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

- Rogue Medic

Voluntary Recall of HYDROmorphone (Dilaudid) – What does it mean?

Today the FDA (Food and Drug Administration) and Hospira announced a voluntary recall of generic Dilaudid (HYDROmorphone HCL – the capitalization is to avoid confusion[1]).

If the intent is safer drug administration, the focus is misdirected.

Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty recall of one lot of Hydromorphone Injection, USP, 2 mg/mL, (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30, due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume.[2]

How much was in that single syringe?

The FDA and Hospira have not yet released that information.

Is it 1.1 mL (2.2 mg, rather than 2.0 mg) in the 2.5 mL syringe, rather than 1 mL?

In that case, the extra medication is not a big difference. The difference in response among patients will have so more of an effect on the dose, that this would not be significant.

Is it 2.5 mL (5.0 mg, rather than 2.0 mg) in the 2.5 mL syringe, rather than 1 mL?

In that case, the extra medication might make a big difference. The difference in response among patients will still have more of an effect on the dose, but this would be worth knowing.

This is what the packaging should look like –


Images credit.[3]

This is what to look for to specifically identify the affected medication.

HYDROmorphone HCL

2 mg/mL

1 mL fill in 2.5 mL Carpuject

NDC 0409-1312-30

The expiration date is December 1, 2013. The expiration date is useful in this case, but not visible here. 😉

The way we should be giving this medication is to break the seal by holding the syringe by the glass with the cap end up, push down on the cap, then insert it in the Carpuject. Screw the plunger on to the stopper and expel all of the air, so that only the medication remains.
 


 

The volume of medication is supposed to be 1 mL, but the recall states that there is a report of one case of a syringe containing more than 1 mL of hydromorphone. While it is possible that this is due to dilution, it is much more likely that the concentration is unchanged and that there is more of the same concentration of hydromorphone in the syringe.

Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.[2]

That is not true. This is a corrected version of what the FDA wrote.

Opioid pain medications such as Hydromorphone MAY have life-threatening consequences if overdosed.

Perhaps they mean to suggest that there is no overdose, unless there are life-threatening consequences.

That does not appear to be a reasonable definition of overdose. An unintentionally large dose that causes permanent disability, but never threatens the life of the patient, should also be considered to be an overdose.

What about an unintentionally large dose that does not cause any harm? Is that not an overdose?

No harm, no foul?

I wouldn’t count on the QA/QI/CYA department taking that approach.

overdose (OD),
n an excessive use of a drug, resulting in adverse reactions ranging from mania or hysteria to coma or death.
Mosby’s Dental Dictionary, 2nd edition. © 2008 Elsevier, Inc. All rights reserved.
[4]

Does this require a recall, or does this require competence on the part of people administering the medications?

Is it appropriate for any medical professional to ever give a medication and not know the dose of the medication being given?[5]

This is the basis of naturopathy – the dose doesn’t really matter – it is more important that the treatment is all-natural. This is an over-simplification of naturopathy, but it is also the essence of naturopathy. Naturopathy depends on the ignorance of trusting in the naturalistic fallacy.[6]

The dose does matter.

A competent person administering the dose is important.

According to Paracelsus, the dose is more important than anything else.

All things are poison and nothing is without poison, only the dose permits something not to be poisonous. – Paracelsus.

Everything, no matter how natural, is poisonous.

Is hydromorphone dangerous?

No.

But it has a black box warning!

WARNING: RISK OF RESPIRATORY DEPRESSION AND ABUSE
Hydromorphone Hydrochloride Injection, USP, is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death. (5.1)
Hydromorphone can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone in situations where the healthcare professional is concerned about increased risk of misuse or abuse. (5.2)
[3]

None of that means that hydromorphone is dangerous in the hands of a competent person.

Here is some much more useful information than that black box warning. This is from the same label,[3] but it receives far less attention than that which must not be named the black box warning. Droperidol is almost never used, because it has a black box warning.

 

Opioid Analgesic Equivalents with Approximately Equianalgesic Potency*
Drug Substance IM or SC** Dose Oral Dose
Morphine Sulfate 10 mg 40 – 60 mg
Hydromorphone HCl 1.3 – 2 mg 6.5 – 7.5 mg
Oxymorphone HCl 1 – 1.1 mg 6.6 mg
Levorphanol tartrate 2 – 2.3 mg 4 mg
Meperidine HCl (pethidine HCl) 75 – 100 mg 300 – 400 mg
Methadone HCl 10 mg 10 – 20 mg
Nalbuphine HCl 12 mg
Butorphanol tartrate 1.5 – 2.5 mg

 

What else is good to know, when we are concerned about the strength, or dose, of what we are giving?

Conditions that affect the strength of the medication –

16.3 Storage
PROTECT FROM LIGHT
Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
[3]

Recommendations: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-873-0312 to arrange for the return of the product.[2]

 

Wouldn’t it be better to have a number to arrange for the return of personnel who do not know how to safely administer medication?
 

Footnotes:

[1] HYDROmorphone has the beginning capitalized to decrease the possibility of confusing hydromorphone with other medications that have similar names, such as these – OXYmorphone, hydroCODONE, DIhydroCODEINE, DIhydroMORPHINE, and DIACETYLDIhydroMORPHINE – the capitalization is of the differences. Morphine and morphone only differ in one letter, but morphine is a natural opium alkaloid and morphone appears to indicate only synthetic opium alkaloids.

[2] Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume
Food and Drug Administration
[Posted 08/16/2012]
Safety Information
Voluntary Recall

[3] HYDROMORPHONE HYDROCHLORIDE injection, solution
[Hospira, Inc.]

FDA label
DailyMed
Label

[4] overdose (OD)
The Free Medical Dictionary by Farlex
Definition

[5] What should be the rules for safe drug administration – Part II
Rogue Medic
Mon, 02 Apr 2012
Article

[6] Appeal to nature
Wikipedia
Article

[7] FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
FDA Safety Announcement
1-13-2011
FDA Safety Announcement

.

Comments

  1. Wouldn’t it be better to have a number to arrange for the return of personnel who do not know how to safely administer medication?

    But isn’t drug administration prehospital just one of three possible dosages?

    – All of it [the vial/syringe/ampule]
    – Half of it
    – Titrate to effect

    • Christopher,

      Wouldn’t it be better to have a number to arrange for the return of personnel who do not know how to safely administer medication?

      But isn’t drug administration prehospital just one of three possible dosages?

      – All of it [the vial/syringe/ampule]

      – Titrate to effect

      – Half of it

      – Titrate to effect

      Heretic!

      Burn him!

      All of nothing is the rule!

      Adjusting doses requires thought.

      Thinking could produce error.

      Error is not permitted.

      Do you prefer oak kindling, or the standard fresh pine kindling that will probably go out before a good fire can be sustained?

      .

      • Heard as a reply to a QA request to elaborate on the dosage “1 amp D50W IV”:

        There is some other dose than the whole amp? I’m pretty sure you’re supposed to give it all.

        • Christopher,

          Heard as a reply to a QA request to elaborate on the dosage “1 amp D50W IV”:

          There is some other dose than the whole amp? I’m pretty sure you’re supposed to give it all.

          When I wrote about giving 10% dextrose, rather than 50%, that was one of the criticisms I received.

          But we have to give the whole amp! The protocol says to!

          If the protocol is for altered mental state, change in level of consciousness, or any variation of that, then it is actually a violation of the way most protocols are written to continue to give a protocol treatment, since the patient no longer meets the criteria for that protocol.

          I have found that even some doctors do not understand this. Apparently, if the protocol does not specifically state to stop shocking the patient, after the rhythm is no longer a shockable rhythm, then we are expected to keep shocking the patient.

          I am still surprised that EMS has progressed as much as it has in some places, but we continue to hire people who blindly follow protocols that are harmful to patients.

          .

  2. How long has this been a problem? My sister possibly died from a dose of Dilaudid in march.

    • Eric Andrist,

      How long has this been a problem? My sister possibly died from a dose of Dilaudid in march.

      There is a report of one syringe of hydromorphone having more than the appropriate amount of medication in it.

      So far, there is no information to suggest that this is a significant problem.

      The greater problem may be with people who do not understand how to give medication and reassess their patients, but this is just an excuse for me to write on that topic.

      Dilaudid (hydromorphone) is very safe. As with any drug, the safety depends on the people administering the drug. Drug safety does not depend on anything inherent in the medication.

      You have my condolences on the death of your sister.

      .

  3. So after cutting through all of the analysis, what is the bottom line reason for the recall? Is it a quality control issue with manufacture affecting the accuracy of the dosage, specifically with the concentration used? Is it a packaging issue? What I mean by that is whether or not there was some sort of problem with the way the drug was was loaded into each syringe. Understanding that while each drug company has a different system for mixing and packaging medications, unless the company is a specialized pharmacy that does custom compounding the work is all done with automated systems configured and programmed by human beings.

    From what you’ve said in this post, it appears that someone isn’t telling the whole story.

  4. In march of 2009, I was given an iv dose of dilaudid & within a half of an hour, my heart stopped.. it continued stopping & I underwent cpr several times b4 being life flighted 2 a larger hospital.. I had 2 get a pacemaker implanted.. they couldn’t give me an explanation as 2 y this happened, only that it may have been caused by the dilaudid.. is this possible??

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