The World Health Organization (WHO) aims to promote health through the use of vaccines as a key to preventing diseases. During April 24th-30th we celebrate the World Immunization Week to spread the word and educate people on why it is so important to get vaccinated.
Vaccines save millions of lives around the world from deadly diseases providing immunity in people at all life stages. Immunization has two very important roles and these are to protect others and to protect yourself. When you get vaccinated, you are able to provide care for those in need without the risk of getting infected. On the other hand, while you protect yourself, you also protect others by not spreading diseases around those that can't get vaccinated such as certain infants, seriously ill adults, and elderly people with a high risk of getting serious diseases.
But why is there people who still hesitate not to get immunizations? There are various reasons, from fear of the ingredients, myths regarding autism, side effects, etc. but all of them lead to a lack of information. The process of vaccine manufacture is lengthy for a reason. Before medications and vaccines get to the market, they go through a lot of experimental processes and are well studied before they are accessible to the public. This goes along with a few concerns regarding certain ingredients within vaccines such as formaldehyde and mercury. All of the ingredients within a vaccine exist in amounts that are proven safe. In addition, ingredients like formaldehyde already exist in living things as they are part of metabolic processes and mercury gets excreted from our bodies. Regarding side effects, most vaccines have mild side effects such as injection site reaction/swelling, redness, and pain and can be treatable. Sometimes it is better to take the risk of a side effect than getting the disease itself. Just like with any medication, everybody reacts differently to vaccines, but so does our bodies to serious and infectious diseases.
Immunization opens the opportunity for achieving health care access early in life, offers every child the chance of living a healthy life and it is a strategy that can eradicate illnesses, curb antimicrobial resistance and improve public health. If we don't spread the word on how important vaccines are, we don't get to prevent, and instead, we will end up treating the illness, trying to save lives which is less effective during outbreaks and it also costs more than prevention. Last but not least, it is important to emphasize that vaccines are not only preventing illnesses but also deaths.
To know more about the importance of immunization, how it works, and to get your questions answered, click here for more information on trusted sources. Remember to spread the word, share your stories, and use #VaccinesWork on social media.
References
WHO. World Immunization Week. https://www.who.int/news-room/campaigns/world-immunization-week/world-immunization-week-2020/key-messages (accessed 2020 Apr 24)
Vimeo. OHP VAXVOX Berlin. https://vimeo.com/382930237/e9a2f2a3ea (accessed 2020 Apr 24)
CDC. Vaccine Safety. https://www.cdc.gov/vaccinesafety/index.html (accessed 2020 Apr 24)
COVID-19 series: Convalescent plasma therapy as a potential lifeline for the sick
Wednesday, April 15, 2020
COVID-19 series: Convalescent plasma therapy as a potential lifeline for the sick
I have come across a lot of speculations regarding potential medication therapy options for the new coronavirus. But what about convalescent plasma therapy? The concept started when doctors first used it against diphtheria in the 1890s and have been continuously used in other recent health crises, such as the SARS epidemic in 2003, 2009-2010 H1N1 influenza virus pandemic and the 2012 MERS-CoV epidemic.Now that we know it has been previously studied and it is considered a promising therapy option, how does convalescent plasma therapy work? Patients that have recovered from the coronavirus produce proteins that can fight the infection, or antibodies, that circulate in the person's blood and they now have the molecular defenses to fight the virus off (immunity). Through convalescent plasma therapy, the plasma from a recovered patient is transferred to a person who is currently sick so their immune system can have a boost with the aid of these proteins and be able to fight better the infection.
Although this concept is not yet approved by the FDA because it lacks safety and efficacy data from clinical trials, it is promising. A recent case series trial in Shenzhen, China demonstrated how 5 critically ill coronavirus patients were treated with convalescent plasma therapy, along with antiviral medications and steroids. All of the patients followed a clinical improvement, but it is very important to mention the study has its limitations. We should all be aware that our bodies react differently when it comes to fighting diseases, but this data demonstrates that it has the potential to work and it should definitely continue to be studied in order to attain relevant safety and efficacy data.
On the other hand, Arturo Casadevall, MD, Ph.D., an expert in infectious diseases at Johns Hopkins, proposed the use of convalescent plasma therapy to treat critically ill COVID-19 patients as well as to carry out a prophylaxis trial. Recently, the interdisciplinary team has been granted FDA approval to perform such a study with the purpose of treating the critically ill as well as to protect health care providers, first responders, and people at high risk of getting infected.
All of this information is just a basic glimpse of what this investigational therapy is and some of the things that are currently happening associated with it. If you are more visual, (like I am)would check this video out from WSJ's Daniela Hernandez for more information.
References
The Wall Street Journal. Why Blood from Coronavirus Survivors Could be a Lifeline for the Sick. https://www.wsj.com/video/why-blood-from-coronavirus-survivors-could-be-a-lifeline-for-the-sick/A2B7F562-2101-4D27-8F4A-DBDB07B35009.html?mod=trending_now_video_2 (accessed 2020 Apr 15)
The Washington Post. Plasma from Recovered Patients Could Help Treat COVID-19 Until We Find a Vaccine. https://www.washingtonpost.com/outlook/2020/04/07/plasma-recovered-patients-could-help-treat-covid-19-until-we-find-vaccine/
Shen C, Wang Z, Zhao F et al. Treatment of 5 Critically Ill With COVID-19 With Convalescent Plasma. JAMA. 2020; 4783.
U.S. Food and Drug Administration. Recommendations for Investigational COVID-19 Convalescent Plasma. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma
HUB Johns Hopkins University. Johns Hopkins gets FDA Approval to Test blood plasma therapy to treat COVID-19 patients. https://hub.jhu.edu/2020/04/03/blood-plasma-sera-covid-19-fda-approval/ (accessed 2020 Apr 15)
Eli Lilly and Company Introduces Insulin Value Program in Response to COVID-19 Crisis
Friday, April 10, 2020
As a consequence of the COVID-19 global health crisis, the U.S. is going through rough times economically speaking. There is an enormous amount of people that have lost their jobs, and no one should struggle with paying their medications. This is why Eli Lilly and Company is introducing the Lilly Insulin Value Program. Diabetic patients with or without commercial insurance may benefit from this program and be able to fill their monthly insulin prescriptions of Lilly insulin for $35. The Lilly Insulin Value Program is effective since April 7th and covers most insulins including all Humalog formulations.
Patients can get the savings by calling the Lilly Diabetes Solution Center at (833) 808-1234 from 8am-8pm (EST) Monday through Friday. Representatives are willing to help patients get the card either through e-mail (within 24-hours) or through the U.S. mail. It is important to mention, that patients who already own a co-pay card from Lilly Diabetes Solution Center with a higher co-pay, can also benefit from this program since the cards have been re-set to a $35 co-pay.
Last but not least, representatives can also direct people to affordability options to lower their existing out-of-pocket costs further, including free insulin for people with minimal to no income. As per federal guidelines, seniors with Medicare Part D plans are not eligible to get this card. Yet such beneficiaries can still contact the Solutions Center for eligibility on other options that include receiving donated insulin for people with lower incomes or even discounted insulin products.
For further details on insulin products, purpose, safety, and patient information click here.
References
investor.lilly.com. New 35 Co-Pay Now Available Through Lilly Insulin Value Program. https://investor.lilly.com/news-releases/news-release-details/new-35-co-pay-now-available-through-lilly-insulin-value-program (accessed 2020 9 Apr)
lilly.com. Amid COVID-19 Lilly Introduces 35 Dollar Copay Insulin. https://www.lilly.com/news/stories/covid19-crisis-lilly-introduces-35-dollar-copay-insulin (accessed 2020 9 Apr)
When it comes to the COVID-19, there is a lot of confusion and misinformation everywhere, especially in social media. There is a lot of rumors about medications and as a pharmacist to be, I would like to get these questions answered.
ACEI's and ARB's: "These medications increase the risk of getting COVID-19 or having serious complications from it"
Angiotensin-Converting Enzyme Inhibitors (ACEI's) and Angiotensin II receptor blockers (ARB's) are used to dilate blood vessels and reduce high blood pressure. Medications such as lisinopril and benazepril are examples of ACEI's as well as the commonly known losartan and valsartan that are examples of ARB's. These medications work in a way that might upregulate the ACE2 receptors, the ones in which the SARS-COV-2 (the virus that causes COVID-19) uses to get into our cells.
Clarification: At this point, the risk is hypothetical. Currently, there is no evidence that these two drug classes increase the risk of getting COVID-19 or that it worsens the infection. On the other hand, I would like to instead emphasize that it is very important not to stop these medications, especially patients with a history of a recent heart attack, heart failure with reduced ejection fraction, or chronic kidney disease due to these rumors and consult with your physician first.
*All of this information goes along with the current thinking of the American Heart Association, American College of Cardiology, and the Heart Failure Society of America. *
NSAIDs: "NSAIDs may increase the risk of severe COVID-19"
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are commonly used over-the-counter (OTC) medications to treat fever, pain, and inflammation. Examples include ibuprofen (Advil), naproxen (Aleve), aspirin (Bayer, Excedrin), and more.
These rumors were followed by a tweet from France's health minister, which seems to be an extension of a warning made in 2019 in France stating that NSAIDs may make infections worse, based on data mostly with strep. In addition, it is also speculated that these medications can upregulate ACE2 receptors.
Clarification: Up to this day, the FDA has not found any pertinent evidence that can confirm this hypothesis. That is the reason why there are health care professionals that still recommend the use of NSAIDs. In this case, it is safe to take acetaminophen (Tylenol or Panadol in Puerto Rico) to treat fevers or minor pain instead of NSAIDs (Advil, Excedrin, Aleve, etc) as a first-line option.
Supplements: "I need immune system boosters, they are sold out almost everywhere.
There is a high demand for products marketed to be "Immune system boosters" such as Emergen-C, Airborne, and anything that contains vitamin C, D, zinc, echinacea, elderberry, etc.
Clarification: There is no good evidence that demonstrates that such supplements prevent COVID-19 or other viruses but it doesn't hurt to take them if you feel more comfortable doing so. It is very important to take these as directed and not exceed the recommended amounts.
References
pharmacist,therapeuticsearch.com. Dispel Misinformation About Meds and Supplements for COVID-19. https://pharmacist.therapeuticresearch.com/Content/Segments/PRL/2020/Apr/Dispel-Misinformation-About-Meds-and-Supplements-for-COVID-19-S2004014 (accessed 2020 Apr 6)
ACC.org. HFSA/ACC/AHA Statement Addresses Concerns Re: Using RAAS Antagonists in COVID-19. https://www.acc.org/latest-in-cardiology/articles/2020/03/17/08/59/hfsa-acc-aha-statement-addresses-concerns-re-using-raas-antagonists-in-covid-19 (accessed 2020 Apr 6)
FDA.gov FDA Advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19 (accessed 2020 Apr 6)
A few months ago, specifically in the summer of 2019, the U.S. Food and Drug Administration (FDA) became aware of laboratory testing that found low levels of NDMA in ranitidine, the generic name of what is commonly known as Zantac. But what is NDMA? NDMA stands for N-Nitrosodimethylamine and it is a contaminant and possible human carcinogen (a substance that could cause cancer), that we actually ingest in certain foods and even water. At low levels, it is not expected to lead to an increase in the risk of cancer yet at sustained levels of exposure it may increase the risk of cancer in humans.
The agency did not have enough scientific evidence to provide to the public and recommend whether to stop or not the use of ranitidine medications so instead, they warned the public in September 2019. New testing has confirmed that NDMA levels do increase in ranitidine even at room temperature and significantly increase in samples stored at higher than room temperature. This becomes a concern during the process of handling and distribution since there is always a likelihood that the products become exposed to high temperatures depending on the location or time of the year. Testing also proved that the older the product is, the greater the level of NDMA. That is specifically the reason why the FDA decided to announce today the request to withdraw all prescription and over-the-counter (OTC) ranitidine medications from the market immediately.
As part of the strategies that are currently being implemented as of today, the FDA is sending letters to all manufacturers of this medication requesting they withdraw their products from the market. In addition, consumers are being advised to stop taking any dosage form of ranitidine at home. Patients being prescribed this medication should speak with their primary care provider about potential treatment options before stopping the medication. There are multiple drugs that are FDA- approved for the same or similar indications that do not carry the same risk (already tested by the FDA) and these are: famotidine (Pepcid), esomeprazole (Nexium), lansoprazole (Prevacid) omeprazole (Prilosec) or cimetidine (Tagamet).
We all know the world is overwhelmed with the COVID-19 crisis and it is definitely not recommended to visit pharmacies at this time to dispose medications. This is why it is very important to follow the instructions in the medication guide or package insert to safely dispose these medications at home. The FDA also recommends a series of steps to safely dispose your medications at home and to make it easier for you guys, here’s the attached link.
Reference
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [news release]. FDA; April 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. Accessed April 1, 2020.
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