Questions and Answers for Pharmacovigilance

What is pharmacovigilance?
Pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

What is GPP?
Good pharmacovigilance practice - It assesses pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients. It is the part of the Inspections and Standards Division of the MHRA.


What is
  • Adverse event: An untoward medical occurrence in a patient or a clinical trial subject administered a medical product and which does not have a necessarily have to have a causal relationship with this treatment.
  • Adverse Drug reaction: A response to a medicinal product 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 restoration, correction or modification of physiological function
  • Serious adverse drug reaction: serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:
  1. results in death,
  2. is life-threatening,
  3. requires inpatient hospitalization or prolongation of
        -   existing hospitalization,
   - results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  • Side effect: A side effect can be defined as any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug.
  • Toxicology: The science concerned with the detection, chemical composition, and biological action of toxic substances or poisons and the treatment and prevention of toxic manifestations.
  • Allergic reaction: Hypersensitivity reaction to a particular allergen; symptoms can vary greatly in intensity.

Difference between AE and ADR? 
It has the causal relationship with drug. Adverse drug reaction is definitely related to drug whereas adverse event not necessarily be due to drug. The event may be may not be related to drug. 

Difference between ADR and side effect.
A side effect can be defined as any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug. Such effects may or may not be beneficial. Side effects are related to the known properties of the drug and can often be predicted.

However, when a side effect occurs above the usual/expected level, it becomes an Adverse drug reaction. 

What is the difference between safety reporting and pharmacovigilance? 
Safety reporting- clinical trials 
Pharmacovigilance- post marketing 

What is the need of pharmacovigilance?
  • To ensure the safety of patients on both short and long term basis.
  • Clinical trials lack the power to detect rare side effects (controlled conditions).
  • Some common side effects escapes detection due to lack of suitable detection technique
  • To improve patient care and safety
  • To improve public health and safety
  • To contribute to the assessment of benefit, harm, effectiveness and risk of medicines
  • To promote education and clinical training
  • To promote rational and safe use of medicines.

What are the various regulatory bodies involved with PV?
US- FDA 
Europe- EMEA 
Japan- MHLW 
Germany-Bfarm 
India-CDSCO 

What are the various modes of data collection?
The various modes of data collection can be categorized into two groups Electronic and Non-electronic.
The electronic modes are:
  • The internet
  • Telephone
  • Fax

The non electronic modes are:
  • Snail mail/post
  • Personal contact

What are the various sources of data collection?
The various sources of data collection are – Health Care Professionals- these include physicians, dentists, pharmacists, nurses and medical representatives.
  • The patients who consume the medication and experience an adverse event.
  • Consumers- a consumer is a person who is not a health care professional.
  • Literature

Who is a
  • Health care professional (HCP)- HCP refers to all paid and unpaid persons working in health-care settings who have the potential for exposure to patients and/or to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air.
  • Consumer- a consumer is somebody who uses a medicinal product or service. A consumer may not be the purchaser of the medicinal product or service
  • Customer- A customer is the person or organization that purchases the medicinal product or service.
  • Reporter- A reporter is any person who reports an adverse event. It can be a HCP, the patient or the customer.

Define Rechallenge and Dechallenge?
Challenge-dechallenge-rechallenge (CDR) is a medical testing protocol in which a medicine or drug is administered, withdrawn, then re-administered, while being monitored for adverse effects at each stage. The protocol is used when statistical testing is inappropriate due to an idiosyncratic reaction by a specific individual, or a lack of sufficient test subjects and unit of analysis is the individual. During the withdraw phase, the medication is allowed to wash out of the system in order to determine what effect the medication is having on an individual.

What are the various scales used for the causality assessment?
Causality assessment is the method by which the extent of relationship between a drug and a suspected reaction is established. Currently wide variety of causality assessment scales exist. These scales include: Karch & Lasagna scale Naranjo's scale WHO probability scale Spanish quantitative imputation scale Kramer's scale Jones scale European ABO system Bayesian system.

Importance of MedDRA in PV?
The importance of MedDRA (Medical Dictionary for Regulatory Activities) in pharmacovigilance is as follows-
  • This international medical terminology is particularly important in the electronic transmission of adverse event reporting, both in the pre- and post- marketing areas.
  • Provides a classification for a wide range of clinical information which further enables to support multiple medical product areas
  • To standardize communication between industry and regulators
  • That can be used through all phases of the development cycle
  • Thus saving time, resources and money.
  • Standardization of data content and structure & facilitates electronic communication.

What are the minimum criteria required for a case to be logged?
The minimum criteria required for a case to be logged are as follows:
  • Patient Details (Name of the patient, Gender, Age, Medical history, Contact details) 
  • Reporter Details (Name of the reporter, Contact details, Reporter type) 
  • Suspected Drug Details (Brand name as reported, Dosage form and strength, Starting date and time, Stopping date and time, Route of administration) 
  • Adverse Event details (Full description of reaction, including body site and severity, the criteria for regarding the report as serious, Description of the reported signs and symptoms, Onset date of reaction, Stop date or duration of reaction)

How can a reporter be identified?
A reporter can either be a health care professional or the patient or a customer. But until and unless, the physician gives the confirmation for the reaction, it can not be reported.

What is expedited reporting? What type of cases requires such reporting?
Expedited reporting is a term used to identify reports which need to be reported immediately, i.e., within 15 calendar days from receipt to the relevant regulatory authorities. For SUSARs (Suspected Unexpected Serious Adverse Reactions), submission not later than 7 days after sponsor had the Information and any follow up information within a further 8 days. 

The standards for expedited reporting are; 
  • All adverse drug reactions that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and any type of clinical or epidemiological investigation. It also applies to cases not reported directly to a sponsor or manufacturer. Expedited reporting of reactions which are serious but expected is not considered. 
  • There are situations in addition to single case reports of "serious" adverse events which need expedited reporting. Information that might materially influence the benefit-risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include: For an “expected” serious ADR, an increase in the rate of occurrence which is judged to be clinically important.

What is volume 9A?
Volume 9A has prepared by the European Commission in close consultation with the Agency, Member States and interested parties and is specifically related to human pharmacovigilance. It brings together general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).


What is an Adverse Drug Reaction (ADR)?
An Adverse Drug Reaction is a harmful or unintended response to a medication which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. Identifying ADRs is a key component of pharmacovigilance to ensure drug safety.

What is a Drug Safety Report and what does it typically contain?
A Drug Safety Report, often known as an Individual Case Safety Report (ICSR), is a document that contains all the information related to an adverse event experienced by a patient. It typically includes patient details, drug information, description of the adverse event, and the reporter's contact information for follow-up.

How do you stay updated with the latest guidelines in pharmacovigilance?
Staying updated is crucial in pharmacovigilance. I regularly follow authoritative websites like the FDA, EMA, and WHO, subscribe to newsletters from regulatory agencies, and participate in pharmacovigilance forums and webinars. This continuous learning approach helps me stay informed about the latest guidelines and best practices.

Explain the difference between passive and active pharmacovigilance.
Passive pharmacovigilance involves collecting reports of adverse events mainly through spontaneous reporting by healthcare professionals or patients. Active pharmacovigilance, on the other hand, proactively seeks out information on the safety of drugs through organized studies and surveillance programs, rather than waiting for reports to come in.

What role does data analysis play in pharmacovigilance?
Data analysis in pharmacovigilance is pivotal for identifying new adverse drug reactions, determining the frequency of known side effects, and assessing risk factors. By analyzing data from various sources, pharmacovigilance professionals can generate insights that lead to safer drug use.

How would you handle a situation where you receive an incomplete adverse event report?
In cases of incomplete reports, I would prioritize obtaining the missing information by contacting the reporter directly, if possible. It's crucial to gather as much relevant data as possible to assess the adverse event accurately and take appropriate action.

What is the significance of the Yellow Card Scheme?
The Yellow Card Scheme is a safety monitoring system in the UK that allows healthcare professionals and patients to report suspected side effects or adverse drug reactions. It's a vital tool for the MHRA (Medicines and Healthcare products Regulatory Agency) to monitor the safety of healthcare products and protect public health.

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