Saudi Vigilance Program: Challenges and lessons learned

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-relate...

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Main Authors: Adel Alharf, Nasser Alqahtani, Ghazi Saeed, Ali Alshahrani, Mubarak Alshahrani, Nasser Aljasser, Mohammed Alquwaizani, Saleh Bawazir
Format: Article
Language:English
Published: Elsevier 2018-03-01
Series:Saudi Pharmaceutical Journal
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S131901641830001X
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author Adel Alharf
Nasser Alqahtani
Ghazi Saeed
Ali Alshahrani
Mubarak Alshahrani
Nasser Aljasser
Mohammed Alquwaizani
Saleh Bawazir
author_facet Adel Alharf
Nasser Alqahtani
Ghazi Saeed
Ali Alshahrani
Mubarak Alshahrani
Nasser Aljasser
Mohammed Alquwaizani
Saleh Bawazir
author_sort Adel Alharf
collection DOAJ
description Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program’s performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.
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spelling doaj.art-4886723faf0640beaccb1fe913db6ffa2022-12-22T03:53:52ZengElsevierSaudi Pharmaceutical Journal1319-01642018-03-0126338839510.1016/j.jsps.2018.01.002Saudi Vigilance Program: Challenges and lessons learnedAdel Alharf0Nasser Alqahtani1Ghazi Saeed2Ali Alshahrani3Mubarak Alshahrani4Nasser Aljasser5Mohammed Alquwaizani6Saleh Bawazir7Saudi Food and Drug Authority, Saudi Arabia; Corresponding author.Saudi Food and Drug Authority, Saudi ArabiaSaudi Food and Drug Authority, Saudi ArabiaSaudi Food and Drug Authority, Saudi ArabiaSaudi Food and Drug Authority, Saudi ArabiaSaudi Food and Drug Authority, Saudi ArabiaSaudi Food and Drug Authority, Saudi ArabiaKing Saud University, Saudi ArabiaPharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program’s performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.http://www.sciencedirect.com/science/article/pii/S131901641830001XPharmacovigilanceSaudi Vigilance ProgramSaudi Food and Drug Authority
spellingShingle Adel Alharf
Nasser Alqahtani
Ghazi Saeed
Ali Alshahrani
Mubarak Alshahrani
Nasser Aljasser
Mohammed Alquwaizani
Saleh Bawazir
Saudi Vigilance Program: Challenges and lessons learned
Saudi Pharmaceutical Journal
Pharmacovigilance
Saudi Vigilance Program
Saudi Food and Drug Authority
title Saudi Vigilance Program: Challenges and lessons learned
title_full Saudi Vigilance Program: Challenges and lessons learned
title_fullStr Saudi Vigilance Program: Challenges and lessons learned
title_full_unstemmed Saudi Vigilance Program: Challenges and lessons learned
title_short Saudi Vigilance Program: Challenges and lessons learned
title_sort saudi vigilance program challenges and lessons learned
topic Pharmacovigilance
Saudi Vigilance Program
Saudi Food and Drug Authority
url http://www.sciencedirect.com/science/article/pii/S131901641830001X
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AT nasseralqahtani saudivigilanceprogramchallengesandlessonslearned
AT ghazisaeed saudivigilanceprogramchallengesandlessonslearned
AT alialshahrani saudivigilanceprogramchallengesandlessonslearned
AT mubarakalshahrani saudivigilanceprogramchallengesandlessonslearned
AT nasseraljasser saudivigilanceprogramchallengesandlessonslearned
AT mohammedalquwaizani saudivigilanceprogramchallengesandlessonslearned
AT salehbawazir saudivigilanceprogramchallengesandlessonslearned