Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East

References

• Ahuja V, Sharma V. Training in post-authorization pharmacovigilance. Perspect Clin Res. 2010;1(2):70–75.
   PubMedGoogle Scholar
• Talbot J, Nilsson B. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 1998;45(5):427–431.
   PubMed Web of Science ®Google Scholar
• Alsalimy N, Elkhalifa D, Shammaa A, et al. Characteristics and quality of adverse drug reaction reporting: a comparison of pharmacists with other healthcare providers at a multi-specialty hospital in Qatar. Drugs Ther Perspect. 2017;33(6):283–289.
   Google Scholar
• Toki T, Ono S. Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: a comparison between consumer reports and healthcare professional reports. J Clin Pharm Ther. 2019;45(3):462–469.
   PubMed Web of Science ®Google Scholar
• Niu R, Xiang Y, Wu T, et al. The quality of spontaneous adverse drug reaction reports from the pharmacovigilance center in western China. Expert Opin Drug Saf. 2019;18(1):51–58.
   PubMed Web of Science ®Google Scholar
• Hauben M, Bate A. Decision support methods for the detection of adverse events in post-marketing data. Drug Discov Today. 2009;14(7–8):343–357.
   PubMed Web of Science ®Google Scholar
• Bergvall T, Norén GN, Lindquist M. vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014;37(1):65–77.
   PubMed Web of Science ®Google Scholar
• Durrieu G, Jacquot J, Mège M, et al. Completeness of spontaneous adverse drug reaction reports sent by general practitioners to a regional pharmacovigilance centre: a descriptive study. Drug Saf. 2016;39(12):1189–1195.
   PubMed Web of Science ®Google Scholar
• Tsuchiya M, Obara T, Miyazaki M, et al. The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade. Int J Clin Pharm. 2020;42:728–736.
   PubMed Web of Science ®Google Scholar
• Alshammari TM, Mendi N, Alenzi KA, et al. Pharmacovigilance systems in Arab countries: overview of 22 Arab countries. Drug Saf. 2019;42(7):849–868.
   PubMed Web of Science ®Google Scholar
• Plessis L, Gómez A, García N, et al. Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal detection. Eur J Clin Pharmacol. 2017;73(6):751–758.
   PubMed Web of Science ®Google Scholar
• Oh I-S, Baek Y-H, Kim H-J, et al. Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. PLoS One. 2019;14(2):e0212336.
   PubMed Web of Science ®Google Scholar
• Crepin S, Villeneuve C, Merle L. Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal. Pharmacoepidemiol Drug Saf. 2016;25(6):719–723.
   PubMed Web of Science ®Google Scholar
• Muñoz MA, Delcher C, Dal Pan GJ, et al. Impact of a new consumer form on the quantity and quality of adverse event reports submitted to the United States Food and Drug Administration. Pharmacotherapy. 2019;39(11):1042–1052.
   PubMed Web of Science ®Google Scholar
• Hotwani J, Rambhia D, Mehta M. Evaluation of completeness of adverse drug reaction case reports published in biomedical journals: a preliminary analysis. J Med Res. 2018;4(2):98–101.
   Google Scholar
• Tsuchiya M, Obara T, Sakai T, et al. Quality evaluation of the Japanese Adverse Drug Event Report database (JADER). Pharmacoepidemiol Drug Saf. 2019;29(2):173–181.
   PubMed Web of Science ®Google Scholar
• Moore TJ, Furberg CD, Mattison DR, et al. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016;25(6):713–718.
   PubMed Web of Science ®Google Scholar
• Joubert M, Naidoo P. Knowledge, perceptions and practices of pharmacovigilance amongst community and hospital pharmacists in a selected district of North West Province, South Africa. Health SA. 2016;21(1):238–244.
   Google Scholar
• Jokinen JD, Walley RJ, Colopy MW, et al. Pooling different safety data sources: impact of combining solicited and spontaneous reports on signal detection in pharmacovigilance. Drug Saf. 2019;42(10):1191–1198.
   PubMed Web of Science ®Google Scholar
• Ball G, Reblin T, Buchanan J, et al. A framework for safety evaluation throughout the product development life-cycle. Ther Innov Regul Sci. 2019;54:821–830.
   PubMed Web of Science ®Google Scholar
• Aronson JK. Post-marketing drug withdrawals: pharmacovigilance success, regulatory problems. Therapie. 2017;72(5):555–561.
   PubMed Web of Science ®Google Scholar
• Post-marketing reporting of adverse drug reactions to human medicines in South Africa [Internet]. Pretoria (South Africa): South African Health Products Regulatory Authority; 2020 Jan 31 [cited 2020 Dec 18]. Available from: http://www.sahpra.org.za/wp-content/uploads/2020/03/2.33_ADR_reporting_postmarketing_v6_Jan2020.pdf
   Google Scholar
• Good pharmacovigilance practices [Internet]. Amstedam (The Netherlands): European Medicine Agency; c1995-2021 [cited 2021 Jan 28]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorization/pharmacovigilance/good-pharmacovigilance-practices#final-gvp-modules-section
   Google Scholar
• The importance of pharmacovigilance [Internet]. United Kingdom: World Health Organization; c2002 [cited 2021 Apr 09]. Available from: http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf
   Google Scholar
• Felix T, Jordan JB, Akers C, et al. Current state of biologic pharmacovigilance in the European Union: improvements are needed. Expert Opin Drug Saf. 2019;18(3):231–240.
   PubMed Web of Science ®Google Scholar
• Wakao R, Taavola H, Sandberg L, et al. Data-driven identification of adverse event reporting patterns for Japan in vigibase, the WHO global database of individual case safety reports. Drug Saf. 2019;42(12):1487–1498.
   PubMed Web of Science ®Google Scholar
• Fernandez-Fernandez C, Lázaro-Bengoa E, Fernández-Antón E, et al. Quantity is not enough: completeness of suspected adverse drug reaction reports in Spain—differences between regional pharmacovigilance centers and pharmaceutical industry. Eur J Clin Pharmacol. 2020;76(8):1175–1181.
   PubMed Web of Science ®Google Scholar
• Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the international diabetes federation diabetes atlas. Diabetes Res Clin Pract. 2019;157:e107843.
   PubMed Web of Science ®Google Scholar
• Gabriel MH, Atkins D, Chisholm L, et al. Adverse events among patients with diabetes and ambulatory practice characteristics: evidence from a nationally representative survey. SAGE Open. 2018;8(2):art # 2158244018782732.
   Web of Science ®Google Scholar
• Razavi-Nematollahi L, Ismail-Beigi F. Adverse effects of glycemia-lowering medications in type 2 diabetes. Curr Diab Rep. 2019;19(11):art # 132.
   PubMed Web of Science ®Google Scholar
• Mohan V, Khunti K, Chan SP, et al. Management of type 2 diabetes in developing countries: balancing optimal glycaemic control and outcomes with affordability and accessibility to treatment. Diabetes Ther. 2020;11(1):15–35.
   PubMed Web of Science ®Google Scholar
• IDF diabetes atlas 2019: ninth Edition [Internet]. International Diabetes Federation. [cited 2020 Mar 26]. Available from: https://diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf#page=42&zoom=auto
   Google Scholar
• Masuka JT, Khoza S. Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded program on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase® from 1997 to 2017. BMC Public Health. 2019;19(1):art # 1166.
   PubMed Web of Science ®Google Scholar
• Masuka JT, Khoza S. An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme. Pharmacol Res Perspect. 2020;8(5):e00657.
   PubMed Web of Science ®Google Scholar
• About Novo Nordisk [Internet]. Bagsværd (Denmark): Novo Nordisk; c2022 [cited 2022 Feb 17]. Available from: https://www.novonordisk.com/about-novo-nordisk.html
   Google Scholar
• Wallace S, Myles PS, Zeps N, et al. Serious adverse event reporting in investigator‐initiated clinical trials. Med J Aust. 2016;204(6):231–233.
   PubMed Web of Science ®Google Scholar
• Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen. 2012;141(1):2–18.
   PubMed Web of Science ®Google Scholar
• Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013;4:art # 863.
   PubMed Web of Science ®Google Scholar
• IBM Corp. IBM SPSS Statistics for Windows. 27.0. Armonk (NY): IBM Corp; 2020.
   Google Scholar
• Physicians per 1000 people 2021 [Internet]. The World Bank; c2021 [cited 2021 Feb 16]. Available from: https://data.worldbank.org/indicator/SH.MED.PHYS.ZS
   Google Scholar
• Terblanche A, Meyer JC, Godman B, et al. Knowledge, attitudes and perspective on adverse drug reaction reporting in a public sector hospital in South Africa: baseline analysis. Hosp Pract. 2017;45(5):238–245.
   PubMedGoogle Scholar
• Bigi C, Bocci G. The key role of clinical and community health nurses in pharmacovigilance. Eur J Clin Pharmacol. 2017;73(11):1379–1387.
   PubMed Web of Science ®Google Scholar
• Kassa B, Mulu A, Geresu B. Health care providers knowledge, attitude and experience of adverse drug reaction reporting. Afr J Pharm Pharmacol. 2017;11(31):362–367.
   Google Scholar
• Abu Hammour K, El‐Dahiyat F, Abu Farha R. Health care professionals knowledge and perception of pharmacovigilance in a tertiary care teaching hospital in Amman, Jordan. J Eval Clin Pract. 2017;23(3):608–613.
   PubMed Web of Science ®Google Scholar
• Rolfes L, van Hunsel F, van der Linden L, et al. The quality of clinical information in adverse drug reaction reports by patients and healthcare professionals: a retrospective comparative analysis. Drug Saf. 2017;40(7):607–614.
   PubMed Web of Science ®Google Scholar
• Khan A, Coffey M, Litterer KP, et al. Families as partners in hospital error and adverse event surveillance. JAMA Pediatr. 2017;171(4):372–381.
   PubMed Web of Science ®Google Scholar
• Serebruany VL, Cherepanov V, Kim MH, et al. Filing sources after oral P2Y12 platelet inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS). Cardiology. 2017;138(4):249–253.
   PubMed Web of Science ®Google Scholar
• Inácio P, Gomes JJ, Airaksinen M, et al. Exploring sociodemographic and economic factors that promote adverse drug reactions reporting by patients. Health Policy. 2018;122(3):263–268.
   PubMed Web of Science ®Google Scholar
• Fadini GP, Bonora BM, Avogaro A. SGLT2 inhibitors and diabetic ketoacidosis: data from the FDA adverse event reporting system. Diabetologia. 2017;60(8):1385–1389.
   PubMed Web of Science ®Google Scholar
• Harinstein L, Kalra D, Kortepeter CM, et al. Evaluation of postmarketing reports from industry-sponsored programs in drug safety surveillance. Drug Saf. 2019;42(5):649–655.
   PubMed Web of Science ®Google Scholar
• Abidli Z, Jadda S, Ammor S, et al. Development and validation of a questionnaire on pharmacovigilance knowledge among health professionals in Morocco. J Young Pharm. 2019;11(4):391–394.
   Web of Science ®Google Scholar
• Bogolubova S, Padayachee N, Schellack N. Knowledge, attitudes and practices of nurses and pharmacists towards adverse drug reaction reporting in the South African private hospital sector. Health SA. 2018;23:a1064.
   PubMedGoogle Scholar
• Said ASA, Hussain N. Adverse drug reaction reporting practices among United Arab Emirates pharmacists and prescribers. Hosp Pharm. 2017;52(5):361–366.
   PubMedGoogle Scholar
• Avong YK, Jatau B, Gurumnaan R, et al. Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, tuberculosis and malaria: a prospective cohort study. PLoS One. 2018;13(8):e0200810.
   PubMed Web of Science ®Google Scholar
• Terblanche A, Meyer JC, Godman B, et al. Impact of a pharmacist-driven pharmacovigilance system in a secondary hospital in the Gauteng Province of South Africa. Hosp Pract. 2018;46(4):221–228.
   PubMedGoogle Scholar
• Ndagije HB, Manirakiza L, Kajungu D, et al. The effect of community dialogues and sensitization on patient reporting of adverse events in rural Uganda: uncontrolled before-after study. PLoS One. 2019;14(5):e0203721.
   PubMed Web of Science ®Google Scholar
• Jokinen J, Bertin D, Donzanti B, et al. Industry assessment of the contribution of patient support programs, market research programs, and social media to patient safety. Ther Innov Regul Sci. 2019;53(6):736–745.
   PubMed Web of Science ®Google Scholar
• Lee I, Jokinen JD, Crawford SY, et al. Exploring completeness of adverse event reports as a tool for signal detection in pharmacovigilance. Ther Innov Regul Sci. 2020;55(1):142–151.
   PubMed Web of Science ®Google Scholar