Alcusky, M.J.

Del Canale, S.

Hegarty, S.E.

Keith, S.W.

Lombardi, M.

Maio, V.

Vegesna, A.

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PHP95 Is there an Association between potentially inappropriate prescribing in the elderly and Hospitalization and Mortality? a Longitudinal, large Cohort study 

A86  VA L U E  I N  H E A LT H  1 8  ( 2 0 1 5 )  A 1 – A 3 0 7  
those of EU and IDF criteria were 91.8% and 86.9% respectively. Similarly the NPV 
was highest for the NCEP criteria followed by the EU (99.3%) and IDF (98.3%) criteria. 
The kappa-statistics showed highest agreement with the NCEP criteria (kappa= 0.90) 
while the IDF (kappa= 0.46) and EU criteria (kappa= 0.33) displayed moderate and 
fair levels of agreement respectively with the WHO criteria. CONCLUSIONS: Our 
findings demonstrate that NCEP criteria displayed best performance parameters 
relative to WHO criteria and may serve as alternative to the WHO criteria when 
comparing other definitions used in older studies to current studies.
PHP94
In tHeIr own words: socIal lIstenIng for “real-world BenefIts” 
from PrescrIPtIon and otc Products
Powell G.E., Duke S.P., Bell H.G., Anderson L.S., Metcalf M.A.
GSK, RTP, NC, USA
OBJECTIVES: The objective of this study was to evaluate “real-world benefit” dis-
cussions from publically available de-identified sources (social media and internet 
forums) that can be obtained through social listening. METHODS: A third party 
vendor collected posts from Facebook and Twitter over the previous year for a variety 
of 15 prescription and over-the-counter (OTC) products. Data vocabularies were 
standardized using a vernacular to MedDRA dictionary for medical conditions and 
a custom curated vernacular dictionary for drugs and OTC products. Next, noise 
was systematically removed via natural language processing and each post was 
characterized as a Mention (drug mentioned but no adverse events) or a Proto AEs 
(potential adverse event mentioned within the context of drug use). Finally, the data 
was de-identified prior to making it available to the research team who then man-
ually reviewed each post and collected “real-world benefit” attributes. RESULTS: 
Overall 2159/7529 (29%) of Mentions and Proto AEs contained “real-world benefit” 
information; of the 2159 posts, 1207 (56%) were positive benefits discussions and 
952 (44 %) discussed lack of effect. Of the positive benefits discussions (N= 1207), 94 
(8%) contained benefit time-to-onset, 28 (2%) contained duration of benefit, 125 (10%) 
indicated partial benefit, 514 (43%) indicated full benefit, 37 (3%) contained benefits 
discussion within the context of cost, 196 (16%) contained benefits discussion within 
the context of adverse events, and 138 (11%) contained benefits information as com-
pared to other treatment options. CONCLUSIONS: Social listening has the potential 
to provide a large amount of information about “real-world benefit” as discussed 
from the consumers’/patients’ perspective. This is the first step in understanding 
how Social Listening can contribute to better characterization of benefit/risk profiles 
using the consumers’ own voice.
PHP95
Is tHere an assocIatIon Between PotentIally InaPProPrIate 
PrescrIBIng In tHe elderly and HosPItalIzatIon and mortalIty? a 
longItudInal, large coHort study
Vegesna A.1, Alcusky M.J.1, Keith S.W.1, Hegarty S.E.1, Del Canale S.2, Lombardi M.2, Maio V.1
1Thomas Jefferson University, Philadelphia, PA, USA, 2Parma Local Health Authority, Parma, Italy
OBJECTIVES: Prevalence of potentially inappropriate prescribing (PIP) of harmful 
medications in the elderly has been widely investigated, but it remains unclear 
whether PIP is predictive of adverse events. Our study objective was to determine 
whether exposure to PIP is linked to increased rates of hospitalization and mortal-
ity. METHODS: We performed a retrospective analysis using the Italian Regione 
Emilia-Romagna (RER) longitudinal administrative healthcare database of all elderly 
patients (≥ 65 years) from 2003 to 2013. The RER database includes de-identified, 
fully-linkable demographic, hospital, and pharmacy claims data for all residents 
in the region. PIP exposure initiated upon the dispensing of a medication that 
“should always be avoided” based on the Maio criteria. To estimate PIP exposure 
we computed the number of days supplied for each medication of interest (using 
Defined Daily Doses) plus 30 days. An exposure period spanned the duration of 
consecutive PIP dispensings. An event, the composite outcome of hospitalization 
or death, was attributed to PIP if it occurred during an exposure period. Rate ratios 
and 95% confidence intervals (CI) were estimated by Poisson generalized estimat-
ing equations modeling. RESULTS: The 1,471,179 elderly individuals living in the 
RER contributed a total of 10,369,120 person-years (PY) of follow-up time and expe-
rienced a total of 1,973,878 events. The unadjusted event rate was 1.572 (95% CI: 
1.562, 1.580) times greater among patients exposed to PIP compared to those not 
exposed (2.87 events/10 PY vs. 1.82 events/10 PY). The unadjusted mortality rate was 
1.473 (95% CI: 1.458, 1.488) times greater with PIP exposure (0.51/10 PY vs. 0.35/10 
PY). CONCLUSIONS: These results indicate that exposure to PIP may be associated 
with higher hospitalization and mortality rates in elderly patients. This analysis, 
using a large cohort of patients, sheds light on the importance of reducing PIP in 
this population.
PHP96
an IntensIve study of adverse events In tHe medIcal unIt of a 
nIgerIan teacHIng HosPItal
Oreagba I.A., Bada S.O., Chuka-Ebene V.
University of Lagos, Lagos, Nigeria
OBJECTIVES: Adverse Events (AEs) has proven to be a significant cause of hospi-
tal admissions, with prevalence rate ranging from 6.5-26.1% and this constitute a 
significant problem with serious consequences and a challenge for public health. 
This intensive study is aimed at determining the prevalence of AEsas well as to 
assess the cause, nature, severity, preventability and outcomes in a Nigerian teach-
ing hospital and to determine the class of suspected drugs most commonly impli-
cated. METHODS: A three months observational study of 221 consecutive adult 
patients of the Lagos University Teaching Hospital medical in-patient ward and 
out-patient clinic. Epi-info statistical software, (Version 3.4.3, 2007) was used to 
analyze and determine prevalence, causality, severity and preventability. A sig-
nificance level of p < 0.05 was used. RESULTS: The prevalence of AEs was 17.6% 
(95% CI; 12.9, 23.3) with 30 (79.5%) of these presenting at admission and 8(20.5%) 
developing during hospitalization. The World Health Organization (WHO) causality 
PHP90
relatIonsHIP Between tHe develoPment of electronIc HealtH 
records and HosPItal accredItatIon decIsIons In france: results 
from tHe e-sI (PrePs-sIPs) study
Perrier L.1, Havet N.2, Durand T.1, Caquot N.1, Amaz C.1, Biron P.1, Philip I.1
1Cancer Centre Léon Bérard, Lyon, France, 2University Lyon 2, Lyon, France
OBJECTIVES: To make eHealth technology more efficient, particularly for the qual-
ity and safety of care, the French Ministry of Health (DGOS) launched the national 
“Hopital numérique 2012-2017” program, a strategic development plan for the 
modernization of health information technology. The aim of this study was to 
assess the impact of the development of electronic health records (EHR) on the 
accreditation results of French hospitals performed by the HAS (French National 
Authority for Health). METHODS: This retrospective study included all of the acute 
care hospitals accredited between October 2012 and April 2014. Three national data-
bases were used: national accreditation database, oSIS (observatoire des systèmes 
d’information de santé-2012), and IPAQSS (indicateurs pour l’amélioration de la 
qualité et la sécurité des soins-2012). National data were provided by the DGOS and 
HAS, together with methodological support. We developed an ordered Logit model, 
where the polytomous dependent variable was ordered according to the follow-
ing descriptions: full accreditation, recommendation, reservation, or delay in the 
accreditation decision. The independent variables were the proportion of EHR used 
(full, partial, or no EHR); type of hospital (teaching, private non-profit, for-profit, or 
other public hospital); accuracy of the care, with versus without home care hospi-
talization; and geographic region. RESULTS: The study included 679 hospitals; 21% 
had full accreditation, 45% recommendation, 25% reservation, and 9% a delay in 
accreditation. We found that the higher the number of full EHR used, the better the 
accreditation decision (p< 0.001). We also observed that the higher the number of 
partial EHR used, the better the accreditation decision (p= 0.002). Finally, the accredi-
tation decision was also better for for-profit hospitals (p< 0.001), private non-profit 
hospitals (p= 0.005), and in the southeast of France (p= 0.02). CONCLUSIONS: Our 
findings suggest that the development of EHR in acute care hospitals is associated 
with a higher performance in accreditation decisions in France.
PHP92
serIous adverse drug events rePorted to tHe food and drug 
admInIstratIon (fda): analysIs of tHe fda adverse event rePortIng 
system (faers) 2006-2011 dataBase
Sonawane K.B., Hansen R.A.
Auburn University, Auburn, AL, USA
OBJECTIVES: In 1998, the Food and Drug Administration (FDA) Adverse Event 
Reporting System (FAERS) (formerly AERS) was launched by the FDA as a post-
marketing safety surveillance program to capture adverse drug events (ADEs) and 
medication errors. From 1998 to 2005, it was found that the number of serious and 
fatal ADEs reported to the FDA increased by 2.6-fold and 2.7-fold, respectively. The 
purpose of this study was to document current trends in serious and fatal ADE 
reports. METHODS: We conducted a retrospective analysis of the 2006-2011 FAERS 
database. Information on patient demographics, primary suspect drug, outcomes, 
and other variables were obtained from data files. Non-US reports and reports 
from clinical trials were excluded. Outcomes were recoded into three categories: 
death, disability (disability or congenital anomaly), and all other serious outcomes 
(hospitalizations, requiring intervention, or life-threatening, or other serious out-
comes). We determined the number of reports by year, the types and sources of 
reports, and age-wise distribution of serious ADEs. A list of drugs with more than 
1,000 reports of serious ADEs was compiled and subgroups of important drugs 
were identified RESULTS: A total of 245,265 reports of deaths (53,447), disabilities 
(20,305), and other serious outcomes (171,513) were reported representing 206,087 
person-reports. The percentage of reports involving death increased from 17.3% in 
2006 to 27.0% in 2011. Analgesics, antihypertensives, and antipsychotics were the 
most common drugs involved in serious reports of ADEs. Drugs with more than 
1,000 serious reports of ADEs included 2 drugs currently withdrawn from market, 4 
drugs under the FDA Risk Evaluation and Mitigation Strategies (REMS) program, 11 
specialty drugs, 3 biologic drugs, and others. CONCLUSIONS: A substantial number 
of serious ADEs were reported from 2006-2011. Drugs under the REMS program, spe-
cialty drugs, and biologic drugs contribute to a significant number of serious ADEs.
PHP93
sensItIvIty, sPecIfIcIty and level of agreement Between dIfferent 
crIterIa used to dIagnose tHe metaBolIc syndrome
Bhounsule P.1, Peterson A.M.2
1University of the Sciences in Philadelphia, Philadelphia, PA, USA, 2University of the Sciences, 
Philadelphia, PA, USA
OBJECTIVES: Numerous diagnostic criteria of the metabolic syndrome exist 
including the recent 2009 World Health Organization definition, criteria for 
National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III), 
International Diabetes Federation (IDF) and European Group for Study of Insulin 
Resistance (EGIR). The multiplicity of definitions makes comparing studies with 
older criteria difficult. Our objective was to compute sensitivity, specificity, posi-
tive (PPV) and negative predictive values (NPV) and level of agreement between 
WHO standard and other definitions to determine which criteria performs best 
when comparing estimates from previous studies. METHODS: The NHANES 2009-10 
and 2011-2012 demographics, examination and laboratory data formed our cohort. 
Prevalence estimates using all criteria were calculated. Sensitivity, specificity, PPV 
and NPV of all criteria keeping the WHO criteria as gold standard were computed. 
Kappa statistics to determine strength of agreement between WHO criteria relative 
to other definitions were estimated. RESULTS: WHO criteria yielded the highest 
prevalence at 22.2% followed by NCEP (19.1%), IDF (9.8%) and EU criteria (6.2%). 
Sensitivity of the NCEP criteria was the highest at 86.2% followed by IDF (38.6%) 
and EU (25.9%) criteria. Specificity of the NCEP criteria was highest at 100% followed 
by EU (99.3%) and IDF (98.3%) criteria. The PPV of the NCEP criteria was 100% while 


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PHP95 Is there an Association between potentially inappropriate prescribing in the elderly and Hospitalization and Mortality? a Longitudinal, large Cohort study

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