International Journal of Risk & Safety in Medicine - Volume 32, issue 2
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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: BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and…Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.
Keywords: SARS-CoV-2, healthcare risk, medicines, supply, European Union
Abstract: BACKGROUND: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and…two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies’ online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.
Keywords: Quality of life, SF-36, EQ-5D, clinical study reports, antidepressants, publication bias, selective reporting, placebo
Abstract: BACKGROUND: Ranitidine injection is not well-known to cause cardiac arrest except in few published case reports. The Eritrean Pharmacovigilance Centre received four cases of cardiac arrest associated with ranitidine injection. OBJECTIVE: To assess the causal relationship between cardiac arrest and ranitidine, and to identify possible risk factors. METHODS: This is a descriptive case series assessment of cardiac arrest associated with ranitidine and data was mined to supplement the cases from the WHO global database of individual case safety reports. RESULTS: In all cases, ranitidine injection was administered fast IV bolus without proper dilution and…the outcome was fatal in three. All patients encountered cardiac arrest within 20 minutes of intravenous use. Causality was found to be probable in two cases and possible in the other two. Cardiac arrest could have been prevented in all cases. On top of this, from the WHO global database, 185 cases of cardiac arrest and cardio-pulmonary arrest associated with ranitidine were retrieved and 49.7% were fatal. In 40% of the cases, ranitidine was reported as a single suspect. In 36 cases, cardiac arrest resolved following withdrawal of ranitidine and reaction recurred in one case after re-introduction of the product. CONCLUSION: There appears a causal link between ranitidine and cardiac arrest, possibly related to medication errors that warrants immediate attention from healthcare professionals.
Keywords: Intravenous ranitidine, administration error, cardiac arrest, WHO global database, healthcare, risk factors
Abstract: OBJECTIVE: This study aimed to investigate the knowledge, usage and attitude of physiotherapists towards non-steroidal anti-inflammatory drugs (NSAIDs) in Karachi, Pakistan. METHODS: A cross-sectional study was conducted among clinical physiotherapists working in Karachi who were enrolled through convenient sampling. A questionnaire was distributed to the participants, which consisted of questions regarding physiotherapists’ current knowledge, current practice and their attitude towards NSAIDs prescription. RESULTS: Responses of 310 physiotherapists out of the 350 questionnaires distributed were received (response rate = 88%). Results show that most physiotherapists (60.3%) recommended NSAIDs to their patients despite having a variable understanding of…the contraindications, adverse reactions and drug interactions of NSAIDs. Most physiotherapists demonstrated poor knowledge of the legislation on NSAIDs prescription as most of them believed that they were allowed to advise (71.9%), prescribe (66.1%) and recommend (72.2%) NSAIDs to their patients. CONCLUSION: This study implicates that physiotherapists should be trained through proper educational sessions such as certification courses on pharmacotherapy (specifically pain medications) in order to become certified to prescribe NSAIDs and other analgesics.
Abstract: BACKGROUND: Despite the improvement of anesthetic-related modalities, the incidence of unintended intraoperative awareness remains at around 0.005–0.038%. OBJECTIVE: We aimed to describe the intraoperative awareness incidents that occurred across Thailand between January to December, 2015. METHODS: Observational data was collected from 22 hospitals throughout Thailand. The awareness category was selected from incident reports according to the Perioperative Anesthetic Adverse Events in Thailand (PAAd Thai) study database and descriptive statistics were analyzed. The awareness characteristics and the related factors were recorded. RESULTS: A total of nine intraoperative awareness episodes from 2000 incidents were observed. The…intraoperative awareness results were as follows: experience of pain (38.1%), perception of sound (33.3%), perception of intubation (9.5%) and feeling of paralysis (14.3%). The observed factors that affect intraoperative awareness were anesthesia-related (100%), patient-related (55.5%), surgery-related (22.2%) and systematic process-related (22.2%). The contributing factors were situational inexperience (77.8%) and inappropriate patient evaluation (44.4%). An awareness of anesthetic performer (100%) and experience (88.9%) were defined as incident-mitigating factors. The suggested corrective strategies were quality assurance activity (88.9%), improved supervision (44.4%) and equipment utilization (33.3%), respectively. CONCLUSION: Nine intraoperative awareness incidents were observed, however the causes were preventable. The anesthetic component seems to be the most influential to prevent these events.
Keywords: Complication, risk, unintentional awareness, national audit project, PAAd Thai
Abstract: BACKGROUND: The National Safety Reporting System, which is developed for Turkey, aims to classify medical errors with a coding methodology that handles errors in subcategories. Error entries done via the system are added to the statistics immediately by advanced live data reporting capabilities of the software. OBJECTIVE: Our aim was to provide information about the Turkey local reporting system to ensure patient safety by detecting medical errors. METHODS: The data used for analyses were obtained from https://www.grs.saglik.gov.tr and the web service used by hospital information systems. The error reporting time, most commonly reported errors, errors…by professions and errors by location were examined under the major error categories and percentages that have been used in relevant data. RESULTS: In total, 53,477 errors were submitted to the National Safety Reporting System in 2016. When these entries were split into relevant categories such as drug errors, laboratory errors, surgical errors and patient safety errors, the most common errors were wrong dosage order, hemolyzed sample, not marking the side to be operated on and patient fall (patient/caretaker related), respectively. CONCLUSION: In order to reduce medical errors and provide patient safety, every institution must first of all do its own self-assessment. New user-friendly systems can be developed in order to increase medical error notifications and thus institutions can improve their healthcare quality.
Keywords: Patient safety, medical errors, National Safety Reporting System, Turkey
Abstract: BACKGROUND AND OBJECTIVE: Improving the safety of surgical care is an area of growing interest in Sierra Leona, a low resource setting where health outcomes remain poor. One tool shown to improve outcomes is the WHO Surgical Safety Checklist. We report an approach for optimising adherence in a public referral hospital in Freetown, Sierra Leone. METHODS: A multi-faceted series of interventions was proposed. Planning involved service evaluation, discussion with key stakeholders and formation of a working group to develop tailored interventions. Implementation involved reformatting the local checklist, formal classroom and simulation training and introduction of protocols and visual…aids. Analysis of impact was performed by prospective observation of safety processes both pre- and post-intervention. RESULTS: Following the intervention, there was a significant increase in the total number of intraoperative safety processes performed (38.1% pre vs 73.0% post, p < 0.001). A significant improvement was noted in the performance of airway evaluation, correct administration of antibiotics, marking of the surgical site and preoperative team briefing. CONCLUSION: This project describes a series of interventions taken to improve the performance of the WHO Surgical Safety Checklist in a low resource setting. We highlight the importance of local partnership working and stakeholder engagement in implementing successful change.