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> This got me thinking that consumers are at fault as well. It's also partially the doctors. If a doctor writes a prescription as "EpiPen," then the pharmacis

> This got me thinking that consumers are at fault as well. It's also partially the doctors. If a doctor writes a prescription as "EpiPen," then the pharmacist has to provide a drug with the brand EpiPen. The doctor has to specify "EpiPen or generic equivalent" on the prescription in order for the pharmacist to be able to fill it with a generic. If doctors don't realize that EpiPen is a name brand -- and "EpiPen" is so ubiquitous as to be nearly genericized at the point -- then doctors may not realize the issue.

dev_dull 8y ago
It’s so ubiquitous in fact I’d say it should probably forfeit its protection as a trademark. Same as fax machine, cell phone, etc.
qeternity 8y ago
Doctors are well aware. But pharma reps treat them well and give them perks so that they don’t write generics. It’s a big kickback scheme.
mikeyouse 8y ago
This isn't typically true -- If a doctor writes a Rx for Lipitor, it'll almost never be filled with the Brand Name Lipitor. All insurance and most formularies expect that the generic will be provided. Doctors have to write "DAW" or "Dispense as Written" on the Rx for the patient to receive the brand name when a generic is available. AJM Confirming that all states have Generic Substitution laws to lower drug costs: https://www.amjmed.com/article/S0002-9343(10)01087-9/abstract https://www.amjmed.com/article/S0002-9343(10)01087-9/abstrac...
- delecti 8y ago
  Every prescription I've received in the last several years had two signature lines. If the doctor signs on one, it's "dispense as written", and if they sign the other it's "substitution permitted". So it's not like they have to do something special to get DAW.
  - mikeyouse 8y ago
    But how many of the prescriptions you received had the signature on the DAW line? It's typically very uncommon. In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given. I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.
    - delecti 8y ago
      None, but that's not the point. I was just saying that there's not an extra hurdle to prescribe DAW like you were implying.
- mjcl 8y ago
  But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.
  - chimeracoder 8y ago
    > But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber. Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.
    - maxerickson 8y ago
      Some of the ones pulled in 2007 or 2008 were generic versions of the EpiPen that existed at the time.
- MBCook 8y ago
  But you can only do that if the FDA has said the generic is a perfect substitute, which hasn’t happened on any previous substitutes. This device is the first one to get that label.
  - refurb 8y ago
    Correct, a drug has to be listed as "AB rated" in the FDA Orange book in order to be substituted automatically for the branded version.[1] AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements Andrenaclick is "BX rated".[2] BX Drug products for which the data are insufficient to determine therapeutic equivalence The new generic version from Teva is "AB rated".[3] [1]https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#tecode https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm0790... [2]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020800 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ... [3]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=090589 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ...
- dboreham 8y ago
  This is the whole point of the article btw : there have been "non-Mylan" EpiPen products on the market in the US for the past year (that are low cost) but they aren't magically associated with the SKU "EpiPen" in the Pharmacy -- you have request them by name. This news is about an alternative autoinjector being approved for that special "Pharmacist can substitute for the real thing regardless" status. Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.
- wutbrodo 8y ago
  As I understand, Epipens have a specific legal exception to this law. Epipen prescriptions are not valid for, say, adrenaclick injectors.
- InclinedPlane 8y ago
  A pill is just a pill, and the FDA accepts many generic drugs as substitutes for the name brand version. But an epipen is not just an epinephrine injector it is, itself, a medical device, and until now your prescription for an "epipen" wouldn't allow you to get a substitute device. Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.
lysp 8y ago
In Australia, the prescription is assumed to allow generics by default. Whenever you go to get your script filled, the pharmacist will ask "would you like a generic?" https://www.humanservices.gov.au/sites/default/files/images/pbs-prescription.png https://www.humanservices.gov.au/sites/default/files/images/... If you look at the above form box #10 - there is a box a doctor will tick if there is a specific reason not to substitute. In that case the pharmacist will not be able to give you a generic version. But that generally is an exception and not the norm.
andrepd 8y ago
That's ridiculous. In my country, it is the law that prescriptions are named by substance/generic name rather than a commercial name, and come with a text saying "You will spend no more than X if you buy a generic.". The pharmacist also must give you the cheapest generic unless you specifically request another.
alphabettsy 8y ago
This is not true. Doctors actually have to specifically state that substitution is not allowed; otherwise pharmacies will fill with generic.
Broken_Hippo 8y ago
I worked at a pharmacy in the US for 8 years. This is simply not quite true, and your telling of it paints a picture that is different from reality. Doctors have to specify when writing a prescription if an generic is acceptable or not. It is always a deliberate choice with each and every prescription. There is no "Just forgetting." Paper prescriptions, for example, have two different places for signatures. Most doctors know that insurances often require generics. There are good reasons not to substitute for some medications: Lithium (common for bipolar disorder), for example, sometimes absorbs differently between brands. Even with drugs that have no generics, most doctors will write a prescription saying that a generic is acceptable in case one has been approved without their knowledge. Doctors really only need to know when there are differences with generics vs brand names. Not only that, but if the doctor requests the brand name, most pharmacies will call the doctor to see if they can switch to a lower-cost generic if the patient requests it. This is done a lot, sometimes simply because the patient doesn't realize the medicacation costs when they are at the doctor's office - they often don't realize the costs until the pharmacy runs the prescription through their insurance. The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.
- KyeRussell 8y ago
  I know there's always at least one non-US resident that pipes into these threads with the same generic comments. But I can't help but be 'that guy' this time. > The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug. The U.S. private health insurance system is so weird.
  - Broken_Hippo 8y ago
    It is, though! I'm in Norway now, and trying to explain the US healthcare generally leaves folks a bit flabbergasted. I am quite happy that I'm no longer in the states - state-sponsored medicine is much simpler and less stressful to deal with. And to make it weirder: The formularies are generally based on agreements the insurer has made with the drug companies and/or pure cost of medicine if there was no deal to be made. I'd not mind some generally accepted standards in treatment based on patient outcome, so long as the patient doesn't have factors that change the standard treatment, but long-term outcome and cost over time doesn't seem to be the focus. This is likely due to many folks not keeping the same insurance long-term.
paulie_a 8y ago
I've had pharmacist question a prescription because it was a brand name. It was going to cost 250 dollars with insurance. She called the doctor and got the equivalent prescription and it cost 10.

dev_dull 8y ago

It’s so ubiquitous in fact I’d say it should probably forfeit its protection as a trademark. Same as fax machine, cell phone, etc.

qeternity 8y ago

Doctors are well aware. But pharma reps treat them well and give them perks so that they don’t write generics. It’s a big kickback scheme.

mikeyouse 8y ago

This isn't typically true -- If a doctor writes a Rx for Lipitor, it'll almost never be filled with the Brand Name Lipitor. All insurance and most formularies expect that the generic will be provided. Doctors have to write "DAW" or "Dispense as Written" on the Rx for the patient to receive the brand name when a generic is available. AJM Confirming that all states have Generic Substitution laws to lower drug costs: https://www.amjmed.com/article/S0002-9343(10)01087-9/abstract https://www.amjmed.com/article/S0002-9343(10)01087-9/abstrac...

delecti 8y ago
Every prescription I've received in the last several years had two signature lines. If the doctor signs on one, it's "dispense as written", and if they sign the other it's "substitution permitted". So it's not like they have to do something special to get DAW.
- mikeyouse 8y ago
  But how many of the prescriptions you received had the signature on the DAW line? It's typically very uncommon. In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given. I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.
  - delecti 8y ago
    None, but that's not the point. I was just saying that there's not an extra hurdle to prescribe DAW like you were implying.
mjcl 8y ago
But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.
- chimeracoder 8y ago
  > But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber. Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.
  - maxerickson 8y ago
    Some of the ones pulled in 2007 or 2008 were generic versions of the EpiPen that existed at the time.
MBCook 8y ago
But you can only do that if the FDA has said the generic is a perfect substitute, which hasn’t happened on any previous substitutes. This device is the first one to get that label.
- refurb 8y ago
  Correct, a drug has to be listed as "AB rated" in the FDA Orange book in order to be substituted automatically for the branded version.[1] AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements Andrenaclick is "BX rated".[2] BX Drug products for which the data are insufficient to determine therapeutic equivalence The new generic version from Teva is "AB rated".[3] [1]https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#tecode https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm0790... [2]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020800 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ... [3]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=090589 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ...
dboreham 8y ago
This is the whole point of the article btw : there have been "non-Mylan" EpiPen products on the market in the US for the past year (that are low cost) but they aren't magically associated with the SKU "EpiPen" in the Pharmacy -- you have request them by name. This news is about an alternative autoinjector being approved for that special "Pharmacist can substitute for the real thing regardless" status. Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.
wutbrodo 8y ago
As I understand, Epipens have a specific legal exception to this law. Epipen prescriptions are not valid for, say, adrenaclick injectors.
InclinedPlane 8y ago
A pill is just a pill, and the FDA accepts many generic drugs as substitutes for the name brand version. But an epipen is not just an epinephrine injector it is, itself, a medical device, and until now your prescription for an "epipen" wouldn't allow you to get a substitute device. Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.

lysp 8y ago

In Australia, the prescription is assumed to allow generics by default. Whenever you go to get your script filled, the pharmacist will ask "would you like a generic?" https://www.humanservices.gov.au/sites/default/files/images/pbs-prescription.png https://www.humanservices.gov.au/sites/default/files/images/... If you look at the above form box #10 - there is a box a doctor will tick if there is a specific reason not to substitute. In that case the pharmacist will not be able to give you a generic version. But that generally is an exception and not the norm.

andrepd 8y ago

That's ridiculous. In my country, it is the law that prescriptions are named by substance/generic name rather than a commercial name, and come with a text saying "You will spend no more than X if you buy a generic.". The pharmacist also must give you the cheapest generic unless you specifically request another.

alphabettsy 8y ago

This is not true. Doctors actually have to specifically state that substitution is not allowed; otherwise pharmacies will fill with generic.

Broken_Hippo 8y ago

I worked at a pharmacy in the US for 8 years. This is simply not quite true, and your telling of it paints a picture that is different from reality. Doctors have to specify when writing a prescription if an generic is acceptable or not. It is always a deliberate choice with each and every prescription. There is no "Just forgetting." Paper prescriptions, for example, have two different places for signatures. Most doctors know that insurances often require generics. There are good reasons not to substitute for some medications: Lithium (common for bipolar disorder), for example, sometimes absorbs differently between brands. Even with drugs that have no generics, most doctors will write a prescription saying that a generic is acceptable in case one has been approved without their knowledge. Doctors really only need to know when there are differences with generics vs brand names. Not only that, but if the doctor requests the brand name, most pharmacies will call the doctor to see if they can switch to a lower-cost generic if the patient requests it. This is done a lot, sometimes simply because the patient doesn't realize the medicacation costs when they are at the doctor's office - they often don't realize the costs until the pharmacy runs the prescription through their insurance. The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.

KyeRussell 8y ago
I know there's always at least one non-US resident that pipes into these threads with the same generic comments. But I can't help but be 'that guy' this time. > The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug. The U.S. private health insurance system is so weird.
- Broken_Hippo 8y ago
  It is, though! I'm in Norway now, and trying to explain the US healthcare generally leaves folks a bit flabbergasted. I am quite happy that I'm no longer in the states - state-sponsored medicine is much simpler and less stressful to deal with. And to make it weirder: The formularies are generally based on agreements the insurer has made with the drug companies and/or pure cost of medicine if there was no deal to be made. I'd not mind some generally accepted standards in treatment based on patient outcome, so long as the patient doesn't have factors that change the standard treatment, but long-term outcome and cost over time doesn't seem to be the focus. This is likely due to many folks not keeping the same insurance long-term.

paulie_a 8y ago

I've had pharmacist question a prescription because it was a brand name. It was going to cost 250 dollars with insurance. She called the doctor and got the equivalent prescription and it cost 10.