Pharmacovigilance Flashcards
what is Pharmacovigilance?
it is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or nay other possible drug-related problems
Nowadays Pv includes?
herbals, traidtional medcine, blood products, biologicals, medical devices, vaccines
What is the purpose of PV?
Provide optimals information to users identify new information or hazard associated with medicines Evaluate changes in benefits and risk Monitor impact of actions taken prevent harm to patients
PV Legislation in the EU
Regulation and directive in the EU and Clinical trials legislation
what is the pharamcovigilance system master file?
it describes the pharmacovigilance system used by the marketing authorisation holder (MAH) and documents the compliance with legal requirements
QPPV stands for?
Qualified person responsible for pharmacovigilance
What are the key tasks of the QPPV
Implementation and maintenance of the pharmacovigilance system
overview of the benefit-risk profile of all approved drugs
contact person for regulatory authorities (24 hourse a day) and for inspections
Who is a QPPV?
a natural person, having knowledge for the performace of PV activities and has acees to experties in relavent areas such as medicine, pharamceutical sciences as well as epidemiology and biostatistics
QPPV should be?
24/7 availability for national comptent authorities and EMA
be independent from the board or directors
must reside in the Community (EU/EEA)
which measures are taken by the EMA in PV
Monitor the outcome of the rsik minimisation measures contained in risk management plan
Assess updates to the risk managment system
Evaluate the data in the EudraVigilance database
what is the graduted plan?
it is a rational aprroach to drug risks, a national risk assessment procedure
Hazard Level 1
Reached as soon as reports to the possibility of newly emerged drug risks
Affected company has to be informed, contacting stakeholders of the graduated plan
Hazard Level 2
initiated after level 1 or in the case of high risks
Consultation of the level plan officer and initiation f measures Announcement of measures to reduce7 avoid the risks
GPO
Graduated Plan Officer
GPO is?
a qualified person who is resident in a MS of the EU
what are the function of the GPO?
Set up and mange a PV system
collect and evalute notifications on medicinal product risk that have become known
Co-ordinate the necessary measures
the granuated plan officer is resonsible for?
medicinal and pharmceutical defects
Differeces between EU-QPPV and GPO in their resonsible
EU: QPPV: the complete European PV system
GPO: local German PV system
Differeces between EU-QPPV and GPO in their Availability
EU-QPPV: single PV ontact point for the comptent authorities in MS and the Agency on a -hour basis
GPO: No requirements (normal office hours)
Product techinal complaints (EU-QPPV and GPO)
EU-QPPV: no resonsibility
GPO: Responsible for all product technical complaints reported
Safety of IMPS (EU-QPPV and GPO)
EU-QPPV: no resonsibility
GPO: Responsible about all product risk also concerning investigation medicinal products
Liability (EU-QPPV and GPO)
EU-QPPV: No special rules
GPO: Personally liable
Quantity (EU-QPPV and GPO)
EU-QPPV: Only one QPPV/ company
GPO: Allowed to have multiple GPO per company (one for PV, for complaints and for CS)
Different between Adverse event and reaction
Adverse Event are events which are does not necessarily have to have a causal relationship with the treatment
Advers Reaction: it is response to a medicial product which is noxious and unintended
A causal relationship between a medicinla product and an anvser event is at last a resonable possibility
Serioud adverse reaction?
adversse reaction which results in death, is life-threatening
unexpected adverse reaction
an adverse reaction, the nature, severity or outcome of which is not consistent with SmPC
Safety Signals
Information on a new or know adverse event/ reaction that ia potentially caused by a medicine and that warrent further investigation
Classification of adcerse reaction
- Case reports are assessed for validity
- meets the minimum criteria
- the receipt data or day 0
- Case reports will be assessed for regulatory reporting
what the 4 minimum criteria
An identifiable reporter
an identifiable patient
At least one suspected substnace/ medicinal product
At least one suspected adverse reaction
the Receipte Date /Day 0 is defined as?
the date on which the MAH had first awareness of the adverse event or the date when a contract or licensing partner of the MAH had first awareness
the case report takes into consideration
Seriousness
Expectedness
Causailty (Relatedness)
unecpected events?
when the nature of severity is not consistent with the SmPC
Causality?
is the relationship of the reported event to the drug
What happends to AR information?
they are used to determine the benefit-risk profile of the product
What are some result of the AR information
Comminication with comptent Authorities
Recall of Bacthes/products
Chnages to the patient information leaflet and updates to the SmPC
Wthdrawal of the product from the market
Black Triangle
Additional monitoring typically for product that are new, or have had a new indication or formulation approved
timelines ofr reporting
Post-marketing:
EU: Serious individual Case safety reporting (ICSR) 15 days
Nono-serious ICSR 90 days at the EudroVigilance Database
US: Serious unexpected ICSRs 15 days
Clinical study:
Suspected unexpected serious adverse reaction (SUSARs)
Clinical study:
Suspected unexpected serious adverse reaction (SUSARs) include
Fatel or life-threatening 7 days
other SUSARs 15 day
Medical Dictinary for regulatory activites (MedDRa)
a standardised medical terminology used by regulatory authorites and the phramceutica industry throughout the entire regulatory process, from pre-marketing to post-marketing activites
MadDRA is managed by
MSSO : Maintenance and support Services Organization
EudraVigilance?
is the system for mangaing and analysing information on suspected adverse reactions to medicines which have been authroised or being studies in clinical trials in the European Economic Area
what are the activies of the EudraVigilance?
Electronic exchange of indivial case saftey reports between EMA, national competnet authorities, MA H and sponsors of clinical trials in the EEA
Earyl detection and evaluation of possible safety signals
Periodic Saftey Udate Report
is a report to be prepared by the MA Holder at fixed intervals. Seves to contanly update the benefit risk assessment. Contains all safety data from the time of authorization
Time frame for the PSUR?
Based on the date of MA: Six monthly report for the first two years fater aprroval
annual reports for the following two years
three-year reports from the date of the renewal of the MA
Risk manageent plan include information on
a medicine’s saftey profile
how its risk will be prevented or minisied in patients
plans fro studies and other activites to gain more knowlegde about the sefty and efficacy of the medicine
measuring the effectiveness of risk-minimisation measures
when the RMP submitted?
at the time of applicatin
