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.

Metformin Hydrochloride Extended-Release Tablets manufactured by Marksans Pharma Limited, are being recalled due to the detection of N-Nitrosodimethylamine (NDMA) impurity.

Time-Cap Labs Inc. Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 mg lots subject to the recall are identified below.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg:

90 counts: 49483-623-09

100 counts: 49483-623-01

500 counts: 49483-623-50

1000 counts: 49483-623-10

Metformin Hydrochloride Extended-Release Tablets, USP 750mg:

100 counts: 49483-624-01

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

The Benefits of Medication Reminders for Non-Adherent and Non-Compliant Patients

Image Source: Pexels

Medication adherence is the degree to which a patient follows a provider’s recommended medication treatment plan. Unfortunately, it is common to be medication non-adherent. It is also common to be medication non-compliant. This is when a patient deliberately and intentionally refuses medication. Both non-adherence and non-compliance are costly, consume health care resources, and contribute to poor health outcomes. Medications play a key role in treatment, which is why adherence and compliance is important. Medication reminders successfully contribute to patients becoming both adherent and compliant.

Medication Non-adherence

Medication non-adherence is when a patient unintentionally or intentionally refuses medication for reasons such as confusion, helplessness, or being overwhelmed. When patients practice some form of medication non-adherence, they are not getting the correct amount of medicine into their bodies at the right time. This can cause possible readmissions to the hospital, especially for people with chronic conditions. Once patients leave the hospital or doctor’s office, it is up to them to follow their medication regimen.

Non-adherence to the medication plan is often found in a patient who experiences the following:

  • Medication-related side effects
  • Belief that the medication is not working
  • Feeling better, belief that the medication is no longer needed
  • Cost of treatment
  • Lack of understanding
  • Lack of family support for medication taking

Medication Non-compliance

Medication non-compliance is the intentional choice to not take a medication according to the prescribed directions. There is a variety of reasons for this such as denial, depression, cultural issues, and questioning of a provider’s competence. Although medications are effective in combating disease, approximately 50% of patients do not take their medications as prescribed. While following instructions for your medications may seem simple, there are a lot of different factors that lead to medication non-compliance.

Non-compliance to a medication plan is often a result of these three factors:

  1. Patient-Related Factors: Inadequate health literacy is the main contributor. In the United States alone, an estimated 90 million adults have inadequate health literacy. Inadequate health literacy can lead to a lack of understanding their condition or medication instructions. To improve compliance, understanding the ‘why’ behind why patients do not take medications correctly and providing the appropriate education is an absolute necessity. The more a patient understands their condition and how to control it, the more likely they are to feel empowered and motivated to manage their disease and adhere to their medications.
  2. Physician- Related Factors: Physicians can often unintentionally lead to medication nonadherence by prescribing complex drug regimens, prescribing medications that may be unaffordable to the patient, or inadequately explaining possible side-effects a patient may experience. A solution to this is incorporating a pharmacist into the care team to provide medication education and spending more time with the patient when developing their care plan.
  3. Health System/Team Building Related Factors: Due to fragmented health systems, physicians do not have easy access to information from a patient’s numerous care providers. This can cause issues when developing an effect care strategy and communicating with a patient. Another factor in health systems that lead to non-compliance are drug costs, which can greatly limit a patient’s access to care. Increased implementation of electronic medical records and electronic prescribing has the potential to increase adherence by identifying patients at risk of nonadherence and targeting them for intervention.

Medication Reminder Apps

Traditional reminders like weekly pill boxes or packaged calendars are helpful for some patients but for others on more complex regiments, they just do not cut it. With electronic reminders it is easier to manage medications more efficiently. They are accessible, educate the patient, and provide a place for medication-specific information creating a more streamlined process.

There is a variety of free apps patients can download for little or no cost. Features of these apps include reminders for refills, medication information, drug discount codes, calendar-based alarms, and a place to log doses amongst others. These applications are a great strategy to incorporate as they aid patients and health care providers to improve medication-taking habits.

A study published in the Journal of Medical Internet Research showed that mobile apps help to improve medication adherence, even for adults who lack experience with smartphones. When patients struggle with adherence and compliance, incorporating and utilizing a mobile app will benefit them as they reach their health goals.

How Does Tria Health Help Prevent Non-Compliance and Non-Adherence?

Tria Health is a no cost benefit offered through select health plans. With Tria, you have the option of receiving a one-on-one private consultation with one of Tria Health’s pharmacists over the phone. During your consultation, your pharmacist will review all your current medications, including vitamins, supplements, and lifestyle habits. Your pharmacist will be able to identify any medication interactions, affordable substitutions and answer any other medication-related questions you may have. At the end of your consultation, you will receive a customized care plan that Tria will assist in coordinating with any of your physicians.

Sources:

  1. https://www.capphysicians.com/articles/noncompliant-vs-non-adherent-patient
  2. https://blog.cureatr.com/importance-of-medication-compliance-for-patient-safety
  3. http://www.bhevolution.org/public/medications.page
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3919626/
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/

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