Objectives
Large population-based studies examining frailty trajectory found a linear increase in frailty over time. The pattern in which frailty changes over time for an individual person is less ...well-described. We examined the frailty trajectory of older adults living in aged-care in Australia.
Materials and methods
This secondary study used data from a randomised controlled trial involving 39 aged-care facilities in Australia. The trial intervention was an on-going pharmacist-led intervention occurring every 8 weeks over 12 months aimed at preventing medicine-induced deterioration and adverse reactions. Frailty was assessed using the Frailty Index. Participants were categorised as non-frail, pre-frail and frail. Individual frailty trajectory over 12 months was visualised using the alluvial plot. Case notes were examined to explore reasons for any rapid transitions in frailty status.
Results
A total of 248 participants was included. At baseline, 40.3% were non-frail and 59.7% were pre-frail. The proportion of participants who were non-frail and pre-frail decreased over time; 15.7% were frail at 6 months and 23.4% were frail at 12 months. Overall, twenty different combinations of frailty transitions were identified over 12 months. Retrospective analysis of case notes suggest that death or transition from non-frail to frail was often preceded by hospitalisation, falls, medication change or clinically significant deterioration in grip strength or cognition.
Conclusion
The degree of frailty increased over time, but there were variations in the individual trajectories. Regular monitoring of events that precede changes in frailty status is needed to identify strategies to prevent further deterioration in residents’ conditions.
Sequence symmetry analysis (SSA) is a potential tool for rapid detection of adverse drug events (ADRs) associated with newly marketed medicines utilizing computerized claims data. SSA is robust to ...patient specific confounders but it is sensitive to the underlying utilization trends in the medicines of interest. Methods to adjust for utilisation trends have been developed, however, there has been no systematic investigation to assess the performance of SSA when variable prescribing trends occur. The objective of this study was to evaluate the validity of SSA as a signal detection tool for newly marketed medicines.
Randomly simulated prescription supplies for a population of 1 million were generated for two medicines, DrugA (medicine of interest) and DrugB (medicine indicative of an adverse event). Scenarios were created by varying medicine utilization trends for a newly marketed medicine (DrugA). In addition, the magnitude of association between DrugA and DrugB was varied. For each scenario 1000 simulations were generated. Average Adjusted Sequence Ratios (ASR), bootstrapped 95% confidence intervals (CIs), percentage of CI's which covered the expected ASR and percent relative bias were calculated.
When no association was simulated between DrugA and DrugB, over 95% of SSA CI's covered the expected ASR (ASR = 1) and relative bias was 1% or less irrespective of medicine utilization trends. In scenarios where DrugA and DrugB were associated (ASR = 2), unadjusted SR's were underestimated by between 11.7 and 15.3%. After adjustment for trend, ASR estimates were close to expected with relative bias less than 1%. Power was over 80% in all scenarios except for one scenario in which medicine uptake was gradual and the effect of interest was weak (ASR = 1.2).
Adjustment for underlying medicine utilization patterns effectively overcomes potential under-ascertainment bias in SSA analyses. SSA may be effectively applied as a safety signal detection tool for newly marketed medicines where sufficiently large health claim data are available.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Pain is an indication for total hip arthroplasty (THA) and it should be resolved post-surgery. Because patients' pain is typically treated pharmacologically we tested whether opioid use can be used ...as a surrogate for patient-reported pain and as an indicator for early surgical failure. Specifically, we evaluated whether the amount of opioids taken within the year after THA was associated with one and five years risk of revision surgery.
A cohort of 9943 THAs (01/2001-12/2012) was evaluated. Post-operative opioid use was the exposure of interest and cumulative daily oral morphine equivalent (OME) amounts were calculated. Total OMEs/90-day periods were categorised into quartiles. Revisions within one and five years were the outcomes of interest.
Of the THAs, 2.0 % (N = 200) were revised within one year and 4.2 % (N = 413) within five years. After adjustments for gender, age, surgical indication, co-morbidities, and other analgesics, revision was associated with amount of OMEs in the second quarter after THA (days 91-180 after discharge). Patients on medium-high amounts of OME (400-1119 mg) had higher risk of one (hazard ratio (HR) = 2.22, 95 % CI 1.08-4.56) and five year (HR = 1.66, 95 % CI 1.08-2.56) revision than a patient not taking opioids. During the same period, patients taking the highest amounts of OMEs (≥1120 mg) had a 2.64 (95 % CI 1.03-6.74) times higher risk of one year and a 2.11 (95 % CI 1.13-3.96) times higher risk of five year revision.
Opioid use 91-180 days post-surgery is associated with higher risk of revision surgery and therefore is an early and useful indicator for surgical failure.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Objective
To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions.
Design and setting
Multicenter, ...open-label parallel randomised controlled trial involving 39 Australian aged-care facilities.
Participants
Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine.
Intervention
Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months.
Comparator
Usual care (Residential Medication Management Review) provided by accredited pharmacists.
Outcomes
Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life.
Results
248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: −0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength.
Conclusions
The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.
Purpose
The safety of nonsteroidal anti‐inflammatory drugs (NSAIDs) commonly used in Asia‐Pacific countries has had limited study. We assessed the risk of hospitalization for gastrointestinal events ...with loxoprofen and mefenamic acid compared with other NSAIDs in Asia‐Pacific populations.
Methods
We conducted a cohort study using a distributed network with a common data model in Australia, Hong Kong, Japan, Korea, and Taiwan. We included patients who initiated diclofenac, loxoprofen, mefenamic acid, or celecoxib and followed them until their first gastrointestinal hospitalization, switch or discontinuation of medication, disenrollment, or end of database coverage. We used Cox proportional hazards models to assess hospitalization risk.
Results
We identified 9879 patients in Japan, 70 492 in Taiwan, 263 741 in Korea, and 246 in Hong Kong who initiated an NSAID, and 44 013 patients in Australia, a predominantly Caucasian population. The incidence of gastrointestinal hospitalization was 25.6 per 1000 person‐years in Japan, 32.8 in Taiwan, 11.5 in Korea, 484.5 in Hong Kong, and 35.6 in Australia. Compared with diclofenac, the risk of gastrointestinal events with loxoprofen was significantly lower in Korea (hazards ratio, 0.37; 95% CI, 0.25‐0.54) but not in Japan (1.65; 95% CI, 0.47‐5.78). The risk of gastrointestinal events with mefenamic acid was significantly lower in Taiwan (0.45; 95% CI, 0.26‐0.78) and Korea (0.11; 95% CI, 0.05‐0.27) but not Hong Kong (2.16; 95% CI, 0.28‐16.87), compared with diclofenac.
Conclusions
Compared with diclofenac, loxoprofen was associated with a lower risk of gastrointestinal hospitalizations in Korea and mefenamic acid with a lower risk in Taiwan and Korea.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Results from a previous study showed that 40 to 60% of the price of off-patent medicines in Vietnam was typically spent to induce prescribers to use the medicines, and to persuade procurement ...officers within hospitals to buy them. In this article we examine how and why inducements were paid by the pharmaceutical industry to health care providers in Vietnam.
We use a theoretically informed analysis to understand pharmaceutical companies' account of giving inducements and prescribers' account of taking them, elicited through in-depth interviews.
Analysis of the emergent concepts derived from our qualitative data led to viewing the constructs from the theoretical framework of opportunities; pressures; and rationalization within a hierarchy of systemic factors and individual factors. Economic survival pressures in an imperfectly competitive market reportedly encouraged pharmaceutical companies and prescribers to be linked financially. Although individual factors such as professional ethics and personal values influenced doctors' responses to corrupt practices, entrenched systemic issues, including lack of transparency, accountability, poor enforcement of legislation and prevalence of corruption emerged as important factors supporting corrupt practice or even making it very difficult for individuals to opt out of corrupt practices.
Our theoretically informed analysis of inducements provides an in-depth understanding of an angle of corruption in Vietnam's health sector, showing the need for multifaceted strategies in the fight against corruption in the health sector. Remedial strategies need to address both systemic and individual factors including interventions to relieve dependencies for survival of health care services on the corrupt system.
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CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
Aged care residents are vulnerable to the harmful effects of medicines; however, data on the prevalence and preventability of adverse medicine events in aged care residents are scarce.
Aim
...To determine the prevalence and preventability of adverse medicine events in Australian aged care residents.
Methods
A secondary analysis of data from the Reducing Medicine-Induced Deterioration and Adverse Reactions (ReMInDAR) trial was conducted. Potential adverse medicine events were identified and independently screened by two research pharmacists to produce a short-list of potential adverse medicine events. An expert clinical panel reviewed each potential adverse medicine to determine the likelihood that the event was medicine related (based on the Naranjo Probability Scale criteria). The clinical panel assessed preventability of medicine-related events using Schumock-Thornton criteria.
Results
There were 583 adverse events due to medicines, involving 154 residents (62% of the 248 study participants). There was a median of three medication-related adverse events (interquartile range IQR 1–5) per resident over the 12-month follow-up period. The most common medication-related adverse events were falls (56%), bleeding (18%) and bruising (9%). There were 482 (83%) medication-related adverse events that were preventable, most commonly falls (66% of preventable adverse medicine events), bleeding (12%) and dizziness (8%). Of the 248 residents, 133 (54% of the cohort) had at least one preventable adverse medicine event, with a median of 2 (IQR 1–4) preventable adverse medicine events per resident.
Conclusion
In total, 62% of aged care residents in our study had an adverse medicine event and 54% had a preventable adverse medicine event in a 12-month period.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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