Adverse drug reactions: resources to support clinical decisions

SPS resources

SPS provides advice on adverse effects. Articles include:

• Managing peripheral oedema caused by calcium channel blockers (SPS page)
• Managing medicines associated with QT interval prolongation (SPS page)
• Managing constipation in people taking clozapine (SPS page)
• Managing reactions to dental local anaesthetic injections (SPS page)

Our Medicines Monitoring (SPS page) can be helpful. The ‘Abnormal results’ section of each monograph lists adverse effects and may note signs and symptoms to watch out for.

Other resources

In addition to our own resources, we recommend the following resources that are free to access:

Clinical Knowledge Summaries

Clinical Knowledge Summaries (CKS) has a topic on Adverse drug reactions (ADR) that provides information and advice. Particularly useful are scenarios describing how to:

• assess a person with a suspected ADR
• manage a person with a suspected ADR

British National Formulary

Drug monographs in the British National Formulary (BNF) and BNF for Children (BNFC) include sections on side-effects, allergy and cross-sensitivity.

MHRA advice and Patient Safety Alerts, where relevant, are found in the ‘Important safety information’ towards the top of drug monographs.

A medicines guidance topic, adverse reactions to drugs, provides advice including on:

• side-effects in the BNF
• prevention of adverse reactions
• drug allergy
• oral side-effects of drugs

Summaries of Product Characteristics (SmPCs)

Product information is available via the electronic Medicines Compendium and MHRA. Useful sections include:

• undesirable effects (section 4.8)
• contraindications (4.3)
• precautions for use (4.4)

Patient Information Leaflets (PILs) also provide information on possible side effects. Effects are grouped by seriousness, explaining which symptoms require patients to take action and what that action should be.

MHRA interactive Drug Analysis Profiles (iDAPs)

Healthcare professionals and patients can report a suspected adverse reaction to a medicine by completing a yellow card report online.

IDAPs display data from the Yellow Card Scheme and provide information on the number of “yellow card” reports of suspected adverse drug reactions (ADRs) received for a medicine.

Finding an iDAP

To find a specific iDAP note:

• iDAPs are listed alphabetically by drug name
• iDAPs are not available for combination products – find the iDAP for an individual ingredient then look at reports for ‘multiple ingredients’

Using an iDAP

When using the iDAP, information is presented in different views. They are:

• Information – explains which brand names and combination products are included
• Overview – shows numbers of total serious reports and reports with fatal outcome from all sources
• Yellow Card Overview – shows numbers of total serious and fatal reports from Yellow Cards, grouped by ethnicity, age and sex.
• Total Report Profile – choose between bar chart or table. Results can be filtered by factors including sex, age, year of report, reaction seriousness and system organ class affected.
• Total Reaction Profile – choose between graph or table. In table format, reports can be narrowed down to specific reactions.

Note that:

• essential context for understanding the report is included at the bottom of each page, to explain the context of the data available.
• reports are for suspected adverse drug reactions – a causal association may not have been confirmed

MHRA Drug Safety Update

Drug Safety update highlights current areas of concern in medicines safety, such as adverse reactions, drug interactions or concerns over medicine use in specific patient groups. The website is searchable and hits can be filtered by therapeutic area or date published.

The MHRA Safety Roundup bulletin is published monthly and provides a summary of safety communications, including Drug Safety Updates.

Further information

If the information is not available on the SPS website or the information resources listed, or if your clinical scenario is complex, we would suggest you seek further advice from our Medicines Advice service (SPS page).

Training resources

If you would like more information on how to approach answering questions on adverse effects, we recommend:

Medicines Learning Portal

The Medicines Learning Portal is aimed at trainee hospital pharmacists but the content is also relevant to clinical primary care healthcare professionals. The portal includes a tutorial on adverse reactions which provides advice on:

• questions to ask when considering questions relating to adverse reactions
• assessing and managing adverse reactions
• how to report adverse effects to the MHRA

MHRA training resources

The MHRA has created e-learning modules for healthcare professionals. Different modules are aimed at doctors, pharmacists and nurses. The pharmacist modules are provided through CPPE and are accessible to pharmacists, pharmacy technicians and trainee pharmacists who are GPhC members. The nurse module requires registration with the Nursing Times.

Two further modules and an online assessment, developed with the British Pharmacological Society, are to support those working across healthcare. They aim to promote a better understanding of what the yellow card scheme is, when to report and how to submit a report effectively.

Update history