Tag Archives: hydrocodone

Opioids: A Stumbling Block to WC Outcomes

On a weekly if not daily basis, there are media reports about the growing impacts of addiction to opioids. The Centers for Disease Control and Prevention (CDC) reports that 78 people a day are dying from the effects of opioid overdose. Families are being systematically destroyed by the multiplicity of effects of this increasingly pervasive problem. In 2014, there were more than 47,000 drug overdose deaths in the U.S., and more than 28,000 of those deaths were caused by opioids (including heroin). The current overdose epidemic is unfortunately only one symptom of a greater problem in the U.S. Our nation consumes 80% of all opioids produced in the world, yet the American population makes up only 5% of the total world population. This strongly implies there is a societal, cultural profile in America that is unlike anywhere in the world, driving such demand and overuse.

As the national “epidemic” of opioid abuse continues to get increasing attention, it’s important to realize the effect it has on employers. Prescription opioid abuse alone cost employers more than $25 billion in 2007. Even if the injured worker never develops an opioid misuse disorder, long-term opioid use is still extremely problematic. The evidence tells us that the effectiveness of chronic opioid therapy to address pain is modest and that effect on function is minimal. In addition, when injured workers are prescribed opioids long-term, the length of the claim increases dramatically and even more so when other addictive medications like benzodiazepines (alprazolam, lorazepam) are prescribed. Perhaps the most troubling statistic of all: 60% of injured workers on opioids 90 days post-injury will still be on opioids at five years.

See also: Potential Key to Tackling Opioid Issues

Workers’ compensation stakeholders are increasing efforts to call more attention to the use of these potent pain-relieving drugs by injured workers. In the highly complex and diverse field of workers’ compensation, entities from state governments to insurers and other workers’ compensation stakeholders are stepping up to address the issues and impacts of opioid use by injured workers in varying degrees through a myriad of methods.

Most work-related injuries involve the musculoskeletal system, and doctors increasingly prescribe short- and long-term opioids to address even minor to modest pain despite broad medical recommendations against long-term use. Because of the prevalence of back injuries in the workplace, opioids are increasingly becoming the treatment of choice for what often starts as a short-term treatment, but frequently becomes long-term, with the likelihood of addiction occurring before treatment is completed.

Claims professionals should understand that there are many variations of opioids, including fentanyl; morphine; codeine; hydrocodone (Vicodin, Lortab); methadone; oxycodone, (Percocet, OxyContin); hydromorphone (Dilaudid) – each with different levels of potency. For example, fentanyl is 50 to 100 times more potent than heroin. No wonder addiction is so often the result.

Paul Peak, PharmD, assistant vice president of clinical pharmacy at Sedgwick, notes that opioids act on receptors in the brain; therefore, it’s expected that certain changes will occur over time as use continues. Each one of us would realize both opioid dependence (this means withdrawal symptoms occur when the drug is stopped) and opioid tolerance (this means more drug is needed to get the same effect as use continues) if we were to take opioids consistently for weeks or months. In many cases, patients who are prescribed opioids chronically will experience a worsening of pain that is actually caused by the opioids themselves.

Because opioids have these profound effects on our brains, engaging injured workers in their own recovery is a best-claim practice, and it is critical to achieving the best outcomes. This should begin early, and a key part of the process includes encouraging workers to ask their doctors questions when they are being treated with drugs for pain. Some of these questions should include:

  • Is this prescription for pain medicine an opioid?

Doctors should educate patients on what an opioid is and how to use it safely to relieve pain.

  • What are some of the potential adverse effects of opioids?

Opioids can affect breathing and should be used with great caution in patients with respiratory issues. They most often cause moderate to severe constipation. Even short-term use can decrease sleep quality and impair one’s ability while driving.

  • Where can I safely dispose of remaining pills?

To protect others from potential misuse, any excess supply should not be saved for later use. Injured workers should be advised not to give them to friends or family, and to dispose of unused pills appropriately. States often provide disposal options/locations for opioids to reduce the chance of leftovers getting into the hands of unintended users. In addition, CDC guidelines now recommend patients are only given a three-day or seven-day supply of opioids, and some states are now putting laws in place following this recommendation.

  • Am I at risk for abuse?

Providers can use risk assessments to help determine those people at greatest risk for abusing opioids if prescribed. Peak notes that opioids do have some benefit in the acute phase post-injury, say within four to six weeks after injury. However, when improvement doesn’t occur in this time frame, continuing use of opioids is not appropriate, as addiction becomes increasingly assured.

These are among the key questions for treating physicians that injured workers should ask. While engagement is a vital part of patient accountability, physician education is even more critical. Peak explains that more is expected of doctors because they are providing the care. Patients and physicians working together in a close relationship is key.

Injured workers and family members should talk to the treating physician immediately if they see signs of addiction or dependence. There are some possible warning signs of addiction, such as craving the pain pills without pain or when pain is less severe, requesting early refills or stockpiling medication, taking more pills at one time or taking them more often than prescribed, or going to multiple prescribers for opioids or other controlled substances. Early detection can help stop the destructive cycle of addiction before it becomes too powerful to resist. Injured workers can also contact an addiction counseling organization.

A note of caution for all whose accountabilities touch this area of treatment – terminating prescription opioids “cold turkey” can be dangerous and even fatal. Throughout the life of the claim and at the end of the day for injured workers using opioids, the relationship with their doctors will be the primary factor in determining how the treatment will end and the outcome that is achieved.

Strategies for the claims team

So where does all this leave claims professionals who want to see injured workers recover successfully and appropriately from their workplace injuries?

See also: Opioids Are the Opiates of the Masses  

Claims professionals must define a strategy for identifying and then monitoring physician prescribing patterns and the specific use patterns in each case. Some of the tactics that should be considered include:

  • Leveraging pharmacy utilization review services
  • Directing patients to doctors who won’t overprescribe opioids; and those who use prescription drug monitoring programs and tools, which are available in most states
  • Engaging nurse case managers early and regularly; their involvement and intervention can help deter addiction; nurses can advocate for other more clinically appropriate options and advocate for best practices including risk assessments, opioid contracts, pill counts and random drug screens
  • Ensuring that injured workers are getting prescriptions through pharmacy benefit management networks
  • Leveraging fraud and investigative resources that are often useful in uncovering underlying, unrelated patterns of behavior that would indicate a propensity for opioid abuse
  • Considering the cost of opioids versus alternatives; while many alternate treatments are more expensive on the front end, certain drugs may be much more expensive in the long term, especially if they lead to addiction
  • Addressing the opioid issue well before case settlement; as with most longer-term open claims scenarios, those with opioid use will only produce worse outcomes and get more expensive over time without appropriate early interventions

Continued vigilance by claims professionals can enable and facilitate a better result at closure and avoid a lot of potential pain for the injured worker along the recovery path.

Gene Testing: Time Is Ripe in Work Comp

Pharmacogenetic testing (PGT) has the potential to help clinicians improve outcomes for injured workers and reduce costs for payers. While research showing the clinical value of PGT continues to grow rapidly, evidence of the return on investment in the workers’ comp space is just beginning to emerge. Practitioners can benefit from the technology without falling victim to the hype of some proponents by becoming better educated about PGT and those providing it.

Because the use of PGT in the workers’ comp population is relatively uncommon, practitioners may find it challenging to realize the true value of the tests. “A few of our customers are trying PGT on select claimants,” said Dianne Tharp, pharmacist and executive clinical liaison for pharmacy benefit manager Healthcare Solutions, an Optum company. “This is a complex area; everything is evolving. It’s relatively new for the industry, and we are all still learning.”

One growing area of interest is in genetic tests that can identify injured workers most at risk for addiction and abuse. However, there are many challenges with such tests, including uncertainty about their predictive performance in clinical settings, which must be overcome before clinicians can use them to help identify whether an injured worker may misuse or abuse a prescribed opioid. While PGT could be a welcome tool, the science is not yet at a level where clinical application is appropriate.

“On the other hand, pharmacogenetic testing for drug response is often more — and in some cases highly — predictive,” said Naissan Hussainzada, senior director of genetics strategy and commercialization at Millennium Health. “For example, certain genetic variations can change how an individual metabolizes some opioid medications. Using this information, clinicians can identify patients at higher risk for medication failure and/or side effects, which may help them make more informed and tailored treatment decisions.”

Injured workers with preexisting conditions or those who develop comorbid conditions post-injury may especially benefit from PGT — as they may be receiving multiple medications that could potentially elevate their risk for drug-drug and gene-drug interactions. PGT information could also help the clinician better understand whether drugs prescribed for comorbid conditions will be effective.

“In the workers’ comp space, PGT could be used to help the clinician optimize medication prescribing and avoid trial and error,” Hussainzada said. “This has the potential to translate to faster recovery, less time away from work and shorter claim duration for the injured worker.”

See also: Genetic Testing: The New Wellness Frontier

Polypharmacy challenges

Multiple medication regimens and comorbid conditions are frequently present in workers who are injured on the job. The inability to work and the presence of pain can result in additional comorbidities, especially depression.

Metabolism can play an important role in how patients respond to medications, particularly antidepressants, opioids, certain anticoagulants and cardiovascular medications. Mental health providers, in fact, were among the first to recognize the value of PGT in guiding medication therapy and dosing.

“Mental health disorders are often assessed subjectively, and drug therapy can be lengthy, unpredictable and suboptimal,” Hussainzada said. “It may take several months to stabilize a patient on an effective antidepressant using trial and error.”

PGT can be especially useful for antidepressants. “There are actionable PGT results with good evidence for the antidepressants,” Tharp said. “That would be an instance where PGT may be useful [among injured workers].”

In addition to antidepressants, Tharp said PGT is also being used to help determine a patient’s ability to properly metabolize warfarin, which is used to prevent blood clots.

Drug-drug interactions

Individuals metabolize medications differently, partly depending on a person’s genetic makeup and partly on clinical factors, such as hepatic (liver) disease, lifestyle factors and administration of other medications. For example, introducing a new medication may change how existing drugs are metabolized, which can change their effectiveness or tolerability. Conversely, an existing medication may have an impact on the metabolism of a new medication.

“There are well-documented drug-drug interactions between opioid analgesics and certain antidepressants,” Hussainzada said. “This is because some antidepressants can inhibit or ‘turn off’ the enzymes responsible for metabolizing opioids. This can lead to the opioid becoming less effective, or in some cases, intolerable or potentially toxic. Making matters more challenging, there are some individuals that carry certain genetic variations that can make them more susceptible to a phenomenon called ‘phenoconversion,’ which can elevate their risk for certain types of drug-drug interactions. For injured workers receiving polypharmacy, PGT may help clinicians identify these higher-risk individuals and help mitigate some of the risks of phenoconversion.”

There are four categories of metabolizer type that correspond to how individuals may metabolize certain medications via hepatic enzymes. Individuals classified as “extensive” metabolizers possess fully functional enzymes and are able to metabolize medications normally. However, some individuals carry genetic variations that lead to reduced or significantly reduced enzyme function, and are classified as “intermediate” or “poor” metabolizers. Finally, some people may have genetic variations that lead to significantly increased enzyme function and are classified as “ultra-rapid” metabolizers. What that means is: Two people taking the same drug at the same dose can have very different responses because of their metabolizer status.

Individuals susceptible to phenoconversion can “switch” metabolism type, for example, from an intermediate or extensive metabolizer to a poor metabolizer. The trigger for these conversions is non-genetic extrinsic factors, such as administering a drug that inhibits the enzyme pathway. Certain metabolizer types are associated with higher risk of phenoconversion and risk of drug-drug interactions.

“Intermediate metabolizers may be at higher risk for phenoconversion compared to normal metabolizers,” Hussainzada said. “However, it can be difficult to identify these patients because they may display normal or typical response to a medication, even if they are metabolizing that drug at a reduced rate. However, if an inhibitor of the drug is added to their regimen, this can shift the individual from intermediate to poor metabolism and lead to medication failure and/or potentially serious side effects.”

For some claimants who take medications for pre-existing conditions, adding a pain medication can increase the risk for drug-drug interactions and phenotypic conversion. “So a claimant who has been taking antidepressants for years is now also prescribed an opioid because of his injury,” Hussainzada said. “If he is an intermediate metabolizer for the opioid, the antidepressant may convert him to a poor metabolizer. This could lead to inadequate pain relief, which may delay recovery and increase risk of poor outcomes.”

In another scenario, an injured worker who is taking opioids for his injury and who later develops depressive symptoms may be treated with concomitant antidepressant therapy. “In this case, the opioid may have been initially effective, but certain opioids would lose analgesic potency once the inhibitor, or antidepressant, is added,” Hussainzada said.

PGT can also help a clinician identify patients who may need to be started with atypical or non-standard doses of certain analgesics. One particular enzyme responsible for the metabolism of a large number of medications is cytochrome P450 2D6, or CYP2D6. Claimants who are reduced metabolizers for the pathway may not respond adequately to a standard dose of oxycodone.

“If you are a CYP2D6 poor metabolizer, standard doses of oxycodone or hydrocodone may not effectively control your pain,” Hussainzada said. “However, without knowing this type of genetic information beforehand, it may appear to the clinician that these individuals are drug-seeking if they continue to ask for higher doses.”

Some poor metabolizers may not get any pain relief, even with very high doses of a medication. Identifying these patients through PGT can lead the clinician to prescribe a different pain medication from the start, something that can be critical to getting an injured worker back to function.

According to a recent position paper from Healthcare Solutions, the rates of comorbidity and polypharmacy are on the rise in workers’ comp and can lead to increased medical costs, delayed returns to work and longer claim durations. Clinical depression is a common comorbidity, and the use of antidepressants is prevalent; however, both are associated with poor recoveries and outcomes.

“For patients taking multiple medications, there may be multiple enzymes that are recruited to metabolize and eliminate these drug combinations from the body,” Hussainzada said. “Some recent data indicates that when you look across multiple enzymes, genetic variation is much more common than when you look at a single enzyme. So for the claimant receiving polypharmacy, it may be even more important to understand how their genetics will contribute to their medication response since it is likely that at least one enzyme system may be variant.”

Clinicians can use PGT information at the beginning of a claim to optimize initial prescribing and dosing of opioids and other medications, which may hasten the recovery time. “In workers’ comp, the data are pretty clear: The faster we can facilitate post-injury recovery and get the claimant back to work, the better their overall prognosis,” Hussainzada said. “Particularly with opioid therapy, we want to use these drugs judicially and effectively.

See also: Urine Drug Testing Must Get Smarter

The future

Researchers and workers’ comp practitioners continue to monitor the clinical evidence for testing in an effort to help clearly identify those injured workers who would benefit most from PGT — in terms of better outcomes and lower costs. For now, there are several types of injured workers who may be good candidates for testing.

“A claimant taking multiple medications from several therapeutic classes, one who has failed several therapies and changing dosages or a patient on ultra-high daily morphine equivalent doses may be a good candidate for PGT,” Healthcare Solutions’ Tharp said.

Ultimately, proponents hope PGT can be a useful tool in getting the right medication at the right dose to each patient. If test interpretations are based on firm clinical evidence, PGT can provide clinicians with a road map for navigating prescribing decisions that can often be complex and subjective. However, providers are advised to become familiar with PGT and, especially, the companies marketing these services.

“Payers, clinicians and patients need to be aware that not all pharmacogenetic testing is equal. Ask questions about the evidence for specific genes and drugs and make sure there are clinical standards in place for how results are interpreted,” Hussainzada advised. “Some tests may not be ready for clinical use, so it’s important to be informed.”

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.

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.