FDA Approves New Dosage for Opioid Dependence Therapy
The FDA has approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. While similar sublingual films – which dissolve under the tongue – already exist for the treatment of opioid dependence, Cassipa introduces a new dosage strength of 16 mg/4mg.
Cassipa should be used as part of a medication-assisted therapy (MAT) program that combines medications with counseling and other behavioral therapies to treat opioid use disorder. Furthermore, Cassipa may only be prescribed after the patient has been stabilized with a different buprenorphine product with a dose no greater than 16mg.
Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive.
Adverse effects commonly associated with Cassipa include oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema (accumulation of fluid causing swelling in lower limbs).
Tags: FDA, opioid dependence, dependence, opioid use disorder, approve, approval
Dr. Silvia Sacalis Discusses Polypharmacy with WC Magazine
Healthesystems’ VP of Clinical Services, Silvia Sacalis, PharmD, BS, was recently featured in WC Magazine, a quarterly news outlet that covers trends and topics related to the cost-effective resolution of workers’ compensation claims.
Dr. Sacalis penned an article that explores how polypharmacy – the simultaneous use of multiple drugs by an individual patient – can frequently be inappropriate and result in health concerns that delay functional improvement and return to work, in turn increasing claim costs.
The article examines how polypharmacy increases the odds of therapeutic duplication, high-risk drug combinations, and adverse drug effects, exploring how early intervention, increased communication between all the doctors involved in a claim and the patient, and drug reconciliation can counteract these concerns.
Tags: Silvia Sacalis, WC Magazine, Healthesystems, polypharmacy
FDA Reassesses Opioid Policies
As the opioid epidemic continues to permeate the country, the FDA has increasingly announced initiatives to influence the prescribing landscape. This includes efforts to better educate prescribers, bolster opioid prescribing guidelines and influence the drug development cycle.
First, the FDA has approved significant updates to the opioid analgesic risk evaluation and mitigation strategy (REMS). REMS enforces significant education requirements that prescribers must complete in order to prescriber opioid medications. However, REMS was previously only applicable to extended-release and long-acting opioid medications. For the first time, REMS will now apply to immediate-release opioids, which are estimated to make up 90% of opioid prescriptions. This means REMS will go from applying to 62 opioid products to 347.
By demanding that prescribers undergo further education on topics such as opioid risks, alternatives, adverse effects, aberrant behavior, tapering, discontinuing, and more, it is the FDA’s hope to influence opioid prescribing. Furthermore, these REMS updates require that more extensive education be made available to other healthcare providers involved in the management of pain, including nurses and pharmacists
The FDA also announced plans to develop new, indication-specific, evidence-based guidelines for appropriate opioid therapy for acute pain. This plan involves awarding a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct studies and public workshops that engage prescribers and other stakeholders, identifying what procedures and conditions associated with acute pain are most commonly prescribed opioids.
NASEM will then prioritize where evidence-based clinical practice guidelines are most needed to help influence prescribing practices, giving the FDA insight on guidelines which they will then generate.
While no word has been given yet as to when such guidelines would be developed, and if such guidelines would be voluntary or mandatory, the introduction of FDA-approved opioid prescribing guidelines could carry significant weight and positively influence prescribing behavior. Furthermore, NASEM’s findings may even potentially influence FDA drug labelling, which could also influence prescribing behavior.
The FDA also announced that they would withdraw 2014 industry guidance related to the development of new pain-relief medications, choosing to replace them with four new guidance documents over the next six-to-twelve months.
This action indicates a potential shift in the types of drugs the FDA seeks to approve, as three of these guidance documents focus on opioid alternatives. One will address alternative medications that can be used in lieu of opioids, while another outlines a path for the development of extended-release local anesthetics that can serve as an opioid alternative. The third would assist sponsors in the development of new, non-opioid chronic pain medications.
The final guidance document will focus on pushing drug makers to better assess the benefits and risks of new opioids in development. The FDA hopes to accomplish this by creating an updated framework for evaluating risks associated with intentional or illicit misuse or abuse of drugs, which opioid developers must work with if they wish to see their drugs approved.
Tags: FDA, opioid, opioid policy, policy, NASEM, opioid alternative
CWCI Releases Polypharmacy Report
The California Workers’ Compensation Institute (CWCI) has released a new study that measures the prevalence of polypharmacy in the California workers’ comp system.
Polypharmacy – the simultaneous use of multiple drugs by an individual patient – can frequently be inappropriate and result in health concerns that delay functional improvement and return to work, in turn increasing claim costs. The insights found in this report can be used to understand where polypharmacy is occurring in claims, giving workers’ comp professionals the knowledge they need to lower the frequency of polypharmacy.
To study the prevalence of polypharmacy in California workers’ comp claims, the CWCI extracted pharmaceutical and claim demographic data from their Industry Research Information System (IRIS) database, sourcing information from nearly 6.1 million claims. CWCI then focused on data from January 1, 2016 through December 31, 2017, and for the purposes of this study, zeroed in on claims with five or more concurrent medications during the study period.
Polypharmacy claims tend to be older, with 21.5% of them being at least 10 years old. Only 6% of non-polypharmacy claims were 10 years old, and when looking at all active polypharmacy claims at the end of 2017, 57.5% of those claims were from 2014 or prior. For non-polypharmacy claims that were still active at the end of 2017, only 21.8% were opened in 2014 and prior.
Furthermore, it was also found that the patients involved in polypharmacy claims tend to be older workers, as 52.3% of polypharmacy claims involved patients aged 50 or older at the time of injury. For non-polypharmacy claims, only 39.3% of claims involved workers of a similar age.
The study also found that 24% of claims with at least one dispensed drug had three or more different prescriptions concurrently dispensed. As for drugs commonly found in polypharmacy claims, opioids and anti-inflammatory analgesics were the top two most common drugs.
In claims with five or more drugs concurrently prescribed, opioids made up 16.7% of drugs, while anti-inflammatory analgesics made up 14.4% of drugs.
Muscle relaxants were also significantly common in polypharmacy claims, making up 9.9% of drugs in claims with five or more concurrent medications, as were gastrointestinal drugs (likely due to opioid side effects such as constipation), which made up 12.3% of drugs under similar parameters.
And when it came to diagnoses tied to polypharmacy, claims involving back conditions without spinal cord involvement made up 21.3% of polypharmacy claims. This was the number one diagnosis tied to polypharmacy, with ruptured tendon, tendonitis, myositis and bursitis making up just 10.2% of polypharmacy claims; the other top diagnoses, such as sprain, heart and circulatory issues, and other musculoskeletal diagnoses, were not far behind percentage-wise.
Tags: CWCI, California, Polypharmacy, older worker, older claim, opioid
Dr. Robert Goldberg Comments on DEA Opioid Manufacturing Quotas
Last month, the DEA proposed a reduction in the manufacture of controlled substances, making this the third year in a row such reductions were made. In 2017, a 35% reduction was approved, and in 2018, a 5% reduction was approved.
This proposed reduction in manufacturing could lower the amount of opioid pain medications available, and many have been hopeful that this could lessen the impact of the opioid epidemic. While this proposal is still being reviewed, WorkCompCentral, an online news service focused on workers’ comp, published an article that explored this issue. The article examined these proposed reductions against an increase in opioid products approved by the FDA, and an increase in opioid overdose deaths.
Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM, was among the experts that WorkCompCentral interviewed for this article. Dr. Goldberg stated that while the reduction may signify a recognition that too many opioids are being manufactured, the prescribing rates remain very high. Opioid quantities could be cut in half, and there would still be enough medication available. Dr. Goldberg commented that efforts should focus on reducing the dosage and duration of opioid prescriptions to better fight the epidemic.
Tags: Healthesystems, Goldberg, Robert Goldberg, WorkCompCentral, DEA, FDA, opioid, quota, manufacture, manufacturing