Skip to main content
Log in

Developing and Initiating Validation of a Model Opioid Patient-Prescriber Agreement as a Tool for Patient-Centered Pain Treatment

The Patient - Patient-Centered Outcomes Research Aims and scope Submit manuscript



Opioid treatment agreements generally are used in pain treatment to delineate the terms and consequences of opioid use and abuse.


The US Food and Drug Administration (FDA) Safe Use Initiative convened a multi-disciplinary working group with outside experts to draft a patient-centered, model opioid treatment agreement named the Model Patient-Prescriber Agreement (model PPA). The model PPA was evaluated for readability and usability in two tests that sampled both healthcare professional and non-healthcare professional FDA employees. In a survey sent to FDA employees in the Center for Drug Evaluation and Research (CDER), 209 respondents assessed the quality of the content and the level of difficulty in reading and understanding the model PPA. Ten other FDA employees participated in usability testing to assess the effectiveness of the model PPA as an educational and decision-making tool.


The majority of the 209 CDER employee survey respondents indicated the model PPA was neutral in tone (67.5 %) and easy or somewhat easy to understand (90.4 %). Usability study participants generally thought the model PPA would facilitate discussion between patient and prescriber and that the content was informative, thorough, and clear.


These studies suggest that the working group was able to develop an opioid PPA that may be acceptable and usable among a diverse population of stakeholders. A follow-up pilot study using the model PPA in medical facilities in the USA with patients is underway and will facilitate this determination.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions


  1. Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press; 2011.

    Google Scholar 

  2. Governale L. Outpatient prescription opioid utilization in the U.S., years 2000–2009. Accessed 18 April 2014.

  3. Olfson M, Wang S, Iza M, Crystal S, Blanco C. National trends in the office-based prescription of schedule II opioids. J Clin Psychiatry. 2013;4:932–9.

    Article  Google Scholar 

  4. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA. 2013;309:657–9.

    Article  CAS  PubMed  Google Scholar 

  5. Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O’Connor PG, Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C. Opioid treatment guidelines: clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113–30.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  6. Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW, American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67–116.

    PubMed  Google Scholar 

  7. Collen M. Analysis of controlled substance agreements from private practice physicians. J Pain Palliat Care Pharmacother. 2009;23:357–64.

    Article  PubMed  Google Scholar 

  8. Fishman SM, Bandman TB, Edwards A, Borsook D. The opioid contract in the management of chronic pain. J Pain Symptom Manage. 1999;18:27–37.

    Article  CAS  PubMed  Google Scholar 

  9. Payne R, Anderson E, Arnold R, Duensing L, Gilson A, Green C, Haywood C Jr, Passik S, Rich B, Robin L, Shuler N, Christopher M. A rose by any other name: pain contracts/agreements. Am J Bioeth. 2010;10:5–12.

    Article  PubMed  Google Scholar 

  10. Arnold RM, Han PK, Seltzer D. Opioid contracts in chronic nonmalignant pain management: objectives and uncertainties. Am J Med. 2006;119:292–6.

    Article  PubMed  Google Scholar 

  11. Collen M. Opioid contracts and random drug testing for people with chronic pain—think twice. J Law Med Ethics. 2009;37:841–5.

    Article  PubMed  Google Scholar 

  12. Hahn MB. Patient compliance; wherefore art thou? Am J Bioeth. 2010;10:13–4.

    Article  PubMed  Google Scholar 

  13. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: The National Academies Press; 2001.

    Google Scholar 

  14. Chelimsky TC, Fischer RL, Levin JB, Cheren MI, Marsh SK, Janata JW. The primary practice physician program for chronic pain (©4PCP): outcomes of a primary physician-pain specialist collaboration for community-based training and support. Clin J Pain. 2013;29:1036–43.

    Article  PubMed  Google Scholar 

  15. Nicolaidis C. Police officer, deal-maker, or health care provider? Moving to a patient-centered framework for chronic opioid management. Pain Med. 2011;12:890–7.

    Article  PubMed  Google Scholar 

  16. Sullivan MD, Leigh J, Gaster B. Brief report: training internists in shared decision making about chronic opioid treatment for noncancer pain. J Gen Intern Med. 2006;21:360–2.

    Article  PubMed Central  PubMed  Google Scholar 

  17. Sullivan MD, Gaster B, Russo J, Bowlby L, Rocco N, Sinex N, Linovich J, Jasti H, Arnold R. Randomized trial of web-based training about opioid therapy for chronic pain. Clin J Pain. 2010;26:512–7.

    Article  PubMed  Google Scholar 

  18. Fishman SM, Gallagher RM, McCarberg BH. The opioid treatment agreement: a real-world perspective. Am J Bioeth. 2010;10:14–5.

    Article  PubMed  Google Scholar 

  19. Office of National Drug Control Policy. Epidemic: responding to America’s prescription drug abuse crisis. Accessed 10 April 2014.

  20. Roskos SE, Keenum AJ, Newman LM, Wallace LS. Literacy demands and formatting characteristics of opioid contracts in chronic nonmalignant pain management. J Pain. 2007;8:753–8.

    Article  PubMed  Google Scholar 

  21. Wallace LS, Keenum AJ, Roskos SE, McDaniel KS. Development and validation of a low-literacy opioid contract. J Pain. 2007;8:759–66.

    Article  PubMed  Google Scholar 

  22. Johnson KE, Schrand LM, Allen M. Evaluation of a chronic pain policy at a rural Indian Health Service clinic. IHS Prim Care Provid. 2005;30:299–305.

    Google Scholar 

  23. Barry DT, Irwin KS, Jones ES, Becker WC, Tetrault JM, Sullivan LE, Hansen H, O’Connor PG, Schottenfeld RS, Fiellin DA. Opioids, chronic pain, and addiction in primary care. J Pain. 2010;11:1442–50.

    Article  PubMed Central  PubMed  Google Scholar 

  24. Fagan MJ, Chen JT, Diaz JA, Reinert SE, Stein MD. Do internal medicine residents find pain medication agreements useful? Clin J Pain. 2008;24:35–8.

    Article  PubMed  Google Scholar 

Download references


The authors would like to thank Lee Zwanziger for her help conducting the usability testing.


No funding has been received by any of the authors for the conduct of this study or the preparation of this manuscript, and there are no conflicts of interest to declare.

Author Contributions

First author and guarantor: Mary Ghods.

Study concept and design: Mary Ghods, Dale Slavin, Brian Lappin, Carol Pamer.

Acquisition of Data: Mary Ghods, Brian Lappin, Carol Pamer, Ian Schmid.

Analysis and interpretation of data: Mary Ghods, Ian Schmid, Carol Pamer, Brian Lappin.

Drafting of the manuscript: Mary Ghods, Ian Schmid, Carol Pamer, Dale Slavin, Brian Lappin.

Critical revision of the manuscript for intellectual content: Mary Ghods, Ian Schmid, Carol Pamer, Dale Slavin, Brian Lappin.

Statistical analysis: Ian Schmid, Brian Lappin, Carol Pamer.

Study supervision: Mary Ghods, Dale Slavin, Brian Lappin.

Author information

Authors and Affiliations


Corresponding author

Correspondence to Mary P. Ghods.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOC 40 kb)

Supplementary material 2 (DOC 76 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ghods, M.P., Schmid, I.T., Pamer, C.A. et al. Developing and Initiating Validation of a Model Opioid Patient-Prescriber Agreement as a Tool for Patient-Centered Pain Treatment. Patient 8, 349–358 (2015).

Download citation

  • Published:

  • Issue Date:

  • DOI: