Safety and Tolerability of Vitamin D Supplementation in the Vitamin D and Type 2 Diabetes (D2d) Study – A Randomized Trial in Persons With Prediabetes

Objectives The routine use of vitamin D supplements has increased substantially in the United States. However, the safety and tolerability of long-term use of high-dose vitamin D are unknown. We assessed the safety and tolerability of vitamin D3 at a dose of 4000 IU daily in the vitamin D and type 2 diabetes (D2d) trial. Methods Persons with overweight/obesity and prediabetes without a recent history of nephrolithiasis, hypercalcemia, hypercalciuria, or other conditions potentially associated with vitamin D use, were randomized to either daily 4000 IU of vitamin D3 or placebo. Participants were allowed to take vitamin D up to 1000 IU/day and calcium up to 600 mg/day, in addition to study medication. Incident adverse events (AE), defined as any untoward or unfavorable medical occurrence, were ascertained in both groups at in-person visits and interim phone or email encounters four times a year. Serious AEs (SAE) were defined as those AEs that resulted in death, new or prolonged hospitalization, persistent or significant disability, or congenital anomaly or birth defect, or were life threatening or represented another significant hazard. Results A total of 8,304 AEs occurred during three years of follow-up. AEs were less frequent in the vitamin D group compared to placebo [4039 (116.1 events per 100 person-years) vs. 4265 (123.8 events per 100 person-years) (Incidence Rate Ratio [IRR] = 0.94; 95% Confidence Interval (CI) 0.90, 0.98)]. The overall frequency of protocol-specified AEs of interest was low, including nephrolithiasis, hypercalcemia, hypercalciuria, and low estimated glomerular filtration rate (eGFR) with no significant between-group differences. There were also no significant differences between the vitamin D and placebo groups in SAEs (IRR = 0.95; 95% CI 0.81, 1.13). Conclusions Vitamin D3 supplementation at 4,000 IU per day was safe and well-tolerated and did not increase risk of AEs or SAEs, including those typically associated with vitamin D excess such as hypercalciuria or nephrolithiasis. Funding Sources National Institute of Diabetes and Digestive and Kidney Diseases, Office of Dietary Supplements of the National Institutes of Health, the American Diabetes Association.

51 Evaluation of a Clinical Pharmacy Service on an Inpatient Ward in an Acute Hospital

Background Intensive clinical pharmacy input from admission to discharge has been shown to improve patient outcomes. The clinical pharmacy service in our institution has historically been under-resourced. The aim of this study is to develop a ward-based clinical pharmacy service and to evaluate its impact using a number of clinical, safety and financial metrics. Methods A clinical pharmacist was assigned to provide pharmaceutical care to patients on a Medicine for the Older Person ward. Over an eight week period, the pharmacist prospectively recorded her interventions/activities. To assess impact on patient care, interventions were graded according to the Eadon criteria. The potential cost avoidance associated with interventions was estimated. Medication incident reporting was analysed to assess the impact on patient safety. Results 87% of patients had at least one pharmacist intervention, across a spectrum of activities including medication reconciliation and clinical review. 90% of interventions requiring follow-up with the medical team were accepted and resulted in a change to patient’s care. Eadon grading of interventions deemed 99% to be significant, with 81% improving the standard of patient care. Two different methods were used to estimate potential cost avoidance: one estimated annual savings of €154,103 - €344,926; the other estimated these at €174,373. Given current pharmacist salary costs, this equates to a cost-benefit ratio of 2.8:1 to 6.3:1. (This does not include the 27% reduction in drug spend observed during the study period. However, more longitudinal data are required to confirm and characterise this phenomenon.) A five-fold increase in medication incident reporting from the ward was observed, suggestive of an enhanced culture of patient safety. Conclusion This study assessed and quantified a wide spectrum of pharmacist contributions to medication management and safety. Costing of these contributions estimates the cost-benefit ratio of the clinical pharmacy service, providing compelling support for the extension of this service throughout the hospital.

FAKTOR PERAWAT TERHADAP KEJADIAN MEDICATION ADMINISTRATION ERROR DI INSTALASI RAWAT INAP

Medication administration error is one of medication error that happened due to unfulfillment of drug instruction or drug administration that is different with the recipe. From the initial survey conducted in 2015, there were 13 events medication errors known in 2014-2015 in RSU Haji Surabaya. Based on Kepmenkes RI nomor 129/Menkes/SK/II/2008 about Minimum Service Standards, medication incident should not be any error occurred in the Hospital.This study was an observational descriptive study aimed to identify factors that contribute to the incidence of medication errors. Respondents were 56 nurses that worked on 7 inpatient wards. Variablesi n this research are: the skills of nurses, nurse's knowledge, and communication between nurse and patients. The result showed that the incidence of medication error in 2014-2016 amounted to 14 events that occurred in most of the inpatient ward (57.1%). Most of inpatient ward (57.41%) had good skill of nurses, most of the inpatient wards (57.1%) had a sufficient knowledge and communication of nurses.From this study it can be concluded that the skills of nurses, nurse's knowledge, communication between nurse and patients are contributing to the incidence of medication errors in RSU Haji Surabaya. Keywords: inpatient ward, medication errors, nurses

How Do Community-Dwelling Persons with Alzheimer Disease Fall Falls in the FINALEX Study

Background: People with dementia are at high risk for falls. However, little is known of the features causing falls in Alzheimer disease (AD). Our aim was to investigate how participants with AD fall. Methods: In the FINALEX (Finnish Alzheimer Disease Exercise Trial) study, participants’ (n = 194) falls were followed up for 1 year by diaries kept by their spouses. Results: The most common reason for falls (n = 355) was stumbling (n = 61). Of the falls, 123 led to injuries, 50 to emergency department visits, and 13 to fractures. The participants without falls (n = 103) were younger and had milder dementia than those with 1 (n = 34) or ≥2 falls (n = 57). Participants with a Mini Mental State Examination score of around 10 points were most prone to fall. In adjusted regression models, good nutritional status, good physical functioning, and use of antihypertensive medication (incident rate ratio [IRR] 0.68, 95% confidence interval [CI] 0.54–0.85) protected against falls, whereas fall history (IRR 2.71, 95% CI 2.13–3.44), osteoarthritis, diabetes mellitus, chronic obstructive pulmonary disease, higher number of drugs, drugs with anticholinergic properties, psychotropics, and opioids (IRR 4.27, 95% CI 2.92–6.24) were risk factors for falls. Conclusions: Our study provides a detailed account on how and why people with AD fall, suggesting several risk and protective factors.

IMPLEMENTATION OF AN ELECTRONIC PRESCRIPTION CHART FOR GENTAMICIN FOR NEONATAL UNITS AND POSTNATAL WARDS

AimSince the introduction of NICE guidance for Early Onset Neonatal Sepsis (EONS)1 in August 2012, the number of locally reported prescribing and administration errors involving gentamicin has increased. This guideline introduced a new, unfamiliar regimen to staff working on the Neonatal Units and Postnatal wards. Analysis of the errors suggested 36 hourly frequency of gentamicin contributed to the errors due to the complexities of prescribing on the paper drug chart. Our aim was to reduce errors involving gentamicin through the introduction of a Microsoft Excel® based electronic prescription chart.MethodLocal medication incident reports for gentamicin were analysed from 1st September 2013 to 3rd October 2014 (prior to the introduction of the new prescription chart). The new prescription chart was introduced from 5 January 2015. Incident reports continued to be monitored until 30th July 2015.The electronic prescription has specific patient demographics, which need to be completed by the prescriber. The spreadsheet calculates the dose (rounded to give a practical administration volume) and generates a prescription with shaded boxes for the times which do not require administration. Built in to the spreadsheet are features including selecting the correct time for administration (based on the time of an initial dose given) and the dates and times that therapeutic drug monitoring (TDM) is due.The prescription is completed by the neonatal doctors, printed out, signed and stapled to the drug chart. The drugs are administered by midwives on the postnatal wards or nurses in neonatal areas.Each gentamicin dose must be signed for by the prescriber before each dose is given, thus prompting the medical team to review any TDM necessary. The prescription lasts for 7 days and then the frequency of gentamicin changes to 24 hourly so the standard chart is used.ResultsPre-implementation, 18 prescribing errors and 17 administration errors were reported over a 13 month period. Post implementation, there were 8 prescribing errors and 12 administration errors over 7 months. The impact on reported error numbers seems minimal. However, review of error reports suggests that the types of errors have changed. Post-implementation, there were no reports about incorrect frequency, poorly completed prescriptions or TDM errors. Post implementation, the errors now focus around practical aspects of using the prescription chart, for example, ensuring the prescription is attached to a drug chart or a missing signature to say that the gentamicin level had been taken and checked and therefore, the dose had been slightly delayed.ConclusionHistorical medication error reports are likely to represent under-reporting. Due to heightened awareness following implementation, it is suggested that almost all errors are being reported. Our results suggest that the introduction of an electronic prescription has reduced the number of error reports resulting in harm to patients and work is on-going to ensure the effectiveness of the prescription chart is maintained. It will also be developed further, in order to target and reduce the new errors which have been reported.