Pharmacovigilance learning module

Here, you will learn what pharmacovigilance is and how it relates to day-to-day clinical practice. You will understand health professionals’ role in contributing to clinical knowledge on the harms of individual medicines and you will learn how to keep updated on the risks of medicines—so you make good treatment choices.

Continuing professional education

The Faculty of Pharmaceutical Medicine (external link) of the Royal Colleges of Physicians of the United Kingdom has approved this learning module for up to three CPD credits. Participants should only record the number of hours spent working through the module.

If you are claiming CPD credits, for audit purposes we recommend that you:

  • retain any pages you print
  • retain any notes you make
  • write a reflective commentary on what you have learned and how this may help in your practice.

Key points

  • Information on potential harm of a medicine is incomplete when the medicine is launched
  • Pharmacovigilance is vital to ensure the continued safety of medicines
  • Health professionals, pharmaceutical companies and regulators play a key role in pharmacovigilance
  • The Yellow Card Scheme is an important method by which potential adverse drug reactions can be detected
  • To safeguard individuals’ health, clinicians need to seek out emerging information on adverse reactions to medicines and to act on it
  • Information on adverse drug reactions is covered in the BNF and the medicine’s summary of product characteristics; important emerging information is provided by bulletins such as Drug Safety Update.

It is best to work through this learning module in the order suggested below. You can test your understanding of the material with the exercise and case studies at the end.


1. Introduction

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2. Adverse drug reactions

Classification of adverse reactions

The impact of adverse effects from medicines and how these effects are categorised 

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3. Pharmacovigilance

Importance of monitoring adverse effects

Who is responsible for pharmacovigilance?

How is the potential new effect assessed?

Why we need to be on the constant lookout for unwanted effects of medicines, who contributes to the information and how it is processed

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4. Information sources on adverse drug reactions

Sources for use in the clinic

Sources for emerging information

Sources for detailed information on adverse reactions

Where to go for information on the risks of medicines and how to drill down for further information

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5. How to report a suspected adverse drug reaction

What is the Yellow Card Scheme?

What should trigger reporting?

Filling out a Yellow Card

What happens to your Yellow Card submission?

UK system for gathering individual reports of adverse effects and your role in the arrangement

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Test yourself

Exercise 1 (finding out about adverse reactions)

Case study 1 (if you encounter a possible adverse effect …)

Case study 2 (filling out a yellow card)

Check your understanding of pharmacovigilance and your role in reporting suspected reactions and keeping informed about the risks of medicines.

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Resources

Further reading

Glossary

Pointers to more information on pharmacovigilance and explanation of some specialist terms


Page last modified: 13 February 2012