Amoxicillin - JASE Medical

Drug Shortages: Causes & Solutions

While things are being done at the national level to combat global shortages, there’s more individuals can do at home.

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The Complexities of Prescription Drug Shortages

Prescription drug shortages have reached unprecedented levels in recent years, disrupting the supply of essential medicines such as, antibiotics, cancer chemotherapies, ADHD medications, and diabetes and weight-loss treatments. These shortages compromise patient care, strain healthcare resources, and place an economic burden on the system. Here we’ll explore the multiple reasons behind drug shortages and examine the efforts being made to ensure patients have continuous access to the medications they need.

Understanding Drug Shortages

A drug shortage occurs when either the actual demand or projected demand for a medication exceeds the available supply. According to the American Society of Health-System Pharmacists (ASHP), active drug shortages in the US reached an all-time high of 323 during the first quarter of 2024, surpassing the previous record set in 2014. The situation is similarly dire in the UK, with the British Generic Manufacturers Association reporting a 100% increase in medicine shortages between January 2022 and January 2024.

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Causes of Drug Shortages

  • Sudden Demand Spikes: Unexpected increases in disease prevalence, such as the rise in Strep A cases among UK children in 2022, lead to a surge in demand for children’s antibiotics. Only a year later, a drastic shortage of children’s antibiotics hit the U.S. in the beginning of the school year in 2023. Each year we face an amoxicillin shortage leading up to and into the start of the school year. Safeguard your kids from these shortages with a KidCase (which includes amoxicillin).
  • Manufacturing and Quality Issues: Recalls, quality problems, or failed regulatory inspections can cause sudden drops in supply. For example, when Indian manufacturer Intas failed a US FDA inspection in 2023, it triggered a nationwide shortage of cisplatin and carboplatin cancer chemotherapies.
  • Raw Material Shortages: Scarcity of active pharmaceutical ingredients (APIs) or delivery mechanisms can contribute to drug shortages. The geographic concentration of API manufacturing in China and India heightens the risk of global supply disruptions.
  • Economic Factors: Extreme price competition among generic manufacturers can undermine investment in manufacturing capacity, quality assurance, and supply chain reliability. Lower-priced drugs are more likely to experience shortages due to a lack of incentives for production.
  • Natural Disasters and Geopolitical Events: Incidents like the 2023 tornado that hit a Pfizer plant in the US can destroy manufacturing facilities. Geopolitical factors such as Brexit, the Ukraine-Russia war, and the Covid-19 pandemic have also significantly impacted drug supplies.

| In the first quarter of 2024, drug shortages in the U.S. hit an all time high, surpassing the previous record set in 2014. |

 

Protocols for Managing Shortages

Many countries have established national reporting systems to facilitate communication about drug shortages. In the US, manufacturers can notify the FDA Drug Shortage Staff via a web portal, and the FDA’s list is updated daily. The FDA works with manufacturers to address shortages and may seek alternative suppliers or importation of products. Also, the American Society of Health-System Pharmacists (ASHP) maintains an up to date list of current drug shortages.

Similarly, in the UK, the Department of Health and Social Care (DHSC) liaises with manufacturers, alternative suppliers, and wholesalers to secure additional supplies. The DHSC has also introduced serious shortage protocols (SSPs) to allow pharmacists to offer alternative products when items are in short supply.

Regulatory agencies like the FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) can take various actions to mitigate shortages, but these are often controversial. Such actions can include: expediting approval processes, granting temporary labeling exemptions, and allowing the importation of unlicensed medicines.

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Efforts to Prevent Future Shortages

  1. Critical Medicines List: In addition to the FDA and ASHP drug shortage lists maintained in the U.S., the European Medicines Agency (EMA) published a list of over 200 critical medicines to prioritize for shortage prevention. The list will be expanded and updated annually.
  2. Supply Chain Resilience Recommendations: The EMA has gone a step further by issuing recommendations for global suppliers to address vulnerabilities in the production and delivery of critical medicines. These include keeping extra back-stock, reviewing past shortages to identify demand patterns, and increasing manufacturing capacity.
  3. Policy Solutions: Legislators in the U.S. have proposed funding domestic manufacturing to combat supply chain issues. The Senate Finance Committee has drafted a bill to incentivize hospital contracting practices that ensure adequate drug supplies.
  4. Appointment of Supply Chain Coordinator: The U.S. Department of Health and Human Services has appointed a supply chain resilience and shortage coordinator to lead efforts in strengthening critical medical supply chains.

In summary

Prescription drug shortages pose a significant challenge to healthcare systems and patients worldwide. The interplay of factors, from sudden demand spikes and manufacturing issues to economic pressures and geopolitical events, requires broad and collaborative approach to ensure patients have uninterrupted access to essential medicines. While national reporting systems, regulatory actions, and policy initiatives aim to mitigate the impact of shortages, more work is clearly needed to address the root causes and build resilience in the global pharmaceutical supply chain.

One thing that individuals can do to hedge against supply shortages and medication availability is have their own supply. Maintaining a personal supply of emergency medications like antibiotics and treatments for sudden illnesses is both prudent and possible. That is why we make the Jase Case—for these unpredictable circumstances.

Additionally, our Jase Daily service can provide you an extended supply of your daily medications for chronic conditions, offering a larger quantity than is typically available through your local physician and pharmacy.

Give yourself the peace of mind you deserve.

– Your partners in preparedness: Jase.com

 

Lifesaving Medications

Everyone should be empowered to care for themselves and their loved ones during the unexpected.

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Our mission is to help you be more medically prepared. Join our newsletter and follow us on social media for health and safety tips each week!

Prepared Equals Peace of Mind

Prepared equals peace of mind

Being “prepared” used to be our way of life. Our just- in- time supply chains weren’t around back then. Amazon, and online shopping didn’t
exist. Back then, if you wanted something you had to either call the company and place an order or mail
a check in.

The Sears catalog, along with many other catalogs would arrive and you and your family would spend
hours poring over the pages. These pages were filled with almost anything you may need or want, from
bed sheets to tools for the shop. In essence, those catalogs were the modern-day equivalent of Amazon.
Sometimes it would take a month or so for the much-awaited order to arrive. This was normal. Back
then, if you wanted something you had to plan for it.

Just in time supply chain

Fast forward to today. With all the wonderful technology, the same day deliveries, and almost any item
at our disposal within a few days, we have become complacent. Don’t get me wrong, we have used this
system to receive much needed items, in some cases almost immediately. This is the wonder of our
technological age. But it comes at a price. We take for granted that these supply chains will always be
running smoothly. Our world economy, for the past several decades has made life more convenient and
opened our lives to new experiences and time saving devices.
Technology- double edged sword

Our global world is a double-edged sword. The convenience we so much rely on, can and has been in the
process of failing over the past few years. The consequences to our healthcare system have been
devastating. Medical supplies such as contrast dye and drugs, have been in short supply or altogether
unavailable with no end in sight. This illustrates how fragile our medical system is. We are only one
natural or manmade disaster, pandemic, political or civil unrest from the complete shutdown of life
saving drugs and medical supplies.

Pharmaceuticals outsourced

The last major pharmaceutical manufacturing operation closed its doors and left the United States in
2004. Since then, nearly all the active ingredients for antibiotics and chronic medications – even
vitamins – are produced overseas, mainly in China and India.
Take, for instance the current amoxicillin shortage.

Across the country many pharmacies have reported a limited or not available supply of amoxicillin.
Amoxicillin is one of the first antibiotics used to treat strep throat, ear infections, urinary tract infections
and many other infections. The shortage includes amoxicillin in pill form, powder to mix with water to
make a suspension, and chewable tablets.

The American Society of Healthcare Pharmacists maintains a database of drug shortages and
manufacturers. They have listed amoxicillin manufacturers who have reported shortages or no
availability.

• Aurobindo, with facilities located throughout the world, refuses to provide availability
information.
• Hikma, based out of the UK, did not provide a reason for the shortage.
• Rising, based out of New Jersey has amoxicillin capsules and tablets available, but doesn’t state
whether they have amoxicillin powder available
• Sandoz, headquartered in Switzerland did not provide a reason for the shortage.
• Teva, which is based out of Israel did not provide a reason for the shortage.

However, the FDA states the only shortage is amoxicillin in powder form. This is because if even one
manufacturer can supply the necessary drug there is no perceived shortage.

This is very disturbing. All it takes is that one manufacturer to declare either a shortage or the drug
not available at all and the US supply is dried up.

Augmentin, (amoxicillin / clavulanate) is one of the antibiotics included in the Jase Case (see below how
to order a Jase Case). This can be substituted for amoxicillin if amoxicillin isn’t available.

Generics less likely to be manufactured

An analysis conducted by the US Pharmacopeia, a group that sets standards around the world for
medicines, found that antibiotics are 42% more likely to be in shortage in the US compared to other
types of drugs. Most antibiotics are now generic.

According to an analysis by the FDA Report “Drug Shortages: Root Causes and Potential Solutions”
identified three root causes of drug shortages.

1. Lack of incentives for manufacturers to produce less profitable drugs. (Generics aren’t very
profitable)
2. The market does not recognize and reward manufacturers for “mature quality systems” that
focus on continuous improvement and early detection of supply chain issues; and
3. Logistical and regulatory challenges make it difficult for the market to recover from a disruption.
The fragile global supply chains mean that if a pharmaceutical factory is down in China, you may not be
able to find your prescription at the neighborhood pharmacy. Lifesaving antibiotics are at risk of running
out faster than any other medicine. Medicines that are now available could easily run out. This could
lead to dire consequences.

Jase Medical is on a mission

JASE Medical is a telemedicine company with a singular focus to change all of that. This platform offers
access to basic emergency preparedness medications for every family in America.

And how will they do that? Well, it won’t happen overnight. But JASE Medical has done its homework
and established a nationwide network of physicians trained to evaluate individual needs, assess
conditions, and prescribe appropriate prescriptions for emergency preparedness purposes. From there,
licensed pharmacists fill your prescription, and the Jase Case is sent to your home.

These are the medications that will become lifesaving for you and the people you care about. And it’s all
done online through the JASE Medical portal.

How it works

When you log on to the platform and begin your consultation, you will find a simple and user-friendly
experience. The consultation takes little over five minutes to complete. After a licensed Jase healthcare
provider has reviewed your health history and any allergic reactions to medications, your prescriptions
are filled, and your Jase Case is shipped to your front door.

What’s in the JASE Case?
The kit contains the following antibiotic medications:
 Amoxicillin/Clavulanate.
 Azithromycin.
 Ciprofloxacin.
 Doxycycline.
 Metronidazole.
(Substitutions are made if allergic to one of the antibiotics)

All medications carry a level of risk, but these five antibiotics were selected for their effectiveness and
optimal patient safety. Guidance from the CDC says it best: “Antibiotics … save lives, and when a patient
needs antibiotics, the benefits usually outweigh the risks of side effects and antibiotic resistance.”

Some of the infections a Jase Case can treat
 Anthrax, plague and tularemia (resulting from bioterror).
 Bite wounds.
 Cellulitis.
 Diverticulitis.
 Intra-abdominal infections.
 Tooth infections.
 Ear infections.
 Pneumonia.
 Sinusitis.
 Strep throat.
 Urinary tract infection.
 and more.

When access to your healthcare provider isn’t possible (you are on vacation, etc.) your Jase case
includes a symptom and antibiotic use handbook titled the “Emergency Antibiotic Guide “with easy-to-
follow instructions to ensure proper use of the antibiotics if indicated.
What about chronic conditions?

Soon, the JASE Medical platform will provide emergency preparedness medicines for those with chronic
medical conditions (such as blood pressure and other chronic conditions). JASE Medical’s same
physician network will assess your condition and the need for appropriate preparedness medicines.

Ongoing support

As part of its mission to prepare you medically, JASE Medical provides unlimited ongoing support from
their physician network for questions about any of the medications prescribed.

What about shelf life?

The good news about antibiotics is that they last longer than you think. The FDA’s Shelf-Life Extension
Program found that 88% of the drugs studied maintained their potency and safety beyond the published
expiration date. The extended usability of these medications ranged from 5.5 years to as many as 23
years beyond their printed expiration!

The JASE Case antibiotics all carry the FDA’s required expiration dates. JASE Medical endorses those
dates.

Value and peace of mind

At the end of the day, this is all about peace of mind and knowing that you are ready for the
unexpected. Knowing that you have found a solution, priced at a fraction of what it would otherwise
cost you, adds to that peace of mind.

Go to JaseMedical.com and secure your emergency medications, an emergency antibiotic guide,
unlimited physician consultation and a team of professionals who are on a mission to keep you and your
loved ones prepared and safe during these uncertain times.

- Brooke Lounsbury

Medical Content Writer

Lifesaving Medications

Everyone should be empowered to care for themselves and their loved ones during the unexpected.

Recent Posts

Keeping you informed and safe.

Join Our Newsletter

Our mission is to help you be more medically prepared. Join our newsletter and follow us on social media for health and safety tips each week!

Is There Really a Shortage of Amoxicillin?

A widespread shortage of a common antibiotic, amoxicillin has swept the country. Amoxicillin is one of the first antibiotics used to treat strep throat, ear infections, urinary tract infections and many more. The shortage includes amoxicillin in pill form, powder to mix with water to make a suspension, and chewable tablets. 

The American Society of Healthcare Pharmacists maintains a database of drug shortages and manufacturers. They have listed amoxicillin manufacturers who have reported shortages or no availability. 

  • Aurobindo, with facilities located throughout the world, refuses to provide availability information.
  • Hikma, based out of the UK, did not provide a reason for the shortage.
  • Rising, based out of New Jersey has amoxicillin capsules and tablets available, but doesn’t state whether they have amoxicillin powder available
  • Sandoz, headquartered in Switzerland did not provide a reason for the shortage.
  • Teva, which is based out of Israel did not provide a reason for the shortage.

However, the FDA states the only shortage is amoxicillin in powder form. This is because if even one manufacturer can supply the necessary drug there is no perceived shortage. 

This is very disturbing. All it takes is that one manufacturer to declare either a shortage or the drug not available at all and the US supply is dried up. 

Augmentin, (amoxicillin / clavulanate) is one of the antibiotics included in the Jase case. This can be substituted for amoxicillin if amoxicillin isn’t available. 

Generics less likely to be manufactured

An analysis conducted by the US Pharmacopeia, a group that sets standards around the world for medicines, antibiotics are 42% more likely to be in shortage in the US compared to other types of drugs. Most antibiotics are now generic.

According to an analysis by the FDA Report  “Drug Shortages: Root Causes and Potential Solutions” identified three root causes of drug shortages.

  1. Lack of incentives for manufacturers to produce less profitable drugs;
  2. The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
  3. Logistical and regulatory challenges make it difficult for the market to recover from a disruption.

The world supply chain is in dire straits. Even if medicine is available, the pending diesel shortage and possible rail strike could make getting the lifesaving medication to you. Talk to your care provider and pick up extra medications, both prescription and over the counter. If you haven’t already, get your Jase cases for your family.  This winter could prove to be a rough one for those not prepared.

 

- Brooke Lounsbury

Medical Content Writer

Lifesaving Medications

Everyone should be empowered to care for themselves and their loved ones during the unexpected.

Recent Posts

Keeping you informed and safe.

Join Our Newsletter

Our mission is to help you be more medically prepared. Join our newsletter and follow us on social media for health and safety tips each week!

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