The Scope of Pharmacovigilance

The nature of the global pharmacovigilance landscape and societal context has been rapidly changing in recent years, and is still changing. SoPI considers it important that the aims of SoPI should reflect this wider scope.

In the view of SoPI, the scope of pharmacovigilance is:

Any area that contributes better knowledge and understanding of the safe and effective use of medicines, pre- and post-marketing, including but not limited to

• Problems related to the active components and ingredients of medicinal products
• Problems related to medicines use, e.g.
• Prescription, dispensing, administration errors
• Adherence to the treatment
• Misuse, abuse, recreational use of drugs of addiction
• Poisoning, accidental overdose
• Substandard/spurious/falsely-labelled/falsified/ counterfeit (SSFFC) medical products.
• Safety problems in relation to mass medication (e.g. vaccines)
• Antimicrobial resistance and other treatment failures.
• Benefit-harm assessment and risk management.
• Quality issues related to manufacturing, transport or storage.
• Environmental effects.
• Regulatory matters pertaining to the above.