Pharmacovigilance (PV) is concerned with the detection, assessment and prevention of adverse effects or other possible drug-related problems.
The Yellow Card scheme relies on all healthcare professionals and patients reporting suspected adverse drug reactions (ADRs). An additional active postmarketing scheme in the UK is Modified Prescription-Event Monitoring (M-PEM) – a national surveillance system conducted by the Drug Safety Research Unit (DSRU).
Questionnaires are sent to GPs for patients identified as receiving new medications to collect data on their baseline characteristics in relation to the safety issues specified in the risk management plan that require further evaluation. Also explored is physician prescribing and decision-making behaviour, as well as adverse events occurring after treatment initiation in primary care.
Since the adoption of new medicines in clinical practice is often facilitated initially by specialists, it is important to also capture data on the use and safety of a new medicine in the secondary care setting, since patients managed by specialists may differ in health characteristics from those managed by GPs. However, there is a paucity of suitable data sources at national and international level.
The Specialist Cohort Event Monitoring (SCEM) scheme is an adaptation of M-PEM that permits large-scale safety surveillance of new medicines, mostly initiated by specialists in hospitals or other secondary care settings (e.g. outpatient clinics). Principle differences of SCEM to M-PEM include the way patients are identified, the need for patient consent and duration of follow-up (12 weeks).
SCEM has recently been applied to monitor the short-term safety and utilisation of rivaroxaban (Xarelto) as prescribed by specialists in secondary care in England and Wales. The Rivaroxaban Observational Safety Evaluation (ROSE) study is based on patients with medical conditions requiring anticoagulation and is looking at real-life bleeding rates, while a second branch is looking at patients with acute coronary syndrome (ROSE-ACS).
Each study is also collecting a contextual cohort of patients receiving best practice standard care relevant to the condition being monitored. Recruitment to ROSE has now ceased and results are expected in 2017, but recruitment for ROSE-ACS is active. A complementary M-PEM study is running concurrently.
There are opportunities for pharmacists across all settings to participate in SCEM or M-PEM studies. For example, SCEM studies could be supported by signposting frequent prescribers of study medications to the research team, while M-PEM studies could be supported by raising awareness of the importance of PV to prescribers in primary care and perhaps completing M-PEM questionnaires.