Lesson 2- Introduction to PV Flashcards
(26 cards)
What is pharmacovigilance (PV)?
The science and activities related to detecting, assessing, understanding, and preventing adverse drug effects or drug-related problems (WHO).
What event marked the origin of modern pharmacovigilance?
The thalidomide disaster (1957–1961), which caused severe birth defects (phocomelia) and led to stricter drug safety regulations.
What was thalidomide’s mechanism of harm?
Inhibited angiogenesis and generated reactive oxygen species, damaging cells. Later repurposed for conditions like multiple myeloma and leprosy.
Who first linked thalidomide to birth defects?
Dr. William McBride (Australia) and Dr. Widukind Lenz (Germany) in 1961.
What is the WHO Programme for International Drug Monitoring (PIDM)?
Established in 1968, it collects global adverse drug reaction (ADR) data through national PV centers.
What is the role of the Uppsala Monitoring Centre (UMC)?
Manages VigilBase (global ADR database), supports signal detection, and provides tools like VigiFlow for data management.
Which countries were founding members of PIDM in 1968?
Australia, Canada, Germany, Netherlands, UK, USA, and others (10 total).
Where is the WHO Collaborating Centre for Drug Statistics Methodology located?
Oslo, Norway; it classifies drugs using ATC codes and defines Daily Defined Doses (DDDs).
List major aims of pharmacovigilance.
- Early detection of unknown ADRs.
- Identify risk factors and mechanisms.
- Detection of increase in frequency of known AR
- Estimate quantitative aspects of benefit/risk analysis and dissemination of information
What does the WHO Collaborating Centre for Advocacy and Training focus on?
- Located in Accra, Ghana
- Advocacy and training in PV across Africa
- Integrating PV into public health programs
- Provide technical support to national PV centers
What is the role of the Rabat, Morocco, WHO Collaborating Centre for Strengthening PV Practives?
- Organize Training courses and workshops
- Build capacity in Arabic speaking and Francophone countries
- Involved in projects like integrated PV systems and patient safety
WHO collaborating Centre For PV Education and Patient Reporting functions?
Located in ’s-Hertogenbosch, Netherlands
- Develops and maintains PV curriculum in University Programmes
- Promote PV curriculum
- Provide training in handling patient reports
- Promote research in PV
What are ATC codes and DDDs?
- Anatomical Therapeutic Chemical codes classify drugs
- Daily Defined Doses standardize drug use metrics.
What is VigilBase?
WHO’s global database of Individual Case Safety Reports (ICSRs).
What is VigiFlow?
A data management tool used by national PV centers to report ADRs to VigilBase.
What regulatory changes followed the thalidomide tragedy?
- Establishment of new regulations and Medicine Evaluation Boards
- Spontaneous ADR reporting systems, to identify potential ADRs in early stage
- Stricter drug approval processes.
What is phocomelia?
A rare congenital defect causing limb malformations, linked to thalidomide use during pregnancy.
What is a Risk Management Plan (RMP)?
Strategies to monitor and minimize drug risks post-approval (e.g., restricted thalidomide use).
How does PV support patient safety?
By detecting ADRs, educating healthcare providers, and ensuring timely communication of risks.
When did Botswana join the WHO PIDM program?
2009, becoming an associate member with its own monitoring center.
What is Pharmacovigilance sans Frontières (PVSF)?
A WHO initiative established in 2007 to strengthen PV in low-resource countries through global collaboration.
What role do patients play in PV?
They can directly report ADRs via systems promoted by centers like the Netherlands’ WHO Collaborating Centre.
How are ATC codes used practically?
For drug utilization studies, reimbursement policies, and comparing medication use across regions.
What is the Daily Defined Dose (DDD)?
A standardized metric to estimate average daily drug consumption for adults.
