A Middle Ground Between Rx and OTC: Super, or Scary?

Another interesting development apropos to recent rants on lowering medical costs, in part by breaking down some traditional delivery mechanisms in favor of a more quick-shop, commercial approach to healthcare: now the FDA plans “to expand the the middle ground between drugs that require a prescription and those that anyone can buy off the shelf.” This new gray area for medications is termed “behind the counter” (BTC).


BTC has already gotten a lot of media play — in the Wall St. Journal, USA Today, Reuters, etc. — and apparently the FDA is serious enough about it to be planning a public hearing on the topic next month (Nov. 14 in Washington, DC). Wow.

BTC is modeled after the “pharmacist-only” prescription system on offer in many European countries. In other words, you could obtain the drug you need directly on-site at the drugstore after consultation with a pharmacist. There are still a ton of open questions with regard to regulatory framework and actual cost savings.

Cost savings will presumably come from bypassing the whole doctor-visit-for-prescription step, and also from increased use of off-label, generic drugs rather than their pricey brand-name counterparts. Seems to me like much of the cost-savings may well end up on the insurance end, meaning the health care system as a whole will save money. Still, the convenience and no-coverage-needed factors are significant benefits for patients.

Here’s the link to the FDA summary document. Looks like they’re trying primarily to help the uninsured, by “increasing patient access to medications that may be underutilized, particularly by patients without health insurance because these medications otherwise would be available only with a prescription.”

The LA Times reports quotes John Tilley, who owns four Zweber pharmacies in Downey, CA, and serves as president of the National Community Pharmacists Assn., as viewing the FDA’s proposal as a “win-win” for patients.

His thinking is that pharmacists are trained to consult about routine medical information, and are often more accessible and spend far more time with customers than do their doctors. He emphasizes also that ” greater access to medications might help patients without health insurance who otherwise might not be getting care.”

“It’s not like people would be getting these medications from a vending machine,” Tilley said. “This would include an adequate level of care.”

So, the question is: does BTC sound scary to you? As dicey perhaps as health clinics in Wal-Mart? Or is it possibly a boon to
people with diabetes, for obtaining things like blood pressure and cholesterol-lowering drugs
(statins) quickly and conveniently? What say?


10 Responses

  1. Anne
    Anne October 15, 2007 at 8:13 am | | Reply

    I have a few friends who are trained pharmacists, and I would have confidence in them to know the drugs (and possible drug interactions, symptoms) well.

    On the other hand, we shouldn’t expect our pharmacists to be doctors and listen to all of our medical conditions, make a diagnosis and “prescribe” (even if a prescription is not necessary) medicines.

    And while having more generic options makes it cheaper for everyone, changing medicines from prescription only to non-prescription means that many people would lose coverage, since, in my experience, my insurance will only pay for medications that require a prescription. It sounds like a boon for health insurance companies and a big loss for those already insured.

  2. Scott
    Scott October 15, 2007 at 8:48 am | | Reply

    I’m curious what pharmacists feel about the new level of responsibility, and whether the new classification might provide pharmacists with possible legal protections? I realize it would apply only to a limited number of drugs classified this way, and the criteria would need to be examined closely, but it sounds like an appropriate plan. Now all we need is to determine whether pharmacists are OK with it!

  3. Eric Link
    Eric Link October 15, 2007 at 8:57 am | | Reply

    I also have some friends who became pharmacists; I would trust them as they are highly trained about drugs and their interactions with each other.

  4. Jim
    Jim October 15, 2007 at 10:54 am | | Reply

    The pharmacists at Rite-Aid and Walgreen barely have time to fill persriptions – both chains keep staffing as low as possible to save money. There is no way the pharmacists can handle the increased the work loads of an “adequate level of care.” This may be good in theory, but just won’t work in practice.

  5. Mandy
    Mandy October 15, 2007 at 11:25 am | | Reply

    There are certain drugs, like statins, that require tests (like liver function) to be run before and periodically throughout treatment to ensure the drug is working and not causing harm. Would the pharmacist then be running tests to make sure the patient can take the drug?

  6. Caro
    Caro October 15, 2007 at 12:13 pm | | Reply

    This system works really well in the UK, but that might be down to the completely different health care structure.

    In the UK, a number of drugs are designated “prescription only”. Only a registered doctor (and where appropriate and within limits other health care professional e.g. dentist, nurse) can prescribe these drugs. All antibiotics and all insulins fall in to this category.

    Some medicines, such as basic painkillers, indigestion remedies, nicotine replacement, cold relief etc are listed on a general sales list or designated GSL. This means anyone can sell them. Some medicines are on this list in restricted quantities, especially painkillers.

    A huge number of medicines make up the middle ground. The are designated ‘P’ and can be supplied only under the direction of a registered pharmacist. It includes a diverse range of things such as triptans for migraine, treatments for thrush, antibiotic eye drops and emergency contraception.

    As the daughter of two pharmacists, I can tell you that this is a huge part of their role. Pretty much anyone can be trained to follow the directions on a doctor’s prescription. In the UK, technicians do most of the actual counting out, labelling and supply or prescribed medicines. Pharmacists check on and train the technicians and also look out for errors on the part of prescribers, since pharmacists are many times more knowledgeable about medicines than most doctors. In the hospital environment they review every patient who is admitted to ensure they are on appropriate medications – this is why they train for four years! In the community, they also consult with patients about symptoms and suggest appropriate remedies – including no remedy, or seeing a doctor or other professional. They are a major, easy-access, first point of call on the high street. So for those who wonder if pharmacists want this responsibly, my response is I’m surprised they haven’t demanded it sooner!

    In the UK this method of drug supply also helps somewhat to maintain the NHS. If every item that is currently bought as a ‘P’ required a visit to a doctor and a prescription, the NHS would have failed long ago. On the flip-side, many drugs bought over the counter are also cheaper for patients who must pay prescription charges – which are rather like an insurance co-pay, but fixed at a single price charged per-item, every item (except birth control!). For those who are exempt from this charge (people with diabetes included) a medicine being designated ‘P’ doesn’t mean you can’t get it on prescription or even reduce the liklihood of that happening. I recognise, however, that this change in the US may have more far reaching consequences for insurance coverage.

    I guess I feel pharmacists are highly trained where drugs and minor symptoms are concerned and personally I would trust them to know more about what medication I should take than many doctors, even if I first needed to get a diagnosis from a doctor!

  7. CrazyACpumper
    CrazyACpumper October 15, 2007 at 12:55 pm | | Reply

    Isn’t it interesting what another country offers? Keeps track of?

    The US seems so far behind. Then someone jumps up and says, “Hey, I have an idea.”

    Unfortunately the US is so capitalist-based that it is hard to tell what “idea” benefits who.

    In regards to pharmacists, I trust them a heck of a lot more then my doctors. I have spent time with my pharmacist reviewing scripts I consistently fill, other options to save money, interactions with new medications and even recommendations of doctors to see!

    Too bad I lost all of that when I lost my insurance.

    So once again, here we are. Those who are uninsured, what are we to do? We can still consult with our pharmacists but the cost, oh the cost.

    So I beg the question again, who would this really benefit?

  8. Angie
    Angie October 16, 2007 at 11:08 pm | | Reply

    On one hand, I’d love easier access to antibiotics for recurring UTIs, for example. On the other hand, as it IS there’s usually a long line at the pharmacy. I can’t imagine what the wait would be like if pharmacists did consults.

  9. Judy
    Judy October 17, 2007 at 6:20 am | | Reply

    If test strips to go in free meters were offered at the pharmacy without a prescription and maybe a little cheaper, I would be jumping on this bandwagon!
    I don’t usually consult with the pharmacist on any prescriptions—-I don’t even go to the pharmacy until I throughly check out the prescribed med online http://www.drugs.com first! I already know exactly what the med is prescribed for and possible side effects. Not much consulting left to do. I use Walgreens pharmacy and, as someone has already said, never see the same pharmacist twice! This does not instill much confidence in consulting with the pharmacist and no, they don’t have time to talk to you anyway!

    I’m lucky enough to be covered by insurance at this time, but am old enough to be concerned about the cost of drugs when I am eligible for Medicare! More generic and affordable drugs is my chief interest. It would be nice not to pay for an office visit to the Dr to get a prescription, tho’.

  10. jamie
    jamie October 17, 2007 at 9:14 am | | Reply

    My husband is a pharmacist and we live in Canada. This is something that is being tossed around in different provinces across the country. Alberta is wanting to give their pharmacist prescribing priviledges and our province, Manitoba, is currently debating this topic.

    There are, however, restrictions on this. Pharmacists won’t be able to prescribe just ANY medication. No drugs that require bloodwork will be prescribed.

    From what I understand (and I can get his word for word on this) that for example, if you have a baby with an ear infection – you won’t have to see your doctor, a pharmacist will be able to give antibiotics for simple things such as ear infections (result of common colds) to the general public.

    He has recieved tons of reading material from the provincial society of pharmacists on this.

    Is he comfortable with this?


    I think it’s a personal thing. He has a friend who is a pharmacist out in Alberta who is looking forward to having prescribing privileges.

    Maybe it’s a personality thing? But based on the high volume of customers at the pharmacy he currently works at, and the staffing issues – it would be extremely difficult to take the time out to be doing this sort of thing with patients. They are too overworked. Unfortunately, this scene is common in most pharmacies. They do take the time to counsel a patient on a prescription that is new though … but if you had walk-in’s coming in with common ailments off the street, every pharmacy in town would be bogged right down.

    Sounds great in theory (do I have faith that my husband and his coworkers could prescribe stuff … yes, I do.) but in reality I’m not sure it would work so good.

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