(Header
as exampled by FDA)
Objective:
- To minimize morbidity and mortality in patients in all areas of health care today.
- To identify rare adverse drug reactions not detected during clinical trials.
- To monitor for increases in already known reactions.
- To identify risk factors or pre-existing conditions that promotes reactions.
Scope:
- Future adverse drug reactions
- Customer reports
- Adverse drug events
Responsibility:
- Pharmacist
Procedure:
- Encourage reporting of serious or unexpected adverse drug reactions to the FDA.
- Monitor for adverse events involving drugs and devices in continual, collaborative fashion.
- Report adverse drug reactions to the FDA.
Quality
of Records:
- Reporting and recording of drugs that are sold and may have new adverse drug reaction.
- List all drugs which has adverse drug reaction.
Forms:
- Logbook and official receipt
End
of Document
