Pharmacovigilance and ADR reporting Form

All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown, even though a particular medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any 'new' information available in relation to their safety profile. A Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the objective behind Pharmacovigilance program.

The purpose, therefore, of the Pharmacovigilance Program of India is to collect, collate and analyze data with a view to ultimately assess and communicate risks to healthcare professionals and to the public at large.

Therefore, with a goal to ensure that the benefits of use of medicine outweigh the risks, and to safeguard the health of the Indian population, we have decided to monitor Adverse Drug Reactions (ADRs) in Indian population. Drug safety covers all aspects of noxious, unanticipated, unintended events reported once a medication is administered to a patient. All the regions / countries where Blue Cross Laboratories Pvt Ltd. markets its medicines are involved in reporting adverse drug reactions (ADR) in the prescribed form (ADR form).

All ADR reports would be submitted to regulatory authorities as per necessary requirements. Blue Cross Laboratories Pvt Ltd. practices recording of adverse events that are captured in a standard format ADR Form. This is modeled on the lines prescribed by CDSCO.

ADVERSE DRUG EVENT REPORTING FORM

For VOLUNTARY reporting of adverse drug events by Healthcare Professionals

ADVICE ABOUT REPORTING

  • Report adverse experiences with medications.
  • Reporting serious adverse reactions. A reaction is serious when the patient outcome is:
    • Death
    • Life-threatening (real risk of dying)
    • Hospitalization (initial or prolonged)
    • Disability (significant, persistent or permanent)
    • Congenital anomaly
    • Required intervention to prevent permanent impairment or damage
  • Report even if:
    • You're not certain the product caused adverse reaction.
    • You don't have all the details (although point nos. 1, 5, 8, 11, 20 & 22 are essentially required)
  • Who can report:
    • Any health care professional (Doctors including Dentists, Nurses and Pharmacists).
  • Where to report:
    • After completing, please return this form to Mr. Gopal Kadam, Asst. Manager - Medico-Marketing, Pharmacovigilance Department of Blue Cross Laboratories Pvt Ltd., Peninsula Chambers, Lower Parel, Mumbai-400 013.
    • You may return this form to peripheral / regional / zonal Pharmacovigilance center
    • A List of country wide Pharmacovigilance centers is available at www.cdsco.nic.in
    • In case of doubt you may send this form to National Pharmacovigilance Center at: Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Nirman Bhavan, New Delhi 110 011.
  • What happens to the submitted information:
    • Information provided in this form is handled in strict confidence. BLUE CROSS Pharmacovigilance Dept. will forward this form to the Regional Pharmacovigilance Centres of CDSCO (Central Drugs Standard Control Organization) where the causality analysis is carried out and the information is forwarded to the Zonal Pharmacovigilance Centres. Finally the data is statistically analysed and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Center in Sweden.
    • The data is periodically reviewed by the National Pharmacovigilance Advisory Committee constituted by Ministry of Health and Family Welfare. The committee is entrusted with the responsibility to review the data and suggest any intervention(s) that may be required.

Confidentiality: The Patient's identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the reporters identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.