FDA Requires Boxed Warning Update for Benzodiazepines
The FDA published a new drug safety communication, requiring a Boxed Warning update across all benzodiazepine medications to better address serious risks associated with the drug.
Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. These conditions are regularly seen in workers’ comp patients, and therefore injured populations are impacted by this update.
According to the FDA, even when taken at recommended dosages, benzodiazepine use can lead to misuse, abuse, and addiction. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medications, such as opioid pain relievers – which are also common in workers’ comp – or other substances including alcohol, or illicit drugs.
Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening.
The FDA believes current prescribing information for benzodiazepines did not provide adequate warnings about the serious risks and harms associated with these drugs, as well as the risks of combining benzodiazepines with other medications and substances.
These risks will now be included in Boxed Warnings across all benzodiazepine products, as well as within patient Medication Guides. Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
Tags: FDA, benzodiazepine, Boxed Warning, warning, precaution, abuse, misuse, addiction
3 Stakeholder Research Findings That Can Improve Patient Experience and Program Outcomes
When developing effective claims programs for workers’ comp, a finely tuned user research process is a crucial tool in ensuring that stakeholders across the board all benefit from the solutions that are implemented.
Stereotypes and assumptions surrounding the wants and needs of injured workers, claims professionals, payers, and other stakeholders stand in the way of effective solution building. Only a true understanding of their experience in the workers’ comp system can highlight negative interactions or gaps that serve as a barrier to positive claims outcomes.
Healthesystems recognizes the importance of an evidence-based, structured approach to identifying the needs, challenges and preferences of different stakeholders as they navigate the workers’ comp system, which is why our user research program regularly inserts research capabilities throughout our innovation pipeline. The insights we gather from these initiatives help inform the development of new solutions and the improvement of existing solutions, to better serve our clients and the workers’ comp insurance market.
We currently have multiple in-depth research initiatives underway, including a continued and concerted focus on the patient experience – the detailed findings of which we make available to our customers. Here we share three high-level findings that identify areas where the industry can improve patient experience and program outcomes.
According to our findings, 50% of patients experienced a delay in reporting their injuries. This occurred for a variety of reasons, including:
To read the full article for more research insights, visit WorkCompWire online, where this article was originally published.
Tags: Healthesystems, WorkCompWire, user research, patient, patient engagement, patient experience, research
Purdue, OxyContin Manufacturer, Loses Federal Case and Will Shut Down
The Justice Department announced a global resolution of criminal and civil investigations with Purdue Pharma. Pleading guilty, Purdue faces a settlement that involves more than $8 billion, the dissolution of the company, and a repurposing of company assets for public benefit.
Purdue Pharma, the drug manufacturer most known for creating the opioid medication OxyContin (oxycodone), agreed to plead guilty in federal court in New Jersey to a three-count felony. These charges claimed that Purdue deliberately misled members of the public regarding the safety of opioid products in order to sell more drugs, despite risks to the public.
Purdue will admit that from May 2007 through at least March 2017, Purdue conspired to defraud the United States by claiming to maintain an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids and by reporting misleading information to the DEA to boost Purdue’s manufacturing quotas.
In addition, Purdue will admit to two counts of conspiring to violate the Federal Anti-Kickback Statute. Between June 2009 and March 2017, Purdue made payments to two doctors through Purdue’s doctor speaker program to induce those doctors to write more prescriptions of Purdue’s opioid products.
Similarly, from approximately April 2016 through December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue’s extended release opioid products – OxyContin, Butrans, and Hysingla.
As part of the settlement, Purdue faces a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. Furthermore, Purdue has agreed to a civil settlement in the amount of $2.8 billion to resolve its civil liability under the False Claims Act.
An important condition in the resolution is that the company would cease to operate in its current form and would instead emerge from bankruptcy as a public benefit company (PBC) owned by a trust or similar entity designed for the benefit of the American public, to function entirely in the public interest.
Over the last few years, several other drug manufacturers have faced similar allegations and made various settlements, however, this recent development includes the largest penalties levied against a pharmaceutical manufacturer.
Tags: Purdue, Justice Department, drug manufacturer, manufacturer, drug, opioid, OxyContin, oxycodone
California COVID-19 Report
The California Workers’ Compensation Institute (CWCI) hosts a COVID-19 & Non-COVID Interactive App, which has been updated with claim data up through October 5, 2020.
A total 44,800 COVID-19 claims have been reported so far this year, while the current count for total claims is 409,579, meaning 11% of claims in California are tied to COVID-19. Approximately 12,909 COVID-19 claims have been denied, meaning 71.2% are accepted.
At this time, COVID-19 claims are trending down; July saw the highest number of reported COVID-19 claims at 13,251, falling to 5,597 in August, and then 1,961 in September. Projected claim estimates are slightly higher but match the downward trajectory.
Across industry, COVID-19 claims are primarily made up of:
Though Los Angeles County has the highest number of COVID-19 cases at 12,397 (27.9%), it had a low concentration of COVID-19 cases per 10,000 employees.
An interactive map of counties across California visualizes COVID-19 claims per 10,000 employees, with high concentrations found in Imperial County, Kings County, Lassen County, and Del Norte County.
Across age groups, COVID-19 claims are most concentrated in:
Across gender, women make up 22,577 COVID-19 claims, or 51.2%.
Tags: COVID-19, California, claim data, CWCI, age, gender, location
Celebrating American Pharmacists Month
October is American Pharmacists Month, a time to recognize pharmacists’ contributions to healthcare and share the positive impact of their work on the frontlines in our communities.
Healthesystems wants to celebrate our Clinical Pharmacists for their passion and dedication to assisting injured worker patients.
The various efforts of our pharmacists do much to impact patients’ lives, adding up for real change. Sometimes this is at a high level, using analytics to identify population risks and develop evidence-based program recommendations, and sometimes this is more personal, when our pharmacists directly reach out to patients to educate them about and assist them with their drug regimen.
The solutions our pharmacists deliver are geared towards intervening with the patient as soon as possible, providing a proactive approach to care that keeps the patient at center focus and addresses their unmet needs.
Help us celebrate our clinical pharmacists by watching this video about our VP of Clinical Services, Silvia Sacalis, BS, PharmD. Learn about her passion for advocating on behalf of patients, what drives her, and more.
Tags: American Pharmacists Month, pharmacists, pharmacist, Silvia Sacalis, pharmacy