Go ahead, let patients buy prescription drugs over the counter

The FDA is deciding whether to allow patients to purchase prescription medications over the counter for many common ailments.

This idea is controversial.

On one hand, deregulation would remove one of the largest barriers to receiving treatment for some conditions – the doctor’s visit. If no doctor’s visit is necessary to receive necessary blood pressure medications or diabetes medications, then patients don’t have to wait for an appointment and the patient/government doesn’t have to pay for the doctor’s visit. The move would also purportedly cost patients more money for their prescriptions because insurance companies (including Medicaid) don’t pay for over the counter medications. Therefore the costs for medications that go over the counter would be shifted to the patients who purchase the medications.

But on the other side, I’m sure that patients will Bing what medications they think they need, and the proposed plan would require patients to answer questions online or at a kiosk and then get input from a pharmacist before the prescriptions could be purchased. So there really isn’t unfettered access to the selected prescription medications.

According to the article, the American Pharmacists Association is embracing the concept while many doctors’ groups are opposing to the idea. Pharmacists believe that their increasing role in a patient’s medical care will be a good thing while physicians see many of their “bread and butter” patients skipping appointments and instead going to the pharmacy kiosk.

Some of the conjectures about such a policy should be addressed.

Will prescription costs for patients go up? If patients have to pay out-of-pocket, then perhaps they would be paying more money for prescriptions, but I doubt that the amount of money would be much more than the copay they were previously paying. I imagine that most of the medications considered for over the counter use would be generic medications from the notorious “$4 list,” so the financial burden on a vast majority of patients would not be great.

However, there are certain medications that have no alternatives. Consider colchicine, vancomycin, and Plavix. Medications similar to these would continue to command a higher price. If patients need such medications or desire name brand medications, then they will keep going to the doctor in order to get their designer medications for a $20 co-pay.

However, medications that do have a generic or over the counter equivalent will see downward pressure on their pricing. Who in their right mind would buy a $300/month name brand medication when the $4 generics (or a combination of $4 generics) work just as well? So pharmaceutical manufacturers would have to justify the price of their expensive medications or would have to lower the price until patients felt that the price justified the benefits over generic medications. That’s free market at work.

Will the public be in imminent danger if they are allowed to self-prescribe? I doubt it. The Angry Pharmacist has a different take on the matter (read the post from behind a blast shield because it is rife with F-bombs). He believes that patients who take some medications need to be medically monitored for adverse effects from the medications. For example, patients who take ACE inhibitors may have deterioration in their kidney function from the medication and may even develop renal failure. If patients are worried about the effects on their kidneys, they can see their doctors for such testing. There are also some online labs that will provide direct-to-patient testing. But if we consider the renal function example, we can also look at Mexico where patients can purchase many medications over the counter. The rates of chronic kidney disease are no higher in Mexico where people can purchase ACE inhibitors over the counter than they are in the US where people cannot purchase ACE inhibitors over the counter. Maybe the adverse effects of medications are balanced by fewer people developing hypertension-related kidney disease because they are controlling their blood pressure. Lots of potential explanations, but we won’t know the real cause and effect without specifically studying the issues. Perhaps this isn’t the most accurate indicator of adverse effects from medications, but comparing health issues in the two countries may show that some of the health concerns raised against this policy are overblown.

Will pharmacists be happy with this policy? Decidedly not. If patients are allowed to purchase prescription medications over the counter, pharmacists all over the country are going to have another very significant and time-consuming task added to their laundry list of things to do while simultaneously being expected by their employers to fill prescriptions at the rate of no less than two per minute. Consider the intent of this policy. What the government is trying to do is shift patients from a paid physician service to an unpaid pharmacist service. Pharmacists are going to be doing a lot of extra work for which they will receive no extra compensation.

And if the patient does develop a serious side effect from over the counter medications provided at a pharmacist’s advice, then the patient (or the family of the dead patient) will have only the pharmacist or the pharmacy to blame because no physician was involved in prescribing the medication. Pharmacy malpractice insurance premiums are about to go up. The Angry Pharmacist notes that there is no one to sue in Mexico if there is a bad reaction to a drug. Do pharmacists really want the target painted on their backs?

This is a case in which I think pharmacists should be careful about what they ask for.

So what’s the right answer?

Deregulation. We shouldn’t stop with medications, either. We also need to deregulate radiologic testing, lab testing, and many medical devices as well.

There shouldn’t be any input required from medical providers before patients purchase a medication, either. If patients want to ask about a medication, that’s fine. Patients don’t need pharmacist input to purchase vitamins, ibuprofen, Tylenol, Prilosec, or Claritin, so why should patients pharmacist input to purchase blood pressure medications? Just as with current over the counter medications, the onus should be on patients to research the side effects and interactions of medications before taking them. For that matter, why should we need a doctor’s permission to get a CBC, have our cholesterol checked, or get an x-ray of an injured ankle? All that the regulations are doing is causing a barrier to access. Very few people are refused x-rays if they go to a doctor and really want them.

There should be some limits on what can be purchased over the counter, though. Controlled substances and antibiotics are a couple of examples of things that should still be off limits to the general public. In fact, so many physicians inappropriately prescribe antibiotics that I think antibiotics should be a controlled substance and that physicians should lose their ability to prescribe antibiotics if they demonstrate a disregard for proper prescribing practices. Coughs, runny noses, and simple toothaches do not require antibiotics. We need to practice 21st century medicine.

So let patients purchase most medications over the counter. Yes, medical providers are still going to have to be Vicodin police and Z-pak police. For the rest of the medications, have at it. There will inevitably be some adverse outcomes and even deaths from wrong doses and from medication reactions. When these adverse outcomes occur, patients will gradually begin to see the value in the services that pharmacists and physicians provide.

We’re there to try to watch out for your interests, we’re not there to keep you from getting care and treatment that you truly need.

If you don’t believe me, you should be able to go and purchase medications yourself, knowing that you alone are responsible for any adverse outcomes that come from using the medications you purchase.

I think that is a fair trade-off.

“WhiteCoat” is an emergency physician who blogs at WhiteCoat’s Call Room at Emergency Physicians Monthly.

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  • http://twitter.com/Nickswetenham Nicholas Swetenham

    Interesting thoughts. Any examples of countries that tried this, or data to back this up?

  • maribelchavez

    Antibiotics should be off-limits but why narcotics?  They’re no more dangerous than alcohol.

  • karen3

    i think this is great. First, my pharmacist (Jill at Walgreens) is the most involved and careful member of my medical care team.  Heads about the rest.  Second, for someone with a chronic disease, the rat race of keeping track of who writes what prescriptions, when they are due, when I need to go back to the doc for umpteen prescripts, and spending afternoon after afternoon cooling my heels at an doctors office is a real chore. I can run up doctor bills of thousands of dollars to get ten prescripts that cost $4-$20 a piece, that I have taken for years with no incident. And every doctor i see has his/her own list of CYA labs that have to be run, necessitating a morning at the lab, and of course, none of them will coordinate, so its the same order for a CBC ordered over and over, even if I bring in the results (if I can pry them out of the lab — my state has a law that I can’t get lab results without my doctors permission).  It is all silly and a major effort for me that might be spent on better taking care of myself. Third, I and other members of my family have been shorted on life-necessary drugs as doctors make unreasonable demands as a condition of a script.  Dad’s primary refused to refill dad’s diabetes pills when mom was in the ICU out of town for four months, because dad wouldn’t make an immediate appointment.  Dad almost lost his sight as his sugars were in the 500s for several months.  I have also had diabetes medication and other critical meds held hostage over some docs needless demands.  

    I would urge that prescription coverage be continued on basic categories of drugs. It is good for people to have access financially and not doing so will just result in people going to the doctor and claiming an adverse reaction to the non-prescription in order to get coverage for the more expensive covered drugs.  that would be dumb. 

    Many, many countries do not have the tight control over “regular” meds that our country has.  In fact, my impression is that we are quite unique in terms of inaccessibility to routine meds.  Most people in other countries with my conditions are able to get their meds without the doctor merry go round and it is good because being a “sick person” for the doctors doesn’t become a side job, with all of the psychological baggage that comes with it.  And, instead of the doctor visit being a business meeting on this drug and that drug, this piece of paper and that, are they all signed, do I need a preauth for that, I might actually have some time to talk about my health.

  • Michael Mitschele

    Teens are abusing some over-the-counter (OTC) drugs, such as cough and
    cold remedies, to get high. Many of these products are widely available
    and can be
    purchased at supermarkets, drugstores, and convenience stores. Many
    OTC drugs that are intended to treat headaches, sinus pressure, or
    cold/flu symptoms contain the active ingredient
    dextromethorphan (DXM) and are the ones that teens are using to get
    high. When taken in high doses, DXM can produce a “high” feeling and can
    be extremely dangerous in excessive amounts.
    Michael Mitschele

  • http://profile.yahoo.com/VZF76HPVOFGGHM5ZPVCZT6AKBU Tracy

    This idea is fine for people who a., have easy access to the internet, which even in the U.S. doesn’t cover everyone, e.g., my aging parents, and b., are intelligent enough to comprehend FDA labeling about risks, benefits, contraindications, interactions, and to weigh all of that against their other drug choices or potential lifestyle interventions. Sadly, the latter does not apply to everyone. When you’re intelligent and savvy, sometimes it’s difficult to imagine how others who aren’t so bright handle decision-making. People make ludicrous, knee-jerk decisions about their health all the time, based on very little evidence. Doctors and pharmacists are a check on that. And don’t argue that the not-super-smart folk will choose to see a doctor because they don’t understand. That’s just not the case. Many will assume they know and understand enough to make their own choices.

    • karen3

      I’ve seen alot of doctors make ridiculous, knee jerk responses based on nothing but their moods.  And many of them are not very technically competent… I had a conversation with a board certified endocrinologist last week where I was told that DHEA is a corticosteroid. It’s not. It’s an androgen.   I know what I am taking, including the supplements. The docs often have no clue as to what they are writing a scrip for.  The pharmacists do.  

    • http://twitter.com/DrMattWhited Matt Whited

      Thank you for your comment. There are a lot of assumptions regarding people’s abilities in the above post and the fact is that a large number of people would mismanage their medications. Many patients don’t even correctly take their prescription medications as indicated by their physician, it’s terribly naive to think that your average person can manage their medication, let alone make a DIAGNOSIS, on their own.

  • http://twitter.com/#!/CloseCall_MD Close Call

    Agreed, everything but antibiotics and narcotics should be over-the-counter.

    Good luck with that, pharmacists of America. You’re about to enter a whole world of hurt.

  • acaffaratti

    Interesting idea… I foresee being busier than ever, but perhaps fewer med refill calls. The FDA took infant cold meds off the market because kids were dying from overuse of fairly innocuous medicine… Just saying…

  • westeasterly

    Why stop at narcotics?  It’s not like people who want them can’t get them as it is.  Same with every other drug.  Since decriminalizing narcotics, Portugal has actually seen a drop in drug addicts.  In the US, many police officers die each year in drug raids, not to mention inner city violence made possible by lucrative street prices.  And let’s not forget who bears the brunt for our prohibition policies….Mexicans, which are murdered at a rate of thousands per year; 49 just 2 days ago ( http://www.cnn.com/2012/05/13/world/americas/mexico-remains/index.html?iref=allsearch).  Legalizing prescription drugs may save some people a little money on doctor’s visits, but ending the insane war on drugs could actually save innocent LIVES.  It’s as though we learned nothing from the 1920′s.

  • westeasterly

    Exactly.  Also, kids are drinking hand sanitizer for the alcohol content.  If this teaches us one thing, it’s that no matter how many laws we pass, people will find a way to do what they want to do.  Laws just push people to do things that are less safe…whether it’s cough syrup, bath salts, sanitizer, or simply not treating your medical condition.  

  • Sophie Zhou

    If the positive is cutting the doctor out of the loop, then how does the patient get diagnosed in the first place? How does a patient self-prescribe anti-hypertensive medications? 

    Doctors are necessary to guide the patient to the right kind of care. The reason it takes doctors so many years to train in medicine is because they need the high level of knowledge in order to help treat their patients. Patients simply do not have the same skill set and letting them diagnose themselves is a harmful mistake that will cost society in the long run.

    - alittlehappi.blogspot.com 

    • sFord48

      I don’t know how many times I have gone to the doctor with a symptom and come away with a recommendation for an OTC medication.  Clearly, I don’t need to continue seeing the doctor to take the medication.

      I take several prescription medications.  Each year I must see my doctor, every year he asks the same cursory questions, every year I get a prescription.  I know what side effects are concerning, I know what type of changes to look for in my condition…mostly because I have heard it over and over again.  What’s the difference if the kiosk asks me the questions instead?

  • pritikin

    Sophie asks: “How does a patient self-prescribe anti-hypertensive medications?”  Most people can walk into most Walgreens now and check their BP for free. If it is on the high side they can buy a home BP monitor. It comes with directions. If after a week or two or monitoring the readings show numerous levels above 140 or 90mmHg the patient can easily go online and determine what type of BP meds they might benefit from. Better yet they might cut way down on salt and eat more fruits and vegetables and see their BP drop into the normal range without any need to buy drugs. If they are unwilling to treat the cause of the HTN then they could try a cheapy BP med or two OTC. Their home BP monitor tells then if its working. If they are unable to control their BP with diet and/or drugs then it is time to seek help from an MD (or better yet a nutritionist). Since HTN is the #1 reason people go to an MDs office each year this ought to save some money. So there may be some risk to OTC BP meds I think it would be pretty easy for Walgreen’s and others to set up a website that walks people through the DX and Tx options for elevated BP. In most cases (certainly not all) an MDs involvement is hardly needed. Same for controlling BS in someone with type 2 DM, or elevated LDL-cholesterol. This stuff ain’t rocket science and to pretend MDs must be overseeing everyone with these conditions seems driven more by greed than reason to me.

    • http://twitter.com/#!/CloseCall_MD Close Call

      Great! High BP is so easy to diagnose and manage.  It’s very simple how this would play out:

      1. Get an accurate reading.  The pharmacy’s on-size fits all BP cuff says one measurement.  My at home one says another.  I wonder which one is accurate.  Oh, I didn’t know I had to be sitting.  Oh, I didn’t know that my arm had to be at the level of my heart.  Oh, I didn’t know that my feet couldn’t be slightly propped up.  Oh, I didn’t know that not all at home BP cuffs are made equal.  

      2. Let’s try a cheapy BP med.  Hydrochlorothiazide.   Big name, but little cost.  I’m going to start taking it in the evening, because that’s when I have my cigarette and that’s when I take my BP and notice it the highest.  Why am I peeing all night?  Do I have diabetes?  I think I have diabetes!  I know I have diabetes!  Time to start metformin.  

      3.  Hmm. The BP is still high after 1 week of treatment.  Time to add another one.  Let’s see.  Lisinopril, metoprolol, norvasc.  Which one do I do?  I wish there was a good site to tell me which one to exactly do next.  Oh wait, there’s a kiosk for that the pharmacy.  Why doesn’t walgreen’s have their’s online?  Oh, that’s right – the whole point is to get me into the store to buy more products.  Their “super-special most-accurate kiosk” is only available in the store.  Another trip to the pharmacy!  Yah!

      4.  Hmm.  So I’m on hydchlorothiazide, lisinopril.  My blood pressure still isn’t going down.  Let me take another drag on my cigarette and think about it.  It’s been 1 week, and still no improvement.  Let me add another blood pressure med.  I think norvasc.  Also, I think the lisinopril is making me nauseated – it says that could be one of the side effects.  But metformin also lists nausea as a side effect.  Which one do I stop?  I think the lisinopril, because I for sure must be over-doing it on the blood pressure meds. 

      5.  So last night as I was getting up to go pee, I tripped on a rug and fell and broke my hip.  DARN YOU NORVASC!  YOU DID THIS TO ME!  YOU MADE ME TRIP!

      6. Hello, hospitalist doctor.  Yes, I do have high blood pressure, but believe me… it’s very well controlled.   

      • pritikin

        Close Call – Not every nonMD is as stupid as you seem to be claiming. None of the problems you list are all that difficult to overcome with a little research – like reading the instructions on the home BP monitor that tells you how to measure your arm to determine the size of the cuff and how to use the machine. Research has proven basing therapy on home BP measurements works better than BP measured in MDs office. BTE – I have had my BP taken in MDs office and the “staff” have never followed proper protocol. Then there’s “white coat HTN” which don’t happen at home. Learning how to take your BP properly ain’t hard if your motivated and can read.

        I had a professor of medicine come through our program with long standing resistant HTN. He had been on 4 different BP meds for several years and had been hypertensive for 20years+. He taught a course to MDs on how to control BP with drugs but he could even control his own.  He had a PhD in pharmacology but still ended up with resistant HTN. In 9 days on a healthy diet and exercise program he was off all his BP-meds and his BP was now controlled without any drugs.

        Maybe we ought to have nutritionists seeing people with HTN instead of MDs?  Those who believe the key to good health are drugs prescribed by MDs (or pharmacists) for largely diet and lifestyled caused ills like HTN, Type 2 DM, atherosclerosis/dyslipidemia perhaps should have taken a course in clinical nutriton from a competent instructor.

        • sFord48

          My husband has borderline hypertension and was told by his MD to get a home monitor to see what is was at home.  If home monitoring is so useless, then why recommend it?

        • http://twitter.com/#!/CloseCall_MD Close Call

          ” None of the problems you list are all that difficult to overcome with a little research.”

          Really?  Are you serious?  How much spare time do you have?  Because you could spend HOURS going through the diagnosis and management of HTN.   Here is just a small sampling of questions and considerations that doctors have to go through when initiating BP treatment:

          1. How accurate is home BP monitoring?
          2. What is the best diet to use for optimal BP control?
          3. How many mmHg on average does a low salt diet bring BP down? Systolic or diastolic?
          4. How much exercise a day is recommend for BP improvement? Does it improve systolic or diastolic?
          5. How many mmHg on average do these recommendations bring BP down?
          6. How long do you try conservative therapies before initiating medications.
          7. What medication should you use first?  What dose do you start at?
          8. How many days or weeks do you give that medication to work?
          9. If the blood pressure is not improved, what medication do you move to next?
          10. Do you add a medication, replace a medication or change a dose?
          11. How many days do you give that new medication to work?
          12.  What monitoring labs should I do for each medication if any?
          13.  What are the main side effects of each medication?
          14.  So now there’s a cough, maybe because of an ace-i or maybe because of post nasal drip or a lingering viral illness.  How do I know which it is?
          15.  How long can a cough last for after stopping an ace-i?
          16.  How long does it take for my leg swelling to get better after stopping ca channel blocker.
          17.  How much will caffeine increase blood pressure?
          18.  How much will lack of sleep?
          19. How much will sleep apnea?
          20. How much will smoking?
          21. If I’m african american, which one should I do first, second, third.
          22. If I’m 80, which one do I do first, second, third.
          33. What are some completely random but not uncommon causes of high blood pressure in guys in their 30s?  How bout 40s? How bout 80s?
          34.  What number should we care more about?  Systolic or diastolic?

          Are you REALLY expecting people to do google searches for all these questions on their own?  Please, if you have a link that answers all these questions… I’d LOVE to see it.   Even with something as “simple” as high blood pressure, doctors still have to look up a ton of stuff, because it’s a complicated subject with years and years of (sometimes conflicting) data behind it.  And I wouldn’t call anyone who doesn’t understand it “stupid”.  I’m just not naive enough to call it “simple”. 

          • pritikin

            As sFord48 notes even the better MDs know home BP monitoring has been proven to be more accurate wat to determine a patient’s BP than MD office BP readings.

            As far as questions 2 & 3 they are far easier for a competent nutritonist to answer than your average MD. Most (not all) MDs pooh pooh the impact of excessive salt intake (what nearly all Americans eat every day even if they never touch a salt shaker) on causing and maintaining pathologically high BP. Better yet a nutritionist can explain how what you ate probably caused your BP to go too high and can tell you how to eat in the future so you can get rid of your hypertension and not ever need to go to an MD or the paharmacy to get drugs (that have a 0% cure rate) again. But you say BP drugs control hypertension. Not all that well compared to diet and lifestyle changes and without the side effects.

            Of course, good luck trying to get your “health” insurance company to pay for expert dietary counseling from a real nutritionist. The system is rigged so as it pays MDs quite well for what they do while paying poorly or not at all for what other in many case far more compenent health professionals do. And we wonder why Americans spend far more for healthcare and die sooner than people in dozens of other countries!?

          • http://twitter.com/#!/CloseCall_MD Close Call

            I think if you search and find out the answers for questions 4-33, you’ll find it not as simple as “curing” HTN.  Diagnosis of essential, secondary hypertension, and just determining what is an elevated blood pressure can be tricky. 

            Yes, home BP monitoring can be good, but even that can be complicated.  People with undiagnosed arrhythmias shouldn’t be monitored solely at home.  Auscultation method is better.  Does a nutritionist have training in picking up arrhythmias?  And even if you do measurements at home, they should be brought in intermittently to a doctor’s office to make sure they’re working properly and compared with auscultation, because… surprise, many home BP cuffs are cheap and cannot insufflate as well over time.

          • pritikin

             “Does a nutritionist have training in picking up arrhythmias?” Close Call

            Nope. In fact by law nutritionists cannot even diagnose HTN, let alone an arrythmia. Dx HTN is pretty easy and treating with diet and excerise is actually easier for a nutritionist than most MDs. The fact is most MDs think salt reduction (and other changes) are far less effective than research and controlled clinical trials show. There pessimism in the efficacy of dietary change for lowering BP is actually paradoxically fueled in large part by their own incompetence at getting their patient’s to actually reduce salt intake. Of course, they never discover their incompetence because apparently it never occurs to them to check the urinary sodium to creatinine level that can reasonably establish whether their patient actually is complying with a low salt diet (at least over the past 24 hours or so). Because MDs who suggest their patient reduce salt rarely see much reduction intheir BP most lose whatever enthusiasm they might have had based on understanding of its pathophysiology learned in Medschool (and that’s assuming they had a competent instructor that follows the clinical nutrition research on salt toxicity – sadly few do).

            Here’s the bottom line. A large % of people with HTN could easily Dx themselves and seek expert dietary counseling on how to adopt a diet high in potassium and markedly reduced in salt. For those just developing HTN and not on drugs or those headed toward HTN and who now have prehypertension diet and lifestyle changes ought to be tried before BP-drugs. Most those already on BP drugs may well need their MD to cut doses or eliminate them when their patients adopt a healthy diet very low in salt and high in potassium rich foods. Sadly few MDs know how to do that and BP drugs can be dangerous for those on a healthy diet. It’s is like MDs get patients dependent on drugs to control diet caused ills and in some cases as with BP or type 2 DM getting off the drugs actually make adopting a healthy diet more complicated and even dangerous.

            So you keep thinking MDs are the answer for ills caused largely by what people eat and see how things work out. Lots of people eating crappy diets high in salt end up with LVH and arrythmias despite the BP meds. At some point in this healthcare crisis we are going to have to pay for less medical intervention and create a healthcare market place where people have equally access to a variety of health professional who in many cases are better equiped than MDs are to treat and certainly prevent ills like obesity, type 2 DM, HTN, and atherosclerosis.

  • karen3

    so, I rely on a med which is necessary to live. the only doc for this speciality covered by medicare within 30 miles within my house somehow got licensed without a clue…. So, I pay $150 for a ten minute phone consultation with a specialist I saw before, he calls in the scrip, but wont do a preauth for a drug that costs $100 without insurance, but $10 with.  Pissing contest between doctor and insurance ensues. I give up and order it online from overseas and it will be here in three days for $4 per month supply.  Undoubtedly there will be another round of peeing over what labs I need and it will be resolved by my ordering the labs for less with a direct lab online deal than I would pay for the doctors appointment to get the labs.  I so, so, so wish I could cut out the doctors because I would have such better coordinated care, and less stress, without them.

  • civisisus

    I admire the restraint you previous posters have showed in refraining from pointing out that the physician urging open shopping season on most if not all medications is an emergency room doc….

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