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.

This content was originally posted at http://ans-solutions.com/abuse-deterrent-opioids-a-new-era-of-opioid-drug-development/

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.

This content was originally posted at http://ans-solutions.com/strategies-to-reduce-patient-reliance-on-opioids-postoperatively/

References

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

Find a better path to medical cost containment, contact ANS Solutions today or visit www.ans-solutions.com.

This content was originally posted at http://ans-solutions.com/chronic-pain-treatment-impacts-of-drug-drug-interactions/

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.

The Perils of Polypharmacy

In the context of large loss workers compensation claims and the treatment of pain in injured workers, polypharmacy is typically associated with the use of four or more medications. As a result, polypharmacy creates an environment where several complications can occur. Here we delve into some critical issues affecting the injured worker as a result of polypharmacy: compliance, drug interaction and risk of addiction.

Dosage Compliance & Drug Interactions

To put it simply, compliance is taking medications the way they are intended to be taken. The lack of compliance with a prescribed treatment regimen is most often unintentional. A patient may inadvertently take the wrong dosage, miss a dosage entirely or mix dangerous combinations of drugs. Further, even though the right dosages may be administered, drug interaction poses yet another harmful risk for the injured worker. Treating physicians may not be communicating with each other and therefore are unaware of existing medications or treatment regimens which may affect quality of care. For example, MAO inhibitors and blood thinners can actually counteract or reduce another medication's effectiveness.

Possible Addiction & Overdose

Addiction and overdose are both related to treatment and dosage compliance. An unfortunate lack in monitoring a patient’s treatment program and progress may result in missed warning signs and missed opportunities to modify a treatment program based on patient’s recovery. Quite often addiction is not self-imposed but rather, factors such as duplicate therapies, inappropriate treatments and excessive dosages of opioids set the stage. Pain treatment through highly addictive opioids, coupled with a lack of patient education on the risks and dangers of these drugs, subjects injured workers to a path of drug addiction which may hinder or prevent recovery.

How Can ANS Solutions Pharmacotherapy Review Help?

Our Pharmacotherapy review program can help uncover possible risks that could have a dramatic impact on the person's health. Typically, Pharmacotherapy Review uncovers major issues including duplicate therapies, dangerous or deadly drug interactions, or behaviors related to drug addiction. All of which may contribute to a longer recovery time, no recovery or even death for an injured worker. By bringing these issues to light and recommending a more appropriate course of action our program can enhance the quality of life for the injured worker while also increasing financial cost for Payers.

To find out more about our Pharmacotherapy Review Program visit the website today at http://www.ans-solutions.com.

This post was originally published at http://ans-solutions.com/the-perils-of-polypharmacy/

6 Benefits of ANS Legal Nurse Consulting Services

The specialized skill-set of legal nurse consultants can play a crucial role in claim settlement and medical legal cases. Here we review six benefits of the services provided by ANS’s highly credentialed and experienced legal nurse consultants:

1) Critical Analysis

Through the critical analysis of medical records, our nurse experts summarize critical events in a case’s history to identify issues such as causality, scope of damages, and standards of care. By analyzing medical causation and exposure they effectively gauge merits of alleged injuries while identifying any missing medical information that may prove valuable to a claim.

2) Collaboration

Multiple parties must be engaged to successfully determine a modified course of treatment, and ensure compliance to the new course of treatment. Legal nurse consultants play an instrumental role in securing the collaboration between prescribing physicians, attorneys and injured workers which optimizes the negotiation and settlement of a claim.

3) Strategic Assessment

Through the exhaustive and strategic assessment of each case, ANS nurse experts uncover causation, mitigating factors, unreasonable medical charges and inappropriate patterns of care while also potentially exposing unnecessary or unrelated care issues. There assessments lead to a recommended course of action that not only improves the living conditions of the injured worker but reduces pharma costs by 25% or more.

4) Legal Support  

Attorneys may call legal nurse consulting experts as witnesses at trial to provide facts, data and opinions based on case evidence. If needed, legal nurse consultants may also locate and retain expert witnesses with specialized insight and knowledge relevant to the circumstances of a case.

5) Education

In the process of deciphering a case, legal nurse consultants educate attorneys regarding medical facts, timelines, treatments, nursing terminology and other relevant health care information. Furthermore, their legal nurse consultant degree and experience gives them the background to bridge the gap between law and medicine.

6) Research

Research is encompassed in every aspect of legal nurse consulting. The research support generated by legal nurse consultants can provide an extraordinarily powerful legal instrument in the negotiation of a claim.

ANS Legal Nurse Consulting

With a background in professional nursing education, training, and clinical experience to the assessment of standards of care, causation, and damages, the support of ANS legal nurse consultants can significantly optimize medical legal case and claim outcomes. To find out more about how an ANS nurse expert can impact your bottom line contact us today or visit www.ans-solutions.com.

This content was originally posted at http://ans-solutions.com/6-benefits-of-ans-legal-nurse-consulting-services/.

No Proven Benefit for the Use of Opioids in Chronic Pain

Millions are addicted to or dependent on prescription opioids. Worse than the dependency, over 200,000 deaths are attributable to prescription opioids, as well as hundreds of thousands of overdoses. What’s the biggest contributor to the epidemic, you ask? Most commonly, it’s the inappropriate prescription of opioids for the treatment of issues like musculoskeletal disorders, chronic low back pain, headaches, and other issues.

Insights from a Leading Pain Expert

A recent study conducted by leading pain expert Gary Franklin, MD, MPH, V.P. of Physicians for Responsible Opioid Prescribing, provides substantial evidence that prescribing opioids for chronic pain offers no real benefit. Franklin has been striving to shed light on this issue which is believed to be contributing in large part to the prescription opioid abuse epidemic sweeping the nation. Opioids such as hydrocodone and oxycodone have increased in prescription from around 76 million in 1991 to nearly 207 million in 2013, making the U.S. the biggest global consumer for these products at nearly 100% of word consumption for hydrocodone, 81% for oxy. Most notably, Dr. Franklin’s research found clear evidence of dose-dependent risk for serious harm:

• A dramatic increase in death with opioids administered at a dose of 100mg MED (morphine equivalent dose).
• A risk of overdose 2-5 times higher when the above MED runs between 50-99mg.
• Doses lower than 100mg MED still result in overdose – even without long-term therapy.
• Opioids administered in combination with benzodiazepines, sedative-hypnotics, or muscle relaxants dramatically increase the risk for harm.
• Double the risk of remaining on disability 1 year for those treated with opioids for at least 7 days (cumulative dose: 150mg MED).

Reversing the Trend

Believed to be the direct result of poor research and outdated teaching practices, the most important step toward reversing the opioid epidemic is simple- putting a stop to improperly prescribed opioids particularly for chronic pain. To aid this effort, t­he American Academy of Neurology and a number of states have produced product guidelines advising against the use of opioids for the treatment of musculoskeletal conditions, headache, or fibromyalgia, and additionally advising physicians to proceed with caution when initiating opioid therapy for pain or long-term use. (Since released, the guidelines created as a result of the drug utilization review have effected a 30% sustained decline in overdose deaths and a substantial decline in injured workers on chronic opioids in Washington State.)

Evidence-based Alternatives

Opioid therapy is not necessarily the only answer to treating chronic pain. Drug utilization review programs such as ANS Pharmacotherapy Review can provide alternative therapy recommendations. ANS deploys an exceptionally credentialed network of nurse experts to deliver recommendations in face-to-face meetings with treating physicians. These recommended treatment options are equally, if not more effective than opioids. Better still, they offer improved quality of care and quality of life for the injured worker.

If the pitfalls of opioid therapies are taking over your workers’ comp claim settlements, the proven drug utilization review protocols at ANS Solutions can show you a better path. Optimized outcomes for the injured worker are possible. Contact ANS today or visit www.ans-solutions.com.

This content was originally posted at http://ans-solutions.com/no-proven-benefit-for-the-use-of-opioids-in-chronic-pain/

Medical Cost Containment Does Not Mean Compromised Care

The existing way that the workers’ compensation industry handles large loss claims has been contributing to diminished quality in care for injured workers, increased costs associated with treatments, and poorly coordinated care. Care delivery within workers’ compensation programs is arguably even more inefficient than in general healthcare but it does NOT have to be this way. Payers can have the best of both worlds with medical cost containment strategies that provide quantifiable outcomes that positively impact the patient’s health while also driving down associated treatment costs.

How does Medical Cost Containment Improve the Quality of Care for Injured Workers?

Interventions with prescribers can be instrumental in improving the quality of life and treatment for patients. ANS PharmaIntervention is designed to help treating physicians detect and correct underlying problems, promote functional improvement and reduce narcotic usage. Our legal nurse experts conduct comprehensive reviews of a patient’s medical history often uncovering risk factors and other considerations that can be overlooked by treating physicians. They are then able to collaborate with treating physicians to improve the current treatment plan based on actionable, evidence based recommendations. The benefits to the injured worker include but are not limited to:

• Reduced risk for prescription opioid painkiller addiction.
• A modified treatment program based on recovery.
• A modified treatment program based on the availability of alternative treatments and therapies that may be more effective, and have fewer side effects.

All of which contributes to measurable improvements in quality of care and life for the injured worker- even increasing the likelihood of returning to work sooner.

How Does Medical Cost Containment Positively Impact Your Bottom Line?

Ensuring injured workers receive the right care at the right time from treating physicians, minimizes the financial impact of catastrophic injuries. The goal of ANS PharmIntervention is to improve quality of care by applying expert clinical knowledge and experience to recommend, where appropriate, alternative treatments and therapies. The financial benefits of the ANS PharmIntervention strategy stem from its ability to aid treating physicians in:

• Improving opioid painkiller practices.
• Avoiding unnecessary or inappropriate pharmaceutical and medical treatments.
• Avoiding duplicate therapies in the event of multiple treating physicians.

When done correctly, medical cost containment ensures that patients receive the highest quality of care balanced with the necessary cost controls.

Care without Compromise

ANS Legal Nurse Consultants provide comprehensive reviews of large loss claims while delivering optimized financial results and quality of care for injured workers. To learn more about our medical cost containment strategies visit our website at www.ans-solutions.com.
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