This Q&A has been developed with the MHRA in 2017 and it reflects MHRA guidance on the use of PGDs for medications which have risk minimisation measures (RMM).
Risk Minimisation Measures (RMM) are a regulatory requirement for some medicines, and are a critical part of the product licence (marketing authorisation) to help maintain a favourable benefit-risk profile. Medicines with a requirement for RMM may not be suitable for inclusion in a Patient Group Direction (PGD).
As well as information on contraindications, warnings/precautions and possible side effects routinely described in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), some medicines have an extra regulatory requirement for additional RMM.
RMM are designed to facilitate informed decision making to support risk minimisation when prescribing, dispensing and/or using a medicinal product, and may be imposed on a product at the time of licensure, or at any time thereafter. RMM may differ in their purpose, design, target audience and complexity, and might include measures to guide appropriate patient selection with the exclusion of patients where use is contraindicated, to support in-treatment monitoring relevant to important risks and/or management of an adverse reaction. The format, content and method of distribution of RMM are agreed on a product-specific basis by the MHRA. Examples can range from extra information for patients, such as an ‘alert’ card, or checklists for health professionals, to the imposition of a controlled access scheme.
When developing a PGD for a medicine, it is important to determine whether the medicine has any RMM associated with the licence.
In accordance with NICE guidance, medicines needing frequent dosage adjustments or frequent or complex monitoring, should not be included in a PGD. In line with this, a medicine with RMM for close monitoring and supervision of patients may not be suitable for inclusion in a PGD.
If a decision is taken to include a medicine with RMM in a PGD, the requirements of the RMM must be included in the PGD. As well as routine reference to the important particulars of the SmPC and PIL, the relevant sections of the PGD template should make specific reference to the key points of the RMM where applicable. If RMM have been developed specifically for patients, the PGD should include instructions to give verbal information to the patient on the important risks described in the RMM, as well as the provision of any written RMM for the patient to take away (along with the PIL), and where additional information may be found. If the RMM includes a checklist for prescribers, the use of the checklist should also be incorporated into the PGD.
Please also refer to the ‘Quality PGDs – 7 steps to success’ for support before and during the stages of developing and authorising PGDs. https://www.sps.nhs.uk/articles/quality-pgds-7-steps-to-success/
Further details of medications with associated RMM can be found at https://www.medicines.org.uk/emc/rmm-directory – please note this may not be a comprehensive list of all medications with RMM.
Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division