PHARMACOVIGILANCE

What is a yellow card?

The Yellow Card is a means of collecting information with regards to the Adverse Effects of pharmaceutical products.


The Healthcare Professionals (medical doctors, pharmacists, carers, etc.) as well as the patients, have the duty to fill in the Yellow Card, each time they suspect that a medication may have caused an Adverse Effect.

Do not hesitate to report Adverse Effects, which are unknown or for which you have doubts regarding their relation to the suspect medication.


The success of the institution of the Yellow Card lies in the AWARENESS of the Healthcare Professionals and the patients/consumers and their will and endeavour to notify on the possible Adverse Effect of medication.


Every notification is important!

If you are a Healthcare Professional or patient, please use the below means to notify of Adverse Effects for a pharmaceutical product for human consumption.


01. By fax

Print the Yellow Card, fill it in and send it by fax to ACESIA PHARMACEUTICALS (+30 210 6000410)
 Possible Adverse Effect Petition Form

 

02. E-form

Please fill in the below form and send to report the Adverse Effect

 

1. Patient details
Patient initials
Patient Record
Age
Weight
Kgr
Height
cm
Sex
2. Adverse Event (ΑΕ)
Please report the DIAGNOSIS or the signs & symptoms
DATE
START
END
Adverse Event Outcome
Are any of the following Adverse Events serious? Yes No
  • Cause of death
  • Directly Life-threatening
  • Causing or prolongation of hospitalization
  • Serious injury or persistent AE
  • Congenital Anomaly / Fault during childbirth
  • Important Medical Event
In case of death, indicate the cause:
Date of Death:
(please attach coroner's finding, if available)
3. Medication
Commercial name / Active Ingredient
Lot No.
(Batch No.)
Address
of administration
Dose
(Units & Frequency)
DATE
START
END
Therapeutic Indication
Classification
4. Additional comments

eg Related Medical History (Allergies, Previous AE, Environmental Factors, Smoking,
Substance Abuse), Course of symptoms, laboratory findings, Correlation, Treatment.

5. Details of Petitioner
Name and Surname
Healthcare Institution
Address
Telephone
Date: 20 January 2018
Petitioner Specialty
  • Hospital Doctor,
    specialty
  • Hospital Pharmacist
  • Private Doctor,
    specialty
  • Private Pharmacist
  • Other,
    clarify
Give the result of the arithmetic operation
calculation
=

HOW TO FILL-IN THE YELLOW CARD
  • TABLE 1:
    PATIENT DETAILS Please fill in as much information as you have available.
  • TABLE 2:
    ADVERSE EFFECT Report ALL adverse effects, even if you are not certain they are related to the medication. DO NOT FORGET THE STARTING DATE.
  • TABLE 3:
    MEDICATION Please fill in as much information as you have available.
  • ATTENTION !
    The minimum requirements for the evaluation of a YELLOW CARD are: DOUBTED MEDICATION – ADVERSE EFFECT with STARTIGN DATE – DETAILS OF PATIENT – DETAILS OF PERSON REPORTING.