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

.

Elderly Emergency Department Patients With Pain Are Less Likely to Receive Pain Medication

At Emergency Physicians Monthly is a listing of the top 10 Practice Changing Abstracts from the most recent Society for Academic Emergency Medicine’s Annual Meeting. The last one is the one that most got my attention. Go read all of them, they are abstracts, so not much time is needed, but here is that abstract that I want to address –

***
Elderly Emergency Department Patients With Pain Are Less Likely to Receive Pain Medication: Results From a National Survey 1999–2008
Platts-Mills et al [Abstract #395]

What were they looking for?
To determine whether elderly patients presenting with pain were less likely than younger patients to receive any analgesic medication or an opioid.

Emergency physicians probably dread the results of these studies about as much as paramedics dread the results of intubation studies. The good news is rare, but the results are important to look at for one very big reason.

No matter how much we deny that there is a problem, the problem does not go away.

The problem does get better, but the problem does not go away.

Methods
Cross-sectional national survey data on ED visits over 10 years (1999–2008) collected by National Hospital Ambulatory Medical Care Survey.
Results
Patients age 75 or older with a pain-related visit were less likely to receive any analgesic (49%, 95% CI 48%-50%) than patients 18–44 (66%, 95% CI 65%-66%), 45–64 (63%, 95% CI 63%-64%), or 65–74 (55%, 95% CI 53%-56%). The same pattern of oligo-analgesia was seen for opioid medication. No analgesic medication was given to 48% of patients 75 or older with moderate pain vs. 32% of patients 18–44 and 30% of patients 75 or older with severe pain vs. 23% of patients 18–44.

This is not even limited to opioids. There are big differences when the choice is any medication.

Any analgesic – ASA (aspirin), APAP (acetaminophen), ibuprofen, celecoxib, et cetera. They do not specify what was included, but it is reasonable to include these medications in the category of any analgesic.

20 years ago, these figures might have been inverted. Rather than 70% of those over 74 years old receiving opioids for severe pain, we might be looking at 70% not receiving opioids for severe pain.

If we look at a graph of this, we can present this in several different ways. The four different age groups with the total 0% to 100% range. There is nothing on the side to take some of the width out of the bars, therefore the differences appear shorter.

Change the information included in the graph to just show from 40% to 70% and all of the totals are still included, but the differences appear to be greater, because the differences are a greater portion of what is displayed. The same results are displayed, but the bottom of the graph is 40% and the top of the graph is 70%.

The graph of the differences with opioid medication is similar. The data were only broken down into the 18 to 44 year old group and the over 74 year old group. Omitting the age groups in between can make the differences seem more dramatic.

The abstract presented the numbers for those who did not receive opioids, which is another way to magnify the differences, since most patients with moderate or severe pain did receive opioids. I converted all of the numbers to patients who did receive opioids, so that they would be consistent with the graphs for any analgesic.

We can also cut out some of the chart to further enhance these differences. The graph below only shows from 40% to 80%.

Why this could change your practice
Don’t forget to medicate elderly patients with analgesics and opioids when they are in pain. This is a nice study showing that elderly adults who present to the ED with pain are less likely to receive pain medication than younger patients, even after controlling for pain severity, sex, and race.

It would be nice to have all of the relevant data, but only the abstract has been printed, so far.

How many of the patients in these groups declined medication?

How many had contraindications, relative contraindications, absolute contraindications, imaginary contraindications?

How many of these patients had their pain resolved, or dramatically decreased, without the need for pain medication?

What were the differences in pain scores? What were the changes in pain scores?

The over 74 year old patients were less likely to receive any pain medicine and less likely to receive opioid pain medicine. But were the elderly patients, who did receive pain medicine, receiving as much relief from the pain medicine they did receive?

For example, for the 18 to 44 year old group with 7/10 pain, was their pain being reduced to 3/10 with opioid medication, while the over 74 year old group with the same 7/10 pain may only have their pain reduced to 5/10 with opioid medication?

What are the different end points used when treating patients over 74 years old as opposed to the end points used for patients between 18 and 44 years old?

There are many factors that might affect the differences in treatment, but this study appears to be just looking at the differences in the medications received according to age groups.

EMS-wise, I prefer to use fentanyl, because it will wear off much more quickly than morphine and I expect the pain management to be continued in the ED (Emergency Department).

This study suggests that my patients might be better off if I adjust my approach. My initial doses for elderly patients could be with morphine, which will last much longer, while some of the repeat doses should still be with fentanyl for the bumpy truck ride to the hospital. In this way, the fentanyl is wearing off en route, so that the patient should be safe without direct observation in the ED and the initial dose(s) of morphine will last much longer for those patients who might not receive further opioid medication in the ED.

Go read the rest of the Practice Changing Abstracts.

The graphs are created with NCES Create A Graph.

.

How Would You Handle This? Heroin Use

A bit of a scenario to see how people would handle some odd situations.

In this case, you are dispatched to a call for a sick person. You arrive and find a heroin addict, who has not used for a couple of days. He is not a happy camper. Between the time his friend called 911 and the time you arrive, he has obtained some heroin. Now all he wants is for you to go away. He will sign the refusal form.

He states that the sooner you go away, the sooner he can feel well again. Once he injects the heroin (substance sold as heroin) he just obtained, his symptoms should resolve.

The address does not appear to be unsafe. No police are available. It’s a Friday night in the Summer. Police dispatch suggests that they are available to deal with a shooting, but not to deal with shooting up. Essentially, you are on your own. How do you deal with this patient’s desire for refusal of care?

.

When Michael Jackson Is The Patient – A Call That Everyone Will Criticize

While there are probably people going to write about the coverage of this being like Elvis all over again, I am just interested in the EMS aspects of what happened.

The 911 call was simple, but it did raise one question for me. Was CPR being done on a bed?

CPR on a surface that absorbs some of the force of compressions, decreases the effect of the compressions. A hard surface that does not move is an important component of effective CPR.

There is a report that CPR had been in progress for an extended period of time and that lidocaine might have been used. No mention of epinephrine, not that either would have changed anything. These drugs, amiodarone as well, are nothing but plumage. ACLS has us focusing on things that are irrelevant.

Marc Eckstein, MD, MPH, FACEP, Medical Director of the Los Angeles Fire Department, told JEMS.com. “They found Mr. Jackson in full cardiac arrest with CPR in progress.”

“LAFD members immediately took over CPR and intiated both basic and advanced life support interventions,” Eckstein continued. “They aggressively attempted resuscitation on scene for approximately 30 minutes, and after consultation with on-line medical control at the UCLA base station, they continued resuscitative efforts during the short transport to the UCLA emergency department. There was no change in the patient’s status during his prehospital course.”[1]

What about Narcan (naloxone)? Since he is reported to have been receiving Demerol (meperidine) wouldn’t Narcan be a life saver?

I have written here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, and here on what naloxone does. Perhaps more specifically these are about what naloxone does not do and why naloxone is rarely the first choice of intervention for opioid overdose.

What naloxone does not do is make a difference when the patient is already receiving artificial ventilation, as is the case here. This would be one of the cases of cardiac arrest where ventilation is important. The focus on continuous compressions is not appropriate when it appears that the arrest is due to respiratory causes. Naloxone does not charm the heart beat into returning. Naloxone does not persuade the brain to function again.

This patient was dead. EMS wanted to pronounce him on scene, but the patient’s private physician insisted that futile resuscitation efforts be continued.

What do you mean futile?

The patient is reported to have been asystolic (my conclusion based on the description of lack of response and desire to pronounce on scene) and unresponsive to half an hour of full resuscitative attempts. I do not know the specifics, but Los Angeles protocols are likely to be very close to the ACLS guidelines. There is nothing about the circumstances that suggests any of the reversible cause of cardiac arrest.

What about OverDose?

It was already being treated by ventilating the patient.

But opioids also cause vasodilation!

And EMS has probably pushed enough epinephrine to make any patient, with a chance at resuscitation, hypertensive and hyperactive. Vasodilation is not a concern. The reason for the lack of blood pressure is the lack of a heart rate, not histamine induced vasodilation.

Demerol toxicity can also lead to seizures, because of accumulation of a toxic metabolite in the body.

This is true, but seizures would have been an improvement at this point. Cadavers do not have to worry about toxicity.

Then why did they work on him for so long at the hospital?

Famous people with lots of money may pursue ridiculous law suits much longer than other people. When a lawyer, who works on a percentage basis, sees no reason to continue, the lawyer will find a way to drop the case. When the client is paying out of pocket, pockets that contain hundreds of millions of dollars, and the client does not care how much it costs, and the client has unreasonable expectations, things will be done differently. The patient’s personal physician was probably part of the reason. I have never heard of any case of resuscitation being continued even half as long as this, except in the case of intermittent return of pulses or a potentially reversible cause of cardiac arrest (such as hypothermia).

On scene, the patient’s doctor is one person, who generally outranks EMS. The same would be true for a hospitalized patient being transferred. As long as the patient’s doctor is present, the patient’s doctor has final say on medical decisions. That may be different in different states. Generally, a doctor needs to get permission from OLMC (On Line Medical Command) to take over treatment decisions from EMS. Part of that is agreeing to accompany the patient to the hospital. The patient’s private physician is probably not covered by this. In a VIP case, like this, I would expect the physician to want to accompany the patient. I doubt that OLMC would want to tell the private physician to let EMS run things, unless the private physician is causing problems other than demanding that care be continued. That is one thing OLMC is unlikely to fight about with the doctor who is there and is the patient’s doctor.

What about the pictures that were published? How could EMS let that happen? That is a HIPAA violation!

The primary responsibility of EMS is to take care of the patient. Privacy comes second. With a team of private security on scene, I would be delegating all privacy management to the people who are paid around the clock to protect his privacy. They also have a responsibility above privacy – his safety. They have already done all they are going to be able to do to address his safety, so privacy may be their primary remaining job.

It is unfortunate that there is a picture of the resuscitation efforts. As with Jett Travolta, the fame, or money, or both, or something else, caused someone to decide that this was a good time to get a picture to share with the gossip rags. Others have republished the picture, because it is already out there.

The blame should be addressed primarily at the people who took the picture, sold the picture, bought the picture, and first distributed the picture. Much less important is blaming those in security, or EMS, who might have prevented this. This kind of picture gets out because there is a huge market for it. The publisher will make a killing in both sales volume and reputation. The purchasers may not be the majority of the population, but there are enough to make this very profitable. We have met the enemy . . . . My doesn’t that reflection make us look unattractive.

So, blame EMS?

No. I don’t even have real criticism for security. They are probably not used to dealing with a death. Not like that.

Blame EMS for not reversing an opioid overdose?

He was already dead. Not much chance of a good outcome when an opioid overdose leads to cardiac arrest. He had probably been receiving inadequate CPR, so what is there to work with in a situation that deteriorates rapidly over just a few minutes.

What about the Demerol?

I will have to write a follow up on the use of Demerol. There is a lot to write.

Again, STATter 911 is the source that seems most current on EMS aspects of this case.

Footnotes:

^ 1 Michael Jackson EMS Response Details Emerge
Posted by Firefighter Nation WebChief on June 26, 2009 at 3:14pm in Fire/Rescue News
View Discussions
citing JEMS.com
Article

.

You just don’t understand my chronic pain!

Nurse K at Crass-Pollination (in her sidebar, read the definition) writes Saturday morning CRAYZEE!!!!!!!!!!!!!! about a response to an old post of hers What do you do when you start to feel like a drug dealer at work?

First, Nurse K works in the ED (Emergency Department).

Let’s think about that. Chronic pain is something that is long term, so it should not generally result in a trip to the ED. Emergencies are the kind of injuries or illnesses that lead to acute pain. There should be a method, for the patient with chronic pain, to deal with break-through pain. The method should not be to go to the ED. The method should not be to procrastinate on refilling a prescription, until the weekend, so that your doctor is not available. This is manipulative and self-destructive.

The problem patients Nurse K describes are patients who are abusing the system. Legitimate chronic pain patients should be just as upset with these patients as Nurse K is.

The abusers of the system only make it more difficult for those with legitimate chronic pain to receive appropriate pain management.

Legitimate chronic pain patients should hate these people who make a mockery of genuine chronic pain. Those who put on an act to receive their pain medications.

How we deal with pain tells a lot about who we are.

I’ve had patients with extremely bad injuries. Injuries so bad that I feel very uncomfortable not giving them something for pain.

When the patient says, “I’ve had worse,” and I doubt that I have; or “I’ll wait until I really need something,” and I’m hoping that will be sometime before the surgeon starts cutting; or “I used to abuse drugs and nothing is worth living like that again;” or is lying in bed with a heart rate of 150, pale and sweaty, but discouraging large enough doses to make a significant dent in the level of pain; with that perspective, we are able to see the range of response to pain.

What is 10/10 pain?

For most people, burns seem to be the worst kind of pain. Imagine a red hot frying pan.

Now, reach out and touch the tip of your finger to the frying pan for half a second. What would happen if this were done for real? You have a burn. It hurts. Few people would repeat that experiment any time soon.

Now, imagine having your hand being held against the red hot frying pan, the entire palm of your hand, it doesn’t matter which one.

Think about that pain for a while.

If you have any kind of imagination, and you do not have a psychological illness that isolates you from this kind of empathy, then this should make you uncomfortable, at least.

The pain scale is not from This Is Spinal Tap. It does not go to 11.

Work on a burn unit. These patients have experienced this kind of pain, but now are experiencing severe chronic pain similar to the acute pain they experienced with the initial burn. This is not the only kind of acute or chronic pain worth treating. That is not what I am stating.

I am trying to give an idea of what debilitating pain is.

Fibromyalgia is a way to give a name to a much lower level of pain. If it has a name and a diagnosis, well then the drug companies can sell you a treatment for it. Pregabalin (Lyrica) an anti-seizure, neuropathic pain medication is approved for treatment of fibromyalgia. Here is an interesting view of the effect of pregabalin.

In a study of recreational users (N=15) of sedative/hypnotic drugs, including
alcohol, LYRICA (450mg, single dose) received subjective ratings of “good drug
effect,” “high” and “liking” to a degree that was similar to diazepam (30mg,
single dose).

Pregabalin does not have any studies that show addiction to it. It is interesting that recreational users of drugs would rate it as similar to benzodiazepines (part of the class of drugs these drug users desired). Pregabalin, the only drug approved for the treatment of fibromyalgia, is not an opioid (a natural or synthetic derivative of the opium poppy, related to morphine). The idea of using opioids to treat fibromyalgia is not one the FDA appears to be endorsing.

I am very liberal with pain medicine (when OLMC allows it) and I do not take pain lightly.

Encouraging people to lie there, and to give in to the pain, is just the wrong approach. The more you give in to the pain, the more pain medicine you need, the more you become dependent on pain medication, the less you are able to take care of yourself, the more you become a victim of your own response to the pain.

You become your own victim – not a victim of the chronic pain.

This is tragic. The epitome of tragedy, Hamlet, said –

there is nothing
either good or bad, but thinking makes it so: to me
it is a prison.


O God, I could be bounded in a nut shell and count
myself a king of infinite space, were it not that I
have bad dreams.


That last line confuses many people, not having the ability to understand Hamlet’s “bad dreams,” but it would never work if he were to say, were it not that I have fibromyalgia.”

Hamlet’s dead father would come to him in his dreams and tell him that he was murdered by Hamlet’s uncle, who is now also Hamlet’s step father and the new King. Very unhappy times for Hamlet and this is just the beginning!

Hamlet may have been the prince of despair, the Shakespearean character most likely to whine, but fibromyalgia would never have worked for him.

Maybe it was King Lear with his prove to me that you love me, or Othello with his willingness to let Iago convince him that his wife was fooling around, but Shakespeare knew how to write tragedy. All of these responses to adversity prove to be tragic. And fatal. And whiny.

Was Nurse K being inappropriate?

Not at all. Chronic pain patients would be better off listening to her, than those who say just lie there and suffer, but do it dramatically.

.

The Joy of Naloxone (Narcan)

Naloxone is an opioid antagonist – it reverses the effects of drugs that are derived from opium – heroin; morphine; fentanyl; the hydrocodone in Vicodin, but does nothing for the acetaminophen (Tylenol); . . . .

We are called for a possible HOD (Heroin OD), we arrive and find a Deborah Peel with pin point pupils, scarred veins with some evidence of recent injections, respirations are less than ten; skin is pale, cool, and dry, . . . .

RM – “How are you doing?”

DP – does not respond.

RM – after applying some painful stimulus, “How are you doing?”

DP – imitates Fred Flintstone cursing, but with worse breath.

RM – might as well start with an easy one “What’s your name?”

DP – “Deborah Peel.”

RM – “It is an honor. Where are you?”

DP – “In my office looking down on all my subjects.”

RM – “That must be some good stuff. What day is it?”

DP – “I forget.” First Monday of the month is not a happy time.

And so it goes with no unusual findings.

Protocols insist that suspected HOD patients receive 2.0 mg naloxone IV.

This patient appears to be protecting his airway and breathing adequately, possibly requiring occasional moderate stimulus to keep up his side of the conversation.

Naloxone would not be in the patient’s best interest – tends to bring on withdrawal, pulmonary edema, hypertension, anxiety, and violence.

Violence is not in my best interest, nor is any deterioration of the patient’s condition.

Time to call OLMC (On Line Medical Command) and request permission to not be complicit in the doctor’s violation of his Hippocratic Oath.

Dr. DP – “Hello, this is Deborah Peel Memorial Hospital, Dr. Peel speaking.”

RM – “Hello, this is RM,” and I proceed to give a colorful description of DP to Dr. DP. Then – “I am requesting permission to withhold naloxone, since this patient does not appear to need it.”

Dr. DP – “Follow your protocol. Give the 2 mg naloxone and transport.”

RM – “We’ll see you in five to ten minutes.”

Well, we were already transporting – no reason to delay on scene with this patient (collected all his belongings and off we went).

I need to set up an IV and am not in a rush – think Reverend Jim getting his license. And I manage to complete the IV and blood draw as we are arriving at the ED. Not wanting to disobey orders, I bring the syringe of naloxone in with me and am getting ready to push it when I see Dr. DP. I point out that things did not happen as quickly as the doctor would have liked and confirm that Dr. DP wants 2 mg naloxone given IV, now.

There is a bed and the nurse directs us to put Deborah Peel in that bed.

Dr. DP – “What is it with you? Just follow orders.”

RM – “OK, but as soon as the drug is in, we are out the door. The patient’s information is all here, with the blood samples, and you have a full report.

Now, I have to point out that this is unfair to the nurses, who will end up doing the majority of the work of dealing with Deborah Peel’s possible withdrawal symptoms and possible violence, but it is tempting to get the nurses to leave the room, call Dr. DP over, give the naloxone, leave, and let the naloxone go to work – it is fast – with nobody to assist the doctor.

I believe that people can learn from their mistakes, some just need things spelled out a bit more clearly than others, but I am an optimist. 🙂

So, we really do not leave.

We stick around to assist with this performance art, but we insist that Dr. DP come and play. As EMS providers, we are cross-trained as rodeo clowns, so we are able deal to with the inner psychiatrist that Deborah Peel is sharing – name calling, kicking, spitting, attempted biting, . . . .

Just what the doctor ordered.

But why would a doctor do this?

Why does this happen regularly, even when the Deborah Peel is not in town?

This is bad for patients.

This is bad for EMS.

And, since it is bad patient care, it is probably also bad for the doctor – legally, ethically, medically, . . . .

You do this one time and word tends to get around. Some see the teaching point, some see a reckless and irresponsible manipulation of orders.

So it goes.

.

Public Perception of Pain Management

From the movie Juno comes this interesting line about pain management:

Doctors are sadists who like to play God and watch lesser people scream.

This received one of the biggest laughs of the movie. One thing about comedy is that there needs to be some truth for it to be funny – stretched to the extreme, maybe, but some truth to it.

Why do so many people believe this about doctors?

Is there any evidence to support this apparently widespread belief?

There are medical command physicians who seem to approach prehospital pain management from the Nancy Reagan perspective – Just say No!

Why?

Is there any evidence that opioids or sedatives are dangerous in the hands of trained medics?

A study in Prehospital Emergency Care (the journal of the National Association of EMS Physicians, National Association of State EMS Officials, National Association of EMS Educators, and National Association of EMTs) strongly suggested that opioids, at least, are safely used by appropriately trained medics.

Pridemark paramedics have administered IV fentanyl under standing order protocols since November 2001. The Pridemark pain management program is very aggressive and field crews receive regular continuing education related to pain management and procedural sedation. The pain management protocol states that an initial dose of 1-2 µg/kg fentanyl can be administered for pain with repeat doses at 1 µg/kg, titrated as needed. The protocol does not limit dosing intervals or maximum total dosing and the contraindications for administration include known hypersensitivity, hypotension, respiratory depression, and myasthenia gravis. The only standing order limitation during the study period was that fentanyl administration for abdominal pain required base contact.[1]

Absolutely no requirement to contact OLMC (On Line Medical Command), except for permission to treat abdominal pain.

That seems very risky!

How can medics possibly make reasonable decisions about the proper amount of medication to use?

Fentanyl is a very powerful drug. In some emergency departments the emergency physicians are not permitted to use fentanyl, since the anesthesia department has convinced the directors of the hospital that it is only safe in the hands of anesthesiologists. Certainly, there is no bias possible in that determination.

If fentanyl is not safe when used by attending emergency physicians, how can it possibly be safe in the hands of lowly paramedics?

How can simple paramedics safely administer this powerful drug on almost unlimited standing orders?

I wish that I worked as a lawyer in that crazy system – or as a mortician!

Well, let’s skip down to the results and find out the death toll.

Wait – we need to find out more about the patients first.

There were 2,315 patients who received IV fentanyl in the field; 186 patients were excluded because they received other medications such as other narcotics, sedatives, or nitrates (see Methods), thus leaving 2,129 patients who received IV fentanyl alone.

The average total fentanyl administration was 118 µg (standard deviation [SD] = 67), with a range of 5400 µg. Similarly, for the subgroup of patients who had their ED charts reviewed, the average total fentanyl administration was 118 µg (SD = 67),
The average dose was 118 micrograms?[1]

Are they trying to tell us that paramedics are starting with small doses, reassessing patients, and giving further doses only when necessary?

That just reeks of responsibility.

I don’t believe it.

Bring on the dead bodies, the malpractice, the horror!

Of the 2,315 patients who received fentanyl in the field, 66 patients had a vital sign abnormality. Of those 66 patients, three were excluded because they received a sedative in addition to the fentanyl. There were 46 patients who were excluded because their vital sign abnormalities occurred before the administration of fentanyl.[1]

66 vital sign abnormalities! Almost 3%. That sounds like something to worry about.

Of the 46 patients who had a vital sign abnormality before the administration of fentanyl, 38 patients’ vital signs improved after the administration of fentanyl, eight patients’ vital signs remained the same, and none worsened.[1]

I guess we can’t really blame the fentanyl for the problems if they happened before the fentanyl, but almost all of them improved after the fentanyl – and none of them got worse.

The medicine helped the patient, that is an interesting concept.

Bring on the less than 1% of problems left.

There have to be some serious problems and a few cadavers in there!

The retrospective chart review of 2,129 patients who were administered fentanyl citrate in the field for pain management revealed that only six patients (0.3%) had a field vital sign abnormality possibly attributed to the narcotic administration. No patients required a reversal or recovery intervention during transport.[1]

No problems outside of the hospital?

Just wait, in the hospital they will have problems!

Of the subgroup of 611 patients who had their ED charts reviewed,[1]

They only reviewed 611 ED charts out of 2,129 field administrations that were reviewed.

They must have been trying to cover something up!

Review of all 2,129 ED charts, instead of only the charts of those patients transported to a single facility, might have revealed more patients with complications. However, the sample subgroup was necessary because 2,129 patients were transported to 19 different hospitals and would have required IRB and HIPAA clearance from 19 individual facilities.[1]

Gosh, that makes sense, out of 19 hospitals they chose one that received 29% of the patients.

A nice busy hospital. They won’t put up with any of this EMS mayhem.

Let’s go back and see the carnage that must have overwhelmed the hospital!

Of the subgroup of 611 patients who had their ED charts reviewed, only seven patients (1.1%) had a vital sign abnormality that could be attributed to the field narcotic administration. The higher rate of vital sign abnormalities in the ED (1.1%) compared with the field rate (0.3%) was anticipated given the short transport times compared with the drug’s duration of action. Only one patient (0.2%) required a reversal intervention in the ED.[1]

Now we are getting some place! A victim!

That patient was an 81-year-old woman with a possible hip fracture who received two doses of 100 µg of fentanyl and developed respiratory depression, which prompted the administration of 0.4 mg of naloxone with an immediate reversal of the adverse effect.[1]

Well, maybe somebody died later – or had other serious complications!

No patient required admission for any complications of pain management, and there were no deaths. These findings demonstrate that fentanyl administration in the field is a safe method for pain management.[1]

But what about the scare tactics that are regularly employed to discourage us from using pain medicines?

Hah! I know what they missed.

They used so little that it didn’t cause any problems, but it also didn’t provide any benefit to the patients.

Where’s the benefit?

The pre-and post-pain-management verbal rating scale scores for all patients who received fentanyl were also evaluated. These data showed evidence of a statistically significant change in verbal rating scale scores after pain management. Clinically, this illustrates an improvement in pain from a categorization of severe to mild and thus supports the effectiveness of fentanyl administration.[1]

From severe pain to mild pain.

What more could you ask for?

Now that we have looked at the results it looks as if they behaved responsibly.

I would even say that they make a good case that it could be copied elsewhere.

Perhaps everywhere.

Why pretend that this study is too small to provide meaningful data; or that the methods were so limited that the results are irrelevant; or that this means it is OK, but only with tight OLMC requirements?

What this really tells us is that not only is there no good reason to limit standing orders (maybe for abdominal pain, which required OLMC in this study), but that there is a significant difference that can be made in patient care.

Why do we have medics treating patients with unsupportable limitations on what they can do without OLMC permission?

If the medics are not capable of providing this level of care, why does the medical director allow such dangerous medics to treat patients?

Why are we denying appropriate care to patients?

Why are we providing less-than-adequate care to patients?

There is no good reason.

Footnote:

[1] Safety and effectiveness of fentanyl administration for prehospital pain management.
Kanowitz A, Dunn TM, Kanowitz EM, Dunn WW, Vanbuskirk K.
Prehosp Emerg Care. 2006 Jan-Mar;10(1):1-7.
PMID: 16418084 [PubMed – indexed for MEDLINE]

I also write about pain maqnagement here:

Pain Management – What is too much?

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OLMC (On Line Medical Command) Requirements Delenda Est

Carthago delenda est.

The secret to appropriate drug dosing is titration. Should a medic who cannot be trusted to titrate opioids, sedatives, and other drugs be trusted to provide ALS care?

“Wait. To the OLMC Batphone, Robin. My Batcompetence will grow 3 sizes on the phone, just as the Grinch’s heart did on Christmas Day.”

Curiously, as the Batmedic completes this OLMC order, his competence disappears like Brigadoon, until he is on the Batphone with OLMC, again – maybe still with the same patient.

When someone is talking on the phone while driving a car, we consider this a dangerous distraction, yet when the same interruption is made in the assessment and treatment of a patient the interruption is expected to have the opposite effect.

Perhaps we should hang up and drive.

Perhaps we should hang up and assess the patient.

Perhaps we should hang up and treat the patient.

Some people learn and develop their abilities. Why is EMS designed to prevent medics from using that improvement in ability to help the patient?

You learn what you do. If you do not learn from this repetition, you are defective and need to be replaced with someone not prone to continually repeating the same mistakes.

The change from OLMC requirements to standing orders has been progressing, like the frog climbing out of the well in the notorious math problem. A little bit of progress, then some recidivism, followed by many repetitions. The progress does exceed the backsliding, but not by a lot.

Medics used to have to call OLMC to get permission to start IVs, then medical directors realized that medics could be taught to make these decisions and we had some early standing orders.

Medics used to have to call OLMC to get permission to give any drug, e.g. “push one amp of the silver box.” Then medics were introduced to pharmacology. After a while, medical directors realized that medics could be taught to make some of these decisions and standing orders were expanded.

There is no demon in opioids or benzodiazepines and these will eventually be administered almost universally on standing orders; administered in doses that would make some of the physicians today blush; administered with few limitations on the conditions to be treated. This is just a predictable continuation of what is already happening. Some choose not to see it.

There will always be places that do not go along, but overwhelmingly the move will be toward more medic autonomy. Not complete autonomy, but changing the physician oversight from the mysticism of OLMC requirements to genuine oversight. Playing whisper-down-the-line with an OLMC physician is oversight in name only. It’s result is an arbitrary denial of care to some patients, a denial of appropriate care to other patients, and permission for only some patients to receive appropriate care. Probably not exactly what Hippocrates had in mind.

There are already places that have the aggressive standing orders that I describe.

It may take ten or twenty years for the rest of the country to catch up.

What is different about those places?

Are the medics with aggressive standing orders killing a greater percentage of their patients than those with OLMC requirements?

More and more medics are becoming doctors and they understand that much can be done for the patient before the patient arrives at the hospital. They understand that making the patient wait until the patient arrives at the hospital may not be consistent with good patient care. Changes in protocols probably do not require any change in the medic scope of practice. This will require a change in the amount and type of standing orders and will require a change to a method of physician oversight that really works.

As increasing numbers of medics become doctors there will be more of a realization that little, if anything, that a medic does is improved by abbreviating the patient assessment and abbreviating the patient treatment to give a hasty report of this interrupted assessment to the OLMC physician.

EMS education needs to be improved significantly, but much of this can be done through remediation. Those who cannot be remediated can be demoted, terminated, or transferred to systems that just don’t get it. Or they could work for the sanitation department – it seems to pay better, has lower quality standards, yet is more important for public health.

The systems that have a bunch of medics showing up on every call will have much winnowing to do. Maintaining skills under those circumstances is impractical. We have been acting as if quantity solves everything. Increasing the quantity of medics makes maintaining the same quality much more difficult. OLMC requirements do not change that.

If the medical directors do not take the lead in directing change in EMS the politicians will. If you want to see that future, just look for the city with the highest concentration of politicians and see if it’s EMS system sets a good example.

The politicians are focused on mainly response times.

If you believe that EMS is primarily a public safety business, then response times may be critically important to you.

If you believe that EMS is primarily a medical business, then taking a little bit longer to get good care to the patient may be critically important to you.

The more we understand about EMS the more we realize that rapid response times are not anywhere near as important as good patient care. Faster response times and scoop and run medical care are not the way to maintain the quality of care or to improve the quality of care.

EMS is presented with many problems.

On Monday, Peter Canning wrote a post about the problems in EMS. Men’s Health: Does EMS Need to Call 911? His comments give you a perspective on many of the problems EMS faces that I do not intend to address.

My other posts on OLMC requirements and Medic X are:

OLMC for President!

OLMC = The Used Car Dealers of EMS?

OLMC For Good Medics

Fun with explosives – NTG.