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 is caused by medicine.
    • All Adverse Events should be reported immediately.

National pharmacovigilance center Online :

AMCO -Pharmacovigilance Department:

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