----Terri Bernacchi, PharmD, MBA, Cambria Health Advisory Professionals
I don’t really think it’s this simple, of course, but since New York Mayor Bloomberg believes in the soundness of his recent decision to outlaw large soft drinks within the walls of his kingdom for the benefit of those (like me) without prudence or self-control, I thought it would be interesting to at least pose the question. Patient compliance with medications is frequently only around 50%; this is a well-documented fact. And the reasons for the non-compliance or non-adherence are as varied as the subjects of the study.
Do we forfeit our liberty to be willful and uncooperative (either by drinking Big Gulps or not getting our prescriptions filled) when others must contribute to the actual costs of our own health care?
The article linked to this discussion recognizes the truth that people often don’t get their prescriptions filled. http://articles.sun-sentinel.com/2012-04-08/health/fl-hk-skipping-medicines-20120406_1_drug-costs-cvs-caremark-drugs-for-chronic-conditions
There are a number of reasons that people do this---and it’s not just because they are obstinate rascals. They don’t get the prescription filled because a) they know it won’t work, b) don’t like the side effects c) don’t want to spend the money, d) they don’t have the money (different than option c), e) they already have a whole stock of that drug at home in the medicine cabinet that they didn’t take last time either, f) they don’t believe that the drug was necessary because their problem is going to resolve quickly and g) other reasons.
However, the system costs of medication non-compliance are well documented. The non-compliant patient is more likely to have costly medical complications. In addition to the obvious higher costs, there are some additional questions that this story raises:
- Buried in the story is this sentence: “Employers and insurers have grown so concerned about the costs of drug skipping that the credit-rating service FICO now offers a service to estimate the likelihood an employee or patient will take medicine correctly.” I think about whether I would want someone to rate my compliance in the same manner as my credit score. That seems a bit too “judgmental” and invasive. I wonder what others think about that. Here’s a link to that offering: http://www.fico.com/en/Products/Scoring/Pages/FICO-Medication-Adherence-Score.aspx
- I wonder how the effects of “electronic-prescribing” “ERX” will change the dynamic of physicians sending a prescription which the patient will never have filled. If the doctor KNOWS that the patient does not get the prescription filled, will it change the patient’s behavior? How will the doctor react when he/she finds out the patient never picked it up or rejected it? One of the benefits of ERX in the professional literature is the fact that if it is electronically sent, it is much more likely to be dispensed. According to Surescripts, “Research shows that 20% of prescriptions never even make it to the pharmacy. A study conducted by Walgreens and Surescripts showed that once a practice starts e-prescribing, 11 percent more of their prescriptions get dispensed.” http://www.surescripts.com/about-e-prescribing/benefits-of-e-prescribing_for-pharmacies.aspx
- The FDA is looking (again) at designating some drugs as a third category, potentially available without a prescription. How will such a new category be impacted by this compliance concern/trend? What will their health coverage be? See well-written analysis here: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/02/on-again-off-again-third-category-of-drugs-is-on-again-at-fda-simultaneous-rx-and-otc-marketing-also.html
Of course, I am just scribbling my thoughts and opinions on this matter in a blog posting. The questions are provocative and the answers are not necessarily clear-----it is my hope that we don’t let the discussion go by the wayside. The way in which we attack the problem of therapy compliance may have unintended consequences in terms of our freedoms and on care quality. We need to embark on the next steps with eyes wide open.
Terri is the founder of Cambria Health Advisory Professionals. Among her current clients: a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders, a small special needs health plan as a 5 Star Consultant, and several other health related clients. The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Health Advisory Professional 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.
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.
