The Medication Blister Pack Lottery Ticket¹

Aetna-sponsored Clinical Trial Of Lottery As Incentive For Coumadin Therapy Adherence

This story has been kicking around for over a month, evoking a variety of responses from the lay press, healthcare-oriented blogs, bioethicists, and the occasional patient compliance junkie.

Apparently, I can’t resist getting in on the action.

The Clinical Trial

The Aetna Foundation is funding a University of Pennsylvania clinical trial to determine if chances to win a daily low-stakes lottery effectively promotes adherence among coumadin patients.

According to the Hartford Courant,²

Patients who do not report taking their medications are also notified if they would have won the cash but were ineligible because they did not follow their medication regimen.

The Responses

Many reports provided a straightforward account of the trial, but others have played up the cash incentive and the lottery/gambling angles. An example of the those focused on the money, by my subjective evaluation, is Bribe Me, Doc.³ The title notwithstanding, the reporting is reasonably balanced (several articles and, especially, posts attacked the use of cash incentives more aggressively on moral grounds), but the questioning of the compliance enhancement strategy being studied is reflected in these excerpts:⁴

Commentary

A full discussion of compliance-enhancing incentives is beyond the scope of this post and has been addressed in this blog previously. Instead, I’ll offer some comments on pertinent issues that were not been covered in the 20 or so articles about this study I’ve read.

Several healthcare professionals raised similar points to that made by Richard Ashcroft, i.e., the use of cash incentives diminishes the personal responsibility of the patient.

My first and almost automatic response is that adherence to healthcare is not exclusively an individual’s personal issue. Noncompliance increases healthcare costs for all of us, one way or another, and unnecessarily uses the resources to the loss of all those individuals (that would be you and me) who may require healthcare services. Productivity is decreased when health problems of workers are not properly treated. Noncompliance may lead to lack of treatment or inadequate treatment of communicable diseases that consequently puts others at risk for the same disorder in the short term and for even more virulent or more difficult to treat forms of the disorder if inadequate treatment leads to the formation of resistant strains of the disease. If the consensus is that forced treatment or quarantine is necessary in some cases to protect the public, then it is difficult to condemn a less rigorous tactic if that is sufficient for public protection.⁵

On consideration, I’m not fully convinced of the premise that cash incentives necessarily destroy personal responsibility. To make that argument, it seems to me, one would also have to protest against penalties for noncompliance on the same grounds. E.g., fines for traffic violations are unethical because they diminish personal responsibility. Individuals should stop at red lights and adhere to speed limits because of internal motivators rather than external coercion. Of course, my reaction may be skewed by too many years on the parent-child battle line, efforts that long ago caused me to abandon the second half of the proposition “you [my son] must do the right thing and do it for the right reason.” A more pragmatic attitude toward motivation prevails on the home front these days.

I do enthusiastically agree with Richard Ashcroft’s observation that “in the health field that people aren’t always rational in their decision-making.” In fact, if I ever ascend to the role of Universal Emperor Of Healthcare, my first decree shall be to require all healthcare theorists to write that line 1,000 times on the chalkboard. Today, however, I will only add that there are few, if any, fields of personal functioning (e.g., caring for ones health, managing money, finding a career, falling in love, … ) in which decision-making is rational.

I find almost no discussion of the impact the lottery aspect of the incentive might have on the patient-doctor relationship. Is there, for example, any risk that the patient who forgot to take his pill for the first time last night, might, on receiving word that he would have won last night’s jackpot had he been compliant, be miffed at the doctor, who will inevitably be seen as representing the incentive system? Or if there is a snafu,⁶ are the folks whose legitimate winnings dissipate in a computer error going to blame the clinician? Who will be responsible for explaining this to the patient, re-establishing a working relationship, taking the time to fix the errors, etc?⁷

As long as incentives are being passed out to patients, how about providing parallel incentives to the responsible clinicians and any family or friends who take the role of care provider on an everyday basis so that all those involved in treatment are headed toward the same goal? Gee, what’s the word for that? Oh yeah, that would align the stakeholders.

In any case, by using the electronic monitoring device described, the researchers are actually testing if chances to win a daily low-stakes lottery effectively promotes the pressing of a “Yes, I took my medicine” button among coumadin patients. My hunch is that it will.

I will also repeat the recommendation I made in a previous post

Footnotes

1. Consider the Medication Blister Pack Lottery Ticket AlignMap’s contribution to pharmaceutical packaging [back]
2. The Courant story, the primary source of this information for most of the blogged and printed reports, is no longer available via live link. I accessed it through the Google cache at Courant Page 1 and Courant Page 2. [back]
3. Misty Harris , Bribe Me, Doc, Canwest News Service. July 01, 2008 [back]
4. It should be noted that those involved in the Aetna funded University of Pennsylvania study also recognize the ethical issues involved. Their stance holds that if the incentives prove successful in enhancing compliance, the moral and ethical points should be debated after the study is complete. [back]
5. Some of the argument I make in this paragraph may be implicitly included under “public health” references made in some articles. [back]
6. Oh my, I just flashed on the concept of the healthcare system as I know it taking on the management of a lottery system. What could possibly go wrong? [back]
7. For what it’s worth, classic contingency management, a behavioral system with much supportive evidence, would provide each patient with $X in his account on day one and remove a fraction of that every day the patient was noncompliant. Regardless of how effective the scheme might prove in improving compliance, I cannot imagine approaching, say, my borderline patients, at every session to announce that their compliance last week had cost them $29. It would not be a pretty sight. [back]

• Payment For Medication Compliance: Incentive or Bribe?
• Compliance Or Defiance When The Stakes Are Life Or Death
• Promoting Compliance With Pharmacy Benefit Incentives
• Cash For Compliance & Other Ethical Dilemmas
• Another Case Of Cash For Compliance

Patient Compliance Enhancement System Wins Columbia Business School Outrageous Business Plan Competition

According to With This Plan, Everyone Wins, a system for packaging a patient’s medication by dosing schedule (e.g., instead of dispensing a month’s supply of the patient’s five different medications each in its own bottle, the pharmacist would repackage the medications into that patient’s prescribed doses - 1 tablet each of medications A, B, and C on awakening, 2 tablets of medication D with breakfast, lunch, and dinner, and 1 tablet of medication E at bedtime) was adjudged the best entry in the Ninth Annual Outrageous Business Plan Competition,¹ an honor accompanied by a $4,575 award.

The referenced post goes on to note that

Prescription noncompliance costs billions in healthcare dollars and thousands of lives each year. Geoffrey Reed ’09 saw the problem first-hand last summer when his grandfather mixed up his medications and ended up in the hospital. Now Reed and Eric Chesin ’09 have come up with a way for pharmacies to organize medications that increases the chance of compliance. The idea, Bluepak, recently won CBS’s 2008 Outrageous Business Plan Competition; their elevator pitch is below.

Commentary

As was the case with the MIT Yunus Challenge award,² it is heartening to find patient compliance recognized as a problem worthy of the efforts of student competitors at these elite universities.

And, I think the idea is reasonable and and worthy of a trial. I am, however less certain a medication repackaging scheme warrants the “outrageous” tag.³ Hospitals have used this strategy for years, and some pharmacists have long provided the service for some patients. Heck, I’ve suggested this idea myself without one person in the audience retorting “That’s outrageous.”

More to the point, Bluepak appears similar to onePAC, a service featured recently on this blog,⁴ and the questions I asked about onePac (see previous posts) would apply to Bluepak. ⁵

Happily, being outrageous or even original, is not a prerequisite for a clinical valid, commercially viable program to enhance medication compliance. Those of us with vested interests in treatment adherence will be interested to see how Bluepak, onePAC, and similar ideas fare in the real world.

Footnotes

1. From the Columbia Business School press release: To enter the competition, teams comprised of at least one Columbia MBA or EMBA student, submit an executive summary of their business plan and tape a two-minute elevator pitch. A panel of judges, comprised of executives from venture capital firms as well as several entrepreneurs who developed their own successful ventures while students at Columbia Business School, evaluated the pitches and narrowed the field down to five teams. In the final round of competition, each team delivered a formal 10 minute presentation to the judges and the audience. Based on these presentations, the judges decided how much money they would award each venture. [back]
2. See Yunus Challenge Award Focuses On Patient Compliance and CellCentives Reconsidered - Still Not DOTS [back]
3. According to the previously noted Columbia Business School press release, “The competition, organized by the Columbia Entrepreneurs Organization and the Entrepreneurship Program, encourages students to develop and present creative entrepreneurial ideas that are sufficiently ambitious in scope and scale to be considered “outrageous.” [back]
4. See Individualized Dose Packets Simplify Medication Adherence, Answers To Questions About onePAC, and More Answers To Questions About onePAC [back]
5. I have, in fact, emailed those queries to the Columbia Business School. [back]

• HIV Treatment Meta-analysis: Single Daily Dose Equal To Or Better Than Multiple Dose Regimens
• Individualized Dose Packets Simplify Medication Adherence
• Fixed-Dose Combinations Improve Medication Compliance: A Meta-Analysis
• Proposed Action Plan For Enhancement Of Medication Adherence A Must Read
• Health Incentives and Minnesota's Healthcare Alignment Plan

Contestant in Australian Rules Medication Compliance tournament receives scores

OK, as far as I know, there are no medication compliance tournaments, but, according to Scores help patients keep pace with prescriptions, by Adam Cresswell in The Australian (March 29, 2008),

The article goes on to point out,

The basic mechanisms of the plan are outlined in these excerpts:

Commentary

I am wholeheartedly in favor of compliance with prescribed healthcare measures, including medications, being monitored - in theory. Simply put, noncompliance will not be recognized, let alone be rectified, unless ongoing, routine monitoring is in in place.

Heck, I think it is even possible that compliance monitoring can be accomplished in practice if sufficient care and planning is invested in the effort.

I do, however, have qualms about the proposal written up in The Australian.

First among them is the notion that “the scores are not designed to imply fault or blame, and no penalties or sanctions will apply to people with low scores.” I’m fully willing to believe that this statement reflects the intent of those responsible for the program.

It does not require much effort, on the other hand, to imagine scenarios in which certain parties would face temptations to change or illicitly abuse this principle.

Not being familiar with systems of Australian healthcare payment or the medico-legal system, I’ll give an example or two based on how the American healthcare system operates.

As healthcare expenses increase, somebody in the government, the insurance industry, or a payer (e.g., an employer) is going to have the epiphany that patients who don’t adhere to prescribed medication dosing cost more than those who do. Clearly it would be not only a cost-saving but also justifiable to reduce the benefits or increase the personal fees paid by this group, members of whom could be identified by an adjustment in the system.

Somewhere else, a lawyer defending a physician accused of malpractice will seek judicial leave to present the patient’s compliance score of 45 as evidence that the treatment failed because of poor adherence rather than the doctor’s error.

And, those justifications may indeed be legitimate. My point is only that there will be pressure to use these scores in ways not currently intended. And once recorded, this compliance rating will be vulnerable to the intrusions of politicians, lawyers, healthcare officials, and others.

My other area of concern is that this important change is predicated on a four month study of 200 patients - “which was run merely to ensure the IT systems worked properly” - and research that “showed patients’ adherence to dosing schedules plunged rapidly in line with the number of daily medicines they were supposed to take.”

While studies tend to show that decreased compliance is coupled with an increased number of doses per day, that research is not unanimous. Nor are the remedies listed, blister packs of medication and simplified drug regimens, both of which are reasonable responses and which are beneficial to some
patients, panaceas for all nonadherence. And, since most physicians try to minimize dosing for all patients, it is difficult to see how that measure will have a dramatic effect.

The enthusiasm demonstrated by some of those 200 patients notwithstanding, one wonders if the novelty of this program may not wilt after a few months with a corresponding decrease in interest by patients and clinicians.

There are other imperfections as well. The compliance formula, which “compar[es] the time it takes patients to return to a pharmacy to have a repeat script filled, with the time it would have taken them had they taken all the previous doses at the appointed times” has several built-in potential flaws, the most significant of which is perhaps that picking up ones prescriptions at the correct times is not synonymous with taking the medications as prescribed. In the US, it is not unusual for a patient to semi-surreptitiously obtain medications from other countries to reduce costs. Doing so would, I assume, bypass the monitoring system.

Perhaps the point of this jeremiad disguised as a post is that monitoring the compliance of all patients in a practice, an insurance group, or a country offers great opportunity to improve healthcare - but not if it addresses only one area of noncompliance with one set of responses, especially since it puts those those patients at some risk of their compliance records being used to make their healthcare more expensive or less accessible.

• Using Pictoral Aids To Enhance Medication Compliance
• France Rejects Attempt To Legalize Pharma’s Medication Compliance Programs
• Cost-sharing and Adherence To Prescribed Medication
• How To Create and Use A Personal Medication Record
• How To Create and Use A Personal Medication Record

I originally published a post about onePAC at Individualized Dose Packets Simplify Medication Adherence. The next day I posted Answers To Questions About onePAC, but two specific queries went unanswered until now.

Exciting, eh?

I received these responses on 26 March 2008 from Nanette Kirsch, Senior Director, Marketing Communication, Parata Systems, LLC

Q: If all of a patient’s prescriptions are processed and sold in 30-90 day bundles, how are changes in that patient’s medication regimen handled, both logistically and financially?
A: That is being managed at the pharmacy level, although we expect to create a process specific to that issue in the near future.

Q: Is there research demonstrating that this type of packaging increases compliance?
A: Not that we have conducted yet. But we anticipate collecting such data as we advance into the market and will keep you in the loop on those outcomes.

• Answers To Questions About onePAC
• Dispensing Pills In Style
• CME: Treatment Nonadherence Among Individuals With Schizophrenia: Risk Factors and Strategies for Improvement
• Dangers Of Making Noncompliance A Medical Condition
• Promoting Compliance With Pharmacy Benefit Incentives

Source:
MIT Spectrum (Helping TB patients. Spring 2008)

CellCentives Compliance Program

This article in Spectrum, a MIT in-house newsletter, celebrates the CellCentives progam, originally discussed in an AlignMap post, Yunus Challenge Award Focuses On Patient Compliance in May 2007.

To recap, CellCentives was one of the winners of the Yunus Challenge, the topic of which was “Increasing Adherence to Tuberculosis Drugs in Rural Developing Country Contexts”

Excerpts:

Commentary

I didn’t get it when I first wrote about this program almost a year ago, but now … well, I still don’t get it now.

Oh, I get the incentive part. What I don’t get is the implication that CellCentives is the equivalent of DOTS. A patient punching in a number from the packaging for a capsule is not the same as a nurse “actually go[ing] to the homes of TB patients to watch them take their medication.” Until there is research demonstrating that CellCentives is as effective as DOTS, the fact that CellCentives is cheaper is an empty boast. A plastic pill dispenser would be cheaper than CellCentives - but so what? Doing nothing is cheaper still.

Perhaps I’m missing something. But until someone can enlighten me, I feel compelled to suggest that despite visit[ing] five cities in India [to survey] tuberculosis patients and their doctors to learn why patients don’t take their medication,” perhaps these students didn’t get the entire story on compliance.

To repeat two of my shibboleths,

1. Being correctly educated to the need for medication and being reminded to take the medication are not the only factors with an impact on medication compliance
2. Removing a pill from its packaging is not as effective a treatment as actually taking the pill

Where’s my prize?

• Dispensing Pills In Style
• Organizing Data About Factors That Affect Compliance
• Connection Between Knowledge and Compliance Unclear
• Negative Effect Of Depression On Adherence To HIV Treatment Dissipates With SSRIs
• The Misdiagnosed Patient

The Research

A study published this week in The Journal of the American Medical Association indicated that expensive placebos were more effective than cheaper placebos.

An article from the March 5, 2008 New York Times, More Expensive Placebos Bring More Relief, summarizes the study:

Inevitably, some readers felt obliged to make comments along the lines of “I’m going to sell a pill for a gazillion dollars that will cure everyone.”

Sigh.

Ron Winslow, at the Wall Street Journal was more on point with his headline, Placebos Might Work Even Better With a Brand Name. He went on to observe

Still, this is the more of the same sort of thinking that has led to the current crisis in American healthcare. The brand names Mr. Winslow references are, after all, those of the same old pharmaceutical manufacturers.
Pharmaceutical manufacturers manufacture pharmaceuticals. The cognitive dissonance of “pharmaceutical manufacturers manufacture placebos” alone would wash out any potential benefit. Besides, if you’re selling Buicks, you can’t just double or triple the price of Buicks and hope that the customers will accept that increase without demanding an explanation.

One must give the customer/patient extra value for the extra price - which brings us to the new AlignMap business enterprise:

the placeboutique

the placeboutique
The Sign Of High Priced & Highly Effective Placebos

The Clinical Retail Strategy

First, The AlignMap research staff carefully leeches out any potential chemically-mediated physiological effect from the products while retaining and, in some cases, expanding the expense of producing these placebos.

The key to the placeboutique business plan, however, is offering really prestige name brands. Check out these samples:

Now, those are names that are worth the extra dollars that will make these pseudo-pills expensive enough to be effective.

While the initial iteration of the placebotique tactics limited inventory exclusively to designer brands, we soon realized our humanitarian responsibilities obligated us to carry more affordable generics.

Consequently, we have developed an in-house category of drugs that lack the designer flare and logo but make their own distinctive, low-key statement by virtue of each pill and capsule bearing an embedded blue star diamond.

Remember: at the placeboutique, the diamonds are real; only the drugs are fake

These are quite presentable and, because they do not incur the cost of a designer, can be offered at a substantial savings. While some placebo categories, such as fake immunosuppressive drugs, may remain beyond the reach of a small percentage of the impoverished, more common remedies, such as the fake antibiotics in this line, are widely available at less than $1,000 per dose.

Several other affiliate deals are in the works. While royalties are still being negotiated, a Grey Goose branded bowel prep, for example, could be on the shelves by the end of the year.

Finally, all placebos sold at the placeboutique carry our unique clinical-fiscal guarantee: if the first course of a placeboutique pill does not result in a cure, we will provide a second course of even more prestigious pills at at least twice the price and effectiveness.

• Compliance In Older Patients
• Dispensing Pills In Style
• Interruptions In Antiretroviral Therapy
• Factors In Lifestyle Change
• More On AlignMap In Cites

A recent AlignMap post, Individualized Dose Packets Simplify Medication Adherence, described onePac, a service of Parata, a company specializing in automated pharmacy services. OnePac is a system allowing local pharmacies to provide all of a specific patient’s oral and topical medications packaged by dose; the press release describes it as ” … a 30- to 90-day onePAC supply comes to patients as a perforated strip of individual onePAC packages, one for each dose, prepared in a convenient dispensing box that displays the next dose to be taken.”

I emailed Parata with questions I had that were not addressed in the release and received a prompt reply from Nanette Kirsch, Parata’s Senior Director of Marketing Communication.

I’ve pasted the questions I asked and the answers I received below:

Q: What, for example, is the incremental cost and is it anticipated that the local pharmacy will absorb it or will it be passed along to consumers? Will third party payers cover this benefit?
A: 1. Most pharmacies charge $10 - $20 for a 30-day supply.
2. We do have a new partner with which we’ll be exploring reimbursement through third-party payors. It is not presently available.

Q: On the technical side, can the onePAC system handle prescriptions calling for non-daily dosing, such as risedronate (Actonel) which is taken once a week?
A: Yes. In whatever manner the prescription is filled by the host system, it is sent to the PACMED system, which prepares onePACs. It will then package for example, a 14-day cycle with Actonel on each Monday in that week’s cycle.

I had other questions that required input from the product manager who was out today. Ms Kirsch hoped to obtain the responses tomorrow. I’ll post those when they arrive, at which time I’ll also have further commentary.

• More Answers To Questions About onePAC
• Self-Reported Vs Actual Compliance With Mammogram Screening By Older Women
• Patient Acceptance Of Monitoring: Followup Info From Intel's Health Systems Research Lab
• Promoting Compliance With Pharmacy Benefit Incentives
• Motivational Interviewing

One Packet Manages Multiple Medications Per Dose

Graphic adapted from myonePAC web site

In a press release issued yesterday, Pharmacists Customize Prescriptions By Patient, Day and Dose with onePAC(TM) Packaging, Parata, which offers automated pharmacy services, announced the availability of onePac, a system allowing local pharmacies to provide all of a specific patient’s oral and topical medications packaged by dose.

According to the release,

One of the potential benefits of the pharmacy generated single dose packs is the elimination of many of the errors some patients make in distributing their medications in simple SMTWTFS pillboxes, reducing unintentional noncompliance.

Similar systems have been in place for some time at inpatient facilities and have been offered by some pharmacies to some patients. To my knowledge, this is the first widely available packaging system of this sort.

Unknown Issues Re onePAC

Because my information at this time is limited to a press release and whatever I could glean online, several important questions are unanswered.

What, for example, is the incremental cost and is it anticipated that the local pharmacy will absorb it or will it be passed along to consumers? Will third party payers cover this benefit?

On the technical side, can the onePAC system handle prescriptions calling for non-daily dosing, such as risedronate (Actonel) which is taken once a week?

If all of a patient’s prescriptions are processed and sold in 30-90 day bundles, how are changes in that patient’s medication regimen handled, both logistically and financially?

Is there research demonstrating that this type of packaging increases compliance?

I have emailed Parata with these questions and will share their responses here.

Update: Two of these questions are answer at Answers To Questions About onePAC. The remaining questions should have responses, I’m told, in the new day or two.

The Potential Utility of Individualized Dose Packets

If the system is practical (e.g., affordable, simple to use), this would be a potentially signficant compliance enhancement for anyone taking more than a single medication daily. Of course, my evaluation may be skewed by the fact that I have previously recommended such a program.

There is a significant gulf between good ideas and research-proven methodologies. And, as software manufacturers have repeatedly discovered, some flaws in any system are not apparent until that system is subjected to widespread implementation by actual end-users.

Nonetheless, onePAK does strike as a dandy idea and one that could benefit folks like my mother - and me.

• Answers To Questions About onePAC
• Does Mistrust Of A Pharmaceutical Manufacturer Cause Patient Noncompliance?
• Evidence Linking Medication Combinations & Adherence
• Fixed-Dose Combinations Improve Medication Compliance: A Meta-Analysis
• A Pragmatic Consideration Of Noncompliance In Patients With (Or Without) ADHD

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.¹

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. ²

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.³

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,⁴ 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:

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:

A more complete rendition of the process is provided by Gizmag:

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:

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.

________________________
Footnotes

1. I first read about IntelliDrug in February 2007, when similar reports surfaced. At that point, I had neither the time nor energy to address it. When a report of this technology reappeared this morning, however, I felt compelled to respond. [back]
2. For the proper “late breaking news” effect, viewers may wish to click on the arrowhead below to trigger the clacking teletype sound for background and read the rest of this aloud with that Walter Winchell staccato phrasing. [back]
3. To achieve the best effect in this instance, viewrs may wish to hum either “We Are The Champions” or “The Theme From Rocky” while reading this portion of the report. [back]
4. These quotes have become almost obligatory for articles on patient compliance:
   Hippocrates: “Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed.”
   Dr C Everett Koop: “Drugs don’t work in patients who don’t take them.” [back]

• News Flash! U.S. Government Discovers Treatment Adherence Not 100% - War On Noncompliance Declared
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• A Cognitive Therapy Approach To Weight Loss - And Patient Compliance
• Enhancing Patient Compliance - A Value-Based Approach To Managing Employee Health
• Patient Adherence To Antidepressant Regimen: Dramatic Improvement Claimed

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]

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.

• Interruptions In Antiretroviral Therapy
• Adherence Especially Important In Outpatient Practice
• Pharmacist-Driven Compliance Enhancement Programs
• LIFE Program Enhances Adherence
• Patient Action Plans

Almost certainly the most commonly used and typically recommended patient compliance enhancement device is the pillbox.

And pillboxes have frequently made appearances on the AlignMap site. Letterman, Pills, & Compliance Enhancement reported on Dave Letterman’s use of a common seven-day pill dispenser with flip lids on his show:

,

A spiffier Bang & Olufsen pill dispenser, capable of producing a visual or acoustic signal to the patient when a dosage is due and providing feedback to the patient via a red, yellow or green lights that indicate how well that individual has been taking the medication. was featured in Dispensing Pills In Style.

Electronic pillboxes are, it seems, quite the thing. This one was featured in The Latest Electronic Pillbox.












And the manufacturer of the model shown below claimed compliance rates of 98.6%, a statistical accomplishment which was explained in the conveniently named AlignMap post, 98.6% Medication Compliance.

Best of all, a pillbox success story was the focus of Pillbox Organizers May Improve Adherence To HIV Treatment.

How To Use Pillboxes and Medication Organizers

As it turns out, recent research shows that pill organizers have a great potential for enhancing medication adherence but also have their own set of recurrent problems. That is hardly unique: most tools that are useful also carry risks. The odd part is that physicians, pharmacists, nurses, health insurance companies, and the rest of the usual suspects rarely do more than recommend that patients use pill organizers. After that, folks are on their own.

That’s probably a mistake.

In upcoming posts, I’ll be reviewing the sparse literature on the use of simple, non-electronic medication organizers, adding my own observations to the findings and recommendations. If I do my job correctly, this should be immediately useful to may patients.

Today’s post, however, is limited to this introduction and the following set of graphics that illustrate, just for grins, the wide world of pillboxes and medication organizers that are practical, decorative, emblematic, clever, cheap, costly, round, square, huge, tiny, and much, much more. Also included are various medication-associated accoutrements, such as pill splitters, reminders, medication logs, etc.) that are often marketed as part of a set, the centerpiece of which is a medication organizer.

And just in time for Christmas.

• 98.6% Medication Compliance
• Dispensing Pills In Style
• How To (Correctly) Not Take Medications As Prescribed
• Asheville Project Patient Compliance Program Expands
• Once More, Everyone - Not Just The Elderly - Needs A Personal Medication Record

Two Wall Street Journal articles that are especially pertinent to patient compliance were published on 20 November 2006 during the AlignMap blog’s holiday hiatus.

Cell Phones Provide Medication Information and Reminders

don’t 4get ur pills: Text Messaging for Health¹ by Rachel Zimmerman explores the use of text messaging on nearly ubiquitous mobile phones as a real time means of conveying information about medical treatment, responding to healthcare queries, and, most significantly for patient compliance, sending reminders about medication doses to patients.

While I have been critical of marketing that promotes reminders of various sorts² to be the complete solution to medication noncompliance or suggests that reminders always result in downright miraculous improvements in adherence rates, I am taken with the notion of cell phone text messaging as a useful tool for patients who have difficulty taking the right medications at the right time (a category in which I frequently find myself when a new medication, such as an antibiotic, is added to my ongoing medication schedule for a one or two week period) and for exchanging information precisely because it requires, for most of us, no new or specialized equipment and fits into our daily routines.

Because I already use an analogous service to text messages to myself about everything from taking out the trash early Monday mornings for the weekly pickup and buying specific items currently on sale at my local grocery to adapting a business presentation in time for a meeting next week, I can see how medication reminders could also integrate into rather than impinge upon ones behavioral patterns. I can also imagine younger individuals, such as my 18 and 21 year old sons who would promptly toss a reminder device that attracted attention to themselves under a passing truck, being comfortable with this type of reminder.

Readers may recognize one service provider mentioned in the article, Intelecare Compliance Solutions, as the group represented by Knight, the author of the Medication Noncompliance Blog:

Patients, Doctors, Dollars, and Communication

Your Doctor’s Business Is Your Business by David Armstrong discusses how patients might best deal with the possibility that their doctor has a potential conflict of interest (e.g., a physician with a financial interest in an orthopedic device he developed might be tempted to prescribe it unnecessarily or a doctor might advise patients to undergo a CT scan at a given facility which he owned). While I certainly see the value of open disclosure on the part of clinicians re special financial considerations they might receive from prescribing a specific treatment, I’m less convinced of the practicality of the course of action promoted by this article. In a framed box entitled “WHAT EXPERTS RECOMMEND,” the recommendations are

Even though I’m a physician myself, I would find it awkward to ask each of my doctors every time they prescribe a medication, operation, physical therapy, etc, if they will personally benefit from that transaction. Using as an example, the treatment I received for my recent hip fracture as an example, I should, according to a straightforward reading of the article, have asked about conflicts of interest when

• My personal physician ordered a diagnostic x-ray from a facility located in a different office of the same medical building as his office
• My personal physician had his nurse obtain blood samples for the hospital admission work-up
• My personal physician referred me to a specific hospital for reparative surgery
• My personal physician referred me to a specific orthopedic group for further diagnosis and treatment
• The orthopedic surgeon recommended a hip pinning rather than other options
• The orthopedic surgeon referred me to a inpatient physical therapist for purchase of an assistive walking device and training in its use as a condition of discharge
• The orthopedic surgeon ordered pain medication for my post-operative use as needed
• The orthopedic surgeon ordered follow-up x-rays of the hip to be done in his office before every follow-up appointment
• The orthopedic surgeon recommended outpatient physical therapy at a specific facility

It seems to me that the real question readers are being prompted to consider is “Is my doctor ripping me off?” And, I think that is a legitimate enough concern; the problem is that if such fiscal treachery is afoot, one would hardly expect the perpetrator to automatically fess up when confronted with a simple question. How useful would it be to ask a car salesman, “By the way, my good man, are you charging me an excessive amount for this automobile and pushing the special undercoating only to build up your own commission?”³

The author of the article, perhaps recognizing this issue, advocates a second opinion if any potential conflict of interest is found. I’ve always pushed my own patients to obtain second opinions to pacify any qualms about my diagnoses or treatment recommendations, but second opinions are themselves often expensive (especially if not covered by insurance) and take time to arrange. Moreover, an expert in the appropriate field whose reputation is blemish-free and who is absolutely independent of potential conflicts may be hard to find on short notice. And, if the course of action recommended in the second opinion differs from the first treatment suggested, does the patient get a third opinion to break the tie? What if it turns out that the doctor providing the second opinion has his or her own financial arrangements that compete with those of the first doctor?

Finally, how significant and how specific to a given treatment does that financial involvement have to be to warrant notifying patients? Should the doctor who sells and dispenses mediations within the office list his profit margins for those medications? Does the prescriber who owns stock in a pharmaceutical company have a different obligation to inform clients than the prescriber who helped developed a medication and receives a royalty for every pill sold? Do doctors working for an HMO who receive an incentive for prescribing generic rather than brand drugs disclose that to every patient? Does a doctor who sends patients to a facility that uses a certain type of CT machine on which holds a patent have a different responsibility to disclose his financial arrangement than a doctor who orders CT scans on his patients done in the office with the CT machine his group practice owns and operates?

If the following statements were true, should I have told patients, “I’m prescribing Prozac for your depression, but you should be aware that Eli Lily, the company that manufactures Prozac, …

… pays me a royalty for every Prozac capsule sold because I helped get FDA approval”
… sells these capsules to our pharmacy wholesale and our pharmacy, which our practice owns, charges you a 200% markup when we sell you your medicine I’m prescribing”
… sends a salesman here every month who takes me to lunch where he tells me why I should prescribe Prozac instead of another medication”
… may be in the portfolio of some of the stock funds in which I’ve invested so their profit would benefit me”
… offered second year medical students at many medical schools in 1973 a free, medium quality stethoscope that I accepted”

I suspect few would think that admitting that I accepted a stethoscope from Lily is either necessary or useful, but defining how much financial involvement by a physician merits or requires disclosure is not a trivial task.

My discomfort with this piece, in fact, is not that the problem of a physician’s conflict of interest doesn’t exist but that the simple fixes the article described belies that complexity of the problem.

Additionally, such questions put to doctors are not always benign and may yield negative results, a concern noted in this excerpt:

Readers may also recognize Trisha Torrey as the author of Every Patient’s Advocate, a blog which occasionally appears here at AlignMap.

Disclosure Statement

Ahem, I have not accepted any financial remuneration from The Wall Street Journal, Every Patient’s Advocate, Medication Noncompliance, their authors, or their associated companies for mentioning them in this post.

One possible reason, in addition to my stalwart Midwestern upbringing, my seven years of perfect attendance at Sunday School, the two semesters I spent at Oklahoma Christian College, and my preternaturally staunch moral fiber, for my incredibly righteous stance in this regard is that none of those entities has (yet) offered me any such remuneration. I mean, if someone were to go to the trouble of, say, placing a manila envelope filled with a significant chunk of cash in small, unmarked bills in a locker at the bus station and sending me the locker key, it would be rude not to at least consider taking the money. Or if Mr Murdoch, who could certainly afford it, saw fit to comp me a daily copy of the WSJ, to which I subscribe at the exorbitant, full-price online subscription rate, I would feel obligated to live up to the standards of politeness instilled in me by my mother and to accept that offer as a no-strings goodwill gesture from a fellow publisher.

I freely admit that both of the individual blog authors mentioned do occasionally email me, typically to tell me or ask me about something going on in the wide world of patient compliance or exchange a tidbit or two about our personal lives. Trisha, for example, moved recently, and we briefly discussed the stresses such endeavors may inflict on households. I am only a teen-tiny bit jealous that their businesses were mentioned in WSJ articles and mine wasn’t. Both bloggers have written positive comments about AlignMap or me in previous posts, which is always nice.

Footnotes

1. If this article falls in the “subscriber-only” section of the WSJ, readers without such a subscription may be able to access this article by first going to the Digg Connection to this piece and then clicking on that link [back]
2. ”Reminders” include wrist watches that signal the time for medication, dispensers with flashing lights, recorded messages, and overtly noxious sounds, telephone calls, orbs that glow at the appropriate time, and a variety of Rube Goldberg contraptions [back]
3. While a villainous doctor might be more forthcoming and the questioning process more amusing and gratifying if one employed more vigorous interrogation methodology such as that used on TV police procedurals or in the Spanish Inquisition, those techniques could prove off-putting to some healthcare professionals and could tend to taint the relationship between physician and patient. [back]

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