FAQs about
Frequently Asked Questions about Pharmacovigilance
1. What is Pharmacovigilance (PV) or Drug Safety?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. (WHO 2002)
2. What is an adverse event?
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.[i]
3. What is adverse drug reaction (ADR)?
A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.[i]
4. What is an Unexpected Adverse Drug Reaction?
An adverse reaction, the nature or severity of which is not consistent with the applicable product information.[i]
5. What are the six seriousness criteria for a Serious Adverse Reaction? (i, ii)
- Death
- Life-threatening
- requires inpatient hospitalization or prolongation of existing hospitalization
- Disability or Permanent Damage
- Congenital Anomaly/Birth Defect
- Important medical event (IME): when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes
6. What is a Suspected Unexpected Serious Adverse Reaction (SUSAR)
An adverse event requires the evaluation of the presence of the following criteria by the sponsor:
- Is it a serious event?
- Is there reason to suspect a causal relationship with the administration of the investigational medicinal product?
- Is the adverse reaction, by its nature and severity, inconsistent with the reference information for the investigational medicinal product?
If the investigator or the sponsor judges all these criteria to be fulfilled, this constitutes a case of a suspected unexpected serious adverse reaction (SUSAR).[iii]
7. What is a product quality complaint?
Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation. It is important to report these defects in a timely manner because sometimes it is necessary to implement urgent measures to protect public health and animal health, such as the recall of one or more defective batch(es) of a medicine from the market or prohibition of supply.[iv]
8. What is an ICSR?
Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.[v]
9. Medical Dictionary for Regulatory Activities (MedDRA)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans.[vi]
10. What is REMS?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.[vii]
11. What are Good pharmacovigilance practices (GVP) and GVP modules?
GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
Guideline on GVP is divided into various chapters that are covered under modules that cover major pharmacovigilance processes and product-or population-specific considerations.[viii]
Guideline on GVP is divided into various chapters that are covered under modules that cover major pharmacovigilance processes and product-or population-specific considerations.[viii]
12. What is a Periodic Safety Update Report (PSUR)?
PSUR is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product and should be prepared at defined time points after its authorisation.[ix]
13. What is a Periodic Benefit-Risk Evaluation Report (PBRER)?
PBRER is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. The main objective of a PBRER is to present a comprehensive, concise, and critical analysis of new or emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile.[x]
14. What is a Signal?
As per CIOMS VIII (2010), Signal is defined as the “Information that arises from one or multiple sources which suggests a potentially new causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verification action”.
15. What is a Risk Management Plan?
The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product.[xi]
16. What is a Development Safety Update report (DSUR)?
DSUR is a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed. A DSUR provides information to assure regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the investigational drug.[xii]
Published on: September 20, 2021
References:
[i] Available from: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A
[ii] Available from: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event. Accessed online on 20 Sep 2021.
[iii] Available from: https://www.bfarm.de/EN/Medicinal-products/_FAQ/Clinical-trials/Clinical-issues/Reporting-of-SUSARs/faq-liste.html?cms_fid=565412. Accessed online on 20 Sep 2021.
[iv] Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls. Accessed online on 20 Sep 2021.
[v] Available from: https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports. Accessed online on 20 Sep 2021.
[vi] Available from: https://www.meddra.org/how-to-use/support-documentation/english/welcome. Accessed online on 20 Sep 2021.
[vii] Available from: https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems. Accessed online on 20 Sep 2021.
[viii] Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices#final-gvp-modules-section. Accessed online on 20 Sep 2021.
[ix] Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs. Accessed online on 20 Sep 2021.
[x] Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-0.pdf Accessed online on 07 Feb 2022.
[xi] Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf. Accessed online on 20 Sep 2021.
[xii] Available from: https://database.ich.org/sites/default/files/E2F_Guideline.pdf. Accessed online on 07 Feb 2022.
