What Went Wrong: Clozapine Bloodwork Monitoring

Clozapine is a drug used to treat severe schizophrenia and schizoaffective disorder. While it is an effective antipsychotic, patients using clozapine have a small but significant risk of developing agranulocytosis (severe lack of white-blood cells).

Every patient on clozapine therapy in Canada is required to complete bloodwork as a condition of dispensing the drug. As clozapine is not as frequently dispensed as other medications of this class, it is particularly important that pharmacists dispensing it be diligent about monitoring patient bloodwork.

Clozapine bloodwork monitoring is an ongoing issue the College continues to remind registrants. See What Went Wrong: Clozapine for an outline of many questions patients and pharmacists ask about drug therapy involving clozapine.

Case:

The College received a complaint that a pharmacy had been dispensing clozapine daily for over a year without ensuring the patient was having regular bloodwork drawn. The pharmacy continued to dispensed clozapine daily despite a mental health care team following the patient. Additionally, the manufacturer sent three reminders for the patient to have bloodwork drawn, the pharmacy never followed up, and the patient never went for bloodwork.

Following an investigation, the Inquiry Committee determined that the pharmacy must have a clozapine bloodwork monitoring protocol. This will ensure the dispensing pharmacist confirms the patient has had recent bloodwork drawn even if there is a health care team involved, before dispensing a clozapine prescription.

Discussion

As part of the requirements to review the prescription, the pharmacist should have ensured the patient’s bloodwork was completed before dispensing a dose of clozapine.

The complaint related to clozapine bloodwork monitoring highlights the important role pharmacists need to play in addressing gaps in care in drug therapy monitoring that can put patient safety at risk. Even when others on a patient’s care team may be involved in monitoring the effectiveness of patient's medications and identifying adverse reactions, a pharmacist is still required to ensure a drug is safe and effective for a patient under the Health Professions Act, Bylaws, Schedule F, Part 1, Section 6(5). This independent review by a pharmacist is an essential step in ensuring patient safety.

A full pharmacist must

Review prescriptions for completeness and appropriateness with respect to the drug, dosage, route and frequency of administration,
Review patient personal health information for drug therapy problems, therapeutic duplications and any other potential problems,
Consult with patients concerning the patient’s drug history and other personal health information,
Consult with practitioners with respect to a patient’s drug therapy unless s.25.92(2) of the Act applies, and (e) take appropriate action respecting a drug therapy problem.

(See Section 6(5) of the Health Professions Act, Bylaws, Schedule F, Part 1)

Best Practices for a pharmacy receiving a new Clozapine prescription

Confirm the prescription with the prescribing physician and/or clinic.
Confirm the “Monitoring Company” the physician will be using (such as the APOTEX or GENPHARM program).
Ensure the patient is issued an “ID Number” from the “Monitoring Company” prior to filling the prescription.
Confirm and document the frequency of patient monitoring.
Ensure the pharmacy is set up to receive the results from the “Monitoring Company” (either by fax or access to the website – the pharmacy will need to set up usernames and passwords to login)
Confirm with the patient the lab they will be using, the frequency of monitoring and reminding the patient of the importance of being compliant.

What Went Wrong ReadLinks Series

Watch for What Went Wrong articles each month on ReadLinks. These articles highlight important pharmacy practice issues and real complaints cases identified through College investigations.

What Went Wrong, adverse drug reaction

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SRD

What Went Wrong: Clozapine Bloodwork Monitoring Aug. 1, 2017 What Went Wrong, adverse drug reaction

What Went Wrong: Clozapine Bloodwork Monitoring

Discussion

Best Practices for a pharmacy receiving a new Clozapine prescription

What Went Wrong ReadLinks Series