Tag Archives: oxycodone

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.

If It Walks Like a Duck, Talks Like a Duck…

Everyone is talking about the dangers of “opioid addiction.” It’s been a topic of conversation among pain management specialists, chiropractors and other healthcare providers for years, but constant news coverage of “opioids” has made it water-cooler talk. Thanks to the media, we’re all experts on the issue.

But here’s the thing: the media – and the public – are missing the point entirely. Even the expression “opioid addiction” is completely off the mark. Because we’re not talking about “opioids” – we’re talking about addiction to heroin derivatives.

“Opioid” is a much safer word than heroin – not nearly as hair-raising or dangerous. But using the word “opioid” is like putting icing on a mud pie – it’s a cover-up at best. And when you make the connection that opioids are actually heroin derivatives, you understand why the addiction has become an epidemic in this country.

The problem, though, is much more sinister than we realize. For one, patients now expect their doctors to prescribe morphine or oxycodone for pain management. Second, there’s money to be made in “opioid addiction.”

See also: Opioids Are the Opiates of the Masses  

As reported in Risk & Insurance, a new study finds that a majority of patients still believe opioids are the most effective remedy for pain. In fact, a full two-thirds of physicians surveyed said their patients expect them to prescribe drugs. And in spite of the highly addictive nature of these drugs, doctors are still influenced by their patients’ expectations.

It gets worse. Despite evidence that oxycodone and morphine are not the most effective medications for pain relief, almost all of the physicians who were surveyed – 98 percent of them – prescribe some form of opioids for pain control. What’s more, the National Safety Council reports that 99 percent of the providers prescribe opioids for longer than the three-day course of treatment the Centers for Disease Control recommends.

Here’s the icing on this mud pie: nearly 90 percent of physicians say they find it difficult to refer patients to treatment for drug abuse or addiction, even when it’s clear their patients need help. It’s a vicious cycle with no easy solution.

Like almost everything in healthcare, we’re overlooking the most important part of the story.

The same doctor who prescribes opioids that lead to addiction can make his best money on the mandatory drug/toxicology testing he performs every month. Many good doctors recognize this as a conflict of interest – they also see that their patients are requiring higher and higher doses to feed their additions – and they intervene in the best interests of their patients. Unfortunately, there are plenty of other physicians who aren’t concerned about scruples. They are perfectly willing to pick up where others leave off. It has become a lucrative, albeit perverse, business model today.

I wish that were the end of it, but we’ve only scratched the surface. The story gets much worse from here. When patients no longer can afford opioids and drug testing (which can cost them $4,000-$10,000 each year), many have resorted to selling a couple of pills on the street in order to cover their costs. In essence, decent, respectable people become law-breaking drug dealers. Some people don’t want to sell their prescription drugs, but still must feed their addiction. Broke and desperate, they buy a cheap, street version of their opioid. This is called heroin.

It’s a trap, and it’s snaring people who never realized they were abusing heroin derivatives. They believed they were treating their pain with safe, physician-recommended oxycodone or morphine. They believe it was their best option for managing their symptoms.

Heroin derivatives are ruining the lives of good, hardworking people across the country. In recent months, I saw the horror firsthand when heroin overdoses stole the lives of two young men in my community – men with their whole lives in front of them. They weren’t your stereotypical druggies – they were addicted to pain meds.

See also: How to Help Reverse the Opioid Epidemic  

I believe addiction to heroin derivatives is far worse than anyone realizes. Someone must throw a wrench in a problem that’s wreaking havoc on families and entire communities. Here’s how Redirect Health is addressing the issue:

1. Strike “opioids” from the discourse: Never call these highly addictive prescriptions “opioids” or “pain killers.” Instead, call them “heroin derivatives,” because if it walks like a duck and it talks like a duck…

Far fewer people will want to start taking these drugs if they understand they’re a form of heroin. Simply changing the semantics will also give providers pause; they won’t be so quick to prescribe heroin derivatives.

2. Provide alternative forms of pain relief: We make it easy and affordable ($0 copays) for people to access other, safer and more effective pain management services. Our chiropractors and primary care physicians work together to help members with practical and customized virtual rehabilitation programs that don’t cost a penny out-of-pocket, don’t require them to miss work, and will provide a long-term, tenable solution to managing their pain.

It’s common sense, but not commonly done.

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.”

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.