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

- Rogue Medic

Protecting Systemic Incompetence – Part I

Thu, 28 Feb 2019 15:01:12 -0500 by

We demand the lowest standards, because we are willfully ignorant and we do not want to understand. The surprise is that so many of us survive our devotion to incompetence. The loudest voices tend to dominate the discussions and the loudest voices demand that their excuses for incompetence be accepted. The rest of us don’t oppose incompetence enough.

A nurse was told to give 2 mg Versed (the most common brand of midazolam in the US) for sedation for a scan, intended to give 1 mg Versed, but actually gave an unknown quantity of vecuronium (Norcuron is the most common brand in the US). The patient was observed to be unresponsive and pulseless by the techs in the scan. A code was called. The family learned the details from a newspaper article, not from the hospital.

A Tennessee nurse charged with reckless homicide after a medication error killed a patient pleaded not guilty on Wednesday in a Nashville courtroom packed with other nurses who came in scrubs to show their support.[1]

The nurse intended to give a medication that should be limited to patients who are monitored (ECG and waveform capnography), because different patients will respond in different ways. This is basic drug administration and deviation from that basic competence may even have been common in this Neuro ICU (Neurological Intensive Care Unit). We demand low standards, because we do not want to understand.

We don’t need to monitor for that, because that almost never happens.

Except these easily preventable errors do happen. And we lie about it. We help to cover it up, because we demand low standards, regardless of how many patients have to suffer for the benefit of our incompetence.

This is a common argument used by doctors, nurses, paramedics, . . . . It makes no sense, but we keep demonstrating that we don’t care.

The people in charge should act responsibly, but they delegate responsibility and we reward them.

Back to the hospital, Vanderbilt University Medical Center (VUMC) is a university medical center, so the standards should be high. VUMC was founded in 1874 and is ranked as one of the best hospitals in America.

There is a drug dispensing machine, from which less-than-skilled nurses can obtain almost anything and administer almost anything, without understanding enough to recognize the problem. This is an administrative problem. This was designed by someone with no understanding of risk management.

The over-ride of the selection is not the problem, because emergencies happen and it is sometimes necessary to bypass normal procedures during an emergency. Ambulances are equipped with lights, sirens, and permission to violate certain traffic rules for this reason.

Some of the many blatant problems are:

* The failure of the nurse to have any understanding of the medication supposed to be given

* The failure of the nurse to recognize that the drug being given was not the drug ordered.

* The failure of the nurse to monitor the patient being given a drug for sedation.

* Most of all, the failure of the hospital – the nurses, the doctors, the administrators, to try to make sure that at least these minimum standards are in place.

* How often do nurses in the Neuro ICU give midazolam?

* Why is a nurse, who is clearly not familiar with midazolam, giving midazolam to any patient?

* How is a nurse, working unsupervised in a Neuro ICU not familiar with midazolam?

* What kind of qualifications are required for a nurse to give sedation without supervision?

* Since this nurse was orienting another nurse, what qualifies this nurse to orient anyone?

* Given the side effects of midazolam, why was midazolam ordered without monitoring?

* Given the side effects of midazolam, was it the most appropriate sedative for use in a setting where monitoring is going to be difficult?

* Was it the more rapid onset of sedation, in order to free up the PET scan more quickly and/or avoid having to reschedule the scan, that led to the choice of midazolam?

* How well do any of the doctors understand the pharmacology of midazolam if they are giving orders for a nurse to grab a dose, take it down to the scan, give the drug, and return to the unit, abandoning the monitoring of the patient to the techs in the PET scan?

* This is not a criticism of the techs in PET scan, but are techs authorized to manage sedated patients?

* Even though they will often scan sedated patients, are the techs required to demonstrate any competence at managing sedated patients?
The nurses being oriented apparently thought that it is customary to give sedation:

1. without even looking at the name of the medication

2. without confirming by looking at the name again, it before administration

3. without double checking with a nurse, or tech, that the label matches the name of the drug to be given
How many of the doctors, responsible for the care of ICU patients, would agree to be sedated, without being monitored, and to have their care handed off to PET scan technicians?

Why didn’t the doctors and nurses see this as a problem before it made the news?

If the problems were reported, nothing appears to have been done to address the problems beyond the usual – Nothing to see here. Move along. or That’s above your pay grade.

That is the primary point I am trying to make.

The problem is well above the pay grade of the nurse.
Here is the part that experienced nurses have jumped on immediately:

Why did the nurse think that midazolam needs to be reconstituted?

Vecuronium (most common brand name is Norcuron) is a non-depolarizing neuromuscular-blocker, which comes as a powder, that needs to be reconstituted.

Image source
1. Read label instructions?

This nurse has repeatedly demonstrated a need to be supervised, but those responsible for that supervision have apparently ignored their responsibilities in a way that far exceeds any failures by this nurse.

Is it possible that this is a one time event and that the nurse has behaved in an exemplary manner at all times while around doctors and other nurses before this day? It is possible, but the number and severity of the failures on the part of the nurse strongly suggest a pattern of not understanding, not caring, or both. I suspect that any lack of caring is due to a lack of understanding, because I have not yet lost all hope in humanity.

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Footnotes:

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[1] Nurse charged in fatal drug-swap error pleads not guilty
By Travis Loller
February 20, 2019
Associated Press
Article

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Edited 3/24/2022 at 00:34 to correct spelling from less-than-killed to less-than-skilled and poweder top powder.

Filed Under: Appearances, Assessment, Ethics, Experience, Heresy, Legal Medicine, Malpractice, Midazolam, Mythology, Pharmacology, Risk Management, Rules of safe drug administration, Sedation, Waveform Capnography

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

Thu, 16 Aug 2012 15:30:38 -0400 by
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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]

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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 —

 

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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]

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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?
 

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Footnotes:

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[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.

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[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

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[3] HYDROMORPHONE HYDROCHLORIDE injection, solution
[Hospira, Inc.]
FDA label
DailyMed
Label

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

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

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[6] Appeal to nature
Wikipedia
Article

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[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

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Filed Under: FDA, Heresy, Opioid, Pharmacology, Risk Management, Rules of safe drug administration

What should be the rules for safe drug administration – Part III

Wed, 30 May 2012 13:45:45 -0400 by
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I mentioned and the right time in Part I and the right dose in Part II.

Karen Sugarpants commented that there are at least ten rights. This isn’t about a number, but about what is right for the patient. As long as we understand the pharmacology of what we are giving and we are reassessing our patients, we should do what is right for each of our patients.

We are taught 10 rights at my college:
Medication
Reason
Site
Dose
Route
Allergies
Frequency
Time
Patient
Documentation
Just thought you’d be interested. 🙂

What about the right frequency?

In How to Torture Patients, that is the problem. The long-lasting paralytic is being given with a sedative that is not even close to long-lasting.

And nothing is being given for pain.

CombatDoc commented –

Of 3% of patients given fentanyl that became hypertensive, could it be possible that they were under medicated?

Changes in vital signs should always encourage reassessment, especially when we are giving a variety of medications. An improvement in vital signs does not necessarily mean that the patient is getting better, or that we are doing a good job medicating the patient. We need to reassess to try to figure out what we are doing right, or what we are doing wrong that is coincidentally producing better looking numbers on the monitor.

If the patient is experiencing extreme stress, we should find out what is going on.

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I have said for years, since Vec and Roc have been added to ambulances with the RSI protocols, EMS needs a long acting sedative or dissociative that is safe to use with hypotension. Versed is good when hypotension is not an issue and Ativan with Fentanyl is adequate with hypotension but, Ketamine or Propofol is better.

Vec is vecuronium (Norcuron), Roc is rocuronium (Zemuron), Succs is succinylcholine (suxamethonium in Commonwealth countries, brand name Anectine) and RSI is Rapid Sequence Induction/Intubation.

There are many possible medication combinations that will work for the chemically paralyzed patient. If we have used RSI to intubate, we will assess (and continually reassess) placement of the tube. Why do so many of us not reassess what we are doing with medications?

Why should we give a drug that lasts a long time with a drug that wears off quickly?

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Part of the right frequency should be the right combination.

Another right. I think I took it to eleven. 😳

It is easy to remember the different duration of different drugs in an environment that is not stressful. When treating a patient who has just been emergently paralyzed and intubated as just the preparation for everything else, the environment can be stressful. Reassessing can remind us of things we have forgotten, but maybe we should avoid these reminders by being better prepared with combinations that go together. Similar onset. Similar duration of effect.

That is not even considering the very real problem of the patient’s pain. What are we giving for pain?

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We have Succs for the intubation and in all reality if we had the proper meds for long term sedation we would not need to use our Vec but, medical directors would rather give us half the tools for patient care than allow us to properly treat the patient. Makes no sense to me that I can use a long acting paralytic but, not a short or long acting sedative that is appropriate for patient condition.

Protocols have some big problems. One is that the people who write them often do not have to follow them. Often, the paramedics involved in writing protocols are members of the QA/QI/CYA committee and may have agenda that do not place patient care anywhere near the top of the list.

There are dramatic differences among protocols in different systems. Some use the protocol as a ceiling, above which no medic may rise, regardless of whether there is a dominus vobiscum from the online medical command permission physician. Protocols that discourage recognizing and treating this patient’s condition, rather than treating this patient as if all patients should be made to fit the protocol.

Kelly Grayson writes about this in his excellent Meditations on Being an EMS Cowboy, which is not just relevant to EMS.

At least, that’s the theory. All too often, the protocols are written in such a way that the strongest medic is forced to lower his level of care to that of the weakest paramedic. The protocols provide a ceiling of care, rather than a floor. So it occasionally becomes necessary to decide, in the best interests of the patient, when to deviate from said protocol.

Highlighting is mine. Unfortunately, we cannot use tools we do not have. We are always going to be limited to what is practical to put into a drug bag/box, but we should have drugs that play well together. Just because drugs are compatible in the same IV line, does not mean that they work well for the patient.

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Filed Under: Heresy, Ketamine, Pharmacology, RSI, Rules of safe drug administration

What should be the rules for safe drug administration – Part II

Mon, 02 Apr 2012 19:00:22 -0400 by
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Continuing from Part I (right time). It is also important to give the right dose.

What is the dose?

The amount of medication in the concentration used over the amount of time the drug is given.

Don’t be silly. We don’t need that kind of information. All we need to know is the amount of drug.

Even the most basic drug administration should include this information.

Do doctors give orders that leave out some of this information?

Of course they do, but bad handwriting is given much more likely to be given as the cause of confusion. We have been told to avoid using certain abbreviations, because they are easy to mistake for other abbreviations. This is only a part of the problem. The problem is that the orders that are given are often incomplete, not just abbreviated, but incomplete. Whatever doctors do badly, we tend to make even worse.

Give an amp of _________.

Is it ever appropriate to give a dose of anything as X cc of drug Z or as X ml of drug Z or as 1 amp of drug Z? (cc = Cubic Centimeters; ml or mL = MilliLiters)

Suppose the drug is morphine.

Give 1 cc of morphine.

What dose is being ordered?

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A bad excuse for knowing what dose is being ordered is to pretend that normally only carrying one concentration is important.

Does the doctor only deal with one concentration?

Does the doctor only deal with one EMS agency?

Has the doctor worked with other EMS agencies that might use different concentrations?

Are you sure? Does that apply to all of the doctors? Should this information be necessary to understand the doctor’s order?

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2 mg morphine in 1 ml saline.

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4 mg morphine in 1 ml saline.

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8 mg morphine in 1 ml saline.

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10 mg morphine in 1 ml saline.

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15 mg morphine in 1 ml saline.

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Give 1 cc of morphine.

What dose is being ordered?

Few patients are going to have negative responses to 15 mg of morphine. The side effects are exaggerated, especially in the presence of competent medical personnel. Of course, the requirement for medical command orders for doses of morphine only encourage medical directors to authorize incompetent paramedics, using the excuse that they have to call for anything dangerous. Too many medical directors do not understand that everything in the drug bag is dangerous. Morphine is actually one of the safest drugs we carry. Fentanyl is even more safe than morphine.

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We need to understand all of the components of the dose being given, including the rate. The rate is also not given in the order above.

Can we give morphine too quickly?

The problem with giving drugs quickly, that are supposed to be given slowly, is that the rate of administration has a big effect on the rate of occurrence of side effects. The faster we push morphine, the more likely we are to produce side effects.

Pushing a drug slowly into the IV line, or hep lock, then flushing it in is idiotic, but it is not rare.

We have been taught to give certain drugs slowly. We slowly give the drug to the tubing, then we quickly flush it into the patient, about as fast as if we were giving adenosine. We have convinced ourselves that what we are doing is smart patient care. Our intent is good, but so what?

We need to have a better understanding what we are doing when we are giving medications.

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Filed Under: Heresy, Pharmacology, Rules of safe drug administration

What should be the rules for safe drug administration – Part I

Fri, 03 Feb 2012 06:30:37 -0500 by
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There are the 5 Rights of drug administration, they are often cited as the defenders of the patients, but I do not think they are adequate. They can even cause harm.

The 5 Rights –

The Right Time.

This one is actually sometimes used to hurt patients. If we do interfacility transports and we have a patient who is in pain, or anxious, and we ask the doctor/nurse to give the patient some of the medication that they obviously have not received enough of – too often the response is, She’s not due for that yet.

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Image credit.

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Keeping to a schedule that requires harming the patient by refusing to treat the patient’s pain/anxiety is not good patient care. Pain and anxiety are both considered appropriate indications for medication. Undertreatment should result in malpractice law suits.

A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines. – Ralph Waldo Emerson.

Is this consistency foolish? When it harms the patient, it certainly is.

If a patient is hyperventilating due to severe pain, should we be worried about respiratory depression?

But the order says to give the pain medicine every 6 hours. We can’t give it too early.

Then call the doctor. If you are a doctor, call your attending. If you have to wake them up, then maybe they will learn to write appropriate orders for when they want to sleep. If the medication wears off before the next dose is due, then that is an important assessment finding that the doctor should be informed about.

Why is the medication not working?

Has the patient’s medical condition changed? We get excited when the patient’s oxygen saturation drops, but is a change in the patient’s level of pain (or anxiety) any less important? Maybe the patient has never been given enough pain medicine.

If you think pain is less important than SpO2 (Saturation of peripheral Oxygen – pulse oximetry reading), ask the patient what is more important. The patient’s priorities are not the same as our priorities, but we should be trying to come to some sort of agreement about priorities. The truth is that both pain and SpO2 are important. So is anxiety.

The Right Time does not mean when it is convenient to document giving the medication in order to go along to get along. That isn’t patient care.

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Some of you are thinking that I should just shut up and give the medication. As if patient care is not a responsibility of the hospital.

1. The patient is still the doctor’s patient until we leave.

2. Do the hospital staff really need to have EMS come in and do their work for them? The patient is supposed to be prepared for transport. Unless this is a sudden change, this is not prepared.

3. There is supposed to be a continuity of care, not abandonment of care. Would it be appropriate to transfer a patient within the hospital without treating the patient? I realize that this is done, but that does not make it right.

4. I may not have protocols that permit me to give the medication, but I will call medical command and ask for permission to give medication, if I need to. Also, I do not carry the doses that may be needed in treating patients with a tolerance to opioids. I do not have a pharmacy available to restock me. If I have other patients with severe pain, I may run out of opioids. I have before. I don’t even carry enough to treat a patient with severe burns.[1]

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What makes me thing that I know enough to question a doctor’s orders?

I am there, assessing the patient. Where is this omniscient doctor?

I am familiar with giving large doses of opioids, benzodiazepines, and combinations of opioids and benzodiazepines.

I am capable of assessing respiratory drive.

Oh, there is one other thing. I can ask the patient to talk to me, if there is any respiratory depression. Not that there is much chance of that with patients who have been deprived of care due to a foolish consistency to a schedule (Right Time is a schedule). This is not quantum physics.

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Footnotes:

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[1] Who Carries Enough to Manage Severe Pain from Burns?
Rogue Medic
Sat, 15 Jan 2011
Article

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Filed Under: Heresy, Mythology, Pharmacology, Rules of safe drug administration