generics?

[biophiliac1]

---

Members don't see this ad.

just curious about generics. the other day i was at kaiser and a guy had a script from his doctor and he was like i can't pay this. so i recommended him to ask his doctor if he could fill it with a generic. was that wrong of me? i'm just wondering because i'm not a pharmacist but i thought it was a good suggestion. is it a bad idea to recommend generics to people because it may not be the same quality or whatever as name brand? because i was thinking they should be the same or pretty much the same accept one's more expensive relative to the other. hmmmm....

 

[ultracet]

It really depends on the circumstance. Legally, I don't know if the law specifies that a tech can or cannot tell them to talk to their doctor about switching to generics (that might fall under counseling).
As far as drugs being equivalent to their generics...
It depends on the drug and the condition it is being used to treat as well as the paticular patient.

There are some drugs that if you start on a brand name you MUST continue on the brand name and substitution could be extremely detramental. At the same point if the patient is started on the generic then they should not be switched to the brand name at any point.
Also the patient should stick with the same generic manufacturer.

Questions I would ask: Is this the first time they are receiving the medication? What did the doctor tell them this was for? Did the doctor say why he/she would want them on a paticular preparation?
But this goes a long with the knowledge of the therapeutic index of paticular drugs.....

Overall, I would say next time, refer to the pharmacist for this info.

I am all for generics.... but sometimes switching is not best.

 

[Glycerin]

just curious about generics. the other day i was at kaiser and a guy had a script from his doctor and he was like i can't pay this. so i recommended him to ask his doctor if he could fill it with a generic. was that wrong of me? i'm just wondering because i'm not a pharmacist but i thought it was a good suggestion. is it a bad idea to recommend generics to people because it may not be the same quality or whatever as name brand? because i was thinking they should be the same or pretty much the same accept one's more expensive relative to the other. hmmmm....

Usually, you can tell if the physician doesn't mind if the generic is dispensed if there is a DAW 0 on the script. Sometimes physicians don't indicate a DAW, in which case a phone call to them would be appropriate (depending on the schedule of drug, of course). I'm not sure if this varies from state to state, but it's how it was done when I worked in retail. We generally asked the patients if they would prefer the generic versus the brand.

 

[jdpharmd?]

Usually, you can tell if the physician doesn't mind if the generic is dispensed if there is a DAW 0 on the script. Sometimes physicians don't indicate a DAW, in which case a phone call to them would be appropriate (depending on the schedule of drug, of course). I'm not sure if this varies from state to state, but it's how it was done when I worked in retail. We generally asked the patients if they would prefer the generic versus the brand.

What are you guys talking about? 😕 The doctor inidicated "DAW 0" on the script? Call to ask to substiture generic?? A "DAW" indicates "dispense as written", meaning whatever is written is what the pt gets (Brand). NOT having a "DAW" means that you can switch it. Nobody in their right mind is going to call the doc to ask if "generic keflex is ok". Yeah, there are a few drugs that should be kept constant (coumadin, thyroid), but just switch people to generics unless they explicitly say otherwise (or there is no generic). I'd like to hear about it if there is a state that makes the doctors write "DAW 0" on their scripts.

 

[LVPharm]

In general (most states), you are only required to dispense the brand if the practitioner signs on the "Dispense as Written" line, or checks that box (depends on his script pad layout). Also, if the patient receives Synthroid, Coumadin, and quite a few pharmacists won't substitute Dilantin, either. I imagine Lanoxin as well.
We have a new Nevada law that requires prescribers to write across the prescription pad, "Dispense as Written" if that's what they want. Otherwise, no matter if they sign that line or check that box, we can fill it with a generic...my preceptor doesn't really care what the prescriber says...he can point to the statute.

 

[Glycerin]

What are you guys talking about? 😕 The doctor inidicated "DAW 0" on the script? Call to ask to substiture generic?? A "DAW" indicates "dispense as written", meaning whatever is written is what the pt gets (Brand). NOT having a "DAW" means that you can switch it. Nobody in their right mind is going to call the doc to ask if "generic keflex is ok". Yeah, there are a few drugs that should be kept constant (coumadin, thyroid), but just switch people to generics unless they explicitly say otherwise (or there is no generic). I'd like to hear about it if there is a state that makes the doctors write "DAW 0" on their scripts.

I no longer work in retail. But, we would substitute generics if the patient was okay with that and the doctor did not sign above the "dispense as written" space on the script. I'm going by what we had to enter in the DAW field during order entry. Sorry for the confusion.

 

[biophiliac1]

i kinda figured what you guys have been saying would be the case. in all honesty...i'm not even a tech or anything. i was just being a "good summaritan" if you will because the guy was freekkiinnnggg out and he had no way of paying for his meds. (i was waiting in line with him to register for an appointment) so i told him he might want to ask his doctor if he could get a generic since he said he was going to tell his doctor about the exceedingly high cost. (by the way i think it was his first filling of 'script) this has been very informative. i suppose you get a hang of these things with some experience in the pharm.? i hope to get a hang of it reallyyy fast. all those acronyms nuemonics or whatever they call it. 🙂 dwa/daw?? i guess it was the humanitarian side of me reaching out to the guy. 😛

 

[ultracet]

Please don't take offense to this comment, its just meant to be an observation that I have made.

It seems that a lot of people (general public, doctors, nurses, etc) really underestimate the amount of work a pharmacist puts into their education and the amount of knowledge they have.
I have heard very few techs that didn't say "i should go back to pharmacy school, i run the pharmacy"
It just amazes me. I mean we (at my school) are being taught that we are the "experts" in the field of medicine (drugs, dosing, MOA, etc. NOT diagnosis) and doctors are the "experts" in disease and diagnosis, while nurses are the "experts" in patient care. I know that this is utopia.....

 

[bananaface]

What are you guys talking about? 😕 The doctor inidicated "DAW 0" on the script? Call to ask to substiture generic?? A "DAW" indicates "dispense as written", meaning whatever is written is what the pt gets (Brand). NOT having a "DAW" means that you can switch it. Nobody in their right mind is going to call the doc to ask if "generic keflex is ok". Yeah, there are a few drugs that should be kept constant (coumadin, thyroid), but just switch people to generics unless they explicitly say otherwise (or there is no generic). I'd like to hear about it if there is a state that makes the doctors write "DAW 0" on their scripts.

Most of the thyroid meds are not AB rated anyway, even though they were treated as such for a long time. If you catch anyone switching them, please point out to them that they ought not to.

Coumadin/Warfarin and Lanoxin/Digoxin are the only two AB rated pairs I can think of where it is a good idea to ask the patient what they have been taking so that you can ensure continuity of treatment. I wouldn't just look at the DAW code and assume the prescriber wrote out the name of the one the patient had been on.

They stopped making brand Keflex, didn't they? It came up once with a pateint who was "allergic" to all generics.

 

[jdpharmd?]

They stopped making brand Keflex, didn't they? It came up once with a pateint who was "allergic" to all generics.

Oh no, people are still willing to pay 3x more for "what my doctor WANTED me to take". I've got brand name keflex in stock! 😎

 

[GravyRPH]

Most of the thyroid meds are not AB rated anyway, even though they were treated as such for a long time. If you catch anyone switching them, please point out to them that they ought not to.

I haven't seen any studies of late so I may be going off old information, but the brand Synthroid manufacturer had to pay large sums of money in a class action lawsuit because of this broad statement that they promoted. In fact, when studied, it was found that the differences between brand Synthroid lots was just as significant, and sometimes more, than the differences between brand and generic.
That being said, I still tell patients to try to stay with what they've been on with thyroid meds, but I chalk it up more to good marketing than actual science.

 

[bananaface]

Synthroid had to pay because they are not the RLD (refererence listed drug) in the FDA's Orange Book, but promoted themselves as such in their ads. The ads said something along the lines of Synthroid being "the standard in thyroid hormone replacement therapy aginast which others have been measured for over 50 yrs". This was a violation of the FDA rules on truth in advertising. The FDA argued sucessfully that an RLD and only an RLD could claim to be the standard against which other drugs are measured.

 

[GravyRPH]

Synthroid Class Action Lawsuit Settlement Approved
Consumers Who Filed to Receive $74 to $111 Each in 2000

August 2000 -- On Tuesday, August 8, 2000, Knoll Pharmaceutical Company announced that Judge Elaine Bucklo of the U.S. District Court for the Northern District of Illinois gave final approval of a settlement of the Synthroid class action lawsuit.

The lawsuit resulted from an investigation, which began in 1996, that alleged that Knoll Pharmaceuticals and parent company BASF were violating consumer protection laws by attempting to prevent publication of the results of a research study showing that generic and competitive brand name levothyroxine drugs were equivalent to the Synthroid brand. Levothyroxine drugs such as Synthroid are used to treat hypothyroidism, an underactive thyroid condition.

The proceeds from an escrow account, which as of June 30, 2000, contained approximately $91 million plus interest (less attorneys' fees and costs) will be paid to consumers who have filed as part of the lawsuit and agree to release all claims against Knoll.

 

[GravyRPH]

"The major paper is the original one by Dong et al, which was finally published in 1997 and showed no difference between the bioavailabilities of Synthroid, Levoxyl, and two generic levothyroxine sodium preparations. It was a single-blind (the primary investigators were blinded), randomized, 4-way crossover trial in outpatients with known hypothyroidism."

Dong, Betty J PharmD et al. Bioequivalence of Generic and Brand-name Levothyroxine Products in the Treatment of Hypothyroidism. JAMA. Vol 277(15); 16 April 1997: pp 1205-1213.

In the words of Dong et al:

?There is no basis (other than cost) for preferring any of these preparations for new patients. For patients who wish to reconsider their choice of levothyroxine preparation, it is reasonable to discuss these options with their physician so that such a change can be monitored if clinical symptoms warrant. The lifetime cost savings are substantial after changing to a nonbranded product even if thyroid function tests are repeated. Routine assessment and monitoring of thyroid function tests are recommended irrespective of the actual brand of levothyroxine taken.?

 

[bananaface]

I was referring to the lawsuit that resulted in this letter from the FDA in 1997. It was that lawsuit that led the FDA to begin curbing interchange of levothyroxine products.

http://www.fda.gov/cder/warn/aug97/5632.pdf

I am not saying one thyroid med is preferable to the other for starting therapy. I'm just saying that not all are interchangeable and that pharmacists ought to on the side of caution and go for continuity of treatment.

 

[GravyRPH]

And I'm just saying this may not be entirely based on science. The study clearly showed the bioavailabilities were the same, so why do we have to be so cautious? The study author's statement clearly shows our continued fear of switching certain medications, so I can't really argue otherwise. But just because it's a narrow therapeutic window medication does not mean a generic switch would produce a therapeutic failure. Beleive it or not.

 

[ultracet]

According to the orange book, synthroid and levothyroxine sodium are rated BX and therefore i would not substitute.

 

[bananaface]

bbmuffin has it exactly right. You can't go around substituting anything you think OUGHT to be substitutible. You are bound by law to follow the FDA's policy on interchangeability. Believe it or not. 😉

 

[jdpharmd?]

bbmuffin has it exactly right. You can't go around substituting anything you think OUGHT to be substitutible. You are bound by law to follow the FDA's policy on interchangeability. Believe it or not. 😉

From what I remember in class, the orange book is NOT a legal standard for substitution. It's a useful tool, but in no way does it substitute for professional judgement. Please correct me if I'm wrong.

"The List contains public information and advice. It does not mandate the drug products which may be purchased, prescribed, dispensed, or substituted for one another, nor does it, conversely, mandate the products that should be avoided. To the extent that the List sets forth FDA's evaluations of the therapeutic equivalence of drug products that have been approved, it contains FDA's advice to the public, to practitioners and to the states regarding drug product selection. These evaluations do not constitute determinations that any product is in violation of the Act or that any product is preferable to any other. "

" These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm#General Policies and Legal Status

 

[ultracet]

It might not be stated in the law that you have to use the orange book. But I bet if you substituted and something happened to the patient...... You would be sued and lose on the basis of the bioequivalance rating set out by the FDA and not following that as a precaution.

 

[jdpharmd?]

It might not be stated in the law that you have to use the orange book. But I bet if you substituted and something happened to the patient...... You would be sued and lose on the basis of the bioequivalance rating set out by the FDA and not following that as a precaution.

The irony is that I bet that you'd be sued for dispensing a product that IS considered bioequivalent in the orange book but has some type of other limitation that the pt does not like (scored vs not scored, allergy to excipients, etc). The lawsuits never end. A defense that "the FDA rating was bioequivalent" wouldn't fly.

 

[bananaface]

From what I remember in class, the orange book is NOT a legal standard for substitution. It's a useful tool, but in no way does it substitute for professional judgement. Please correct me if I'm wrong.

OK! 😀

In Illinois (JD you live there, right?).....
"A generic drug determined to be therapeutically equivalent by the United States Food and Drug Administration (FDA) shall be available for substitution in Illinois in accordance with this Act and the Illinois Food, Drug and Cosmetic Act, provided that each manufacturer submits a notification containing product technical bioequivalence information as a prerequisite to product substitution when they have completed all required testing to support FDA product approval and, in any event, the information shall be submitted no later than 60 days prior to product substitution in the State."
- Pharmacy practice act of 1997

....In my state (WA) it doesn't say the Orange Book must be used, specifically. You can use any nationally published pharmacopeia. But, you can't just look at studies and decide what to substitute on your own.

We were so close to getting our ibuprofen Rx's exchanged for Oxycontin!

 

[jdpharmd?]

In Illinois (JD....)....."

I'm in Arizona. 😉

 

[bananaface]

I'm in Arizona. 😉

You make me do all this extra WORK! 🙁

http://www.pharmacy.state.az.us/0104AZNWSLTR.pdf

The clarification you seek lies between pages 1 and 2.

 

[jdpharmd?]

We were so close to getting our ibuprofen Rx's exchanged for Oxycontin!

RX ibuprofen? Heck, I was looking to get my OTC ibuprofen exchanged for oxycontin...

 

[bananaface]

I heard if you go to Rite Aid they will exchange the pastel easter M&M's for Oxycontin or BC... your choice JD 🙂

 

[jdpharmd?]

You make me do all this extra WORK! 🙁

http://www.pharmacy.state.az.us/0104AZNWSLTR.pdf

The clarification you seek lies between pages 1 and 2.

That's EXACTLY what I was looking for. Ok, now find some information that will help me on my immuno final tomorrow. ...quick man, I haven't got all day!! 😛

(?Generic equivalent? or ?generically equivalent? means
a drug which has an identical amount of the same active
chemical ingredients in the same dosage form, which meets
applicable standards of strength, quality and purity according
to the United States [P]harmacopeia or other nationally
recognized compendium and which, if administered
in the same amounts, will provide comparable therapeutic
effects. Generic equivalent or generically equivalent does
not include a drug that is listed by the federal [F]ood and
[D]rug [A]dministration (FDA) as having unresolved
bioequivalence concerns according to the administration?s
most recent publication of approved drug products with
therapeutic equivalence evaluations ([otherwise] known
as the [?]Orange Book[?]). The Orange Book or another
reference that reproduces the information contained in the
Orange Book is required by administrative rule to be present
in every pharmacy?s reference library by rule R4-23-
612(9)(d). Generic substitution with unapproved products
by pharmacists is a violation of the Arizona Pharmacy Act
and may result in discipline.")

 

[GravyRPH]

For some reason, I have to keep repeating my statements in these forums because I guess I don't make myself very clear. I stated that I would NOT substitute for someone continuing therapy, only that I felt this practice was not based on good science.
Orange book schmorange book. I could care less what the Orange book says unless it is based on more recent and better setup/powered studies then those done by Dong et al. I don't know for sure, but I doubt it is.
Some states are mandated to follow the Orange book and thus have no choice. Even though I live in a "non-orange book" state, let me say it one more time, I still wouldn't switch a patient that was continuing therapy. I just proposed the possibility that we might put too much faith in references like the Orange book or that ntw meds are impossible to substitue.

 

[Superflyjsc]

Well where i work, unless the doctor or customer specifically prescribes or asks for the brand, we always fill wit the generic.