Recall of Metformin Hydrochloride ER Tablets

Metformin Hydrochloride Extended Release Tablets are being recalled for having more carcinogen NDMA than the FDA’s acceptable allowance. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.1 With levels above admissible according to the FDA it is being recalled ensuring no adverse reactions arise during consumption. If any adverse reactions are experienced you can submit them online here or find more information on how to mail or fax here. Many different retailers might be involved so it is important to check your label and bottle.

What products are being recalled?

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are being recalled. They are the prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.1

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.1

Metformin HCI Extended Release Tablets manufactured by Bayshore Pharmaceuticals, LLC are also being recalled.

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg lots subject to the recall are identified in the table below.

What’s next?

  • Because Metformin is used to treat serious medical conditions, patients taking the recalled Metformin should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.

Sources:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended#recall-announcement
  2. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
  3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
  4. https://www.miamiherald.com/news/health-care/article245133825.html

Keeping Employees Safe from the Inside Out

Image by Adam Niescioruk on Unsplash

National Safety Month

June is National Safety Month and while you should always be safety conscious, we felt this was a great opportunity to highlight a lesser known safety topic – medication adherence! Whether you’re supporting your employees or managing your own health, medication adherence is a critical component.  

Medication Adherence is An Important Safety Factor in Managing Chronic Conditions

Every year there are more than 125,000 pre-mature deaths due to medication non-adherence in the U.S. Many people are non-adherent because they don’t remember to take their medication or they can’t afford their medication, so they don’t take their medication without realizing the health and safety risks that can occur. Encouraging better safety medication practices improves overall health and reduces total health care costs..

More than 145 million Americans suffer from chronic conditions. Most chronic conditions are managed through medications prescribed by doctors and many times patients don’t understand the importance of taking a medication as prescribed.  However, for some it can mean additional health problems when adherence is not followed.. The Centers for Disease Control and Prevention (CDC) estimated that non-adherence caused 30-50 percent of chronic disease treatment failures2 and those who stopped treatment were likely to experience more problems.

Tips for Medication Management:

  1. Take medication at the same time every day.
  1. Include your medication with a daily routine. (i.e brushing your teeth or getting ready for bed) Before choosing a mealtime for your routine, check if your medication should be taken on a full or empty stomach. Also, check if your medication should be taken in the AM or PM
  2. Keep a “medicine calendar” with your medication and note each time you take or miss a dose.
  3. Use a pill container. Some have sections for multiple doses at different times, such as morning, lunch, evening, and even weeks.
  4. When travelling, be certain to bring enough of your medication, plus a few days extra, in case your return is delayed. Always travel with medication in your carry on, incase of lost luggage and temperature regulations.

Have questions regarding your medication?

Tria Health’s Pharmacy Advocate Program offers one-on-one, private consultations with a Tria Health Pharmacist. Your pharmacist will work with you and your doctor(s) to ensure the intended outcomes from your medications are being received.

Call the Tria Help Desk with any questions at 1.888.799.8742

Sources

  1. https://www.pillsy.com/hubfs/4481181/Pillsy_May2018/images/articles/medication-adherence-infographic-pillsy.png
  2. https://www.fda.gov/drugs/special-features/why-you-need-take-your-medications-prescribed-or-instructed

Tips for Traveling with Medications

Airplane
Image Source: Deniz Altindas/Unsplash

Memorial Day is approaching and many of you are most likely preparing for weekend travels to see family or friends. We all know the worst part about any vacation is packing. What makes packing even more complicated is packing for air travel. There are a multitude of regulations to keep track of and if you have a chronic condition, the idea of managing your medications can seem overwhelming.

To help you get ready for vacation season, here are a few tips and tricks to keeping your medications safe and organized!

The Medication Screening Process

The Transportation Security Administration (TSA) requires that medications in pill or other solid form must undergo security screening. You can also bring any medically necessary liquids or creams, but they must be screened separately from the rest of your belongings.

To make things easy, the TSA recommends you:

  • Store medications in clearly labeled containers
    • Check with state laws regarding prescription medication labels
  • If you’ve already thrown away your prescription containers, get a letter from your doctor explaining what the medication is and why you need it.
  • Declare any accessories associated with your liquid medication

Dosage Schedule

If you happen to travel to somewhere in a different time zone, you may need to discuss the time you take your medications with your doctor. If you must take your prescriptions at a certain time, we recommend setting alarms on your phone or watch to help remind you when to take your medications.

 

Have Any Questions?

Contact the Tria Health Help Desk:

1.888.799.8742

National Drug Take Back Day is 4/28!

Close up of assorted pills and prescriptions
Image Source: iStock.com/klenova

Disposing of medications safely can help protect your family from getting or using medications that are expired or out of date; prevent the illegal use of unused medications and minimize any potential negative impact on the environment. For this reason, the DEA is giving the public an opportunity to dispose of unwanted and/or expired prescription drugs. This is a FREE and anonymous service—take medications back, no questions asked!

Where do I go?

Visit the DEA’s website to find a collection site:

https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1

Why can’t I throw out my medications at home?

Unfortunately, there are a lot of harmful myths floating around regarding medication disposal. Many people will try to flush their medications down the toilet or crush their medicines before throwing them in the trash. Flushing can end up polluting our waters and crushing medicines can put trash handlers at risk of exposure if the drug were to encounter their skin or if they were to breathe in the dust. Medicine take back programs are the best way to dispose of unwanted medicine.

 How can Tria Health Help?

As a member of Tria Health, if you have multiple medications and are afraid you’ll throw away the wrong medication, we can provide additional assistance in selecting the proper medications. Tria provides one-on-one consultations with a clinical pharmacist who assists you with your medication management.

 Questions?

Call the Tria Health Help Desk at 1.888.799.8742

 

The Cost of Non-Optimized Medications

Money within a Pill Bottle_iStock.com/slobo
Image source: iStock.com/slobo

Did you know, if the drugs you’re taking are wrong, skipped, or make you sick, there’s the possibility of incurring additional cost? A recent study published by The University of California – San Diego estimated that the current cost of each possible consequence and estimated total annual cost of illnesses and deaths that result from non-optimized medication therapy to be $528.4 billion. They estimated that the average cost of an individual experiencing treatment failure, a new medical problem or both after initial prescription use to be approximately $2,500.

How do Non-Optimized Medications lead to additional cost?

Here’s an example of non-optimized medications: You are diagnosed with asthma and your doctor prescribes you with a rescue inhaler. When you go to fill your prescription, you discover that the copay is too expensive for your budget and you choose not to purchase it. You later suffer from an asthma attack and must go to the hospital. You’re now stuck with a very expensive medical bill.

This isn’t the only example in which you could incur additional costs, sometimes medications lead to side-effects resulting in the need for added treatment.

What can we do to solve this?

The University of California – San Diego’s study reached the conclusion that to improve medication-related care, we need to expand comprehensive medication management programs, in which clinical pharmacists have access to complete medical records, improved dialogue with other members of a patient’s health care team and input as a medication is prescribed — similar to what is now taking place at many U.S. Veterans Affairs clinics.

How can Tria Health help?

Tria Health provides one-on-one consultations with pharmacists, allowing you to review all your medications and make sure everything is safe, affordable and effective.

Visit www.triahealth.com to learn more!

 

Source: Jonathan H. Watanabe, Terry McInnis, Jan D. Hirsch. Cost of Prescription Drug–Related Morbidity and Mortality. Annals of Pharmacotherapy, 2018; 106002801876515 DOI: 10.1177/1060028018765159