Fashionable Medications

Jul 07 2011 Published by under Pharmaceuticals

Image courtesy of PhotoXpress.com

The July 7 issue of New England Journal of Medicine includes an article on Trade Dress of medications, something I never gave much thought. Greene and Kesselheim discuss the concept in their article, Why Do the Same Drugs Look Different? Why do companies go to the expense of coloring their pills?

Trade dress refers to nonfunctional properties of preparations that could lead to confusion if imitated. In addition, the property must have a secondary association with the product. One example in the paper is the Coca-Cola bottle. Its unique shape does not affect the formulation or flavor of the beverage, but it is strongly associated with the drink. If a similar cola were packaged in a similar bottle, consumers could be deceived into buying an imitator.

Originally trade dress received protection to protect consumers. They would be able to tell if a substitution had been made in a drug, either for a generic or a similar but not-the-same agent (so-called palming off by pharmacies). Trade dress is serious business; Viagra will lose its patent, but "the little blue pill" is protected by law forever. Will generic sildenafil also be blue? It's hard to know; in the 1950's the "soothing" pink color of Pepto-Bismol was declared to provide "therapeutic value" so was not protected as trade dress!

So why is protection of trade dress potentially harmful? First, as patents expire, a number of bio-equivalent generic preparations become available. As pharmacies negotiate for better prices, the supplier and the appearance of the drug may change over time. The article illustrates four drastically different generic forms of the drug commonly known as Prozac. Having a drug change its appearance could confuse patients, perhaps leading to issues with treatment adherence.

Synthroid

Standardization of colorization and packaging could also improve patient care. For example, Synthroid (the major brand of thyroid hormone) cleverly colored each dose differently (see figure). Instead of remembering the size of the pill, patients could relate the color to confirm their dose. Exploring a couple of web sites reveals that generics also color code their doses to roughly the same shade as the Abbott product, but shapes vary.

The authors also cite an effort in the United Kingdom to standardize color of asthma inhalers. All bronchodilators became blue, while steroids were colored brown, orange, or burgundy. Patients could then be told to use the blue unit for acute attacks, and to take the other colors on a regular schedule.

Since the 1970's federal law has provided regulation of generic drug production and assurance, for the most part, of bio-equivalence with brand name pharmaceuticals. Some degree of standardization of appearance may help patients adhere to treatment plans, especially as chronic diseases requiring long-term use of multiple medications dominate the practice of medicine.

The article addresses an important but overlooked issue in the care of patients. Click on over and read the whole thing. The authors make a strong argument for legislation to promote standardization of drug appearance as well as activity.

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Prescription for Profit

May 27 2011 Published by under MedicoLegal Concerns

The May 26 New England Journal of Medicine includes an editorial on Prescriptions, Privacy, and the First Amendment. The free full-text article discusses a recent Supreme Court case about data mining in Vermont, specifically the practice of selling information about individual physician's prescribing practices to drug companies  for targeted detail visits:

This is the way it works: Retail pharmacies retain information about all drug prescriptions that they fill, including the patient’s name, the identification of the prescriber, the name, dosage, and quantity of the prescribed drug, and the date the prescription was filled. This information is collected, along with the patient’s age, sex, and drug history, and sold, with the individual prescribing doctors identified but the patient’s names encrypted, to data-mining companies (IMS Health is one such company). The data-mining companies then further process the information by collating each physician’s prescribing history for each patient, and they sell it to pharmaceutical companies. The prescribing information of individual doctors can be linked to the Physician Masterfile of the American Medical Association (AMA), thereby enriching the data on prescribing physicians (the Masterfile, which is sold by the AMA, includes information on every physician’s education, licensure, certification, hospital privileges, and practice details). The companies’ marketing departments use the information to develop strategies to sell drugs to individual doctors, and the schemes are applied by pharmaceutical sales representatives (“detailers”) to make pitches to the doctors in their offices. These solicitations are not intended to communicate evidence-based information to doctors; they are intended to sell expensive drugs.

It is a very successful business. When drug detailers have the prescribing history of the physicians they are visiting, they sell more drugs. This is one of the principal reasons why the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization of the pharmaceutical industry, joined the data miners as a party to the lawsuit. It is quite clear who profits from the sale of the prescribing information: retail pharmacies, data-mining companies, drug companies, and the AMA. In the end, the costs are passed along to patients, and physicians’ prescribing practices are manipulated by drug salespeople who know the details of their interactions with their patients.

Personally, I find this practice abhorrent. Until this lawsuit, I did not realize that my information could be sold in  this manner. Being one of the more than 80% of physicians who has not joined the AMA, I was also unaware that I could opt out of the use of my prescribing data by salespeople, although I cannot prevent the sale of my data to drug companies via this mechanism. The opt-out site has been minimally effective (<3% of prescribing physicians), in part because so few belong to the AMA and because this service is not exactly front and center on their web site.

Click for source

If you are a physician reading this post, you can opt out by clicking here.

Vermont tried to make the sale of data to the mining companies an opt-in requirement; only if you allowed it would your individual data be shared. The fact that data-mining companies and PhRMA have paid lawyers to take this all the way to the Supreme Court tells me something:

Those data are worth a lot of money.

So what is the legal argument here?

At issue in this important case is the conflict between the privacy of physician-identified drug- prescribing information and the First Amendment right of a business to communicate about its products (“commercial speech”). In contrast to public discourse, which is protected by the First Amendment as a fundamental part of the democratic process, protection of commercial speech under the First Amendment is a relatively recent development in the law. According to the Supreme Court, government regulation of commercial speech must directly promote a substantial governmental interest and must be no more extensive than necessary to meet that interest.

The law in question does not prevent drug companies from advertising the hell out of their products in any way. It will prevent drug companies from using individual physician prescribing habits to tailor a marketing campaign for an individual physician. An opt-in program will produce less data from which the mining companies and the AMA may profit. Given the role of the government in financing and regulating so much about healthcare in the US, the government has a compelling interest in speech that increases healthcare costs - as this sort of data-mining certainly must - or influences the health of the nation.

It will be interesting to see how the Supremes come down on this case. I fear the same group that gave corporations the same protections for political donations as individuals will not see the logic in Vermont's law. Be sure and read the NEJM article in full; the authors make the point in more detail and with greater eloquence and expertise than I can.

In the meantime, let's all opt out of the scheme via the AMA's little-known site. It's the least we physicians can do.

 

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Setting the Bar Before We Measure It

Nov 19 2010 Published by under Uncategorized

Yesterday I attended a session at the Annual Meeting of the American Society of Nephrology regarding changes to reimbursement for nephrology services through the Center for Medicare and Medicaid Services (CMS). Dr. Barry Straube, a nephrologist and Director of CMS, spent 90 minutes discussing the alphabet soup of changes wrought by both CMS and the Affordable Care Act.

One innovation is Quality Incentive Programs (QIP), a move to reward physicians (and the health care team) for meeting or exceeding quality standards. Reimbursement would be lowered for practices delivering sup optimal care. Sounds like a wonderful plan, doesn't it?

Fast-forward to half an hour of Q&A.

"How are we going to set QIP standards?"
Mostly through the use of expert committees.
"Hmmm... That's how we set anemia standards a few years back. Those standards led us to push hemoglobin higher than necessary in patients, levels we now know increase teak of cardiovascular morbidity and mortality. How can we set a bar without data on where to set the bar?"
We have to start somewhere.
"So we may end up penalizing providers for not achieving goals that may not turn out to be the correct goals?"

It's great to say we will reward quality care and outcomes; however, we need to be able to define those outcomes using real data, not opinion and conjecture. We must also recognize that therapeutic goals should be individualized. Attaining blood pressure goals for a large group of patients may prove beneficial for the group, but achieving tight lowering for some patients may cause significant side effects affecting quality of life. Should caregivers be penalized because patients cannot or will not or even should not meet the published guidelines? These exceptions to general goals become especially problematic in smaller practices. If I have 100 patients in my center and 5 fail to meet the goal, 95% are on target if I only care for 6 patients (not an unusual number of children for a dialysis center) and even one doesn't make that target, my success falls to 83%.

We do need to find ways to control healthcare costs and reward thought and quality. Before QIPs can be the answer, we need to know what quality is. This task will take funds and time. We must be careful to avoid over-penalizing before we have defined what we really want.

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Regulation of Continuing Education in Medicine

Sep 14 2010 Published by under Continuing Development, Regulation, [Education&Careers], [Medicine&Pharma]

Last week we examined the history of continuing medical education (CME) in the US, and the various levels of regulation of physician practice.  Today's post explores the regulation of CME.

Initially, no one certified CME. Courses run by medical schools and local medical societies existed for the edification of those they served. Only when the AMA/PRA Category 1 Credit(TM) became necessary for practice did CME become regulated. Today we have a confusing, circuitous system of checks and balances, primarily to keep CME from becoming merely marketing for new drugs and devices.

US CME Regulation, 2010

The trip through the illustration should begin with the American Medical Association (AMA), the group that owns the coin of the realm in CME. The AMA, along with 6 other medical organizations, elects the Board of Directors of the Accreditation Council for Continuing Medical Education (ACCME). ACCME accredits national providers, including the AMA. The AMA certifies state medical societies as providers of CME. State societies can accredit sponsors of CME that serve participants from a single state; generally, the audience must be at least 70% participants from the state or region in question. The ACCME reviews and recognizes state medical societies, but has no real regulatory power; only the AMA can revoke the ability of these organizations to grant CME credit.  At present time, the ACCME certifies 727 national providers.; there are 1560 state-level providers in the US.

Over time, the ACCME has increased its regulatory heft, requiring more justification of the content of offerings, reports of conflict of interest, and other compliance efforts. Assessments for accreditation have also increased over time, along with the paperwork. It is unclear if the time and funds invested have improved the CME process, let alone physician practice or patient outcomes.

Enter the report of the Institute of Medicine which provides five broad messages for US CME:

  1. There are major flaws in the way CE is conducted, financed, regulated, and evaluated. Among various problems, health professionals and their employers tend to focus on meeting regulatory requirements rather than identifying personal knowledge gaps and finding programs to address them. Many of the regulatory organizations that oversee CE also tend not to look beyond setting and enforcing minimal, narrowly defined competencies.
  2. The science underpinning CE for health professionals is fragmented and underdeveloped. These shortcomings have made it difficult, if not impossible,to identify effective educational methods and to integrate those methods into coordinated, broad-based programs that meet the needs of the diverse range of health professionals.
  3. Continuing education efforts should bring health professionals from various disciplines together in carefully tailored learning environments. As team-based health care delivery becomes increasingly important, such interprofessional efforts will enable participants to learn both individually and as collaborative members of a team, with a common goal of improving patient outcomes.
  4. A new, comprehensive vision of professional development is needed to replace the culture that now envelops continuing education in health care. Such a vision will be key in guiding efforts to address flaws in current CE efforts and to ensure that all health professionals engage effectively in a process of lifelong learning aimed squarely at improving patient care and population health.
  5. Establishing a national interprofessional CE institute is a promising way to foster improvements in how health professionals carry out their responsibilities. The committee proposes the creation of a public-private entity that involves the full spectrum of stakeholders in health care delivery and continuing education and that is charged with developing and overseeing comprehensive change in the way CE is conducted, financed, regulated, and evaluated.

The call had been made to fundamentally change CME in this country. These are exciting times for those of us who deliver and study continuing professional development, as the IOM report suggests we rename CME.

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Regulating Medical Practice

Sep 10 2010 Published by under Regulation, [Education&Careers], [Medicine&Pharma]

The era of modern medicine in North American began after Abraham Flexner's 1910 report. In 1915 the National Board of Medical Examiners formed  to develop and certify medical doctors. This group helped establish national certification exams (the United States Medical Licensing Examination or USMLE) based on the science-based curricula that sprouted from Flexner's work. Passing the USMLE is only one hoop today's physicians must jump through to practice in North America.

Licensing Exams

Regulation of medical licensure falls to State Medical Boards, all of which require some sort of examination. While some acceptable alternatives exist, all 50 states accept passage of the USMLE. This examination actually includes 4 separate tests of a physician's competence.

  • Step 1 covers the basic sciences important for the practice of medicine in a multiple choice format. Medical students in traditional programs take this test at the end of their second year.
  • Step 2 consists of 2CK (for clinical knowledge) and 2CS (for clinical skills).  2CK is another multiple choice exam; for 2CS students must travel to testing centers where examiners observe each student taking a history and performing a physical exam on a standard patient (an "actor" trained to present with specific symptoms and findings). For 2CS the student also must demonstrate the ability to synthesize findings and create a plan for diagnosis or treatment that they successfully communicate to the standard patient. Students in the fourth year of a traditional curriculum take the portions of Step 2.
  • Step 3 returns to the multiple choice format, but focuses it questions on patient management. This step is taken after successful completion of the medical degree.

Once a doctor passes all components of the USMLE, they are eligible for medical licensing in North America.

Medical Licensing: Location, location, location

Regulating medical practice belongs to state governments, and requirements vary from state-to-state. Most states will grant a full, unrestricted license after passage of all 3 steps of USMLE plus 1-2 years of post-graduate training. Historically, the first year after medical school was a rotating internship; completion of that year would allow one to be a general practitioner or GP. Family Medicine, officially recognized in 1969, has essentially replaced general practice in the US. Physicians practicing family medicine complete 3 years of post-graduate training and can be board certified in their specialty.

Licenses must be renewed periodically. After some set time period each state assesses a physician's practice record (have there been any complaints or crimes?), and most require some documentation of attendance at continuing education programs.

Board Certification

Specialty board certification occurs after completion of an approved training program. Upon completion of a residency or fellowship, a physician becomes Board Eligible (BE). After demonstrating an unrestricted medical license, certificate from a training program, and the ability to write a really large check, BE physicians take another test focusing on their specialty. For us sub-specialists, the process happens twice! First we must become board certified in our primary specialty (Pediatrics in my case, Internal Medicine in others). Then, after appropriate fellowship training, we get to take another exam for our new skill set.

Specialists tested before 1984 generally have life-long board certification. Those of us examined after that date have time-limited certification; we get re-examined every few years. In the last 5 years, the Boards have moved from a testing focus to Maintenance of Certification (MOC). Continuing education, practice improvement, and testing are all components of MOC.

One has to have a valid, unrestricted medical license to qualify for MOC. Continuing education is a requirement for that license in most states, and some MOC requirements can be used to meet this component for licensing. MOC is not (yet) required for a medical license or to practice a specialty in the US. Board Certification is generally required for practice in academia, and rumors abound suggesting that medical insurers may eventually require MOC for payment of specialists. The American Society of Nephrology has worked closely with the American Board of Internal Medicine to develop MOC-friendly offerings; more information about this process for (adult) nephrologists can be found here.

Some images in this post are used courtesy of PhotoXpress.

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