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
Health Care Sciences & Services
Warisara Srisuriyachanchai, Anthony R. Cox, Narumol Jarernsiripornkul
Summary: This study investigated the practices, barriers, and attitudes of healthcare professionals (HCPs) towards monitoring and reporting severe adverse drug reactions (ADRs). The results showed variations in ADR monitoring practices among different professions, and identified barriers to ADR reporting. Improving knowledge and cooperation among HCPs is essential to overcome these barriers.
Article
Medicine, General & Internal
Dina Mohamed Ibrahim, May Ahmed Shawki, Mohamed Hassan Solayman, Nagwa Ali Sabri
Summary: The study aimed to assess the impact of a pharmacovigilance educational program on the knowledge, attitude, and practice of healthcare professionals. Results showed that the educational program significantly improved the KAP scores of healthcare professionals towards pharmacovigilance and adverse drug reaction reporting.
INTERNATIONAL JOURNAL OF CLINICAL PRACTICE
(2021)
Article
Pediatrics
Daniel B. Hawcutt, Mitul Jadeja, NIkita Bhoombla, Sophie Smith, Stephen J. McWilliam
Summary: The new guide for children and young people to report suspected adverse drug reactions (ADRs) received positive feedback, increasing their knowledge and confidence in reporting.
ARCHIVES OF DISEASE IN CHILDHOOD
(2022)
Review
Pharmacology & Pharmacy
Philip Alexander Routledge, Robert Bracchi
Summary: This study conducted a systematic review of interventions to stimulate spontaneous reporting of suspected adverse drug reactions by healthcare professionals and/or patients/carers. The results showed that educational and engineering strategies were most commonly associated with improvements in reporting rates by healthcare professionals, but the evidence for sustained impact was weak. Further research is needed to examine the effects of economic strategies and reporting by patients, carers, and the public.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Mansour Adam Mahmoud, Shihabeddein Siddig Abdul Rahman Ali, Hanaa Gamal Abdalla Ahmed, Alnada Abdalla Ibrahim, Md Ashraful Islam, Syed Ata Ur Rahman
Summary: This study aimed to evaluate healthcare professionals' knowledge, practice, experiences, encouraging factors and barriers to adverse drug reactions (ADR) reporting. The results showed that the majority of participants lacked knowledge about ADR reporting, with only a small percentage reporting ADRs correctly. Increasing awareness was identified as the most important facilitator to ADR reporting, while the lack of reporting forms was the main barrier.
LATIN AMERICAN JOURNAL OF PHARMACY
(2022)
Article
Medicine, General & Internal
Ronald Kiguba, Norah Mwebaza, Ronald Ssenyonga, Helen Byomire Ndagije, Victoria Nambasa, Cordelia Katureebe, Kenneth Katumba, Phil Tregunno, Kendal Harrison, Charles Karamagi, Kathryn A. Scott, Munir Pirmohamed
Summary: This study aims to evaluate the effectiveness of the Med Safety mobile application in improving pharmacovigilance and investigate the barriers and facilitators to its uptake in HIV patients in Uganda. The study will be conducted as a pragmatic cluster-randomised controlled trial involving 382 cART sites.
Article
Pharmacology & Pharmacy
Louis Letinier, Julien Jouganous, Mehdi Benkebil, Alicia Bel-Letoile, Clement Goehrs, Allison Singier, Franck Rouby, Clemence Lacroix, Ghada Miremont, Joelle Micallef, Francesco Salvo, Antoine Pariente
Summary: The study developed an automated system to code ADRs from patient reports, with the gradient boosting trees (LGBM) model showing the best performance in identifying ADRs based on testing and external validation.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Article
Pharmacology & Pharmacy
Xiaomei Mo, Xiaowei Leng, Jinli Zhang, Ruqiong Du, Xiaofen Yang, Ming Liu, Jianghai Wang, Gang Sun, Chunli Zhang, Jin Wang, Mengting Yin, Huahui Li, Meixing Yan
Summary: Despite being a focus of drug authorities in China, knowledge and understanding of adverse drug reactions (ADRs) and pharmacovigilance concepts are lacking among healthcare professionals and the public. The public needs to deepen their understanding of ADRs, while medical personnel should enhance their professional knowledge on ADRs.
LATIN AMERICAN JOURNAL OF PHARMACY
(2023)
Article
Public, Environmental & Occupational Health
Adisu Asefa, Nitsuh Derjachew, Abebe Muche Belete, Feredegn Talargia, Daniel Molla Melese, Bekalu Getachew
Summary: This study aimed to assess the adverse reactions to COVID-19 vaccines among Ethiopian healthcare professionals in 2022.
FRONTIERS IN PUBLIC HEALTH
(2023)
Article
Pharmacology & Pharmacy
Robert C. Bracchi, Foteini Tseliou, Lauren Copeland, Philip A. Routledge, Alison Thomas, Fiona Woods, Alana Adams, Jenna Walker, Mitul Jadeja, Mark D. Atkinson, Pauline Ashfield-Watt
Summary: The study conducted on the HealthWise Wales platform found that an information video intervention can increase public awareness of the UK Yellow Card scheme, leading to improved reporting of suspected adverse drug reactions by the public.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Article
Pharmacology & Pharmacy
Louis Bioletti, Charlotte Woodward, Mitul Jadeja, Daniel B. Hawcutt
Summary: The Medicines and Healthcare products Regulatory Agency Yellow Card scheme aims to collect spontaneous reports of suspected adverse drug reactions in the UK. However, reporting of suspected ADRs by young people is uncommon. This study utilized an anonymous online survey to provide updated information to young people and assess their awareness and willingness to report ADRs. The results showed that the provided information increased awareness and willingness to report among young people. Suggestions for improvement included altering content or length of the text and improving graphic design.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
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)
Review
Medicine, General & Internal
Zakir Khan, Yusuf Karatas, Maria Auxiliadora Parreiras Martins, Shazia Jamshed, Hazir Rahman
Summary: This systematic review identified a gap in knowledge, attitude, and practices of healthcare professionals in Turkey regarding pharmacovigilance and adverse drug reaction reporting. Many healthcare professionals were unaware of the national pharmacovigilance center in Turkey and did not consider ADR reporting important, with a low rate of ADR reporting practice. Addressing these issues through mandatory unified PV education intervention is crucial for improving the healthcare system.
CURRENT MEDICAL RESEARCH AND OPINION
(2022)
Article
Ophthalmology
Ilaria Testi, Taha Soomro, Carlos Pavesio, Ameenat Lola Solebo
Summary: Ocular inflammatory events following COVID-19 vaccination have a very rare prevalence in the UK. There is no increase in the reporting rate of uveitis, optic neuritis, and scleritis following COVID-19 vaccination when compared with the range of incidence in the UK population. The use of the Yellow Card System is important for monitoring medication safety.
BRITISH JOURNAL OF OPHTHALMOLOGY
(2023)
Article
Infectious Diseases
Ronald Kiguba, Charles Karamagi, Sheila M. Bird
Summary: The study found that only one in four in-patients received timely diagnosis and treatment for malaria. Over half of the malaria microscopy results were not promptly available. The majority of patients initiated on injectable short-term medication did not receive the recommended oral treatment.
Article
Infectious Diseases
Paul Kutyabami, Edson Ireeta Munanura, Rajab Kalidi, Sulah Balikuna, Margaret Ndagire, Bruhan Kaggwa, Winnie Nambatya, Pakoyo Fadhiru Kamba, Allan Musiimenta, Diana Nakitto Kesi, Victoria Nambasa, Allan Serwanga, Helen Byomire Ndagije
Summary: The study assessed the clinical utilization of ceftriaxone in Uganda and found that there was a significant rate of inappropriate use, with some patients not completing their prescribed doses. Factors associated with appropriate ceftriaxone use included gender, pregnancy status, days of hospitalization, health facility level of care, health facility type, and type of prescriber.
Article
Infectious Diseases
Henry Zakumumpa, Freddy Eric Kitutu, Helen Byomire Ndagije, Nakitto-Kesi Diana, Jacquellyn Nambi Ssanyu, Ronald Kiguba
Summary: According to clinicians in ART clinics in Uganda, DTG-based regimens are generally well tolerated by most patients, but some patients experience suspected adverse drug reactions, with hyperglycemia, insomnia, and reduced libido being key concerns. Further studies are recommended to investigate the prevalence of dolutegravir-induced hyperglycemia in Ugandan patients.
BMC INFECTIOUS DISEASES
(2021)
Review
Pharmacology & Pharmacy
Ronald Kiguba, Sten Olsson, Catriona Waitt
Summary: Low- and middle-income countries (LMIC) face unique challenges in establishing robust pharmacovigilance systems, including language translation, shortage of healthcare providers, high use of traditional medication, and limited awareness and investment in pharmacovigilance. Collaboration between public health programs and regulatory authorities is lacking, hindering the systematic embedding of pharmacovigilance. Furthermore, low reporting rates and poor quality reports impede signal detection analyses.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Ronald Kiguba, Helen Byomire Ndagije, Victoria Nambasa, Cordelia Katureebe, Henry Zakumumpa, Stella Maris Nanyonga, Jacquellyn Nambi Ssanyu, Phil Tregunno, Kendal Harrison, Corinne S. Merle, Marie-Eve Raguenaud, Freddy Eric Kitutu
Summary: This study aims to test the feasibility and effectiveness of a peer support intervention for reporting ADRs among PLHIV receiving CART in Uganda, identify barriers and facilitators to the intervention, and characterize ADR reporting and management.
Article
Medicine, General & Internal
Ronald Kiguba, Norah Mwebaza, Ronald Ssenyonga, Helen Byomire Ndagije, Victoria Nambasa, Cordelia Katureebe, Kenneth Katumba, Phil Tregunno, Kendal Harrison, Charles Karamagi, Kathryn A. Scott, Munir Pirmohamed
Summary: This study aims to evaluate the effectiveness of the Med Safety mobile application in improving pharmacovigilance and investigate the barriers and facilitators to its uptake in HIV patients in Uganda. The study will be conducted as a pragmatic cluster-randomised controlled trial involving 382 cART sites.
Article
Medicine, General & Internal
Jacquellyn Nambi Ssanyu, Ronald Kiguba, Ronald Olum, Juliet Kiguli, Freddy Eric Kitutu
Summary: This study aims to investigate the prevalence of COVID-19 misinformation and vaccine hesitancy in Buikwe district and pilot a social mobilisation intervention using community influencers. Mixed-methods, including qualitative and quantitative approaches, will be used for data collection and analysis. The findings will be used to inform interventions and will be disseminated through scientific gatherings and peer-reviewed journals.
Editorial Material
Public, Environmental & Occupational Health
Manal M. Younus, Mayada Alkhakany, Priya Bahri, Angela Caro, Hadir Rostom, Helen Byomire Ndagije, Mohamed A. Elhawary
Article
Public, Environmental & Occupational Health
Ronald Kiguba, Henry Zakumumpa, Helen B. Ndagije, Norah Mwebaza, Ronald Ssenyonga, Phil Tregunno, Kendal Harrison, Munir Pirmohamed
Summary: This study explores the acceptability of Med Safety, a mobile application for adverse drug reaction (ADR) reporting, among health workers in Uganda. The majority of health workers expressed willingness to adopt Med Safety and recommend it to others. Factors that could influence uptake include age, technology proficiency, functionality of the app, availability of internet hotspots, willingness of health workers to report ADRs, and limitations of conventional reporting tools. However, barriers such as registration process, smartphone compatibility, internet cost and connectivity, language barrier, and feedback to ADR reporters need to be addressed.
Editorial Material
Public, Environmental & Occupational Health
Mohamed A. Elhawary, Comfort K. Ogar, Monica Tarapues, Angela Caro, Helen Byomire Ndagije, Ghita Benabdallah, Houda Sefiani, Hadir Rostom
Review
Pharmacology & Pharmacy
Helen Byomire Ndagije, David Walusimbi, Joanita Atuhaire, Sheila Ampaire
Summary: Pharmacovigilance in Africa has grown over time, with the majority of countries being members of the WHO Programme for international drug monitoring. However, challenges such as weak regulation, insufficient resources, and differing policies still exist. This expert opinion offers insights from long-term experience and suggests solutions for implementing pharmacovigilance in resource-limited settings.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Medicine, Research & Experimental
Jackson K. Mukonzo, Helen Byomire Ndagije, George Tsey Sabblah, Wangui Mathenge, David A. Price, Thaddeus H. Grasela
Summary: Drug regulatory institutions are increasingly interconnected globally, with efforts to strengthen capacities in low- and middle-income countries. However, there is a tendency to focus on transferring knowledge and skills from high-income countries to low-income countries, while overlooking the unique insights that low-income countries can bring to regulatory deliberations.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE
(2023)
Article
Infectious Diseases
Ronald Kiguba, Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Elijah Kirabira, Allan Serwanga, Sten Olsson, Niko Speybroeck, Jackson Mukonzo