Tuesday, March 15, 2016

FDA Focuses on Opioid Policy

The FDA has recently acknowledged its own need to establish a “far-reaching action plan to reassess the agency’s approach to opioid medications” in order to reduce the trend, deemed by the U.S. Department of Health and Human Services as “a serious public health issue.” Now the leading cause of accidental death in the U.S., more Americans currently die from drug overdoses annually than motor vehicle crashes, the majority of which can be linked back to opioid prescription medications such as oxycodone, hydrocodone, codeine, morphine, fentanyl, and others.

National Attention

In addition to spurring the FDA to action, Health and Human Services Secretary Sylvia Burwell identified the boundlessness of the epidemic, citing the importance of both state and federal leaders coming together to form “a coordinated and comprehensive approach to address this crisis.” President Obama has also taken part in multiple efforts to curb the issue, including his 2010 National Drug Control Strategy to address opioid use disorders and overdose, as well as an October 2015 Memorandum to Federal Departments and Agencies calling for improved prescriber training and improved access to treatment for those addicted.

Recent Court Cases Press the Issue

The limelight on opioids has also triggered debate in the political arena, as well as even deeper scrutiny by the medical and workers’ comp communities, particularly following an array of eye-opening court cases in which doctors are being held liable for opioid prescribing practices. The most recent? February 2016’s Tseng Conviction, in which a California general practitioner was sentenced 30 years to life for the prescription of unnecessary painkillers which contributed to the fatal overdose of three patients.

The FDA Proposal to Combat the Epidemic

In response to the crisis, the FDA “has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities.” Among the steps being taken…
  • Advisory committees to review new drug applications, especially for opioids without abuse-deterrent properties.
  • New warnings and safety labels to help doctors better understand risks and safe prescription practices.
  • Upholding new requirements for drug companies to provide new data on the long-term impact of opioid drugs.
  • Improved and updated CME training, including proven uses for opioids and safe prescribing practices, to decrease inappropriate prescriptions.
  • Creating/expanding access to abuse-deterrent opioid formulations (ADF) to discourage abuse by spurring innovation, as well as generic formulations, of ADF products.
  • A re-examination of the risk-benefit paradigm for opioids to include consideration of the widespread public health effects of drugs.

ANS Pharmacotherapy Review

Our approach to pharma review and intervention is the only face-to-face program of its kind offering evidence-based and actionable treatment recommendations that reduce pharma spend while offering improved quality of care for the injured worker with reduced risk of overdose and addiction. Contact http://www.ans-solutions.com to learn more about our comprehensive pharma review and intervention programs today.

This content was originally posted at http://ans-solutions.com/fda-focuses-on-opioid-policy/

SOURCES:
http://www.pbs.org/wgbh/frontline/article/how-bad-is-the-opioid-epidemic/
http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf
https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector
http://www.hhs.gov/about/news/2015/09/17/hhs-hosts-50-state-convening-focused-preventing-opioid-overdose-and-opioid-use-disorder.html#
http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm
http://nationalpainreport.com/commentary-the-debate-over-opioids-should-be-much-more-than-it-is-8829446.html
http://www.consumerreports.org/cro/magazine/2014/09/the-dangers-of-painkillers/index.htm

Monday, February 29, 2016

Potential Workers Compensation Cost Drivers- Private Label Topicals

We are seeing a trend in which doctors are increasingly prescribing private label topical drugs for the treatment of chronic pain. Awareness of these expensive and clinically unproven products is becoming increasingly important due to their potential safety and cost implications.

What are they?

Differing from custom compounds, private label topicals are similar to over-the-counter (OTC) topical products, with varying formulations that are not clinically tested for either safety or efficacy. Private-label topical analgesics are not recommended according to evidence-based guidelines and they are not approved by the FDA.

From a clinical perspective, private-label topicals offer no greater benefit to the patient than over-the-counter (OTC) alternatives found in national retail chains and in most cases they are significantly more expensive. The potential cost per prescription is disproportionately high with prices points upwards of several hundred dollars yet these drugs being dispensed by physicians and small, independent pharmacies for the treatment of pain when comparable OTC alternatives such as IcyHot® or BenGay typically retail for less than $10.

Curbing the Issue

When recommending any topical product, whether prescription or OTC, physicians must consider patient safety and evidence-based guidelines. More appropriate, less costly alternative treatment strategies may be available for the effective treatment of pain.  ANS Pharmacotherapy Review can help uncover and address private label drug prescription practices. For more information contact us today or visit www.ans-solutions.com.

Monday, February 15, 2016

Innovating Clinical Intervention

The lack of communication among treating physicians for injured workers has been a known deficit in large loss claims for some time. Professional liability insurance companies have recently issued statements concerning the trend of incomplete patient information, missing tests and poor communication among physicians resulting in lengthier recoveries and costly medical treatment regimens.

Current clinical intervention programs embraced by the industry merely scratch the surface of success as they focus solely on a patient’s medication therapy. The reality is that in today’s landscape of multiple doctors and pharmacies, shortened appointments, and conflicting priorities, not all prescribers have the time to conduct an extensive review of a patient’s medical history. Critical factors that can change the trajectory of a claim may be missed such as:
  • lab and diagnostic results;
  • additional therapies may not have been tried;
  • inconsistency in diagnosis between doctors and;
  • high risk patient behavior could be present

Optimized Treatment Outcomes through Pharmacotherapy Review

Missed intervention opportunities such as those listed above result in a less than optimal treatment outcome and are often costly. Through the advanced clinical analytical capabilities of ANS nurse experts, our Pharmacotherapy Review program removes the blindfold and brings to light the patient’s full medical history and contributing health factors. The result delivers a complete view of the patient that informs accurate and impactful care decisions. Safety concerns most often uncovered include:
  • Duplication of therapy
  • Drug-Disease Interactions
  • Lack of evidence for use of current treatment therapies
  • High dose of medication(s)
  • High incidence of side-effects
  • Excessive duration of therapy
  • Patient age concerns
Our unique Pharmacotherapy Review program provides a holistic clinical assessment to deliver informed and extremely detailed patient recommendations. Recommendations that benefit the outcome of large loss workers compensation claims for the injured worker and the payer alike. To find out more about our medical cost containment strategies contact us today at www.ans-solutions.com.

This content was originally posted at http://ans-solutions.com/innovating-clinical-intervention/

Monday, February 1, 2016

6 Ways Pain Management is Mismanaged

There is a significant body of evidence suggesting that many Americans suffer from chronic pain and much of that pain is inadequately or ineffectively treated. Particularly in the case of chronic pain treatment via opioid analgesics, proper chronic pain management is critical in determining whether opioids are used in a manner that is both medically appropriate and in compliance with regulations. Pain management is an important area of patient care that is integral to the practice of medicine, yet so often it is mismanaged. Here we review six most common ways pain is mismanaged:
  • Inadequate attention to patient education and informed consent. Deciding to begin opioid therapy for chronic pain should only be made after a physician and patient discuss the risks. Pain patients should have a clear understanding that the clinical basis for the use of these medications for chronic pain is limited, risk of addiction is real, and that taking opioids with other substances or certain conditions (i.e. depression or a history of substance abuse) may further increase risk.
  • Inadequate attention to initial assessment. A proper assessment will help to determine if an opioid based pain treatment regime is medically appropriate and necessary. It will also help in uncovering risks associated with use for a particular individual.
  • Inadequate monitoring during the use of habit forming medications. Due to its highly addictive and dangerous nature, opioids are associated with drug addiction and abuse. Chronic pain treatment benefit from opioid dose reductions or tapering or weaning off the opioid.
  • Excessive reliance on opioids for chronic pain management without adequate attention to alternative treatments. Prescribers should use opioid therapy only when safer and equally as effective alternative therapies prove to be ineffective.
  • Baseless dosage increases without adequate attention to risks or alternative treatments. The risks associated with opioids increase with higher doses and even more in conjunction with other comorbidities (i.e. mental illnesses, respiratory disorders, pre-existing substance use disorder and sleep apnea) and with concurrent use with respiratory depressants such as benzodiazepines or alcohol.
  • Lack of utilization of available tools or lack of knowledge of available tools for risk mitigation. Our Pharmacotherpay Review program uncovers major issues including duplicate therapies, dangerous or deadly drug interactions, or behaviors related to drug addiction. All of which can have a dramatic impact on a patient’s health.

ANS Pharmacotherapy Review

A well informed physician’s practice can improve safety and the outcome of chronic pain treatment for patients. This is an area where the expert medical cost containment solutions of ANS Solutions can help. Our Pharmacotherapy Review Program provides three highly effective stages that not only contribute to lower medical costs in workers’ compensation claims, but greatly enhance the quality of life and care for injured workers.
For more information, visit www.ans-solutions.com.

Tuesday, January 19, 2016

Abuse Deterrent Opioids a New Era of Opioid Drug Development

The prevalence of opioid use and abuse has led to a new era of opioid drug development: Abuse deterrent (AD) opioids.

The goal?....
Maintain the efficacy of opioid formulations while improving their ability to deter abuse. Following guidelines developed by the FDA to categorize new opioid formulations, pharmaceutical companies are now on a quest to develop tomorrow’s safety net against opioid abuse.

How will the FDA be categorizing these new AD opioid formulations?

  1. Physical/chemical barriers
    Physical barriers that prevent the crushing, cutting, grating, grinding, or chewing of opioid formulations, alone or in combination with chemical barriers, which can resist extraction with common solvents (water, alcohol, organic solvents).
  2. Agonist/antagonist combinations
    Formulations with the addition of an opioid antagonist, released only when opioid drugs are manipulated. When triggered, the agonists “interfere with, reduce, or defeat” opioid induced euphoria commonly associated with abuse.
  3. Aversion
    The addition of a noxious component to formulations to produce an unpleasant effect when opioids are manipulated, or when a higher dose than prescribed is consumed. (For example, a nasal irritant to deter snorting.)
  4. Prodrug 
    Biologically inactive substances metabolized inside the body to their active form: That is, the drug must be taken by its intended route and form in order to be properly metabolized.
  5. Delivery system
    The implementation of more difficult to manipulate drug delivery systems, such as subcutaneous implants, depot injectable formulations, beads within a capsule, and erodible matrix technology.
  6. Combination of 2 or more of the above
    Combining 2 or more of the above methods to decrease the likelihood of abuse.

More questions than answers

Though AD technology is advancing, it continues to carry with it an onslaught of unmet expectations/unanswered questions…
  • Is making an uncrushable pill really going to curb opioid abuse when it can be consumed in other ways?
  • Why aren't efforts being made to explore more economically responsible, alternative therapies that don't involve any form of opioids at all?
  • Will this approach yield enough penetration in the chronic pain treatment community to persuade physicians and patients to switch from their current prescriptions to abuse deterrent forms?

Helping curb the opioid epidemic

Only time will tell how the development of AD opioids will progress and effect the growing opioid abuse epidemic. Fortunately, you don’t have to await developing AD technology to take steps towards making a positive change. Readily available programs, including ANS expert nurse consulting and pharmacotherapy review can help you better address the need of pain patients, providing better outcomes, faster recovery times, and less risk than common opioid treatment regimens.

Ready to be part of the change? Contact ANS today and learn more about how ANS Pharmacotherapy Review can provide superior results for injured workers. Visit us at www.ans-solutions.com for more information.

Monday, December 28, 2015

Strategies to Reduce Patient Reliance on Opioids Postoperatively

Surgeons across the nation are increasing efforts to reduce their overall use of opioids for the long term treatment of chronic pain post-operatively. The driving force- Curtailing the opioid abuse epidemic, an unfortunate but growing trend.

Well-Documented Risks

An epidemic effecting 5 million Americans, half of all opioid-related overdose deaths in the U.S. have been linked to prescription drugs – not “street” or “recreational” drugs. Opioid use, even short term, is particularly problematic for patients with a history of substance abuse.

Changing Practices

Seeing the effects of this epidemic, many surgeons are taking steps to better help patients manage the healing process without potentiating future substance abuse issues. To that end, treatment strategies have emerged to reduce patient reliance on opioids postoperatively. Some of these methods include:
  • A reduction in the use of opioids for the short-term management, including the time period two to three days post-op, to prevent the potential for abuse and misuse.
  • Pre and perioperative treatment strategies designed to reduce patient reliance on opioids for moderate to severe post-op pain (commonly the first line of therapy).
  • The implementation of patient pain contracts to engage patients in their own care and formally educate them on pain management, compliance, prescription use, and routine drug monitoring.
  • ERAS (enhanced recovery after surgery) protocol, incorporating the use of short-acting anesthetics, nonsteroidal anti-inflammatory drugs (Exparel, Pacira), ileus control, invasive monitoring, and intensive care treatment combined with minimally invasive surgical techniques designed to enhance post-op recovery by preventing problems resulting from exaggerated inflammatory reactions to procedures (poor healing, infections, organ dysfunction). This technique has been associated with an improved postoperative length of stay and morbidity and reduced reliance on opioids post-operatively.

A Study in Possibilities

A recent study shows how even simple changes may affect opioid use. In the study, a pink reminder card was included in patient files to encourage hand surgeons to discuss with patients prior to surgery postoperative pain management options, explain the risk of opioids, and recommend alternatives. The card – and subsequent discussions - netted a 15% decrease in opioid prescriptions written. Likewise, a survey of dermatologic surgeons found 64% of surgeons prescribing opioids post-operatively for fewer than 10% of surgical patients.

Looking Ahead

While this is a good place to start in the fight against opioid epidemic, when it comes to chronic pain and workers compensation claims, a true drug utilization review program can also contribute to enhancing the quality of treatment and reducing medical costs. ANS Solutions drug utilization review program through pharmacotherapy review is the most advanced of its kind. To find out more about our effective medical cost containment strategies contact us today or visit www.ans-solutions.com.


References
Dunleavy, Brian. Curbing Opioids Postoperatively, an Increasing Focus of Many Surgeons. PainMedicineNews.com; November 26, 2015.

Tuesday, December 15, 2015

Chronic Pain Treatment: Impacts of Drug-Drug Interactions

Polypharmacy, the use of 4 or more medications simultaneously, is a dangerous but frequent practice for chronic pain patients. Unfortunately, because many patients undergoing chronic pain treatment suffer multiple chronic health issues, exposure to drug-drug interactions (DDI) is a common but unintended result, leading to severe consequences for the physical health of patients, as well as a significantly increased financial burden for all involved: patients, providers, and society.

What defines a drug-drug interaction?

A pharmacokinetic DDI involves two or more drugs interacting in such a way that the effectiveness and/or toxicity of one or more of those agents is affected. Physicians' and pharmacists' track record of identifying DDIs have been shown to be poor in the past, with reliance on electronic record keeping that may or may not link with other physician/pharmacist systems further complicating matters. Identifying DDIs has also been made increasingly difficult by the fact that they may present themselves as an alteration in patient physiology, mimicking almost any clinical presentation including other diseases a patient is under treatment for or the physiological changes of aging. Reports are also inconsistent, with wide ranges: 2–30% for hospitalized patients and 9–70% for ambulatory patients, for example.

Will new studies on DDIs shed sufficient light on the subject?

Five recent broad, foundational studies assessing the health care utilization and associated medical costs of opioid analgesics for patients under 18 years undergoing non-cancer chronic pain treatment were assessed. These studies focused on drug-drug exposure (DDE) which is more easily identified and is strongly linked to increasing the potential for DDIs. Researchers’ results yielded a number of findings related to the potential risks and economic implications of DDIs including:
  • That drug–drug exposures are prevalent
  • DDIs result in significantly higher and substantial costs when they occur
  • DDIS can occur in any age group.
  • Physicians should consider ways to limit their patients' exposure to potential DDIs.

What measures are being taken to disseminate information on DDIs?

Further studies are being called for to better understand the pharmacokinetics of DDIs and how the costs of DDIs further contribute to the overall cost of the health care system. In the meantime, clinical awareness of the seriousness and scope of drug-drug exposure and interactions prevents effective control of the situation, thus dissemination of this knowledge is key to a positive outcome. All avenues of the medical community are currently involved, including government FDA research and drug label upgrades on selected medications, physician and patient awareness programs from pharmaceutical companies and nonprofits, and enhancement of technology including more streamlined, accurate, prescription databases.

Suitable alternate solutions can be found that do not expose patients to the risk of DDIs

With the chronic pain population growing, awareness of the issues surrounding DDIs is more important than ever. A well informed physician’s practice can improve safety and the outcome of chronic pain treatment patients through doctor/patient education, careful monitoring of chronic pain patients who take concurrent medications, avoiding the prescription of multiple concurrent medications specifically when opioid analgesics ( i.e. codeine, fentanyl, hydrocodone, methadone, oxycodone, tramadol etc.) are involved. This is an area where the expert medical cost containment solutions of ANS Solutions can help. Our Pharmacotherapy Review Program provides three highly effective stages that not only contribute to lower medical costs in workers’ compensation claims, but greatly enhance the quality of life and care for injured workers.



References
Pergolizzi Jr. , Joseph V., Puenpatom, R. Amy, Summers, Kent H., Taylor Jr., Robert Ecomonic Implications of Potential Drug-Drug Interactions in Chronic Pain Patients. Expert Rev Pharmacoeconomics Outcomes Res. 2013;13(6):725-734.