International Journal of Risk & Safety in Medicine - Volume 32, issue 4
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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: Pityriasis rubra pilaris (PRP) is a rare, acquired, chronic papulosquamous dermatosis which can occur in all ages. PRP can be associated with infection, autoimmunity, drugs and malignancies, and can be idiopathic. OBJECTIVE: PRP following vaccination has been rarely described in the literature. To the best of our knowledge, we report the first case of PRP two weeks following COVID-19 vaccination (Covishield). CASE REPORT: A 72-year-old male presented to the outpatient dermatology department at All India Institute of Medical Sciences – Bhopal with minimally pruritic superficial plaques since one week. The patient was vaccinated against COVID-19…with Covishield two weeks earlier. The lesions developed as erythematous scaly follicular papules and plaques over axilla that rapidly spread to the trunk in the following weeks and involved palms and soles as well as thickening and fissuring. The clinical features suggested PRP. The histopathology showed epidermal acanthosis with hypergranulosis alternating with parakeratosis and orthokeratosis with broad rete ridges with follicular plugging. The patient had started taking topical corticosteroids and emollients, which proved effective. There was no recurrence after receiving a second dose on follow-up. CONCLUSION: In patients presenting with new onset PRP in this COVID-19 era, the possibility of vaccine as a trigger should be taken into consideration, and further dosing should be carefully monitored in view of possible recurrence.
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. OBJECTIVE: 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 in the adult population 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 a potentially 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: 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: Post-SSRI sexual dysfunction (PSSD) is an underrecognized and poorly understood medical condition characterized by sexual dysfunction that persists despite SSRI discontinuation. OBJECTIVE: We conducted a survey of individuals with PSSD to better characterize this condition and its impact on various quality of life concerns. METHODS: Surveys were distributed to an online support group for individuals with PSSD. Surveys assessed medications suspected of causing PSSD and symptoms experienced during and after treatment. Respondents reported the trajectory of their condition, the efficacy of different treatments, and the impact of PSSD on their quality of life.…RESULTS: 239 survey responses were included in this study. A majority of respondents had a history of SSRI use (92%) compared to only SNRI or atypical antidepressant use (8%). The overall severity of symptoms improved for 45% and worsened or remained the same for 37% of respondents after discontinuing treatment with serotonin reuptake inhibitors. Only 12% of respondents reported being counseled regarding potential sexual dysfunction while taking antidepressants. The majority rated the effect of PSSD on their quality of life as extremely negative (59%) or very negative (23%). CONCLUSION: PSSD can have an overwhelmingly negative impact on quality of life. Currently, it is unclear why certain individuals develop PSSD and there are no definitive treatments for this condition. Further research of PSSD and greater awareness of this condition is needed among prescribers of serotonin reuptake inhibitors to improve patient care.
Keywords: Post-SSRI sexual dysfunction, selective serotonin reuptake inhibitors, sexual dysfunction, adverse effects, drug side effects
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