Recalls Impacting Workers’ Comp

Last month, Healthesystems reported on several companies issuing recalls for ranitidine hydrochloride due to confirmed contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

Ranitidine hydrochloride capsules are indicated for the treatment of duodenal ulcer, benign ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.

Relevant to workers’ comp, patients taking opioid pain medications may experience gastrointestinal side effects, requiring a gastrointestinal agent and potentially be prescribed ranitidine hydrochloride.

The recalls began in September with Sandoz Inc, followed later by Sanofi, Perrigo, and Dr. Reddys. However, even more companies have issued recalls for ranitidine hydrochloride.

Novitum Pharma, Amneal Pharmaceuticals, Apotex, Aurobindo Pharma, Golden State Medical Supply, Walgreens, and Kroger have all issued nationwide recalls for ranitidine hydrochloride tablets. Meanwhile Lannett Company, Inc. is recalling ranitidine syrup for similar impurities of NDMA, as is American Health Packaging.

Furthermore, the FDA is now advising other companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake. In addition to ranitidine, FDA is also requesting manufacturers test and potentially recall nizatidine, commonly known as Axid, if NDMA levels are above acceptable daily intake levels due to chemical similarities.

In other news, Mylan Pharmaceuticals Inc. is recalling one lot of alprazolam tablets due to the potential presence of foreign substance, which can cause infection.

Alprazolam tables are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia. Mental health medications are not uncommon in workers’ comp claims, especially if workplace injuries reduce physical function and cause mental stress.

The recall specifically targets a bottle of 500 USP C-IV 0.5 mg tablets of alprazolam, lot number 8082708, with an expiration date of September 2020, and an NDC of 0378-4003-05.


Tags: Recall, ranitidine hydrochloride, ranitidine, alprazolam, Mylan, Sanofi, Sandoz, Perrigo, Dr. Reddys, Novitum, Apotex, Walgreens, Kroger, Lannett, Amneal, Aurobindo, Golden State Medical Supply, American Health Packaging, nizatidine


Rehabilitating Your Rehab Program: Better Metrics for Physical Medicine

Injured worker care requires a variety of components, and beyond prescription medications and medical devices, patients may benefit from physical medicine services to help rehabilitate their injured bodies.

Physical medicine services already make up 13% of medical costs in workers’ comp claims, and as providers shift away from opioids, they have begun to embrace more physical medicine treatments, meaning that future claims could see more utilization.

But just like managing pharmacy benefits, physical medicine programs require strong oversight to ensure patients receive services that are appropriate for their condition, are cost effective, and result in clinical improvements over time.

With this in mind, what should payers know about optimizing physical medicine programs?

Continue reading the full article online at RxInformer clinical journal.


Tags: RxInformer, Physical medicine, data, metrics


HHS Publishes Opioid Tapering and Discontinuation Guideline

The Department of Health and Human Services (HHS) published a new guide for clinicians on appropriate dosage reduction or discontinuation of long-term opioid analgesics.

This guide recommends reviewing the risks and benefits of current opioid therapy with patients, tailoring tapering or discontinuation plans to specific diagnoses, circumstances, and unique patient needs, while also coordinating with a patient’s other treating physicians.

HHS advises against rapid tapering or discontinuation, as this can cause withdrawal, exacerbation of pain, psychological distress, and thoughts of suicide. Guidelines advise clinicians to consider tapering to a reduced opioid dosage, or tapering and discontinuing opioid therapy, in the following situations:

  • Improvement in the underlying pain condition
  • Patients request dosage reductions or discontinuation
  • Pain and function are not meaningfully improved during opioid therapy
  • Patients receive higher opioid doses without evidence of any potential benefit from the higher dose
  • Patients demonstrate current evidence of opioid misuse
  • Opioid side effects diminish quality of life or impair function
  • Patients experience overdose or have warning signs of potential overdose
  • Patients are taking other medications or have other medical conditions that increase the odds of adverse outcomes

Furthermore, the guide suggests integrating behavioral therapies into tapering strategies to help manage pain, as failure to manage comorbid mental health disorders such as depression, anxiety, and post-traumatic stress disorder (PTSD) can increase the odds of adverse opioid events. This can include offering or arranging for a consultation with a behavioral health provider prior to initiating a taper.

Key to the guidelines is the practice of making shared decisions with patients, working together to individualize the taper rate and collaborate on a plan to manage pain while shifting away from opioids. This includes discussing the various options available to them, including non-opioid pain medications, treatment for opioid-use disorder, strategies to avoid withdrawal, and more.

Healthesystems has previously reported on opioid tapering strategies in RxInformer clinical journal, including similar information reported in the HHS guidelines, along with information on withdrawal symptoms, comorbidities, adjunctive therapies, comprehensive pain management centers, and more.


Tags: Opioid, taper, HHS, Health and Human Services, withdrawal, OUD, opioid-use disorder, discontinuation


More States Scrutinize Gig Economy Classifications

Shortly after California passed a new law to establish the “ABC” test to clarify if a worker should be classified as an independent contractor or an employee entitled to benefits such as minimum wage, health insurance, and workers’ comp, two more states have begun to take action surrounding worker classification.

New Jersey labor auditors are investigating Uber and Lyft to see if rideshare companies are misclassifying drivers as independent contractors instead of employees, utilizing the same “ABC” test used in California.

The state sent out surveys to drivers over the last year, seeking information about work arrangements and tax status in order to determine if Uber and Lyft should be responsible for minimum wage, overtime, disability insurance, employment taxes, and other responsibilities tied to employment.

Meanwhile, rideshare and technology companies testified before a New York Senate panel regarding employee classification. Gig economy organizations like Lyft and Uber claim that workers wish to maintain the flexibility of being independent contractors, for qualifying them as employees could come with many drawbacks to the workers. Others state that workers deserve benefits that come with an employee classification, including workers’ compensation.

The purpose of this meeting was to find a middle ground between distinct employee and contractor classifications, with some suggesting the Black Car Fund to provide workers’ comp benefits to workers by charging a tax to rideshare transactions, while others claim such a tax could increase costs to the consumer, significantly impacting business and in turn impacting workers.

Healthesystems previously published an in-depth article on growing questions of compensation in the gig economy, which is available online at RxInformer journal.


Tags: gig economy, Uber, Lyft, rideshare, employee misclassification, independent contractor, employee benefits, Senate, employee benefits


The Economic Impact of Non-Medical Opioid Use

The Society of Actuaries (SOA), the world’s largest actuarial professional organization dedicated to research and education to lead the measurement and management of risk, recently published a report on the economic impact of non-medical opioid use in the United States.

SOA estimates that the total economic burden of the opioid crisis from 2015-2018 was at least $631 billion, including costs associated with additional healthcare services, premature mortality, criminal justice activity, child and family assistance programs, education programs, and lost productivity.

At nearly a third of that economic burden, a $205 billion loss is attributed to excess healthcare spending for individuals experiencing opioid use disorder (OUD) and complications resulting from OUD, while lost productivity costs total $96 billion when accounting for absenteeism, reduced labor force participation, incarceration for opioid-related crimes, and employer costs for disability and workers’ comp benefits to employees with OUD.

SOA conducted this report by combining methodologies and data from several other reports, including those from the White House Council of Economic Advisers (CEA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS), the Analysis Group, Altarum published estimates, the U.S. Census Bureau, and many more.

At over 90 pages, this report contains a wide range of information. Key to workers’ comp, highlights include:

  • Non-medical use of opioid cost employers $362 million in 2015, growing to $500 million in 2018
  • Short-term disability costs due to opioid use increased from $312 million in 2015 to $417 million in 2018
  • Additional disability and workers’ comp costs for employees with OUD totaled over $3.4 billion from 2015-2018

The publication of this report comes at an interesting time, for various opioid manufacturers are settling lawsuits waged against them, claiming that these manufacturers are responsible for the harm of the opioid epidemic and seeking financial restitution.

Roughly a month after major drug manufacturer Johnson & Johnson was ordered to pay $522 million an additional four large drug companies agreed to a $260 million settlement to avoid going to trial in Ohio for similar charges.

Many states and cities in the last few years have brought lawsuits against opioid manufacturers, claiming they are responsible for the harm of the opioid epidemic, and earlier this year, Purdue Pharma paid Oklahoma state a $270 million settlement, while Teva Pharmaceuticals paid $85 million.

But when compared to the billion dollars of economic burden estimated by the SOA, it seems that these various settlements could merely be a drop in the bucket when it comes to healing the harms caused by the opioid epidemic. If this is true, the search for more resources to combat the epidemic may continue for quite some time.


Tags: Society of Actuaries, opioid, economic, lawsuit, settlement