Have you ever been the victim of a medical error? Before you answer, consider if you’re one of the hundreds of thousands of American patients who had an adverse drug reaction but didn’t tell your doctor or pharmacist. While medication errors don’t always lead to catastrophic outcomes, they are still capable of causing harm. The NCBI.gov article, “Medication Errors“ by Dr. Rayhan A. Tariq and Clinical Pharmacist Yevgeniya Scherbak, examined the problem and estimated the numbers. Their research determined that drug-related errors cause numerous problems, including 7,000 to 9,000 deaths each year in America alone.
Since opioids began monopolizing the medication error spotlight, you’ve probably heard very little about other drug issues. Narcan overdose supplies, emergency police responders, and emergency health services have strained government finances. Washington Attorney General, Bob Ferguson, has joined other states in suing opioid manufacturers, shippers, and others in the chain of the drug’s distribution.
As you contemplate the recent overdoses and deaths, it’s important to remember that many overdoses occurred while the victims were taking opioid medications legitimately prescribed by their healthcare providers. Of the 742 overdose deaths in Washington during 2017, The National Institute on Drug Abuse documented 343 deaths due to prescription opioids.
Other drug error numbers seem small by comparison but they’re still out there. Drug errors are consistently included among the top medical errors, both nationally and in Washington. The Washington Insurance Commissioner’s 2017 Medical Malpractice Annual Report lists drug errors under the category “Error/Improper performance.” The report is an analysis of medical malpractice insurers in the state and lists only basic details for the 196 drug error cases included.
The numbers aren’t exactly staggering but that’s primarily because many drug errors remain unreported. The totals include reported, settled, and/or closed prescription drug-related claims in these categories.
Drug Errors are Medical Malpractice. Medication errors occur because a nurse, pharmacist, prescribing physician, or practitioner failed to meet “the accepted standard of care“ as defined by the Revised Code of Washington. While not every error causes major problems, some do. They cause a range of injuries from minor illnesses and conditions to fatalities. Because injured patients don’t always report suspected medication problems, the problems continue unabated.
People rely on prescription medications and their healthcare providers give them what they need (and sometimes what they want.) Although the written prescription rate has gone down from previous decades, the numbers are still high. The CDC’s report, Prescription Drug Use in The United States, 2015 to 2016, projects some interesting data from their Health and Nutrition Survey:
Tariq and Scherbak’s medication research determined that a key part of the drug problem is that there are numerous medication options. Healthcare providers have over 6,800 different medication choices when prescribing drugs for their patients. It’s easy to see why 50 percent of drug errors occur during the ordering/prescribing stage. The sheer number of brands and variations complicate the prescription process.
Healthcare providers sometimes specify the wrong medication, the wrong dose, or the wrong frequency. Errors also occur during prescription transcribing, dispensing, administration and monitoring. Providers write illegible prescriptions. Pharmacists put the wrong instructions on medication labels. Medical providers dispense medication to the wrong patients. Physicians fail to research and monitor patient allergies and organ functions. Drug interactions occur when providers fail to document vitamins, herbs, supplements, over-the-counter medications, and other prescriptions.
Drug errors weren’t as much of a problem in previous decades. That’s primarily because medical professionals didn’t prescribe as many medications as they do now. That increase didn’t happen by accident. Drug companies have helped mold patients into the drug consumers they are today. As with most manufacturers, they increased their profits by employing traditional marketing methods:
Long before Americans started buying ED prescriptions online or asking their doctors about RLS or OAB, pharmaceutical companies decided it was time to include drug consumers in their marketing schemes. “A History of Drug Advertising,“ a PubMed/Millbank Quarterly article by Julie Donohue, discusses how drug manufacturers began direct-to-consumer advertising (DCTA) in the early 80s. The idea of selling directly to patients was a timely concept that supported consumer’s medical rights trends. It also challenged the public in several ways:
The Food and Drug Administration laid out the DCTA ground rules in the Prescription Drug Marketing Act of 1987. The rules are included in the Code of Federal Regulations, Title 21, §202, Prescription Drug Advertising and §203, Prescription Drug Marketing. You probably don’t know these guidelines, but TV commercials, radio spots, and magazine ads adhere to the rules.
Drug ads must follow specific rules for layout, proprietary names, and ingredients. Each ad promoting a proprietary drug must also include warnings describing side-effects and contraindications. Pharmaceutical companies have no choice so they comply with these guidelines (mostly) but they do it creatively. When a commercial airs, patients don’t necessarily hear or see those warnings. Drug companies have become masters of creating commercials that both inform and entertain.
If you’ve seen the Toujeo diabetes medication commercial, it probably made you smile… and maybe even dance. Of course, you missed the warnings: “allergic reactions,” “body rash,” “trouble breathing.” You were probably too distracted by the cool middle-aged guy dancing through the office and flirting with the cute girl at the gym. You probably didn’t hear the warnings and side effects: the song “Let’s Groove Tonight” upstaged those messages throughout the entire commercial.
In the “See Me Now” Cosentyx commercials, Cyndi Lauper and her friends might have sucked you in with their tragic psoriasis “before” selfies and their beautifully bare “after”Cosentyx skin. You might not have heard the soothing voice-over explaining “inflammatory bowel disease” and other unpleasant side effects.
Disclaimers attempt to make drug consumers responsible for bad drug reactions or allergies. A few ads include a phrase that begins, “Don’t take ____ if you’re allergic to…” Companies word these disclaimers to make medication research and monitoring seem like a patient’s responsibility when it’s clearly a medical professional’s duty. Some consumers might know if they are allergic to blueberries or even penicillin. Most have no way of knowing if they’re allergic to a new drug until after they’ve taken it and suffered the consequences. That won’t prevent an attorney from asserting an assumption of risk liability defense on behalf of a drug distributor or seller. After all, the commercial told you not to take it.
Drug ads follow FDA guidelines by describing side-effects during their commercials. The Toujeo commercial and others also post written warnings on the screen. Unfortunately, they make it easy to overlook them. The side-effect/warnings voice-overs are often soft, sexy, or mellow. If you hear warnings over the music or notice them in spite of the dancing, they come across as harmless, even silly; but that’s the point. They’ve done what manufacturers want drug commercials to do: sell you on the benefits, warn you about the risks, but keep you interested enough to schedule a visit with your doctor.
One interesting aspect of these commercials is that each manufacturer must get FDA approval before marketing a drug. FDA’s compliance division also monitors drug ads on TV, print media, and websites. Drug manufacturers walk a fine line between compliance and non-compliance. Based on examples of actual FDA warning letters, the risk of non-compliance involves few consequences.
Drug companies can’t market a new medication until it’s jumped through the FDA’s hoops, but they have an alternative to grab the spotlight. They market the disease instead. Before a company sells a drug, the FDA must review its formula, uses, patents, and a long list of additional factors. They must also approve a company’s marketing plans before they introduce their new drug to consumers.
The pharmaceutical company strategy for addressing FDA restrictions and delays involves targeting the consumer long before they release a drug. Often, the initial on-air marketing campaign for a new drug doesn’t mention the drug at all. These unbranded commercials inform consumers about diseases and their potential consequences. Sometimes it’s a disease you never heard of. Other times its an old condition with a catchy new name (Dry Eye, Low-T, HPV, etc.).
Disease marketing creates a need by grabbing the target market’s attention. They create a sense of urgency that makes people take notice of conditions they might have been ignoring for years. These types of campaigns create “disease awareness.” Unbranded ads encourage viewers to recognize “problems” that they might not have considered problematic before. When a drug company finally releases the appropriate drug, consumers are ready to buy.
The JAMANetwork.com article, “Medical Marketing in the United States, 1997-2016“ by Doctors Lisa M Shwartz and Steven Roloshin, discusses how current DTC marketing strategies developed. Drug advertisers increased their DTC spending from 1.3 billion dollars in 1997 to 6 billion dollars in 2016. If you sense that they used a lot of that money to bombard you with TV ads, you’re right. The number of televised drug ads increased from 72,000 commercials in 1997 to 663,000 in 2016.
In the BMJ Journal of Medical Ethics “Viewpoint” article, pharmaceutical and academic professionals discuss “Inventing a disease to sell low libido.” The article talks about “condition branding.” This marketing technique often begins with physicians. Drug companies fund accredited medical education courses that promote condition awareness. To sell the condition low libido, for example, multiple online classes educated medical personnel about “hypoactive sexual desire disorder,” a disease a woman might not realize she has. Coincidentally, the FDA was simultaneously considering approval for a drug to treat the condition.
Before a drug company begins developing a drug or initiating a disease marketing campaign, they gage its chances for financial success. If their potential medication is for an existing, not-so-urgent condition, they give the condition a makeover. The goal: make it identifiable and memorable.
For example, drug companies rebranded erectile dysfunction to ED, giving it a far simpler name. They also reinvented RLS, SAD, and other new yet old conditions. When a person relates to a condition and it’s easy enough to remember, they may mention it to their doctor. The doctor will know about it because drug companies will have educated them ahead of time.
Drug companies are experts at sales, drug development, and marketing. It’s important that consumers understand that. Knowing that fact, you must still act prudently if you’re already taking medication.
If you or a loved one was injured because of an adverse drug reaction, you need a medical errors attorney to protect your legal rights. Most medical malpractice attorneys will offer a free initial consultation and will take their cases on a contingency fee basis, so you will pay nothing unless your attorney secures a settlement or judgment on your behalf.