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      Patterns of adverse drug reactions (ADRs) in Saudi Arabia.

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          Abstract

          Pharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded.

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          Multiple sclerosis in the real world: A systematic review of fingolimod as a case study.

          Tjalf Ziemssen, Catherine Mitchell, C. Couto … (2017)
          The aim of our study was to systematically review the growing body of published literature reporting on one specific multiple sclerosis (MS) treatment, fingolimod, in the real world to assess its effectiveness in patients with MS, evaluate methodologies used to investigate MS in clinical practice, and describe the evidence gaps for MS as exemplified by fingolimod.
          Article 0 comments Cited 29 times – based on 0 reviews     Review now
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            Pharmacovigilance in Italy: An overview

            Carmela Mazzitello, Stefania Esposito, Adele E. De Francesco … (2013)
            Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy. Materials and Methods: The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Results: The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs. Conclusion: A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.
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              Incidence of adverse drug events and medication errors in Japan: the JADE study.

              Atsushi Hiraide, Jinichi Toshiro, D Bates … (2011)
              The epidemiology of adverse drug events (ADEs) and medication errors has received little evaluation outside the U.S. and Europe, and extrapolating from these data might not be valid, especially regarding selecting and prioritizing solutions. To assess the incidence and preventability of ADEs and medication errors in Japan. The Japan Adverse Drug Events (JADE) study was a prospective cohort study. A cohort of 3,459 adults admitted to a stratified random sample of seven medical and eight surgical wards and three intensive care units in three tertiary care hospitals over 6 months. We measured ADE and medication error rates from daily reviews of charts, laboratories, incident reports, and prescription queries by on-site reviewers; presence of a signal was considered an incident. Two independent physicians reviewed incidents to determine whether they were ADEs or medication errors and to assess severity and preventability. We identified 1,010 ADEs and 514 medication errors (incidence: 17.0 and 8.7 per 1,000 patient-days, respectively) during the study period. Among ADEs, 1.6%, 4.9% and 33% were fatal, life-threatening and serious, respectively. Among ADEs, 14% were preventable. The rate per admission was 29 per 100 admissions, higher than in U.S. studies because associated with of the long length of hospital stay in Japan (mean, 17 days). The epidemiology and nature of ADEs and medication errors in Japan were similar to other countries, although more frequent per admission. Solutions that worked in these countries might thus improve medication safety in Japan, as could shortening hospital length of stay.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): Saudi Pharm J
                Title: Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society
                Publisher: Elsevier BV
                ISSN: 1319-0164
                ISSN (Print): 1319-0164
                Publication date (Electronic): Jan 2022
                Volume: 30
                Issue: 1
                Affiliations
                [1 ] Department of Epidemiology and Biostatistics, College of Public Health and Health Informatics, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
                [2 ] Drug Sector, Saudi Food and Drug Authority, Riyadh, Kingdom of Saudi Arabia.
                [3 ] King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
                [4 ] First Riyadh Health Cluster, Ministry of Health, Riyadh, Saudi Arabia.
                [5 ] Alfaisal University, Riyadh, Saudi Arabia.
                Article
                Publisher Item ID: S1319-0164(21)00161-4
                DOI: 10.1016/j.jsps.2021.08.014
                PMC ID: 8802091
                PubMed ID: 35145342
                SO-VID: aa1f85d2-bf90-4ae3-bfa6-a1fed699398d
                History

                Keywords: Saudi Arabia,SFDA,Pharmacovigilance,Adverse drug reactions
                Data availability:
                Keywords: Saudi Arabia, SFDA, Pharmacovigilance, Adverse drug reactions

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