According to many scientists and clinicians, antimicrobial resistance is one of the greatest threats to human health worldwide. However, without a clear understanding of the vital role of antimicrobials, and more specifically, antibiotics in modern life, a statement like ‘antimicrobial resistance is the greatest threat to human health worldwide’ may seem like hyperbole.
The discovery of antibiotics in the 1930s fundamentally transformed the way physicians care for patients. Treatment-focused approaches based on antibiotic use allowed physicians to save countless lives.
Since then, we have seen the top causes of mortality in humans change from things like kidney disease, gastrointestinal infections, and pneumonia to cancer and heart disease. More than eight decades later, the medical advances enabled by antibiotics are now threatened by rising antibiotic resistance. Without effective medications to treat infections, many fields of medicine will be hindered. Care of the critically ill, surgery, transplant medicine, neonatology, and the treatment of cancer patients, among others. Our ability to respond to national security threats like bioterrorism or pandemics will also be affected.
The causes of antimicrobial resistance are multifactorial and complicated. Chief among them is the lack of antibiotic stewardship. According to the Centers for Disease Control and Prevention (CDC), antibiotic stewardship is the effort to measure and improve how antibiotics are prescribed by clinicians and used by patients. Improving antibiotic prescribing and use is critical to effectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance.
The CDC lists four primary efforts to address antibiotic stewardship in an outpatient setting. They are: 1 – a means to measure antibiotic prescribing, 2 – improve antibiotic prescribing by clinicians and use by patients so that antibiotics are prescribed and used when needed, 3- minimize misdiagnoses or delayed diagnoses leading to underuse of antibiotics, and 4- ensure that the right drug, dose, and duration are selected when antibiotics are needed.
Over the last 10-20 years, the medical community and general public in developed nations worldwide have made considerable gains in the implementation of antibiotic stewardship. For example, there has been a concerted effort to increase awareness about the inappropriateness of prescribing and using antibiotics to treat viral infections. At JASE, we strive to continue this trend while empowering our patients to care for themselves when access to appropriate and timely medical treatment may not be available.
The effectiveness of antibiotics is a limited resource, and we must treat them as such. Nevertheless, they are crucial to our health and well-being, and we should respect them as powerful medications that save lives but can cause significant harm when misused.
Trying to find a silver lining to the cloud of the coronavirus pandemic can be challenging. However, one such silver lining is how the pandemic highlighted our fragile supply chain here in the United States, if not the world’s global supply chain. The world’s supply chain issues existed before the pandemic, and they have only grown worse since. There doesn’t seem to be an industry that isn’t affected in one way or another.
Before the pandemic, our health care industry was experiencing shortages regularly of basic medical supplies, including pharmaceuticals. The problem is now even more severe.
The FDA’s Center for Drug Evaluation and Research director said, “Historically, the production of medicines for the U.S. population has been domestically based. However, in recent decades, drug manufacturing has gradually moved out of the United States.” Now nearly 3/4ths of the active ingredients used in medicines sold in the United States are produced overseas. Today, the majority of pharmaceutical production takes place in China and India.
In an interview Senator Chris Coons, D-Del said, “If we have another global pandemic that leads to the world to close borders and leads global supply chains to shatter or to break down, we are distinctly vulnerable because we are now dependent upon globally integrated supply chains.”
Many will remember donning their mask and venturing out into the eerily quiet streets to visit an essential business such as the grocery store only to see bare shelves. We have lived through supply chain shortages caused by a global pandemic, but many other potential causes may disrupt our fragile supply chain. Other causes include local disasters in the countries or cities of pharmaceuticals factories or a terror attack on infrastructure anywhere along the supply chain.
At JASE Medical, we are on a mission to help our community prepare for the worst. We want to empower our neighbors to be self-sufficient and not have to rely on others when it comes to their well-being. We are starting that mission with emergency use antibiotics.
Over the years many lists have been published in an effort to rank the most “revolutionary inventions or discoveries in history”, or the “greatest breakthroughs of all time”. Invariably these lists include “penicillin” or “antibiotics”. In fact, a list published by The Atlantic in 2013 listed the discovery of penicillin in 1928 as number three in their article of “The 50 Greatest Breakthroughs Since the Wheel”.
The discovery of penicillin by Alexander Fleming in St. Mary’s Hospital, London ushered in the modern age of medicine. He is credited with the following quote, “One sometimes finds what one is not looking for. When I woke up just after dawn on Sept. 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer. But I guess that was exactly what I did.”
So why, exactly, was Fleming’s discovery so revolutionary? Prior to the beginning of the 20th century, bacterial infections accounted for the top causes of death in the world. The average life expectancy was just 47 years. Diseases like cholera, pneumonia, tuberculosis were rampant. The antibiotic era revolutionized the treatment of infectious diseases. The average life expectancy rose to 79 years. Antibiotics and other factors like improved sanitation, vaccinations, public health measures, and education are the reasons developed nations such as the United States have seen such a dramatic increase in overall life expectancy and quality of life.
With such impactful consequences to humankind it is easy to see how the discovery of penicillin warrants a top 3 placement in “The 50 Greatest Breakthroughs Since the Wheel”. We have grown so accustomed to the use of antibiotics that it is hard to imagine a world where once again infectious disease becomes a top killer. By preparing for the worst and hoping for the best, we at JASE Medical are on a mission to provide everyone the opportunity to ensure themselves and their families piece of mind should, one day, a world where antibiotics are in short supply or impossible to obtain becomes a reality.
When you receive your antibiotics you will see a ‘use by’ date printed on the prescription label. Most states require pharmacists to print a ‘use by’ date one year from the date the prescription was filled. Don’t confuse this ‘use by’ date with a true expiration date. This one-year date is how long until the PRESCRIPTION expires. The actual expiration of the medication is another matter. In the case of antibiotics, the subject has undergone extensive study.
Since 1979 in the United States all drug manufacturers are required to place an expiration date on their products. The expiration date printed by the manufacturer represents the date by which full potency and safety of the drug can be guaranteed. However, most drug companies don’t have the motivation to study their product for years and years to demonstrate how effective or safe the medication may be after 5, 10, 20, or more years.
Fortunately, there is an on-going and extensive study undertaken by the FDA on behalf of the United States Department of Defense. The so-called ‘Shelf Life Extension Program’ (SLEP) was commissioned to reduce medication costs for the military. The military maintains large stockpiles of supplies including medications and was having to rotate their stock regularly due to published expiration dates from the drug manufacturers. This constant need for stock rotation was expensive and efforts were made to study the potency and safety of medication beyond its printed expiration. The scientists in the SLEP study found that the vast majority of the drugs studied (88% representing 122 different drugs) maintained their potency and safety beyond the published expiration date by more than a year, with the average extension being 5.5 years, and a maximum extension of 23 years!
The most stable drugs are those in solid form such as tablets and capsules. Solutions or liquids lose their potency relatively quickly after their expiration dates.
An important caveat, certain medications have a narrow therapeutic index meaning that their safe and effective dose must be exact and kept within certain narrow parameters. Decreases or increases beyond these parameters can result in serious consequences. These types of drugs should not be used beyond their expiration date. An example of such drugs would be vancomycin and monoclonal antibodies.
The antibiotics included in the JASE Medical Emergency Antibiotic Kits are among those studied and shown to be safe and effective for at least 2 years beyond their published manufacturer expiration dates and in some cases for a lot longer. However, neither JASE Medical nor its partner pharmacies or drug manufacturers are included as participants of the FDA’s Shelf Life Extension Program and we therefore officially recommend and follow the manufacturer’s published expiration dates.
Check out these interesting and useful links from official sources:
FDA – Expiration Dating Extension
Journal of the American Medical Association (JAMA) – Drugs Past Their Expiration Date