Pharmacovigilance activities include: 

• The collection and assessment of safety-related information to determine the benefit/risk impact – (e.g., through Yellow Card reporting of adverse drug reactions).
• Implementing risk management strategies to minimise risks associated with medicines use – see the sections on risk management plan and strategy and risk minimisation measures for more information.
• Communication of any risk to the public and healthcare professionals (HCPs) – (e.g., through distribution of educational materials or tools containing key safety messages).
• Assessing the effectiveness of pharmacovigilance activities – (e.g., marketing authorisation holders (MAHs) to evaluate effectiveness and success through studies and surveys with patients and HCPs and monitoring of before and after the adverse drug reaction incidences). 

For further information, see the WHO website and European Medicines Agency (EMA) website.

Why is pharmacovigilance important? 

Once a medicine is launched, ongoing safety monitoring is crucial, because when the MA is granted, the medicine will have been tested on a relatively small number of patients for a limited amount of time.

Rarer adverse reactions may only start to be reported once the medicine has been used in a larger number of patients (who may differ from the study population, e.g., ethnicity, age, genetic background, polypharmacy and other medical conditions) and/or over a long period.

It’s important to quickly identify and report new risks (e.g., medication errors) or any changes to the known risks associated with a medicine. For example, reporting suspected adverse drug reactions to the Yellow Card scheme – you may find our Yellow Card Scheme guide helpful.

Pharmaceutical companies and regulatory authorities continue to monitor the safety profile of their medicines. Actions can then be taken to minimise the risks of changes in the safety profile, maximise the benefits and promote the safe and effective use of the medicine by patients.

For pharmacovigilance to be effective, it requires the input of: 

• HCPs, including pharmacists – by reporting suspected adverse drug reactions to the Yellow Card scheme.
• The public, including patients or their carers – by reporting suspected adverse drug reactions to the Yellow Card scheme.
• Regulatory authorities, pharmaceutical industry associations and pharmaceutical companies – using tools such as risk management plans.

How pharmacists can support pharmacovigilance

Pharmacists can help minimise the risk associated with medicines in the following ways:

• Identify new risks (such as medication errors) or any changes to the known risks associated with the use of any medicine as quickly as possible (e.g., identifying and reporting suspected adverse drug reactions to the Yellow Card scheme).
• Pharmacists may be involved in the further dissemination of key safety messages/alert cards to patients or carers during the dispensing process, (e.g., a pharmacist may support patients taking oral anticoagulant medicines and issue appropriate anticoagulant alert cards).
• Pharmacists may educate other HCPs or spread educational materials about the safety requirements for medicines.
• For medicines supplied under controlled access programmes, pharmacists should document receipt of and understanding of information on the serious risk of the product – see the section on controlled access programmes.
• Pharmacists may be approached to participate in surveys or studies to help MAHs evaluate the success and effectiveness of their risk minimisation activities (e.g., to identify patients or facilitate audits of pharmacy and patient records).
• Sign up to receive patient safety alerts (e.g., from RCPharm and the MHRA).
• Pharmacists should be familiar with where to access risk minimisation materials – see where to access risk minimisation materials.

Risk management plan and strategy

A risk management plan (RMP) is a set of activities designed to characterise, prevent and/or minimise the risk of a medicine. An RMP is written by a pharmaceutical company as part of its application for an MA and is continually updated throughout the life cycle of a medicine, increasing the knowledge of a medicine’s risk/benefit over time.

An RMP is an important tool for dealing with safety concerns associated with a medicine. A safety concern is an important identified risk or potential risk, or missing information associated with a medicine. A safety concern may be addressed using more than one risk minimisation measure, and a risk minimisation measure may address more than one safety concern.

An RMP must include a risk minimisation strategy that documents the risk minimisation measures (routine or additional) for a medicine. See the section below on risk minimisation measures for more information. 

Further information on RMPs can be found on the EMA website. 

Risk minimisation measures

Risk minimisation measures can either reduce the severity of the risk when it occurs or reduce its frequency. These measures may consist of:

• Routine risk minimisation activities.
• Additional risk minimisation activities. 

Routine risk minimisation activities

Routine risk minimisation activities apply to all medicines and include tools such as:

• Summary of product characteristics.
• Patient information leaflet.
• Labelling.
• Packaging.
• Legal status of the medicine.

For most medicines, routine risk minimisation is considered sufficient. However, for some medicines, additional risk minimisation activities are required to improve the benefit/risk profile.

Additional risk minimisation activities

Additional risk minimisation activities are required for some new medicines, as well as older medicines where a safety issue has been identified. Measures are put in place to improve the benefit/risk profile of the medicine. These activities require review and prior approval by the MHRA before they can be implemented and used.

Examples of additional risk minimisation activities include: 

• Educational programmes for HCPs, patients and carers (e.g., training videos).
• Patient screening or monitoring guides.
• Patient alert cards (e.g., anticoagulants).
• Prescriber/HCP product guides.
• Posters.
• Dosing tools.
• Checklists.
• Direct healthcare professional communications.

These measures may be used to:

• Guide the selection of patients who can receive a medicine. 
• Identify those patients in whom the medicine is contraindicated.
• Monitor patients on a medicine for important known risks. 
• Enable management of an adverse reaction once detected.
• Minimise the risk of medication errors. 
• Ensure appropriate administration techniques are used.

For risk minimisation material for individual medicines, see the further information section.

Controlled access programmes 

Controlled access programmes are more restrictive types of activities beyond routine risk minimisation activities. They specify requirements and actions HCPs and patients need to fulfil before a medicine is prescribed and/or dispensed. This is to prevent and minimise a safety concern/risk associated with significant public health or individual patient impact. 

Examples of controlled access programmes include:

• Pregnancy prevention programmes (e.g., thalidomide, retinoid, valproate – see our valproate and oral retinoids guides.
• Clozaril patient monitoring service (e.g., clozapine – see section on further information).

Specific requirements and actions may include:

• Specific testing and/or examination of the patient to ensure compliance with strictly defined clinical criteria.
• Prescriber, pharmacist and/or patient documenting their receipt and understanding of information on the serious risk of the product.
• Explicit procedures for systematic patient follow-up through enrolment in a specific data collection system (e.g., clozapine patient registry).
• Medicines made available for dispensing only to pharmacies that are registered and approved to dispense the product.
• Requirements to test or monitor a patient before and/or during treatment (e.g., with electrocardiograms, regular blood tests or pregnancy tests (which can be part of a pregnancy prevention programme)).

Risk minimisation materials 

You can access additional risk management materials in the following ways:

• Via the electronic medicines compendium (emc).
• As an alert card provided in the product pack.
• Directly from the MAH.

Information may also be communicated and delivered by MAH’s field-based teams, (e.g., sales force for medical scientific liaison teams). In this instance, the activity is strictly non-promotional and isn’t associated with the promotion of a medicine.

Further information

RCPharm

• Yellow card scheme guide.
• Black Triangle Scheme guide.
• Oral retinoids and the pregnancy prevention programme.
  • Valproate and the pregnancy prevention programme.

External

• Clozaril Connect – patient monitoring service.
• emc – Risk Minimisation Materials.
• EMA – RMPs.
• Legislation.gov.uk – The Human Medicines Regulations 2012.
• WHO – guidance on pharmacovigilance.
• MHRA – product information about medicines.
  • MHRA – Alerts, recalls and safety information: medicines and medical devices.
  • MHRA – Yellow Card scheme.