Pharmacovigellence

Question 1

Definition of pharmacovigilance?

Answer 1

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Question 2

What is risk management plan?

Answer 2

RMP aims to identify, characterise prevent minimise risk of med

• identified what info is missing and what studies are needed to fill gaps
• continuously updated throughout life of med

Question 3

Risk Minimisation

Answer 3

• risk severity or frequency
• tools such as SPC, PIL, labelling, packaging legal status
• controlled access programmes: requirements that need to be fulfilled before rx, like pregnancy prevention and valproate

Question 4

VigiBase

Answer 4

computerised pharmacovigilance systemwide which info is recorded; purpose to provide evidence from which potential med safety hazards can be detected
-Eudravigilance- eu system wide, all members report to

Question 5

MHRA

Answer 5

• Monitors the everyday use of medicines to identify previously unrecognised effects or changes in pattern of adverse effects
• Assesses the risks and benefits of medicines to determine what action is needed to improve their safe use
• Provides information to healthcare professionals and patients to optimise safe and effective use of medicines
• Monitors the impact of any action taken

Question 6

What can you report using yellow card?

Answer 6

• Side effects (or ADRs) to a medicine, vaccine, herbal or homeopathic remedy
• Medical device adverse incidents
• Defective medicines (not of an acceptable quality)
• Counterfeit or fake medicines or medical devices
• Safety concerns for e-cigarettes or their refill containers (e-liquids)

Report Illicit Drug Reactions (RIDR)
-The MHRA and PHE have launched a scheme for reporting the effects of new psychoactive substances (NPS) and other illicit drugs

Question 7

How to identify ADRS

Answer 7

• Patients may tell you about symptoms they have experienced since taking a new medicine
• Linking a sign or symptom to either current or previous therapy (can include OTC and unlicensed herbal remedies)

Be also alert to:

• abnormal clinical measurements (eg temperature, pulse, BP…) while on drug therapy
• abnormal laboratory results while on drug therapy
• if new drug therapy is started which may be used to treat the symptoms of an ADR
• listening to the patient’s own concerns regarding drug therapy
• considering the opinion of a parent if concerning a child

Question 8

Children

Answer 8

react differently to medicines the pharmacodynamics and pharmacokinetics of a medicine may be very different when compared with adults
-many drugs which are routinely used to treat children are not extensively tested in children for their use; many used ‘off-label’
drugs may affect the way a child grows and develops or may cause delayed ADRs which do not occur in adults
-available formulations may not allow precise dosing in children or may contain excipients that should not be used such as alcohol
-the nature and course of illnesses and suspected ADRs may differ between adults and children

Question 9

over 65

Answer 9

-because of changes in pharmacokinetics and pharmacodynamics

-

Question 10

Black triangle Products

Answer 10

New drugs, biologicals and vaccines are being intensively monitored to confirm their risk/benefit profile (EU wide) = additional monitoring scheme (black triangle)

They also cover:
new combinations of drugs
new routes of administration for established drugs
established drugs with significant new indications