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MHRA publish guidance on Risk Minimisation Measures (RMM)
The Medicines and Healthcare products Regulatory Agency (MHRA) have published guidance on risk minimisation measures for medicines to ensure their safe and effective use. These measures are a requirement for Marketing Authorisation Holders (MAHs) and include routine practices like prescription-only status and patient information leaflets.
The MHRA collaborates with MAHs to implement and approve these measures. Some are required as conditions for product licensing or as safety review outcomes. The guidance outlines several risk minimisation measures for medicines to ensure safe and effective use. These include:
- Routine measures: Prescription-only status, controlled pack sizes, and mandatory patient information leaflets.
- Patient guidance: Brochures, leaflets, checklists, and patient cards to inform users about risks and proper medicine use.
- Healthcare professional guidance: Educational materials for doctors and pharmacists on prescribing, administering, and monitoring medicines.
- Patient cards: Included with medicine packs to highlight key safety messages.
- Educational tools: Training programs in various formats for both patients and healthcare professionals.
- Controlled access programmes: Restrictions ensuring medicines are only used for specific conditions or patient groups.
- Controlled distribution systems: Ensuring proper tracking to prevent misuse.
- Pregnancy prevention programmes: Special measures for medicines that pose risks to unborn children.
Each measure is designed to reduce adverse events and ensure informed decision-making. The following is how each risk minimisation measure works in practice:
- Routine measures: Medicines may be prescription-only, ensuring that healthcare professionals oversee their use. Pack sizes are regulated to prevent excessive intake, and Patient Information Leaflets (PILs) are included to provide essential details on proper usage and risks.
- Patient guidance: Patients receive brochures, leaflets, checklists, and patient cards to help them understand the risks, correct administration, and monitoring requirements. For example, a leaflet may instruct a patient to attend regular blood tests while on certain medications.
- Healthcare professional guidance: Doctors and pharmacists receive educational materials to help them prescribe, administer, and monitor medicines safely. This may include contraindications, dosage adjustments, and steps to support patient adherence.
- Patient cards: These are included in medicine packs to highlight key safety messages, such as potential adverse effects and steps to take if they occur. In some cases, patient cards serve as emergency reference materials to inform healthcare professionals or caregivers about critical information.
- Educational tools: Training is provided through videos, printed materials, online modules, or in-person sessions to help healthcare professionals and patients understand the correct use and potential risks of specific medicines.
- Controlled Access Programmes: Some medicines require strict prescribing criteria, meaning only certain patients who meet eligibility criteria (e.g. failed other treatments) can receive them. Diagnostic tests and follow-ups may be mandated to ensure proper monitoring.
- Controlled Distribution Systems: Medicines with high risks or potential for misuse are closely tracked through the supply chain, preventing diversion or unintended distribution outside authorised channels.
- Pregnancy Prevention Programmes (PPP): Medicines that pose risks to unborn children require additional safeguards, such as pregnancy testing, risk awareness forms, and commitments to use effective contraception while taking the medicine.
Each measure ensures that medicines are used safely and effectively, reducing potential harm while empowering both patients and healthcare professionals with necessary information.
