City Sues Oxycontin Drugmaker: New Way to Combat Abuse of Prescription Drugs?

In January, the L.A. Times reported that the city of Everett, Washington, prompted by the L.A. Times’ 2016 investigation (summarized here), filed a lawsuit against Purdue Pharma, the maker of Oxycontin, alleging that the company turned a blind eye to the criminal sale of Oxycontin in Everett while the company went on to “reap large and obscene profits.”

The civil complaint, filed by Everett city lawyers, alleges that Purdue is guilty of gross negligence, creating a public nuisance, and that the company should pay the cost of handling the now severe opioid crisis in Everett, as well as punitive damages–figures that could run in the millions of dollars.

This is a bold move on the part of a municipality, and the first of its kind (that I’m aware of) to take place against Purdue Pharma. Since federal regulators (FDA, DEA) have been unsuccessful in their efforts to curb the opioid epidemic in the United States, it may be up to individual litigants, and even cities, like Everett, to assert the misconduct of Purdue Pharma in court, and to hold the drug-making giant accountable for its incredibly lax practices which lead, to the current rampant opioid abuse in the U.S. today.

Although the likelihood of Everett’s success on the merits is low, I applaud the city of Everett and its lawyers for paving the way for future lawsuits from other municipalities, and hopefully holding Purdue Pharma accountable for its unethical practices. I’m a big believer in the free market. I’m also an equally big believer in holding people and companies accountable for unethical behavior, particularly when those entities have knowledge of how their product is harming the public, yet refuse to act on it for decades.

What do you think? Feel free to comment below with thoughts on Everett’s lawsuit, Purdue Pharma, and potential solutions to the opioid epidemic.

 

A Revolutionary New Way of Understanding Addiction

Maia Szalavitz’s book, “Unbroken Brain: A Revolutionary New Way of Understanding Addiction” unearths new truths and challenges established societal and medical opinions on understanding and treating addiction. In light of the overwhelming public health crisis addiction has become, her ideas and theories are more salient now than ever.

The main takeaways from “Unbroken Brain” include the following:

1. Addiction is best understood as a learning disorder.

Addition as a learning disorder contains three critical components: (1) the behavior has a physiological purpose (to assist the brain/person cope in situations where he or she is either over OR under stimulated), (2) the specific learning pathways involved make it nearly automatic over time (particularly when an individual begins using a substance in adolescence), and (3) the behavior does not stop when it is no longer adaptive (i.e., use of a substance continues even when it no longer assists an individual with coping with over or under stimulation in their life). [p. 36].

2. Timing matters in addiction.

The time frame in which an individual is exposed to a substance matters. The most sensitive periods in brain developments are in infancy and adolescence, so if an individual is exposed to a substance during one of these times periods, he or she’s brain will be more sensitive to addiction. Further, the timing of taking the substance (habituation of consumption) increases the likelihood of addiction. Conversely, timing matters in preventing or combating addiction, and well-timed intervention can change an individual’s pathway towards addiction. [p. 44].

3. Genetics can predispose you to addiction, but they aren’t the determining factor.

Three traits serve as indicators for individuals with a high risk of addiction: (1) impulsivity and a desire for new experiences, (2) inhibition and/or anxiety, and (3) a combination of the two. All three of these pathways indicate the same underlying problem: difficulty with self-regulation. However, the mere existence of these traits does not predict whether one is an addict or not, but rather, whether the individual with these traits has a desire to use substances for a maladaptive purpose–i.e., to assist the person who is either over or under stimulated cope in their environments. [p.61].

4. Criminalization and moralization of addiction does not effectively combat addiction.

Criminalization and punishment of addiction has been shown, statistically, to not effectively treat or cure addiction. Further, the modern medical approach to addiction has typically been a combination of medical advice with a directing of patients to treatment centers and meetings centered on the 12 Step Program (i.e., Alcoholics Anonymous or Narcotics Anonymous). The underlying difficulty with these programs is that they moralize the behavior associated with addiction, rather than treating the underlying learning disorder. Nowhere else in modern day medicine is morality or religion introduced as a “cure” to a medical problem, and its singular use in addiction treatment is not only concerning, but generally ineffective.

In sum, addiction is a symptom of an individual’s maladaptive behavior that he or she has learned over time to assist the individual psychologically. Timing matters, as most addiction begins in adolescence, when the brain is undergoing significant change, and is most vulnerable to the influence of drugs or alcohol. Genetics plays a factor, but doesn’t explain all of addiction. And finally, our current AA and crime and punishment approach to addiction isn’t working–for society, or those seeking a cure from their addictions. Even if her theories do not resonate with you, her overall cry for a new, effective way to compassionately treat the increasing problem of addiction is something all healthcare providers should be able to get behind.

 

 

 

 

 

 

You’ve Been Investigated by the Department of Health. Now What?

whats-nextIn many states, an investigation into a healthcare provider’s license by the Department of Health may begin with a phone call, letter, or in-person meeting between a healthcare provider and a Department of Health investigator. While all individuals have a right to have an attorney present at an interview with a Department of Health investigator, most individuals may not realize they have this right until after the interview has passed. Which may leave you asking: what now?

In Tennessee, once an individual has been investigated by the Department of Health, the Department of Health investigator will prepare an investigative report, composed of his or her findings, including all evidence he or she collected, and a summary of each individual he or she interviewed. This report will then be handed over to the attorney in the Department of Health Office of General Counsel. The attorney will review the investigative report in conjunction with a consultant, who is typically in the same licensed profession as the individual investigated, to determine what to do next. Together, the consultant and attorney will determine whether the complaint should be dismissed, if a letter of concern or warning should be issued, or if discipline should be imposed. If discipline is proposed by the Department of Health, the healthcare provider will be sent a 4-5-320(c) letter. See here for my prior post on 4-5-320(c) letters.

The time frame from when an investigative interview takes place, and the healthcare provider investigated is notified of the outcome of the investigation can take weeks, or in most cases, months. What should a healthcare provider do in the interim?

1. Hire an attorney, if you haven’t already.

An attorney can represent you in whatever steps happen next, and this will give you a great peace of mind as you wait for the outcome of the investigation. Additionally, your attorney can advise you regarding any employment questions you may have–i.e., how and when to report to your employer that you were investigated, for example. If you’re not sure how to find an administrative law attorney in your state, contact your state professional organization (for example, the Tennessee Medical Association for physicians). Your professional organization should have a list of attorneys with experience in administrative law available for its members.

2. Maintain your practice, if you are safe to do so.

Unless you have an addiction, or other condition that would prevent you from safely engaging in your profession, continue to practice. Be mindful of any mandatory notice you need to provide to your current or prospective employers regarding the pending investigation. Otherwise, unless your license has been summarily suspended pending the outcome of the investigation, your license will be valid and unencumbered until you either (1) agree to discipline, or (2) have discipline imposed as the result of a hearing before your professional board.

3. If the investigation revealed some areas where you need to improve your practice, take it upon yourself to implement necessary improvements.

If you are investigated for poor documentation, sign up for continuing education on documentation, and implement what you learn at your CEs in your practice. If you’re investigated for prescribing too many controlled substances, reduce the amount of controlled substances you prescribe, and ensure that your documentation justifies your prescribing. You can begin to implement the necessary changes that the investigation has revealed you need without waiting for your professional board to order you to do so.

4. If the investigation was a result of some addiction or substance abuse, seek appropriate treatment.

Most states have professional organizations that provide confidential assistance to physicians, nurses, and nurse practitioners. Further, every metro area has free AA and NA meetings at local churches and community centers. Take it upon yourself to implement whatever change is necessary to ensure that you are safe to practice. And as mentioned before, if you are not safe to practice, don’t go back to work in a hospital or clinic. Period. The risk of harming a patient is too great to take such a gamble.

5. Try not to panic.

Spending the next eight months of your life holed up in your house like a hermit, losing sleep over the investigation into your licensure will not change the outcome of the investigation. I promise. If you made a mistake that lead to the investigation, take steps to ensure that you don’t make such a mistake again. If the investigation reveals ways that you can improve your practice, take steps to improve your practice. While the length of time between an investigation and the outcome can seem overwhelming, look at this time as an opportunity for you to take proactive steps to demonstrate to your professional board what sort of person and provider you are–the sort of provider who doesn’t wallow in self-pity, but rather, does what it takes it make sure that he or she is the best doctor, nurse practitioner, or nurse he or she can be.

If you have further questions about the investigation or complaint process, feel free to reach out to me at [email protected], or (615) 465-6006.

 

Real Alternatives to Opioids for Pain Management

Healthcare providers are aware of the current opioid epidemic in the United States, as well as the risks—both to the provider’s patients, and to the provider’s licensure—of prescribing opioids to patients for the management of chronic pain. So, what do we do about it? Healthcare providers know that opioids can be harmful to patients long-term, and harmful to providers who may face licensure discipline due to strict regulations surrounding the prescribing of narcotics. However, patients are still showing up at healthcare providers’ offices complaining of very real, chronic pain. How should healthcare providers address these patient concerns if they aren’t going to use opioids?

  1. Yoga.

    Yoga is scientifically proven to gradually loosen the muscles and connective tissues around bones and joints, bring oxygen and blood to cartilage, and increase blood flow to all cells in the body, improving their functionality. Although yoga can be expensive, depending on the city you live in and where you choose to practice, yoga can also be free–or close to it. Yoga videos can be found for free on youtube.com, most YMCAs offer a few yoga classes a week, and some cities have free community yoga classes around town. If you live in the Nashville area, Small World Yoga, a local non-profit, offers several free yoga classes each week.

  2. Weight Loss.

    Studies show that obesity negatively impacts the musculoskeletal system, and increases mechanical stress to the joints and tissues of the body. Many healthcare providers may be reluctant to address weight with patients, as this may seem like a matter of physical attractiveness rather than a legitimate health concern to many patients. However, any personal discomfort in initiating such a conversation should be superseded by a desire to improve a patient’s wellbeing by frankly and compassionately discussing the physical stressors on a patient’s body as a result of obesity. A dietitian can support a patient’s weight loss, as well as in-person and online support groups, such as Weight Watchers.

  3. Cessation of the Use of Tobacco.

    Researchers have found that smoking can cause chronic pain by contributing to osteoporosis and the deterioration of spinal discs, and actually interfering with a smoker’s nervous system, causing an increase in a smoker’s perception of pain. Similar to weight loss, smoking cessation can be done by the individual on their own, or with the assistance of prescription or over the counter smoking cessation aides, as well as in-person and online support groups.

  4. Therapy.

    Emotional stress can lead to the tensing and constricting of muscles, leading to muscle fatigue and inefficiency. Further, traumatic events can lead to the overstimulation of the sympathetic nervous system, resulting in increased cortisol levels (a stress-related hormone), and a decreased ability of the body’s immune system to respond to illness and heal the body. Patients who have experienced a traumatic event (for example, the death of a loved one, a serious illness, or who were the victim of a crime) may be experiencing emotional stress that, at the very least, may contribute to chronic pain. Such underlying emotional stress or trauma can be addressed with a mental healthcare professional. Most health insurance providers include mental health services, and many cities have mental health services for free or a reduced cost based on a patient’s income.

Pain is an important tool of evolution. It’s our bodies’ way of saying, “Hey listen up! Something is seriously wrong!” When the main form of treatment by healthcare providers is to mask pain signals to a patient’s brain, rather than addressing the underlying conditions, we are simply kicking the can down the road, and this may result in more pain and decreased mobility for patients long-term. By contrast, when healthcare providers compassionately address patients’ underlying causes of chronic pain—obesity, nicotine use, trauma—patients have a higher likelihood of reducing their pain, and improving their quality of life in the long-term. That’s a win for everyone–except the makers of opioids. And I’m not too worried about them.

Thoughts? Feel free to email me directly at [email protected], or comment below.

Oxycontin’s 12-Hour Problem: L.A. Times’ Investigation, and What Doctors and NPs Need to Know About Prescribing the Drug

oxycontin-470x260Earlier this summer, the L.A. Times reported on its investigation into Oxycontin, and the results aren’t pretty: the Times found that Oxycontin’s main selling point, that it lasts for 12 hours, is not supported by clinical research. In spite of this, the Times found overwhelming evidence indicating that not only did Purdue Pharma (the marker of Oxycontin) have knowledge of Oxycontin wearing off well before the 12-hour mark, Purdue intentionally repressed this knowledge from doctors, patients, and the FDA for the past 20 years.

The L.A. Times investigation reports the following:

Purdue Pharma submitted falsified research numbers to the FDA when they gained approval for Oxycontin in 1996, stating that the drug treats pain for 12 hours. The problem with Purdue’s claim is that Oxycontin only treats pain for roughly half that time.

Purdue Pharma, despite continual feedback for the past 20 years from patients, doctors, and their own pharmaceutical reps that the drug wears off long before the 12 hour mark, has continued to market the drug as a “12 hour drug,” to give themselves a competitive advantage over other pain medications. The only problem with this, despite the obvious lying to consumers part, is that prescribing a strong narcotic for 12-hour cycles, when it only relieves pain for 6-8 hours, actually sets up patients for addiction due to dangerous pain relief/withdraw cycles.

Further, Pharma reps encouraged doctors to stick to the 12-hour prescription cycle, but simply prescribe higher doses. A study from Canada showed that this method of prescribing resulting in an overdose for 1 out of every 33 patients. It’s hard to imagine, but this study shows that Oxycontin prescribed in the method encouraged by Purdue Parma reps is more likely to kill a patient than anything else (really, anything else) in the world.

Why does this matter?

The prescription drug epidemic is HUGE in America. It’s a public health crisis, particularly so in the Southeast (where my practice as an attorney is based). It’s a difficult problem to understand, particularly the big question–who is at fault? People who simply like to abuse drugs? Doctors who are prescribing inappropriately? A culture as a whole that views “pain” as a problem to be eradicated by their healthcare provider? Now we have a small answer to this huge, multi-faceted question–who is at fault? A drug company–who has made billions for the past 20 years–that knowingly instructed doctors (WITH the FDA’s approval) to prescribe medication at a dangerously high dosage, and at intervals that all-but set up patients for addiction–at the low end of the spectrum–and death at the high end.

What can doctors and nurse practitioners do in response to this information?

  1. As always, monitor your patients, and realize that simply because a medication is approved for treatment by the FDA does not mean that it is the right treatment for YOUR patient.
  2. Despite the necessary and often beneficial role that pharmaceutical sales reps play in educating physicians and NPs about new technology and medication available, be mindful that these sales reps are in your office or at your hospital for their own financial gain. It is incumbent that healthcare providers not rely on sales reps as your sole source of information about medications that you may be prescribing.
  3. Finally, (and hopefully, most obviously), be mindful of your prescribing of Oxycontin. Monitor each patient individually for his or her feedback on when the drug wears off, and consider switching treatment based on your patient’s feedback. Do not rely on your sales reps, or even the FDA to know what is best for your patients. Regardless of what your opinion is on the role of prescription writers in the current opioid epidemic in America, we can all agree that doctors and nurse practitioners have a responsibility and an opportunity to be a part of the solution.

Comments or thoughts? Please feel free to comment below, or contact me directly at [email protected].

The Hardest Pill to Swallow

Dr. Tracy Jackson discusses chronic pain in her May 2016 TEDx Nashville event. Dr. Jackson, a Vanderbilt physician, researches and works in the chronic pain management field, and she discusses how and why the healthcare system’s current approach to chronic pain management is failing patients–and society as a whole–in her TEDx talk.

Why does this matter? For healthcare providers, particularly those in the southern part of the United States, the prescribing of controlled substances for the management of chronic pain has become a hotly debated and highly regulated activity. For the protection of one’s license, and the safety of one’s patients, it is incumbent on healthcare providers to educate themselves on the most effective and safe ways to treat chronic pain.

For those who aren’t healthcare providers? It still matters. Opioid overdose is the number one cause of accidental death in the U.S. (See, Tedx Talk, 8:10). Let that sink in for a minute. Even if pain management and the use of opioids does not affect you professionally as a health care provider, it likely has or will affect you or someone you love personally. It is incumbent upon all of us to be aware of what we are putting in our bodies, and how it effects us.

Main Take Aways From ‘The Hardest Pill to Swallow:’

  1. Chronic Pain is the # 1 presenting complaint to U.S. doctors, the #1 reason people are out of work, and it costs the U.S. economy up to $630 billion dollars a year. It’s a big deal, for the individuals suffering from it, and for our U.S. economy as a whole. (See 1:20).
  2. Kids often get tummy aches when they are stressed or trying to avoid a stressful situation–right?

    “Kids describe a physical symptom based on an emotional issue, yet as adults we continue to deny that pain from mental stress can manifest as pain in the body. When did we forget the tummy ache?”

    (See 5:02).

  3. Pain pathways, sleep pathways, and mood pathways are all interconnected–we cannot separate them. If one goes awry, all pathways will be effected. (See 5:45).
  4. The hardest pill to swallow is that there is no quick fix–but there is a fix. (See 15:00).
  5. Each of us can make a difference by admitting that stress and lifestyle choices can contribute to and even cause chronic pain at any age. We can hold ourselves and our loved ones accountable to seeking real and durable relief, even when a pill is available on every corner. (See 17:10).

Take 18 minutes out of your day to watch Dr. Jackson’s TEDx Talk–I promise, it’s well worth your time. Feel free to comment below with any thoughts or responses, and as always, feel free to reach out to me directly–[email protected]

Investigated by the Department of Health or Facing Licensure Discipline? You Have Options.

Licensure Investigation: How and Why?

The Department of Health in the state where a provider is licensed has a duty to investigate valid complaints against healthcare providers. Complaints against healthcare providers can be made anonymously, and most states, like the Tennessee Department of Health, have an landing page on their websites that makes it easy to file a complaint. If the complaint is frivolous, such as “This doctor is a jerk,” the complaint will be reviewed and likely dismissed by staff at the Department of Health without further inquiry. If the complaint is more serious, such as “This doctor is overprescribing narcotics to his patients,” then the complaint will likely be investigated further.

Once a complaint has been deemed serious enough for investigation, a Department of Health investigator will be assigned to make an inquiry into the complaint. This will likely begin with a telephone call or letter addressed to the health care provider who the complaint is about. If an investigator from the Department of Health contacts you, you have the right to be represented by counsel. At this point, most healthcare providers will be very upset, concerned, and frustrated to find out a complaint has been filed against their license. As such, retaining counsel who can represent them with stoicism throughout the investigation will likely result in less stressful and more productive interactions with the Department of Health through the investigation.

The Investigation Has Concluded: Now What?

Typically after meeting with an investigator, the Department of Health will inform a healthcare provider about the outcome of the investigation within 3-9 months. The outcome of the investigation is one of the following: (1) the complaint is dismissed; (2) the healthcare provider is sent a letter of concern or a letter of warning, and the case is closed; or (3) the Department of Health chooses to pursue formal disciplinary action. This formal discipline will be communicated to a healthcare provider in the form of a letter setting forth what the Department of Health determined in the course of their investigation (sometimes referred to as a 4-5-320(c) letter) with an attached “Consent Order” for the healthcare provider to sign and return to the Department of Health within a set number of days.

If you have not yet hired counsel, I recommend hiring an attorney to represent you through the negotiation of any consent order. Most consent orders are negotiable, and even if the proposed disciplinary action seems acceptable to you, your attorney can review the facts in the order to ensure that you are not admitting to any violation of criminal or civil law that would open you up to additional liability.

Hiring An Attorney: Who To Look for, How To Find Them, and Does It Really Make a Difference?

When seeking an advocate to assist you through the investigation and/or discipline of your health care license, it’s important to seek out an attorney with expertise in this area. Just as you wouldn’t hire a dermatologist to perform brain surgery, don’t hire your divorce attorney, or estate planning lawyer to represent you in an administrative action (unless he or she also happens to have a great deal of expertise in administrative law).

How do you find someone experienced in administrative law before your regulatory board (such as The Board of Medical Examiners or The Board of Nursing)? First, you can start by checking with your statewide professional association (for example, the Tennessee Medical Association or Tennessee Nurses Association). Generally most professional associations maintain a list of attorneys for referral. Second, you can independently do your own research by asking other healthcare providers you know, as well as researching online. Third, you may even be able to get a name of an attorney for referral from the administrative staff of your state regulatory board, or the attorney representing the Department of Health. And finally, if you are recently out of medical or nursing school, your professors or mentors from school may be a good source of referral to an experienced administrative attorney.

Having your license investigated or disciplined is generally the most stressful experience of a healthcare professional’s career. Having a competent advocate who can guide you through the regulatory maze, let you know what to expect, and advocate on your behalf makes the process less stressful and invasive in your personal life, and permits you to make informed decisions about how best to proceed.

Bottom line: Licensure investigation or discipline is a highly stressful process, and it’s beneficial to have an advocate guiding and counseling you through the process. If you have any questions or comments, as always, feel free to reach out to me at [email protected]

What is the OIG Exclusion List, and How Could it Affect Your Practice?

The Office of the Inspector General (OIG) of the U.S. Department of Health & Human Services maintains a list of healthcare providers who are excluded from participating in Medicare, Medicaid, and all other Federal health care programs. This list is known as the “List of Excluded Individuals/Entities (LEIE)” and it is a BIG DEAL for the healthcare providers who unfortunately find themselves on this list. Inclusion on the list seriously prohibits a provider’s ability to treat patients, as well as their ability to obtain employment opportunities.

For what actions or events will a healthcare provider find themselves on the OIG Exclusion List?

Permissive Exclusions: The OIG has discretionary authority to exclude individuals and entities for the following reasons:

  • Misdemeanor convictions related to fraud or the obstruction of an investigation or audit;
  • Misdemeanor convictions related to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances
  • The suspension, revocation, or surrender of a license to provide health care for reasons bearing on professional competence or financial integrity;
  • A provider’s exclusion or suspension under Federal or State health care programs;
  • The submission of false or fraudulent claims to a Federal health care program by the provider;
  • A provider’s default on health education loans or scholarship obligations; or
  • A provider’s role in controlling a sanctioned entity as a manager, officer or owner.

Mandatory Exclusions: The OIG is required by law to exclude individuals and entities for the following reasons:

  • Conviction of Medicare or Medicaid fraud;
  • Patient abuse or neglect;
  • Felony convictions for other health care-related fraud, theft, or other financial misconduct; or
  • Felony convictions relating to unlawful manufacture, distribution, prescription, or dispensing of controlled substances.

For a complete list, and more details about permissive and mandatory exclusions, see 42 U.S.C.A. § 1320a-7. For more information about the OIG Exclusion list, visit the Office of Inspector General’s website here.

Bottom line: for physicians, nurse practitioners, and other health care providers facing disciplinary charges by their state medical or nursing board, or those healthcare providers facing potential criminal charges, it is important to know that licensure discipline and criminal charges, among other things, could land a provider on the OIG Exclusion list, and lead to an even steeper uphill battle back to the practice of medicine or nursing.

For employers, it is important to know that an entity can face severe penalties for attempts to recover payment from the federal government for patient care performed by an individual on the OIG exclusion list. I recommend that employers check the Exclusions Database prior to hiring new health care providers to determine if potential hires fall on this list, and to avoid potential liability for the organization.

If a provider is currently on the OIG exclusion list, he or she can apply for reinstatement to participate in Federal health programs once the specified period of exclusion ends. To apply for reinstatement, follow the instructions found here.

CDC and FDA Add New Guidelines and Regulations Aimed at Curbing Overprescribing of Opioids

The Center for Disease Control and the Federal Drug Administration both recently released new guidelines, from the CDC, and new regulations, from the FDA, aimed at addressing the rising concern about the nationwide opioid epidemic. Not coincidentally, these guidelines and regulations were announced within a week of one another. I think this signals a strong message from the federal government to both state governments and health care providers: if you won’t fix this problem, we will.

CDC’s New Guidelines for Prescribing Opioids for Chronic Pain

Although many states have released their own guidelines for the management of chronic pain (Tennessee’s guidelines, released in 2014, are accessible here), this is the first set of guidelines available nationwide to healthcare providers. The CDC’s guidelines include 12 main recommendations, which include establishing treatment goals with patients prior to starting a patient on opioids, and avoiding concurrent opioids and benzodiazepines whenever possible.

The starting dosage recommendation of 50 mg morphine equivalent will likely result in some push back from providers, but I think this low number indicates how strongly the CDC feels about the riskiness of prescribing opioids at all for chronic pain in patients. Health care providers—physicians, nurse practitioners, and physician assistants—who have the ability to prescribe and who provide care for patients with chronic pain need to ensure that they are properly documenting justification for their medical diagnosis of patients with chronic pain, as well as their chosen treatment of each patient’s chronic pain.

Federal Drug Administration’s Safety Label Changes for Immediate-Release Opioid Pain Medications

The FDA released new regulations last week with required labels on immediate release (IR) opioid pain medication, including a box on IR opioid prescriptions warning about the risks for misuse, abuse, addiction, overdose and even death. These regulations are a follow up to the FDA’s 2013 prescription warnings on extended-release/long-acting (ER/LA) opioids resulting from the FDA’s concern of the risks associated with long acting opioids. Today, the FDA is acknowledging and clarifying that immediate release opioids are also dangerous, and play a persistent role in addiction, abuse, and overdose mortality related to opioid use.

What Do These Guidelines and Regulations Mean?

The CDC’s Guidelines for prescribing opioids and the FDA’s new labeling requirements for IR opioid pain medication indicate concern at the federal level regarding the prescribing of opioids. Healthcare providers who prescribe opioids should be cautious about their prescribing of these medications, and always document to demonstrate the provider’s decision-making in prescribing an opioid, and the patient’s clear medical need for the medication.

When Personal & Professional Life Intersection: Notifying Your Licensing Board About your Criminal History

As a licensed professional, it can be difficult to remember that your personal life is not completely separate from your professional life. In the state of Tennessee, health care providers such as physicians, nurse practitioners, and physician assistants are required by law to update their online profiles with the Department of Health regarding criminal convictions, as well as other adverse events.

Here’s the law in Tennessee: Health care providers (defined in T.C.A. § 63-51-102(b)) must update information “required to be reported” to the Department of Health within 30 days after the occurrence of an event or attainment of a status. T.C.A. § 63-51-117(d).

What is information that is “required to be reported?”

  • Criminal convictions for felonies and “serious misdemeanors,” as determined by the Board, within the past ten (10) years;
  • Any final disciplinary action by a licensing board in any state within the past ten (10) years;
  • Any peer review action taken by a hospital resulting in a provider’s loss or restriction of privileges;
  • All health care liability civil court judgments against a provider over a certain threshold (this threshold varies with profession—for example, the threshold to report is $75,000 for chiropractors, but only $50,000 for dentists). (T.C.A. § 63-51-105).

Failure to accurately and timely update the Department of Health could result in civil penalties, disciplinary action, or the inability to renew your professional license. (T.C.A. § 63-51-117(e); T.C.A. § 63-51-118). Be aware of the reporting requirements in your state, and do your best to comply with such requirements in order to avoid fines, discipline, or an inability to renew your license. Further, ensure that your mailing address is up-to-date with your licensing board. Many boards only communicate via snail mail, and updating your address with your licensing board ensures that you don’t miss any important correspondence regarding your license.