Risk minimisation activities are required for each safety concern of a product listed in a Risk management Plan (RMP). These are interventions that aim to optimise the benefit-risk balance of a drug by minimising its risks in clinical practice. Risk minimisation activities have become increasingly standard practice for medicines over the last 10 years and we need to remember there is no “one-size-fits-all” approach.
Routine risk minimisation activities may include:
- Product Information/Consumer Medicines Information
- Directions for use document, labelling, pack size and design
- Legal (prescription) status of the product
Dr David Gillen, Head of Patient Safety and Risk Management EMEA/APAC, Celgene, presented on risk management activities at the 2015 ARCS Scientific Congress and advised that these are usually multi-dimensional. He also pointed out that the same intervention can be applied to more than one risk. Routine risk minimisation may, however, not be sufficient and some additional risk minimisation tools may need to be developed.
Additional risk minimisation activities may include:
- Education programs for patients
- Health Care Professional (HCP) education programs
- Dear HCP letter (or perhaps an alert programmed into software at prescribing or dispensing)
- Controlled access program and/or registry.
Dr Gillen noted that all these activities should be part of a lifecycle approach and measures should be clearly defined, easy to use, reproducible and practical. The ongoing evaluation of measures was emphasised to determine the effectiveness of these risk minimisation activities.
Risk minimisation activities are in addition to routine pharmacovigilance activities such as collection, follow-up and reporting of adverse events, analysis of data and reporting in PSUR. Additional pharmacovigilance activities may also include clinical trials, post-authorisation safety studies, drug utilisation studies, patient registries, physician surveys and prescription event monitoring.
For assistance with any of your pharmacovigilance needs, call us on +61 3 9251 0777.
This article was written by Tina Mason from our Drug Safety team.