Anticoagulant loses its lustre : The Lancet (dabigatran/patient safety)

open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....

Introduction

"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]....."

Summary Points

• Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
• In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
• For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
• In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
• Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
• Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

FDA fines Red Cross $9.6 million - Healthcare business news and research | Modern Healthcare (includes copies of letters FDA and Red Cross)

"....The Red Cross said in a written statement that the fine focuses on one inspection conducted at a donor and client support center in Philadelphia more than a year ago. The not-for-profit also said it is addressing other issues cited by the FDA in the letter.

“We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made,” the Red Cross said. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”

Analysis of Australian newspaper coverage of medication errors

Conclusion
Australian newspaper reporting of medication errors was relatively limited. Given the high prevalence of errors and the potential role consumers can play in identifying and preventing errors, there is a clear argument for increasing public awareness and understanding of issues relating to medication safety. Existing coverage of this issue is unrelated to research evidence. This suggests the need for patient safety researchers and advocacy groups to engage more strongly with the media as a strategy to increase the productive public discourse concerning medication errors and gain support for evidence-based interventions.

video: Patient Safety Advocates Talk About the Bureaucracy in Canadian Health Care - Leslie Worthington/Val Lee - Winnipeg

1)  video: Sisters Leslie Worthington and Val Lee (Winnipeg)
The Patient Factor.com

2)The Patient Factor: Leslie Worthington "Her Father's Voice"

DOTmed.com - Most patient harm events slip through hospital reporting systems (patient safety)

National Patient Safety Foundation: ASPPS - info/membership (fee based membership)

Membership in the American Society of Professionals in Patient Safety is open to professionals whose primary responsibility is patient safety, as well as to individuals across other healthcare disciplines, medical students, providers, risk managment and quality leaders, patient safety advocates and all those committed to safe patient care. Individual membership is the newest addition to NPSF’s portfolio, which includes continuing education credits through the Professional Learning Series, the NPSF Annual Patient Safety Congress, and other high-value programs. S

AHRQ: Health Care: 20 Tips to Help Prevent Medical Errors: Patient Fact Sheet

Canadian Patient Safety Institute - and the patients are where????

 Blogger's Note: and the patients are still not at the table as equal 'partners' - only in Canada, eh? Reminder of the "Nothing for us, without us" (UK) 

"The Canadian Patient Safety Institute (CPSI) is a not-for-profit organization that exists to raise awareness and facilitate implementation of ideas and best practices to achieve a transformation in patient safety. We envision safe healthcare for all Canadians and are driven to inspire extraordinary improvement in patient safety and quality.

We invite governments, health organizations, leaders, and healthcare providers to join us and use the evidence-based tools and resources we develop and provide. Together, we can inspire, learn, apply, and improve the quality of care for patients, residents, and clients.​​​​​​​..."

extract: Balancing Access and Evaluation in the Approval of New Cancer Drugs, June 8, 2011 — JAMA (patient safety etc)

".....Patients with cancer who lack effective treatment desperately seek novel interventions that might extend their lives. They do not have time to wait for the US Food (blogger's note - or any other nation) and Drug Administration's (FDA’s) regular approval process, which requires that sponsors demonstrate “substantial evidence of clinical benefit (or efficacy) from adequate and well-controlled investigations.”........

Evidence Updates including professional commentaries: Safety of Probiotics to Reduce Risk and Prevent or Treat Disease.

"....Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium.

Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further.

Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants.

Conclusions. There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence."

"From Tears to Transparency" Series - trailers, books....patient safety/care

Author Insights: Erythropoietin and Cardiovascular Concerns « news@JAMA (Epogen, Procrit, Patient Safety, adverse events)

May 2 blog: (privacy-Freedom of Information and Protection of Privacy Act - FIPPA) Ontario Hospital Association - The Facts on FOI and Hospitals' Quality of Care Records

Note: the facts from the perspective of the OHA; references patient safety, communication, data sharing
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The Facts on FOI and Hospitals' Quality of Care Records

"I’m going to use today’s blog to address an issue that has recently generated a great deal of controversy: whether Ontario’s Freedom of Information and Protection of Privacy Act (FIPPA) should be amended to protect a specific, narrow and well-defined class of information created by hospitals for the purposes of quality improvement.

Schedule 15 of Bill 173, Better Tomorrow for Ontario Act (Budget Measures), 2011, proposes to exempt, from the FIPPA, “information provided to, or records prepared by, a hospital committee for the purpose of assessing or evaluating the quality of health care and directly related programs and services provided by the hospital.” Bill 173 is currently being considered by the Standing Committee on Finance and Economic Affairs (SCFEA). This proposed amendment would align Ontario with other jurisdictions in Canada, as well as the United Kingdom and Australia, with respect to the treatment of quality of care information.

Without this kind of protection documented, conversations that health care professionals regularly have about enhancing patient care, as well as documents developed relating to quality, safety, and risk management, may be subject to public disclosure. This would have a chilling effect on the willingness of hospital staff to identify or comment on patient care and quality issues.

To read our submission to the Standing Committee on Finance and Economic Affairs respecting this amendment to FIPPA, click here.

Ontario hospitals unequivocally support openness and transparency; they also support continuous quality improvement. They are keen to strike an appropriate balance between improving care and improving access to information.

The proposed amendment has been criticized by organizations that either do not fully understand its purpose, or are deliberately trying to mislead the public. This has caused confusion about why these protections are necessary, which is incredibly unfortunate.

For me, the fundamental question is, do patients want to be treated in hospitals where issues of quality and safety are examined and discussed by hospital staff on a daily basis, or in ones where they are not? If the answer to the question is “yes, safety and quality matter,” then it is critical to support this amendment. The OHA does, and so do individuals like patient safety expert Dr. Ross Baker from the University or Toronto, as do organizations like the Ontario Medical Association.

We have created a special webpage to explain the truth about the amendment, why it is necessary, and why we support it. You can access it at www.oha.com/thetruth. I encourage you to visit it to learn more."

Tom Closson

(OHA)

Giving Doctors Orders - NYTimes.com (patient safety)

Test Results Management (Canadian Patient Safety/College of Physicians & Surgeons Ontario)

Ovarian cancer patient ‘failed by consultant’ (The Bolton News) - case of misconduct

Blogger's note: odd that the story didn't mention how the patient is doing ??

"....The panel heard that at a later consultation, the progress of the condition was again not identified and acted on, with poor notes made.
A specialist was not consulted and clinical standards of care were not met...."

Patient Safety in Surgery | Full text | Patterns of unexpected in-hospital deaths: a root cause analysis

full free text: The safety implications of missed test results for hospitalised patients: a systematic review -- BMJ Quality and Safety (references World Alliance for Patient Safety)

Introduction

The World Alliance for Patient Safety recently identified poor test follow-up as one of the major processes contributing to unsafe patient care.1 Failure to follow up test results increases the risk of missed or delayed diagnoses. This may produce suboptimal clinical outcomes2–8 with potential medicolegal implications.9–12......

.........All seven studies explored the impact on patient outcomes31–33 35–38 which included no negative effects,31 a delayed diagnosis from a missed x-ray report,37 one case of missed positive Chlamydia where the patient subsequently developed pelvic inflammatory disease,36 inappropriate or unnecessary antibiotics prescribed,35 missed cancer diagnoses33 and death.38.....cont'd

full free access: Preventable adverse drug events and their causes and contributing factors: the analysis of register data — Int J Qual Health Care (patient safety)

"In recent years, the number of patient complaints has also increased, probably because patients are more aware of their rights and more attention has been paid to patient safety [18]. These complaints contain detailed narratives about the case, and these data can be used to understand which factors contribute to errors in health care [1].

The purpose of this study was to evaluate the nature of preventable ADEs based on data from national supervisory authority. In particular, the study focuses on the potential causes and contributing factors of preventable ADEs from the information management point of view.
The study aims to answer the following questions:
1. What are the causes of ADEs, and in which phase of the medication management process are the causes for ADEs present?
2. How does information management affect the origin of ADEs?
3. What are the contributing factors for ADEs in information management?