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Questions and Answers
What is the main focus of a national pharmacovigilance system as mentioned in the text?
What is the main focus of a national pharmacovigilance system as mentioned in the text?
What was the process through which the minimum requirements for a national pharmacovigilance system were developed?
What was the process through which the minimum requirements for a national pharmacovigilance system were developed?
What is one of the functions of a national pharmacovigilance system?
What is one of the functions of a national pharmacovigilance system?
How does a national pharmacovigilance system contribute to public health according to the text?
How does a national pharmacovigilance system contribute to public health according to the text?
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What type of issues does a national pharmacovigilance system help identify with regard to medicines?
What type of issues does a national pharmacovigilance system help identify with regard to medicines?
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Study Notes
Definition and Importance of Pharmacovigilance
- Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.
- PV is crucial to prevent drug-related adverse effects in humans, ensure patient safety, and promote the rational use of drugs.
Current Status of Pharmacovigilance
- PV is well established in most industrialized countries, but its practice in low and middle-income countries is variable.
- Some countries have no PV systems, while a few have systems comparable to those in industrialized countries.
WHO's Initiative for Pharmacovigilance
- The World Health Organisation (WHO) has embarked on a consultative process to produce a Pharmacovigilance Strategy for all countries.
- The strategy aims to advance PV systems through the Global Fund and similar health initiatives.
Minimum Requirements for Pharmacovigilance
- The minimum requirements for a national PV system include guaranteed funding and a focus on patient safety.
- The requirements were developed through a consultative process involving experts and stakeholders.
Functions of a National Pharmacovigilance System
- The functions of a national PV system include: • Promoting PV and collecting/managing ADR reports, medication errors, and suspected counterfeit/substandard drugs. • Identifying signals of medicine safety and unknown or poorly characterized adverse events. • Assessing risk and options for risk management. • Identifying quality problems in medicines resulting in ADRs. • Providing effective communication on medicine safety. • Applying pharmacovigilance information for public health programmes, patients, and national medicines policies. • Developing and maintaining drug utilization information. • Identifying issues associated with unregulated prescribing and dispensing of medicines.
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Description
Explore the fundamental concepts of pharmacovigilance, which involves detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. Learn about the importance of pharmacovigilance in ensuring patient safety and promoting the rational use of drugs.