Tag Archives: tramadol

Opioids Are the Opiates of the Masses

One day in 2014, before most people could even spell “opioids” (two “i’s), the CEO of a company named Healthentic asked me to review a white paper based on the output of its new analytics tool. Healthentic’s tool is far more focused on the “80” of the “80-20” rule than competing tools are. So, rather than drowning readers in data, the tool is supposed to help certain figures jump off the pages and lead to action.

As my role in life appears to be the thankless task of finding errors in other people’s work, I was pleasantly surprised that Healthentic called me to plausibility-check the tool early in the process, rather than disseminate it and wait for me to publish “highlights” of my analysis after the fact, as I am wont to do.

As usual, I noticed some highly suspect information. In this case, it was prescriptions for Tramadol, Oxycontin and Hydrocodone. With my usual charm, grace and humility, I said: “These figures can’t possibly be right. This isn’t an NFL team in constant pain. If these figures were correct, it would mean that 40% of their employees filled a prescription for a synthetic opioid in a single year.” We rechecked the figure and the raw data several times. And yet the original statistic refused to bend. It was accurate.

See also: Paging Dr. Evil: The War Over Opioids

Ironically, the particular Healthentic customer profiled in the white paper was obsessed with employee health. Its staff could recite how many employees had high blood pressure or high cholesterol, participated in the “steps challenge” or the “biggest loser contest” or didn’t buckle their seat belts. But opiates and synthetic opioids — the elephant in the room capable of magnitudes more damage to employee health and productivity than any of the wellness vendor siren songs — had been completely overlooked.

In the days that followed, we talked through four possible scenarios and ruled out three:

  1. Employees were being injured due to safety hazards and accidents — but the company’s OSHA reports were clean and, in any event, those prescriptions would have shown up in workers’ compensation, not group benefits;
  2. Certain local doctors were prescribing way too many of these pills — but the prescriptions seemed to be coming from many different doctors;
  3. Employees were reselling their prescription meds — but if that were the case they’d have enough sense not to purchase these pills through the PBM;
  4. A sizable number of employees were at-risk or already addicted to opiates.

It was definitely the last. Little did we know this was the leading edge of the belatedly discovered synthetic opioid epidemic.

Healthentic analysis consistently finds that opioids are some of the most prescribed drugs for all employers. “Take two aspirin and call me in the morning” has become: “Take some Oxy and text me in the morning.” It wasn’t hard for a person with a few dental or medical procedures to have several months’ supply of the drug.

Pain is no laughing matter. It is human nature to ease suffering. But the cost and consequences of treating chronic pain so freely with opioids is shockingly high. Not a week goes by without more national news being made on the topic, such as Prince’s death. Of course it isn’t just famous people who are susceptible. Opioids — synthetically designed cousins of heroin — are so addictive there’s a Super Bowl commercial for another drug to treat constipation from chronic use. Obviously a market has to be quite sizable to merit a Super Bowl ad.

See also: Progress on Opioids — but Now Heroin?

The good news is that it doesn’t have to be this way. Pursuing early detection of a large supply of opioids and putting treatment goals in place will help a great deal in avoiding chronic use and addiction. Employers can help to head off chronic use before it turns into addiction. Independent analysis of your data should identify the three key risk factors for this population:

  1. a 45-day or greater supply;
  2. 10 or more prescription refills; or
  3. overlapping synthetic opioid and benzodiazepine prescriptions.

As brokers and employers, you can flag this population to the medical carriers and providers. You yourselves won’t be aware who is at risk, in conformance with the new CDC guidelines.

I emphasize the word “independent” because of how far behind the curve the payers are. One insurance carrier told an employer not to worry about the 150 people Healthentic had tagged for being at risk for chronic opioid use. “We know about these people. They are in our medication compliance program. Most are on palliative care.” That would be an obvious whopper even if these employees had worked at Chernobyl, and a quick analysis confirmed there wasn’t a single palliative care referral in the group.

Employers’ obsession with wellness, and carriers’ unwillingness to run the data, is great for my business, and for Healthentic’s. Unfortunately, it is not so great for employees at risk for opioid addiction. The only good news is that at least they won’t be constipated.

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.

Would a Formulary Help in California?

Introducing a closed pharmaceutical formulary into California workers’ compensation could produce two main benefits. The first is to further lower the cost of pharmaceuticals by either restricting or eliminating certain medications. The second is to reduce the possibility of drug addiction.

An October 2014 California Workers’ Compensation Institute (“CWCI”) report titled, “Are Formularies a Viable Solution for Controlling Prescription Drug Utilization and Cost in California Workers’ Compensation” states that pharmaceutical costs could be reduced by 12%, or $124 million, by introducing the Texas workers’ compensation pharmaceutical formulary.

To achieve the second benefit, an assembly member introduced AB1124 to establish an evidence-based medication formulary and wrote, “The central purpose of our workers’ comp system is to ensure injured workers regain health and get back to work. When workers get addicted to dangerous medications, goals of the program are not met. An evidence-based formulary has proven to be an effective tool in other states and should be considered in California.”

To confirm whether these benefits could be achieved through the introduction of the Texas formulary, a review of the CWCI study and the opioid medications available under the Texas formulary was conducted. The findings, summarized below, suggest that the answer is no.

Although California does not restrict or limit medications in treating injured workers, it does limit the prices paid and provides an opportunity to question prescribed medications that appear to be out of the ordinary. Medi-Cal prices (California’s Medicaid health care program) are used for establishing the maximum prices for workers’ compensation medications, in contrast to states such as Texas, which use the average wholesale price (AWP).

A review of two cost-saving examples that referenced specific medications calculated projected savings based on CWCI’s ICIS payment data for prescriptions paid between Jan. 1, 2012 and June 30, 2013.

The first example compared 50mg Tramadol prices from five different suppliers. The highest was $190, followed by $23, $18, $12 and $8 per script. Here, CWCI suggested that the manufacturer of the highest-priced script be removed from the California formulary. From mid 2009 through 2013, however, the unit price for 50mg Tramadol from the supplier of brand name Ultram and at least 10 other suppliers in California was nine cents, so the AWP for a script was $2. So, overpaying for medications is an issue even if the $190 supplier is removed.

The Workers’ Compensation Research Institute (WCRI) also reported that California claims administrators paid a unit price of 35 cents for 5mg Cyclobenzaprine and 70 cents for 10mg while the unit price from Californian suppliers was 10 cents for 10mg and 15 cents for 5mg. Again, the prices suggest that California claims administrators were paying more than the maximum prices.

Based on randomly selected manufacturers and strengths of the top 20 medications identified in the 2013 NCCI prescription drug study, California’s prices were on average 20% lower than the AWP and in some cases as little as 1/24th the cost. California prices were found to be at the lowest retail price range compared with those published on goodrx.com. Pharmacies located in Los Angeles, Miami and Dallas were used for comparison. Findings suggested employers in California workers’ compensation are paying no more than the general public for medications, whereas in Texas employers are paying more by using the AWP.

The second example compared script prices of seven opioid agonists, including Tramadol and Oxymorphone. Oxymorphone was the highest-priced script at $600 and Tramadol the lowest at $60 per script, suggesting a saving of as much as $540 if Tramadol were to be prescribed instead of Oxymorphone.

But prescribing oxymorphone when tramadol could suffice or vice versa could be regarded as an act of gross negligence by the physician. On the World Health Organization (WHO) analgesic ladder, tramadol and codeine are weak opioids regarded as “step two” while acetaminophen and NSAIDs are “step one.” “Step three” opioids include medications such as morphine, oxycodone and oxymorphone, which all differ in their pharmacodynamics and pharmacokinetics, so choosing one or more to treat pain becomes a balance between possible adverse effects and the desired analgesic effect. Oxymorphone (stronger than morphine or oxycodone) is recommended for use only when a person has not responded to or cannot tolerate morphine or other analgesics to control their pain.

A list of opioid medications published by Purdue Pharma was used to identify which opioids were excluded from the Texas formulary. The list of more than 1,000 opioid analgesics was prepared by Purdue to comply with the state of Vermont law 33 V.S.A. section 2005a, requiring pharmaceutical manufacturers to provide physicians with a list of all drugs available in the same therapeutic class. Being in the same class, however, does not necessarily mean they are interchangeable or have the same efficacy or safety.

The list showed available strengths and included (1) immediate and extended release, (2) agonists such as fentanyl, oxycodone, hydrocodone, oxymorphone, tramadol, codeine, hydromorphone, methadone, morphine, tapentadol and levorphanol and (3) combinations such as acetaminophen with codeine, oxycodone with acetaminophen, oxycodone with asprin, oxycodone with ibuprofen, hydrocodone with acetaminophen, hydrocodone with ibuprofen, acetaminophen-caffeine with dihydrocodeine, aspirin-caffeine with dihydrocodeine and tramadol with acetaminophen.

It appears that extended-release medications used for around-the-clock treatment of severe chronic pain have been excluded or are not listed in the Texas formulary, with a few exceptions. For example, 80mg OxyContin (Oxycodone) ER 12 hour (AWP $18, Medi-Cal $15) is excluded. 120mg Hysingla (Hydrocodone) ER 24 hour (AWP $41, Medi-Cal $34) is not listed. However, 200mg MS Contin (Morphine) ER 12 hour (AWP $31, Medi-Cal $26) and 100mcg Fentanyl 72 hour transdermal patch in both brand name and generic forms are approved under the Texas formulary. Immediate-release generic medications such as oxycodone, hydromorphone and hydrocodone with acetaminophen in all strengths are approved, but immediate-release hydrocodone with ibuprofen and oxymorphone in either immediate or extended release are excluded.

Would the objective of AB1124 be achieved by utilizing the Texas formulary? The above review suggests it would not. All the opioid medications available through the Texas formulary have the potential to cause addiction and be abused, possibly leading to death either accidentally or intentionally. As an example, the executive director of the Medical Board of California has filed accusations against Dr. Henri Eugene Montandon for unprofessional conduct including gross negligence. His patient was found dead with three 100mcg fentanyl patches on his upper chest. The autopsy revealed he potentially had toxic levels of fentanyl, codeine and morphine in his bloodstream at time of death. These three opioids are available under the Texas formulary.

An article published on the website www.startribune.com described the challenges in treating returning soldiers from combat duty. The article discusses Zach Williams, decorated with two Purple Hearts who was found dead in his home from a fatal combination of fentanyl and venlafaxine, an antidepressant. Venlafaxine in both immediate- and extended-release form is approved in the Texas formulary. In addition, the following statement was made in a 2011 CWCI study into fentanyl: “Of the schedule II opioids included in the Institute’s study, the most potent is fentanyl, which is 75 to 100 times more powerful than oral morphine.”

The top 20 medications identified by the 2013 NCCI prescription drug study were also compared with the Texas formulary, and six medications were found to be excluded, including three extended-release opioids, OxyContin (Oxycodone), Opana ER (Oxymorphone) and the once-daily Kadian ER (Morphine). The twice-daily, extended-release morphine MS Contin, however, was approved. Flector, a non-steroidal anti-inflammatory transdermal patch used for acute pain from minor strains and sprains, was excluded, as was carisoprodol a muscle relaxant classified by the DEA as a Schedule IV medication (the same as Tramadol). The Lidocaine transdermal patch, which is a local anesthetic available in both brand name and generic. was also excluded. Lidocaine patches have been found to assist in controlling pain associated with carpal tunnel syndrome, lower back pain and sore muscles. Apart from carisoprodol, it would appear the remaining five were excluded from the Texas formulary because of their high price rather than concerns regarding their safety or potential for abuse.

The U.S. Food and Drug Administration (FDA) is responsible for the approval of all medications in the U.S. Its approved list is the U.S. pharmacy formulary (or closed formulary). California workers’ compensation uses this list for treatment and the Medi-Cal formulary for medication pricing. In comparison, Texas workers’ compensation uses its own formulary, which is a restricted list of FDA-approved medications, and pays a higher price for approved medications than California’s system does.

Implementing an evidence-based formulary, such as in Texas, may result in an injured worker’s not having the same choice of medications as a patient being treated for pain under California’s Medicaid healthcare program. How can this be morally justified? Will we see injured workers paying out-of-pocket to receive the medications necessary to control their pain?

Claims administrators can greatly reduce pharmaceutical costs through their own initiatives by (1) ensuring that they pay no more than the Department of Industrial Relations (DIR) published price for a medication, (2) ensuring that physicians within their medical provider network (MPN) treat pain using the established pharmacological frameworks such as the WHO analgesic ladder, (3) ensuring that quantities and medication strengths are monitored, along with how a person has responded to analgesics, (4) ensuring that, when controlling pain with opioids, there is a heightened awareness for potential abuse, misuse and addiction, (5) establishing a multimodal pain management regimen including non-pharmacological therapies such as acupuncture, aerobics, pilates, chiropractic and physical therapy tailored to a person’s medical condition and, (6) for chronic pain, considering introducing an Internet-delivered pain management program based on the principles of cognitive behavioral therapy.

The progress of many of these initiatives can be automatically monitored through a claims administrator’s technology solution, where a yellow or red flag is raised when prices paid exceed the legislated maximum amounts, when a pharmacological step therapy or progressive plan has been breached or when non-pharmacological therapy goals have not been achieved.

Using these initiatives, as opposed to restricting specific manufacturers or medications through a closed formulary, will undoubtedly yield a far better outcome for the injured worker and lower the cost to the employer, benefiting all involved.

Urine Drug Testing Must Get Smarter

Medical treatment guidelines, such as the American College of Occupational and Environmental Medicine and the Work Loss Data Institute’s Official Disability Guidelines, recommend urine drug testing (UDT) for monitoring injured workers who are prescribed opioids. Yet studies show that few physicians actually order the tests.

There are a variety of concerns about UDT, including its potential overuse, underuse, effectiveness and cost. The guidelines are fairly nonspecific in terms of the frequency and type of testing that are most appropriate for injured workers. The fact is, all UDTs are not created equal and should not be used interchangeably.

Immunoassay tests, for example, are preferred when simply trying to detect the presence or absence of illegal drugs in a person’s system. More sophisticated tests, such as liquid chromatography, may be more suitable for clinical applications. They are far more accurate than immunoassay tests, can identify parent medication and metabolites and can identify specific medications, rather than just drug classes.

The differences in the types of drug testing have important ramifications for patients. For example, inappropriate or insufficient testing can put injured workers at risk for drug overdoses.

“The type of testing clinicians use should depend on the purpose,” said Steve Passik, vice president of Clinical Research and Advocacy for San Diego-based Millennium Health. “The immunoassay test comes from a forensic application and vocational application. In those settings, only the most egregious offenders are meant to be caught.”

Job seekers, workers involved in workplace accidents, and athletes are among those typically subject to forensic tests. For them, immunoassay testing is appropriate and is based on the Mandatory Guidelines for Federal Workplace Drug Testing Programs, developed by the U.S. Department of Health and Human Services.

Because much of UDT today has its roots in forensic applications, the methods and mindsets of simple immunoassay testing are often used in clinical settings. These tests are subject to a high number of false positives; therefore, only positive results are typically sent for confirmatory testing to avoid falsely accusing people of drug use that might have dire consequences, such as job loss.

“This is problematic,” Passik said. “An injured worker who is using drugs and has a false negative result is potentially at risk if the physician uses a forensic mindset and only confirms positive test results. If the injured worker’s pain medications are mixed with whatever drugs he may be abusing, he could suffer an overdose. Or, his addiction could worsen since it is not being detected by the workers’ comp claims administrator.”

Immunoassay tests are generally cheap, fast and readily available. However, they are not designed for, nor are they very effective for, many clinical applications on their own.

“Take a worker who is being prescribed pain medications and is overusing them. The worker runs out of his or her medication and then borrows some from a friend or family member and even further supplements by abusing heroin when these are unavailable,” Passik said. “If his result on an immunoassay test comes back positive for an opioid, this lends a false sense of security that it is, in fact, the prescribed opioid that caused the result. This result is actually a ‘clinical false negative’ for the non-prescribed opioid and heroin. If the clinician has a forensic mindset that sets out simply to catch people but not falsely accuse them, the testing would end there.”

Another example might be seen in the worker prescribed an opioid for pain but also using cocaine who knows not to use it within two to three days of doctors’ visits to avoid testing positive on the immunoassay. The immunoassay test would likely yield a false negative, and testing would, again, end there. “This worker could be quite vulnerable and might even engage in the type of self-deception whereby he convinces himself that he has no drug problem because he can stop in time to produce a negative specimen for cocaine, ”said Passik.

The mixing of cocaine or heroin and prescribed and borrowed pain medications would make the worker susceptible to an overdose and to other drug interactions or to triggering his addiction. But the medical provider in this case would have no idea the person is abusing drugs.

“That’s the rub,” Passik said. “If I were using UDT in a worker’s comp setting, I would have a more flexible policy that allows the provider to use his clinical judgment to determine whether to send either positive or negative results from immunoassay tests to a lab for confirmation testing, or simply skip the immunoassay test and go straight to the lab.”

Immunoassay tests often produce false negative results because of the high cutoff levels that prevent the tests from detecting low levels of medications. They may also fail to detect opioid-like medications such as tramadol and tapentadol, as well as synthetic opioids such as fentanyl and methadone.

False positive results also occur, because certain immunoassay tests are subject to cross-reactivity from other medications and over-the-counter drugs and may produce inaccurate results. And there is a limited specificity for certain medications within a class.

Liquid chromatography tests, on the other hand, enable detection of a much more expansive list of drugs. This is significant, as virtually all injured workers on opioid therapy would be expected to test positive on a drug screening. The liquid chromatography test could detect which opioid was present in the injured worker’s system and at which levels.

In a 2012 study that analyzed results for point-of-care tests using immunoassay in physicians’ offices or labs, Millennium Health found 27% of the test results were incorrectly identified as positive for oxycodone/oxymorphone. The low sensitivity of immunoassay tests can mistakenly identify codeine, morphine or hydrocodone as the same drugs. Similarly, the study results showed the immunoassay tests missed the identification of benzodiazepines in 39% of the results.

One example of clinical chromatography is liquid chromatography tandem mass spectrometry (LC/MS-MS). These tests are far more accurate than immunoassay tests, can identify parent medication and metabolites and identify specific medications, rather than just drug classes.

“Professionals can now accurately test with both great sensitivity and specificity to understand whether patients are taking their prescribed medication, avoiding the use of non-prescribed licit controlled substances and whether or not they are using illicit drugs, which allows for better clinical decision making,” Passik explained. “LC/MS-MS results are now rapidly available to clinicians, allowing for a much greater integration of these results into clinical practice.”

In fact, Passik says much of the growth in the use of LC/MS-MS in recent years is because of the speed with which results can now be obtained, often within 24 hours.

In terms of drug monitoring for injured workers, Passik says immunoassay testing alone does not provide the physician with an accurate basis on which to make good clinical decisions. These tests may be positive for opiates – which, if the person has been prescribed opiates, would be expected.

“In this case, a positive result would need to be sent to the lab to confirm that the opioid detected in the test was solely the medication prescribed and there are no other licit — or illicit — drugs present. The immunoassay positive result by itself doesn’t provide enough information,” Passik said. “However, if the worker is well known to the prescriber and has a long history of UDTs showing he is taking his medications as prescribed, the provider might decide the immunoassay test result will suffice at that point. But, again, it would need to be in the context of appropriate results of UDTs and a clinical exam that do not suggest otherwise.”

Beyond the confusion about the types of UDT, a handful of unscrupulous clinicians are overusing the tests by performing them in their offices or labs they own, regardless of the patient’s risk factors for abuse or overdose. Payers are overcharged by these providers, as they do more testing than is necessary and charge for the initial test, analysis and confirmatory test (because virtually all tests on injured workers receiving opioid therapy would be positive), resulting in three separate bills.

There are also questions surrounding the frequency with which these tests should be performed on a given injured worker. Passik and other experts say the frequency of the tests should be determined by a medical provider based on the injured worker’s risk factors. An injured worker who is depressed, male, a smoker and has a personal or family history of substance abuse would likely warrant more frequent testing than someone with no known risk factors who is fully cooperating with those handling his claims and is eager to do, or is already doing, light duty work. It’s a tough call, and, so far, it is not an exact science.

“If the patient is older and has no history of addiction or other risk factors, you would probably test her a couple of times a year,” Passik said. “But a coal miner in southeastern Kentucky who has been traumatized from an accident, has addiction history in his family, lives in an area where he can make money [by selling the drugs] — that’s a high risk person who likely needs to get tested more often. Most people fall in between, so it’s best to rely on the clinician’s extensive training and individual assessments of their patients and potential risk factors to consider when developing a treatment plan.”

Part of the decision making on the part of medical providers involves figuring out strategies to integrate the two methods of testing, immunoassay and chromatography – “specificity when you need it and the frequency when needed so you can do it in the most cost effective fashion,” Passik said. “The tests should be integrated in a smart way.”

The nature of workplace injuries is such that more testing up front may be required. “Unfortunately, workers’ compensation is heavily loaded with high-risk patients,” Passik said. “They tend to be younger, traumatized because they are injured, and suffer from depression — all of which are risk factors for addiction.”

The best advice for practitioners is to look for thorough documentation from providers, communicate with all parties, especially the injured worker, and become informed on the type and frequency of UDTs performed for each injured worker.