HARMS Program

HARMS Program


Risk Stratification

An innovative clinic-wide system that tailors monitoring and prescribing practices to an individual's level of risk.

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.

Risk stratification is also important so that resources for monitoring are tailored to a patient’s level of risk. For example, it would be low-yield to do weekly UDT on a low-risk patient. Conversely, doing yearly UDT on a high risk patient could miss concerning substance use.   Initial risk stratification can be done using any combination of questionnaires (Opioid Risk Tool, SOAPP-R, SOAPP-12, etc), previous urine drug tests results and/or subjective physician concerns (previous early refills, poorly defined pain diagnosis, etc). Assign the initial risk category as low, moderate, high or "structured" (very high risk, essentially managed like a patient on opioid agonist treatment for addiction). Risk stratification is meant to be practical. If it is not possible to do a questionnaire on patients, or to do a baseline UDT, then just use the information available to estimate initial risk category. If there is no time at all, then everyone could be put in the low-risk stream (this is better than nothing). The most important thing is that patients are subject to some UDT. If someone that should have been high risk was actually stratified as low risk, he/she may be detected on subsequent UDT and then have risk category escalated.

Urine Drug Testing

Urine Drug Testing (UDT) is the core of HARMS.

The other components of HARMS complement the UDT to make it practical. Central features of HARMS therefore include:

Risk stratification: (see above - risk stratification is important to guide the frequency of UDT based on the patient's individual level of risk)

Monitoring with urine drug testing: The patient's risk category is used to guide urine drug testing frequency. Low risk patients are randomly selected to provide UDT at ~10% per month, moderate risk patients at ~20% per month, and high risk patients at ~50% per month. "Structured" (very high risk) patients have regular UDT (q1-2w typically). A master list of patients and corresponding risk category is kept by clinical administration and patients are randomly selected each month from this list at the corresponding frequency for the given risk category. Over the course of the month, those patients will be called and booked a UDT appointment at the clinic within 36h of the phone call. If a patient doesn’t pick up the phone, no-shows or cancels then he/she is kept on a recall list until the UDT is provided. The physician is notified if patient continues to not provide UDT. When the patient attends the UDT appointment, he/she submits an immunoassay test (“presumptive testing”) and has the same sample sent for liquid-chromatography gas-spectrometry (LC-MS – “confirmatory testing”). START-IT is used for the administration of the UDT and unexpected results are then sent to the prescriber.

START-IT: START-IT is a national award-winning software tool built to allow expansion and further evaluation of the HARMS Program. It is meant to facilitate uptake of UDT at any clinic by making the process automated. The clinic staff conducting the UDT use a tablet PC to administer START-IT. START-IT then collects self-reports about prescribed opioids, as well as drugs and medications not prescribed. The patient then provides a urine sample and the results of the immunoassay are entered into START-IT. The algorithms then interpret the results automatically and explain the results within the limitations of the test. This information is then automatically entered into the patient’s electronic medical record (EMR). In addition to increasing uptake of UDT by making it simple, START-IT also collects data securely which can be combined with data from provincial databases (ICES) to evaluate the HARMS Program.

Guidance on how to manage UDT results: perhaps the greatest challenge for prescribers up to this point with UDT is that there is no system to give guidance on what to do with the results. HARMS borrows from principles used in the prescribing of opioid agonist treatment for addictions (methadone and buprenorphine/naloxone) to guide clinicians about how to act on UDT results. Risk category is adjusted dynamically based on the UDT monitoring. For example, a low-risk patient who has a concerning UDT would have his/her risk category elevated (monitoring is tightened). Over time, a patient may declare himself/herself as having opioid addiction or other misuse in which case appropriate treatment may be offered (opioid agonist treatment or tapering and discontinuation of opioid medication, respectively).

Clinic-wide, clinic-led: HARMS is a system that applies universal precautions to everyone at the clinic prescribed opioids for CNCP. HARMS was created knowing that primary care providers are busy and the only way to make a program like this work is to put the UDT component in the hands of the clinical administration. It would be impossible for providers to manually keep track of all of their patients’ risk categories, UDT requested/provided, etc. For this reason, the responsibility was off-loaded to clinical administration. All that prescribers need to do is decide risk category, notify the front-staff, and then act on the UDT result.

You can find out more information about the HARMS Program in this handout here.

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