RISK FACTORS OF OCCUPATIONAL INJURIES AND RELATED DISABILITIES AMONG AUTO MECHANICS IN THE INFORMAL SECTOR OF KUMASI, GHANA

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AEs for each drug annually over two decades. SAS 9.4 and Microsoft Excel were used to conduct the data analysis.  Results: Rofecoxib had the highest percentage (48.32%) of all COX-2 inhibitors reported adverse events. Female populations and populations around 60 years of age were found to be the most susceptible to report adverse events related to COX-2 inhibitors. Rofecoxib had the highest total of reported deaths (n= 9506), while lumiracoxib and etoricoxib had the highest rates of death (13% and 9%, respectively). Dyspnoea was the most frequent common adverse event across all five drugs. The rates of cardiovascular adverse events were higher with rofecoxib (10.88) and valdecoxib (7.55), while the rates of renal adverse events were higher with lumiracoxib (3.75) and rofecoxib (3.51).  Conclusions: the results showed that cardiovascular and renal adverse events related to COX-2 inhibitors were significant and increased the rate of morbidity and mortality. PHP111 WHAT IMPACTS THE QUALITY OF COMPARATIVE-EFFECTIVENESS RESEARCH: A CLASSIFICATION AND REGRESSION TREE ANALYSIS USING THE GRACE CHECKLIST Bryant A 1, Mendelsohn A B 1, Viswanathan S 2, Dreyer N A 1 .

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1Quintiles, Cambridge, MA, USA, 2Quintiles, Rockville, MD, USA

Objectives: The GRACE checklist is a tool for evaluating the quality of comparative effectiveness research (CER) studies. The checklist consists of 11 questions on data and methods and was developed through literature review, expert consultation, and testing by 113 raters across five continents. The purpose of the present research was to determine which checklist questions are most predictive in identifying quality CER.  Methods: Twenty-two volunteers recruited from academia, industry, and government applied the GRACE checklist to 28 CER articles, for a total of 56 assessments. We used Classification and Regression Tree (CART) methodology, a binary, recursive, partitioning methodology, to identify the checklist questions that were most predictive of quality CER articles. Quality was defined as a composite outcome of three indictors: journal impact factor, article citations per year, and expert assessment of whether the research was designed and executed well enough to be reliable. An article was considered to meet all three quality criteria if journal impact factor was higher (> 2.5), there were frequent article citations per year (> 2), and the expert assessment of overall quality was classified as “sufficient”.  Results: The CART analysis revealed high sensitivity (71.43%, i.e., ability to detect a “quality” CER article, based upon the composite score) and high specificity (80.95%, i.e., ability to identify a CER article not meeting sufficient quality standards). The use of a composite outcome in the CART analysis yielded higher sensitivity and specificity than any of the outcomes individually. Alteration of the default tree settings by varying the “penalty” for misclassifying sufficient vs. non-sufficient quality articles had minimal impact on the sensitivity and specificity. The use of a sensitivity analysis was the strongest predictor of quality.  Conclusions: The high specificity of the tree indicates the checklist, particularly the sensitivity analysis question, can be used to identify articles that do not meet a sufficient quality standard. PHP112 PRESCRIPTION PRACTICES AND PERCEPTIONS OF HEALTH CARE PROFESSIONALS REGARDING RATIONAL DRUG USE Jan S U University of Balochistan, Quetta, Pakistan .

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Objectives: The aim of this study was to evaluate the prescription practices and perception of health care professionals regarding rational drug use.  Methods: A descriptive study was designed to assess the rational drug use perception of health care professionals using the services of trainee Pharmacists and Teachers. A questionnaire of three sections was designed to include WHO indicators regarding drug use indicators, facility and perception of prescribers that are relevant to rational drug use was carried out in a large teaching City Hospital from May, 1st to June, 30th 2014. A retrospective chart was constructed to assess socio-demographic and drug use indicators (DUIs) in the selected prescriptions. Data was collected using patient’s prescriptions and direct patient communication using the check list for the indicators.  Results: Total 1000 prescriptions were evaluated during the study. The results showed that, the average consultation time was 5.5 Minutes. A total number of 5098 drugs were prescribed in 1000 prescriptions with a mean number of drugs per prescription of 5. Percentage of generic drugs prescribed was 0%. The percentage of prescriptions with one or more injections was 15%. A high proportion of drugs prescribed (88.27%) were from the essential drug list (EDL). The percentages of prescriptions with antibiotics and analgesics were 90.2% and 43% respectively. Further, adherence to Standard Treatment Protocols (55%), patient’s knowledge of correct dosage (32%) and adequately labeled drugs was (5%). We also observed a significant difference between the prescription perception among senior and junior practitioners.  Conclusions: In conclusion, several areas of deficiency in rational drug use have defined in this study that can be remedied. We recommend that efforts should be made to improve rational drug use practices in Hospitals. Regular training programs should be organized for health care professionals to promote the concept and practice of rational drug use. PHP113 DIFFERENCES BETWEEN PATIENT AND PHYSICIAN PERSPECTIVES TOWARD STARTING BIOLOGICS: STRATIFICATION BY MINORITY PATIENT RESPONSE VERSUS WHITE/UNDETERMINED PATIENT RESPONSE Teeple A 1, Kariburyo M F 2, Ingham M 1, Tan H 2, Xie L 2 Scientific Affairs, LLC, Horsham, PA, USA, 2STATinMED Research, Ann Arbor, MI, USA .

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1Janssen

Objectives: This study aimed to understand differences in patients’ openness and preference toward biologics and biologic modes of administration (MOA), compared to physicians’ perception of the openness and preference of their patient population. A stratified analysis was conducted to understand differences between Minority vs White responses.  Methods: Patients (N= 263) and physicians (N= 100) completed a self-administered web-based survey. Patients were identified through

the Sample Czar nonprofit-focused panel or All Global online consumer panel. Patients were U.S., aged ≥ 18, with no prior biologic experience. Only patients that responded consistently with non-contradictory responses were included in this analysis. 170 patients responded consistently to preference questions and 169 patients responded consistently to openness questions. In order to compare physician responses about their patient population vs. patient responses, population samples for both were derived using bootstrapping statistical techniques (responses were randomly over sampled 10,000 times with replacement).A stratified-analysis of responses of Minority patients vs White/Undetermined patients was conducted. Student t-tests were used to calculate p-values. Only results displaying p-values were significant.  Results: OPENNESS: Physicians significantly overestimated patients openness to biologics in general, (85.46% vs 74.61% respectively, p< .0001) but, underestimated patients openness to Intravenous (IV) MOA (55.97% vs. 63.96% respectively). Minority patients (N= 42) showed greater openness to biologics (92.90%), to IV MOA (83.32%), and SQ MOA (90.52%) compared to White/ Undetermined patients (68.44%, 57.45%, 59.77% respectively N= 127). PREFERENCE: Overall physicians significantly underestimated patients’ preference to IV MOA (22.07% vs 24.35% respectively, p< .0001) and SQ MOA (48.84% vs 54.69 respectively p< .0001). Minority patients (N= 27) had greater preference for IV MOA (59.23%), and a lower preference to SQ MOA (40.77%) compared to White/Undetermined (39.25%, 57.24% respectively N= 143).  Conclusions: The results from this study suggest differences between minority and white/undetermined patients’ openness and preferences to biologics and biologic MOA highlighting the importance of cultural factors in shared decision making. PHP114 SOCIAL MEDIA DATA SHOWS UTILITY FOR THE ASSESSMENT OF BENEFIT-RISK EARLY AFTER PRESCRIPTION TO OVER-THE-COUNTER SWITCH Schifano L 1, Bell H G 1, Anderson L S 1, Shaikh S 2, Powell G E 1 .

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1GSK, RTP, NC, USA, 2GSK, Uxbridge, NC, USA

Objectives: Social media’s increasing popularity globally as a communications tool extends to communications concerning patient healthcare experiences. Social media may offer an untapped resource of pharmacovigilance data. We hypothesized that social media listening may be well-suited to monitor the benefit-risk of a prescription-to-OTC switch product during the early post-launch phase.  Methods: Prescription Flonase™ (fluticasone propionate nasal spray) has been marketed globally for over 20 years. All publicly available, English posts from Facebook and Twitter referencing Flonase™ between 01Feb2014 to 30Apr2015 were obtained and de-identified. 5479 posts were categorized into two groups: three months postlaunch and one year pre-launch as comparator. Questions were pre-determined to assess benefit-risk of the OTC product. Posts were manually reviewed for extraction of pertinent data.  Results: Average monthly social media posts increased 8-fold during an OTC marketing campaign. An increased post-launch monthly volume (87 proto-AEs/month) of social media confirmed proto-AEs (post resembling an adverse event) compared with pre-launch (17 proto-AEs/month) was observed, but at a lower percent (pre-launch: 11%, post-launch: 7%) of total posts. Monthly rate of confirmed proto-AEs from social media increased over 400% from pre-launch versus a 47% increase of spontaneous AEs. Over 25% of posts mentioned indication which allowed for monitoring of indication including off-label use.  Conclusions: Social media provided a supplemental source of pharmacovigilance data allowing for assessment of the benefit-risk profile of a prescription-to-OTC switch product in the early post-launch phase. The increase in rate of confirmed proto-AEs from social media listening compared to spontaneous reporting post-launch demonstrated that social medial data has the ability to quickly identify increased activity related to safety with a newly launched prescription-to-OTC switch product. Safety data obtained from our project were consistent with the known benefit-risk profile of Flonase™. More research is needed to fully understand the value of this tool within pharmacovigilance. PHP115 RISK FACTORS OF OCCUPATIONAL INJURIES AND RELATED DISABILITIES AMONG AUTO MECHANICS IN THE INFORMAL SECTOR OF KUMASI, GHANA Agyei-Baffour P 1, Boateng K 2, Nuamah G B 3, Boateng K S 3, Addai-Donkor K 3 Nkrumah University of Sciences and Technology (KNUST), Kumasi, Ghana, 2Komfo Anokye Teaching Hospital, Kumasi, Ghana, 3Kwame Nkrumah University of Science and Technology, Ghana, Kumasi, Ghana .

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1Kwame

Objectives: The informal sector accounts for over three-quarters of the economies of developing countries and host varying socio-economic activities. Due to unorganised nature of these activities, there is high likelihood of incidence of injuries and disabilities. However empirical evidence of these in the informal sector remains scanty. This paper examines the incidence and risk factors of occupational injuries and disabilities in the informal sector of Kumasi, the second largest city of Ghana,  Methods: A cross-sectional study was conducted with randomly selected 1288 auto mechanics to quantitatively estimate the incidence and risk factors of occupational injuries and disabilities at the Tafo-Suame magazine in Kumasi. Data were summarized into descriptive and inferential statistic in STATA version 11 with statistical significant level set at 5%, 95% confidence interval,  Results: The sex injury ratio was 9:1 in favour of males. Injuries were found in all the varying occupations. Out of the 1,285 respondents, 619 representing 47.9% (95% C.I. [45.2%, 50.6%] had injury person working hour in the past 12 months. There were 82.1% minor injuries and 17.9%, major injuries. The site and type of injury were bruise on hands, 28.4%, cuts on hands, 4.4%, cut on head, 5.7% and eye 9.4%. The risk of injury increased significantly with pushing (OR= 3.1, p< 0.001), lying down (OR= 3.7, p< 0.001), and run (OR= 7.0, p< 0.001) compared with sitting while working. Stretching part of the body while working had a 20% reduced risk (OR =  0.8, p= 0.69) of injury as compared to sitting,  Conclusions: The incidence of injury among informal sector auto mechanics is close to 1 in 2 person working hour with 8% disability while pushing, postures, lying down, and running are the risk factors. These have policy implications for injury prevention and control programmes.

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PHP116 THE CONCEPTUAL FRAMEWORK CONSTRUCTION OF A PATIENT-REPORTED SYNDROME SCALE: QI-DEFICIENCY SYNDROME (PRS-QDS) Zhang H Y 1, Chen Z H 2, Wu T S 2, Yu L 1, Li Q 2, Zhang M C 2, Yang K X 2, Wang S 2, Pang L L 2, Yang G L 2 1Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, 2Liaoning university of Traditional Chinese Medicine, Shenyang, China .

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Objectives: Syndrome is charaterized in Chinese Medicine, which can reflect disease progession as well as health status. Thus, it was greatly aprreciated by Chinese practitioners. Nowadays, syndrome diagnostic scales had already been developed, which are only for clinicians. Since syndromes will be full of variety with the disease progession. Therefore, how to assess the variation comes vitally important for patients themselves. This study aims to establish the conceptual framework for a Patient reported syndrome scale: Qi-Deficiency Syndrome (PRSQDS).  Methods: There are 3 steps to develop the framework for PRS-QDS: 1) the research team was formed and literature review was conducted to generate a graft framework. 2) In-depth interviews among patients diagnosed with differnet disease with Qi deficiency were carried out to collect the quality of life related symptomes. 3) a focus group including 8 experts was formed into discussion to modify the framework.  Results: Firstly, through literature review, Qi deficiency syndrome was defined as insufficient primordial Qi as well as hypofunctional internal organs, manifested as shortness of breath, fatigue, disinclination to talk, sweating, lack of energy, light tongue and weak pulse. Secondly, 26 eligible patients (average age: 61, 10 males), diagnosed cardiovascular, respiratory, urinary, endocrine, hematologic diseases, were interviewed, Patients’ concerning concentrated in 4 dimensions that fatigue, lack of energy, shortness of breath, and disinclination to talk. Finally, four dimensions were clasified into 10 items related to patients’ quality of life shown as: need rest, lack of appetite, affect daily activity and become lazy due to fatigue (items 1-4); disinclination to talk(5); shortness of breath when talking and breathing (6,7); hobby, sleep and moods influnced by insufficient energy (8-10). Patients didn’t pay much attention to sweating, tongue and pulse, which are more suitable for diagnosis other than evaluation.  Conclusions: Four dimensions including 10 items were primarily formed as the framework for PRS-QDS. PHP117 A STUDY OF ITEMS SELECTION FOR A PATIENT REPORTED SYNDROME SCALE: QI-DEFICIENCY SYNDROME (PRS-QDS) Zhang H Y 1, Wu T 2, Yu L 1, Chen Z H 2, Li Q 2, Zhang M C 2, Yang K X 2, Wang S Q 2, Pang L L 2, Yang G L 2 1Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, 2Liaoning university of Traditional Chinese Medicine, Shenyang, China .

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Objectives: This study aims to preliminarily develop a Patient reported syndrome scale: Qi-Deficiency Syndrome (PRS-QDS) for the evaluation of the common traditional Chinese medicine (TCM) syndrome Qi-Deficiency Syndrome.  Methods: According to conceptual framework construction of PRS-QDS, the experts wrote questions and select 5-point Likert to form option. The items of PRS-QDS were selected by epidemiological investigation. It is based on the completion rate and understanding of the items to assess their feasibility. When the completion rate is lower than 85%, the item is deleted. The frequency of the first and last option is used to analyze ceiling effects and floor effects. When the frequency of the first or last option is greater than 40%, the item is deleted. The test is used to distinguish the normal people. If an item cannot distinguish the normal people, it is discussed by the experts whether to delete or not.  Results: Fifty-two subjects (average age: 56, 20 males) were asked to complete the PRS-QDS which consisted of 10 items. There were 2 patients not fit to complete the questionnaire because of badly ill and not willing to cooperate. So the completion was 96%. The frequency of all the first and last option was lower than 40% which means no ceiling or floor effects. But the frequency of the first option of question (2) was 38%, draw near the ceiling effects. Question 2: Whether weakness affect you appetite? 19(38%) patient were confused on the relationship between weakness and appetite. So we adjusted the question 2 as whether fatigue affect you appetite.  Conclusions: A Patient Reported Syndrome scale-Qi Deficiency Syndrome was preliminarily developed after adjusting one question through the above methods. The PRS-QDS containing ten items will be applied to clinical investigation to examine its reliability and validity in the next stage. PHP118 KNOWLEDGE, ATTITUDE, AND PRACTICES OF HEALTH CARE PROFESSIONALS REGARDING PHARMACOVIGILANCE IN PAKISTAN Atif M 1, Arslan B 1, Quratulain S 1, Zainab A 1, Aminah N 1, Sonia A 1, Azeem M 1, Rehan Sarwar M 1, Chioma S E 2 1The Islamia University of Bahawalpur, Bahawalpur, Pakistan, 2Lagos University Teaching Hospital, Lagos, Nigeria .

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Objectives: Monitoring of adverse drug reactions (ADRs) and establishment of a system of pharmacovigilance is the need of the day to ensure patient safety and prevent drug related morbidity and mortality. The present study was conducted to assess the knowledge, attitude and practices of healthcare professionals regarding pharmacovigilance (PV) in the Bahawalpur district of the Punjab province of Pakistan. The respondents were also asked about their knowledge regarding Isosorbide 5-mononitrate tragedy in the country (2011–2012).  Methods: This was a non-experimental, descriptive, questionnaire based cross-sectional survey that was carried out in the Bahawal Victoria Hospital and the Civil Hospital between December 2014 and March 2015. Using the convenient sampling technique, all the consented healthcare professionals were asked to self-complete a purpose designed structured questionnaire. A scoring scheme was used to assess the knowledge of the healthcare professionals regarding PV. Counts and proportions were used to present the data. The relationship between the characteristics of the respondents and the median knowledge score was analyzed by using the Mann-Whitney-U test and the Kruskal Wallis test. A p-value of less than .05 was considered significant.  Results:

A total of 107 health care professionals, including 88 medical doctors and 19 pharmacists, participated in the study. The median (25th, 75th) knowledge score of the respondents was 8 (7, 11) out of a maximum possible score of 17. Most of the respondents exhibited positive attitude towards implementation of PV system in the healthcare sector. Of all, 24 (22.4%) respondents did not know the actual cause of death among the patients taking Isosorbide 5-mononitrate. The ADRs reporting and monitoring was not practiced routinely owing to multiple factors.  Conclusions: After about three years of Isosorbide 5-mononitrate tragedy, our respondents still exhibited poor knowledge, and there was lack of PV related practices. However, positive attitude towards implementation of PV system is good omen. PHP119 ITEMS SELECTION FOR A PATIENT-REPORTED SYNDROME SCALE: PHLEGM SYNDROME (PRS-PS) Zhang H Y 1, Li Q 2, Yu L 3, Pang L L 2, Wu T S 2, Zhang M C 2, Yang K X 2, Wang S Q 2, Chen Z H 2, Yang G L 2 1Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, 2Liaoning university of Traditional Chinese Medicine, Shenyang, China, 3Affiliated Hospital of Liaoning university of Traditional Chinese Medicine, Shenyang, China .

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Objectives: This study aims to preliminarily develop a Patient reported syndrome scale: Phlegm Syndrome (PRS-PS) for the evaluation of the common traditional Chinese medicine (TCM) syndrome Phlegm Syndrome.  Methods: According to conceptual framework construction of PRS-PS, the experts wrote questions and select 5-point Likert to form option. The items of PRS-PS were selected by epidemiological investigation. It is based on the completion rate and understanding of the items to assess their feasibility. When the completion rate is lower than 90%, the item is deleted. The frequency of the first and last option is used to analyze ceiling effects and floor effects. When the frequency of the first or last option is greater than 50%, the item is deleted. T test is used to distinguish the normal people. If an item cannot distinguish the normal people, it is discussed by the experts whether to delete or not.  Results: 61 subjects (average age: 59, 19 males) were asked to complete the PRS-PS which consisted of 11 items. 10 (16%) didn’t answer the question tongue which means the item isn’t suitable for people to evaluate. 18 (30%) thought the question lost of taste and full of taste express the same meaning which means the two items is repeated semanteme. The frequency of all the first and last option were lower than 50% which means no ceiling or floor effects. Only the item lost of taste, expectoration, dizziness and tongue could distinguish the normal subjects, which may be caused by insufficient sample. According to the above results, the item tongue and full of taste were deleted.  Conclusions: A Patient Reported Syndrome scale: Phlegm Syndrome was preliminarily developed after deleting two items through the above methods. The PRS-PS containing nine items will be applied to clinical investigation to examine its reliability and validity in the next stage. PHP120 JOB SATISFACTION SURVEY OF PHYSICIANS WORKING AT THE CLINICAL CENTRE OF THE UNIVERSITY OF PÉCS Laczkovics N 1, Boncz I 1, Gyuró M 1, Endrei D 1, Horváthné Kívés Z 2 1University of Pécs, Pécs, Hungary, 2University of Pécs, Pécs, Hungary .

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Objectives: This research aims to examine the physicians’ job satisfaction, health behaviour, and stress level at the clinical departments of the Pécs University, and explore the effect of migration on this institution. Methods: A quantitative, cross-sectional survey was carried out among physicians working at the Pécs University clinics by non-random sampling (n= 120). The data collection tool is a questionnaire with the following topics: socio-demographic data, issues relating to the workplace, scope of activities, health behaviour, working relationships and drop-out rates. Validated questionnaires are as follows: Questionnaire on Effort, Reward and Imbalance, Perceived Stress Scale, Minnesota Satisfaction Questionnaire. Descriptive statistics, χ 2-test, ANOVA, and Kruskal-Wallis test, and Mann-Whitney test were used (p< 0.05). SPSS version 22.0 program was applied for data analysis.  Results: Mean satisfaction 68,69±11,53 scores on a 100-score scale where a higher point means higher satisfaction level. Physicians working in a shift combined with night shift (p= 0.006), those who have already thought to leave the institution (p= 0.001), or the doctors who think that the current workplace fails to fulfill their demands (p< 0.001) have significantly lower scores. Stress score 25.3, women (p= 0.025) and those who have already thought to leave the institution, have significantly higher stress scores. Physicians who change the place of their working at the institution several times weekly (p= 0.008) and those who have already thought to leave the institution sustained work environment as wrong (p= 0.001). 64% of the respondents thought to leave the institution and 50% of them took steps to change. Their motivation includes dissatisfaction with work environment, salary, and moral recognition.  Conclusions: Factors that increase stress level and dissatisfaction can be terminated by optimal work organization and communication. The study provided useful information for the medical management. Therefore, they can promote satisfaction with the job and the reduction in migration by organizational and supportive changes or chances. PHP121 EVALUATION OF ADVERSE DRUG REACTIONS IN A HOSPITAL IN SOUTHERN TAIWAN Lin Y Kaohsiung Veterans General Hospital Tainan Branch, Tainan City, Taiwan .

Objectives: According to the definition of adverse drug reaction (ADR): “An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the produtct.” Data collection and analysis from our hospital, which can provide healthcare professionals as a reference in clinical practice.  Methods: This study is a retrospective investigation of ADRs enrolled in our hospital in southern Taiwan in 2015. Assessment of ADRs contains that occurring sources, gender and age, Anatomical Therapeutic Chemical (ATC) classification of suspected drugs, types