Date: Sunday, August 21, 2011 11:48:17 PM EDT
Subject: Question 4
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1. Identify and discuss management of medication risk including efforts by the FDA and the healthcare community. How have these procedures/processes been addressed in your practice? Did it work? Any other suggestions?
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Risk, as defined by the FDA website, is “potential for an unwanted outcome resulting from an incident, event, or occurrence, as determined by its likelihood and the associated consequences.” (FDA Safe Use Initiative) There are many risks that are associated with using drug therapy. These include, but are not limited to, medication errors, drug‐related adverse events, and adverse reactions. On the other side of the spectrum you have your unavoidable risk such as gaps in current knowledge and unpreventable known side effects. (FDA)
The FDA has done a lot to try to prevent what can only be described as your manageable risks. These efforts include this very pamphlet in which I am answering this discussion question from. One of the key medication risks the FDA has identified is human medication error. We are all fallible as mere mortals, there may not be a man/woman among us who has not, once in their lives, made a mistake. This also happens on the job with medications, as much as we may try to prevent them. FDA efforts in this area include trying to prevent mistakes in transcription, misinterpretation of the instructions for use, confusing two products that have similar names, and selecting the wrong product because of similar appearance. (FDA)
Broader FDA efforts include, efforts to improve communication, efforts to mitigate the risks of unintended exposure, and efforts to mitigate drug‐specific safety risks. (FDA) Basically the FDA has a hand in almost every piece of the drug related pie in the United States.
In the Army we handle risk by the conduction of frequent risk assessments. It is understood that all risk will never be eliminated and soldiers are taught not to be risk adverse when the payoff is greater than the risk. On the medical side of the army, all medics are expected to conduct the six rights before giving one of their fellow soldiers any medication, these are, right medication, route, time, soldier, dosage, and documentation. This is a standard practice in all healthcare settings and was most likely first standardized by the FDA. It works.
work cited
http://www.fda.gov/downloads/Drugs/D.../UCM188961.pdf