Safety of Vaccinations

Image Source: Canva

The CDC considers vaccinations to be one of the top 10 public health achievements of the 20th century.1-3 Thanks to vaccines, the incidence, morbidity, mortality, and prevalence of vaccine-preventable diseases have considerably diminished since vaccinations became available. However, now that the COVID-19 vaccine has finally arrived, consumers are wondering whether it will be safe.

If you are having COVID-19 vaccine hesitation, know that the FDA has considered the vaccine adequately safe and effective. The Pfizer and Moderna vaccine have both received Emergency Use Authorization (EUA) from the FDA for public use. To further ease any vaccine fears, below is information about vaccine safety, facts and myths about the COVID-19 vaccine and the benefit vaccines have on your health.

How the COVID-19 Vaccine works

This new vaccine works unlike any previous vaccinations, using a molecule called messenger RNA (mRNA) in a mechanism researchers have been developing for over 30 years. When infected with COVID-19, the virus uses a “spike protein” to attach and enter human cells. The vaccine uses mRNA to provide the body with a blueprint which stimulates human cells to make their own version of a spike protein (not the real virus) that triggers the immune system to make antibodies against it. Once the body makes antibodies against this synthetic spike protein, the body will be able to recognize the actual COVID-19 viral protein and quickly fight the real virus before it attaches to human cells and causes harm.

Herd Immunity

Herd immunity is when a large portion of a community (herd) becomes immune to a disease, lessening the spread of the disease from person to person. Current research shows that the development of natural immunity in people who have previously built-up antibodies from COVID-19 is not going to be enough to cause herd immunity within the community. Not everyone with a previous COVID-19 diagnosis is developing natural antibodies which protect against the spread of the virus, and those who do develop antibodies may begin to lose them over time. Therefore, routine vaccination against COVID-19 is essential to prevent living through another pandemic a year full of face masks and social distancing. Vaccines will first be prioritized to high-risk populations, including healthcare personnel and long-term care facilities. Recommendations suggest 2 shots into the muscle of the upper arm 3-4 weeks apart depending on the manufacturer (Pfizer vs Moderna). Per the FDA, available data currently shows receiving 2 doses of the vaccine is between 90.3% to 97.6% effective at preventing COVID-19.

The benefits vaccines have on health

There are two main benefits for vaccination:

  1. You can help lower your chance of getting certain disease
    • Hepatitis B vaccine lowers your risk of liver cancer.
    • HPV vaccine lowers your risk of cervical cancer.
    • Flu vaccine lowers your risk of flu-related heart attacks or other flu-related complications from existing health conditions like diabetes and chronic lung disease.
  2. You can lower your chance of spreading disease.
    • Some people in your family or community may not be able to get certain vaccines due to their age or health condition. They rely on you to help prevent the spread of disease.
    • Infants, older adults, and people with weakened immune systems (like those undergoing cancer treatment) are especially vulnerable to infectious disease.10

Facts surrounding the COVID-19 vaccine

There is now an authorized and recommended COVID-19 vaccination in the Unites States and many people are concerned about its safety. It is crucial to make sure you are getting accurate information about the vaccination. Below are FACTS from the CDC about COVID-19 vaccines:

  1. The COVID-19 vaccine will not give you COVID-19. It is not a traditional vaccination, currently none of the COVID-19 vaccines use the live virus that causes COVID-19. This vaccination helps our bodies fight the virus without us having to get the illness.
  2. Even if you have gotten sick with COVID-19, you may benefit from getting vaccinated. Re-infection is possible; therefore, it is advised to get a vaccination even if you have had COVID-19 before.
  3. Right now, there is a limited supply of the vaccine in the United States, but more will come in the following weeks and months.
  4. Getting a vaccine that uses mRNA will not change your DNA.  The COVID-19 vaccine contains mRNA or messenger ribonucleic acid which is best described as instructions for how to make a protein. It is important to know that that mRNA is not able to alter a person’s DNA. The mRNA from the COVID-19 vaccine will not enter the nucleus of the cell, where our DNA is found.

Myths surrounding the COVID-19 vaccine

There is a lot of misinformation about the COVID-19 vaccination. Below are MYTHS about the vaccine:

  1. Other immunizations such as the flu shot will prevent COVID-19.
  2. Infertility or other serious medical problems will occur if you get the COVID-19 vaccine.
  3. You will get a positive COVID-19 viral test if you get the COVID-19 vaccine.
  4. There will not be enough vaccinations for everyone.

If you are struggling to find credible vaccine information, use this link for recommendations of trustworthy sources: https://www.cdc.gov/vaccines/vac-gen/evalwebs.htm.

Stats on the safety and effectiveness of vaccines

Vaccines are both safe and effective. They go through years of testing before the FDA licenses them for use. Both the CDC and FDA continue to track the safety of all licensed vaccines.6 The CDC tracks the safety of vaccinations through The Vaccine Adverse Event Reporting System (VAERS). VAERS was created in 1990 to detect any potential safety issues with U.S. vaccines. If anyone experiences problems after an immunization, they can submit a report to VAERS. This monitoring system makes it possible to spot any unusual side effects from vaccinations as well as identify any risks for health issues related to vaccinations. If you are ever concerned about the safety of immunizations, you can have peace of mind knowing they are constantly being monitored.9

Below are the facts and figures that show the safety and effectiveness of vaccinations:

  • According to the World Health Organization, immunizations prevent 2-3 million deaths every year from vaccine-preventable diseases.5
  • Most childhood vaccinations are 90% to 99% effective in preventing diseases.7
  • The flu vaccination can reduce the risk of flu illness by between 40% and 60%.6
  • The CDC estimates that immunizations will prevent more than 21 million hospitalizations and 732,000 deaths among children born in the last 20 years.8
  • About 85-90% of vaccine side effects are mild and not serious.9

How Pharmacists can Help

Pharmacists are also in a unique position to identify those patients who are in target groups for certain vaccinations. They may also be able to ease the fears of many patients by providing them with facts such as clinical data and by dispelling common misconceptions and myths about vaccinations; they can also stress the significant risks associated with not being vaccinated.4

Tria Health was founded on the belief that pharmacists play a vital role in the management of high-risk patients. 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 answer any questions you may have regarding vaccinations.

Sources:

  1. Oldfield BJ, Stewart RW. Common misconceptions, advancements, and updates in pediatric vaccine administration. South Med J. 2016;109(1):38-41. doi: 10.14423/SMJ.0000000000000399.
  2. Ventola CL. Immunization in the United States: recommendations, barriers, and measures to improve compliance: part 2: adult vaccinations. P T. 2016;41(8):492-506.
  3. Temoka E. Becoming a vaccine champion: evidence-based interventions to address the challenges of vaccination. S D Med. 2013;(theme issue): 68-72.
  4. https://www.pharmacytimes.com/publications/issue/2019/january2019/adult-vaccination-rates-are-rising-but-fall-short
  5. https://www.who.int/news-room/facts-in-pictures/detail/immunization
  6. https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm#:~:text=Recent%20studies%20show%20flu%20vaccine,to%20the%20flu%20vaccine%20viruses.
  7. https://www.healthychildren.org/English/safety-prevention/immunizations/Pages/Vaccine-Safety-The-Facts.aspx
  8. https://www.cdc.gov/media/releases/2014/p0424-immunization-program.html
  9. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html
  10. Reasons for Adults to be Vaccinated | CDC
  11. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fvaccine-myths.html
  12. https://coronavirus.ohio.gov/wps/portal/gov/covid-19/covid-19-vaccination-program/19-vaccine-myths-vs-facts
  13. Herd immunity and COVID-19 (coronavirus): What you need to know – Mayo Clinic

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

Zantac (ranitidine) Recall

The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. This medication is being recalled due to low levels of a nitrosamine impurity. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

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 and found in water and foods, including meats, dairy products and vegetables.

What products are recalled?

The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots. The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.

Patient Information

  • FDA is not recommending individuals stop taking all ranitidine medicines at this time.
  • Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
  • Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

Sources:

  1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  2. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevate

Interested in CBD Oil? Talk to Your Pharmacist First

Bottle of CBD Oil
Image Source: Caleb Simpson/Unsplash

The CBD industry has been booming as of late and you might be wondering if CBD oil is right for you. Unfortunately, the popularity of CBD products is growing faster than researchers can keep up, and there are a lot of unknowns when it comes to the benefits and drawbacks.1 Currently, the FDA has not approved CBD oil as a standalone medication. While doctors can still recommend it, they cannot currently write a prescription. Before purchasing CBD oil, it’s important to talk with a pharmacist to avoid any negative medication interactions.

What is CBD Oil?

Cannabidiol is extracted from the flowers and buds of marijuana or hemp plants. It does not produce intoxication; marijuana’s “high” is caused by the chemical tetrahydrocannabinol (THC). The non-intoxicating marijuana extract is being credited with helping treat a host of medical problems — everything from epileptic seizures to anxiety to inflammation to sleeplessness.2

Is CBD Oil Safe?

Last year, a U.S. Food and Drug Administration advisory panel unanimously recommended approval of the CBD medication Epidolex to treat two rare forms of childhood epilepsy.3 As for CBD’s usefulness in treating other conditions, the consensus is still unclear. One current concern regarding the efficacy of CBD oil is the lack of regulation. The FDA does not currently regulate products like CBD oil which can lead to a variation in ingredients product-to-product.

CBD Oil and Medication Interactions

It’s very important to talk to a pharmacist before starting CBD oil, because it can interact with a lot of common and daily medications. CBD oil is broken down by enzymes in your liver and during that process, it can block those same enzymes from breaking down other medications. Drugs for anxiety, cholesterol, seizures, blood thinners and heart medicines can all interact negatively with CBD oil.1 While we’re not saying that you should avoid CBD oil all together, you should always speak with a doctor or pharmacist before purchasing.

Tria Health Can Answer Your Medication Questions

If Tria Health is offered through your benefits plan, 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 and supplements. If you’re interested in exploring CBD Oil, Tria’s pharmacist will be able to provide you with recommendations.

Sources:

  1. https://www.wbir.com/article/news/health/pharmacists-cbd-may-interfere-with-some-daily-medications/51-142c8c3e-0fd7-43c8-b6e8-6fb68a3d5e97
  2. https://www.webmd.com/pain-management/news/20180507/cbd-oil-all-the-rage-but-is-it-safe-effective#1
  3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

Infant Ibuprofen Recall

Tris Pharma, Inc. has issued a voluntary nationwide recall of infant ibuprofen amid concerns the medication, which was destined to be sold at several major retailers, may contain a higher concentration of ibuprofen than labeled. The lots were sold under Walmart, CVS Pharmacy and Family Dollar. As of now, the company has not received any reports of serious adverse events related to the recall.

Why is it being recalled?

Per Tris Pharma, “The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses more than 700% of the recommended dose.” If Ibuprofen is taken in excess, a side effect could be permanent kidney injury, nausea, vomiting, stomach pain, diarrhea, tinnitus, headaches or possible stomach bleeding.

What products are recalled?

Affected products are labeled “Infants’ Ibuprofen Concentrated Oral Suspension” and were labeled to contain 50 mg. of ibuprofen per 1.25 mL. 

NDC; LOT; EXPIRATION; DESCRIPTION ; COMPANY;
49035-125-23 00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 00717024A 08/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle CVS Pharmacy
55319-250-23 00717024A 08/19 Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Family Dollar Services Inc.

Next steps you should take

  • To determine whether a specific product has been recalled, patients should look at the drug name and see if the NDC, Lot, and expiration dates matches those listed above.
  • If you have one of the recalled medicines, follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

Source: https://www.fda.gov/Safety/Recalls/ucm627780.htm