21 February 2008

Recognizing Adverse Drug Events

Via Medscape, a free subscription with loads of fine medical- and health-related articles. 

Contrary to the public's common belief, all drugs are dangerous. Just because a drug is approved by the US Food and Drug Administration (FDA) does not mean that it won't cause problems; all usually do, from minor side effects to permanent disability, to life threats, and even death.

Unless you talk to a trial-lawyer of course.  Then, the evil drug companies intentionally release dangerous chemicals disguised as medication just to watch the pain and suffering as they chuckle maniacally.

Table. The Naranjo Algorithm

To assess the adverse drug reaction, please answer the following and give pertinent score.
Question Yes No Do Not Know Score
1. Are there previous conclusive reports on this reaction? +1 0 0  
2. Did the adverse event appear after the suspected drug was administered? +2 -1 0  
3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? +1 0 0  
4. Did the adverse reaction reappear when the drug was readministered? +2 -1 0  
5. Are there alternative causes (other than the drug) that could on their own have caused the reaction? -1 +2 0  
6. Did the reaction reappear when a placebo was given? -1 +1 0  
7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? +1 0 0  
8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? +1 0 0  
9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 0 0  
10. Was the adverse event confirmed by any objective evidence? +1 0 0  
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-245. Reprinted with permission.

Naranjo scores of 9 or 10 indicate that an event was "definitely" an ADR; scores of 5-8 rate the likelihood as "probable"; scores of 1-4 are "possible"; and scores of less than 1 are "doubtful."

The article also discusses confounding factors which are things that make diagnosing an Adverse Drug Reaction more complicated than you might otherwise expect.

I've found that while some of the articles might get a little technical for the layman, almost all of them have enough context to get some really good knowledge out of them.  I encourage you to read the entire article, then browse around to see if there is a particular newsletter you want to subscribe to. 

As with the Wireless Amber Alert post, I have no financial interest in making this recommendation and it is done with clear conscience.

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