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.
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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?
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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.
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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)

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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 Jennifer Pruskowski, PharmD, BCPS, BCGP, CPE, a palliative care pharmacist at University of Pittsburgh, School of Pharmacy by Winnie Ho, Program Coordinator 

​Overview:  This intervention is taking place in the University of Pittsburgh Medical Center (UPMC) Senior Communities in Pittsburgh, Pennsylvania. Dr. Pruskowski's work is funded by The Beckwith Institute. 

​Tags: Deprescribing, Older Adult Care, Medications, Program Management

​NaRCAD: Hi Jennifer, thank you for taking the time to speak with us today! You are breaking new ground on a deprescribing academic detailing project in Pittsburgh. What role does deprescribing play in improving health outcomes in nursing homes?

Jennifer: Deprescribing is the identification and discontinuation of potentially unnecessary or inappropriate medications. What I really love about deprescribing is that it’s really patient-centered.
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For example, one medication class might be appropriate for one patient, but maybe not for the next. Within the UPMC Senior Communities, I have developed, implemented, and evaluated a clinical pharmacy-driven deprescribing initiative named the DE-PHARM Project, which stands for the "Discussion to Ensure the Patient-centered, Health-focused, Prognosis-appropriate and Rational Medication regimen". Say that 5 times fast!

​This project allows pharmacists within the nursing home setting to review medication regimens and conduct conversations with nursing home residents, their families, and their caregivers. Deprescribing allows us to rebalance the equation when there may be medication overload, and helps us to reduce the burden on our patients. 

NaRCAD: What are unique factors when approaching deprescribing work in nursing homes?

Jennifer: While a lot of patients outside of the nursing home are complex, the nursing home population is one of the most obvious and at-need, due to their reduced functional status and their need for additional services. Nursing home residents also tend to receive their care, essentially, from one provider. So, it’s very conducive for deprescribing, and it allows us as an academic detailing program to overcome one of the main barriers to deprescribing, which is tracking down and contacting potentially numerous prescribers.

NaRCAD: That's a pretty common barrier, to track down and identify the multiple providers that are supporting the patient.

Jennifer: Absolutely. The other thing to consider is that there are already regulations in place within a nursing home setting that encourages deprescribing. Every nursing home that receives Medicare or Medicaid has certain regulations to follow, which is basically all of them. For example, since the mid 2000’s, there’s been verbiage around ‘gradual dose reduction’ for anti-psychotics, and then in the last 5 to 7 years, this was expanded to antimicrobials as well to try to curb growing antibiotic resistance.

Nursing homes are built for deprescribing, in the sense that these medications are continuously monitored and every quarter, they need to justify to CMS why someone is on a medication at a certain dose.

​However, what gets challenging is integrating care goals, functional status, patient perspectives, and evidence-based literature into deprescribing. Nursing home settings often times have a comfort-focused treatment plan. The medications that I tend to focus on when encouraging deprescribing may not be the same as other detailers. For example, many detailers are working on opioid-related campaigns. Opioids are crucial for deprescribing, but if you think of a patient who is closer to the end of life, opioids are typically not what we target because the medication tends to align with their treatment plan and goals.
​ 
NaRCAD: That’s a really interesting and complicated situation. What are some of the other challenges you’re facing with approaching deprescribing in nursing homes?

Jennifer: One of the big challenges is that no studies have been done about the initiation of certain medications in nursing home residents. Most clinical trials are also done in healthier, younger adults. We don’t have the most literature to guide a lot of what we do, and it’s critical because our prescribing goals are going to be different for the nursing home population as compared to the general population.

NaRCAD: This can often be a challenge when initiating an academic detailing campaign in a field that may not have as many other detailers. One of the foundations of academic detailing is the dissemination of evidence based information, but as you mention, there are not as many resources and studies in the work you’re about to partake in.

As you and your team begin to initiate your program, how do you plan on approaching this paradox?

Jennifer: So, the first thing that we’re doing is determining the medication that we’re going to target. We’re taking a look at prescribing cultures within the nursing homes that we’re targeting, and our working group is looking at what medication regimens are potentially inappropriate, or deprescribing eligible.

There is an evidence-based algorithm that we utilize for our intervention based on what medication class we will target from deprescribing.org, run by Barb Farrell, a friend and colleague of mine in the Canadian Deprescribing Research Network. So for some medications, such as proton pump inhibitors or histamine blockers, there are resources that have been created.

​However, as we do the groundwork for our program, we could potentially find ourselves targeting a medication class that doesn’t have a lot of evidence-based literature around it, and then that will be both the challenging and fun part of developing verbiage and guidelines around that. 

NaRCAD: Someone’s always got to do it first! It can be difficult getting programs started, and we are very lucky to have a growing population of people who are interested in integrating academic detailing into their programs.

As you’re reflecting and planning for the future, what would be important for someone else in your shoes to know about starting a new program?

Jennifer: The most important part is really thinking through the needs assessment. We know that there is a problem, and now it’s about identifying the specific issues and critically thinking through a solution. We will really need to understand the prescribing behaviors that exist in our nursing homes. Much of the prescribing culture there is based off inertia, extrapolation, and people doing their best to adapt important regimens from information that doesn’t directly address their unique situations with nursing home residents.

​We are trying to see if, for example, our providers are prescribing certain medications because they see this problem a lot in other populations they work with, or if they are working off of knowledge that has not been updated in many, many years. These would be two very different academic detailing interventions.

NaRCAD: And finally, as we begin a brand-new decade in 2020, what would you say to anyone else looking to consider academic detailing?

​Jennifer: Jump in! Academic detailing is a proven intervention to effectively disseminate evidence-based literature. I would say that as much as academic detailing can feel like a one way street – as a detailer coming to give a provider information – it really is more of a two-way street than people think. I think in the small amount of time that I’ve done this, I feel like I’ve actually gotten more information from our prescribers than I feel like I’m giving to them at the end of the day.

NaRCAD: A fantastic note to end on. Thank you so much for taking the time to speak to us, and we wish you and your team continued success in 2020! 

Jerry Avorn, MD, Co-Director, NaRCAD
Tags: Detailing Visits, Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications, Opioid Safety
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​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.
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These can involve “non-scientific” issues such as:

• “This patient is hurting and I want to help them but am not sure how, so I’ll give them the strongest thing I can think of.”​
• “The patient is demanding narcotics and I don’t know if I’m being scammed or not.”
• “I keep getting memos from bureaucrats and managers telling me I’m using too much opioid, but these people don’t have a clue what it’s like trying to do my job.”
• “I can’t manage this patient’s diabetes, angina, hypertension, memory loss, and depression in my too-short visit – how am I supposed to deal with their pain and all these new opioid constraints at the same time?”

​​… and dozens of other issues.

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.

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.

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.

The exponential increase in computing power and data storage capacity, coupled with the sharp decrease in data processing costs, have made possible an era of ‘big data’ that is transforming many aspects of life and commerce.  In health care, this evolution is enabling access to information that was impossible to imagine in the era when I first began this work when most prescriptions and test orders were still written on little scraps of paper. As applied to academic detailing, this growing capacity opens up a veritable armory of double-edged swords.

Knowing what doctors are ordering: This information has always been an important advantage of the pharmaceutical industry, which routinely buys the detailed prescribing records of specific physicians from intermediaries such as IMS, who in turn purchase these records from nearly every pharmacy in the nation. In the hands of an agile pharmaceutical representative, knowing a doctor’s drug preferences can be a powerful tool in shaping a promotional message tailored to that person. 

Many of us in have had mixed views about the use of such data. On the one hand, it can make possible a more precisely focused discussion about optimal ordering of tests and treatments that is based on a given practitioner’s actual behavior. On the other hand, the approach comes with several risks. One is the concern that clinicians may feel “spied upon” – a problem that doesn’t seem to come up much in industry visits. This in turn can divert the conversation to discussion of “Why are you visiting me?” rather than a conversation about optimal patient care. 

​Data feedback to clinicians also degenerates frequently into he said-she said debates that often come down to “My patients are different!”  We welcome feedback from academic detailing programs on how this use of data has worked (or hasn’t) in their own settings.

​What patients are (or aren’t) doing:  The computerization of dispensing records opened an era of hitherto-difficult research on patient adherence to their medication regimens, with generally depressing findings of low adherence.  The full import of this rampant epidemic of non-compliance is still not well understood by most prescribers. The rapid growth in mobile and wearable technologies that capture physical activity and other lifestyle choices provides another potential source of data on patient behavior, but the best applications of this information are even less well understood. 

In principle, academic detailing programs embedded in health care organizations can provide feedback to clinicians on how much or how little their patients are taking medications as directed or complying with other medical advice, and – more important – what to do about it. Is this a useful component of the educational encounter?  Again, we would welcome hearing how this use of big data to provide feedback on adherence or patient behavior does or doesn’t fit into the work of ongoing academic detailing programs.
 
In the coming years, we will see even greater access to terabytes of data on who is ordering what, and what patients are doing with their prescriptions and other treatments. Used well, this technological revolution can provide added power to programs designed to improve that clinical decision making. 

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.

Jerry Avorn, MD, NaRCAD Co-Director

Tags: Detailing Visits, Health Policy, Jerry Avorn, Medications

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.

by Jerry Avorn, M.D., NaRCAD Co-Director
​
Tags: Health Policy, Jerry Avorn, Medications

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.