Jerry Avorn, MD, Co-Director, NaRCAD
Of all the medication use issues facing the U.S., the most pressing is of course that of opioid mis-prescribing. When the anatomy of that mis-use is dissected, it becomes clear that the principles and methods of academic detailing are especially well suited to addressing this crisis, for several reasons.
First is the problem of information deficit: before the mid- to late-1990s, practical issues of the assessment and management of pain were often poorly covered (or not at all) in most medical school or residency training programs – so there’s a lot of good that can be accomplished by simple personalized knowledge transfer, to start with.
Second is dealing with the contamination of dis-information: the growing documentation of the fact that sales reps for OxyContin, for example, actually under-stated the drug’s risks and over-stated its potential indications when describing their product to prescribers – distortions for which the company had to pay $600 million in penalties.
Third is the fact that for this therapeutic category more than for most others, a prescriber’s attitudes and motivations play an especially important role.
These can involve “non-scientific” issues such as:
There is ample evidence that simple “gotcha” letters accusing a prescriber of opioid over-use have no effect. Similarly, draconian restrictions imposed by governments or health care systems limiting the amount of opioid that can be prescribed to a given patient clearly run the risk of under-treating genuine pain – a grotesque example of health care rules that seem guaranteed to increase patients’ suffering.
Evidence-based guidelines, such as those promulgated by the CDC, are fine as far as they go, but most doctors haven’t read them, and even fewer have integrated them into their practices.
But a well-trained, skilled academic detailer can interact with a prescriber to understand just what issues lie behind the apparent misuse of opioids by that physician, and present a set of interactive messages tailored to those particular needs.
This will involve constructing a personalized blend of new knowledge transfer, dis-information detoxification, practice facilitation (including help accessing Prescription Drug Monitoring Program data less burdensomely), accessing local resources for help in patients with opioid use disorder, and assistance with patient education.
A similar approach could also be enormously helpful for encouraging naloxone prescribing and improving the care of patients with opioid use disorder, including medication-assisted treatment, where information deficits and attitudinal issues are even more prominent.
Together, this kind of individualized outreach education can accomplish far more than mailed guidelines, accusatory nastygrams, or legal restrictions – and in doing so, do more to improve patient care and reduce preventable misery than can be expected from more old-fashioned interventions.
Jerry Avorn, MD, Co-Director, NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use. Read more.
Jerry Avorn, MD, Co-director of NaRCAD
As I write this in mid-January, it is difficult to know how the health care system will be transformed in the coming weeks, months, and years. But one thing is clear: the new administration and Congress are intent on repealing the Affordable Care Act, and they will have the votes in Washington to do so. Despite their holding this policy position for six years, followed by a long (if issues-light) campaign season, it is not at all clear what will replace it.
But one thing is certain: the new administration is committed to reducing federal support for health care for enormous numbers of American citizens. “Better coverage and lower costs” is more bumper-sticker rhetoric than plausible policy, and doesn’t meet the basic criteria of arithmetic.
This means that all those who care for patients in the U.S., as well as policymakers, will be forced to live under the yoke of that awful cliché, “doing more with less.” (Our colleagues in Canada and overseas must be reading this message from the richest nation on earth with a mixture of horror and pity.) Appropriate clinical decision making is about to be transformed from a noble goal we should all strive for to a literal matter of life and death.
As the ranks of the uninsured and underinsured swell, prescribing a costly drug when a more inexpensive one would work as well will increasingly mean that patients without adequate coverage will simply be unable to afford treatment for their atrial fibrillation, hypertension, or heart failure. The aftermath of the November election will convert a bumpy, imperfect patchwork of coverage into a public administration catastrophe, soon to be followed by a public health debacle.
These changes will transform the active provision of evidence-based, non-commercial information about clinical care from a smart choice for quality improvement to an urgent requirement. Practitioners who care for the millions of patients whose coverage is legislated away will desperately need the very best information about comparative efficacy and cost-effectiveness.
Most of us engaged in academic detailing programs have shied away from emphasizing cost-containment as a primary feature or goal of such programs, and for good reason. But just as battlefield medicine often has to dispense with the niceties of office practice to address front-line emergencies, we will need to consider the possibility of “battlefield academic detailing” in the coming year to help deal with the widespread health care financial trauma that patients throughout the U.S. will be confronting, along with their health care professionals.
Most of us in American medicine – patients and clinicians alike – will find our hazard ratios going up, and our quality of life going down. Now more than ever, it will be imperative to communicate the best science as effectively as we can.
Biography. Jerry Avorn, MD, Co-Director of NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist, geriatrician, and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use, particularly in the elderly. Read more.
Jerry Avorn, MD, NaRCAD Co-Director
For over a century, appropriate medication use in the U.S. has relied heavily on the regulation of what manufacturers can say about their products. One of the first powers given to the Food and Drug Administration when it was created in 1906 was the ability to require that makers of “patent medicines” state what was actually in their products. (Often, it was a mixture of ineffective ingredients laced with alcohol or opium, but accurate information was a start.) Over time, the agency was granted the authority to regulate claims about efficacy and safety that companies made about prescription drugs.
This has begun to change, with potentially important implications for academic detailing. Currently drug manufacturers promoting their medications to clinicians are limited to discussing indications for which they have obtained approval from FDA, Last year, however, FDA announced its openness to considering policies to make it easier for drug manufacturers to present doctors with their own views about off-label uses of their products that FDA did not consider appropriate. A follow-up “draft guidance” would similarly open the door for manufacturers to provide information about side effects that differs from the determinations of FDA scientists and outside advisers.
Most recently, the agency has revealed plans for a national conference on whether limiting drug-makers’ promotional statements might infringe on these companies’ corporate free speech rights. And a bill that has progressed through Congress, The 21st Century Cures Act, will make it easier for drugs to be approved on the basis of looser standards, including lab tests or other surrogate measures of efficacy rather than actual patient outcomes.
These developments will have important implications for academic detailing. If we are entering a period of lessened government regulation of what pharmaceutical manufacturers are permitted to tell prescribers about off-label uses of their products, or their safety profiles, there will be an even greater need for balanced, evidence-based communication to inform medication use decisions. Just as travelers to developing countries that have polluted water supplies often prefer to drink bottled water, clinicians may increasingly feel the need for access to non-contaminated information sources if they can’t be sure what’s coming out of an increasingly de-regulated informational tap.
All of us concerned with optimal use of medications will need to monitor these developments closely. If the proposed changes prevent FDA from regulating the promotional claims made by drug manufacturers as closely as in the past, then health care systems and individual practitioners will have increasingly greater need for the more reliable sources of information that academic detailing services can provide. Stay tuned.
Highlighting Best Practices
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