Definition of Pharmacovigilance and Adverse Event. How to report an Adverse Event

This article contains definition of Pharmacovigilance and Adverse Event, Importance of Pharmacovigilance, how to report Adverse event, Content of adverse report form and Main task of pharmacovigilance in pharmaceutical.

1.0 What is Pharmacovigilance?

As per WHO Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem.

2.0 Importance of Pharmacovigilance

Below are some important Pharmacovigilance goals:

2.1 Improve and protect patient and user safety

2.2 Improve and protect patient and user health

2.3 Evaluation of harm, effectiveness and risk of medicines.

2.4 Pharmacovigilance is helpful to promote understanding, education and clinical training.

2.5 Pharmacovigilance education is effective communication to the public about medicine harm, safety, effectiveness and risk of medicines

3.0 What is an Adverse Event?

As per ICH (International Council for Harmonization) Adverse event is 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.

4.0 Responsibility of Pharmacovigilance or Adverse Event Investigation Team

4.1 The collection, investigation, processing of Adverse Events.

4.2 Reporting applicable to Health authorities within the defined time limits, in accordance with Health Regulations and Patient Safety procedures.

5.0 How to report an Adverse Event

5.1 If any abnormal effect occurs after medication, then first of all check the side effect details of that medicine. If this abnormal event is part of side effect, then this abnormal event is not considered as adverse event. But if abnormal event is not part of side effect, then this abnormal event is considered as adverse event

5.2 Reporter (Patient) should report the details about the adverse event to manufacturer and health authority.

5.3 If you become aware of an Adverse Event, collect as much information as possible, including:

  • Reporter (name and contact information).
    • Patient information (Patient initials, gender, age or age group and number of patients directly linked to a specific event.)
    • Product details
    • Adverse event details.

5.4 Any employee who receives information about a potential Adverse Event and/or other safety information, MUST forward this to the Pharmacovigilance Department within 24 hours (the same day if received before a weekend or holiday), and should indicate the date on which this information was received.

5.5 Do not delay the reporting of adverse events even if you do not have all the details from the reporter.

5.6 Fill the details of Adverse Event in Adverse Report Form.

5.7 Below is the adverse event process flow chart:

Adverse event reporting form, Pharmacovigilance
Adverse Event Flow Chart
6.0 Content of Adverse Event Reporting Form

6.1 General Information

6.1.1 Complaint received by

  • Name
  • Email
  • Designation

6.1.2 Event Type

  • Adverse Event only
  • Product complaint only
  • Adverse Event and Product complaint both

6.1.3 Date employee was notified

6.1.4 How was of Adverse Event and/or Product Complaint reported

  • By Email
  • By Phone
  • By Fax
  • Other

6.2 Reporter Information:

  • Name
  • Address
  • Language Speaking Information
  • Contact Information – Phone, email, Fax
  • Is reporter health care professional

6.3 Patient Information:

  • Name
  • Age, Gender, Date of birth
  • Address
  • Contact Information – Phone, email, Fax

6.4 Event details:

  • Describe the Event
  • Describe what event(s) occurred
  • Where event(s) occurred
  • Did patient go to hospital
  • Additional products used
  • When during therapy the event occurred

6.5 Product Information:

  • Name of product
  • Strength of product
  • Serial Number / Batch Number – Known / Question not asked to reporter / Reporter did not know
  • Not a manufacturer product

6.6 Additional Information

  • Additional comment
  • If attachment available for more details
7.0 Main Tasks of Pharmacovigilance

7.1 To establish a pharmacovigilance system in collaboration with all relevant interfaces (eg management, business units, legal departments, medical affairs, regulatory affairs, quality assurance) within the company.

7.2 To process all notifications of adverse drug reactions and other safety information with the medicinal product: collection, recording, documentation, follow-up, archiving.

7.4 To notify all serious cases to Health Authorities, immediately and no later than 15 days after receipt of first information by any employee.

7.5 To perform the training regarding Pharmacovigilance for all employees, and on a yearly basis for all employees facing healthcare professionals (marketing, sales, medical affairs, customer services, technical services…)

7.6 To ensure compliance with regulations and to have internal procedures.

8.0 Following must also be reported to Pharmacovigilance (but not limited):

8.1 Therapeutic product overdose, whether accidental or intentional 

8.2 Therapeutic product abuse

8.3 An event occurring from therapeutic product withdrawal

8.4 Any failure of expected pharmacological action (i.e., “lack of effect”)

8.5 Unintended exposure to a therapeutic product during pregnancy, intrauterine exposure, and/or lactation exposure

8.6 Inadvertent or accidental therapeutic product exposure (e.g., product leaking or being spilled onto a patient or caregiver)

8.7 Unexpected therapeutic or clinical benefit from the therapeutic product (e.g., medication for blood pressure caused hair growth)

8.8 Suspected transmission via a medicinal product of an infectious agent

8.9 Medication errors (e.g. incorrect route of administration, incorrect dosage, or use of an incorrect product

8.10 Off-label product use – The therapeutic product is used intentionally for medical purposes and not according to official product information

9.0 References:

9.1 Importance of Pharmacovigilance – WHO

9.2 ICH glossary

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