Post-authorisation safety studies (PASS) in hospitals
Our hospital PASS studies (in secondary care or specialist care) follow our Specialist Cohort Event Monitoring (SCEM) methodology, which addresses 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.
- Our ability to conduct hospital-based PASS studies and access a network of prescribers in secondary or specialist care is almost unique in the fields of pharmacovigilance and pharmacoepidemiology in the UK healthcare setting.
- For these hospital PASS studies, event data is gathered from medical records of consented patients by hospital prescribers or care teams.
- The DSRU benefits from the near-unique healthcare system in the UK, where information about patients’ health is available from the cradle to the grave.
- To facilitate patient recruitment we collaborate with the NIHR CRN (National Institute for Health Research Clinical Research Network) and other networks across the UK to identify hospital-based prescribers in the relevant speciality.
- These prescribers recruit patients into the studies and provide safety outcomes and other relevant information about the patients who are taking the drug under study.
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Click here for examples of our secondary/specialist care PASS
Our methodology for hospital PASS studies is explained in this short video:
Post-authorisation safety studies (PASS) in primary care
Our primary care PASS studies follow our Modified Event Monitoring methodology.
- These modified event monitoring studies are based on a well-established post-marketing surveillance technique.
- They are designed to monitor the use, safety and the identification of possible new unexpected adverse events of marketed medicines as used in real-life clinical practice.
- The prescribing general practitioner (GP) is asked to complete enhanced customised data collection questionnaires in order to allow us to examine specific recognised or suspected safety risks of a medicine and relevant characteristics of the patient, such as risk factors and confounders.
Click here for information about our primary care PASS methodology