Validity testing of patient objections to acceptance of tamper-resistant opioid formulations

Figures & data

Table 1 Protocol for testing validity of objections to tamper-resistant opioids

Objection	Response
Causes more adverse events than my previous opioid	• Check the product label, manufacturer/FDA updates, and manufacturer medical information
	• Search PubMed for published reports of AEs
	• Check ClinicalTrials.gov for unpublished trial results
	• Conduct an informal Internet search to determine what recreational drug users/abusers are saying about the drug
	• Attempt to switch a patient reporting AEs with one TRF opioid to a different TRF opioid
Less effective than my previous opioid	• Check the product label, manufacturer/FDA updates, and manufacturer medical information
	• Search PubMed for published reports on efficacy and subjective effects
	• Check ClinicalTrials.gov for unpublished trial results
	• Conduct an informal Internet search to determine what recreational drug users/abusers are saying about the drug
	• Continue treatment long enough to confirm that the complaint is actually due to reduced analgesia
	• Switch a patient reporting reduced efficacy with one TRF opioid to a different TRF opioid
Not covered in my formulary	• The formulary status of a medication can be easily determined
More expensive than my previous opioid	• Check with the patient’s pharmacy about the patient’s out-of-pocket expense with the drug
	• Because all TRF opioids are branded products, patients who cannot afford the out-of-pocket costs may require a switch to a generic non-TRF opioid
	• Medicare recipients with limited resources or experiencing coverage gaps may have access to buying assistance programs

Abbreviations: AE, adverse event; FDA, US Food and Drug Administration; TRF, tamper-resistant formulation.

Table 2 Available tamper-resistant opioid formulations

Formulation	Mechanism
OxyContin® (oxycodone controlled release; Purdue Pharma, Stamford, CT, USA)	• Resists crushing and chewing
	• Turns into a viscous gel in liquids that resists intravenous abuse
OPANA® ER (oxymorphone extended release; Endo Pharmaceuticals Inc, Chadds Ford, PA, USA)	• Formulated in a hard polyethylene oxide matrix (INTAC™, Grünenthal GmbH, Aachen, Germany) designed to resist crushing
	• Turns into a highly viscous gel in liquids
Nucynta® ER (tapentadol extended release; Ortho-McNeil-Janssen Pharmaceuticals, Titusville, NJ, USA)	• Formulated in a hard polymer (INTAC®, Grünenthal GmbH, Aachen, Germany) designed to resist crushing
	• Turns into a highly viscous gel in liquids
Oxecta® (oxycodone immediate release; King Pharmaceuticals, Bristol, TN, and Acura Pharmaceuticals Inc, Palatine, IL, USA)	• Aversive ingredients cause irritation if the product is crushed and inhaled

Abbreviation: ER, extended release.