The FDA/DEA are coming after your CII opiates !!

[Pharmacist.steve]

This is their REMS program.. IM ...many docs will just drop back to prescribing Hydrocodone/APAP and NSAIDS

The US Food and Drug Administration's (FDA's) controversial opioid risk evaluation and mitigation strategies, known as REMS, are in the final stages of development and could be ready this summer.

The plan will alter the prescribing landscape for opioid therapies and is expected to have important implications for clinicians, the patients who use these drugs, and the companies that make them.

The agency has yet to release details about the new plan, but this weekend Bob Rappaport, MD, from the FDA's Center for Drug Evaluation and Research hinted it will include mandatory education.

Speaking here at the American Pain Society 29th Annual Scientific Meeting, Dr. Rappaport said he is unable to confirm any details but suggested that education will factor prominently.
Dr. Bob Rappaport, FDA

"Physician and patient education would be the most beneficial component," he said. "Clinicians could be educated to maintain prescribing privileges for CII opioids and must be willing to require their patients be engaged in safety messaging."

[Maria]

Better include a viable plan to get us off the stuff

[Pharmacist.steve]

Originally Posted by Maria

Better include a viable plan to get us off the stuff

All the FDA/DEA is interested in is dealing with the 7 people a day that overdose.. stats suggested that ~50% of these "over-doses" are really suicide by drug...but.. it is cheaper/easier and serves a purpose .. to label it as a "over-dose"...

I guess that someone who dies from a gun shot to the head .. could be classified as dying from a "accidental lead overdose" ...

There are also stats out there that ~80% of the people that die from a drug overdose... don't have a Rx for the drugs involved.

Of course, >1000/day die from use of tobacco products and another 50/day die at the hands of drunken drivers...

No one suggested that we should "track" those that purchase tobacco products and/or alcohol products...

[mmglobal]

I used to deal with the pain management doctor who was the biggest prescriber of schedule II narcotics in Orange County, CA. Most of the time, he was great! His office was very well run and even back in 2001, was already on board with the safeguards that we see today... contracts with the patients about how they acquire their meds through only one source, no replacement for lost meds, etc...

The reason that I say 'most of the time', he was great is because he complained that he spends 1/2 of his time justifying his practice to the DEA. Whenever I'd see him just after he'd been raked over the coals... he was too conservative. It seemed like he'd forgotten that I had asked to reduce meds last time, with the understanding that if it didn't work out, we'd go back up to the higher dose. I never knew if I was going to be seeing the kind, compassionate pain management doctor that I knew and loved, or the guy who'd just gotten is ass kicked by the DEA for trying to help his patients. Even back then, it was an impossible situation.

Like Steve expressed above, I have never understood why we go berserk about airline safety, when we kill 500 people on the road EVERY HOLIDAY WEEKEND. Much of what the FDA and DEA does is good work that protects us the unscrupulous or careless, but when they go overboard they are more of a hindrance, standing in the way of quality care. I wish we could strike a better balance.

Just my 2 cents.

Mark