AlignMap

Techno-Monster Vanquished

My extraordinarily talented web site consultant has performed his usual heroics and wrestled this site’s recent technological problems (see In The Midst Of Draining The Swamp …) into submission.

Unless new catastrophes declare themselves, business should resume in the next day or two.

Again, my apologies for the hassles.

Changes (gleefully described as an “upgrade” by the code-mongers) in the software used to publish this web site have resulted in all manner of havoc, disarray, and no small amount of frustration.

One especially confusing consequence has been that the AlignMap blog now turns up on its own page, AlignMap Blog and as the AlignMap Home Page.

I’m wanted to assure readers that I am aware of the glitch and am working to repair it.

I apologize for the hassles.

While noncompliance with procedures such as colonoscopies may be driven by any number of reasons, it is difficult — at least for anyone who has undergone such examinations — to discount the possibility that the procedure’s discomfort and embarrassment are the primary hindrances to adherence.

Avoiding such problems is the raison d’tere of the swallowable pillcam. As Medgadget describes their appliance (Nemo),
The objective of the NEMO project is to increase patient compliance with currently recommended screening guidelines by developing an advanced cancer screening system that is patient-friendly, highly sensitive and specific for early detection of cancer. To achieve this NEMO will converge optical technologies with nano-technologies, biosensing & maneuvering technologies to create a unique PillCam capsule endoscope capable of secretion analysis and the detection of marked and deep tissue disorders. The consortium believes the combination of the image and molecular analysis to mark the tumor may provide a novel and effective medical device for mass screening for GI cancer

The device travels through the esophagus in about three minutes, images are transmitted to a recorder belt worn by the patient, and the pillcam passes through the GI tract within 24-72 hours.

Commentary

About damn time

An October 11, 2006 FDA Warning Letter addressed, among other issues, the claim by Orapred that the addition of flavor enhancers improves compliance with its product. The FDA letter, excerpted below,¹ focuses on the need for evidence of such claims.

Unsubstantiated Claims

The “NEW INSTITUTIONAL 10-PACKS” link on the main product website claims that Orapred is “ENGINEERED FOR COMPLIANCE,” and the main product website contains the tagline, “Perfecting the Science of Compliance.” Similarly, the “About Orapred” page on the product website claims that Orapred “helps mask the bitter taste of prednisolone, making it easier to take without experiencing the natural gag reflex commonly induced by other liquid formulations of prednisolone.” In addition, the “NEW INSTITUTIONAL 10-PACKS” link on the main product website contains claims such as, “Designed to taste better, ease administration.”

We acknowledge that Orapred contains flavor enhancers. However, these claims misleadingly suggest that because of its formulation, patients gag less often when taking Orapred or that the taste of Orapred is superior to that of other formulations of prednisolone and thus that Orapred improves rates of compliance. FDA is not aware of any evidence to support these claims. If you have data to support these claims, please submit them to FDA for review.

Commentary

The FDA’s insistence on scientific evidence rather than the “common sense” assumption that better tasting medications will achieve higher compliance rates is laudable.

My impression is that compliance claims based on a specific quality of a medication (e.g., decreased side-effects, oral rather than parenteral administration, reduced dosing frequency) receive far more regulatory attention than claims made on behalf of non-pharmaceutical compliance enhancers such as adherence monitoring devices, medication reminders, and patient education compliance programs.

Because the notion of expanding governmental oversight gives one pause, and it’s difficult to imagine another source of funding for an independent agency that would serve as a sort of Consumer’s Union for the field, perhaps the message to those of us working with patient compliance is to maintain a high index of suspicion about such claims and to straightforwardly and repeatedly raise the expectation that claims of improved compliance be clarified (e.g., terms defined) and supported by evidence.

1. The entire Warning Letter can be viewed at FDA Warning Letter To Orapred↩

There’s No Noncompliance Like Show Business Noncompliance

Eye Fix Backfires On Celebutard
Richard Johnson New York Post January 19, 2007


Although I had not planned to post new material on this blog while reworking the AlignMap.com site, I cannot pass up the opportunity to reference a patient compliance item from the “Page Six” section of the New York Post in timely fashion.




The Background: According to The Post,¹ “The muscles of her [Ms Hilton's] left eye were supposedly damaged” six years ago from surgery she underwent at that time “to lift her lids.”

Treatment Noncompliance:
The treatment compliance issue is addressed in this excerpt:

Hilton … has made things worse by wearing blue- tinted contact lenses over her naturally brown irises. “They have been drying out lately,” dished the tipster. “She is ignoring doctors’ orders to not wear her tinted contacts.” Paris’ rep Elliot Mintz told Page Six, “To the best of my knowledge, Paris has never had any kind of cosmetic surgery and has not mentioned any medical procedures having to do with her eyes.”

Commentary

Yep, it’s AlignMap.com for your complete coverage of patient compliance.²

Footnotes

1. The New York Post’s source is identified as “a Beverly Hills source”↩
2. Also see Letterman, Pills, & Compliance Enhancement↩

I’m making some organizational changes in the AlignMap web site over the next several days and do not anticipate posting new entries during this period.

Noncompliance With Aromatase Inhibitors

In a paper presented at the 29th Annual San Antonio Breast Cancer Symposium (December 2006), Ann Partridge, MD, reported that although postmenopausal women with early-stage, hormone-sensitive breast cancer can reduce their risk of recurrence by use of estrogen-lowering medication (aromatase inhibitors), 15% discontinued refilling their prescriptions for their aromatase inhibitor within one year of beginning that medication. In another portion of the study that looked at the prescription filling habits of 1,111 women on this medication, 19% failed to fill prescriptions for at least 20% of the year.

Source: Early-stage breast cancer: 1 in 5 patients may not adhere to hormone therapy

Commentary

Dr. Partridge notes “Non-adherence is a very complex issue, and the reasons that a patient may not take her medication as directed can include fear of or the experience of side effects, cost of treatment, and negative health beliefs, like the treatment will not help.”

Obviously, this list of possible causes of noncompliance is not exhaustive (nor does Dr. Partridge imply that it is) although I suppose “negative health beliefs” can become used as an elastic clause, encompassing a wide range of patient perceptions.

Just teasing out the role played in noncompliance by the various factors subsumed within the notion of patients interpreting and trusting information about medications is dauntingly complex.

I came across an observation about this story in Cancer Blog: Breast cancer survivors reject chemoprevention drugs:

Notwithstanding my sense that many patients and their families clamor for the latest and greatest biochemical agents available and my own faith in clinical studies, this mistrust of relatively new medications that have been well tested but have been used in routine clinical practice only a brief time has a rational basis and an intuitive appeal. Weighing the risks of taking such a medication against the risks of not taking it until it is historically proven safe and effective is not a trivial decision, either in terms of difficulty or consequences.

Similarly, a given patient, especially one who has survived a chronic disease, may mistrust a specific pharmaceutical manufacturer or pharmaceutical companies in general (see Does Mistrust Of A Pharmaceutical Manufacturer Cause Patient Noncompliance?). In such cases, a pharmaceutical company’s sponsorship of clinical trials may cause a potential user to devalue the results of that research.

Or, a patient may bring to treatment feelings about the medication that may not be voiced unless and until the clinician asks the right question (see Interview-based Patient Adherence Observations).

The patient-clinician relationship likewise has an impact on the patient’s confidence in information about medicines conveyed by his or her healthcare professional.

While still other items could be added to this listing, these should be sufficient to indicate the intricate, interlocking, multifaceted nature of the process involved in a patient’s conscious decision to agree to or reject a medication recommendation.

Finally, I suggest reading this vignette about the problematic attempt to prescribe a new medication to a recently diagnosed diabetic, chronic hypertensive patient that places these theoretical concerns in a real-life, clinical context. The scene is described by a third year medical student who observed the event and wrote about it in his blog at ~ Nothing to do… ~

The Asheville Project: Long-Term Clinical and Economic Outcomes of a Community Pharmacy Diabetes Care Program. Cranor C.W.; Bunting B.A.; Christensen D.B. Journal of the American Pharmaceutical Association Volume 43, Number 2, 173-184. 1 March 2003

Pharmacists score a healthy win as diabetes coaches By Ian Urbina New York Times News Service December 30, 2006




Highlighted in the newspaper article is a 10 year old program for municipal workers in the city of Asheville, North Carolina that supplies free diabetes medicines and supplies if those employees agree to monthly counseling from the program specified pharmacists.

By the account given, results have been dramatic:.

The Asheville program features pharmacists who, for a per-session fee paid by the program, serve as “coach, clinician and cheerleader for patients.”

The co-author of the March 2003 study of the Asheville Project published in by the Journal of the American Pharmacists Association, Carole Cranor, a pharmacoeconomist who was then at the University of North Carolina and now is a clinical pharmacist at Dorothea Dix Hospital in Raleigh, N.C., attributes the program’s success in helping patients control blood sugar with fewer cases of relapse than one would expect, to pharmacists:

About 40 other employers across the country have adopted versions of the program.

Finally, the newspaper article notes, “GalaxoSmithKline and Sanofi-Aventis, which make diabetes drugs, have jointly given about $1 million in the past five years to the American Pharmacists Association Foundation, a non-profit research group, to help promote and replicate the program.”

Commentary

1. In addition to the skills the pharmacists bring to the program, I would also suggest that compliance may have been enhanced by the patient’s buy-in itself. Patients who seized the opportunity to buy into the program, trading that enrollment for free diabetic supplies, may have then become more likely to adhere to treatment, or those who agreed to join the program may have, in effect, constituted a preselected group that was, by the nature of its members, more likely to follow the diabetic protocols.

2. Although it is a more sophisticated arrangement than paying patients to take medications, it could be argued that providing free supplies for patients who cooperate with a compliance program is merely a more covert form of bribery. As I noted in Cash For Compliance & Other Ethical Dilemmas, discerning between acceptable and unacceptable compliance enhancements is a difficult task unless one takes a radically polarized position.

Aids causes life insurers to take stock
by Mariette le Roux. Mail&Guardian Online. 28 December 2006

This newspaper article reports on South African insurance companies that offer life insurance to HIV-positive individuals at prices that are significantly more affordable than traditional costs contingent upon adherence to a treatment program.

This innovation is summarized in this excerpt:

The link to treatment compliance is clearly delineated: “Clients have to commit to treatment once their CD4 count (a measurement of the strength of the immune system) falls below 200, with the company monitoring and encouraging adherence. Defaulters have their cover slashed. ‘Unlike traditional insurance companies, your history is almost irrelevant to us. It is how you are going to behave in the future that is important. We tell you exactly what you must do to live a long life,’ said [AllLife co-founder and managing director Ross Beerman].”

Commentary

While the availability of limited amounts of life insurance is hardly a panacea, the alignment of lower premiums and adherence, based on market forces rather than charity, provides a heartening model of compliance enhancement. Following the results of this naturalistic experiment should be enlightening.

Factors Influencing Patient Acceptability of Diabetes Treatment Regimens

Jayant Dey, MD, Lawrence Blonde, MD, and Richard Guthrie, Jr., MD. Clinical Diabetes Vol. 18 No. 2. Spring 2000

Compliance With Diabetes Treatment

This paper is a straightforward discussion of two points: (1) the evidence linking adherence to a diabetes treatment regimen and protection from the complications of that disorder and (2) the aspects of antidiabetic agents likely to have an impact on patient compliance, especially side effects, hypoglycemia, and frequency of administration.

Commentary

While the immediate value of this article has lessened with the passage of time (e.g., its discussion of troglitazone (Rezulin) became moot for clinicians once Rezulin was withdrawn from the U.S. market, I’ve featured it here because much of the data remains helpful and, more significantly, I was struck by the utility this format offers. Clinicians in any field are likely to be familiar with the relative effectiveness and primary contraindications of any of the medications they routinely prescribe but are less likely to have the data necessary to make a careful analysis of the factors that could lead to noncompliance in a given patient. While tables laying out the results of well constructed studies directly assessing adherence to specific regimens would be ideal, such information is rarely available because well done adherence trials are themselves rare. The next best information, however, is the type identified in this article and is readily available.

Gordidto Doesn’t Mean Healthy

Gordidto Doesn’t Mean Healthy¹ is targeted toward Latino parents, offering information about the dangers of obesity in children and methods for feeding their children nutritiously without forgoing traditional dishes.

As the Publishers Weekly blurb notes,

Commentary

Iconoculture, a market research firm, regularly tracks cultural phenomenon that affect economic trends and purchases of good and services. Their take on Gordidto Doesn’t Mean Healthy is that it’s part of a much larger movement within the Latino population of the United States to maintain the essence of their cultural heritage while eliminating certain aspects that are potentially detrimental.

This combination of respect to tradition, sensitivity to an ethnic group, and efforts to improve health being recommended to retailers seems a worthwhile model for healthcare as well.

1. Gordidto Doesn’t Mean Healthy is available at Amazon and other bookstores↩

Source:
Mental Illness Drug Payments Call
BBC News. January 1, 2007

Cash Incentives For Treatment Adherence: Pros and Cons

This is an interesting discussion of the practical aspects of compliance management in day-to-day clinical practice.

The issues are basic:

• Noncompliance is a common problem in psychiatric practices; 20-50% of these patients are believed to be non-adherent to prescribed medication
• Paying people with severe mental illnesses to take medication may encourage some to stick to their drug regime
• There are practical and ethical concerns about using cash payments to enhance compliance

Commentary

While the clinical study is interesting, the BBC story is more provocative, and its issues may well be more significant than the research findings in determining if the strategy of financially rewarding patients for adherence is put into practice.

The quote from Marjorie Wallace, of the charity Sane, exemplifies the resistance to this tactic:

Even the chief author of the study, Dr Dirk Claassen, indicated that such measures, if used at all, would be applied to a limited group: “Financial incentives might be a treatment option for a high-risk group of non-adherent patients with whom all other interventions to achieve adherence have failed.”

While the use of loaded terminology such as “bribes” triggers a multitude of negative connotations, especially when the patients bear psychiatric diagnoses, the same basic considerations are the essence of the ethical struggle over any compliance enhancement schemes.

It seems intuitively apparent, for example, that the approval of an authority figure can be as powerful or more powerful than a cash payment. Are the urgings of the doctors as unacceptable as monetary reinforcements? What if the urgings come from friends and family? How about reminders to take medication or a physician’s listing of research indicating the effectiveness of a medications? Is there any difference in promoting compliance with psychiatric medications and adherence to treatment for HIV disorders? If paying patients to take an anti-psychotic unethical, should states rescind laws legally forcing resistant patients to take drugs to treat tuberculosis? For that matter, should the government be allowed to enforce regulations requiring childhood vaccinations or restricting the use of tobacco or serving of certain foods?

Indeed, one school of bioethics maintains that any reinforcement, encouragement, or even commendation of treatment adherence is the equivalent of coercion on the part of the clinician, some holding that even subtleties as seemingly innocuous as a physician’s tone of voice, however benign his or her intent, represent intimidation of the client.

For clinicians such as myself, however, the notion of simply laying out various treatment options, including no treatment at all, in a value-neutral manner without indicating my recommendation is unpalatable and smacks of shirking ones duties.

The precedent that comes to mind is the battle between physicians and the antivivisectionists in the early 20th century.¹

My guess is that most clinicians charged with the care of patients make many decisions every day that involve parsing such ethical dilemmas with the well-being of a human being in the balance. For that reason, if no other, I believe that an automatic dismissal of material inducements, one of the few compliance enhancements strategies shown to routinely be effective, is counter to the best interests of patients and deserves further consideration.

1. E.g., William Osler performed vivisection to study typhoid and tapeworm in pigs and testified against antivivisection legislation in government hearings in the U.S. and England↩