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.
2. What is the minimum criterion required for a
valid case?
a. An identifiable reporter
b. An identifiable patient
c. A suspect product
d. An adverse drug event
3. 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.
4. 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.
5. What is the 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.
6. 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
a. Death
b. Life threatening
c. Hospitalization or prolongation of
hospitalization.
d. Congenital anomaly
e. Disability
f. Medically significant
7. Name the regulatory bodies in USA, UK, Japan and
India?
USA: United States Food and drug administration
(USFDA).
UK: European Medicines Agency (EMEA).
Japan: Ministry of Health, Labour and Welfare
(MHLW).
India: Central Drugs Standard Control Organization
(CDSCO)
8. What is Volume 9A?
Volume 9A brings together general guidance on the
requirements, procedures, roles and activities in the field of
pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent
Authorities of medicinal products for human use; it incorporates international
agreements reached within the framework of the International Conference on
Harmonisation (ICH).
Volume 9A is presented in four parts:
Part I deals with Guidelines for Marketing
Authorisation Holders;
Part II deals with Guidelines for Competent
Authorities and the Agency;
Part III provides the Guidelines for the electronic
exchange of pharmacovigilance in the EU
Part IV provides Guidelines on pharmacovigilance
communication.
9. 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).
10. 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 event.
11. What are the objectives in Pharmacovigilance?
Understanding
the concepts of ADR, Medical Errors, Public Health Significance, Regulatory
Interventions, ADR Monitoring schemes.
12. What are the types of Pharmacovigilance (PV)?
Two types. 1.
Active PV and 2.Passive PV
Active PV: Active (or proactive) safety surveillance
means that active measures are taken to detect adverse events. This is managed
by active follow-up after treatment and the events may be detected by asking
patients directly or screening patient records. The most comprehensive method
is cohort event monitoring (CEM)
Passive PV: Passive surveillance means that no
active measures are taken to look for adverse effects other than the
encouragement of health professionals and others to report safety concerns.
Reporting is dependent on the initiative and motivation of the potential
reporters. This is the most common form of pharmacovigilance. It is commonly
referred to as “spontaneous” or “voluntary” reporting.
13. What are the due dates for safety reporting?
Safety
reporting due dates are 7days for IND Reporting and 15 days for NDA Reporting
14 What are Data assessments in Pharmacovigilance?
Data
assessments are
Individual case report assessment
Aggregated assessment and interpretation
Signal detection
Interactions and risk factors
Serial study
Frequency
Estimation
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