What is pharmacovigilance?

Pharmacovigilance is defined as “The science and activities relating to the detection, assessment , understanding and prevention of adverse effects or any other drug-related problems”.


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”.


What is side effect?

Side effect defined as “any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug.


What are the advantages of ADRs reporting system?

  • Reduces drug-related problems leading to better treatment outcome.
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  • Improves the quality of care offered to patients
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  • Improves patient confidence in professional practice
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  • Is a cost effective method of monitoring the safety of medicinal products throughout its lifetime
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  • Remains the primary method of data –collection used in most countries
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  • Is an easy and fast way to submit an urgent health related issues.
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  • Provides feedback information on drug related problems reported nationally and internationally

Will reporting have any negative consequences on you as a healthcare professional and your patient?

Sometimes you as a healthcare professional fear that reporting ADRs may reflect negatively on your competence or put you at risk of litigation. Therefore you and your patient’s identify are held in strict confidence by SFDA and protected to the fullest extent of low, and will not be used in any way against you. The information obtained from your report shall be used to promote safe use of medicines in Saudi Arabia.


What should be reported?

All Adverse reactions that might be related to use of medicines, vaccines, herbal products and cosmetics.

Report ADRs on any of the following:

  • All suspected reactions for new drugs including minor ones
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  • All serious and/or unexpected reactions for well-known drugs
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  • Any increased in frequency of a given reaction.
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  • All suspected ADRs associated with drug-food or drug-herb or food supplement interactions.
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  • All reactions in special populations such as pregnant and breast feeding women, children and elderly
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  • When suspected ADRs are associated with drug withdrawals
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  • Any other situation where you believe it needs to be reported.

Who can report?

All healthcare professionals including physicians, dentists,pharmacist,nurses and others, as well as patiens, should report ADRs to the national pharmacovigilance center.


How to report ADRs?

Fill ADRs reporting from and send it to Saudi Food and Drug Authority through the following:

Online:www.sfda.gov.sa
E-mail:npc.drug@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