Given the dearth of recent posts to AlignMap, this is, I suppose, a clarification rather than a notification.

A convergence of family and business responsibilities, the illness of a close friend, and some relatively minor but time-consuming healthcare issues of my own make routine updating of this blog as well as AlignMap In Cites impossible.

The most likely scenario for the immediate future has me sporadically and unpredictably posting items when the opportunity arises.

My hope is to return to my original 3-5 posts per week schedule when the current tempests are quelled.

• Medication Noncompliance - The Blog
• Sick Call
• AlignMap In Cites - More Content, Less Delay
• Hiatus
• Nonadherence To Posting Schedule

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]

• Individualized Dose Packets Simplify Medication Adherence
• The Top Ten Patient Compliance Points: #8
• Medication Noncompliance As Plot Device
• Evidence Linking Medication Combinations & Adherence
• CellCentives Reconsidered - Still Not DOTS

Patient Education Goes Bollyhood

Once again, AlignMap takes patient education from the sad and drab ghetto of mainstream materials to the fab world of entertainment.

Check out Tracey Ullman’s conceptualization of patient counseling performed by the pharmacist.

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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.

• Inhaled Insulin - Possible Compliance Enhancement
• The Impact of Parents’ Medication Beliefs on Asthma Management
• Once More, Everyone - Not Just The Elderly - Needs A Personal Medication Record
• Healthcare Cost-sharing And Medication Compliance
• Connection Between Knowledge and Compliance Unclear

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
• Individualized Dose Packets Simplify Medication Adherence
• Another Medication Dose Packaging Plan Promoted
• Factors In Lifestyle Change
• Evidence Linking Medication Combinations & Adherence

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?

• Yunus Challenge Award Focuses On Patient Compliance
• Another Medication Dose Packaging Plan Promoted
• Economics, Gadgets, & HIV Treatment
• Adherence Improvement Battle Fought On Many Fronts
• Contact Info

AlignMap readers will, I suspect, find little new in “Doctors Without Orders,” an article about medication noncompliance by Jessica Wagner at Slate.com.

In fact, the material may seem very familiar to those readers of AlignMap posts because much of the article is indeed based on an interview with me and data drawn from the AlignMap site.

Even the material dredged from these archives, however, seems altogether more impressive when Ms Wagner writes it under the Slate aegis.

Jessica Wagner’s Slate.com essay on medication noncompliance can be found at

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As some readers know, in my pre-AlignMap life, three colleagues and I formed EnrichMap to develop a system for grouping patients according to their behavioral patterns pertinent to compliance. That information would allow customized, group-specific strategies to minimize unnecessary treatment failures caused by noncompliance. That decrease in treatment failures would, in turn, reduce the consequent morbidity and mortality, research confoundments, delays, and financial waste.

Our efforts resulted in the Emap Profile, a model that, based on an individual’s responses to a brief (20-25 items) questionnaire, divides the adult, cognitively-intact population into six segments, each with different implications for patient compliance:

1. Sage and Satisfied
2. Security Seeking
3. Self Starting
4. Uncertain and Concerned
5. Spontaneous and Impulsive
6. Vigilant and Suspicious

The problem was that we were unable to find a practical means of testing the tool.¹ Consequently, we set the project aside. I began the AlignMap web site and blog, in fact, to provide an outlet for my continuing interest in treatment adherence.²

It now appears likely that my partners and I will be able to work with one of the companies involved in clinical trials to determine, in exchange for future considerations for their use of the this technology, if the Emap Profile does what we think it does.

And thus is reincarnation accomplished in the business world.

One manifestation of this corporate revitalization is the EnrichMap.com web site, which just came online. EnrichMap.com offers, naturally, more information about the Emap Profile, including the opportunity for a visitor to determine which of the six groups best describes his or her pattern of responses to healthcare instructions.

I’m posting about EnrichMap not only because I’m proud of that work but also because visitors to this site should know that I have a personal and financial interest in that service.

Information about EnrichMap and the Emap Profile is available at ~ EnrichMap ~

Footnotes

1. ”Practical means of testing the tool” translates into “a clinically and statistically valid method for testing our hypothesis that we could afford out of pocket.” [back]
2. Yes, if I had known we would be resuscitating EnrichMap, I might have chosen a name for this site other than “AlignMap,” which will inevitably be confused with “EnrichMap.” [back]

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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.

• Cute, Cuddly Robot Pets Remind Elderly To Take Pills
• Color Me Compliant
• The Latest Electronic Pillbox
• 98.6% Medication Compliance
• Dispensing Pills In Style

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.

• Individualized Dose Packets Simplify Medication Adherence
• More Answers To Questions About onePAC
• Another Medication Dose Packaging Plan Promoted
• Prescription Information Not Given In Patient’s Language
• Diabetic Kids, Blood Glucose Monitors, & Compliance

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.

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• Physician Counseling Promotes Healthier Lifestyle in Patients With Type 2 Diabetes
• Understanding Medication Compliance and Persistence from an Economics Perspective
• Written exercise instructions improve patient compliance
• Selling generic drugs via vending machine not only spares patients a trip to the pharmacy, but improves medication compliance
• Adherence to Initial Adjuvant Anastrozole Therapy Among Women With Early-Stage Breast Cancer
• Claimed Benefits of Aerosolized Antibiotics Not Proven
• Depression needs to be discussed during rheumatoid arthritis doctor visits
• Medication adherence and cognition
• HIV/AIDS Advocacy Groups, Scientists React to Swiss Claim About Antiretrovirals, HIV Transmission
• Video: Why many blood pressure patients stop taking their prescription medications
• Handing off teens’ care to the teens
• It costs an average of $6533 to recruit a patient for a trial, and three times that amount to recruit a new patient if one is lost due to noncompliance
• New Developments and Research in Treatment Adherence in Schizophrenia
• Impediments to Prescription Compliance

• Heart Risk Profile: Treatment Motivator

• Is hole in DOTS policy playing a role in the evolution of an XDR-TB strain?

Footnotes

1. AlignMap In Cites is a new tumblelog I’m auditioning as an augmentation to the AlignMap web site and weblog. (See AlignMap In Cites - More Content, Less Delay [back]

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