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The HARMS Program was created to improve the safety of opioids in chronic pain by making urine drug testing practical.

It was created by primary care physicians, for primary care physicians.

"Healthcare systems and individual practices will need to be redesigned to support routine UDT"

Bair and Krebs, 2010

The HARMS Program was designed to be such a system

Summary of Key Features

  • HARMS applies proven risk mitigation strategies from the addictions literature to chronic pain patients being prescribed opioids
  • Designed for a primary care setting
  • Systems-based so can be implemented easily by any clinic, with minimal resources
  • Applies Urine Drug Testing (UDT) in a systematic way
  • START-IT is a key feature of HARMS, and uses Automated Urine Drug Testing to interpret and compile UDT results
  • Gives recommendations to prescriber on what to do with UDT results
  • Early research suggests that the HARMS Program works

The HARMS Program (High-yield Approach to Risk Mitigation and Safety) was designed and implemented by family physicians who wanted safer opioid prescribing in chronic non-cancer pain (CNCP). HARMS works based on the simple principle that every patient has some level of risk and should have prescribing and monitoring strategies tailored to that risk. Higher risk patients should have tighter control, but even patients thought to be “low risk” need some level of systematic monitoring. Every patient on opioids for CNCP is monitored systematically based on his/her risk category, and that risk category itself is adjusted dynamically based on the results of that monitoring. Urine drug testing (UDT) is the pillar of HARMS Program monitoring. We call this overall approach of monitoring and risk adjustment “Dynamic Risk Stratification”. It is drawn from key principles in the prescribing of opioids for addiction (methadone and buprenorphine/naloxone). The HARMS Program is the first of its kind in that it applies principles of Dynamic Risk Stratification to chronic pain. Early research suggests that the HARMS Program is effective, with plans for expansion and more rigorous scientific evaluation underway.

 

Listen to our CBC Interview about the HARMS Program with Dr. Ryan Patchett-Marble here.

Read an article published by CBC about the HARMS Program here.

Urine Drug Testing

Evidence for best practice in the monitoring of patients being prescribed opioids for CNCP is lacking. Current Canadian guidelines (2017) advise that the prescriber may use urine drug testing (UDT) as a risk mitigation strategy. In patients with active substance use disorder, these guidelines suggest UDT. CDC Guidelines  (2016) however, suggest that the prescriber "should use [UDT]" in all patients being prescribed opioids for CNCP. Other tools to assess risk, such as patient self-assessment, is useful for history taking but it suffers from patient subjectivity as patients often withhold drug use information. UDT, however, is an objective test that is easy to perform in a clinical setting and gives powerful information about patient drug use. Helpful preliminary information can be quickly obtained in a point-of-care setting through inexpensive UDT immunoassays. Confirmatory testing with highly accurate mass spectrometry is available in most laboratories as well. UDT is especially useful for detecting unexpected drug use (drugs not prescribed), and if concerns are found then results can be acted on to improve safety. Patients prescribed opioids with a substance use disorder are at higher risk of opioid addiction, overdose and death. Information about substance use is therefore critical to assessing a patient's risk with opioid medications.

Although there is a lack of evidence surrounding the use of UDT in opioid risk mitigation, there are studies that suggest it can be an effective tool. The Marathon Family Health Team (MFHT) designed and implemented HARMS as a practical and easy-to-use approach for the prescribing and monitoring of opioids that is centered around the use of UDT. HARMS aims to assess the risk of a patient through systematic monitoring with UDT to adjust their risk. Based on the results of the UDT the patient's risk category is adjusted so that ongoing monitoring and prescribing can be tailored to that evolving level of risk. Preliminary research suggests that the HARMS Program works. Over a 12-month period, nearly 20% of patients initially stratified as low risk had direct changes to management based on results of UDT (escalation to higher risk stream or addiction program, or taper and discontinuation). Results have been presented at conferences across Canada and are currently being submitted for peer-reviewed publication. These results are promising and warrant further investigation (See Research and Awards section).

START-IT Tool

The START-IT tool is a national-award winning, application-based software that any healthcare provider can use on a tablet or PC in the clinical setting. This novel software analyzes the results from UDT immunoassays, interprets the results for the physician automatically and can insert the results into the local electronic medical records. This tool can automatically compile large amounts of UDT data for research purposes. For the healthcare user, the START-IT tool can indicate any drugs or substances that may have caused an expected or unexpected result, possible reasons for false positives or negatives, the likelihood that the sample was tampered with and possible follow-up actions that should occur with patient management. With the START-IT tool, UDT result interpretation can occur easily, removing a barrier for UDT utilization in the clinic. When used in conjunction with the HARMS Program, this software can increase the safety of opioid prescribing and assist physicians in improving patient management.