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Ripal Sheth, BS
SUMMARY POINTS
The Pennsylvania state legislature mandated the use of opioid treatment agreements when starting chronic pain patients on long-term opioid therapy via Act 112 of 2019.
Pennsylvania’s sample opioid treatment agreement has mutual responsibilities for both the patient and the provider.
Act 112 shifted the focus of treatment agreements away from protecting provider liability to a more patient-oriented focus on their chronic pain goals.
Maintaining provider discretion for urine drug testing and discontinuing long-term opioid therapy may further exacerbate racial disparities apparent in long-term opioid therapy.
ANALYSIS
Background
In 2019, the Pennsylvania (PA) legislature passed Act 112, which required prescribers to use an opioid treatment agreement before starting a patient with chronic pain on long-term opioid therapy. These efforts were aimed at addressing the role prescribers have played in the current opioid crisis.
Opioid treatment agreements (OTAs), also known as opioid contracts, have been used for decades by prescribers to educate patients about the benefits, risks, and limitations of opioids in the treatment of chronic pain. Despite the widespread use of these contracts, the efficacy of these types of documents on patient welfare has not been well documented. Additionally, concerns about prioritizing prescriber interests, stigmatizing patients with chronic pain, and exacerbating racial inequities in healthcare have placed these opioid treatment agreements under scrutiny. As a result of these concerns, the Pennsylvania Act 112 of 2019 made some adjustments to recommendations for prescribers utilizing treatment agreements. Understanding how these changes affect the treatment of chronic pain can help patients and providers understand the utility of OTAs.
Findings
Traditionally OTAs included “rules” that were aimed at affecting patient behavior. Failure to abide by the contract meant the loss of access to their medications [1]. Providers are also notoriously undertrained in detecting or treating patients with a substance use disorder or those diverting medications. Thus, stigmatization and distrust have compromised the use and effectiveness of OTAs. One study found that chronic pain patients reported struggling to “negotiate trust with their clinicians, a process which is fueled by the inherent subjectivity of pain symptoms” [2]. The PA Act 112 of 2019 aimed to improve this issue.
Review of the most recent sample OTAs, provided by the PA State Government, detailed responsibilities to be fulfilled by both the patient and provider. Provider responsibilities include understanding their patient’s experiences with pain, providing support for patients, and educating patients on overdose prevention and reversal [3]. By including provider responsibilities as a part of the sample opioid treatment agreement, Act 112 potentially improved OTAs by making them more collaborative, effective, and patient-centered. While this does not necessarily change a provider’s perception of their patient, it can help foster different types of conversations.
Historically, views on the focus of OTAs have been towards mitigating provider liability, rather than patient education, or excuses for discontinuing treatment. A 2014 study interviewing primary care providers (PCPs) found that “most primary care physicians believed that using an opioid treatment agreement with a patient would protect him or herself, or that other providers use them to protect themselves” [4]. Additionally, a 2012 study found that of patients reported to have signed an OTA, less than 20% recalled signing one [5]. Subsequently, the PA Act 112’s OTAs aim to shift that focus to patient education. Much of the agreement now emphasizes education for the patient by using language such as, “we talked about” and “we discussed” [3]. Shifting the language to focus on patient education can help providers guide discussion and allow patients to make well-informed decisions about their care.
Despite these changes, patient education still poses many barriers. For patients who struggle with reading or for patients that do not retain written information, this agreement can still be ineffective in their education [1]. However, Act 112 emphasizes that in order for patients to receive proper education on long-term opioid therapy, it must be paired with proper discussion and space for patients to ask questions [3].
Racial bias has also played a role with OTAs. In healthcare and the justice system, there is a higher degree of suspicion toward black patients, resulting in higher rates of drug testing, discontinuation of treatment, and a greater likelihood of facing jail time for drug offenses [6]. Much of the racial disparities that lie in with OTA contracts have to do with physician discretion, which includes determining whether patients are to be drug tested or not, and when an OTA should be initiated and terminated [7]. The PA Act 112 OTA maintains provider discretion when it comes to urine drug testing [3]. Additionally, the PA Act 112 OTA continues to not define when an OTA should be terminated or not. According to the legislation, the treatment agreement must contain a statement to ensure that patients understand “the conditions under which the treatment of the individual may be terminated” [3]. However, in both the published legislation and the published sample treatment agreement, there are no clear guidelines established for providers to discontinue treatment. This has the potential to exacerbate existing health disparities between racial groups. In fact, a retrospective longitudinal study found that black patients were more likely to have long-term opioid therapy stopped after a positive urine drug screen as shown in Figure 1 [8]. Since there are no clear guidelines on termination, black patients may be more likely to be discontinued from long-term opioid treatment due to reasons such as a positive urine drug screen than white patients.
Figure 1. Percentage of patients discontinued from long-term opioid therapy by race following a positive urine screen. SEE ARTICLE from Gaither JR, Gordon K, Crystal S, et al. Racial disparities in discontinuation of long-term opioid therapy following illicit drug use among black and white patients. Drug Alcohol Depend. 2018;192:371-376. doi:10.1016/j.drugalcdep.2018.05.033
Discussion
The Pennsylvania Act 112 of 2019 made provisions to improve upon previous OTAs. By shifting focus from provider liability to patient education and emphasizing provider responsibility in the management of long-term opioid therapy, this piece of legislation made large strides in changing the paradigm of what an opioid treatment agreement consists of. However, by maintaining physician discretion in the use of urine drug testing, and with no clear guidelines on discontinuation of treatment, the risk for racial bias remains in long-term opioid treatment programs. Ultimately, while OTAs can be useful tools for educating patients on the safe use of opioids, they are not a universal solution for managing opioid treatment. More data needs to be gathered on the implementation and efficacy of treatment agreements to universally adopt treatment agreements as a tool for opioid treatment in chronic pain management.
REFERENCES
1 Tobin DG, Keough Forte K, Johnson McGee S. Breaking the pain contract: A better controlled-substance agreement for patients on chronic opioid therapy. Cleve Clin J Med. 2016;83(11):827-835. doi:10.3949/ccjm.83a.15172
2 Buchman DZ, Ho A. What's trust got to do with it? Revisiting opioid contracts. J Med Ethics. 2014;40(10):673-677. doi:10.1136/medethics-2013-101320 3 Health and Safety – Opioid Treatment Agreements 2019 (PA). P.L. 764, No. 112. Accessed June 29, 2022. https://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2019&sessInd=0&act=112
4 Starrels JL, Wu B, Peyser D, et al. It made my life a little easier: primary care providers' beliefs and attitudes about using opioid treatment agreements. J Opioid Manag. 2014;10(2):95-102. doi:10.5055/jom.2014.0198
5 Penko J, Mattson J, Miaskowski C, Kushel M. Do patients know they are on pain medication agreements? Results from a sample of high-risk patients on chronic opioid therapy. Pain Med. 2012;13(9):1174-1180. doi:10.1111/j.1526-4637.2012.01430.x
6 Hausmann LRM, Gao S, Lee ES, Kwoh KC. Racial disparities in the monitoring of patients on chronic opioid therapy. Pain. 2013;154(1):46-52. doi:10.1016/j.pain.2012.07.034
7 Beck AS, Svirsky L, Howard D. 'First Do No Harm': physician discretion, racial disparities and opioid treatment agreements [published online ahead of print, 2021 Jul 30]. J Med Ethics. 2021;medethics-2020-107030. doi:10.1136/medethics-2020-107030
8 Gaither JR, Gordon K, Crystal S, et al. Racial disparities in discontinuation of long-term opioid therapy following illicit drug use among black and white patients. Drug Alcohol Depend. 2018;192:371-376. doi:10.1016/j.drugalcdep.2018.05.033
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