1. 2017; 20;S3-S92Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines
   Guidelines
   Laxmaiah Manchikanti, MD, Adam M Kaye, PharmD, Nebojsa Nick Knezevic, MD, PhD, Heath McAnally, MD, Konstantin Slavin, MD, Andrea M. Trescot, MD, Susan Blank, MD, Vidyasagar Pampati, MSc, Salahadin Abdi, MD, PhD, Jay S. Grider, DO, PhD, Alan D. Kaye, MD, PhD, Kavita N. Manchikanti, MD, Harold Cordner, MD, Christopher G. Gharibo, MD, Michael E. Harned, MD, Sheri L. Albers, DO, Sairam Atluri, MD, Steve M. Aydin, DO, Sanjay Bakshi, MD, Robert L. Barkin, PharmD, Ramsin M. Benyamin, MD, Mark V. Boswell, MD, PhD, Ricardo M. Buenaventura, MD, Aaron K. Calodney, MD, David L. Cedeno, PhD, Sukdeb Datta, MD, Timothy R. Deer, MD, Bert Fellows, MA, Vincent Galan, MD, Vahid Grami, MD, MPH, Hans Hansen, MD, Standiford Helm II, MD, Rafael Justiz, MD, Dhanalakshmi Koyyalagunta, MD, Yogesh Malla, MD, Annu Navani, MD, Kent H Nouri, MD, Ramarao Pasupuleti, MD, Nalini Sehgal, MD, Sanford M. Silverman, MD, Thomas T. Simopoulos, MD, Vijay Singh, MD, Daneshvari R. Solanki, MD, Peter S. Staats, MD, Ricardo Vallejo, MD, PhD, Bradley W. Wargo, DO, Arthur Watanabe, MD, and Joshua A. Hirsch, MD.

BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use.

OBJECTIVES: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique.

METHODS: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).

Summary of Recommendations:
i. Initial Steps of Opioid Therapy
1.
Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong)
2.
Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate)
3.
Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong)
4.
Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate)
5.
Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong)
6.
Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate)
7.
Establish medical necessity based on average moderate to severe (? 4 on a scale of 0 – 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate)
8.
Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate)
9.
Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate)
10.
Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)
ii. Assessment of Effectiveness of Long-Term Opioid Therapy
11.
Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate)
12.
Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate)
13.
Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong)
14.
Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong)
15.
Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong)
16.
Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong)
17.
Periodically assess pain relief and/or functional status improvement of ? 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate)
18.
Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)
iii. Monitoring for Adherence and Side Effects
19.
Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong)
20.
Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong).
21.
Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)
iv. Final Phase
22.
May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate)
23.
Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate)

CONCLUSION: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.

Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversion

Disclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a “standard of care.”