Friday, February 13, 2009
Apparently the FDA is planning on undertaking a wide-reaching risk mitigation program for prescription opioids. The press-release implies it's focused on 'working with industry' to ensure their safe and appropriate use. No particular mention is given to working with clinicians and patients, or where their voice will be in all this (although that has been mentioned in other blog posts on the topic).
At this point we know very little about this, or what it will look like, but I am confident anything which smells of further scrutiny will increase the already existent barriers to chronic opioid therapy. I am still waiting for any sort of evidence that inappropriate clinician prescribing (e.g. either reckless or not done with analgesic/therapeutic intent) is a major/systematic contributor to the rise of prescription drug abuse, although if you read the literature many people seem to believe this even without supporting data. I don't want to suggest risk abatement etc. are bad things, of course they aren't, but if not done well/sanely it will be our patients who suffer the consequences.
I am not a policy maven, but know that some pain policy types read this blog and would appreciate any comments, links, or organizing information about this.
If you're interested in some thoughtful common sense about opioids for chronic pain the current issue of Journal of Pain has 3 American Pain Society guidelines about the topic (issue table of contents here, guidelines are towards the top). The one I'd highlight in particular, persuant to the above topic, is the one on research gaps which thoroughly describes just what we don't know.