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ADVERSE EVENT REPORTING

ADVERSE EVENT REPORTING

We at BSVL are firmly committed towards the efficacy and safety of our products. Any medicine may cause side effects in some patients. "Some information" on side effects and related risks may be known only after a drug is consumed in large numbers of patients across a wider population. We want to make sure that the therapeutic benefits of the medicine outweigh the risks.

We would like to know about every adverse event that occurs in patients after taking a BSVL medication. Reporting any issue related to the safety or quality of our medicines is mandatory for every BSVL employee if she/he become aware of such instances. Every adverse event report is entered in a database and assessed, thus ensuring compliance with applicable regulations.



FAQs

What is an adverse event?

An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as a “side effect”.

It includes:

  • Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
  • Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
  • Overdose
  • Misuse and Abuse
  • Use in pregnancy and breastfeeding
  • Product technical complaints e.g. discolored or deteriorated products, improper labeling

Why should I report an adverse event?

We don’t want to miss out on important data which could help us use our medicines more effectively and safely. If you report an adverse event It would also help us identify rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications

What to report? (Necessary minimum information)

1. Patient particulars

This identifies the person who experienced the Adverse Event.
The particulars include initials, age, gender etc.

2. Event particulars

These describe the symptom/sign. Additional data include: onset, course and outcome of the event.

3. Reporter details

You should provide your name, address and phone number as you may need to be contacted for further information.
If you are not a healthcare professional, provide details of the prescribing doctor too.

4. Drug details

These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event.

Who can I report to?

You can report to:

Any health care professional (Doctors, Dentists, Nurses, Pharmacists,Patients etc)

Non healthcare professional (Patient, relative, friend, etc)

How do I report?

If you wish to report a suspected adverse reaction/side effect that occurred with our drug, you can report it by choosing any of the following options:

  • Call our PV Phone No. +91- 22-45043347, Monday to Friday, between 9:00 am to 5:30 pm. (After office hours, you can keep message which will be auto recorded).

  • Complete and submit the Adverse Event Reporting (AER) form online available on this website.

SUSPECTED ADVERSE DRUG EVENT (AE) REPORT FORM
Check all that apply *
 Adverse Event/Side Effect  Pregnancy/lactation  Overdose
 Lack of efficacy  Misuse  Abuse  Product Complaint
 Medication Error
Patient Information

  Male    Female    Other
(e.g., child, elderly)
Event Description

(at the time of this report)
  Complete recovery  Ongoing   Recovering  Unknown
 Died  Other (specify)
Drug Use Detail

* Suspect Drug details
(Unit dose
/strength & Form)
Indication Dosage/ Unit/ Frequency Route Expiration Date
1.
2.

* Start Date End (or Ongoing) Lot/Batch # Expiration Date
1.
2.

Reporter Information

  Yes    No


You may contact the pharmacovigilance unit of Bharat Serums and Vaccines Limited at
Fax: +91- 22-45043355
Phone: +91- 22-45043347
E-mail: pv@bharatserums.com

Address:

Clinical Research & Pharmacovigilance,
Bharat Serums and Vaccines Ltd.,
3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza,
Kalwa Industrial Estate, Airoli, Navi Mumbai, India – 400708.

Confidentiality : The patient's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the reporter’s identity in response to a request from the public.