Search

A study to ascertain mortality rate and incidence of venous thromboembolism (VTE) by administration of erythropoiesis-stimulating agents (ESAs) to cancer patients to treat anemia is conducted. Results raised concerns over the safety of administration of ESAs which increased the risk of VTE and mortality among patients.

A study was conducted to evaluate the structure, operations, and preliminary findings from the Research on Adverse Drug events And Reports (RADAR) project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration. The result showed that a new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance and improve patients safety.

Objective: To report the financial impact of diagnosing and treating the dermatologic toxicities (dTs) that develop in patients receiving targeted anticancer therapies. Design: Single-center retrospective and prospective medical record data extraction. Setting: Department of Dermatology, Northwestern University, Chicago, Illinois. Patients: One hundred thirty-two adults who presented between November 1, 2005, and June 30, 2008, and who were diagnosed as having 1 primary cancer type and were treated with 1 molecularly targeted agent. Main Outcome Measure: Standard billable costs to the patient for dT-related medications, clinic visits, laboratory and diagnostic testing, and therapeutic procedures. Results: The 132 patients had a median of 3 clinic visits for dT management with a median cost of $1920 per patient. Sorafenib was associated with the most costly overall median cost per patient ($2509 per patient), and imatinib was associated with the least costly overall median cost per patient ($1263 per patient). Among the 7 targeted drugs and all 10 dTs, the most costly dT (measured by cost of treatment with medications) was hand/ foot skin reaction, associated with sorafenib therapy (median cost, $968 per patient) (P<.001). The second most costly dT was panitumumab-associated acneiform eruption (median cost, $933 per patient) (P<.001). Conclusion: The cost of diagnosis and treatment of dTs associated with targeted agents contributes to the overall economic burden of cancer care. Efforts toward the prevention of dTs may be important for decreasing the financial burden in oncology. [ABSTRACT FROM AUTHOR]

Importance: Detailed information regarding perioperative risk and adverse events associated with Mohs micrographic surgery (MMS) can guide clinical management. Much of the data regarding complications of MMS are anecdotal or report findings from single centers or single events., Objectives: To quantify adverse events associated with MMS and detect differences relevant to safety., Design, Setting, and Participants: Multicenter prospective inception cohort study of 21 private and 2 institutional US ambulatory referral centers for MMS. Participants were a consecutive sample of patients presenting with MMS for 35 weeks at each center, with staggered start times., Exposure: Mohs micrographic surgery. MAIN OUTCOMES AND MEASURES Intraoperative and postoperative minor and serious adverse events., Results: Among 20 821 MMS procedures, 149 adverse events (0.72%), including 4 serious events (0.02%), and no deaths were reported. Common adverse events reported were infections (61.1%), dehiscence and partial or full necrosis (20.1%), and bleeding and hematoma (15.4%). Most bleeding and wound-healing complications occurred in patients receiving anticoagulation therapy. Use of some antiseptics and antibiotics and sterile gloves during MMS were associated with modest reduction of risk for adverse events., Conclusions and Relevance: Mohs micrographic surgery is safe, with a very low rate of adverse events, an exceedingly low rate of serious adverse events, and an undetectable mortality rate. Common complications include infections, followed by impaired wound healing and bleeding. Bleeding and wound-healing issues are often associated with preexisting anticoagulation therapy, which is nonetheless managed safely during MMS. We are not certain whether the small effects seen with the use of sterile gloves and antiseptics and antibiotics are clinically significant and whether wide-scale practice changes would be cost-effective given the small risk reductions.