International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press
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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: Governmental regulations of drug registration and licensing are not always followed by healthcare providers. OBJECTIVE: To explore the global research growth and patterns on systemic use of off-label and unlicensed drugs to gain knowledge about the magnitude of the problem and the main research themes encountered in this field. METHODS: SciVerse Scopus was searched for papers on off-label and unlicensed drug use from 1990 until December 31, 2020, without any language limitations. A bibliometric methodology was adopted to present the following indicators: top-cited documents, the most productive countries, top active journals, international research collaboration, the…most frequent author keywords, and research themes. RESULTS: The search query returned 1320 papers with an h-index of 66, published in 721 different journals. The Hospital Pharmacy journal ranked first (n = 43, 3.3%). In total, 5777 authors (median = 3) from 85 different countries contributed to the retrieved papers. The USA (n = 381, 28.9%) ranked first, followed distantly by Germany and Italy. The percentage of documents with international authors for active countries was from 8.8% for China to 42.3% for the Netherlands. The most frequent author keyword next to off-label was children/pediatrics. The keyword unlicensed was less frequently encountered than that for off-label. Major research themes in the retrieved papers focused on off-label drug use in hospitalized children/pediatrics, biological drugs such as rituximab and rFVIIa, psychiatric disorders, regulations, and questionnaire-based knowledge/attitude studies among community pharmacists and physicians. CONCLUSIONS: Research activity on off-label drug use has witnessed a general increase in the past two decades. The major research theme was off-label drug use in hospitalized children/pediatrics/neonates. The USA and certain European countries made a major contribution to this field.
Abstract: BACKGROUND: Using benzodiazepines (BZDs) or Z-drugs in poly-therapy is a critical issue. OBJECTIVE: Identifying factors influencing the use of BZDs/Z-drugs in poly- vs mono-therapy in patients with or without substance use disorders (SUDs). METHODS: 986 inpatients were analysed. Socio-demographic and clinical variables were collected. BZD/Z-drug doses were compared via the Defined Daily Dose (DDD) and standardized as diazepam dose equivalents. Mann-Whitney, Chi-square, Fisher test, hierarchical multivariate regression analyses were run referring to the whole sample and to subjects with current SUDs, lifetime SUDs, current and lifetime SUDs, non-SUDs. RESULTS: In the whole sample the…variance of being mono- vs poly-therapy users was explained by BZD/Z-drug formulation, DDD, duration of treatment, age of first BZDs/Z-drugs use (ΔR 2 = 0.141, p < 0.001). Among those with current SUDs (ΔR 2 = 0.278, p = 0.332) or current and lifetime SUDs (ΔR 2 = 0.154, p = 0.419), no variables explained the variance of being mono-vs poly-therapy users. Among lifetime SUDs subjects, the variance of being mono- vs poly-therapy users was explained by BZD/Z-drug formulation and age of first BZD/Z-drug use (ΔR 2 = 0.275, p < 0.001). Among non-SUDs subjects, the variance of being mono- vs poly-therapy users was explained by DDD and duration of treatment (ΔR 2 = 0.162, p = 0.001). CONCLUSIONS: Tablets, high drug doses, long duration of treatment, and early age of first use were more likely associated to poly- than mono-therapy. This suggests that patients have different clinical features and a pharmacological prescription should be tailored to them also based on the variables here analysed.
Keywords: Mono-therapy, poly-therapy, poly-pharmacy, substance use disorder, benzodiazepine, Z-drug
Abstract: BACKGROUND: Companies often defending their products when there are concerns about their safety and/or effectiveness. OBJECTIVE: This study looks at drugs removed from the Canadian market from 1990 onward and examines how companies responded. METHODS: This descriptive analysis used a previously published article and a hand search of a Government of Canada website to generate a list of drugs withdrawn from Canada from 1990 onwards. For each product the following information was extracted: brand-name, generic name, company, date of withdrawal and evidence base for withdrawal. Google and Factiva searches were used to identify sources containing statements…from the company about the withdrawal. Statements were independently graded by two people into the following categories: company agrees with the withdrawal; drug could be used safely with certain precautions; company may reintroduce the drug; company disagrees with the withdrawal. Searches were carried out between September 15–20, 2020. RESULTS: There were 22 drugs for which there were company statements. In 10 statements, the companies disagreed with the decision to withdraw the drug and in 7 they agreed with the decision. In the other 5 cases they felt that the drug could have been kept on the market with restrictions (2 cases) or they might reintroduce the drug (3 cases). The level of evidence for the withdrawal did not seem to influence the companies’ position. CONCLUSION: In 15 out of 22 cases, the company either disagreed with the decision to withdraw the drug or felt that the drug should continue to be available to Canadian patients.
Keywords: Drug withdrawals, Health Canada, level of evidence, pharmaceutical companies
Abstract: BACKGROUND: Pheniramine abuse is reported not only in patients with psychiatric disorders but also in the general population. CASE REPORT: We report a case of pheniramine dependence in a patient with obsessive-compulsive disorder. The patient took about 250 mg orally daily and injected about 90 mg every week from the last six months. It reduced his anxiety, was cheaper than his other psychiatric medications, and free of stigma. He had lethargy, headache, uneasiness, anxiety, and poor sleep as withdrawal symptoms. RESULTS: This case highlights the vulnerability of those with psychiatric disorders towards pheniramine abuse. Hence, this report advocates…the strict evaluation of over-the-counter drugs for patients with pre-existing psychiatric disorders.
Abstract: BACKGROUND: Environmental hazards in healthcare institutions affect the quality of patient care as well as personnel and patient safety. OBJECTIVE: The aim of this study was to develop and apply a semi-quantitative risk assessment method to calculate occupational health risk levels with regard to the sensitivities of healthcare institutions. METHODS: The present research was conducted in three phases. In phases 1 and 2, the model was developed using a review of different risk assessment methods, extracting expert opinions (N = 10) through semi-structured interviews, and using the fuzzy analytical hierarchy process (FAHP). In phase 3, in…order to validate the proposed method, one of the five public hospitals was randomly selected and a case study comprising 6 sections was performed. RESULTS: A total of 43 health risks were identified and evaluated using the present method, 41.86% of which were at very high levels, 16.27% at high levels, 30.23% at substantial ones, 9.3% at medium and 2.32% at low levels. The highest health risks were found in paraclinical and operating room wards. CONCLUSION: To overcome the shortcomings of the proposed health risk assessment methods, a semi-quantitative method was used in the present study to more accurately calculate the risk levels in the healthcare institutions and also calculate the risk level of each hospital unit. The proposed semi-quantitative method can be used as a tool for assessing occupational health risks as a key element of risk management. In addition, by focusing on an appropriate framework for occupational health risk assessment, specialists in the organization will be able to take significant and effective steps to implement an efficient risk management system.
Keywords: Healthcare institutions, risk assessment, semi-quantitative method, occupational health
Abstract: BACKGROUND: Off-label drug (OLD) use is common in neonates. There is a dearth of information associating the OLD use and the risk of medication errors in critically ill neonates. Hence, the present study was carried out. METHODS: Drug prescriptions in neonates admitted to the intensive care unit of a tertiary care hospital between September 2018 and June 2019 were evaluated. Details on their demographics, reason for admission in intensive care unit, drug-related information and serum creatinine were extracted. United States Food and Drug Administration approved drug labels were compared. World Health Organization (WHO) anatomy, therapeutic and chemical (ATC)…classification was used for drug categorization. We assessed the risk of medication errors using a validated tool, medication risk score (MERIS). RESULTS: One hundred and seventy-one neonates with 2394 prescriptions were included in this study. Seventy one percent of the neonates in the present study received at least one OLD/unlicensed prescription item. A trend in increased numbers of OLD/unlicensed drug use in more premature and lower birth weight neonates were observed. Medication risk score was significantly higher in neonates receiving OLD/unlicensed drugs compared to those with only labelled drugs. Very and extreme pre-term (along with very low and extremely low birth weight) neonates were at higher risk of medication errors compared to others. Presence of OLD/unlicensed prescribed items is associated with an increased risk of medication errors by an odds ratio of 20.4 compared to labelled drugs. CONCLUSION: Significant proportions of critically ill neonates received at least one OLD/unlicensed drug and such use was associated with potentially increased risk of medication errors.
Keywords: FDA, off-label drug, drug regulatory authority, labelled drug
Abstract: OBJECTIVE: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. To meet these and support AstraZeneca’s ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making. METHOD: In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and simplifying the procedural…framework. RESULTS: It was delivered in a focused effort by internal PS resources with cross-functional input. The framework simplification resulted in a 71% reduction in procedural documents and a survey of PS staff revealed an increase in satisfaction of 10%–20% across all scores. CONCLUSIONS: With >3 years of observation time, this project has provided AstraZeneca with a PS organisation able to provide strategic safety, supporting successful portfolio delivery, while ensuring patient safety and maintaining compliance with global pharmacovigilance regulations. It has driven efficiency and set the foundation for continued organisational evolution to meet future business needs in an everchanging environment.
Abstract: BACKGROUND: Post-SSRI Sexual Dysfunction (PSSD) is characterized by sexual and emotional symptoms associated to the exposure to Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Noradrenaline Reuptake Inhibitors (SNRI). OBJECTIVE: The present study provides a comprehensive picture on demographic and clinical characteristics associated to PSSD. METHODS: An online survey was run on subjects self-declaring as affected by PSSD. The survey collected socio-demographic and clinical data via questions created ad hoc and three standardized scales (Arizona Sexual Experiences Scale, Hospital Anxiety and Depression Scale, World Health Organization Wellbeing Index). RESULTS: A total of 135 subjects (115…males; mean age 31.9 ± 8.9 years) was analysed. The syndrome was more represented among young, heterosexual males after the exposure to SSRI/SNRI at relatively high doses. The major findings involved the temporal sequence of symptoms: 118 subjects had symptoms both during and after SSRI/SNRI administration, and 17 only after, thus deposing for a iatrogenic action of SSRI/SNRI. Different variables, represented by both emotional and sexual symptoms, accounted for the variability of the severity of the sexual dysfunction as well as of wellbeing. CONCLUSIONS: Based on the present results, PSSD is a complex iatrogenic syndrome in need of being further studied and understood.
Keywords: Sexual dysfunction, SSRI, PSSD, discontinuation, SNRI
Abstract: BACKGROUND: Neurosensory impairment is a common complication following inferior alveolar nerve (IAN) damage. OBJECTIVE: To document and report the various causes, diagnosis, and management of IAN damage secondary to orthodontic treatment. METHODS: An electronic search for studies that reported IAN damage in patients undergoing orthodontic treatment was performed up to July 15, 2020 using MEDLINE, EMBASE, and PubMed databases. Descriptive analyses and linear regression model were performed. RESULTS: A total of 15 case reports were identified including 16 patients with an overall mean age of 23.3. All the included studies reported temporary sensory alterations…which manifested as anesthesia (19%, n = 3), paresthesia (75%, n = 12), or combined (6%, n = 1). The majority of cases managed by stopping the orthodontic force (75%, n = 12), followed by appliance adjustments (19%, n = 3), providing a bite plate (13%, n = 2), and/or providing pharmacological management (38%, n = 6). Full recovery median duration reported in all cases following the aforementioned managements was 17.5 days. CONCLUSIONS: IAN damage secondary to orthodontic treatment is emerging in the literature in recent years. Identifying high risk patients with close proximity to the IAN canal is a must to formulate a proper treatment plan to avoid such complications.