Appendix I: HARMS Program Implementation

Consideration prior to implementation
There are numerous elements you should consider preparing for prior to implementing a UDT system such as HARMS. The key here is that you will ideally have everyone at the clinic on board, and by preparing appropriately you can avoid some of the challenges that we faced with implementation of our system.

Physician education
1) Theory about why UDT is useful – using parts of this manual (Chapter 9 in particular), or one of our online videos (harmsprogram.ca/harms-program/) is a good place to start.

2) UDT Interpretation: In addition to getting physicians behind the idea that UDT is useful and – in a structure such as HARMS – not too onerous, it is important to inform physicians that we are, on the whole, not adept at UDT interpretation. Understanding this limitation will hopefully prevent misinterpretation of UDTs, and subsequent mismanagement decisions. Reviewing Chapter 8 of this manual, or even simply by using START-IT, is a good place to start to avoid misinterpretation errors.

3) Myths: there are a few physician cognitive errors that are important to dispel. The absence of observing behavioural concerns is not enough to conclusively say that the patient is not being harmed by opioids (hence why we recommend UDT with everyone prescribed opioids for CNCP). Secondly, it is important that physicians understand that the goal of UDT is not to punish patients. The goal is simply to inform the risk/benefit balance and guide if/how we may prescribe opioids.

Administrator education
The goal here is to educate administrators on their role within the HARMS Program. That really comes down to taking the burden of the UDT system off of physicians as much as possible, as we try and identify who might be harmed by opioid medications. There are chapters within the manual, identified at the top with the administrator symbol, that are particularly relevant for the administrators. Also of importance, we are not trying to “catch” patients. If the staff has a positive non-judgmental attitude, then this will filter down to the patient experience. We would strongly encourage discussion/roll-out of the program at a clinic staff meeting(s) so that everyone is informed and can ask questions, etc.

Patient education
It is important that patients are aware of the program and why it’s being done. Once again, there are likely to be misconceptions. UDT often takes on punitive connotations and patients may initially feel as though it is inappropriate. At the same time, everyone has heard about the opioid crisis and by describing it as a universal precaution to do our part with the opioid epidemic, there should be little push-back. While methods for patient education in a small town such as ours is likely different from larger communities, you may consider placing brochures around the office (link to our brochure), and secondary methods include the previous topics of ensuring that clinic medical staff, and non-medical staff, are educated on how the program works and why it is being done.

Decisions around UDT conduction:

UDT Clinics
We recommend creating a few “UDT clinics” per week, where patients are booked sequentially in blocks, as opposed to booking them sporadically throughout the week. This is for several reasons: if you are using any anti-tampering measures in the bathroom then you only have to set it up twice per week; if you have a part-time staff member conducting the UDT then this staff member can do all the UDT in these blocks, as opposed to either having him/her available throughout the week and/or relying on healthcare providers like nurses.

We book each appointment for 20 minutes. We also allow drop-ins (most relevant for the population with addiction). Consider holding UDT clinics on Tuesday and Thursday. Monday would be an inconvenient time for a clinic because you would have to notify patients on the Friday before which gives 3 days lead-time, and Friday there may be issues with transport to the lab or holidays.

Frequency of UDT Clinics
The vast majority of UDT at our clinic are for opioid agonist treatment monitoring in addiction. Even if your clinic has 300 patients in the HARMS Program for CNCP and they average 2 UDT per year (medium risk), this is still only 12 UDT per week which could be booked in a single 4-hr clinic.

Choosing a method for UDT (IA and/or LC-MS)
A UDT can be provided either in clinic, or at the lab. In our Family Health Team, we prefer that UDTs are provided at the clinic and then as indicated we may send the sample to the lab for “confirmatory” testing. However, we do allow patients that have work conflicts or otherwise cannot attend an appointment to provide a sample directly to the lab. If your clinic has the capacity to conduct UDT on-site (staffing, washroom, supplies, etc.), then we would recommend it over providing the sample at the lab. On-site testing allows for application of START-IT and all of its potential benefits for IA (self-report, automated interpretation, recommendations about confirmatory testing, etc.), as well as anti-tampering techniques (if your clinic chooses to use these). As discussed further below, your clinic may even consider just conducting confirmatory testing and skipping IA altogether in which case really the only potential advantage to providing at the clinic is that you have more control over how the sample was provided. We are aware of labs giving the patient a urine specimen container to go home and asking them to bring it back, certainly making it easier to tamper.

If your clinic does not have the capacity to do UDT on-site, then you may still apply the HARMS Program but you would be reliant on using the lab instead. In this case, a requisition would be given to the patient (or faxed directly to the lab) typically for a “broad spectrum urine tox screen” (confirmatory testing with LC-MS). If so-desired, you could order a “urine tox screen” or “drug of abuse screen” (these both indicate IA) instead of, or in addition to, LC-MS.

Choosing IA Panels
There are a number of factors when deciding about which IA panels to use at your clinic. If you want the best “bang for your buck” you want to use panels that capture commonly prescribed drugs, as well as those that are commonly abused in your region. Manufacturers of IA panels can often make whatever combination of panels you want. We use a standard 5-panel with Morphine (“opiates”), Oxycodone, EDDP (methadone), Benzodiazepines, and cocaine. Note that we do not use fentanyl panels because fentanyl is not commonly abused here, and we don’t use methamphetamine panels because of false positives. These are personal decisions however. You also have the option of buying a kit that actually has the panels built directly into the cup, anti-tampering built-in (Creatinine/specific gravity/pH) and innumerable other options/combinations.

START-IT considerations
We would recommend using START-IT to simplify the whole UDT process. That said, there are pros and cons.

• Pros
  • Saves ++ time
  • Avoids IA interpretation errors
  • Gathers self-report
  • EMR integration (no paper)
  • QI and research capabilities
  • Future capabilities to: administer BPI and treatment agreements, collect consent
• Cons
  • Some basic set-up required to optimize it (tablet PC, OCEAN platform)
  • If you don’t have one of the EMRs supported on OCEAN (TelusPSS, Acuro, OSCAR) then EMR integration won’t work and it will take more time
  • Cost – ~$50/month subscription for OCEAN platform

Anti-tampering methods
As alluded to throughout this manual, choosing which anti-tampering methods to use is not easy. For over 5 years, we have been using blue water in the toilets, taping the faucets, temperature checks, creatinine/specific gravity and pH checks, and despite this we’ve only had a single urine detected as potentially being tampered (it was too cold). It may not be worth the effort to use all of these methods. In fact, if Dr. RPM were doing this again he wouldn’t use any of them.

Consent from patients
We collect consent when initiating the program, but it may be worth collecting consent at each visit. If your clinic decides to do this, then the next version of START-IT will facilitate this through automation of the process.

Staff selection
When we first started the program, we used our RPN appointment slots to conduct the UDT. We then applied for a small grant to hire a part-time, non-medical staff member to conduct the UDT and this was successful. If possible, hiring someone to work part-time doing UDT and facilitating the program would be worthwhile. Either way, you will have to decide: i) Who conducts UDT? ii) Who is designated admin for the program? This second question is important so that physicians have a point-person – this person maintains the master list and communicates with the physicians. Ideally, you can have the same person both conduct the UDT and administer the program. We have our regular booking staff phone the patients to book the appointments.