Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis with Antiepileptic Drugs: An Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS)

Objective Stevens‐Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and potentially fatal adverse skin reactions that are most commonly triggered by certain medications. One class of medications that has been highly associated with SJS/TEN reactions is antiepileptic drugs (AEDs). We sought to quantify the risk of SJS/TEN associated with AEDs as a class, as well as individual AEDs, in the United States. Methods An analysis was performed of the US Food and Drug Administration Adverse Event Reporting System (FAERS) from July 2014 through December 2017. Rates of SJS/TEN were calculated for each AED compared with all other non‐AEDs. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and 95% confidence intervals (CIs) were calculated using OpenEpi. Results With 198 reports, AEDs had more reports of SJS/TEN than any other medication class. AEDs as a class had an ROR of 8.7 (95% CI 7.5‐10.2) and a PRR of 8.7 (95% CI 7.5‐10.2) compared with all other non‐AEDs. The AEDs with the highest risk estimates were zonisamide (ROR 70.2, 95% CI 33.1‐148.7; PRR 68.7, 95% CI 32.9‐143.5), rufinamide (ROR 60.0, 95% CI 8.3‐433.5; PRR 58.9, 95% CI 8.4‐411.5), clorazepate (ROR 56.0, 95% CI 7.8‐404.1; PRR 55.1, 95% CI 7.8‐385.0), lamotrigine (ROR 53.0, 95% CI 43.2‐64.9; PRR 52.2, 95% CI 42.7‐63.7), phenytoin (ROR 26.3, 95% CI 15.5‐44.7; PRR 26.1, 95% CI 15.4‐44.2), and carbamazepine (ROR 24.5, 95% CI 16.0‐37.5; PRR 24.3, 95% CI 16.0‐37.1). Significance Although AEDs as a class were associated with 9 times the risk of SJS/TEN compared with non‐AEDs, there were 6 AEDs with risk estimates greater than 20. Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS/TEN signs/symptoms, may help mitigate the number and severity of these adverse events

Geriatric Assessment for the Nephrologist

Dialysis providers are increasingly being presented with progressively older and frailer patients, in all healthcare settings from the acute hospital to the community dialysis center. These patients commonly bring more than kidney failure with them, with a complex constellation of chronic illness, comorbidity, and functional and cognitive impairment. Navigating these challenges and coordinating the care of these highly complex patients significantly increase the work of the whole dialysis team. This article reviews the role of Comprehensive Geriatric Assessment in these patients and discusses how each of its elements interacts with routine dialysis care.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/94506/1/sdi.12027.pd

Consequences of an Intervention to Reduce Restrictive Side Rail Use in Nursing Homes

To examine the effect of an advanced practice nurse (APN) intervention on restrictive side rail usage in four nursing homes and with a sample of 251 residents. A secondary question explored the association between restrictive side rail reduction and bed-related falls. DESIGN : Pre- and posttest design. SETTING : Four urban nursing homes. PARTICIPANTS : All nursing home residents present in the nursing home at three time points (n=710, 719, and 707) and a subset of residents (n=251) with restrictive side rail use at baseline. INTERVENTION : APN consultation with individual residents and facility-wide education and consultation. MEASUREMENTS : Direct observation of side rail status, resident and nurse interview for functional status, mobility, cognition, behavioral symptoms, medical record review for demographics and treatment information, and incident reports for fall data. RESULTS : At the institutional level, one of the four nursing homes significantly reduced restrictive side rail use ( P =.01). At the individual participant level, 51.4% (n=130) reduced restrictive side rail use. For the group that reduced restrictive side rails, there was a significantly ( P <.001) reduced fall rate (−0.053; 95% confidence interval (CI)=−0.083 to −0.024), whereas the group that continued restrictive side rail did not demonstrate a significantly ( P =.17) reduced fall rate (−0.013; 95% CI=−0.056–0.030). CONCLUSION : An APN consultation model can safely reduce side rail use. Restrictive side rail reduction does not lead to an increase in bed-related falls. Although side rails serve many purposes, routine use of these devices to restrict voluntary movement and prevent falls is not supported.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/65685/1/j.1532-5415.2007.01082.x.pd

Evaluation of risk of falls and orthostatic hypotension in older, long-term topical beta-blocker users

Background: Falls are a serious problem in the elderly, and have recently been described as cardiovascular-mediated side effects of beta-blocker eye drops. Therefore, we investigated the possible association between the long-term use of beta-blockers, prostaglandins and their combinations in eye drops, and falls, dizziness and orthostatic hypotension in older patients. Methods: All participants were long-term users of eye drops containing beta-blockers, prostaglandins or their combinations. They underwent a structured falls interview and blood pressure measurement for testing of orthostatic hypotension. The odds ratio for presence of orthostatic hypotension or a positive falls history according to use of beta-blocker eye drops was calculated with a binary logistic regression analysis. The main outcome measures were a positive falls history and the presence of orthostatic hypotension. Results: In total, 148 of 286 subjects participated. After adjustment for age, gender, and use of fall-risk-increasing drugs other than beta-blocker eye drops, we found no significant difference in fall risk [odds ratio (OR): 0.60; 95% confidence interval (CI): 0.268-1.327] between patients using ophthalmic beta-blockers or a combination of ophthalmic beta-blockers and prostaglandins, and patients using ophthalmic prostaglandins only. Although prevalence of orthostatic hypotension was higher in the beta-blocker group (OR: 1.67; 95% CI: 0.731-3.793) compared to the prostaglandin group, this was a non-significant difference. Conclusions: In our study, we did not find a significant association between long-term use of beta-blockers eye drops and falls, dizziness or orthostatic hypotension in older ophthalmic outpatients, compared to long-term use of prostaglandin eye drops

Can Fire and Rescue Services and the National Health Service work together to improve the safety and wellbeing of vulnerable older people? Design of a proof of concept study

Older adults are at increased risk both of falling and of experiencing accidental domestic fire. In addition to advanced age, these adverse events share the risk factors of balance or mobility problems, cognitive impairment and socioeconomic deprivation. For both events, the consequences include significant injury and death, and considerable socioeconomic costs for the individual and informal carers, as well as for emergency services, health and social care agencies.Secondary prevention services for older people who have fallen or who are identifiable as being at high risk of falling include NHS Falls clinics, where a multidisciplinary team offers an individualised multifactorial targeted intervention including strength and balance exercise programmes, medication changes and home hazard modification. A similar preventative approach is employed by most Fire and Rescue Services who conduct Home Fire Safety Visits to assess and, if necessary, remedy domestic fire risk, fit free smoke alarms with instruction for use and maintenance, and plan an escape route. We propose that the similarity of population at risk, location, specific risk factors and the commonality of preventative approaches employed could offer net gains in terms of feasibility, effectiveness and acceptability if activities within these two preventative approaches were to be combined

Evaluation of postural balance in postmenopausal women and its relationship with bone mineral density- a cross sectional study

Background: Low bone mineral density (BMD) and falls are common problems encountered in the postmenopausal women. The purpose was to evaluate the association between postural balance and BMD in postmenopausal women and its relation to risk for falls.Methods: In this cross-sectional study, 225 women in amenorrhea > 12 months and age >= 45 years were included and divided, according to BMD, in T-score values > -2.0 SD (n = 140) and <= -2 SD (n = 85). Those with neurological or musculoskeletal disorders, history of vestibulopathies, uncorrected visual deficit or drug use that could affect balance were excluded. History of falls (last 24 months), clinical and anthropometric characteristics were evaluated. Postural balance was assessed by stabilometry (force platform). For statistical analysis were used Wilcoxon's Test, Chi-Square Test and logistic regression method for fall risk (Odds Ratio-OR).Results: Patients with BMD > -2.0 SD were younger, with shorter time since menopause, and showed higher BMI as compared to those with low BMD (<= -2 SD) (p < 0.05). It was observed that 57.8% of the participants reported fall episodes without significant difference distribution between the groups (p = 0.055). No differences were found from the comparison between the groups (p > 0.05) for stabilometric parameters. Risk for falls increased with age (OR 1.07; CI 95% 1.01-1.13), current smoking (OR 2.19; CI 95% 1.22-3.21) and corrected visual deficit (OR 9.06; CI 95% 1.14-4.09). In contrast, hormone therapy (HT) use was significantly associated with reduced risk for falls (OR 0.48; CI 95% 0.26-0.88).Conclusions: In postmenopausal women, BMD did not show association with postural balance or risk for falls. Age, smoking and corrected visual deficit were clinical indicators of risk for falls whereas HT use showed to be a protective factor

The development of a multidisciplinary fall risk evaluation tool for demented nursing home patients in the Netherlands

BACKGROUND: Demented nursing home patients are at high risk for falls. Falls and associated injuries can have a considerable influence on the autonomy and quality of life of patients. The prevention of falls among demented patients is therefore an important issue. In order to intervene in an efficient way in this group of patients, it is important to systematically evaluate the fall risk profile of each individual patient so that for each patient tailor-made preventive measures can be taken. Therefore, the objective of the present study is to develop a feasible and evidence based multidisciplinary fall risk evaluation tool to be used for tailoring preventive interventions to the needs of individual demented patients. METHODS: To develop this multidisciplinary fall risk evaluation tool we have chosen to combine scientific evidence on the one hand and experts' opinions on the other hand. Firstly, relevant risk factors for falling in elderly persons were gathered from the literature. Secondly, a group of Dutch experts in the field of falls and fall prevention in the elderly were consulted to judge the suitability of these risk factors for use in a multidisciplinary fall risk evaluation tool for demented nursing home patients. Thirdly, in order to generate a compact list of the most relevant risk factors for falling in demented elderly, all risk factors had to fulfill a set of criteria indicating their relevance for this specific target population. Lastly the final list of risk factors resulting from the above mentioned procedure was presented to the expert group. The members were also asked to give their opinion about the practical use of the tool. RESULTS: The multidisciplinary fall risk evaluation tool we developed includes the following items: previous falls, use of medication, locomotor functions, and (correct) choice and use of assistive and protective devices. The tool is developed for the multidisciplinary teams of the nursing homes. CONCLUSION: This evidence and practice based multidisciplinary fall risk evaluation tool targets the preventive interventions aimed to prevent falls and their negative consequences in demented nursing home patients

Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

Background: Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS) software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design: Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion: Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care trial will provide rigorous evidence on the clinical and cost effectiveness of CCDS for paramedics in the care of older people who have fallen