On 7 November 2007, US News & World Report posted Many Patients Stop Taking Cholesterol-Lowering Drugs, a brief account of a study to be presented today at the American Heart Association’s annual meeting in Orlando, Florida. An excerpt follows:

Even though cholesterol-lowering statin drugs are known to be effective, many patients stop taking them, and researchers say a number of factors may be to blame. In their study, researchers in Chicago analyzed a large pharmacy’s database. They found that statin discontinuation rates among more than 768,000 patients were 28 percent after three months, 41 percent after six months, and 59 percent after one year.

“We found that subjects who were on high-dose statins, paid high co-payments, or spoke Spanish were significantly more likely to discontinue,” said the investigators at Radiant Research Inc. Patients who used the Internet, had heart disease or high blood pressure were significantly less likely to stop taking statins.

Commentary

Once again, a study of adherence to a long term medication regimen - a study with an altogether impressive population of 768,000 patients - has produced results that were all too predictable: discontinuation rates of “28 percent after three months, 41 percent after six months, and 59 percent after one year.”

Yet, despite hundreds, if not thousands, of clinical trials with similar findings, new articles continue to appear in the medical and lay press headlining the fact that many and perhaps even most individuals do not follow the course of treatment prescribed for them despite solid evidence that it works.

Of course, my conspicuously idiosyncratic reaction to this observation is that these conspicuously disappointing compliance findings are the conspicuously reliable result of the inherent conceptual flaws in our thinking about compliance, AKA adherence, AKA concordance, … .

But if I can’t sell that - which is becoming conspicuously obvious - I suggest those of us who work in the field (and therefore should, at least, know better) discourage the idea that noncompliance with diabetic regimens, inhalers, low-salt diets, medication, and other prescribed treatment is in any way surprising and point out that 50% noncompliance with treatments such as long-term medication is the expectation, not the exception.

• Use Of Cardiovascular Disease Medication Low, Consistent Adherence Lower
• Lipitor Would Rather Fight Than (Have Patients) Switch
• Statin Compliance
• Adherence To Treatment For Hypertension
• Statin Choice Tool Clinical Trial

The Hospital Compliance Improvement Project

There is a much to be learned about patient compliance from a recent New York Times article.¹ Some excerpts and paraphrases follow:

Sounds pretty routine (with the exception of the near-100% compliance), doesn’t it?

Well, as it turns out, Selling Soap By Stephen J. Dubner And Steven D. Levitt (New York Times, September 24, 2006) is not about improving adherence to an antibiotic regimen, a diabetic diet, a prenatal care program, or, indeed, any treatment program but is rather about enhancing doctors’ compliance with hand washing protocols.

The congruence of this hospital’s experience in attempting to improve their doctors’ adherence to hand hygiene regulations with efforts to enhance patients’ cooperation with prescribed healthcare is impressive, offering a new and potentially useful perspective on the management of patient compliance.

This worthwhile , which also presents a brief, interesting history of the sometimes awkward relationship between hospitals, germ theory, hand washing, and doctors, is available at ~ Selling Soap ~

Footnotes

1. While I refer to this piece from the New York Times as an “article,” it is technically a column from that paper’s Freakonomics series. [back]

• None Found

Good Reasons To Keep Taking Your Medication
by Jane Collingwood.
Published at Psych Central October 19, 2006

The Joy Of Compliance

This brief (nine paragraph) essay by Jane Collingwood, a freelance writer specializing in health issues, provides a useful, easy to read summary of the central principles associated with adherence as an independent determinant of wellness, i.e., the notion that those who adhere to treatment accrue health benefits beyond the value of the medications or other prescribed therapy.¹

Some of the most significant pertinent research is described with full citations given. The tone of the article is positive without crossing over into hyperbole and unwarranted optimism based on hopefulness instead of scientific evidence.

My only quibble is over the title, “Good Reasons To Keep Taking Your Medication,” which seems to imply that the multiplicity of advantages enjoyed by those who are, by their nature, “healthy adherers,” will also befall those whose adherence is learned behavior, a premise that, as far as I can determine, has not been tested, let alone proved.

This article is worthwhile as an introduction to the concept of the Healthy Adherer for healthcare professionals, and its clear, jargon-free prose makes it ideal for readers from outside the field.

Footnotes

1. See AlignMap post, Adherence As An Independent Marker Of Decreased Mortality [back]

• Adherence As An Independent Marker Of Decreased Mortality
• Addressing Cultural Threats To Health
• Knowledge & Insight
• The Top Ten Patient Compliance Points: #3
• Results Of Differing Methods Of Communicating Treatment Benefits To Patients

The Recommendation

Enhancing Prescription Medicine Adherence: A National Action Plan, the report referenced in my snarky August 1, 2007 post,¹ is available² and worth reading by anyone involved with healthcare.

The Report

While I won’t go into detail about the Report’s content, I will note that the prose is lucid and well organized,³ the ideas are drawn from a wide and diverse group of sources, supportive evidence is provided, and the conclusions are neither grandiosely nor apologetically offered.

The headings of the Report’s 10 PRIORITIES FOR ACTION are excerpted below:

1. Elevate patient adherence as a critical health care issue.

2. Agree on a common adherence terminology that will unite all stakeholders.

3. Create a public/private partnership to mount a unified national education campaign to make patient adherence a national health priority.

4. Establish a multidisciplinary approach to compliance education and management.

5. Immediately implement professional training and increase the funding for professional education on patient medication adherence.

6. Address the barriers to patient adherence for patients with low health literacy.

7. Create the means to share information about best practices in adherence education and management.

8. Develop a curriculum on medication adherence for use in medical schools and allied health care institutions.

9. Seek regulatory changes to remove roadblocks for adherence assistance programs.

10. Increase the federal budget and stimulate rigorous research on medication adherence.

The Potential

The strength of the proposal lies in its promotion of patient compliance as an essential factor in healthcare and, even more significantly, its campaign to unite stakeholders in an unified effort.

Of course, much of my current enthusiasm is generated by the fact that I’ve been singing the alignment of stakeholders hymn for years.

And, there are potential problems as well. While the Report covers many strategies, its sponsor, the National Council on Patient Information and Education, as indicated by the organization’s name itself and its ubiquitous motto, “Educate Before You Medicate,” has historically held patient education to be the touchstone of effective medication prescription and administration. As its web site proudly points out, NCPIE’s historical mission has been assuring patient safety through “enhanced communication.” Given that the plan NCPIE proposes, unsurprisingly enough, places NCPIE at the center of this new alliance of stakeholders, there is the risk that its organizational culture and its bias toward patient education could skew the campaign’s strategies. A similar but lesser concern is that the program will focus predominantly or exclusively on medication compliance rather than adherence to treatment in general because that has been NCPIE’s heritage.⁴

Also, persuading the government to fork over more money, even when the need is clear and the uses of the funds worthwhile, will not be a simple matter.

Perhaps even more difficult will be garnering the buy-in of clinicians, governmental agencies, for-profit and not-for-profit healthcare organizations, employers and other funders of healthcare, pharmaceutical companies, and patients to the same plan.

Nonetheless, Enhancing Prescription Medicine Adherence: A National Action Plan seems the most cogent and potentially workable large scale medication compliance enhancement plan published to date.

Accessing Enhancing Prescription Medicine Adherence: A National Action Plan
The report is available in PDF format at ~NCPIE Report and Action Plan PDF~

A Note Re Yesterday’s AlignMap Post
My post yesterday, News Flash! U.S. Government Discovers Treatment Adherence Not 100% - War On Noncompliance Declared, which referenced this Report (which I hadn’t been able to access at the time), was sardonic, mocking, and critical.

In light of what I’ve written in today’s post, the comments in yesterday’s blog entry - are still valid and still heartfelt.

Specifically, I maintain now as I did yesterday when I wrote the preceding post that (1) healthcare noncompliance is not a new discovery but has been a concern to many of us for a long time, (2) there is nothing I find in my initial reading of this report about the nature of noncompliance and its causes that is new, and (3) to the extent that patient education is the total focus of any new program, that program’s potential success is severely and needlessly limited.

Footnotes

1. See News Flash! U.S. Government Discovers Treatment Adherence Not 100% - War On Noncompliance Declared [back]
2. There is some potential for confusing the the report with its press release. The press release (aka Media Advisory), which is more useful than most examples of its genre, is entitled “America’s Other Drug Problem Poor Medication Adherence” and can be found at Online Press Release re NCPIE Report. The press release is also available as a four page PDF document at PDF of Press Release re NCPIE Report. While it’s not clear from the press release, the 34 page report itself is available on the web site of the National Council on Patient Information and Education, the group that organized the study. On that site, the link to the report (in PDF format) is Enhancing Prescription Medicine Adherence: A National Action Plan, which is the same name found on the title page of the report. [back]
3. The clear writing is unusual enough in papers of this kind to warrant a recommendation for reading [back]
4. I should note that while I have no direct connection with NCPIE, I’ve used their materials extensively over the years and have found them a trustworthy organization providing useful services and materials. [back]

• Cost-sharing and Adherence To Prescribed Medication
• Suicide As Sequela of Noncompliance
• Adherence To Treatment For Hypertension
• Mom, Take Your Pills - Oh, And Happy Mother's Day
• Individualized Dose Packets Simplify Medication Adherence

This Is News?

On first reviewing Report: Skipping Doses Could Be Deadly, an AP story by Lauran Neergaard published July 30, 2007, I placed it in my Might Be Worth An AlignMap Post Sometime If Nothing Better Comes Along stack.

After all, the largest portion of the article is little more than a competently done riff on your standard Patient Compliance Story Template, i.e., medication noncompliance is rampant, noncompliance is responsible for huge proportions of unnecessary healthcare costs as well as increases in mortality and morbidity, healthcare literacy, cost of medication, and forgetfulness ares part but not all the problem, X% of all patients with Disorder Y are noncompliant, consider these statistics about and examples of medical noncompliance,¹ … .²

The only additional items in the story are (1) the report of the specific study referenced, which turns out to be a review of recently completed research showing that medication noncompliance is rampant, noncompliance is responsible for huge proportions of unnecessary healthcare costs as well as … and (2) the information that The Agency for Healthcare Research and Quality plans to launch “an ‘in your face’ campaign to improve medication adherence.”

The promotion of “Report: Skipping Doses Could Be Deadly” from back-up fodder to today’s topic is consequent to the story being picked up, as far as I can determine, by every existent newspaper and healthcare blog, many of which seem to be presenting it as news.

To which I can only respond, What the heck?

OK, perhaps a key motivation for dragging myself from the cheap and tawdry novels that have been transformed into legitimate reading material by my official status of convalescent to my keyboard to produce this post is that I’m a tad miffed that while some of us have been plugging away about patient compliance for years, perhaps even, say, creating a web site and blog about treatment adherence, it’s The Agency for Healthcare Research and Quality that somehow earns notoriety throughout the media for stumbling over the phenomenon in mid-2007.

Well, better late than never, I guess.

And even I would find it difficult not to like any physician or bureaucrat, who declares, as did Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality,

We go into this [campaign against noncompliance] with some humility. … It’s really pretty appalling how badly we [deal with noncompliance].

Is This Rediscovery Of Noncompliance Different From Earlier Discoveries Of Noncompliance?

Clinicians have battled noncompliance since at least the fifth century BC (and no doubt long before that) when Hippocrates advised physicians1 to “keep watch also on the faults of the patients which often make them lie about the taking of things prescribed.”³

Interest in patient compliance has waxed and waned. A medical journal devoted to compliance was, in fact, published briefly. Individuals or research groups or pharmaceutical companies or someone is always coming up with the news that noncompliance exists.

Public interest is likewise sporadic. The first words from the body of the AP article published yesterday, “Consider it the other drug problem,” calls to mind the June 2, 1998 New York Times feature on healthcare noncompliance by Zuger, called “The ‘Other’ Drug Problem: Forgetting to Take Them.” And it was C. Everett Koop, a U.S. Surgeon General of these United Sates, who semi-famously observed that “Drugs don’t work in patients who don’t take them.”

And what’s come of all this? I quote from my favorite source, The AlignMap site. In this case, the relevant text is excerpted from The Verdict From Patient Compliance Research:

The labors of compliance researchers have resulted in an impressive number of papers published (a Medline search for “patient compliance” turns up more than 27,000 articles over the past 20 years; and the chart below by Dusing et al indicates the pace of such publications is accelerating), a similarly impressive Internet presence established (Google shows about 408,000 hits for “patient compliance”), numerous post-graduate degrees earned, some positive PR generated, and, occasionally, an isolated, situation-specific improvement in compliance rates.

None of this, however, has led to reproducible methodologies that can reliably and enduringly enhance compliance. Nor has a foundation been laid for the progressive growth of knowledge about and ability to manage treatment adherence.

The most damning evidence of the practical ineffectiveness of contemporary compliance enhancement theories and programs is the absence of their influence on day to day clinical practice. My experience as well as that of my colleagues over many years of medical practice in various settings, locations, and specialties is that patient compliance is only rarely a discrete topic in clinical settings or an issue that comes quickly to the minds of most clinicians, even in situations, such as treatment failure, in which noncompliance is a likely, and perhaps, the likely cause. Even fewer clinicians (other than those treating a few special populations, such as HIV infected patients and organ transplant candidates) implement specific interventions with the goal of managing noncompliance.

After almost 2500 years of pondering, healthcare’s consensus is that compliance problems are complex, and the most promising solutions are also complex, as well as impractical and diverse, with no sure means of determining which interventions are most likely to work for a specific patient. And, few reviewers confidently endorse any specific tactic without extensive hedging.

The Agency for Healthcare Research and Quality Campaign

Quoting from the article,

Got it - the key is educating the patient with ads, better drug labels, and web-based videos.

And now to quote from - ahem - the AlignMap site, The Top Ten Patient Compliance Points: #7

#7. “Better patient education” is the answer — but only if the question is “What is the only response made to correct noncompliance in 90+% of cases?”⁴

This is a specific case of Mencken’s observation, For every complex problem, there is a solution that is simple, neat, — and wrong

There is no indication that patient education is uniformly the appropriate corrective reaction to noncompliance; there is evidence that patient education, regardless of how well structured the teaching process and how motivated the client, is unsuccessful in achieving compliance in a significant portion of cases.

More information does not necessarily result in more compliance. It is a difficult intuitive leap, for example, to concur with the bureaucratic a priori rationale that providing a patient a three-page listing of a medication’s adverse effects (instead of a one-page list of a subset of those adverse effects) will result in that patient taking the medication more faithfully.

Educating the patient without first determining if education will solve the problem for that patient in that situation is no more rational than automatically prescribing antibiotics to every patient complaining of coughing and a sore throat.

Footnotes

1. I believe, but lack the motivation to double check, that nearly every factoid mentioned in the article, along with, of course, many more, is currently on display on the AlignMap web site [back]
2. The author does earn extra points for eschewing the use of the nearly ubiquitous quotation from Hippocrates warning physicians to “keep watch also on the faults of the patients which often make them lie about the taking of things prescribed” or its occasional substitute, C. Everett Koop’s observation that “Drugs don’t work in patients who don’t take them,” both of which I reference later in this post. [back]
3. Wright EC, Non-compliance-or how many aunts has Matilda? Lancet 1993; 9; 342(8876): 909-913. [back]
4. This material was published on this site on 09-19-2006 and was written years earlier for a presentation. I’m one prescient son-of-a-gun, eh? [back]

• Adherence To Treatment For Hypertension
• Consumer Reports Healthcare Survey: Patient Compliance
• Use Of Cardiovascular Disease Medication Low, Consistent Adherence Lower
• Drug Courts
• More On AlignMap In Cites

Take As Directed: A Prescription Not Followed; New Survey Shows Improper Medication Use Reaching Crisis Proportions 12/15/2006

According to a national medication adherence survey¹ just released by the National Community Pharmacists Association (NCPA) and Pharmacists for the Protection of Patient Care (P3C), “nearly three out of every four consumers admit they don’t always take their prescription medications as directed.”

Interestingly, 64 percent of respondents said they follow their physician’s instructions “extremely closely,” but 74 percent also admit to non-adherent behavior.

Other findings follow:

• 49 percent said they had forgotten to take a prescribed medication.
• 31 percent had not filled a prescription they were given.
• 24 percent had taken less than the recommended dosage.
• 11 percent had substituted an over- the-counter medication instead of filling the prescription they were given.

The survey’s press release goes on, “The good news out of the survey was that consumers appeared open to tapping into the unique expertise of their pharmacist in order to improve medication adherence.”

Commentary

While the noncompliance results are hardly surprising, they are useful numbers and reinforce or complement earlier findings. Cynic that I am, I am less impressed with the findings of a survey sponsored by two groups of pharmacists that those surveyed had positive responses to queries about their confidence in pharmacists. Watching market research being carried out over a span of several years, I am acutely aware of the effect the phrasing of a survey’s queries has in prompting a wished-for response. On the other hand, I do believe pharmacists may have a unique, potentially effective role to play as compliance enhancement agents.


Footnotes

1. The telephone survey of 1,000 adults was conducted by the Polling Company, Inc. between Oct. 25-29. The margin of error for the survey is 3.1 percent at the 95 percent confidence level. [back]

• Consumer Reports Healthcare Survey: Patient Compliance
• Welcome To The AlignMap Clinic
• Smoking Persists Despite Related Diseases
• Discussion of Chronic Illness Taboo
• TV Fiction As Public Health Instruction And Motivation

Creating Compliance Pharmaceutical Executive Europe Oct 1, 2006

This interview with Christian Husegaard, the head of sales and marketing for Bang & Olufsen Medicom, contains little, if any, new information but does nicely summarize the basic noncompliance issues and provides some insight into commercial development of compliance enhancements, especially electronic devices to remind patients of their medication regimens.

This excerpt is Mr. Husegaard’s response to the query, “How are approaches to patient non-compliance changing?”

Commentary

Given that this article is, after all, on some level, a puff piece promoting Bang & Olufsen Medicom, perhaps my expectations were unreasonable. Nonetheless, it is disappointing to find Bang & Olufsen, a company with extensive resources and a reputation for design and quality, focused primarily on updated, electronic versions of older methodologies, especially reminders and patient education. While contemporary technology does offer added value, such as providing feedback to prescribing clinicians, the underlying processes have not historically resulted in notable improvements in adherence. One fears that this may be a case of developing a new, more attractive version, with extra bells and whistles, of minimally useful tools.

• Communication & Transparency
• Pharma Compliance Programs Labeled Advertising
• Pharma-Supported Compliance Programs: Today's Problems & Tomorrow's Solutions
• France Rejects Attempt To Legalize Pharma’s Medication Compliance Programs
• The Neverending Search For Determinants Of Patient Compliance and Persistance

The Eyeforpharma Wiki Review & Followup

This post is the followup to the review of the Eyeforpharma Wiki published on the AlignMap blog at Wiki.eyeforpharma.com: A New Source Of Patient Compliance Information. As I noted there, the quality of this nascent wiki is uneven but it is apparent that Wiki.eyeforpharma.com offers a significant opportunity to provide not only worthwhile information but a valuable perspective on patient compliance to clinicians, politicians and bureaucrats, and the lay community as well as those within the pharmaceutical industry. Currently, only a portion of that potential is now being realized. These recommendations are made in that context.

Caveats:
First, readers are well advised that, as the hoary joke has it, free advice is worth exactly what one pays for it. Further, these recommendations fall under the “If I Were King” rubric (i.e., they do not take into account obligations, budgets, plans, etc. to which the Eyeforpharma Wiki may be committed). Finally, readers should be aware that my interest in and thoughts about the Eyeforpharma Wiki are driven exclusively by my conviction that

The folks developing the Eyeforpharma Wiki may well have different goals or at least be less monomaniacal.

Suggestions For The Eyeforpharma Wiki

1. Define the Wiki’s theme
I have yet to grasp the focus of the Eyeforpharma Wiki. While this may be my failing, I did make an extensive but unrequited attempt to figure it out. Others may have the same problem.

In comparison, I am confident that I understand, for example, that the focus of the Wikipedia. Its Five Pillars describe a vigorously edited encyclopedia characterized by a neutral point of view and evidence-supported accuracy. Similarly, the WikiCPA declaration that it is “dedicated to all things CPA” and the MormonWiki’s objective, to be “the free encyclopedia about Mormons from the perspective of faithful members,” provide a context for reading or creating their content.

Without such an orientation, contributors are left to guess what material and styles fit. For example, my criticism the Patient Compliance entry promotes specific compliance programs by quoting the creators of those programs rather than citing research references would, I suspect, be congruent with the Wikipedia ideals. If, however, the Wiki were based on something akin to the MormonWiki’s “perspective of faithful members,” the testimonial approach could prove acceptable. The problem, of course, is that various contributors may have different notions of what is appropriate.

Consequently, a clear orientation/mission statement/theme is essential.

2. Change the Wiki’s designation to a neutral name
While Eyeforpharma has every right to append their name to any of their projects, I submit that ones motivation to contribute to this Wiki and the likelihood that one will view it as unbiased are attenuated by the use of the corporate name and logo in the Wiki’s title and by the Eyeforpharma.com URL.

3. Tighten the infrastructure
Stylistic guidelines, including consistent capitalization, punctuation, and parallel structure, should be established and enforced for easier reading and greater credibility. The Wiki’s organizational scheme should also be revised. If listings of individuals and companies, for example, are to be included in the Index along with entries dealing more general topics, such as Patient Compliance, E-tailing, and CNS Drugs, separate categories should be established to aid navigation.

Conclusion

Those who have previously visited this blog will not be surprised to learn that my original catalog of recommendations was far more extensive and detailed. I have come to realize, however, that inflicting my complete wish list on readers would be burdensome to them without a compensatory increase in impact on the Eyeforpharma Wiki.

In any case, I understood at the outset that, in general, unsolicited advice is rarely considered, let alone embraced, and that the chances of any changes being effected as a result of these ideas were small. Still, when any opportunity to push compliance enhancement arises, I find it hard to ignore. That the Eyeforpharma Wiki could be a forum with the potential for influencing the entire pharmaceutical industry’s perception of patient compliance proved irresistible.

So, I’ll return to the modest aspiration of minding my own blogging but will continue to watch the evolution of the Eyeforpharma Wiki in the hope that it proves a huge success.

• None Found

Improving Medication Adherence: Challenges for Physicians, Payers, and Policy Makers
Patrick J. O’Connor.
Arch Intern Med. 2006;166:1802-1804.




In his thought-provoking editorial, Dr. O’Connor succinctly summarizes the problems of noncompliance:

The Challenges

The majority of the paper consists of eight challenges:

CHALLENGE 1: Can we stop blaming patients for medication nonadherence?

CHALLENGE 2: Can we develop office systems or teams that provide necessary information on new medications at the time of prescription?

CHALLENGE 3: Can we develop communication and coordination systems to reduce medication errors at transitions in care?

CHALLENGE 4: Can we use more combination tablets and inexpensive “polypills” to achieve better medication adherence and lower costs?

CHALLENGE 5: Can we promote the use of especially beneficial drugs and reduce the use of less beneficial drugs?

CHALLENGE 6: Can we educate our patients to be nonadherent in a rational way?

CHALLENGE 7: Can anything good come out of drug formularies?

CHALLENGE 8: Can we resist the temptation to medicalize life from birth to death?

Commentary

Implicit in the range of issues encompassed by O’Connor’s eight challenges is the principle that has become my central theme: significant improvement in patient compliance is possible only when the interests of all the stakeholders, including patients, clinicians, and policy-makers are aligned. I’m especially supportive of the notion that patient noncompliance should be considered a potentially valid choice rather than automatically designated healthcare’s cardinal sin. I also admire O’Connor’s endorsement of financial incentives, one of the few compliance enhancements that has been demonstrated to be effective in multiple settings with different patient populations.

While the eight challenges are not of equal significance and do not exhaust the potential issues of adherence to treatment, they do represent the most comprehensive and, more importantly, most potentially useful battle plan for improving adherence that I’ve found. This editorial is an essential read for anyone interested in patient compliance with treatment.

• None Found

This post consists of a single bit of data but it is a particularly poignant and telling example of the impact of noncompliance. The text is from slide 14 of the set, Maximizing Contraceptive Service Delivery:

Compliance counts in the contraceptive process because a significant portion of contraceptive success is associated with compliance-related issues. Using a rough figure of 10 million U.S. women who might be taking oral contraceptives, every 1% decrease in effectiveness could result in approximately 100,000 unintended pregnancies. That means if one method is just 1% more effective in the long run than another, we may be able to avoid up to 100,000 unintended pregnancies. Moreover, if two methods are equally efficacious, the better the compliance for one method, the better the effectiveness will be for that method.

This slide can be found at
~Compliance Is Critical to the Contraceptive Equation~

The entire slide set, which can be downloaded from the Contraception Online site, begins at
~Maximizing Contraceptive Service Delivery~

• None Found

In 1975, Mattar and colleagues analyzed the extent to which 300 pediatric patients received their prescribed medication regimen (from their parents) for the treatment of acute otitis media.¹ The results follow:

• 36% of the children received an insufficient number of doses
• 37% of the children did not receive a complete course of antibiotic because the parents unilaterally discontinued the medication early
• 20% of the children received the wrong dosage because of incorrect labeling, misunderstood instructions, and other unintentional errors
• 7% of the children received the medication exactly as prescribed

Commentary

While these blog posts usually deal with more contemporary research or events, the Mattar article is today’s focus because it is one of the first studies I happened to read that led to my realization of the remarkable extent and pervasiveness of noncompliance. In this case, thorough adherence to treatment is the aberration and noncompliance is the norm.

Footnotes

1. Mattar ME, Markello J, Yaffe SJ. Inadequacies in the pharmacologic management of ambulatory children. J Pediatr. 1975;87:137-41. [back]

• None Found

When Advice on Diabetes Is Sound, But Ignored Gina Kolata. New York Times October 17, 2006

The questions explored in this article are easy to grasp, difficult to resolve, and profoundly important to understand if compliance management is to advance:

How long does the clinician wait (and, in the process, allow a disorder to persist) if noncompliance negates the best possible course of therapy (i.e., the safest effective treatment) for a disorder such as type 2 diabetes to recommend another treatment that is either less effective or less safe but more likely to be followed by the patient? And, by extension is the optimal initial treatment recommendation for a disorder such as type 2 diabetes (1) the best possible course of therapy (i.e., the safest effective treatment) for which compliance is known to be low or (2) another treatment, either less effective or less safe, for which compliance is known to be higher?

In the case of diabetes 2, for example, research findings clearly indicate that diet and exercise can delay onset of symptom for years if not indefinitely. Moreover, among fully compliant patients, exercise and diet have been shown to be more successful in preventing diabetes than metformin, the most frequently recommended medication. (Rosiglitazone may be more effective than either metformin or diet and exercise but does have a risk of side-effects.)

The clinker in the equation, of course, is that, without an extensive and prohibitively expensive reinforcement program, a very low percentage of patients adhere to the exercise and diet programs.

This noncompliance has resulted in a change in the international treatment guidelines, which have traditionally hedged by recommending that patients with full spectrum Type 2 diabetes first attempt a program of exercise and weight loss with medications prescribed only after that trial failed. As of August, however, the guidelines recommend starting patients on metformin immediately since most are unable to follow the lifestyle recommendations. By the time the lifestyle change attempt was acknowledged to have failed, the patients could have suffered from uncontrolled diabetes for months or years. The new guidelines are the result of the reasoning that the consequences of untreated diabetes are too severe to risk noncompliance.

Commentary

Type 2 diabetes is a good example of this problem but hardly the only one. Grappling with this concept is key to redefining “patient compliance” into a model that provides clinical guidance and utility.

• Aligning The Interests Of Uninsured Patients And The Hospitals That Care For Them
• Religious Practices and Patient Compliance
• Lancet Recommends European Union Mandate Vaccination Against Cervical Cancer Virus
• Compliance Is Compliance Is Compliance
• Watching Compliance