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#HERETOHELP: A COVID-19 RESPONSE

MEDISCA, MEDISCA Network, and LP3 Network are dedicated to collectively utilizing resources to provide compounding pharmacists on the frontlines with the practical support they require to navigate through these challenging times. From potential drug shortage formulation support from MEDISCA Network, to COVID-19 education program and online education solutions from LP3 Network, to chemical and product supplies from MEDISCA, together, we are #HERETOHELP.




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5/15/2020

COVID-19 Comprehensive Global Pharmacist Support Document

Pharmacist Support Document-Available For Free

From the first news of a novel coronavirus being discovered, to the official classification of a global pandemic due to COVID-19, information regarding temporary and emergency protocols, proposed guidelines as well as public safety recommendations, to name a few, have continually been updated and revised as more information regarding the virus is discovered. Heath care providers, such as pharmacists, search for credible sources of information to not only educate themselves on this pandemic but on how to advise and care for their patients as well. In an effort to help consolidate the most up-to-date regulatory and professional organizational guidelines and policies, MEDISCA Network has created a document to serve the healthcare community as a resource for providing such information. Some of the major topics of concern have been included and are subcategorized by the countries of Australia, Canada and the United States as well as other potentially relevant international documents. We are #heretohelp the global compounding industry!

Click Here to View the Pharmacist Support Document.

 

 

 


4/22/2020

Over 100 Potential Shortage Support Formulas – Available For Free!

MEDISCA Network makes keeping up with FDA, ASHP, Health Canada, and TGA shortage lists appear easy with the number of formulas they keep rolling out!

Over the last month, MEDISCA Network’s formulation department has worked around the clock developing formulas to support compounding pharmacists address drug shortages accumulating across the globe in consequence of COVID-19 manufacturing disruptions.

From antiseptic solutions, to critical care medications, to antipyretics, analgesics, sedatives, disease-modifying anti-rheumatic drugs, antimicrobials, and much more, MEDISCA Network has published over 100 formulas, to date (and growing), in support of potential shortages. Further to this, all of the shortage support formulas are FREELY accessible on MEDISCA Network’s Potential Shortage Support webpage…!

“Our primary objective right now is to provide the resources and expertise support that our compounding pharmacists on the frontlines need during this critical time” said Marlene Abouassaly, Technical Support Service Manager at MEDISCA Network, “and formulas are such an essential part of the compounding process”. All of MEDISCA Network’s formulas are  fully referenced with details on ingredient quantities, special ingredient considerations, calculation templates, preparatory instructions, estimated BUDs, package requirements, auxiliary labels, and more. Certain formulas, such as Hydroxychloroquine Sulfate 25 mg/mL oral liquid, also have references for extended beyond-use dates (BUD); in this particular case, a BUD of 90 days when compounded in MEDISCA’s Oral Mix and packaged in PrecesieDose™ Syringes. In determining shortage support needs, MEDISCA Network’s team is staying ahead of the curve by closely monitoring shortage list updates published by the FDA, ASHP, Health Canada, and the TGA.

To further support pharmacists during these times, for the remainder of the month, MEDISCA Network will be offering 10% discounts on all their Technical Support Service bundle packages for new subscribers. Package options include access to a databank of 8,000+ formulas, customized formulation design, consultation services, and a dedicated customer support help line. From formulation chemists, to compounding pharmacists, and lab technicians MEDISCA Network’s team has made it clear they are #HERETOHELP. For more details visit here and/or contact MEDISCA Network at information@medisca.net.


4/16/2020

Can a government stimulus package benefit your pharmacy?

We have researched how government stimulus packages could benefit compounding pharmacies around the world. Read through the following information to see how your business might be effected. We are #Heretohelp.

United States

  • US lawmakers have passed $2 trillion stimulus package. The legislation includes direct payments to individuals, a boost to unemployment benefits and a $500 billion lending program.
  • Congress has already approved more than $112 billion to ramp up vaccine research and provide two weeks of paid sick leave for those who are being tested or treated for COVID-19.
  • The Federal Reserve has let loose a tsunami of stimulus measures in recent days. That includes an initial pledge to purchase $700 billion in US Treasuries and mortgage-backed securities, which now has no cap and can include corporate bonds and bond exchange-traded funds. The Fed also announced $300 billion in new financing to keep credit flowing to businesses and consumers.

Canada

  • In a rare session, Canadian lawmakers passed legislation that will subsidize up to 75% of workers’ salaries to avoid even more mass layoffs during the COVID-19 pandemic.
  • Canadian Prime Minister Justin Trudeau, now out of quarantine after his wife tested positive for the virus in March, attended the scaled-down session with a "quorum" of about 20 lawmakers.
  • Opposition parties joined Trudeau’s governing party to unanimously approve the wage-subsidy scheme, which will cost more than $50 billion (in US currency) and will be applied retroactively to days worked since March 15.
  • A majority of Canadian companies are likely to qualify for the subsidy.

Australia

  • Other stimulus measures include inexpensive bank financing which is aimed to stimulate borrowing, part of this was announced by the Reserve Bank of Australia.
  • The government also announced a $20 billion loan guarantee to help impacted small/medium-sized businesses meet cash flow requirements. If you include these total loan guarantees with the direct fiscal stimulus, then the total stimulus in the economy is worth around 10% of GDP.
  • There are also RBA interest rate cuts and three-year government bond purchases to meet the 0.25% yield target. 
  • Details of the package announced to include: increase the payment of the Newstart allowance (an additional $550/fortnight) and expanded eligibility for income support (the Newstart allowance). It also includes:
    • Further $750 payment (on top of the $750 already announced) for those on welfare support (5.2 million Australians), and Job Keeper Payments
    • Early access to superannuation for those whose wages have been directly affected by the virus (draw up to $10K from superannuation this and next financial year) tax-free, 
    • More flexibility around retirees on drawing down on their superannuation and increasing cash payments to SMEs ($20K payment up to $100K).
  • The Prime Minister said that more stimulus initiatives are likely, and citizens should expect more direct cash handouts to Australian households to be announced over the next few weeks. 

United Kingdom

  • The UK government has unveiled £330 billion ($397 billion) in loan guarantees and suspended local business taxes for the retail, hospitality and leisure sectors for 12 months. It will also cover 80% of workers' salaries for at least the next three months, up to a maximum of £2,500 ($2,900) a month. It's unclear how much that initiative will cost.
  • In addition, the UK government promised to provide the self-employed with a cash grant of 80% of their average monthly profit, up to £2,500 ($3,000) a month, over the next quarter.
  • The Bank of England has said it will increase its holdings of UK government and corporate bonds by £200 billion ($242 billion).

European Union

  • Germany has unveiled a rescue package worth up to €750 billion ($825 billion) that includes measures to spur lending to businesses and take direct stakes in companies.
  • France has approved €45 billion ($50 billion) in relief for small businesses and unemployed workers. It is also guaranteeing €300 billion ($330 billion) in corporate borrowing.
  • Italy has greenlit €25 billion ($27.5 billion) to help workers and support the country's health system, while Spain has put up €200 billion ($220 billion).
  • The European Central Bank has said it will spend €750 billion ($824 billion) buying government debt and private securities before the end of 2020, and stands ready to do more if necessary. That's on top of €120 billion ($133 billion) in extra purchases it announced previously.

China

  • So far, China has announced at least 116.9 billion yuan ($16.4 billion) in financial relief and stimulus, plus 800 billion yuan ($112.5 billion) in tax and fee reductions. .
  • The People's Bank of China has adopted various credit easing measures, allocating at least 1.15 trillion yuan ($162 billion) to help businesses hit by the virus.

4/14/2020

ASHP and FDA Drug Shortage Lists

Utilizing ASHP and FDA Drug Shortage Lists during COVID-19

While the world is watching the ever-quickening spread of COVID-19, we need to be aware of the potential disruptions in the drug supply chain. These disruptions can prevent drug manufacturers from producing life-saving medications for patients around the world. With some countries on total lockdown, this will become a national security issue unless the Food and Drug Administration (FDA) and State Boards of Pharmacy untie the hands of the compounding industry.

The United States needs a plan to provide timely, transparent information and increase patient access to medically necessary drugs during shortages. Traditional compounding pharmacies and outsourcing facilities have filled this role in the past by working from the FDA’s drug shortage list, but it is often delayed and can result in gaps causing patient harm. However, allowing the compounding and manufacturing of drug shortages listed by the American Society of Health-System Pharmacists (ASHP) will quicken the response and reduce the gap in patients' access to medications. 

We are asking the FDA to allow our industry to use both the FDA’s and the ASHP lists. Traditional compounding pharmacies have been compounding for shortages for decades using the FDA shortage list. This led to the creation of outsourcing facilities by congress (and regulated by the FDA)  by federal statute, to ease the burden of the shortages by manufacturing drugs to the same cGMP standards of the original pharmaceutical manufacturers. 

According to the FDA, 40% of all manufactured drugs are imported to the United States, and 70% of the top 40 drugs in the U.S. are imported. Hurricane Maria, and the year-long market disruption that followed, is a perfect example of what happens when we are too dependent on a single geographical location to supply of our finished drugs and essential raw materials.  This is the time for action. We need to put a plan in place before supply chain issues greatly diminish patient care. 

After several requests to State Boards of Pharmacy and the FDA, hand sanitizer was allowed to be produced at local compounding pharmacies to fill the gap in the first line of defense of COVID-19. This is what our industry was made for: to fill the gaps where large pharmaceutical companies can't provide for patients' needs. There are thousands of traditional compounding pharmacies around the country and around 70 large outsourcing facilities that are working around the clock to meet the needs of these patients. All we need is more timely, transparent information about drug shortages and the needs of the industry. 

We are starting a discussion, and we are asking for health care professionals to let the FDA know that although we are ready and willing to help during this crisis, there needs to be better access to information. Two hundred forty-two drugs on the ASHP shortage list is too many when you have high-quality products and professionals available to help during this pandemic. Compounding is #HeretoHelp.


4/1/2020

LP3 Network Announces NEW Live Stream Education – Attend Seminar and Receive CPE Credits from Home

LP3 Network Announces NEW Live Stream Education – Attend Seminar and Receive CPE Credits from Home

To support the COVID-19 isolation measures and LP3 Network’s commitment to providing industry-leading continuing healthcare education, LP3 Network is happy to announce that they will be bringing their North American live seminars to your home through live streaming solutions. This innovative learning experience allows you to attend seminars and receive Continuing Pharmacy Education (CPE) credits (as you would if you were in person) from the comfort and safety of your home. “In real time, you will connect with fellow peers and facilitator(s), virtually through our online learning platform” said LP3 Network General Manger, Maurizio De Stefano. “This platform will allow you to see and interact with subject-matter experts as they light up the stage from their living room to yours!”

A list of upcoming LP3 Network Live Stream Seminars and links to their corresponding course pages can be found below:

Contact Information: info@lp3network.com | www.lp3network.com | 1-844-408-9453


3/31/2020

FDA Hand Sanitizer Update

FDA Update for Compounding Hand Sanitizer

As the compounding industry answered the call to create hand sanitizer during COVID-19, the FDA has been working to resolve questions surrounding the effort. They issued a guidance document on Friday, March 27 that aimed to clarify which materials could be used in creating the sanitizer, but after receiving even more questions, they requested a call with stakeholders to help clear up any misunderstandings. MEDISCA and partners participated on the call and came away with a few notes that we feel will help compounding pharmacies understand what the FDA is expecting. Please see below for general notes from the call, and be sure to review the latest guidance document for the official position of the FDA.

 

1. INGREDIENTS

       a. Alcohol/Ethanol: In the discussion, the FDA stated that the ethanol does not need to be USP nor ACS grade. Using consumable or distillery grade will work if it is produced in concentrations that are high enough that the finished product is 80% alcohol by volume. It is best to use 94.5% ethanol – similar to the USP standard.  The FDA wants to ensure that during the production of the chemical, impurities were not introduced, which may happen when using lower grades. 

       b. Glycerin/Glycerol (humectants used for the final product to be kind on the hands): The FDA is requesting that only a USP or food grade can be used in formulating hand sanitizer. The FDA has stated that at this time glycerin cannot be substituted for propylene glycol. They recommend keeping it at 1.45%, although the FDA would not object to the lower amount listed in the guidance document in the footnote.

       c. Isopropyl Alcohol: If using IPA as an active ingredient, it needs to follow the USP standard. 

       d. Water: The FDA was very clear in their statement that sterile water was to be used and that it can be sterilized by boiling, distilling or purification processes. The FDA strongly cautioned that once it is sterilized, it is to be used quickly so that it remains sterile. A question was asked to the FDA if an RO system can be used, and they said it could be used if the system is well maintained, properly designed, and is well documented. 

2. DENATURANT

       a. The FDA was very insistent that the only denaturants to be used are the ones listed in the guidance document. Others might be considered in the future, but not at this moment. This is in line with the World Health Organization’s’ position. Both organizations feel that hand sanitizer could be attractive to small children. The FDA explained with the higher use of hand sanitizers, the curiosity of small children, and the extended time at home, poison control calls have increased by 50%. The FDA used the example that a child consuming of 1.5tsp could result in an ER visit. 

       b. It is important to note that the FDA specifically asked compounders not to use Acetone as a denaturant. They found that Acetone becomes harmful over weeks of topical use due to its toxicity.

3. PACKAGING LABEL

       a. The FDA was also insistent that each bottle of hand sanitizer be labeled in accordance with the guidance document. They felt that this was another way to let parents know of what was in it, and hopefully avoid kids ingesting it. 

       b. Specifically, the FDA called out that they should all be labeled with “keep out of reach from children”.

4. EXPIRATION/BUD

       a. The FDA suggested that each bottle receive an expiry date or BUD. These products are expected to be used soon after production, during the pandemic.

       b. Once the situation is stable or back to normal, FDA stated that they will issue a statement to retract the guidance document authorizing the compounding of hand sanitizers. This means that when the retraction statement is issued, all hand sanitizers compounded can no longer be sold and must be destroyed immediately.

 


3/27/2020

World Congress of Compounding 2020 – Canceled

World Congress of Compounding 2020 – Canceled

As a result of the COVID-19 pandemic, MEDISCA, MEDISCA Network, and LP3 Network have decided to cancel the World Congress of Compounding Event scheduled to be held at ARIA, Las Vegas on October 2-3, 2020. Given the uncertainty we are currently facing, we have decided to be proactive as there is no higher priority for us than the health, safety, and physical well-being of each of you, together with everyone else involved in the event.

Contact Information: info@compoundingcongress.com | www.compoundingcongress.com | 1-866-833-5318


3/24/2020

Meet the Inventors of the 3D Printed N95 Mask

Compounders are #HereToHelp develop a solution to the current global shortage of PPE for healthcare workers!

Three men in Billings, MT have put their heads together to solve one of the most perplexing and anxiety provoking issues we are facing during this global pandemic – the lack of personal protection equipment for medical providers.


Dentist Spencer Zaugg, DDS, and his son Colton Zaugg, have a knack for tinkering and often like to throw around ideas with Billings Clinic Neurosurgeon, Dusty Richardson, MD. This week, they developed a mask using a 3D printer that could serve as a reusable alternative to n95 disposable masks.


The mask is printed in plastic, with a special space to insert the n95 filtering material. By disinfecting the plastic mask between patients and replacing the filter when necessary, this mask could revolutionize the way PPE is manufactured and distributed in the future, and could be the answer to the industry’s desperation.


After creating a prototype and working to improve their initial designs, the team posted all their instructions and printing files online for free and urged everyone to use them by saying, “We are encouraging all hobbyist, dentists, schools, universities, and anyone with 3D printers to start making these masks and delivering them to your local hospitals!”


From there, people all over the country are starting to take this idea and run. A group called "Make the Masks", is complied of stay-at-home moms, engineers, coders, doctors, dentist, manufacturers, all which began networking to pool resources, improve the design, get it tested, and start making the masks. They created makethemasks.com, and are working with the inventors to develop an infrastructure that can turn this idea into a reality. 


The Zauggs and MaketheMasks represent a growing number of people that are mixing brilliance and altruism to solve global problems. Groups like this support the idea that the people of this country aren’t sitting back while things fall apart – they are ready and willing to go to work to improve our collective situation without thinking of themselves.
Medisca became connected with these groups and hopes to continue this type of innovative discussion in the compounding industry through the #HeretoHelp campaign. 
Join us for a call on Friday, 3/27 at 1pm to hear our discussion with Dr. Zaugg and MaketheMasks group leader DeEtte Jones to learn more about these incredible developments to our industry. We will have a panel of pharmaceutical experts to discuss how inventions like these can harness the power of innovation that fuels the compounding industry and help improve the health of our nation. 

The call is open to anyone, and we are anxious to hear any ideas on how to improve on these designs or other ways for compounders to make a difference. No contribution to this effort is too small. We want to take on the issues that matter most – and we want to hear your ideas. 

Join the team! 


3/23/2020

MEDISCA Network Adds Formulations to their Potential Shortage Support Page

MEDISCA Network Adds Formulations to their Potential Shortage Support Page

MEDISCA Network is closely monitoring potential shortages occurring across North America and Australia on a daily basis. In the last week, MEDISCA Network has added acetaminophen, epinephrine, diltiazem, bumetanide, hydroxychloroquine, chloroquine, lopinavir-ritonavir, and vitamin D3 formulations among more. All potential shortage formulations are freely accessible to all. For a full list and access to formulations that may address potential shortages, please visit the following address:

 

Contact Information: information@medisca.net | www.medisca.net | 1-866-333-7811


3/20/2020

LP3 Network Announces COVID-19 Webinar – Mitigating Risk, Addressing Shortages, Achieving Therapeutic Needs

LP3 Network Announces COVID-19 Webinar – Mitigating Risk, Addressing Shortages, Achieving Therapeutic Needs

As the impact of COVID-19 on pharmacies becomes more apparent, LP3 Network is ramping up efforts to develop a webinar addressing the latest empirical evidence on COVID-19 transmission and management. The webinar will place special attention to the compounding pharmacist’s role in mitigating risk, addressing shortages, and achieving therapeutic needs. The webinar will be airing live across the globe next Thursday, March 26, 2020 at 5:00 pm EDT (2:00 pm PDT or 9:00 pm GMT or Friday, March 27, 2020 at 8:00 am AEDT). This webinar is open to all and is freely accessible at the following link. The webinar will be recorded and made available on-demand after the live webinar.

 

Contact Information: info@lp3network.com | www.lp3network.com | 1-844-408-9453


3/13/2020

MEDISCA, MEDISCA Network, and LP3 Network Announce COVID-19 Prevention Procedures & Product Update

MEDISCA, MEDISCA Network, and LP3 Network Announce COVID-19 Prevention Procedures & Product Update

Prevention Procedures

As a company spanning over 50 countries around the world, we are witnessing the widespread effect of the Coronavirus (COVID-19) and are dedicated to minimizing the spread of this global pandemic. As such, the following procedures have been put in place and are effective immediately:

  • All business travel has been suspended including meetings, conferences, tradeshows, events, etc. for the immediate future.
  • Cancellation/postponement of the following MEDISCA and LP3 Network Training Activities:
    • 10th Annual Student Pharmacist Compounding Competition (SPCC), Florida: March 14-15: Canceled
    • Non-Sterile Training, Montreal, QC: March 13-15: Canceled
    • Non Sterile Training, Richmond, BC: March 20-22: Canceled
    • Non-Sterile Training, Florida: April 17-19: Canceled

    The same training activities and the entire LP3 Network training catalogue will be available as of May 2020. (See https://www.lp3network.com/calendar)

    Similarly, all LP3 Network trainings offered via Medisca Australia currently remain available as posted on their site (https://www.medisca.com.au/healthcare-courses).  The upcoming Nutraceutical course in April is currently under evaluation and registrants will be notified of any changes.

    LP3 Network has swiftly taken action and contacted all participants registered to the canceled training programs in March and April ensuring a solution has been provided for future enrollments and credits on file extended until December 2020.  For any additional information, certainly contact info@lp3network.com or 1-844-408-9453.

  • Outside sales representatives will conduct business from home to provide support for their customers and avoid visiting pharmacies in person.
  • Heightened restrictions for visitors to our locations worldwide, relying heavily on teleconferencing to conduct business.
  • Enhanced daily professional cleaning of all common areas in MEDISCA facilities
  • Providing necessary resources to our team to encourage continuity of work in case of voluntary quarantine.

We recognize that these cancellations and changes will inconvenience many of our customers and we sincerely apologize for the disruption. As we continue to put the health and safety of our team, customers, and pharmacies as our first priority, we ask for your patience and cooperation in working to end this pandemic.

 

Product Availability

We appreciate you choosing MEDISCA as your compounding partner and would like to honor that relationship by continuing to supply you with high-quality products throughout this crisis. Although some products are in shortage industry-wide, we are working to minimize supply chain issues and would ask that you place orders based on your current needs and typical inventory flow.  Please note that some items (like facemasks, 70% IPA) are out of stock or in short supply but inventory is being replenished.  We will continue to closely monitor the shortages and keep you informed of any updates. 

We would also like to provide your pharmacies with resources and services that may enhance your ability to serve in this time of need. Compounding can offer relief and stability during traditional drug shortages and MEDISCA can help formulate alternative options for all wellness needs, including sanitizing, nutraceutical and medication needs. Please contact MEDISCA Network for ideas as your resource to formulas that could benefit your community and improve the overall health of your patients. Visit our page for available sample formulas to assist you in this time of need https://www.medisca.net/technical-services/tss/shortage-support or call us at 1-866-333-7811 for any additional support.

 

Product and Packaging Safety

We have received several questions regarding the possibility of the virus spreading via product surfaces or packaging, and would refer you to statements made by the Center for Disease Control (CDC) and the World Health Organization (WHO):

“In general, because of poor survivability of these coronaviruses on surfaces, there is likely very, very low risk of spread from products or packaging that are shipped over a period of days or weeks at ambient temperatures.”

       - Dr. Nancy Messonnier, CDC Director for Immunization and Respiratory Diseases, 26 February 2020

“The likelihood of an infected person contaminating commercial goods is low and the risk of catching the virus that causes COVID-19 from a package that has been moved, travelled, and exposed to different conditions and temperature is also low.”

       - WHO Website “Q&A on Coronavirus (COVID-19)”, 9 March 2020




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The MAZ has been an extremely valuable asset to our Pharmacy during this pandemic, allowing us to complete the large influx of compounded prescriptions refills rapidly, while still giving us the time to create bulk hand sanitizer for patients coming to the pharmacy. Which has brought in a new revenue stream for us.



FIND OUT HOW MEDISCA IS #HERETOHELP


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Live Virtual Seminars

To support the COVID-19 isolation measures, LP3 Network will be bringing their North American live seminars to your home through live streaming solutions. This innovative learning experience allows you to attend seminars and receive Continuing Pharmacy Education (CPE) credits (as you would if you were in person) from the comfort and safety of your home. In real time, you will connect with fellow peers and facilitator(s), virtually through LP3 Network’s online learning platform. This platform will allow you to see and interact with subject-matter experts as they light up the stage from their living room to yours!





A list of upcoming LP3 Network Live Virtual Seminars and links to their corresponding course pages can be found below:


View upcoming Live Virtual Seminars
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COVID-19 WEBINAR

As the impact of COVID-19 on pharmacies became significant, LP3 Network’s team quickly ramped up efforts to develop a webinar addressing the latest empirical evidence on COVID-19 transmission and management, with special focus on the compounding pharmacist’s role in mitigating risk, addressing shortages, and achieving therapeutic needs. The webinar aired live on March 26, 2020 and the recording can be found online and is freely accessible to all:

COVID-19: The Pharmacist’s Role in Mitigating Risk, Addressing Shortages, and Attending to Therapeutic Needs

ONLINE EDUCATION SUBSCRIPTION PLAN

While isolation measures continue, you can also take advantage of LP3 Network’s online subscription plan featuring over 35 webinars and eLearning programs covering the latest hot topics (cannabis-based therapy, opioid use), niche markets (hormones, dermatology, vet, pediatrics, nutraceuticals), regulatory updates, pharmaceutical calculations and procedures, among more. Benefit from education that you can take from the comfort and safety of you home.

LP3 Network’s Online Education Subscription Plan





LP3 Network Contact Information: info@lp3network.com | www.lp3network.com | 1-844-408-9453

MEDISCA Australia Contact Information: sales_au@medisca.com | www.medisca.com.au | 1300 786 392





FORMULATION SUPPORT

Compounding can offer relief and stability during potential drug shortages and MEDISCA Network’s formulation support can assist during these times. Access to MEDISCA Network formulations including, antiseptic solutions, emergency medications, antipyretics, disease-modifying antirheumatic drugs, nutraceuticals, among more, are freely accessible and continually being updated:

MEDISCA Network’s Potential Shortage Support

Contact Information: information@medisca.net | www.medisca.net | 1-866-333-7811




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