Podcast
Questions and Answers
What defines an adverse drug event?
What defines an adverse drug event?
- Any negative reaction that occurs only at high doses of a drug.
- A harmful and unintended response at any dose.
- Any untoward medical occurrence during drug treatment that may not have a causal relationship. (correct)
- An intended effect of a drug that is not related to its pharmacological properties.
Which of the following best explains a side effect?
Which of the following best explains a side effect?
- An effect that is related to the pharmacological properties of a drug used at normal doses. (correct)
- A medical occurrence that does not relate to the use of drugs.
- An allergic reaction that occurs only in rare cases.
- An occurrence that happens outside of normal doses.
What describes drug interactions?
What describes drug interactions?
- Alteration of a drug's pharmacological activity due to another drug, substance, or disease. (correct)
- Only interactions that occur between two drugs.
- Interactions that cause the body to ignore the effects of a drug.
- Interactions that enhance the therapeutic effect of a drug.
According to the WHO definition, what qualifies as an adverse drug reaction (ADR)?
According to the WHO definition, what qualifies as an adverse drug reaction (ADR)?
Which type of adverse drug reaction is categorized as idiosyncratic?
Which type of adverse drug reaction is categorized as idiosyncratic?
What is the primary focus of pharmacovigilance?
What is the primary focus of pharmacovigilance?
Which of the following describes one of the aims of pharmacovigilance?
Which of the following describes one of the aims of pharmacovigilance?
What term is sometimes used interchangeably with pharmacovigilance?
What term is sometimes used interchangeably with pharmacovigilance?
Which statement accurately reflects a component of the scope of pharmacovigilance?
Which statement accurately reflects a component of the scope of pharmacovigilance?
What does the WHO define as pharmacovigilance?
What does the WHO define as pharmacovigilance?
What is a key objective of pharmacovigilance?
What is a key objective of pharmacovigilance?
Which of the following medical products is NOT covered by pharmacovigilance?
Which of the following medical products is NOT covered by pharmacovigilance?
Which activity contributes to the protection of patients in pharmacovigilance?
Which activity contributes to the protection of patients in pharmacovigilance?
What is the first step in the further process of data entry in pharmacovigilance?
What is the first step in the further process of data entry in pharmacovigilance?
What does the query process in pharmacovigilance involve?
What does the query process in pharmacovigilance involve?
Which document is NOT used to understand the drug safety profile?
Which document is NOT used to understand the drug safety profile?
What is a Serious Adverse Event (SAE)?
What is a Serious Adverse Event (SAE)?
What is included in the action taken to prevent adverse drug reactions?
What is included in the action taken to prevent adverse drug reactions?
Which of the following is considered when identifying adverse drug reactions (ADRs)?
Which of the following is considered when identifying adverse drug reactions (ADRs)?
What does causality assessment focus on in medical review?
What does causality assessment focus on in medical review?
What is a characteristic of an adverse drug reaction (ADR)?
What is a characteristic of an adverse drug reaction (ADR)?
What characteristics define type A adverse drug reactions?
What characteristics define type A adverse drug reactions?
Which example best represents a type B adverse drug reaction?
Which example best represents a type B adverse drug reaction?
What type of adverse drug reaction is characterized by time-related effects that often appear after drug use?
What type of adverse drug reaction is characterized by time-related effects that often appear after drug use?
Which of the following is true regarding type E reactions?
Which of the following is true regarding type E reactions?
What common characteristic defines type F adverse drug reactions?
What common characteristic defines type F adverse drug reactions?
Which example is associated with type C adverse drug reactions?
Which example is associated with type C adverse drug reactions?
Which statement correctly differentiates between an adverse drug event and an adverse drug reaction?
Which statement correctly differentiates between an adverse drug event and an adverse drug reaction?
Which type of ADR is considered uncommon and usually arises from prolonged use without accumulation?
Which type of ADR is considered uncommon and usually arises from prolonged use without accumulation?
What characterizes a severe adverse drug reaction (ADR)?
What characterizes a severe adverse drug reaction (ADR)?
Which agency in Ghana is responsible for receiving and processing adverse drug reactions?
Which agency in Ghana is responsible for receiving and processing adverse drug reactions?
What is the primary source of information in pharmacovigilance?
What is the primary source of information in pharmacovigilance?
Which of the following elements is NOT included in a case report for reporting an ADR?
Which of the following elements is NOT included in a case report for reporting an ADR?
Who among the following can report an adverse drug reaction?
Who among the following can report an adverse drug reaction?
What should be reported about the suspected drug(s) in an ADR report?
What should be reported about the suspected drug(s) in an ADR report?
What is the purpose of the confidentiality clause regarding the reporter's information in an ADR case report?
What is the purpose of the confidentiality clause regarding the reporter's information in an ADR case report?
What should healthcare professionals do when they observe adverse experiences with medications?
What should healthcare professionals do when they observe adverse experiences with medications?
Flashcards
Pharmacovigilance
Pharmacovigilance
The process of detecting, evaluating, and preventing adverse reactions to medicines.
Adverse Drug Events (ADE)
Adverse Drug Events (ADE)
Harmful or unintended effects from a medicine.
Adverse Drug Reaction (ADR)
Adverse Drug Reaction (ADR)
A harmful, unintended effect of a medicine at a normal dose.
Type A ADR
Type A ADR
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Type B ADR
Type B ADR
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Type C ADR
Type C ADR
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Type D ADR
Type D ADR
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Type E ADR
Type E ADR
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Type F ADR
Type F ADR
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Spontaneous Reporting
Spontaneous Reporting
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Case Collection
Case Collection
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Case Processing
Case Processing
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Signal Detection
Signal Detection
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Risk Management
Risk Management
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WHO Pharmacovigilance Program
WHO Pharmacovigilance Program
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Drug-related problems
Drug-related problems
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Safety Data
Safety Data
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FDA
FDA
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UMC
UMC
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Patient Safety
Patient Safety
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Public Health
Public Health
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Assessment of benefits and risks
Assessment of benefits and risks
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Global
Global
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Study Notes
Pharmacovigilance
- Pharmacovigilance is the process of detecting, evaluating, and preventing adverse effects of medicines.
- It aims to improve patient care and safety, public health, and the assessment of benefits and risks of medicines, encouraging their safe and effective use.
WHO Pharmacovigilance Program
- The World Health Organization (WHO) defines pharmacovigilance as the science and activities related to detecting, assessing, understanding, and preventing adverse effects or drug-related problems.
- The WHO Pharmacovigilance Program aims to ensure the safe and effective use of medicines globally.
Pharmacovigilance Process
- The pharmacovigilance process involves collecting, analyzing, and evaluating safety data to identify and manage potential risks associated with medicines.
- It involves four key stages:
- Case Collection: Gathering information about suspected adverse drug events (ADEs) through spontaneous reporting.
- Case Processing: Analyzing, reviewing, and processing the collected ADE reports.
- Signal Detection: Identifying potential patterns or signals in the data suggesting a possible link between a drug and an adverse effect.
- Risk Management: Implementing measures to mitigate the identified risks and ensure the safe use of the medication.
Adverse Drug Reactions (ADRs)
- An ADR is a harmful and unintended response to a medicine that occurs at doses normally used in humans.
- ADRs are categorized based on different mechanisms and types:
- Type A (Augmented): Dose-related, predictable, and linked to the pharmacology of the drug.
- Type B (Bizarre): Non-dose related, unpredictable, and often related to allergic reactions.
- Type C (Chronic): Dose and time-related, usually occurring with prolonged use.
- Type D (Delayed): Time-related, occurring sometime after drug use.
- Type E (End of Use): Withdrawal reactions that occur after stopping a drug.
- Type F (Failure): Unexpected failure of therapy due to drug interactions or other factors.
Reporting of Adverse Drug Reactions
- Spontaneous reporting is the most common method of collecting ADR data.
- Healthcare professionals are encouraged to report any suspected ADRs to relevant authorities to ensure patient safety.
- Reporting forms are available at pharmacies, clinics, and hospitals.
- FDA is the agency mandated to receive, process, and forward ADRs to the UMC.
- Reporting ADRs allows for the further evaluation of drugs and the implementation of necessary safety measures.
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