PHARMACOVIGILANCE

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

Regulatory compliance

Involves the collection and reporting of Adverse Events/Adverse Drug Reactions

1. What is Pharmacovigilance?

2. What to report?

3. How to report?

4. Where to report?

5. When to report?

6. Why is it important?

key questions in pharmacovigilance

adverse event AE
product quality Compliant PQC

Counterfeiting or tampering

Other reportable information (ORI)

types of reports

Adverse Event AE

• Any untoward or undesirable medical occurrence in a patient.

• Does not necessarily have a causal relationship with the treatment.

• Includes adverse drug reactions, overdose, dose reductions, and discontinuation of drug therapy.

  • Adverse Drug Reaction: A response to a drug that is noxious, unintended, and occurs at doses normally used.

Adverse drug reaction

• A response to a drug that is noxious, unintended, and occurs at doses normally used.

Product Quality Complaint

• A potential defect related to the identity, strength, quality, or purity of a product.

• Examples:

  • Change in product appearance

  • Product delivery malfunction

  • Missing components

  • Product mismatches

  • Product packaging defects

Medical Device Event: Malfunction or deterioration in the characteristics/performance of a device, or inadequacy in labeling/instructions.

Medical Device Event

• Malfunction or deterioration in the characteristics/performance of a device, or inadequacy in labeling/instructions.

Counterfeiting or tampering

• Counterfeiting: Use of trademark, trade name, or identifying mark to adulterate or falsely represent a product.

• Tampering: Fraudulent and unauthorized intervention that alters a product's quality.

Counterfeiting

• Use of trademark, trade name, or identifying mark to adulterate or falsely represent a product.

Tampering

Fraudulent and unauthorized intervention that alters a product's quality.

Maternal pregnancy or paternal exposure

Exposure during breastfeeding

Suspected or actual administration of an expired medicine

Missed dose

Suspected transmission of an infectious agent via a medicinal product

Suspected abuse or misuse

Medication/Administration errors

Drug interaction

Drug overdose/under dose

Off-label use (unapproved)

Unexpected benefit

Failure of expected action

other reportable information ORI

Product

reporter

event

patient

Basic information needed for reporting

• Brand/generic name

• Batch #

• Duration of use

• Other drugs involved

Product (components)

• What happened

• When

• What was done

• What was the outcome

Event (components)

name

contact details

Reporter (components)

Initial, gender, age

Patient (component)

1. Social Media

2. Phone

3. Emails

4. In-person reports

5. Newspapers

6. Mail/Post

sources of reports

email number of pharma distributor

reporting platforms

1 hour

timeline for reporting:

Report immediately, within______to the Product Vigilance Team/DPOC.

1. improve patient care and safety

2. improve public health and safety.

3. Ethical and moral responsibility.

4. Regulatory compliance.

why pharmacovigilance is important

1. Legal action (Civil or criminal)

2. Market Restriction/Product Recall

3. Imprisonment

4. Monetary Fine

Risk for Not properly handling reports