Adverse Event Reporting
We at Zydus believe that patient safety is our prime concern ahead of commercial or other interests.
The aim of Pharmacovigilance is to protect public health by identifying, evaluating and minimizing safety issues in all possible ways.
So, we encourage consumers, health care professionals, our employees and others to report the following to our Pharmacovigilance department:
Medical occurrence temporally associated with the use of our medicinal product, including an abnormal laboratory finding but not necessarily causally related.
Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. AEFIs can be related to the vaccine itself (product or quality defect-related reactions), to the vaccination process (error or stress related reactions) or can occur independently from vaccination (coincidental).
A 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 modification of physiological function.
The phrase "responses to a 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.
The patient has taken, (accidentally or intentionally) above/below the maximal /minimal recommended dose as stated in the product label/authorized product information or as prescribed
Includes an interaction with another drug, device, disease, food or alcohol
Accidental exposure to Zydus product may or may not be a result of one’s occupation
Use of a Zydus product during pregnancy/lactation even though there are no adverse events/adverse drug reactions
Drug exposure of embryo or foetus via semen due to father taking Zydus product
Inappropriate use of Zydus product that was not intended. This may be an actual error that occurred, an error that was intercepted (near miss) or an error that could occur (potential).
Medication errors are captured whether or not the product was ingested or administered
Medication errors are captured whether or not it resulted in an adverse event
→ 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.
Type of medication error involving confusion between Zydus products or confusion between a Zydus 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
May be intentional (e.g., off label use, misuse, or abuse), unintentional (e.g., medication error), or the intention is not known
Zydus drug was ineffective (did not work) or the expected effect was not achieved
Beneficial effect of a product aside from the use for which it has been given
Concern/issue with product quality
→ Tablet was broken
→ Tablet colour changed
→ Tablet was missing or blister was empty
→ Label is illegible/Font is very small to read
Points to Consider :
- 1. Provide as many details as possible. This will help us to understand the case better.
- 2. The patient/reporter's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the patient/reporter’s identity in response to a request from the public.
- 3. The data may be shared with the competent authorities as required to comply with the regulatory requirements.
- 4. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.