Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

FDA Safety Alert Adenosine Prefilled Glass Syringes

The FDA (Food and Drug Administration) sent out a safety alert about malfunctions of adenosine pre-filled glass syringes when used with needleless IV (IntraVenous) tubing.

AUDIENCE: Critical Care Medicine, Emergency Medicine, Cardiology, Risk Manager[1]

I don’t think it is unreasonable to assume that they mean to include EMS, as well.

Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems.[1]

Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.[1]

This does not mean that we should replace all prefilled adenosine, but that we should have another method of giving adenosine if the prefilled syringe is not working.

FDA is interested in receiving information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needless IV access devices. FDA is especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been identified or implemented by users of these products.[1]

The U.S. Food and Drug Administration (FDA) is seeking your help in communicating an important safety message about pre-filled needleless glass syringes to people affiliated with your organization. We hope you will share this information to ensure they are aware of this issue and can take steps to remedy the problem.

The FDA has received reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. In some cases, the syringe may damage the IV tubing and/or the needleless connector and require reestablishment of intravenous access.[2]

This is much more of a problem with adenosine than with most other drugs, because we act in a somewhat civilized manner, when giving other drugs. Not with adenosine for SVT (SupraVentricular Tachycardia).

Adenosine is SLAMMED in.

The reason adenosine is given through a large bore IV as close to the central circulation, is that adenosine is metabolized very quickly.

How quickly adenosine is metabolized depends on the patient being treated. Anyone who tells us any specific time frame is exaggerating their understanding of adenosine. Does it matter if the half life is 10 seconds, 14 seconds, 30 seconds, or something else? It only matters for someone trying to come up with test questions.

How do they know what they are telling us? They read it somewhere. As with everything else about the human body, there is a range of normal and there are even plenty of abnormal presentations. One specific number is supposed to apply to all of them? Real life does not work that way.

Adenosine is metabolized very quickly, so we do want IV access in a vein that will not blow when we forcefully push the adenosine and immediately follow that with a 20 ml flush. The 20 ml syringe can contain 0.9% Saline, or D5W, or Lactated Ringers, any other IV solution that is handy, as long as there is no dose of medication in it. Draw this up before you begin to give the adenosine, otherwise it doesn’t do anything good for the patient.

I miss the old 2 needle in one port method, but with a needleless system, we need to either immediately switch syringes or have the flush syringe in another port. If those are not possible, clamp the IV line above the port we are using for the adenosine, put a blood pressure cuff around the IV bag, inflate it to over 200 mmHg, and release the clamp immediately after pushing the adenosine. This is not a great method, but it is much faster than the run the IV wide open method used by people who do not understand what they are doing.

The faster we SLAM the adenosine in, the more likely that 6 mg will be effective. The slower we push the adenosine in, the more likely that even 12 mg will not be effective.

And most important of all – don’t treat asystole that appears right after adenosine. Wait at least a minute. If we give epinephrine or atropine (not in the new asystole algorithm) expect the patient to regain a rhythm and pulse just the same way they would have if we had given a healthy dose of benign neglect, but now the tachycardia that we were treating may be a lethal rhythm.

How fast was the heart rate before the adenosine?

Adenosine almost always wears off in less than a minute. Then the rhythm breaks or the tachycardia returns.

Assume that the patient had a heart rate of over 200 beats per minute without epinephrine – how fast will the heart rate be after being hit with a dead person dose of epinephrine?

If we want to give atropine, we should first consider our initial treatment for SVT.

Vagal maneuvers.

The quickest way to break the rhythm is with a vagal maneuver. Atropine is an anti-vagal drug. The vagal nerve keeps the vital signs under control. We were using the vagal maneuvers and the adenosine because the vital signs were not under control. Now the vital signs are even less likely to be controlled any time soon.

Following adenosine with epinephrine or atropine is a clear case of a malignant intervention.

But the patient is in asystole!

Don’t worry. It will wear off.

Consider how adenosine is metabolized. All cells use adenosine to make energy. This is one drug that does not need to be circulated through the liver or kidneys to be metabolized. A dead patient with red blood cells that have not yet clotted, is still metabolizing the adenosine. If the blood in the patient’s veins has clotted, then epinephrine and atropine will not matter. This is the reason for pushing adenosine so quickly.

Treat the patient – not the monitor.

Given all of that – it is very important that the adenosine syringe function properly. The ones listed below might not.

Below is the information about the specific syringes from the FDA Safety Alert.[2]

Adenosine             Teva                               00703-8781-23
Adenosine             Sagent                           25021-0301-72
Adenosine             Baxter                           10019-0063-08(07)
Adenosine             Wockhardt                   64679-0630-01(02)
Amiodarone         Sagent/Gland             25021-0302-73

Adenosine Teva

1 0703-8781-23 10 SYRINGE In 1 TRAY contains a SYRINGE (0703-8781-21)
1 0703-8781-21 2 mL In 1 SYRINGE This package is contained within the TRAY (0703-8781-23)[3]

Adenosine Sagent

1 25021-301-72 10 CARTON In 1 BOX contains a CARTON
1 1 SYRINGE In 1 CARTON This package is contained within the BOX (25021-301-72) and contains a SYRINGE
1 2 mL In 1 SYRINGE This package is contained within a CARTON and a BOX (25021-301-72)[4]

Sagent also makes a 12 mg syringe, but that is not included in the lot numbers provided in the FDA Safety Alert.[1] No explanation is given. We should expect the same thing to happen with their 12 mg syringe. Not including the 12 mg syringe is probably a clerical error, not a sign that everyone needs 12 mg. Below is the information on the 12 mg syringe.

2 25021-301-76 10 CARTON In 1 BOX contains a CARTON
2 1 SYRINGE In 1 CARTON This package is contained within the BOX (25021-301-76) and contains a SYRINGE
2 4 mL In 1 SYRINGE This package is contained within a CARTON and a BOX (25021-301-76)[4]

Adenosine Baxter

1 10019-063-08 10 BOX In 1 PACKAGE contains a BOX (10019-063-07)
1 10019-063-07 1 SYRINGE In 1 BOX This package is contained within the PACKAGE (10019-063-08) and contains a SYRINGE, GLASS (10019-063-34)
1 10019-063-34 2 mL In 1 SYRINGE, GLASS This package is contained within a BOX (10019-063-07) and a PACKAGE (10019-063-08)[5]

Adenosine Wockhardt

1 55648-630-07 10 SYRINGE In 1 CARTON contains a SYRINGE, GLASS (55648-630-01)
1 55648-630-01 2 mL In 1 SYRINGE, GLASS This package is contained within the CARTON (55648-630-07)
2 55648-630-08 10 SYRINGE In 1 CARTON contains a SYRINGE, GLASS (55648-630-02)
2 55648-630-02 4 mL In 1 SYRINGE, GLASS This package is contained within the CARTON (55648-630-08)[6]


And –

Amiodarone Sagent

1 25021-302-73 10 SYRINGE In 1 CARTON contains a SYRINGE
1 3 mL In 1 SYRINGE This package is contained within the CARTON (25021-302-73)[7]

No picture

Footnotes:

[1] Needleless Pre-filled Glass Syringes: Stakeholder Advisory – Compatibility Problems with Needleless Intravenous Access Systems
Reports Received on Adenosine and Amiodarone Products
[Posted 11/17/2010]
FDA Safety Alert

[2] Letter to Stakeholders: Communication on certain needleless pre-filled glass syringes
Drug Safety and Availability
November 17, 2010
FDA
Letter

[3] ADENOSINE injection
[Teva Parenteral Medicines, Inc]
FDA Label
DailyMed
Label with link to PDF download of FDA Label

[4] ADENOSINE injection
[Sagent Pharmaceuticals, Inc]
FDA Label
DailyMed
Label with link to PDF download of FDA Label

[5] ADENOSINE injection, solution
[Baxter Healthcare Corporation]
FDA Label
DailyMed
Label with link to PDF download of FDA Label

[6] ADENOSINE injection
[WOCKHARDT LIMITED]
FDA Label
DailyMed
Label with link to PDF download of FDA Label

[7] AMIODARONE HYDROCHLORIDE injection, solution
[Sagent Pharmaceuticals]
FDA Label
DailyMed
Label with link to PDF download of FDA Label

.

Comments

  1. Interestingly enough BuyEMP notes that certain IV sets are not compatible with their prefilled syringes and caution buyers against that. I think it is the Leur-like CLAVE(tm) sets that cause the issue.

    Adenosine (Adenocard) Prefilled Syringe Description:
    Features:
    Per Federal Law, all of the items list on this webpage are prescription drugs and/or devices. Before your account can receive these items, we must have a completed Prescription Drug Authorization Form on file signed by your Medical Director. Orders from individuals will not be accepted.

    Specifications:

    NOTE: 301-72 AND 301-76 ARE NOT COMPATIBLE WITH ANY HOSPIRA or ICU MEDICAL SETS.

    From Adenosine (Adenocard) Prefilled Syringe.

    • Christopher,

      Interestingly enough BuyEMP notes that certain IV sets are not compatible with their prefilled syringes and caution buyers against that. I think it is the Leur-like CLAVE(tm) sets that cause the issue.

      I don’t know if the problem is with the syringe, the tubing, or the combination, but the FDA seems to have concluded that the problem is with these few syringes.

      Do we really need to have these in prefilled syringes, or can medics safely draw up a medication into a syringe and use that?

      How much of a delay is involved?

      From the EMP link you provided, the cost difference is –

      6 mg prefilled syringe – $36.95.
      6 mg vial – $27.85 + less than a dollar for an extra syringe.
      About $8 less for each dose.

      12 mg prefilled syringe – $74.95.
      12mg vial – $49.95 + less than a dollar for an extra syringe.
      About $24 less for each dose. Most ALS gear I have seen has two 12 mg doses for each one 6 mg dose.

      Multiply that difference by however many sets of ALS gear, the number of doses carried, and by the amount of restock carried and stored. That can be a significant amount of money for very little benefit. In the case of a malfunction, for a delay in treatment.

      Adenosine is part of the treatment of unstable tachycardia (below), but how much of a delay is involved?

      If the tachycardic patient is unstable with severe signs and symptoms related to a suspected arrhythmia (eg, acute altered mental status, ischemic chest discomfort, acute heart failure, hypotension, or other signs of shock), immediate cardioversion should be performed (with prior sedation in the conscious patient) (Class I, LOE B). In select cases of regular narrow-complex tachycardia with unstable signs or symptoms, a trial of adenosine before cardioversion is reasonable to consider (Class IIb, LOE C).

      Overview
      2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
      Part 8.3: Management of Symptomatic Bradycardia and Tachycardia
      Free Full Text Article from Circulation with links to Free Full Text PDF download

  2. I actually had a malfunction last night while attempting to connect the Adenosine to a needle-less port on my IV tubing for an SVT patient. As I twisted the syringe into the port, the threaded part of the Adenosine syringe actually separated from the rest of the syringe leaving the part containing the medicine and plunger in my hand. I was able to re-attach them, but it would leak under the pressure of pushing the drug. I ended up not using that syringe of the medicine.

    I subsequently twisted the next syringe into the port by holding the threaded hub of the Adenosine while twisting; not the glass containment body of the syringe.

    • Joffre,

      As I twisted the syringe into the port, the threaded part of the Adenosine syringe actually separated from the rest of the syringe leaving the part containing the medicine and plunger in my hand.

      That is the way I have always attached syringes, but I do not recall ever having this happen with any syringe.

      I subsequently twisted the next syringe into the port by holding the threaded hub of the Adenosine while twisting; not the glass containment body of the syringe.

      That seems like a good way to correct this problem.

      Unfortunately, we don’t know if this is only an occasional problem or something that is expected with each glass syringe. I expect that it is only an occasional problem. This means that while your solution seems like a great way to deal with this problem, you probably were using the solution on a syringe that was not going to cause a problem. Your solution seems as if it would work, but we really don’t have enough information to tell if this prevented the problem. On the other hand, the same thing may have happened, if you did not hold the threaded hub, while attaching the syringe.

      It does seem to be a good idea to hold onto the threaded hub, while attaching these grass prefilled syringes, at least until the problem is corrected.

      This is a nice example of thinking on the job and improvising a solution.

  3. I am a new medic and it happened to me on my first time using it. while on an intercept call with another town. made the connection but was unable to push it at all, assumed it was me and tried another one, ultrasite flushed well witrh a dsaline flush, the plunger pushed well as air was purged, the line was flowing perfectly, but the same thing happened again with the second syringe. I resorted to pulling the plunger and drawing up the med with a separate syringe and needle. This was a horrible way to get started.

    • FNG,

      You may think that was a horrible way to get started, but this is the way we learn if we have what it takes to be a medic. There will be other times when things do not go as planned. You have shown that you are capable of thinking while treating patients.

      You were faced with an obstacle to providing the treatment that you wanted to give. You used your ability to think to come up with an alternative. That did not work, so you came up with another alternative. That worked, but if it had not worked, you probably would have tried to come up with other alternatives.

      This is what is important in EMS. There is no possible way to include all possibilities in protocols. It is not easy to prepare people for these kinds of situations, but they do happen. The important thing is not to give up, unless there is a reason to reconsider whether the treatment is right for that patient. I have had that happen. I always want to be looking for reasons not to give a treatment, because if they are there and I don’t notice them until after giving the treatment, that may be very bad for the patient.

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