Naloxone and Pharmacist Liability

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.

bmanzo

New Member
5+ Year Member
Joined
Jan 10, 2017
Messages
5
Reaction score
1
Hello all,

I am currently on a pharmacy law rotation with a firm and going to meet with some community executives regarding the various state naloxone laws (standing order, etc.).
I was posed a question, which I am told was from the client, about what protection may be available for community pharmacists' in the event of an emergency-type situation.
There is documented immunity for prescribers, dispensers, and lay administrators (Good Samaritan) in most states, but the concern is whether or not a pharmacist would be protected as an 'administrator' (not a dispenser) in the emergency event that a patient presented to the pharmacy due to opioid overdose?

I have done quite a bit of research via The Network for Public Health Law (attached file to this thread) and have found some online resources:
http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone

I guess what I am asking for is opinions on whether the decision to administer, as a pharmacist, is an ethical dilemma (such as administering an epi to a pt presenting w/anaphylaxis without an active prescription), or if anyone knows of any literature that details pharmacist liability in a situation such as this.

Any insight/help is appreciated.

Members don't see this ad.
 

Attachments

  • Public Health Law Naloxone Details.pdf
    1 MB · Views: 73
  • Like
Reactions: 1 user
Hello all,

I am currently on a pharmacy law rotation with a firm and going to meet with some community executives regarding the various state naloxone laws (standing order, etc.).
I was posed a question, which I am told was from the client, about what protection may be available for community pharmacists' in the event of an emergency-type situation.
There is documented immunity for prescribers, dispensers, and lay administrators (Good Samaritan) in most states, but the concern is whether or not a pharmacist would be protected as an 'administrator' (not a dispenser) in the emergency event that a patient presented to the pharmacy due to opioid overdose?

I have done quite a bit of research via The Network for Public Health Law (attached file to this thread) and have found some online resources:
http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone

I guess what I am asking for is opinions on whether the decision to administer, as a pharmacist, is an ethical dilemma (such as administering an epi to a pt presenting w/anaphylaxis without an active prescription), or if anyone knows of any literature that details pharmacist liability in a situation such as this.

Any insight/help is appreciated.
"Drug Administration" was added to most states' scope of pharmacist practice in order to allow for vaccination in pharmacies.

That being said, who are you asking if they are "protected" from? Criminal charges, civil liability, or Board of Pharmacy administrative punishments?
 
Hello all,

I am currently on a pharmacy law rotation with a firm and going to meet with some community executives regarding the various state naloxone laws (standing order, etc.).
I was posed a question, which I am told was from the client, about what protection may be available for community pharmacists' in the event of an emergency-type situation.
There is documented immunity for prescribers, dispensers, and lay administrators (Good Samaritan) in most states, but the concern is whether or not a pharmacist would be protected as an 'administrator' (not a dispenser) in the emergency event that a patient presented to the pharmacy due to opioid overdose?

I have done quite a bit of research via The Network for Public Health Law (attached file to this thread) and have found some online resources:
http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone

I guess what I am asking for is opinions on whether the decision to administer, as a pharmacist, is an ethical dilemma (such as administering an epi to a pt presenting w/anaphylaxis without an active prescription), or if anyone knows of any literature that details pharmacist liability in a situation such as this.

Any insight/help is appreciated.

I am unsure...and others more clinically-knowledged than I may correct me...what is the harm of giving someone naloxone? Isn't it just a pure antagonist. What kind of reaction would someone get besides the unusual case of hypersensitivity.
 
Members don't see this ad :)
I am unsure...and others more clinically-knowledged than I may correct me...what is the harm of giving someone naloxone? Isn't it just a pure antagonist. What kind of reaction would someone get besides the unusual case of hypersensitivity.
Google the lawsuit against CVS where someone claims they were permanently blinded by using an ear drop in their eye once. Just because harm is medically nearly impossible doesn't mean someone can't sue.
 
I think the biggest risk is that Evzio costs like $4k and somebody's gotta pay for it if you decide to be a Good Samaritan and run out in the street to administer it.


Sent from my iPhone using SDN mobile
 
  • Like
Reactions: 1 user
I think the biggest risk is that Evzio costs like $4k and somebody's gotta pay for it if you decide to be a Good Samaritan and run out in the street to administer it.
Sent from my iPhone using SDN mobile

4 k ????? That is crazy! I can't imagine very many Good Samaritan's would pony up that much money!
 
I think the biggest risk is that Evzio costs like $4k and somebody's gotta pay for it if you decide to be a Good Samaritan and run out in the street to administer it.


Sent from my iPhone using SDN mobile

We learned that the hard way in VA. Turns out that we get "reimbursed under EMTALA." For those of you that seem to be hopeful, that's a euphemism for you, the practitioner, pays for it. The way that EMTALA is written, the practitioner bears the expense for non-reimbursed care. Glad you volunteered!

VA is not subject to EMTALA, but I wouldn't be surprised if CVS, Walgreens, and the rest of the chains make a collectively rational decision to refuse to carry the product (kind of like how Walgreens used to not carry Plan B in certain districts due to avoiding political opposition). Is it really worth selling to those type of customers? No margin, no mission.
 
  • Like
Reactions: 1 user
"Drug Administration" was added to most states' scope of pharmacist practice in order to allow for vaccination in pharmacies.

That being said, who are you asking if they are "protected" from? Criminal charges, civil liability, or Board of Pharmacy administrative punishments?

Yes, civil, criminal, and disciplinary, but I have a survey document that goes over most state information in short hand for prescribers, dispensers, and lay administrators etc.

I think what I will be working on is a 50+ state survey of the different laws and regulations for the company, so I will make sure to look into the state specific dispensing-administration laws.

Google the lawsuit against CVS where someone claims they were permanently blinded by using an ear drop in their eye once. Just because harm is medically nearly impossible doesn't mean someone can't sue.

This was kind of the reasoning behind the search. With recent lawsuits such as the McDonald's "hot coffee," they just want to make sure they know where the pharmacy and pharmacists are protected because these days people will find a way to sue for anything.

Thank you for your feedback!
 
Last edited:
I think the biggest risk is that Evzio costs like $4k and somebody's gotta pay for it if you decide to be a Good Samaritan and run out in the street to administer it.


Sent from my iPhone using SDN mobile

I did see on Evzio's site that the auto injector can be obtained for $0 if they get a prescription from the doctor and have commercial insurance (says it will still be $0 if the commercial insurance does not cover it). So I guess for someone who it is really beneficial for such as family of an addict etc. there are ways of obtaining it.

There is also an option for those who do not currently have insurance to obtain it for $0 via Kaléo Cares, but as always they have certain requirements that need to be met.

My guess is this is something that will most often be obtained prior to an event, so I'm sure a prescription can be obtained.
 
With recent lawsuits such as the McDonald's "hot coffee," they just want to make sure they know where the pharmacy and pharmacists are protected because these days people will find a way to sue for anything.

If you act as negligent as McDonald's in that situation id hope you'd get sued and the bop goes after you
 
https://www.naloxonesaves.org/files/2016/05/Statewide-Standing-Order-Dated-6-20-2016-signed.pdf

This is the standing order for naloxone in NC. The final point listed as eligibility criteria, in my opinion, would cover a pharmacist as the person being dispensed to. There would have to be formal dispensing under the standing order. Now, if the pharmacist requested and purchased the filled rx and had it in his possession, why wouldn't he be covered like any other Good Samaritan? I'm not sure of this answer and doubt there is any case law surrounding it at this point... when you work within what would be considered reasonable and in the best interest of the patient, I'd have to hope that goodness would prevail.

Witnessing an overdose and pulling it off the the pharmacy shelf to administer prior to proper rx processing and dispensing to the entity that fits the eligible criteria - now I would think you are walking a fine line. Even if you save the guy's life you'll have some explaining to do.


Sent from my iPhone using SDN mobile
 
Top