Pharmacovigilance.

Procedure:

• An adverse event can be any unfavorable & unintended sign, symptom or disease temporarily associated with the use of LVPs (large volume parenteral).
• Adverse Drug Reaction (ADR): All noxious & unintended responses to administration of LVPs related to any dose is considered as an ADR.
• Serious Adverse Drug Reaction: A SAE or reaction is any untoward medical occurrence that at any dose:
• results in death
• is life threatening
• requires inpatient hospitalization
• results in persistent or significant disability / incapacity
• congenital anomaly / birth defects.
• Events that do not fit in any of the above definition are to be considered as non-serious adverse events.
• Critical safety, Quality or Regulatory issues that can pose a substantial risk to the patient must be reported, managed & addressed through Pharmacovigilance in order to achieve resource prioritization, communication, timely action & resolution.
• The head of Pharmacovigilance / person responsible for pharmacovigilance shall be responsible for reporting any pharmacovigilance issue arising out of product complaint. He / She shall report to Country Head-Operations (MD) & to Global if required.
• Global Pharmacovigilance is also responsible for review & management of significant or potentially significant safety, quality or regulatory issues linked to pharmacovigilance activities.
• The local pharmacovigilance committee shall constitute the same members as that of Drug Recall Committee, i.e. the following shall be there,
• Managing Director
• Technical Director
• Head-Legal & Finance
• Head-QA
• Plant Head
• Business Head
• A Pharmacovigilance issue is that critical issue that may adversely affect the safety of the container, adversely affect the manufacturing & marketing of production or produce a highly undesirable regulatory outcome [Refer definition of SAE, ADR etc.]
• The following stages must be operational:
• Detection
• Problem definition
• Crisis management plan
• Evaluation & follow-up
• Conclusion
• There shall be a continuous monitoring plan with respect to pharmacovigilance for all post marketed products.
• In case of exported products, the reporting shall be mandatory to Global as well as the MOH (Ministry of Health) of the importing country if applicable.