• Any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

• A response to a drug that is noxious and unintended and that occurs at doses normally used in patients for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function The phrase “responses to medicinal products” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

• Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information

• A change in a drug’s effect on the body when the drug is taken together with a second drug. This can decrease or increase the action of either or both drugs or cause adverse effects.

• A drug-food interaction occurs when food and medicine interfere with one another or certain foods may delay or decrease the absorption of the drug.

• An exposure to a medicinal product as a result of one’s professional or non-professional occupation. This does not include exposure to raw materials during the product manufacturing process.

• The collection of safety information in the Pediatric or elderly population is important.

• Exposure of embryo or fetus to medicinal products either through maternal exposure and/or paternal exposure if the suspected medicinal product was taken by the father needs to be reported even if there is no adverse event.

• Medication errors are broadly defined as any error in the prescribing, dispensing, or administration of a drug, irrespective of whether such errors lead to adverse consequences or not.

Examples:

→ Injection for intravenous use prescribed as intramuscular or subcutaneous.
→ Prescribing a drug to which the patient is allergic.
→ Wrong drug dispensed, due to illegibility of prescription or drug/brand sounds alike.

Product Confusion – Type of medication error involving confusion between Glenmark products or confusion between a Glenmark product with another manufacturer’s product. May involve similar packaging, the image of a dosage form, the sound of a product’s name, or unclear labeling or instructions for use.

• Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorization.

• Situations where a medicinal product is intentionally and inappropriately used not in accordance with the terms of the marketing authorization.

• Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.

• The medicinal product doesn’t work as expected for the given dose.

• Fault in quality, packaging, labelling of the product.

Falsified medicines are fake medicines that are designed to mimic real medicines.

Example:

→ The product is discolored, no batch number, missing tablets, missing patient information leaflet, damaged packaging, blunt needle, cracked vial.
→ Tablet was broken
→ Label is illegible/Font is very small to read

• Any suspected transmission of an infectious agent via a medicinal product should be considered as a serious adverse reaction.
• Any organism, virus or infectious particle (e.g. prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic, is considered an infectious agent.
• A transmission of an infectious agent may be suspected from clinical signs or symptoms, or laboratory findings indicating an infection in a patient exposed to a medicinal product.