What is it? Why is it important?

Pharmacovigilance (PV):

  • Is a system monitoring the safety of marked approved Medicinal Products (MP) (e.g. refines, confirms or denies the safety of marketed approved MPs)
  • Is a duty of any healthcare professionals prescribing / giving / using marked approved MPs (regulated by TPA)
  • Is required for category A studies, as these studies investigate market approved products

PV is important as it:

  • Ensures ongoing surveillance regarding the detection, assessment and prevention of A(D)Rs, which were not detected during product development (e.g. pre-clinical- and phase I-III studies)
  • Allows the detection of Safety Signals (SS). A SS is any significant safety-related information on:
    • A new potential association or new aspects of a known association between a MP and an AE that requires further investigation in order to be classified as an A(D)R
  • Monitors the safety of MP in everyday usage (e.g. consumer acceptance, product use-patterns and conditions responsible for A(D)Rs)
  • Provides data supporting non-safe MPs to be pulled from the market

More

In studies the efficacy and safety of new MPs are generally studied and followed-up on a few thousand carefully selected participants. Therefore, during MP development only very frequent A(D)Rs, and mainly those depending on the MP's pharmacological properties, will be detected.

Once the MP has been market approved, a much larger and often polymorbid population will become exposed to the MP. This may lead to changes in the MP's hitherto known safety profile. A(D)Rs will be reported and observed more frequently, including those that occur only sporadically and independently of the MP’s pharmacological properties.

The reporting of serious and/or previously unknown A(D)Rs plays a vital role in the detection of potential MP risks at an early stage. Through ongoing A(D)R surveillance, potential Safety Signals (SS) become apparent. It allows for an ongoing monitoring and evaluation of the risk-benefit profile of marketed products. Still, the early detection of unknown and unexpected SS from post marketing surveillance data is one of the major challenges of PV.

In order to ensure that these newly discovered A(D)Rs are added to a still incomplete drug safety profile they must be reported on an ongoing basis. Thus, thanks to ongoing PV, the drug’s safety profile is continuously updated, including an evaluation whether benefits still outweigh expected risks.

What do I need to do?

As a SP-INV and Site-INV familiarise yourself with safety reporting requirements of category A studies. Apart from ClinO reporting requirements. PV reporting also applies.

Report to Swissmedic (e.g. through the electronic vigilance reporting system (ElViS)), the occurrence of any A(D)R in Switzerland within:

  • 15 days of diagnosis for serious A(D)Rs
  • 60 days of diagnosis for A(D)Rs that are insufficiently or not yet documented in the MP product information
  • 60 days of diagnosis for all other medically significant A(D)Rs

A proven causality between the A(D)R and the MP is not required, suspicion alone is sufficient.

Criteria for a risk category A study requires that the MP:

  • Has a marketing authorization in Switzerland, and
  • Is used according to the Product Information or
  • Is used in an indication or dosage different form the Product Information but according to given criteria, or
  • Is recognized a standard in internationally accepted guidelines

More

Reporting to Swissmedic is done through the electronic vigilance reporting system (ElViS)). As a SP-INV you can request assistance from the PV regional centre at your hospital (e.g. there are 5 such centres in Switzerland). They can support you in the assessment of any suspected A(D)R and how to report to Swissmedic.

When reporting through ElViS provide:

  • A precise description of the A(D)R including symptoms and findings (e.g. lab results)
  • The temporal relationship between the administration of the MP and the onset of the A(D)R
  • Information on whether or not symptoms resolved or improved after stopping drug intake (outcome of the event)
  • Details on concomitant medication (e.g. other medications apart from the MP)
  • Details of the differential diagnosis and non-drug-related factors that may have influenced the clinical picture of the observed event (e.g. other causes that may have caused the event)

PV reporting is the duty of any healthcare professionals prescribing / giving / using marked approved MPs (regulated by TPA). Consumers can also report undesirable MP effects to Swissmedic.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • Pharmacovigilance
  • Vigilance-System (reporting of A(D)R / ElViS)
  • Reporting adverse drug

reactions for doctors and pharmacists

References

ICH - see in particular guideline

  • E2E Pharmacovigilance Planning

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 812.21 TPA

ClinO – see in particular article

  • Art. 19 Categorisation of IMP

TPA – see in particular articles

  • Art. 54 (7b+c) for clinical trials
  • Art. 58 market surveillance
  • Art. 59 mandatory notification, notification system and the right to notify
Abbreviations
  • A(D)R – Adverse (Drug) Reaction
  • AE – Adverse Event
  • CE - conformity marking
  • ClinO –Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • ElViS – Electronic Vigilance System
  • FEDLEX – Publication Platform for Federal Laws
  • ICH – International Council for Harmonisation
  • MP – Medicinal Product
  • SP-INV – Sponsor Investigator
  • SS – Safety Signals
  • Site-INV – site investigator
  • TPA – Therapeutic Product Act
  • PV – Pharmacovigilance
Basic ↦ Safety ↦ Safety Vigilance ↦ Pharmacovigilance
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Safety ↦ Safety Vigilance ↦ Pharmacovigilance

Please note: the Easy-GCS tool is currently under construction.