PV 4 Flashcards
What is the primary purpose of pharmacovigilance?
To monitor the safety of medicines and detect adverse drug reactions (ADRs)
What percentage of ADR reports in the WHO-ADR database come from high-income countries?
The majority
What are some limitations of ADR reporting in randomized control trials?
- Limited population size
- Exclusion of extremes of age
- Potential bias from pharmaceutical companies
Why is spontaneous reporting of ADRs important in hospitals?
Severe ADRs are most likely to be observed in hospitals
What did the systematic review from 2005 to 2014 reveal about doctors’ knowledge of ADRs?
Doctors could define ADRs but had inadequate knowledge of the reporting procedures
What obstacles do physicians face in reporting ADRs?
- Problems in diagnosis
- Lack of knowledge
- Uncertainty on how to report
- Time and workload issues
What solutions did physicians propose to improve ADR reporting?
- Define reporting priorities
- Improve communication with pharmacovigilance systems
- Feedback from reported ADRs
What is the role of pharmacists in ADR reporting?
Pharmacists should take responsibility in ADRs reporting as part of the healthcare team
What barriers do pharmacists face in reporting ADRs?
- Lack of knowledge
- Belief that only serious ADRs should be reported
- Fear of non-appropriateness
- Lack of time and interest
What are some systems-related barriers to ADR reporting by pharmacists?
- Lack of guidelines
- Inability to access patient records
- Lack of training and incentives
How can nurses improve their practice in ADR reporting?
- Ensure adequate education
- Provide reporting protocols
- Improve interprofessional collaboration
When did patient participation in ADR reporting begin in Australia?
1996
What was the median number of patient reports per year in a study of fifty countries?
3678 reports
What are some key obstacles to ADR reporting in Sudan?
- Poor resources
- Lack of guidelines
- Lack of motivation and collaboration
- Poor documentation
What is a signal in the context of ADR reporting?
Reported information suggesting a possible causal relationship between an adverse event and a drug
What is the purpose of data mining in ADR reporting?
To identify potential drug safety issues efficiently
What does signal assessment involve?
- Assessing the likelihood of a causal relationship
- Identifying possible risk factors
What actions can be taken to minimize risks from identified adverse effects?
- Adding new adverse effects to existing lists
- Restricting uses and revising dosage recommendations
- Removing the medicine from the market if necessary
What is the role of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP)?
To provide advice on safety issues relating to medicinal products and guide pharmacovigilance
Fill in the blank: The official country joining of the WHO National Programme for International Drug Monitoring in Sudan was in _______.
2007
True or False: The majority of patients have a positive attitude towards ADR reporting.
True
