Continuing from Part I –
It was good fortune that no one around Mayer, Ariz., called 911 to report a seizure during the three weeks this year that the local fire district had no drugs to treat the condition.[1]
Consider the possibilities –
Are they required to carry the medication?
Was there a bad outcome?
Clearly, the only way to predict the future is by multiple choice exam –
A. They did not give the medication and there was a bad outcome that might have been prevented, or minimized by giving the appropriate medication that is commonly given by EMS.
B. They gave the medication – the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. There is a maximum dose in the protocols that may not be exceeded.
C. They gave the medication and- the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. There is a maximum dose in the protocols that may only be exceeded with medical command permission, which was inexplicably denied.
D. They gave the medication – the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. They continued to give medication until they ran out, but they do not carry much, so the potency was not adequate to stop the seizures.
Or –
E. They gave the medication – the appropriate medication that is commonly given by EMS was effective – possibly because in spite of decreased potency, EMS continued to give medication until the medication was effective, so the potency was adequate to stop the seizures.
Why do we arbitrarily limit the amount of benzodiazepine that may be given for seizures, even though the side effects should be manageable by basic EMTs?
Why do we arbitrarily limit the amount of benzodiazepine that may be given for seizures, even though management of an overdose should be within the skills of basic EMTs?
This is the essence of the question –
Is giving an expired drug less safe than giving nothing?
Based on what?
Does anything change when we are treating an emergency that can cause permanent disability or death?
Assuming that the drug is the appropriate treatment, that there is no readily available substitute, and there is no sign of anything growing in the medication, is there any good reason to avoid using the expired drug(s)?[2]
If you answered yes, please stay out of EMS (or any other patient care setting).
What are we taught in EMS?
Exactly the opposite – until recently.
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What is an indication of bacterial growth?
Epinephrine is supposed to be clear, regardless of expiration date.
Some anti-seizure medication, such as the diazepam (Valium) pictured, is not supposed to be clear. This greenish/yellowish tint is normal for diazepam. If there is no greenish/yellowish tint to the diazepam, there is probably only water in the syringe.
Diazepam is supposed to be the color of diazepam regardless of expiration date. We are supposed to know this.
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Oregon health officials last week began allowing ambulances to carry expired drugs, and southern Nevada has extended the expiration dates for drugs in short supply. Arizona has stopped penalizing ambulance crews for running out of mandated medications.[1]
Is nothing better than something effective?
Is nothing better than something safe?
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In Arizona, nine EMS agencies or the hospitals where they’re based have told the state they can’t get all the drugs they need to meet the state’s minimum supply that ambulances are required to carry. Before the state relaxed the rules last November, ambulances risked being taken out of service.[1]
Is nothing better than something effective?
Is nothing better than something safe?
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To be continued in Part III and Part IV.
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Footnotes:
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[1] Paramedics turn to expired drugs due to shortages
boston.com
By Jonathan J. Cooper
Associated Press / July 12, 2012
Article
.
Who determines expiration date? FDA? Manufacture?
Is this based on science?
Go out of the US and you will find no attention being paid to expiration dates 6. 12 months passed.
Manufactures set the expiration date. What is this based on?
Some medications like epinephrine have know “changes” when exposed to heat and light. Given that few EMS agencies can maintain all drugs at the recommended temperature range – should we believe their is harm even within the expiration date?
Few can qualify for the Federal shelf-life extension program because we son’t maintain environmental records of our storage areas – nor can we afford to pay for the testing.
Why pay a lab $2,500 to test a $2 medication?
Sadly, EMS is late to this game of drug shortage. We have no effective lobby to put pressure on regulators or suppliers. We will ride the wave until the few who make these medications are back in production. We will be forced to adapt to what is available – opening ourselves to new concentrations and packaging that will likely lead to patient safety issues – harm and potentially death.
A sad chapter in our history.
Joseph Zalkin
Raleigh, NC
The expiration date is a date selected by the manufacturer for which they will no longer guarantee the efficacy of that medication. They are required by law to include an expiration date on the label, but the date is arbitrary and determined by the manufacturer.
The only testing done that I can find was conducted by the FDA at the request of the military. It determined that 90% of 100 various (prescription and OTC) medications tested were not only safe, but just as potent up to 15 years beyond the expiration date. The obvious exceptions to this are light sensitive meds, liquid antibiotics, and those with known stability issues like epinephrine and insulin. This is also assuming that the original packaging was intact. You obviously wouldn’t want to use a bottle of eye drops that was opened a year ago. Keeping meds in a climate controlled environment is also a part of this equation. The part that we in EMS probably fail the most often.
I do remote work these days and it is not uncommon for us to use expired medications on a regular basis. One of my favorite war stories is that of using expired fentanyl and versed for a conscious sedation in order to debride burn victim. The meds were 2 years beyond expiration. I calculated the normal dosages based on weight, then simply titrated to effect. It worked beautifully with only a slight increase in the total amount given.
Wouldn’t the safety be determined based on the drug? I know that some antibiotics can become toxic past their expiration date. Some drugs become more potent. Some become less potent. For many there is no perceptible change. Shouldn’t a more appropriate answer be “it depends, based on the particulars of the drug and storage conditions”, rather than an unconditional “yes”. If a drug does become toxic past the expiration date, it may well be that giving an expired drug is worse than nothing.
Where does this idea of toxicity come from? Someone please name me the antibiotic that becomes toxic. Bueller? Bueller? Bueller?
The only research performed on this topic was conducted by the FDA at the request of the US military around 1985. Smaller scale replications on some newer meds have been conducted (around ’97, ’00, & ’03, I believe) and all came to the same conclusion: 90% all medications are usable and safe 15 years beyond the printed expiration date. Look it up for yourselves.
I can’t speak to the accuracy of this information, but according to Wikipedia:
Expired Doxycycline may cause Fanconi Syndrome
It’s possible that this information is wrong. But even so, that doesn’t mean that other drugs can’t become toxic after some point. Personally, I think there should be a mechanism in-place to allow for FDA testing/approval for prolonged expiration dates on a lot of the stuff which is rarely used. Heck, I’d like to have a bottle of Ibuprofen that I manage to use before it expires.
Garrett,
Doycycline is a tetracycline. This is from the paper cited by Wikipedia. I do not have access to the book that is also cited. I skimmed through my Goodman and Gilman’s, but did not see anything on this.
http://www.inchem.org/documents/ehc/ehc/ehc119.htm#SubSectionNumber:5.1.3
That paper is dated 1991. It is referring to a problem that was considered ancient in 1991. As pointed out in the article I linked to, and as pointed out by others in the comments, this does not appear to be a current problem. there do not appear to have been any similar incidents since then.
Half a century ago.
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The FDA does not worry about whether your drugs expire before you consume them. The FDA does worry about whether the drugs lose potency before the expiration date.
Suppose that you buy 100 ibuprofen at $5 – $10 and take it home. Where you store the medication probably has more to do with the potency of the medication than anything else. Many people seem to store medication in bathrooms, where it is intermittently humid. That is not recommended.
My container of ibuprofen expired in 2007 and is still close to full. I do not get many headaches. I am a carrier.
I consider the medication not being used to be a sign of health. I consider insurance not being used to also be a sign of health.
Both are reassuring to have, in case there is a need. Rarely having a need for use, or not having a need for use, is much better than using them.
.
This my post from Part I of this topic….
“Some medications become toxic with age (antibiotics), so the choice to use expired medications adds a level of complexity to use.”
Patently false. Antibiotics do not become toxic. There was a concern dating back to the early ’60s that expired tetracycline could possibly cause kidney damage, but that was never confirmed. The particular formulation of tetracycline in question is no longer manufactured.
Rogue is correct that any medication’s life span and potency are influenced more by proper storage than anything else. The FDA recommends keeping meds tightly sealed in their original container and in the refrigerator. Common sense rules also apply (see the bit about eye drops), but in general the expiration date printed on labels means very little.