Adverse Event And Special Situation Reporting

What is an Adverse Event (AE)?

Any untoward change to medical condition affecting a patient receiving a medicine, although it is not known whether a causal relationship to treatment with this medicine exists.

Adverse event can therefore be:

  • Adverse drug reactions that include cough, nausea, vomiting, diarrhea, and headaches. Skin reactions (i.e. rashes, itching) are the most common form of allergic     drug reaction, Jaundice, anemia, a decrease in the white blood cell count, kidney damage, and nerve injury that may impair vision or hearing etc are also reported     after taking medicines.
  • Disease temporarily associated with the use of a medicinal product, whether or not a causal relationship with the treatment.
  • All AEs must be reported to Ibn Sina Pharmacy L.L.C even if the event is described in the Patient Information Leaflet (PIL) or Summary of Product Characteristics (SPC) or the event has already been reported to Health Authority

    Special Situations

    • Pregnancy
    • Lack of efficacy
    • Overdose
    • Misuse and abuse / overuse
    • Medication and administration errors
    • Occupational exposure
    • Suspected transmission of infectious agents via a medicinal product
    • Counterfeits
    • Reports from lawsuits
    • Deaths
    • Off-label use
    • Disease progression related to the use of the product
    • Drug interactions, drug addiction and withdrawal syndrome

    Date of Reciept of Notification

    All adverse events and Special Situations notifications must be passed to Ibn Sina Pharmacy L.L.C within 1 working day of learning 4 minimum criteria as follows:

    • Identifiable patient - (initials, gender, date of birth, age or age group – mandatory to report at least one of the categories)
    • Identifiable reporter - name and available contact information of the reporter (phone, facsimile, address, e-mail).
    • Adverse event or special situation
    • Suspected medicinal product of Ibn Sina Pharmacy L.L.C

    All other medically relevant information on the report must also be provided in order to allow assessment of the case.

    How To Report Adverse Events

    Data Protection

    Patient confidentiality must be respected throughout.The aim is to ensure that medical and safety-relevant data is collected by Ibn Sina Pharmacy L.L.C for evaluation of the Marketing Authorization Holder with the purpose to monitor on a continuous basis the benefit-risk of the products.

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