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14 Articles in Volume 18, Issue #7
A 2018 Update: The Federal Pain Research Strategy
A Commentary on Medical Cannabis
Are Abuse-Deterrent Opioids Appropriate for Your Pain Patient?
Behind the AHRQ Report
Challenges Facing Abuse-Deterrent Formulations
Demystifying Opioid Abuse-Deterrent Technologies
Editorial: Our Clinical Pain Neighborhood
Independent Pain Practice: A Case Example
Inside Performing Arts Medicine
Letters to the Editor: ACT Therapy; Compounded Topicals
Nerve Growth Factor and Targeting Chronic Pain
Pain Control for Athletes: What Works?
Quality Training: One Center’s Experience with Pain Assessment
The Importance of Developing Professional Relationships in Pain Practice

Are Abuse-Deterrent Opioids Appropriate for Your Pain Patient?

Despite limitations, prescribers should optimize the potential of these formulations.

A PPM Ask the Expert Column

Over the past decade, the number of abuse-deterrent opioids (ADOs) has increased from one (Oxycontin) to nearly 10, with more in the pipeline. Given the extent of opioid misuse and abuse, it would be constructive to have some certainty that these agents are helpful to patients. So, Are Abuse-Deterrent Opioids Appropriate for Your Pain Patient?

 

A Q&A sign (Source: 123RF)

Although these formulations are meant to deter abuse and misuse of opioids, ADOs still pose a risk of abuse and addiction. With the same therapeutic and adverse event profiles as their regular formulation counterparts, physicians may benefit from understanding current regulatory guidance in appropriately prescribing ADOs. Collaboration with community pharmacists may also offer an enhanced approach toward effectively managing and monitoring patients who receive opioids for necessary pain management.

Weighing Addiction and Responsibility

Since the rise of the opioid epidemic, a growing number of physicians have become hesitant to prescribe opioids, whether or not they have abuse-deterrent formulations. State and federal agencies have launched programs to aid physicians in the prescribing, however, many of these strategies require added time for the clinician, leaving less time to work directly with the patient. Physician burnout, addressed in the April/May 2018 issue of Practical Pain Management, represents a growing problem in the healthcare field, making partnership among professionals crucial to opioid evaluation, prescribing, and appropriate ongoing use.

The introduction of ADOs was prompted by FDA efforts to help enhance drug safety in the face of the growing rate of opioid overdoses. The implementation of the agency’s Risk Evaluation and Mitigation Strategies (REMS) for opioids began with extended-release (ER) and long-acting (LA) formulations, mandated in 2012.1 The requirements of REMS included manufacturer-developed opioid analgesic training for clinicians. The REMS recently evolved to include immediate-release (IR) opioids, requiring each product to contain boxed warnings on the label outlining the risk for abuse, overdose, and death.1 Within the same timeframe, findings from a cross-sectional study of US ambulatory office-based visits indicated that a large percentage of opioid prescriptions are written for chronic, non-cancer pain, with nearly one-fifth of all pain patients receiving an opioid.2

FDA released a final guidance for industry related to the development of ADOs in 2015,3 with initial updates regarding generic ADOs issued in 2017.The FDA-approved ADOs function via two core deterrence mechanisms: physical barriers to avert drug extraction and pharmacological barriers to counter-act opioid agonist activity at receptors with an active antagonist.

Currently, there are eight FDA-approved ADO products, as well as several FDA-approved opioids that contain abuse-deterrent mechanisms, which have not been recognized as an ADO-approved product.5 New drug applications for Troxyca ER and Vantrela ER were withdrawn from the market in May 2018.6 All available ADOs currently on the market are branded products as the FDA only recently finalized industry guidance for the evaluation and labeling of generic abuse-deterrent formulations.4 Table I lists the current approved ADO medications along with their mechanisms of deterrence and clinical considerations. All products listed are available in the US.

Clinical Considerations for Use of FDA Approved Abuse-Deterrent Opioids(Table provided by author)

A systematic literature review examined the abuse potential of ADOs via 16 premarket studies. These studies compared oral and intranasal manipulation of ADO formulations (intact and crushed) to generic IR/ER counterparts (crushed) in non-dependent recreational drug users.The authors reported a primary outcome as “drug liking” on a 0 to 100 mm Visual Analog Scale. The study population consistently rated non-ADO formulations higher in drug liking than ADO products.

One example in the review reported that users rated oral oxycodone IR higher than (VAS score of 81.8) Xtampza ER crushed (73.4) and intact tablets (68.8). Similarly, users preferred intranasal administration of crushed RoxyBond IR (71.1) and oxycodone IR (82.9). The scores indicated that the deterrent properties of ADOs affected the abuse potential of the product, the users felt a lesser effect after attempting to manipulate the ADO products. All findings were statistically significant, with the exception of Targiniq ER. The study authors indicated that any clinical significance was unclear as there is no defined threshold on the topic.7 This review provided limited evidence for decreased abuse potential of ADOs, and when compared to other findings, the effectiveness of ADOs for deterring abuse remains debatable.

Use Your Pharmacist to Enhance Treatment Plan

Since the availability of ADOs is not sufficient to provide full-proof or complete assurance of proper use, the American Academy of Family Physicians (AAFP) published a five-step evaluation to assess patient eligibility for chronic opioid therapy.8 One recommendation is to utilize the applicable state Prescription Drug Monitoring Program (PDMP) to monitor for drug use and abuse. To assist clinicians, pharmacists in the community may be engaged to actively implement a patient-specific PDMP. The efficacy of a PDMP in pharmacy practice was established by a cross-sectional study in Indiana.9 The study found that 53% of pharmacists accredited their change in dispensing patterns to the use of a PDMP; these pharmacists were also 6.4 times more likely to dispense fewer controlled substance products. When a discrepancy is flagged, a pharmacist is well positioned to make a recommendation to the physician about altering a current opioid prescription or to consider initiating an ADO in the patient treatment plan. Admittedly, health insurance coverage must be considered in this process. With no generic equivalents on the market, insurers have been reluctant to reimburse for ADOs without first attempting alternative therapies or obtaining prior authorization.7

In addition, the CDC Guideline for Prescribing Opioids for Chronic Pain state that non-pharmacologic and non-opioid treatment are preferred as first line therapy, and these strategies should still be utilized when opioids are indicated.10

Pharmacists are readily accessible to most patients who seek to fill their medication prescriptions, and their community visibility enhances their understanding of patient adherence, lifestyle, and medication use habits. A team effort in which the physician and pharmacist work together to taper patients off current opioid therapy, initiate opioid rotation, and share in educating patients about their options introduces an approach to enhance the effectiveness of patient pain management care.

If a physician recommends opioid therapy, IR products may be suggested by the pharmacist as the first option before trying ER/LA formulations, which may lessen the need to consider use of ADOs.10 Continuous patient education on pain management and self-treatment is an essential element in managing the subjective perception of pain. Pharmacists may also serve as a readily available source for patients considering the selection of non-pharmacological treatment alternatives for pain management and keep an open line of communication with the prescriber to share patient progress and any adverse effects.

Toward More Efficient Pain-Prescribing

There is still no clear path to solving the opioid epidemic, and abuse-deterrent opioids have limitations such as cost and a lack of convincing evidence for eliminating misuse. Special considerations related to their selection (eg, inability to crush/split, most are long-acting drugs) based on the community and individual characteristics of the patient must be addressed. These next steps may be most effectively achieved through a collaborative effort of the prescribing physicians and the local pharmacist to optimize drug efficacy, patient safety, monitoring and followup.

 

See also PPM's Pain Scan literature review on this topic.

Last updated on: October 11, 2018
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Why Prescribers Need to Adopt Abuse-Deterrent Opioids
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