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Implementation of Adverse Event Trigger Tool System for Assessing Patient Safety
A822
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP) and the EudraCT. We selected the ATMPs trials after elimination of duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organization. We classified ATMPs by type and trial status: ongoing, completed, terminated, discontinued, and prematurely ended. Then we calculated the rate of discontinuation. Results: 143 withdrawn, terminated or prematurely ended ATMPs clinical trials were identified between 1999 and June 2015 and 474 ongoing and completed clinical trials. Therefore, the rate of discontinuation of ATMPs trials is 23.17% similar to non-ATMPs drugs in development. The probability of discontinuation is respectively 27.35%, 16.28%, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (44%) followed by cardiology and immunology/inflammation (22.2%). It is almost the same for commercial and non-commercial sponsors (24%); Suggesting discontinuation may not be financially driven. Conclusions: No failure risk rate per development phase is available for ATMPs. Discontinuation rate may prove helpful when assessing expected net present value to support portfolio arbitration. These results carry limitation as the reason for discontinuation is unknown. Further research about the reasons of discontinuation and the risk of negative results is needed to inform manufacturers and investors decisions. PHP45 Outcomes From Homeopathic Prescribing in Secondary Care Homeopathic Hospital: A Prospective Study Dobariya N1, Tiwari P1, Dhiman K2, Sareen P2, Anand T2, Sharda S2, Manku Tk2, Kaur R2 1National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali), Punjab, India, 2Homeopathic Medical College and Hospital, Chandigarh, India
Objectives: Despite its presence in most parts of the country, very little is reported about the variety of illnesses, course of treatment and outcomes in patients in the homeopathic medical treatment. The research aims to explore the outcomes of homeopathic treatment in patients who are using homeopathic medicine. Methods: This prospective questionnaire based study used the data obtained from the patients attending a public homeopathic healthcare facility. The information collected included patient’s age and gender, demographics, medical condition, duration of illness & homeopathic medicine prescribed. Additionally, the patient reported outcome on a 100-point visual analogue scale was also captured. Per protocol analysis was performed for analysing the data. Results: Of the 655 patients screened, only 194 patients qualified to be included in analysis. Their mean age was found to be 37.6 years (±13.3). The mean height and weight were 163.7 cm (±8.3) and 65.44 kg (±12.1), respectively. 59% of patients were female. 52% patients were having normal BMI while 8%, 29% and 11% were underweight, overweight and obese respectively. 58% of patients belonged to upper socioeconomic class where 21% each were from middle and lower class. The most common reason for preference of homeopathic system of medicine were perceived surety of relief and belief in its safety. Out of all, 87% patients presented with a chronic illness. The mostly prescribed drugs were Pulsatilla, Sulphur, Rhus Toxidendron, Lycopodium Clavaton, Arsenic Album, and Belladonna. Outcome from one or more follow up per patient condition was captured for all 194 patients (64% patients improved, 4% reported worsening and 32% reported no change). Positive outcome was observed in patients with cough, allergy, bodyache, PCOS, piles, renal calculi and URTI. Conclusions: The homeopathic treatment is most preferred by the patients having chronic disease. In disease severity, there is sustained improvement following homeopathic treatment period. Our findings demand longer follow up and a larger sample. PHP46 High-Risk Medications and Unplanned Hospitalizations: A Case– Time–Control Study Lin C1, Wen Y2, Chen L3, Hsiao F1 1National Taiwan University, Taipei, Taiwan, 2Chang Gung University, Taoyuan, Taiwan, 3Taipei Veterans General Hospital, Taipei, Taiwan
Objectives: Empirical data of medication-related hospitalization are very limited. The aim of this study is to investigate the associations between 12 high-risk medications (diabetic agents, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, antiplatelets, antihypertensives, antiarrhythmics, anticonvulsants, antipsychotics, antidepressants, benzodiazepine (BZD)/Z-hypnotics, and narcotics) and unplanned hospitalizations. Methods: A population-based case–time–control study was performed using the 2000 -2011 Taiwan’s National Health Insurance Research Database. Patients who experienced an unplanned hospitalization (index visit) were identified as index subjects and matched to a randomly selected reference visit within users of a specific category of high-risk medication. Discordant exposures to the high-risk medication during the case period (1-14 days before the visit) and the control period (366-379 days before the visit) were examined in both index and reference visits. For each high-risk medication category, conditional logistic regression models were used to estimate the odds ratios (ORs) of unplanned hospitalizations, and attributable fractions (AFs) for unplanned hospitalizations were calculated. Results: Antipsychotics was associated with the highest risk of unplanned hospitalizations (aOR: 1.54, 95% confidence interval [1.37-1.73], AF: 35.0%), followed by NSAIDs (1.50, [1.44-1.56], 33.3%), anticonvulsants (1.34, [1.10-1.64], 25.6%), diuretics (1.24, [1.15-1.33], 19.1%), BZD/Z-hypnotics (1.23, [1.16-1.31], 18.8%), antidepressants (1.17, [1.05-1.31], 14.7%) and antiplatelets (1.16, [1.07-1.26], 14.0%). NSAIDs and narcotics were associated with the highest risks of unplanned hospitalizations with a length of stay ≥ 10 days. Conclusions: Antipsychotics, NSAIDs, anticonvulsants, diuretics, BZD/Z-hypnotics, antidepressants, and antiplatelets were significantly associated with increased risks of unplanned hospitalizations. These drugs should be targeted for clinical and policy interventions. PHP47 Implementation of Adverse Event Trigger Tool System for Assessing Patient Safety Vilakkathala R1, Mallayasamy S1, K V1, Rodrigues GS2, BH AR2 1Manipal University, Manipal, India, 2Kasturba Medical College, Manipal, India
Objectives: Assessing the quality of health care service is an important issue of international relevance. The rate of Adverse Events (AEs) among the hospitalized patients is one of the important indicators of patient safety. This study was aimed to develop and validate a trigger tool system to identify adverse events in the surgery department. Methods: A list of triggers was prepared and validated by suitable methods. The final list contained 77 triggers of three different categories such as, surgical care, critical care and medical care module. This list used to identify triggers in the reviewed case records over a period of 36 months (20 cases per month). The actual AEs were identified by the final consensus of surgeons. The resulting harm was categorized according to NCCMERP index. Results: Totally 679 triggers were present in the 236 cases with an average of 2.88 ± 2.92 triggers per case and in 211 case records, the triggers were able to identify actual adverse events. Majority of the events were minor in severity. Most important five AEs identified were bleeding, lab value abnormality, constipation, breathing difficulty and pyrexia. It was found that higher the number of triggers present, higher the chances of occurrence of AEs. Surgeons were of the opinion that AEs are a problem in their practice and there is a need to monitor and prevent them and the present trigger tool system appears to be effective in monitoring. Conclusions: The developed trigger tool system was found to be effective and relevant approach for ensuring appropriate monitoring of AEs in the surgery department of the study hospital. This tool has potential application to review the cases for adverse events at or near the time of their occurrence and to prevent the harm. PHP48 What are the key concerns of health care providers in china? Qualitative investigation of a double-blind telephone survey Sun Y1, Liu GG1, Wang T2, You X1, Zhao H1 University, Beijing, China, 2Shenyang Pharmaceutical University, Shenyang, China
1Peking
Objectives: The aim of this study is to investigate the job satisfaction and some noteworthy concerns on Chinese public hospitals among one of the most important stakeholders – doctors and nurses. Methods: We used open-ended questions and double-blind telephone interview method to collect the information. Interviewers documented all of the answers, and then two analysts independently read the manuscripts to identify the key points and to extract the representative words. The identified key points are concluded to some major factors. Results: 299 doctors and nurses from tertiary and secondary hospitals in 27 provinces were contacted for the interview. 23.7% of them are holding no concerns on their current work environment, or satisfied with their job. Besides, among those with concerns, 18.7% mentioned that they were overloaded with work and suffering high pressure, indeed, over 24% stated that they work was unfairly undervalued by hospitals, government and society. 33.4% of the interviewees indicated that the core competitiveness of hospitals, including the scale, reputation, and location of hospitals, the number of admissions, and the development of hospitals, was the key aspect determines their resignation. Another reason of resignation was family with 15.7% of the responses. Moreover, about 9.8% mentioned the importance of management in hospitals, such as the promotion system, the management of performance, target and talent. Conclusions: In China, the job satisfaction of doctors and nurses is relatively low. A great number of them are suffering high workload and pressure, with relatively lower payment. The ongoing public hospital reform should embody the non-profit nature of public hospitals; meanwhile, guarantee the appropriate payment to medical personnel to improve their incentives to provide efficient and high-quality healthcare.
PHP49 Factors Associated with 90-Day or 180-Day Long-Term Use of Anxiety-Hypnotic Prescriptions and Economic and Safety Outcomes: A Retrospective Cohort Study Lin H1, Tsai H2, Liu F3, Liao C4, Li C5, Lin C4, Chou C4, Chang C4, Simonavice CA4, Li T1 1China Medical University, Taichung, Taiwan, 2Providence University, Taichung City, Taiwan, 3Hsuan Chuang University, Hsinchu City, Taiwan, 4China Medical University Hospital, Taichung, Taiwan, 5China Medical University Hospital, Taiwan, Taichung, Taiwan
Objectives: The World Health Organization defines continuous use of medications for more than 180 days as long-term use. Caution should be used when treating elderly with Benzodiazepines (BZD) for more than 30 days and non-BZD hypnotics for more than 90 days. This study aimed to examine the factors associated with long-term use of anxiety-hypnotics and its economic and safety outcomes in Taiwan. Methods: A retrospective cohort study was conducted using Taiwan’s National Health Insurance (NHI) Research databases. NHI beneficiaries who were newly prescribed with at least one anxiety-hypnotic medication in outpatient settings were grouped as long-term users (i.e., ³ 180 day or ³ 90 day) or corresponding non-long-term users by using a propensity score matching approach. Demographics, health-care utilizations, disease status, and related risks were examined for their associations with long-term use using logistic regression analyses. The economic and safety outcomes among long-term and non-long-term users after two-year follow-up were compared and stratified into either elderly or nonelderly groups. Results: 138,624 patients in the sample were newly prescribed with anxiety-hypnotic medications in 2009. 2.39% and 7.11% were identified as 180-day or 90-day long-term users, respectively. Age, prior medical expenses, cardiac disease or insomnia, and use of some pain killers and Chinese medications were statistically associated with both 90-day and l80-day long-term use. After two years of follow up, long-term hypnotic users had higher medical expenses and a significantly higher risk for dementia. 90-day users had a significantly higher risk for intoxication, but less fractures. Non-elderly 180-day users had more internal fixations. Conclusions: Patients with certain characteristics tended to be prescribed with anxiety-hypnotic medications for more than 90-days or 180-days. The risk of dementia and higher expenses is a concern in all long-term users. Caution also should be used when treating non-elderly patients, in addition to the elderly.
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP) and the EudraCT. We selected the ATMPs trials after elimination of duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organization. We classified ATMPs by type and trial status: ongoing, completed, terminated, discontinued, and prematurely ended. Then we calculated the rate of discontinuation. Results: 143 withdrawn, terminated or prematurely ended ATMPs clinical trials were identified between 1999 and June 2015 and 474 ongoing and completed clinical trials. Therefore, the rate of discontinuation of ATMPs trials is 23.17% similar to non-ATMPs drugs in development. The probability of discontinuation is respectively 27.35%, 16.28%, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (44%) followed by cardiology and immunology/inflammation (22.2%). It is almost the same for commercial and non-commercial sponsors (24%); Suggesting discontinuation may not be financially driven. Conclusions: No failure risk rate per development phase is available for ATMPs. Discontinuation rate may prove helpful when assessing expected net present value to support portfolio arbitration. These results carry limitation as the reason for discontinuation is unknown. Further research about the reasons of discontinuation and the risk of negative results is needed to inform manufacturers and investors decisions. PHP45 Outcomes From Homeopathic Prescribing in Secondary Care Homeopathic Hospital: A Prospective Study Dobariya N1, Tiwari P1, Dhiman K2, Sareen P2, Anand T2, Sharda S2, Manku Tk2, Kaur R2 1National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali), Punjab, India, 2Homeopathic Medical College and Hospital, Chandigarh, India
Objectives: Despite its presence in most parts of the country, very little is reported about the variety of illnesses, course of treatment and outcomes in patients in the homeopathic medical treatment. The research aims to explore the outcomes of homeopathic treatment in patients who are using homeopathic medicine. Methods: This prospective questionnaire based study used the data obtained from the patients attending a public homeopathic healthcare facility. The information collected included patient’s age and gender, demographics, medical condition, duration of illness & homeopathic medicine prescribed. Additionally, the patient reported outcome on a 100-point visual analogue scale was also captured. Per protocol analysis was performed for analysing the data. Results: Of the 655 patients screened, only 194 patients qualified to be included in analysis. Their mean age was found to be 37.6 years (±13.3). The mean height and weight were 163.7 cm (±8.3) and 65.44 kg (±12.1), respectively. 59% of patients were female. 52% patients were having normal BMI while 8%, 29% and 11% were underweight, overweight and obese respectively. 58% of patients belonged to upper socioeconomic class where 21% each were from middle and lower class. The most common reason for preference of homeopathic system of medicine were perceived surety of relief and belief in its safety. Out of all, 87% patients presented with a chronic illness. The mostly prescribed drugs were Pulsatilla, Sulphur, Rhus Toxidendron, Lycopodium Clavaton, Arsenic Album, and Belladonna. Outcome from one or more follow up per patient condition was captured for all 194 patients (64% patients improved, 4% reported worsening and 32% reported no change). Positive outcome was observed in patients with cough, allergy, bodyache, PCOS, piles, renal calculi and URTI. Conclusions: The homeopathic treatment is most preferred by the patients having chronic disease. In disease severity, there is sustained improvement following homeopathic treatment period. Our findings demand longer follow up and a larger sample. PHP46 High-Risk Medications and Unplanned Hospitalizations: A Case– Time–Control Study Lin C1, Wen Y2, Chen L3, Hsiao F1 1National Taiwan University, Taipei, Taiwan, 2Chang Gung University, Taoyuan, Taiwan, 3Taipei Veterans General Hospital, Taipei, Taiwan
Objectives: Empirical data of medication-related hospitalization are very limited. The aim of this study is to investigate the associations between 12 high-risk medications (diabetic agents, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, antiplatelets, antihypertensives, antiarrhythmics, anticonvulsants, antipsychotics, antidepressants, benzodiazepine (BZD)/Z-hypnotics, and narcotics) and unplanned hospitalizations. Methods: A population-based case–time–control study was performed using the 2000 -2011 Taiwan’s National Health Insurance Research Database. Patients who experienced an unplanned hospitalization (index visit) were identified as index subjects and matched to a randomly selected reference visit within users of a specific category of high-risk medication. Discordant exposures to the high-risk medication during the case period (1-14 days before the visit) and the control period (366-379 days before the visit) were examined in both index and reference visits. For each high-risk medication category, conditional logistic regression models were used to estimate the odds ratios (ORs) of unplanned hospitalizations, and attributable fractions (AFs) for unplanned hospitalizations were calculated. Results: Antipsychotics was associated with the highest risk of unplanned hospitalizations (aOR: 1.54, 95% confidence interval [1.37-1.73], AF: 35.0%), followed by NSAIDs (1.50, [1.44-1.56], 33.3%), anticonvulsants (1.34, [1.10-1.64], 25.6%), diuretics (1.24, [1.15-1.33], 19.1%), BZD/Z-hypnotics (1.23, [1.16-1.31], 18.8%), antidepressants (1.17, [1.05-1.31], 14.7%) and antiplatelets (1.16, [1.07-1.26], 14.0%). NSAIDs and narcotics were associated with the highest risks of unplanned hospitalizations with a length of stay ≥ 10 days. Conclusions: Antipsychotics, NSAIDs, anticonvulsants, diuretics, BZD/Z-hypnotics, antidepressants, and antiplatelets were significantly associated with increased risks of unplanned hospitalizations. These drugs should be targeted for clinical and policy interventions. PHP47 Implementation of Adverse Event Trigger Tool System for Assessing Patient Safety Vilakkathala R1, Mallayasamy S1, K V1, Rodrigues GS2, BH AR2 1Manipal University, Manipal, India, 2Kasturba Medical College, Manipal, India
Objectives: Assessing the quality of health care service is an important issue of international relevance. The rate of Adverse Events (AEs) among the hospitalized patients is one of the important indicators of patient safety. This study was aimed to develop and validate a trigger tool system to identify adverse events in the surgery department. Methods: A list of triggers was prepared and validated by suitable methods. The final list contained 77 triggers of three different categories such as, surgical care, critical care and medical care module. This list used to identify triggers in the reviewed case records over a period of 36 months (20 cases per month). The actual AEs were identified by the final consensus of surgeons. The resulting harm was categorized according to NCCMERP index. Results: Totally 679 triggers were present in the 236 cases with an average of 2.88 ± 2.92 triggers per case and in 211 case records, the triggers were able to identify actual adverse events. Majority of the events were minor in severity. Most important five AEs identified were bleeding, lab value abnormality, constipation, breathing difficulty and pyrexia. It was found that higher the number of triggers present, higher the chances of occurrence of AEs. Surgeons were of the opinion that AEs are a problem in their practice and there is a need to monitor and prevent them and the present trigger tool system appears to be effective in monitoring. Conclusions: The developed trigger tool system was found to be effective and relevant approach for ensuring appropriate monitoring of AEs in the surgery department of the study hospital. This tool has potential application to review the cases for adverse events at or near the time of their occurrence and to prevent the harm. PHP48 What are the key concerns of health care providers in china? Qualitative investigation of a double-blind telephone survey Sun Y1, Liu GG1, Wang T2, You X1, Zhao H1 University, Beijing, China, 2Shenyang Pharmaceutical University, Shenyang, China
1Peking
Objectives: The aim of this study is to investigate the job satisfaction and some noteworthy concerns on Chinese public hospitals among one of the most important stakeholders – doctors and nurses. Methods: We used open-ended questions and double-blind telephone interview method to collect the information. Interviewers documented all of the answers, and then two analysts independently read the manuscripts to identify the key points and to extract the representative words. The identified key points are concluded to some major factors. Results: 299 doctors and nurses from tertiary and secondary hospitals in 27 provinces were contacted for the interview. 23.7% of them are holding no concerns on their current work environment, or satisfied with their job. Besides, among those with concerns, 18.7% mentioned that they were overloaded with work and suffering high pressure, indeed, over 24% stated that they work was unfairly undervalued by hospitals, government and society. 33.4% of the interviewees indicated that the core competitiveness of hospitals, including the scale, reputation, and location of hospitals, the number of admissions, and the development of hospitals, was the key aspect determines their resignation. Another reason of resignation was family with 15.7% of the responses. Moreover, about 9.8% mentioned the importance of management in hospitals, such as the promotion system, the management of performance, target and talent. Conclusions: In China, the job satisfaction of doctors and nurses is relatively low. A great number of them are suffering high workload and pressure, with relatively lower payment. The ongoing public hospital reform should embody the non-profit nature of public hospitals; meanwhile, guarantee the appropriate payment to medical personnel to improve their incentives to provide efficient and high-quality healthcare.
PHP49 Factors Associated with 90-Day or 180-Day Long-Term Use of Anxiety-Hypnotic Prescriptions and Economic and Safety Outcomes: A Retrospective Cohort Study Lin H1, Tsai H2, Liu F3, Liao C4, Li C5, Lin C4, Chou C4, Chang C4, Simonavice CA4, Li T1 1China Medical University, Taichung, Taiwan, 2Providence University, Taichung City, Taiwan, 3Hsuan Chuang University, Hsinchu City, Taiwan, 4China Medical University Hospital, Taichung, Taiwan, 5China Medical University Hospital, Taiwan, Taichung, Taiwan
Objectives: The World Health Organization defines continuous use of medications for more than 180 days as long-term use. Caution should be used when treating elderly with Benzodiazepines (BZD) for more than 30 days and non-BZD hypnotics for more than 90 days. This study aimed to examine the factors associated with long-term use of anxiety-hypnotics and its economic and safety outcomes in Taiwan. Methods: A retrospective cohort study was conducted using Taiwan’s National Health Insurance (NHI) Research databases. NHI beneficiaries who were newly prescribed with at least one anxiety-hypnotic medication in outpatient settings were grouped as long-term users (i.e., ³ 180 day or ³ 90 day) or corresponding non-long-term users by using a propensity score matching approach. Demographics, health-care utilizations, disease status, and related risks were examined for their associations with long-term use using logistic regression analyses. The economic and safety outcomes among long-term and non-long-term users after two-year follow-up were compared and stratified into either elderly or nonelderly groups. Results: 138,624 patients in the sample were newly prescribed with anxiety-hypnotic medications in 2009. 2.39% and 7.11% were identified as 180-day or 90-day long-term users, respectively. Age, prior medical expenses, cardiac disease or insomnia, and use of some pain killers and Chinese medications were statistically associated with both 90-day and l80-day long-term use. After two years of follow up, long-term hypnotic users had higher medical expenses and a significantly higher risk for dementia. 90-day users had a significantly higher risk for intoxication, but less fractures. Non-elderly 180-day users had more internal fixations. Conclusions: Patients with certain characteristics tended to be prescribed with anxiety-hypnotic medications for more than 90-days or 180-days. The risk of dementia and higher expenses is a concern in all long-term users. Caution also should be used when treating non-elderly patients, in addition to the elderly.