Background: Guidelines for treatment of acute and chronic non-cancer pain (CNCP) should be developed considering the balance of risks, harms and benefits to promote safe and effective use. The evidence of effectiveness of opioids for pain and function is of low quality. Their adverse effects are often under-appreciated or ignored. Opioids are now the leading cause of injury deaths in the US and Canada. Other adverse effects are common; effectiveness for other than severe acute pain is variable and quite limited.

Objectives: To summarise the methods for consideration of risks, harms and benefits in guideline development.
To present the balanced approach used in the development of the revised ACOEM opioid guideline.
To support clinician, patient, employer and payer decision making, considering risks v benefits

Methods: We used the ACOEM methodology to search, critically assess and synthesise the literature about the positive and negative effects of chronic opioid use for acute, subacute and chronic pain.

Results: A summary of generally low-quality evidence revealed very small improvements in subjective pain. Evidence of effectiveness had multiple methodological issues. On the other hand, opioids affect most organ systems, with common effects on the GI system and less frequent but significant risks of road crashes, respiratory and cognitive problems, overdose and death among patients and members of the public using others’ opioids. These effects are related to dose, age, gender, comorbidity, and concurrent use of multiple opioids and sedative/hypnotic and psychiatric medication. Review of observational studies is an important part of guideline recommendation development when trial evidence is not available. 

Conclusions: Clinicians, patients, employers, payers and medical organisations should consider the balance of positive and negative effects of drugs such as opioids on personal and public safety, quality of life, total costs, and mortality and morbidity. Given the minimal evidence of benefit of opioid use for chronic pain, informing stakeholders about effects and risks is critical to objective informed decision making.