Risk Management Plans – What You Need To Know
To address risk minimisation, Healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A Risk Management Plan will include an Action Plan outlining risk minimisation activities that are carried out to reduce the probability of an adverse reaction occurring or its severity should it occur. The governing EU directive is;
DIRECTIVE 2001/83/EC as amended, 28b Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions. 28c. Risk management plan: a detailed description of the risk management system.
Routine risk minimisation activities are applicable to all drugs and include warnings and information contained within the Summary of Product Characteristics and Patient Leaflet and the careful use of labelling and packaging.
Educational tools and materials, pregnancy prevention programmes (PPP) and DHPCs are examples of additional risk minimisation measures. The requirement to produce educational material is evaluated from a risk perspective and is only used when deemed necessary for the safe and effective use of a product.
The following are examples of educational materials: Guide to prescribing or dispensing, Checklist for actions for prescribing or dispensing, Patient Information Brochures, Patient Alert Card.
Only educational materials which are included in an EU-RMP or which are a condition of the marketing authorisation require HPRA approval. Review and approval of educational materials and tools is handled by the Vigilance Assessment section of the Human Products Monitoring department of the HPRA.
Guidance on RMPs and educational materials and tools is available in:
- GVP module V – Risk Management Systems
- GVP module XVI – Risk minimisation measures: selection of tools and effectiveness indicators.
- GVP Module XVI Addendum I – Educational materials
Another form of risk minimisation measure distributed in the Healthcare industry is the DHCP (Dear Healthcare Provider) letter. Circulation of DHCP letters are at the discretion of the MAH and/or a Competent Authority. DHCP letters are generally used in situations where a manufacturer has been made aware of a serious problem or when there is a need to provide updated information about the safe use of a drug. These letters are distributed to physicians and others responsible for patient care. In January 2014 the FDA issued the following guidance document “Dear Health Care Provider Letters: Improving Communication of Important Safety Information”. The FDA has outlined that DHCP letters should be clear, concise and no more than 2 pages. Factors to be decided on for a DHCP letter are as follows; the need for a DHCP letter, how the information is presented, the target audience and the timeframe for distribution.
Guidance for DHCP letters in the EU is available in:
- GVP Annex II – Templates: Direct Healthcare Professional Communication (DHPC)
Here at Acorn Regulatory, we have had wide exposure with the management of the educational material and DHCP elements of Client RMP’s. We have built up excellent working relationships with applicable audited suppliers to support us with this activity.
If you would like to discuss this issue further with us, then please call us on 00353 52 61 76706 or complete your details below.