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Patients And Health Care Providers Seek Improved Quality As Report Shows Extensive Errors
The Washington Post reports on efforts by hospitals to tally their avoidable mistakes and describes "hundreds of incidents of death or serious medical harm disclosed in the past year by hospitals in the Washington region, preventable errors that until recently have not required public reporting. Under laws that took effect last year in Virginia and a few years earlier in the District and Maryland, hospitals must report to health regulators many serious injuries that patients suffer in the course of treatment. The laws are different in each jurisdiction. For example, Virginia"s public records identify the hospitals by name, while Maryland"s and the District"s do not. But they all allow the public to glimpse the breadth of mistakes that health experts dub "never events" (because they should never happen): sponges left inside patients after surgery, operations on the wrong limb, medication errors, falls that lead to needless deaths (as well as other events). At least 20 states require hospitals to report every incidence of hospital-acquired infection. Patients, insurers and regulators are beginning to use this information to prod health-care providers to ensure that such events really never happen."
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FDA Approves Expanded Use Of ISENTRESS® (raltegravir) In Combination Therapy For Adult Patients With HIV-1 Infection
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ISENTRESS®. The broadened indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatment-experienced adult patients. ISENTRESS is used in combination with other antiretroviral (ARV) medicines for the treatment of HIV-1 infection in adult patients. The indication for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 48 weeks in three double-blind controlled studies. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRT, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
News of the day
D-Pharm Receives FDA Clearance To Commence A Phase III Trial Of DP-b99 In Acute Stroke Patients
D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel.
Sexual Health

Strategies Evolving As Retractable Safety Syringe Suppliers Strive For Traction

Following the lead of the Needlestick Safety and Prevention Act in the U.S., government regulations regarding syringe needle handling and disposal continue to proliferate worldwide, fostering increased demand in the use of safety syringes. Retractable syringes represent the most elegant approach to addressing the caregiver sharps risk issue by lowering the risk of user error and de-emphasizing the need for a separate sharps disposal step. New retractable designs address caregiver preferences while reducing part counts and manufacturing steps. These refinements are helping to close the price gap with naked disposable syringes and non-retractable safety devices, and this development will help retractable syringe manufacturers and their distribution partners make a stronger sales case with the healthcare buying groups that account for the vast majority of syringe purchases. Historical retractable syringe unit growth continues to be modest, hovering in the single digits. While price points remain the single most important factor limiting market penetration, several unrelated issues are slowing the market acceptance of retractable syringes. Many participants in this sector are undercapitalized and unprepared for the lengthy development, approval and sales cycle steps required to establish a foothold against entrenched devices, user habits, buying cycles and competitors. Patent and IP challenges are another risk area that has impacted and in some cases derailed the product plans of aspiring market entrants, while draining the financial res of others. Several sector companies are evolving their business strategies to focus on niche opportunities for which retractable safety syringes present strong business and use cases. These developments, long overdue, signify a willingness on the part of syringe developers to accept the role of retractable syringes as a specialty device. Greystone Associates


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