AlignMap

Carefully monitored treatment can help two-thirds of those who suffer from depression from HealthOrbit, Inc.

The six year Sequenced Treatment Alternatives to Relieve Depression(STAR*D) study of 3,671 patients treated in real-world settings, demonstrates that “more than two-thirds of those suffering from major depression can become symptom-free if they work with their doctors and try various treatments to determine which work best for them.”

Remission was reached by

• 37% after the first treatment step
• 31% after the second treatment step
• 14% after the third treatment step
• 13% after the fourth treatment step

Commentary

The finding that many patients require more than a single trial on a medication for successful treatment of depression is congruent with the clinical experience of most of us in the field. The message here is that compliance is vital, not only to assure that the patient has the best chance for his or her medication to work as it should but also to provide accurate data to determine that treatment failures are the result of ineffective agents rather than ineffective administration.

Pertussis Outbreak in an Amish Community—Kent County, Delaware, September 2004–February 2005 From the Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report 2006;55:817-821. JAMA Vol. 296 No. 16, October 25, 2006. 1960-1964.

Noncompliance With Pertussis Vaccination

While the theological tenets of the Amish permit vaccination, the CDC continues to document low coverage for routine childhood vaccinations in many Amish communities. In this case, 345 cases of pertussis occurred, mostly in preschool children, during a September 2004–February 2005 outbreak in such a group in Delaware.

After the initial cases were reported, “control measures and active surveillance for additional cases were instituted, including enhanced contact investigation and outreach and special community pertussis clinics at Amish schools.” Laboratory confirmation of the diagnosis was also obtained.

In addition, a self-administered survey and interviews with volunteer households were used to obtain data re vaccinations. Pertinent results follow:

In an editorial note, the CDC points out that “among the diseases for which universal childhood vaccination is recommended in the United States, only pertussis has had an overall increase in reported cases since 1980, increasing from 1,730 cases in 1980 to 25,827 cases in 2004.” In the outbreak afflicting this Amish community, the younger children (1-5 year old) were overrepresented, accounting for 41% of all cases, a rate congruent with that seen throughout the US prior to the availability of vaccination.

Commentary

The too-often repeated sequence of inadequate community adherence to vaccination schedules followed by outbreaks of preventable disease is one more reminder of the importance of the need to actively promote compliance enhancement to prevent as well as treat disorders.

To Prevent Amputations, Doctors Call for Aggressive Care By Elizabeth Svoboda. New York Times November 7, 2006

The central point of this article is the possibility of preventing amputation as a consequence of disease, especially diabetes. This is not an uncommon outcome; 1.8 million Americans have had amputations, and more than 100,000 non-accident-related, lower-limb amputations are performed annually in the United States.

The issue of patient compliance, however, is paramount.

Commentary

In addition to the importance of amputations themselves, this article is significant because (1) it is a reminder that, while medication compliance receives the lion’s share of attention in the field of patient compliance, nonadherence is a frequent and devastating problem in almost every kind of treatment regimen and (2) clinicians have a responsibility to make treatment recommendations that are based on realistic expectations of compliance in general and a realistic assessment of the specific patient’s capacity for compliance.

From: Jeffrey Nard and Mark Townsend. “Finding the balance in bipolar disorder: focus on mania and safety.” An industry-sponsored symposium presented in conjunction with the U.S. Psychiatric & Mental Health Congress, New Orleans, La., November 16-19, 2006. Reviewed in Diagnosing And Treating Bipolar Disorder By Jeff Minerd. November 21, 2006

While patients and clinicians often assume that medication noncompliance among patients with bipolar disorder, an especially common problem, is typically caused by the the patient’s hope to regain the euphoria associated with manic episodes, this is, according to a survey published in Psychopharmacology Bulletin, the reason least cited by noncompliant patients, being named as the primary cause for noncompliance by only 2% of patients. In comparison, approximately 30% said they failed to comply with medication because of side effects, such as sexual dysfunction and weight gain.

Happy Thanksgiving

No new AlignMap posts are anticipated during the Thanksgiving Holiday. Regular postings will resume Monday, 27 November 2006.

Medication Costs Infrequently Addressed When Newly Prescribed

According to a UCLA study that will appear in the November issue of The American Journal of Managed Care, only one third of patients receiving new medication prescriptions are given information about costs or the opportunity to discuss obtaining the medications by their physicians despite the importance of costs to adherence.

185 patients were studied through surveys and transcriptions of patient visits. They were seen by 15 different family physicians, 18 internists, and 11 cardiologists. The patients averaged 55 years old; half were male, 83 percent were white, most had health insurance, and more than three-fourths paid less than half of their prescription drug costs out-of-pocket.

Commentary

This finding is hardly surprising but nonetheless disheartening. Cost is one of the many elements that must be addressed with every patient if adherence rates are to be improved.

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.

Medication Compliance Research: Still So Far to Go Albert I. Wertheimer, Thomas M. Santella Journal of Applied Research in Clinical and Experimental Therapeutics 2003; 3(3): 254-261.

The authors have compiled the compliance research, dividing it into six categories:

1. Articles identifying adherence as a problem
2. Articles identifying the causes of noncompliance & exploring solutions
3. Articles analyzing adherence with respect to specific ailments
4. Articles exploring the patient’s role with respect to compliance
5. Articles exploring the pharmacist’s role with respect to compliance
6. Articles exploring the physician’s role with respect to compliance

The bulk of this article deals with the prevalence, incidence, and costs of noncompliance; examples of the compliance enhancements currently available; the theoretical models of medication compliance; and the incapacity of the healthcare professions to effect positive changes.

The conclusions are disheartening.

The final recommendation is limited to

Commentary

This article is useful as a survey, but its categorization of articles seems arbitrary and of minimal utility. Similarly, the recommendation that research focus on the clinician is followed not by an explanation or support but by confessions that previous studies provide little direction for this tack.

Patient compliance From Wiki.eyeforpharma.com

The Eyeforpharma Wiki

Eyeforpharma, which describes itself as “the leading pharmaceutical business strategy information provider” and produces industry conferences as well as supplying news, events, research reports, and interviews with movers and shakers in the field, recently opened the Eyeforpharma Wiki, modeled on the Wikipedia, that focuses on information relevant to the pharmaceutical community.¹

As of this posting, the content of this nascent wiki is limited to brief descriptions of pharmaceutical companies (e.g., GSK and Merck) and individuals (most of whom seem to work for Eyeforpharma) and a handful of industry-specific articles that range from two lines on Medicare and Medicaid to three screens on E-detailing.

Most pertinent to the AlignMap blog’s interests, of course, is the significant entry on Patient compliance.

Patient Compliance On Wiki.eyeforpharma.com

The article is divided into eight sections:

1. Description
2. Case Studies And Recent Findings
3. Talking up compliance
4. Patient non-compliance a “rampant” problem
5. Latest Thoughts
6. Ways to improve adherence
7. A role for the pharma industry
8. Patient compliance through education and adherence programs

Description
The basic data about treatment adherence found in Description is clearly written, well referenced, and accurate although it offers little that is unique and that couldn’t be found in standard reviews in the literature or other sites such as AlignMap.com.

Case Studies
Similarly, the Diabetes and Osteoporosis Case Studies are interesting and insightful but are, by necessity, arbitrary choices. Heart disease, asthma, or HIV disorders, for example, could have served the purpose equally well. More to the point, there is again little information or analysis here that couldn’t be found in several other sites or articles in print.

Talking up compliance
Talking up compliance, on the other hand, does deal with less common issues — the interface of communication among patients, clinicians, and the pharmaceutical industry, including the impact of explicit points of discussion. This material is not typically featured in the medical literature. Further, my experience has been that such content, when covered in newsletters and web sites within the pharmaceutical industry, seems most often presented to promote or defend a program or strategy rather than to explore and evaluate the issues with an evidence-based approach.

Patient non-compliance a “rampant” problem
Patient non-compliance a “rampant” problem returns to a standard exposition of basic facts about the prevalence and incidence of nonadherence and, in fact, might more logically fit in the initial Description section.

Latest Thoughts
Latest Thoughts is a thoughtful take on the importance of enhancing adherence and the means of achieving this goal.² The section’s themes can be summarized by these three quotes:

1. Improving adherence might be the best investment for tackling chronic conditions effectively.
2. Interventions for removing barriers to adherence must become a central component of efforts to improve population health worldwide.
3. For outcomes to be improved, changes to health policy and health systems are essential.

Ways to improve adherence
Ways to improve adherence is a reiteration of the empowered patient concept. While this approach has obvious appeal, is politically correct – and may even work, it is disheartening to find it reported here as fact without any references or support.

A role for the pharma industry
A role for the pharma industry begins, “The main role of the pharmaceutical industry is to develop safe and efficacious treatments” although it does go on to advocate the education of patients about those products. While this may be accurate in the most restrictive sense, its tone seems oddly incongruent with the preceding points in this same Patient Compliance entry that emphasize the imperative to enhance adherence by any means possible. For example, “Increasing the effectiveness of adherence interventions might have a far greater impact on the health of the population than any improvement in specific medical treatments” implies, by my reading, that pharma’s responsibility extends beyond providing “safe and efficacious treatments.” An even more directly conflicting declaration is embedded in Latest Thoughts, “Medicines won’t work if you don’t take them. Even the best treatment plan will fail if it isn’t followed.”

Patient compliance through education and adherence programs
Patient compliance through education and adherence programs also promotes specific methodologies. Two excerpts that characterize this section follow:

Mirroring my comments on the Ways to improve adherence section,³ these approaches have obvious appeal, are politically correct – and may even work (although it is far from certain that either patient education or medication reminders is a panacea⁴ ), but it is, again, disheartening to find such theories reported as self-evident facts without any references or support other than the (hardly surprising) endorsements by those responsible for those programs.

Commentary

The quality of this early offering is uneven but it is apparent that the 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. A course correction at this early point could have a significant impact that will be impossible later. I’ll offer specific recommendations for improving the situation⁵ in a future post (either the 16 November or 19 November entry).

Update
The recommendations and followup can be found at Recommendations For Wiki.eyeforpharma.com


Footnotes

1. The Eyeforpharma Wiki joins a group of other information sharing sites emulating the Wikipedia, including WikiCPA, “dedicated to all things CPA,” the RHIO Wiki Web site, an online clearinghouse for Regional Health Information Organizations, and MormonWiki, “the free encyclopedia about Mormons from the perspective of faithful members.”↩
2. “Thoughtful take,” of course, means the author agrees with what I’ve been pushing.↩
3. It is not clear to me why Ways to improve adherence and Patient compliance through education and adherence programs are separate sections↩
4. See Myth #3. Noncompliance Can Be Eliminated By Educating The Patient, Motivating The Patient, Eradicating Or Relieving Side-effects, Simplifying The Treatment Plan, … in Patient Noncompliance Myths↩
5. The folks at Eyeforpharma are, no doubt, breathless with anticipation of my oracular pronouncements.↩

Effect of Medication Nonadherence on Hospitalization and Mortality Among Patients With Diabetes Mellitus
Ho, P et al
Arch Intern Med 2006;166:1836-1841

The results of this study can be condensed into two points:

1. Noncompliance with diabetes treatment is prevalent
2. Noncompliance with diabetes treatment is associated with increased risk of hospitalization and death

Data

Ho and colleagues retrospectively studied 11,532 patients with diabetes mellitus, calculating adherence as the proportion of days covered (PDC) for filled prescriptions of oral hypoglycemics, antihypertensives, and statins and defining nonadherence as PDC< 80%. The primary outcomes were all-cause hospitalization and all-cause mortality between January 2004 and April 2005.

21.3% of patients were noncompliant. This group, which tended to be younger and have fewer comorbidities compared with adherent patients, had higher all-cause hospitalization (23.2% vs 19.2%) and higher all-cause mortality (5.9% vs 4.0%).

Commentary

As was true with Ho and colleagues’ post-MI treatment compliance study, the results here are not surprising but are convincing affirmations of the significant prevalence and consequences of nonadherence and are evidence of the need for further research and pragmatic solutions to this clinical problem.

Prime time to learn By Susan Brink, Los Angeles Times November 13, 2006

This especially interesting article convincingly presents an intriguing premise outlined in its first paragraph:

Screenwriters are far more capable than healthcare professionals to gain and retain the viewer’s attention, to educate, and to inspire without sacrificing accuracy.

Examples of the power of television programming to move the audience include an increase in contraceptive sales of 23% the first year a Mexican telenovela, “Acompañame,” dealing with an impoverished woman’s efforts to prevent having more children, aired (compared with an increase of 7% the previous year) and an increase in the reported condom use during the last sexual encounter from 34% among South Africans who did not tune into a soap opera called “Tsha Tsha” to 60% among those who watched 10 or more of the programs.

According to the article,

Further, a popular TV program accesses an audience much larger than any group of physicians can hope to reach.

Commentary

My only caveat is that this well-researched article is dedicated to the thesis that TV programming is a positive force for healthcare. Little attention is given to the potential problems such programming could cause. An example that comes quickly to mind is the creation of unrealistic expectations by the physicians portrayed by expert actors abetted by a script that describes miraculous cures, astounding diagnoses, and cases wrapped up in 60 minutes compared to real-life clinicians who are harried and haven’t the advantage of a convenient script to fall back on.

Nonetheless, this is a valuable idea and one that seems potentially useful conveying a concept as complex as adherence to treatment.

Impact of medication therapy discontinuation on mortality after myocardial infarction
Ho, P et al
Arch Intern Med 2006; 166: 1842-7

The results of this study can be condensed into one dramatic point

Data

Results: Of 1521 patients discharged with the following three medications, aspirin, beta-blockers, and statins,

• 184 discontinued use of all 3 medications at 1 month post-discharge;
  Survival rate 1 year post discharge: 88.5%
• 56 discontinued use of 2 medications at 1 month post-discharge;
  Survival rate 1 year post discharge: 96.4%
• 272 discontinued use of 1 medication at 1 month post-discharge;
  Survival rate 1 year post discharge: 97.8%
• 1009 continued taking all 3 medications at 1 month post-discharge;
  Survival rate 1 year post discharge: 97.8%

Patients who discontinued all medications had a lower survival rate than those who continued taking one or two of the three prescribed medications.

Of the demographic factors analyzed, the most significant finding was that patients who did not complete high school were more likely to discontinue all three medications than the group that did graduate from high school.

CME

A related CME course is available at www.archinternmed.com

Commentary

Given the congruence of these results with other studies, neither the extent of noncompliance or the extent of its effect on mortality are surprising. Nonetheless, the numbers are dramatic and convincing.