drug shortages - 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

 

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We Aren’t On the Brink-We Are Here

The tsunami of strikes, hospitals and clinics closing departments- or shuttering their doors altogether-along with drug and medical supply shortages is the strongest indicator that our health care system is in total collapse.

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Hospitals

  • York (Maine) Hospital is closing its birthing center by the end of the month. Hospital officials noted that the decision to do so is the result of a decline in births and a shortage of workers.
  • West Des Moines, Iowa-based MercyOne will shutter its Albert Lea clinic on Dec. 31, eliminating its only facility in the state of Minnesota.
  • Inglewood, Calif.-based Centinela Hospital Medical Center is ending maternal child health services on Oct. 25 amid continued fallout over the death of a patient earlier this year.
  • According to Beckers Hospitals Reviews, 18 strikes by healthcare workers have taken place since September 26.
  • In addition, on October 9th a 5-day strike of 1,500 healthcare workers at St. Francis Medical Center in Lynwood walked off the job and picketed outside while nonunion nurses and staff were brought in to keep the hospital open, according to union organizers. This strike is following on the heels of the recent
  • Kaiser Permanente 3 days strike of over 75,000 healthcare workers- the largest healthcare worker strike in history just took place.

To not be left out, pharmacies are experiencing strikes.

  • While the Kaiser Permanente strike was taking place, Kaiser pharmacists in western Washington and Oregon were also on strike.
  • Walgreens and CVS pharmacy, two of the largest drugstore chains pharmacists walked out for 3 days (October 9-11).
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Longer response times for EMS

Do you or someone you know have a defibrillator and know how to use it? Do you and those around you know trauma first aid? Do you have a well-stocked first aid kit in your home and when traveling?

Earlier this week, I was traveling along a very rural stretch of highway and came across a car that had flipped over and landed in a ditch. The passenger, a woman, was lying on the ground next to the car. This accident had just happened. Luckily, a state trooper had arrived. There were other motorists that had stopped to help. No ambulance in sight. Since there was already help at the scene I did not stop. If I had arrived 10 minutes earlier, I would have been the first responder.

Are you ready for such an emergency?

The Emperor has no clothes

Blind conformity, vanity and pride sums up the Hans Christian Anderson story of the little boy who dared speak the truth. Speaking the truth can be scary but is also necessary in times such as this.

We are now in a new and troubling world that isn’t going back to “normal” anytime soon. It is imperative that you do not become or remain a zombie. A zombie is “a person who is or appears to be lifeless, apathetic, or totally lacking in independent judgment.” The time is now to shed the zombie suit-the safe facade and see the world for what it really is.

Use social media wisely

I attribute the consumption of social media for a large part of producing zombies.

If you are on social media, use it to help solve problems. Use it to become aware of local news, events, and community building. Don’t let yourself become paralyzed and feed into the narrative. Become a producer, not a consumer. When you do consume, make wise decisions, don’t feed into the emotional rhetoric.

Focus on solutions, not media hype. Look ahead to the future and how you can mitigate disaster  in your home and for those in your community.

We can become overwhelmed with all that is going on in the world, let alone national and local collapses of our health care system. As this collapse intensifies and becomes more real, with people unable to access healthcare in a timely manner, as supply chains tighten their grip on availability of life saving drugs, it will be up to each individual and community to pool their resources to learn new skills, stock supplies, and teach every able-bodied individual how to manage emergencies.

In other words, be part of the solution, not part of the problem. It’s up to all of us.

- Brooke Lounsbury, RN

Medical Content Writer

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Pharmacy Techs Report Massive Drug Shortages

A highly concerning survey conducted by the Pharmacy Technician Certification Board, who grants a Supply Chain and Inventory Management for certification, has stated that nearly 96% of respondents report the pharmacy they work for faces drug shortages.

Established in 1995, the PTCB became the first certification organization for pharmacy technicians. PTCB is the only nonprofit pharmacy credentialing organization in the US. They have established patient safety and best practices, ensuring their certification program provides the most widely accepted credentials for pharmacy technicians across the country.

Drugs the survey respondents reported shortages on were:

  • Chemotherapy drugs (See Whitehouse.gov statement below)
  • ADHD medications
  • Local anesthetics, such as lidocaine,
  • Weight loss and diabetic medications such as Ozempic and Wegovy
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No end in sight for chemotherapy drugs shortages according to the Biden-Harris administration.

According to the Whitehouse.gov website, ongoing shortages of chemotherapy drugs continue to plague our nation.

The White House goes on to state that there is a shortage of 15 cancer drugs due to manufacturing and supply chain issues. Three of the most widely used generic drugs-methotrexate, carboplatin, and cisplatin- have been used for decades for cancer treatment. Because of these supply issues and delays, serious impacts on patient care have occurred.

Approximately 400,000 patients per month receive cancer treatments. Healthcare systems, the FDA, and manufacturers are working together to ensure that these patients receive their treatments. The Whitehouse also states, “The FDA continues to work with drug manufacturers and healthcare providers to restore access to these cancer treatments and other medications that are currently in short supply.”  However, no stable and solid solution is in place for these shortages- now or in the future.

As pharmacists scramble to find alternative drugs for their patients, there seems to be no end in sight.

Even our own government, cannot tackle this massive drug shortage. It’s time to take matters and responsibility into your own hands for the health of you and your family.

A brief survey over at Drugs.com reveals the following shortages:

  • Epinephrine 0.1mg injection- (other strengths available)
  • Doxycycline oral suspension-Lupin, the manufacturer has given no reason or estimated time frame for resupply.
  • Penicillin G Benzathine / Penicillin G Procaine- shortage due to demand
  • Nystatin Topical Powder- insufficient supply for usual ordering
  • Duloxetine Delayed Release Sprinkle Capsules-Manufacturer has no estimate when product may be available.

Drug shortages are a national security threat

Earlier this year, a Homeland Security briefing and testimony report from October 2019 brought to attention underlying factors responsible for drug shortages. Citing up to 80-90 percent of drugs manufactured overseas along with supply chain disruptions and the current geopolitical landscape,

Senator Gary Peters, a Democrat of Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs states,” “Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, but they also represent serious national security threats.”

As WW3 seems to be more likely each day that passes, our dependence on lifesaving drugs and medical supplies is in the crosshairs. Being prepared now is more important than ever.

- Brooke Lounsbury, RN

Medical Content Writer

Lifesaving Medications

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

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World War 3 Draws Closer to Reality- Are You Prepared?

China prepares for its annual war exercises outside of Taiwan with an unprecedented number of war planes, sparking fears of an escalating conflict.    

In an interview with MSNBC Taiwan Foreign Minister Joseph Wu was asked if China could accidentally spark a conflict that could lead to war he states: “It is possible. If you look at the history of war, there are plenty of wars out of accidents — out of inadvertent accidents.”

The United States has a history of maintaining close unofficial ties with Taiwan, and has approved 9 sales of military equipment since the start of the current administration, which experts agree has inflamed China.

The terrifying reality is not just a supply chain disruption, but the possibility of nuclear war grows every day.

The escalating threats across the globe- mainly China, Russia and North Korea along with their supporting countries set the stage for sanctions, raw material scarcity and port interruptions that are becoming more of a reality every day.

In fact, Foreign Minister Sergei Lavrov issued a press release after the US authorized delivery to Ukraine of nuclear capable F-16 jets by stating “Russia cannot ignore the ability of these aircraft to carry nuclear weapons. No number of assurances will help here,” Lavrov was quoted as saying by the Russian Foreign Ministry. “In the course of combat operations, our servicemen are not going to sort out whether each particular aircraft of this type is equipped to deliver nuclear weapons or not.

“We will regard the very fact that the Ukrainian armed forces have such systems as a threat from the West in the nuclear sphere.”  No specific country has been scheduled to deliver the F-16 jets as of this writing, however. (Quotes retrieved from The Moscow Times)

Medical supplies already in short supply and even rationed

In Connecticut’s largest hospital, Lori Lee, senior vice president of clinical operations at Yale New Haven Health “There are probably hundreds of outages of items that we order that do not come in,” She says the list of shortages includes basics such as IV tubing and catheters, which are used constantly in hospitals. Her story isn’t the only one. Across the nation, hospitals, clinics and pharmacies are reporting chronic shortages of drugs, supplies and even lifesaving equipment and parts to fix the machines.

The 10th annual Report for Drug Shortages for 2022 has listed drug supply shortages that dwarf pandemic era shortages. In the past year, FDA has seen manufacturers in the United States and abroad continue to experience quality issues as well as struggle with capacity constraints. Additionally, as demand increased for numerous drugs over the last several years as a result of the COVID-19 pandemic, as well as an earlier than typical flu and respiratory virus season, FDA has seen additional strain on the pharmaceutical supply chain.

Root Cause of Drug shortages

The 2019 Drug Shortages Report, Updated February 21, 2020 lists :

  1. Lack of Incentives to Produce Less Profitable Drugs,
  2. Market Does Not Recognize and Reward Manufacturers for Mature Quality Management Systems, and
  3. Logistical and Regulatory Challenges Make It Difficult for the Market to Recover After a Disruption. This is probably the single most pressing reason for the massive drug and medical supply shortage. Given the port delays and possible sanctions from China(where most of our drugs are manufactured) the report goes on to state:” Over the past two decades, the drug supply chain has become longer, more complex and fragmented as companies have located more production overseas. Although typical markets would respond to a shortage by increasing production, logistical and regulatory challenges, especially the complexity of the supply chain, can limit the ability of drug manufacturers to increase production. When companies wish to increase production, either by modifying an existing facility or building a new one, they may have to obtain approvals from many different national regulatory bodies, and/or find a new source of active pharmaceutical ingredients (APIs). If a new manufacturer wants to enter the U.S. market and start selling a drug that addresses a shortage, the manufacturer must first develop and file an application with FDA and await its approval.”

 

We haven’t seen anything yet, in the realm of drug and medical supply shortages. It is easy to let our guard down, especially when summer activities beckon us to the great outdoors. However, with everything ramping up at warp pace, please take the time to itemize and replenish your stock of medications, both prescription and over the counter, along with food, water, and shelter (heating for winter). Keep a positive attitude and don’t get paralyzed by all the news. Use it to motivate you into action. If you haven’t already, speak to your care provider about obtaining a year’s worth of prescription medications. If they are unable to, check out Jase Daily list of over 800 and counting medications and get that years supply -before everything shuts down-which may be sooner than we think.

- Brooke Lounsbury, RN

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.

Be Prepared for Life’s Unexpected Moments

Be Prepared for Life’s Unexpected Moments

3 Reasons EVERYONE should have emergency medications avaiable. It's all about access—access to medications and care when you need it most. And when things happen outside of your control that access can disappear.Below are 3 examples of how easily this access can be...

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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