A517number of expedited approval programs. The objective of this study was to evaluate these programs by examining whether drugs included in them have provided larger health gains than drugs excluded from them. Methods: We considered the FDA's priority review, accelerated approval, and fast-track programs. We estimated health gains in terms of quality-adjusted life-years (QALYs) for drugs approved for the first time between 1999 and 2011, relative to treatments available at the time of their approval. We identified QALY estimates from published cost-utility analyses, and comparative effectiveness studies that estimated relative effectiveness using QALYs. We excluded studies that compared drugs to placebo or no treatment when an alternative active treatment was available, and to be conservative we excluded estimates from studies supported by the pharmaceutical industry. We compared QALY gains for drugs included in the designation programs vs. drugs excluded from them using Mann Whitney U tests. Results: We identified QALY gain estimates for 102 drugs, representing approximately 40% of drugs approved between 1999 and 2011. We included 15 of 37 drugs approved through accelerated approval, 54 of 149 drugs approved through priority review, and 24 of 65 drugs approved through fast-track designation. Drugs in the priority review program had mean QALY gains of 0.35 vs. -0.02 for drugs excluded (p= 0.011). Drugs included in the accelerated approval program had mean QALY gains of 0.43 vs. 0.13 for drugs excluded (p= 0.039). Drugs included in the fast-track designation program had mean QALY gains of 0.34 vs. 0.12 for drugs excluded (p= 0.014). ConClusions: This study suggests that drugs included by FDA in accelerated review programs have larger clinical gains than drugs excluded from the programs.

To compare the health-related quality of life (HRQoL) and the prevalence of depression of older adults with stage 5 chronic kidney disease (CKD) on haemodialysis versus non-dialysis therapy. Methods: This cross-sectional study was conducted in six haemodialysis centres located in the Klang Valley, Malaysia. We administered the EuroQol EQ-5D and the 4-Item Geriatric Depression Scale (GDS-4) to older adults aged 65 and above with stage 5 CKD (eGFR < 15mL/ min/1.73 m2): 100 participants were undergoing haemodialysis and 100 were on optimal medical therapy for at least 90 days. Demographic and clinical data were collected from the medical records. Independent t-test, Pearson's chi-square test, Fisher's exact test and the Mann-Whitney U test were used to compare participant characteristics, EQ-5D index, EQ VAS and GDS-4. Results: Median age for the haemodialysis population was 71 years; 79% were Chinese, 14% Malay, 6% Indian and 1% were from other ethnic origin. Median age of the non-dialysis population was 73 years; 44% were Chinese, 34% Malay, 20% Indian and 2% were from the other ethnic origin. Gender and co-morbid conditions were not statistically different between the groups. The EQ-5D index was significantly lower in the haemodialysis population, median = 0.673 (IQR 0.363-0.814) compared to those on non-dialysis therapy, median = 0.727 (IQR 0.620-0.848), p = 0.02. The participants on haemodialysis scored lower EQVAS, mean (SD) = 54.9 (13.8) compared to the non-dialysis population, mean (SD) = 62.1 (13.4), p < 0.001. Older adults undergoing haemodialysis were more likely to be depressed (GDS-4: 1-4) than those on non-dialysis therapy, χ 2 = 14.5, p < 0.001, OR 3.17. ConClusions: Among older adults with stage 5 CKD, HRQoL was significantly worse among those undergoing haemodialysis compared to those on non-dialysis therapy. Healthcare providers must move beyond traditional renal-specific goals and aggressively treat symptoms in older people undergoing haemodialysis.

No abstract

A557collated and analyzed descriptively. Results: The implementation of LED-guided drug picking significantly reduced near misses for wrong drug [7.18 ± 3.17 vs 2.71 ± 1.36, p< 0.001] and wrong strength [3.47 ± 2.48 vs 1.82 ± 1.13, p= 0.02]. There was no significant difference in the frequency of picking near misses for wrong quantity [17.8 ± 9.88 vs 14.0 ± 4.64, p= 0.162]. Overall, there was a significant reduction in the frequency of total picking near misses [28.4 ± 13.2 vs 18.1 ± 5.44, p= 0.007]. Pharmacy staff's acceptance towards LED-guided picking was generally positive with majority preferring the LED over no LED-guided drug picking. ConClusions: Incorporation of LED into drug picking significantly decreased near misses of wrong drug and strength that potentially prevented costly medication errors. Pharmacy staff were generally receptive to LED-guided picking. PHP249 EvidEncE REviEw GRouP (ERG) cRitiquE of SyStEmatic REviEwS (SR) SubmittEd to nicE aS PaRt of SinGlE tEcHnoloGy aPPRaiSalS (Sta) oR multiPlE tEcHnoloGy aPPRaiSalS (mta) in tHE laSt tHREE yEaRS

A905 health problems using logistic regression models. Results: In multivariate linear analyses controlling for variables representing socio-demographic conditions, health conditions, and lifestyle habits, Both EQ-5D index and VAS scores of older adults declined progressively from good to poor sleep quality; and for sleep durations ranging from 7 to < = 6 hours or from 8 to > = 10 hours. In multivariate logistic analyses, poor sleep quality and extreme sleep durations (short and long) were associated with problems of mobility, pain/discomfort, and anxiety/depression. In both linear and logistic analyses, the associations were more evident for sleep quality than sleep duration. ConClusions: Perceived poor sleep quality and extreme sleep durations were negatively associated with HRQOL in older Chinese adults.