Basic principles of pharmacovigilance

                      Basic Principles of Pharmacovigilance

PHARMACOVIGILACE:

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem.

Ø  collects, records, codes ADEs / ADRs

Ø  analyses and assesses the reports

Ø  promotes the safe use of drugs

Ø creates appropriate structures and means of communication needed to perform its tasks

GOALS OF PHARMACOVIGILANCE :

Ø  to improve patient care and safety

Ø  to improve public health and safety       

Ø  to contribute to the assessment of benefit, harm, effectiveness and risk of medicines  

Ø  to promote education and clinical training

Ø  to promote effective communication to the public

Ø to promote rational and safe use of medicines

ADVERSE DRUG REACTION :

Adverse Reaction means a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

 DATA SOURCES IN PHARMACOVIGILANCE :

Ø Spontaneous Reporting Systems

 • National PV Centre / Drug Authority

• from the published scientific literature and

Ø  Adverse Reaction Case Reports by the MA holder (e.g. collected by sales representatives)

Ø Periodic Safety Update Report (PSUR) provided by MA holder

ROLE OF SPONTANEOUS REPORTING :

Ø  covers all drug use of all populations

Ø  13/18 of the most important ADRs before 1982 have been ’signaled’ for the first time by SRs

Ø  More than 50% of all ’alert’ black boxes in the PDR derive from SRs

AE / ADR-REPORTS ASSESSMENT :

Ø  Seriousness / Severity

• ICH

• NCI

Ø  Frequency

Ø  Causality

Ø Pattern, e.g. pre-disposing risk factor

MINIMUM CRITERIA TO REPORT AN ADVERSE DRUG:

Ø  ‡ an identifiable source

Ø  ‡ an identifiable patient

Ø  ‡ a suspected product

Ø ‡ a suspected reaction

SERIOUS ADVERSE REACTION :

Serious adverse reaction means an adverse reaction which results in death, adverse reaction which results in death, hospitalisation, or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly / birth defect.          

WHAT IS SIGNAL :

A signal is a set of data constituting a hypothesis that is relevant to the rational and safe use of a drug in humans.

A signal is reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously.

SIGNAL GENERATION :

Ø three convincing ADR-reports

Ø  specified ADR-Reports Prescriptions

Ø  specified ADR-Reports (PRRs) all Reports

Ø  specified Reports / Exposed Persons Background Incidence

REFERENCES :

Ø  Volume 9 – PHARMACOVIGILANCE

Ø  CIOMS: Reporting Adverse Drug Reactions: Definition of Terms and Criteria for their use

Ø CIOMS: Geneva 1999