Saturday, November 27, 2010

On the issue of propoxyphene, pain control and drug safety

Terri Bernacchi, PharmD, MBA, Health Advisory Professionals
As a pharmacist in the 80’s, I did not have a great esteem for the drug Propoxyphene or its various combinations. I believed the drug to be nothing more than a weak narcotic with placebo-like analgesic benefits. The product was long held in disregard by the medical community in my periphery and was believed to be pretty harmless. Old ladies and malingering patients were offered it, every 4 hours, around the clock, to deal with levels of pain that the physician may have believed were benign, self-limiting or minimal. One problem with this attitude on the use of any analgesic drug is that there is a tendency by patients to increase their dosage when their pain becomes more severe. Unfortunately, this could result in addiction and even death, especially with elderly people or folks who like to drink alcohol.

Because the product was a cheap multisource option, it had become one of the most frequently used analgesics, especially the acetaminophen combination product (and the benefit of analgesia was often thought to be due to the acetaminophen component).  Propoxyphene containing products are estimated to have had 20 million prescriptions dispensed in 2007 in the US. Propoxyphene was introduced to the US market in 1957, before products approved by the FDA had to establish anything more than safety. The drug was banned by Britain in 2005, by Europe in 2009; that same year an FDA advisory committee recommended the removal of propoxyphene-containing products, but that recommendation was rejected by the agency which believed the product still had an acceptable risk-benefit profile at appropriate doses. The FDA ordered a study of the drug's effects on the heart by the manufacturer of the branded form (Xanodyne).

Recently (on November 19, 2010), in describing its reasons for asking the manufacturers to cease producing the drug, the FDA noted that even when patients took the recommended doses of these drugs, meaningful changes could occur to the electric activity of the heart, potentially resulting in sudden death. Specifically, “These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.” (See the FDA announcement at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm )

It is clear to me as I look backward to those years that the medical, nursing and pharmacy communities may lose perspective on frequently used drugs like propoxyphene. We may forget that what we ask the patient to do vis-à-vis dosing instructions and guidance on how to handle side effects may not actually be what they do when they go home. Instead, they follow predictable patterns of self-care and they may not understand the consequences of their actions when they increase the dose because the pain relief is inadequate. I’m not sure that it amounts to callousness on the part of the medical practitioner so much as the stickiness of the routine and the mundane in our daily efforts.
Although there were people trying to get the drug removed since 1978, it was not until the recently released study that a definitive decision was made. But it does give me a new respect for the potential for any drug----even those that we think are completely safe or even inconsequential----to cause harm.
Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets. The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago. She has both a BS and a PharmD in Pharmacy and an MBA.

Thursday, November 4, 2010

Impending FSA Change Rules by IRS Creates Interesting Contradictions in Logic

--By Anna Shepherd, Health & Personal Finance Professional
The government recently published new rules, effective at 2010 year’s end, that change what an FSA (Flex Spending Account) covers at the local pharmacy. They will no longer be permitted to cover over-the-counter medications such as pain relievers or cold medicine. My focus is on an article that involves the coverage of breast pumps and the bigger picture.

The NY Times article (see Link below) explains a strange irony in US tax law that allows acne treatment to be paid for by a pre-tax FSA or HSA, but will not allow breast pumps to be covered. Personally, I don’t understand why it makes fiscal sense to make it MORE difficult to self-fund health care expenses especially in this climate. And why would something so natural and so relevant to health care be explicitly excluded? http://www.nytimes.com/2010/10/27/business/27breast.html?src=busln

Well, I did some research and the best answer I found? Taxes. It can cost upwards of $500 for a pump and accessories and it appears that the IRS is worried about abuse which will reduce tax yield. Furthermore, the people that save the most are the ones in the higher tax brackets, aka the “wealthy”. That’s all, the bottom line.

Now, to avoid going into a rant about the inherent absurdity of letting the IRS decide that something mothers have done for millennia is “not medically necessary”, though I would really love to, I’m going to talk about the greater implications of this story.

To get around this inconvenience and still be able to purchase the soon-to-be excluded items, all you need is a doctor’s note. Not too hard, right? But why does it make sense to make someone have to make, and more importantly pay for, a doctor’s appointment to get an official doctor’s note to save money on aspirin, cough medicine, breast pumps and the like? You know you need these things to stay healthy; a doctor didn’t have to tell you that. Why would you force someone to enter into the system and jump through an extra hoop to get some very basic medical supplies? It is, plain and simple, a waste of time for all involved.

More importantly, I think the biggest implication in these new rules is what it means for the future of FSAs and similar plans. When health care costs per person are increasing at unsustainable rates, why wouldn’t you want to help people, any proportion of society really, help themselves? These accounts make sense! They make health purchases a reality connected to your own bank account rather than some abstract insurer. They force you to plan ahead and think about what is important in your health. BUT, as the Times article said, FSAs are slated to cost the government $68b (in tax revenues) in the next decade. And as I stated before, they are most beneficial to the higher earners. You do the math. I feel like this might just be the beginning.
   
PS: http://technorati.com/women/article/irs-refuse-tax-break-on-breast/
I couldn’t resist mentioning this: As this blog on Technorati indicates, the IRS deems baby formula a “necessary expense” for mothers on the WIC program (a USDA nutrition program for Women, Infants and Children). The government spent over $200m in 2009 to subsidize it. Irritating anomaly, no?

Tuesday, November 2, 2010

Is Shared-Decision-Making Compatible with Current US Medical Delivery Models?

By---Terri Bernacchi, PharmD, MBA, Health Advisory Professionals
Based on the title of this log entry, you already understand the premise of this debate. The current US Medical Delivery Model is probably not ideally tuned into the concept of Medical Shared-Decision-Making. At its root, this philosophy involves a patient who is actively, rather than passively, involved in driving his own treatment. It implies that the patient (and family members theoretically most affected by his health) has enough information about the options available and the consequences of his own behavior on successful outcomes.

Surprisingly, perhaps, the discussion of these concepts in the literature is just beginning to mushroom, but the patient and his or her active compliance has always been the 800 lb gorilla in the room. Ask any cardiologist what the most important variable in a patient’s outcomes, and he is likely to tell you that it is the patient himself. How much salt; how much exercise; how compliant is he with necessary medications and diet?


While it’s amazing to me that this has taken so long to be center-stage in health care, our financial realities may the primary driver for why it will finally happen. Shared decision making is now a topic of global concern as individual governments face bankruptcy and austerity world-wide. To be sure, in those countries where the government funds all or most of the health care cost, the common sense reality that is sinking in is for reformation starting with how the patient himself figures into the system.

For example, the recent debate over this concept in the United Kingdom within the NHS has centered on reluctance on the part of clinicians to offer a choice (see October 22 blog). The British government is undertaking reforms as part of wide-ranging changes due to be implemented in early 2011, with a renewed emphasis on joint decision-making by patients and healthcare professionals. (See the recent article in the Irish Times by a medical doctor, Muiris Houston, discussing the debate: http://www.irishtimes.com/newspaper/health/2010/1026/1224282000782.html )

One downside is the time it consumes. After all, it takes precious time from the doctor-patient interaction to discuss the alternatives---and it is hard to think about how to squeeze more time out of a day, without adding a lot more cost. And even with that, there are some patients that want the doctor to make all the decisions about what is best for them.

The same is true in the US, where the business model of the medical practitioner centers on how to treat an acute disease, provide preventive services such as vaccinations and monitor vital signs, adjusting medication, diet, and exercise programs to delay chronic disease. The patient (or more commonly, the health plan) pays for the service and the doctor moves through the day like a conveyor belt, seeing patients, making decisions, and filling out paperwork.

The article in the British Medical Journal suggests that least three factors are critical to boost shared decision-making to its place as centerpiece of clinical practice:  
  1. ready access to evidence-based information regarding;
  2. clinical guidance on how to rank the options;
  3. a supportive clinical culture that facilitates patient engagement.
My position on this is simple: The first three things are possible now more than they ever have. The #3 factor is coming, albeit slowly, but is being forced by the economic tsunami we are facing with our aging populace.

I would add a fourth factor: someone besides the primary clinician (who stands to gain financially each time a visit is made, a test ordered, or a surgery performed) needs to be available to talk frankly to the patient about his circumstances----helping to objectify the decision and weight the factors that are within the control of the patient. This advisor MUST NOT be involved in the recommendations nor the path chosen (and therefore cannot be paid by the insurance company to contain costs or the doctor’s office, to promote procedures). The patient can see his advisor on his own terms, referred by friends, the health plan or the doctor. But it is the patient’s own decision that is the critical path.

This is the basis for the evolving business model promoted by Health Advisory Professionals, LLC -----seeking a future state where the empowered patient understands the options and consequences and makes rational decisions based on what is right for him or her, as only he or she can know. 
Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets. The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago. She has both a BS and a PharmD in Pharmacy and an MBA.