Navigating a Disorienting Healthcare Landscape | Jerry Avorn, MD, NaRCAD Co-Director
First, about the grammar. Readers under 65 will be forgiven if they never heard of the daytime television quiz show “Who Do You Trust?” that aired from 1957 to 1963. In it, male contestants were asked if they wanted to answer a question or whether they ‘trusted’ their wife to do so. Concerns by snarky little kids like me that it really should have been “Whom Do You Trust?” did not diminish the show’s popular appeal. Gender issues went totally undiscussed.
All grown up now and confronting a changing health care landscape, that still-sometimes-snarky little boy often wonders, as do many of my clinician colleagues, who can be trusted in the world of medical information, especially in relation to prescription drugs. Gone are the simpler times when one had to worry only about whether the drug ads and sales reps were really presenting a balanced picture of all the evidence, which was a hard enough challenge.
We now know that we also have to be concerned about off-label marketing campaigns offering impermissible (and often downright deceptive) statements about efficacy – excesses for which over $16 billion has now been paid to state attorneys general in legal penalties and settlements.
As I’ve noted previously, the courts and the FDA are also moving toward much more permissiveness with company claims about efficacy and safety. And in last year’s 21st Century Cures Act, Congress instructed the FDA to be more open to accepting lower standards for drug approval.
Then there are newer sources of information whose trustworthiness is not always clear. More and more, this includes the prescription benefit management (PBM) companies, which seem to be holding on to an ever-larger fraction of the funds flowing through their rich payment pipelines, yet provide little transparency about who gets to keep what rebate dollars, and for what reason. Once billed as cost-savings protectors and comparative effectiveness gurus, the PBMs are under increasing scrutiny, and asked to make their financial data transparent and to clarify just who’s saving what for whom (or is it ‘for who?’).
Nor can we always be sure what angle the payors are playing. Why is Drug A on the formulary, but not its sibling Drug B? It may be an astute purchasing decision, or just the result of a rebate hack. And how much are prior authorization rules and growing co-payments designed to promote evidence-based care, or other less worthy goals? Even clinical guidelines put out by third parties vary from the most rigorous to pretty sketchy.
This leads to one good answer to the ungrammatical question in our title. With these galloping changes in an ever-more marketplace-oriented health care system, every prescriber needs and deserves a smart, superbly informed colleague to rely on to get the best possible syntheses of the clinical evidence – someone who has no other agenda or motivation other than getting the facts right and transmitting them faithfully.
Each year, we can take less comfort in counting only on FDA-approved indications, or payor policies, or PBM choices, or advertised claims. The more compromised each of these sources becomes, the more we’ll need ‘honest brokers’ like well-trained and un-conflicted academic detailers, whose only duty is to communicate the fairest evidence summaries as effectively as possible. Like lightweight clothing in an era of global warming, it’s a need that’s only going to increase.
Thoughts? Reactions? Sound off below.
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, 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.
An Interview with Paula Walker, Clinical Pharmacist
Baylor, Scott & White Health | Dallas, Texas
Tell us a bit about yourself. How did you get into care redesign and transitional care? I grew up in the area of Inman Square Pharmacy in Cambridge, Massachusetts. After graduating from Northeastern University in 1990, I began my career in community pharmacy. Soon after I entered the pharmaceutical industry, I spent many years representing the biological division of Rhone-Poulenc. I continued to keep connected with public health by practicing in the community part time; I’ve also been serving in a family practice clinic for over 8 years now. Three years ago, upon recommendation from our clinic director, I joined The Institute of Chronic Disease and Care Redesign at Baylor Scott and White Health in Dallas.
Tell us about the institute. What does your team focus on with regards to providing transitional care? What approach do you take?
Our multidisciplinary team focuses on improving outcomes among chronically ill older adults. Our innovative approach includes using advanced technology to identify patients at most risk for readmission. With a focus on heart failure, COPD, and pneumonia, patients are identified and supported as they transition from one level of care to the next. Our transitional care team encourages each specialty to work at the very top of their license to assist patients whose recovery is complicated by cognitive impairment, frailty, and social issues. Our team shares offices together so each discipline is available to all team members at all times. A strong team and constant communication is the key to our success.
What does a typical day or week look like for you in this field? How do you incorporate academic detailing techniques into your work?
My role is to perform the medication reconciliation on all of my patients and communicate any concerns with the appropriate providers. I attend weekly rounding with my team and need to be able to make and support any medication recommendations. In terms of using academic detailing techniques, our team practices evidence-based medicine in the care and treatment of our population with chronic disease. It’s also key for a pharmacist in this role to be able to communicate to providers quickly and effectively regarding drug selection, dosage, and titration. Learning and practicing the skills required to communicate effectively in this environment is essential. In a typical day I will consult with a geriatric specialist, cardiology, nephrology, APRN, social worker, and corporate administration. That is a lot of communicating!
You attended our Academic Detailing Techniques Training a few years back. What parts of the program worked well for you, and what are the most useful resources or information that you’re still using today? I found the skills learned during the NaRCAD training to be useful and confidence building. There is an art to being able to research information then applying it to support a recommendation in a short amount of time. NaRCAD brings together professionals from different disciplines that are focused on improving the communication of science-based information in their practice or facility. It is useful to connect with others that require these skills in their work. The small class size made it very easy to meet all the participants and learn from their experiences. I believe you can never be too experienced, and I constantly learn from the experience of others.
What are some future successes you’re looking forward to in your work and in the field in general? As we prepare to expand the Transitional Care Model at Baylor Scott and White Health under the population health infrastructure, I look forward to the pharmacist’s role to expand as well. Our goal of disease management, well above the national standard, will require evidence based medicine and the sharing of clinical information to all members of the care team. I look forward to continuing my relationship with NaRCAD—together we can help each other transform care, resulting in an improvement in the quality of life for our patients. And I’m looking forward to NaRCAD’s 3rd International Conference on Academic Detailing this November in Boston!
Biography: Paula Walker, Clinical Pharmacist, joined the Baylor Scott & White Health Transitional Care Team in 2012. Paula is the team pharmacist and oversees all medication reconciliation for their older adult population with heart failure, COPD, and pneumonia. Prior to joining BSW, Paula has worked in community pharmacy, clinic pharmacy (still active), and the pharmaceutical industry. Paula holds BS in Pharmacy from Northeastern University.
by Jerry Avorn, M.D., NaRCAD Co-Director
A number of academic detailing programs began in the 1990s or early 2000s, when the cost of many useful medications in primary care was prohibitive. Some were available then only as expensive brand-name products: clopidogrel (Plavix) as an anti-platelet agent, alendronate (Fosamax) for osteoporosis. Others could plausibly be replaced in some patients by similar agents in the same class: atorvastatin (Lipitor) for elevated cholesterol, celecoxib (Celebrex) for arthritis and pain, omeprazole and esomeprazole (Prilosec and Nexium) for acid-peptic disease. Then came the game-changing developments around 2011-2012, when the patents on blockbuster drugs like Lipitor and Plavix expired. This was referred to as the “patent cliff” by some; others dubbed it “Pharmageddon.”
Meanwhile, discount drug stores, led by Wal-Mart, had been introducing the $4-a-month generic prescription. Within a short period of time, most common drug categories had one or more key medications available that made it possible to manage many common primary care problems—hypertension, high cholesterol, diabetes—for a modest monthly cost.
While these developments were a boon to patients and payors, they were not good news for the large pharma companies, which had to reassess their business models in the post-blockbuster era. But Pharmageddon also had an impact on another, much smaller group: the tiny international academic detailing community. Many sponsors of academic detailing programs had been attracted by the prospect that promoting evidence-based practice could also help contain rising drug costs. While that was never the main goal of such work for many of us, it was an attractive feature—at least in part—for many funders in both the public and private sectors.
Stark evidence of this came in a conversation I had with a health insurance executive about the possibility of starting an academic detailing program for primary care providers. “Frankly,” he told me, “we’re not focusing much attention any more on drugs in primary care. Many of them are pretty cheap now. All our energies are going to the expensive specialty drugs.”
I guess if the bottom line is all that matters, any M.B.A. would come to the same conclusion about academic detailing in primary care. However, if the mission of academic detailing is to help health care professionals take better care of their patients, then the goal of quality improvement serves as reason enough in itself. Several state government agencies get this (PA, SC, VT, MA, etc.), as do some Canadian provinces and other nations. But in many private U.S. health care systems, the bottom line still rules.
Luckily, things are changing yet again to make academic detailing potentially attractive even for those whose focus is mostly on finances. Growing impact of the HEDIS measures (Healthcare Effectiveness Data and Information Set) and the Medicare “stars” rating system means that millions of dollars of reimbursement now depend on how a health care system performs on several quality measures. Many of these measures depend upon optimal medication use for conditions such as diabetes, hypertension osteoporosis, and elevated cholesterol; others assess cancer screening and other non-medication-related priorities that can be addressed by academic detailers.
So for those of us who always felt that academic detailing is about optimizing patient care, that goal remains as important as ever. And for those who are concerned with how academic detailing can affect a health care system’s bottom line, even though Pharmageddon temporarily took the edge off some of those concerns in primary care, the renewed focus on outcomes and quality measures, many of which are so drug-dependent, means that this reason to improve prescribing is also now back on the table.
About the Author: Dr. Jerry Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics. A general internist and geriatrician, 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. Dr. Avorn has published over 250 papers on these topics over the past three decades.
This article originally appeared in NaRCAD’s Winter 2014/15 Newsletter.
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