Alice Bhasale - Academia.edu (original) (raw)

Papers by Alice Bhasale

Research paper thumbnail of Clinical Incidents in General Practice : Warfarin Prescribing

Australian Family Physician, 1996

Research paper thumbnail of Clinical Incidents in General Practice : Childhood Immunisation

Australian Family Physician, 1996

Research paper thumbnail of Clinical incident monitoring

Australian family physician, 1996

Research paper thumbnail of Breast cancer--could it have been diagnosed earlier?

Australian family physician, 1996

Research paper thumbnail of Clinical incidents in general practice. Keeping on track with test results

Australian family physician, 1996

The incident Monitoring in General Practice Project began as an initiative of the Professional In... more The incident Monitoring in General Practice Project began as an initiative of the Professional Indemnity Review. Anonymous data from general practitioners about unintended and possibly adverse events were collected in order to develop preventive strategies that might ultimately increase patient safety and therefore reduce litigation. Feedback and sharing of experiences and ideas about these events, possible management strategies or about the project as a whole are invited from readers.

Research paper thumbnail of Collecting data on potentially harmful events: a method for monitoring incidents in general practice

Research paper thumbnail of Additional file 1: of Recognising and responding to deteriorating patients: what difference do national standards make?

Survey of Recognition and Response Systems: This is a copy of the electronic survey given to resp... more Survey of Recognition and Response Systems: This is a copy of the electronic survey given to respondents. (PDF 753 kb)

Research paper thumbnail of Garlic for the common cold (2014 Review)

Cochrane Database of Systematic Reviews, 2014

Garlic is popularly believed to be useful for the common cold. This belief is based on traditiona... more Garlic is popularly believed to be useful for the common cold. This belief is based on traditional use, and some laboratory evidence that garlic has antibacterial and antiviral properties. On average, adults have two to four common colds per year. The evidence is current to the 7 August 2014. Of the eight studies identified, only one fulfilled the criteria for the review. This study assessed 146 participants over a three-month period. Half the participants took a placebo tablet and half took a garlic tablet during this time. The participants then wrote in a diary when they had symptoms of a cold. The included study found that people who took garlic every day for three months (instead of a placebo) had fewer colds. That is, over the three-month period, there were 24 occurrences of the common cold in the garlic group, compared to 65 in the placebo group. When participants experienced a cold, the length of illness was similar in both groups (4.63 versus 5.63 days).

Research paper thumbnail of Regulatory post‐market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies

Pharmacology Research & Perspectives, 2020

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-... more This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Research paper thumbnail of A sorry tale of unnecessary secrecy about medicine safety

Internal Medicine Journal, 2021

Research paper thumbnail of Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

British Journal of Clinical Pharmacology, 2021

AIM Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, bu... more AIM Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. METHODS Semi-structured qualitative interviews with 40 primary care physicians, endocrinologists, and other generalist specialists in Boston USA and Australia. Coding and analysis were carried out inductively and iteratively to identify and examine key factors. Analysis centred around four areas; physicians' awareness of drug safety information, preferred information sources, opinion-forming, and sharing of information with patients. RESULTS Uncertainty, trust, and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion, and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the 'clinical grapevine' for awareness, and on clinical colleagues, specialists, and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs. CONCLUSION Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance, and accessibility, and address physicians' needs in communicating risk to patients.

Research paper thumbnail of A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States ‐ 2007 to 2016

Pharmacoepidemiology and Drug Safety, 2020

To determine the frequency and characteristics of safety advisories issued by medicines regulator... more To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US).

Research paper thumbnail of Communicating emerging risks of SGLT2 inhibitors—timeliness and transparency of medicine regulators

Research paper thumbnail of 14 Quality improvement standards to prevent inappropriate use of colonoscopy in australian healthcare services

Poster Presentations, 2019

Most colonoscopy in Australia is carried out for the purpose of bowel cancer detection or prevent... more Most colonoscopy in Australia is carried out for the purpose of bowel cancer detection or prevention. Australia has a well-established national bowel cancer screening program based on faecal occult blood testing, with lower rates of mortality and advanced cancer diagnosis seen in participants.1 Strong evidence supports the use of colonoscopy for bowel cancer screening or surveillance in high-risk individuals. However, most colonoscopy procedures do not arise as a result of the National Bowel Cancer Screening program and both overuse and underuse are evident, contrary to both the epidemiology of bowel disease and evidence-based guidelines.2 Medical Benefits Schedule reimbursed diagnostic colonoscopy, with and without polypectomy, increased respectively by 177% and 51% between 2004 and 2015. It is estimated that for every 1 million Australians aged 50 years and over, 80,000 people at average risk of bowel cancer are being over-screened with colonoscopy and 29,000 people at increased risk are not having the colonoscopy they need.2 Overuse of the procedure also makes it harder for patients in greatest need to access care with 75% of colonoscopies being carried out in private hospitals, while only 50% of Australians have private health insurance. Although the risk of complications is low, inappropriate use increases exposure to potential harms including perforation, sedation-related complications and adverse patient experience, reducing future participation in screening. The Australian Commission on Safety and Quality in Health Care developed the Colonoscopy Clinical Care Standard to define minimum requirements for high quality colonoscopy care. The standard reflects current guidelines and addresses primary care, clinical referral, bowel preparation, sedation, colonoscopist certification, patient-centred care, and evidence-based surveillance. Shared decision-making and fully informed financial and procedural consent are emphasised. Quality indicators are specified for colonoscopy care that are equivalent to the indicators required for ongoing recertification of colonoscopists. All acute hospitals and day procedure services are required to demonstrate implementation of the colonoscopy standard when undergoing mandatory accreditation to the National Safety and Quality Health Service (NSQHS) Standards. Implementation of the standard was piloted in two public hospitals, a private hospital and a day procedure unit from May to August 2019, including a simulated accreditation against the NSQHS Standards. While quality improvement programs exist in other countries, the Colonoscopy Clinical Care Standard represents an integrated approach to national health service accreditation to improve quality and safety and address inappropriate colonoscopy use. References Australian Institute of Health and Welfare 2018. Analysis of bowel cancer outcomes for the National Bowel Cancer Screening Program: 2018. Cat. no. CAN 113. Canberra: AIHW. Australian Commission on Safety and Quality in Health Care and Australian Institute of Health and Welfare. The third Australian atlas of healthcare variation. Sydney: ACSQHC, 2018.

Research paper thumbnail of Media coverage of drug regulatory agencies’ safety advisories: a case study of citalopram and denosumab

British Journal of Clinical Pharmacology, 2020

This article has been accepted for publication and undergone full peer review but has not been th... more This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as

Research paper thumbnail of Recognising and responding to deteriorating patients: what difference do national standards make?

BMC Health Services Research, 2019

Background: The Australian Commission on Safety and Quality in Health Care released a set of nati... more Background: The Australian Commission on Safety and Quality in Health Care released a set of national standards which became a mandatory part of accreditation in 2013. Standard 9 focuses on the identification and treatment of deteriorating patients. The objective of the study was to identify changes in the characteristics and perceptions of rapid response systems (RRS) since the implementation of Standard 9. Methods: Cross-sectional study of Australian hospitals. Baseline data was obtained from a pre-implementation survey in 2010 (220 hospitals). A follow-up survey was distributed in 2015 to staff involved in implementing Standard 9 in public and private hospitals (276 responses) across Australia. Results: Since 2010, the proportion of hospitals with formal RRS had increased from 66 to 85. Only 7% of sites had dedicated funding to operate the RRS. 83% of respondents reported that Standard 9 had improved the recognition of, and response to, deteriorating patients in their health service, with 51% believing it had improved awareness at the executive level and 50% believing it had changed hospital culture. Conclusions: Implementing a national safety and quality standard for deteriorating patients can change processes to deliver safer care, while raising the profile of safety issues. Despite limited dedicated funding and staffing, respondents reported that Standard 9 had a positive impact on the care for deteriorating patients in their hospitals.

Research paper thumbnail of Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom

JAMA Internal Medicine, 2019

Conflict of Interest Disclosures: Ms Ferris reported receiving grants from the Bureau of Justice ... more Conflict of Interest Disclosures: Ms Ferris reported receiving grants from the Bureau of Justice Assistance Harold Rogers Prescription Drug Monitoring Program Category 2 during the conduct of the study and being employed by Audacious Inquiry and contracted full time with the Chesapeake Regional Information System for our Patients, the Maryland state-designated health information exchange. Ms Lyons reported receiving grants from the Bureau of Justice Assistance, US Department of Justice, during the conduct of the study. Dr Weiner reported receiving grants from the US Department of Justice to the Maryland Department of Health during the conduct of the study. No other disclosures were reported.

Research paper thumbnail of Secret safety warnings on medicines: A case study of information access requests

Pharmacoepidemiology and Drug Safety, 2019

Purpose: There has been less attention to the transparency of postmarket evidence of harmful effe... more Purpose: There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian "direct health professional communications" (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA). Methods: We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow-up freedom-of-information (FOI) request to the TGA. Results: Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality; the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful. Conclusions: Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases.

Research paper thumbnail of All colonoscopies are not created equal: why Australia now has a clinical care standard for colonoscopy

Medical Journal of Australia, 2018

Maintaining the quality of colonoscopies is vital if promised reductions in colorectal cancer are... more Maintaining the quality of colonoscopies is vital if promised reductions in colorectal cancer are to be achieved * For the full clinical standard, see www.safetyandquality.gov.au/ccs or www.safetyandquality. gov.au/our-work/clinical-care-standards/colonoscopy-clinical-care-standard. u Perspective MJA 209 (10) j

Research paper thumbnail of Effect of a National Standard for Deteriorating Patients on Intensive Care Admissions Due to Cardiac Arrest in Australia

Critical care medicine, 2018

To assess whether a national standard for improving care of deteriorating patients affected ICU a... more To assess whether a national standard for improving care of deteriorating patients affected ICU admissions following cardiac arrests from hospital wards. Retrospective study assessing changes from baseline (January 1, 2008, to June 30, 2010), rollout (July 1, 2010, to December 31, 2012), and after (January 1, 2013, to 31 December 31, 2014) national standard introduction. Conventional inferential statistics, interrupted time series analysis, and adjusted hierarchical multiple logistic regression analysis. More than 110 ICU-equipped Australian hospitals. Adult patients (≥ 18 yr old) admitted to participating ICUs. Introducing a national framework to improve care of deteriorating patients including color-coded observation charts, mandatory rapid response system, enhanced governance, and staff education for managing deteriorating patients. Cardiac arrest-related ICU admissions from the ward decreased from 5.6% (baseline) to 4.9% (rollout) and 4.1% (intervention period). Interrupted time...

Research paper thumbnail of Clinical Incidents in General Practice : Warfarin Prescribing

Australian Family Physician, 1996

Research paper thumbnail of Clinical Incidents in General Practice : Childhood Immunisation

Australian Family Physician, 1996

Research paper thumbnail of Clinical incident monitoring

Australian family physician, 1996

Research paper thumbnail of Breast cancer--could it have been diagnosed earlier?

Australian family physician, 1996

Research paper thumbnail of Clinical incidents in general practice. Keeping on track with test results

Australian family physician, 1996

The incident Monitoring in General Practice Project began as an initiative of the Professional In... more The incident Monitoring in General Practice Project began as an initiative of the Professional Indemnity Review. Anonymous data from general practitioners about unintended and possibly adverse events were collected in order to develop preventive strategies that might ultimately increase patient safety and therefore reduce litigation. Feedback and sharing of experiences and ideas about these events, possible management strategies or about the project as a whole are invited from readers.

Research paper thumbnail of Collecting data on potentially harmful events: a method for monitoring incidents in general practice

Research paper thumbnail of Additional file 1: of Recognising and responding to deteriorating patients: what difference do national standards make?

Survey of Recognition and Response Systems: This is a copy of the electronic survey given to resp... more Survey of Recognition and Response Systems: This is a copy of the electronic survey given to respondents. (PDF 753 kb)

Research paper thumbnail of Garlic for the common cold (2014 Review)

Cochrane Database of Systematic Reviews, 2014

Garlic is popularly believed to be useful for the common cold. This belief is based on traditiona... more Garlic is popularly believed to be useful for the common cold. This belief is based on traditional use, and some laboratory evidence that garlic has antibacterial and antiviral properties. On average, adults have two to four common colds per year. The evidence is current to the 7 August 2014. Of the eight studies identified, only one fulfilled the criteria for the review. This study assessed 146 participants over a three-month period. Half the participants took a placebo tablet and half took a garlic tablet during this time. The participants then wrote in a diary when they had symptoms of a cold. The included study found that people who took garlic every day for three months (instead of a placebo) had fewer colds. That is, over the three-month period, there were 24 occurrences of the common cold in the garlic group, compared to 65 in the placebo group. When participants experienced a cold, the length of illness was similar in both groups (4.63 versus 5.63 days).

Research paper thumbnail of Regulatory post‐market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies

Pharmacology Research & Perspectives, 2020

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-... more This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Research paper thumbnail of A sorry tale of unnecessary secrecy about medicine safety

Internal Medicine Journal, 2021

Research paper thumbnail of Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

British Journal of Clinical Pharmacology, 2021

AIM Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, bu... more AIM Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. METHODS Semi-structured qualitative interviews with 40 primary care physicians, endocrinologists, and other generalist specialists in Boston USA and Australia. Coding and analysis were carried out inductively and iteratively to identify and examine key factors. Analysis centred around four areas; physicians' awareness of drug safety information, preferred information sources, opinion-forming, and sharing of information with patients. RESULTS Uncertainty, trust, and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion, and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the 'clinical grapevine' for awareness, and on clinical colleagues, specialists, and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs. CONCLUSION Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance, and accessibility, and address physicians' needs in communicating risk to patients.

Research paper thumbnail of A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States ‐ 2007 to 2016

Pharmacoepidemiology and Drug Safety, 2020

To determine the frequency and characteristics of safety advisories issued by medicines regulator... more To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US).

Research paper thumbnail of Communicating emerging risks of SGLT2 inhibitors—timeliness and transparency of medicine regulators

Research paper thumbnail of 14 Quality improvement standards to prevent inappropriate use of colonoscopy in australian healthcare services

Poster Presentations, 2019

Most colonoscopy in Australia is carried out for the purpose of bowel cancer detection or prevent... more Most colonoscopy in Australia is carried out for the purpose of bowel cancer detection or prevention. Australia has a well-established national bowel cancer screening program based on faecal occult blood testing, with lower rates of mortality and advanced cancer diagnosis seen in participants.1 Strong evidence supports the use of colonoscopy for bowel cancer screening or surveillance in high-risk individuals. However, most colonoscopy procedures do not arise as a result of the National Bowel Cancer Screening program and both overuse and underuse are evident, contrary to both the epidemiology of bowel disease and evidence-based guidelines.2 Medical Benefits Schedule reimbursed diagnostic colonoscopy, with and without polypectomy, increased respectively by 177% and 51% between 2004 and 2015. It is estimated that for every 1 million Australians aged 50 years and over, 80,000 people at average risk of bowel cancer are being over-screened with colonoscopy and 29,000 people at increased risk are not having the colonoscopy they need.2 Overuse of the procedure also makes it harder for patients in greatest need to access care with 75% of colonoscopies being carried out in private hospitals, while only 50% of Australians have private health insurance. Although the risk of complications is low, inappropriate use increases exposure to potential harms including perforation, sedation-related complications and adverse patient experience, reducing future participation in screening. The Australian Commission on Safety and Quality in Health Care developed the Colonoscopy Clinical Care Standard to define minimum requirements for high quality colonoscopy care. The standard reflects current guidelines and addresses primary care, clinical referral, bowel preparation, sedation, colonoscopist certification, patient-centred care, and evidence-based surveillance. Shared decision-making and fully informed financial and procedural consent are emphasised. Quality indicators are specified for colonoscopy care that are equivalent to the indicators required for ongoing recertification of colonoscopists. All acute hospitals and day procedure services are required to demonstrate implementation of the colonoscopy standard when undergoing mandatory accreditation to the National Safety and Quality Health Service (NSQHS) Standards. Implementation of the standard was piloted in two public hospitals, a private hospital and a day procedure unit from May to August 2019, including a simulated accreditation against the NSQHS Standards. While quality improvement programs exist in other countries, the Colonoscopy Clinical Care Standard represents an integrated approach to national health service accreditation to improve quality and safety and address inappropriate colonoscopy use. References Australian Institute of Health and Welfare 2018. Analysis of bowel cancer outcomes for the National Bowel Cancer Screening Program: 2018. Cat. no. CAN 113. Canberra: AIHW. Australian Commission on Safety and Quality in Health Care and Australian Institute of Health and Welfare. The third Australian atlas of healthcare variation. Sydney: ACSQHC, 2018.

Research paper thumbnail of Media coverage of drug regulatory agencies’ safety advisories: a case study of citalopram and denosumab

British Journal of Clinical Pharmacology, 2020

This article has been accepted for publication and undergone full peer review but has not been th... more This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as

Research paper thumbnail of Recognising and responding to deteriorating patients: what difference do national standards make?

BMC Health Services Research, 2019

Background: The Australian Commission on Safety and Quality in Health Care released a set of nati... more Background: The Australian Commission on Safety and Quality in Health Care released a set of national standards which became a mandatory part of accreditation in 2013. Standard 9 focuses on the identification and treatment of deteriorating patients. The objective of the study was to identify changes in the characteristics and perceptions of rapid response systems (RRS) since the implementation of Standard 9. Methods: Cross-sectional study of Australian hospitals. Baseline data was obtained from a pre-implementation survey in 2010 (220 hospitals). A follow-up survey was distributed in 2015 to staff involved in implementing Standard 9 in public and private hospitals (276 responses) across Australia. Results: Since 2010, the proportion of hospitals with formal RRS had increased from 66 to 85. Only 7% of sites had dedicated funding to operate the RRS. 83% of respondents reported that Standard 9 had improved the recognition of, and response to, deteriorating patients in their health service, with 51% believing it had improved awareness at the executive level and 50% believing it had changed hospital culture. Conclusions: Implementing a national safety and quality standard for deteriorating patients can change processes to deliver safer care, while raising the profile of safety issues. Despite limited dedicated funding and staffing, respondents reported that Standard 9 had a positive impact on the care for deteriorating patients in their hospitals.

Research paper thumbnail of Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom

JAMA Internal Medicine, 2019

Conflict of Interest Disclosures: Ms Ferris reported receiving grants from the Bureau of Justice ... more Conflict of Interest Disclosures: Ms Ferris reported receiving grants from the Bureau of Justice Assistance Harold Rogers Prescription Drug Monitoring Program Category 2 during the conduct of the study and being employed by Audacious Inquiry and contracted full time with the Chesapeake Regional Information System for our Patients, the Maryland state-designated health information exchange. Ms Lyons reported receiving grants from the Bureau of Justice Assistance, US Department of Justice, during the conduct of the study. Dr Weiner reported receiving grants from the US Department of Justice to the Maryland Department of Health during the conduct of the study. No other disclosures were reported.

Research paper thumbnail of Secret safety warnings on medicines: A case study of information access requests

Pharmacoepidemiology and Drug Safety, 2019

Purpose: There has been less attention to the transparency of postmarket evidence of harmful effe... more Purpose: There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian "direct health professional communications" (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA). Methods: We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow-up freedom-of-information (FOI) request to the TGA. Results: Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality; the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful. Conclusions: Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases.

Research paper thumbnail of All colonoscopies are not created equal: why Australia now has a clinical care standard for colonoscopy

Medical Journal of Australia, 2018

Maintaining the quality of colonoscopies is vital if promised reductions in colorectal cancer are... more Maintaining the quality of colonoscopies is vital if promised reductions in colorectal cancer are to be achieved * For the full clinical standard, see www.safetyandquality.gov.au/ccs or www.safetyandquality. gov.au/our-work/clinical-care-standards/colonoscopy-clinical-care-standard. u Perspective MJA 209 (10) j

Research paper thumbnail of Effect of a National Standard for Deteriorating Patients on Intensive Care Admissions Due to Cardiac Arrest in Australia

Critical care medicine, 2018

To assess whether a national standard for improving care of deteriorating patients affected ICU a... more To assess whether a national standard for improving care of deteriorating patients affected ICU admissions following cardiac arrests from hospital wards. Retrospective study assessing changes from baseline (January 1, 2008, to June 30, 2010), rollout (July 1, 2010, to December 31, 2012), and after (January 1, 2013, to 31 December 31, 2014) national standard introduction. Conventional inferential statistics, interrupted time series analysis, and adjusted hierarchical multiple logistic regression analysis. More than 110 ICU-equipped Australian hospitals. Adult patients (≥ 18 yr old) admitted to participating ICUs. Introducing a national framework to improve care of deteriorating patients including color-coded observation charts, mandatory rapid response system, enhanced governance, and staff education for managing deteriorating patients. Cardiac arrest-related ICU admissions from the ward decreased from 5.6% (baseline) to 4.9% (rollout) and 4.1% (intervention period). Interrupted time...