What is Pharmacovigilance?
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
What is the minimum criterion required for a valid case?
An identifiable reporter
An identifiable patient
A suspect product
An adverse drug event
What is an Adverse Drug Event (ADE) ?
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
What is an Adverse Drug Reaction (ADR) ?
An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use.
What is the basic difference between an ADE and ADR ?
There may not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.
When do you consider an event to be serious ?
If an event is associated with any one of the following, it is considered to be serious.
Death
Life threatening
Hospitalization or prolongation of hospitalization.
Congenital anomaly
Disability
Medically significant or Important Medical Event
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Name the regulatory authorities in USA, UK, Japan and India ?
USA : United States Food and drug administration (USFDA).
UK : Medicines & Health Care Products Regulatory Agency (MHRA)
Japan : Pharmaceuticals and Medical Device Agency (PMDA)
India : Central Drugs Standard Control Organization (CDSCO)
Australia : Therapeutic Goods Administration
Canada : Health Canada
GVP Guidelines ? Total 16 Modules present, which replaces VOL 9A.
When do you consider a case to be medically confirmed?
A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional)
Note: HCP can be a Physician, Nurse, Pharmacist, Coroner or psychologist (only in Germany).
What do you mean by causality ?
Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug reactions, like Related, Unrelated and Possible.
Name some data elements in ICSR ?
Patient demographics : Age, gender and race.
Suspect product details : Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.
What should a Safety narrative consist of ?
A narrative should consist of precise and concise information about the source of report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner.
This vary to type of reports like Spontaneous, Clinical trial and Literature and as per the Sponsor conventions as well. In upcoming article, we would share a full article of Safety Narrative.
What do you mean by MedDRA : Medical Dictionary for Regulatory Activities.
14. Explain the hierarchy in MedDRA :
System Organ Class (SOC)
High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)
Abbreviations : Common terminology used in day to day PV Activities
a) SUSAR : Suspected Unexpected Serious Adverse Reaction
b) SAE : Serious Adverse Event
c) CIOMS : Council for International Organizations of Medical Sciences
d) ADE : Adverse Drug Event
e) SSAR : Suspected Serious Adverse Reaction
f) ADR : Adverse Drug Reaction
g) ICSR : Individual Case Safety Report
h) PSUR : Periodic Safety Update Report
i ) ICH : The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
j) HIPAA : Health Insurance Portability and Accountability Act
h) ESTRI : Electronic Standards for the Transfer of Regulatory Information.
ICH Guidelines : ICH-Efficacy Guidelines, E2A to E2F
E2A : E2A guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
E2B : E2B guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports.
18. E2D :This document provides a standardised procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided.
19. E2E : Pharmacovigilance Planning, This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this Guideline, the term “drug” denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application.
20. E2C : This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort.
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
What is the minimum criterion required for a valid case?
An identifiable reporter
An identifiable patient
A suspect product
An adverse drug event
What is an Adverse Drug Event (ADE) ?
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
What is an Adverse Drug Reaction (ADR) ?
An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use.
What is the basic difference between an ADE and ADR ?
There may not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.
When do you consider an event to be serious ?
If an event is associated with any one of the following, it is considered to be serious.
Death
Life threatening
Hospitalization or prolongation of hospitalization.
Congenital anomaly
Disability
Medically significant or Important Medical Event
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Name the regulatory authorities in USA, UK, Japan and India ?
USA : United States Food and drug administration (USFDA).
UK : Medicines & Health Care Products Regulatory Agency (MHRA)
Japan : Pharmaceuticals and Medical Device Agency (PMDA)
India : Central Drugs Standard Control Organization (CDSCO)
Australia : Therapeutic Goods Administration
Canada : Health Canada
GVP Guidelines ? Total 16 Modules present, which replaces VOL 9A.
When do you consider a case to be medically confirmed?
A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional)
Note: HCP can be a Physician, Nurse, Pharmacist, Coroner or psychologist (only in Germany).
What do you mean by causality ?
Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug reactions, like Related, Unrelated and Possible.
Name some data elements in ICSR ?
Patient demographics : Age, gender and race.
Suspect product details : Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.
What should a Safety narrative consist of ?
A narrative should consist of precise and concise information about the source of report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner.
This vary to type of reports like Spontaneous, Clinical trial and Literature and as per the Sponsor conventions as well. In upcoming article, we would share a full article of Safety Narrative.
What do you mean by MedDRA : Medical Dictionary for Regulatory Activities.
14. Explain the hierarchy in MedDRA :
System Organ Class (SOC)
High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)
Abbreviations : Common terminology used in day to day PV Activities
a) SUSAR : Suspected Unexpected Serious Adverse Reaction
b) SAE : Serious Adverse Event
c) CIOMS : Council for International Organizations of Medical Sciences
d) ADE : Adverse Drug Event
e) SSAR : Suspected Serious Adverse Reaction
f) ADR : Adverse Drug Reaction
g) ICSR : Individual Case Safety Report
h) PSUR : Periodic Safety Update Report
i ) ICH : The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
j) HIPAA : Health Insurance Portability and Accountability Act
h) ESTRI : Electronic Standards for the Transfer of Regulatory Information.
ICH Guidelines : ICH-Efficacy Guidelines, E2A to E2F
E2A : E2A guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
E2B : E2B guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports.
18. E2D :This document provides a standardised procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided.
19. E2E : Pharmacovigilance Planning, This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this Guideline, the term “drug” denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application.
20. E2C : This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort.
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