The DSRU has many years’ experience of providing advice on and conducting studies for Drug Risk Management Plans (RMPs). We have expertise in designing protocols that are scientifically robust according to good pharmacoepidemiological practices, as well as meeting the methodological standards required by regulators. The DSRU can also provide advice on constructing a study protocol or the practicalities of undertaking a study.
In pharmacovigilance, a Risk Management System is “A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions” (Good Pharmacovigilance Practice (GVP) Module V).
All drugs have risks associated with their use, including adverse reactions, interactions between drugs and with environmental factors, as well as the risk that the product may not work as effectively as expected. The key point is the balance between benefits and risks. To optimise this balance the aim must always be to maximise benefit and minimise risk. Regulators, health professionals, manufacturers and patients all are required to perform risk management activities.
The core objectives of Risk Management are outlined in this short video:
The importance of risk management has increased dramatically since July 2012 when the revised EU Pharmacovigilance Legislation came into force, requiring that every new medicinal product has an RMP. There are many other instances when submission of a RMP may be required during the lifetime of a medicine, as listed in Good Pharmacovigilance Practice (GVP) Module V. Thus having a RMP in place allows for a proactive approach to better understand risks already identified but not fully understood, as well as potential risks where there are suggestions that they may occur and information missing from premarketing development programs. Also where necessary, the RMP includes actions to prevent, mitigate or manage specific risks post-authorisation. The DSRU has conducted studies to monitor and assess the effects of risk minimisation measures.
Examples of studies that have been designed and undertaken by the DSRU as part of a risk management plan are given below.
In primary care using information provided by General Practitioners (GPs):
- Asenapine – a modified prescription-event monitoring study designed to examine the safety of this atypical antipsychotic when it is prescribed in primary care. A sister study (OBSERVA) is underway to examine the safety and utilisation of this drug when it is prescribed in specialist care.
- Rivaroxaban – a modified prescription-event monitoring study designed to examine safety of this oral antithrombotic agent when it is prescribed in primary care. A sister study (ROSE) is underway to examine the safety and utilisation of this drug when it is prescribed in secondary care
- Fentanyl buccal tablets
- Testosterone patch (Intrinsa)
In secondary care using information provided by Specialists:
- Observational Assessment of Safety in Seroquel (OASIS) – completed
- Observational Safety Evaluation of Asenapine (OBSERVA) – patient recruitment completed
- Rivaroxaban Observational Safety Evaluation (ROSE) – patient recruitment completed
- The Rivaroxaban Observational Safety Evaluation post-Acute Coronary Syndrome (ROSE ACS) Study – currently recruiting