Assessment of clinician adherence to Fingolimod instructions and its effect on patient safety.

OBJECTIVES: To assess clinicians' adherence to fingolimod's effective use according to the prescribed recommendations to reduce safety risk, identify the consequences, and highlight areas for improvement to policy makers for the benefit of both patient and care-giver. METHODS: A retrospective observational study conducted at a tertiary hospital targeting multiple sclerosis patients on fingolimod from January 2017 to December 2021. The physicians' adherence to the manufacturer's instructions was assessed and categorized into good, moderate, and poor based on adherence to fingolimod instructions and monitoring measures. Four monitoring measures were assessed: bradycardia observation, ophthalmic examination, liver enzymes, and infections. In addition, the impact of adherence on patient safety was also assessed. RESULTS: A total of 140 patients were included. Seventy-twopatients (51.4%) had physician with poor adherence (followed only one instruction or none). Sixty-five patients (46.4%) had 2-3 manufacture recommendations where physician's adherence was moderate. Three patients (2.10%) had all manufacturer's recommendations. In terms of fingolimod complications, 18 patients found to have bradycardia after the first does, macular oedema and infections was reported in 4 patients, and the elevation in hepatic enzymes was reported in 6 patients. Poor physician's adherence has resulted in treatment incompleteness and highest fingolimod discontinuation or switching to other treatment options. CONCLUSION: Adherence to fingolimod instructions was poor among physicians which resulted in highest drug switching or discontinuing rate.

The Prevalence of Prescribing Inappropriate Medications Among Older Adults in Saudi Arabia with Dementia Based on Beers Criteria: A Retrospective Study.

Background: Dementia is a common neurogenerative disease among older adults. Therefore, they are more prone to potentially inappropriate medication (PIM), which is medication that causes more harm rather than protecting the health of an individual. Hence, the American Geriatrics Society (AGS) has recognized the risk of certain medication classes on this population and released PIM according to Beers criteria, which is a helpful guide for clinicians to ensure the safety of medication before it is prescribed. The aim of this study is to assess the prevalence of PIM use among older adults with dementia as a risk factor in comparison to other older adults without dementia. Methods: A retrospective study was conducted in an outpatient setting in a tertiary hospital targeting elderly patients aged 65 years old or over from January 2020 to September 2022. A total of 598 patients were screened, and 270 patients met the inclusion criteria. The eligible patients were then divided into two groups: 168 were in a non-dementia group and 102 were in a dementia group. Results: PIM use was reported in patients with and without dementia. The most inappropriate medication that was prescribed comprised atypical antipsychotics PIM for both patients with and without dementia. However, the prevalence was higher in the dementia group for quetiapine (75% vs 24% respectively), olanzapine (82% vs 17% respectively) or risperidone (92% vs 7%, respectively). Anticholinergics were highly prescribed in older adult without dementia as compared to dementia patient and was statistically significant for solifenacin (96% vs.3.6% respectively) and amitriptyline (88% vs 11% respectively). Conclusion: Among elderly patients in outpatient care settings, the prevalence of PIM use is considered high in dementia patients for antipsychotics, while a higher use of benzodiazepine and anticholinergics was found in non-dementia patients.

Characteristics and causes of reported clozapine-related medication errors: analysis of the Ministry of Health database in Saudi Arabia.

BACKGROUND: Clozapine has shown great efficacy in treating treatment-resistant schizophrenia, but it is associated with a variety of medication- related safety problems. Despite this, there remains a lack of research on medication errors (MEs) associated with its use. AIM: To characterize the nature and contributory factors of clozapine-related MEs reported from government hospitals and primary care centres in Saudi Arabia (SA). METHOD: A cross-sectional analysis was carried out on MEs related to clozapine use reported to the General Administration of Pharmaceutical Care at the Ministry of Health (MOH) in Saudi Arabia between 2018 and 2022. The data were analysed descriptively to examine the nature and contributory factors of MEs. RESULTS: A total of 1,165 MEs were reported. The majority of reported errors involved patients aged > 18 years old, with 72.2% (n = 841) being male. The central region was found to report errors more frequently (32.3%, n = 376). Pharmacists were reported to detect errors most frequently (59.6%, n = 695). MEs most often occurred in the prescribing stage (77.8%, n = 906), with "missing prescription information" (30.1%, n = 351) being the most frequent finding. The most frequent contributing factor was the lack of policy (33.1%, n = 351). The majority of errors did not reach the patients (92.3%, n = 1,075), and those that did reach patients rarely resulted in harm (0.3%, n = 2). CONCLUSION: This study identified areas for improvement which could expedite the development of remedial interventions to reduce the risk of errors.

The Contraindications to Combined Oral Contraceptives among Reproductive-Aged Women in an Obstetrics and Gynaecology Clinic: A Single-Centre Cross-Sectional Study.

This study aimed to determine the estimated proportion of contraindications among women taking combined oral contraceptives (COCs) and to assess the risk factors associated with their contraindications. This study was cross-sectional. Reproductive-aged women (18-49 years) on any COCs between 2018 and 2020 were recruited from one obstetrics-gynaecology clinic in a university-affiliated hospital and were included. Contraindications were defined using the World Health Organization (WHO) Medical Eligibility Criteria (MEC) for Contraceptive Use. Data were collected from electronic medical records for all included women, as well as a standardised, pretested, structured survey for one-third of the women. In this cross-sectional study, 380 women using COCs were included. Their mean age was 31.645 ± 7.366 years. Among them, 131 (34.5%) participated via a survey and electronic records, while the other 249 (65.5%) participated via electronic records only. The majority of the participants had a Bachelor's degree (59.0%) and were married (62.1%). The overall estimated proportion of patients with at least one contraindication to COCs according to category 3 (relative contraindications) or 4 (absolute contraindications) was 31.3% (95% CI 26.63-35.99). The most common contraindications observed were controlled hypertension, category 3 (12.1%); major surgery with prolonged immobilisation, category 4 (4.7%); migraine with aura at any age, category 4 (4.2%); breastfeeding from six weeks to less than six months postpartum, category 3 (4.0%); and diabetes mellitus with complications, category 4 (3.2%). Significant factors associated with contraindications to COCs were married women (OR 2.19, 95% CI 1.38-3.46), those aged 35 years or more (OR 2.33, 95% CI 1.49-3.66), and those with one or more live births (OR 2.19, 95% CI 1.38-3.46). Ensuring proper assessment prior to prescribing and considering alternatives suitable for long-term use among women taking an oral contraceptive regularly is recommended.

Medication Safety in Mental Health Hospitals: A Mixed-Methods Analysis of Incidents Reported to the National Reporting and Learning System.

BACKGROUND: Medication safety incidents commonly occur in mental health hospitals. There is a need to improve the understanding of the circumstances that are thought to have played a part in the origin of these incidents to design safer systems to improve patient safety. AIM: This study aimed to undertake a mixed-methods analysis of medication safety incidents reported to the National Reporting and Learning System in England and Wales in 2010 to 2017. METHOD: Quantitative analyses of anonymized medication safety incidents occurring in mental health hospitals that were reported to the National Reporting and Learning System during an 8-year period were undertaken to characterize their type, severity, and the medication(s) involved. Second, a content analysis of the free-text reports associated with all incidents of at least moderate harm severity was undertaken to identify the underlying contributory factors. RESULTS: Overall, 94,134 medication incident reports were examined, of which 10.4% (n = 9811) were reported to have resulted in harm. The 3 most frequent types of reported medication incidents involved omission of medication (17,302; 18.3%), wrong frequency (11,882; 12.6%), and wrong/unclear dose of medication (10,272; 10.9%). Medicines from the central nervous system (42,609; 71.0%), cardiovascular (4537; 7.6%), and endocrine (3669; 6.1%) medication classes were the most frequently involved with incidents. Failure to follow protocols (n = 93), lack of continuity of care (n = 92), patient behaviors (n = 62), and lack of stock (n = 51) were frequently reported as contributory factors. CONCLUSIONS: Medication incidents pose an enduring threat to patient safety in mental health hospitals. This study has identified important targets that can guide the tailored development of remedial interventions.

Prevalence, Nature, Severity and Preventability of Adverse Drug Events in Mental Health Settings: Findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) Study.

INTRODUCTION: Adverse drug events (ADEs) constitute a significant problem in hospitals worldwide. However, little is known about their burden in mental health hospitals. OBJECTIVE: The objective of this study was to determine the prevalence, nature, severity and preventability of ADEs across three mental health trusts in England. METHODS: Trained clinical pharmacists retrospectively screened randomly sampled medical records to identify ADEs. An expert panel assessed all suspected ADEs to determine their causality, preventability and severity. Multivariable regression analysis (adjusted for clustering between hospitals) examined risk factors associated with ADEs. RESULTS: In total, 227 patient admissions comprising 10,164 patient-days of follow-up were included in the study. The adjusted rate of confirmed ADEs was 12.6 (95% confidence interval [CI] 5.6-26.0) per 100 admissions and 2.6 (95% CI 1.0-6.9) per 1000 patient-days, with almost a fifth of these ADEs judged as preventable 19.1% (n = 9/47). The majority of ADEs were of at least moderate clinical severity (29/47; 61.7%), and medicines from the central nervous system class were most commonly implicated in ADEs (45/47; 95.7%) including antipsychotics (31/45; 68.8%) and antidepressants (7/45; 15.5%). Patients with a hospital stay of more than 30 days (odds ratio 16.58, 95% CI 3.77-72.85) and patients with a stay of 8-30 days (odds ratio 5.32, 95% CI 1.22-23.07) were more likely to experience an ADE compared with patients with a stay of 1-7 days. CONCLUSIONS: Adverse drug events in National Health Service mental health hospitals pose an important threat to patient safety. Targets for remedial interventions have been suggested for further exploration to improve patient safety in this setting.

Prevalence, nature and predictors of omitted medication doses in mental health hospitals: A multi-centre study.

OBJECTIVE: Limited evidence concerning the burden and predictors of omitted medication doses within mental health hospitals could severely limit improvement efforts in this specialist setting. This study aimed to determine the prevalence, nature and predictors of omitted medication doses affecting hospital inpatients in two English National Health Service (NHS) mental health trusts. METHODS: Over 6 data collection days trained pharmacy teams screened inpatient prescription charts for scheduled and omitted medication doses within 27 adult and elderly wards across 9 psychiatric hospitals. Data were collected for inpatients admitted up to two weeks prior to each data collection day. Omitted doses were classified as 'time critical' and 'preventable' based on established criteria. Omitted dose frequencies were presented with 95% confidence intervals (CI). Multilevel logistic regression analyses determined the predictors of omitted dose occurrence, with omission risks presented as adjusted odds ratios (OR) with 95% CI. RESULTS: 18,664 scheduled medication doses were screened for 444 inpatients and 2,717 omissions were identified, resulting in a rate of 14.6% (95% CI 14.1-15.1). The rate of 'time critical' omitted doses was 19.3% (95% CI 16.3-22.6%). 'Preventable' omitted doses comprised one third of all omissions (34.5%, 930/2694). Logistic regression analysis revealed that medicines affecting the central nervous system were 55% less likely to be omitted compared to all other medication classes (9.9% vs. 18.8%, OR 0.45 (0.40-0.52)) and that scheduled doses administered using non-oral routes were more likely to be omitted compared the oral route (inhaled OR 3.47 (2.64-4.57), topical 2.71 (2.11-3.46), 'other' 2.15 (1.19-3.90)). 'Preventable' dose omissions were more than twice as likely to occur for 'time critical' medications than non-time critical medications (50.4% vs. 33.8%, OR 2.24 (1.22-4.11)). CONCLUSIONS: Omitted medication doses occur commonly in mental health hospitals with 'preventable' omissions a key contributor to this burden. Important targets for remedial intervention have been identified.

Frequency and Nature of Medication Errors and Adverse Drug Events in Mental Health Hospitals: a Systematic Review.

INTRODUCTION: Little is known about the frequency and nature of medication errors (MEs) and adverse drug events (ADEs) that occur in mental health hospitals. OBJECTIVES: This systematic review aims to provide an up-to-date and critical appraisal of the epidemiology and nature of MEs and ADEs in this setting. METHOD: Ten electronic databases were searched, including MEDLINE, Embase, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Scopus, British Nursing Index, ASSIA, Web of Science, and Cochrane Database of Systematic Reviews (1999 to October 2016). Studies that examined the rate of MEs or ADEs in mental health hospitals were included, and quality appraisal of the included studies was conducted. RESULT: In total, 20 studies were identified. The rate of MEs ranged from 10.6 to 17.5 per 1000 patient-days (n = 2) and of ADEs from 10.0 to 42.0 per 1000 patient-days (n = 2) with 13.0-17.3% of ADEs found to be preventable. ADEs were rated as clinically significant (66.0-71.0%), serious (28.0-31.0%), or life threatening (1.4-2.0%). Prescribing errors occurred in 4.5-6.3% of newly written or omitted prescription items (n = 3); dispensing errors occurred in 4.6% of opportunities for error (n = 1) and in 8.8% of patients (n = 1); and medication administration errors occurred in 3.3-48.0% of opportunities for error (n = 5). MEs and ADEs were frequently associated with psychotropics, with atypical antipsychotic drugs commonly involved. Variability in study setting and data collection methods limited direct comparisons between studies. CONCLUSION: Medication errors occur frequently in mental health hospitals and are associated with risk of patient harm. Effective interventions are needed to target these events and improve patient safety.