Fernandez-Egea and McCutcheon’s editorial makes a compelling epidemiological case for revising clozapine’s haematological monitoring requirements. ^{Reference Fernandez-Egea and McCutcheon1} I would add that this framing understates a related consequence: current protocols are among several factors limiting initiation of the only licensed treatment for treatment-resistant schizophrenia (TRS). I recognise, as the editorial itself notes, that evidence directly linking relaxed monitoring to increased clozapine initiation remains limited – including from the Netherlands experience and Oloyede et al’s international analysis ^{Reference Fernandez-Egea and McCutcheon1} – and I do not claim this causal link is established. My argument is narrower: that access consequences deserve equal weight in the reform debate, regardless of how that empirical question is ultimately resolved.

The evidence for over-cautious monitoring is substantial. The risk of clozapine-induced agranulocytosis is concentrated almost entirely in the first 6 months of treatment, yet UK protocols still mandate near-lifelong testing largely unchanged since the 1990s. ^{Reference Fernandez-Egea and McCutcheon1} The clinical justification for this intensity has narrowed considerably, whereas its consequences for treatment access have received comparatively less attention.

Monitoring burden is not the sole explanation for clozapine underuse – clinician unfamiliarity, service capacity and patient acceptance also contribute ^{Reference Parkes, Mantell, Oloyede and Blackman2} – but a systematic review identified monitoring requirements as a recurrent, significant barrier from the patient perspective. ^{Reference Parkes, Mantell, Oloyede and Blackman2} The College of Mental Health Pharmacy told The Pharmaceutical Journal that current blood-testing requirements represent a significant barrier to clozapine use, noting they consume substantial secondary-care resource. ^{Reference Janković3} I recognise the editorial’s countervailing concerns: monitoring visits sustain specialist follow-up, support patient recognition of neutropenia symptoms, flag interacting medications with neutropenic risk and provide structured contact for a population that benefits from it. ^{Reference Fernandez-Egea and McCutcheon1} These are legitimate functions worth preserving; my position is that they argue for redesigning monitoring’s structure, not for retaining its current intensity by default.

Internationally, reform is already underway. Following a 2025 Pharmacovigilance Risk Assessment Committee review, the European Medicines Agency (EMA) revised its haematological monitoring recommendations to absolute neutrophil count (ANC)-only testing, with revised thresholds – including twice-weekly monitoring for ANC 1.0–1.5 × 10⁹/L and discontinuation below 1.0 × 10⁹/L – and adjusted criteria for patients with benign ethnic neutropenia. ^{Reference Lally, Conaty, Bourke and Keating4} These changes retain surveillance where risk is concentrated while reducing burden elsewhere, and offer a concrete template UK guidance could adapt rather than design from scratch.

The regulatory landscape is moving faster than clinical practice. The US Food and Drug Administration (FDA)’s 2025 removal of its Risk Evaluation and Mitigation Strategies (REMS) reporting requirement is a related but distinct development: it eliminated a federal reporting mandate rather than establishing a specific monitoring schedule. ⁵ It should be read as creating an opportunity to reconsider UK practice, not as evidence that reduced monitoring itself improves access. The Medicines and Healthcare products Regulatory Agency (MHRA’s) parallel review, seeking views from patients, families and clinicians, is a further sign that practice may shift. ⁶ Absent updated national guidance modelled on frameworks such as the EMA’s, prescribers may reasonably default to existing conservative practice out of caution rather than evidence.

I suggest two additions to the reform agenda. First, UK guidance should adopt a risk-stratified schedule of the kind the EMA has implemented – differentiated by ANC level and time since initiation, with explicit provision for concurrent neutropenic-risk medications and benign ethnic neutropenia – rather than uniform, near-lifelong testing. Second, reform should be evaluated against prespecified implementation outcomes, including rates and timeliness of clozapine initiation, alongside continued haematological safety monitoring, so that improved access and preserved safety are assessed together rather than one being assumed from the other.

The epidemiological evidence now strongly supports reconsideration of current monitoring requirements. The remaining challenge is translating that evidence into monitoring policies that measurably improve timely access to clozapine while preserving the safety oversight and clinical support that monitoring has also provided.