Pharmacy Newsflash

Medtronic Diabetes is voluntarily recalling Quick-set infusion sets that have lot numbers starting with the number "8" ("Lot 8" Quick-set infusion sets). These infusion sets are used with MiniMed Paradigm insulin pumps. Considering the significance of this project, we appreciate your willingness to work with us in assisting our recall process for the benefit of your members.

Very recently, it has come to our attention that certain insurance companies and/or providers are recommending that members switch to competitor infusion sets and/or insulin reservoirs in response to this recall. While this is ultimately a patient's choice, we believe this unnecessary based on our plan for adequately providing replacement Medtronic infusion sets to your members and ensure continuity of pump therapy.

Perhaps more important, using non-Metronic products with a Medtronic pump will void the Medtronic pump warranty if any damage is caused by the non-Medtronic products. Moreover, should any damage occur, patients may be without their insulin pumps for a length of time (if they do not have a back-up pump). The specific Medtronic warranty language is as follows:

"This warranty is valid only if the Medtronic MiniMed Insulin Pump is used in accordance with the manufacturer's instructions. This warranty will not apply if damage results from use of non-Medtronic reservoirs and/or infusion sets."

We of course have a direct interest in continuing to serve patients with our own products. We believe, however, that these warranty issues may be important factors for patients considering competitor supplies. As you would agree, patients should be fully informed before making decisions about their therapy. Therefore, to the extent relevant and/or necessary, we strongly encourage you to communicate this warranty issue to members as applicable.

As we stated before, we are taking this recall action voluntarily to ensure the safety of our patients (and your members). We are doing all that we can to make this process as timely and as easy as possible and, as mentioned, ensure continuity of care for all affected patients.

Most inhalers contain CFC (chloroflourocarbon) as an ingredient to help propel the drug. These CFCs make their way to the Earth's stratosphere and reduce the amount of protective ozone available. Eventually all CFC inhalers will be replaced with HFA (hydrofluoroalkane) inhalers.

Albuterol will only be available as an HFA Inhaler after December 31, 2008. All of the HFA albuterol inhalers will be brand names, and not generics. Because of this, they will cost more.

In what ways are HFA inhalers the same as CFC inhalers?

• HFA inhalers are just as safe and effective as CFC inhalers when used appropriately.
• The shape and size of the inhalers is almost identical

In what ways are HFA inhalers and CFC inhalers different?

• HFA inhalers are better for the environment.
• HFA inhalers might taste, feel, and smell different than CFC inhalers. People usually say the puffs feel warmer and are less forceful than their old inhalers.
• HFA inhalers need to be cleaned more often. At least once a week, you should remove the metal canister and rinse the plastic part of your inhaler with warm water for about 30 seconds. Then let it air dry thoroughly. This will help prevent clogging.
• HFA inhalers generally need to be primed less frequently. Before you use your albuterol inhaler for the first time, or if you haven't used it for two weeks or more, prime it by firing three (ProAir HFA) to four puffs (Proventil HFA, Ventolin HFA) into the air. Other HFA inhalers, like levalbuterol (Xopenex HFA), have different requirements for priming. Levalbuterol inhalers must be primed with four sprays if they haven't been used for more than three days.

August 19, 2008 -- Since issuing Information for healthcare professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking exenatide (Byetta). Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Source: Food and Drug Administration

Actavis has initiated a class 1 recall for all strengths of oral use Digitek (digoxin).

On April 25, 2008, Actavis initiated a class 1 recall of Digitek (digoxin) all strengths for oral use. The products are also distributed under the Bertek label by Mylan Pharmaceuticals and UDL. This voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. Those tablets may contain twice the approved level of active ingredient than is appropriate. Double strength tablets may pose a risk of toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive digitalis intake. Several reports of illness and injuries have been received. Digitek is used to treat heart failure and abnormal heart rhythms.

Sudden discontinuation of Digitek without your doctor's knowledge can also cause serious health problems. Please speak with your doctor immediately about this Digitek recall.

What you should do:

you are currently using Digitek, please contact your prescriber immediately. and your prescriber should discuss the best therapy options for you, and then obtain a 10-14 days supply prescription to be filled locally. Medco will be sending notification to all patients who are currently taking the medication.

• • If you have refills for Digitek you can safely refill by calling the toll free number located on your prescription medication bottle to receive medication which is not impacted by the product recall.
• • If you do not have refills remaining, please obtain a new mail order prescription and mail it to Medco to receive medication which is not impacted by the product recall.

Important Note: Medco is working to secure an alternative generic manufacturer for future Digitek or digoxin new and refill prescription requests. If we are unsuccessful, all prescriptions previously filled for Digitek will be filled as the brand name product, Lanoxin, and you would be charged your plan's brand copay or co-insurance.

For more information:

For Product Return Information and Reimbursement and any other inquiries, Actavis has provided a toll free number for patients to obtain a product return kit by calling, 1.888.276.6166 Monday through Friday, 8 a.m. to 5 p.m. eastern time or visit www.actavis.us.

If you have any additional questions or concerns relative to this medication recall or about your prescription drug benefit, please call the phone number on your prescription bottle label or ID card.

If you have medical questions please contact your health care provider.

The information on this site is not intended to take the place of your doctor or other healthcare professionals. It is a resource to help you make the best decisions and get the most from the medical services available to you. A licensed physician should be consulted for diagnosis and treatment of all medical conditions.

On or about May 21, Medco By Mail will exhaust its supply of clopidrogel bisulfate, the generic version of the blood thinner Plavix. Per an August 31, 2006 court order, the generic manufacturer has been barred from sending clopidrogel to pharmacies because of patient litigation. Once supplies are depleted, Medco will dispense Plavix and charge plan members the brand co-payment. Beginning the week of May 14, Medco will insert the attached letter into the literature pack accompanying all prescriptions for Plavix.

The letter informs members that their prescription has been filled with the brand-name drug Plavix instead of the generic equivalent because Medco's mail-order pharmacies no longer have the generic in stock; they will be charged their plan's brand co-payment; the generic's removal from the marketplace was due to a patent issue and not because of any safety issue; and if they have questions, they should call the number on the back of their prescription card.

The Health Plan Pharmacy Health Services division is available to answer any additional questions the members may have. Please call 740.695.7914 or 1.800.624.6961, ext 7914.