International Journal of Risk & Safety in Medicine - Volume 33, issue 1

Authors: Ralph Edwards, I. | Lindquist, Marie

Article Type: Editorial

DOI: 10.3233/JRS-228000

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 1-3, 2022

Authors: Khosravizadeh, Omid | Ahadinezhad, Bahman | Maleki, Aisa | Najafpour, Zahra | Golmohammadi, Rohollah

Article Type: Review Article

Abstract: BACKGROUND: Reducing interpersonal contact has been one of the least expensive and most widely used COVID-19 control strategies. OBJECTIVE: This systematic review has been conducted with the aim of identifying social distancing strategies and policies and their impact on the COVID-19 pandemic. METHODS: In order to compile this systematic review, Google Scholar, PubMed, Scopus, Web of Science, Science Direct, Magiran, SID, and Irandoc databases were searched from the COVID-19 outbreak until March 2021. Keywords included “social”, “physical”, “distance”, “outbreak”, “incidence”, “prevalence”, “spread”, “new case”, “death*”, “mortality*”, “morbidity*” , “covid-19”, “coronavirus”, “sars-cov-2” and “time series*”. The articles …were qualitatively evaluated by two researchers using the STROBE tool. Finally, the study data were divided into three conceptual categories by three researchers, who then agreed on one category. The practical suggestions were also categorized in the same way. RESULTS: The policies and strategies adopted to implement social distancing were included in five categories of restrictions, prohibitions, closures, incentives, and punishments. Transportation and travel restrictions, crowded places and schools closure, use of telecommunications and virtual communications, and financial and psychological support to society members were the main policies in this area. CONCLUSION: Rapid and complete vaccination of all people around the world is out of reach, therefore social distancing and the implementation of physical restraints, especially in crowded and densely populated environments, should be done extensively until COVID-19 is eradicated. Show more

Keywords: Social distance, new cases, death, COVID-19, coronavirus, time series, health

DOI: 10.3233/JRS-210037

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 5-22, 2022

Authors: Bhandutia, Dron Kinnarbhai | Nayok, Swarna Buddha | Akshatha H.S., Dhanashree | Thimmaiah, Sathyanarayana Malleshwara

Article Type: Case Report

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. Show more

Keywords: Antihistamine, abuse, dependence, pheniramine, obsessive-compulsive disorder

DOI: 10.3233/JRS-200053

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 23-26, 2022

Authors: Lim, Cynthia Ciwei | Kadir, Hanis Bte Abdul | Tan, Ngiap Chuan | Ang, Andrew Teck Wee | Bee, Yong Mong | Lee, Puay Hoon | Goh, Bandy Qiuling | Ang, Alcey Li Chang | Xin, Xiaohui | Kwek, Jia Liang | Lam, Amanda Yun Rui | Choo, Jason Chon Jun

Article Type: Research Article

Abstract: BACKGROUND: Individuals with diabetes mellitus (DM) may be susceptible to non-steroidal anti-inflammatory drug (NSAID)-induced acute kidney injury (AKI) but data on NSAID-related adverse renal events is sparse. OBJECTIVE: We aimed to evaluate the risk of acute kidney injury and/or hyperkalemia after systemic NSAID among individuals with DM and diabetic chronic kidney disease (CKD). METHODS: Retrospective cohort study of 3896 adults with DM with incident prescriptions between July 2015 and December 2017 from Singapore General Hospital and SingHealth Polyclinics. Laboratory, hospitalization and medication data were retrieved from electronic medical records. The primary outcome was the incidence of …AKI and/ or hyperkalemia within 30 days after prescription. RESULTS: AKI and/or hyperkalemia occurred in 13.5% of all DM and 15.8% of diabetic CKD. The association between systemic NSAID >14 days and 30-day risk of AKI and/or hyperkalemia failed to reach statistical significance in unselected DM (adjusted OR 1.62, 95% CI 0.99–2.65, p = 0.05) and diabetic CKD (adjusted OR 0.64, 95% CI 0.15–2.82, p = 0.64), but the odds of AKI and/or hyperkalemia were markedly and significantly increased when NSAID was prescribed with renin-angiotensin-aldosterone system (RAAS) blocker (adjusted OR 4.17, 95% CI 1.74–9.98, p = 0.001) or diuretic (adjusted OR 3.31, 95% CI 1.09–10.08, p = 0.04) and in the absence of diabetic CKD (adjusted OR 1.98, 95% CI 1.16–3.36, p = 0.01). CONCLUSION: NSAID prescription >14 days in individuals with DM with concurrent RAAS blockers or diuretics was associated with higher 30-day risk of AKI and/or hyperkalemia. Show more

Keywords: NSAID, COX II inhibitor, renal failure, diabetes

DOI: 10.3233/JRS-200096

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 27-36, 2022

Authors: Healy, David | Mangin, Dee | Lochhead, Jonathan

Article Type: Research Article

Abstract: BACKGROUND: The majority of antidepressants inhibit serotonin reuptake and include the selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and the serotonin reuptake inhibiting tricyclic antidepressants. OBJECTIVE: The objective of this study was to investigate and describe the range and impact of reported adverse visual effects linked to serotonin reuptake inhibiting antidepressants. METHODS: Using data from a global database of patient spontaneous reports of drug adverse events, we systematically identified eligible reports of visual problems linked to the use of serotonin reuptake inhibiting antidepressants. We analyzed these data using simple descriptive statistics to present the …range and impact. RESULTS: We identified 124 reports of visual problems. Reports originate from 18 countries and involve 11 different drugs. The most commonly reported symptoms were vision blurred/visual acuity reduced (n = 79, 63.7%), night blindness (n = 22, 17.7%), vitreous floaters (n = 21, 16.9%), photophobia (n = 19, 15.3%), diplopia (n = 15, 12.1%), palinopsia (n = 13, 10.5%), visual field defect (n = 12, 9.7%), photopsia (n = 11, 8.9%) and visual snow syndrome (n = 11, 8.9%). 74 patients indicated that the side effect was bad enough to affect everyday activities, 62 had sought health care, and 50 indicated that their work had been affected. 49 patients reported an enduring vision problem after discontinuation of treatment. CONCLUSIONS: The data suggest that serotonin reuptake inhibiting antidepressants can produce a range of adverse effects on vision that in some cases can be long-lasting after discontinuation of the drug. Further efforts are needed to understand the mechanisms involved, the incidence among those prescribed these medications, and identify any risk or mitigation factors. Show more

Keywords: Antidepressants, selective serotonin reuptake inhibitors (SSRIs), vision, night blindness, visual snow syndrome

DOI: 10.3233/JRS-210018

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 37-47, 2022

Authors: Ahuja, Varun | Krishnappa, Mohan

Article Type: Review Article

Abstract: BACKGROUND: When more than one drug is manufactured at a shared facility or equipment in pharmaceutical manufacturing, the potential carry-over of the retained residue of existing drug product on product contact parts of the equipment to the next product can be a source of cross contamination. Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. OBJECTIVE: The objective was to present a comprehensive …review of available scientific knowledge for derivation of PDE. METHODS: PubMed and ScienceDirect databases were searched using keywords “PDE” and “pharmaceuticals” and all the relevant literature up to March 2021 was reviewed. We have also calculated PDEs for Tobramycin (CAS No. 32986-56-4) and Acetyl Salicylic Acid (ASA, CAS No. 50-78-2). RESULTS: This research will be useful for scientists working in the PDE domain. The given examples emphasize the importance of use of human data in calculating PDE. CONCLUSION: The duty of the risk assessor entrusted with setting PDEs is to derive a data driven, scientifically justified value that is safe for patients, while avoiding unjustified conservativeness that puts unnecessary burden on manufacturing. Show more

Keywords: HBEL, ADE, PDE, health based exposure limit, acceptable daily exposure, permitted daily exposure

DOI: 10.3233/JRS-210021

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 49-64, 2022

Authors: Healy, David | Bahrick, Audrey | Bak, Maarten | Barbato, Angelo | Calabrò, Rocco Salvatore | Chubak, Barbara M. | Cosci, Fiammetta | Csoka, Antonei B. | D’Avanzo, Barbara | Diviccaro, Silvia | Giatti, Silvia | Goldstein, Irwin | Graf, Heiko | Hellstrom, Wayne J.G. | Irwig, Michael S. | Jannini, Emmanuele A. | Janssen, Paddy K.C. | Khera, Mohit | Kumar, Manoj Therayil | Le Noury, Joanna | Lew-Starowicz, Michał | Linden, David E.J. | Lüning, Celine | Mangin, Dee | Melcangi, Roberto Cosimo | Rodríguez, Omar Walid Muquebil Ali Al Shaban | Panicker, Jalesh N. | Patacchini, Arianna | Pearlman, Amy M. | Pukall, Caroline F. | Raj, Sanjana | Reisman, Yacov | Rubin, Rachel S. | Schreiber, Rudy | Shipko, Stuart | Vašečková, Barbora | Waraich, Ahad

Article Type: Research Article

Abstract: BACKGROUND: A set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin. OBJECTIVE: To develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD). METHODS: The original draft was designed using data from two published case series (Hogan et al., 2014 and Healy et al., 2018), which represent the largest public collections of data on these enduring conditions. It was further developed with the involvement of a …multidisciplinary panel of experts. RESULTS: A set of criteria were agreed upon for each of the above conditions. Features of PSSD, PFS and PRSD commonly include decreased genital and orgasmic sensation, decreased sexual desire and erectile dysfunction. Ancillary non-sexual symptoms vary depending on the specific condition but can include emotional blunting and cognitive impairment. PGAD presents with an almost mirror image of unwanted sensations of genital arousal or irritability in the absence of sexual desire. A new term, post-SSRI asexuality, is introduced to describe a dampening of sexual interest and pleasure resulting from a pre-natal or pre-teen exposure to a serotonin reuptake inhibitor. CONCLUSIONS: These criteria will help in both clinical and research settings. As with all criteria, they will likely need modification in the light of developments. Show more

Keywords: Post-SSRI sexual dysfunction, antidepressants, selective serotonin reuptake inhibitors, finasteride, isotretinoin

DOI: 10.3233/JRS-210023

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 65-76, 2022

Authors: Sweileh, Waleed M.

Article Type: Research Article

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. Show more

Keywords: Off-label, unlicensed, pharmacy practice, bibliometric analysis

DOI: 10.3233/JRS-210012

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 1, pp. 77-89, 2022