The New Yorker published a great piece on the prescription drug epidemic this week. The article is written by Celine Gounder, a physician with personal experience dealing with chronic pain patients.
I found one section of the article particularly helpful in explaining why doctors prescribe these powerful medications even when many of them know it's wrong for the patient:
"The pain-pill epidemic has also forced doctors like me to consider our own role. Doctors have a duty to relieve suffering, and many of us became doctors to help people. But giving that help isn’t straightforward, especially when it comes to chronic pain. Try explaining the downsides of narcotics to a patient while declining to give him the medication he wants. He might accuse you of not understanding because you’re not the one in pain; he might question why you won’t give him what another doctor prescribed; he might give you a bad rating on a doctor-grading Web site. He might even accuse you of malpractice. None of this is rewarding for doctors: we’re frustrated that we can’t cure the pain, and that our patients end up upset with us.
Doctors have a hard time saying no, whether a patient is asking for a narcotic to relieve pain or an antibiotic for the common cold. We are predisposed to say yes, even if we know it isn’t right. Some of us just don’t want to take the extra time during a busy day to explain why that prescription for a narcotic isn’t a good idea. Some of us also use the promise of prescription narcotics to persuade patients to keep their medical appointments, or to take their other medications."
This is the reality in the average physician's office today. These are the cold hard facts of dependence and addiction. And this is why the inappropriate use of prescription pain killers isn't going away any time soon.
This is also why we have to come at these prescribers with more than just medical treatment guidelines that suggest the current drug regimen is inappropriate. Many of these doctors (whether they openly acknowledge it or not) are already aware that the treatment is outside the boundaries of contemporary medical evidence.
So what do we do?
1) Prevent the inappropriate use of these medications in the first place.
2) Where dependence or addiction has arisen, offer the doctor and injured worker alternatives. Cognitive behavioral therapy, functional restoration, referrals to a specialist, comprehensive pain programs, etc.
Is the quality of these various options highly variable? Yes.
Are they potentially expensive? Some more than others, but yes, there's cost associated with these paths.
But as PRIUM's own Nurse Linda likes to say, "If you're going to take away my Hershey Kisses, you have to give me something else."
Michael
On Twitter @PRIUM1
Michael Gavin, President of PRIUM, focuses on healthcare issues facing risk managers in the workers' compensation space and beyond. He places particular emphasis on the over-utilization of prescription drugs in the treatment of injured workers.
Wednesday, November 13, 2013
Tuesday, November 5, 2013
FDA 2013: A Study in Inconsistency
Let's review the recent activities of the Food and Drug Administration in the area of prescription opioids. If you're scratching your head as you read this, know that you won't be alone:
April 16, 2013:
The FDA announced two related decisions simultaneously. First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation. Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety. This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER. I wrote about this back in May.
This isn't great news for payers, but it's not the worst possible outcome. Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term.
My view: Good news.
May 7, 2013:
The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology. The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation. Yes, extended release oxymorphone will be a lot cheaper. But it will also be a lot easier to abuse, it's street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant.
My view: I'm confused.
But wait, the message gets even more muddled...
September 10, 2013:
The FDA announced label changes to extended release / long acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety. While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.
My view: Good news.
October 24, 2013
The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone to from Schedule III to Schedule II, placing more controls on these drugs. There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access. That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled.
My view: More good news.
October 25, 2013 (the very next day!):
The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology. This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug. Further, the study methods used in the approval process were questionable, at best.
My view: Wait... what?
I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented. But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.
I wonder what 2014 will bring.
Michael
On Twitter @PRIUM1
April 16, 2013:
The FDA announced two related decisions simultaneously. First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation. Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety. This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER. I wrote about this back in May.
This isn't great news for payers, but it's not the worst possible outcome. Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term.
My view: Good news.
May 7, 2013:
The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology. The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation. Yes, extended release oxymorphone will be a lot cheaper. But it will also be a lot easier to abuse, it's street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant.
My view: I'm confused.
But wait, the message gets even more muddled...
September 10, 2013:
The FDA announced label changes to extended release / long acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety. While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.
My view: Good news.
October 24, 2013
The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone to from Schedule III to Schedule II, placing more controls on these drugs. There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access. That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled.
My view: More good news.
October 25, 2013 (the very next day!):
The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology. This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug. Further, the study methods used in the approval process were questionable, at best.
My view: Wait... what?
I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented. But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.
I wonder what 2014 will bring.
Michael
On Twitter @PRIUM1
Monday, November 4, 2013
Close to Home: Tragedies Continue
I came to work Friday to learn that a family friend of two PRIUM employees had passed away from a heroin overdose after a year-long struggle with prescription pain pills. This morning, I found a note in my inbox from one of our physician reviewers about an incredibly sad (and similar) story about a 25-year old New York man who overdosed on heroin after a battle with prescription drugs.
Sitting on my desk is the latest copy of Business Insurance with a front page article about the risks facing physicians who attempt to wean or discontinue prescription drugs. Some doctors feel threatened by some addicts who appear to be willing to inflict physical harm or engage in violence in order to get what they want. The story was light on actual statistics, but the phenomenon is real. We hear about it all the time among the prescribers we engage.
I read last week about Joe Paduda's survey on opioids in work comp. "Here's the key takeaway," he wrote, "most respondents understand the problem and know (generally) what needs to be done, but their organizations aren't doing many of the things they should be." I couldn't possibly agree more with that statement.
Depressing, right?
Time to roll up our sleeves and work harder. We have to do more to educate, to engage, to change this destructive pattern of "treatment."
The note from PRIUM's physician reviewer summed it up: "Please, please, please keep pushing your message. I keep trying to tell my [peer to peer] providers that this is not about the money!"
There's no doubt in my mind our efforts help save payers money. There's no avoiding that, frankly. But we're helping to improve people's lives and, in some cases, save people's lives.
Happy Monday. Let's get to work.
Michael
On Twitter @PRIUM1
Sitting on my desk is the latest copy of Business Insurance with a front page article about the risks facing physicians who attempt to wean or discontinue prescription drugs. Some doctors feel threatened by some addicts who appear to be willing to inflict physical harm or engage in violence in order to get what they want. The story was light on actual statistics, but the phenomenon is real. We hear about it all the time among the prescribers we engage.
I read last week about Joe Paduda's survey on opioids in work comp. "Here's the key takeaway," he wrote, "most respondents understand the problem and know (generally) what needs to be done, but their organizations aren't doing many of the things they should be." I couldn't possibly agree more with that statement.
Depressing, right?
Time to roll up our sleeves and work harder. We have to do more to educate, to engage, to change this destructive pattern of "treatment."
The note from PRIUM's physician reviewer summed it up: "Please, please, please keep pushing your message. I keep trying to tell my [peer to peer] providers that this is not about the money!"
There's no doubt in my mind our efforts help save payers money. There's no avoiding that, frankly. But we're helping to improve people's lives and, in some cases, save people's lives.
Happy Monday. Let's get to work.
Michael
On Twitter @PRIUM1