Tag Archives: medical malpractice

How to Manage Risk of Medical Malpractice

For nursing professionals, medical malpractice is the 200,000-pound monster in the room. If a nurse inadvertently commits an error and a patient is injured, and then the patient decides to sue the nurse for malpractice, the resulting settlement payments and legal expenses can cost, on average, a total of $201,916.

In this article, we’ll discuss what nursing professionals need to know about medical malpractice, look at a legal claim study and offer some risk management recommendations on how you can reduce the chance of getting bitten by the malpractice monster.

What Is Malpractice?

When you pass your licensing exams, your state board of nursing provides you with a professional license that certifies that you have the knowledge necessary to provide treatment and care in your state.

Malpractice is defined as the failure to provide the degree of care required under the scope of your license that results in an injury. Legally, four elements must exist for malpractice to occur:

  1. Duty: A nurse-patient relationship is present. The nurse has the duty to treat the patient according to the standards of care recognized by the nursing profession.
  2. Breach: A breach of that standard has been established. Examples: Failure to notify the attending physician of a change in the patient’s condition; failure to properly complete a patient assessment; or failure to administer the correct dose of a medication.
  3. Cause: The patient sustained an injury caused by the nurse’s error.
  4. Harm: The injury resulted in damages, such as pain, medical bills or loss of income.

Patients tend to define malpractice more loosely. They may initiate a lawsuit because of the perception of wrongdoing. Real or perceived, win or lose, an allegation of malpractice can be devastating and typically results in an investigation by your state board of nursing. Depending on the outcome of that investigation, action may be taken against your license.

For these reasons, making good risk management habits routine can help increase the likelihood of positive patient outcomes, reducing the chances of a lawsuit alleging malpractice.

See also: What Shapes Malpractice Coverage?  

Who Can Allege Malpractice?

The injured patient can allege malpractice, as can legal counsel or, in the case of a minor, it could be the parents or guardian. In the event of a death claim, it could be the estate of the deceased party.

Examples of Damages

When a malpractice lawsuit is initiated, injured parties will seek damages to “make them whole.” Tangible losses are called economic damages. Intangible losses are called non-economic damages.

  • Economic Damages
    • Medical expenses
    • Loss of income
    • Funeral expenses
  • Non-Economic Damages
    • Mental anguish
    • Pain and suffering
    • Loss of consortium

Notice of Claim

A notice of a claim informs you of legal proceedings against you. The notice outlines the allegations that caused the injury and will include a demand for services or money. A claim notice can also mean the filing of a suit or the starting of arbitration proceedings.

Notice of a claim may include any of the following:

  • Summons/complaint
  • Letter demanding free services or money
  • Oral threat or complaint
  • Notice of arbitration

Act Early: Spotting and Reporting Incidents

Recognizing potential incidents, acting quickly and reporting them to your supervisor or employer’s risk manager and to your professional liability insurance carrier may help reduce the likelihood of a claim. If a patient sustained an injury as a result of any of the following scenarios, report it immediately to document the incident. Such incidents may include:

  • Slip and fall accidents
  • Treatment-related injuries such as burns or fractures
  • Complaints about unusual pain or discomfort
  • Concerns over adverse treatment results
  • Medication-related injuries

Malpractice Claim Dos and Don’ts

  • Do
    • Contact your manager or supervisor
    • Contact your organization’s risk manager
    • Contact your malpractice liability insurer
  • Don’t
    • Add or delete information in the patient’s chart
    • Try to resolve the situation on your own
    • Discuss the matter with anyone other than your defense attorney or your insurer


Legal Case Study

This case study involving an ER nurse illustrates how easy it is to get drawn into a malpractice lawsuit—and how following good risk management procedures can help avoid a guilty verdict.

Situation

A patient was brought to the ER where he was well-known to the department staff. He was intoxicated, agitated and aggressive. For the patient’s safety, four point physical restraints were ordered. Per hospital protocol, security staff applied the restraints and checked the patient’s person for contraband.

The ER nurse performed patient monitoring and assessment checks every 15 minutes as ordered, missing only one check to care for a critically ill patient. The missed check, along with the ER nurse’s monitoring and assessment findings, were fully documented.

Shortly after the ER nurse performed a 15-minute check, the patient attempted to burn off his restraints with a cigarette lighter, igniting his bed linens and clothing. The patient suffered severe burns over 25% of his body, including both hands, causing him to lose his fingers on one hand.

Allegations

The patient sued the attending physician, the hospital and ER nurse. The allegations against the nurse included failure to properly assess and monitor the patient and failure to provide proper care in a safe environment.

Results

Although the patient suffered life-changing injuries, it was determined that the ER nurse acted within the standard of care. The nurse’s documentation of events made an aggressive defense possible and ultimately successful.

While this was a favorable outcome for the ER nurse, the resulting malpractice claim took 12 years and two trials to resolve, and the total cost to defend the ER nurse was $500,000.

Nurse Practice Act

To understand the standard of care required, know the Nurse Practice Act in your state. You can find your state’s Nurse Practice Act and keep abreast of changes to the law by visiting the National Council of State Boards of Nursing website.

The Importance of Good Documentation

The ER nurse’s documentation was key to successfully defending her case. A patient’s record is a legal document. Your notes can provide evidence of the treatment you provided, as well as acts against any miscommunication with that care.

As a general rule, if it wasn’t documented, it wasn’t done. Your legal team can prove you provided specific treatment and care if it is found in the patient’s record.

  • Document your patient care assessments, observations, communications and actions in a timely, accurate and complete manner.
  • Never alter a record for any reason unless it is necessary for the patient’s care.
  • If it is essential to add information to the record, properly label the delayed entry.
  • Never add any documentation to a record for any reason after a claim has been made.

Dos and Don’ts of Documentation

  • Do
    • Read and act on progress notes of previous shift
    • Be specific and objective when you document your observations
    • Document complete assessment data
    • Document interventions and status of patient following any intervention
    • Communicate any changes in the patient’s condition in a timely manner
  • Don’t
    • Use vague expressions
    • Record a symptom without including what you did about it
    • Use shorthand or abbreviations unless they are approved
    • Give excuses
    • Record for someone else
    • Record care ahead of time

Policies and Procedures

Wherever you work, the facility will be engaged in patient safety measures. Make sure you know and understand your facility’s policies and procedures for preventing errors and ensuring positive outcomes.

Learn the documentation standard in your facility for how to chart, correct errors, make late entries and copy/paste in the electronic record.

See also: Empathy Transforms Health Insurance  

Should a malpractice claim occur, your defense team will analyze your documentation, and when complete records are available can use it to build a strong defense. It can also weaken a defense if it looks like the entries were copied and pasted from a previous patient.

Lastly, know your facility policy on incident reporting and chain of command.

Key Takeaways for Protecting Your Career

  • Know and comply with your state scope of practice requirements, Nurse Practice Act and facility policies, procedures and protocols.
  • Follow documentation standards established by nurse professional organizations and comply with your employer’s standards.
  • Develop, maintain and practice professional written and spoken communication skills.
  • Emphasize continuing patient assessment and monitoring.
  • Maintain clinical competencies aligned with the relevant patient population and healthcare specialty.
  • Invoke the chain of command when necessary to focus attention on the patient’s status and any change in condition.

While no healthcare professional is immune to the 200,000-pound malpractice monster, you keep it from affecting your career by making sound risk management procedures a part of your practice. Following the recommendations outlined in this article is a good place to start.

Are Malpractice Claims Fading? (Video)

Healthcare Matters sits down with Dr. Richard Anderson, chairman and CEO of the Doctors Company. In Part 6 of the series, we ask Dr. Anderson if further tort reform is necessary, given that the medical malpractice insurance industry is experiencing a drop in claims and medical malpractice insurance rates continue to fall, creating what is essentially the longest softest market in history.

What Shapes Malpractice Coverage?

Healthcare Matters sits down with Dr. Richard Anderson, chairman and CEO of the Doctors Company. In Part 5 of the series, we discuss with Dr. Anderson the most effective provisions of the Medical Injury Compensation Reform Act (MICRA) and how MICRA has shaped the medical malpractice insurance climate in California since 1975.

Medical Malpractice Disputes (Video)

Healthcare Matters sits down with Dr. Richard Anderson, chairman and CEO of the Doctors Company. In Part 4 of the series, we ask Dr. Anderson to share his impressions of alternative dispute resolution systems, ranging from mediation and arbitration, to specialized health courts staffed by independent panels of medical experts, to “safe harbor” systems, in which physicians who showed they followed best practices would be immune from litigation.

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.