Levemir Insulin (Novo Nordisk):Stolen vials still may be on market

FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

Read the complete MedWatch 2009 Safety summary including a link to the FDA News release and the original June 13,2009 alerts at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm

Join us for the next Coffee House Conversations™ telephone call!

To empower and educate individuals affected by chronic kidney disease (CKD), transplantation and donation, the National Kidney Foundation’s People Like Us hosts monthly Coffee House Conversations™ telephone calls. On these free, interactive telephone calls, you will hear from experts, and be given an opportunity to ask them questions.

Dial in to the toll free number and enter the password below for all Coffee House Conversations™ telephone series calls.

Call-In Number: 888-603-9220
Password: KIDNEY

The next call is:

• Get Ready for an Emergency
  Tuesday, September 15
  7:00 p.m. - 8:30 p.m. ET
  call in: 1.888.603.9220
  Pass code: KIDNEY
  

*Space is limited! You can register online now, call 1-888-JOIN-NKF (888-564-6653) or fill out this registration form (PDF* download).

Send an e-mail to coffeehouse@kidney.org for more information or to submit questions about upcoming calls.

August 24, 2009

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals. Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). This information is posted here.

August 13, 2009

GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology

Audience: Diabetes healthcare professionals, hospital risk managers, patients. FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

• [08/13/2009 - Public Health Notification - FDA]
• [08/13/2009 - Advice for Patients - FDA]

PATIENT EDUCATION WEEK

National Emergency Preparedness Education Week For Kidney Patients
September 13-19, 2009

The week of September 13-19, 2009 has been designated as the time for education and emergency preparedness for all patients requiring renal replacement therapy. All dialysis and transplant facilities across the United States will prepare each patient for the unexpected.

• Color poster
• Faxblast

KCER READY!

In honor of National Preparedness Month, we are very pleased to introduce KCER READY!

KCER READY! is a self assessment to help dialysis facilities and ESRD organizations promote a higher level of disaster preparedness for their staff and patients. We invite you to take a short quiz to evaluate your level of preparedness. Some of these questions are based on the national Readiness Quotient and others are based on the ESRD Conditions for Coverage regarding emergency preparedness. Are you KCER READY?

• KCER READY Memo
• Take the KCER READY! quiz

Surviving the Storm - A Success!

Thank you to everyone for making "Surviving the Storm: Disasters and Dialysis" a success. Our speakers included representatives from the Medical Reserve Corps and the National Weather Service. There were more than 75 registered attendees, including dialysis providers, industry leaders, government officials, and ESRD Networks.

For those who could not attend the meeting, please review the presentations and handouts posted at http://www.kcercoalition.com/cpp.htm.