Day 2 :
Keynote Forum
Ashok Srivastava
ClinFomatrix, USA
Keynote: Challenges in breast cancer treatment and drug safety
Time : 10:00-11:00
Biography:
Ashok Srivastava is a Chief Executive Officer and Chief Medical Officer of ClinFomatrix Oncology, USA. He was also the Founder and Chief Medical Officer of Global Pharmatek Clinical and Drug Safety Oncology, USA and Chief Medical Officer of CareBeyond - A Radiation Cancer Center in USA. He has more than 15 years of experience in drug development, medical affairs and commercialization of cancer drugs including radiopharmaceutical and supportive care. He is Leader in Cancer drug development worldwide large Phase-2 and 3 clinical trials in many countries. He has contributed to 21-INDs and 7-NDAs of Cancer Drugs and supportive care, acquisition /merger of company and drug for more than $300 million. He has published more than 85 papers in national and international journals, more than 120 abstracts, 3 book chapters and 2 patents. He is a leader in drug safety, pharmacovigilance of hematology, oncology drugs and built a global drug safety and pharmacovigilance companies in USA and India.
Abstract:
Breast cancer is the most common cancer in women worldwide. It is also the principle cause of death from cancer among women globally. Despite the high incidence rates in Western countries, 89% of women diagnosed with breast cancer are still alive 5 years after their diagnosis, which is due to detection and treatment. Breast cancer incidence has been increasing. In 2015, an estimated 231,840 new cases of invasive breast cancer are expected to be diagnosed in women, along with 60,290 new cases of non-invasive (in situ) breast cancer. About 2,350 new cases of invasive breast cancer are expected to be diagnosed in men in 2015. A man’s lifetime risk of breast cancer is about 1 in 1,000. Breast cancer incidence rates in the U.S. began decreasing. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) after the results of a large study called the Women’s Health Initiative were published in 2002. These results suggested a connection between HRT and increased breast cancer risk. About 5-10% of breast cancers can be linked to gene mutations. Mutations of the BRCA1 and BRCA2 genes are the most common. On average, women with a BRCA1 mutation have a 55-65% lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 45%. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women. An increased ovarian cancer risk is also associated with these genetic mutations. In men, BRCA2 mutations are associated with a lifetime breast cancer risk of about 6.8%; BRCA1 mutations are a less frequent cause of breast cancer in men. All drugs for breast cancer treatment developed and in market cause mild to several side effects and the safety, pharmacovigilance, signal detection and risk management of breast cancer drugs are difficult to manage. A series of challenges of breast cancer therapy and the drug safety will be discussed at the meeting.
- Pharmacovigilance and Risk Management | Clinical Research and Statistics | Regulatory Affairs
Chair
Ashok Srivastava
ClinFomatrix Oncology, USA
Session Introduction
Chun-Bae Kim
Yonsei University, Republic of Korea
Title: From visiting a physician to expecting antibiotics: Korean perspectives and practices toward respiratory tract infections
Time : 11:20-11:55
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.
Rahul Hajare
Indian Council of Medical Research, India
Title: New developments in adverse drug reaction of ART and tertiary care
Time : 11:55-12:30
Biography:
Rahul Hajare has completed his PhD from Vinayaka Missions University. He is a former Post-Doctoral Fellow of (7th 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.
Delphine Bertram
Xendo B V, Netherlands
Title: Open access pharmacovigilance databases: Analysis of 11 databases
Time : 12:30-12:45
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.