Article
Medical Informatics
Ayako Fukushima, Noha Iessa, Madhava Ram Balakrishnan, Shanthi Narayan Pal
Summary: This study systematically assessed smartphone ADR-reporting applications and their impact on ADR reporting. The findings suggest that smartphone apps offer added value compared to conventional reporting tools. Factors such as user type and user environment influence app usage.
BMC MEDICAL INFORMATICS AND DECISION MAKING
(2022)
Article
Chemistry, Medicinal
Anne T. M. Dittrich, Nori J. L. Smeets, Emma F. M. de Jong, Juliet L. Kamink, Yvet Kroeze, Jos M. Th Draaisma, Eugene P. van Puijenbroek, D. Maroeska W. M. te Loo
Summary: Knowledge about adverse drug reactions (ADRs) is crucial for drug safety in pediatric patients, but underreporting of ADRs is a serious problem. This study aimed to increase the quantity of ADR reporting while maintaining or improving the quality. By educating healthcare providers and introducing an active supporting system, the quantity of ADR reports significantly increased without compromising the quality. This study suggests that an active reporting system has the potential to enhance our knowledge about ADRs in pediatric patients.
Article
Pharmacology & Pharmacy
Michael O. Reumerman, Jelle Tichelaar, Milan C. Richir, Michiel A. van Agtmael
Summary: The study demonstrates that medical students are capable of effectively screening and reporting adverse drug reactions in hospitalized patients, identifying and reporting some previously undetected serious ADRs, and assisting in optimizing the treatment of ADRs to a certain extent.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Review
Public, Environmental & Occupational Health
Joel Fossouo Tagne, Reginald Amin Yakob, Thu Ha Dang, Rachael Mcdonald, Nilmini Wickramasinghe
Summary: Despite existing national and international guidelines, there is significant variability in the standards of adverse drug reaction (ADR) reporting among healthcare facilities. There is room for improvement in ADR reporting rates among consumers and healthcare professionals. A thorough assessment of barriers and enablers to ADR reporting at the primary healthcare level is necessary, and interventions such as the black triangle scheme and GuildLink may benefit from further improvement and awareness programs.
JMIR PUBLIC HEALTH AND SURVEILLANCE
(2023)
Article
Pharmacology & Pharmacy
Lara Magro, Elena Arzenton, Roberto Leone, Marilisa Giustina Stano, Michele Vezzaro, Annette Rudolph, Irene Castagna, Ugo Moretti
Summary: The study found that about one-third of patients exposed to potential drug-drug interactions actually experienced serious adverse drug reactions, and that a spontaneous reporting database can be used to identify and describe ADRs caused by drug-drug interactions. Among these ADRs, warfarin was the most frequently reported interacting drug and the most common ADRs were gastrointestinal or cerebral hemorrhagic events.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Medicine, General & Internal
Laura Lopez-Valverde, Elia Domenech, Marc Roguera, Ignasi Gich, Magi Farre, Carlos Rodrigo, Eva Montane
Summary: The study analyzed spontaneously reported ADRs in pediatric patients between 2010 and 2020, finding that nervous system disorders were the most common type of ADR in pediatric patients, and medication errors were more frequent in patients under two years of age.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Health Care Sciences & Services
Andreas Sandberg, Veera Salminen, Susanna Heinonen, Mia Siven
Summary: The study found that healthcare professionals in Finland have under-reporting issues when it comes to reporting adverse drug reactions (ADRs), mainly due to the reactions being already known or unclear reporting procedures. Training, information campaigns, and reporting reminders can help enhance ADR reporting rates.
Article
Medicine, General & Internal
Zhigang Zhao, Jiashu Shen, Chuanyong Shen, Bin Zhu, Jun Sun, Jinyang Yu, Feng Sun, Haibo Song
Summary: Chinese healthcare professionals generally have good awareness of pharmacovigilance, and pharmacovigilance is relatively more advanced in China compared to other developing countries.
CURRENT MEDICAL RESEARCH AND OPINION
(2021)
Article
Pharmacology & Pharmacy
Faris El-Dahiyat, Khawla Abu Hammour, Rana Abu Farha, Qusai Manaseer, Ala'a Al Momanee, Aya Allan, Rama Alkhawaldeh
Summary: The study aimed to evaluate the knowledge, attitudes, and practice of the general public regarding Adverse Drug Reactions (ADRs) reporting and pharmacovigilance in Jordan. A survey was conducted using social media platforms, and the results showed that the participants had fair knowledge about ADRs but lacked awareness of the Jordan National Pharmacovigilance Centre (JNPC). Therefore, educational activities and intervention programs are needed to raise awareness about the JNPC and ensure safe medication use in Jordan.
SAUDI PHARMACEUTICAL JOURNAL
(2023)
Article
Pharmacology & Pharmacy
Haona Li, Jianxiong Deng, Peiming Yu, Xuequn Ren
Summary: This study analyzed individual case safety reports (ICSRs) with an outcome of death to characterize drug-related deaths in China. The results showed that young children, elderly patients, and female patients aged 20-34 years have a higher risk of drug-related deaths. Further research on the safe use of drugs for these populations is recommended.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Public, Environmental & Occupational Health
Malahat Khalili, Bita Mesgarpour, Hamid Sharifi, Asieh Golozar, Ali Akbar Haghdoost
Summary: The study analyzes the reporting and trend of Adverse Drug Reactions (ADRs) from 1999 to 2017 in the Iranian Pharmacovigilance Center, estimating a considerable underreporting rate of ADRs. Despite an increasing trend in ADR reporting over the 19 years, there is still a significant proportion of ADRs going unreported.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
(2021)
Article
Pharmacology & Pharmacy
Dongxuan Li, Jinghui Gou, Jun Zhu, Tongyan Zhang, Feng Liu, Daojun Zhang, Liyang Dai, Wenjun Li, Qinglong Liu, Chunmeng Qin, Qian Du, Songqing Liu
Summary: This study provides a comprehensive landscape of culprit-drugs for severe cutaneous adverse reactions (SCARs) by analyzing reports from the FDA Adverse Event Reporting System database. It reveals the risk characteristics of different drugs and may help optimize patient management.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Meiwen van der Boom, Florence van Hunsel
Summary: The vaccination campaign for monkeypox virus in the Netherlands resulted in the collection of adverse event reports related to the vaccine. The majority of these reports were focused on injection site reactions and general systemic reactions, which aligns with the manufacturer's product information.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
M. Reumerman, J. Tichelaar, M. C. Richir, M. A. van Agtmael
Summary: By establishing a Junior-Adverse Drug Event Managers (J-ADEMs) team, medical students showed improved competence in managing and reporting ADRs, with patients recognizing the importance of their ADRs being reported. This intervention was seen as a win-win-win approach, benefiting patients, physicians, and students, by enhancing pharmacovigilance skills and improving ADR detection and management in hospitals.
NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
(2021)
Article
Oncology
Zhiming Jiao, Zhanchun Feng, Ziqi Yan, Jinwen Zhang, Gang Li, Ganyi Wang, Qianyu Wang, Da Feng
Summary: This study collected 431 ADR reports related to antineoplastic drugs in pediatric patients, finding that myelosuppression was the most frequent ADR. The median age of patients was six years, with higher reporting rates in the age group of 1-3 years. Three off-label ADRs were identified through signal mining, calling for further research and attention.
FRONTIERS IN ONCOLOGY
(2021)
Letter
Medicine, General & Internal
Sophie H. Bots, Michelle M. Schreuder, Jeanine E. Roeters van Lennep, Sarah Watson, Eugene van Puijenbroek, N. Charlotte Onland-Moret, Hester M. den Ruijter
Article
Pharmacology & Pharmacy
Nafise Ghalandari, Hubertina J. M. J. Crijns, Jorieke E. H. Bergman, Radboud J. E. M. Dolhain, Eugene P. van Puijenbroek, Johanna M. W. Hazes
Summary: The study evaluated the impact of different non-TNFi biologics on congenital malformations, showing that except for belimumab and vedolizumab, the association with other drugs was not significant.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Review
Public, Environmental & Occupational Health
Bastiaan T. G. M. Sallevelt, Toine C. G. Egberts, Corlina J. A. Huibers, Jimmy Ietswaart, A. Clara Drenth-van Maanen, Emma Jennings, Cian O'Mahony, Katharina Tabea Jungo, Martin Feller, Nicolas Rodondi, Francois-Xavier Sibille, Anne Spinewine, Eugene P. van Puijenbroek, Ingeborg Wilting, Wilma Knol
Summary: The study aimed to assess the detectability of medication errors (MEs) with a STOPP/START-based in-hospital medication review in older people with polypharmacy and multimorbidity prior to a potentially preventable drug-related hospital admission (DRA). The results showed that a significant portion of MEs were not detectable during the medication review, and the recommendations made during the review were not implemented.
Article
Pharmacology & Pharmacy
Lieke H. Roest, Leanne J. Kosse, Jette A. van Lint, Helen R. Gosselt, Joep H. G. Scholl, Eugene van Puijenbroek, Harald E. Vonkeman, Sander W. Tas, Michael T. Nurmohamed, Bart J. F. van den Bemt, Naomi T. Jessurun
Summary: The study compared patient-reported adverse drug reactions (ADRs) attributed to adalimumab and etanercept between different inflammatory rheumatic diseases (IRDs). The results showed no significant differences in ADR frequencies and nature between different IRDs. However, the use of etanercept, combination therapy, and age were found to influence the risk of reporting specific ADRs.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Chemistry, Medicinal
Anne T. M. Dittrich, Nori J. L. Smeets, Emma F. M. de Jong, Juliet L. Kamink, Yvet Kroeze, Jos M. Th Draaisma, Eugene P. van Puijenbroek, D. Maroeska W. M. te Loo
Summary: Knowledge about adverse drug reactions (ADRs) is crucial for drug safety in pediatric patients, but underreporting of ADRs is a serious problem. This study aimed to increase the quantity of ADR reporting while maintaining or improving the quality. By educating healthcare providers and introducing an active supporting system, the quantity of ADR reports significantly increased without compromising the quality. This study suggests that an active reporting system has the potential to enhance our knowledge about ADRs in pediatric patients.
Article
Pharmacology & Pharmacy
Leontine van Balveren, Eugene P. van Puijenbroek, Linda Davidson, Florence van Hunsel
Summary: Reactivation of BCG scar is observed after COVID-19 vaccination with mRNA and viral vector vaccines, characterized by erythema and pain within a few days. The exact mechanism remains unknown, but heat shock protein 65 may be involved.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Public, Environmental & Occupational Health
Ingrid Oosterhuis, Joep Scholl, Eugene van Puijenbroek, Agnes Kant, Florence van Hunsel
Summary: Due to the large-scale COVID-19 vaccination campaign, the Dutch PV Centre Lareb developed a dedicated system to enable near real-time vaccine safety monitoring. Through automated processing and daily triage, 99.9% of the Individual Case Safety Reports (ICSRs) were processed within the compliance timeframe, and signal detection was performed during the campaign.
Article
Rheumatology
Nafise Ghalandari, Hubertina J. M. J. Crijns, Radboud J. E. M. Dolhain, Johanna M. W. Hazes, Eugene P. van Puijenbroek
Summary: This study compared fetal outcomes in SLE patients who stopped versus continued belimumab treatment during pregnancy. The results showed no statistical difference in fetal death rate between the two groups, suggesting that continuing belimumab during pregnancy is feasible.
Article
Pharmacology & Pharmacy
C. A. M. Hartwig, R. Robiyanto, S. de Vos, J. H. J. Bos, E. P. van Puijenbroek, E. Hak, C. C. M. Schuiling-Veninga
Summary: This study investigates the association between antidepressant use during pregnancy and the risk of ADHD in offspring, using a case-control sibling study. The results suggest that in utero exposure to antidepressants does not increase the risk of ADHD in children.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Oncology
Jette A. van Lint, Naomi T. Jessurun, Sander W. Tas, Harald E. Vonkeman, Martijn B. A. van Doorn, Frank Hoentjen, Michael T. Nurmohamed, Eugene P. van Puijenbroek, Bart J. F. van den Bemt
Summary: This study describes the pattern and characteristics of fatigue as an adverse drug reaction of biologics in IMID patients, and compares patient and treatment characteristics with patients reporting other ADRs or no ADRs.
Article
Public, Environmental & Occupational Health
Jonathan L. Richardson, Alan Moore, Rebecca L. Bromley, Michael Stellfeld, Yvonne Geissbuehler, Matthew Bluett-Duncan, Ursula Winterfeld, Guillaume Favre, Amalia Alexe, Alison M. Oliver, Yrea R. J. van Rijt-Weetink, Kenneth K. Hodson, Bita Rezaallah, Eugene P. van Puijenbroek, David J. Lewis, Laura M. Yates
Summary: This article describes the development of a reference framework for collecting core data elements in pregnancy pharmacovigilance studies, aiming to improve the speed and quality of evidence-based statements about the safety of medication use during pregnancy.
Article
Psychiatry
Robiyanto Robiyanto, Marjolein Roos, Jens H. J. Bos, Eelko Hak, Eugene P. van Puijenbroek, Catharina C. M. Schuiling-Veninga
Summary: The study examines the switching pattern and dose adjustment of antidepressants prescribed to pregnant women in the Netherlands. The continuation rates for antidepressant users increased over time, while the switching rate remained consistently low. Most women prefer to continue their antidepressant medication rather than switch during pregnancy.
ARCHIVES OF WOMENS MENTAL HEALTH
(2023)
Article
Multidisciplinary Sciences
Renee Veldkamp, Karin Hek, Rinske van den Hoek, Laura Schackmann, Eugene van Puijenbroek, Liset van Dijk
Summary: A population-based COVID-19 cohort was established in the Netherlands to comprehensively understand the short- and long-term effects of COVID-19 in the general population. The cohort recruited participants through electronic health records and questionnaires, providing a complete image of the severity of symptoms and healthcare usage during the acute phase of COVID-19.
Review
Rheumatology
Barbara J. M. Bergmans, Biniyam Y. Gebeyehu, Eugene P. van Puijenbroek, Katrijn Van Deun, Bennett Kleinberg, Jean-Luc Murk, Esther de Vries
Summary: This study aimed to provide an integrated overview of infections in rheumatoid arthritis (RA) patients using biological or targeted synthetic drugs, and identify potential predictors of infection risk. The study found that the proportion of patients experiencing any kind of infection was high, while the proportion of serious infections was low. However, there was significant heterogeneity in infection risk and no consistent predictors were identified. Future studies should use a standardized method of reporting infectious adverse events and focus on non-serious infections and their impact on treatment decisions and quality of life.
RHEUMATOLOGY AND THERAPY
(2023)
Article
Geriatrics & Gerontology
Nikki M. F. Noorda, Bastiaan T. G. M. Sallevelt, Wivien L. Langendijk, Toine C. G. Egberts, Eugene P. van Puijenbroek, Ingeborg Wilting, Wilma Knol
Summary: The ADR trigger tool had a positive predictive value of 41.8%, but usual care already recognized the majority of ADRs, especially possible and certain ones. Its implementation is unlikely to improve the detection of unrecognized ADRs in older patients acutely admitted to the geriatric ward.
EUROPEAN GERIATRIC MEDICINE
(2022)