Tag Archives: mark pew

The Next Opioid Epidemic: Fentanyl

Fentanyl has been in the news:

In 2014, it began being reported on the U.S. East Coast that heroin was being laced with fentanyl, creating a combination that is “untenably addictive.”

The Sacramento Bee reported in April that 51 overdoses, including 11 deaths, had been reported thus far in the Sacramento area in 2016; toxicologists tied eight of the deaths directly to fentanyl (watch the short video in the article that describes “death as collateral damage” to the drug dealers interested in market dominance).

Later in April, the L.A. Times reported the issue had migrated to the San Francisco area, where fentanyl pills made to look like Norco were a primary culprit.

The chief health officer in British Columbia proclaimed a Canadian public health emergency because of more than 200 overdose deaths during the first three months of 2016; a large portion of them involved “greenish pills purporting to be OxyContin 80 mg tablets.”

In June, it was confirmed that Prince died from an accidental overdose of fentanyl, unbelievable because he was an outspoken advocate of clean living (from having a “swear jar” to not consuming alcohol)

One of the common threads throughout these stories is China’s involvement. The Wall Street Journal published a front-page article on June 23 titled “China’s Role in U.S. Opioid Crisis.” The opening paragraph sets the stage:

Last spring, Chinese customs agents seized 70 kilograms of the narcotics fentanyl and acetyl fentanyl hidden in a cargo container for Mexico. The synthetic opium-like drugs were so potent that six of the agents became ill after handling them. One fell into a coma.

The article goes on to describe how fentanyl often is disguised as hydrocodone and Xanax on the black market — dangerous drugs by themselves but not nearly as potent or fatal as fentanyl. Because China does not regulate fentanyl or analogs used to create fentanyl, there is a significant financial incentive for the drug dealers — $810 of materials can create 25 grams of fentanyl and yield as much as $800,000 in pills sold on the black market.

See also: Opioids Are the Opiates of the Masses

According to the Canadian Globe’s expose on the issue (an excellent look at the black market), accessing fentanyl can be as easy as “Sign up for an account, choose a method of payment, and receive the package in three to four business days.” Reinforcing the financial model: “A kilogram ordered over the internet – an amount equal in weight to a medium-sized cantaloupe – sells on the street in Calgary for $20 million, making it a drug dealer’s dream.”

So, fentanyl is a problem. It’s 25 to 50 times more potent than morphine. It’s highly addictive. It’s available fairly easily on the black market. And it is prescribed by doctors. Way too often.

Approved by the FDA and on script pads supplied by the DEA, its federal legitimacy adds to the lack of stigma associated with use. Which is one reason why I think Prince could rationalize his use. A doctor likely prescribed it for his chronic pain — and other patients fall into that same trap (with fentanyl and other dangerous prescription drugs).

According to the FDA’s own warnings (as reported on drugs.com):

Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Fentanyl Transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.

See also: How to Help Reverse the Opioid Epidemic  

In my opinion, fentanyl should be used to help people die with dignity during end-of-life care. Period. It’s that dangerous. And yet we see it being prescribed, used and paid for.

Month. After. Month.

If you are prescribing fentanyl: Why?

If you are being prescribed fentanyl: Why?

If you are paying for someone’s fentanyl: Why?

Too many people are overdosing and dying not to ask a simple question: Why?

23 Questions on the Use of Narcotics

During my Feb. 23  webinar titled “History of Heroin Use: Impact on Prescription Drug Abuse,” there were a series of questions that I could not address during the Q&A time. In fact, 23 questions. I finally finished my written responses, and One Call Care University is distributing them to the 938 confirmed attendees of the webinar. However, I thought it might be an interesting exercise to make them more broadly available here.

BTW, because of the very positive feedback from attendees, One Call Care University has scheduled another webinar on the same subject on Aug. 25 (obviously with some updated content). I appreciate their support. So, if you missed the Feb. 23 webinar, pencil in Aug. 25 on your calendar.

See Also: Progress on Opioids–but Now Heroin?

Also, in case you didn’t notice, I have written two heroin-related blogposts since February 23 that provide even more context – “Breaking Point: Heroin in America” and “The Heroin Triangle … in My Hometown.”

And now, the 23 questions … and answers. I would appreciate any additional insights you may have, so I can continue to expand my perspective and understanding, so feel free to submit comments.

  1. Will the recent conviction of Dr. Tseng in the overdose death of three patients have an impact on physicians dispensing narcotics? I certainly hope so. It is a very high-profile prosecution and conviction of a physician who was prescribing for the benefit of her pocketbook and not for the patients. As with other high-profile events, this could be used as a launching point for even further prosecution (beyond the continuing investigations that typically result in surrendering MD or DEA licenses). Whether this affects the opinions (and actions) of actual prescribers, only time will tell.
  2. As a workers’ comp adjuster, I received a request for approval of Narcan for an injured worker who is taking morphine medications. It was denied, but what would be the ramifications of approving Narcan to a workers’ comp injured worker? Would there be a chance of getting a death claim if the injured worker died after the Narcan dose? I’d be interested in knowing the rationale for denial – was it deemed unrelated/non-compensable, or were there concerns about its medical efficacy, or was it a concern along the lines of your second question as to the implications or liability? The latter is an interesting question, because by approving Narcan it could be extrapolated that you know the dangers of the drugs for which you’re approving an antidote. On the other hand, if you don’t approve the Narcan, did you not perform the necessary due diligence to ensure the patient didn’t die from an overdose. These are legal questions – I’m not an attorney, so you should probably consult yours – but I could see both respective questions and answers creating issues. Ultimately, the best thing that can be done for the patient/injured worker is to help him taper from the dangerous drugs he’s using to a treatment that does not introduce the possible side-effect of death (i.e., remove the need for Narcan by removing the drugs). As I mentioned on the webinar, we’ve made a mess, and now we have to clean it up. I believe the cleaning up process is going to be a major focus for many years to come.
  3. What can be done about the physicians who are ordering unnecessary narcotics such as hydrocodone and oxycodone and seem to be the majority? It’s upsetting when a patient goes to an urgent care and is given narcotics for simple injuries such as a small laceration to a finger, or a bumped toe – how and why is this happening? Part of the solution is better education for prescribers – they should be informed of all treatment options and focus on those with the least amount of negative side effects that helps the patient (which may mean not giving patients the drugs they think they need). Part of it is better education for the patient – own your healthcare, ask questions and if the side effects are worse than the original malady then do your own research (plenty of free resources on the Internet). Part of it is the pharmacy/pharmacist/PBM – leverage common sense (and automated triggers) to connect the potency of the drugs to the illness/injury being treated. Part of it has to be legislated – mandatory access of PDMPs where real-time access is available, CME for doctors to ensure they know everything they need to about the treatment of pain, investigations by the DEA and state and local enforcement, restrictions on physician dispensing. Ultimately, prescribing behavior needs to change. But putting the responsibility solely on the prescriber is not sufficient.
  4. How do you view chronic use of Tramadol? Tramadol was added as a Schedule IV drug as of Aug. 18, 2014. Prior to then, it had not been scheduled (i.e. was not a controlled substance). The DEA changed the classification because the long-time arguments were all disproved: that people can’t get addicted, there is no withdrawal process, and there is no possibility of overdose. If it quacks like a duck and walks like a duck and smells like a duck – it’s a duck. More research showed that Tramadol quacked and walked and smelled like a narcotic. That said, it’s less potent and has less serious side effects than Schedule II (e.g. oxycodone, methadone) or Schedule III (e.g. Vicodin, Tylenol with Codeine). Per all EBM guidelines, long-term use of narcotics can be supported if the patient has exhausted all conservative non-pharma and pharma treatment, has adequate pain control and levels of function/quality of life and is on the lowest possible dosage. That obviously leaves open the possibility of long-term use, but the bar is fairly high. Anybody in this position should talk with a doctor.
  5. How do you view long-term use of Flexeril (Benzodiazepine)? Flexeril (cyclobenzaprine) is a muscle relaxant. While it is less dangerous than Soma (carisoprodol), the side effects from any muscle relaxant can be dangerous (check out my favorite website’s assessment). In general, muscle relaxants are not recommended for long-term use, but, as with the above question on Tramadol, use should be based on the effects (positive and negative) to the patient and whether there are treatment options (non-pharma and pharma) that might equally resolve the condition without the dangers. Anybody in this position should talk with a doctor.
  6. What do we tell patients who have chronic back pain, who have failed all conservative treatment and who are unable to obtain strong-enough medication for short-term exacerbations, and their physician will not prescribe any narcotic? What choice do they have but to seek street drugs? This is the tricky part – not restricting access to drugs to the point that people who really need them can’t get them. That is often the concern raised by advocates for opioids. If the patient has not shown signs of abuse (e.g. running out of their 30-day supply in 22 days, doctor/pharmacy shopping, using illicit drugs or non-medical prescription drugs) then the doctor should consider prescribing the lowest possible dosage to resolve the issue, whether it’s chronic pain or momentary exacerbations. That prescription should be accompanied by accountability tools like pill counts and random drug tests and opioid treatment agreements. And it should also be accompanied by counseling to address the psychosocial needs of the patients (e.g. giving them methods to cope with the pain, helping them deal with problematic family situations, providing vocational rehab to provide some work outlet). In my mind, this decision starts and ends with an honest and transparent dialogue between the doctor and patient. If the patient doesn’t feel listened to, or the doctor feels like the patient isn’t being honest, bad decisions can be made. If, after all these controls have been introduced, the doctor still doesn’t feel like narcotics are the answer, then the patient should likely solicit a second opinion. Of course, in workers’ comp, that would process through the payer (carrier, TPA, self-insured) … So the circle of honest and transparent dialogue also needs to include them.
  7. Have you seen correlation for suicide for people taking Xanax and drinking alcohol? The biggest concern in combining Xanax and alcohol is accidental death from side effects such as slowed respiration and heart rates and seizures. Severe depression is another potential side effect, which could certainly lead to a suicide attempt. Suicidal thoughts as a specific side effect are not nearly as common as just going to sleep and never waking up again. My suggestion? Never mix alcohol with any opioid, benzodiazepine or muscle relaxant. Period.
  8. Do you think that decreasing the use of prescription opioids will just push more people to street heroin? It already has. And that is why we have concurrent epidemics of prescription painkiller abuse and heroin. For those who have become dependent or addicted to opioids, they need to be helped by a methodical tapering process to other methods for resolving their pain and non-pharma ways to deal with that pain (e.g. yoga, stretching exercises, an active lifestyle) and psychological treatment (e.g. CBT, establishing coping mechanisms). It is inhumane to remove drugs, especially those with high possibility of abuse and addiction, and not replace them with other mechanisms to treat their physical and psychological pain. Just detoxing or removing access will likely just force patients into finding other methods to self-medicate (heroin or other illicit drugs, alcohol, etc.) So, the answer to this Rubik’s Cube is difficult because only removing supply of opioids could create unintended consequences that could be as bad or even worse than the original problem.
  9. Why aren’t MDs (particularly pain management specialists) held more accountable for addiction? Isn’t it malpractice? That argument could certainly be made. Doctors, in general, are given great latitude to practice the art of medicine. That latitude has often resulted in great treatment that would have otherwise not been tried – the discovery of penicillin, the transition of minoxidil (Rogaine) from high blood pressure to hair growth, any number of treatments for cancer. But with latitude comes responsibility for bad choices, and once discovered taking an alternate path. At this point, it could not be argued that opioids are very dangerous and overused and that extreme care is needed to ensure that the benefits outweigh the risks. So why do physicians/prescribers, including pain management specialists, often still prescribe when the evidence is clear? And why aren’t they held accountable? We’re seeing increasing accountability by the DEA, state and local law enforcement who are actively pursuing “pill mills” and inappropriate prescribing patterns. We’re seeing increasing accountability from the use of PDMPs and prescribing profiles from PBMs to target high-quantity prescribers. We’re certainly seeing increasing accountability from investigative media who are searching for stories. When will that translate into medical malpractice (defined as “any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient”) is anyone’s guess, but I can see that as a natural consequence over time by patients and their attorneys.
  10. What can be done to report opioid abuse? Each state’s PDMP (prescription drug monitoring program) is a macro way of recognizing abuse and misuse by patients and prescribers — some states have combined data. However, for now, access is limited to prescribers, pharmacists and in some cases law enforcement. So the primary means of identifying abuse and misuse will be the prescriber and family/friends. So how do they report it, and to whom? The first step should be intervening directly with the abuser/misuser to help her recognize, admit and enact changes to stop her substance abuse. That intervention may require involving a professional in substance abuse or mental health. If the abuser will not admit there is a problem, the next step will be determined by the level of abuse, illegality and connectedness. If you know someone who is abusing opioids or other dangerous drugs, and he won’t respond to your private conversations about the issue, then engage with a professional.
  11. If Rx opioids are intended for post-surgical pain and end of life, why do doctors prescribe them for WC back injuries with no end game plan in sight, and why won’t the WC judges  get involved? Why are doctors not held accountable for this problem? As mentioned in an earlier answer, the motivations for prescribing and using outside the on-label uses for these drugs can be varying. As can the accountability. But I think that is changing as doctors become more aware of the epidemic and their role in it. I have seen a generational shift by new doctors who attended medical school, while media including USA Today and CNN have ensured the general population knows we have a problem. The doctors who were in practice or in medical school during the mid-1990s when advocates complained of opioid phobia and under-treatment of pain are coming to a similar conclusion. By no means has there been enough education yet, or conversion of prescribing behaviors, but pressure from the White House to the governor’s house to a mom’s house is certainly creating momentum toward appropriate use. Those of us who serve as educators will continue to be unrelenting in the battle for hearts and minds, but ultimately it comes down to individual decisions by both prescribers and patients to do the right thing.
  12. Do you know if authorities who arrested Tseng confiscated the $5 million she made? I’ve not seen any evidence they did.
  13. Why do people snort pills vs. taking them normally? Drugs like OxyContin and Opana are ER (extended release) and formulated to take effect over a period of 10 to 12 hours. That does not provide the intense and immediate high desired by people addicted to or dependent upon heroin-type euphoria. When pills are crushed and snorted or injected, users bypass the wait associated with the extended release. Abuse deterrent formulations are an important component to help make the high more difficult to obtain. I spoke at a summit on Abuse Deterrence in Alexandria, VA, on March 19, so be watching for a post on what I learned from the speakers prior to my presentation.
  14. Is Demerol similar to or it is also an opioid? Similar to morphine? Demerol (meperidine) is indeed an opioid. Morphine is 10 times more potent than Demerol, however it is NOT recommended for palliative care (i.e. for chronic pain). According to drugs.com, it has 73 major, 701 moderate and seven minor drug interactions along with 16 disease interactions. So it’s a very complicated drug.
  15. What do you recommend someone take with a chronic illness that is not life-threatening? There are many people who take, appropriately, prescription drugs to manage chronic conditions like diabetes, hypertension, rheumatoid arthritis and a variety of other ailments – and without those drugs, their health (and often their life expectancy) would be compromised. Chronic pain, physical or psychological, is real. And unique to each individual, both in the pain itself and the ability to manage it. Which means the treatment is often unique for that specific individual, and therefore the road map can be filled with trial and error. In some cases, chronic pain can be appropriately managed by prescription drugs. But likely that isn’t the only method for management, and in some cases prescription drugs create more issues (i.e. side effects) than they solve. Finding a pain management clinician who believes in the BioPsychoSocial model and thinks drugs are used only after all conservative options are exhausted is key. Following is a list of alternative treatments that is at least a starting point: Physical – An active lifestyle; seven to eight hours of sleep each night; Proper nutrition and weight management; Alternative treatments like acupuncture, massage therapy, yoga; Reducing or removinge alcohol consumption; Smoking cessation. Psychological – Cognitive Behavioral Therapy to adjust attitudes about pain; Develop coping mechanisms through methods like deep breathing, meditation, biofeedback; Dealing with the anxiety or depression that often comes with chronic pain; Developing a support system of family and friends; Decreasing avoidance by enhancing the “fight” attitude; Reducing stress. For further reading, two good articles can be found at http://www.webmd.com/pain-management/guide/11-tips-for-living-with-chronic-pain and http://www.medscape.com/viewarticle/576064
  16. How long does a person need to be on methadone for weaning? That varies on the person, the complexity and scope of the drug regimen being weaned and any co-morbidities that might complicate the process. One clinical resource I’ve read says a patient with significant risks can be tapered in a closely monitored environment over seven to 14 days, but typically it’s a slow process of 5% to 10% declination every one to two weeks (so how long it takes depends upon the starting dosage).
  17. Many providers order opioids in workers’ comp and are not willing to budge in discontinuing/weaning these medications. What recommendations do you have to assist in this process? In some cases, opioids are appropriate, so don’t automatically assume all opioids (and the corresponding drugs/classifications to address side effects) are inappropriate. If the opioids are creating more harm than good (based on levels of activity, quality of life, number/severity of side effects, subjective assessment of pain), and if evidence-based medicine indicates there are other treatment options that should be tried, that information should be relayed to the prescriber. If the prescriber will not talk to anyone, or does not accept the evidence of a better way, then the goal would be to either compel the prescriber to change the drug regimen or to change to a different provider. The path for that is different for each jurisdiction and often includes utilization review, independent medical exam (IME), forcing a provider change, a legal challenge, reporting the provider to the state’s medical association or discussion directly with the injured worker. First, every effort should be made to present objective, clinical evidence in a collegial manner to the prescriber to help him see things differently. If, given the evidence and the chance to review, the prescriber still refuses to listen or change then there is ample evidence of your due diligence that will demonstrate your desire to do the right thing for the injured worker.
  18. I have been informed that once a person is on meth he always goes back. People are never able to get off it. Is that true? If not, do you know the statistics for successful results? There are circumstances where somebody could successfully detox and stay off meth, but it is so addictive that the odds are high they will relapse or die. I found a statistic that 93% of those in rehab for meth addiction relapse, and the national rate of recovery is 16% to 0%. This article provides a good overview: http://luxury.rehabs.com/crystal-meth-addiction/recovery-statistics/.
  19. Is Hep C a germ that develops or is it an actual virus passed by dirty needles? Hepatitis C is a “virus (a type of germ) that causes liver disease.” From my study of opioids and heroin, it’s clear that Hep C can be a direct result of heroin use because of shared needles. “Dirty needles” typically means ones that have been contaminated by bacteria or blood residue from previous user(s) of that needle, and that can certainly be a method for addicts who are scrounging for resources (like needles) to continue their habit. Dirty needles are one reason why communities may have a “clean needle” program. Which is an interesting conversation – does providing clean needles encourage heroin use, or is it a helpful precaution? For more information, this can be a helpful resource: http://health.williams.edu/keephealthy/general-health-concerns/hepatitis-c/.
  20. What is your take on nurse-monitored injection sites, and have they been found to decrease community outbreaks of disease? What have been some of the community concerns related to these sites? This is a trend I’ve read about, not only in the U.S. (Indiana’s response to the Hepatitis C outbreak because of heroin abuse is a needle exchange program via Senate Enrolled Act 461) but abroad (Canada, Portugal, Netherlands). The programs are often called “injection rooms” or “safe havens” or “needle exchanges,” sometimes even coming with outright legalization or decriminalization of drugs like heroin. Concerns are whether providing these options legitimizes use and therefore enables the addicts. Obviously, the preference would be to help people rid themselves of addiction and corresponding behavior. As far as results, studies in Portugal indicate decriminalization has not affected drug usage but has dramatically decreased drug-related pathologies like STD and Hep C and HIV. For more information about that, please read https://en.wikipedia.org/wiki/Drug_policy_of_Portugal.
  21. So what is the generally correct progression or step down in using an opioid after surgery? What would be a “pre-red flag”? Step therapy is going to be directly related to the level of pain associated with the effects of the surgery or injury. In some cases, that could be one to two days with a rapid de-escalation (e.g. Percocet to Tramadol to Ibuprofen). In other cases, where the trauma is significant or followed by painful physical therapy, step therapy could be two to three weeks or even months. Not only is the titration related to the severity of the pain, but so is the tolerance to pain or the side effects by the patient (e.g. the constipation is enough for the patient to want something different). Following are some “pre-red flags” that you might consider: Did the provider prescribe an unusually high days’ supply or quantity (e.g. a 30-day supply or 60 pills)? Did the patient run out of supply before the next office visit? Is there no evidence in the provider’s notes that a discussion occurred with the patient on the tapering process (i.e. articulating the exit strategy)? Was there a tapering attempted, but the patient did not respond well? Instead of tapering down (e.g. 20mg to 10mg, Percocet to Tramadol) is the potency increasing (Percocet to OxyContin)? Is it clear that the patient is not moving toward therapy and activity per expectations? In other words, “pre-red flags” are going to be gleaned from the provider’s notes during and post-surgery and prescribing patterns.
  22. Have you seen Suboxone prescribed as a painkiller vs. a manner by which to wean off heroin? What are your thoughts on Suboxone? The FDA is very clear in its labeling – “SUBOXONE sublingual film is a partial-opioid agonist indicated for treatment of opioid dependence.” Therefore, use of Suboxone for pain is considered off-label. Typically, the FDA approves uses (on-label) where the manufacturer can clearly document the benefits of use for a specific condition, so being considered off-label means the evidence was either not clear or not presented. There are many drugs prescribed off-label (the FDA allows off-label use, only restricting manufacturers from advertising or advocating off-label use), and Suboxone certainly qualifies. For all of the labeling details, go to http://www.accessdata.fda.gov/scripts/cder/drugsatfda. Interestingly, Butrans is another buprenorphine formulation that has been approved “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” There are some benefits to both in their built-in abuse deterrence mechanisms. While they’re not 100% airtight, they do put enough obstacles in place to make abuse more difficult (although Suboxone is highly abused in prisons). The concern I’ve heard from payers is that these drugs do not facilitate the tapering of opioids, so they are just added to the overall drug regimen, and they are much more expensive than many of the generic opioids, so reconciliation of therapeutic value vs. financial value is troublesome. Unfortunately, abuse deterrent mechanisms are not as widely available for generics as for name brands My personal opinion is there are less expensive treatment options than Suboxone, so it should be reserved for exceptions.
  23. Do you believe that legislation will be written in the near future that will penalize health providers if they exceed recommended narcotic treatment guidelines? Public policy is not only something based on evidence but also on politics. There certainly are enough treatment guidelines available from a variety of sources that indicate thresholds and areas of concern that would highlight abuse while protecting access to patients who receive benefits. Unfortunately, many of those guidelines don’t come with the necessary mandates or penalties for non-adherence. There are powerful lobbyists employed to maintain the status quo. At some point, I think the evidence of death and destruction from our prescription drug abuse epidemic will overwhelm the lobbyists and public policy will not only create mandates but also stronger enforcement mechanisms. The momentum is clearly on the side of more oversight. And it would not surprise me if personal injury lawyers start issuing more lawsuits and medical malpractice to rid the medical practice of the bad actors. Until then, it’s up to the DEA and state/local law enforcement to find and prosecute inappropriate prescribers, to provide help to substance abusers and to educate everybody of the dangers.

Novel Controls on Physician Dispensing

As you know, I’m not a fan of physician dispensing. In limited cases, there can be benefits from patient compliance and convenience and from immediate treatment. However, my opinion is that in most cases physician dispensing creates a motivation to continue prescribing (because revenue to the physician is at stake) and causes patient safety issues (by bypassing the people who really understand drugs — pharmacists and pharmacies — and possibly not taking into account drug interactions).

On top of that, physician dispensing can increase lost time by an injured worker, as documented in a study of Illinois. When evaluating the differences between physician-dispensed and non-physician-dispensed medications, the study found:

  • For physician-dispensed, non-narcotic drugs — medical costs ▲ 39%, indemnity costs ▲ 27%, lost-time days34%, average total claim ▲ 31%, # of prescriptions = 2.99
  • For physician-dispensed narcotic drugs — medical costs ▲ 78%, indemnity costs ▲ 57%, lost-time days ▲ 85%, average total claim ▲ 64%, # of prescriptions = 3.20

Several states have tried to combat inappropriate physician-dispensing over the past few years, using fee schedule and rules and even felonies as countermeasures. Some efforts have been successful, while others have just created a continuing cat-and-mouse game for repackagers and physicians vs. payers.

Well, effective Jan. 1, 2016, Nevada instituted its own type of reform, specific to workers’ comp. The bill does not appear to be ambiguous or up for interpretation. The bill (SB 231) was signed by the governor on May 27, 2015, but the intended (and unintended) ripple effects started last Friday. Read the entire act here. To highlight:

  • Section 1.1.a – A “provider of healthcare” can only provide an initial 15-day supply of Schedule II or III controlled substances to an injured worker. Note that this excludes pharmacists and hospitals, both reasonable carve-outs. Any subsequent such controlled substances must be dispensed by a pharmacy. Excellent.
  • Section 1.1.b – The “provider of healthcare” dispenser must include the original manufacturer’s national drug code (NDC) on bills and reports. Good. This doesn’t necessarily fix the issue of repackagers becoming “manufacturers” of unique (previously unnecessary) dosages and inflating prices, but …
  • Section 1.1.c – A repackaged drug must not be used. Booyah.
  • Section 1.1.d – For outpatient care, a non-prescription drug will not be reimbursable. Excellent.

While not all dangerous or clinically inappropriate drugs are Schedule II or III, these new rules should certainly make a dent in direct dispensing of those that are. This bill does not outlaw physician dispensing, but it does remove revenue motivation so a “provider of healthcare” will focus on the most clinically appropriate care (which may not be a drug). Working as a team, the “provider of healthcare” and the pharmacist should determine what, if any, drugs are clinically appropriate for the injured worker/patient.

It will be interesting to see how the repackaging industry responds. For an example of the state of the industry in Nevada, check out this website. (Nine uses of the word “revenue” on the repackager’s home page. Hmmmm.)

If you operate in Nevada, keep your eyes and ears open. And if you see reactions, please let us all know!

Progress on Opioids — but Now Heroin?

You’ve probably noticed recent reports, within the workers’ comp pharmacy benefits manager (PBM) industry and elsewhere, that prescription opioid use and overdoses are on the decline. It is a long journey, and we cannot yet see the destination, but progress is being made. One of the goals has been to make it more difficult to secure clinically inappropriate prescription opioids through legitimate (physician, dentist) and illegitimate (pill mills, street sales) means. Abuse deterrent formulations have also helped, creating a hassle factor for those who want to abuse them. The increase in focus on the subject in the media and government has made it more top-of-mind. Although even one death or the creation of one addict is too many, and we have lots of cleanup to do today on the damage already done to individuals and communities, the trends are heartening.

However, for every intended consequence, there are also unpredictable unintended consequences. And one of those that I’ve been following for some time, that two recent clinical studies have codified as accurate, is the dramatic increase in the abuse and misuse of heroin. A good amount of that increase is theorized to be coming from those who may have become addicted or highly dependent upon the euphoric effect or dulling of the pain from opioids. Because today’s heroin is “pharma quality” and less expensive than opioids on the street, heroin has become the primary alternative choice. If you think this is a recent issue, this USA Today article titled “OxyContin a gateway to heroin for upper-income addicts” was my initial warning, on June 28, 2013.

The reasons for this switch are multiple and complicated. An excellent article on this issue was published in the June 2015 edition of “Pain Medicine News.”

Three quotes that struck me the most:

  • “Fewer than 20% of chronic pain patients benefit from opioids.”
  • “The prolific normalization of opioid use for chronic pain within primary care has seeded the epidemic of heroin addiction.”
  • “We are going to see the biggest explosion of heroin addiction ever in the next five years.”

Obviously, heroin is an illegal drug and therefore cannot be tracked or managed within a PBM. But everyone needs to be watching. While heroin use may not be a “workers’ comp problem,” it is a societal problem, which ultimately always rebounds as an issue for everyone (and everything) else.

The CDC just published (or at least publicized on Twitter) a “Vital Signs” report specifically on the subject. This should be required reading for everyone concerned with the epidemic of substance abuse in the U.S. Note that I said “substance abuse,” because as has been clearly stated the issue is not specific to prescription drugs or heroin or cocaine or alcohol binge drinking — it is a cultural issue of people either wanting to have a good time or just to check out from life or pain. According to this CDC report, more than 8,200 people died from heroin overdoses in 2013. When you add that to the more than 175,000 people who have died from prescription drug overdoses since 1999, the people affected is staggering. Not just those who lost their lives, but friends and family left behind and communities (and, in some cases, employers) dealing with the aftermath.

While there is a treasure trove of information included in the CDC’s report, the most important point for me (given my focus since 2003) was the advice to states:

  • Address the strongest risk factor for heroin addiction: addiction to prescription opioid painkillers

If you still don’t believe that opioid use and the abuse of heroin (and other drugs) are related, you just aren’t paying attention. Or you don’t want to connect the dots. I will let the CDC prove my point …

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The use of heroin is no respecter of income level, age, gender, education or geographic location. However, the CDC did outline those most at risk for use:

  • People who are addicted to prescription opioid painkillers
  • People who are addicted to cocaine
  • People without insurance or enrolled in Medicaid
  • Non-Hispanic whites
  • Males
  • People who are addicted to marijuana and alcohol
  • People living in a large metropolitan area
  • 18- to 25-year-olds

Do yourself a favor. Take 10 minutes and read the report from the CDC. It will only be wasted time if the information does not influence you to action.

Next Tsunami of Work Comp Payments

2009 was a milestone in workers’ comp. In that year, the Centers for Medicare and Medicaid Services (CMS) formally announced that it would review future prescription drug treatment in Workers’ Compensation Medicare Set-Aside (WCMSA) proposals based on “appropriate medical treatment as defined by the treating physician.” While the U.S. culture and Centers for Disease Control and Prevention (CDC) had already noticed the prescription drug epidemic, this new requirement more clearly highlighted high-cost drug regimens that were doing more clinical harm than good.

Yes, the monthly drug costs were already known to be expensive. Yes, reserves often had to be raised annually. But until the workers’ comp industry had to follow explicit rules to calculate the lifetime cost associated with continued inappropriate polypharmacy regimens, the problems hadn’t really registered.

The new requirement dramatically changed the ability to settle and close a claim, so addressing the overuse and misuse of prescription drugs, primarily related to non-malignant chronic pain, became a white hot priority. The financial exposure highlighted by the WCMSA was a tsunami that changed the contours of the claims shoreline.

Well, another milestone has been achieved for workers’ comp. I have been talking about it, as well, over the past three years, because I could see the riptide indicators of the next tsunami to hit. And now the surge is about to hit the shore.

This next workers’ comp tsunami? Death benefits that will be paid because of drug overdoses.

This has already been affirmed in a handful of states, among them Pennsylvania (James Heffernan), Tennessee (Charles Kilburn) and Washington (Brian Shirley). Death benefits have been denied in other states, including Connecticut (Anthony Sapko) and Ohio (John Parker). I’m sure this is not a complete list. The list shows how individual circumstances and jurisdictional rules can drive different decisions, but what is not up for debate is whether payers face an issue concerning injured workers dying from an overdose (intentional or unintentional) of prescription drugs paid for by workers’ comp.

The game-changer could be a new decision in California, South Coast Framing v. WCAB. The full Supreme Court decision can be found here, and a good article that gives additional context can be found on WorkCompCentral (requires a subscription).

To summarize, Brandon Clark died on July 20, 2009. The autopsy reported his death “is best attributed to the combined toxic effects of the four sedating drugs detected in his blood with associated early pneumonia.” Elavil, Neurontin and Vicodin were being prescribed by his workers’ comp physician, while Xanax and Ambien were prescribed by his personal doctor. Of that list, the four sedating drugs are Elavil, Vicodin, Xanax and Ambien — obviously a mixture of workers’ comp and “personal” drugs.

The qualified medical evaluator (QME) doctor ascribed the overdose to the additive effect of Xanax and Ambien and not the workers’ comp drugs. However, he allowed that Elavil and Vicodin could have contributed (the deposition quotes on pages three and four remind me of a Monty Python skit, as he tried inartfully to not provide apportionment). So … what is the strength of causality between the industrial injury and death? Tort is much more precise in its understanding — cause, in fact, and proximate cause. Workers’ comp (which is no-fault) is not tort, and neither is its definition of causality — contributing cause of the injury.

Did Clark misuse or overuse the drugs through willful misconduct? Possibly. Should one of his physicians have recognized the additive sedative effects from the combination of drugs and done something different? Probably. Was Clark trying to address continued legitimate pain that originated with his workplace injury? Likely. Is this a tragedy? Definitely.

So the decision came down to whether the workers’ comp drugs (Elavil and Vicodin) could have been part of why Clark died.

The Court of Appeal concluded that Elavil only “played a role” and was not a “significant” or “material factor.” The Supreme Court found the evidence to be substantial that Elavil and Vicodin, to some degree, contributed to his death. Therefore, they awarded death benefits to Clark’s wife and three children.

What does this mean? At least in California, it means that the bar of establishing causality (did workers’ comp drugs somehow contribute) is not as high as you might have expected. There is no further debate because this is a Supreme Court decision. Does that mean more death benefits are to come in California? In a highly litigious state where representation is commonplace. And prescription drug use for chronic pain is an overwhelming problem. Hmmm …. My “magic eight ball” is in for maintenance, but my educated guess (I am not an attorney) would be yes.

What about other states? Well, every state has different rules and case history, but because trends often start in California, and the Supreme Court was articulate in its decision-making process, it’s possible this causes a re-examination by all parties. The fact that some states already have established case law to grant death benefits could be a compounding effect. Therefore, it’s a definite maybe.

This may be an isolated case that has no repercussions in California or elsewhere. On the other hand … Consider this your RED FLAG warning for the riptide that precedes the tsunami. And you thought paying for drugs was expensive!