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Are Abuse-Deterrent Opioid Products A Double-Edged Sword?

A review and analysis of formulations and efficacy of medications designed to lessen access to active ingredients while maintaining analgesic effects for chronic pain patients with appropriate need.
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The United States Department of Health and Human Services states that the United States is in the midst of an “opioid epidemic,” referring to the dramatic increase in abuse, misuse, and diversion of prescription opioid medications in the past decade.1 Between 2004 and 2011, emergency department visits involving prescription opioid abuse increased by 153%.2

On an average day in the United States, 3,900 people will initiate “nonmedical use” of a prescription opioid, which is defined as taking a prescription drug, whether prescribed or otherwise, in a manner for which it was not prescribed.1,3 In 2015, nearly 22,000 deaths—approximately 62 deaths each day—involved medical or nonmedical use of natural, semi-synthetic, and synthetic prescription opioid analgesics.This surpasses the annual number of deaths due to major diseases such as lymphomas or skin cancer.5

Solving the opioid epidemic is complex because of the multifactorial underlying causes. Complicating this issue is the need to maintain access to opioids for patients with chronic pain conditions for which prescription opioid analgesics are the only effective treatment.6 Any attempts to mitigate opioid abuse must not have the unintended consequence of eliminating a viable treatment option for patients using opioid medications appropriately and experiencing meaningful clinical improvement.

National Effort to Curb Abuse

In 2011, the Office of National Drug Control Policy (ONDCP) issued a multifaceted national strategy to curb drug abuse that called on pharmaceutical firms and regulatory health agencies to collaborate in developing abuse-deterrent formulations (ADFs) of opioid medications.7,8 Abuse-deterrent medications use unique formulation strategies and technologies that make it more difficult or less rewarding for a user to abuse or divert the medication’s active ingredient but maintain the drug’s analgesic effects for appropriate patients.9

Although ADFs are designed to reduce the likelihood of misuse and abuse, they do not completely eliminate their possibility because ADFs do not prevent someone from taking multiple oral doses. Therefore, a 2011 ONDCP report outlined the need for postmarketing assessment of the impact of abuse-deterrent opioid medications on public health. Evidence remains limited on the short-term and long-term impact of ADFs on clinical outcomes related to opioid abuse.10,11

There has been a significant concerted effort by the US government, regulatory agencies, and pharmaceutical companies to increase the presence of ADFs on the prescription opioid market in recent years. Despite this, many questions remain about the use of this class of medications in clinical practice. For example, the variety of technologies used in ADFs may be unclear to many prescribers, and concerns about efficacy may arise, especially when weighed against the cost of these medications.

Therefore, the objective of this review is to compare and contrast available abuse deterrent technologies and evaluate the literature related to their impact on opioid abuse and public health.

ADFs for Different Methods of Abuse

To understand the strategies employed in developing ADFs, an appreciation of the methods of opioid abuse is necessary. Abuse is defined as an intentional nontherapeutic use of a drug to achieve a desirable psychological or physiological effect.12 To achieve this psychological or “high effect,” abusers seek absorption of the highest maximum concentration of the opioid into systemic circulation and the brain in the shortest amount of time.

Although immediate-release (IR) products are the easiest to manipulate, extended-release (ER) and controlled-release dosage forms tend to have more appeal to abusers because of the large amount of active ingredient per pill that may be released at once if the drug delivery system is manipulated.13 Thus, many pharmaceutical manufacturers focus on developing ADFs of ER products instead of IR products. The ease with which a delivery system can be manipulated and the active ingredient released also are major factors that influence the likeability, or appeal, of the drug for abusers.14

Common manipulation methods to accomplish the “high effect” that abusers seek include crushing the product, dissolving it in a solvent such as ethanol, or chemically extracting the active ingredient.12 The method of manipulation may depend on the route of abuse that the user prefers. The most common routes of abuse for prescription opioids are oral ingestion (including chewing or taking multiple doses or extra doses), inhalation (snorting, smoking, or inhaling), and injection (intravenous, intramuscular, or subcutaneous).

Clinicians should be aware that the route of abuse a patient prefers may depend on a range of factors, including age, sex, geographic location, and duration of abuse.15 It has been reported that drug abuse usually begins with oral routes and transitions over time to nonoral routes, such as snorting and injecting.16 In addition, favored routes of abuse may vary based on the specific drug of abuse.12 Oxycodone tablets, for instance, have been shown to be abused primarily via oral or intranasal routes, whereas morphine tablets are preferentially abused through oral or intravenous routes. This is important because the route of abuse has a significant impact on the potential for harm to the abuser.17 Injecting and snorting are methods that are associated with an increased risk of opioid dependence and a higher fatality rate. Abuse-deterrent formulations should take into account the preferential routes of abuse for similar medications.18

Choosing an Appropriate ADF Product

Abuse-deterrent opioid products use a variety of technologies to accomplish the goal of reducing abuse while maintaining efficacy for legitimate users (Table 1).10 A familiarity with the characteristics of different ADF technologies may help practitioners choose the agent that will have the greatest potential to deter abuse in a specific patient. Many abuse-deterrent opioid products contain a combination of 2 or more abuse-deterrent technologies. There are benefits and limitations of different strategies, but no single formulation can be expected to deter all types of opioid-abuse behaviors.19, 20

Last updated on: May 16, 2017
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