Death of the Pharma Sales Rep?

We’re not feeling a whole load of Christmas cheer among the pharmaceutical industry this festive season.

First came the news that GSK is phasing out all payments to doctors and will no longer be bonusing their reps based on sales.  Now, a new study suggests the end of the road may be nigh for pharma sales reps.

According to a survey of nearly 3,000 physicians undertaken by CapGemini and QuantiaMD, when it comes to receiving clinical and medical info, reps rank last as a resource behind print, digital media and phone links.

• 67% of physicians say digital media is their preferred source of information from drug-makers
• 40%  believe digital media has the most relevant and personalized content
• 52% believe sales reps will eventually become information coordinators
• Only a paltry 20% say reps are their favorite source of information

In parallel, more health care providers are shifting toward larger, organized health systems, which make it more difficult for reps to reach physicians for visits. Sixty four  percent of those surveyed say they restrict rep visits and 31 % of physicians in organized health systems do not allow reps any access, due to corporate policies.

Newer and younger physicians are more likely to rebuff reps – as many as 80%  impose restrictions. 90% of new physicians are joining organized health systems right out of medical school.

“Physicians today are in a time crunch, juggling more commitments than ever before and no longer have the time to dedicate to in-person meetings with pharmaceutical representatives. So the reliance on more digital channels comes as no surprise,” said Dan Malloy, Senior Vice President at Quantia. “This study supports what we’re already seeing from our 200,000 members–that a physician-centric, digital communication model is the most effective way for reaching and engaging doctors.”

On a more positive note, reps slightly edge out other resources when it comes to finding product info and patient education.

Hala Qanadilo, a principal in life sciences at CapGemini says, “While the more traditional face-to-face, in-office visits might decrease, the role of these representatives is projected to be as important as ever. Moving forward, they will need them to be the directors of multiple information sources, customizing their outreach so it is more personalized and physician-centric.”

How are you tackling the changing healthcare environment in these increasingly restrictive times?  We’d love to hear from anyone out there in Pharmaland.

Holiday Hellth!

For many of us the holidays mean family, feasting and fun.  But for our nation’s 18 million health care workers  – 28% of whom will be working on Thanksgiving, all celebrations will be placed on hold while they help those who are sick or injured.

And, as Christmas approaches, things don’t get any better.  The number of 911 calls and hospital visits spike as the temperatures plummet. For example, around 5,800 people are treated for holiday decorating injuries alone, each year. On top of this, the number one day for cardiac deaths is December 25th with December 26th and January 1st coming in a close second and third.

To raise awareness of the strain put on healthcare workers during the holiday season and some ways they can address it, Carrington College, has released these infographics:

Whatever you end up doing tomorrow, let’s not forget to say a word of thanks to our healthcare professionals. And if you do end up in their care be thankful they’re there.

FDA ups the Ante on Pharma Ads

As the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

The course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

• GlaxoSmithKline – Paxil, Wellbutrin, Avandia
• Pfizer – Bextra, Geodon, Zyvox and Lyrica
• Johnson & Johnson – Risperdal, Invega, Natrecor, Levaquin, Procrit
• Abbott Laboratories – Depakote
• Eli Lilly – Zyprexa
• Merck – Vioxx
• Serono – Serostim
• Purdue Pharma – OxyContin
• Allergan – Botox
• AstraZeneca – Seroquel
• Bristol-Myers Squibb – Abilify

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

 Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

Doctors “Bending” Ethical Norms to Best Serve Their Patients who can’t Bend their Joints

Rheumatic diseases, such as rheumatoid arthritis and lupus, are a common cause of disability. they affect all sectors of the population, diminish quality of life and have a significant social impact.

Yet, despite the benefits of early treatment and effective therapies, access to rheumatologic services may be difficult, involving long wait times, even difficulties finding providers.

C. Ronald MacKenzie, MD, a rheumatologist at Hospital for Special Surgery in New York City conducted a survey among rheumatologists entitled “Bending’ Ethical Norms to Serve Patients’ Interests:Tensions in Medical Professionalism,” to examine the medical, moral and ethical dilemmas doctors face when trying to do what’s best for their patients in the current health care environment.

The study was published in the October issue of the journal Arthritis and Rheumatism. “When people receive a diagnosis, the cost of effective treatment may render it unaffordable for many,” says Dr. MacKenzie. “While an optimal or fair system would mitigate these impediments to care, our survey of the American College of Rheumatology members suggests that this is often not the case. In fact, physicians report they frequently find themselves in situations of ethical conflict in an effort to best serve their patients.”

The survey consisted of 14 closed-ended and two open-ended questions and was sent to 5,500 members of the American College of Rheumatology.

Physicians reported ways in which they see themselves as ‘bending’ ethical standards and presented justifications for doing so. Examples included ‘embellishment’ of symptoms to help patients obtain prior authorization from insurance companies; stretching the truth to obtain diagnostic tests and necessary medications and or physical therapy.

“The delivery of medical care takes place in a particular social context, and when this context includes conditions that are unfair, healthcare practitioners may be forced to struggle with ethical conflicts, making trade-offs that may go unrecognized or are not adequately discussed.”

Medicine is not merely the scientifically based treatment and care of illness. It also involves ethical issues of right and wrong. In some cases, tough ethical dilemmas force doctors and other health care providers to make difficult decisions, all while upholding the Hippocratic oath to which all doctors are bound.

In today’s health care world, where the number of health care options can be great, medical ethics is of particular concern.Awareness of this problem and its consequences is only the first step in finding solutions to the challenges that physicians face.

Fixing the system in which physicians feel they have to ‘bend’ ethical norms and compromise ethical principles in order to provide the care their patients need, is clearly what’s so desperately needed.

 

 

 

 

 

 

Pharma Under Fire for Fair Balance Failings

Uh oh! Seems like the Pharma industry is in trouble again.

Research published in the Journal of General Internal Medicine suggests that family physicians receive “little or no information” about adverse effects associated with medicines in the majority of drug promotions made by sales representatives.

In the study, 255 family doctors from urban practices in the US [Sacrameto], France [Tolouse] and Canada [Montreal and Vancouver] answered questionnaires following visits from sales representatives.  The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

The findings showed that sales representatives did not provide any information about common or serious side effects, or identify the patients who should not be using the drug, in 59% of the promotions. In Canada, no potential side effects were mentioned for 66% of promoted products, according to the results.

The researchers also indicated that although 57% of the promoted drugs carried boxed warnings from the FDA or Health Canada, serious adverse events were only discussed in about 6% of the sales pitches.

Félicitations to the French reps who provided information on harm for 61% of the promotions, compared to only 34% in Canada and 39% in the US.

Despite this lack of “fair balance” overall, the doctors considered the quality of the scientific information to be good or excellent for 54% of the promotions and indicated that they would be willing to prescribe the drugs 64% of the time.

“Laws in all three countries require sales representatives to provide information on harm as well as benefits,” says lead author Barbara Mintzes, Assistant Professor at the University of British Colombia. “But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”

Despite widespread belief by physicians to the contrary, the information provided by pharmaceutical sales representatives has been shown to influence prescribing. Greater exposure to promotion is associated with higher prescribing volume and costs.  And while regulations in all three countries require sales representatives to provide information on the risks as well as the benefits of their drugs, there are differences.  It’s interesting, to correlate the above results with the fact that that France has the strictest information standards, whereas Canada relies on industry self-regulation.

However, across all three countries, the results of this study would appear to question if current approaches are adequate to protect patient health.

The Pharma Industry should take note.  Time to clean up your act before the Government and Regulatory Authorities do it for you.

A Ray of Sunshine?

It’s already 15 months overdue and it will be another year still before the information is public, but last week  the government  set out  the final rule for the Physician Payment Sunshine Act (Sunshine Act) in a 287 page document!

The Sunshine Act (passed in 2010 as part of the Affordable Care Act) requires manufacturers of drugs, devices, biologicals, and medical supplies to report all payments and other transfers of value to physicians and teaching hospitals. The rule was supposed to be published in October 2011, but has suffered continuous delays amongst intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA).

The final rule announced February 1^st, officially puts the Industry on notice. They have until March 2014 to get their payments reporting act together. The U.S. Centers for Medicare and Medicaid Services (CMS), will then input the data, including payment information from August through December of this year, into a publicly available database which, they say, will be online by September 2014.

And its not only payments to doctors of medicine that have to be reported. Under the definitions of the Act, “physicians” include doctors of osteopathy, dentists, podiatrists, optometrists and chiropractors.

The rule also requires reporting on both the form and nature of payment or transfer of value made by a manufacturer to a physician.

Forms of payment included under the final rule :

• Cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
• Any other form of payment or transfer of value

While, nature of payments include:

• Consulting fees
• Compensation for services other than Consulting
• Honoraria
• Gifts
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a Speaker for a medical education program
• Grants
• Any other payment

Advocates of the Sunshine Act have long argued that the public needs to know when doctors are getting paid and by who. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

This increased transparency is also intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. For example, last year an advisory panel voted 15-11 to support the approval of Bayer‘s Yaz birth control pills, but allegations later surfaced that four committee members had ties to the manufacturer.

Once the bill is introduced, doctors will get 45 days after information is submitted to vet it for accuracy.

The American Medical Association (AMA) is not happy.  The doctors’ group wants physicians to have more than 45 days to challenge information in the government’s database and add commentary to explain the payments. It also wants some corporate contributions to physicians excluded from disclosure, including sponsorships for educational activities and “indirect” payments, such as unsolicited contributions a company might make to a nonprofit group affiliated with doctors or to physicians’ employers or practices.

AMA president Jeremy Lazarus wants to ensure “the registries will provide a meaningful and accurate picture of physician-industry interactions. It is critical that the final rule provide physicians with a clear way to correct any inaccurate information and not place any substantial administrative burden on physician practices.”

And the AMA is not alone. Unsurprisingly, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary lobbying group for drugmakers, said that while it supports more disclosure, the new regulations should take into account the importance of context in the publication of physician payment information.

“Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust,” said Matthew Bennett, a spokesman for PhRMA. The principle behind the so-called sunshine provision “is complementary to this belief and it has great potential for helping patients understand the ways in which such collaboration benefits their health and medical innovation,”

What’s your take on this new rule? Is the government helping to let the sun shine in or is this a dark, dark day for doctors and pharma?  Let us know your thoughts.

Geriatric Medicine?

Picture this…a distinguished vascular specialist in his 80’s performs surgery, then goes on vacation, forgetting he has patients in the hospital; one subsequently dies because no doctor was overseeing his care.

Or imagine this? An internist who suffered a stroke gets lost going from one exam room to another in his own office.  Crazy? Unbelievable?? Well how about the beloved general surgeon with Alzheimer’s disease who continues to assist in operations because hospital officials don’t have the heart to tell him to retire.

No, these aren’t plots from a new medical drama, they are all real-life examples, exemplifing an emotionally charged issue that is attracting the attention of patient safety experts and hospital administrators.

About 42% of the nation’s 1 million physicians are older than 55.  21% are older than 65. And their ranks are expected to increase as many work past the traditional retirement age of 65, for reasons both personal and financial.

Unlike commercial airline pilots, who by law must undergo regular health screenings starting at age 40 and must retire at 65, doctors are subject to no such rules. And while most states require continuing education credits to retain a medical license, “you can sleep through a session, and if you sign your name, you’ll get credit,” observes Ann Weinacker, chief of the medical staff at Stanford Hospital.

“The public thinks that physicians’ health and competence is being vigorously monitored and assessed. It isn’t,” said geriatrician William Norcross, 64, founding director of a program at the University of California at San Diego that performs intensive competency evaluations of doctors referred by state medical boards or hospitals. The program, known as PACE, (Physician Assessment and Clinical Education) is one of about 10 around the country.

Norcross, who evaluates 100 to 150 physicians annually, estimates that about 8,000 doctors with full-blown dementia are practicing medicine. And as if that in itself isn’t worrying enough, studies have found, that approximately one-third of doctors don’t even have a personal physician, who might be on the lookout for deteriorating hearing, vision and motor coordination, or the cognitive impairment that precedes dementia.

Although doctors are not immune to the effects of aging, those with cognitive and neurological problems almost never have insight into their problems many deny that anything is wrong.

While few experts would argue that age alone should control who can continue to practice, some studies suggest that doctors’ skills tend to deteriorate over time. A 2006 report found that patient mortality in complex operations was higher among surgeons older than 60 than among their younger colleagues.

“Colleagues have a code of silence,” says New Hampshire health-care consultant Jonathan Burroughs who spent 30 years as an emergency department physician. During his career, Burroughs said he followed several elderly doctors around, quietly correcting their orders to prevent mistakes. According to him, such experiences are nearly universal in medicine. But that kindness can backfire, subjecting patients to potentially disastrous consequences such as serious injury or death, and the faltering physician to a malpractice suit or the loss of a medical license.

Although an older doctor can be a font of wisdom and experience, their skills have not necessarily kept pace; meaning that although they claim they’re practicing state-of-the-art care it’s maybe 20 or 30 years out of date.

Even so, rheumatologist Ephraim Engleman, who will turn 102 in March, said he plans never to quit. One of the nation’s oldest practicing physicians, Engleman drives from his San Mateo home to the medical campus of the University of California at San Francisco three days a week. There he sees about eight longtime patients per week.  “I’m very much opposed to retirement,” said Engleman, “As long as I’m able intellectually and physically, I’m going to continue.” His only impediment, he said, is severe spinal stenosis, which has left him stooped and dependent on a cane. “I walk like an old man,” he said.

Informed that Stanford, his undergraduate alma mater, has recently begun requiring doctors older than 75 to be tested, he quipped, “I’m glad they don’t do it here.”

So next time you catch yourself thinking cops are looking younger, maybe you should start taking a closer look at your healthcare provider.

Healthy Trends for Digital Health

Doctors and patients are increasingly tapping, zooming, and clicking in a flurry of connectivity.  According to Fred Pennic author of HIT Consultant’s Mind Blowing HIT Stats and Trends:

• 85% of US Physicians own or use any smartphone professionally
• 62% of US physicians own a tablet
• 81% of physicians own an iPad
• 50% of tablet owning physicians have used their device at the point of care
• 39% of US physicians communicate online with patients via email, secure messaging, instant messaging, or online video conferencing
• Two-thirds of physicians use online video to learn and keep up to date with clinical information
• 88% of physicians would like patients to be able to track or monitor their health at home

Physicians spend an average of 11 hours online for professional purposes per week. And those with three screens (tablets, smartphones, and desktops/laptops) spend more time online on each device and go online more often during the workday than physicians with one or two screens.

In addition to communicating with patients, most doctors say they wish they could wirelessly access electronic medical records, prescribe, monitor both in- and out-patients and track patient referrals.

And it’s not just doctors. Patients and consumers are at it too!  Health related Google searches are up 47% from last year, and:

• 20% of patients would like to monitor their fitness & wellbeing
• 18% would like to allow a physician to remotely monitor a condition
• 80% of Internet users look online for health information
• 20% search for health related content on mobile devices
• 23% use social media to follow health experiences of friends

Even more mind-blowing…in 2012 consumers were willing to spend $14 Billion on digital health products. This included $700 Million on mobile health applications, $4 Billion on health related video games and $8.9 Billion on resources rating doctors & hospitals.

No word from Fred on how much of their health information people are getting from blogs such as Word on Health. But with thousands of views each day, and increase in readership of >100% versus 2011, we certainly seem to be part of this upwards digital healthcare trend.

Where do you get your healthcare information? We’d love to hear from you.

Doctors Deficient in Anaphylaxis Care

Having just returned from the American College of Allergy, Asthma and Immunology (ACAAI) annual meeting, we’re spoiled for choice of news. But among all the science there was one stand out shocker.  In a session on Sunday, physicians presented the results of a survey, sponsored by the Asthma and Allergy Foundation of America (AAFA). During this, they revealed that a disturbingly high proportion of primary care and emergency physicians don’t know how to treat anaphylaxis.

Interviews with 318 physicians indicated that:

• substantial numbers do not always provide epinephrine to patients – even those  they believe are having anaphylactic reactions
• they often fail to refer anaphylaxis patients for follow-up care
• they believe incorrectly that some patients should not receive epinephrine auto-injectors

Myron Zitt, MD, says the results reveal “likely deficiencies in physician knowledge,” and corroborate results from earlier chart review studies.

In the telephone-based survey, researchers conducted interviews lasting an average of 19 minutes with approximately 100 emergency room physicians, 100 allergists, 50 adult primary care physicians, and 50 pediatricians.

82% to 99% of respondents in each group said they had treated at least one anaphylaxis case.

Although epinephrine is supposed to be given to all patients having such reactions, about 10% of emergency room physicians and 20% of primary care and pediatric physicians said they had done something else.  These “something else’s” included prescribed another drug, sending the patient to a hospital, or an “other” action.

Prescribing of auto-injectors for patients to take home also was far from universal. Barely 60% of emergency room physicians said they did. In fact, emergency physicians were generally bad at all phases of follow-up care. They rarely referred patients for diagnostic tests, they almost never demonstrated use of an auto-injector, and seldom explained that auto-injectors have an expiration date.

Another disturbing finding from the survey, Zitt said, was that many physicians of all types – even the allergists – mistakenly believed that some patients should never receive epinephrine.

In the same session, Akhil Chouksey, MD, reported that anaphylaxis care in a major teaching hospital usually failed to meet guidelines established by a consortium of allergy societies including the ACAAI.  In a 10-year review of anaphylaxis cases only 15% met the standards of care recommendations i.e. that epinephrine be administered within 30 minutes of triage, that auto-injectors be prescribed at discharge, and that patients be referred to an allergist or immunologist for follow-up investigations and treatment.

The review also found that in 26% of cases in which anaphylaxis was definitively confirmed, the patients never received epinephrine.  Antihistamines, such as benadryl (diphenhydramine), were given in nearly all cases but epinephrine was omitted in one-quarter. In fact, epinephrine was only the third most commonly administered medication, with corticosteroids such as methylprednisolone, taking the second spot after antihistamines.

During the question-and-answer period, an audience member suggested that, when patients present with relatively mild symptoms, the treating physicians may decide that epinephrine isn’t needed at that point.  Zitt countered, that this was a very dangerous approach.

The national guidelines state explicitly that there are no absolute contraindications to epinephrine. Nevertheless, 16% of the pediatric allergists and 32% of the other allergists said there were such contraindications, as did 38% of adult primary care and emergency physicians.

Also common were beliefs that schools, restaurants, and ambulances always stock epinephrine. In fact, Zitt said, there are no general requirements for schools or restaurants to do so, and approximately half of all ambulances do not have epinephrine on hand.

Clearly there is much work still to be done in terms of education.  SRxA’s Word on Health suggests a first step would be to instill a healthy fear of anaphylaxis into doctors and the general public while simultaneously removing the fear of epinephrine.

Or as Dr Zitt says, “Give epinephrine first, ask questions later.”

Halloween Health Hazards

While fake blood and creepy costumes help make Halloween a howl, this October 31, beware of the hidden hazards that can turn the night downright dangerous. SRxA’s Word on Health shares these top tips from top docs, to keep you safe.

While there’s few things that says Halloween like a Jack-O’-Lantern, the American Academy of Pediatrics caution that pumpkin carving is no craft for children. Instead, they suggest that young kids limit themselves to drawing designs that adults can cut out. And rather than using candles to light your lantern, they suggest you consider glow sticks to get that long-lasting luminosity.

The American Academy of Ophthalmology, warns that if you want to see another Halloween you shouldn’t turn a blind eye to the increasingly popular crazy colored contact lenses on sale in party stores.  Although cat-like contacts may look cool, these over-the-counter lenses aren’t worth the risk. They can cause serious eye disorders and infections that could result in blindness.

And it’s not just contact lenses. Other parts of your Halloween costume can also be hazardous to your health. Over-sized costumes can quickly turn trick-or-treating into trip-and-tumbling.  And to avoid having to drop and roll, the  U.S. Food and Drug Administration recommends you only wear costumes made from flame-resistant fabrics.

Similarly, choose your mask carefully. Whether you chose “The Scream, Frankenstein, or Romney, make sure so you can see what’s coming. Some masks limit peripheral vision, so much so that you may end up being the thing that goes bump in the night.  But before you decide to skip the mask in favor of  makeup, don’t forget this has its own hazards too.  Sure, well-applied makeup can transform seven the most perfect skin into ghoulish festering  wounds, warts and scars, but it can also leave a rash that lingers into November. The FDA suggests testing the makeup on a small patch of skin a couple of days before using it on your face. And check out the agency’s list of approved makeup additives. If the makeup contains unapproved ingredients, toss it.

Finally don’t get tricked by your treats! The FDA recommends that children have their Halloween loot  inspected by an adult who can remove risky treats and anything that isn’t commercially wrapped. If you’re not sure what it is – get rid of it.

Whatever you do, please stay safe out there this Halloween.