Modified Prescription-Event Monitoring (M-PEM) studies
Prescription-Event Monitoring (PEM)
The technique of Prescription-Event Monitoring (PEM) is a well established post-marketing surveillance technique designed to monitor the use, general safety and the identification of possible new unexpected risks of newly marketed medicines as used in real-life clinical practice. Dispensed prescription data are used to identify general practitioner (GPs) who prescribe a new medicine to a new user cohort of patients. These GPs are then asked to abstract event information from the patients existing medical charts in relation to a specific time-period since the patient first started treatment with the medicine. The questionnaires are then returned to the DSRU for review and inclusion onto the study database.
The Move to Modified Prescription-Event Monitoring (M-PEM)
In parallel with scientific developments in pharmacoepidemiology and regulatory requirements in pharmacovigilance and risk management, the technique has evolved to become a more targeted safety surveillance known as Modified PEM (M-PEM). These studies use enhanced customized data collection questionnaires to examine specific recognised or suspected safety risks of a medicine. Such studies are usually specifically designed to examine potential risks, identified risks and missing information identified in Risk Management Plans (RMPs). The DSRU is grateful to GPs for continuing to complete these more complex forms.
Modified Prescription-Event Monitoring is explained in this short video:
Modified Prescription-Event monitoring (M-PEM) study processes
The figure below describes the step wise approach by which data is obtained and processed for M-PEM studies.
|DSRU notifies NHS Business
Services Authority of study drug
|DSRU receives data from
dispensed primary care NHS prescriptions issued in England by GPs from
the date of market launch
|M-PEM questionnaires sent to GPs
(e.g. ≥3/6/12 months after first primary-care
prescription issued for patient)
|Information requested on
questionnaire includes baseline demographic and general health data,
e.g. body mass index; causes of death if died; study drug treatment
start date and starting dose details; indication and duration of
indication; first initiation-responsible clinician and setting;
co-morbidities at treatment initiation and new onset events
during/after treatment; other selected medication use within
pre-defined period prior to starting and during treatment; study drug
treatment stop date and reasons for stopping
|M-PEM questionnaires returned,
scanned, reviewed and data entered into DSRU database
|Selected events of medical
interest ,deaths (where cause not known) and pregnancies followed up
Patient confidentiality is maintained throughout under Section 251 of the National Health Service Act 2006. The DSRU has received support from the Ethics and Confidentiality Committee of the National Information Governance Board to gain access to and process patient identifiable information without consent for the purposes of medical research.
The DSRU uses M-PEM methodology to:
- monitor the rate of introduction of new drugs onto the market and study the reasons for physician prescribing preferences
- provide drug utilisation information and the characteristics of patients using specific medications, such as the patients’ previous medical history, concomitant medication use and concordance to the prescribed medication under study. Such information frequently fulfils the requirements to study missing information identified in the RMP.
- conduct targeted surveillance on a particular event or outcome of interest, such as potential or identified risks highlighted in the RMP
- quantify and compare the incidence of events reported prior, during or after treatment (with appropriate comparators) and explore patterns of onset over time
- characterise factors that are associated with onset of particular events