Betty Moody, a 40-year-old partially disabled veteran from Sidney, Maine, had been taking little blue pills for her arthritis for five years and expected no problems when she asked for a refill in March from the Togus veterans’ hospital.
She noticed the new pills – a drug called Piroxicam – were green. In fact, she says, she called the Veterans Affairs pharmacy because she is allergic to yellow dyes – just as it says in her medical chart – and she knew yellow dyes are used to make green. She says she was told not to worry.
A week later, she broke out in hives and her face swelled so badly that her husband, Dennis, a totally disabled vet, had to get friends to rush her to the hospital.
Moody survived her adverse drug reaction, though she’s sobered by it. So is the Togus VA Medical and Regional Office Center, which plans to “pay more attention on specific issues like this” from now on. In fact, Dr. Arnold Brown, the chief of staff, says he’s “happy this issue of adverse drug reactions is on the front burner.”
It certainly is, and about time.
Two weeks ago, Canadian researchers stunned the medical world – and everybody else – with a study estimating that in one year alone (1994), somewhere between 76,000 and 137,000 Americans died from adverse reactions to prescription drugs. More than 2 million had reactions serious enough to land them in the hospital or complicate hospital care they were getting.
That’s enough fatalities to rank adverse reactions as the sixth leading cause of death, and possibly as high as fourth.
What makes the study by University of Toronto researchers even more compelling is that they didn’t count errors in drug administration, overdoses, abuse, or minor or merely possible adverse reactions.
There is absolutely no question that overall, medications “have enormous benefits,” says Dr. Bruce Pomeranz, a co-author of the study. But what the new study makes clear is that bad reactions have been vastly under-reported. In 1994, the year his team found roughly 106,000 deaths, the FDA tallied only 3,500 such deaths, and data from death certificates showed only 156.
Even at 100,000 deaths a year, the adverse reaction rate is relatively low, given the 2.5 billion prescriptions written every year, says Dr. John SiegfriedCQ, speaking for the Pharmaceutical Research and Manufacturers Association.
In fact, “drugs are remarkably nontoxic,” insists Dr. Hershel JickCQ, a Boston University researcher whose work is funded by drug companies. “No reasonable person could really expect drugs to be any less toxic than they are.”
Maybe so. But even if that’s true, there are ways for reasonable people – and hospitals – to at least minimize the chance of bad reactions.
For instance, hospitals could scan their own computerized laboratory and pharmacy data for orders for antidotes used to combat bad reactions, says Dr. David Bates, an internist at Brigham and Women’s Hospital. These red flags could help spot trends early, says Bates, who has studied adverse reactions and wrote an editorial accompanying the Canadian research in the Journal of the American Medical Association.
Hospitals could also monitor their patients’ kidney function more closely – and some are. If kidney function slips, patients need less medication temporarily because they excrete drugs more slowly.
In fact, hospitals may have to do more monitoring for adverse drug reactions, if pending new federal regulations are approved. If re-written properly, Bates contends, these regulations could “provide a major impetus for quality.”
And there’s lots you can do yourself, outside the hospital.
Most important, tell your doctor – and pharmacist – what other drugs, prescription and non-prescription, you are taking every time you get a new prescription, and be sure to mention if you’ve ever had an allergic reaction to a drug. (One quarter of the deaths in the study were from allergic reactions.)
You should also ask your doctor and pharmacist to be specific about the risks and benefits of your new prescription, and to tell you whether the drug is likely to interact with your current medications.
Pharmacists, of course, should be alert to possible interactions whether you ask or not. But at least one study shows that when someone shows up with two prescriptions for drugs that should not be taken together, a third of pharmacists fill both without issuing a warning, says pharmacist Larry SasichCQ of the Public Citizen Health Research Group, a Washington advocacy group.
Ask the pharmacist to give you the FDA-approved package insert, not just the pharmacy’s own summary. “If the pharmacy says it’s not allowed to give out the FDA-approved insert, that’s not true,” says Sasich, “and you should get a new pharmacist.
When you get the package insert, read it. If you can’t read the fine print – and microscopic type is an issue the FDA is trying to rectify – get a magnifying glass. If you can’t read at all – many adults are illiterate or have poor eyesight – ask someone to read it to you, because it’s important to know what side effects to look for.
You may also want to ask about the so-called “therapeutic range,” that is, how far a toxic dose is from the safe, effective dose. The bigger the range, the better. While you should never exceed the dose prescribed by your doctor, this is especially important to know when the safe and toxic doses are close.
It’s also a good idea to ask whether there are any special precautions you should take while on the drug – like avoiding certain foods or staying out of the sun.
And it’s worth knowing if the drug has FDA approval for your diagnosis. Doctors can prescribe for one use a drug that’s been approved for another, but chances are there’s less data on the safety and efficacy for the nonapproved use.
If your medical problem is chronic, as most conditions are, ask your doctor whether you can “taper up” on medication, that is, try small doses first, then increase if you have no bad reactions. This won’t work in emergencies, though, and may not be wise with some drugs, like antibiotics, because low doses may increase the chances that the microbes will develop resistance.
Be especially alert with new drugs – including free samples and drugs advertised on TV – unless they have documented advantages over older ones. New drugs can be great, but by definition, doctors have less experience with them. Side effects that did not show up in relatively small, pre-marketing studies often become apparent when more people begin taking a drug.
Generic drugs, by the way, should have the same risks and benefits as their brand name equivalents, but if you’re worried, ask your pharmacist.
Finally, if you experience any worsening in your health, the first thing to suspect is the last drug you added. And the first thing to do is tell your doctor, then the drug company. You can also call the FDA directly, 1-800-332-1088.CQ
Doctors aren’t required to report serious adverse reactions to the FDA, but manufacturers are. It may not help you directly to make sure the government hears about serious adverse drug reactions, but there’s a good chance it will help someone else.
To learn more about drugs
- Remind your doctor and your pharmacist – about other drugs you’re taking whenever you get a new prescription.
- Ask about possible interactions among the drugs you take.
- Ask about risks and benefits of the new drug – how likely you are to have side effects and how likely it is to help.
- Ask what side effects to watch for.
- Ask the pharmacist for a copy of the FDA-approved package insert that comes with your medication.
- Read it.
- Ask whether there are any special precautions to observe while taking this drug – like avoiding certain foods or staying out of the sun.
- Ask if you can “taper up” your dose – start with low doses and then, if side effects are tolerable, increase slowly.
- Be especially attentive to new drugs because doctors have less experience with them. Be especially alert to side effects.
- Tell your doctor immediately if you have side effects.
LEADING CAUSES OF DEATH
A new study estimates that adverse drug reactions are so common that are one of the nations biggest killers. PLEASE SEE MICROFILM FOR CHART DATA GLOBE STAFF CHART