The Royal is a specialized mental health centre that provides services to people with complex and serious mental illness across eastern Ontario.
Clients at The Royal who are prescribed clozapine for treatment resistant schizophrenia require close clinical monitoring as part of the safe administration of this medication.
Health Quality Ontario had a chance to catch up with Trudy Kelly, RN, BScN, CPMHN (c), Local Step Down Clozapine Coordinator at The Royal, to find out how the team improved the safe use of clozapine within a complex community mental health system.
Can you describe clozapine and how it’s used?
For those that are not familiar with this medication, it is one with significant evidence-based outcomes for the treatment of schizophrenia. In the community, clozapine management is a high clinical priority. Without the medication, a client can decompensate quickly and be readmitted to hospital, sometimes through police apprehension.
To ensure its safe use, clients must receive blood work as per Health Canada requirements to ensure patients are not experiencing agranulocytosis – a serious depletion of white blood cells that negatively impacts a person’s immunity.
When adherence is interrupted for a period of three days, a client must be restarted on the medication as if new to clozapine. As such, the workup needs to be repeated. Any interruption in taking the medication puts a person at risk of severe, life-threatening side effects.
The Clozapine Support and Assistance Network (CSAN) is a national centralized monitoring system which receives blood work from laboratories and determines how a client is tolerating the current dosage, including its effect on white blood cell count. These blood results are then sent to a client’s pharmacy in the community.
Pharmacists access CSAN before dispensing clozapine. In the CSAN system, a green flag means there are no issues with the current medication dispensing, a yellow flag means medication dispensing can go ahead, but repeat blood work is required to ensure neutrophils are at a safe level, and a red flag means the medication may be affecting the client’s immunity. Blood work needs to be repeated and the physician must decide if the treatment is to continue or be withheld. The physician looks at the total clinical picture of the client and decides to maintain or change the dosage as appropriate.
How did you identify the gaps in care related to the use of clozapine?
When a person is prescribed clozapine in the hospital, the prescribing, dispensing, blood work sampling, and monitoring can occur in a relatively closed circle, limiting the number of errors. In the community, the situation is vastly different and prone to errors that risk client safety.
Unlike the hospital environment, a client in the community can choose which lab and pharmacy to go to. Using recovery principles, we support client choice and encourage self-management as much as possible. However, this also means that clozapine management is partly dependent on organizations outside of our own.
We would get calls from clients saying that the pharmacy would not dispense clozapine on Fridays because the pharmacist could not see the blood results or would see a red flag in the CSAN system and could not connect with a physician to confirm dispensing the medication or withholding it. I started to write up incident reports when clients were not getting their medications as needed. Because of these errors associated with clozapine, The Royal decided to conduct a failure modes and effect analysis (FMEA).
Over the course of a year, all the steps and possible failures in each step for clozapine management were tracked and analyzed as part of the FMEA.
Luba Shumsky, Manager, Patient Safety and Clinical Risk Management, had gathered the right people – physicians, lab staff from the community and within the organization, the clozapine coordinator and the surrounding area pharmacists – for the FMEA.
As a group, we went through each step and identified communication patterns, like who spoke to whom and how, in each of those steps. Then we changed our focus to look at the areas with the highest failures and focused our efforts on what we could do to improve those parts of the clozapine management process.
What steps did you take to improve coordination of care?
Striking a partnership with Dynacare:
The results of the FMEA showed that many clients would lose their lab requisition and struggled to explain why they needed lab work. Together, we developed a requisition with Dynacare that never expires as long as the client is taking clozapine. Dynacare scanned these requisitions into their computer system. The client went to any Dynacare community lab for blood work and Dynacare pulled the requisition from their computer screen thus eliminating one type of failure.
We also created a plastic card for clients that could be presented to Dynacare staff to bridge the communicate gap. When a client presents the card, Dynacare staff are signaled to review the computer system for the requisition. We made the plastic card the same size as a health card and included a phone number that lab staff could call if they didn’t understand why the client had arrived. We received feedback from clients telling us the card system worked so much better.
Using the CSAN portal:
We worked with CSAN to give us access to the lab results through their portal. Lab results were not always being communicated in a timely fashion to pharmacies and the flagging system was not well understood. Now, with the portal, we can see the results and pick up the phone and call the pharmacy when there is a red flag alert or any delay with blood results being sent to the community pharmacies.
We can now see many of the errors before they reach the client and correct them before it becomes a failure so that clients can get their medication. Prior to this, we didn’t have any visibility into the CSAN results system so we could not proactively intervene, and patients would end up without their medication.
What have your results been?
We have introduced a tracking system specifically for this medication. Since implementing our strategies, our last major failure (such as a pharmacy not dispensing clozapine for reasons described above) was two years ago. Prior to this, about one third of clients on clozapine had some type of failure (such as a lab not drawing the correct bloodwork) and we are not seeing that anymore.
CSAN has given us feedback that we have one of the highest adherence rates. We definitely have improved in that regard because we know there are less instances of clients being denied medication when they arrive at their local pharmacy.
Since the CSAN portal required some education with community pharmacists, there has been an increase in the number of pharmacies that are now more capable to dispense clozapine. We have increased community access and client choice as a result of our changes.
What advice would you give to others looking to make similar improvements?
For anyone wanting to look at the clozapine management process in community mental health teams, the place to start is to join the Pathways to Better Care Improvement through Collaboration Community of Practice. They have a monthly conversation about how to safely manage clozapine use in the Ottawa area. This group has had a lot of discussion regarding the use of lab requisitions that don’t expire, just as we implemented.
Remember that you need to give staff the time to deal with each failure. They are trying something new and will need the space to sort through the details. Not everything works well, or exactly as planned, and that’s okay.
Lastly, don’t underestimate the need to be involved in educating outside of your own organization when you work on community-based care processes. You will need to work with other organizations and help people understand the risks and benefits of clozapine.