PASS studies in secondary care (SCEM)
To complement the already well-established technique of Modified Prescription Event Monitoring (M-PEM), the DSRU has developed Specialist Cohort Event Monitoring (SCEM) in response to the need to provide safety studies in secondary care, specifically for patients who receive initial or all drug treatment in hospitals or hospital outpatient clinics. By capturing data in specialist care through SCEM studies, safety data is collected on those who may be more complex in terms of underlying disease, co-morbidities and concomitant medications than in the general disease population.
Our SCEM methodology for studies in secondary care is explained in this short video:
Differences between PEM/M-PEM and SCEM
This new methodology has been developed in parallel with the European Medicines Agency (EMA) regulatory requirement for pharmaceutical companies to undertake a Risk Management Plan (RMP) as part of the post-marketing safety monitoring on some of their newly-licensed drugs. Patients are identified through a network of specialists and are enrolled into the study only after the clinical decision to prescribe the study drug has been made by the clinician.
Using secondary care medical records, data is collected at treatment initiation and post initiation (the length of the observation period depends on the research question). Where necessary, and to ensure completion, outcome data can be obtained from both the specialist and the general practitioner.
In SCEM studies, data on individual patients’ general health, medical history, exposure and outcomes on exposure are captured. SCEM methodology is naturalistic in nature, reflecting clinical practice, is non-interventional, and allows for broad inclusion criteria. SCEM studies can also allow collection of comparative cohorts.
SCEM study process
The SCEM study process is shown below, describing the step-wise approach through which data is collected during a SCEM study:
The DSRU is already conducting SCEM studies across a range of therapeutic areas. Further information on the current active SCEM studies can be found here.
Observational Assessment of Safety in Seroquel (OASIS) SCEM study
The DSRU has recently completed the Observational Assessment of Safety in Seroquel (OASIS) SCEM study. The OASIS study was conducted as part of the risk management plan for the product Seroquel XL. It was designed to examine the short-term (up to 12 weeks) safety and use of quetiapine fumarate in the prolonged-release formulation (Seroquel XL™), along with a comparator group started on the immediate-release formulation, quetiapine IR. Any adult patients in England were eligible for inclusion once the clinical decision had been made to prescribe either the XL or IR preparation as part of normal clinical practice for the clinical diagnosis of schizophrenia and mania associated with bipolar disorder. The DSRU worked in collaboration with the Mental Health Research Network (MHRN) to recruit over 900 patients. The study enabled the systematic collection and reporting of safety data on patients newly initiated on treatment with quetiapine XL within the mental health care trust setting. Data from the OASIS study will be published shortly.
Drug Safety February 2015, Volume 38(2): 153–163