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 :
- Identifiable Reporter:
- Medically qualified HCP e.g. Physicians, Nurses, Pharmacists……etc.
- Non-medically qualified e.g.: Patients, Family, Friends…etc.
- Identifiable Patient:
- Required Information: gender, age, weight or height..etc.
- Suspected medicinal product:
- Any medicinal product where AMCO is the MAH, Promotion or distributor.
- 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@Alhaya-Medical.com
- Qualified Person for Pharmacovigilance (QPPV): +966 11 465 5075. Ext. 527.
