Perhaps author Charles Pierce was on to something in his book, Idiot America: How Stupidity Became a Virtue in the Land of the Free. As he points out, there’s just something ironic about placing a saddle on a dinosaur, suggesting that humans and dinosaurs roamed the earth together millions of years ago. And to think that we celebrate such idiocy throughout the United States is just another reason why we cannot allow politicians to practice medicine.
Here to give an example of such idiocy is Dr. Erica Wegrzyn, who is studying to become a specialist in the world of pain management.
Here’s what she had to say…
On September 18, 2015 in “Are You Kidding ME?” collaborating co-authors Dr. Jacqueline Pratty-Cleary and (then student) Dr. Mena Raouf, discussed the state of Maine Medicaid (MaineCare) requirement for patients to first fail naltrexone tablets for opioid reversal before approving take-home naloxone. Today we are happy to report that the new FDA approved Narcan nasal spray is now listed as a preferred product on the MaineCare formulary. Unfortunately, Maine did not get the whole message and naltrexone tablets are still listed as an option for “narcotic reversal”, just above Narcan. Really Maine? You still think a person on the brink of death from opioid induced respiratory depression (OIRD) will be able to swallow and absorb naltrexone tablets before brain damage begins?! Regardless, we do applaud Maine for beginning to right this wrong on the MaineCare formulary, ensuring lifesaving naloxone is available to those who need it when they need it. It remains grossly unfortunate though, for those that died from opioid-induced respiratory depression during the several months that Maine legislators bantered over this. And, it remains unfortunate that certain people at risk of OIRD that happen to have seasonal allergies or some sort of nasal defect, that are not candidates for nasal administration, don’t have the option of the Evzio auto-injector.
Be that as it may, today I must call your attention to legislation in another state, Kentucky, who must have been taking notes from our friends in Maine. Kentucky law 201 KAR 9:270 entitled, Professional standards for prescribing or dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone, provides detailed circumstances, parameters and the “minimum qualifications” for which a provider can prescribe buprenorphine. The law states:
“Section 2. Professional Standards for Prescribing or Dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone for Medically-Supervised Withdrawal or the Treatment of Opioid Dependency. (1)(a) Except as provided in paragraph (b) of this subsection, Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone shall only be prescribed or dispensed for medically-supervised withdrawal or as a maintenance treatment for a patient diagnosed with opioid dependence.
(b) Transdermal delivery of Buprenorphine-Mono-Product may be used for treatment of pain.”
Before we discuss the issues with this law, let’s first take a look at the history. In 2012, Kentucky enacted House Bill 1 in an attempt to crack down on illegal pill mills by placing restrictions on pain management clinics, setting prescribing limits and requiring prescriber use of the state Prescription Drug Monitoring Program, KASPER. Just prior to this, in 2011 Florida began addressing its own pill mill crisis through similar legislative action. The “Florida Pipeline” was responsible for suppling a large number of illicit opioids directly into the Kentucky market. These two pieces of legislation created a void for irresponsible providers who were negligently prescribing opioids for profit and supplying addicts. While these pieces of legislation did begin to crackdown on pill mills it inadvertently created a new market. The entrepreneur-prescribers soon discovered the high demand for Suboxone and began charging upwards of $300 cash only for an office visit. At one point it was reported that 80% of the prescriptions written for Suboxone were prescribed by just 20% of the 470 certified Suboxone prescribers in the state. It was this new cash-for-pills market that Kentucky attempted to address with 201 KAR 9:270.
So, if 201 KAR 9:270 is trying to address such a serious issue, what could be problem you ask?
There is a serious problem. This law excludes the use of Belbuca, a buprenorphine buccal film that is FDA approved for chronic pain, not an opioid abuse disorder. Belbuca is a Buprenorphine mono product formulated as a buccal film and FDA approved for the treatment of pain in March of 2016. The wording of this law completely denies the residents of Kentucky accessibility to a safe and effective treatment option. As noted above, Butrans TDS is exempt and may be used for the treatment of pain; however, Kentucky has neglected to allow for the development of new technologies, whether it be Belbuca or some other new dosage form.
Buprenorphine, as previously discussed in the recent blog post “Painfully Buprenorphine”, offers a unique treatment option for chronic pain through mixed agonist/antagonist activity at the mu-opioid receptor resulting in decreased euphoria and a plateau effect of CO2 accumulation leading to decreased risk of OIRD. As a result, it is arguably one of the safest opioid treatment options available for pain. In fact, buprenorphine was first approved for the use of pain in Europe in the 1970’s and was only introduced for medication assisted therapy for opioid addiction in the US in 1996.
Some, likely these very same legislators, might ask why should we care that Belbuca is excluded when Butrans TDS, with the same active ingredient, can be prescribed? While Butrans TDS offers an excellent option, there are some documented dermatologic allergic reactions (rash) to the patches transdermal delivery system. While triamcinolone aerosol can be given to help prior to patch placement to alleviate the uncomfortable symptoms and rash, this is not always a perfect or complete fix. Belbuca film is intended for placement on the mucosal tissue of the cheek and is not known to cause topical allergic reactions. Additionally, Belbuca is approved in many different film strengths and higher doses allowing for flexible titration options in higher strengths compared to Butrans TDS. In Europe Butrans patch is approved at higher doses and can be changed more frequently than every 7 days. Belbuca may offer the opportunity to continue with an FDA approved Buprenorphine formulation after a patient has titrated to the maximum doses of Butrans TDS.
It is likely that legislators never imagined the possibility of a product like Belbuca when designing the language for 201 KAR 9:270; however, this is a prime example of legislators practicing medicine without a license and ignoring novel drug development, resulting in legitimate pain patients being unable to obtain an FDA approved treatment option.
It amazes me how each of 50 states makes their own opioid rules in a silo and how each believe they’re smarter than the other. Some have established their own daily morphine equivalents, as if there were even a universally accepted conversion (see The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development by Fudin et. al.), others require referrals to pain specialists as if there were enough to go around or that are willing to take on patients requiring chronic opioid therapy. One state, Missouri, still doesn’t have a prescription monitoring system (that’s smart, right?), and it just keeps getting more ridiculous. One would think therefore that the Feds should chime in with some universal oversight. Oh, wait a minute – there’s the CDC Guidelines, and how disastrous is that?
So here we are left with some legislative Maine-iacs in Kentucky. Hopefully they’ll figure out that science is faster than the lawmakers who lack the expertise to oversee the very drugs they are charged to govern. My goodness Kentucky, if you’re trying to improve safety, make sure that both Belbuca Film and Butrans TDS are available for chronic pain sufferers. Adjust your regulations to allow any buprenorphine product that is FDA approved for analgesia to fall within legal prescriptive options. The simple truth is, any buprenorphine products FDA approved for chronic pain treatment are safer alternatives to any pure opioid agonist and your regulations need to support these options.
As always, comments are welcome!
Erica Wegrzyn, B.A., B.S., PharmD is currently completing a PGY-2 Pain and Palliative Care residency at the Stratton VA Medical Center, Albany NY. Dr. Wegrzyn received her PharmD from Western New England University College of Pharmacy, Springfield MA and completed a PGY-1 residency at Maine General Medical Center, Augusta ME. Prior to completing her PharmD, Dr. Wegrzyn also received her bachelors’ degrees in Biochemistry and Music (trombone) from Ithaca College.