Pharmacovigilance:
The science and activities related to the detection, assessment, understanding and prevention of adverse events and/or any other medicine-related problem.
What is adverse drug reaction (ADR)?
ADR is defined as “a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man”.
The Importance of Pharmacovigilance?
Monitoring and surveillance the adverse event of medicines in post-marketing for protecting patients because during clinical studies the number of patients and study duration are not sufficient in most cases for detection and assessment the adverse events .
Sources of Adverse Events Reports :
- Health Care Professionals.( Physicians , nurses, pharmacists …..etc.)
- Health Authorities
- Patients
- Literature research
- AMCO staff.
Minimum requirements for reporting any adverse event :
1. Identifiable Reporter
-Medically qualified
HCP e.g. Physicians, Nurses, Pharmacists……etc.
-Non-medically qualified
e.g.: Patients, Family, Friends…etc.
2. Identifiable Patient:
Required Information: gender, age, weight or height..etc.
3. Suspected medicinal product
Any medicinal product where AMCO is the MAH, Promotion or distributor.
4. Suspected Adverse Event
The adverse event that caused by medicine.
All Adverse Events should be reported Immediately
National pharmacovigilance center Online :
http://ade.sfda.gov.sa
E-mail: Npc.drug@sfda.gov.sa
Toll free number: 8002490000
AMCO -Pharmacovigilance Department
Safety mailbox: Safety@Alhaya-Medical.com
Qualified Person for Pharmacovigilance (QPPV):
Ph. Mohammed Alomair, E-mail: malomair@Alhaya-Medical.com
Mobile : +966 53 011 8998
Tel. : +966 11 465 5075. Ext. 527.
Fax : +966 11 4646441.
Fresenius Kabi Scientific Office