FDA Tightens Restrictions for Transmucosal Fentanyl Products

The FDA has announced changes to the Risk Evaluation and Mitigation Strategy (REMS) program for transmucosal immediate-release fentanyl (TIRF) products, implementing new safety requirements for the utilization of these medications.

REMS programs are drug safety programs required for certain medications, meant to reinforce behaviors and actions that support safe use of powerful medications with serious safety concerns. Though TIRF products already have comprehensive REMS requirements, further safety measures are being introduced as FDA data indicates that 35-55% of patients treated with a TIRF product were not opioid tolerant.

TIRF products are indicated for the treatment of breakthrough pain –sudden extra pain experienced for short periods of time that is not alleviated by a patient’s normal drug regimen – in cancer patients. According to the FDA, many patients who receive a TIRF prescription received them for the treatment of pain not indicated on the drug label, which is concerning due to the sheer strength of fentanyl products.

New REMS requirements for immediate-release TIRF products include:

  • Documenting opioid tolerance concurrently with each prescription of a TIRF product for outpatient use
  • Requiring inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized
  • Requiring TIRF products to be dispensed for outpatients only with evidence or other documentation of safe use conditions
  • Requiring the development of a new patient registry to monitor for serious adverse events including overdose

These actions further demonstrate the many initiatives that the FDA and a variety of other organizations are undertaking to combat the opioid epidemic, especially as fentanyl products in particular have led to higher opioid overdose death rates, as noted by the Centers for Disease Control and Prevention (CDC).

For more information, read the FDA press announcement.


Tags: FDA, opioid, overdose, fentanyl, REMs, TIRF, transmucosal, immediate release


Patient Engagement is Personal: How to Help Injured Workers Help Themselves

Patient engagement is an important aspect of healthcare strategies to achieve the triple aim of improving population health and the patient experience, while also reducing the cost of care. A large collection of studies from around the world have shown that positive patient engagement leads to better health outcomes,1 as well as stark differences in the healthcare experiences of engaged vs non-engaged patients.

For example, a Commonwealth Fund Survey of 11 countries found that engaged patients reported fewer medical errors, more positive views of their healthcare systems and, by a significant margin, higher quality of care than their non-engaged counterparts.2

Patient engagement has also been credited with reducing costs. One study showed that patients who received enhanced decision–making support had 5.3% lower medical costs and another study demonstrated a more dramatic inverse correlation – disengaged patients incurred costs up to 21% higher than those who were highly engaged.3

Interestingly, while there is broad agreement within the healthcare community that patient engagement reaps many benefits, there is much less consensus on precisely how to define it. Some confusion stems from similar terms, such as patient experience, which is a broader concept, and patient empowerment or patient activation, both of which are components of patient engagement.

Continue reading the full article online at RxInformer clinical journal.


Tags: patient engagement, patient, RxInformer


The Impact of the Changing Workforce

The National Council on Compensation Insurance (NCCI) released a new report on changing workforce demographics and their impacts on workplace injury.

According to NCCI, workplace injuries have fallen by one-third, although this is not attributable to any one segment of the workforce; workplace injury rates fell among all workers. However, the report notes that different patient demographics experienced different types of injuries more frequently, indicating that with shifting demographics may come shifts in the types of injuries seen in claims.

Key highlights of the report include:

  • The share of workers aged 55+ increased by one-third
  • Female employment has grown slightly
  • Younger workers have lower injury frequency than older workers, a reversal from 10 years ago
  • Younger workers have relatively more contact injuries and fewer falls, slips and trips
  • Men have higher injury frequency than women, primarily driven by contact injuries, though male injuries are concentrated in sectors that have high contact injury rates
  • Goods-producing sectors, such as Construction and Manufacturing, have higher injury frequency that most service sectors
  • Injury frequency rankings between sectors have not changed

Insights such as these speak further to how care programs must accommodate a workforce that continues to diversify in order to promote more positive patient outcomes.

For instance, as the aging workforce continues to grow, one in four workers is expected to be aged 55 or older within the next decade, highlighting the need for care programs to examine how they should approach medication management and comorbidities for aging populations.

But on the other end of the spectrum, the younger millennial segment of the workforce is also growing. Soon they are expected to make up half the workforce, and not only is this workforce more culturally diverse – which may come with unique health considerations depending on cultural impact towards health – but this population is more receptive to utilizing technology, alternative therapies, medical marijuana, and psychosocial counseling, a far step from patients of the past.

And of course, as the female workforce grows to nearly half the workforce, it is critical that care programs understand that women face different drug therapy risks than men. In some cases, this is due to biological factors, such as hormonal and body composition differences, and sometimes it is due to social factors, such as how differently doctors prescribe medications to women when compared to men.

But it isn’t just women who experience different narratives with drug therapy; there are significant risk disparities with opioid use among diverse populations. Different demographics experience different opioid risks, and this includes ethnicity, socioeconomic status, geographic location, mental health, age, gender, and occupation.

The workforce will only continue to diversify as time goes on, making it important that workers’ comp professionals stay ahead of evolving trends to provide the best care possible suited for unique patient populations.


Tags: changing workforce, workforce, patient diversity, patient, diversity, older workers, women, millennial, opioid


Marijuana Continues to Take Major Steps Forward

The last several weeks have seen major developments for marijuana policy, most prominent being news surrounding H.R. 1595, a bill from the U.S. House of Representatives written to give banks and insurers nationwide the ability to legally process cannabis transactions.

This bill has passed the House Financial Services Committee and will soon receive a full Congressional vote. If enacted, this bill could help facilitate more medical marijuana transactions in the healthcare system, increasing patient utilization within the healthcare system, including workers’ compensation.

And speaking of increasing marijuana utilization down the line, the FDA announced steps to advance the evaluation of potential regulation pathways for cannabis-containing and cannabis-derived products. These steps are being taken to lay the groundwork for the potential approval of more marijuana-based medications; if such FDA-approved medications entered the market, doctors would be more likely to prescribe or recommend marijuana.

Among the efforts the FDA is taking, they have announced a public hearing for May 31st to gather public comments and obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

This opportunity will give stakeholders from a wide range of professions the chance to provide the FDA with input relevant to regulatory strategy surrounding lawful pathways for marketing marijuana. This will include the gathering of information on mode of delivery, potency, affects, drug interactions, and more.

And on a state-by-state level, some states are considering legislation that would impact the use of marijuana in workers’ comp. Maryland Senate Bill 854 unanimously passed the Senate, bringing the state one step closer to requiring workers’ comp to cover medical marijuana. Other states have introduced similar bills, but this one seems to have made the most progress so far and is now headed to the Maryland House of Representatives.

Policies across the country continues to change as the public voices more and more support for marijuana. 62% of Americans support legalization, including 74% of millennials. In fact, marijuana use is rising among older populations, and marijuana support has grown so prevalent that CVS announced they will sell cannabidiol (CBD) products in 800 select stores across eight states.

The pharmacy chain will carry creams, sprays, lotions, and salves, hoping to meet consumer demand for alternative care options, while putting policies in place to test for THC and other contaminants. Shortly after this development, Walgreens announced they will sell CBD creams, sprays, and patches in 1,500 stores in nine states.

With so many developments, it seems unlikely this marijuana momentum will stop soon, meaning workers’ comp stakeholders must keep informed and be ready to handle changing times.


Tags: marijuana, medical marijuana, utilization, marijuana utilization, CBD, cannabidiol, Maryland, FDA, Congress, House of Representatives


Oklahoma Reaches $270 Million Settlement with Opioid Manufacturer

Across the United States, various state, city and local governments have sued opioid manufacturers, claiming that pharmaceutical companies deliberately misled doctors and patients regarding the safety of opioid products, resulting in the harm of the opioid epidemic.

At least 41 state Attorney Generals banded together to investigate drug makers and distributors, while federal courts oversee more than 200 lawsuits. For years, more and more entities have raised suit against manufacturers, and in a landmark development, Purdue Pharma, the creator of OxyContin, has agreed to pay a $270 million settlement to the state of Oklahoma.

Over $102.5 million will be put towards establishing a national addiction treatment and research center at Oklahoma State University, with additional payments of $15 million a year for five more years. Approximately $12.5 million will be given to local governments within the state, while another $20 million a year for five years will fund addiction treatment and opioid rescue medications.

Though Purdue Pharma has settled, the specific lawsuit filed by the Oklahoma Attorney General involved four drug manufacturers. While Purdue will no longer be brought to trial by the state of Oklahoma, the other three manufacturers will see their case begin on May 28th.

With so many lawsuits in motion across the nation, this development could indicate further settlements to come, potentially impacting opioid manufacturing, distribution and more down the line.


Tags: opioid, manufacturer, drug developer, settlement, lawsuit, litigation, opioid manufacturer, Purdue