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Antibiotics

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    Posted: October 30 2019 at 4:32am
There has been lots of discussion about how to keep your antibiotics past the use-by-date.

I thought I would sum up:

Don't even try to store liquid antibiotics.    They go bad realy fast.

Protect the wrappers. Maybe even wrap them again and seal carefully.     Some antibiotics like Trimethoprim/sulfamethoxazole are profoundly stable - unless they get wet, AND THEY ARE DELEQUESCENT. Some react with oxygen in the atmosphere too.

Keep them cold, but not frozen.
     Some chemical bonds fracture if frozen. All biochemical processes go slower in the cold.

If they are very out of date, use two at once to cover for loss of some potency.
    Otherwise the bacteria might survive and learn from its experience how to avoid the drug in future.

Use the tetracyclines up first.     There is much controversy about tetracycline becoming poisonus after the expiry date. There is only one case of poisoning listed and this may be utterly appocryphal. So, the "tetracycline becomes toxic" statement may well be wrong, but don't take ANY chances you don't have to.

Keep them in the dark.    Ultraviolet light can break some chemical bonds.

And finally some new information: Penicillins may be underused as not everyone who beleieves themselves allergic actually is:

Think you're allergic to penicillin? You are probably wrong, study suggests

Date:
    October 29, 2019
Source:
    University of Georgia
Summary:
    More than 30 million people in the United States wrongly believe they are allergic to penicillin.
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FULL STORY

More than 30 million people in the United States wrongly believe they are allergic to penicillin -- resulting in millions of dollars in added health care costs, adverse side effects from the use of more powerful antibiotics and a risk in the rise of dangerous antibiotic resistant infections.

This misconception and public health threat could be corrected, said Christopher M. Bland, clinical associate professor at the University of Georgia College of Pharmacy, by asking those who say they are allergic to penicillin to answer a simple one-page questionnaire and, if necessary, take a penicillin allergy skin test, or PAST.

"In many instances we don't have to go past the questionnaire," Bland said. "We're finding out that what most of these patients think is an allergic reaction is really only a side effect that may have happened once and might never happen again. Patients tell us that they became dizzy or nauseated after taking penicillin years ago or that their father was allergic to penicillin, so they thought they were allergic as well."

Bland said penicillin often gets blamed when it may not be the culprit. Even those who may have once been allergic to penicillin are no longer allergic today, he said. After five years, studies show that half of the individuals who had an allergic reaction -- like hives, wheezing, shortness of breath or anaphylaxis -- to penicillin were no longer allergic. At 10 years, that number jumps to 80 percent, he said.

In research presented recently at IDWeek, the international infectious diseases meeting in Washington, D.C., Bland and colleagues demonstrated how many penicillin allergies were removed from patient records after patients were interviewed by UGA pharmacy students.

"We are able to reduce the number of those who think they have penicillin allergy by 20 percent right away, just by talking to them through our questionnaire," said Bland. "Our pharmacy students were able to debunk the allergy claim by many patients just by getting a detailed history."

While the Infectious Diseases Society of America has recommended that penicillin allergy assessment be promoted as a way to erase this label on medical records for those who are not allergic, most of the studies that have included PAST as a way to accomplish this have been done at academic medical centers by trained allergists.

Bland and Bruce Jones, an infectious diseases clinical pharmacy specialist at St. Joseph's/Candler Health System and adjunct UGA College of Pharmacy assistant professor in Savannah, said this isn't necessary and can be done in hospitals that do not have dedicated trained allergists on staff. They are working with more than 50 hospitals throughout the country, sharing best practices that will allow PAST to be performed and medical records updated.

In a grant-funded study, Bland and Jones found that PAST done on patients who believed that they were allergic to penicillin -- the most effective antibiotic available with the least side effects -- demonstrated no real allergy.

These research findings were published in Open Forum Infectious Diseases. The duo worked with nurses at Candler Hospital and found that skin testing can be done safely in a community hospital setting. When skin testing was performed at the hospital by trained nurses, 98 out of 100 patients in the study who had a penicillin allergy on their medical record were deemed not be allergic to the antibiotic.

This allowed for an immediate change to a penicillin type antibiotic for most patients, which is often safer and cheaper, improves outcomes and reduces adverse effects, the goal of the federal antimicrobial stewardship program requiring hospitals to ensure that antibiotics are used only when necessary.

In addition to the public health benefit, Bland estimated that health care savings would be in the tens of millions of dollars annually if patients could be switched back to penicillin from more costly antibiotic treatments. The study at Candler Hospital found an average cost savings of $350 a patient, which includes the cost of the skin test.

"Our team is on a mission right now," said Bland. "Our goal is that every penicillin allergy is questioned and reconciled, with most coming off medical records and allowing patients to get the best antibiotic for their particular infection, which is often a penicillin."

Story Source:

Materials provided by University of Georgia. Note: Content may be edited for style and length.
of Georgia. "Think you're allergic to penicillin? You are probably wrong, study suggests." ScienceDaily. ScienceDaily, 29 October 2019. <www.sciencedaily.com/releases/2019/10/191029140728.htm>.

Source:   https://www.sciencedaily.com/releases/2019/10/191029140728.htm
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This is a really interesting study for those who want to research further: https://zenodo.org/record/1229249#.Xbl1ftWnyM8

So is this onehttp://www.formatex.info/microbiology4/vol3/1721-1725.pdf although it is difficult to read, so here is the important bit at the end:   The most common pharmaceutical formulations for antibiotics are the tablets and hard gelatin capsules. The typical shelflife of these dosage forms is five years. In the most countries of the world it is required by the law that the expired medications have to be disposed following the respective regulations. Furthermore, it is common sense not to use the expired medications. The present study was intended as an academic investigation only and it was aimed to examine the in vitro dissolution performance of at least 10 years expired amoxicillin, ampicillin, or doxycycline tablets or hard gelatin capsules.

The dissolution tests were performed using the Apparatus 2 technique as described in the US Pharmacopoeia
(USP 35/ NF30) respective monographs. For the comparison, the non-expired antibiotics registered in European Union (EU) and available in the community pharmacies of Estonia were used. The respective USP tolerance limits for the dissolution tests were applied to qualify the formulations tested as “passed” or “failed”. Expectedly, all EU registered nonexpired formulations passed the USP test. But all tablets and hard gelatin capsules of the expired antibiotics passed the USP tests as well.

In conclusion, our results demonstrate that the shelf-life of antibiotics in the dosage forms of tablets or hard gelatin capsules is underestimated what concerns their in vitro dissolution performance. However, the authors in no way promote the use of expired medications, neither was it completely out of the study to give any hint on the therapeutic value of these expired medications.

AND THE BEST ONE OF ALL

http://thesurvivaldoctor.com/2015/08/05/expired-antibiotics/

What That Expiration Date Really Means

In the U.S., a medication’s expiration date is like the pharmaceutical company’s guarantee: they stand by the product until that day; after that, all bets are off. The med has been tested and proven to hold up that long—if the container is unopened and stored correctly.

“It would be very unusual for a drug to have an expiration date shorter than one year or greater than five years,” Craig K. Svensson, PharmD, PhD, dean of Purdue University’s College of Pharmacy, said via email. The reasons for the limits are complex, but it’s clear that especially for pills (as opposed to less-stable liquids), the date doesn’t always mean the drug won’t last longer. It’s often simply how long the medication has been tested for.

But here’s the twist: for prescription medicines, the manufacturer’s expiration date may not even be the one you see.

When a pharmacist dispenses a drug, they assign it a discard date, usually one year from the date of dispensing (unless the manufacturer’s expiration date is sooner than that). That’s because the prescription is only valid for 12 months, explains the National Community Pharmacists Association. If you bring that bottle back to the pharmacy for a refill and it’s over a year old, the pharmacist knows you need a new prescription.

Also, once the drug is removed from its original packaging and sent home with the patient, it’s exposed to damaging environmental effects, such as humidity and heat, so it won’t last as long as it would have in its original home.

    “By the time you get prescription pills, the expiration date is at its shortest and most prudent.”

Bottom line: by the time you get prescription pills, the expiration or “discard” date is at its shortest and most prudent.

But here’s where twist two comes in: in 1986, the U.S. government decided that all this prudence and limited testing weren’t cutting it—for itself anyway. So it set up its own study to determine what we all want to know: how long drugs actually last. It’s called the Shelf Life Extension Program. And it’s changed how many people thinks about medication longevity—maybe a little too much.
The Great, Big Longevity Study

Referred to as SLEP, the Shelf Life Extension Program has provided unprecedented information about medication longevity.

SLEP started in 1986 as a way to save the U.S. government money. The Department of Defense stockpiles medications in case of emergency. (Feds, they’re just like us!) The agency grew tired of spending millions of dollars replacing those meds once they expired. So it decided to see if the medications would last past their expiration dates.

SLEP was established in cooperation with the Food and Drug Administration. In the program, certain important stockpiled medications are kept well past manufacturer expiration dates and are periodically tested to make sure they’re still good.

The medications in SLEP are divided into lots. Each lot usually goes through two testing processes:

    Accelerated stability testing: A sampling from the lot is stored under bad conditions for 60 days: 122 degrees F and 75 percent humidity. The results indicate how long the drug would probably remain good if stored ideally. The lot is given a new expiration date based on this data.
    Room temperature testing: After the new expiration dates are assigned, the lot is stored under optimal conditions, and a sample is retested once or twice a year to make sure it’s still good.

The FDA says it errs on the side of caution when extending expiration dates. However long they think the med will last, they mark the date sooner than that. Currently, no drug gets an extension longer than 10 years past its original expiration date.

But 10 years is a lot longer than one. So the fact that some medications last this long is quite interesting, eh? Except … the thing is, in SLEP, medications are stored under absolutely ideal conditions. And there’s the rub for preppers.
How Real Is “Ideal”?

Though SLEP is often cited as proof your antibiotics will outlast your dog, what’s not often emphasized is the fact that most people don’t store their prescription medications ideally, like they’re stored in the study.
The best way to store antibiotics to make them last.

The bathroom medicine cabinet is one of the worst places to store antibiotics.

For one thing, at home, prescription meds are usually in a pharmacy-provided pill bottle, not factory sealed, noted Svensson. These bottles aren’t humidity proof, “which is one reason that it is generally recommended that they not be kept in a bathroom that has a shower,” he said. (You’ve probably heard similar advice: the bathroom medicine cabinet is one of the worst places to store meds.)

Also, sometimes medicines are left in cars or otherwise exposed to extreme temperatures. Life is just not as ideal as a cozy SLEP warehouse.

So before applying the SLEP findings to your stash, consider that in the program, the medications are stored in the original packaging and always exactly according to the manufacturer’s labeled instructions.
How to Store Antibiotics at Home

So first things first: let’s just get your antibiotics to last at least to the expiration date you’re given. To do that, store them in tight containers at room temperature (59 to 86 degrees F).

Even if the pills get really hot one time (for example, you leave them in the car on a hot summer day), that could be enough to render them unusable, Prabhavathi Fernandes, Ph.D., founder and president of Cempra Pharmaceuticals, said in an email interview. “Some of them could be partially or completely destroyed. Some could be fine.”

Storing the pills below room temperature, however, might not be a bad idea. “Refrigeration will prolong the life of most drugs. But each drug will behave differently,” said Fernandes, whose company is focused on developing antibacterials. “Once opened, one must be careful, as some of the tablets may absorb moisture. Freezing could prolong life, but some drugs may be unstable to a freeze-thaw cycle. Repeated freezing can cause a drug to break down.”

Some preppers wonder whether vacuum sealing could help. Fernandes thinks it might but in most cases isn’t necessary.

If you’re thinking about storing your pills in a container other than the one the pharmacy gave you, consider that the United States Pharmacopeial Convention, which sets quality standards for medications, even has standards for packaging material. For example, manufacturers must ensure plastic doesn’t leach into the drug or vice-versa.

    “Most liquid drugs must be refrigerated and have a short life. They should not be used past their expiry date.”

It should be noted that all of these storage instructions are about pills. Liquid antibiotics have their own concerns. “Most liquid drugs must be refrigerated and have a short life,” Fernandes said. “They should not be used past their expiry date. In addition to the drug, there are excipients added for flavoring, color, etc., that can also go bad.”

Essential Drugs: Practical Guidelines (2013), a guidebook for health care providers from Médecins Sans Frontières, or Doctors Without Borders, advises, “Freezing may be detrimental, particularly for solutions, leading to the precipitation of active ingredients or the shattering of ampoules.” (Doctors Without Borders is a humanitarian organization that provides medical care where it’s hard to access, such as in countries affected by conflict or natural disasters.)
What Happens When an Antibiotic Pill Goes Bad

So what’s the big deal if an antibiotic does go bad?

Well, there’s good news and bad news. The good news is toxicity usually isn’t a concern. “There are very few medications that actually break down into something that could specifically cause harm as the product ages,” said Svensson, the dean at Purdue’s College of Pharmacy. “An example would be [the antibiotic] tetracycline, whose degradation products can cause liver injury.”

The bad news is a decrease in potency is a concern—a big one. “The use of expired antibacterials does not cure an infection and also favours the emergence of resistant strains,” says Essential Drugs. In other words, you’ll still be sick—only now possibly with mutant bacteria. Even a just-from-the-factory version of that antibiotic probably won’t kill your newly resistant bugs.

You’ll also have contributed to antibiotic resistance outside yourself. If a family member catches your illness, they’ll have those antibiotic-resistance germs.
Can you tell whether an antibiotic is bad by smelling it?

Like bad meat, a weakened antibiotic doesn’t usually smell or look any different.

Just try a different antibiotic? They’re often not swappable. Most illnesses have one or more preferred antibiotics that work better for them.
Can You Tell Whether an Antibiotic Is Bad?

Sniffing meat left on the counter does not tell you whether it’s gone bad. The same goes for antibiotics.

“The stability of the antibiotic within a tablet or capsule cannot be judged by simply looking, smelling or tasting the tablet or capsule,” Svensson said. “The same is true for a liquid antibiotic. Occasionally, a suspension will physically look different as it ages, but the potency of the antibiotic will often be reduced prior to the time the physical appearance changes.”

However, if an antibiotic does have an altered appearance, that’s a warning sign, according to Essential Drugs. For example:

In time, certain drugs undergo a deterioration leading to the development of substances much more dangerous, thus an increase in toxicity. Tetracycline is the principal example: the pale, yellow powder becomes brownish and viscous, its use therefore being dangerous even if before the expiry date.

    “An increase in allergen strength has been observed in certain drugs such as penicillins and cephalosporins.”

An increase in allergen strength has been observed in certain drugs such as penicillins and cephalosporins [both antibiotics].

Suppositories, pessaries, creams and ointments that have been melted under heat should not be used. The active ingredient is no longer distributed in a homogenous manner.
How Long Specific Antibiotics Can Last

So now you’ve gotten all this bad news and a little good news, and the question remains: If you store them under ideal conditions—factory sealed and everything—how long can antibiotics last?

The answer, for most of them, is longer than their expiration date. How much longer varies quite a bit, from around one year to, in a few cases, more than 10.

A 2006 report published in the Journal of Pharmaceutical Sciences summarized SLEP’s findings from the previous 20 years. Below are the antibiotics included in the report.

You’ll notice that there’s quite a variation in extension times. Experts we spoke with cautioned that each antibiotic is different. If one lasts 10 years, that doesn’t mean they all will, by any stretch. If an antibiotic you’re curious about isn’t included in this list, you can’t make any assumptions. There’s even variability from lot to lot. One lot may last five years; another lot of the same medication may not.

One note: You may wonder what “powder” refers to in this list. That’s a powdered form of the drug, which pharmacists use to make injectable solutions.
                 Extension Time (Mos.)
Antibiotic      Dosage Form      No. Lots Tested      Mean      Range
Amoxicillin sodium      Tablets      21      23      22–23
Ampicillin      Capsules      5      49      22–64
Ampicillin sodium      Injection-solution      8      57      29–87
Cefazolin sodium      Powder      10      82      63–110
Ceftriaxone sodium      Powder      4      60      44­–69
Cefoperazone sodium      Powder      4      46      25–57
Cefoxitin sodium      Powder      10      24      24–55
Cephalexin      Capsules      6      57      28–135
Cephaprin sodium      Powder      13      74      50–114
Chloroquine HCl      Injection-solution      4      64      27–98
Ciprofloxacin      Suspension      7      32      25–40
Ciprofloxacin      Tablets      242      55      12–142
Clindamycin phosphate      Injection-solution      31      44      18–77
Doxycycline hyclate      Capsules      13      50      37–66
Doxycycline hyclate      Powder      31      27      14–52
Doxycycline hyclate      Tablets      169      27      15–91
Erythromycine lactobinate      Powder      4      60      38–83
Neomycin and polymyxin B sulfates and bacitracin zinc      Ophthalmic ointment      5      28      12–40
Penicillin G      Powder      15      49      22–95
Penicillin G benzathine      Suspension      4      70      61–84
Penicillin G procaine      Powder      7      70      67–72
Primaquine phosphate      Tablets      12      55      41–80
Spectinomycin HCl      Suspension      8      83      55–109
Sulfacetamide sodium      Ophthalmic ointment      4      39      35–44
Sulfadiazine silver      Cream      37      57      28–204
Sulfadozine and pyrimethamine      Tablets      8      67      34–93
Sulfisoxazole      Tablets      4      56      45–68
Tetracycline HCl      Capsules      11      50      17–133

A different SLEP paper, last updated in 2009 (click here to download the doc), got dosage-specific about a few drugs. These are the two antibiotics included:
Product      Length of Original Dating      Average Total Years Extended      Total Shelf Life Obtained
Doxycycline 100mg tablets      2 years      5 years      7 years
Ciprofloxacin 500mg tablets      3 years      10 years      13 years

Finally, in a study unrelated to SLEP from the Institute of Pharmacy at the University of Tartu in Estonia, researchers tested antibiotic tablets and capsules they found that were at least 10 years expired.

All of the antibiotics, which were manufactured in various countries, passed their test: they contained a level of active ingredients that was acceptable by U.S. Pharmacopeial Convention standards.

The medications had been stored at the department of pharmacy at the University of Tartu in a closed cupboard at room temperature (about 68 degrees). “Some of the packages of the plastic vials of the expired formulations were opened and closed again, but none of the tablets or capsules tested was during the storage years directly exposed to the environment,” the study says. “The formulations in blister packages were not opened.”

The study doesn’t appear to have been published in any peer-reviewed, English-language scientific journal. The antibiotics, tested during the second half of 2011, were as follows:
Antibiotic Type      Brand      Dosage Form      Expiration Date
Amoxicillin      Upsamox      Capsule, 500 mg      12/01
Amoxicillin      Upsamox      Capsule, 250 mg      7/01
Amoxicillin      Moxilen      Capsule, 250 mg      6/97
Ampicillin      Pentrexyl      Capsule, 500 mg      12/99
Ampicillin      Apo-Ampi      Capsule, 250 mg      12/00
Doxycycline      Apo-Doxy      Capsule, 100 mg      5/95
Doxycycline      Doxy-M-ratiopharm, 100 mg      Tablet      12/31/94
Doxycycline      Doxycyclinum, 100 mg      Capsule      2/1/99

The researchers caution that they “in no way promote the use of expired medications,” especially since this was a laboratory study, not one done in people to confirm whether the drugs in fact remained effective. But they also say, “neither was it completely out of the study to give any hint on the therapeutic value of these expired medications. Further studies are essential to verify the clinical efficacy of the expired antibiotics.”
What It All Means for You

After considering all this information, it’s clear that it’s most prudent to replace stored antibiotics before they expire. Taking expired antibiotics, especially if they haven’t been consistently stored optimally, poses risks that could be life threatening.

    “It is evident that a drug does not become unfit for consumption the day after its expiry date.”

But what if you’re in a survival situation already and all you can get are expired antibiotics? This becomes a judgment call. You can hope your body is able to fight off the illness without antibiotics or that the disease is actually viral (in which case antibiotics wouldn’t work anyway), or you can chance taking the drug. Either way, there are potential risks.

“It is evident that a drug does not become unfit for consumption the day after its expiry date,” Essential Drugs acknowledges. For medications in general, if they’ve been stored optimally and “modification of aspects or solubility have not been detected,” Essential Drugs advises:

t is often preferable to use the expired drug than to leave a gravely ill patient without treatment.

Expiry dates for drugs that require very precise dosage should be strictly respected due to a risk of under-dosage. This is the case for cardiotonic and antiepilectic drugs, and for drugs that risk becoming toxic, such as cyclines.

Often for survival scenarios, there are no easy, black-and-white answers, even for highly trained health care providers. The best plan, as with many things, is excellent preparation.

If you choose to store antibiotics, store them constantly as directed, and replace them before you have to worry about the expiration date. That way, if you do get into a survival situation, you’ll know you have a little wiggle room to work with.



Leigh Ann Hubbard has been a health journalist for over a decade. She’s the editor of TheSurvivalDoctor.com and the owner of Revolutionary Writing Consultants, a writing agency specializing in health.

Don’t miss part 1 of this series: Do fish antibiotics work in humans?

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