Wednesday, March 21, 2012

Who benefits from more OTC medications?

Thursday and Friday (March 22 & 23) the FDA is holding its public hearings on "using innovative technologies and other conditions of safe use to expand drug products considered nonprescription". You know, moving more drug categories to OTC status.

The initial response that I had, and that has been voiced through several outlets, is that this may be the step that is needed to enable pharmacists to be recognized as providers. My thoughts were that this should not move forward unless the OTC move was restricted to pharmacies-only with a built-in means for reimbursement to the pharmacists providing the consultation. This would keep the consultation separate from the drug product. This could be very good for the profession.

But now I've had a few days to mull this around in my head. Something just doesn't sit well with me on this.

I've never known our government or any of its agencies to move quickly on issues, especially when it comes to our profession. But for this issue, the notification for the hearing was filed on February 27, published in the Federal Register on February 28, with a deadline to present oral comments & presentations of March 9. That's less than two weeks. With the hearing being held less than two weeks after the deadline.

3-1/2 weeks from the notice of hearing in the Federal Register until the hearings begin seems to be moving rather quick to me. Which makes me skeptical.

Who are the entities that are pushing for this?

Who has been working behind the scenes with the FDA to get this agenda advanced? How much have they prepared for the hearings prior to the announcement?

It will be interesting to see who actually makes oral presentations and comments at the hearings. With such short notice, I doubt that there will be very many, if any, practicing pharmacists at the hearings.

My concern is that the entities who stand to profit the most from this will dominate the hearings and the voice of the practicing pharmacists will not be heard. And we all know who stands to profit the most.




Manufacturers know that moving the items from prescription status to non-prescription status will decrease the competition for their product. Not too many manufacturers are competing for the generic OTC market, so the brand-name manufacturers can keep a better market share by going OTC. When you consider the rebates that they must give on Medicare/Medicaid scripts, they potentially will make more profit with the switch.

Then there are the insurers. No-brainer for them. Our plan does not cover over-the-counter medications. They can eliminate several medications that are standard on formularies. For them, OTC = $$$.

Then there are the chain pharmacies. We all know that the chains are looking to decrease labor costs, especially pharmacist labor. Sure the move of certain medications to OTC status will decrease script counts, but that gives them a reason to decrease pharmacist payroll. Nevermind that the pharmacist will get pulled aside every seven minutes to consult a patient about these new OTC meds. Chain pharmacy staffing follows a simple equation... X scripts/hr/pharmacist. If you are not hitting the numbers, you lose the payroll. The profit on an OTC medication is better than the standard dispensing fee from insurers, so why wouldn't the chains be on-board?

I hope my gut is wrong on this one. But less than four weeks from the time of announcement until the FDA hearing just makes me think that something funny is going on... and not for the betterment of our profession.

What do you think?

Thursday, March 15, 2012

But you didn't.......

Today starts the beginning of the NCAA Basketball tournament. St.Patrick's Day and all of its merriment is a couple days away.

I came upon this a couple days ago on one of the apps that I waste time on. I don't know if it was written by somebody who actually suffered a loss, but this struck a chord with me.

As we go about celebrating springtime here in the United States let us remember those who aren't safe at home, but are allowing us to be safe at home.

Monday, March 12, 2012

Medications available under "safe use"

Recently I came upon a blog post by APhA CEO Tom Menighan where he brings up the FDA's idea of making certain prescription medications available without a prescription, provided that the medications are provided under conditions of safe use.

This proposal combines a couple of the ideas that have been floating around for several years...a pharmacist-only class of medications as well as limited pharmacist prescribing. Under one safe use provisions, the sale of these agents might be limited to certain health care settings, such as a pharmacy. I emphasize the word might, as Docket No. FDA-2012-N-0171 use the word might rather than would when it discusses whether or not the sales would be restricted to pharmacies.

I believe that this proposal is a step in the right direction for pharmacy. Opening up access to pharmacists as providers with limited prescriptive authority could ease the burden on primary care practitioners and help advance our profession. My concern is that pharmacy will provide this service without ensuring a reimbursement structure for the pharmacists who are providing the service.

We can't continue to give away our services without getting paid because face it, at the end of the day pharmacy is still a business and if your business isn't generating cash-flow it won't be a business very long. This may be the chance that our profession can capitalize on and be granted the provider status that we have been petitioning for over the last several years.

We need to make sure that the regulations contain language that requires pharmacist intervention, not suggests or recommends t. We also need to make sure that provisions are included that allow for reimbursement for services. We can't rely on building the professional fee into the price of the product because people will not see our services as being professional. They will simply look for the pharmacy that has the lowest price and go there. The consultation with the pharmacist must be removed from the product if we truly hope to advance the professional scope of our practice.

Sorry for getting this out so late. The notice came out in the Federal Register on Feb 28 and the deadline for being able to present oral presentations and comments has already passed. However, electronic and written comments will be accepted until May 7, 2012. I encourage you to chime in on this topic.