Guidance

Risk minimisation measures for medicines

Published 16 April 2025

Purpose of risk minimisation measures

Risk minimisation measures are put in place to facilitate the safe and effective use of medicines by healthcare professionals, patients and their carers or guardians.

It is a requirement for Marketing Authorisation Holders (MAHs) to implement routine risk minimisation measures, such as the legal status of a medicine (for example prescription-only), pack size of a medicine, and a Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for every medicine. These measures are standard requirements to address safety concerns once a product is on the market. But for certain medicines, additional risk minimisation measures are required for their safe and effective use.

The purpose of additional risk minimisation measures is to reduce or prevent the risk of an adverse event, or to reduce the severity or impact on the patient should an adverse event occur. They can be used to support discussion between a patient and their healthcare professional(s), to ensure an informed decision is made regarding a particular treatment. They can also be used to support treatment monitoring, prevent medication error and ensure appropriate administration of a medicine.

Risk minimisation measures cannot be used for commercial purposes to promote a product or programme. They should be available in a range of formats to facilitate access by healthcare professionals and patients. Materials should also include information on how to report adverse events to the Yellow Card scheme where possible.

Decisions on risk minimisation measures

MAHs may choose to implement risk minimisation measures independently and these are agreed by the MHRA. The MHRA may also request that MAHs produce risk minimisation measures as a condition for issuing a product licence, or as an outcome of the findings of a safety review into a particular risk.

Before requesting that additional risk minimisation measures are put into place by the MAH, the MHRA considers the likely impact of risk minimisation measures on patients and caregivers; any unintended consequences such as inadvertently raising awareness of an off-label use of a medicine; and feasibility issues for the implementation of new measures in the healthcare system.

Risk minimisation measures must be agreed by the MHRA before being distributed by MAHs. Where appropriate, patients and healthcare professionals are consulted on draft materials before publication.

Examples of risk minimisation measures

Patient Guidance

This is guidance for patients who are taking, or who are planning to take a particular medicine. Its primary purpose is usually to provide the patient with clear guidance on the benefits and risks of taking a particular medicine, with clear actions on what to do if they think they might be experiencing an adverse event.

It may provide information on how to correctly administer a medicine, or any important steps that need to be taken by a patient during a course of treatment, for example needing to attend blood test appointments.

Where appropriate, it can signpost patients to external organisations who can provide support, resources or counselling, such as patient health charities.

It can come in several different forms such as:

• brochures
• leaflets
• checklists
• patient cards

In most cases it should be accessible to patients online, but it can also be given to them in print form. Patient guidance should be clear, accessible and written in patient-friendly language. Easy-read formats should be made available where possible.

Healthcare Professional Guidance

This is guidance provided to healthcare professionals about a particular medicine. It may be deemed necessary where there are complex considerations; or requirements around safely prescribing or dispensing a particular medicine; or caring for patients who are taking a particular medicine.

It can include information such as:

• contraindications and warnings associated with a medicine
• recommendations on patient selection
• requirements prior to the start of treatment e.g. blood tests
• instructions for appropriate administration of a medicine
• advice on treatment management and appropriate monitoring
• information that should be provided to patients who are taking, planning to take, or planning to stop taking a medicine

It can come in several different forms such as brochures, leaflets, posters or checklists and it should be accessible to healthcare professionals online or sent to them in print form. It should provide clear and actionable information.

Patient Cards

Patient cards are provided with a medicine pack. The purpose of a patient card is to highlight key messages about a medicine, such as:

• risk of adverse events associated with the medicine
• actions patients need to take if they experience an adverse event
• situations in which a patient should not be taking the medicine (for example if they have a specific health condition or are pregnant)
• instructions for taking a medicine correctly.

Patient cards are not a substitute for the Patient Information Leaflet (PIL) but serve as a means for highlighting key messages to the patient around taking a medication. PILs are included in every medicine pack as a legal requirement in the UK, whereas patient cards are only included where additional risk minimisation is necessary. Patients who receive a patient card should also be encouraged to read the PIL for further information about the medicine they are taking. By highlighting key risks, patient cards can further aid patients to make informed decisions about their treatment.

Patient cards can also be used as a means for patients to carry important information about a medicine they are taking on their person. This information can then be presented to a healthcare professional, caregiver, or in an emergency situation to a member of the public. It is a means to inform them of what medicine the patient is taking and the associated adverse reactions. If this is the purpose of a patient card, it should be small enough to facilitate this, for example, it should be able to fit into a wallet.

Patient cards can be included as a separate insert in the packaging of a medicine, or as an extra part of the packaging itself which can then be cut out. Extra patient cards can sometimes be made available to pharmacists to ensure they are included where medicine packs need to be split in order for certain quantities of the medication to be dispensed. 

Other Educational Tools

MAHs can also produce other educational tools and programmes for healthcare professionals or patients to raise awareness or provide training. These can be delivered in different formats such as audio, video, web or in-person.

Controlled Access Programmes

Controlled Access Programmes are put in place to ensure a medicine is only used in certain situations or by certain patient groups, to minimise an important risk with significant public health or individual patient impact. This goes beyond routine risk minimisation measures for control of medicines such as the legal status.

Controlled Access Programmes should only be put in place where a medicine carries significant risks for patients who do not meet specific treatment criteria, but where it carries a significant benefit for patients who do meet the criteria due to differences in the benefit: risk balance between the patient groups. For example, it may only be suitable for patients who have failed all other existing treatments options with lower associated risks.

There are usually strict procedures for healthcare professionals to follow before they can prescribe or dispense a controlled access medication such as testing the patient to ensure they meet diagnostic criteria, documenting understanding of product risk, recording information in patient registries, systematically following-up patients and pharmacy registration and approval to dispense the product.

Controlled Distribution System

Controlled Distribution Systems ensure that a product is traced through the distribution system up until it is dispensed to a patient. This can be put in place to prevent misuse or abuse of certain medicines by ensuring that they cannot go missing from the distribution chain.

Pregnancy Prevention Programmes

A Pregnancy Prevention Programme (PPP) may be put into place when a medicine has a known or potential teratogenic effect (it can cause harm to an unborn child). The purpose of this programme is to ensure that pregnancy is excluded in women of childbearing potential before they start taking the medicine, and that the risk of them becoming pregnant during therapy or shortly after finishing therapy is minimised as much as possible.

The MHRA can require MAHs to implement a PPP to minimise the risks to unborn children associated with a medicine. The MHRA would never require the implementation of a PPP without full consideration of the risks and benefits, including any potential negative impacts on patients (for example, as a result of health risks associated with switching medications). Decisions on whether to implement a PPP are made only after consultation with independent experts such as the Commission on Human Medicines (CHM).

A PPP combines the use of education tools for patients and healthcare professionals with requirements around prescribing and dispensing of the medicine. Additional risk minimisation measures may be required as part of a PPP such as Risk Acknowledgement Forms or Risk Awareness Forms that must be presented to the patient by the healthcare professional and signed by the patient to indicate they are aware of the risks.