Clozapine in the community: Improved access or risky free-for-all?

Clozapine is the most effective treatment for people with treatment-resistant schizophrenia (Conley and Buchanan, 1997; Kane et al., 1988). Unfortunately, clozapine’s efficacy is tempered by potentially fatal adverse drug reactions (ADRs) which require regular blood monitoring. Concerns about these ADRs, in particular neutropenia and agranulocytosis, led to clozapine being restricted to prescribing by psychiatrists and dispensing by pharmacists in hospitals.

What is going to change and why

Most clozapine is prescribed by hospital specialists and dispensed by pharmacists in public hospitals. From 1 July 2015, community pharmacies will no longer need to be affiliated to a hospital to dispense clozapine. This will impact consumers and prescribers.

Psychiatrists in private practice and general practitioners (GPs) currently prescribing clozapine will no longer need to prescribe through a pharmacy affiliated with a hospital. All pharmacies (hospital and community) will be eligible to dispense clozapine for maintenance therapy regardless of the location of the prescriber or pharmacy, and the level of pharmacy remuneration for dispensing clozapine will be the same as for all other medicines (Department of Human Services, 2015).

These changes are occurring because Medicare recognises that most people living with schizophrenia who take clozapine reside in the community and that access to clozapine for these people needs to be easier. We believe that this expansion in access is a positive step for quality use of medicines in this vulnerable consumer group and has the potential to reduce stigma. There is a risk, however, that this opportunity will not be realised and could lead to consumer harm if key issues are not addressed.

Why change is needed

Clozapine is currently dispensed by pharmacies affiliated with hospitals. This affiliation has two main disadvantages. First, people taking clozapine living in the community have to attend specialist appointments at the hospital (mostly) on a 4-weekly basis. This leads to a burden on consumers, carers and hospital staff and budgets.

Second, the current hospital arrangement may lead to fragmented service delivery between primary and secondary care. Decision support systems, such as ‘dispensing interaction checkers’, may not identify potential drug interactions when multiple pharmacies are dispensing various medications for one person. There is poor communication about management of psychiatric and physical comorbidities between multiple prescribers (e.g. hospital psychiatrists, community GPs and private psychiatrists). Clinical governance and accountability for some aspects of care are often unclear.

Allowing and encouraging clozapine prescribing by private psychiatrists and trained GPs for dispensing from trained community pharmacies could improve safe access to clozapine.

Potential issues/risks

Consumers

Consumers may be concerned with this change in service delivery. First, the issue of access and convenience means that consumers should be able to access all of their medicines from the same pharmacy and one of their choosing. Consumers need to be able to access their clozapine and other medicines from one pharmacy with suitably trained staff. Second, the cost of clozapine needs to be considered. Currently, some hospitals subsidise consumers who cannot afford the Pharmaceutical Benefits Scheme (PBS) co-payments for clozapine. This is unlikely to continue in the community pharmacy environment, and the consumer will have to pay the patient co-payments.

Prescribers: GPs

Clozapine prescribing is regulated by state and territory laws. In some states, GPs can be approved to prescribe clozapine. In practice, this is not common due to the difficulties in accessing community dispensing. The change in PBS regulations may lead to more GPs receiving approval to prescribe clozapine. There are four issues that may create disincentives to GPs applying to prescribe clozapine:

1. GPs will be required to coordinate a strict regime of dates for full blood counts and quantities of clozapine prescribed (1 week or 4 weeks’ supply). The Therapeutic Goods Administration requires both companies who supply clozapine to maintain a monitoring database due to the risk of agranulocytosis associated with clozapine. In order to prescribe and monitor clozapine, GPs will need to register for access to one or both clozapine monitoring websites to view blood test results. This is a potentially time-consuming process.

2. The processes for remuneration have not been adequately considered for the longer and more detailed patient consultations required. Freezes on Medicare bulk billing fees may be a disincentive for GPs to take on mental health consumers who lack the financial capacity to pay private fees above the Medicare rebate.

3. Many GPs may not have sufficient knowledge about clozapine treatment. Training to ensure safe prescribing systems is required. Access to appropriate training and ongoing support from experienced clozapine coordinators will be required, especially in the early transitioning stages, to ensure safe consumer access to clozapine. Clarity on who will fund and provide this training and support is required.

4. The consumer may not have access to appropriate follow-up. For example, a GP may decide not to prescribe clozapine (e.g. due to low white cell counts or >72 hours of missed doses). The consumer will then need access to an appropriate secondary care mental health specialist to manage the situation and provide ongoing support. We need to establish appropriate pathways to ensure GPs have direct access to support.

Private psychiatrists

While some private psychiatrists may have experience with clozapine, a key barrier to uptake of clozapine prescribing is the resource implications associated with clozapine monitoring. Clozapine requires a strict regime of blood tests, associated limitations on the quantities of clozapine prescribed and data entry into clozapine monitoring databases.

Psychiatrists in private practice may lack the time and resources to assertively follow up consumers who miss blood tests, leading to a risk of interruption of clozapine supply and possible relapse of psychotic symptoms. There is rarely funding for clozapine coordinator roles for private psychiatrists not associated with hospitals.

Private psychiatrists will need to locate and liaise directly with community pharmacies that have chosen to dispense clozapine, which can be time-consuming and not remunerated.

Pharmacists

Community pharmacies may be reluctant to dispense clozapine due to many of the same issues as those mentioned for GPs. The lack of increased remuneration is potentially an even larger issue for community pharmacists as their remuneration comes in the form of a ‘one size fits all’ dispensing fee. Community pharmacists will need training to manage the complexities of clozapine monitoring to ensure clozapine is not dispensed when consumers are neutropenic and to avoid inappropriate disruptions in supply. There is a lack of clarity on who will support community pharmacies and their consumers when clozapine monitoring issues arise. Some pharmacies may choose not to take on this increased workload, leaving consumers with their current hospital dispensing arrangements.

Public hospital pharmacies that transfer dispensing for their patients to the community will lose a small amount of PBS reimbursement, but for most hospital pharmacy departments this will be offset by the reduction in required staff.

Conclusion

Expanding clozapine dispensing to community pharmacies has the potential to be highly beneficial. We can learn pragmatic ways to achieve this change safely and efficiently from experiences in South Australian and New Zealand (Holmes et al., 2015; SA Health, 2015). We believe there are four essential requirements: (a) training for GPs seeking to prescribe clozapine, (b) training for community pharmacists and technicians in clozapine dispensing, (c) robust clinical protocols and procedures for prescribing and dispensing of clozapine and (d) adequate time allocation and funding of hospital-based clozapine coordinators for liaison and support to GPs, private psychiatrists and community pharmacies.