8^th Global Pharmacovigilance & Drug Safety Summit July 06-07, 2017 Kuala Lumpur, Malaysia

Biography:

Tetsufumi Koga is currently a Senior Scientist at the Laboratory Animal Care & Management Group of Daiichi Sankyo Co., Ltd., Japan. He has presented more than 10 papers regarding the evaluation of antibiotics, mechanisms of antibacterial agents and animal infection models.

Abstract:

Campylobacter spp. are zoonotic pathogens and a major cause of gastroenteritis for humans. The transmission of Campylobacter infection is due to consumption of animal products and water and through contact with animals and environments such as soil and rivers. Consequently, Campylobacter infection is of great importance to public health. We have performed the isolation of Campylobacter spp. in cynomolgus monkeys that were purchased from China (more than 2 animal producers), Cambodia, Indonesia (more than 1 animal producer), Philippines and Vietnam. From 1 animal producer of China, Cambodia and Indonesia, Campylobacter spp. were isolated from the feces of monkeys. Prevalence rates of each country were different and the pattern of antimicrobial resistance was also varied. Multi-resistant isolates (isolates simultaneously resistant to more than three or more different classes of antimicrobials) of C. coli were found in monkeys from all 3 countries and an isolate simultaneously resistant to five different antimicrobials (Penicillin, Tetracycline, Chloramphenicol, Aminoglycoside and Quinolone) was isolated from Indonesia. Although only limited information from humans and animals is available on the antimicrobial resistance of Campylobacter spp., similarly patterned resistance profiles, which had been previously reported, were observed in each country. We did not characterize these isolates with molecular typing techniques; however, these geographic areas would be contaminated with these pathogens. Antibiotic resistance is a growing global public health threat and a particularly serious problem in Asia due to the historic overuse and misuse of antimicrobials in human health and animal agriculture. We should conduct global surveillance on drug resistance in bacteria of not only human origin but also animal origin. This surveillance is also included in pharmacovigilance. In addition, antimicrobial stewardship initiatives and infection control programs should be instituted for both human and animal therapy.

Biography:

Abhay Chimankar is a Physician by profession, Global Leader with expertise in Drug Safety and Pharmacovigilance Regulatory Affairs with additional experience in Medical Writing, Clinical Trials, BA/BE Monitoring and Auditing. He is well-versed in Global Regulatory Guidelines and Speaker at international conferences and is known as a keen planner, strategist, and implementer with solid track record of results that deliver business value through streamlined PV operations. His areas of PV expertise include: Pharmacovigilance guidelines in key areas of the globe, with in-depth knowledge on patient safety, practical implications of EU GVP, particularly all effective modules, establishing PV operations, Argus implementation and electronic gateway setup and compliance with quality standards, SOPs, ICH-GCP and/or other guidelines. He has experience previously working in Cipla Ltd, TCS and Novartis. He is currently working with Pharmaviz Pvt. Ltd. as the CEO.

Abstract:

With the ever-increasing requirement from various regulatory authorities across the globe, the marketing authorization holders (MAHs) are required to comply with these requirements. To meet the expectations from multiple regulators, it becomes difficult for MAHs to sustain the team, resources and also to manage the global team within the budget. One of the challenges is to have global compliance in terms of regulatory reporting, identification, assessing, reviewing the ICSRs and reporting them on-time. At the same time, the ICSRs are to be exchanged with the global partners. Right at the start and sustain the rightness through various processes including the risk based audits of various functions is the key to this compliance. Well trained and experienced resources and retention strategy play important role in the PhV system. Automation processes which are validated and compliant to the requirements help MAH to minimize the manual inputs wherever possible e.g., literature imports, identification of key index term, using auto mails for follow up communications, generating various reports like KPI dashboard and compliance reports. The safety databases to be used to its fullest capabilities, right IT partners (in-house or outsourced) helps in this to align.

Biography:

The aim of this work is to review the current patient Adverse Drug Reaction (ADR) reporting system in 50 countries and to analyze its implication on pharmacovigilance system. National Competent Authorities (NCA) is surveyed and a literature review was conducted in fifty countries across five continents. Of the 50 countries included in this study, patient report ADR to NCA in 44 countries (88%) were taken. Twenty-six countries (59%) have created a patient-specific ADR reporting form. Depending on the country, the way to declare an ADR is more or less easy to find from the NCA website but on the average 3 clicks are requested to access the ADR form. The total number of fields to complete per ADR form varies from 6 (Brazil) to 59 (Austria) with a mean of 36 items. Reports from patients represent an average 9% of total ADR reports compared to HCP reports received by NCAs but a fairly large disparity can be observed. Efforts are still to be made in the field of pharmacovigilance to encourage patients to report ADR especially in developing countries. However, the majority of the 50 countries surveyed in this study really began to implement a patient ADR reporting system (16 countries began in 2012 or 2013), which can explain the fact that the patient reporting is fairly low compared to HCP. When NCA implemented an online ADR reporting form, the rate of reporting is increasing. Means to report should be extended for the development of applications in mobile devices enabling faster return at any time. Only few countries have currently implemented a mobile application. Each country should promote ADR reporting system using all means of communication included Internet and social networks.

Abstract:

The aim of this work is to review the current patient Adverse Drug Reaction (ADR) reporting system in 50 countries and to analyze its implication on pharmacovigilance system. National Competent Authorities (NCA) is surveyed and a literature review was conducted in fifty countries across five continents. Of the 50 countries included in this study, patient report ADR to NCA in 44 countries (88%) were taken. Twenty-six countries (59%) have created a patient-specific ADR reporting form. Depending on the country, the way to declare an ADR is more or less easy to find from the NCA website but on the average 3 clicks are requested to access the ADR form. The total number of fields to complete per ADR form varies from 6 (Brazil) to 59 (Austria) with a mean of 36 items. Reports from patients represent an average 9% of total ADR reports compared to HCP reports received by NCAs but a fairly large disparity can be observed. Efforts are still to be made in the field of pharmacovigilance to encourage patients to report ADR especially in developing countries. However, the majority of the 50 countries surveyed in this study really began to implement a patient ADR reporting system (16 countries began in 2012 or 2013), which can explain the fact that the patient reporting is fairly low compared to HCP. When NCA implemented an online ADR reporting form, the rate of reporting is increasing. Means to report should be extended for the development of applications in mobile devices enabling faster return at any time. Only few countries have currently implemented a mobile application. Each country should promote ADR reporting system using all means of communication included Internet and social networks.

Biography:

Abstract:

Unsafe medication practice and medication errors are a leading cause of patient safety incidents across the world.   Patient safety culture is an essential element of universal health coverage and affects the sustainability of a health care system through decreasing errors and providing an optimal service.  Many publications on patient safety exist but the organizational climate within Qatar has not been studied and can be compared to other non-Western countries where a few studies have been done. Patient safety can be defined as the avoidance and prevention of patient injuries or adverse events resulting from the process of health care delivery.

Aim: The aim of this study is to describe patient safety culture at HMC Qatar.

Design/Method: A validated questionnaire was used to conduct a web-based cross-sectional survey amongst health professionals; doctors, nurses and pharmacists in HMC.  HMC includes seven different hospitals in Doha Qatar.  The start date was Feb 2015 until July 2016.  Study was approved by IRB, medical Research Center, HMC, Doha, Qatar and funded by the National Priority Research Program (NPRP) cycle 7.

Results: A total of one thousand, six hundred and four responses were received over the study period.  Most responses (67.9%) were received from nurses followed by doctors (13.3%) and pharmacists (12.9%)  Around three quarters (70.9%) were female and aged less than 40 years (76.0% and almost half (48.1%) had more than ten years of experience as a health professional in secondary care. The percentage agreement (strongly agree and agree) for each statement and the mean percentage agreement for each domain were calculated. Those domains with the lowest levels of agreement were: non-punitive response to errors (24.0%); staffing (36.2%); communication openness (50.5%); handoffs and transitions (53.1%); and supervisor/manager expectations and actions promoting patient safety (56.5%). The highest levels of agreement were: organizational learning – continuous improvement (85.1%); team working within unit (82.1%); and management support for patient safety (75.4%).

Conclusions: Most responses were derived from female Nurses comprising of 3/4 of the population aged less than 40 years. Continuous improvement, team working in unit, and management support were found more prominent factors in patient’s safety culture.

Biography:

Antibiotic resistance is steadily rising worldwide. Respiratory tract infections (RTIs) are common indications, mostly imprudent, for antibiotic prescriptions in outpatient setting. In Korea, antibiotic prescription rate for RTIs is still high. As physician visit and antibiotic prescribing are influenced by patient's perceptions and beliefs, we aimed to explore the general public's perspectives and practices toward RTIs and to develop the ‘RTI clinical iceberg.’ A cross-sectional survey was conducted in Wonju Severance Christian Hospital (WSCH) among 550 adults attending outpatient departments during January 2016. Differences in distributions between groups were examined using two-tailed Pearson χ² test. Using the Andersen's behavioral model as a conceptual framework, we constructed logistic regression models to assess factors associated with physician visit. Of 547 participants with complete questionnaires, 62.9% reported having experienced an RTI in the previous six months; 59.3% visited a physician for the illness, most commonly because the symptoms were severe or prolonged, and approximately 16% of them expected an antibiotic prescription from the visit. Perceptions of symptoms severity, the need factor, most strongly influenced physician visit. Predisposing and enabling factors such as inappropriate expectations for antibiotic for a sore throat or having national health insurance also influenced physician visit. Almost all participants who reported asking for an antibiotic were prescribed one, with a 37.1% non-adherence rate. Conclusively, public education on self-care for RTI symptoms that addresses their main concerns may reduce physician visits. Improving physician-patient relationship and informing patients about the lack of antibiotic benefit for most RTIs may also reduce antibiotic prescriptions.

Abstract:

Antibiotic resistance is steadily rising worldwide. Respiratory tract infections (RTIs) are common indications, mostly imprudent, for antibiotic prescriptions in outpatient setting. In Korea, antibiotic prescription rate for RTIs is still high. As physician visit and antibiotic prescribing are influenced by patient's perceptions and beliefs, we aimed to explore the general public's perspectives and practices toward RTIs and to develop the ‘RTI clinical iceberg.’ A cross-sectional survey was conducted in Wonju Severance Christian Hospital (WSCH) among 550 adults attending outpatient departments during January 2016. Differences in distributions between groups were examined using two-tailed Pearson χ² test. Using the Andersen's behavioral model as a conceptual framework, we constructed logistic regression models to assess factors associated with physician visit. Of 547 participants with complete questionnaires, 62.9% reported having experienced an RTI in the previous six months; 59.3% visited a physician for the illness, most commonly because the symptoms were severe or prolonged, and approximately 16% of them expected an antibiotic prescription from the visit. Perceptions of symptoms severity, the need factor, most strongly influenced physician visit. Predisposing and enabling factors such as inappropriate expectations for antibiotic for a sore throat or having national health insurance also influenced physician visit. Almost all participants who reported asking for an antibiotic were prescribed one, with a 37.1% non-adherence rate. Conclusively, public education on self-care for RTI symptoms that addresses their main concerns may reduce physician visits. Improving physician-patient relationship and informing patients about the lack of antibiotic benefit for most RTIs may also reduce antibiotic prescriptions.

Biography:

Rahul Hajare has completed his PhD from Vinayaka Missions University. He is a former Post-Doctoral Fellow of (7^th Batch) Indian Council of Medical Research New Delhi in 2013, where he achieved Post-doc Degree under the guidance and supervision of Eminent Scientist Dr. Ramesh Paranjape, retired as Director and Scientist ‘G’ National AIDS Research Institute, India. He has published more than 47 papers in reputed journals and has been serving as an Editorial Board Member of repute.

Abstract:

The present study reported that clinical pharmacist play a key role in patient safety. Particularly in ART department, they are important for educating guiding the health care professionals related to safety use of medications. Even though drug related problems were found, after reporting information to physicians, we are minimizing harm to patients. In future, clinical pharmacy services are one of the effective services in hospital to improve the quality of life of patients in hospitals. By implementing such practices in the hospitals and country, we can make the country and society free of diseases. These findings raise the issue related to control of HIV multiplication. It is hoped that with the introduction of a new role, the situation for patient living with HIV/AIDS in the hospitals in India will continue to improve. This includes less relocation of PLHA; hence the claim by outstanding importance of inpatient cares in HIV infection in people. This also shows the outstanding importance of inpatient care in PLHA and provided indications that the patient's life could lead to less relocation, because relocation basically means risks and stress for all concerned.

Biography:

The concept of transparency regarding scientific data is more and more obvious, this work aims at describing and analyzing what kind of safety data can be obtained from Pharmacovigilance (PV) databases that offer public access. Nine national pharmacovigilance databases (Australia, Canada, Denmark, Germany, Netherlands, New-Zealand, Japan, United Kingdom, USA) plus the World Health Organization (Vigibase) and the European Pharmacovigilance databases were compared according to the type of data provided, the possible requests (by drug, by adverse reaction) and the format of the safety data. Public access to PV databases is thus classified as high, medium or low. The results show that six databases grant case-level access, the others only provide aggregated data. In terms of general case information, the USA and Canada come first by sharing case ID, the type of report, the reporter and their qualification, whereas Vigibase does not provide any general information. Other databases mostly provide only one of these three items: Source, case ID, or type of report. Overall, the databases from Denmark, Japan, Netherlands, UK and VigiBase were classified as providing a low level of access to available safety information; those from Australia, Eudra Vigilance, Germany and New Zealand as providing a medium level of access; and those from the USA and Canada, as providing a high level of access. The 11 PV databases were analyzed, except for those in North America, provide limited information. This may be acceptable for patient use but not for research purposes.

Abstract:

The concept of transparency regarding scientific data is more and more obvious, this work aims at describing and analyzing what kind of safety data can be obtained from Pharmacovigilance (PV) databases that offer public access. Nine national pharmacovigilance databases (Australia, Canada, Denmark, Germany, Netherlands, New-Zealand, Japan, United Kingdom, USA) plus the World Health Organization (Vigibase) and the European Pharmacovigilance databases were compared according to the type of data provided, the possible requests (by drug, by adverse reaction) and the format of the safety data. Public access to PV databases is thus classified as high, medium or low. The results show that six databases grant case-level access, the others only provide aggregated data. In terms of general case information, the USA and Canada come first by sharing case ID, the type of report, the reporter and their qualification, whereas Vigibase does not provide any general information. Other databases mostly provide only one of these three items: Source, case ID, or type of report. Overall, the databases from Denmark, Japan, Netherlands, UK and VigiBase were classified as providing a low level of access to available safety information; those from Australia, Eudra Vigilance, Germany and New Zealand as providing a medium level of access; and those from the USA and Canada, as providing a high level of access. The 11 PV databases were analyzed, except for those in North America, provide limited information. This may be acceptable for patient use but not for research purposes.