By THERESA BROWN, RN
In my mid-twenties, I was twice prescribed the common antihistamine
Benadryl for allergies. However, my body’s reaction to the drug was anything
but common. Instead of my hives fading, they erupted all over my body and my
arms filled with extra fluid until they were almost twice normal size. I subsequently
described my experience to a new allergist, who dismissed it as “coincidence.”
When I later became a nurse, I learned that seemingly “harmless” medications often cause harm, and older adults are particularly vulnerable. Every year, Americans over age 65 have preventable “adverse drug events” (ADEs) that lead to 280,000 hospital stays and nearly 5 million outpatient visits. The Lown Institute in Boston draws attention to this underrecognized problem in their recent report, Medication Overload: America’s Other Drug Problem. Policymakers, patients, and health professionals must act, because over the next decade, medication overload is predicted to cause 4.6 million hospitalizations of older Americans and 150,000 premature deaths.
Nearly half of all older adults take at least five
prescription drugs, a 300 percent increase from 25 years ago. The
more drugs we take, the likelier it is that one of them, or some combination,
will cause serious harm. When you add in non-prescription medications,
including over-the-counter drugs like ibuprofen and Tylenol, as well as
vitamins and herbal supplements, the potential for harm only goes up.
I’ve seen this in my
work. It is not unusual for elderly, very ill patients on hospice to have
prescriptions for 20 to 30 drugs. Several of their medications may treat the
same problem, amplifying any serious side effects. Blood pressure medications provide
a good example. As older patients become more debilitated, lose weight, and are
taxed by other health issues, the effect of these medications can intensify,
severely lowering blood pressure, and causing the patients to fall. Indeed, if
I am following up with a hospice patient who has fallen, the first thing I
check is their prescription medications for hypertension.
In 2007-8, when counterfeit versions of heparin, a blood-thinning drug, were shipped from China to the United States market, 149 people died. In the last few months, bogus versions of the cancer drug Avastin, apparently shipped from the Middle East, have surfaced in clinics in California, Illinois and Texas. Thankfully, so far as we know, they haven’t killed anyone, but more and more cases of dangerous fake drugs are being reported by the Food and Drug Administration. Numerous incidents surely go unreported, the evidence swallowed, the deaths incorrectly attributed to natural causes.
Fighting the fake-drug menace is like playing whack-a-mole. It is technically illegal for individuals to order drugs online from other countries. And yet no sooner does the F.D.A. shut down one dubious online pharmacy than another pops up. According to the National Association of Boards of Pharmacy, only 3 percent of the 9,600 online pharmacies it has reviewed complied with industry standards. Many were based overseas, so their sales to Americans were illegal; others did not require doctors’ prescriptions. And some were very likely peddling dangerous counterfeit drugs.
The Food and Drug Administration is considering removing prescription requirements for medications that treat common conditions, such as high blood pressure, diabetes, asthma, migraines and high cholesterol. This means that you would be able to go to your local pharmacy, fill out a questionnaire, receive a diagnosis and purchase a medication, all without intervention or direction from a physician.
As a doctor, I think this is a very bad idea. Although it is true that diagnoses are often missed — reports estimate that as many as 7 million diabetics in the U.S. remain undiagnosed — and although easier access to drugs could theoretically encourage patients to take their medications, I am concerned that expanding over-the-counter access will lead to wrong diagnoses with improper treatments, which carry side effects.
Remember, medicine is an art, practiced on an individual basis. A medication that works for one person doesn’t always work for another. I am constantly changing cholesterol or high blood pressure medications for my patients because of unanticipated side effects such as muscle aches or dizziness.
Lack of follow up
What would happen if I weren’t involved to monitor treatments and make necessary changes? The upfront cost savings from cutting out doctors and their office fees will be more than made up by longer term costs of improper diagnoses or unmonitored complications.
Advocates of expanding over-the-counter medications point to aspirin or allergy drugs as examples that have proved successful without a doctor’s prescription. But for every patient who is glad not to have to visit my office for an allergy prescription, I can point to another patient who has suffered side effects like fatigue that he or she didn’t realize were due to that same pill, or where the allergic reaction was due instead to food.
The fact that common painkillers have been available over the counter for decades also doesn’t provide a convincing argument for bypassing prescriptions. Consider that more than 100,000 Americans are hospitalized every year due to bleeding from aspirin or other OTC non-steroidal anti-inflammatory pills, and acetaminophen is the No. 1 cause of acute liver failure.Continue reading…
As physicians, our primary concern is ensuring the health and safety of our patients. The Food and Drug Administration has offered a new concept to make more prescription drugs available over the counter (OTC). Proponents claim it could improve patient health and outcomes, reduce patient costs and promote proper medication use. We are skeptical that it would achieve any of these goals.
The American Medical Association is concerned about patients taking certain drugs without physician involvement — especially patients with chronic diseases. No evidence has been offered that the innovative technologies underpinning this concept would actually allow patients with high blood pressure, high cholesterol, asthma or migraine headaches to self-diagnose and manage these serious chronic medical conditions safely on their own.
As a chronic condition evolves, treatment changes are often needed from a physician. Without physician involvement, patients might take the wrong medication or dose for their needs, potentially causing harm. Self-diagnosis and treatment conflict with the care coordination and disease management that new health care payment and delivery models are trying to achieve.
A top executive I know recently decided to take Inderal before making high-pressure/high-anxiety presentations. The impact was immediate. She felt more relaxed, confident and effective. Her people agreed.
Would she encourage a comparably anxious subordinate to take the drug? No. But if that employee’s anxiety really undermined his or her effectiveness, she’d share her story and make them aware of the Inderal option. She certainly wouldn’t disapprove of an employee seeking prescription help to become more productive.
No one in America thinks twice anymore if a colleague takes Prozac. (Roughly 10% of workers in Europe and the U.K. use antidepressants, as well). Caffeine has clearly become the (legal) stimulant of business choice and Starbucks its most profitable global pusher (two shots of espresso, please).
Increasingly, prescription ADHD drugs like Adderall, dedicated to improving attention deficits, are finding their way into gray market use by students looking for a cognitive edge. When one looks at existing and in-the-pipeline drugs for Alzheimer’s and other neurophysiological therapies for aging OECD populations with retirements delayed, the odds are that far more employees are going to be taking more drugs to get more work done better.
Performance-enhancing (or degraded performance-delaying) drugs will become as common as that revitalizing cup of afternoon coffee.
Should that be encouraged? Or should management pretend those options don’t exist?
Most managers would believe they’re doing a good thing if they encouraged a hard-of-hearing employee to explore a hearing aid or a visually-impaired colleague to consider glasses. By contrast, encouraging an under-performing subordinate to lose 25 pounds, get a hair transplant or contact-lenses would likely inspire a formal complaint to Human Resources and/or a possible lawsuit. Ironically, the money isn’t the issue here; the business norms associated with perceived cosmetic and aesthetic concerns are radically different from those attached to job performance and productivity.Continue reading…
At Dr. Huberto Merayo’s bustling psychiatry practice in Coral Gables, Fla., hundreds of poor patients on Medicaid walked away each year with prescriptions for powerful antipsychotic drugs.
Merayo’s prescriptions for the drugs totaled nearly $2 million in 2009 alone, state records show.
The 59-year-old psychiatrist is also in demand by the makers of these drugs. He’s earned more than $111,000 since 2009 delivering promotional talks for AstraZeneca, Eli Lilly & Co. and Pfizer, according to ProPublica’s database of drug-company payments to doctors.
This year, Florida regulators finally challenged Merayo’s enthusiasm for the pricey drugs, which are used to treat schizophrenia and bipolar disorder. A state review found he hadn’t documented why patients were prescribed the pills and had given them to patients with heart ailments or diabetes despite label warnings.
In May, Florida summarily ended his contract with Medicaid. But the action, though decisive, followed years of high prescribing by Merayo, according Florida’s own statistics. And he was booted only after public questioning by U.S. Sen. Charles Grassley, R-Iowa, who had asked states to investigate such cases.
Merayo’s situation is one of at least three in which Florida allowed physicians to keep treating and prescribing drugs to the poor amid clear signs of possible misconduct.
The state’s responses were marked by head-scratching errors, including the misspelling of Merayo’s name on official documents, and lengthy delays.
In another example, Florida allowed Dr. Joseph M. Hernandez of Lake City to continue prescribing narcotic pain pills to Medicaid patients for more than a year after he was arrested and charged in 2010 for trafficking in them.
Doctors can and often do prescribe medications for different purposes than what the FDA has approved them for. But drug companies face tight restrictions on communicating with physicians about these so-called “off-label” uses. If the pharmaceutical industry has its way, those restrictions may soon ease. Such a change would be healthy overall.
Drugs undergo clinical trials for specific indications, such as Avastin for colorectal cancer. The label received from the FDA upon approval allows the manufacturer to promote the drug to physicians for those specific indications only. But a drug that works for one disease may work for a related disorder (e.g., another form of cancer) or something that seems totally different, like macular degeneration. Often the drug company will follow its initial clinical trials with trials for other indications in order to broaden the label and expand sales, but salespeople can’t bring up these uses until they’re officially on-label.
Drug companies get in trouble all the time for off-label promotion. According to the Wall Street Journal (The Free Speech Pill), 15 off-label cases were settled between 1996 and 2010 for a total of $8.7B.