Frequently Asked Questions, "GENERAL QUESTIONS"

Q: What is Pharmacovigilance?

A: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.



Q: What is the Egyptian Pharmacovigilance Center (EPVC)?

A: Egyptian Pharmacovigilance Center (EPVC) is established with in the Ministry of Health which is in direct contact with the world health organization (WHO). EPVC collect and evaluate Information about the harms associated with the normal use and misuse of medicines.



Q: What is Adverse Drug Reaction (ADR)?

A: It is the description of the response to a medicinal product which is noxious and unintended which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease; or for the restoration or modification of physiological function.



Q: What is a serious ADR?

A: It is the ADR which leads to one of the followings: <br/> 1. Death <br/> 2. Life threatening <br/> 3. Patient hospitalization <br/> 4. Permenant disability <br/> 5. Congenital anomaly <br/> 6. Required medical intervention



Q: What is a yellow card?

A: It is the form used for collecting information on suspected adverse drug reactions to medicine and it is designed in English and Arabic forms, you can submit it to the center by one of the following means: fax, post, over the phone, email, or online submission. The yellow card consists of mainly five main parts. The 1st part is for patient details, the 2nd one is for suspected drug(s), the 3rd part is for suspected reaction(s), the 4th one is for the concomitant drug(s) taken with the main suspected drug(s) and the last part is for the reporter details.



Q: Who can Report an ADR?

A: Marketing Authorization Holder (MAH), HCP (Physicians, pharmacists, dentists & nurses), patients, patients` relatives, patients` friends, and anyone who can report on ADR .



Q: Is there any responsibility upon the reporter of the ADR?

A: We would like to confirm that there is no responsibility upon the reporter of the ADR, also the information in the report is confidential and totally protected including both patient and reporter identity. Moreover, this voluntarily reporting help to evaluate the safety of the drugs marketed in our country.



Q: What is the importance of reporting ADR?

A: We would like to confirm that there is no responsibility upon the reporter of the ADR, also the information in the report is confidential and totally protected including both patient and reporter identity. Moreover, this voluntarily reporting help to evaluate the safety of the drugs marketed in our country.



Q: What is the importance of reporting ADR?

A: Any drug is registered based on clinical trial data which proves its efficacy and short term safety. These trials have several limitations, including: restricted number of participants, short durations, highly selected inclusion/exclusion criteria, restricted protocol. All these necessitate post marketing pharmacovigilance, and to stay vigilant for all drugs that are marketed.