems, researching potential interactions with other medications or patient conditions, determining other similar failed therapies in an attempt to justify the prescribed therapy, and others.  There are even instances when a patient presents to the hospital for admission to a Hospitalist, and the physician’s office sends the patient’s current medication list to corroborate current therapies only to find differences between the patient’s medication bottles and the current list due to therapeutic switching by the insurance company.  Another even more potentially problematic perception of the physician respondents (59.5%) involved arbitrary delays or outright denials of prescribed therapies by the insurers.

What’s the Motive?

So, you ask what the basis is for this and how do the insurers get away with such mandates?  It all boils down to money.   Typically businessmen run insurance companies, and these businessmen are making business decisions without any inkling of understanding of medicine or seeing an actual patient.  Medical News Today recently reported a survey performed by Global Healthy Living Foundation, a non-profit patient advocacy group, that corroborates the Maryland MedChi findings:  ”…up to 70 percent of prescription medications are changed by health insurers, denying patients the drugs their doctors prescribed” because the substituted drug is actually cheaper.  This survey has identified serious sequellae to this business practice such as adverse reactions, poor recovery rates and worsening of chronic conditions.

The trickle-down-effect of these business practices, in addition to the physical effects on the patient, involve basic economics.  Physician practices have to spend more time in communication with the insurer, the patient and the pharmacy trying to address the problem, taking time away from patient care with n0 compensation (up to 60 hours a week in some practices according to the Maryland MedChi survey).  Some busier practices have had to hire experienced medical professionals (up to $75,000/year salary) simply to intervene with the insurers for pre-approvals and authorizations.  Additionally, patient adverse outcomes and/or worsening of chronic conditions often lead to hospitalizations, time off work, and even job loss.  This seriously affects work production, family income, and in some cases, can lead to permanent disablility placing additional strain on the already over-burdened Medicare/Medicaid system.

How Did this Happen in the First Place?

My question is, how did businessmen get into the practice of prescribing medications?  After all, physicians have spent 4 years in undergraduate programs, 4 years in medical school, and 3+ years in residency and sometimes 1+ years in fellowships to learn medicine and pharmacologic interventions.  These businessmen have perhaps spent 4 years as business majors (not a lick of medicine) and maybe 2 years in a Masters of Business program (still no medicine) in order to dictate what medications an ill patient is taking?!  So, when did these businessmen get their degree to prescribe?  Essentially, that is what they are doing!  And for all of our kicking and screaming, it is still going on in 49 states and the District of Columbia.

The Louisiana “Purchase” Law

The state of Louisiana has led the way in fighting this trend; they passed legislation last year prohibiting the insurance companies from switching medications once they are prescribed.  Currently, New York, California and Missouri have legislation pending that would prohibit this practice, as well.  More states need to advocate for their citizens with regard to such practices; it would also help the physicians and other mid-level providers who prescribe medications provide effective patient care.  The anticipated physician shortage (124,000 less providers nationally by 2025) can only worsen as physicians threaten to retire early, sell their practice or move to other more physician-friendly states (not to mention the move to “boutique medical practices” that would bypass insurers completely) due to dissatisfaction with the profession.  The general public needs to be calling, emailing or writing letters to their legislators to advocate for these changes!  ”Mayberry” may never exist, but we can make the system better for everyone.

What’s your story?  Has this happened to you or someone you know? What can be done about this?

Image from maliasmiles.com

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Chronic Pain

Thursday, December 2nd, 2010
We are very pleased to introduce a new guest blogger to our readers – Kaye Miller, R.N. Kaye has had a long, illustrious career in various fields of nursing (OB/GYN, Labor and Delivery, Nursery, Neonatal Intensive Care – to name a few). She is currently working as a nurse in a cardiac catheterization lab in Kentucky. In addition to her clinical work, Kaye Miller is a member of the National Alliance of Certified Legal Nurse Consultants and the principal owner of North Star Legal Nurse Consulting.

Kaye brings a fresh new approach to Eye Opener. While our firm’s members have been practicing in the field of medical negligence litigation for decades, it is exciting for us to have someone, who actually gives care to patients in the real world of medicine, periodically provide insights and knowledge to you, our readers,  on matters that may affect your daily lives or the life of someone you know and love.

With that said, we present Kaye’s initial blog for Eye Opener - a topic that affects many people every day of their lives – chronic pain.

Chronic Pain
by Kaye Miller, RN, CN-III, CAPA, CLNC

Intractable or chronic pain was once a condition an individual simply had to learn to live with. The economic, psychosocial, and physiological effects of chronic pain are far-reaching. Medical advances in pain control management can now afford patients complete or partial relief of their pain in lieu of invasive surgical procedures. When given an informed choice, many people prefer this more conservative route of therapy.

Epidural steroid injections, facet and medial branch blocks, and stellate ganglion blocks are a few of the options that can be life savers for patients suffering the consequences of chronic pain (lasting more than 3 months). The procedure may be done under local anesthetic or with the assistance of IV sedation. When aided by fluoroscopy (specialized x-ray), the medication can be directed at the site with reduced risks/complications. Undesirable side effects can include:

  • Increased pain
  • Elevated blood glucose
  • Loss of function in the extremity or extremities
  • Temporary weakness/numbness from the neck down
  • Loss of bowel or bladder control
  • Infection
  • Nerve injury
  • Reaction to medications
  • Hematoma (bleeding)
  • Pneumothorax (collapsed lung)

The procedure is usually performed by an anesthesiologist or radiologist. Anesthesiology is a highly skilled, and many times overlooked, discipline in the medical field; a topic I will address at a later time. Injections are usually done in a series of three in order to achieve optimal outcome. Positive effects may start to present immediately after the first treatment or may not appear until the series is completed.

As with any medical procedure, it is imperative the patient is forthcoming regarding medical history. This includes a list of present medications as well as use of other drugs, legal and illicit. One should not discount the effects of herbs and over-the-counter medications as harmless and not worthy of mentioning to the health care provider. Make sure you do so.

One anesthesiologist estimated that 50-60% of his patients were in his clinic for less than honorable aspirations. For this type of patient, the pain goes much deeper…deeper than any pill or injection the health care facility can provide.

If you are truly suffering from chronic pain, consider discussing treatment alternatives with your physician. Be aware of the risks, benefits and alternatives and make a wise, informed choice.

A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?

Friday, October 22nd, 2010

This week’s press release by the US division of the German based Boehringer Ingelheim pharmaceutical company is certainly a breakthrough for patients. The company announced the FDA approval of their drug Pradaxa (dabigatran etexilate). This is the first new oral anticoagulation drug approved in the US in more than 50 years.The drug was approved for stroke and systemic embolism prevention in people who have atrial fibrillation not caused by a failing/defective heart valve.

The press release touts impressive results. National studies have shown when Pradaxa 150mg was taken twice daily, there was a 35% reduction in stroke and embolism when compared with the traditional drug known to most as Coumadin (Warfarin). In addition, at the same dosing level both types of stroke (embolic/clot and hemorrhagic/bleeding) were greatly reduced when compared to Coumadin. More good news for patients taking the drug…

  • Very few drug interactions,
  • No more dietary restrictions, and
  • No more routine blood testing and dosing changes as required when taking Coumadin.

WHAT IS ATRIAL FIBRILLATION AND WHY DO YOU NEED TO TAKE BLOOD THINNING DRUGS?

Atrial fibrillation is a heart rhythm disorder caused by a malfunctioning electrical conduction system within the heart – see video.  It is usually identified by an irregular rapid heart rate that begins in the upper heart.The smaller 2 upper heart chambers, known as the atria, begin to contract quickly and in an irregular fashion. As electrical signals leave the atria and enter the 2 lower heart chambers known as the ventricles, they too begin to contract quickly and in an irregular fashion.  This irregular and rapid heart rate is unable to pump the blood through the heart and out to the body in a strong, efficient manner. Thus blood can pool in the heart and the lower extremities allowing clots to form. These clots dislodge and travel to the heart, lungs, and brain leading to a stroke. Therefore it is important to prevent the clots from forming by correcting the abnormal heart rhythm,  and by lowering the blood’s ability to form dangerous clots.

The press release noted an estimated 2.3 million Americans have atrial fibrillation and the number is expected to increase to 5.6 million by 2050. A large US-based managed care organization used their data to show 95% of all persons with atrial fibrillation have no heart valve problems. Atrial fibrillation increased the risk of stroke 5 times, and is an underlying condition in 15% of all US strokes. Atrial fibrillation related strokes are twice as likely to be fatal or severely disabling when compared to strokes from other causes.

MedicineNet.com today reported recent studies by the New England Journal of Medicine and the American Heart Association found Pradaxa was also more effective in preventing clots in patients experiencing acute coronary syndrome. Sweden reports the drug can be safely used in conjunction with Plavix and Aspirin drug therapies.

WHAT ARE THE DOWNSIDES?

With the good news, comes the drug’s downside. The company is forthcoming in reporting Pradaxa when administered in 150mg doses results in a higher rate of gastrointestinal bleeding related complications when compared to Coumadin. This dose was reported to also cause an increase in adverse GI reactions such as dyspepsia, abdominal and gastric pain, GERD, esophagitis, gastritis, and ulcer. Importantly, in patients older than 75 years of age, the risk of bleeding complications may be greater than Coumadin. Also noteworthy is the finding that the risk of myocardial infarction was greater in studies with patients taking the 150mg dose than those taking Coumadin.

The company warns patients taking other blood thinners, non-steroidal anti-inflammatory medicines, St. John’s Wort, and any drug that can cause abnormal bleeding reactions need to be avoided. Over the counter medications are included in this warning. The company’s public package leaflet notes the drug will interact with Amiodarone and Verapamil and Pradaxa dosing will need to be reduced. The drug may also affect the liver but not more then Coumadin. It is contraindicated in patients who are in kidney failure, liver failure, and pregnancy. Some report a Quinidine interaction.

The FDA has approved dosing in capsule forms of 75mg and 150mg twice a day. Those persons taking larger doses of 150mg need to be fully informed of the above possible complications before switching from Coumadin to an easier life with Pradaxa.

EASIER TO LIVE WITH, BUT WHAT WILL IT COST?

It will take 3 to 6 months before distribution begins and pricing is not known. As with any new drug introduced in the US, speculation is the cost will be just short of prohibitive. Canada Pharmacies online sell Pradaxa 60 capsules both 75mg and 150mg doses at approximately $350.00 each. Generic Coumadin 100 pills at variable doses sell for approximately $34.00 to $50.00. The high drug price for US patients may offset the life style improvements for many who pay out of pocket for drugs. It is not known if prescription drug plans will approve partial or full payment for the drug.

It is generally reported that Coumadin is not a popular drug. Consumers and physicians alike resound with the same low opinion of the drug.  It is a difficult drug for physicians to manage, and it has a great impact on quality of life for patients. If Pradaxa continues to show its improved lifestyle value with no hidden serious side effects, patients will be the winners. Hopefully over time competitors will surface and prices will be driven into an affordable range for the growing US atrial fibrillation patient population.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Related Post:

Follow-Up Blog: Important Questions and Answers on Pradaxa

Bone-Strengthening Drugs and Esophageal Cancer – Potential Link Should Not Be Ignored

Monday, September 6th, 2010

In the last year, there has been considerable debate about the link between bone-strengthening drugs, also known as bisphosphonates, and esophageal cancer. It started last year when the FDA released information regarding nearly two dozen cases of esophageal cancer in patients that have been taking oral bisphosphonates such as Fosamax. According to Diane Wysowski, PhD, the FDA official who first claimed that there may be a link between bisphosphonates and esophageal cancer, the FDA has continued to receive reports of esophageal cancer in patients on bisphosphonates since 2009.

The FDA’s announcement was followed by the release of a research study of more than 80,000 people, which focused on the link between bisphosphonates and esophageal cancer. The study, which was recently published in the Journal of the American Medical Association, claims that the link between bisphosphonates and an increased risk for developing esophageal cancer is insignificant.

“[Researchers] compared the rates of esophageal and stomach cancer in 83,652 people, half of whom had received at least one prescription for oral bisphosphonates in the previous decade. Just over 80% of the participants were women, and the average age was 70. … Eighty-nine and 92 cases of esophageal cancer were reported in the bisphosphonate and control groups, respectively, as were 49 and 57 cases of stomach cancer—a negligible difference.”

The authors conceded, however, that the study was not perfect.  For example, the study lasted for only 4.5 years, an insufficient period of time to measure the risk of esophageal cancer among patients on bisphosphonates.  Researchers were also not able to insure that all of the study participants actually took bisphosphonates as prescribed. Additionally, they did not account for other comorbidities and risk factors that might increase the risk for esophageal cancer.

According to Chris Cardwell, PhD, the study’s lead author: “Our study is the largest to date, but on the basis of our results we cannot rule out small increases in esophageal cancer risk in individuals taking bisphosphonates.”

A more recent study on the same subject was published last week in the British Journal of Medicine.  This study concluded that that there is an increase in the incidence of esophageal cancer among patients who have been taking oral bisphosphonates for several years (ten or more prescriptions or prescriptions over the course of five years).

“Researchers tracked almost 3,000 people with cancer of the esophagus or throat for eight years and compared them with a group of 15,000 people who did not have the disease. All were over age 40. The scientists found that 90 of the cancer patients had been prescribed the bone-building drugs, while 345 people in the larger group were taking the medication.”

According to this latest research study, the normal incidence of esophageal cancer among patients 60-79 who are not on oral bisphosphonates is about one per 1000. In the same age group, researchers found that the incidence of esophageal cancer doubled among those patients that have been on oral bisphosphonates for several years. It is suspected that bisphosphonates cause inflammation of the esophagus that may predisposes the patient to esophageal cancer.

Both of these studies seem to indicate a positive correlation between oral bisphosphonates and esophageal cancer.  Whether or not the correlation is significant is a determination the patient should be making with his or her physician.  The risk for developing esophageal cancer should not be ignored considering the number of people who take oral bisphosphonates on a regular basis. It is estimated that about 10 million women are diagnosed with osteoporosis in the U.S.  In this population, about 4.7 million take oral bisphosphonates on a regular basis.

If you have been taking oral bisphosphonates for five years or longer, discuss the risk of developing esophageal cancer with your physician and explore available alternatives if you are at risk. More important perhaps, be on the lookout for signs and symptoms consistent with esophageal cancer. They include throat, chest and digestive discomfort as well as difficulty swallowing.  If you have these symptoms, consult a physician immediately.

Contributing author: Jon Stefanuca

Drug information found lacking

Thursday, August 19th, 2010

Millions of people take daily or weekly medications for a variety of health concerns.  As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc.  The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.

Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications:  lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet).  The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability.  The reason for these variances?  Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not.  The FDA only provides recommendations for leaflets.  Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.

The differences found by Dr. Kimberlin were striking.  Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet.  Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria.  Only one leaflet for metformin met this same criteria.  The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.

While the differences in content were significant, the study found that even greater differences existed in readability.  It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons.  All of this can make deciphering these leaflets even more difficult.

In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.”  For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.

The bottom line – carefully read the product leaflet that comes with your prescription.  And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly.  You may not be able to rely on the information contained in the product leaflet.


Stevens-Johnson Syndrome: one mother’s plea to ‘get the word out’ and one son’s story of horror.

Sunday, July 25th, 2010

Last week I wrote a blog based on a report in USAToday about how many doctors and parents – primarily the latter – are likely to avoid giving their children pain medication when it’s prescribed and needed.

Within minutes of posting this piece, I received a reply on Twitter from a woman who seemed to take exception to the blog or at least wanted me to be aware of the potential dangers of using pain medication in children. Specifically, she wanted me to be aware of what had befallen her son after he had taken Motrin – he was stricken with a horrible condition known as Stevens-Johnson Syndrome.

After communicating back and forth with her that day and going to her blog about her son’s coming home from the hospital following his treatment, I asked her if I could use her son’s story as the nucleus for a blog on Stevens-Johnson Syndrome and how medication can be a cause for this potentially fatal problem. She told me this would be fine since she wanted to get the word out about Stevens-Johnson Syndrome and the role medications can have in its development.

What is Stevens-Johnson Syndrome?

Rather than paraphrase the experts on what this syndrome is, here’s how the Mayo Clinic defines it online.

Stevens-Johnson syndrome is a rare, serious disorder in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

Stevens-Johnson syndrome is an emergency medical condition that usually requires hospitalization. Treatment focuses on eliminating the underlying cause, controlling symptoms and minimizing complications.

The authors then note that it can take “weeks to months” to recover from Stevens-Johnson Syndrome. If it’s determined that it was caused by a medication, then “you’ll need to permanently avoid the medication and all others related to it.”

What are the risk factors?

While Stevens-Johnson Syndrome (SJS) is a rare and unpredictable condition, certain factors can increase a person’s risk to suffering this complication: viral infections (such as the common cold), HIV and systemic lupus erythematosus (SLE) – relative compromises of the body’s immune system. It is also reported that if you carry a gene known as HLA-B12, you may be more susceptible to SJS. Some claim that people of Asian ancestry are at increased risk if taking certain medications (Carbamazepine (Tegretol); screening for such special susceptibility is available, according to some reports.

How sick are people who suffer from SJS?

They typically require hospitalization in an intensive care unit. As mentioned, the treatment can take weeks to months.

How is it treated?

There is no known treatment other than supportive care in the form of fluid replacement, skin care and medications to treat the symptoms (e.g. antihistamines for itching, steroids for inflammation of your skin, pain medication and the like) and to prevent the progression of SJS by giving immunoglobulin intravenous (IGIV) therapy to improve and bolster the patient’s immune system.

What areas of the body are affected by SJS?

According to an article published on emedicine.medscape.com:

SJS typically involves the skin and the mucous membranes. While minor presentations may occur, significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes may develop in the course of the illness. GI and respiratory involvement may progress to necrosis. SJS is a serious systemic disorder with the potential for severe morbidity and even death (my emphasis).

What is Toxic Epidermal Necrolysis (TEN) and what is the difference between SJS and TEN?

SJS is often discussed in the same literature that relates to the another condition known as Toxic Epidermal Necrolysis (TEN). While there is some disagreement among those in medicine, a number of experts consider SJS and TEN to be expressions of erythema multiforme.  Often the conditions are commonly referred to as SJS/TEN. One definitional classification differentiates the two conditions in this manner:

  • Stevens-Johnson syndrome – A “minor form of TEN,” with less than 10% body surface area (BSA) detachment
  • Overlapping Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) – Detachment of 10-30% BSA
  • Toxic epidermal necrolysis – Detachment of more than 30% BSA

What are the causes of SJS/TEN?

While opinions vary, the causes are often listed as (1) infectious, (2) drug-induced, (3) malignancy-related, and (4) idiopathic (unknown). Some report that more than half the patients with SJS/TEN have had a recent upper respiratory tract infection.

What medications can cause SJS/TEN?

SJS and TEN are often associated with taking certain forms of medications: NSAIDS (non-steroid anti-inflammatory drugs -), Allopurinol, Phenytoin (Dilantin), Carbamazepine, barbiturates, anticonvulsants, and sulfa antibiotics (common examples - Septra®, Bactrim® and Pediazole®).

What race, sex and age groups are most affected?

Caucasian males between ages 20 and 50. (Source: emedicine.medscape). Needless to say, this group is simply identified as the most statistically likely to suffer from SJS/TEN. For example, the ratio is 2:1 for men; children as young as old as three (3) months of age have been diagnosed with this dreaded condition. Some claim that African-Americans and Asians are at increased genetic risk for SJS/TEN. One wonders – are these statistics really helpful in making a diagnosis?

What are the signs and symptoms of SJS/TEN?

Once again, relying on the experts at the Mayo Clinic, here is a list of some of the signs and symptoms:

  • Facial swelling
  • Tongue swelling
  • Hives
  • Skin pain
  • A red or purple skin rash that spreads within hours to days
  • Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
  • Shedding (sloughing) of your skin

If you have Stevens-Johnson syndrome, several days before the rash develops, you may experience:

  • Fever
  • Sore throat
  • Cough
  • Burning eyes

How many people affected by SJS/TEN die?

Mortality is determined primarily by the extent of skin sloughing. When BSA sloughing is less than 10%, the mortality rate is approximately 1-5%. However, when more than 30% BSA sloughing is present, the mortality rate is between 25% and 35%, and may be as high as 50%. Bacteremia/sepsis may also contribute to mortality. (See source)

What is the lesson, if any, learned?

Needless to say, this posting is not in any way intended to be a full-blown medical research article on SJS/TEN. Having heard this mother’s story of her son’s fight to overcome the ravaging effects of SJS, his continuing problems with scarring and her concern that such might befall some other parent’s child, I decided to simply “get the word out” on this little known but horrible syndrome.

Where does the answer lie on this issue of medications? How does one assess the risks versus the benefits of taking medication? I don’t purport to have the answers to these questions. Be aware of the risk; be aware if you are in a risk group; be aware of the signs and symptoms.

Seek immediate medical care if you believe you are having an adverse reaction to a medication.

While there is no magic pill or cure, immeidiate supportive medical management and care in a proper facility are essential to minimizing the ravaging effects of the syndrome. As noted by many medical authors, since SJS/TEN is such a relatively rare disorder, it is many times not diagnosed in a timely fashion. If you suspect that what you are seeing is SJS or TEN – even as a lay person – raise the issue with your treating physician. Remember – early, effective intervention is your best chance to arrest the progress of this horrible condition.

Many thanks to my new friend on Twitter, who brought this issue to my attention and let me use her son’s story to “get the word out.” Speedy and complete recovery to you, Andrew!