Alert on Certain Abbott Blood Glucose Meters
On October 27, 2005, the FDA notified health-care providers and patients of a problem with the blood glucose meters made by Abbott Diabetes Care in Alameda, California. The meters can accidentally be switched from one measurement unit to another, which could possibly cause the patient to misinterpret his or her glucose test results. The meters in question include the FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, and MediSense Optium. Abbott meters are also sold under private-label brands such as ReliOn, Ultima, Rite Aid, and Kroger.
The meters were originally designed to allow patients to see their test results in units customarily used in their own country. The user has the option to switch between two different measurement units: mg/dL, the standard for the United States, and mmol/L, used in many other countries. The measurement units can switch without the patient realizing it. The switch can occur when the patient resets the date and time or changes the battery and can even occur if the meter is bumped or dropped. If the switch goes unnoticed by the patient, this could lead to taking an incorrect dosage of insulin or a diet change resulting in hypoglycemia.
A 2-page urgent message was distributed to all Abbott diabetes customers alerting them to the potential hazard with their meters. The message can be found at http://www.ab-bottdiabetescare.com/news/20051014_urgentdevicecorrection.aspx. Scroll down to "Related Resources" under "Urgent: Medical Device Correction." The message can be printed in PDF format and reviewed with your patients. Abbott also has listed a toll-free number to use for any questions or concerns for consumers: 1-800-553-4105. This number can be used if the patient is unable to or is having difficulty in changing the measurement units on his or her meter.
In an effort to further resolve the problem, all new Abbot meters now have the correct unit of measurement locked in place. Patients can continue to use their older units, but they should continue to monitor their units to ensure they display the glucose test result in mg/dL.
Additional Information:
FDA MedWatch Safety Alert 2005-Abbott Diabetes Care Blood Glucose Meters. Available at http://www.fda.gov/medwatch/safety/2005/safety05.htm#glucose
Abbott Diabetes Care: Available at http://www.abbottdiabetescare.com/news/20051014_urgentdevicecorrection.aspx
FDA Patient Safety News is available at http://www.fda.gov/psn.
Dispensing Error Alert: NovoLog Mix 70/30 and NovoLog
Novo Nordisk Incorporated and the FDA notified pharmacists of an initiative to help prevent dispensing errors in NovoLog Mix 70/30, a premixed insulin analog, and No-voLog, a rapid-acting insulin analog. Color-branding labeling is being introduced for these two products. Until recently, the labeling was very similar except for the product names.
NovoLog Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia and has a peak pharmacodynamic activity 1 hour after injection; it should be administered with meals. Hypoglycemia is the most common adverse effect, and NovoLog Mix 70/30 should not be mixed with any other insulin product. Previous packaging is white with a blue band. Current packaging is very similar and remains white with a blue band.
NovoLog is a rapid-acting insulin analog and is a clear and colorless solution. It is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. NovoLog has a more rapid onset and shorter duration of action than regular human insulin. Because of this rapid onset, NovoLog injection should be followed immediately by a meal. The previous packaging is white with a blue band. Current packaging is now white with an orange band.
Read the complete FDA Med-Watch 2005 Safety summary, including links to the Dear Pharmacist letter, at:http://www.p1source.com/common/ads/click.asp?at=8&a=1132&c=767&z=40&u=34121.
CMS Awards Administrative Contracts
On January 6, 2006, The Centers for Medicare & Medicaid Services (CMS) announced that it awarded contracts for four specialty contractors that will be responsible for handling the administration of Medicare claims from suppliers of durable medical equipment, prosthetics, and orthotics. This is CMS's first attempt to improve service to beneficiaries and providers and to provide greater administrative efficiency and effectiveness for fee-for-service Medicare.
The new contractors, titled "Durable Medical Equipment Medicare Administrative Contractors (DME MACs)," were selected through a competitive bidding process. The new contractors will replace the current Durable Medical Equipment Regional Carriers (DMERCs). According to CMS, the geographic jurisdictions have been slightly realigned. The new DME MAC contracts, which will have a combined potential value of $542 million, are the first of 23 to be awarded by 2011. This will fulfill the requirements of the contracting reform provisions of the Medicare Modernization Act of 2003.
According to CMS Administrator Mark B. McClelland, MD, PhD, "[horizontal ellipsis]for the first time in Medicare's 40-year history, we have been able to select our administrative contractors through a full and open competition to provide the best service at the lowest cost." The companies were awarded based on the best overall value to the government, in light of costs, technical qualifications, past performance, corporate responsibility, and their understanding of the special requirements involved in processing claims for medical equipment and prosthetics.
The current system consists of "fiscal intermediaries" who process claims for Part A providers such as hospitals, skilled nursing facilities, and other institutional providers. "Carriers" process claims for physicians, laboratories, and other suppliers under Medicare Part B. When the reform is fully implemented, the fiscal intermediaries (Part A) and the carriers (Part B) will be replaced by Medicare Administrative Contractors (MACs) that will be responsible for both Part A and Part B claims. This will mean beneficiaries and providers each have a single point of contact with the Medicare program. Once operational, the DME MACs will serve as the point of contact for all Medicare suppliers, and beneficiaries will refer their questions to the Beneficiary Contact Centers.
The contracts were awarded in January 2006 and will include a base period and four 1-year options. The DME MACs will have opportunities to earn award fees based on their ability to meet or exceed the performance requirements set by CMS. These requirements include enhanced provider customer service, increased payment accuracy, improved provider education and training leading to correct claims submissions, and realized cost savings resulting from efficiencies and innovation. These contracts will be put out for competitive bidding at least every 5 years.
The transition will begin immediately, with full responsibilities for claims process completed by July 1, 2006. The DME MACs will not include any pre-pay or post-pay medical review function or benefit integrity functions. CMS awarded separate payment safeguard contracts for these functions in early December 2005.
The following is a list of Jurisdiction and DME MACs:
For more information, see:http://www.cms.hhs.gov/MedicareContractingReform/
Free Diabetes Information for Older Adults
The American Society on Aging has available on their Web site free resource information for consumers and professionals. It was created in collaboration with the Centers for Disease Control and Prevention and the National Diabetes Education Program for professionals serving older adults.
The site contains information, tools, and resources to meet the challenge of preventing and managing diabetes in older adults. There are six chapters to the module. The first chapter is a basic introduction to diabetes and includes such topics as definition of diabetes, prevention methods, controlling the disease, treatment in older adults, and common myths. One topic of interest is "controlling the ABCs of diabetes."
* A1C = the measure of blood glucose over a 2- to 3-month period. An A1C of less than 7% is considered optimal, according to the American Diabetes Association.
* Blood pressure = approximately 73% of people with diabetes are also being treated for high blood pressure. Normal range for systolic blood pressure is 120 or below, and normal diastolic is considered to be at 80 or below.
* Cholesterol = preventing high LDL levels and keeping it below 100 mg/dL, a goal recommended by the American Diabetes Association.
Chapter two discusses "Supporting People with Diabetes" and includes topics regarding physical activity, weight loss, and nutrition. One item of note in this chapter is a table listing physical examinations and laboratory tests and how often they should be done to effectively manage the disease.
Chapter three features examples of innovative programs to overcome barriers to diabetes care by addressing cost, culture, language, environment, and navigability (how easily one can maneuver through the system to receive services). This chapter presents an extensive outline on addressing cultural issues and how to effectively deal with diabetes in our diverse population of aging adults.
Chapter four highlights existing curricula identified by the National Diabetes Education Program that have been successfully used in the past. This information is helpful to those starting a new program for elders with diabetes in their community or who want to add variety to their current program. There are also print-ready sheets and materials that can be easily downloaded.
Chapter five contains information on developing programs that will assist you in obtaining funding from other organizations and provide you with clear guidelines on planning and evaluating programs that more likely to receive continued sources of funding.
The module concludes with chapter five and contains a multitude of handouts and information available for download and print for both patients and professionals.
The module was developed by Sandra Maldague, MPH, American Society on Aging, and Carolyn Leontos, MS, RD, CDE, University of Nevada. Technical support was provided by the National Diabetes Education Program, older adults. Published in September 2005.
REFERENCE