Sunday, March 30, 2014

A Lemon Law for Medications?

I always hear about expensive medications and what a racket that is for Big Pharma.  A recent exacerbation of asthma was an eye opener for me.  I have had to discard a lot of medications prescribed for me in the past because they either were not indicated (like an antibiotic for cellulitis when I really had gout) or medications that I thought were too risky (they shall remain nameless).

I posted some of my experiences with medications taken for asthma.  Over a two month period I took oral prednisone in addition to corticosteroid inhalers and beta agonist bronchodilators.  All of the medication was only moderately effective over a two month period and this necessitated switching between different preparations.  It also involved discarding some after only one or two doses due to intolerable side effects.  That trial and error came an a high cost.  Like most employees these days I have a high deductible health insurance plan.  That deductible is $3,000.  The final tab between the dates January 20, 2014 and February 25,  2014 was $3,000 out-of-pocket.   So I guess the good news is that I met my deductible for this year.

The drug costs are instructive. Some of the inhalers retail for $500 apiece. The out-of-pocket costs for a high deductible insurance plan varies from $50.65 to $251.03. The total out-of-pocket drug cost for one month of treatment for asthma was $1,284.92. The most important part was that about half of that cost was for medications that could not be tolerated or were ineffective and had to be discontinued ($565.72). This is a form of cost shifting that nobody ever talks about. I have over $500 worth of medication sitting on the shelf and ready to be discarded because it was ineffective or could not be tolerated. When I think about how many times I have prescribed a medication for a patient only to have the PBM fax me to say that they would only fill 90 days worth of the medication, I wonder about how many tens of thousands of these prescriptions are sitting out there unused.

What about really expensive medications? Some of those are about the equivalent in cost to a new car or several new cars. To give two examples of medications I recently learned about consider Olysio (simeprevir) and Sovaldi (sofosbuvir) new drugs for hepatitis C. Sofosbuvir costs $954.90 for a 400 mg tablet or a full course of therapy for $35,000 - $70,000. Simeprevir is $753.37 for a single 150 mg capsule. I have already read the cost-benefit analyses of theses medications and like most analyses of very expensive medications they seem justified. What happens when you take a very expensive agent like this and it is ineffective or you can't tolerate the side effects? Medicine may be the only area in American life where the customer underwrites the product cost no matter what. What other product works like that? Lemon laws protect car purchases. If you buy a new house, as part of that agreement you either sign an arbitration agreement or you are free to sue if something happens to that house. Most big ticket item retailers have return policies. With medications you are often left with an unused bottle staring at you from the medicine chest and reminding you of what it costs. It probably takes on a lot more importance now that the average employer plan leads to very high out-of-pocket costs.

I don't mean to imply that any of these products are ineffective.  My thoughts on what the FDA does in terms of drug approval are recorded here in this blog.  This all has to do with biological variability and balancing Type I versus Type II error.  Some of the medications I could not tolerate work exceedingly well for other people.  Some of the medications I take are toxic to others.  There are no medications that work well with minimal side effects across the entire population.

Is there a solution to this problem?  I think there is a very straightforward one.  Give the pharmacist the option of supplying a smaller portion of the prescription for the patient to test.  For example, a week of pills or an inhaler with a week of inhalations.  That would have saved me nearly $400 in unnecessary costs.  The environmental costs are also unknown.  There has only been recent interest in what happens to discarded pharmaceuticals when they enter our waste disposal systems and waterways.  That cost is currently unknown but needs to be considered.  This post also highlights the difference between biological products like prescriptions and non biological products like cars.  If a car is a lemon, that is independent of the biology of the owner.  Whether a prescription drug is a lemon or not is solely determined by biology.  

As the cost of health care is shifted back to the consumer, the financing needs to  be like any other expensive consumer good.  That would include some safeguard of value for the money.

George Dawson, MD, DFAPA


  1. Rx samples had their abuses, but they also had their benefits. I have seen sample inhalers with a small number of doses. Also, back in the day, doctors would write a script for a weeks supply of meds and one for maintenance doses to be filled if the trial week went OK. However, I am not sure how that works out today with electronic Rxs and insurance being what it is.

    A side note on electronic Rxs. I recently had my levothyroxine changed and for the life of us (endocrinologist and I) we could not figure out how to get the Epic system to accept the instructions. There was a text limit on the instruction field, but it also seemed to be choking on the number of doses. The doctor said she'd just used canned text of 'Take 1 tab QD' and add 'Take a total of 9.5 tabs a week' and let the pharmacy call her. At the pharmacy, the pharmacist sat me down to discuss the instruction change, read the label and said "I have no idea what this means". I told her that it meant take 1 tab daily with an extra one on Tues/Thurs and an extra half tab on Sunday. And then she said "As long as you know what it means, I am fine with it".

    I love all things computer, and I really think EMRs could be a good thing. Yet, when I look at how they are being implemented, I know that those working on the software have no idea what they are doing.

  2. Agree with you on the samples but doctors and clinics have no business dispensing them. In the last clinic I worked at with free samples, it took on the average another 20-30 minutes to figure out whether we had the medication, packaging it, and writing down the lot numbers, etc. In many cases we had to be in constant contact with drug reps to keep certain samples in stock. And of course the biggest problem was people who would get an entire months supply in samples because that was their only source of medication.

    On the other hand, I agree with you - the sample lost did contain inhalers with just one week of puffs and they would work perfectly for this implementation.

    Very familiar with the EHR implementation problems. I can recall one iteration of the EHR where the pharmacy interface was totally changed. I am surprised QD was canned text since most systems don't allow it. For the past 3 months I have tried about 6 times without fail to get 75 - 3 ml ampules of albuterol and no matter what I try only 75 ml or 25 ampules comes out of he system. The human factor that used to be able to correct these errors has been taken out of the system.

  3. You do bring back memories. I was aware it was difficult for staff to record lot #s and dates of samples, yet from pharmacy's viewpoint it was the fact that outdated meds were being handed out that was the biggest problem [besides the drug rep influence or any rare recall]. I am sure I spent a year's worth of time in my dozen or so years as a pharmacy tech, checking expiration dates for meds stored all over the hospital and in the clinics. I recall frequently saying I had to make it to heaven, because in heaven, there are no outdated meds.

    I owe you a correction. QD was my abbreviation used in writing my comment; hard habit to break. I honestly do not know what my doctor typed as 'daily' was already displayed when I saw her struggling with the directions.

    Your ampule example makes me sad.