New ACP Guideline Regarding Generic Drugs

Last week, The American College of Physicians released a new guideline addressing the use of generic medications.  The authors addressed 5 questions: 1) How commonly are brand-name medications used when a generic version is available? 2) How does the use of generic medications influence adherence?  3) What is the evidence that brand-name and generic medications have similar clinical effects? 4) What are the barriers to increasing the use of generic medications? 5) What strategies can be used to promote cost savings through greater generic medication use?

In response to the first question, the committee looked at several studies of Medicare beneficiaries which revealed that from one-fourth to more than one-third of the time, such patients were receiving brand-name drugs when identical generic versions were available.  It was recognized that in the VA system, with its central formulary, there is a much greater use of generics. However, it is also notable that physicians frequently choose newer, more expensive medications when older, similarly effective medications could be chosen – even when guidelines support the use of the less expensive drug – and that changing this behavior might result in greater savings than using identical generics.

Regarding adherence, there is evidence that use of generics is associated with greater adherence.  By extension, this would be expected to lead to cost savings because downstream costs are lower when adherence is higher.  The data is mainly observational; it is unlikely a randomized controlled trial will ever be done.

A long-standing concern has been that generics could be therapeutically inferior to their brand-name counterparts.  The FDA only requires bioequivalence, which is determined by looking at pharmacological parameters rather than therapeutic outcomes.  The debate over thyroid hormone is probably the best known controversy in this regard.  The committee reviewed evidence showing that, with a few exceptions, there is no reason to suspect inferior therapeutic performance.

Barriers to greater use of generics are discussed.  Most of the discussion centers on provider and patient preferences, driven by perceptions of efficacy or safety.  Some states prohibit automatic generic substitution, so the fact that providers often refer to medications, with available generics, by the trade name results in more brand-name prescriptions.  There is a brief discussion of the link between physician acceptance of industry gifts and likelihood of reporting the use of brand-names at a patient’s request.

The paper concludes by listing strategies for promoting more use of generics, which will be expected to result in cost savings.  Provider-level strategies include EMRs that provide formulary status of medications in CPOE and academic detailing (see my last blog post for a reference to this); it has not been determined if “gift bans” will positively affect prescribing behavior.  Patient-level interventions, such as education campaigns, have not been well-studied.  At the payer level, payment reform is expected to have the most dramatic impact on use of generics as a cost-containment strategy.

The recommended “best practice advice” is that clinicians should prescribe generic medications, if possible, rather than more expensive brand-name medications.  There is a table that summarizes the advice and opportunities to implement the strategy.  I urge you to review the guideline.

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Escalating Drug Prices Are Unsustainable

The release of several new, astonishingly expensive, specialty medications has renewed the discussion over prescription drug pricing.  The new hepatitis C drugs, Harvoni ($94,500 for a 12-week course) and Sovaldi ($84,000 for a 12-week course) are emblematic.  Kaiser Health News reported, “If all 3 million people estimated to be infected with the virus in America are treated at an average cost of $100,000 each, the amount the U.S. spends on prescription drugs would double, from about $300 billion in one year to more than $600 billion.”  The new cholesterol-lowering PCSK9 inhibitors are not quite as pricey ($14,000 per year) but would be applicable to a much larger population of patients.

At the Fall Board of Governors meeting, we heard an address from Jerry Avorn, Professor of Medicine and Chief of Pharmacoepidemiology at Harvard.  He spoke to the issue of medication costs and educated on sources of information, such as the Campaign for Sustainable Rx Pricing.  Another topic of discussion was the controversial 21st Century Cures Act, which seeks to promote development and shorten the approval of new drugs and devices, but at what appears to be the cost of neutering the FDA – more accurately, encouraging the agency to accept lower forms of evidence to support approval.  In June Dr. Avorn coauthored a Perspective piece in the New England Journal of Medicine on the subject which last week engendered several interesting replies.   In his address to the BOG, he also asked us to pick up the mantle of education through academic detailing.  An excellent resource for this is the Alosa Foundation, which has  a number of modules that reinforce evidence-based medication use.  In keeping with ACP’s High Value Care initiative, it is important to recognize that the issue is not only cost, but value – how much benefit for the money spent.  But the other critical step towards reining in pharmaceutical costs is to get legislation that will allow Medicare to negotiate drug prices.  Check out this Wall Street Journal piece on that topic and look for the link to the report from Carleton University and Public Citizen.  This is something for which we should continue to advocate.

This is obviously a complex topic, about which I have only scratched the surface.  I encourage you to maintain awareness and lend your voice to the conversation.

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Last month, ACP released a position paper on telemedicine in primary care settings.  The use of telemedicine is growing rapidly, so the policy recommendations are timely.  In the paper, four types of telemedicine are described: 1) asynchronous, which consists of sending information to be used at a later time – the example given is a radiograph of a broken bone being sent to an orthopedist who will see the patient subsequently; 2) synchronous, in which real-time interaction between physicians and patients occurs, such as a physician conducting “e-visits” or a rural community health center connecting remotely with a physician; 3) remote patient monitoring, where data is accumulated and then forwarded to the physician for interpretation and action – for example, blood pressure measurements, which are electronically forwarded to the primary physician; and 4) mobile health care services, such as the use of mobile technology to send texts to promote healthy behaviors or track conditions.

The paper outlines 13 specific recommendations, several with sub-recommendations. Most particularly there is a clear call for the existence of a valid patient-physician relationship.  If there is not an existing, ongoing relationship, several steps should be taken to establish such a relationship, including consulting with a physician who currently oversees the patient’s care.  There are also recommendations for public policy including guidelines for data security, licensing and reimbursement.  I encourage you to review the Position Paper.

Coincidentally (or not), the Cochrane Collaboration published their review “Interactive telemedicine: effects on professional practice and healthcare outcomes” the same week. Their findings in the end were not so robust: use in the management of heart failure is no better than face-to-face or telephone delivery of care; there is some evidence for improved glycemic control in diabetes; cost and acceptability are not clear due to limited data reported for these outcomes. Not much to go on.  Unfortunately, though, many studies that have come out in the past 18 months were not included because of the time and effort required for such a rigorous review from the time it was initiated, highlighting the difficulty in trying to conduct systematic reviews when a topic is rapidly evolving.

In Connecticut, Governor Malloy signed into law Public Act 15-88, which took effect October 1.  The act requires that the provider communicate through real time using two-way technology; has access to or knowledge of the patient’s medical history; give the patient his/her license number and contact information; and conform to the standard of care expected for in-person care.  Prescription of controlled substances in prohibited, as is charging of a facility fee.  The act also sets requirements for insurers.

Have a comment or relevant experience?  Share it with us!



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Physician Wellness & Burnout

A lot of attention is being directed towards Physician Wellness, and its opposing condition, Physician Burnout.  And with good reason: evidence is mounting that highly stressed physicians may not provide high quality patient care.  Physicians with burnout are more likely to self-report medical errors, have lower empathy scores, and have higher job dissatisfaction, which in turn results in lower patient satisfaction and a lower likelihood that patients will follow treatment recommendations.  As we begin to understand the etiology and consequences of burnout, it becomes even more important to pursue prevention strategies.

Resilience is the burnout antidote.  Three general themes arise when examining what determines resilience among physicians.  First, there are job-related sources of gratification: finding meaning in relationships with patients and success in practice, in terms of efficacy (diagnostic, therapeutic, etc.).  Second, there are practices or routines that physicians use to counteract stress, which include engaging in leisure-time activities, professional development, establishing boundaries between work and life and ensuring time with family and friends, and self-reflection, to name a few.  Third, there is the adoption of certain attitudes, such as acceptance or realism (not engaging in wishful thinking), self-awareness, and recognition of when change is needed.  I mentioned in a previous post that the ACP Board of Governors is pursuing a theme of “Restoring the Narrative”.  This relates to the first theme, finding meaning in practice.

You might also remember that I distributed a questionnaire to explore some of these themes and the sources of burnout that you encounter.  We will be reviewing the results of the survey at the Annual Chapter Meeting on October 30, so I hope you will be there!

Notably, ACP has established a new criterion for the Chapter Excellence Award: “the chapter has a practice satisfaction and/or physician wellness program which may include programs that promote resilience and practice efficiencies.”  The Connecticut Chapter is developing a Physician Wellness Committee, and we are interested in your ideas about what form this might take.  If you want to be involved with the committee, let me know!

Last, I refer you to the work of Drs. Christine Sinsky and Mark Linzer, who have been pioneers in this area:  Christine Sinsky, In Search of Joy in Practice; Mark Linzer, Epidemic of Physician Burnout presentation.  For those of you in the New Haven area, look for Dr. Sinsky to appear at Yale Medical Grand Rounds the first week in October.





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ICD-10 is coming…

As I write this, the ICD-10 Countdown Clock on the CMS website reads 54 Days, 14 Hours, 22 Minutes, and 13 Seconds (no, 8 Seconds, 5…). The fact that this clock exists gives you some idea of the import of this transition and the anxiety it is provoking. ICD-10 refers to the International Classification of Disease, tenth edition, published by the World Health Organization (WHO). ICD-9 has been in use since January, 1979. WHO started work on ICD-10 in 1983, but did not finish until 1992. Other countries started implementing it in the late ‘90s. In fact, the United States is one of the few developed countries that has not yet made the transition. We made the change from ICD-9 for coding and classifying mortality data from death certificates in 1999. The Department of Health and Human Services proposed in 2008 that we begin using ICD-10-CM, the Clinical Modification and ICD-10-PCS, the Procedural Coding System, for reporting. The recommendation became rule with an implementation date of October 2013. That got pushed back twice, and now we are finally staring down the drop-dead date of October 1, 2015.

Hopefully, your preparations to manage the transition are well underway. If not, CMS suggests the following steps: talk with your practice management vendor; be sure systems have been upgraded to the 5010 standards; discuss implementation with billing services and payers, including discussing with payers if contracts are affected; identify necessary changes in workflow and address staff training needs; conduct test transactions in advance of the October 1 deadline to be sure they are successfully received.  [CMS ICD-10 Basics]

ACP provides resources to address the ICD-10 transition: check them out here.


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Chapter Member Spotlight: Chris Sankey

Here is another installment in our continuing series highlighting Connecticut Chapter members who have been involved with ACP at the national level. Christopher B. Sankey, MD, FACP is an Assistant Professor of Medicine and academic hospitalist at Yale University. He is the Physician Editor for The Brief Case, a clinical vignette series that appears in ACP Hospitalist.  Dr. Sankey writes:

“One of my greatest clinical interests to date has been the development of clinical vignettes and mentorship of students and residents in this process. In true “friend-of-a-friend” fashion, I discovered that ACP Hospitalist was looking to develop a section in their publication devoted to clinical vignettes. In speaking with Jamie Newman at Mayo, we decided to have me helm this new section, entitled “The Brief Case”. The Brief Case comes out in ACPH every other month, and typically features an “installment” (5-6 cases) from a medical center or hospitalist group (usually an academic center), along with an individually-submitted case (usually a community-based provider). The goal of the Brief Case is to give clinical pearls that are relevant to the practicing inpatient provider.

The Brief Case has been a great success. We have had a tremendous interest from institutions and individuals alike; the volume became so substantial that I enlisted the assistance of recent Yale IM grad and current Montefiore Hospitalist Jamie Galen to be my deputy editor.”

Dr. Sankey will be featured at our Annual Chapter Meeting on October 30; he will be presenting a workshop called “Case Writing for the Busy Clinician: Opportunities and Obstacles.”  This interactive workshop will provide “hands-on” experience. Activities will be aimed at all levels of training and prior experience with case writing. The goals of the workshop are to identify essential elements of a case, overcome common obstacles, identify the appropriate type and venue for submission, and assist attendees in the preparation of an outline of a draft for submission. Dr. Sankey will share his own experience, ranging from how he published his first clinical vignette to his experiences as an editor, in order to guide participants on a relevant, practical path towards a successful case write-up and submission. Pearls will be highlighted to help improve the likelihood of a fruitful submission.

The latest installment of The Brief Case can be seen in the July issue of ACP Hospitalist.

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Restoring the Narrative

This year, the Board of Governors is taking up the theme of “Restoring the Narrative” to medical note-writing. I think most of us recognize adoption of the EHR as a factor accelerating the loss of narrative, although this process was already well underway. In fact, the time pressures placed on clinicians have probably done as much, or more, to erode the narrative from the medical record. But templated EHR documentation, with its discrete inputs and generic presentation, has effectively buried the narrative. If we hope to improve patient care through better communication, restoring narrative will be an important factor. Eliminating extraneous content to truly achieve EHR use that is meaningful (as opposed to Meaningful Use) should be an objective worth striving for.

A related theme is that of the patient’s voice. In addition to the factors mentioned above, the rise of data has also inadvertently minimized the patient’s voice in construction of the medical history. As Bradby et al state: “There is no suggestion that medical professionals intend to disregard patients’ narratives or to deem them inadmissible to clinical decision-making, particularly given that medical students continue to be taught to listen to their patients. Rather, the epistemology of epidemiologically-informed, statistically significant evidence that underpins the interpretation of results from tests and assays trumps the nature of patients’ stories as a form of knowledge at almost every turn.”(1)

Every day, we encounter and try to reconstruct patient stories. Communicating these stories in a manner that is more pertinent and relevant will lead to better patient care. I welcome your comments about “Restoring the Narrative”!

1) Bradby H, Hargreaves J, Robson M. Story in health and social care. Health Care Anal. 2009 Dec;17(4):331-44.

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