Plan B-OTC

[ultracet]

This has been a hot topic of discussion in our classes recently. And they are wanting to place it in all OTC outlets (including gas stations etc.)

Of course we are a religious school. It wouldn't suprise me if our incomings were asked about it in interviews i.e. the Rph in TX that got fired for making the stand that they made about not filling it.

I was just wondering everyone's opinion.

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[ckv34l]

I think having it otc will lead to misuse by teenage women. Making this drug otc will increase sexual freedom and immorality. Having to use this implies that a condom wasnt used and so I think using this would be positively correlated with STD's. If they do have the tho OTC it should be in a locked up place where only those over a certain age maybe 16 or 18 should have access to it. Then again many older women would buy it for youger women. So I dont know.

 

[LVPharm]

There was a proposal years ago (decades?) for 3 classes of drugs: Rx only, OTC, and "For Sale by Pharmacists Only". Certainly one can make the case that Plan B should fall under the last category. Pharmacists can provide counseling, but will allow patients who need it to have it within 72 hours of a "contraceptive accident", without having to wait for a physician's rx. However you feel about this issue, I think we can all agree that this isn't Tylenol. However, this is a rather safe drug to take. It's simply high dose levonorgestrel found in a few oral contraceptives (albeit at lower doses). I think some people think this is an abortifacient like Mifeprex (RU486) which can cause major problems (excessive bleeding, etc).

As for the "pharmacist only" classification, nobody has ever brought this up as a possible solution, not even by the APhA in their press releases on this matter.

 

[moobymaster]

Originally posted by ckv34l
Making this drug otc will increase sexual freedom and immorality.

Thumbs up to that...nothing wrong with sexual freedom. Increasing immorality though is a moral judgement that doesn't have a universal fit.

 

[ultracet]

Well the major problems i can see with it are the following:
1. There are certain PMH questions that must be asked before it is dispensed. For Instance "are you pregnant?"
2. I don't think most people realize that the plan-b pill is absolutely useless if the person is pregnant. I mean come on progesterone is secreted during pregnancy to quiet the uterine muscles and increase mucosal membranes so there is no miscarriage.
3. Since it is a "weaker" pill and doesn't have the effects that the estrogens have (incredibly sick) such as preven there might be more likely that people will use it more than once.
4. While it is safer and it isn't the Rph's job to judge sexual encounters I just wouldn't feel comfortable with people (teenagers especially i'm sure) being able to pick it up.

In many states some C-Vs are OTC but you must sign for them and be at least 18 yrs old (I only know AL law).
It might be a good idea just because most places can't sell scheduled drugs.

As far as APHA i think they are mainly focusing on the medicare plan right now though I do know that the seperate class of drugs has been brought up just in general discussions. It is a special concern now that the antihyperlipidemics are being discussed OTC. Without monitoring who knows what people will do to themselves.

 

[lord999]

Say what you will about the Pharm. D. training, I don't think that the majority of us will have sufficient clinical backgrounds to make that judgment call.

Add to that, the Medical Records nightmare for keeping track of sales and I really don't think pharmacy should embrace this idea.

On another note, Tylenol and Benadryl are the two most frequent accidently OD'ed drugs on the market (although Benadryl is caused more from illicit use). I'm actually not comfortable with that supersized 650 mg APAP sitting on the OTC rack.

And for the "pharmacist recommended" drugs, I believe the term is called "ethical drugs." Certain OTCs were (and still are) kept behind the counter only for pharmacists to sell to the right people. Insulin, Ichthammol, and Syringes are examples of them in AZ.

 

[LVPharm]

Originally posted by lord999

And for the "pharmacist recommended" drugs, I believe the term is called "ethical drugs." Certain OTCs were (and still are) kept behind the counter only for pharmacists to sell to the right people. Insulin, Ichthammol, and Syringes are examples of them in AZ.

...and so should "Plan B", behind the counter. Considering the safety of the drug, it isn't absolutely necesarry for a pharmacist to conduct a thorough "medical assessment" as is required in Washington, or acquire a collaborative practice agreement with a prescribing physician in order to dispense. That's a legal and record keeping nightmare most pharmacists won't go for. But there are questions that need to be asked of the patient. The drug simply shouldn't be out there in the front end somewhere between the condoms and the water-based lubricants! Not that there are any problems associated with overdosage of levonorgestrel, but it's entirely conceibable that a "freaked-out" patient could buy and consume a large amount of this drug. Also, concerns that people may use this drug as a standard means of contraception in lieu of condoms is not completely unfounded. I can imagine uninformed patients believing that since this is a higher dose of a drug found in some OC's, they will use these instead. (Although at 30 bucks a pop, that's admittedly stupid)

Beyond that, I think patients should be informed that about a quarter of the patients who take this will experience nausea, and can have some abdominal pain with some minor effects on menses that can freak some women out if they didn't know.

This drug should be readily available without a prescription because the first dose needs to be used within ~72 hours of a contraceptive accident. But it shouldn't be so easy to acquire as to be able to purchase it in the front end of the store with your bottle of mouthwash without having to talk with a pharmacist first.

 

[LVPharm]

Maybe I spoke too soon, APhA and Barr Laboratories also agree that this drug should be dispensed with an RPh present

http://www.drugtopics.com/be_core/content/journals/d/data/2004/0126/d2switch1b.html

...note the actual examples of potential inappropriate use: "A second patient wanted the medication because she said she swam in a swimming pool with men and felt she needed EC."

 

[ultracet]

Originally posted by LVPharm
...note the actual examples of potential inappropriate use: "A second patient wanted the medication because she said she swam in a swimming pool with men and felt she needed EC."

OMG Why am I not suprised

 

[ultracet]

Originally posted by lord999
I'm actually not comfortable with that supersized 650 mg APAP sitting on the OTC rack.

The lethal dose is up around 4g and if you take 1Q8H you're not getting close to that. If that bothers you then what about everything else that is OTC at Rx strength i.e. the new max strength zantac.
Or what about prilosec??? How often is that missused? And actually that will mask the symptoms of gastric tumors.
Anything you're not comfortable with can always be pulled behind the counter.
Anything misused can kill someone.
levonorgestrel will be vomited up before anyone ODs. (on a side note FYI when dispensing always suggest an antiemetic b/c when they throw up the pill it won't work).

And Ironically enough, plan-b will never actually kill anything.

 

[jdpharmd?]

Originally posted by bbmuffin
The lethal dose is up around 4g and if you take 1Q8H you're not getting close to that. If that bothers you then what about everything else that is OTC at Rx strength i.e. the new max strength zantac.

The lethal dose of APAP is much higher than 4g. The MINIMAL toxic dose is 10g. 20-25g is considered lethal. I wouldn't advise more than 4g/day, but it's certainly not lethal.

 

[GravyRPH]

To who is it not lethal? To that 1 person who takes 4 grams and croaks it sure would be. Why would you not feel comfortable recommending it if it has no chance of being lethal?

If a drug only kills 0.00000000001% of its users, it's still 100% to that one dead person.

 

[jdpharmd?]

Originally posted by GravyRPH
To who is it not lethal? To that 1 person who takes 4 grams and croaks it sure would be. Why would you not feel comfortable recommending it if it has no chance of being lethal?

If a drug only kills 0.00000000001% of its users, it's still 100% to that one dead person.

By your own logic, every drug is lethal in normally prescribed quantities. 4g is excessive, and I've seen articles that show no difference between APAP doses above 1g. Just because something can cause damage, doesn't mean it's lethal. I wouldn't advise papercuts, but I don't think they're lethal either.

 

[ultracet]

Originally posted by jdpharmd?
The lethal dose of APAP is much higher than 4g. The MINIMAL toxic dose is 10g. 20-25g is considered lethal. I wouldn't advise more than 4g/day, but it's certainly not lethal.

Thanks for the correction. That was just what we were told in our Pcol class. I already knew that some of the profs are stupid but i guess now i know how stupid they really are.

 

[jdpharmd?]

Originally posted by bbmuffin
Thanks for the correction. That was just what we were told in our Pcol class. I already knew that some of the profs are stupid but i guess now i know how stupid they really are.

We JUST talked about it in school yesterday, so it was fresh in my mind. It's not like I know that stuff off the top of my head. I guess it's a popular way to commit suicide in European coutries without guns. Learn something new every day!