Inconsistency seen in safety labeling for generic drugs

An article published in  Pharmacoepidemiology and Drug Safety notes that over two-thirds of generic drugs in the U.S. have safety warning labels that differ from the equivalent brand-name medications.

According to the lead author, Jon Duke, "generic drug labels may contain incomplete or incorrect safety information."  This becomes problematic when the generic label is used by the physician to make prescribing decisions. If side effects, information on durg interactions or other safety issues are not in the label, then the patient may be at an increased risk for adverse events.

Out of more than 1,000 generic drugs, nearly 70% had some discrepancies in their safety labeling. Strikingly,  9% had differences of more than 10 side effects.

Mobile App for Oncology Adverse Events And Graft-Versus-Host Disease

Velos Aversi, an iPad app for clinicians in oncology and bone marrow transplantation has recently been released.

Velos Aversi is designed to record, track, and export patient adverse events (AE) and Graft-Versus-Host Disease (GVHD) at point-of-care in hospital and ambulatory care settings. With a few touches on the iPad, clinicians, physicians, and research nurses can review and manage their patients’ AE and GVHD histories anytime, anywhere—freeing them from large and cumbersome paper files. The app allows for more accurate attribution and reduces transcription errors that can occur when AE data entry is delayed. Direct and immediate input by clinicians saves time and ensures the quality of the record, particularly when grading events.

Antinausea Drug Withdrawn From US Market

The FDA announced that the 32 mg dose of Zofran (ondansetron), an anti-nausea medication, will no longer be marketed in the US due to the potential the risk of Torsades de pointes, a serious cardiac rhythm abnormality.  The event occurs when there is a prolongation in the QTc interval, an important part of the electrical activity of the heart.  Prolongation of the QTc can be fatal.  Information from the FDA can be found here.

Patient safety education for undergraduate medical students

The authors of an article published in BMC Medical Education conducted a survey of the medical literature related to patient safety education in the medical curriculum of medical schools.


The article notes that there are only a few relevant published studies on the inclusion of patient safety education in the undergraduate curriculum in medical schools either as a selective course, a lecture program, or by being integrated into the existing curriculum.  The search included developed countries with advanced health and education systems. 


It is clear that the integration of patient safety education into the existing curriculum in medical schools internationally, provides significant challenges and needs.

Medical students benefit from learning about patient safety in an interprofessional team

An article published in Medical Education by 

Elizabeth Anderson, 

Lucy Thorpe, 

David Heney and 

Stewart Petersen describes how d

elivering patient safety education interprofessionally heightens students’ awareness of the importance of effective team-working for safe care and care delivery.  This is not something that is routinely taught in either medical schools or in post-graduate training programs.  The authors conclude that designing a a workshop on team-based patient safety towards the end of medical education can enable students to assimilate all aspects of their curriculum relevant to safety. Students learn that there is a link between team factors and safety and this is increased when students learn interprofessionally.

Outsourcing Pharmacovigilance

Not long ago many within Pharma thought that Drug Safety was an evil, unnecessary cost center. Over time the perception has changed and it's now recognized that Pharmacovigilance is an important function which is essential to protect the patient, public and product. Nevertheless, budget restraints and the rising costs of maintaining a professional workforce have led many across the industry to consider outsourcing. There's yet another reason for outsourcing: The shear volume of data coming in which needs to be collected at call centers, entered into databases, queried, cleaned, analyzed and reported makes this a task that must be shared round the clock and globe.