Adverse Drug Reactions Are A Big Killer: Study
8 CommentsBy Ed Silverman // March 18th, 2008 // 1:26 pm
More than 3 percent of all deaths seem to be caused by adverse reactions to medical drugs, according to new research, according to a report in Nature. If substantiated by further work, this would make fatal adverse drug reactions the 7th most common cause of death in Sweden, where the research was done.
James Ritter, the editor-in-chief of the British Journal of Clinical Pharmacology, which published the research, calls the finding “striking.” “It is a surprisingly high figure,” Donald Singer, a pharmacology expert at the University of Warwick, tells Nature, while wondering if the results can easily be generalized to other areas.
Adverse drug reactions are known to be responsible for between 3 percent and 12 percent of hospital admissions, and fatal drug reactions account for about 5 percent of deaths of those patients in US hospitals, the mag notes.
One might expect that fewer people in the general population would die because of adverse reactions compared with hospital patients, but evidence is hard to come by, Anna Jönsson, lead author of the research and a pharmacologist at Linkoping University, tells Nature. Previous population-based studies “have been based on death certificates alone,” she tells the mag, but adverse drug reactions are under-reported on death certificates.
The researchers examined randomly one seventh of all deaths in three Swedish counties in 2001. Of 1,574 deaths, 3 percent were probably caused by an adverse drug reaction, the authors wrote. The highest proportion of deaths was from hemorrhage, which is associated with drugs such as aspirin or the warfarin blood thinner, Nature writes. Of course, this doesn’t mean these patients would still be alive if they’d not taken those drugs.
“This is only looking at one side of the coin,” Simon Thomas, a therapeutics expert at Newcastle University, UK, tells Nature. “The kind of drugs that cause hemorrhage actually have large benefits. What the figures don’t pick out is the number of patients with cardiovascular risks who don’t have myocardial infarction or stroke because they are taking aspirin.” Thomas adds he wasn’t too surprised by the results.
The researchers are now examining case records again to see if they can determine whether any of the deaths could have been avoided. Existing literature on fatal adverse drug reactions give the percentage of avoidable deaths at between 18 percent and 70 percent, Joönsson tells Nature.
Dan
If something is a drug, it has a side effect. It’s a fact of nature. An adverse effect, however is harmful, instead of just being undesirable, such as a side effect. Some feel side effects and adverse effects are synonomous with each other.
This is something that should be analyzed more thoroughly as a drug works its way through the approval process.
Ken Thomas, RN
I think more research will reveal that the adverse effects are a compilation of several side effects interacting from the polypharmacy most patients experience. We don’t really know what’s going on until something manifests itself when a person is taking three or more drugs simultaneously. Hard to study what side effects to expect when you study them and then prescribe them in the presence of multiple drugs in the real world.
Justice in Michigan
As I recall, there was a 1998 study in JAMA which had the relative proportions even higher in the U.S.. AEs were estimated to between the 4th and 6th leading cause of death.
JAMA wrote an editorial, “Now is the Time to Act on Drug Safety,” in which were included essentially the same proposals that we have seen from the IOM, GAO, etc. reports. The editorial notes the same proposals go back to the 1970s.
Virtually all of them remain unimplemented.
Jack2
electronic prescribing.
I don’t think all the phase 4 monitoring possible would improve drug safety as much as electronic prescribing. And electronic prescribing would cost a lot less too.
Carol
All the e-prescribing in the world won’t stop ADRs. E-prescribing can reduce errors. ADRs are about bad things happening even though drugs are prescribed and used according to FDA guidelines. The fact is, given the way phase 3 clinical trials are conducted, many of the chemical interactions and their biological consequences are simply not discovered until drugs are launched into the real world. There are ways to find and know these, but that requires a different approach to post-marketing surveillance.
Bob Freeman
Carol, I think you’ve presented an excellent case. To add to your point, clinical trials are conducted on relatively uncomplicated patients simply through the patient inclusion criteria. To your exact point, when the drug is used on real patients who may have signficant co-morbidities and associated poly-pharma regimines, the ADEs start being observed. Throw in OTC and supplements used by the patient and not recorded and you’ve got a real mess. I’ve always been amazed at the number of drugs prescribed just to manage the side effects of other drugs.
To the other point, e-prescribing offers advantages, certainly as long as the patient frequents one community pharmacy.
Melody
FYI, FDA recent held a workshop. Topic: “Maximizing the Public Health Benefit of Adverse Event Collection Throughout hte Productive Life Cycle.” Event was held 1/29/2008, and transcript is now posted at:
http://www.fda.gov/ohrms/dockets/dockets/07n0480/FDA-2007-N-0000-TR-(07N-0480).pdf
All I can add, after reading is . . . it’s a beginning.
Carol
Bob — I agree that e-prescribing adds its own value today. I used to work for such a company and I truly see the worth.
Having said that, the big opportunity will come at the “great convergence”, when new surveillance methods, emerging clinical / biological knowledge, new-age predictive engines and personal health information all meet up. The e-prescribing tools will alert in real-time that adding a particular medication would likely create an adverse drug reaction in a particular person.
I’m NOT talking about today’s ultra-false-positive DURs. It’s about something wholly new.
A girl can dream, eh? More than that, a girl can start to create some of these pieces. Wish me luck. !!