The Implications of Tamper–Resistant Formulations for Opioid Rotation

Abstract

Because rates of both opioid prescribing and opioid abuse have increased, drug companies have responded by considering strategies to make opioid formulations less attractive for abuse without compromising safety or efficacy for patients with legitimate pain management needs. The emergence of tamper–resistant opioid formulations is intended to deter abuse by creating obstacles to crushing or dissolving opioid tablets and capsules. At present, 2 long–acting and 1 immediate–release (IR) opioids are available in tamper–resistant formulations. Oxycodone controlled–release and oxymorphone extended–release tablets have each been reformulated with a hardened matrix that resists crushing or dissolution in liquids, making them difficult to prepare for nasal insufflation or intravenous use. Oxycodone IR has been reformulated with aversive ingredients that create nasal discomfort if the tablet is crushed and insufflated. Tamper–resistant opioid formulations are likely to be selected for patients who are identified as being at risk for abuse. However, patients vary in their response to individual opioids and may require rotation to a series of alternative opioids before finding one that is effective and sufficiently well tolerated. With only a few tamper–resistant opioid formulations currently available, switching and rotation may become difficult. As a result, patients who do not respond to a tamper–resistant opioid formulation or experience intolerable adverse events may require rotation to a formulation without tampering safeguards. Prescribers will need to be on guard for patients who may make false claims of poor response or adverse events to avoid tamper–resistant opioid formulations. Moreover, prescribers need to be aware of any tamper–resistance mechanisms that may affect efficacy or tolerability in patients with legitimate pain management needs compared with formulations without tampering safeguards.

Keywords:

• chronic pain
• opioids
• pain management
• substance abuse
• tamper resistance