Recall of Metformin Hydrochloride ER Tablets

Amneal Pharmaceuticals LLC Bridgewater is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. They were alerted by the U.S. FDA when testing seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, it showed Nitrosodimethylamine (NDMA) amounts above acceptable consumer FDA levels. Out of caution Amneal agreed to recall all seven lots and has not reported any adverse events directly related to the recall.

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

Why is it being recalled?

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.

What products are being recalled?

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are 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

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

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

The Benefits of Telemedicine

Image Source: Hal Gatewood/Unsplash

With the spread of COVID-19 on the rise, the need to social distance is especially necessary if you are considered high risk for severe illness. Since staying home is the only way to ensure you stay healthy telecommunication has never been more necessary and helpful. This pandemic has sparked a surge in telemedicine, telehealth and online resources to offer various health-related services remotely.1

How Can Telepharmacy Help?

Appropriately trained and equipped pharmacists can use telepharmacy to provide pharmaceutical care over the phone. With the use of telepharmacy, pharmacists can improve patient access to care, provide credible information and awareness (eg, hand hygiene, cough and sneeze etiquette, remind patients to get influenza vaccine), enable successful comprehensive medication management, provide recommendations for symptom management, and help triage and refer patients to higher levels of care when diagnostic testing is warranted.

Tria Health utilizes pharmacists to provide these services over the phone with success in outreaching to high risk patients, improving patient health and helping them find ways to reduce costs.

Patient Success with COVID-19

Tria Health provides chronic condition management, meaning many of our patients are at a higher risk for COVID-19, so Tria Health’s pharmacists have been actively educating engaged patients on risk factors, medication safety and prevention techniques. With Tria Health’s telephonic capabilities, we are actively engaging to ensure the health and wellness of our members. Take for example these two patient experiences:

A 64-year-old patient with heart failure could not afford one of their critical medications. As a result, they were going to their cardiologist office every 2-3 weeks to get samples. In the midst of COVID-19, these office visits were exposing the patient to unnecessary risk with frequent trips to their doctor. The Tria Health pharmacist was able to sign the patient up for a manufacturer coupon at an affordable copay. In addition, Tria Health had the prescription sent to a pharmacy with a drive through pick up to allow for appropriate social distancing for this high-risk individual.

A 43-year-old patient with asthma was extremely anxious about their underlying asthma and their risk for COVID-19. The patient informed their Tria Health pharmacist that they were worried about distinguishing their asthma symptoms from possible COVID-19 symptoms. The Tria Health pharmacist educated the patient about the difference in symptoms and how to monitor themselves. The pharmacist stressed the important components of hand hygiene and social distancing.  The patient was incredibly appreciative for this information and felt much less anxious with their improved knowledge.

Tria Health is providing additional communication and outreach to stress the importance of good health management and inform members that Tria’s pharmacists are a valuable and convenient resource during this current health crisis. Tria Health is committed to assisting members with any questions they may have about their medications, risk factors or ways they can mitigate their risk. 1.888.799.8742.

Sources:

  1. https://www.drugtopics.com/latest/telehealth-services-online-resources-aim-enhance-health-care-amid-covid-19-pandemic

COVID-19 and Ibuprofen (NSAIDs) Safety

Image Source: WHO

Unfortunately, with the spread of Coronavirus, the spread of misinformation has increased. It’s understandable to have anxiety with this current climate, but it’s also important to look to validated resources when searching for answers. One common claim we’ve seen spread as of late, is regarding the use of ibuprofen (NSAID) and having COVID-19.

Is It Dangerous to Take Ibuprofen to Treat COVID-19?

Both the World Health Organization and the FDA are currently unaware of existing evidence connecting the use of NSAIDS (Ibuprofen) with worsening COVID-19 symptoms. The FDA will continue to investigate the issue and report their findings when available.2 If patients are concerned, but require NSAIDs to manage their conditions, we recommend speaking with a health care provider and identify a possible alternative.2 While NSAIDs are not reported to worsen COVID-19 symptoms, it’s important to note that they do reduce inflammation and fever, which may diminish the utility of diagnostic signs in detecting infections.  

What’s the Current Verdict? Overall, no direct recommendation for use of NSAIDs for COVID-19 symptoms until more evidence becomes available.2

Tria Health’s Pharmacists can Answer Your Questions

Tria Health is a no cost benefit available through select members’ health plans. Tria Health’s pharmacists are here to talk with patients about their risk factors for COVID-19 and ways they can mitigate risk. We are here to support all our members in their time of need. If you have any medication or COVID-19 related questions, please call our help desk at 1.888.799.874

Sources:

  1. https://www.facebook.com/WHO/posts/2993742374004459
  2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19

National Pharmacists Month

Image Source: mohamed_hassan/pixabay

Happy National Pharmacists Month! The goal of this month is to recognize pharmacists for the significant role they play in effective medication management, patient education and overall medication safety. Learn more about how pharmacists can help you every day.

Safe and Effective Medication Use

Pharmacists help ensure that medications control conditions the right way. They help minimize any side effects and safeguard against any possible interactions with other medications that lead to more expensive health care costs such as emergency room visits, hospitalization, etc.

Preventative Services

Did you know that more than 300,000 immunization-trained pharmacists administer vaccines, and nearly one in four adults receive their influenza vaccinations at their community pharmacy?1 Pharmacists can provide guidance on all vaccine-preventable diseases and which immunizations are best for you.

OTCs and Supplements

Pharmacists are experts in prescription medications, supplements and over the counter medications. They can tell you about potential interactions with foods, other drugs, or dietary supplements. And they can help you pick the perfect product. With over 100,000 over-the-counter products on the market, your pharmacist is always there to lend a helping hand!1

Condition Management

Did you know that pharmacists are experts and more than just medications?  They are trained and educated in how to manage conditions as a whole. Tria Health has pharmacists who are certified diabetic educators on staff.  This allows them to treat the person rather than the medication.  They focus on non-pharmacy and pharmacy strategies to accomplish control of a disease.

Tria Health’s Pharmacists

Tria Health was founded on the belief that pharmacists play a vital role in the management of high-risk patients that drive the majority of health care spend. If Tria Health is currently a part of your healthcare plan, call the Tria Health Help desk today for any of your medication-related questions.

Tria Help Desk: 1.888.799.8742

Source: http://67.222.18.91/~aphm/pharmacists-can-help/