Case Study: Outsourcing Medical Monitoring for antipsychotic medication

The Challenge

Clozapine is an antipsychotic medication used in treatment-resistant schizophrenia and psychosis in Parkinson’s Disease. Treatment with clozapine comes with a risk of agranulocytosis.

Since the introduction by the MHRA for white blood cell count monitoring in clozapine patients, the incidence of those developing agranulocytosis has decreased markedly.

When a clozapine monitoring service is not used, evidence suggests a mortality rate from agranulocytosis of 0.3% (compared to 0.01% when clozapine is used in conjunction with a monitoring service.

Key requirements for the client

It is a regulatory requirement that blood monitoring should be carried out in clozapine patients in alignment with specific official recommendations, including daily blood monitoring in patients that fall below a certain threshold.

Given the frequency of testing of clozapine patients, the often urgent need to access support for the service, and the complexity of the testing protocols, the client was in need of robust and high quality Out of Hours support solution.

Our solution

1: Setting up a helpline

Together with the client, ESMS implemented an Out of Hours call centre solution to support the Office Hours support provided in house by the client..

ESMS Information Scientists hold a minimum qualification of a life science degree (including toxicology, pharmacology and pharmacy); they are rostered on shifts around the clock 24/7/365 to ensure that scientists are always available to handle enquiries.

2: Protocols and training

ESMS worked with the client to understand the intricacies of the monitoring protocols and develop a detailed process for the handling of enquiries which was aligned with the client’s internal processes.

A bespoke training programme was also created to ensure that Information Scientists had a thorough understanding of the monitoring service, testing protocols, online system and specific pharmacovigilance requirements.

3: Our ongoing monitoring service

Together with the client, we have established a clozapine monitoring support service including the following features:

  • Ongoing updates to Out of Hours procedure to maintain process alignment.
  • Immediate support provided to nurses, pharmacists and physicians in entry and confirmation of results in the clozapine monitoring database.
  • Accurate guidance for healthcare professionals with regards to testing protocols.
  • Administrative support for online monitoring system users.
  • On-call access to the client’s haematologist with back-up support provided by the ESMS medical team.
  • Regular support provided during office hours when required.
  • Accurate and timely reporting of Adverse Events and Product Complaints.
  • Calls answered in a timely manner (98% of calls answered within 30 seconds).
  • All calls recorded and all cases logged into ESMS’s validated enquiry database.
  • Triage of enquiries regarding technical support for Near Patient Testing (NPT)s.

Outcome and benefits

  • Expertise in the setup and management of a bespoke scientific call centre service.

  • Security in knowing that high quality, professional support for the client’s monitoring service was available around the clock.

  • Flexibility to utilise ESMS for office hours support to handle call surges and ‘out of office’ periods including maternity leave, training days and office parties.

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