Behind-the-counter drugs?

[roka]

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This article was in a email sent to me from Pharmacy Week. The article discusses possible FDA approval for "behind-the-counter" drugs being approved by pharmacists and dispensed without the need for a MD's prescription. These drugs could include BCPs, cholesterol drugs, etc.

I thought it was interesting. Has this proposal come up before?

Thoughts, anyone?

http://www.latimes.com/features/health/la-fi-drugs5oct05,0,369201.story

 

[Farmercyst]

Definite ramifications in both medical and pharmacy communities. Don't really have the time to do a good pros vs cons, but the article mentions a few valid points I think.

 

[genesis09]

They've been talking about this for several years privately. It'll be interesting to see how it pans out and which drug will be the first one to try for BTC status.

 

[Hels2007]

They've been talking about this for several years privately. It'll be interesting to see how it pans out and which drug will be the first one to try for BTC status.

Or not so privately. On November 14 FDA is holding an all-day public meeting on that exact topic. The Federal Register posted the list of about 25 questions (some with subsections). You are welcome to submit your comments. 🙂

I will make my students discuss it in class tomorrow, too - I've been waiting since last Thursday, when I got the notice and edited my slides!

 

[roka]

This link was the first I've heard about the proposal. I'm intrigued and also kind of wondering why I didn't hear about this before. I'm curious to see how it will all play out.

I will make my students discuss it in class tomorrow, too - I've been waiting since last Thursday, when I got the notice and edited my slides!

Hey, why can't I have a discussion on this in one of my classes?! That's just not fair. 😛

 

[sdn1977]

Yep - its been discussed for many years. The most opposition comes from those who, validly IMO, feel that pharmacists either will not or cannot take the time to properly counsel & monitor these patients.

At this time, I feel it would be a mistake without more certification, documentation & communication with PCPs. Although some medications can be safely given without problems, its not the drug side effects or adverse reactions to be concerned with - its the complete health of the patient.

We cannot order liver enzymes to properly monitor statin drugs & you can't take statin drugs outside of the complete cardiac health of the patient. I would challenge any retail pharmacist to be able to even hear a heart "click" or a carotid bruit let along know it was a new finding nor would we be able to properly keep that kind of charting.

Likewise, bcps are often very, very safe. But, if that pt doesn't get that annual exam, she is most likely not getting a PAP smear either. How is a dysplasia or ovarian growth going to be detected? Certainly not by the retail pharmacist.

I'm all for expanding our practice areas - but, only within the limits of what our experience is. I'm a very experienced acute care pharmacist & I wouldn't want to take the place of a cardiologist or even the IM or FP who can & does a complete physical exam.

 

[VCU07]

I agree that additional certification should be required to manage patients with BTC drugs. How would one measure cholesterol levels in a retail pharmacy? Liver enzymes? Cholestek machines are great, but cannot take the place of labs. Also, I think the general public would think that they are taking very good care of themselves and would skip that yearly check up with their PCPs. How about expanding state laws that would allow us to give that pt who is out of refills on statins(as well as other classes) to go ahead and authorize them (of course for a specific number so they would still be reqd to go see their pcp for f/u). What do you guys think?

 

[genesis09]

We talked about this proposal back in P-1 year. We were told the reason the FDA historially has been hesitant to back this idea is the fear that pharmacists won't say no to a patient. They see pharmacy has very profit and product oriented.
The fact is that many other countries have a BTC class. There are a number of drugs which have been earmarked as perfect for the class.

 

[sdn1977]

We talked about this proposal back in P-1 year. We were told the reason the FDA historially has been hesitant to back this idea is the fear that pharmacists won't say no to a patient. They see pharmacy has very profit and product oriented.
The fact is that many other countries have a BTC class. There are a number of drugs which have been earmarked as perfect for the class.

So true about pharmacists not being able to say no!

Also - not able or willing to take the time & effort it takes to consider all aspects of "complete" care in most current settings.

Some - like Kaiser & the VA have different settings, but not for most retail locations.