A study in the Archives of Internal Medicine ($ required) was published this week that found that from 1998 to 2005, adverse drug reactions increased 2.6 times (89,842 in 2005) while the number of scripts written only went up 0.65 times (65%). Fatal events increased 2.7 times.
The real interesting things about the study were the fact that very few of the drugs that caused problems in 2005 were related to a subsequent safety withdrawl from the market. As I got into this paper I started to think that this is another piece of evidence for a broken approval system. However, I found this enlightening tidbit: approximately 2/3 of the adverse events came from drugs that have been around forever. For example, adverse events related to insulin went up more than 4 times! Other big problems included estrogen, morphine, acetaminophen/hydrococone (tylenol w/ codine), oxycodone, and fentanyl.
There are a couple of causes as I see it:
1) These old drugs are increasing in use more than most (i.e. greater than the 65% increase) and the % of problems is staying the same. Diabetis is up, and medicinal pain management is being used more often (that’s a good thing).
2) We’re (Drs, pharmacists, nurses…ETC) getting really lax about drug safety for drugs that have been around awhile. It’s human nature to be less cautious as you are around the drug for a greater period of time.
3) We’re getting really lax about drug safety in general. Pharmacists or doctors not taking the time to discuss the dangers of not taking the drug correctly. Nurses, ETC getting sloppy with administration or looking out for warning signs. We may be forgetting that drugs can harm as well as help and/or medical professionals are simply over worked.
4) The combo of drugs people take is getting more complex leading to more complications.
5) Reporting to the FDA is getting better so we’re seeing more reports.
6) “Well, we put may cause heart failure in the warning” excuse. Possibly the big ‘ol warnings on the inserts are no longer being read by doctors or patients and are so long that they almost mean nothing to most people. It’s like CA prop 65, useful in some respects but requires labeling of everything that contains something cancerous or of reproductive harm whether or not it’s an actual risk or not. When your mineral spirits AND your pesticides AND your galvinized nails AND your dish soap AND your drugs have the warnings on them that all start to sound the same, people stop paying attention.
There are probably other possibilities too but for now it’s all up in the air. Hopefully someone gets to the bottom of this and finds out it’s #5, but I doubt it.