Abuse-Deterrent Opioids (ADOs) – The Mayday Project

The goal of the Mayday Scholars Project was to improve the treatment of pain for all patients by changing public policy, removing regulatory barriers to pain management, and reducing fear on the part of healthcare professionals. So in this post, let’s take a closer look at Prescribing Abuse-Deterrent Opioids (ADOs) – The Mayday Project:

The leaders of the project recognized that effective changes in policy and practice can occur only over the long-term and that the project would serve as a catalyst for continued progress in policy development beyond the lifespan of the project itself.

Starting in the mid-1990’s, and extending through the decades that followed, the Mayday Pain Project produced numerous volumes of scholarship that address the delicate balance to be struck between policy that would increase access to analgesic medications for those who suffer the disease of pain, and policy that would decrease access to diverted medications illicitly made available to support substance abuse behaviors.

Publications by Mayday Scholars review the importance of policy related to the drug product itself, as well as policy related to the way the drug product is used. It’s all about Pain Management and the balance and adoption of ADOs (Abuse-Deterrent Opioids). One of the original studies reviews how regulatory control and third-party payment restrictions limit access to drugs that could be considered clinically preferable for a patient but are difficult to prescribe and dispense due to regulatory and payment limitations.

The high cost of some opioid products, particularly those that are extended release formulations and are still exclusively available only from one manufacturer, challenge health care professionals to develop pharmaceutical care plans that are both effective for the patient and efficient for the payer. You don’t want to get in similar situations as some surgeons that need to work with their self-developed EMRs, do you?

At the federal level, a regulatory collaboration between the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) has been discussed in project scholarship, resulting in the suggestion that extensively studied drugs deemed safe and effective by the FDA not be overly restricted by the DEA.

FDA approval of ADO formulations is an example of enhanced collaboration between that agency and the DEA. WQuite a few hospitals and clinics have already taken tentative ADO steps and implemented EMRs to work in line with DEA regulations. These formulations provide a specific mechanism for restricting abuse without interfering with legitimate therapy.

The responsibilities of DEA registrants who oversee opioid analgesic distribution and use are complex and sometimes daunting according to Mayday Scholars. Licensing agency investigations and administrative discipline of those who aggressively treat pain with opioids have not yielded consistent results, and this inconsistency may have led to a chilling effect on opioid prescribing.

Licensed practitioners struggle to understand the standard against which their opioid prescribing is being measured when no standard is evident or there appear to be various and potentially conflicting schools of thought. Prescription Drug Monitoring is not only a tool for pharmacists, but actually for all healthcare workers that prescribe controlled substances and medication.They are understandably reluctant to undertake a standard-less responsibility.

While medical boards are developing a greater appreciation for the challenges licensees face in the treatment of chronic pain, the use of opioid analgesics continues to bring with it far greater regulatory risk for overprescribing than for under-prescribing.

There is also the possibility that harm to patients associated with the use of opioids will lead to the filing of civil liability lawsuits or criminal charges against the health care practitioners involved. Sometimes, simply convincing patients to take in antioxidants will already be highly beneficial to their overall health.

Apprehensions of healthcare professionals of exposing themselves to administrative discipline and malpractice liability are well-founded and could lead to inappropriate use of ADO formulations as a strategy to avoid accusations of regulatory noncompliance, at the expense of good clinical decisions made in the best interests of patients.

The development and dissemination of clear standards for ADO use could restore the clinicians focus on patient care as opposed to self-preservation in a time of regulatory uncertainty. Extra careful should we be when prescribing ADOs to pregnant women as they are at a higher risk to develop various diseases like diabetes, so think many experts.

The processes of clinical care, drug distribution and drug regulation are addressed from several perspectives by Mayday Scholars in their consideration of the system-related barriers that must be overcome to improve the practice of pain management.

Ambiguous terminology, conflicting guidelines, and the lack of high quality continuing education for healthcare professionals are structural obstacles that restrict the effective use of opioid products.

A potential drawback of ADOs is that they will mistakenly be viewed as a single solution to the problem of opioid misuse, leading to clinical practices that fail to reflect the many system failures that lead to prescription drug diversion and abuse.

While ADOs can be an effective tool in the reduction of diversion and abuse, they cannot supplant the many other activities that are undertaken to assure responsible prescribing and use of opioid analgesics. Please note that blood-vessel inflammation also puts patients at a higher risk and may signal diabetes or a stroke!

The experience of patients in pain was a sustained interest of the Mayday Scholars. Mayday scholarship validates the positive effect of aggressive pain management in of end-of-life care.

When experiences with pain management are positive, the prescriber-patient relationship can be enhanced. If regulatory barriers to effective pain management cannot be overcome, then the relationship between prescribers and their patients can deteriorate.

Public policy can be effectively utilized to promote a patient-centered ethic of pain management, challenging opiophobic notions that the use of opioid analgesics inevitably leads to addiction, that there is value in suffering, and that underprescribing of opioids is the least risky and most appropriate way to treat pain patients. See also this post: Health Threats – Who’s in Charge?

A patient’s experience of pain is influenced by culture, and patients use of opioid analgesics varies based on cultural acceptance of these medications. Clinicians have a responsibility to provide sympathetic, individualized care that transcends cultural boundaries.

Disparities in the treatment of pain based on race, ethnicity, and gender support the point that clinicians must resist bias in selecting patients who are appropriate recipients of opioid analgesic therapy. The stigma of opioid use is an important factor in considering whether to prescribe ADOs.

Patients for whom these drugs are prescribed could be labeled as drug diverters. The choice to use an ADO product could adversely affect the prescriber-patient relationship unless such a product came to be prescribed indiscriminately to all patients undergoing opioid therapy.

Even in this unlikely eventuality, there is the potential for stigmatization, just as has been pointed out by those who caution against imposing opioid use agreements and random urine drug screens on all patients receiving opioid therapy.

Clear standards for product selection, based on identified risks and not on bias, would facilitate an understanding of the context within which the decision to use the product was made.

The foundational policy issues addressed by the Mayday Scholars invite further consideration of the various means through which sound pain management policy can improve the quality of drug therapy, while at the same time reduce the diversion and abuse of controlled substances.

The introduction to the market of opioid analgesic products with abuse-deterrent characteristics has the potential to both improve pain management and reduce prescription drug abuse. These potentially beneficial products will not achieve their potential unless strong public policy accompanies their addition to the therapies that can be chosen by clinicians for the treatment of patients.

Regulatory, ethical, and economic issues must be addressed so that clinicians can be guided by sound policy in the selection of ADOs for appropriate patients when the risk of diversion and abuse is high, while products without abuse-deterrent characteristics continue to be the recommended option when diversion and abuse are not significant issues.

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