Volume 10, Issue 1
Hello Friends and Colleagues,
It is hard to believe, but 2017 is our 20th anniversary of our company. Med-ERRS always strives to provide you, our valued clients, with the highest quality, timely and pertinent medication safety information as we work on your trademarks, packages and labels, and other issues that may arise in the development and marketing of your product. We hope to continue in this fashion for the next 20 years for you.
Additionally, in light of all of the media coverage of recent diplomatic relations, which is impacting the rest of the world, I feel compelled to emphasize our steadfast support for our international colleagues. In my opinion, medication safety is something that should not be a partisan issue, nor should it have any relation to which country you were born in, live in, or do business in. I believe that healthcare practitioners and pharmaceutical industry professionals are all trying to develop and use drug products in the safest way possible regardless of where in the world they reside. Politics should not be involved in making and keeping patients healthy, or in helping patients to live a better life.
We at Med-ERRS stand with all of our medication safety colleagues across the globe, and are dedicated to ongoing cooperation and communication. We all have a shared goal and mission of keeping patients from harm, and if we continue to work together, we can continue to make a real difference that benefits the entire healthcare community. We hope that you feel the same.
With my warm regards,
- FDA issues final guidance for industry: Nonproprietary Naming of Biological Products
- Federal Register Notice regarding guidance
- FDA new drug approvals down in 2016; List by therapeutic area
- EMA approvals also lag in 2016
Recent News from ISMP Medication Safety Alert! Newsletter
Look-alike levetiracetam and valproate sodium vials
ISMP continues to receive reports about vial size and color similarities with levetiracetam and valproate sodium, both from Fresenius Kabi (Figure 1). This is worsened by each sharing anticonvulsant indications. Also, the same concentrations are listed on the labels—500 mg per 5 mL. ISMP first wrote about this in April 2016. More recently, a hospital reported a mix-up with these during batch preparation, which required staff to remake all the doses. We spoke with Fresenius Kabi again, and beginning next month, valproate will be manufactured with a redesigned label (Figure 2) and should start to flow into the distribution channel in December 2016.
Key takeaway: Label redesign is one strategy that can be employed to help reduce the risk of confusion. Practice-based solutions such as barcode scanning software in the IV room, a strategy all hospitals need to have in place, may have prevented this error and also avoided wasted doses and the time required to prepare them.
Excerpted from ISMP Medication Safety Alert! October 20, 2016 Volume 21 Issue 21
T for two (or maybe 5)
Over the last few years the US Food and Drug Administration (FDA) has approved many new products to improve blood sugar control in adults with diabetes. Five of these newly approved medications have a few things in common. Four are long-acting injectable pens, three are indicated for type 2 diabetes, BUT all five of these begin with the letter “T.”
TRADJENTA (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor, is an oraltablet indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
TRULICITY (dulaglutide) injection, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once-weekly injectable prescription medicine to improve glycemic control in adults with type 2 diabetes mellitus.
TANZEUM (albiglutide) for injection, also a once weekly GLP-1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
TOUJEO SOLOSTAR (insulin glargine) pen, a long-acting insulin, is available in a 300 units/mL concentration for adults with diabetes who have taken insulin and for those who haven’t. Its release is gradual to provide stable insulin levels for a full 24 hours and beyond.
TRESIBA FLEXTOUCH (insulin degludec) pen is a long-acting insulin for adults with diabetes and is available in 2 concentrations: 200 units/mL and 100 units/mL.
Although ISMP has not received any error reports detailing mix-ups among these products, pharmacists have expressed concerns in discussions at professional meetings. It would not be surprising if name and strength confusion occurs with these products.
Key takeaway: Trademark confusability testing prior to regulatory submission may uncover some of these similarities. Other practice-based mitigation strategies such as the following may help as well. Practitioners should be proactive and assess how these products are displayed and selected in your computer system, evaluate where and how these products are stored, take steps to differentiate names and concentrations on computer screens and product packaging and provide patient counseling at the point-of-sale and include a review of the product with the patient.
Excerpted from ISMP Medication Safety Alert! Community/Ambulatory Edition September 2016 Volume 15 Issue 9
- PREVIEW-ERRsm: This service is used to rapidly eliminate unacceptable trademark candidates from client’s lists of trademark candidates by providing preliminary, top-of-mind, expert healthcare professional opinions and reactions to proposed names before any trademark searching or testing has been completed.
- SCREEN-ERR®: Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
- ERRS MODEL®: Med-ERRS has developed this service for evaluating the safety of trademarks. ERRS MODEL incorporates various techniques recommended by the FDA to proactively help prevent medication errors by testing for potential look-alike and sound-alike confusion with proposed trademarks.
- EVALUATE-ERR®:A safety consulting service that examines a unique aspect of a product (such as a dosage form, special packaging, or trademark) and its vulnerability to user error.
- Package and Label Evaluation: Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and worldwide regulatory authorities.
- Safety Consulting: Provides consultative services which are related to a variety of medication safety-related issues.
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