Check The Fine Print For Noncompliance - Part 2
Are Prescription Labels Readable? Clues From The Marketplace
The preceding post, Check The Fine Print For Noncompliance - Part 1, included a couple of studies indicating that, indeed, there are problems deciphering the medication information and instructions printed on prescription pill bottles in a font size technically known - on this blog - as “too damn small.” That these texts are too often smudged, faded, irregular, and disorganized, as well as plastered onto a curvilinear surface, is just a bonus.
In addition, the marketplace also suggests that the difficulty of reading prescription labels is a recognized and widespread problem.
Otherwise, why would products like the Label Enlarger exist?
Label Enlarger
This Label Enlarger and gadgets like it can be purchased from a number of sources for less than $10.
A more sophisticated device, the pill bottle capable of providing audible label information, was originally developed for blind patients but is now marketed to a wider market, including those with age-impaired vision.
The Talking Pill Bottle
Like the Label Enlarger, the Talking Pill Bottle is available in several versions and from several sources.
Specialized labels, warning symbols, and large print labels are available to patients to transform prescription bottle label information into a format that is clearer and less given to misinterpretation.
Pill Bottle Labels
This, of course, begs the question of why patients have to provide this service for themselves.
What Have We Learned?
The proposition that follows is my own idiosyncratic take on the matter, but it is so basic that I am confident I can defend it easily enough.
- If special aids are required to read medical instructions on pill bottles, those instructions are too hard to read.
- Instructions that are too hard to read will not be read as often or as accurately as instructions that are easy to read.
- Instructions that are not read accurately or not read at all will cause unintentional noncompliance.
- Noncompliance leads to unnecessary fiscal costs and increased morbidity and mortality.
Other Lessons From The Marketplace
The problem with font size is not limited to prescription medicines.
And the problem doesn’t seem to be going away on its own.
Wanna see something scary? The label formats displayed below are currently offered for sale to pharmacies (I have changed only the pharmacy name; otherwise, these are unchanged from their presentation on the printing companies web site).
Prescription label form sold to pharmacies (click on graphic to view larger image)
Prescription label form sold to pharmacies (click on graphic to view larger image)
Imagine these overfilled, pre-faded labels affixed to the curved surface of a pill bottle. Imagine my Aunt Hazel and Uncle Foster, both in their 90s, trying to read that text.
The Solution and Why It’s Important
Before Ross Perot was a third-rate third-party presidential candidate, he was a creative, successful businessman who would, on occasion, observe, “If you see a snake, just kill it - don’t appoint a committee on snakes.”
Well, in this case, the snake is pretty obvious: The US population is aging with the huge boomers cohort approaching the age when visual changes make reading small print more difficult. Many prescription labels contain medication information and instructions written in especially small type. The inability to read a prescription label or, even worse, the inaccurate interpretation of medical instructions because of impaired vision and tiny print leads to unintentional noncompliance and that, my friend, is a snake.
Having identified this specific snake, killing it turns out to be a straightforward matter - at least, hypothetically. How about this? The government simply passes a regulation forbidding the use of a font size below, say, 12 points, on prescription labels.
Some may protest that providing sufficient information in larger print on a small label is a physical impossibility. Solving that design problem seems, however, less complex than, for example, decreasing automobile pollutants and increasing fuel mileage to meet those progressively more demanding governmental mandates.
Further, some pharmacies have already been at work on this problem. I came upon this example of from HealthPartners.com.
Even the “After” label isn’t perfect but it’s certainly a significant improvement.
Another heartening example I serendipitously discovered comes from Pharmacy In Focus, the Ulster Chemists’ Association’s official trade publication:
While Mr Perot might point out that there seems to have been more snake committee-forming in this process than was essential, especially since the nurses were already aware that “patients had raised previous concerns about their medicines,” a better label system was introduced.
I suspect clever designers could come up with a variety of inexpensive, easy to implement solutions, but even an unsophisticated approach, such as a page attached at one corner to the pill bottle that folded out to reveal the information in readable text, would be better than ignoring the fact that a large and growing number of people can’t reliably read the the essential information about their medication from the labels.
Larger fonts on medication labels is not a panacea for all noncompliance, nor is it a sexy issue likely to attract a high ranking celebrity as spokesperson for the cause.
Instead, it’s a simple problem with simple solutions. Mainly, it requires dropping the pretense that the use of small, unreadable print is a necessary annoyance and changing a few printers to eliminate a lot of grief, decrease the course of treatment for many, and save more than a few lives.
Related Posts:
Check The Fine Print For Noncompliance - Part 1
Inadequate Font Size As A Cause Of Noncompliance
While young at heart, I am presbyopic of vision. Consequently, I have become aware of the difficulty reading certain types of texts that one routinely encounters on a frequent basis. The day to day category that has proved most troublesome is, by a wide margin, prescription medication labels.
It will surprise no one familiar with my interest in patient compliance that I have been speculating on the likelihood that misunderstanding and frustration engendered by problems reading the instructions jammed onto these labels lead to unintentional noncompliance with medication.
The potential for problems of this sort seems so high, in fact, that I have been surprised how infrequently this issue is listed as a possible cause. Illiteracy and instructions being written in a language other than the patient’s, for example, are much more common in the literature.
This week, I happened onto an exception to this pattern: Barriers to Medication Adherence in Poorly Controlled Diabetes Mellitus by Peggy Soule Odegard, PharmD and Shelly L. Gray, PharmD,1 identifies challenges to adherence behaviors in 77 patients taking diabetic medication. The pertinent results show that “taking more than two doses of DM medication daily and difficulty reading the DM medication prescription label were significantly associated with higher hemoglobin A1c.”2
The Variability and Quality of Medication Container Labels
Shrank and colleagues published The Variability and Quality of Medication Container Labels3, an assessment of “the format, content, and variability of prescription drug container labels dispensed in the community.”
Excerpted from the abstract:
To illustrate the results of materials printed font sizes, I have provided, in the graphic that follows, lines in Arial typeface in those same font sizes, rounded to the nearest whole number (which is given in parentheses).
Dr. Shrank’s findings are damning, and there is more, but that’s the next post.
Next
Small Print and Noncompliance - Part 2: More Evidence, Solutions, and Why This Issue Is Important (and not just to me)
Footnotes
- Peggy Soule Odegard, PharmD and Shelly L. Gray, PharmD, Barriers to Medication Adherence in Poorly Controlled Diabetes Mellitus The Diabetes Educator, Vol. 34, No. 4, 692-697. 2008 [back]
- Increased A1c is used here as a proxy for poor adherence [back]
- William H. Shrank, MSHS, MD; Jessica Agnew-Blais, et al. The Variability and Quality of Medication Container Labels. Arch Intern Med. 2007;167(16):1760-1765. [back]
Related Posts:
Welcome To Australian Rules Medication Compliance
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.
Related Posts:
John Edwards On Patient Compliance
And Bloggers On John Edwards
Were one to draw the Venn diagram of patient compliance and presidential campaigns, one would anticipate the intersecting portion would be minuscule if it existed at all. Further restricting that intersection to an overlap patient compliance, presidential campaigns, and public controversy certainly, one would think, doom that result to the ignominy of the null set.
Well, as of 2 September 2007, one would be wrong.
That day, presidential candidate, John Edwards elaborated on his healthcare plan to the folks in Tipton Iowa in a speech described in Edwards Backs Mandatory Preventive Care, the AP news story by Amy Lorentzen:
From the lighting of that fuse to explosions of outrage in the conservative blogosphere required only a few hours.
Consider, for example, a Newsalert post published at 7:52 PM the same day the speech was given:
The AP reports on Comrade Edwards:
… [An excerpt from the AP story referenced above follows] …
Comrade Edwards is going to force you to go to the doctor whether you like it or not.You will not be free because Comrade Edwards wants a monopoly on your health care.
And, just in case the reader doesn’t pick up on the subtle political connotations of “Comrade Edwards,” the post is headed by the following emblem:
How about a few other examples, just for grins?
From the post with my favorite title, Healthcare Part VIII - Drop that Twinkie or I’ll Shoot! at Angry Bear,
No word if Edwards will give us veggies.
And from John Edwards: “you can’t choose not to go to the doctor for 20 years” posted at Althouse, come these passages:
Daystar51 goes beyond lambasting Edwards for promoting “mandatory preventive health care” to speculating on the possible origins of this notion buried in the candidate’s psyche:
Mandatory preventive health care? Come on, no one could think that.
But Edwards says he does. He says if you’re going to be in the system, “you have to go in and be checked and make sure that you are OK.” Only he doesn’t happen to mention any way to opt out of the system. His plan “requires that everybody be covered. It requires that everybody get preventive care.” Not only that, but mental health is part of Edwards’s plan. I can only take this to mean that annual check-ins with a psychiatrist would be required, cradle to grave.
I wonder whether Edwards’s plan is designed to fund pill police to make sure you choke down all the good things Doctor gives you.
Interestingly, medical malpractice litigation was Edwards’s specialty when he practiced law. He tried more than 60 med-mal cases, more than half of which brought verdicts exceeding $1 million. He reported an AGI of $11.4 million in 1997. Tidy.
Perhaps Edwards is now enthralled with doctors because his wife has breast cancer. Perhaps his compulsory exam plan is a token of his appreciation, a way of paying doctors back.
An blog/article, dated September 5, 2007, in US News & World Report wields the British healthy practices incentives plan as a blunt instrument to batter the obligatory preventive care Edwards espouses:
The dream of universal healthcare, as outlined so far in the Democratic presidential race, looks like this to me: Every American (says John Edwards) gets health insurance or at least most people (says Barack Obama). Will it mean higher government spending? Probably. But it can be paid for via higher taxes on wealthy Americans (Edwards). But who knows, maybe through greater use of technology, cost savings will be enough to avoid a tax increase (Hillary Clinton).
But as the various plans get looked over, explained, and debated, it seems very likely that all sorts of unanticipated aspects to them will pop up, such as this recent piece of insight from Edwards regarding his plan, via an AP story:
“It requires that everybody be covered. It requires that everybody get preventive care,” he told a crowd sitting in lawn chairs in front of the Cedar County Courthouse. “If you are going to be in the system, you can’t choose not to go to the doctor for 20 years. You have to go in and be checked and make sure that you are OK.”
Certainly at first glance, Edwards seems to be advocating a system where you get health insurance only if you follow certain government-prescribed healthcare routines, like regular doctor visits. Now after re-examining the Edwards plan, liberal blogger Ezra Klein concludes that patients “will have incentives to avail themselves of preventive options. But there won’t be any mandate for X doctor’s visits every Y years.” Maybe he’s right. But then again, maybe Edwards was accidentally describing the future of any government-directed healthcare system. Just look at Great Britain. That nation’s national health system already demands that obese patients lose weight before receiving hip replacements. But the out-of-power Tory Party wants to go further, according to London’s Evening Standard (via the Drudge Report):
Failing to follow a healthy lifestyle could lead to free NHS treatment being denied under the Tory plans. Patients would be handed “NHS Health Miles Cards” allowing them to earn reward points for losing weight, giving up smoking, receiving immunisations or attending regular health screenings…. But heavy smokers, the obese and binge drinkers who were a drain on the NHS could be denied some routine treatments such as hip replacements until they cleaned up their act…. Those who abused the system—by calling an ambulance when a trip to the GP would be sufficient, or telephoning out of hours with needless queries—could also be penalized…. Yet while the Health Miles Card would award points for giving up smoking and losing weight, it could penalise those who are already fit and well because they would receive no benefits under the scheme.
Weird Is Relative, writing in What’s the punishment for noncompliance? Endless jury duty?, implies that the Tipton Iowa speech may be fatal to the Edwards candidacy:
It would be difficult to misunderstand the perspective of Not Larry Sabato, who exclaims in John Edwards on Health Care,
This kind of crap is exactly what allows politicians like George Allen to talk about the “nanny state” and collect votes. I totally support universal health care so every American has coverage- but if some people choose not to use that coverage they are given- that is their decision. How is Edwards going to enforce this - will he send the police out to get people who miss their scheduled preventative doctor’s appointments?
In fairness, not every blogger or commenter was bashing Edwards, but pro-Edwards postings are difficult to find. Plunderchat is a one of those few who straightforwardly support the mandatory preventive care, declaring in John Edwards Looking Good on Health Care that
First: “It requires that everybody be covered.”
To make health care affordable for everyone, you need to spread the cost out across the entire population. Twenty-year-olds will often opt out of healthcare because they rarely need it while seventy-year-olds require constant medical- especially if they’ve had little or poor health care while they were younger. If you can keep the twenty-year-olds in the health care pool- then the cost goes down for everyone else.
Second: “It requires that everybody get preventive care.”
It is MUCH cheaper to prevent major medical problems than it is to treat them once they hit. Under the Edwards Plan “If you are going to be in the system, you can’t choose not to go to the doctor for 20 years. You have to go in and be checked and make sure that you are OK.”
If he keeps up like this, I might actually be able to look past his accent. Maybe.
Commentary
1. It turns out that the complete healthcare plan Edwards supports apparently allows folks to opt out of the program if they wish to manage their own healthcare without government mandates. This discovery disappoints me; when I read about the Tipton speech, I envisioned a post about Edwards declaring Patient Compliance “Mission Accomplished.” Then, I would go on to sardonically observe that “the answer to noncompliance was right in front of us - just issue a presidential proclamation that compliance was obligatory. And so on. If folks have the alternative of leaving the system, the obligatory preventive care lacks the extremity of arrogance that would otherwise render this notion an appealing target.
2. Few bloggers noted that we already have a batch of healthcare mandates on the books, including reporting and quarantine of various infectious diseases, undergoing certain vaccinations, obligating parents to follow doctor’s orders re their sick children, lest they be made wards of the state, and, more recently, restrictions on smoking and intake of some foods.
3. I have to wonder if Mr. Edwards and his advisers have considered the difficulty of monitoring, let alone enforcing patient compliance. While checking attendance records to determine who kept and didn’t keep a doctor’s appointment seems simple enough (although distinguishing between appointments missed because of traffic, scheduling snafus, and family emergencies from those missed through noncompliance may require compliance interrogations abetted by bright lights, good copy-bad cop tactics, and polygraphs), medication compliance, for example, is notoriously difficult to determine, and adherence to diet, exercise, and similar non-medication prescriptions is rarely even attempted. Enforcement methods, short of the Pill Police, are relatively easy to come by; e.g., dropping healthcare coverage for noncompliant patients or tying official authorizations such as driver’s licenses to certificates of healthcare compliance would be simple enough, but even a compliance-pusher like me recognizes that this would be a major shift in the patient-clinician relationship as well as in the role of government in this country.
Related Posts:
Ted Nugent, Patient Compliance, and Jerry Lewis
Ted Nugent On Compliance and Healthcare Policy
Appearing on the Glenn Beck Program on CNN Headline News this morning (the screenshot atop this post is from that show), Ted Nugent (AKA Great Gonzos, The Motor City Madman), the hard rock guitarist-singer with a long list of hits, including “Wang Dang Sweet Poontang,” “Fred Bear,” “Cat Scratch Fever,” “Motor City Madhouse,” “Paralyzed,” “Great White Buffalo,” and “Wango Tango,” offered his take on national healthcare and personal responsibility in a single phrase:
Nugent elaborated, suggesting that, for example, the first step for smokers obtaining healthcare would be to stop smoking.
Ted Nugent Offstage
For the past decade, Nugent has been an outspoken proponent of a politically conservative point of view, emphasizing his anti-drug, anti-alcohol, and pro-hunting beliefs. He supports the Ted Nugent Kamp for Kids (which combines a curriculum of hands-on hunting, conservation, archery and a strong anti-drug message aimed mainly at underprivileged inner-city children), the National Field Archery Association, Mothers Against Drunk Driving, Big Brothers Big Sisters of America, and the National Rifle Association.
Commentary: Celebrities And Their Healthcare Causes
I’ve long lamented, primarily as a rhetorical technique, that no organization has dedicated itself to increasing public awareness of and raising funds for research into medical noncompliance although it is a healthcare problem of epidemic proportions. Similarly, no celebrity has associated himself or herself with or served as the spokesperson for such a movement.
This is hardly a trivial issue. As Arthur L. Caplan points out in Cause célèbre - Why every disease needs a celebrity
Well, noncompliance isn’t an illness, but it surely qualifies as a cause, and it clearly lacks the celebrity spokesperson it needs. Perhaps Ted “The Atrocious Theodocious” Nugent is the man for the job.
While “If you don’t care about your health, how dare you ask for healthcare,” may be a tad oversimplified, most one line slogans dealing with messy political, bureaucratic, and medical issues are likely to suffer from that flaw. And, there is something compelling about the notion of sentient adults taking responsibility for their own health in keeping with their role in a workable healthcare system. If nothing else, one knows where Ted Nugent stands on a given question.
Besides, take a look at the second verse of his best known single, Cat Scratch Fever:
-
The first time that I got it
I was just ten years old
I got it from some kitty next door
I went and see the Dr. and
He gave me the cure
I think I got it some more
The guy is stricken with a childhood disorder, goes to the doctor, gets cured, and then has a recurrence. No more than a minor rewrite would be required to create an anthem to the need for adherence to treatment.
Heck, if a guy wielding a semi-hollow Gibson Byrdland guitar, a crossbow, and a deer rifle recommended I follow my doctor’s orders, I’d pay attention.
Update: Ted Nugent Redux
Related Posts:
Directly Observed Therapy For HIV-Infected Children
Source:
Directly Observed Highly Active Antiretroviral Therapy for HIV-Infected Children in Cambodia Patricia Myung, David Pugatch, Mark F. Brady, Phok Many, Joseph I. Harwell, Mark Lurie, John Tucker Am J Public Health. 2007 Jun;97(6):974-7. Epub 2007 Apr 26.
Directly Observed Therapy
While Directly Observed Therapy is typically associated with the treatment of tuberculosis and is often viewed as expensive and draconian, this study of suggests that those stereotypes may be inaccurate and may unnecessarily restrict its implementation.
Abstract
Antiretroviral medications are becoming available for HIV-infected children in resource-limited settings. Maryknoll, an international Catholic charity, provided directly observed antiretroviral therapy to HIV-infected children in Phnom Penh, Cambodia. Child care workers administered generic antiretroviral drugs twice daily to children, ensuring adherence.
Treatment began with 117 late-stage HIV-infected children; 22 died of AIDS during the first 6 months. The rest were treated for at least 6 months and showed CD4 count increases comparable to those achieved in US and European children. Staffing cost for this program was approximately US $5 per child per month, or 15% more than the price of the medications. Drug toxicities were uncommon and easily managed.
Directly observed antiretroviral therapy appears to be a promising, low-cost strategy for ensuring adherent treatment for HIV-infected children in a resource-limited setting.
Commentary
While the vital information is contained in the abstract, it may be helpful to think of the statistics for these children in these terms:
- T helper cells tripled
- Children gained weight
- Drug toxicities were rare and easily managed
- The annual cost per child broke down to $400 for medications; $60 to pay the professionals who administered the drugs
This preliminary study does not prove the value of the program. As the authors point out, a randomized, controlled trial comparing Directly Observed Therapy with standard care is necessary, as is a cost-benefit analysis
The study does, however, lend support to the notion that Directly Observed Therapy could prevent some cases of drug resistance and reduce the number of treatment failures and the number of cases requiring a shift to less efficient alternative therapies - an extraordinarily encouraging prospect.
Related Posts:
Patient Noncompliance Negates Screening Programs
Impact Of Asthma Screenings Blocked by Nonadherence
An American Thoracic Society workshop reports that while population screenings make sense in theory, the benefits are unproven for children with asthma.
According to Lynn Gerald, Ph.D., M.S.P.H., workshop co-chair,
Commentary
I’ve focused on this concern that noncompliance blocks implementation of clinical action when screenings detect possible pathology because it spotlights a hidden cost of nonadherence.
It is an often overlooked albeit obvious fact that the time, human resources, and money expended to discover a case of untreated asthma - or any other disease - are lost unless the that patient pursues clinical confirmation of the disorder and any necessary treatment.
The reality of noncompliance is crystallized in Dr. Gerald’s recommendation that the limited resources of public health should be used for children with active symptomatology rather than screenings.
Source:News-Medical.Net
Related Posts:
Suicide As Sequela of Noncompliance
The Annual Report on Suicide Prevention
Source: National Suicide Prevention Strategy For England - 2006 Report
In a generally optimistic report by the National Institute for Mental Health in England on the effort to reduce suicide in that nation by 20 per cent by 2010, there is a somber note about the role of noncompliance in suicide:
The Avoidable deaths report published last year estimated that 56 mental health patients discharged from hospital die every year following non-compliance with medication or loss of contact with services. Supervised Community Treatment, a measure to improve clinical risk management that the Government is introducing in its Mental Health Bill, has the potential to help prevent those deaths. Having a severe mental illness is a known risk factor of suicide and a significant number of suicides occur during in-patient care or shortly after discharge. Avoidable deaths showed around 200 suicides a year - or 14 per cent of all suicides - follow non-compliance with treatment. Better compliance with treatment and closer supervision were highlighted by clinicians as the main ways of reducing suicide risk.
Commentary
I’ve selected this as the focus of today’s post to serve as a dramatic reminder of the importance of compliance enhancement efforts.
Related Posts:
Disease Vs Disease: Battling For Priority
Political Agenda As Treatment Plan
According to a 9 May 2007 news release, Zero Tolerance to Asthma Attacks - Make Asthma a Political and Medical Priority, a “group of medical experts and patient representatives today called on politicians, clinicians, regulators and colleagues to take immediate action and work together to ease the plight of the 32 million people in Europe with asthma, and free up more than eight million hospital days each year. The statement is part of the Brussels Declaration, a ten point action plan to challenge the current status quo and make asthma a political and medical priority.”
These excerpts characterize the Declaration:
The ten points identified for action are summarized as follows:
1. All stakeholders must recognize asthma as a serious public health issue and consequently make asthma care a political priority.
2. Policy makers and Professional Bodies, including European Patients’ Associations must respond now to the developing understanding of asthma including recognition as a respiratory manifestation of systemic inflammatory processes.
3. The medical community, guided by its Professional Bodies, must ensure that it rapidly responds to the latest scientific understanding of asthma, recognising that asthma presents differently for adults, children and infants and different ethnic groups and management cannot necessarily be extrapolated from one group to the other. Studies and recommendations must recognise this.
4. There should be an immediate update of the European Medicines Agency (EMEA) Regulatory Guidance Note on asthma which is essential to ensure that asthma treatment and diagnosis responds to the latest scientific knowledge, clinical and real world experience, and that relevant national organisations, including patient groups and organisations, should be involved in a process for an ongoing and timely update of asthma management guidelines for both adults and children, backed by support for clinicians and patient organisations to help them integrate these guidelines into practice.
5. Guidelines should continue to use the results of traditional randomised clinical trials where these add to our understanding; however, in addition, they should seek evidence from other studies such as health economic and health outcomes studies that focus on a broader range of end points and patients that reflect ‘real-world’ patient care and family life including studies that particularly address the child/infant.
6. Funders at national and EU level must consider funding new studies that help to answer questions about the impact of co-morbidities on asthma, how to promote adherence to optimal treatment by both professionals and patients and advance patient-centred care, effective prevention strategies and prevalence studies.
7. Policy makers, politicians, clinicians and third parties (including those representing patients’ perspectives and opinions) must explore variation in asthma care across Europe and distinguish between normal variation due to differences in healthcare systems and cultures, and variation that can be reduced through policies that improve organization of care and clinical practice and create a more informed and engaged public who are aware of the needs of patients with asthma and allergies.
8. National policies should incentivize the organization of care so that people with asthma can actively participate in and make choices about their care. The EU and national agencies must improve their ongoing pharmacovigilance processes and medical utilisations in asthma to ensure that medications are used appropriately and that potential safety issues in terms of medicines and their usage are quickly and clearly identified, communicated and monitored.
9. The EU and national governments must liaise with other agencies to understand and reduce the impact of environmental factors on asthma such as smoking, air pollution, hazards in schools, day care, the work place and home, as well as other environmental triggers.
10. National policies should set targets for healthcare providers to keep registries, reduce hospitalisations, emergency healthcare use, days off work and days off school experienced by people with asthma and encourage use of tools/instruments to assess asthma control and reasons for poor control where it exists in the individual.
Commentary
The importance of treating asthma optimally is unquestioned.
And, the importance of treating major depression optimally is unquestioned.
And, the importance of treating cardiac disease, AIDS, tuberculosis, traumatic head injury syndromes, schizophrenia, … optimally is unquestioned.
Can they all have priority?
Is competitive lobbying the best use of the talents and time of medical experts?
Is a disease by disease approach to compliance, as exemplified in such clauses as “National policies should incentivize the organization of care so that people with asthma can actively participate in and make choices about their care” and “Funders at national and EU level must consider funding new studies that help to answer questions about the impact of co-morbidities on asthma, how to promote adherence to optimal treatment by both professionals and patients and advance patient-centred care, effective prevention strategies and prevalence studies.” viable?
Related Posts:
Incredibly Banal Ideas Tarted Up In Fancy Dress
Cervantes at Stayin’ Alive blogs about public health & healthcare policy, areas of thought which may offer insight into patient compliance.
Theoretical Models of Health-Associated Behaviors
Two recent Stayin’ Alive posts, Why can’t you behave yourself? and
Sesquepedalianism in the service of truth are especially pertinent to adherence because they deal with theoretical models designed to explicate how and why individuals behave as they do regarding healthcare, including compliance and noncompliance with treatment.
My own contention has been and continues to be that such theories, however impressive on paper, are fundamentally flawed because they are implicitly or explicitly stipulate that individuals operate in an exclusively rational manner. In reality, if a purebred rational man ever existed, it was in a land far away and a time long ago. My more extended discussion of this topic can be found at Patient Behavior
Cervantes, who writes clearly, bluntly, and, sometimes, passionately, takes a congruent stance, albeit with less nuance, and offers an alternative behavioral hypothesis.
His feelings, for example, about the classical health behavior theories can be ascertained from this excerpt:
Subtle, eh?
Regardless, these two posts are enlightening and entertaining. Further, while only the occasional post on this blog addresses compliance directly, many public health policies have an impact on which healthcare elements are made available and which hoops through which one has to jump before accessing that care, which, in turn, has an impact on compliance.
Related Posts:
Proposing Coerced Treatment Compliance
The Issues
In a drama that one can imagine scripted by John Kani or Tony Kushner, the post-apartheid politics of South Africa, the physiological and psychological dynamics of AIDS, a life and death struggle with a potentially global impact, the clash of national and ethnic traditions, cultures, and mores, medical research, the concept of individual freedom and dignity of the individual, the reality of clinical healthcare practice in places like KwaZulu-Natal, the sovereign authority of a recognized nation Vs the needs of the world community, the role of international public opinion, the pronouncements of a self-described institution of bioethics, and the socio-economic forces associated with poverty, homosexuality, and race are joined together in agonized battle by a paper issued in a forum with the prosaic, even by bureaucratic standards, title of the “Public Library of Science Medicine.”
The Proposal
In the January 2007 (Vol. 4) issue of the Public Library of Science Medicine Journal, Drs. Jerome Amir Singh and Nesri Padayatchi of the Centre for AIDS Programme of Research in South Africa and Dr. Ross Upshur, the director of the Joint Centre for Bioethics at the University of Toronto, propose that patients with XDR-TB, a drug-resistant form of tuberculosis, who refuse treatment be involuntarily detained in hospitals or other health care facilities in South Africa.
The following excerpt from that paper accurately reflects, I believe, the authors’ thinking, but has been significantly truncated. I heartily recommend reading the original paper, which is freely available at XDR-TB in South Africa: No Time for Denial or Complacency and is just over six pages, including references.
The Public Library of Science Medicine Journal paper carefully discusses the pragmatic difficulties of treating patients in South Africa, the epidemiology that threatens populations far outside the borders of that country, the criteria for determining when the risk to public safety abrogates individual freedoms and rights, and more.
The proposal specifically recommends that South Africa end its policy stipulating that those hospitalized at state expense lose their social welfare benefits, a regulation that encourages patients to avoid hospitalization and, all too often, treatment of any sort.
The Reactions
Official reactions to the proposal range from cautious agreement to cautious opposition.
The South African Department of Health released this supportive statement from its adviser, Ronnie Green-Thompson, “The issue of holding the patient against their will is not ideal but may have to be considered in the interest of the public. Legal opinion and comment as well as . . . the opinion of human rights groups is important.”
These excerpts from South Africa may lock up “killer TB” patients, written for the Associated Press (24 January, 2007) by Maria Cheng, is representative of the latter perspective:
Others worry that involuntarily detaining people would result in “driving patients underground,” said Dr. Tido von Schoen-Angerer, of Medecins Sans Frontieres, the international medical aid group.
Tuberculosis experts at the World Health Organization believe XDR-TB is as serious a threat to global health as either bird flu or SARS. But Dr. Mario Raviglione, director of WHO’s Stop TB department, isn’t certain involuntary confinement is warranted just yet. Without proper patient data from South Africa, Raviglione says it is unknown whether lack of compliance is a significant factor.
Commentary
While the threat to world health and the tragedy of those currently afflicted with XDR-TB are themselves compelling, even broader and more fundamental concerns are raised by this situation. The long-debated conflict between individual rights and the good of the community, the authority and responsibility of the state to protect all its citizens, personal morality and accountability, and the large scale economics of public health, among others, are unavoidably and usefully raised by a thoughtful review of this paper.
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Incentives To Enhance Compliance With Addiction Treatment
Controversy and Compliance
From The Independent 1/26/2007
A draft of the formal guidelines for treatment of substance abuse by The National Institute for Health and Clinical Excellence (NICE) recommends that drug addicts receiving treatment should be given shopping vouchers, worth up to £10, if they adhere to treatment and tests indicate they are drug free.
According to this report, International trials have shown modest financial incentives can help hardened addicts stay off drugs.
Commentary
I’ve isolated the clinical essence of this story in the two preceding sentences.
Of course, the notion is not that simple. Most of the newspaper story, in fact, is given over to (1) anticipated resistance to the proposal (e.g., “The National Institute for Health and Clinical Excellence accepts that the idea is controversial”) and (2) justifications of the proposal beyond clinical evidence. In the latter category, NICE notes that the tactic would be cost-effective and that ” there would also be a public health benefit because addicts could also be screened for infectious diseases - such as HIV and tuberculosis.”
Just in case clinical evidence, cost-effectiveness, and incidental discovery and treatment of infectious diseases are insufficient defenses of gh plan, the Department of Health spokesman takes pains to point out that “This is not final Nice guidance to the NHS. It is a draft guideline for consultation and will be developed further in response to the comments received as part of the consultation” and “This is one of a range of approaches that may support better outcomes. These are potentially important suggestions that warrant further discussion.”
I am hardly disputing the accuracy of the presumptions implicitly and explicitly laid out in this news story. Many denounce use of public funds to deal with substance abuse as clinical rather than criminal matters. The idea of providing shopping vouchers to reinforce compliance for such treatment is sure to arouse criticism.
My fear, in fact, is that the proposal may be altered or attenuated and the possibility of political pressures overcoming good science is painful to contemplate.
My contention is that forgoing the use of incentives in this case, in which its advantages are clear cut is as dangerous to the healthcare profession as acquiescing to pseudo-populist community organizations who wish to forbid well-supported diagnoses and treatments proven effective (e.g., ECT for otherwise intractable depression) because of moral, cultural, or political convictions.
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