International Journal of Risk & Safety in Medicine - Volume 30, issue 3
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: OBJECTIVE: To compare primary medical adverse event keywords from reporters (e.g. physicians and nurses) and harm level perspectives to explore the underlying behaviors of medical adverse events using social network analysis (SNA) and latent Dirichlet allocation (LDA) leading to process improvements. DESIGN: Used SNA methods to explore primary keywords used to describe the medical adverse events reported by physicians and nurses. Used LDA methods to investigate topics used for various harm levels. Combined the SNA and LDA methods to discover common shared topic keywords to better understand underlying behaviors of physicians and nurses in different harm level medical…adverse events. SETTING: Maccabi Healthcare Community is the second largest healthcare organization in Israel. DATA: 17,868 medical adverse event data records collected between 2000 and 2017. METHODS: Big data analysis techniques using social network analysis (SNA) and latent Dirichlet allocation (LDA). RESULTS: Shared topic keywords used by both physicians and nurses were determined. The study revealed that communication, information transfer, and inattentiveness were the most common problems reported in the medical adverse events data. CONCLUSIONS: Communication and inattentiveness were the most common problems reported in medical adverse events regardless of healthcare professional reporting or harm levels. Findings suggested that an information-sharing and feedback mechanism should be implemented to eliminate preventable medical adverse events. Healthcare institutions managers and government officials should take targeted actions to decrease these preventable medical adverse events through quality improvement efforts.
Keywords: Patient safety, Social Network Analysis (SNA), latent Dirichlet allocation
(LDA), medical adverse event, medical adverse event reporting system
Abstract: OBJECTIVE: To assess if lithium treatment in patients with mood disorders, for instance depression, bipolar disorders, and schizoaffective disorders, has an effect on total mortality and suicide. DESIGN: Systematic review and meta-analysis. MAIN OUTCOME MEASURE: Total mortality. Secondary outcome was suicide. DATA SOURCES: PubMed and ClinicalTrials.gov. Eligible trials were randomized double-blind trials comparing lithium with placebo in patients with mood disorders who were not already on lithium before randomization in order to avoid withdrawal effects in the placebo group. DATA EXTRACTION AND ANALYSIS: Two researchers extracted data independently. Data were analysed with…Review Manager 5.3 (Peto odds ratio). RESULTS: We found 45 eligible studies. Only four studies reported any suicides or other deaths in the lithium or placebo group. There was a significant reduction in total mortality (two versus nine), odds ratio 0.28 (95% confidence interval 0.08 to 0.93). There was no statistically significant reduction in suicides, (none versus three), odds ratio 0.13 (0.01 to 1.27). CONCLUSION: According to our study, lithium reduces total mortality in mood disorders but not suicide. Because of small numbers and unreliable data, the findings should be interpreted with caution.
Abstract: OBJECTIVE: A petition to the European Medicines Agency provided an opportunity to collect reports of a specific adverse event from patients and healthcare professionals, along with details of clinicians’ attitudes when asked to endorse patient reports. METHODS: We approached a cohort of patients reporting post-SSRI sexual dysfunction (PSSD) to an adverse event reporting website, RxISK.org. The responses of patients on their interactions with healthcare professionals were subject to a qualitative analysis. RESULTS: A total of 62 participants from 23 countries provided details of their experiences. While some had received support and validation of their condition, many…described a number of difficulties including a lack of awareness or knowledge about PSSD, not being listened to, receiving unsympathetic or inappropriate responses, and a refusal to engage with the published medical literature. CONCLUSIONS: Healthcare professionals are nervous about or reluctant to engage with novel problems on a treatment. This is not widely appreciated and the reasons for this concern are not understood.
Abstract: Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) was laid on the premises of rewarding monopolistic patent rights to the innovator. Stronger patent protection was advocated to promote technology transfer from developed nations to the rest of the world. To boost domestic innovative potential and to maintain trade ties, most developing countries signed the TRIPS agreement. Impact of patent laws in the pharmaceutical industry was crucial as it posed threat to access health. This paper aims to analyze the impact of pharmaceutical product patent laws incorporated under the TRIPS agreement using 65 countries panel dataset from 1995 to…2016. The data is empirically analyzed using negative binomial regression and Poisson regression. Results clearly indicate that the number of pharmaceutical patents filed in US Patent and Trademark Office (USPTO) has decreased after TRIPS compliance in both low and middle income countries. However, the decline is larger in upper middle and lower middle income countries than in low income countries. The phenomenon of low patent activity has an increasingly declining trend across low and middle income countries. Hence the claimed hypothesis that stronger patent rights would increase innovative potential does not seem to stand true, which raises serious affordability concerns of bringing patents in the pharmaceutical sector.