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

Journal of Pain Research

Volumn 6, Issue , 2013, Pages 367-373

  Argoff, Charles E ^a   Stanos, Steven P ^b   Wieman, Matthew S ^c  

^a ALBANY MEDICAL COLLEGE   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c ENDO PHARMACEUTICALS INC   (United States)

Author keywords

Chronic pain; Opioid analgesics; Substance abuse; Tamper resistant formulations

Indexed keywords

OXYCODONE; OXYMORPHONE; TAPENTADOL;

ADVERSE OUTCOME; ANALGESIA; ARTICLE; CHRONIC PAIN; CLINICAL PRACTICE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DRUG COST; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; HEALTH CARE ACCESS; HEALTH INSURANCE; HUMAN; PATIENT ATTITUDE; PHARMACY; SELF CONCEPT; TAMPER RESISTANT FORMULATION; UNITED STATES; VALIDATION STUDY;

EID: 84878551783     PISSN: 11787090     EISSN: None     Source Type: Journal    
DOI: 10.2147/JPR.S37343     Document Type: Article

References (31)

1. Purdue Pharma LP. To determine the fasting bioequivalence of reformulated OXY tablets and original OxyContin® (OXY) tablets. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2010 [updated May 6, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00801788. NLM identifier: NCT00801788. Accessed February 21, 2013.
2. Purdue Pharma LP. To determine the fed bioequivalence of reformulated OXY tablets and original OxyContin® (OXY) tablets. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2011 [updated October 7, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01101178. NLM identifier: NCT01101178. Accessed February 21, 2013.
3. Purdue Pharma LP. A study to determine the fasting bioequivalence of reformulated OXY tablets and original OxyContin® (OXY) tablets. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2010 [updated May 17, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01100086. NLM identifier: NCT01100086. Accessed February 21, 2013.
4. Purdue Pharma LP. A study to determine the fed bioequivalence of reformulated OXY tablets and original OxyContin® (OXY) tablets. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2010 [updated April 13, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01099709. NLM identifier: NCT01099709. Accessed February 21, 2013.
5. Purdue Pharma LP. A study to determine the fed bioequivalence of reformulated OXY tablets and original OxyContin® (OXY) tablets. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2010 [updated May 6, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01100320. NLM identifier: NCT01100320. Accessed February 21, 2013.
6. Black R, Coplan P, Cassidy T, et al. Effects of reformulated OxyContin® among patients assessed for substance abuse treatment in the NAVIPPRO sentinal surveillance network. J Pain. 2012;134:S58.
7. Cassidy T, Coplan P, Black RA, Chilcoat H, Budman SH, Butler S. Initial findings on abuse rates and routes of administration following introduction of reformulated OxyContin® in a sentinel surveillance system of patients in substance use treatment. Proceedings of PAINWeek; September 7-11, 2011; Las Vegas, NV, USA.
8. Cicero TJ, Ellis MS, Surratt HL. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 2012;367(2):187-189.
9. Purdue Pharma LP. Dear Healthcare Professional. Stamford: Purdue Pharma LP. Available from: http://www.purduepharma.com/pdfs/ dearHCPletter.pdf. Accessed February 21, 2013.
10. Purdue Pharma L.P. FDA Advisory Committee on Reformulated OxyContin. Stamford: Purdue Pharma LP; 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM249272.pdf. Accessed March 6, 2013.
11. Butler S., Benoit C, Budman SH, et al. Development and validation of an Opioid Attractiveness Scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J. 2006;3:5.
12. Schoedel KA, McMorn S, Chakraborty B, Potts SL, Zerbe K, Sellers EM. Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone in recreational opioid users. J Opioid Manag. 2011;7(3):179-192.
13. Aetna Inc. 2012Aetna Preferred Drug Guide: 4-Tier/Open Formulary Plan. Hartford: Aetna Health Inc; 2011. Available from: http://media.mcclatchy. com/static/healthworks/pdf/11/20124Tier.pdf. Accessed March 6, 2013.
14. United Healthcare and Affiliated Companies. United Healthcare 2013 Prescription Drug List. Minneapolis: United Healthcare; 2013. Available from: https://www.unitedhealthcareonline.com/ccmcontent/ ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Pharmacy%20Resources/ PDL_Phys_Bk.pdf. Accessed March 6, 2013.
15. Kaiser Permanente. Kaiser Permanente 2013 Comprehensive Formulary. Rockville: Kaiser Permanente; 2013. Available from: https://healthy.kaiserpermanente.org/static/health/en-us/pdfs/nat/ Medicare_2013_NAT/comprehensive_formulary.pdf. Accessed February 21, 2013.
16. Medco Health Solutions Inc. Medco Medicare Prescription Plan® (PDP) 2012 Formulary (List of Covered Drugs). Franklin Lakes: Medco Health Solutions Inc; 2011. Available from: http://www.q1medicare.com/2012/ content/includes/pdpPlanMaterials/Medco-2012_Value_Formulary.pdf. Accessed February 21, 2013.
17. Aetna Inc. Aetna Medicare 2012 Formulary: List of Covered Drugs. Hartford: Aetna Health Inc; 2011. Available from: http://www.aetnamedicare.com/documents/individual/2012/formularies/2012_medicare_preferred_drug_list.pdf. Accessed March 6, 2013.
18. Anthem Blue Cross Life and Health Insurance Company (Anthem). Blue Cross MedicareRx Gold (PDP): 2012 Formulary (List of Covered Drugs). Woodland Hills: Anthem Blue Cross; 2011. Available from: http://www.anthem.com/ca/shop/content/olspublic/pdf/2012/ english/PDP_ComForm_MRx_Gold_CA.pdf. Accessed February 21, 2013.
19. Ontario Ministry of Health and Long-Term Care. Change in Funding Status of Oxycodone Controlled Release Tablet - (Discontinuation of OxyContin and Introduction of OxyNEO). Toronto: Ontario Ministry of Health and Long-Term Care; 2012. Available from: http://www.ocfp. on.ca/docs/annual-scientific-assembly/important-notice-regardingchange-in-funding-status-of-oxycodone-controlled-release-tablet. pdf?sfvrsn=0. Accessed March 6, 2013.
20. Purdue Pharma. Information for Vermont Prescribers of Prescription Drugs: OxyContin® (Oxycodone HCl Controlled-Release) Tablets. Stamford: Purdue Pharma LP; 2013. Available from: http://www. purduepharma.com/vermont/Oxycontin_vt.pdf. Accessed February 21, 2013.
21. Healthcare.gov [webpage on the Internet]. Healthcare blog: what is the donut hole? Washington: US Department of Health and Human Services; 2010. Available from: http://www.healthcare.gov/blog/2010/08/donuthole.html. Accessed March 6, 2013.
22. Benedek IH, Jobes J, Xiang Q, Fiske WD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drug Des Devel Ther. 2011;5:455-463.
23. Fiske WD, Jobes J, Xiang Q, Chang SC, Benedek IH. The effects of ethanol on the bioavailability of oxymorphone extended-release tablets and oxymorphone crush-resistant extended-release tablets. J Pain. 2012;13(1):90-99.
24. Janssen Pharmaceuticals. NUCYNTA® ER (tapentadol). Full Prescribing Information. Titusville: Janssen Pharmaceuticals, Inc; 2012. Available from: http://www.janssenmedicalinformation.com/assets/pdf/ products/files/NUCYNTA%20ER/pi/ENC-010401-11.pdf. Accessed February 21, 2013.
25. Rappaport RA. Division director's review and summary basis for approval NDA 200533. In: FDA.gov [website on the Internet]. Silver Spring, MD: US Food and Drug Administration; 2011 [updated August 25, 2011]. US Food and Drug Administration. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/ 200533Orig1s000SumR.pdf. Accessed February 21, 2013.
26. Cassidy TA, McNaughton EC, Butler S., Budman SH. Changes in prescription opioid abuse after introduction of an abuse deterrent opioid formulation. Proceedings of PAINWeek; September 4-7, 2012; Las Vegas, NV, USA.
27. Bartholomaeus J, Arkenau-Marić E, Galia E. Opioid extended-release tablets with improved tamper-resistant properties. Expert Opin Drug Deliv. 2012;9(8):879-891.
28. Purdue Pharma LP. OxyContin® (Oxycodone HCl Controlled-Release Tablets). Full Prescribing Information. Stamford: Purdue Pharma LP; 2010. Available from: http://app.purduepharma.com/xmlpublishing/ pi.aspx?id=o. Accessed February 21, 2013.
29. Smith ML, Hughes RO, Levine B, Dickerson S, Darwin WD, Cone EJ. Forensic drug testing for opiates. VI. Urine testing for hydromorphone, hydrocodone, oxymorphone, and oxycodone with commercial opiate immunoassays and gas chromatography-mass spectrometry. J Anal Toxicol. 1995;19(1):18-26.
30. Slatkin NE. Opioid switching and rotation in primary care: implementation and clinical utility. Curr Med Res Opin. 2009;25(9):2133-2150.
31. Butler S., Fernandez KC, Chang A, et al. Measuring attractiveness for abuse of prescription opioids. Pain Med. 2010;11(1):67-80.