By Mark Pew, Senior VP, Preferred Medical
Most of the United States has come to the conclusion that prescription opioids may not be the best choice for long-term treatment of non-malignant chronic pain. And, in some cases, not the best option for acute pain either. While they can work for some individuals (defined as providing function and quality of life, side effects do not escalate the complexity of care, and the benefits exceed the risks), they did not work for others (the objective statistics and anecdotal stories are well known). And so a “new normal” has set in since the decline in number of scripts began in 2013. But as scripts have declined, education on alternatives has not necessarily increased a commensurate amount. That is evidenced by some physicians deciding to no longer prescribe opioids without thinking through appropriate tapering plans, sending patients on a perilous journey. It is also evidenced by some payers still not fully embracing reimbursement for alternative treatment modalities (overheard at a recent workers’ compensation conference – “why would we pay for CBT when pills are so much cheaper”).
All of this means that society, healthcare and work comp is in this strange place called “transition.” For some, that transition has been smooth. For others that transition has been bumpy. For still others, that transition has not yet occurred.
Whatever the phase various stakeholders may be in, it is incontrovertible that the opioid option cannot be removed without replacing it with other options. According to the CDC’s September 14, 2018 “Morbidity and Mortality Weekly Report,” 50 million U.S. adults had chronic pain and 19.6 million had high-impact chronic pain. In work comp, chronic pain often is a primary symptom for “legacy” claims, of which there are thousands across the country. All of this means some type of treatment is required.
Sometimes that alternative can be a prescription or over-the-counter medication. Following are some of the most prominent options for work comp, listed in descending order of preference.
Ibuprofen (patented in 1961, available in the U.S. starting in 1974) and naproxen (available as a prescription drug in 1976) have a long history of pain relief. While mostly used over-the-counter, the COX-2 inhibitor prescription NSAID celecoxib (Celebrex, approved by the FDA in 1998) has been in the top 10 lists of utilized drugs in work comp by cost for at least the past decade so they are certainly not new to the scene. There are certainly side effects, mostly related to long-term and high dose usage that can create cardiovascular risks, stomach or intestinal bleeding and liver damage. Interestingly, the California Work Comp Institute documented in February 2019 that NSAIDs had surpassed opioids as the most common therapeutic drug class (the stage of pain was not identified). That should not come as a surprise since the California drug formulary lists 18 of 20 “Analgesics – Anti-Inflammatory (NSAID)” drugs as “Exempt” (not requiring pre-authorization). It is obvious that the prescribing trajectories are going in different directions. While not benign (no medication is), these medications appear to be the (currently) leading substitute for opioids.
Gabapentin and Pregabalin
These anticonvulsant prescription medications are used frequently for the treatment of non-malignant chronic pain, often beyond what the FDA approved (fibromyalgia, nerve damage from diabetes or shingles, or nerve pain from a spinal cord injury). Like celecoxib, both drugs have been in top 10 work comp drug lists for at least the past decade. However, what is relatively new is a regulatory perspective that they are potentially dangerous enough to be a controlled substance. As of April 1, 2019 the United Kingdom changed both drugs from unscheduled to Schedule 3. While the DEA has classified pregabalin as Schedule V since 2005, four states (Kentucky and Ohio in 2017, West Virginia in 2018, Michigan in 2019) have now also classified gabapentin as Schedule V. The concern largely comes from evidence of abuse, diversion and addiction as both drugs can enhance the impact of other drugs like alcohol, opioids and benzodiazepines. In addition, at high dosages (e.g. 600mg 3 times per day) they can dramatically alter quality of life (extreme drowsiness). So while these drugs may be beneficial to some patients, the risks mean that patient screening and monitoring is highly recommended and therefore might not be the best candidate for a systemic substitution for opioids.
While appropriate for a diagnosis of depression (hence their name), and depression (and anxiety) often accompanies chronic pain, only duloxetine (Cymbalta) was approved by the FDA to also treat pain (fibromyalgia, specifically). Interestingly, the two private providers of treatment guidelines whose drug formularies have been adopted by various jurisdictions (ODG by MCG and ACOEM by Reed Group) differ in their opinions on duloxetine for the treatment of pain. ODG only lists the drug for depression (so being unlisted for pain means it requires pre-authorization) while the California version of ACOEM does not require pre-authorization for chronic pain (but does for specific body parts) and the New York version of ACOEM … is … complicated. Given the complexities in state-mandated formularies it may be surprising that duloxetine has also been in top 10 work comp drug lists for at least the past decade. But among pharmaceutical options for pain, the evidence is mixed.
While the opioid epidemic has struck a nerve in the social consciousness of the U.S. for the past decade, there has been a parallel over-prescribing epidemic that is just as dangerous – the use of benzodiazepines. Of the 338 million antidepressant prescriptions written in 2016, alprazolam (Xanax) was the second most prescribed drug. Until work comp drug formularies were implemented, the prescription “holy trinity” (at least one opioid, at least one benzodiazepine, and carisoprodol), whose combination creates a heroin-type euphoria (and tremendously increases the possibility of central nervous system depression), was highly prevalent in long-term claims. When tapering a complex and inappropriate polypharmacy regimen, benzodiazepines should be the last drugs tapered because of their significant withdrawal symptoms, complexity of interactions and their highly addictive nature. The 2016 CDC opioid guidelines strongly recommend not combining opioids with benzodiazepines because of a higher possibility of fatal overdoses – but the CDC does not recommend benzodiazepines for pain by themselves either. However analyzed, the use of benzodiazepines for pain is problematic at best, deadly at worse.
There are other drug classifications that fit the “painkiller” theme. Muscle relaxants like tizanidine (Zanaflex), cyclobenzaprine (Flexeril) and baclofen have supplanted carisoprodol (Soma) because of its danger as an addictive medication with significant withdrawal issues and complicated drug interactions (the “vegas cocktail” is an opioid mixed with carisoprodol that creates a heroin-type euphoria). Most of these medications work by depressing the central nervous system but because they can be habit forming are recommended for only short-term use. Interestingly, cyclobenzaprine has been a popular medication for physician dispensing and third-party billers. Sedative/hypnotics like eszopiclone (Lunesta) and zolpidem (Ambien) can help promote sleep (an important component to managing chronic pain) but that can come at a price. In May 2019 the FDA added a “black box warning” (which means there is a heightened risk of injury or death) about “complex behaviors” (sleepwalking, sleep driving, engaging in other activities while not fully awake) tied to the drugs. Obviously, they should not be considered front-line therapy. And then, of course, there is medical cannabis, which has been explicitly promoted by Colorado, Illinois, New Jersey, New York and Pennsylvania as an opioid (prescription and/or illicit) alternative. Some say the science does not support marijuana as a vehicle for managing chronic pain, but policymakers in those states (and others) disagree. And discussion of that disagreement deserves its own separate article.
The primary question to be asked about any of the above medications, especially in regards to chronic pain, is should these medications be used every day for the rest of a patient’s life. Relying on medications today likely means relying on them into the foreseeable future, and most of these are not recommended for “eternal” use.
It was once said that nobody got fired for choosing IBM. In some ways, nobody will get fired for choosing medications. But using medications to treat chronic pain is only half of the story.
Next week’s article will go beyond the Bio-Medical model with some non-pharma alternatives that might require a paradigm change for payers.
About Mark Pew
Mark Pew, Senior Vice President of Product Development and Marketing for Preferred Medical, is a passionate educator and agitator. Known as the RxProfessor, Mark is focused on the intersection of chronic pain and appropriate treatment, particularly as it relates to the clinical and financial implications of prescription painkillers, non-pharma treatment modalities and the evolution of medical marijuana. He is a strong champion for the workers’ compensation industry to #PreventTheMess and #CleanUpTheMess, movements he created to drive attention to the importance of individualized appropriate treatment for injured workers. Mark is a vocal advocate of the BioPsychoSocialSpiritual treatment model.
Mark serves on the IAIABC’s Medical Issues Committee and SIIA’s Workers’ Compensation Committee. In addition, he serves as technical advisor to regulators and legislators in 20+ jurisdictions on subjects such as drug formularies, treatment guidelines, Opioid Task Force initiatives, encouraging support of non-pharma treatment options and the medicinal use of cannabis. Mark received the WorkCompCentral Magna Comp Laude award in 2016 and the IAIABC’s Samuel Gompers Award in 2017.