Modified Prescription-Event Monitoring
For certain drugs, the information collected using standard prescription-event monitoring (PEM) methodology is not sufficient to fulfil the aims of the study. In these situations, the DSRU uses modified PEM methodology (M-PEM).
M-PEM methodology can be classified as an extension of the standard PEM methodology. These studies are non-interventional observational cohort studies similar to PEM. To conduct an M-PEM study, a specific M-PEM questionnaire is developed by the DSRU, requesting additional information than that collected from a standard PEM green form. M-PEM studies can monitor both safety and health outcomes in patients who were prescribed a particular drug as well as determine patient eligibility for a particular study. In addition, M-PEM methodology can be used to compare the events reported before drug use to the events reported after drug use in patients who were prescribed a particular medication. Information on drug utilisation and the characteristics of patients using particular medications can also be collected using M-PEM.
In the past, the DSRU has used M-PEM methodology to monitor the introduction of new drugs onto the market, requesting the patients’ previous medical history, concomitant medication use and concordance to the prescribed medication under study. The DSRU has also used M-PEM methodology to provide targeted surveillance on a particular adverse drug reaction of interest. In addition, it has been used to monitor the safety of products containing CFC-free propellants.
M-PEM studies completed by the DSRU include:
Prospective observational study to monitor the introduction of Ventolin Evohaler in England
Observational study to monitor the introduction of Seretide Evohaler in England
Observational study to monitor the introduction of Flixotide Evohaler in the United Kingdom
Cohort surveillance study to monitor Carvedilol’s use and risks when treating chronic heart failure in clinical practice by general practitioners in England.