Treating chronic pain: Could antidepressants be the solutions?

October 18, 2023

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A potentially groundbreaking meta-analysis of 176 studies was published earlier this year in the Cochrane Database of Systematic Reviews that assessed individual antidepressant medications and whether they proved effective in treating chronic pain in adult patients. In this blog, I will explore the results and how they might soon impact chronic pain treatment methodologies in complex pharmacy management (CPM). 

The far-reaching effects of chronic pain

Chronic pain is any long-standing pain — on-and-off or continuous — that persists beyond the usual recovery period of three months. The type of pain can be due to a primary condition or occur in the context of a disease. According to the American Academy of Pain Medicine, more than 1.5 billion people around the world suffer from chronic pain, and it is the most common cause of long-term disability in the U.S., affecting about 100 million Americans.

Chronic pain often has detrimental impacts on a person’s overall well-being, ability to work and physical capabilities. Consequently, it is one of the global leading causes for sickness-related absence and people being unable to work or return to work. Chronic pain is also one of the costliest health problems in the U.S., as it often results in medical expenses, lost income and productivity and compensation payments. 

Effective chronic pain management can result in significant improvements in quality of life — including decreased anxiety and depression — and is essential for improvement of pain, mood, sleep and physical function.

Could antidepressants improve chronic pain? 

Although antidepressant medications were originally developed to treat medical illnesses like depression, it can also be used “off-label” in clinical practice to treat other conditions, including chronic pain. Research suggests that antidepressants may be effective for pain because the same chemicals that affect mood might also affect pain, according to the meta-analysis. 

However, not all medications are created equal — different class types of antidepressants work in different ways. Previous research has shown that certain antidepressants may be effective in reducing chronic pain with some benefit; however, this was the first review that examined first-line antidepressants across most common chronic pain conditions. 

Meta-analysis details

The Cochrane analysis leveraged relevant studies that compared any antidepressant with any other treatment for chronic pain, then compared all treatments against each other — allowing researchers to rank the effectiveness of different antidepressants from best to worst. The study excluded patients with depression and anxiety, as those mental health conditions already often accompany chronic pain.

Among the 176 studies reviewed across medical databases, the most common pain conditions examined were fibromyalgia (59 studies), neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The three most common antidepressant drug classes investigated for their effects on chronic pain were selective norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), and tricyclic antidepressants (TCAs). Each class targets a different pathway and helps manage various mental health diseases. 

Primary outcomes of the analysis included substantial (50% or higher from baseline) pain relief, and improvements in terms of pain intensity, mood and adverse effects, while secondary outcomes of the analysis included moderate improvements (between 30% and 50% higher than baseline) in terms of pain relief, physical function, sleep and quality of life.

Key findings

One anti-depressant medication consistently ranked highest and proved superior to all others across efficacy outcomes: duloxetine (otherwise known by its brand name, Cymbalta). The analysis explained that duloxetine (Cymbalta), “probably has a moderate effect on reducing pain and improving physical function.” For every 1000 people taking standard-dose (60 mg) duloxetine, 425 will experience 50% — or substantial — pain relief, the study found. Additionally, the standard dose was equally as effective as a high dose (>60 mg) for most outcomes. 

One alternate medication, milnacipran, often ranked as the next most efficacious antidepressant in chronic pain treatment, although the certainty of evidence was lower than that of duloxetine. Across all secondary efficacy outcomes (including moderate pain relief, physical function, sleep and quality of life), duloxetine and milnacipran again ranked highest with moderate-certainty evidence.

The study’s primary conclusion states that despite investigating 25 different antidepressants, the only medication researchers are certain about for treating chronic pain is duloxetine. Some evidence for milnacipran is promising, although further high-quality research is needed to be confident about any conclusions. Evidence for all other antidepressants was low certainty.

While the findings from this meta-analysis can be pertinent for future chronic pain treatment, many questions remain. As the average study included in the meta-analysis lasted 10 weeks, there is no usable data beyond that period. This information would be crucial to understanding long-term effects as most chronic pain lasts beyond 10 weeks. To that end, there is no reliable evidence concerning the safety of taking antidepressants for chronic pain, for example, and there is not enough data to be certain about subsequent unwanted effects of taking it and the length of treatment.

What this review could mean for CPM

Cochrane reviews can be particularly helpful in re-examining generic medications that have little new research surrounding its efficacy since the medication attained FDA-approved labeling years or decades earlier. That allows us to look at, for example, TCA’s — among the earliest antidepressant class developed, introduced in the early 1950’s — in comparison to duloxetine (Cymbalta), an SNRI medication that the FDA approved in 2004. In comparing the two, we can analyze: What have we seen in each drug’s history? What works, what doesn’t? Which patient profile might benefit from SNRIs, instead of TCAs, and vice versa? 

In assessing any patient’s treatment, several factors must be weighed to find the right balance. No two patients are exactly alike — making it critical to adopt a people-focused approach. At Sedgwick, we focus on individualizing care while ensuring prescribing patterns are in line with evidence-based guidelines and that employees are receiving optimal support to facilitate their recovery.

We view patients’ cases retrospectively, and holistically. CPM nurses and pharmacists make recommendations to the injured worker’s prescribing physician with this goal in mind. Each recommendation is bolstered by sharp clinical reasoning and lies within the framework of current guidelines — all while aligning with the context of the patient’s medical history. 

New research is critical, as evidence-based discoveries can inform future updates to the national guidelines used daily to recommend treatments to patients. Due to the guidelines’ ever-changing nature, CPM clinicians consistently reassess best practices to ensure the best possible treatment is in place.

Moving forward

Sedgwick’s complex pharmacy team is in the process of reviewing best practices and routing rules, while watching closely for updated national/state guidelines considering this analysis. The potential impact this might have is yet to be determined — until then, we will continue adapting our best practices to better support injured workers.

Learn more  read about Sedgwick’s pharmacy solutions for U.S. workers’ compensation claims.

Crisis and critical incidents: clinical resource response

October 10, 2023

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The landscape of crisis and critical incident response within the claims industry is expanding. Where once teams managed cases almost exclusively involving the critically injured, new layers of care and response are emerging that address the “ripple effect” of trauma experienced by third parties, bystanders and witnesses to a crisis.

This broadening of both definition and services by critical incident response teams stems from an increase in new client demands in the aftermath of an incident—specifically, by individuals not directly related to the incident. For example, demand for treatment services may come not just from somebody who has had a severe fall at work, but from individuals who witnessed the fall or shared an environment with the injured worker at the time of the incident and been impacted by the event.

At Sedgwick, our approach to crisis care has shifted to include a broader spectrum of cases and claimants that reflect these trends. The rise in popularity of recovery program components like behavioral health services signals not only impacts for employers navigating return to work procedures, but an industry-wide embrace of viewing recovery and treatment through a holistic lens of overall well-being. If we can understand how an event impacts a person’s life, the thinking goes, we can provide more targeted care solutions and get them on a faster road to recovery. It is a modern but structured approach to crisis care that is resulting in better claims outcomes and happier, healthier customers.

Role of the practitioner in recovery

The case management process begins when crisis care specialists are contacted by claims staff or clients directly. Immediate needs may be obvious, as when an injured worker is hospitalized. A field case manager may be dispatched to the hospital where the injured has been admitted overseeing triage service with regular medical updates. Once the injured worker is discharged, a nurse may be assigned to assist with case management for post hospital care needs. Alternatively, claimants may seek different avenues of case management outside of critical injury, such as behavioral health services management, or in instances where multiple practitioners may be involved, and the claimant needs assistance facilitating setup of a care network. 

Case management is an intricate part of the recovery process. Especially for injured persons who just want to focus on getting better, case managers really serve to take the pressure off — whether it is by educating injured workers on their recovery rights, ensuring continuity of treatment services, or simply acting as a reliable touchpoint for communications during what can be an otherwise lonesome and isolating time.

One type of practitioner as in-demand for recovery services (after physicians and nurses) are behavioral health services providers, including licensed mental health clinicians. The difficulty of returning to “normal life” following a traumatic incident can be pronounced. Claimants may have anxiety about returning to a workplace where they witnessed a catastrophic event. Others may be facing a longer road to recovery after suffering catastrophic injuries. Behavioral health professionals are coming into focus not just as an essential facilitator of return-to-work, but as agents for overall health improvement.

The trend toward a holistic view of care means a variety of practitioners can apply their specialties to better identify potential barriers to care (preexisting conditions, family structure), uncovering in the process how individual lives are affected by crisis, and tailor treatment solutions accordingly.

Employers’ role in improving return to work 

In many ways, the COVID-19 pandemic changed how employers approach policies around absenteeism, disability leave and return to work. The diagnosis of “long COVID,” for example, compelled employees and employers to come to the table and reevaluate how employee roles might be adjusted to ensure they can work if they want to and so productivity losses are avoided. 

From a crisis care perspective, standards relating to recovery time and return to work have not changed. However, there is a greater awareness that crisis recovery is complicated, as employers learn more about what their workers need, and as mental wellness becomes more of a central discussion point. A positive outcome of the pandemic’s effect on the workplace definitely includes more of an openness to talk about these care points as potential barriers to return to work, as well as successful outcomes relating to management of employee disabilities and improved integration of these individuals into operations. 

For those employees in recovery who will be able to return to work eventually, employers can take a proactive approach to accommodations. In other words, what are the best options for getting this employee back to work? Thinking outside the box about what can help from the individual’s perspective and maintaining open communication will support greater employee satisfaction in the long term.

Most injured workers recovering from a crisis or critical incident want to get back to work as soon as possible; their routine represents normalcy. That said, the last thing employers want to do while transitioning an employee back to work is retraumatize or re-trigger the individual. People can relapse after a crisis so it is important to set realistic expectations early on.

Create a successful return to work plan by optimizing an employee’s capacities in combination with the right resources at the right time. Employers will see enhanced productivity and potentially improved health outcomes. The sooner a purpose and interpersonal engagement can be re-introduced into an employee’s life, the better the likelihood of a successful return to work transition.

Learn more > Our behavioral health solutions identify and address work-related injuries and traumatic eventsin an effort to help employees get the care they need to recover and return to work.

EU Health groups propose solutions to MDR and IVDR concerns

October 2, 2023

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Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in some lifesaving products being pulled from the market, EU medical groups have begun to voice their own suggestions for how to rectify the issue.

Earlier this year, the European Health Commission provided an extension to May 2026 for companies to comply with the MDR and IVDR. However, industry stakeholders want the European Health Commission to do more to address their concerns with the regulatory framework.

Calls for structural reform

Along with 34 national associations, MedTech Europe, a European medical technology trade association, recently sent a letter to the European Commissioner for Health, Stella Kyriakides, calling for structural reform to both the MDR and IVDR. The groups hope that reforms will help ensure that medical technologies can reach healthcare systems across Europe in a timely manner.

In the letter, MedTech Europe and the other signatories called for the designation of a more efficient CE marking system to reduce administrative burdens. The groups have also called for the designation of an ‘innovation principle’ to connect emerging technologies more swiftly with patients and health systems through earlier dialogues with developers, and they’ve argued for the establishment of an accountable governance structure to oversee and manage the regulatory system and notified bodies.

Aligning with regulatory trends

The proposal to create an ‘innovation principle’ would align the MDR and IVDR more closely with current European Commission regulatory trends. Other pharmaceutical and medical device regulations that were introduced more recently than the MDR and IVDR by the Commission have sought to prioritise innovation and market access alongside product safety. For example, the European Clinical Trials Regulation (CTR) will create greater regulatory convergence and efficiency by streamlining the application process for clinical trial applications, allowing for companies to place a greater focus on innovation than on the administrative process.

Similarly, the European Commission’s recently proposed pharmaceutical regulation package also prioritises innovation and market access with measures to (1) provide incentives for companies that produce medicines that achieve public health objectives, (2) reduce the standard regulatory protection period, and (3) increase access to pharmaceuticals.

Meanwhile, another group of healthcare experts have published an academic article outlining recommendations on evaluating high-risk medical devices for children. Their recommendations also include the establishment of a task force on ‘orphan devices’, plus the designation of a clear definition for the term ‘orphan device’ itself (the name given to devices that treat rare health issues and are produced in small quantities). The group explains that resolving this issue would enable the taskforce and other groups to find ways to protect designated critical orphan devices.

Considering these calls for reform to the MDR and IVDR and the fact that Commissioner Kyriakides has admitted more changes to the regulations are likely needed, manufacturers should continue to take advantage of opportunities to engage with regulators and provide input on the reform process.

Ensuring eligibility and increased regulatory obligations

It is also critical for manufacturers to ensure they have completed the necessary administrative steps to be eligible for the MDR transition extension. Companies should also ensure they understand if they are eligible and what category of eligibility they might fall into per the Medical Device Directive.

In proposing the establishment of a new accountable governance structure to oversee regulatory agencies and notifying bodies, industry members should understand that this will likely lead to significantly increased regulatory obligations for manufacturers amid greater enforcement power for that entity.

Learn more > Trusted by the world’s leading brands, Sedgwick brand protection has managed more than 7,000 of the most time-critical and sensitive product recalls in 100+ countries and 50+ languages, over 25 years. To find out more about our product recall and remediation solutions, visit our website here.

FDA shares update on its dietary supplement program amidst continued focus on the category

September 26, 2023

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The U.S. Food and Drug Administration (FDA) continues to work through the redesign of its organizational structure into one unified Human Foods Program (HFP) and recently highlighted its dietary supplements program as a critical priority.

In an update from FDA Commissioner Robert Califf, he outlined how the dietary supplements program would fit into the new proposed HFP structure, as well as previewed steps the agency was taking to improve food safety and bolster agency oversight.

The proposed new structure would see the creation of a new Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). Instead of operating as a separate entity, the Office of Dietary Supplement Programs (ODSP) would report to the OFCSDSI while still remaining “the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act.” With the new OFCSDSI, the FDA seeks to “modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.”

The unified HFP will also facilitate a more effective risk management framework across the foods program and allow for resource sharing across offices, according to Commissioner Califf. The FDA is also looking to develop and adopt new surveillance methods and tools to enhance its oversight capabilities, providing for earlier and more accurate identification of potential public health threats.

As we noted in the most recent edition of the Sedgwick brand protection Recall Index report, dietary supplements have been gaining the attention of regulators for the past several quarters. There were 16 recalls for dietary supplements in Q2 2023, which is an increase from the 11 recalls in Q1 2023 and the eight recalls in Q4 2022.

While this increase in recalls may reflect recent regulatory activity, it may also result from growth in the dietary supplements market. A study from the Centers for Disease Control and Prevention (CDC) found that more than half of American adults took at least one dietary supplement each day. But this study only includes data from 2017 to 2020, and experts say it’s likely that supplement use is even higher now.

While it remains to be seen whether unifying the ODSP under the HFP will result in better regulatory outcomes for dietary supplements, the benefits that arise from increased resource and information sharing will likely have an impact on supplement quality and consumer safety. At Sedgwick, we’ll continue to watch the recall data to see how the FDA’s HFP reorganization impacts oversight of dietary supplements. As the FDA moves forward with its restructuring, manufacturers and retailers should pay close attention to updates from the agency and should consider how their operations may be impacted by a new regulatory framework.

Trusted by the world’s leading brands, Sedgwick brand protection has managed more than 5,000 of the most time-critical and sensitive product recalls in 100+ countries and 50+ languages, over 25 years. To find out more about our product recall and remediation solutions, visit our website here.

Recovering from dental practice losses without pain reliever

September 25, 2023

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The healthcare sector is evolving at an astonishing rate. Consider for example that it took biotechnology company Moderna just one hour in January 2020 to formulate an effective SARS-CoV-2 vaccine, based on their messenger ribonucleic acid (mRNA) technology. Advancements in technology are changing the dental field, too, but like other healthcare facilities, dental practices are not immune to property losses. In this commentary, we explore typical equipment found in a dental office, common perils, post-loss recovery options and how collaborating with manufacturers helps instill certainty.

Read EFI Global’s latest commentary paper. Click here.

Pharmacy trends: pain management in workers’ compensation

September 14, 2023

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Pain is one of the most common reasons adults seek medical care in the United States. According to the Centers for Disease Control and Prevention (CDC), American healthcare providers write 259 million prescriptions for opioid pain medication each year — enough for every adult in the country to have their own bottle of pills. Meanwhile, there is insufficient evidence to support the long-term benefits of opioid therapy for chronic pain.

This longtime rise in opioid prescriptions has occurred in tandem with sharp increases in opioid-related overdose deaths and widespread opioid use disorder (OUD). Due to alarming reports regarding this epidemic, opioid use is finally trending down, according to the CDC — except for synthetics like fentanyl. Guidelines have changed in recent years to curb the use of opioids as a first-line approach to pain treatment not associated with cancer.

Prescribers are moving away from opioids and searching for safer pain treatment options. At the same time, patient prescriptions and workers’ compensation claims are seeing an uptick in opioid dependency management medications.

From opioids to alternatives: trends

As prescribers shift to alternative pain management methods, opioid prescription trends are moving in the right direction, as suggested in a 2023 Enlyte LLC report. From 2021 to 2022, the proportion of opioid scripts and costs dropped 1.3% and 2.5%, respectively. The number of injured employees using opioids has continued to decline (down 2.7%) as well.

Opioid potency in prescriptions has also dropped. Morphine milligram equivalents (MME) and morphine equivalency doses (MED), values used to compare the potency of an opioid dose relative to milligrams of morphine, determine a person’s cumulative intake of opioids in 24 hours and are helpful indicators of dose-related risk for adverse reactions, including overdose.

Dosages higher than 50 MME per day increase the risk of overdose at least twofold, compared to smaller ones, says the CDC. Importantly, opioid claims with high MED decreased from 2021, and average daily MED levels per script decreased as well (down 5.3% and 2.8%, respectively).

Opioid dependency/reversal medications on the rise

Even as workers’ comp claims involving opioid decline, there has been a notable rise in prescriptions for managing opioid use disorder (including in workers’ comp). These drugs, commonly referred to as medication-assisted treatment (MAT) or medications for opioid use disorder (MOUD), do not cure OUD — there is no known cure. It merely quells withdrawal symptoms. The drugs are, however, demonstrably safe and effective in treating OUD in combination with psychotherapy, such as cognitive behavioral therapy (CBT).

For patients using MAT, there is no real “exit plan” once beginning the treatment and no clear guidelines on how long to continue taking such medications. The Enlyte report found that claims involving prescriptions of MAT medications increased 11.6% from 2021 to 2022, while costs fell during that period. The increase can be attributed in part to injured workers staying on those medications indefinitely and the subsequent push for MAT treatment to be part of their workers’ comp benefits. It also reflects healthcare providers’ efforts to take a proactive and preventive stance on opioid dependency.

Naloxone, a drug used to reverse opioid overdose, is also on the rise in workers’ compensation claims. In 2022, 7.3% of injured workers prescribed opioids with MED>50 (an opioid dosage that increases the risk of overdose twofold) received naloxone, up from 2.5% since the year prior.

Recent regulatory changes likely influenced this trend. In some states, providers are now required to prescribe the drug anytime a high-dosage opioid prescription is filled. This is positive news. Naloxone can act as a safety net for patients — including injured workers — if they do overdose on opioids, and at the very least prevent the financial burden of an emergency room visit.

Effective pain management options

Solutions that have emerged to replace opioids include anti-convulsants (the generic prescription medications gabapentin and pregabalin), nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, acetaminophen (i.e., Tylenol) and anti-depressants (duloxetine, for one). These medications have proven effective at improving symptoms of chronic pain and garner less dependence, which explains the significant increase in prescriptions.

There is still, however, potential for misuse or abuse. Use of gabapentinoids, specifically gabapentin and pregabalin, have raised concerns — even being FDA approved to treat neuropathic pain — that the medicines are being overprescribed. Both medications can be taken recreationally to produce a high. Some misuse the medications alongside opioids, which significantly increases the risk of unintentional opioid poisoning and death. Still, clinicians are increasingly prescribing both drugs for pain instead of opioids. A 2021 Workers’ Compensation Research Institute (WCRI) report explored the growing use of gabapentinoids for managing pain arising from work-related injuries, and according to a 2022 WCRI study, anti-convulsants are one of the top-three categories of medications by payment share that are prescribed to injured workers.

It is best to consider every patient holistically, as there are often psychological comorbidities that underlie pain and interfere with its resolution. Extensive evidence points to the benefits of nonpharmacologic treatments, such as behavioral health, coupled with non-opioid pharmacologic treatments. Exercise or stretching can increase function, and CBT has been shown to reduce pain intensity in chronic-pain sufferers.

Other types of pain management treatments, such as spinal cord stimulation and nerve blockers, come up in the context of workers’ comp claims, but few studies support their medical use.

Safety, regulatory concerns

Since opioids have fallen out of favor, some physicians have begun prescribing and dispensing over-the-counter, private-label topical medications that are not just expensive and contain higher than recommended strengths of active ingredient; they are also not FDA-approved. Private label topicals are considered specialized products and bypass established pharmacy safety measures with little-to-no utilization review. Drug companies are marketing directly to providers to dispense and prescribe their products — posing a clear financial conflict of interest and safety risk. Many states do not have regulations in place to address these concerns, and any state allowing physician dispensing cannot control how these medications are distributed.

To address such concern, Sedgwick’s dedicated and highly trained team of nurses and pharmacists uses our established proprietary risk analysis indicators and evidence-based medical treatment guidelines to identify unsafe medications, drug combinations and dosages. They utilize evidence-based practices to evaluate medication regimens and collaborate with prescribers to ensure patient safety and medication compliance on our clients’ workers’ compensation claims. Our team of pharmacy experts is here to help employers protect injured workers from harmful medications, treat their symptoms safely and effectively, and control prescription drug costs.

> Learn more — read about Sedgwick’s pharmacy solutions for U.S. workers’ compensation claims.