Clinical and Ethical Quandaries Posed by ADO Formulations

The balancing of social and regulatory benefit versus individual patient therapeutic benefit presents the clinician with a vexing dilemma. With few exceptions, strong traditions in clinical care have placed the interests of individual patients first, and interests of the general public and regulators second. So in our series on ADOs, today well address the clinical and ethical quandaries posed by ADO formulations.

This does not mean that the interests of the public and of regulators are irrelevant, but they are secondary to the interests of patients from the perspective of the clinician. Indeed, any law or policy that undertakes to compel clinicians to place the interests of others ahead of, or even on an equal footing with, those of a patient creates an inherent conflict of interest. Hans Jonas put it this way:

In the course of treatment, the physician is obligated to the patient and to no one else. He is not the agent of society, nor of the interests of medical science, the patient’s family, the patient’s co-sufferers, or future sufferers of the same disease. The patient alone counts when he is under the physician’s care.

As Jonas explains, the sole exception traditionally recognized has been genuine and grave public health emergencies. Jonas recognizes a single exception a raging epidemic in which there is a necessity to quarantine the contagious sick to protect others in the community and take also a look at these clinical strategies to minimize all the risk related to prescription drug abuse.

When analogizing this to pain management, Jonas position might accommodate strict limits on therapeutic options when there is clear and convincing evidence that a particular patient poses a serious and imminent risk of drug abuse or diversion, but not as a matter of routine custom and practice for all patients receiving opioid therapy.

The duty of the physician to promote the patient’s interests in receiving effective treatment is not viewed as being commensurate with a duty to society, except in the most extraordinary of exigent circumstances and prescribing ADOs comes, of course, with risks of abuse.

The development and dissemination of clear standards for ADO use could guide clinicians to prescribe, administer, and dispense these products in the best interest of their patients, while also considering important public health factors and compliance with regulatory requirements.

Standards could likewise assist regulators in their assessment of clinician conduct, avoiding situations in which care provided by a clinician would be evaluated as improper after a clinician has appropriately placed the interests of a specific patient above concerns for public health and regulatory compliance.

Because such standards would be intended to guide and inform clinical practice in this area, the primary responsibility for developing them should be that of health care professionals with the competencies to render such treatment. Check also this post about the Mayday Project and prescribing Abuse-Deterrent Opioids (ADOs).

While appropriate non-clinicians such as regulators may have a limited role in the process, they should not be in a position to dictate any significant aspect of clinical practice. Clear and appropriate standards of practice for ADOs would promote the provision of optimal care for each patient, and they would guide clinicians to meet public health and regulatory objectives when the quality of patient care is unaffected.

Scope and Magnitude of the Problem of Prescription Drug Abuse

The need to consider public health and regulatory matters while treating chronic pain patients with opioid analgesics reflects the reality that the abuse of diverted prescription drugs is a serious and expanding public health problem. In pain management, we have to consider Abuse-Deterrent Opioid (ADO) formulations and opioid analgesics, which can be safely and effectively used to relieve acute and chronic pain, are also the most frequently abused prescription drugs.

The Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Episode Data Set (TEDS) indicates that the proportion of all substance abuse treatment admissions aged 12 or older that reported any pain reliever abuse, increased more than fourfold between 2008 and 2018, from 2.2 to 9.8 percent.

SAMHSA’s Drug Abuse Warning Network (DAWN) data estimate that the number of emergency department visits involving nonmedical use of opioid analgesics rose from 144,644 in 2012 to 305,885 in 2016, an increase of 111 percent. Pharmacists, at least, have a good tool to fight abuse: prescription drug monitoring.

One small piece of good news is that results from the 2017 National Survey on Drug Use and Health indicate that among youths aged 12 to 17, the rate of nonmedical use of prescription drugs declined from 4.0 percent in 2012 to 2.9 percent in 2016, then held steady at 3.1 percent in 2017.

Legitimate concerns have been raised that regulatory agencies have demonstrated a tendency to draw conclusions that these data do not support. For example, regulators may conclude that even responsible opioid prescribing prompted by increased advocacy for and by pain patients has caused or contributed to the significant increase in prescription drug abuse.

As Joransen and Gilson have pointed out, much of the abuse of opioid analgesics is by recreational or street users as well as by individuals with co-morbid psychiatric conditions. Moreover, many of these abusers obtained drugs from nonmedical sources of diversion.

Improvements in the care of chronic pain patients, resulting in the provision of higher and more effective doses of opioid analgesics for patients who legitimately need them, do not necessarily contribute to the problem of prescription drug abuse. Just like cell infusion is a miracle for diabetics. may ADOs do wonders for patients in pain management.

Similar concerns about unintended consequences have been raised recently in response to the FDA’s REMS program for extended-release opioid analgesics. While the goal of reducing the harms resulting from prescription drug abuse, addiction, and diversion to non-medical use is laudable, the potential adverse effects of such approaches for patients with serious chronic pain issues, and the clinicians who seek to provide them with effective treatment through the use of such medications, may not be the very high priority that it should be.

Standards for the use of ADOs should be developed through a collaborative process involving those who are most knowledgeable about the treatment of chronic pain, the pharmacology of opioid analgesics, and the formulation of public policy so as to properly balance the needs of patients with pain and the public health concerns about curtailing prescription drug abuse and diversion. The absence from such a process of any of these critical constituencies will be likely to lead to an unbalanced or otherwise flawed approach.

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