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  1. Bala AA, Jatau AI, Yunusa I, Mohammed M, Mohammed AH, Isa AM, et al.
    Ther Adv Drug Saf, 2020;11:2042098620935721.
    PMID: 32944213 DOI: 10.1177/2042098620935721
    Introduction: Snakebite envenoming (SBE) is an important occupational and public health hazard especially in sub-Saharan Africa. For optimum management of SBE, adequate knowledge of Snake antivenom (SAV) is very critical among the healthcare practioners in this region. Information related to the knowledge of SAV use in the management of SBE, as well as SAV logistics is scarce among the Health Care Professionals (HCPs) in Nigeria, particularly in the northern region. We therefore aimed to develop, validate and utilize a tool to assess the SAV knowlegde among HCPs in northern Nigeria. We also sought to implement and evaluate an intervention that could improve the SAV knowledge among the HCPs.

    Methods: The proposed study will be conducted in three phases: Phase I will involve the development of the item-pool to be included in the tool, followed by a face, content validity and construct validity. The tool reliability, readability and difficulty index will be determined. Phase II will involve the utilization of the tool to assess baseline SAV knowledge among the HCPs followed by an educational intervention. Multiple Linear Regression analysis will be used to determine the factors associated with SAV knowledge among the HCPs. Lastly, Phase III which will be a repeat of Phase II to assess and evaluate the knowledge after the intervention.

    Discussion: The study design and findings may guide future implementation and streamline the intervention of improving SAV knowledge in HCPs training and practice.

    Lay Summary: Knowledge assessment and educational intervention of snake antivenom among healthcare practitioners in northern Nigeria: a study protocol Snakebite envenoming (SBE) is an important occupational and public health hazard especially in sub-Saharan Africa. For optimum management of SBE, adequate knowledge of snake antivenom (SAV) is very critical among the healthcare practitioners. The baseline knowledge SAV dosage, mode of administration, availability, and logistics is very relevant among healthcare professionals, particularly those that are directly involved in its logistics. It is paramount that SAV is handled and used appropriately. The efforts and advocacy for the availability for more SAV will be in vain if not handled appropriately before they are used. This study protocol aims to develop a tool, to assess SAV knowledge and effects of educational interventions among healthcare professionals (HCPs) in northern Nigeria. This protocol suggests conducting studies in three phases: (a) Development and validation of SAV knowledge assessment tool, (b) Baseline assessment of SAV knowledge assessment tool among HCPs, and (c) Development, implementation and evaluation of an educational intervention to improve SAV knowledge among HCPs in northern Nigeria.

  2. Shrestha S, Danekhu K, Kc B, Palaian S, Ibrahim MIM
    Ther Adv Drug Saf, 2020;11:2042098620922480.
    PMID: 32587678 DOI: 10.1177/2042098620922480
    Background: Bibliometric analyses have been used previously to study the measures of quality and impact of research performed in several health-related areas such as adverse drug reactions (ADRs) and pharmacovigilance (PV), etc. This method can assess the research performance of publications quantitatively and statistically. There is no evidence of bibilometric studies analyzing ADRs and PV from Nepal. Therefore, the present study aimed to assess scientific output on ADRs and PV-related research activities in Nepal using a bibliometric analysis of publications from 2004 January to December 2018, that is, 15 years.

    Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. 'Adverse Drug Reactions' or 'ADRs' or 'ADR' or 'Adverse drug reaction' or 'AE' or 'Adverse Event' or 'Drug-Induced Reaction' or 'Pharmacovigilance' or 'PV' and 'Nepal'. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles.

    Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%).

    Conclusions: During the study years, there was an increase in scientific publications on drug safety. A total of 124 published articles were found during bibliometric analysis of ADRs and PV research activities in Nepal.

  3. Daher AM, Al-Momen H, Jasim SK
    Ther Adv Drug Saf, 2019;10:2042098619880123.
    PMID: 31636883 DOI: 10.1177/2042098619880123
    Background: The health care industry is witnessing an increasing trend in the use of generic medicines because of their presumed low cost compared with innovator medicines. The aim of this study was to determine and compare the performance of the copy drug Osveral® and its innovator drug deferasirox (Exjade®).

    Methods: A prospective observational study including 223 patients receiving the branded medicine Exjade® and 101 patients receiving the copy Osveral® was carried out. Data were assessed for a 1-year period and included clinical symptoms, serum ferritin (SF), serum creatinine (SC), and alanine aminotransferase (ALT). Data were analyzed with SPSS version 22 software (SPSS, Chicago, IL, USA).

    Results: The median age of the sample was 8 years. There was no significant difference in gender distribution between the two groups (p = 0.625). Nausea was the most frequently reported adverse effect followed by diarrhea and abdominal pain in both groups. Patients receiving Exjade® had a higher relative reduction of SF at the end of the study compared with the Osveral® group (19.9% versus 9.93%, p = 0.028). SC was found to be significantly higher in the Osveral® group than in the Exjade® group throughout the study period. The mean platelet count was higher in the Exjade® group. ALT was significantly higher among patients receiving Osveral® over the last three months of the study.

    Conclusions: Exjade® showed a better ability to reduce SF, with less liver toxicity, and better hemostasis profile. No congenital anomalies associated with short-term use of both drugs during pregnancy were observed or reported.

  4. Jatau AI, Shitu Z, Khalid GM, Yunusa I, Awaisu A
    Ther Adv Drug Saf, 2019;10:2042098619852552.
    PMID: 31258886 DOI: 10.1177/2042098619852552
    Background: The burden of adverse drug event (ADE)-related emergency department (ED) visits is increasing despite several preventive measures. The objective of this paper was to develop and validate a conceptual model for a better understanding of ADE-related ED visits and to guide the design and implementation of effective interventions.

    Methods: The development of the model involved a systematic review of the literature using PubMed and Embase databases. Studies reporting the risk factors associated with ADE-related ED visits were included. The methodological qualities of the included studies were assessed using the Mixed Methods Appraisal Tool (MMAT). The model was mapped and validated using face and content validity by an expert panel. Deficiencies and targeted interventions were identified, and steps for the design and implementation were recommended.

    Results: The literature search generated 1361 articles, of which 38 were included in the review; 41 risk factors associated with ADE-related ED visits were identified. All factors were mapped, and the model was validated through face and content validity. The model consisted of six concepts related to sociodemographic factors, clinical factors, ADE-related to ED visits, ADE while in the ED, outcomes, and consequences. Interventions could be targeted at the factors identified in each concept to prevent ADE-related ED burden.

    Conclusion: A conceptual model to guide the successful design and implementation of strategies to prevent ADE-related ED visits and the occurrence of ADE at ED was developed. Clinicians should take these factors into consideration to prevent untoward events, especially when treating high-risk patients.

  5. Taib IA, McIntosh AS
    Ther Adv Drug Saf, 2010 Dec;1(2):53-63.
    PMID: 25083195 DOI: 10.1177/2042098610389850
    OBJECTIVE: A reliable database on the causes and contributing factors of medication errors can inform strategies for their prevention. To form a single database from multiple databases requires a process of integration that both maximizes the utility of the new data and minimizes the loss of information. Unfortunately, the terminologies used by different studies and databases may limit integration; therefore, terminologies must be standardized prior to integration.

    METHODS: The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Taxonomy of Medication Errors was applied to standardize the different terminologies in 11 studies that reported the causes or contributing factors of medication errors.

    RESULTS: After standardization, 57% of the reported causes and contributing factors were integrated to form a database while 43% were not integrated because the terminologies could not be standardized or were not similar to the taxonomy.

    CONCLUSIONS: This study highlights the challenges to standardizing and integrating databases and the importance of adopting and applying a standardized terminology to record medical errors.

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