TRIAGING OUT OF ELECTIVE SURGERIES DURING THE COVID-19 PANDEMIC: THE WRONG APPROACH?

Commentary

Triaging out of elective surgeries during the COVID-19 pandemic: The wrong approach?

Takhliq Amir

Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON

Abstract

The devastating burden of COVID-19 on the health of individuals and capacities of health systems has led to blanket cancellations of elective surgeries globally. In response, surgery and anesthesia societies worldwide have published perioperative guidelines to inform the continuation of elective surgical procedures during the pandemic and the resumption of services in the intra- and post-pandemic phase. The effects of these widespread cancellations on the health of patients or the overall cost to the health systems are unclear but emerging anecdotal evidence is painting a grim picture. This commentary aims to review the current literature on the cancellation of elective surgeries in response to the COVID-19 pandemic, summarize broad recommendations from recently developed perioperative guidelines, and discuss key considerations for the resumption of elective surgeries in the intra- and post-pandemic world.

Keywords: Elective surgery, Triage, COVID-19

Corresponding author: takhliq.amir@medportal.ca

Introduction

The COVID-19 pandemic and its resultant toll on individuals of all ages have severely overwhelmed the capacities of healthcare systems worldwide. In the midst of managing an ongoing and rapidly evolving pandemic—and ensuring capacity for anticipated surges—the past year has seen blanket cancellations of elective surgeries globally (1). In comparison to emergency surgeries, elective surgeries are procedures that are scheduled in advance for conditions that are not acutely life- or limb-threatening. However, ‘elective’ does not equate to optional. Rather, the line between urgent and non-urgent for many elective procedures is blurry, with many procedures potentially a life-changing option for patients. For instance, while vascular surgeries may be scheduled as elective, cases of limb ischemia or aneurysmal disease are still urgent and require immediate treatment (1,2). The protracted delay of elective operations, such as tumour resections or hip replacements, runs the risk of increased morbidity, decreased quality of life, and increased costs for individual patients due to increased disability and time off from work (3). Some arguments in favour of the cancellation of elective surgeries include protecting patients and healthcare providers from risks of in-hospital COVID-19 transmission, increasing availability of ICU beds for COVID patients, preserving PPE, and redirecting surgeons and perioperative teams to provide support in other areas, such as critical care (4). A retrospective cohort study from China on asymptomatic patients undergoing major surgery during the incubation period of the COVID-19 infection found that intensive care was required by 44% of the patients due to COVID-19 disease progression postoperatively, with a 20% mortality rate post-ICU admission (5). However, the evidence was considered low quality and the sample size was small. Despite limited evidence, the fear of COVID-19 transmission led to blanket cancellations of elective surgeries worldwide in the initial peak of the pandemic without knowledge of short- or long-term impacts on individual patient health and health systems. The issue has since become a matter of policymaking by individual institutions and regional healthcare bodies—balancing the risk of harm due to delay of elective procedures against the possibility of increased exposure to COVID-19 in hospitals. A study in Ontario estimated the surgical backlog between mid-March to mid-June 2020 to be over 148,000 surgeries, with an estimated time of 84 weeks needed for clearance (6). Results from the study demonstrated a drop in surgical volume by 38% for cancer, 42% for cardiac, 73% for vascular, 81% for transplant, 94% for pediatric surgeries, and 96% for other adult surgeries in April 2020 compared to April 2019. For many of these patients, at best, cancellations equate to a prolonged wait to healing. At worst, they equate to progressively debilitating pain/complications and the potential for irreversible disease progression.

Development of surgical triage guidelines

Back in March 2020, when Italy’s health system became incapacitated by the pandemic, the Italian College of Anesthesia, Analgesia, Resuscitation, and Intensive Care released guidelines for triaging care. These guidelines included factors such as age, comorbidities, and pre-existing functional status in the algorithm for decision-making regarding ICU admissions (7). Since then, several surgery and anesthesia societies have published guidelines regarding the provision of surgical care during the COVID-19 pandemic, many of which balance broad public health safety considerations and resource availability with individual acuity of need. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and The European Association for Endoscopic Surgeons (EAES) released recommendations regarding surgical response during the pandemic (8). Their guidelines suggested postponing elective surgical and endoscopic procedures based on the burden of COVID-19 locally, general recommendations for procedural considerations (i.e., dedicated ORs, minimizing OR staff numbers, etc.), and practical measures for laparoscopic, endoscopic, and other surgical procedures. The American College of Surgeons (ACS) statement focused on emphasizing regional cooperation to ensure capacity and resources for surgical procedures, principles for prioritization strategies (i.e., phased re-opening of ORs, specialties’ prioritization, etc.), and discussed considerations for surgical care from the preoperative phase to post-discharge care planning (9). The ACS further published individualized guidelines for various types of surgeries (i.e., vascular surgery, pediatrics, etc.) aimed at facilitating local decision-making (10). Others, such as the Federation of Surgical Specialty Associations (U.K.), have published regularly updated guidelines that define appropriate timelines based on the type of condition and procedure (11). For example, an aortic dissection or empyema with sepsis should be treated with emergency surgery within 24 hours, while surgery for aortic stenosis can be performed within 1 month. In Ontario, Ontario Health released a report titled A Measured Approach to Planning for Surgeries and Procedures During the COVID-19 Pandemic, which included thresholds for acute care capacity, protective equipment, and personnel availability before elective surgeries could be resumed (12). While many of these guidelines likely provide some much-needed direction to individual institutions, the limited research evidence to support their recommendations continues to present a challenge. In a scoping review on the short- and long-term effects of the pandemic on the delivery of surgical services, it was found that many of these newly developed perioperative guidelines only offer anecdotal data based on individual care provider expertise (13). Upon review of the guidelines, it also becomes clear that beyond general safety and resource availability recommendations, they offer no consensus on the process of prioritizing certain procedures, surgical specialties, or defined plans for the restart of surgical care in the postpandemic phase. While the value of individual expertise should not be undermined, this has inadvertently left the door open for considerable uncertainty in best practices and likely increases

the moral and ethical dilemma faced by surgeons, anesthesiologists, and perioperative teams involved in healthcare.

Considerations for elective surgeries in the intra- & post-pandemic phase

Given the extraordinary nature of the pandemic and the massive scale-back of elective surgeries globally, it remains a challenge to identify the best method to manage the backlog of elective procedures after the pandemic. One study, led by the COVIDSurg Collaborative, projected an estimated 28 million elective procedures to be cancelled or postponed during the 12-week peak of the pandemic (4). They also estimated that a median of 45 weeks would be required to clear the backlog with a 20% increase in surgical volume in the post-pandemic setting. Arguably, the burden of COVID-19 on those facing delays in care may have just as devastating of an impact on the health of individuals as that caused by the virus itself. Articles in mainstream media are rife with examples of people suffering from health consequences due to cancelled surgeries (i.e., heart disease or cancer care) (1). Cancellation of elective surgeries also present substantial—and potentially catastrophic—consequences for health systems globally. A study published in August 2020 calculated the potential cost of postponing elective procedures for at least 3 months in the United Kingdom (U.K.) (2). With the possibility of 40,000 elective procedures cancelled, the authors estimated that the cost of clearing the resultant backlog would be over £2 billion, or ~$3.5 billion CAD. This cost is likely to be significantly higher if patient morbidity caused by delays in healthcare was taken into account. While the solution to this problem remains to be identified, it has become clear that complete cancellations of elective surgeries do not take into account the nuances of individual patient needs, operative indications, and the spectrum of disease that is involved. A starting point in resuming elective surgical care, then, should be a more granular approach that slowly triages surgical patients back into care based on the urgency of their condition. Engelman et al.’s proposed principles for adult cardiac surgical programs is one example to guide the re-initiation of surgical care: 1) collaboration to achieve increased case volumes based on local resources available within the healthcare system; 2) prioritization of patients based on factors suggesting that they are at a high-risk; and 3) constant re-evaluation of local conditions to monitor the rise in hospital admissions, availability of resources, and risk of transmission to healthcare providers and patients (14). Another approach places the emphasis on lifesaving operations unless resource scarcity necessitates a shift to prioritization based on quality of life years saved (15). With this approach, considerations for surgical care can be divided into two different phases—before and after the peak of the pandemic—with a staggered approach aiming to ensure gradual recovery of surgical volumes. To guide prioritization of individual patients, the MeNTS (medically necessary, timesensitive procedures) scoring system can be utilized (16). It includes 21 factors related to the procedure (i.e., length of hospital stay, duration of operation, etc.), disease (i.e., risk of delay on

the outcome, alternative non-surgical therapeutic options, etc.), and the patient (i.e., age, preexisting comorbidities, etc.). The total scores are then used to estimate the level of surgical risk, risk to personnel, and resource utilization. The use of such a tool can help to identify patients most in need of surgeries and reduce moral and ethical burdens placed on healthcare providers who have to make challenging decisions that measure individual patient needs against broader public health risks. Other recommendations can be more practical in nature and warrant consideration for future pandemic planning. Ensuring adequate PPE for healthcare workers, having protocols for designated ORs, ICUs and wards, maintaining constant public health communication, and ensuring that hospital leadership secure enough supply of resources to provide support for patients are all imperative to maintaining a functioning healthcare system (17,18). Where procedures are cancelled, providing simple reassurance to patients through telemedicine can go a long way towards ensuring that they are not falling through the cracks (19).

Conclusion

While the COVID-19 pandemic has posed significant risks to individuals worldwide, the need to allocate resources and care safely and equitably is crucial. Blanket cancellation of elective surgeries is dangerous for the health of countless individuals and communities, likely made worse by the inability to measure the full impact on patients’ health outcomes at this time. It is likely that in the aftermath of this pandemic, epidemiological and clinical data will emerge regarding the perioperative factors and postoperative outcomes that are most significant when prioritizing surgical services. Research to evaluate the effects of elective surgery cancellations on ‘collateral damage’—both the health costs to patients and the economic costs to healthcare systems as a result of declining quality of life and worsened conditions owing to a delay in care—is greatly needed. In the post-pandemic world, then, it would be crucial for health systems to develop a disaster plan that includes policies and processes for the continuation or delivery of surgical services during public health crises. Until then, all healthcare bodies and institutions should deeply reconsider the potentially catastrophic impacts of the cancellation of elective surgeries on the health of those unable to receive timely care during this pandemic.

References

1. Rosenbaum L. The untold toll—the pandemic’s effects on patients without Covid-19. N

Engl J Med. 2020 Jun;382:2368-2371.

2. Ding A, Onida S, Davies AH. The painful cost of cancelling surgery due to COVID‐19‐can we do anything about it? Br J Surg. 2020 Aug;107(9):e336.

3. Fu SJ, George EL, Maggio PM, Hawn M, Nazerali R. The Consequences of Delaying

Elective Surgery: Surgical Perspective. Ann Surg. 2020 Aug;272(2):e79–e80.

4. Negopdiev D, Collaborative C, Hoste E. Elective surgery cancellations due to the COVID19 pandemic: global predictive modelling to inform surgical recovery plans. Br J Surg. 2020 Jul;107(11):1440-9.

5. Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, et al. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection.

EClinicalMedicine. 2020 Apr;21:100331.

6. Wang J, Vahid S, Eberg M, Milroy S, Milkovich J, Wright FC, et al. Clearing the surgical backlog caused by COVID-19 in Ontario: a time series modelling study. CMAJ. 2020

Nov;192(44):E1347-56.

7. Craxì L, Vergano M, Savulescu J, Wilkinson D. Rationing in a pandemic: lessons from

Italy. Asian Bioeth Rev. 2020 Sept;12(3):325-30.

8. Francis N, Dort J, Cho E, Feldman L, Keller D, Lim R, et al. SAGES and EAES recommendations for minimally invasive surgery during COVID-19 pandemic. Surg

Endosc. 2020 Jun;34(6):2327-31.

9. Jou J, Waterman R, Rhodes L, Haworth J, Moberg A, Schaefer R, McHale M. Essential surgery during the covid 19 pandemic: The implementation of a pre-operative universal covid testing program. The American Journal of Surgery. 2021 Apr 1;221(4):770-1.

10. American College of Surgeons [Internet]. Joint Statement: Roadmap for Maintaining

Essential Surgery during COVID-19 Pandemic; 2020 [updated 2020 Aug 10; cited 2020

Nov 23]. Available from: https://www.facs.org/covid-19/clinical-guidance/nov2020roadmap

11. American College of Surgeons [Internet]. COVID-19: Elective Case Triage Guidelines for

Surgical Care; 2020 [updated 2020 Mar 27; cited 2020 Nov 23]. Available from: https://www.facs.org/covid-19/clinical-guidance/elective-case

12. The Federation of Surgical Specialty Associations [Internet]. COVID-19 documents; [updated 2021 May 13; cited 2020 Nov 23]. Available from: https://fssa.org.uk/covid-

19_documents.aspx

13. Ontario Health [Internet]. A Measured Approach to Planning for Surgeries and Procedures

During the COVID-19 Pandemic; 2020 [updated 2020 May 7; cited 2020 Nov 23].

Available from: https://www.ontariohealth.ca/sites/ontariohealth/files/202006/A%20Measured%20Approach%20to%20Planning%20for%20Surgeries%20and%20Pr ocedures%20During%20the%20COVID-19%20Pandemic.pdf

14. Søreide K, Hallet J, Matthews JB, Schnitzbauer AA, Line PD, Lai PB, et al. Immediate and long‐term impact of the COVID‐19 pandemic on delivery of surgical services. Br J Surg. 2020 Sep;107(10):1250–1261.

15. Engelman DT, Lother S, George I, Ailawadi G, Atluri P, Grant MC, et al. Ramping up

Delivery of Cardiac Surgery During the COVID-19 Pandemic: A Guidance Statement from

The Society of Thoracic Surgeons COVID-19 Task Force. Ann Thorac Surg. 2020

Aug;110(2): 712–717.

16. Brindle ME, Doherty G, Lillemoe K, Gawande A. Approaching surgical triage during the

COVID-19 pandemic. Annal Surg. 2020 Aug;272(2):e40.

17. Prachand VN, Milner R, Angelos P, Posner MC, Fung JJ, Agrawal N, et al. Medicallynecessary, time-sensitive procedures: a scoring system to ethically and efficiently manage resource scarcity and provider risk during the COVID-19 pandemic. J Am Coll Surg. 2020

Aug;231(2):281-288.

18. Cavallo JJ, Donoho DA, Forman HP. Hospital capacity and operations in the coronavirus disease 2019 (covid-19) pandemic—planning for the nth patient. JAMA Health Forum. 2020 Mar;1(3):e200345-e200345.

19. Mayol J, Pérez CF. Elective surgery after the pandemic: waves beyond the horizon. Br J

Surg. 2020 Aug;107(9):1091-1093.

20. Ives J, Huxtable R. Surgical ethics during a pandemic: moving into the unknown? Br J

Surg. 2020 Aug;107(9);1089-1090.

Commentary

Opioid treatment agreements in chronic nonmalignant pain: The solution or the problem?

Jasper C Ho and Yasovineeth Bhogadi

Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Canada

Abstract

Opioid treatment agreements (OTAs) are routinely used in the primary care setting for patients initiating chronic opioid therapy for non-malignant pain despite limited empirical evidence supporting their use. In this commentary, we contextualize current practices in Ontario with regard to OTAs. We highlight the lack of high-quality evidence showing that utilizing OTAs leads to beneficial outcomes for patients or prescribing physicians, and explore the ethical quagmire they create in clinical practice. Physicians utilizing OTAs need to be aware of the limitations of OTAs and sensitive to their potential impact on the physician-patient relationship. We advocate for a return to a collaborative, patient-centered approach with physicians encouraged to involve patients in a shared decision-making process to set mutually agreeable goals for treatment with opioids, to obtain informed consent from patients, and to better tailor these agreements to reflect the interests of all parties involved. Further research and debate are required to improve the effectiveness and ethical justification for using OTAs in clinical practice.

Keywords: opioids, ethics, primary care, opioid treatment agreement, contract.

Corresponding author: vineeth.bhogadi@medportal.ca

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Introduction

Opioid treatment agreements (OTAs) are a ubiquitous part of managing chronic opioid use in the primary care setting. First introduced in a 1994 abstract by Kirkpatrick et al. and formalized in 1995 by Burchman and Pagel (1,2), the original opioid “protocol-contract” (Figure 1) for nonmalignant chronic pain has faded from the literature, and current clinical practice has diverged from its roots. Original formulations of OTAs began with a statement of the lack of evidence of opioids for the treatment of chronic non-malignant pain. Patients were clearly warned about the risks of constipation, sedation, cognitive impairment, respiratory arrest, physical and psychological dependence, tolerance, and neonatal abstinence syndrome (2). Further iterations focused on patient expectations: analgesia as an approach to maintaining function and not to completely eliminate pain; opioids as bridging measures while developing pain management behaviours; and frequently scheduled re-evaluations of opioid requirements and response (1). In contrast, modern OTAs delineate strict limits on behaviours, doses, refills, and firmly defend the right of the physician to terminate the prescription or relationship (3). Although today’s iterations seem more proscriptive and less informative, OTAs used in major United States academic pain centres even in the late 1990s had consistent themes of disallowed behaviour and termination procedures (4). In this article, we aim to provide commentary on OTAs in the current local context given the shift in the opioid-related landscape over the past few decades. We narratively summarize pertinent evidence supporting utilization of OTAs in practice, potential ethical concerns associated with their use, and advocate for a transition away from OTAs to a more collaborative, patient-centered approach towards chronic pain.

I understand that I am receiving opioid medication from Dr ______ to treat my pain condition. I agree to the following conditions under which this medication is prescribed:

1. I will not seek opioid medication from another physician. Only Dr ______ will prescribe opioids for me. 2. I will not take opioid medication in larger amounts or more frequently than is prescribed by Dr ______. 3. I will not give or sell my medication to anyone else, including family members; nor will I accept any opioid medication from anyone else. 4. I will not use over-the-counter opioid medications. 5. I will only fill my prescriptions at one pharmacy, which is: _____________ 6. I understand that if my prescription runs out early for any reason, I will have to wait until the next prescription is due.

I understand that if I break these conditions, Dr ______ may choose to cease writing opiate prescriptions for me, and this will be noted in my medical record.

Figure 1. Example opioid treatment agreement, adapted from Kahan 2006 (3).

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Current utilization of opioid treatment agreements in Canadian practice

There are no specific Canadian federal or provincial legislative requirements for clinicians to use OTAs when prescribing opioids. However, national regulatory and medico-legal bodies have made recommendations in this context (5). The official stance of the College of Physicians and Surgeons of Ontario (CPSO) is that OTAs may be considered, but not required when prescribing opioids (5). The Canadian Medical Protective Association has recommended the use of OTAs based on now-outdated guidelines (6). These recommendations have made their way into provincial standards and metrics for primary care as well: Ontario’s Family Health Teams (FHTs) may require OTAs for every patient on chronic opioid therapy regardless of individual risk for misuse or diversion, and Health Quality Ontario’s Primary Care Reports delivered biannually to FHTs specifically suggest OTA uptake (7).

Rationalizing opioid treatment agreement use

If not strict legal or professional requirements, what drives this practice? The indoctrination of OTAs as standard management of patients on chronic opioids in the primary care setting may originate from physician unease with opioids. In their paper, Arnold and colleagues theorize that physicians cling to OTAs due to “opiophobia” originating from hyper-awareness of the negative effects of opioids on individuals and society—thereby ensuring legal and moral defensibility of their prescribing practices—as well as a need to control the perceived inherent uncertainties associated with patients on chronic opioid therapy (8). Concordantly, medical residents demonstrate increased use of OTAs compared to more experienced clinicians, suggesting that they may be more malleable to expectations of “good clinical practice” given their relative inexperience (9). Furthermore, the use of OTAs increases residents’ comfort and sense of reward with managing chronic opioids, which tend to be low at baseline (10,11). Symbolic control codified as OTAs may justify overly rigid limits, unilaterally modifying treatment plans, or limited individualization of treatment plans.

Evidence for opioid treatment agreements is limited

A 2010 systematic review showed a 7–23% absolute risk reduction in opioid misuse with OTAs in four cohort studies (12). However, the overall evidence was of poor quality and high heterogeneity, limited by considerable variation in the definition of opioid misuse in the identified studies (12). Additionally, most studies included were conducted in specialty pain clinics or primary care practices with complex management strategies not representative of the outpatient settings where most patients are prescribed long-term opioids for chronic nonmalignant pain (12). Most recently, the 2017 Canadian Guidelines for Opioids for Chronic NonCancer Pain did not recommend OTAs based on a meta-analysis of four studies, which concluded that formal structured treatment agreements did not lead to a significant difference in opioid misuse rates in patients with chronic non-cancer pain and resulted in a small trend towards harm (13). Most analyses and guidelines discuss the effects of agreements on opioid misuse or diversion: these are real and pressing public health and safety concerns that happen to directly

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challenge the ego of physician authority. Yet, beyond misuse, there was an astonishing lack of evidence in the literature for whether OTAs decrease inappropriate opioid prescribing; decrease the duration of such therapy; increase patient satisfaction, pain control, or functional status; or reduce the adverse effects of chronic opioid therapy. One nonrandomized study conducted in Arizona showed that OTAs are negatively associated with opioid discontinuation and have no impact on decreasing opioid dosage (14). These individualized patient-centered outcomes should be more important in our clinical practice than determining misuse or diversion and should be more thoroughly explored.

OTAs damage the physician-patient relationship and are ethically questionable

OTAs significantly conflict with our basic duty: primum non nocere or first, do no harm. When OTAs are used to alleviate physician discomfort, the measured balance between benefits and harms to individual patients is disrupted with paternalistic considerations that constrain the freedoms and rights of patients (8). The potential for harm resulting from “best practice” opioid management cannot be ignored. Physicians who tend to use urine drug tests (UDTs), OTAs, and other “opioid best practice” tools tend to be more likely to discontinue opioids for patients with aberrant opioidrelated behaviours; paradoxically, they are more likely to confidently prescribe opioids in the first place (15). These same practices may exacerbate bias and discrimination in pain management. For example, Black primary care patients are less likely to have their pain documented or to be seen by a pain specialist, but more likely to have higher numbers of UDTs and to be referred for substance abuse assessments (16). OTAs provide prior justification for this nonrandom screening. Results of these UDTs are inconsistently interpreted: when positive for heroin or cocaine, opioid renewal rates are significantly lower than if nonprescribed marijuana, opioids, or benzodiazepines are found (17). Yet, logically, concomitant use of so-called illicit drugs does not necessarily negate valid indications for opioids. Requiring patients to sign OTAs can be construed as coercive, particularly when presented as a mandatory condition to treatment. Coercion prevents informed consent in all circumstances (18). Patients, especially those with chronic pain, are by design placed into a situation where they have no choice but to sign an agreement that is physician-centric in order to obtain controlled medications, or risk being under-treated (19,20). One ethically concerning study forced patients already on chronic opioids into choosing to comply with OTAs and UDT, wean opioids, or leave the practice (21). No consideration in the analysis was given to factors in their decisions. Unsurprisingly, patients who sign OTAs worry more about having their opioids discontinued and feel less trusted by their doctor (22). As with other aspects of healthcare, the true meaning of OTAs remains inaccessible to the layperson. Only half of patients with OTAs are aware of them (23). The language used is typically eight grade levels above the recommended reading level for healthcare documents (24). It is reasonable to question whether patients can justifiably be threatened with penalties, when a significant portion of them cannot understand or acknowledge the very nature of their agreement, limiting true informed consent. Given that adequate pain control is a fundamental human right as well as a core obligation of physicians, we should be more vigilant about reducing these barriers to better treatment of chronic pain (25).

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Moving past treatment agreements

OTAs were initially devised with positive intentions in the wake of increasing recognition of the harms of opioids, leading to uptake and inclusion of recommendations by regulatory and medicolegal bodies such as the CPSO to prevent opioid misuse and diversion. However, we need to openly acknowledge the limited high-quality evidence to date supporting their effectiveness and impact on patient-centered health outcomes (12,26,27). Recommendations for their use should be based on proven benefits and harms in practice. It is therefore difficult to draw meaningful conclusions on the effectiveness of OTAs or necessarily advocate for their exclusion from clinical practice. Physicians should utilize caution and reflect on their personal rationale for utilizing OTAs and the specific contents therein. In lieu of continuing to promote the use of OTAs via medical dogma and organizational standards, this defensive contractual approach to patient care should be modified into a less rigid, more individualized patient-centered approach. This will be an enormous challenge given their integration into many facets of medicine. Yet, their lack of certain benefits counterbalancing significant potential ethical issues calls for change at all levels. We encourage physicians to engage patients in a shared decision-making process where both parties can negotiate, settle on mutually agreeable goals for treatment, and carefully document informed consent for that plan (28). In a return to original intentions, more emphasis should be placed on communicating the potential benefits and harms of opioids, and frequent reevaluation of response and requirement for chronic opioid therapy should be strongly considered. Foreseeable challenges are that shared decision-making models of chronic opioid therapy and monitoring likely require more time, attention, and careful consideration in day-to-day practice. Many physicians may require additional support and education from their institutions, regulatory bodies, and government health authorities to effectively navigate such conversations with patients. At the minimum, health-care practitioners should be aware of the scope and limitations of the available evidence supporting OTAs in current clinical use. As a whole, we should advocate for more research and clinical integration of patient-centered outcomes and collaborative opioid treatment in primary care.

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References

1. Kirkpatrick AF, Derasari M, Kovacs PL, Lamb BD, Miller R, Reading A. A protocolcontract for opioid use in patients with chronic pain not due to malignancy. J Clin Anesth. 1998;10(5):435–43. 2. Burchman SL, Pagel PS. Implementation of a formal treatment agreement for outpatient management of chronic nonmalignant pain with opioid analgesics. J Pain Symptom

Manage. 1995 Oct;10(7):556–63. 3. Kahan M, Srivastava A, Wilson L, Mailis-Gagnon A, Midmer D. Opioids for managing chronic non-malignant pain: safe and effective prescribing. Can Fam Physician. 2006

Sep;52(9):1091–6. 4. Fishman SM, Bandman TB, Edwards A, Borsook D. The opioid contract in the management of chronic pain. J Pain Symptom Manage. 1999 Jul;18(1):27–37. 5. CPSO - Advice to the Profession: Prescribing Drugs [Internet]. [cited 2020 Nov 11].

Available from: https://www.cpso.on.ca/Physicians/Policies-

Guidance/Policies/Prescribing-Drugs/Advice-to-the-Profession-Prescribing-Drugs 6. Canadian Medical Protective Association. Opioids: We can do better [Internet]. 2016 [cited 2020 Nov 15]. Available from: https://www.cmpa-acpm.ca/static-assets/pdf/about/annualmeeting/com_16_opioid_We_can_do_better-e.pdf 7. Primary Care Practice Reports - Health Quality Ontario (HQO) [Internet]. [cited 2020 Nov 11]. Available from: https://www.hqontario.ca/quality-improvement/practicereports/primary-care 8. Arnold RM, Han PKJ, Seltzer D. Opioid contracts in chronic nonmalignant pain management: objectives and uncertainties. Am J Med. 2006 Apr;119(4):292–6. 9. Touchet BK, Yates WR, Coon KA. Opioid contract use is associated with physician training level and practice specialty. J Opioid Manag. 2005;1(4):195–200. 10. Fagan MJ, Chen JT, Diaz JA, Reinert SE, Stein MD. Do internal medicine residents find pain medication agreements useful?. Clin J Pain. 2008;24(1):35–8. 11. Yanni LM, Weaver MF, Johnson BA, Morgan LA, Harrington SE, Ketchum JM.

Management of chronic nonmalignant pain: a needs assessment in an internal medicine resident continuity clinic. J Opioid Manag. 2008;4(4):201–11. 12. Starrels JL, Becker WC, Alford DP, Kapoor A, Williams AR, Turner BJ. Systematic review: treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. 2010;152(11):712–20. 13. Busse J. The 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain. Cancer

Pain. 2017;105.

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14. Patchett D, Grover M, Kresin M, Bryan M, Nordrum J, Buras M, et al. The benefits of a standardized approach to opioid prescribing. J Fam Pract. 2019;68(6):E1–7. 15. Razouki Z, Khokhar BA, Philpot LM, Ebbert JO. Attributes, Attitudes, and Practices of

Clinicians Concerned with Opioid Prescribing. Pain Med. 2019 Oct 1;20(10):1934–41. 16. Hausmann LRM, Gao S, Lee ES, Kwoh CK. Racial disparities in the monitoring of patients on chronic opioid therapy. Pain. 2013;154(1):46–52. 17. Hosain F, Lee J, Ata A, Bhullar RK, Chang AK. Physician Renewal of Chronically

Prescribed Controlled Substances Based on Urine Drug Test Results. J Prim Care

Community Health. 2019;10(101518419):2150132719883632. 18. Berg J, Appelbaum P, Lidz C, Parker L. Informed Consent: Legal Theory and Clinical

Practice. Implementation Science and Practice Advances Research Center Publications [Internet]. 2001 Jan 1; Available from: https://escholarship.umassmed.edu/psych_cmhsr/121 19. Rager JB, Schwartz PH. Defending Opioid Treatment Agreements: Disclosure, Not

Promises. Hastings Cent Rep. 2017 May;47(3):24–33. 20. Deep K. Use of narcotics contracts. AMA J Ethics. 2013;15(5):416–20. 21. McCann KS, Barker S, Cousins R, Franks A, McDaniel C, Petrany S, et al. Structured

Management of Chronic Nonmalignant Pain with Opioids in a Rural Primary Care Office.

J Am Board Fam Med JABFM. 2018;31(1):57–63. 22. Sherman KJ, Walker RL, Saunders K, Shortreed SM, Parchman M, Hansen RN, et al.

Doctor-Patient Trust Among Chronic Pain Patients on Chronic Opioid Therapy after

Opioid Risk Reduction Initiatives: A Survey. J Am Board Fam Med JABFM. 2018;31(4):578–87. 23. 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 Malden Mass. 2012;13(9):1174–80. 24. Roskos SE, Keenum AJ, Newman LM, Wallace LS. Literacy Demands and Formatting

Characteristics of Opioid Contracts in Chronic Nonmalignant Pain Management. J Pain. 2007 Oct 1;8(10):753–8. 25. Lohman D, Schleifer R, Amon JJ. Access to pain treatment as a human right. BMC

Medicine. 2010 Jan 20;8(1):8. 26. Anderson E, Burris S. Opioid treatment agreements are the answer. What is the question?.

Am J Bioeth AJOB. 2010;10(11):15–7.

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27. Staehler TMM, Palombi LC. Beneficial opioid management strategies: A review of the evidence for the use of opioid treatment agreements. Subst Abuse. 2020 Apr 2;41(2):208–15.

28. Payne R, Anderson E, Arnold R, Duensing L, Gilson A, Green C, et al. A rose by any other name: pain contracts/agreements. Am J Bioeth AJOB. 2010;10(11):5–12.

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