OTC Drugs

BTC as the 3rd Class of medication

NYRXMAN Posted this in the Plan B thread:

Actually the BTC concept is not new, but different. About 20 years ago Florida passed a "third class of drugs" law that allowed pharmacists in that state to prescribe and dispense a very limited number of legend Rx drugs without an MD's authorization. At the time, I went to Florida to interview a number of pharmacists across the state to see how they were coping with their "new found" freedom as prescribers. It turned out that only a very small percentage of the pharmacists in Florida were willing to prescribe and dispense these legend drugs from "behind the counter" for fear of liability and malpractice exposure.

What we have today is very different. Todays "BTC drugs" are not "legend drugs" but potentially dangerous OTC medications. I was always a proponent of pharmacists being able to prescribe and dispense a limited amount of Rx drugs that have proven to be safe and effective to the general population over the years. I just don't think pharmacists 20 years ago were ready or prepared for that challenge. I think the new breed of PharmD's being graduated today are.

I'd be interested in hearing other opinions on this subject

I would like to open this discussion here.

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KMiller's picturePharmacy TechnicianKMillerJoined: Aug, 2009
Location: Colorado Springs, CO
Posts: 130

Included in this list will

Included in this list will have to be PlanB and anything used to make Meth (even though this is a farce). What should be included is; some CV cough medicines, Tessalon perels, Birth control pills, some acid reducers. I do not agree with antibiotics being included the risk of breeding resistance is too high.

nyrxman's picturePharmacistnyrxmanJoined: Mar, 2009
Location: Lyndhurst, NJ
Posts: 21

KMiller, Thanks for moving

KMiller, Thanks for moving this topic to a separate forum item! It really does deserve its own space.

Yes, you are correct in the products you listed; but I think it should be expanded. I also think with health care reform around the corner, pharmacists are in the best position to handle these drugs.

Currently these BTC and 3rd class of drug laws vary from state to state, but to make them really effective, I think we need a national formulary of drugs that would be permitted to be sold from "behind the counter" (OTC and Rx) can only be prescribed and sold by pharmacists. Your choices so far are good ones. As you know many H2 acid reducers have gone OTC, but there are PPIs on Rx that may eventually be proven safe and effective enough for pharmacists to sell them BTC. There is a move in the UK to move certain statins to an OTC status. They may be a good target here eventually for BTC drugs. Perhaps this 3rd class of drugs could be behind the counter prescribed and sold by pharmacists only until they are proven safe and effective for the general population, and then moved to full OTC status.

I agree that for now antibiotics should not be in that category; but perhaps I wouldn't rule them out forever, especially 1st and 2nd generations of antibiotics. Also, if this concept of BTC or 3rd class of drugs to be sold only by pharmacists were to be resurrected nationally, there would have to be some strict protocols attached to their sale (like patient record review, etc.)

Health care reform will eventually be passed in the U.S. And when it is, pharmacists should stake their claim. This is certainly one way for pharmacists to get more involved and respected as the true health care professionals they are.

pharmaciststeve's picturePharmacistpharmaciststeveJoined: Jul, 2009
Location: New Albany, IN
Posts: 118

There are so many obstacles

There are so many obstacles to get BTC medication to being a reality.

The Pharmas can generate more revenue by taking a med OTC

The Insurance companies have regularly resisted paying Pharmacist for cognitive services.. Just look at the Ashville Project.. reportedly a huge success for over a decade and has yet to be duplicated or used as a template to expand such cognitive services to MTM on other disease states.

The reluctance for Pharmacist to participate in such program because of liabilities, but could their resistance be more of the additional liabilities without added compensation from the employer... or a revenue sharing program.

There is the general population belief that in the pharmacy environment... the Pharmacist's advice has always be FREE.. imagine the shock on a patient face when asked to pay for the Pharmacist's time to sell them a product. Even if the cost is equal or less than the cost of their insurance co-pay for a office visit.

Could the Pharmacist's fee for cognitive services be yet another issue to allow the large corporate pharmacies to prostitute pharmacy via making it a commodity?

If/when some sort of national health insurance program is created.. Depending on how many currently under/uninsured people are included and how low/high deductibles and co-pays are... how quickly the cost to the system accelerates and the back-log to see a healthcare professional grows. Pharmacists may find themselves quickly granted limited prescriptive authority...

nyrxman's picturePharmacistnyrxmanJoined: Mar, 2009
Location: Lyndhurst, NJ
Posts: 21

Pharmaciststeve, I have to

Pharmaciststeve, I have to respectfully disagree with many of your points. First, while what you say is true about Pharma companies generating more revenue by taking an Rx drug directly to OTC status is true, the issue of whether a drug will be sold BTC or OTC is really not in their hands; it will be an FDA decision. I was merely suggesting that BTC might be a first step for the FDA to move a drug to full OTC status. It will allow the agency to monitor the drug being sold without a prescription in a somewhat controlled environment before making it generally available to patients without a prescription.

To your second point... The concept of the Ashville project and MTM has been, and is continuing to be, successfully replicated around the country in a number of pharmacy settings, including some major regional chains and independents. Pharmacists are getting paid for their MTM services in these locations. I agree the insurance companies have been slow to reward pharmacists, but hopefully health care reform will take care of that. Insurance companies will eventually come to the understanding that consultative services actually lower their health care costs in the long run by keeping patients out of hospitals.

I agree that liability continues to be a major concern and hopefully tort reform will help the pharmacist through those issues.

You are correct about pharmacists giving away their information for free, but I'm afraid that your attitude towards getting paid for MTM services is unfortunately generational. I don't know your age but many pharmacists who have been practicing for a good number of years have the same mindset. They cannot grasp, or don't want to move forward, on the concept of getting paid for MTM and that is primarily why they continue to give away information for free. They are waiting until it comes to them and that is just not going to work.

As mentioned before, there are many pockets of pharmacy practice in this country where patients are actually paying for consultative services (as well as some insurance companies).

Finally, the issue of pharmacists being granted limited prescriptive authority is to a large extent up to pharmacists themselves. As mentioned in my earlier post, limited prescriptive authority is not a new concept. It was tried in Florida over 20 years ago and was largely rejected by pharmacists in that state. In fact, some 30 plus states today have legislated limited prescriptive authority and protocols with physicians. However, for prescriptive authority to become more widespread, pharmacists again have to realize that it will not be handed to them. They have to exhibit the willingness and desire to enter into this new realm of pharmacy. Until that happens, pharmacists who resist the change will find themselves doing exactly what they are doing today relative to getting paid for their consultative services....nothing.

Some of this movement forward has been hampered by a traditional shortage of pharmacists over the past decade or more. There simply were not enough pharmacists to make it happen. But that is changing. More pharmacists are being graduated from pharmacy schools than ever in the history of pharmacy. These students are leaving school with PharmD degrees. They are ready for the challenge of prescriptive authority and paid consultative services. Like many pharmacists themselves, chain management has to change their mindset about the duties of the pharmacists that work for them and encourage payment for their services. It certainly won't happen overnight. State and national associations also have to step up their efforts in taking up this coarse of action and lobby more on behalf of their memberships. If all of this does not happen, the profession will remain stagnant and we will be talking about these same issues another decade from today.

pharmaciststeve's picturePharmacistpharmaciststeveJoined: Jul, 2009
Location: New Albany, IN
Posts: 118

I ran into one of my

I ran into one of my Pharmacist friends - outside of the work place - he works for Krogers and he told me that the company was MANDATING him to become certified to give shots... if anyone declined ... the employee would NEVER get another PAY RAISE ! On top of that... the company was cutting back on both Pharmacists and tech hours..
It would appear that this company is all about patient safety... and a safe work environment.

pharmaciststeve's picturePharmacistpharmaciststeveJoined: Jul, 2009
Location: New Albany, IN
Posts: 118

NYRXMAN... I have been

NYRXMAN... I have been working in a pharmacy for FOUR + DECADES. My memory pre-dates third parties and DEA. I currently only temp - if you call working 40+ hrs a week temping - in LTC. In a sense, I "prescribe" daily.. be it recommending changes in drug therapy, for various reasons to dosing IV antibiotics. Today, I find the prescriber to accept my recommendation nearly 90+% of the time. I can't say that this has always been the case earlier in my career.

While no doubt there will be isolated pockets of innovation.. but just like docs and boutique practices are flourishing in various areas... they are most limited to areas where there is a high interest in personal health and deeper pockets to pay for these services.

I see the retail work environment - especially corporate pharmacy - that is not conducive to personal/intimate assessing a pt's needs and prescribing.

This past winter there was a big push for Pharmacists to give flu shots. The largest corporate pharmacy - at least in my area - did not give shots via appointments. In my mind... that does not convey to the general public that the Pharmacist's time has any value. It also demonstrates the the people waiting to get their Rxs filled are of less importance than those getting shots... the Pharmacist cannot be two places at one time.

Likewise, Medicare would pay a "administration fee" for both flu & H1N1.. but many private insurances would only pay the fee for the normal flu shot but since no product was being paid for with the H1N1.. they declined to pay an administration fee.

While the FDA may have the final say in what goes OTC.. it does seem very strange that many drugs have been determined "safe" just as the patent is expiring.

If I remember correctly one of the major health insurers tried to get Prilosec OTC before the patent expired and the Pharma fought it off .. Once the patent expired... it became safe for OTC sales.
We now have two PPI's OTC... which makes one wonder why the remainder of the Rx PPI's are so unsafe as to not be OTC as well ?

Personally, I do not put a lot of faith in the national associations.. as I remember one ( APhA) was 100% behind the professional fees for filling Rxs as the third parties came on the scene in the late 60's. The claim was that it would make us more professional... separating the product from our professional service. IMO.. that concept did not work out too well in the long run.

I see Pharmacists being incorporated into large medical practices and be given prescriptive authority from the practice.

Of course, the 800 lb gorilla in the room (national health insurance).. could cause pharmacy to have to re-write our business plan

nyrxman's picturePharmacistnyrxmanJoined: Mar, 2009
Location: Lyndhurst, NJ
Posts: 21

Sounds like we are both

Sounds like we are both saying the same thing with one exception. I don't believe giving flu shots should be a pharmacist's responsibility except perhaps in a national emergency.

As far as OTC drugs are concerned, let's face reality, of course pharmaceutical companies are going to wait until the patent on the Rx expires; that's a given. I was referring to the course of events specifically related to those drugs that are targeted by the pharmaceutical company to go OTC and that time period near the end of a drug's patent life (maybe 6 months to a year)and the time the FDA grants approval of the drug for OTC status. I think a suitable course of action in that circumstance is to label the drug as a legend 3rd class of drugs to be prescribed/dispensed behind the counter only by pharmacists.

KMiller's picturePharmacy TechnicianKMillerJoined: Aug, 2009
Location: Colorado Springs, CO
Posts: 130

Prior to tort legislation the

Prior to tort legislation the best way to protect your self is the same way providers do insurance. I am a CPhT and I carry liability, malpractice and personal insurance. Being involved in Health Care mandates some responsibility in case of errors or ill effects.

pharmaciststeve's picturePharmacistpharmaciststeveJoined: Jul, 2009
Location: New Albany, IN
Posts: 118

Sounds like we are both

Sounds like we are both saying the same thing with one exception. I don't believe giving flu shots should be a pharmacist's responsibility except perhaps in a national emergency.

IMO.. corporate pharmacy is using the ability of Pharmacists being able to give flu shots just another "carrot & stick" to get people into the pharmacy. In fact Walgreens is pushing it so hard that when I called a Walgreens today - on the doc's line .. I was asked - before they knew who was calling - if I was interested in getting my H1N1 shot today..

On one blog... a Pharmacist was "ranting" about his company requiring him to become certified to give flu shots.. and the Pharmacist at my local Walgreens was joking the other day that next year .. they were going to start doing PAP SMEARS !

IMO corporate pharmacy has turned their front end into a convenient store - how much longer before we see gas pumps at the local corporate pharmacy... and they are trying to be everything to everybody.. and their employee/Pharmacists are going right along with them...

pharmaciststeve's picturePharmacistpharmaciststeveJoined: Jul, 2009
Location: New Albany, IN
Posts: 118

Healthmart's new TV

Healthmart's new TV advertising is strongly re-enforcing the Pharmacist and his/her FREE ADVICE ! Since Healthmart is part of Mc Kesson... how is our profession every going to dig us out of this "free advice" hole.. when all the major players keep digging the hole deeper