Adverse Event Reporting(ADR)

Drug safety monitoring is a continuous process throughout the lifecycle of a drug product, aimed at updating its safety profile by monitoring any unintended effects or other safety-related aspects in drugs that are already available in the market. This effort promotes the rational use of medicinal products with minimal risk to all consumers.

Scott-Edil encourages reporting of Adverse Drug Reactions (ADRs) by all healthcare professionals (HCPs) and consumers who encounter issues associated with the intake or administration of our drug products. This reporting system enables us to continuously assess the benefit-risk profile of all our drug products.

Therefore, ADR monitoring is essential for improving healthcare, ensuring drug safety, and safeguarding patient health.

WHAT IS ADR?

According to the World Health Organization (WHO), an Adverse Drug Reaction (ADR) is defined as "any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function."

WHAT TO REPORT?

You should report any of the following events or issues related to Scott-Edil drug products:

• Adverse Events (AE) or Side Effects: Any adverse event or side effect experienced after taking a Scott-Edil drug product.
• Misuse or Abuse: Overdosing, abuse, misuse, or off-label use of a drug.
• Special Population Issues: Use during pregnancy, breastfeeding, or lactation, with or without adverse effects.
• Medication Errors: Any medication errors involving Scott-Edil drug products, with or without adverse effects.
• Product Quality Issues: Complaints related to the quality of Scott-Edil drug products, such as damage, discoloration, misshaping, tampering, etc.
• Drug Interactions: Adverse reactions due to drug interactions involving Scott-Edil drug products.
• Occupational Exposure: Issues related to occupational exposure to Scott-Edil drug products.

TYPES OF ADVERSE EVENTS:

Serious Adverse Drug Reactions: Report reactions that lead to patient outcomes such as death, life-threatening situations, hospitalization (initial or prolonged), significant disability, congenital anomalies, or interventions needed to prevent permanent impairment or damage.

Non-serious Adverse Drug Reactions: Report both known and unknown, frequent, or rare adverse drug reactions associated with Scott-Edil drug products.

WHO CAN REPORT AN ADR/AE?

• Healthcare Professionals: Including doctors, clinicians, dentists, pharmacists, nurses, etc.
• Non-Healthcare Professionals: Such as patients, relatives, or friends who have sufficient knowledge about the adverse event.

By encouraging widespread reporting, Scott-Edil aims to ensure comprehensive monitoring of drug safety and thereby improve patient care and overall public health.

HOW TO REPORT ADR/AE?