Pharmacovigilance

 
When medicine is released into the market there is a lot to be learned about its safety and efficacy. Pharmacovigilance is a legal obligation for all MAHs and is subject to strict requirements under national legislation. To protect patient safety in the dispensing and utilization of specialized medications.

What is pharmacovigilance?

According to the World Health Organization, pharmacovigilance is defined as: 

“…the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”  Essentially, it is drug safety. Pharmacovigilance ensures the rigorous testing of clinical drugs to improve patient care and reduce the risk of negative side effects. Present throughout the drug lifecycle, PV certifies whether a drug works and if it is safe to use.

What is an adverse event?

An adverse event is a negative reaction caused by taking a drug, more commonly known as a side effect. This can include any unexpected or unwanted symptoms experienced by the patient, including temporary reactions and those previously not associated with that drug.

A serious adverse event is a reaction that causes life-threatening harm to the individual, resulting in hospitalisation, significant disability or incapacitation, congenital abnormality, or at worst, death. Anything that requires intervention to prevent these is also classified as serious. In any case, adverse event reporting is compulsory and critical to the success of PV.

Why we report?

The purpose of reporting  is to provide an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about

To report any side effect

National Parmacovigilance Center (NPC)

Saudi Food and Drug Authority-Drug sector

Email: Npc.drug@sfda.gov.sa

Online: http://ade.sfda.gov.sa

Call NPC at +966-1-2759222
Ext : 2317 -2356- 2353-2354- 2334-2340
Fax:+966-1-2057662

Mail:

National Parmacovigilance Center (NPC)
Saudi Food and Drug Authority-Drug sector
3292 Northern Ring Road
ALNafal district
Riyadh 13312 – 2688
Kingdom of Saudi Arabia

 

Pharmacovigilance Department in Avicenna IHS

• Tel: +966-11- 205 5636
• Email: info@avicenna-ihs.com

Or:
In case of experiencing any side effect while using any of Avicenna IHS medications please fill our ADR Report.

Please download the our ADR report here