Mission Accomplished: Noncompliance Bites Dust
Little did I suspect when I began my routine daily scan of scientific, news, and commercial reports pertinent to patient compliance that I would be reading about the imminent demise of healthcare noncompliance, my central professional interest for the past several years.
The opening sentence of Science sinks its teeth into 2500 year-old drug problem, a story in the 15 January 2008 online edition of Science Centric, provides the basic information, albeit a tad obliquely.
A new prosthetic tooth that releases a controlled dose of medication at regular intervals may achieve a goal that has eluded doctors for 2500 years: finding a way to help patients follow treatment.
The introduction’s subjunctive voice (“may achieve”) and generic quality (“help patients follow treatment”), which finesse the issue of claims being made for this device and preclude accusations of overstatement, dissipate by the final lines of the article, giving way to a more positive and, eventually, a fully triumphant timbre.
If successful, it could revolutionise treatment. The device can be applied to any drug, and Dr Beiski sees applications for hypertensive patients to combat morning increases in blood pressure. Chronic pain, diabetics and Alzheimer’s patients could benefit, too, making it an attractive system for patients and doctors.
For pharmaceutical companies, it is even more attractive, offering the equivalent of patent protection for generic drugs using the system. The combination would be protected by IntelliDrug intellectual property.
But perhaps most important of all, it will mean, finally, an end to the 2500 year-old patient compliance conundrum. [Emphasis mine]
Well, that’s that. Clinicians no longer have to worry about nonadherent clients. The patient compliance research projects can start winding down, the pharmaceutical companies can end their medication reminder programs, and all those electronic gadgets that track compliance and set off bells, whistles, lights, sirens, email messages, or fireworks to signal that it’s time for a medication dose can be consigned to eBay.
Perhaps I can reorient AlignMap.com as as a nostalgia site with a spiel along the lines of this:
You kids may not know this, but once upon a time, some patients didn’t automatically take their medication as instructed – back in the old days, we called that “noncompliance.” That’s a funny word, isn’t it? But all that was before everyone had a prosthetic tooth that releases a controlled dose of medication at regular intervals.
And, after the wizards responsible for the prosthetic tooth that will end 2500 years of patient noncompliance have that issue under control, maybe they can take a crack at perpetual motion or world hunger or existential angst or …
But before that, let’s take a look at that tooth, or as I like to think of him -
Marshall Molar, Medication Modulator
The article first establishes its credentials by quoting both Hippocrates and Koop on compliance, noting that standard but misleading statistic that “studies indicate that up to 50% do not take their medicine,” and listing a number of negative consequences of noncompliance.
Information about the medication-packing tooth itself follows the introduction:
IntelliDrug, a project funded by the European Commission, has developed a system that delivers controlled drug doses at appropriate intervals, keeping the dose delivered within the exact therapeutic window. Better yet, it is easy to maintain and requires no invasive procedure.
The answer to the 2500 year-old compliance conundrum? A prosthetic tooth, just two molars in size, containing a reservoir, valve and programmable timing controls. It can even be controlled by infrared, which allows doctors to adjust doses during the course of treatment. Ultimately, it could allow patients on pain medication to self-medicate, if necessary.
That device looks something like this model.
Heck, I’m impressed already – and I’m curious about the technique they use to remove two molars from the patient’s jaw and install that prosthesis with its ersatz tooth cover without resorting to an invasive procedure.
The article also discusses the increased bioavailability of the drug caused by passing it through the buccal tissue.
IntelliDrug’s Operative Mechanism
Excerpted from Science sinks its teeth into 2500 year-old drug problem:
Here is how it works. The micro-system contains a reservoir and release mechanism; a programmable circuit, micro-sensors, an infrared sensor, micro-actuators and batteries. All housed in a tiny package. The circuit acts like a miniscule computer, releasing the dose required at the right time.
Ultimately, the batteries should last three months. Refilling the reservoir would vary, depending on the type of drug and dosage, but could range from every week to every month.
A more complete rendition of the process is provided by Gizmag:
The dental prosthesis consists of a drug-filled reservoir, a valve, two sensors and several electronic components,” explains Dr. Oliver Scholz of the Fraunhofer Institute for Biomedical Engineering IBMT in St. Ingbert, where the sensors and electronics were developed. Saliva enters the reservoir via a membrane, dissolves part of the solid drug and flows through a small duct into the mouth cavity, where it is absorbed by the mucous membranes in the patient’s cheeks. The duct is fitted with two sensors that monitor the amount of medicine being released into the body. One is a flow sensor that measures the volume of liquid entering the mouth via the duct, while the other measures the concentration of the agent contained in the liquid. Based on the measurement results, the electronic circuit either opens or closes a valve at the end of the duct to control the dosage. If the agent has been used up, the electronic system alerts the patient via a remote control, which was also developed at the IBMT. This control permits wireless operation of Intellidrug, and can be used by the patient or doctor to set the dosage required. The patient has to have the agent refilled every few weeks. This could be done using a deposit system whereby the patient swaps the empty prosthesis for a newly refilled one. At the same time, the battery could be replaced and the device could be serviced,« says Scholz.
According to the piece, IntelliDrug, which could be applied to any drug, could be on the market in three years. On the other hand, a poster I downloaded just now from the IntelliDrug Project Site confidently asserts that “The prototype will be ready and tested by the end of 2006. It is expected that in 2007 the device will be available on the market.”
Just A Few Questions
For the sake of this post, let’s assume the tooth works perfectly. After all, it’s just “a reservoir and release mechanism; a programmable circuit, micro-sensors, an infrared sensor, micro-actuators and batteries. All housed in a tiny package.” What could go wrong?
Even so, questions arise. A representative but not exhaustive list follows:
- How much will the IntelliDrug appliance, its installation, and its ongoing operation cost?
- Who will pay that bill?
- Really? Which insurance company?
- If the candidate for the IntelliDrug doesn’t happen to have a handy two molar sized space in his or her jaw, is the plan to remove two healthy teeth – noninvasively – to make room for the device?
- What percentage of patients, according to the studies those folks on IntelliDrug must have done, will agree to have their medication compliance enhanced through installation of the bionic molar medicator, let alone endure the removal of two teeth if that is necessary?
- If we all think real hard, is it possible that we might come up with an alternative or two that might cost less, be less traumatic, and give the patient control of his or her own body?
Another Solution
IntelliDrug seems a legitimate, scientific project that could have an impact in some cases in which medication noncompliance is too dangerous or too costly to risk and the patient is cooperative.
Transforming an expensive potential tactic to improve adherence among a relatively small group of individuals into “an end to the 2500 year-old patient compliance conundrum” makes the project seem a joke and leads to mistrust of any future claims of effectiveness, however reasonable they might otherwise be.
My recommended solution to this problem follows:
Don’t make ridiculous claims for a
compliance-enhancing device or program
Update
Some time after completing this post, I discovered that the Science Centric article, dated 15 January 2008, I first read this morning is actually a virtually unchanged copy of a report released 18 Oct 2007 by ICT Reports, which describes itself thusly, “The ICT Results service was developed in 2003 for the European Commission’s Directorate-General Information Society and Media. It changed names in 2007 and is now operated by a consortium with experience in research, editing, communication and marketing services, led by ESN and partners Assystem. ICT Results features online news and analysis on the emerging results from information and communications technology research. It reports on prototype products and services ready for commercialisation, as well as work in progress and interim results with significant potential for exploitation.”
So much for the “breaking news” angle. It seems the solution to medication adherence was announced three months ago, but I didn’t notice the change.
I must have been distracted.
__________
An Introduction To AlignMap In Cites
AlignMap In Cites is a new tumblelog I’m auditioning as an augmentation to the AlignMap web site and weblog.
For readers who are in the adult, non-geek population, the Wikipedia definition of tumblelog is provided below:
A tumblelog (or tlog) is a variation of a blog that favors short-form, mixed-media posts over the longer editorial posts frequently associated with blogging. Common post formats found on tumblelogs include links, photos, quotes, dialogues, and video. Unlike blogs, tumblelogs are frequently used to share the author’s creations, discoveries, or experiences while providing little or no commentary.
It may also be helpful to think of AlignMap In Cites as the quicker, less obsessive, happy go lucky younger sibling of the curmudgeonly, prolix, and sometimes abstruse AlignMap Weblog.
Both the design of tumblelogs described above and Tumblr, the software that powers AlignMap In Cites, make posting a link to a site, such as an online abstract or text, the home page of a compliance-enhancing product, or another blog covering an aspect of adherence, a quick, easy process. Posting a link to web site X can be accomplished without leaving web site X.
The ease and speed of posting makes this process ideal for pointing to items that require little or no explanation beyond, “Hey, look at this.” It’s not unlike mentioning to a colleague over lunch that he might be interested in a study on noncompliance of 50-60 year old males with hip fracture rehabilitation programs in the new issue of the New England Journal.
Although I just began posting to AlignMap In Cites this morning, I’ve been playing with Good Clean Wholesome Fun, the tumblelog sidekick for my personal Heck of a Guy blog, for four or five days and feel as though I’m getting the hang of the thing.
While I’m convinced this format is worth trying, I am not yet convinced of its utility. As I said, it’s a tryout, and you get free tickets to the dress rehearsal.
The first two AlignMap In Cites entries are online at
Source: Effects of a Behavioral Intervention on Antiretroviral Medication Adherence Among People Living With HIV: The Healthy Living Project Randomized Controlled Study
Johnson, Mallory O, PhD; Charlebois, Edwin PhD; Morin, Stephen F PhD; Remien, Robert H PhD; Chesney, Margaret A PhD. JAIDS Journal of Acquired Immune Deficiency Syndromes. 46(5):574-580, December 15, 2007.
The Study
The study examined the effect of a 15-session individually delivered cognitive behavioral intervention on the self-reported antiretroviral (ART) medication adherence of 204 HIV-infected patients. 3800 HIV-positive participants were randomly assigned to participate in the counseling program or not to participate in the program. Investigators focused on changes in adherence patterns among “low adherers,” that is, the 204 participants who reported at baseline taking fewer than 85% of their doses. The mean adherence of this group was between 60 to 65% and did not differ between the counseled and non-counseled group.
The Compliance Enhancement Program
The program consisted of 15 structured, individual counseling sessions, each of which explored environmental, emotional and behavioral aspects of risk-taking behavior.
According to Effects Of Adherence Support Programmes May Be Short Lived by David McLay, AidsMap, January 02, 2008, the intervention program included three Modules:
Module One (Stress, Coping and Adjustment) addressed issues surrounding quality of life, coping and building supportive social networks and was delivered during the first five months of the study.
Module Two (Safer Behaviors) addressed avoiding sexual and drug-related risk of transmission of HIV and other infections and disclosure of HIV status. Module Two was delivered during months five and ten.
Module Three (Health Behaviors) addressed access to medical care, adherence to anti-HIV treatments and participation in health care decisions. The final module was presented from months ten to 15. Participants were then followed up to month 25.
Results
[Excerpted from abstract]
A significance difference in rates of reported adherence was observed between intervention and control participants at months 5 and 15, corresponding to the assessments after the Stress, Coping, and Adjustment module (5-month time point) and after the Health Behaviors module (15-month time point). The relative improvements among the intervention group compared with the control group dissipated at follow-up.
Commentary
The study is not optimal. Because the population studied was the low adherence group, part of their improvement in compliance may have been simply a regression toward the mean. Further, the compliance rate was calculated from patients’ self-reporting, a methodology repeatedly shown to overreport actual adherence.
Nonetheless, the trend toward improvement in compliance while the enhancement program is ongoing and deterioration of that improvement after completion of the program does support the concept that patient compliance is a behavior requiring constant nurturing rather than a deficit requiring a one-time educational intervention.
