Blog

COVID-19 Vaccine Development and the Pharmacist’s Role

In the United States, new cases of COVID-19 have been on the rise with daily numbers ranging between 50,000 and 60,000 since late June. Predictions are showing a larger spike in new cases through mid-August.  Luckily, while numbers continue to surge, so do efforts to develop a vaccine.

As the United States’ leading expert on infectious disease, Dr. Anthony Fauci and his team have plans for a large clinical trial involving approximately 30,000 participants that will be underway later this month. This large-scale study would help determine if the vaccine they have been developing with the National Institute of Health and Moderna Inc. has potential to shield against COVID-19. For this vaccine to be effective it must induce T-cells to create memory cells, as well as specialized T-cells that activate B-cells to produce the appropriate antibodies to tag or neutralize the virus for elimination. Additionally, Oxford and AstraZeneca have been working together on a vaccine currently in the Phase III clinical trial. Data on immunity and safety for this vaccine is expected August 2020. Globally, with hundreds of vaccines under development and testing, the possibility of seeing one soon may no longer be just wishful thinking.

However, initial trials for both vaccines have shown concerning signs of side effects. The Phase I and 2 results for Moderna’s vaccine showed signs of chills, headaches, and fatigue appeared in participants after the second dose. Oxford’s initial trials showed that about a third of participants had moderate to severe side effects including muscle aches, chills, low grade fever, headache, malaise, and fatigue. Currently, participants for Oxford’s vaccine in the Phase III trial are given acetaminophen along with the vaccine; possibly to reduce the side effects already seen in previous trials. Once on the market, side effects will be a large concern and pharmacists should be prepared to help with side effect management for those getting the vaccine.

The limiting factor could be the vials and syringes needed for the vaccines. Current supplies will not meet the demands of approximately 6 billion people globally who will require vaccination to obtain “herd immunity.” With rising demands, governments and pharmaceutical companies around the world are contracting with multiple manufacturers in hopes of producing enough vials once vaccines are launched. In the US, the Trump administration has contracted with domestic manufacturers; some of which produce their products in Asia or Europe. Some of the companies include Corning, a US glass maker; BD, a worldwide medical supply company; Retractable Technologies, a company in Texas that produces syringes; and ApiJect Systems, a company that makes prefilled syringes. To push demands even further, most vaccines under trial require two doses to be administered. If this is the case with the final vaccines, pharmacists will need to track the patients first and when the second dose is needed. In addition, pharmacists should know the CDC expects 10 ml vials holding 8 to 15 doses to be the standard once vaccines are available.

As of 2019, 46 states, as well as D.C. and Puerto Rico, have given authority for pharmacists to administer any type of adult vaccinations. The remaining 4 states; New Hampshire, New York, West Virginia, and Wyoming; have limitations on what immunizations pharmacist can administer. This progress in public health has allowed easier and quicker access to immunization for the public and will be essential in the context of a possible COVID-19 vaccine. Pharmacists should not only be prepared to administer vaccinations once available, but also provide education on the topic.  Staying informed about the latest developments on COVID-19 and the vaccines in progress will help prepare pharmacists for any questions or concerns that their patients may have. Once a vaccine is developed, pharmacists should discuss with patients that a vaccine is not a cure but rather a preventative measure. Providing written materials and verbal counseling discussing potential side effects and risks associated with the vaccine will further patient education. In addition, pharmacists will need to discuss methods of side effect management with patients. Pharmacists will prove to be a valuable resource in the fight against COVID-19.

References

  1. John Hopkins. COVID-19 United States Cases. https://coronavirus.jhu.edu/us-map. (Accessed 2020 July 17).
  2. Neergaard L. First COVID-19 vaccine tested in US poised for final testing. AP News. https://apnews.com/e4d5259bfc6c74fcb090d885737c55a6. (Accessed 2020 July 17).
  3. Early-Stage Trial Data on AstraZeneca COVID-19 Vaccine Due Monday – Lancet. U.S.News. 2020. https://www.usnews.com/news/top-news/articles/2020-07-15/positive-news-on-oxford-astrazeneca-covid-19-vaccine-could-come-on-thursday-itv. (Accessed 2020 July 17).
  4. Bastian H. Covid-19 vaccines with ‘minor side effects’ could still be pretty bad. 2020. https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-could-still-be-pretty-bad/ (Accessed 2020 Aug 3).
  5. Rowland C. A race is on to make enough small glass vials to deliver coronavirus vaccine around the world. The Washington Post. (July 2020).
  6. APhA/NASPA. Pharmacist Administered Vaccines. (January 2019). https://naspa.us/wp-content/uploads/2019/04/IZ-Authority-012019.pdf. (Accessed 2020 July 17).

 

Posted August 2020

The U.S. Plans to Start Stockpiling API by Entering into a Contract with a Startup Company

The government recently signed a 4-year, $354 million contract with Phlow Corp in an effort to bring drug ingredient manufacturing back to the United States.  There is an option for the contract to extend to 10 years, totaling $812 million. The contract’s main goal is to the reduce the reliance of the U.S. drug supply chain on foreign countries such as India and China.

Why has the U.S. decided to make this change now? The FDA estimated that the U.S. receives 40% of all generic medications from India. India receives two-thirds of the active pharmaceutical ingredients (API) it requires to produce these generic medications from China, who is the world’s largest raw ingredients manufacturer. The recent COVID-19 pandemic called attention to how drastically the drug supply chain could be impacted when ingredient production is concentrated outside of the United States.

Phlow’s CEO, Dr. Eric Edwards, stated Phlow will be responsible for implementing the first strategic API reserve. The reserve will consist of over a dozen medications to treat conditions such as hypertension, chronic pain, and infections. Phlow will lead a team with several other entities, including Civica Rx, Medicines for All Institute, and AMPAC Fine Chemicals, to execute this plan. There are concerns that the government is entrusting this large task to a new startup when an established manufacturer may be more adept to tackle this . A spokesperson for the Association for Accessible Medicines believes that this issue requires a policy discussion and not a singular .

Using stockpiled API before its expiration date will require rotating the stock and detailed attention to storage, production, and selling finished goods.  Used or expired API will need to be replenished to maintain the stockpile volumes. How does pricing factor into the stockpile?  Ingredient costs must be competitive in the market or Phlow will have difficulty selling a higher cost generic that is sourced from the United States.  Until Phlow’s plan is released, the logistics and pricing factors are uncertain and could impact the success of the project.

 

Posted July 2020

COVID-19 Testing – SnNOout vs. SpPIn, What Does it Mean?

As a pharmacist’s role within the COVID-19 pandemic expands, pharmacists need to have the capability to administer COVID-19 tests and communicate the results to patients. Pharmacists need to evaluate a test to ensure patients receive all pertinent information on their results. Sensitivity and specificity are two ways to evaluate a laboratory test and describes how often the test is right.

Sensitivity describes the true positive (TP), or the probability of a positive test result. Specificity describes the true negative (TN), or the probability of a negative test result. There are two acronyms to assist with remembering this concept, SnNOut and SpPIn. SnNOut refers to a highly Sensitive test, if Negative, rules Out the condition. SpPIn refers to a highly Specific test, if Positive, rules In the condition. The importance lies in that not all tests are 100% accurate.  Pharmacists should investigate the sensitivity and specificity of available tests and include those factors when selecting the test to offer. Therefore, by reading and understanding the “performance characteristics” of test package labels, pharmacists can communicate the probability that a test result can be trusted.

The following chart will be used to walk through an example. For instance, the Cellex qSARS-CoV-2 IgG/IgM Rapid Test is 93.8% sensitive and 95.6% specific. If 200 patients are tested using this method and 100 receive positive test results, then 93-94 patients will have a positive test result and have COVID-19 (A) and 6 to 7 patients will have a positive test result and not have COVID-19 (C). Furthermore, 100 patients receive a negative test result. Of those 100 patients, 95 to 96 patients will have a negative test result and not have COVID-19 (D) and 4 to 5 patients will have a negative test result but have COVID-19(B).

Sensitivity and specificity

The key takeaway is that even though a patient may receive a negative test result, this does not preclude the patient from having the disease and vice versa. Therefore, always check a test’s “performance characteristics” to be able to guide a patient through understanding their results and interpreting their meaning.

References

 

Posted July 2020

COVID-19 Guidelines Lay the Foundation for an Expanding Digital Health Market

With the world adapting to remote working and online learning, digital therapeutics (DTx) are positioned to improve patient care now more than ever. Personal Connected Health Alliance (PCHAlliance) has partnered with the Digital Therapeutics Alliance (DTA) to define and further establish the field of digital therapeutics. PCH Alliance contributes the infrastructure, reach and resources with the expertise, focus, and leadership of DTA through a strategic partnership. PCHAlliance also launched a Digital Therapeutics Task Force, which will focus on high priority projects for both organizations.

The term digital therapeutics refers to software programs designed to deliver patient care to prevent, manage, and treat a wide range of diseases, with their key focus on delivering clinical . DTx are a distinct, independent category of digital health products. Not all technology related healthcare products qualify as digital therapeutic products. For a product to be approved by the FDA as a digital therapeutic product, it must display either clinical evidence, proven outcomes, or direct therapeutic interventions. Products such as online patient portals, pill box dispensers with electronic alerts, or fitness trackers do not qualify as digital therapeutic products. Each digital therapeutic product falls under one of four categories based on its intended use:

  1. Address a medical condition
  2. Manage or prevent a medical disorder
  3. Treat a medical disorder
  4. Optimize medication

DTx products offer an opportunity for patients to personalize their health care and address any potential unmet needs they may have.

Patients can use digital therapeutic technology conveniently at home through mobile apps. This remote access creates new opportunities for patients to obtain health-related services that may have otherwise been unattainable. Digital therapeutic software systems can be used independently or in combination with other therapies. DTx offer a variety of health services, including general counseling and information, cognitive behavioral therapy, synchronization of DTx apps to medical equipment, and addressing chronic conditions in conjunction with a drug regimen. Through the utilization of DTx, patients and providers gain insight into patient response through safe, effective, and reliable tools and guidance.

Telehealth is on the rise as patients seek safe and preventative measures to stop the spread of COVID-19. Digital therapeutics make up just one of the many digital health categories experiencing expansion during the pandemic. Millions of Americans have sought care by connecting virtually with their providers, possibly for the first time ever. The “Coronavirus Preparedness and Response Supplemental Appropriations Act”, instituted on March 6, 2020, loosened existing telehealth restrictions to enhance patient access to these services. Although the increased utilization of telehealth has provided convenient alternatives to traditional healthcare during the COVID-19 pandemic, areas of concern remain for telehealth. Some of these areas include prescriber training, billing and reimbursement, and patient skepticism. How are you using or preparing for digital therapeutics and telehealth?

 

To find more information on the topic:

https://dtxalliance.org/wp-content/uploads/2018/09/DTA-Report_DTx-Industry-Foundations.pdf

To look at updates regarding the “Coronavirus Preparedness and Response Supplemental Appropriations Act: https://www.ashp.org/Advocacy-and-Issues/Key-Issues/Other-Issues/Issue-Brief-COVID-19?loginreturnUrl=SSOCheckOnly

PHSL Previous Blog: http://phsirx.com/blog/digital-therapeutics-the-future-of-healthcare

Digital Therapeutics & The Role of the Pharmacist presented at ASAP by Ann Johnson

 

Posted: June 2020

A Closer Look at COVID-19 Testing at Pharmacies

As of April 8, 2020, pharmacists have been given authorization to order and administer COVID-19 tests under the guidance of the Public Readiness and Emergency Preparedness (PREP) Act. This includes nasal and serology tests. On May 19, 2020, the Office of General Counsel (OGC) released a document answering whether PREP Act preempts state licensing laws that restrict pharmacists to order and administer these tests. The conclusion is that the PREP Act preempts any state or local laws that would restrict “a qualified person”, a licensed pharmacist under PREP Act, from ordering or administering FDA-authorized COVID-19 tests. A practicing pharmacy must apply for a Clinical Laboratory Improvement Amendment (CLIA) certificate of waiver before they can accept human samples for diagnostic testing. In some states, such as Pennsylvania, pharmacies must obtain a state-specific CLIA waived lab license in addition to the federal CLIA waiver. In the Emergency Use Authorization (EUA), the FDA specifies which patient care settings are authorized for the tests. If the FDA authorizes a test as a point-of-care test, the test is CLIA waived for the duration of the emergency declaration and can be used in pharmacies. The Department of Health and Human Services Centers for Medicare & Medicaid Services manages the process to obtain CLIA waivers.

Pharmacists may administer tests which are authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance. Tests allowed include the ID NOW COVID-19, Accula SARS-COV-2 Test, Xpert Xpress SARS-CoC-2 test, and serology tests. A complete list of COVID-19 tests given Emergency Use Authorizations (EUA) and their authorized settings can be found here. The FDA is allowing development and distribution of serological tests without going through the EUA process. However, these tests to identify to SARS-CoV-2 must be validated, and the FDA must be notified of the validation.

Tests using patient saliva are currently available by prescription only and intended for at-home collection and mail in for results.

APhA is also offering COVID-19 Specimen Collection Training, COVID-19 educational videos (link 1 link 2), and COVID-19 fraudulent medical device and scam guidance to train pharmacists and keep them up to date and aware of the latest science and data pertaining to COVID-19. Many pharmacies are already offering testing at no cost to eligible individuals who meet criteria set by the CDC. Most pharmacies require patients to preregister in advance to be directed to the nearest testing location. Testing can deliver results in as little as 15 minutes.

With 90% of Americans living within 5 miles of a community pharmacy, testing can become much more accessible, which can lead to earlier identification and improved outcomes relating to COVID-19.  Hopes are that many more patients will be tested and can take appropriate measures to reduce the spread of COVID-19. Is your pharmacy prepared to participate and offer COVID-19 point-of-care testing?

 

 

Posted May 2020

A New Way to Control Pain

The Food and Drug Administration (FDA) recently gave approval to GlaxoSmithKline (GSK) for their new OTC pain product, Advil Dual Action with Acetaminophen. This pain medication contains 250mg of ibuprofen and 500 mg of acetaminophen. It is the first OTC combination of ibuprofen and acetaminophen for pain control. This combination fights pain in two different ways. The first way is with ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), that targets pain at the source by blocking the production of prostaglandins which cause swelling and pain signaling in the body. The second way is with acetaminophen, which blocks pain signals from being sent to the brain. This medication gained approval based on several studies to demonstrate efficacy and safety for pain relief. The data from these studies support that the fixed dose combination of ibuprofen and acetaminophen had better outcomes for pain relief than using ibuprofen or acetaminophen individually.  Advil Dual Action will be available later in 2020.

 

Posted April 2020

Non-Alcoholic Steatohepatitis (NASH) Updates

Non-Alcoholic Steatohepatitis (NASH) is characterized by fat accumulation in the liver that causes inflammation and cell damage without regard to alcohol use. If you would like to know more about NASH, please click here to read our previous blog post.

The FDA has not approved any medications to treat NASH. This condition is important to identify early on and treat by means of lifestyle modifications. Due to the prevalence of NASH and the possibility that an afflicted patient could progress to cirrhosis or even liver cancer, drug manufacturers have been studying products that could be of potential use. There are a few pharmacological treatments close to entering the market – maybe as early as this year.

For patients unable to lose enough weight or maintain weight loss, pharmacological treatment is necessary. This is particularly true if a patient has progressed to the later stages of NASH, as they are at a higher risk for serious complications (i.e. cirrhosis, liver failure, and, in some cases, liver cancer). Some patients have used pioglitazone or vitamin E off label, but there is not enough data to support recommending these products. Benefits and risks must be weighed for individual patients.

Genfit and Intercept have manufactured the two most promising treatment options. Genfit is in Phase 3 studies for its drug elafibranor, a peroxisome proliferator-activated receptor (PPAR) alpha/delta dual agonist. PPARs are nuclear receptors that play major roles in the development of NASH and its comorbidities. Pioglitazone is a PPAR-gamma agonist. Activation of the gamma receptor is associated with weight gain, edema, and fluid retention, making it a less viable option.

Intercept is in Phase 3 studies for its drug obeticholic acid (OCA). The company filed an NDA for FDA approval in September of 2019. OCA is a farnesoid X-receptor (FXR) agonist. OCA is available as brand name product, Ocaliva, indicated for use in the treatment of biliary cholangitis. A month of treatment is estimated to cost $7,000.00, making it an expensive option. Although this drug has displayed the ability to stabilize and sometimes reverse the features of NASH, its high cost will be a clear limitation to its widespread use.

Due to the lack of successful treatment options, drug manufacturers are anxious to launch approved products to serve the NASH market of over 300 million potential patients worldwide. The question is, when a drug does hit the market, will payers cover it, and will patients be able to afford it? The first step to accessing treatment will likely be a diagnosis of NASH and fibrosis staging through a liver biopsy. Payers will need to weigh the cost of these new medications against the cost of alternatives, such as bariatric surgery or a liver transplant. There are few existing alternatives, and if a patient has damage that is too severe, they will likely require medication.

At this time, healthcare professionals should recommend lifestyle modifications and emphasize the need to control comorbid conditions, such as diabetes, hypertension and dyslipidemia. FDA-approved drugs will likely be available in the near future – stay up to date and knowledgeable!

 

Posted April 2020

Medication Clean Out and Disposal

A great way to keep yourself busy and tidy up your medicine cabinet is to participate in National Clean Out Your Medicine Cabinet Day on Friday, April 17, 2020.  There are still ways you can dispose of your medications, even with the postponement of the DEA Prescription Drug Take Back Day scheduled for April 25th.

For medications that have a greater potential for misuse, one simple way to dispose of medications may be by flushing them. You can check the patient information leaflet that comes with the medication or the FDA flush list to see if your prescription medication is one of the 15 active pharmaceutical ingredients that can be flushed down the sink or toilet.  The flush list has details on safe disposal. You may wonder if this will have an impact on the environment. The FDA and Environmental Protection Agency published a paper stating they have not found any negative environmental effects from flushing the ingredients specified on the flush list. The FDA also suggests that the benefits outweigh the risks when other disposal options are not available.

If you are concerned with flushing medications, you can still dispose of the medications in your household trash. Follow the steps listed below for prescription and over-the-counter (OTC) pills (tablets and capsules), liquids, drops, patches, and topical products (creams, ointments, lotions, gels, etc.).

  1. Remove the drugs from their original containers and mix them with something undesirable, such as used coffee grounds, dirt, or cat litter. This makes the medicine less appealing to children and pets and unrecognizable to someone who might intentionally go through the trash looking for drugs.
  2. Put the mixture in something you can close (a re-sealable zipper storage bag, empty can, or other container) to prevent the drug from leaking or spilling out.
  3. Throw the container in the garbage.
  4. Scratch out all your personal information (including the Rx number) on the empty medicine packaging to protect your identity and privacy. Throw the packaging away.

Disposing of unwanted or expired medications decreases the risk of someone taking or misusing your medications and prevents confusing an older medication with a newer one.  These steps will help ensure that a child or pet cannot access or ingest the medications after they are in the trash.

If you do not feel comfortable disposing of medications at home, you can contact your local pharmacy or health care provider, as they may have other options to dispose of your medications. Local police or fire departments may have drug disposal bins, and there are also options to mail back medications to a disposal company. With the current pandemic and social distancing orders, the options may be more limited for disposing of medications at a pharmacy or police station. Finally, there are pouches that can be purchased to effectively get rid of unwanted medications.  Products such as DisposeRx® (www.disposerx.com) and Deterra Drug disposal pouches  (www.deterrasystem.com) can be purchased for environmentally safe drug disposal.  No matter the route, discarding expired and unwanted medications will help protect you and your family from accidental medication exposure.

 

Posted April 2020

America’s Pharmacies – Ready and Open

Pharmacy Healthcare Solutions, LLC shares this message from the National Association of Chain Drug Stores (NACDS) supporting pharmacies across the nation.

 

Rise from NACDS

Posted April 2020

 

Poison Prevention Week 2020

Poison Prevention Week started in 1961 and is the third full week of March each year. The American Association of Poison Control Centers (AAPCC) 2018 report stated that over two million cases were managed by poison control, a call to poison control was made every 12 seconds, and that nearly two billion dollars of medical costs were saved because of poison control centers.

What is poison?Tips for med safety

Anything that can cause harm if used in the wrong way, if used by the wrong person, or if used in the wrong amount.

When is Poison Prevention Week?

March 15, 2020 to March 21, 2020

Why is there a Poison Prevention Week?

The United States dedicates a full week to poison prevention to raise and promote awareness about the risk of poisoning.

How can pharmacists help?

Pharmacists are the most available and easily accessible healthcare professionals. They can provide the public with information on poison and where to go for help, educate patients about the importance of proper medication storage, provide over the counter medication safety, promote awareness about common medications that can be toxic, and information on resources for local medication take back locations.

Where to gPoison Helpo for help?

Poison Control phone number 1-800-222-1222

Text POISON to 797979 to save the contact information for poison control in your phone

Online help at PoisonHelp.org

 

Local poison control center.

Pittsburgh Poison Center

University of Pittsburgh Medical Center

200 Lothrop Street

Pittsburgh, Pa 15213

 

Additional Resources on poison prevention:

https://aapcc.org/

https://www.poison.org/

 

Published March 2020