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Pharmacovigilance

PharmacovigilanceBlue Cross Laboratories has Pharmacovigilance system in place to protect health of the patients by promising drug safety.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.

What is an Adverse Drug Reaction (ADR)?

It is a noxious response to a drug which is unintended and which occurs at doses normally used in human for prophylaxis, diagnosis, or therapy of a disease or for modification of physiological function of the body.

What is an Adverse Event (AE)?

An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does necessarily have to have a causal relationship with treatment.

What is the Difference between Side Effect and Adverse Event?

A side effect is any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug.

What is a Serious ADR or a Serious Adverse Event (SAE)?

Any untoward medical occurrence that at any dose:

  • Results in death.
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization.
  • Results in persistent or significant disability/incapacity. or
  • Is a congenital anomaly or birth defect.

What is Individual Case Safety Report (ICSR)?

ICSR is an adverse event report for an individual patient and is source of data in pharmacovigilance.

Who can Report Adverse Drug Reaction(s)?

  • All healthcare professionals including clinicians, dentists, pharmacists, nurses etc.
  • Consumers such as patients, relatives etc.
  • Pharmaceutical companies.

Consumers can either brief ADR/AE to their treating physician or report directly through ‘Medicines Side Effect Reporting Form’

Why to Report ADR?

As a healthcare professional and citizen of India its moral responsibility to report adverse reaction associated with pharmaceutical products to safeguard public health and help in improving patient safety.

What Type of Adverse Drug Reaction(s) to be Reported?

In order to nurture the culture of reporting, it is recommended to report all types of suspected ADRs- irrespective of whether they are known or unknown, serious or non-serious, and frequent or rare

How to Report ADR?

This is to be reported in a prescribed format. Healthcare professionals can use ‘Suspected ADR Reporting Form’ whereas consumers can fill the ‘Medicines Side Effect Reporting Form’.

 

Please click on the following hyperlinks to download forms and instructions to fill these forms.

You can also get these forms from our sales representatives.

Where and Whom to Submit these Form(s)?

You can choose any one of the following option:

1. Through Sales Representatives/MR: Healthcare professionals can submit the filled ‘Suspected ADR Reporting Form’ to our sales representatives.

OR

2. By Email: Reporter i.e., healthcare professionals/consumers can send the filled ‘Suspected ADR Reporting Form’ or ‘Medicines Side Effect Reporting Form’ by email drugsafety@bluecrosslabs.com

OR

3. By Post: Reporter can send filled form by post to the following address: Blue Cross Laboratories Pvt Ltd. Medical Services Department, Peninsula Chambers, Peninsula Corporate Park, G. K. Marg, Lower Parel, Mumbai – 400013, Maharashtra, India.

OR

4. Toll Free / Helpline Number: Toll free/helpline numbers can also be used to report adverse event / reaction(s) to our medicines. You can call to these numbers and ask any query related to ADR reporting. We have dedicated staff to help you on reporting of spontaneous ADRs.

• Mr. Gopal Kadam – Pharmacovigilance Officer In-Charge (PvOI).

Helpline No. 022 66638042.

• Dr. Prabhu Kasture – Pharmacovigilance Duty-In-Charge.

Helpline No. 022 66638043.

• Toll Free Number: 1800 123 6385.

These numbers shall be operational from Monday to Friday and on 2nd, 4th, and 5th Saturday from 10.00 am to 05.30 pm. If a call is not attended or unanswered, then drop a voice message for call back on voice recording system (E.g., I am .…., calling from …. city, I have called you to report an ADR, so, please call me back).

Will there be any Legal Issue if I Report ADR(s)?

No, there will not be any legal issues as the information will be used for drug safety. Further, submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

What about Confidentiality of Reporter?

The patient’s as well as reporter’s identity is held in strict confidence and protected to the fullest extent.

What is Pharmacovigilance Programme of India (PvPI)?

Pharmacovigilance Programme of India (PvPI) is a flagship drug safety- monitoring programme of Government of India. Indian Pharmacopoeia Commission (IPC), Ghaziabad is functioning as a National Coordination Centre (NCC) for PvPI. The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby sensitizing the stakeholders to reduce the risk associated with use of medicines

Where can I get More Information on PvPI and India’s Drug Regulatory Authority?