Frequently Asked Questions in Pharmacovigilance Interview

1.What Is the definition of Pharmacovigilance (DAUP)?

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

Detection– Here section refers to identification of adverse effect of drugs/ molecule. So, when this detection start, Is it phase IV when general public is taking that drug or is it when drug is in development stage. Answer is very simple. It starts from the moment when any molecule is given to human to assess its efficacy or safety.

Assessment– What do we asses? It is basically drug relatedness of the AE/ADR

Understanding– To understand the causality of the ADR/AE

Prevention– To prevent that AE/ADR from occurring.

2.What Is the Minimum Criterion Required for a Valid Case or Minimum Criteria for Safety Report or ICSR to be valid?

  • An identifiable reporter
  • An identifiable patient
  • A suspect product
  • An adverse drug event

Identifiable patient, means the patient identity such as name, age, date of birth, gender and even age group (neonate, infant, adolescent, adult and elderly) is also an identification.

Identifiable reporter means  his/her qualification, Profession or email id, address, phone number through which we can identify them

3.Significance or objective of Pharmacovigilance?

  • The collection of better data on medicines and their safety
  • Rapid and robust assessment of issues relating to the safety of medicines
  • Effective regulatory action to deliver safe and effective use of medicines
  • Empowerment of patients through reporting and participation
  • Increased levels of transparency and better communication

4.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.

5.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.

  • Response to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility
  • Implied relationship” – spontaneous reports of adverse events/experiences where the causal relationship is unknown/unstated should still be reported.

6.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.

7.What is Special Situation Reports (SSRs)

There are few situation/incident/ADR where we consider the event to be of special situation. These are the situations which are not performed while clinical trial such as we don’t include pregnant lady, children or elderly for trials and researchers don’t have any data about these scenarios. Please find list of such demerits below.

  • Drug exposure at conception (maternal or paternal) or Drug exposure during pregnancy or lactation
  • Overdose (intentional/accidental/prescribed, Misuse, Abuse or Occupational Exposure
  • Lack of efficacy/lack of therapeutic response, The drug did not provide its expected benefit/the patient did not respond as expected Including drug resistance and drug tolerance and Interactions (drug : drug, drug : food/drink)
  • Medication errors (including near misses), Administration error (e.g. wrong route of administration)
  • Suspected or actual transmission of infected agents
  • Unexpected/unintended beneficial therapeutic response
  • Off-label use, Including use in unlicensed indications, dosages higher than maximum recommended dosage, Use in circumstances contraindicated in the Summary of Product Characteristics (SPC) or Indications for Use (IFU)

8.What is Seriousness Criteria for ICSR Reports

There are some events which investigator, marketing authorization holder or company consider serious also called medically significant events and these are listed in IME (Important medical event) list. Apart from those event or even those if cause any of the below outcome will be considered as serious.

Suppose patient took drug which resulted in pneumonia which requires hospitalization. Now here company IME list will consider pneumonia as serious and also it lead to hospitalization, so we consider 2 seriousness criteria i.e, Hospitalization and Medically significant.

  • Death
  • Event was considered life-threatening
  • Incapacity
  • Disability
  • Congenital anomaly
  • Hospitalization
  • Patient is already admitted but prolongation of hospitalisation is required- Here interviewer can try to trick by asking how long stay in hospital is considered as prolongation and answer is more than 24 hours.
  • Event Preferred MedDRA term appears in the IME (Important Medical Event) listing
  • Event considered to be of “medical significance” by the reporter (HCP/ Investigator)

9.What are the important reporting Timelines?

Various manufacturers have set their own timelines to avoid any late cases. Timelines changes from one drug to another and also on basis of causality and seriousness.

The most common timelines

Death/Life-threatening cases: 7 days

Other seriousness criteria: 15 days

Non-serious: 90 days

10.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

11.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).

12.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.

13.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.

14.What Should A 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.

15.What Do You Mean By Meddra?

Medical Dictionary for Regulatory Activities.

16.Explain The Hierarchy In Meddra?

  1. System Organ Class (SOC)
  2. High Level Group Term (HLGT)
  3. High Level Term (HLT)
  4. Preferred Term (PT)
  5. Lower Level Term (LLT)

17.What are reporting sources in Pharmacovigilance?

Report Sources – Unsolicited/ Spontaneous

An unsolicited report/ 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 reaction in a patient who was given one or more medicinal product and that does not derive from a study or any organized data collection

Unsolicited – “Given or supplied without being requested or asked for”

Report Sources – Solicited/ Non-spontaneous

Solicited reports of suspect adverse reactions are those derived from organised data systems, which include clinical trials, non-interventional studies, registries, post-approval names patient use programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.

Solicited – asked for or tried to obtain (actively seeking out AE reports/ADR reports/SSRs)Report Sources (Continued)

18.What are Types of Unsolicited reports:

  • Direct reports (consumers, healthcare professionals, other)
  • Medical information enquiries
  • Literature – via literature searching of medical and scientific journals
  • Lay literature (press/media) – non-medical/scientific literature
  • Internet/digital media (website, internet forum, chat room, blog, social network)

 Sources of Solicited Reports

  • Clinical trials
  • Non-interventional studies
  • Registries
  • Post-approval named patient programmes
  • Patient support programmes (PSPs)
  • Surveys of patients/HCPs

19.What Do You Know About E2a, E2b And E2c Guidelines?

  • 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.
  • E2c: E2b guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.

20.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

21.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.

22.Name The Regulatory Bodies In Usa, Uk, Japan And India?

  1. USA: United States Food and drug administration (USFDA).
  2. UK: European Medicines Agency (EMEA).
  3. Japan: Ministry of Health, Labour and Welfare (MHLW).
  4. India: Central Drugs Standard Control Organization (CDSCO)

23.What is SUSAR?

A suspected unexpected serious adverse reaction is known as a SUSAR. Sometimes during a clinical trial for a certain drug, a subject may experience serious adverse reactions that may or may not be dose-related but are unexpected, as they are not consistent with current. information. Reporting a SUSAR is an important aspect of clinic. A SUSAR may occur during clinical trials or clinical care and reporting varies by country or region depending on the regulations set forth by the governing bodies in each area. 

  • The European Union: Reporting of SUSAR is mandatory for clinical investigators in the European Union. A report must be submitted to the national competent authority within 15 days of occurrence (seven days in case of death or life-threatening issue).
  • The United States: In the U.S., reporting of adverse events during clinical trials is mandatory, but during clinical care it is voluntary. The U.S. FDA has a reporting system for serious adverse events (SAEs) through the AERS (FDA Adverse Event Reporting System, also known as FAERS). During the reporting process and assessment, it is decided if the adverse event was unexpected. FDA regulations require reporting within 15 days for any reactions that are both serious and unexpected.
  • Canada: Clinical trial sponsors in Canada are required to report SUSARs to Health Canada. Clinical trial sponsors, also known as applicants, must report within 15 days of occurrence (seven days in case of death or life-threatening issue) to Health Canada any SUSARs that occurred inside and outside Canada while the drug is in clinical trials in Canada. Within eight days of informing Health Canada of the SUSAR, a complete report which includes an assessment of the importance and implication of any findings must be submitted to Health Canada.

24.What is Day Zero

The first date on which any representative of an organisation was first notified of the minimum essential elements for expedited reporting. This date also implies in when any of the company partner/ vendor receive the report.

25.What is Day of Receipt

The day of receipt is the date on which company/ manufacturer was provided with an AE report/ADR report.

26.What is the yellow card in pharmacovigilance?

The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.

27.What is informed consent?

Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.

28.Difference between NDA and ANDA?

NDA means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.

ANDA means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.

29.What are the phases of clinical trials?

Phase I studies assess the safety of a drug or device. 

Phase II studies test the efficacy of a drug or device.

Phase III studies involve randomized and blind testing in several hundred to several thousand patients. 

Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.

30.What are important Abbreviations

  • Suspected Unexpected Serious Adverse Reaction
  • SAE
  • Serious Adverse Event
  • Council for International Organizations of Medical Sciences
  • ADE
  • Adverse Drug Event
  • SSAR
  • Suspected Serious Adverse Reaction
  • ADR
  • Adverse Drug Reaction
  • ICSR
  • Individual Case Safety Report
  • PSUR
  • Periodic Safety Update Report
  • ICH
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • Health Insurance Portability and Accountability Act
  • Electronic Standards for the Transfer of Regulatory Information
  • IBD
  • International Birth Date

31.What is IND approval?

The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

32.What is EudraVigilance?

The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.

  1. What is inverted Black triangle in Pharmacovigilance?

A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.The black triangle also highlights the need for surveillance of any adverse drug reaction (ADRs) that might arise from the use of a new medication.

34.What is Pharmacovigilance Programme of India (PvPI)?

The Central Drugs Standard Control Organisation (CDSCO), New Delhi has initiated a nation-wide pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare, Government of India. The programme is coordinated by The Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. The National Coordinating Centre (NCC) is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions in India.

35.What is a signal?

A ‘signal’ consists of reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.

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