Dangerous Doses

The use of pharmaceutical medications is an essential element of the American health care system. For many people these prescribed drugs help to treat acute illnesses and maintain control of chronic conditions. However, medication use can also result in side effects. These may occur when treatment goes beyond the desired effect such as a hemorrhage triggered by the use of anticoagulants like warfarin or heparin; or problems that occur in addition to the desired therapeutic effect i.e. the nausea, vomiting, fatigue and  hair loss associated with chemotherapy drugs used to treat cancer.

In other words, side effects can occur as a result of unintentional overdosing by the patient, medication errors such as incorrect prescribing and dosing and even when drugs are taken as directed.

Even so, SRxA’s Word on Health was shocked to read the latest News and Numbers from the Agency for Healthcare Research and Quality (AHRQ).

It seems the rates of medication-related adverse outcomes are increasing. More worrisome, this trend is likely to continue with the aging of the population, the growth in the number of comorbidities, and so called polypharmacy – when patients take multiple drugs, often way more than they need.

According to the report released last week, the number of people treated in U.S. hospitals for illnesses and injuries resulting from taking medicines jumped 52%  between 2004 and 2008.

They now estimate that each year close to 1.9 million Americans suffer either medication side effects or injuries caused by being given the wrong medicine or dosage.

The top 5 categories of medicines that resulted in people being treated and released from emergency departments were:

  • unspecified medicines  
  • pain killers
  • antibiotics
  • tranquilizers and antidepressants
  • corticosteroids and other hormones

For patients admitted to the hospital, the top five categories causing side effects and injuries were: corticosteroids, painkillers, blood-thinners, drugs to treat cancer and immune system disorders and heart and blood pressure medicines.

More than half of hospitalized patients were age 65 or older, while only 3% were under age 18. Children and teenagers accounted for 22% of emergency cases.

The increase in medication side effects coupled with the ensuing massive drain of healthcare finances and manpower suggest to us that pharmaceutical companies need to dedicate more resources to ensure that both doctors and patients are educated about side effects and how to recognize, minimize and manage them.

Big Brother may not be watching, but the FDA, it seems is!

Here at SRxA, we all know how much physicians like to put on their marketing hats. In future, it seems, they might have to reach for their safety helmets instead!

According to our fellow bloggers at Good Promotional Practices doctors are starting to be held accountable to the same promotional compliance standards as pharmaceutical companies.

As most of our readers know, when FDA approves a drug it does so for a given use or indication. However, physicians are still free to make their own decisions based on how a device is used based on their best judgment. When a drug, biologic, or medical device is used for some indication other than the one approved by the FDA it is said to be “off-label.”

In this almost perfect dichotomy, it is perfectly legal, in the United States, for a physician to use a drug or device for “off-label” but it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Furthermore, based on the flurry of DOJ, OIG and FDA activity, such as the massive fines leveled out to Allergan ($600M), GlaxoSmithKline ($750 M), Novartis ($422 M) and Pfizer (2.3 billion) companies must keep the practices of their marketing and sales department in check to ensure compliance.

Until now the “it is unlawful to market, advertise or otherwise promote off label use of a drug” has been aimed at Pharmaceutical companies and third parties acting on their behalf.  Now people are asking “What if the hospital or physician group is doing the marketing themselves, not the company?

We’ve all seen the billboards and free in-flight magazine ads promoting the latest medical treatments from liposuction to joint and hormone replacement.  With physicians are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Blogger Sean McCarthy uses the example of the irregular heart rhythm Atrial Fibrillation (AF, AFib).  While there are very few approved drugs or devices to treat atrial fibrillation, upwards of 2.5 million Americans suffer from this debilitating condition.  Not so surprising then, that physicians use an array of off-label drugs and devices to treat this disease. So, now the hospital or physician communicates their ability to help AFib patients by promoting their latest treatment for the disease on a billboard or newspaper article. Isn’t this the same thing as a company promoting off-label use?

State Attorney Generals, the DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.  McCarthy says he’s heard rumors of a state Attorney General investigating a doctor about his referral patterns and advertising activities.

Who better than the pharmaceutical industry to take the lead in providing education to physicians  to help them prevent compliance snafus.  After all we’ve been there, done this!

Contact SRxA today to see how we can get you started.

FDA Warning – Time to get personal

In a move guaranteed to send shock waves around the industry, FDA lawyers just announced that CEOs of pharmaceutical companies could face prosecution for off-label drug marketing.

The FDA’s Deputy Chief of Litigation, Eric Blumberg, said, “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion. It’s clear we’re not getting the job done with large, monetary settlements.”

Although the lawyer didn’t specify when the agency will start to implement sanctions, he warned company executives not to wait until the first charges are brought.

If you’re a corporate executive or are advising a corporate executive, now is the time to comply,” continued Blumberg.

Non-compliance with the order could result in executives incurring fines of up to $100,000 and up to one year in jail. In addition, regulators could also bar individuals from working in the drug industry.

Prosecuting executives for violations of the federal Food, Drug and Cosmetic Act falls under the Park Doctrine, a long forgotten, and rarely used statute named after the 1975 U.S. Supreme Court case against a retail food chain president.   In essence, the Park Doctrine allows prosecutors to hold CEOs responsible for the crimes of their underlings, even if they had no specific knowledge of their actions, on the general principle that CEOs have a responsibility to ensure that their organizations follow the law.

For small companies with rigorous compliance in place this should not be a problem, but for the giant pharma entities with upwards of 100,000 employees is it realistic, let alone possible, for the CEO to make sure they’re all obeying the law?

If you’re a CEO of a pharma company, or an employee who would like to stay employed, then look no further than SRxA.  We are here to help you through the complexities or compliance and create worry-free marketing and educational initiatives, guaranteed to help you and your boss sleep at night.

Contact us today for further information.

FDA launches BadAd campaign

Stethoscope? Check. White Coat? Check. Whistle? Pardon!!!

Citing a limited ability to identify violative pharmaceutical advertising and promotional activities, the FDA has announced the launch of its “Bad Ad” Program.  The Program encourages health care prescribers to directly report false and / or misleading drug advertising, marketing materials and promotional activities to the FDA – specifically activities that:

  • omit or downplay the risks of a drug
  • overstate the effectiveness of a drug
  • promote off-label uses
  • compare drugs in a misleading manner

In addition  to asking doctors to whistle-blow on violations that occur during speaker programs, sales presentations, TV, radio & print advertisements, websites and print materials the FDA wants doctors to “monitor promotional activities that occur in private.”

FDA is particularly interested in what pharma reps say during sales calls, presentations, discussions at medical conferences, and in other face-to-face interactions.

Health care professionals who encounter suspect claims or activities are asked to notify the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). As part of the program, the FDA will offer physicians training at medical conferences on how to identify misleading sales aides. In addition, the agency has simplified the reporting process which now includes a hotline and email address.  Submissions may be anonymous.

DDMAC enforcement activity has  risen dramatically over the past year, and the “Bad Ad” Program suggests that FDA hopes to take even more enforcement action in the future.  The issue of concern here is whether by directly engaging the help of doctors as informal enforcement agents, the FDA is creating an “us against them” culture – where “us” is FDA and doctors, and “them” is the pharmaceutical industry.

While Word on Health is all for marketing compliance we wonder if doctors will  answer the call.   Do they have the time to be on the  look-out for bad ads?  Will they want to engage in time consuming activities for which there is no reimbursement? And do they want to be seen as the “enforcers?”

But assuming they will, SRxA can help guide you through the complex world of marketing compliance. We can help you deliver non-violative information to physicians. Contact us today for more information.

Putting an “i” in adherence!

Poor adherence to medications has been a bugaboo in the healthcare system for a long time. When sick patients don’t take their meds, they often get even sicker and end up in the hospital.  According to the New England Healthcare Institute, patients who don’t take their medicine when they’re supposed to cost the U.S. healthcare system a mind-boggling $290 billion per year.

This problem caught the attention of entrepreneurs from MIT and physicians affiliated with Harvard Medical School and has led to the creation of several innovative solutions. Among these is an electronic pill box called “Maya” that uses wireless technology and sensors to alert patients with chronic diseases when they don’t take their pills on time.

Another medication-reminder technology is GlowCaps.  These “intelligent” caps fit onto standard pill bottles and use light and sound to signal when it is time to take a pill. They also sense when the bottle is opened and wirelessly relay their status to a secure network. If the bottle is not opened after two hours, the user is automatically reminded with a telephone call.  Additionally, each week, a report summarizing progress is emailed to the user or care-giver. The caps can even call with refill reminders and connect the patient to their pharmacy as pills deplete.

Other solutions include iPhone apps such as MediMemory.

One company has even developed pills that deliver wireless signals after they are swallowed.

Even though such systems have shown to be effective, there’s still a question of who should pay for the technology. “The way that the economic models are currently set up,” says Joseph Kvedar, director of The Partners Healthcare Center for Connected Health , “it’s the patient’s responsibility to take their medication, and nobody will give them a cash subsidy to cover a program like this.”

Given that costs increase dramatically when patients don’t take their drugs, Word on Health suggests it’s about time insurers started paying attention to initiatives such as this.

In the meantime, SRxA’s Health Outcomes group are standing by to help pharmaceutical companies improve patient adherence to their drugs.  Contact SRxA for more information.

Pharma’s Missing Millions

As Word on Health has previously reported, patients not taking or refilling medications on time costs the pharmaceutical industry billions each year.  The recent global economic crisis has helped write a whole new chapter in the adherence story.  Higher numbers of new prescriptions simply go unfilled because patients either cannot afford, or are unwilling, to pay for them.

In the U.S., the total number of prescriptions filled grew a modest 2.7% last year. Yet the rate of prescriptions submitted to a pharmacy but never picked up rose 24%.

According to Dea Belazi, a consulting practice leader for Wolters Kluwer Pharma Solutions,  “What’s peculiar is that the rate of increase among patients walking away is almost unprecedented. Over the last two years, pharma has been trying to understand the abandonment situation, particularly in which parts of the country patients tend to abandon more.”
Among commercial health plan patients, the abandonment rate for new prescriptions at the pharmacy reached 6.3% in 2009. The abandonment rate for new prescriptions of brand-name drugs alone was 8.6%, up 23% from 2008 and nearly 70% since 2006.

Rising co-pays are one reason.  However, macroeconomic factors such as the housing crisis, subsequent recession and lower household incomes are thought to be the main culprits behind rising price sensitivity and soaring abandonment rates.
Health plan denials compound the problem.  Taken together, patient abandonment and payer denials resulted in 14.4% of all new, commercial-plan prescriptions going unfilled in 2009, a 5.5% increase from 2008.
Where can pharma go from here? Abandonment varies geographically. It is highest in Delaware, North Carolina and Florida, whereas denial rates for new prescriptions of brand-name meds are highest in California, Delaware and Florida.

SRxA’s team of world class Health Outcomes experts can help create tactics and strategies to help pharmaceutical companies address abandonment, denial and compliance. Contact us to find out more.