Pharmacovigilance Interview Questions And Answers
What is Pharmacovigilance?
The World Health Organization (WHO) has defined Pharmacovigilance as “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
What is an Adverse Event (AE)?
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 or any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
What is an Adverse Drug Reaction (ADR)?
A response to a medicinal product that is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from the use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse, and medication errors.
What is the difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)?
There may not be a causal relationship between a drug and an adverse event, whereas, there is always a causal association between a drug and an adverse drug reaction.
What is Unexpected Adverse Reaction?
An adverse reaction, the nature, severity, or outcome of which is not consistent with the applicable product information.
What is an Advanced therapy medicinal product (ATMP)?
A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product, or a tissue-engineered product as defined in Regulation (EC) No 1394/2007.
What is the Quality system of a pharmacovigilance system?
The organizational structure, responsibilities, procedures, processes, and resources of the pharmacovigilance system as well as appropriate resource management, compliance management, and record management.
What are Unsolicited or Spontaneous reports?
An unsolicited report or communication is received from a healthcare professional, patient, or consumer to a competent authority, marketing authorization holder, or other organization that describes one or more suspected adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection system.
Examples of Unsolicited or Spontaneous reports:
• Direct reports from patients, consumers, healthcare professionals, etc.
• Medical information enquiries
• Literature reports
• Internet/digital media (website, internet forum, chat room, blog, social network).
What does Day Zero mean?
The first date on which any representative of an organization was first notified of the minimum essential elements for expedited reporting. This date also implies when any of the company partners/vendors receive the report.
What is SUSAR?
A suspected unexpected serious adverse reaction is known as a SUSAR. A SUSAR is defined as an untoward and unintended response to a study drug, that is not listed in the applicable product information, and meets one of the following
serious criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
What is GVP (Good pharmacovigilance practices)?
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP applies to market authorization holders, the European Medicines Agency (EMA), and medicines regulatory authorities in EU Member States. They cover medicines authorized centrally via the Agency as well as medicines authorized at the national level.
What is the relation between Volume 9A and GVP?
With the application of the new pharmacovigilance legislation from July 2012, Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.
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). HCPs can be physicians, nurses, pharmacists, etc.
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.
What should a narrative consist of?
A narrative should consist of precise and concise information about the source of the report, patient demographics, patient’s medical history, concomitant medications, suspect product details, and adverse event details in an orderly manner.
Do you have any idea about VigiBase?
It is the largest repository of drug safety data across the globe. It is maintained and managed by Uppsala Monitoring Centre (UMC).
What are the different GVP modules?
Module I – Pharmacovigilance systems and their quality systems
Module II – Pharmacovigilance system master file
Module III – Pharmacovigilance inspections
Module IV – Pharmacovigilance audits
Module V – Risk Management Systems (Rev.2)
Module VI – Collection, management, and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)
Module VI Addendum I – Duplicate management of suspected adverse reactions reports.
Module VII – Periodic safety update report
Module VIII – Post-authorisation safety studies
Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorization safety studies (Rev.3)
Module IX – Signal management
Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
Module X – Additional monitoring
Module XV – Safety communications (Rev.1)
Module XVI – Risk minimization measures: selection of tools and effectiveness indicators (Rev. 2)
Module XVI Addendum I – Educational materials
Module XVI Addendum II – Methods for effectiveness evaluation
What is meant by the Compassionate use of a medicinal product?
Making a medicinal product available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorized medicinal product (the medicinal product concerned must either be subject of an application for a central marketing authorization or must be undergoing clinical trials).
What is an Individual case safety report (ICSR) or Adverse (drug) reaction report?
Format and content for the reporting of one or several suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.
What is PASS?
Any study relating to an authorized medicinal product conducted to identify, characterize, or quantify a safety hazard, confirm the safety profile of the medicinal product, or measure the effectiveness of risk management measures. A post-authorization safety study may be an interventional clinical trial or may follow an observational, non-interventional study design.
What is the Misuse of a medicinal product?
Situations where the medicinal product is intentionally and inappropriately used not by the authorized product information.
What is Overdose?
Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information.
What is Occupational exposure to a medicinal product?
To report cases of suspected adverse reactions, an exposure to a medicinal product as a result of one’s professional or non-professional occupation. It does not include the exposure to one of the ingredients during the manufacturing process before the release as a finished product.
What is Lack of Efficacy (LOE)?
The lack of expected or desired effects related to therapy. Lack of efficacy/effect is evidence of less than the expected effect of a product.
What is a Product counterfeit?
Counterfeits of original medicinal products that look like the original may:
Contain substances of lower quality or the wrong dose.
Be deliberately and fraudulently mislabelled to avoid identifying the source.
Have counterfeit packaging, wrong ingredients, or a lower proportion of the active substance.
What is Drug interactions?
Drug interaction is a reaction between two (or more) drugs or between a drug and a food, beverage, or supplement. Taking a drug while having certain medical conditions can also cause a drug interaction. For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.
How many times MedDRA is updated in a year?
The MSSO releases updated MedDRA versions twice a year - in March and September. The English translation is released on the 1st of March and September and all other translations are released on the 15th.
What are SMQs?
Standardized MedDRA Queries (SMQs) are tools developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development.
SMQs are validated pre-determined sets of MedDRA terms grouped after extensive review, testing, analysis, and expert discussion.
SMQs are a unique feature of MedDRA and provide a strong tool to support safety analysis and reporting.
The SMQ topics are intended to address the important pharmacovigilance topics needed by regulatory and industry users. The SMQs are maintained with each release of MedDRA by the MSSO.
What is DIBD?
Developmental International Birth Date (DIBD) is the date of approval of the first authorization for conducting an interventional clinical trial in any country. The first data lock point for the DSUR is the first anniversary of the DIBD.
What is IBD?
International Birth Date (IBD) is the date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.
If a marketing authorization holder has no information on the actual IBD for a product, it should first refer to listings of birth dates that some regions develop and make publicly available. If the product is not included in any listing, it should propose to the regulatory authority a birth date that is based on the earliest known marketing authorization of the substance and then obtain the regulatory authority’s agreement.
What is the difference between PBRER and PSUR?
A PSUR primarily serves as an interval safety report whereas a PBRER is meant to be a cumulative benefit-risk report.
Unlike a PSUR, a PBRER includes data on efficacy and effectiveness from ongoing or updated clinical trials and cohort studies.
What is DHPC?
A communication intervention by which important information is delivered directly to individual healthcare professionals by a marketing authorisation holder or by a competent authority, to inform them of the need to take certain actions or adapt their practices about a medicinal product.
What is PADER?
A PADER (Periodic Adverse Drug Experience Report) is a part of post-cumulative safety reports that need to be submitted to the United States Food and Drug Administration (USFDA).
What is a Closed signal?
In periodic benefit-risk evaluation reports, a signal for which an evaluation was completed during the reporting interval. A safety signal can be closed either because it is refuted or because it is determined to be a potential or identified risk following evaluation.
What is an Ongoing signal?
In periodic benefit-risk evaluation reports, a signal remains under evaluation at the data lock point.
What is a Newly identified signal?
In periodic benefit-risk evaluation reports, a signal is first identified during the reporting interval, prompting further actions or evaluation.
What is the Confirmed signal?
For the signal management process in the EU, a validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that requires further analysis and prioritization by the Pharmacovigilance Risk Assessment Committee (PRAC), according to the PRAC Rapporteur or (lead) Member State.
What is a Validated signal?
A signal for which the signal validation process has verified that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.
What is the EudraVigilance database?
EudraVigilance is the system for managing and analyzing information on suspected adverse reactions to medicines that have been authorized or are being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
What is AMR?
The eRMR is a tool to perform signal detection in EudraVigilance. This tool provides aggregated data related to the ICSRs submitted to EudraVigilance stratified by different parameters and incorporates the Reporting Odds Ratio (ROR) as a statistical measure. Users will be able to retrieve different eRMRs depending on the selected reference period. These reports will retrieve valid cases transmitted to the EVPM module only.
What are EVDAS line listing reports?
The EVDAS line listing report provides the user with the listing of individual cases for specific substance/s and specific MedDRA terms when appropriate. The report also provides the possibility to restrict the data to a specific period.
What is CCSI?
Company Core Safety Information (CCSI) is the safety information contained in the CCDS. The CCSI is generally used in all countries where the company markets the medicinal product and is the reference information used to determine listed and unlisted events for periodic reporting for marketed products.
What is the Company Core Data Sheet (CCDS)?
A Company Core Data Sheet (CCDS) is a document that reflects the full company’s knowledge and data evaluation for a medicinal product. For medicinal products, a document prepared by the marketing authorization holder containing, in addition to safety information, material related to indications, dosing, pharmacology, and other information concerning the product.
What is a Package leaflet?
A leaflet containing information for the user which accompanies the medicinal product.
Important Abbreviations:
ADR: Adverse Drug Reaction
AE: Adverse Event
AEFI: Adverse event following immunization
AESI: Adverse event of special interest
aRMM: Additional risk minimization measure
ATMP: Advanced therapy medicinal product
CCDS: Company core datasheet
CCSI: Company core safety information
CHMP: Committee for Medicinal Products for Human Use
CIOMS: Council for International Organizations of Medical Sciences
CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures – Human
DDPS: Detailed description of the pharmacovigilance system
DEC: Drug Event Combination
DHPC: Direct healthcare professional communication
DIBD: Development of international birth date
DLP: Data lock point
DME: Designated Medical Event
DSUR: Development Safety Update Report
eCTD: Electronic common technical document
eRMR: Electronic Reaction Monitoring Report
EEA: European Economic Area
EMA: European Medicines Agency
EPAR: European Public Assessment Report
EPITT: European Pharmacovigilance Issues Tracking Tool
EU: European Union
EudraCT: European Clinical Trials Database
EuRD: EU reference date
EV: EudraVigilance
EVCTM: EudraVigilance Clinical Trial Module
EVDAS: EudraVigilance Data Analysis System
EV EWG: EudraVigilance Expert Working Group
EVMPD: EudraVigilance Medicinal Product Dictionary
EVPM: EudraVigilance Post-Authorisation Module
EVWEB: EudraVigilance Web application
FAERS: FDA Adverse Event Reporting System
GCP: Good clinical practice
GVP: Good pharmacovigilance practices
HLGT: Higher level group term
HLT: High-level term
IBD: International Birth Date
ICSR: Individual Case Safety Report