Pharmacovigilance is a very important part of the pharmaceutical industry. The pharmacovigilance interview questions are designed to help identify and assess any risks associated with your medication, as well as make sure that you are taking it responsibly. This article will address some of these questions in detail and provide examples for how to answer them correctly.
1. What is Pharmacovigilance?
Ans. Pharmacovigilance is a science that monitors the adverse effects of drugs, it is an important step in drug development. It studies the gathering and assessment of data on the adverse effects of pharmaceutical products. The data is collected through a variety of ways including spontaneous reporting from doctors, nurses, and pharmacists. Reporting from the public via social media, or other websites is also monitored for any adverse effects that have been reported by consumers.
The goal of this process is to provide safety information to clinicians and patients involved in drug therapy at every point in the healthcare cycle, from before prescription to post-marketing surveillance.
2. What is an Adverse Drug Event?
Ans. An adverse drug event is when a medication causes an adverse reaction in the person who is taking it.
Adverse events are usually categorized into four groups:
- An allergic reaction to the drug.
- A toxic effect caused by too much of the drug.
- An antibiotic-resistant bacteria caused by taking a prescribed antibiotic.
- A problem with how the body handles a medication due to genetics or age
3. What is an Adverse Drug Reaction?
Ans. Adverse drug reactions are a very common and serious problem. A person can have an adverse reaction to drugs for many reasons, such as allergies to a specific ingredient, or because their body cannot metabolize the medication properly.
4. What is ICSR?
Ans. ICSR Stands for Individual Case Study Report, it is a written document about an adverse event. It contains background information on the person, the medication(s) taken, and what happened during or after taking them. The report concludes with a description of how to manage future exposures if they occur.
5. What is ADR?
Ans. ADR stands for Adverse Drug Reaction. It is an adverse event that occurs after taking a medication, other than those classified as expected or known reactions to the drug.
6. What are some common ADRs?
Ans. Common adverse events with medications include pain in the abdomen/chest area; sleep disturbances; nausea and vomiting (sometimes accompanied by abdominal pain); and skin rash.
7. State the differences between ADE and ADR.
Ans. ADE stands for Adverse Drug Effect, which is any harmful unintended effect that occurs as a result of drug use. ADE includes both ADRs and DRPs (Dose-Related PROs).
DRP stands for Dose Related PRO, it is an adverse event related to the dose or frequency of medication administration. They are usually labeled as expected or known reactions.
8. What is an AE? What are the two types of AEs?
Ans. AE stands for Adverse Event and can be classified into two groups, Serious AE (SAE) and Non-serious AE (NSEA).
- SAE stands for Serious Adverse Event, which is a life-threatening health event or an event that results in death.
- NSEA stands for Non-serious Adverse Events, it’s not life-threatening and may result from the use of a drug.
9. How does pharmacovigilance differ from medical surveillance?
Ans. Pharmacovigilance is a system designed to collect, monitor, analyze and distribute information about the adverse events associated with pharmaceutical products in order to update product labeling or marketing practices; Medical Surveillance also monitors for potential drug-related problems but its goal is not to update labeling or marketing.
10. What are some of the regulatory bodies in USA, UK, Japan, and India?
- USA: The FDA is the regulatory body in the USA.
- Japan: TGA, JETRO, and PHARMA are some of the regulatory bodies in Japan.
- UK: MHRA is one of the regulators for drugs in the UK.
- India: Central Drugs Standard Control Organization (CDSCO) is one among several agencies that regulate drug manufacture and distribution in India.
11. What is MedDRA?
Ans. MedDRA is a comprehensive, computerized medical dictionary for adverse event reporting. It covers more than 34,000 indications from 8,000 drugs by 1.4 million terms and sub-terms in over 900,000 concepts that provide the basis for coding and searching adverse events reported to FDA’s Adverse Event Reporting System (FAERS).
12. Explain E2a, E2b, and E2c guidelines for pharmacovigilance
Ans. The European Medicines Agency (EMA) has drawn up guidelines for a series of questions to ask about every adverse reaction that is observed when authorised medicines are used under normal conditions. These questions are referred to as the E2a, E2b, and E2c guidelines for pharmacovigilance. “E” stands for evidence; these questions must be asked in order to try and gather as much information about the reactions as possible in order to determine whether an association with treatment can no longer be excluded. The term “pharmacovigilance intelligence” refers both to the analysis of unpublished data in clinical trials (trial intelligence) and also includes the collection of spontaneous reports from doctors or patients (post-authorisation safety data).
13. What does causality mean?
Ans. The WHO defines causality as “a description of the relationship between an event (or exposure) and a health outcome, where there is evidence of temporality, strength, and dose-response/relationship.
14. What is spontaneous reporting?
Ans. Spontaneous reporting is a mechanism for gathering real-world safety information about marketed drugs. As opposed to other sources of postmarketing data, spontaneous reports provide important first-hand, real-world evidence about drug effects and are a key element in the early detection of safety concerns with pharmaceuticals. The FDA defines spontaneous reporting as “a passive mechanism whereby healthcare professionals are not required to report adverse events or product quality problems.”
15. What is Vigibase?
Ans. Vigibase is the most comprehensive collection of information on drug safety available today. It has been collecting and analysing detailed data on suspected adverse reactions to products since 1997, with a combined searchable database containing more than 750 million individual case reports from across the globe.
16. How can Vigibase help the pharma industry?
Ans. Vigibase provides detailed information on more than 750 million cases, including all those received since 1997. The database contains well characterised individual case reports from across the globe for a wide range of drugs in a variety of therapeutic areas, including analgesia, anti-infectives, cardiovascular disease, and gastroenterology.
17. Define Re-Challenge.
Ans. A re-challenge is the repeated administration of a drug after that has caused an adverse reaction. This may be performed by the same or a different clinician and in some instances may involve a change in dose, formulation, or route of administration.