Adverse Event Reporting Form


Glenmark Pharmaceuticals Ltd.: Adverse Events Reporting

Our mission at Glenmark has always been towards making healthcare safer. Patient safety is the bedrock of everything we do and ensuring patients receive the safest care possible is and will always remain our highest priority.
The aim of Pharmacovigilance is to protect public health by identifying, evaluating and minimising 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:

Reporting of side effects: If you experience any side effects, speak to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Adverse Event/Adverse Drug Experience
  • 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.
Adverse Drug Reactions
  • 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.
Overdose
  • 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
Drug - Drug Interaction
  • 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.
Drug-Food Interaction
  • 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.
Occupational Exposure
  • 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.
Paediatric/Geriatric Exposure
  • The collection of safety information in the pediatric or elderly population is important.
Use of a Glenmark Product During Pregnancy/Breastfeeding​
  • Exposure of embryo or foetus 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 Error
  • 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.

Off-Label Use

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

Misuse

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

Abuse

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

Lack of Effect
  • The medicinal product doesn’t work as expected for the given dose.
Product Complaints
  • 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

Suspected Transmission of Infectious Agent Via Medicinal Product (STIAMP)
  • 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.

Points to Consider

  1. Provide as much 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.
  5. To know more about how we use your data please visit our Privacy portal at the bottom of the page

 

 

If you wish to report by any other means like Telephone, Email, Postal Mail, etc., you may select one from the following options: