FDA Nudges Developers to Create Over-the-Counter Naloxone

The FDA announced an initiative to encourage drug companies to develop over-the-counter (OTC) formulations of naloxone, the opioid overdose reversal agent, in order to improve consumer access to the drug and reduce opioid-related fatalities.

A key step to being granted FDA approval on an OTC drug is the development of a consumer-friendly drug facts label (DFL) alongside studies demonstrating that consumers can understand how to use the product without the supervision of a healthcare professional.

Many have claimed this process to be a barrier to development. To spur OTC development, for the very first time the FDA has proactively developed and tested DFLs for an OTC product, releasing model DFLs for naloxone auto-injectors and nasal sprays.

Going a step further, the FDA also conducted the necessary label comprehension testing, establishing that these DFLs are consumer friendly and essentially clearing a primary hurdle for drug developers, allowing drug makers to insert product-specific information into their labels and focus on product development.

It is very likely that this will lead to the creation of OTC naloxone products, as naloxone has seen a variety of legislative and regulatory actions over the last several years, expanding access to this life-saving drug. In fact, in certain states, select pharmacies sell naloxone without a prescription. However, as an OTC, the utilization of naloxone may go unnoticed in workers’ comp, whereas its mere presence in a claim could serve as a helpful red flag to spot issues with opioid utilization.

For more information, read the FDA’s press announcement.


Tags: FDA, naloxone, OTC, over the counter, over-the-counter, label


Marijuana – What to Expect in 2019 and Beyond

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Risk & Insurance magazine recently conducted a video interview with Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM, and AVP of Advocacy & Compliance, Sandy Shtab, regarding the growing impact of medical marijuana from the public policy and healthcare perspectives – including workers’ compensation.

Marijuana’s growing support has unfolded a variety of complex and multifaceted considerations that impact care providers, payers, and patients. Risk & Insurance’s Roberto Ceniceros leads a provocative conversation focusing on:

  • The potential benefits and risks faced by workers’ compensation payers in reimbursing medical marijuana as a treatment for chronic pain
  • Current perspectives on marijuana as a partial solution to countering the negative outcomes associated with opioid use
  • Growing acceptance among physicians of marijuana as a viable treatment option
  • Employer concerns over workplace safety and impairment testing
  • Current and future roles of PBMs in helping payers to navigate the fast-changing medical marijuana landscape

Risk & Insurance’s coverage can be accessed here, with extended interview video content available on Healthesystems’ YouTube page.


Tags: Marijuana, medical marijuana, recreational, Risk & Insurance, Sandy Shtab, Shtab, Sandy, Goldberg, chronic pain, pain, reimbursement, opioid, workplace safety, impairment, PBM


Troubling Trends for Benzodiazepines

Benzodiazepines are a class of psychoactive drugs with sedative properties, often prescribed in workers’ comp for the treatment of anxiety, muscle spasms, insomnia, neuropathic pain and other indications. Though benzodiazepines have their place in care, they are not meant to be taken long-term due to adverse effects such as cognitive impairment, physical dependence, respiratory depression, overdose, and more.

And while the opioid epidemic has dominated headlines due to rampant harm, problematic concerns surrounding other prescription drugs still grow, and benzodiazepines are seeing increases in prescribing, use, misuse, and overdose.

A new study from the Journal of the American Medical Association (JAMA) examined 386,457 ambulatory care visits from 2003-2015, taken from the National Ambulatory Medical Care Survey, finding that benzodiazepine prescribing has nearly doubled, occurring in 3.8% of visits in 2003 and 7.4% of visits in 2015. It should be noted that the results in JAMA are not reflective of the workers’ compensation population specifically - however the overall trend of increased prescribing is worth noting.

While prescribing trends remained steady among psychiatrists, they increased among all other types of physicians, doubling for primary care physicians, who prescribed half of all benzodiazepine prescriptions.

Prescribing rates for anxiety and depression diagnoses increased from 26.6% to 33.5%. But also of note is that prescribing also increased for some conditions commonly seen in workers’ comp –prescribing for back and/or chronic pain more than doubled. Co-prescribing of benzodiazepines and opioids, a dangerous and potentially fatal combination, also increased.

And unfortunately, more prevalent prescribing seems to be contributing to a higher incidence of overdose deaths, especially as research by the American Journal of Public Health, looking at data from the Medical Expenditure Panel Survey from the Centers for Disease Control, found that the rate of overdose deaths involving benzodiazepine quadrupled from 1996-2013.

Patient-solicited data also supports that more Americans are using benzodiazepines. A recent study from Psychiatric Services examined 2015 and 2016 data from the National Survey on Drug Use and Health, limiting results to adults aged 18 and older, finding that 30.6 million Americans, or 12.6% of the population, reported using a least one benzodiazepine within a year of taking the survey.

The study also found that misuse accounted for nearly 20% of benzodiazepine use overall, with 5.3 million adults, or 2.2% of the population, misusing benzodiazepines. The misuse rate was particularly higher among adults aged 18-25 at 5.2%, and lower for adults 65 and up at 0.6%. However, those aged 50-64 saw the highest rate of prescribing at 12.9%. Other studies indicate that benzodiazepine use is twice as prevalent in women than men, sending more women to emergency rooms than men, making population analysis critical.

Commonly prescribed benzodiazepines include Xanax (alprazolam), Valium (diazepam), and Atvian (lorazepam). JAMA claims that alprazolam is the most commonly misused benzodiazepine, and that the most commonly cited reasons for benzodiazepine misuse was relaxation and help sleeping, with older adults in particular using benzodiazepine for insomnia.


Tags: benzodiazepine, JAMA, American Medical Association, American Journal of Public Health, Psychiatric Services


PTSD Coverage: More States Draft Legislation

As Healthesystems previously reported, legislation across the country continues to expand workers’ compensation coverage for post-traumatic stress disorder (PTSD), particularly for first responder occupations. And as legislative sessions across the country kick into gear, more and more states have begun introducing legislation to establish or expand PTSD coverage in workers’ compensation.

In January, Kentucky pre-filed B.R. 140, proposing changes that would clarify the definition of “injury” for first responders to include psychological, psychiatric, or stress-related changes in the human organism that are not a direct result of physical injury. As written, the bill recognizes first responders as police officers, firefighters, emergency services personnel, and front-line staff, casting a slightly wider net than other states.

But casting a somewhat smaller net than other states, Connecticut introduced Senate Bill 699, which would allow only police officers and firefighters to use workers’ compensation coverage for the treatment of post-traumatic stress disorder (PTSD), discounting emergency service personnel who are typically included in these bills. As currently drafted, the Connecticut bill is a placeholder for what could later become a more robust piece of legislation. The current draft lacks clarity on the types of covered injuries and thresholds for eligibility.

Speaking of a need for clarity, West Virginia lawmakers introduced House Bill 2321 and Senate Bill 114, identical bills that would recognize PTSD as a compensable injury for first responders under workers’ compensation. These bills do not explicitly clarify whether a physical injury is necessary for compensation, but they state that PTSD is compensable if a licensed psychiatrist makes the diagnosis and finds that the disorder occurred as a result of events within the scope of duty. As currently written, there is enough ambiguity that the coverage could apply to non-physical injuries.

And late last year, the Idaho Industrial Commission wrote the first draft of a bill to provide first responders with workers’ compensation coverage for PTSD, though this draft specifically excluded coverage of PTSD claims that do not involve a physical injury. In a recent interview with the press, Idaho House Representative Matt Erpelding spoke of his support for a PTSD bill currently in the House, stating that the bill has gained support across the state. However, it was not clear if the bill he spoke of is the same bill as the one presented by the Industrial Commission.

As chatter surrounding these individual bills grows, the larger conversation on how to manage PTSD within a workers’ comp claim will continue to ring on the national platform. To learn about formulary and claims management considerations for employee populations at risk for PTSD, read Hero’s Welcome: Growing PTSD Coverage for First Responders from RxInformer journal.


Tags: PTSD, legislation, first responder, police, firefighter, West Virginia, Idaho, Connecticut, Kentucky


Opioid Marketing Tied to Higher Prescribing and Overdose

In January, the Journal of the American Medical Association (JAMA) published Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses, a study that explores the connection between opioid marketing and opioid overdose.

The study involved a population-based, county-level analysis that compared three sets of data.

The first data set was industry marketing information pulled from the Centers for Medicare and Medicaid Service (CMS) Open Payments database, which tracks every transfer of value in marketing from a pharmaceutical company to a physician. This data includes the monetary value of payments in dollars, the medications marketed, the type of marketing, and the physician practice location. For this study, data was limited to payments tied to an FDA-approved opioid product.

This marketing payment data was compared to two data sets from the Centers for Disease Control and Prevention (CDC); one on opioid prescribing and another on opioid mortality from overdoses.

Overall, study data was limited to the period of August 1, 2013 through December 31, 2015. Approximately $39.7 million was spent in opioid marketing, targeting 67,507 physicians across 2,208 U.S. counties.

The study found that increased county-level opioid marketing was associated with elevated opioid overdose mortality, an association mediated by higher county-level opioid prescribing rates as well.

An interesting finding was that, per capita, a higher number of marketing interactions with physicians was demonstrated with greater opioid overdose mortality, as opposed to the dollar value of opioid marketing, indicating that a consistent marketing persistence may be what fuels increased prescribing and associated mortality.

The study also found that marketing dollars were highly concentrated in counties with:

  • Mixed racial demographics
  • A lower percentage of individuals aged 65 or younger
  • Higher prevalence of high school completion
  • Greater unemployment
  • Lower poverty
  • Higher median household income
  • Lower income inequality
  • Metropolitan location

The U.S. Northeast saw particularly high concentrations of opioid marketing, with the Midwest seeing the lowest concentrations.

This study is particularly interesting as, circa March 2018, over 41 states and over 200 cities and counties have filed lawsuits against opioid manufacturers over the last few years, claiming manufacturers misled doctors and patients regarding the safety of opioid products. Investigative reports from the Los Angeles Times even claim that manufacturers encouraged doctors to prescribe higher doses of opioids than necessary to avoid changing dosing schedules, while also encouraging doctors to prescribe opioids for common conditions such as back aches and knee pain.

Last year, the U.S. District Attorney announced the creation of a new Prescription Interdiction & Litigation Task Force to hold opioid manufacturers accountable for unlawful practices and examine existing state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide in those lawsuits.

Just how this JAMA study will impact the bigger picture of opioid marketing remains to be seen, but research like this could potentially impact aspects of regulation and policy down the road.

For more information, read the study in full.


Tags: JAMA, American Medical Association, marketing, opioid, mortality, overdose, opioid overdose, CMS, CDC, Medicare, Medicaid