U.S. to make More Drugs Easily Available, Cutting Role Doctors Play
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As it is, the only medications that require a prescription to buy in Saudi are psychotropic ones, narcotics, and most recently, antibiotics. Things like insulin, birth control medications, hypertension medications, even antidepressants and anti-psychotics- they are all OTC. And I think they should remain so, because from what I've seen the damage from misusing those drugs against pharmacists' advice is far less than the damage from going without them due to the difficulties encountered in seeing a doctor.
The reason that this is the norm here is twofold; one, health insurance wasn't much of a thing here until a few years ago. The second reason (and the reason health insurance didn't factor in until recently) is that the socialized healthcare system here was (and still is) stretched thin; seeing a doctor to get prescriptions for every little thing becomes prohibitively difficult, with appointments taking months.
It's asinine to expect someone suffering from, say, an acute athsma attack to try to navigate ERs or try to see a doctor on short notice during a crisis, when a pharmacist would be able to dispense the exact medication needed, leaving the others free for more complex cases that need closer attention.
Edit: this actually created a bit of culture shock for an older friend of mine. He was traveling to an EU country for the first time and didn't do his homework- he thought he he could simply walk into any pharmacy and ask for a pack of his cholesterol medication, as he usually does back home. I don't envy the poor pharmacist that had to keep trying to explain the dispensing system to him and to emphasize that yes, they are aware that it's Lipitor, not morphine, it's just how the regulation is.
Second, i think such a system makes pharmacists de facto community doctors, but without the time, training, or patient medical data to function correctly. Community doctors can make better decisions when they see the same patient multiple times, and have access to blood pressure readings, a list of other medical conditions etc. Buying over the counter makes a lot of this difficult and inefficient.
Third, I think it leads to a risk of encouraging patients to manage conditions without valid medical advice. For instance, depression is often treated best with psychotherapy. By buying antidepressives OTC, it prevents patients getting the holistic care needed. Similarly, patients may follow quack medical advice and do themselves significant injury by taking medications not needed (in the short term or long term).
Ultimately doctors offer a lot of value more than just prescribing medication, and often medicines need oversight to ensure the benefits outweigh the risk.
Yes, medications carry risk. But, "without a doctor's prescription" does not mean randomly. People still take advice from doctors and pharmacists, they just aren't required to have proof that a doctor has decided something. In any case, a pharmacist is a pharmacology specialist and probably more knowledgable about drug risk and safety than anyone.
>> makes pharmacists de facto community doctors.
Again, depends on the ideal you are comparing to. You are implying an ideal community doctoring setup, where a local doctor knows people and is accessible to them. An ideal that exists for maybe 1%-2% of the world. The problem that pharmacist/nurse led care solves is that this ideal does not exist. GPs are inaccessible, cost $75 for 10 minutes or don't have appointments available. A pharmacist probably sees someone every time they're sick. Doctors... only if it's bad.
I feel like this sort of issue comes up often, when discussing primary medicine. The comparison isn't fair. When listing the pros and cons of pharmacist or nurse led care, we get a laundry list of real life issues. When listing pros and cons of doctor led care, we get an idealisation. IRL, most GPs prescribing antidepressives do exactly as much "holistic care" as pharmacists would. Patient asks for ADs. Doctor spends 2-3 minutes going through a checklist. Done. Whether or not that's ideal has little to do with who writes the script.
Anyway, I don't have a problem with the way primary care works here. It works well. I didn't mean any of this as a slight on the job doctors do. But... I also think pharmacists and other trained people can prescribe medication, tests and such. There is value in accessibility. If they can (as I think some of these ideas take as premise) provide walk in service, there is good reason to do it.
I know people prescribed antidepressants from GPs, in the UK as well. 10 minute appointments several times per year.
A U.S. Pharma.D is a professional doctorate degree. They don't just study organic chemistry, but also little things like treatment indications and counter-indications, patient management, etc.
Having access to the patient's medical history is a solvable problem. Some pharmacists already have access to and make use of such information.
Regarding patient time, there are more pharmacists in the U.S. than primary care physicians--roughly 290,000 versus 250,000. (See https://www.statista.com/statistics/185723/number-of-pharmac... and https://www.ahrq.gov/research/findings/factsheets/primary/pc...)
The problem today is that we waste our physicians' expertise on trivial stuff. It's an inefficient allocation of resources. Pharmacists have traditionally always been on the front-lines. The past half century in the U.S. has been anomalous in how underutilized are our pharmacists. Fortunately their training is still quite rigorous. They regularly catch physician errors, including a significant portion not related to drug interactions. (See https://www.sciencedirect.com/science/article/pii/S131901641...)
As long as the lines of communication are kept open, what's the issue? An M.D. or O.D. doesn't make one omnipotent. And U.S. pharmacists are better trained than the pharmacists in many other countries who enjoy greater independence and authority. The sky isn't falling in those places, AFAICT.
I agree with you that a pharmacist is capable of dealing with many of these issues, but (at least in the uk) they are not primarily set up to deal with long term health conditions, and don’t develop that expertise in a single patient. If they become like GPs (which they feasibly could), it would work. But why do that when there is already a doctor who specialises in that? Maybe my arguments work less well in America, but my knowledge of that healthcare system is limited.
Ultimately though it seems we agree medications need some form of specialist oversight, rather than being freely available.
Probably due to people previously being able to buy saline over the counter, and using it to inject themselves with etc. Misuse of things by people generally ends up with knee-jerk responses by regulators.
I don't think you should need a prescription for saline, but it's a little more complicated than salt water.
I’ve absolutely benefited from my endocrinologists over the years, but 80 appointments for 2-3 prescription changes (prompted by my request each time) seems like excessive rent seeking.
I think there's a bit of Dunning-Kruger at play here. People think they can make their own judgements based on the drug monograph and simply checklist over the contraindications/interactions and call it a day. And there are others who share their pills with relatives/family members because "its worked for me before". There's another special group of people who think that piecing together a pharmacological narrative will bring about a clinically meaningful result (it works in theory, so it must work in practice!). Others think statistical significance == clinical significance.
The typical community pharmacist is absolutely not equipped with the tools, incentives, and workplace conditions to assume the role of a GP. We are trained in evidence-based drug therapy management, not diagnosis. I'm also deeply concerned about how retail pharmacy corporations will adapt to this. I imagine that there will be a new metric: prescriptions sold/visit that regional directors will be optimizing for. If not a prescription, then you need to sell an OTC product.
A lot of people think they can DIY medicine. It will be a disaster. I've worked in a very high-income area with a very professional clientele (business owners, health care workers, lawyers, finance), and many are completely swayed by false information or "studies" they read online (because they are intelligent professionals, after all).
We need better access to high-quality healthcare, but not through DIY medicine. This proposal is the result of people running out of ideas and giving up.
So, a person having an obvious anaphylactic shock and being denied an epipen (and dying) is not problematic to you because that would be "DIY medicine"
http://www.foxnews.com/health/2013/12/23/girl-dies-after-pha...
Then why not consult a doctor? It is already an immense legal risk to recommend starting a course of drugs like this without seeking medical advice, I don't see why it would be any different if you could technically self-administer an anti-hypertension drug.
Most people don't go to the doctor before taking Claritin or Sudafed; when you go to the doctor and get a "script" for Sudafed, that's your signal that you wasted yours and the doctor's time.
The tragedy of the situation is that most prescriptions aren't as effective as marketing campaigns lead people to believe. For example, statins are good for improving patients' cholesterol lab #'s, but make them achey, and only prevent a handful of heart attacks for every 100 patients treated (statins have a poor 'number needed to treat' [0] ratio).
[0] https://en.m.wikipedia.org/wiki/Number_needed_to_treat (the section titled "simple example" says ~98 people had to take the studied cholesterol drug for 3.3 years to prevent one cardiac event.)
Number needed to harm is another important factor. All patients were harmed by DES [1], before it was withdrawn...
>>> Americans may soon be able to get cholesterol-lowering medications
Going to the doctor to get such a medication is one more occasion to be reminded to check your diet before jumpin' on pills...
For the newly available medication, I'd suggest to raise their price by half the price of going to thte doctor to get the script. That money would then be given back to social health care system :-) So the patient pays less, have more flexible access to the medication and healthcare system benefits too :-)
It seems in the us, seeing a doctor already is a luxury.
I think allowing diabetics access to life saving medication is preferable, even if there's some moron that's going to kill himself by injecting something he has no idea about (and they do that already)
The proposal wouldn't allow the sale of controlled medication like antidepressants
The rest just sounds like undue gatekeeping
>Please don't insinuate that someone hasn't read an article. "Did you even read the article? It mentions that" can be shortened to "The article mentions that."
In particular, I was replying to Lanthanide’s comment on the system in Saudi Arabia.
I agree with IanCal, giving insulin to someone not already prescribed it is hard to justify. The risk of harm is much greater than the possible benefit, especially when they could just go see a doctor (routinely or as an emergency). I am from the UK so perhaps I live in what you would consider a nanny state, as guns are not freely available. As a point of information, in the UK antidepressants are not controlled more than any other prescription drug, I don’t know how that differs in the USA
I don't think anyone is arguing for diabetics to not have access.
My problem here is how someone knows they are diabetic.
But I saw little in the article actually describe what the process would be for deciding what can be sold like this, I know diabetes is not mentioned.
Again, I don't really see why this would be the problem of the person selling it, unless you prefer living in a nanny state.
There are a multitude of OTC and other readily sellable stuff that if misused can cause death. Complaining about selling insulin freely and the dangers of it in a place where guns are sold like candy is a farce.
Make them sign a waiver and be done with it.
People regularly poison their livers with hypervitaminosis A, yet vitamin A supplements, liver meat, and other extremely dense sources of vitamin A are not labelled in any way which would indicate this danger. Beyond products, the sheer number of ways you could kill yourself in this world is staggering, why is it more wrong to be exposed to risk from pharmaceuticals than from something like traffic or supplements?
I currently live in the Maghreb and the situation is here as it was described for Saudi Arabia. An important difference to Western countries is that pharmacists seem to play a much more important role here: I have to justify every purchase (even for very common broad spectrum antibiotics) and locals tell me they regularly seek advice at the local pharmacy first. Think "doctor's appointment pre-screening". And my highly subjective impression is that the quality of this pre-screening surpasses service in western pharmacies by far.
Though, the problems you point out are very real, just mitigated by the different situation.
Another thing that makes the situation incomparable to western countries is the low density of qualified doctors: If you need psychotropics here in my village you would have to move several hours away into the next big city to do a therapy. So it is: diagnosis, prescription and off you go. One can go on with a single prescription for years and I dare to say that the debate on whether this is good or bad here is still open.
Being able to go from "Ask your doctor about..." to "Try..." is a major shift.
This type of aggressive drug ads is pretty much unique to the US. It's your MD's job to stay up to date with drug developments and prescribe what would work for you.
Big name pharmacies like Walgreens or CVS won’t dispatch u a medication without a prescription, the town pharmacies (Mom and Dad) would do it.
A week ago I avoid the hassle and loss of time (travel, waiting time, and $) just going through the town pharmacy and asking for a antibiotic, having a prescription won’t make any difference as the insurance plan won’t cover it.
As OP says, this system exists in the real world and how it actually works can be studied.
Preventing people from getting the medication they need is a terrible idea.
The self-medication thing is a seriously double-edged sword. You elucidated why very clearly. I have two reasons though to believe that it's a SLIGHTLY less risky practice over here;
1, pharmacists are very engaged with patients in recommending medications and constantly steer them to doctors- and they are more confidant with in-class substitutions rather than dispensing to a patient outright without vitals or history (beyond what is disclosed orally by the patient). However, they'll still recommend medications freely when they judge them as being unlikely to go to a doctor otherwise, hence risking more damage. Lesser evil and all that.
2, a long history of OTC availability of medications, where controlled prescriptions are the exception rather than the norm, seems to have lead to a culture of caution and careful reading of medication leaflets, asking the pharmacists, etc. I don't mean this as necessarily a good thing, I think this is more of a "you're on your own" mentality with regards to being careful with medications. This mentality grew, I think, partially from issues with access to doctors (governmental neighborhood health centers, kind of like small GP practices in the US/UK, are a somewhat new thing here. It was all centered around huge hospitals in the past). The bigger problem, in my opinion, is that this mode of thinking is about to be reinforced further by rising healthcare costs in the face of the rapid privatization of the healthcare sector, and it will clash with increasing OTC regulations.
One aside I will say about antidepressives which you mention; I think this merits a special examination separate from the rest of the healthcare issues. I've slowly come to realize that a massive portion of the population here are actually on antidepressants (mostly SSRI and SNRI meds). Why is this notable? Because it's not anywhere near commensurate with the number of people using psychotherapy or visiting psychiatrists. The reason, I believe, is because there is such a stigma around mental illness here that I think it would be very difficult to get many of these patients into more suitable therapy, and OTC Prozac or what have you helps hide the ""shame"". We're finally, FINALLY slowly moving past this stigma, probably catching up with the public attitude of the US/EU towards mental health in the 1980s or so. I really hope this will eventually lead to mental health patients not feeling that they need to self-medicate.
Edit: I forgot to mention that you're also completely correct in the assumption about quack medicine. It is, unfortunately, endemic here. It's a constant struggle to convince loved ones that, no, Supplement X is neither a peer-reviewed medication nor is it an alternative for treatment. At the very least the regulatory environment is increasingly more strict about misleading medical claims on herbal products, etc
This would be so nice. Every time I switch providers, I have to hear the same tired "Lisinopril is the modern blood pressure medication and it's certainly all that you need!" "No asshole, it doesn't work for me and it makes me cough 17 times a minute, 1440 minutes a day. Just give a water pill, which does work and has worked for years."
I get that treatment is frequently trial and error when it comes to medications, but the doctor/patient/pharmacist loop is BS, particularly for minor/frequent issues.
Take for example that I seem to run myself into poison ivy a couple times a year while mountain biking. Do I really need to fight to see a doctor/nurse/whatever just to have the same prescription I've gotten the last couple years straight? Or for that matter, maybe I should experiment more with stronger allergy medications to avoid the nasty withdraw I seem to get from prednisone.
Worse, what irritates me, is like the GP, it seems a lot of the common "safe" prescriptions in the US are over the counter in the rest of the world.. I know this, but got myself quite a surprise last time I was in mexico, because the hotel gift shop had viagra next to the advil!
What tends to happen in some EU countries is that the retail drugs are heavily subsidized by the government, and then all kinds of kludges are put in place to prevent people buying bulk quantities and reselling them in some other EU country where the price is much higher - the export itself being 100% legal on the single market.
(unless Austria, where this happened, really does have very strict OTC drug laws on medical grounds)
This would be off-topic here, but I think most people outside of the region would be stunned about the state of sex-change operations over here. They happen VERY frequently, albeit with a heavy veil of privacy.
When people start self prescribing antibiotics even for minor stuff, it’s not a problem because of the minor risks to them, but because of the major risk to the entire society. We are seeing more and more antibiotic resistance germs and if we don’t collectively work to reduce antibiotic usage we end up exasperating the issue.
As far as I can see all drug advertisements (including things such as social media promotions) have to be approved by the Saudi FDA, and they don’t seem lenient at all in allowing ads for anything beyond the aforementioned meds.
For the short term prescriptions though, cutting the doctor out of it makes people much more susceptible to marketing (instead of 'ask your doctor if you need X' we'll get 'You need X if you have any of a, b, and c...get it now before it's too late'.
Also, the doctor is aware of your health history and can spot reasons you specifically shouldn't take a drug, or better alternatives. Maybe you are overweight and one diabetes drug would work for you, but this other one will also help you lose weight. Maybe you have a loss of kidney function, and shouldn't be taking metformin. Your pharmacist should catch drug interactions, but they can't catch problems that would result from your past medical history.
For me this is big pharma getting their way, at our cost, in more ways than one.
Citation needed. I'm sure are a few doctors out there who do that, but I have a hard time believing that's so widespread that it's a "habit" of "doctors." For instance, my doctor will reissue my long-term prescription if I call him, the next I hear of it is when the pharmacy sends me a notification saying it's ready.
That said, I'm sure there are prescriptions that actually do require regular long term medical monitoring by a professional, even if a lot of people are annoyed by that and therefore think it's unnecessary.
33% certainly counts as more than a "few" in my book.
Citation:
https://www.reuters.com/article/us-birth-control/women-seeki...
It seems to me that, of many imperfect systems, one where doctors have control is more preferable. They are legally and duty bound to serve their patients. The same can't be said of pharma company marketers, not by a long shot.
Let's solve the right problem (updating doctors with new training), not the wrong one (let people but prescription drugs they may not understand). Not all drugs are as cut and dry as birth control pills may seem to be.
It discusses a series of studies on the "ability of patients to self-screen for birth control pill eligibility", and determines that patients are good enough at self-screening that the medication may as well be over-the-counter.
It sounds like, from the initial article, that the FDA is taking a similar approach: "Drug companies would have to submit data to the FDA that shows consumers are capable of accurately assessing their need for a medication and their ability to use it correctly."
Obviously we'd need to wait to see what the FDA actually approves/disapproves for these purposes, but it actually seems quite likely the approved drugs will, in fact, be restricted to cut and dry ones, such as birth control pills.
BTW, the 33% number you cite in parent comment doesn't include responses to the pap smear question, only the pelvic exam, and is specific to family doctors.
In the US, where we have no standards of care, this is true. In centralized systems like France, doctors receive updates to expected standards of care annually based on analysis of the latest evidence.
This has interesting effects. My father did the statistical work for a set of expert consensus guidelines in psychiatry. He found an interesting pattern: the European practitioners produced basically the same decision tree, from Sweden to Spain (that is, physicians practicing in completely independent healthcare systems). American practitioners were so scattered that sometimes you couldn't extract guidelines.
This is also why you can have an operation done safely in a rural hospital in Italy, whereas in a rural hospital in the US, the only thing you should let them do is put a bandage on you and transfer you to a real medical center in a major urban area.
In the US, with the cost of attorney-mediated access to the judicial system, this is not really a protective constraint for the bottom 90-95% of the population against exploitation by unethical medical providers.
I'm interested in discussions about data transparency: anonymized, aggregated data about the patient population seen, the outcomes, and the amount spent, per doctor or set of doctors (if multiple specialists are seen). The former data set so doctors don't start cherry-picking for best outcome patients. The latter data set so doctors can start observing the average and median standard of care, and there is more uniformity of care across the field.
At the moment, only the health insurance companies have access to this kind of data.
It doesn't come close to making anybody whole when things go wrong, but the threat of litigation certainly modifies the way medicine is practiced.
> It doesn't come close to making anybody whole when things go wrong...
You are advocating that the system works for a value of "works" that rises above the hurdles of incentives where the minuscule fraction that trickles down to the patient and where "the way medicine is practiced" is a lucrative enough target for the expensive litigation. If you build software systems like you advocate for course corrections in medical practice, then you'd bin every trouble ticket until it came from a "big enough" customer with a "severe enough" problem. To each their own, but I'm personally in favor of granular, incremental changes that are more manageable and responsive to the market.
Waiting for litigation to change medical practices is no different than ignoring a defect in the design, implementation, and testing phases of software, and letting users find it beat down your door before fixing it. US doctors largely won't even adopt checklists yet, despite proven efficacy. It is unacceptable to have to wait for future litigation to see it adopted in mainstream medical practice.
For the record, I agree that there are many things that could be improved in the current medical system.
Pap smears (when done at the recommend intervals - most doctors overtest) are extremely beneficial screening tool and they save lives, but they have nothing to do with birth control - the purpose of a pap smear is to screen for cervical cancer.
In fact, the current recommendation is to wait until a women turns 21 before starting pap smears, yet many (most?) women will require contraceptives before 21.
It's also false that "birth control pills aren't really safe." - "potential to have serious side effects" is not even remotely the same thing as "not really safe." Oral contraceptives are not more dangerous than NSAIDs like ibuprofen. Both The American College of Obstetricians and Gynecologists [1] and The American Academy of Family Physicians [2] recommend over the counter access to oral contraceptives based on the availabile evidence
[1] https://acog.org/Clinical-Guidance-and-Publications/Committe...
[2] https://www.aafp.org/about/policies/all/otc-oral-contracepti...
It's a huge step to go from "they're not completely safe" to "...and therefore a doctor needs to be constantly checking up on you". Lost of things have potentially serious side effects, including most OTC medicine. And?
I mean, peanuts are pretty dangerous too; they kill people every year, and the side effects are potentially extremely severe. Does that mean a doctor needs to be involved in the process of me buying peanuts?
> It seems reasonable to have periodic checks for those, if you're taking them.
Reasonable is a low bar. Your suggestion does seem reasonable, inasmuch as I can see a reason why you'd want to do it. I can see reasons why you wouldn't too. We need more than that.
Pap smears and pelvic exams, however, are not checks for the potential serious side effects of birth control pills.
It's about like being forced to have a colonoscopy before being allowed to get NSAIDs, because NSAIDs have potentially serious side effects.
It isn't just that it is safer than being pregnant. It is seriously better for some folks to take birth control because of the severity of their monthly cycle.
Some folks can't take tylenol. Ibuprofen can cause ulcers. Folks take heartburn pills (such as Prilosec) without being diagnosed. A body can form a dependence on certain laxatives. This doesn't mean they aren't generally safe for folks when used properly. Having some of these only available after talking to a pharmacist shouldn't shouldn't be a big deal, especially if you have to get the first dose with a prescription from the doctor.
What isn't reasonable is folks having to have an actual visit to the doctor every time a prescription runs out. It isn't reasonable to force people to have unnecessary pap screens to get birth control either - so long as your tests are normal and you aren't having other issues, there is no reason to have one every year even. Every 3 years tends to work out just fine.
I was getting an annual physical from the doctor who had written a prescription that was expiring. We discussed the condition and agreed I needed a renewal. I was told I had to come back for a separate visit "because Obamacare required it" My translation: because he couldn't bill for writing out the prescription during well-check, and because he wanted/needed to charge for it. Oh, and blaming Obamacare because I live in a predominantly Republican area.
It was directly the grandparent's case, of doctors requiring unnecessary visits to maximize their profit.
Even if I had no deductible or co-pay, where do you think the insurance company gets the money to pay for this extra visit? It's from the insurance premiums we all complain about (that is, from my pocket).
Again, I don't think the doctor thinks of it that way. He just thinks, "We have to separate well-patient visits from any other services", not, "If I make this patient pay $300 and spend 2 hours, I can pocket another $100 for 1 minute's work."
This "citation needed" thing for every little fact and factoid is getting weary. Yes, often facts are cited that require more evidence than merely recitation. But if you overuse "citation needed" then it loses its power as you come across as attempting to pettily shut down people you disagree with. Use it with care.
The above mentioned case of doctors who require a pap smear for birth control is unrelated; it’s a barrier to access to contraceptives, which is motivated not by medical concerns or even greed, but by politics.
Things are probably different if this is a long term doctor you've established a relationship with; but in my experience no lab tests were done, just a lot of unnecessary paperwork and pay the lady at desk.
Doctors have insane liability standards, particularly in the US.
https://www.nhs.uk/common-health-questions/medicines/what-is...
https://www.pharmacyregulation.org/education/pharmacist-inde...
https://www.nhs.uk/NHSEngland/AboutNHSservices/pharmacists/P...
Also in the case of oral contraceptives, a change recently went through here (last year I believe) making oral contraceptives OTC as long as the purchaser had been prescribed them within the last 3 years. Bit of an odd compromise, but a nice stepping stone towards greater liberalisation if it doesn't end up causing issues.
They can and do. See, e.g., https://www.sciencedirect.com/science/article/pii/S131901641...
Pharmacists in the U.S. are highly trained medical professionals. A Pharm.D is a professional doctorate. Their expertise extends beyond chemistry, and more importantly are trained well enough to know when to seek the advice of, or refer a patient to, an M.D.
It's not that pharmacists aren't trained well enough to do these things. The real issue is that most electronic medical records are locked behind proprietary walled gardens. Outside HMOs and similar vertically integrated medical systems, pharmacists don't have reliable access to medical histories. This is a solvable problem, though.
Your doctor skims your notes in the 20 seconds between the receptionist calling your name and you entering her office, in handwriting she can barely read herself, and has forgotten you before you’re even back in the waiting room after spending 5 minutes talking to you while she’s really thinking about the new Audi. That’s as far as the awareness goes.
I have multiple friends who made it all the way through residency and have since stopped practicing within years of "graduating. The OP describes the profession much better than you do, as a whole.
Double booking patients, requiring certain revenue targets, massive amounts of useless paperwork, etc. Considering the varying ranges of where they took up residency I'd say this is endemic industry-wide. Also jives with my personal experiences with the medical field.
Big companies have more people doing billing alone than doctors themselves. Pretty clear cut case that regulation is the enemy of efficient markets.
The issue is that doctors work for insurance companies and that means you need to do things a certain way they like while matching the way they practice and document their medical decisions.
I could explain more since I am part of one of these startups :)
I’m ok and I think glad that pharmacists don’t even have access to that information.
Not trying to be snarky--I understand the argument--just pointing out how absurd that seems to be to some.
The problem is, my neuros keep retiring, so I have to start over, begging for an appointment from a new one who doesn't have anything sooner than three months out. When I finally get in, I tell them my previous dosage, and they write me a script.
Reminds me, some time ago I researched a supplement extensively before taking it. Then when it turned out to be helping me, I asked my doc if it was safe to continue taking it. He just Googled it, clicked on the first search result, and determined it was safe.
To add to the discussion however, I would include sub-components of supplements such as BioPerine which is just a commercial version of piperine. Several supplements I take have this and it changes how drugs are processed in the liver. Drugs that would normally have a small chance of minor side effects can suddenly have dramatic and unpredictable side effects.
I'm with you up until all the people who "know" they need antibiotics for things that antibiotics don't work for. There's strong public health justification for putting a doctor in the loop on occasion.
Remember when you needed to go to a doctor to get a prescription for Fexofenadine or one of the many other antihistamines? Seems ridiculous in retrospect. We should limit ourselves to a year, maybe two at most, of prescription-required status for new drugs that should be over-the-counter, and only to get some experience (data). Some drugs should require a new N-year prescription every N years as patient conditions might change requiring examination.
There is a reason why we have specialists. Yes, you could be your own lawyer, doctor and engineer but there are very good reasons they exist: to make sure you aren't doing dumb things they know better.
I'm an adult. It's legal for me to buy and drink bleach. It would be very stupid of me to do that, but I can. I should be able to do the same with prescription drugs, if I want to. Yes, including eating a whole bottle of warfarin and dying messily. It's my body and my life, not yours.
The difference is there isn't a massive industry that will try to persuade consumers to do something as dumb as choosing to represent themselves pro se. There's no way for others to profit off that kind of stupidity.
On the other hand, the drug industry already advertises to consumers heavily to convince them to take prescription medication that they may very well not need. That kind of consumer stupidity can be very profitable, so the vultures will descend from the heavens to persuade people that the dumb choice is really the best one for them.
Wouldn't you like to attend my seminar on the importance of representing yourself? Also, check out my book. And follow me on Twitter.
That doesn't happen, or at least it doesn't happen at anything close to the scale of prescription drug advertising.
Also, representing yourself pro se is a daunting, complicated endeavor. Buying a pill is not if you have the money, as you can clearly see with the supplement industry.
On the other hand, the average adult requires six or more years of education and training to manage warfarin appropriately.
I'm being somewhat glib for effect, but do you not see a critical distinction there?
In the interest of public health, we make all kinds of laws to protect people from things they cannot be expected to do safely. Why is it unreasonable to protect people from dangerous medications?
However, it's far more likely that a layman gains cursory information about a drug and its effects, while lacking the specialized knowledge required to safely prescribe it.
In short, it's far easier to accidentally poison yourself with prescription medication that it is with bleach, and we have measures in place to prevent such accidents for a reason.
I believe that a number of children and adolescents tried to consume Tide detergent pods. [1]
[1] https://www.usatoday.com/story/news/nation-now/2018/01/11/ti...
I suspect @shub would disagree.
Bypassing the prescription requirement is of course of significant value to drug companies, who expend quite a bit of resources to sway doctors with free lunches, conferences and soft persuasion tactics.
Usually I welcome the freedom to chose but this doesn't increase availability: the bottleneck is not with the doctors, it's with pricing. Drug prices aren't going to go down with this measure, and will remain 3-5x the price of the exact same meds sold in Europe.
Walmart sells Novolin R/N for 25$ a vial without prescription. In all but three states I think, it is legal to purchase veterinary needles.
Novolin isn't probably as good as what you've been prescribed. But it will keep you alive.
with that said, as a type 1 - if I was in a predicament you bet i would go, if i recall they sell it for 25 a vial, whereas a vial of normal, fast acting insuling is ~250.
*usd
The drugs the FDA wants OTC are drugs that have already gone generic like statins. There is very little financial incentive to push consumers to buy drugs they don’t need.
I have to disagree: Homeopathics and Viagra.
In general I am in favor of this change, but homeopathy and vitamins are 'generic' and companies see a huge incentive to sell them, even if we do not need them. Supplemental vitamins are mostly wasted when you urinate.
Viagra is another drug I can (and do) see a lot of money spent to encourage people to take even if they do not need it.
Most generic companies make their profit off the first 6 months of exclusivity. The rest of the time they are barely breaking even (hence the drug shortages).
I read that it was due to factory outages and the government keeping tight control over production of controlled substances. The FDA actually forced Pfizer to give up their quota this year to other manufacturers because they didn't produce enough of it due to their factory outages. It seems more like a large business playing hardball with the government and insurers than a lack of profit.
Also, you need to provide proof of your assertion of generics barely breaking even. I just glanced at Mylan who sells generics. They bring in 2B a year in operating cash flow on 12B in revenue.
Not quite. It's allowed in New Zealand too. There have been many calls to change that, but so far it's still allowed.
I've never really noticed much direct-to-consumer marketing, except for Viagra and Cialis.
Relevant book on this topic, and highly recommended read: https://www.amazon.com/Overdosed-America-Promise-American-Me...
http://theconversation.com/australia-leads-the-world-in-hepa...
There is a more cynical view, and you should definitely take it. Less doctor involvement means more people taking prescription drugs (the pharma companies hope).
As an aside, I cannot tell you how angry our direct-to-consumer drug advertisements make me. Especially the ones that are marketed to people with terminal diseases offering them hope (but in the small print offering perhaps 3 months longer life, not guaranteed).
Everyone involved in the process should be ashamed of themselves.
After reading an related article (http://slatestarcodex.com/2013/07/17/who-by-very-slow-decay/) a few weeks ago, it's no surprise that the market has answered the calls of those who really do want doctors to do everything and anything to prolong their loved ones lives. The selling point for these medications are hope, and I agree that it'd be sensible to regulate advertisements so consumers can truly weigh the benefits versus the costs before they in an emotional state.
A cynic might think this policy is intended to juice US pharma profits.
Our current situation is terrible; this just makes it worse.
You appreciate this is the largest part of the problem, surely?
I think this is the point of the nurse practitioners that CVS (or was it walgreens/etc?) had in some of their stores a few years ago. When my kids were in day care and got frequent ear infections, I could tell by their behavior it was time to check their ears and.. well i'm not a doctor but I can probably tell if you have an ear infection with my cheazy/plastic over the counter otoscope I impulse purchased from said drug store. Going to the doctor to get the same prescription I had filled two months previously is just silly.
Same thing with my poison ivy...
I get that the initial diagnosis is the biggest part. But there is a ton of domain knowledge in drug interactions, expiration, etc that doctors just don't deal with on a daily basis. It makes sense to separate the jobs so each individual can get the best at their role. I don't mean to undermine diagnosis that's a huge deal, but I'd love to see doctors focus on what they do best.
Edit it will also lead to over prescribing of antibiotics and cause drug resistance to rise
Once a chronic but potentially well-managed condition is diagnosed, let people record their blood pressure, blood sugar, weight, and whatever and submit it for records. Let them renew their prescription with the pharmacy without spending hours finding an appointment that then takes hours to actually be seen. If their condition hasn't changed, once or twice a year with the doctor should be plenty.
But I suspect that they probably have two at most patients like me as opposed to the nephrology specialists who see dozens of people like me each week.
I have hypertension. I've had it for years. It doesn't just go away, but it doesn't (at least in my history) rapidly get worse. I can take my blood pressure at home and chart it. The same medication I have always taken works and at the same dosage. Yet most doctors want to see me every two months to renew the prescription, prescribing a one-month supply with one refill. The stuff's shelf stable for a few years. Why can't I get a six month prescription?
I'd hope not. I used to be asthmatic. At one point in my life, getting--and paying co-pay for--a doctor's appointment was not easy. There were nights when I weighed suffering a little longer against the risk of triggering an ER visit. Being able to go to a pharmacy to get albuterol would have made a tough time easier with minimal risk to anyone else.
I managed the allergic reactions that were causing it. Far too late in life, I discovered I'm allergic to grass. So I avoided hiking in grass and started popping a Zyrtec when my dog came back from running around in it. (I'm still allergic to my cat, but unless he sleeps on my chest it's manageable.) Solved the problem sufficiently that I no longer have an inhaler.
1) Eating better. Low level inflammation is terrible for people with auto-immune disorders, to which the trio of asthma, eczema, and allergies belong.
2) Moved closer to the ocean - salt air is great for the lungs, and really has a way of helping deal with any allergies you might have to local pollen
3) RUN! seriously, aerobic exercise for 45 minutes to an hour (anything less doesn't count) is a literal life-changer. Yeah, it really does suck for the first two weeks (if you're doing it every other day), but after that you'll start to feel amazing. You'll lose weight, which also helps with the breathing. And you'll have way more energy and higher happiness levels, which will help you want to move around more and be outside, which again will help with your asthma. Seriously, if I could do only one, this one is it. Run. Or swim if you can't (I only run on sand or dirt because my knees are shot).
Best of luck!
Part of the issue with exercise-induced asthma, for me personally, was also general nutrition and health - I found that as I earned more income, and switched to a diet higher in fats and vegetables and lower in carbohydrates, my condition significantly improved, providing a positive feedback loop with the exercise that eventually has brought me to being nearly symptom-free today (34). Your mileage may of course vary.
The main reason I focused so much on the running is because for most of my life I thought it would kill me, and always told myself that the reason that I didn't run is that it was bad for me. In the end it was exercising more and eating better (in a better environment) that saved me. Hopefully you'll find the trick for you - living with asthma is really unpleasant, to understate it.
No, I had to physically go to the doctor to get the prescription renewed every so often.
This perhaps will save me some travel costs every few years when I go to restock the personal pharmacy.
Sounds like a good time to see an NP/PA. Things should be triaged more effectively. Pharmacists <-> PA/NP <-> MD/DO.
It's not just pharmacists or PAs, it's psychologists, optometrists, dentists... The problem is we have this over regulated system that doesn't recognize the actual capabilities of many in the system that could be doing a lot more than they are, we're it not for professional lobbying around turf.
There are huge unrecognized bottlenecks to care that have everything to do with inaccurate regulatory assumptions about who can do what, starting with the consumer themselves.
I get a little upset about the idea of triaging down a chain, because the triage chain itself is a flawed idea. I dream of a much more competitive system where people get drug advice from professionals based on those professionals' training and expertise, regardless of specific training pathway or background.
I don’t care if you want a free market, or you want socialized medicine, both are preferable to government-enforced racketeering.
IE, there’s a reason not every uncontrolled substance is OTC.
And yes, I mean only antibiotics. You popping Vicodin for fun doesn't directly affect me, so it's none of my damn business.
I also think pharmacokinetic effects are likely underappreciated by the general public.
Then, weigh the two against one another.
Let us know what you conclude. Then we start the lobbying process...
Perhaps obvious but perhaps not: in the US and most EU countries I'm aware of, you can choose a new doc. You can shop around. Despite the flaws in online reviews, just as with Amazon, you can read between the lines. Choosing instead to avoid healthcare completely seems self-defeating.
I'm sorry to read so many horror stories - going to the doctor even for docs (especially for docs?) can be a frustrating experience. But while you're burning down the FDA, at least shop around and find yourself a good primary care doc.
I think the FDA's prohibitive authority does more to protect the interests of established pharmaceutical manufacturers, than the interests of consumers.
What gives you the idea it was a conspiracy?
For example, depression is usually "solved" by prescribing SSRIs, but if you do some research, you find that there are perhaps hundreds of possible causes for it, none of which are usually tested for.
When I see a headline like this, I have to seriously ask myself: "Is this when the bubble finally pops, or will it be status quo for another generation?"
The US medical and pharmaceutical community is a very powerful political lobbying group as a whole and while some of this might be good for them they are not great at change, so it will be fought for years to come.
Medicine in the US may become more affordable, but will not lose its prestige or the solid return on investment for physicians overall, IMO.
Do you have any reason to think otherwise?
Hmm, pharmaceutical industry lobbying seems to have had a significant bump in 2017, from $250 million to $280 million based on lobbying paperwork filed... https://www.opensecrets.org/lobby/indusclient.php?id=H04&yea...
If the drug (or a similar in class competitor) is available OTC then they also can't charge as much via prescription.
So both ways, prices go down.
The one difference in this example, the one 800mg pill is less harsh on the stomach than taking 4 of the 200mg pills. Which is the reasoning usually for this type of prescription, that and convenience for the patient.
Insurance does not actually pay that much. Because of drug rebates (paid by the drug manufacturer), clawbacks, and Co-Pays, in total the drug manufacturer gets about the same as they would for the OTC drug.
See here: https://money.cnn.com/2018/05/07/news/economy/drug-prices-re... (and that article barely scratches the surface).
Destroying that entire money-network would be probably the #1 thing that could help US medical spending. And as much as people hate Trump, he's probably the only one with the actual ability, and desire to do something about it.
Other presidents have cared, but they were too risk adverse, Trump would be like "hmm, looks good - do it and let's see what happens". That kind of risk taking gets him in a lot of trouble, but it's why he was elected, and why he still has support despite the INCREDIBLY stupid things he says.
When I worked on doing data analytics for one of the large speciality pharmacies a while back, some of their medications had rebates in the low 5 figure range, the medications were typically a low 6 figure prescription. But for the generic meds they carried, there was no rebate and insurance paid the full fair at whatever was negotiated for the class of medications. That was a fun/educational project but also a bit depressing seeing how the system works. The pharmacies are also in this weird middle position where they have to process a lot of the data (and business rules), but can easily get squeezed out of the profit if they aren't savvy.
I am with you, destroying the supply chain money antics would be a huge benefit in the US to cutting down the waste and useless spending.
I'll believe he has either the ability or the desire when I see it.
The generic is $7.
This is OTC vs. Prescription.
Although I bet your insurance company doesn't actually pay $200 if they cover it - they probably get rebates that cover the difference, and then make you pay a higher co-pay.
My personal logic is they typically have lobbied to keep most drugs regulated (or split) so to keep their reimbursements as high as possible. Most drugs once they go into the OTC market drop in margin, and volume does pick up but only to a point plus it comes with increased competition now.
The last few allergy medications like Zertec, Allegra, Claritin etc that were once prescription only went OTC and margins dropped for the OTC versions. However, you will find at least in the case of a couple of them the companies were pushing for them to be OTC from the beginning because they had developed the drug with the intent to be OTC. However, even if you look at OTC allergy meds, most can still be prescribed and hence paid for by medical insurance and the per pill price is drastically higher, but the out of pocket expense for the consumer is lower (which is just screwed up IMO). Last point on this, once it goes OTC the competition on manufacturing skyrockets, again driving down margins for everyone, similar to when a prescription med comes off patent initially.
I could see an argument though where the AMA and other physician lobbying groups here may diverge from the pharmaceutical lobbying but in general from my knowledge they work pretty close together.
I wonder if the regulations are written in some way to allow them to keep charging prescription prices without a prescription. The article definitely suggests it's a new "status", not merely making more things OTC.
From the OP:
> Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years.
> The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance."
Note, since they aren't typically _covered by insurance_. A new designation that would be covered by insurance, fit into insurance schedules under "prescription", but not actually require a prescription -- hey, "everyone" wins!
From: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u...
"Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system. Today’s new FDA draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription."
The (very brief) draft guidance itself: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...
90% of Americans avoid doctors like the plague. 10% blow out their insurance like they just won the lottery.
Then there’s the billing: you don’t know what you’re going to pay until months later, after you sign a form saying you’ll pay anything they want! They will never quote upfront and will never itemize what they did.
The A-players have left the insurance system or are in academia, make no mistake.
For some cost-prohibitive things such as surgery, you really don't have much choice, though.
Go overseas. To one of the medical tourism destinations. The care is far superior and the cost a fraction. Cheaper than the insurance premiums alone.
It's kind of like low tech automation.
Basically, the schools jack up the medical practitioners with hundreds of thousands in debt, and the practitioners will do absolutely whatever is required to pay it off and eek out a living :(
Its really not surprising that the expensive part isn't the drug but the expertise to select the correct drug; it's true in lots of fields that the equipment or consumables aren't nearly as expensive as the brain to choose which of those to use and how.
Bits are a lot less expensive than the software engineers that arrange them.
For example, employment based health insurance is largely a relic from WW2 because companies couldn't increase wages and offered it to entice workers. This was logical at the time, but in the 21st century makes very little sense.
Until we can turn it into a true public service, little will change. We can band aid the solution as much as we want but we will never be able to resolve the true core problems.
The primary issue I am concerned with is self ownership of my body, and the freedom to choose for myself which drugs I will consume. Transferring the permission process from a human medical professional to an algorithmic goverment agent does not give me anymore of what I want.
My goal isn't to reduce friction for accessing medicine. A person would be a fool to not jump through the hoops required to gain access to life improving medications. The low cost of a quarterly doctor's visit for a continuous prescription is well worth the benefits a modern pharmaceutical can provide.
My goal is to have ownership of my body. It's a personal insult that I even have to ask permission.
Local governments can also regulate what food is purchaseable, more specifically, who is legally allowed to sell food; restaurants have to agree to pass health inspections, for instance. As another example: Peking Duck was effectively illegal because of health regulations until legislators (of Asian descent) were able to pass laws saying otherwise: https://www.nytimes.com/1982/03/31/us/around-the-nation-cali...
In Australia (VIC at least), Naloxone is available for free over the counter at the pharmacy. Needles are also readily available (and I'm fairly sure they're free).
It doesn't really make sense for Naloxone to be prescription. Smack users aren't going to go to the doctor for a prescription. You can't get high off the stuff, all it can do is take you off a high and keep you breathing until an ambulance arrives.
On the other hand, if I want painkillers with opioids like panadeine (codeine + acetaminophen), I need to get a prescription. Same if I want cold medicine containing psuedaephidrine, because I might make methamphetamine with it.
If there was actually a proper system to enable evidence based and cost-effective usage of pharmaceuticals without doctors it might improve things for patients, but I don’t see that there is.
The downside is that insurance wouldn't cover these often expensive medications if they are OTC.
something like 20% of US health spend is on outpatient care. i dont know how much of that relates to medication management, but id imagine a lot does. PCPs get paid more when they manage a patients medication, and many psychiatrists make nearly all their income from adjusting prescriptions. im sure other specialties are similar. so this theoretically enables some of that work to be done without the physician. this could significantly reduce cost of outpt services, although it will depend very much on how hard it is for pharma companies to demonstrate non rx use of their products is safe and effective. it may be the case that only a few meds actually are eligible, or that many are, once the guidance is finalized
i havent read the guidance doc yet so dont really know how this would play out in terms of who decides what to rx if not a doc.
i personally am sort of disappointed to see doctors becoming even more sidelined. doctors really do an important job of filtering info for patients, advocating / negotiating with insurance companies, and looking out for them. this could potentially be one less protection for patients as large companies get more power to control info. id like to see cost taken out of the system by reducing pricing power by breaking up large providers rather than disintermediating doctors, but that isnt within fda's mandate, so i understand why fda would go for something like this
this could be good for patients if it is implemented in a way that doesnt give pharma too much power over patients. cost would decrease and access to meds could increase. however there may be more patients taking medicines for reasons other than the health benefits (ie marketing power / influence)
Tell that to my doctor, who on a routine checkup sent me to the lab for lab work without clearing it with my insurance company. I got a nice $600 bill for the lab work that the insurance company didn't agree was 'preventative.' After calling the insurance company they ended up waiving it, but told me that in the future I should clear every single thing the doctor orders with them, because the doctors won't do it.
The supply of doctors in the US is artificially constrained, and physician care costs more here than anywhere else in the world. Anything that removes them from the equation, especially for basic things like prescriptions, is a plus in my book.
Many of the major profitable blood pressure and statins are off patent, so the drug companies need to make more money.
I’m sure this status will limit or eliminate insurance contributions, so now you’ll pay more for generic because 50 million individuals lack the buying power of CVS and the other PBMs.
https://www.walmart.com/search/?query=ibuprofen%20200mg%2050...
Patients aren't price sensitive when their insurance provider is paying. It creates a suboptimal three (or four) party pricing problem.
It seems like it would be preferable if patients chose whether to follow a physician's instructions based on whether they got sufficient utility or quality of life improvements from the pharmaceutical to justify the cost. Likewise, if patients incur lower costs on the insurance provider their business is more valuable, and competing insurance providers will try to undercut them resulting in lower prices.
The only "loser" in this scenario seems to be the pharmaceutical companies, which will come in the form of a combination of short term reduced shareholder profits, and long term slower pharmaceutical research. However, it is not difficult to argue that if drug expenditures are too high, it ultimately comes down to paying the bills for over investment in research rather than the cost of production.
As for the effect on pharmaceutical companies, it could go either way. On one hand, it makes it much easier for customers to buy them. On the other, the customer is paying for it out of pocket, and the price is right there on the box. If there are multiple drugs that treat the same condition, customers will take into account price when choosing which one to buy, and so you'll start to see the effects of a free market encouraging competition and driving down prices. Of course, if there isn't any competition for that drug category they can make the price whatever they want and the poor will wind up screwed.
Insurance premiums will go down since OTC drugs are not covered by insurance. Pharmaceutical profits will also go down because people are much more price sensitive for OTC drugs, so they can't charge as much.
According to the article, these drugs won't be considered OTC, they still need a pharmacists approval. I don't know how that will affect coverage, if at all.
Yes, that is correct. But the idea here is to have a person decide to take it without having a Dr prescribe it, so insurance will not cover it.
You can have a drug interaction that is red-flagged but can be deemed harmless depending the patient's medical background (QT prolongation). In other cases the interaction can be undocumented, and relies on the instinct and knowledge of the medical professional to piece together the pharmacology and make a judgement of the risk to the patient (co-sedating drugs, drugs that are processed by CYP2C19 vs CYP3A4 enzymes -- there's a big difference).
Also need to take into consideration the timeline of administration. Some drugs clear very slowly from the body, and simply taking one drug after the other is discontinued can be a dangerous assumption to make (antipsychotics).
There are a lot of other interactions that are flagged, but after careful appraisal of the evidence, they're not that much of a concern to the patient.
Also consider route of administration. Does taking a transdermal patch interact with an oral medication? What about eyedrops and inhalers? What are the absorption/distribution/metabolic/excretion characteristics of the drug? Peak drug concentration levels?
Some of these details are picked up online. But you need to be aware of fundamental gaps in your understanding of medicine. It's like being a self-taught developer. Sure you can learn enough on your own to be useful, but without the years of theory and fundamentals, you will hit a roadblock which can be costly.
My guess is greater reliance on pharmacy systems.
Drug interaction problems happen now; the current scheme fails to prevent this. Can you provide evidence that the proposed change will be significantly worse?
As some point the parade of horribles we're confronted with whenever any change is offered becomes preferable to the reality we're actually living.
Day 2: Websites showing the correct answers to get anything you want show up.
This is an absolutely bonkers idea.
While I could quite easily get ahold of Marijuana and other illegal drugs on the street or the dark side of the net, I have never seen an offer for non-narcotic prescription drugs.