Adverse Event Reporting


All pharmacologically effective drugs have benefits and risks. The risk may be insignificant or may be acceptable in relation to the drug's therapeutic action. Continuous monitoring of the safety of a drug throughout the duration of its use helps to ensure that its risks and benefits remain acceptable. AstraZeneca is committed to protecting the safety of patients who receive our products.

"Report any suspected Adverse Events to AstraZeneca medications through the established procedures."

 


Why report Adverse Event?

  • Adverse Event reporting helps AstraZeneca to identify rare and very rare adverse effects
  • Reporting leads to regular review of safety database for new risks or signals.
  • Adverse Event reports help to provide current and accurate updates on safety profiles of the drugs
  • Adverse Event reports help to identify different profiles of known adverse reactions with regards to severity, nature or outcome

 

What does this include?

Adverse Event includes undesirable medical condition that can be symptoms (for example nausea, chest pain), signs (for example tachycardia, enlarged liver) or the abnormal results of an investigation (for example laboratory findings, electrocardiogram). Adverse Events are not necessarily caused by the medication – the event just needs to have occurred after taking a medicine and AstraZeneca also collects the reports of :

  • Drug exposure during pregnancy and breastfeeding
  • Lack of drug effect
  • Drug overdose or medication error
  • Drug abuse or misuse
  • Transmission of infectious agents via an AstraZeneca product
  • Drug Interactions
  • Death of unknown cause

 

What to report?

1. Patient identifier

  • Who experienced the Adverse Event?
  • Patient and reporter identifier is important to avoid case duplication and facilitate follow up of appropriate cases
  • The term identifiable in this context refers to the verification of the existence of a patient (e.g. you might provide: sex, age etc)

 

2. Event description

  • What was the Adverse Event?
  • Describe the nature of the adverse event, any signs and symptoms and outcome of the event

 

 3. Reporter

  • Who is reporting the Event?
  • Give your name, address and phone number as you may need to be contacted for further information
  • If you are reporting on behalf of a healthcare professional (e.g. if you are a sales representative), be prepared to also give their details.

 

4. Drug

  • What AstraZeneca product was taken by the patient?
  • Provide the name of the AstraZeneca product taken by the patient

If you do not have all the details listed above, please still report the Adverse Event. In addition, you can report any other details you have about the Adverse Event.

Report the Adverse Event even if you don’t think it is serious, relevant or caused by AstraZeneca product.

 

How to report?

You can report the Adverse Event by using the Adverse Event Report Form.

Click here to download the Adverse Event Report Form (DOC 93kb)

Or Click here

Contact AstraZeneca Patient Safety at

Tel: +91-80-67748000 (Ext. 8458)

E-mail : patientsafety.india@astrazeneca.com