A Team Effort: Strong Provider-Detailer Relationships to Amplify Evidence-Based Care (Part II)11/3/2020
Overview: The DETAILS blog presents a special two-part series of what it takes to build a strong provider-detailer relationship from the perspective of a long-time academic detailer and then, from one of her local physician partners that’s received AD for almost 15 years. You can read Part One here. In Part Two, we get a chance to speak with Dr. Robert ‘Bob’ Schwartz, a Vermont family physician and medical director who discusses the impact of AD on his clinical practice. Bob reflects on what a strong provider-detailer relationship looks like from the perspective of a clinician, especially in the midst of COVID-19, and offers his advice to other providers considering AD. An interview with Winnie Ho, NaRCAD Program Coordinator. Tags: Detailing Visit, Evidence-Based Medicine ![]() Winnie: We’re so excited to have the chance to speak with a clinician who’s been receiving AD for a long time! Can you tell us a little bit about how you came to work with the Vermont Academic Detailing Program? Bob: It’s been several years that I’ve been blessed with Amanda Kennedy’s presence on the AD service. I would say that it actually all started back when we first decided we were not going to allow pharmaceutical representatives in the office about 20 years ago. We decided that it wasn’t a good use of our time. Then Amanda and the Vermont Academic Detailing Service came onto the scene. They presented a formal alternative to learn about medications from a non-biased view – and so we’ve participated in every single session since then. W: That’s incredible! ![]() B: The program is great – I think what’s really critical is that the program has such a high level of professionalism that you can be completely trusting of the information that you’re getting. My colleagues and I are always so thrilled when there’s another topic ready. I know how long it takes to get these things set up. You know it’s not just something someone slaps together on a random afternoon. Amanda is an absolutely amazing professional, and the fact that she’s been with us for so long helps develop a personal relationship and it builds trust. W: This relationship has been developed over more than a decade! Here at DETAILS, we don’t always get a chance to ask about what happens after the detailer leaves the office. What challenges in clinical care make it critical to lean on Amanda as a trusted source of evidence and resources? B: I like that AD is not about a specific medication, but rather a specific medical condition. As a clinician, I think about the patient sitting in front of me with COPD, not about who I can get on a specific drug. Pharmaceutical detailers only talked about specific medications and you couldn’t trust the information as unbiased. They never gave you the whole picture. What’s really important in medicine is how all the pieces fit together, and that’s really hard as a clinician to figure out on your own. With AD, I can reach out to say that I have COPD patients and I really want to get more knowledge about COPD. ![]() W: Right, and there’s an abundance of research that’s difficult to sort through on your own. B: AD is one of the few places that you can get this comprehensive evaluation of a specific condition and the medications that surround that. The other thing is that they bring materials. It might be a one-page sheet with diabetes medications based on class, relative cost, brand and generic names, and dosage. Or, it might be a COPD assessment score tool that I can easily refer to. These clinical aids are a big part of what detailers bring for us. W: Absolutely – those materials take a long time to create! I wanted to dive a little deeper into the provider-detailer relationship. What role do you think trust plays in sustaining a provider-detailing relationship for the long-term? ![]() B: When we ask Amanda a question that she doesn’t know the answer to, she will tell us that she doesn’t know, but will look into it. A week later, you get an e-mail with information that she’s put together. We trust her and know that the dynamic of the relationship is not manipulative. We know that the information is carefully researched and that she’s not going to fill in the blanks by winging it. All of our detailing sessions have an unstructured portion where we can ask specific questions of Amanda. It allows the providers in our practice to have an organic conversation about a specific issue, and it can be hard to replicate this without the support of a detailing program. W: It’s always important to acknowledge what we know and what we don’t know, especially right now with COVID-19. It’s disrupted a lot of things, and I imagine for our healthcare providers, more than ever, there’s a lot of extra challenges. Our detailers’ main goals have always been to support their local providers and to be there with them through obstacles as they arise. What would you want detailers to understand about the challenges that COVID has brought on for clinicians? ![]() B: Everything has been changing over the last several months and navigating COVID challenges takes up a lot of time. However, we still have to take care of our diabetes and our COPD patients and so more than ever, it’s critical that we have access to information that is streamlined, accurate, and that we can be confident in. I always tell people that medicine and life are team sports, and if you think you’re going to excel at either one of those alone, you’re going to be disappointed every time. We need Amanda on our team because she fills this vital role, that’s even more vital to have filled today. W: And finally, we know that there’s a lot of other clinicians who may be on the fence about receiving AD because they’re unfamiliar with it, or may have lingering distrust from pharmaceutical representatives. As someone who’s received AD for a long time, what advice would you give to other providers who may be considering these visits? ![]() B: I conceptualize AD like this – it’s like getting on the super highway instead of taking the secondary roads. I could drive to Chicago and never leave a two-lane highway, or I can get on the 90 and drive on that to Chicago all the way. To other clinicians – we have certain responsibilities to ourselves and our patients, and one of those responsibilities is to keep up with what’s going on and to know how to use it to better care for our patients. What I would tell other clinicians is that, you have this responsibility anyway – why not have another team member who’s an expert on this and give this information to you in an hour what would have taken you six hours to do yourself? We’ve loved our partnership with Amanda, and we look forward to what comes next out of it. Have thoughts on our DETAILS Blog posts? You can head on over to our Discussion Forum to continue the conversation! ![]() Bob Schwartz, MD, is a family physician at Northshire Medical Center in Manchester, Vermont. He’s served as the Associate Medical Director for Dartmouth Hitchcock Putnam, a multi-specialty group in the southwestern part of Vermont. Dr. Schwartz completed his family medicine training at Lancaster General Hospital in Lancaster, PA following his medical education in the Honors program at Northwestern University. He currently lives in East Dorset, Vermont. Evidence into Value and Action: Reflections on 30 Years of AD in South Australia (Part Two)10/5/2020
An interview with Debra Rowett, BPharm, Adv Prac Pharm, FPS, the Director of the Drug and Therapeutics Information Service (DATIS) in Adelaide, Australia. Debra joins Winnie Ho, NaRCAD Program Coordinator in a two-part conversation about a 30-year career of pioneering academic detailing in Australia and reflects on the past, the present, and the future of the field. In Part Two, we discuss the evolution of academic detailing as the world of healthcare changes. You can read Part One here. Tags: Detailing Visits, Evidence-Based Medicine, International, Medications, Program Management ![]() Winnie: You wear so many hats when it comes to AD. How have those roles changed over your time with DATIS? Debra: Before I was Director of DATIS, my role was primarily around developing our detailing materials, and evaluating the evidence and our program. I was always interested in the synthesis of evidence and turning that into value for clinicians. I was a clinical pharmacist who was working with people across many disciplines, and there was a growing body of evidence, but translating that into practice was always a challenge. ![]() W: I think you touch on a fundamental aspect of AD – that we turn evidence into value, and that we translate all this research into action. It’s very critical that AD continues to provide that independent, trusted, unbiased source of information to ensure evidence is disseminated responsibly and utilized properly. D: I would agree with that, very much. We live in an information-dense era and much of the information is synthesized and aggregated at the population-level, but clinicians are responsible for decisions at the individual patient level. I think AD is about bringing evidence to the point at which clinical decision making is made. W: I’m curious about your experience with evaluating evidence for AD materials. It’s clearly a difficult, but super important aspect of AD. You have all these clinicians who are trying their best to make the best possible decision for their patient – and AD comes in, and in many ways, helps share in that responsibility. ![]() D: Evaluating evidence is also about recognizing what we don’t know in the evidence. When reviewing the evidence for an AD program, we look for where there are gaps in the evidence, where there’s controversies, and differences in opinion about the evidence. No matter how well done, you make choices along that entire process about what to include, what to exclude – and even with the synthesized evidence, there is still human judgement about how to use it. W: Right, and that human judgement also needs to focus on how that evidence came to be and how it was produced. D: Absolutely. As we know evidence-based medicine is not just about the randomized controlled trials and published evidence, it’s about the intersection of published evidence, clinical judgement, and the patient’s specific needs, goals, and circumstances. The real opportunity for AD is that you can personalize this information for the provider to work with. ![]() W: It’s extraordinarily rewarding work, and it’s a constant process in grappling with the things we don’t know. As someone who has been in this work for a long time and has had to adapt a long-standing AD program to changing guidelines and medical evidence, you’ve likely seen some big shifts in the medical consensus. Take opioids for example – the consensus around the safety of its use has had a dramatic change over the years. How have you adapted when the evidence base can sometimes change quickly within a few years? D: It’s important that we come to providers with a balanced view, and that we acknowledge with them that there is uncertainty, that there is complexity, and that it isn’t easy to make these decisions with their patients. There’s a lot of things that we don’t know. If you come with too much certainty, you lose credibility because translating evidence into routine clinical practice is complex. Every time a medicine is prescribed for and used by a patient, we’re forecasting how the future will proceed - the exact benefits and harms that a patient will experience are uncertain. ![]() People are living longer and with multimorbidity which presents new medical challenges. We’re seeing more people living with issues like musculoskeletal problems, hypertension, diabetes, renal problems, atrial fibrillation, and surviving their myocardial infarctions. The number of medications that patients take now compared to 30 years ago have increased. There are individual guidelines for each condition, that don’t necessarily take the other comorbidities into account. The drugs used to treat one issue may lead to treatment conflicts for another condition and needs to be taken into consideration. It’s not just in one area of practice that has changed too, or just our demographics – we’re seeing fewer solo General Practitioners and more team-based practice in Australia. AD needs to take all of that into account when considering how to detail, and also who to detail. ![]() W: Can you explain what you mean by “who to detail”? D: It’s important to understand who the decision-maker is and what the decision you’re trying to address is – for some of our AD programs it might involve other health professionals; it’s not always the doctor. W: Right, and this whole of office approach looks at all the players involved in the continuum of care, and acknowledges that they may play a role in how clinical decisions are ultimately made. ![]() D: Yes, and I think this is why AD is even more important now than it was when we first started. It allows us to bridge individual condition silos, and helps providers navigate multimorbidity. Healthcare is never a one-size fits all, even for an individual. Their circumstances and treatment goals can change over the course of their lives. AD can personalize the information and tailor it to the needs of the clinician. AD can also be the conduit between population level evidence and its translation into clinical decision making - that is one of its greatest strengths. W: NaRCAD has been lucky to see overarching growth of AD programs everywhere, along with all of its exciting new innovations and evolutions. Any final thoughts on AD before we hear from you at our upcoming conference? D: One of the things I try and impart when teaching the method of AD is to value the knowledge of the person you are detailing. There is a lot of listening that occurs in successful AD if you are truly to meet the needs of the provider you are visiting. If you keep at the very heart of what you do, respect for learning together and hold true to the principles of academic detailing, you will meet incredible people everywhere you go. It makes for a wonderful career. (Part Two of Two) Have thoughts on our DETAILS Blog posts? You can head on over to our Discussion Forum to continue the conversation! ![]() Debra Rowett, BPharm, Adv Prac Pharm, FPS, has led an academic detailing team for over 20 years and is a member of the team which designed, developed and delivered the “Best Practice in Educational Visiting” training for academic detailers in Australia. Debra has worked closely with NPS Medicinewise since their inception and has provided consultancies to other national and international academic detailing programmes. Debra is an experienced academic detailer with expertise in designing, developing, training, implementing and evaluating academic detailing programmes. Debra has served as the President of the Australian Pharmacy Council and is currently the Vice President of the Council of Pharmacy Schools. Debra has worked extensively in the area of quality use of medicines, inter-professional practice, policy and health workforce development in Australia. Debra is a member of the national Drug Utilisation Sub-Committee of the Australian Pharmaceutical Benefits Advisory Committee (PBAC). An interview with Debra Rowett, BPharm, Adv Prac Pharm, FPS, the Director of the Drug and Therapeutics Information Service (DATIS) in Adelaide, Australia. Debra joins Winnie Ho, NaRCAD Program Coordinator in a two-part conversation about a 30-year career of pioneering academic detailing in Australia and reflects on the past, the present, and the future of the field. In Part One, we introduce you to DATIS and academic detailing in the Australian context. Stay tuned for Part Two! Tags: Data, Evidence-Based Medicine, International, Program Management ![]() Winnie: We’re so glad to have a chance to chat with you about your long career in AD, Debra! Debra: This is a great part of the job, talking to other people in the AD community. It really is a great privilege to be working with academic detailing organizations in different countries. I’ve loved getting to meet and learn from so many different people. W: I would agree! I’m sure you have some great stories of what it’s like to work internationally in this field. D: One of the things that it has really highlighted is the nuance of language. At a training workshop in the U.S early in my career, I was saying how we would meet with doctors in their "surgery", and how important it was to meet them in their surgeries close to where they make decisions. The workshop participants really politely said to me, but isn’t surgery a really bad time to detail? Oh! Surgery – I meant their office. ![]() W: We really would have quite a different communication model if we had detailers visiting providers mid-surgical operation! This does gives us a good starting point into discussing how Australian AD is unique. Besides the context of the word "surgery", what else would our non-Australian colleagues need to know about Australia to understand the context of what you do with the Drug and Therapeutics Information Service (DATIS)? D: I have been involved with DATIS since its formation in 1991. I was a clinical pharmacist at the Repatriation General Hospital, a teaching hospital, when Jerry Avorn’s paper was published. His work on how AD could influence clinical decision making really resonated with us in Adelaide. One of the big things to know about Australia is that we have a National Medicines Policy, which aims to improve positive health outcomes for all Australians through access to and quality use of medicines. DATIS was one of the first programs funded through the Quality Use of Medicines initiative, and in 1998 NPS MedicineWise (formerly the National Prescribing Service) was funded. ![]() W: Australia is enormous - it must be a challenge to cover. What is the geographical coverage of your AD program? D: South Australia has a population of about 1.4 million people and a vast geographic reach – the furthest of my AD visits is about 800km (500 miles) away from where we are! We work to provide AD to over 85% of all family physicians in South Australia, so about 1,300 General Practitioners (GPs) each year. We provide AD services to aged care, primary care and hospital providers. We also work in partnership with NPS MedicineWise who have implemented AD at the national level. W: That’s certainly an enormous coverage zone, especially for those core 12 people! How has this work manifested in South Australia? ![]() D: At the heart of our program is service, and we build our program to emphasize that. There are three aspects of DATIS: service delivery of detailing visits, training of detailers, and research. We have a core team of 12 people who carry this work out alongside our colleagues who join us for various projects. Because of our multiple different contracts, the clinicians we provide services to can see us for multiple reasons in a year. Between visits, providers will ring us with clinical questions about therapeutic issues that have arisen in their practice. We have also developed interprofessional communication training to support interprofessional practice with a focus on pharmacists and physicians. Our AD programs usually seek to address a therapeutic area or clinical issue however a recent AD program we developed with our hospital pharmacy colleagues was to support pharmacist preceptors implement a performance outcome framework based on entrustable professional activities for interns and undergraduate pharmacy students. W: It's incredible that DATIS has such a focus on this three-pronged approach, because it continues to help push our understanding of best practices in AD through implementation, study, and training others to carry on the work. Can you tell us a little more about the foundation that DATIS is built upon? ![]() D: Behavior change theory and implementation science has informed our work from the outset in 1991, including the development of the training program which was designed in collaboration with psychologists and experienced GP medical educators. Social marketing frameworks, an adult learning approach, the concept of cognitive biases, clinical reasoning all recognize the many interacting and complex influences on behavior. We try to learn from these and apply to the design and implementation of AD. We also use pharmacopidemiology methods to understand evidence to practice gaps and for evaluation. As AD evolves and changes, something I really emphasize is staying true to the principles of AD – this is a rigorous process. W: We’re seeing innovations all over the world and across so many clinical topics. Are there any unique innovations that you feel differentiates Australia AD from other AD programs? ![]() D: One innovation that we're exploring is applying the principles of AD to patient behavior change interventions. As part of person-centered care, it is important for patients to understand their medicines, and to be involved and empowered in shared decision making. We haven’t called this work AD, but have applied the principles of AD in this research. Complex clinical decisions need to be made each and every day by providers, and it's a privilege to be able to bring providers the best available evidence through academic detailing services, part of the power of AD is the adaptability and personalization to providers along the continuum of care. We are seeing the world of healthcare change, and we have so much to learn as it does. (Part One of Two) Have thoughts on our DETAILS Blog posts? You can head on over to our Discussion Forum to continue the conversation! ![]() Debra Rowett,BPharm, Adv Prac Pharm, FPS, has led an academic detailing team for over 20 years and is a member of the team which designed, developed and delivered the “Best Practice in Educational Visiting” training for academic detailers in Australia. Debra has worked closely with NPS Medicinewise since their inception and has provided consultancies to other national and international academic detailing programmes. Debra is an experienced academic detailer with expertise in designing, developing, training, implementing and evaluating academic detailing programmes. Debra has served as the President of the Australian Pharmacy Council and is currently the Vice President of the Council of Pharmacy Schools. Debra has worked extensively in the area of quality use of medicines, inter-professional practice, policy and health workforce development in Australia. Debra is a member of the national Drug Utilisation Sub-Committee of the Australian Pharmaceutical Benefits Advisory Committee (PBAC). ![]() Tags: Detailing Visits, Evidence-Based Medicine, Materials Development, Jerry Avorn Here’s the good news: academic detailing is becoming so widely accepted that everyone wants to help provide the evidence that is disseminated. That’s also the bad news; worrisome examples range from the grotesque to the sinister. One eminent health policy expert wanted to know how much it would cost to put together a nationwide academic detailing program (my heart leaped) that would be underwritten by the pharmaceutical industry (dammit). Prescription drug management (PBM) companies now offer so-called academic detailing services as part of their contracts with payors to oversee drug choices and spending. Sounds good until one realizes that a large chunk of PBM revenue come from payments by manufacturers to move market share to their products. So much for communicating evidence that is neutral, unbiased, and non-commercial. You’d think we’d have learned our lesson by now. Do universities or insurers or government fail to offer enough continuing education about prescribing? No problem, drugmakers will be more than happy to fill the gap, either for free or at amazingly low cost…. often with really great food. That local clinical expert who shows up at Grand Rounds to provide an overview of all the new treatments for diabetes, at no cost to the hospital? Don’t ask who’s paying him to be there. And those convenient smartphone apps that provide so much handy dosing information for any drug you can think of? All you have to do is read the commercial messages that pop up on your way to the data, as the vendor promises its pharmaceutical sponsors the chance to "embed your brand message at multiple points across the care continuum." ![]() There is a solution to the concern about who’s providing the content for academic detailing programs, and it’s much easier than figuring out whether a particular Facebook ad is brought to you by a Russian bot. Just expect that any purveyor of AD information will reveal clearly all the financial ties it and its authors have with any drug or device maker, in relation to program sponsorship as well as the creation and editing of the clinical content. After years of being misled about hidden data on adverse events or failed studies, we’ve developed a higher set of expectations about disclosing all information about clinical trials, and the need to reveal authors’ financial ties for published studies. Those same higher standards must also be applied to academic detailing programs, so that its audiences will know whether the material is the carefully vetted work of a team of unconflicted reviewers who don’t work for any manufacturers, or is instead yet another terribly sophisticated new way to market particular products. Want more? Peruse the archive of Jerry's pieces here on DETAILS. _____________________________________________________________ Biography.
Jerry Avorn, MD | NaRCAD Co-Director 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, Co-Director, NaRCAD Tags: Detailing Visits, Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications, Opioid Safety 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. ![]() Biography. 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. Navigating a Disorienting Healthcare Landscape | Jerry Avorn, MD, NaRCAD Co-Director ![]() Tags: Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications 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. ![]() Biography. 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. Tags: Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications Listen closely, and you’ll hear the other shoe dropping. For several years FDA has been besieged by litigation brought by drug makers and their supporters which argued that the agency’s limiting companies’ promotional claims violated those corporations’ First Amendment-protected rights to ‘commercial free speech.’ Then the 21st Century Cures Act signed by still-President Obama in December of 2016 authorized FDA to consider less demanding standards in approving medications. 2017 began with a new administration vowing to free the pharmaceutical industry from the onerous regulatory burdens of the FDA. Now all these forces are coming together in a worrisome confluence of regulatory derangement. ![]() The House Energy and Commerce committee in mid-July held hearings on how best to implement the Congressionally mandated loosening of drug approval standards set forth in the “Cures” act. At the same time, the new FDA Commissioner has argued that FDA’s “public health mandate” should be met by relieving manufacturers of some of those troublesome requirements to demonstrate clinical benefit, in order to get drugs to the public more easily. At the same time, he noted, as FDA reduces the complexity and duration of the drug approval process, this speeding of new drugs onto the market will help contain their high prices. Nevermind that FDA’s approval process is already the swiftest in the world, clocking in at a mere 6 months for priority decisions. And nevermind that the cost of the regulatory process accounts for only a small portion of medication prices. And just ignore the fact that worrying about cost never has been part of that agency’s mandate. Justifying the reduction of FDA’s regulatory standards to meet its “public health mandate” is a troubling Orwellian development that is likely to have exactly the opposite effect. It is eerily reminiscent of the notorious Vietnam-era claim by the military that a village “had to be destroyed in order to save it.” Invoking FDA’s public health mission to justify approving drugs that have not been adequately shown to help patients is both bizarre and irrational. These developments raise the ante for evidence-based prescribing in general, and for academic detailing in particular. Most clinicians and health care systems are not yet aware that FDA approval may become an eroded imprimatur to guide medication decisions, and most people will continue to believe that pharmaceutical company claims have to pass muster with FDA for their accuracy, even as this becomes less and less true in the coming years. ![]() Even if we cannot stop these disturbing developments, we must at least make sure that they are understood by our colleagues in medicine, so that academic detailing services – by definition rigorously evidence-based and non-commercial – can play an increasingly large role in informing prescribing decisions, as an antidote to these worrisome ongoing developments. Share your thoughts in our discussion forum below. ![]() Biography. 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. Sharing the History & Origins of AD via Jerry Avorn's 2017 NEJM Article Tags: Evidence-Based Medicine, Jerry Avorn ![]() Thirty-eight years ago, a US federal research agency issued a request for proposals on “Improving the Quality and Economy of Prescription Drug Use.” Recently out of my residency and concerned about the mismatch I was seeing between the best evidence and prevailing patterns of prescribing, I suspected that the problem might result in part from an imbalance in the effectiveness of communication coming from commercial vs academic sources. The pharmaceutical industry was impressively adept at sending well-trained change agents (drug “detailers”) to provide information about company products engagingly and interactively to physicians in their offices, in order to increase product sales. Academics, by contrast, who may have had a more impartial and thorough understanding of the evidence, tended to be passive and inelegant communicators, standing behind podiums in optional continuing education courses, delivering one-way didactic presentations in darkened rooms, often doing little to change actual practice. Click here to read the whole article at NEJM's "Piece of My Mind" Archive. Jerry Avorn, MD Harvard Medical School; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; Co-Director, NaRCAD JAMA. 2017;317(4):361-362. doi:10.1001/jama.2016.16036 Jerry Avorn, MD, Co-Director of NaRCAD, Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital Tags: Evidence-Based Medication, Jerry Avorn, Medications ![]() Consider the following recent news development: A large multinational company is discovered to have purposely hidden the risks of one of its best-selling products by suppressing information about its adverse effects and presenting only a selective set of data about its impact, to cast it in a more favorable light than was accurate. The magnitude of this distortion was so great that it posed health risks for hundreds of thousands of people throughout the industrialized world. The company admitted guilt and said it would try to do better in the future. No criminal charges were pressed, and none may ever be. I refer, of course, to Volkswagen. Last year, the carmaker was found to have rigged the pollution-control devices in its diesel cars to make it appear they were reducing emissions, but only when the car was being inspected. The rest of the time the autos spewed out pollutants far in excess of the allowed limits. The engineers and executives who perpetrated this enormous hoax were not demons. They were employees of a large corporation who let the need for profit (or shareholder value, a more polite term) push them beyond the limits of accurately presenting data about their products. These things happen in large companies, including drugmakers, who have in the last decade or so had to pay over $15 billion in legal settlements, most of which dealt with such mis-statements of benefits and harms. Nothing personal; it’s just business. Anyone who is shocked about this should go back to review the imperatives of corporate life, as defined by the Nobel Prize-winning economist Milton Friedman. In a 1970 article, he noted that “There is one and only one social responsibility of business -- to use its resources and engage in activities designed to increase its profits….” Unfortunately, the second half of that sentence is often omitted: “…so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud.” In an era of an overstretched and sometimes overmatched FDA, there’s a greater need than ever to present clinicians with an accurate depiction of the good and harm that medications can do. Of course, academic detailing is about far more than just correcting the excesses or misstatements of drugmakers. Our job is to present a comprehensive, un-skewed overview of the benefits and risks of medications and other health care decisions. But in doing so, we sometimes have to address misconceptions generated by some drugmakers who are, I suppose, just trying to give their shareholders a good return on their investment. Whether a company makes cars or drugs, its staff at all levels are under tremendous pressure to increase sales. This can often draw otherwise reasonable employees close to – or sometimes over – the line of what’s deceptive. In academic detailing, we don’t have to worry about sales goals or profit margins. The only currency we need to maximize is accurate evidence; our only “shareholders” are patients and the clinicians who care for them. In a way, that’s the easiest and best part of our jobs. ![]() by Michael Fischer, MD, MS, & Bevin K. Shagoury Tags: Detailing Visits, Evidence-Based Medicine, Training Changes in healthcare are accelerating faster than ever, amplified by the immediacy of virtual communication. New research studies or guidelines appear simultaneously in traditional media, online news sites, and social media. Front-line clinicians may not have the time to review the actual data before incorporating new information into their practices. We’ve seen this recently with topics such as managing cholesterol and hypertension, the safety and possible overuse of pain medications, and new treatments for hepatitis C. These topics present a challenge not only for clinicians and their patients, but for those who work on medical education and quality improvement efforts. Educational messages cannot be static; rather, organizations working to promote change and improvement need to identify new evidence, incorporate it into interventions and bring it to frontline clinicians. Amidst the steady stream of research and new discoveries, along with ongoing debates about those findings, how do organizations work to effectively assess needs, share best evidence, and improve healthcare outcomes? NaRCAD is uniquely positioned to help address this question, serving as a powerful and integral link between the best evidence and frontline clinicians by supporting academic detailing programs and related outreach interventions. We’re leaders in the field, providing training and support to health care organizations to establish effective academic detailing programs, working with partners to develop academic detailing program templates which can be adopted by others, and sustaining a network of programs sharing best practices in academic detailing to improve patient health outcomes. Evidence aside, observation and insight tells us that healthcare, like the populations it serves, is organic; constantly changing, growing, and redefining the best next steps to improve the quality of care and patient outcomes. As new medical evidence emerges and new delivery system innovations are introduced, we at NaRCAD look to help those changes enter practice in a way that most benefits patients and public health. Learn more about us, or tell us how we can help you. |
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