FDA allowing patients to self-diagnose

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This is not a step in the right direction... blood pressure drugs OTC?
 
“The problem is medicine is just not that simple,” said Dr. Matthew Mintz, an internist at George Washington University Hospital. “You can’t just follow rules and weigh all the pros and cons. It needs to be individualized.”


Nailed it...
 
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Under the changes that the agency is considering, patients could diagnose their ailments by answering questions online or at a pharmacy kiosk in order to buy current prescription-only drugs for conditions such as high cholesterol, certain infections, migraine headaches, asthma or allergies.
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because we don't have enough antibiotic resistance already..
 
You weren't able to self-diagnose before? If you have high blood pressure, it's not that difficult to diagnose.

Anyways, the reason I don't think this is a good idea is one of the reasons that was mentioned in the article. This is going to cause health insurance companies to drop some coverage which might price out some patients or cause them to scale back their needed dosages.

Additionally, a physician is needed to be able to gauge the individual patient's needs. For instance there are different types of blood pressure medications and given a patient's individual circumstances a different medication might be the optimal way to go.

Also there is the saying, "A doctor who treats himself has a fool for a patient."
 
There is a difference between self-diagnosis and self-treatment/self-perscription
 
There are very few instances of correct self diagnosis. fewer of self treatment
 
SpecterGT260 said:
There are very few instances of correct self diagnosis. fewer of self treatment
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Exactly. I self-diagnosed pink eye, told my boss, she writes an rx --> corneal ulcer. Oops. (Other moral here: take out your contacts at night. Every night.)

The self-diagnosis thing is a big problem. But what about in the face of an existing, stable diagnosis (ex: asthma)? An rx will have a limited number of refills, so is there a serious benefit to making an office visit every time you need a re-up on your inhaler? Not after the first visit, probably, but once satisfactory control has been achieved.
 
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painmd87 said:
Exactly. I self-diagnosed pink eye, told my boss, she writes an rx --> corneal ulcer. Oops. (Other moral here: take out your contacts at night. Every night.)

The self-diagnosis thing is a big problem. But what about in the face of an existing, stable diagnosis (ex: asthma)? An rx will have a limited number of refills, so is there a serious benefit to making an office visit every time you need a re-up on your inhaler? Not after the first visit, probably, but once satisfactory control has been achieved.
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Many PCPs will allow Call in for refills. In my experience unnecessary office visits is not the norm.
 
SpecterGT260 said:
Many PCPs will allow Call in for refills. In my experience unnecessary office visits is not the norm.
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I understand. I agree this is how it works.

But if it's just a phone call -- why do you even need to make the phone call? There's the opportunity cost to you for making the call, the receptionist for taking the call, the MA/RN reviewing the chart, the doc to sign the script. (Or for the MA/RN/doc to call the script in -- plus the pharm tech to answer the call, not counting wait times).

You can't put inhalers OTC because you need an rx to get the right one and not kill yourself with it, but once you're successful, I see very few legitimate reasons why unlimited refills shouldn't be standard.
 
Meds wont necessarily work forever. Yearly checkups are still probably a good idea.
 
Wolverines83 said:
I don't see what can go wrong. As we all know there is only one cause of high blood pressure and it is easily and accurately diagnosed via WebDO.
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I didn't think of that, if you have high blood pressure caused by pheo and just take OTC blood pressure medications...

You're in for a rude awakening.

But I think for the majority of the cases it's the usual cause. Still one should see a doctor.
 
UrshumMurshum said:
I didn't think of that, if you have high blood pressure caused by pheo and just take OTC blood pressure medications...

You're in for a rude awakening.

But I think for the majority of the cases it's the usual cause. Still one should see a doctor.
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Tailoring medicine to "the majority of cases" is the exact opposite of what we should be doing. It doesn't take a genius to handle the cases that come in 99% of the time. But that 1% will be missed approaching 100% of the time if we keep moving towards taking the professionals out of the equation.
 
painmd87 said:
I understand. I agree this is how it works.

But if it's just a phone call -- why do you even need to make the phone call? There's the opportunity cost to you for making the call, the receptionist for taking the call, the MA/RN reviewing the chart, the doc to sign the script. (Or for the MA/RN/doc to call the script in -- plus the pharm tech to answer the call, not counting wait times).

You can't put inhalers OTC because you need an rx to get the right one and not kill yourself with it, but once you're successful, I see very few legitimate reasons why unlimited refills shouldn't be standard.
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Alright, we agree for the most part. But I'm against the word unlimited. Unlimited basically says "My treatment was flawless and will apply 100% in the future." It doesn't take into account progression of a disease, change in lifestyle, or change in health that seems (to the patient) to be unrelated to the Rx. Plus, it opens the door to selling of said drugs.

I like something along the lines of "Here's drug X, get y amount of refills and we'll meet up again in x days/weeks/months to see your progress."
 
Wolverines83 said:
Alright, we agree for the most part. But I'm against the word unlimited. Unlimited basically says "My treatment was flawless and will apply 100% in the future." It doesn't take into account progression of a disease, change in lifestyle, or change in health that seems (to the patient) to be unrelated to the Rx. Plus, it opens the door to selling of said drugs.

I like something along the lines of "Here's drug X, get y amount of refills and we'll meet up again in x days/weeks/months to see your progress."
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Isn't that more or less what we have now? You can write a script, w/ refills (is there a limit for all or just schedule III/IV?) and tell them to come back.

You're right -- unlimited refills can lead to problems. This would have the best chance to be successful when piloted in diagnoses with limited/no progression, and treatments that are non-addictive and with very low/no street value. That's why I suggested asthma.

Consider migraines: I've had migraines regularly for a decade, and long ago a neurologist wrote me for a triptan. I get a limited supply (4) per month, so it's almost impossible for me to induce rebounds from daily use. I have to call my internist every so often to get the refill. I waste my time, the receptionist's time, the MA's time, the doctor's time whenever I call for a refill. Then I have to wait for them to call the pharmacy. With unlimited refills, I could just go to the pharmacy and get it (they'd know if I was due), and if my condition worsens beyond stable, regular migraines, I am forced to go see the doctor rather than try to self-medicate. The idea is that I don't need regular maintenance of my medication, but if something suggests that my condition is no longer simply migraines, then I must go see someone.

I'm no more interested in taking prescribing power away from us than you are, but there is a gray area between what should be sold OTC and what requires an rx every time. If you're writing w/o seeing the patient, you're losing money and wasting the patient's time. If you're seeing the patient without a reasonable idea that something has changed, then you're wasting the patient's/insurer's money. I don't doubt the ability of the FDA to screw this up, but there is an effective way to improve efficiency by allowing unlimited refills in certain non-progressive diagnoses with stable, non-habit-forming treatments.

With all that said, I'll admit there's next to no chance this proposal actually flies.
 
Now that I think about it... this is a great way to control the growing population in the U.S. before it really gets out of hand. Imagine how great traffic would be in the morning if half the people lost the ability to drive due to drug complications.

Vote this policy in, people.
 
Lovely idea. TV commercial coming soon: "For all your medical needs, consult our 24/7 self-service automated kiosk located next to the Redbox. Don't forget our special sale on goat's milk moisturizing lotion for $9.99, this week only." :rolleyes:
 
IDBasco said:
Its about time we stopped fighting so hard against darwinism. :D
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no joke ive used this very argument to support apathy for mid-level advancement. eventually enough people will die that the system will rebound
 
painmd87 said:
Isn't that more or less what we have now? You can write a script, w/ refills (is there a limit for all or just schedule III/IV?) and tell them to come back.

You're right -- unlimited refills can lead to problems. This would have the best chance to be successful when piloted in diagnoses with limited/no progression, and treatments that are non-addictive and with very low/no street value. That's why I suggested asthma.
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:eek:

With respect, asthma is a disease that NEEDS periodic re-assessment, and has the potential for real DISEASE progression (with increase morbidity and mortality). And it's a disease that can go from controlled to uncontrol fairly quickly. People do DIE from asthma (both short term and long term). Hint - why is there a blackbox warning on advair/symbicort?

Having a patient who is frequently using albuterol (or refilling albuterol) is a concern that must be addressed (WHY is the patient frequently using albuterol?) Maintenance medications must also be tailored and adjusted base on disease severity and control.

To be honest, I can't think of a chronic disease state that a patient can self-maintain. Medications for hypertension all requires periodic monitoring - is HCTZ really the right drug? What if your patient has a history of hyponatremia, or gout, or sarcoid? Would patients know enough to not take HCTZ (if it is OTC) if they have that? What about ACE in an elderly gentleman with critical AS? Or history of acute renal failure from dehydration/UTI? Or beta-blockers in patients with heart failure (indicated but would you prefer letting physicians titrate beta-blockers, or would you like your patients to self-titrate?) I'm sure you can give CCBs without worry :rolleyes:

Hyperlipidemia - which statins and how much? Any potential drug-drug interactions with the patient's other drugs? Who will monitor LFTs? And there is increasing evidence that link statins with IPF. Will patients really take a drug every single day (when asymptomatic)? When the patient comes to your office with diffuse muscle ache, will the patient tell you that they are on a statin (otc)?


We don't have patients periodically return just to collect co-pays. It's to re-assess how the patients are doing, if medications should be changed or discontinued, or escalate, and if indicated, periodic monitoring.
 
group_theory said:
:eek:

With respect, asthma is a disease that NEEDS periodic re-assessment, and has the potential for real DISEASE progression (with increase morbidity and mortality). And it's a disease that can go from controlled to uncontrol fairly quickly. People do DIE from asthma (both short term and long term). Hint - why is there a blackbox warning on advair/symbicort?

Having a patient who is frequently using albuterol (or refilling albuterol) is a concern that must be addressed (WHY is the patient frequently using albuterol?) Maintenance medications must also be tailored and adjusted base on disease severity and control.

To be honest, I can't think of a chronic disease state that a patient can self-maintain. Medications for hypertension all requires periodic monitoring - is HCTZ really the right drug? What if your patient has a history of hyponatremia, or gout, or sarcoid? Would patients know enough to not take HCTZ (if it is OTC) if they have that? What about ACE in an elderly gentleman with critical AS? Or history of acute renal failure from dehydration/UTI? Or beta-blockers in patients with heart failure (indicated but would you prefer letting physicians titrate beta-blockers, or would you like your patients to self-titrate?) I'm sure you can give CCBs without worry :rolleyes:

Hyperlipidemia - which statins and how much? Any potential drug-drug interactions with the patient's other drugs? Who will monitor LFTs? And there is increasing evidence that link statins with IPF. Will patients really take a drug every single day (when asymptomatic)? When the patient comes to your office with diffuse muscle ache, will the patient tell you that they are on a statin (otc)?


We don't have patients periodically return just to collect co-pays. It's to re-assess how the patients are doing, if medications should be changed or discontinued, or escalate, and if indicated, periodic monitoring.
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I think the real question is...who are the patients going to sue when they improperly medicate themselves? The pharmacist? The pharmacy? The vending machine manufacturer? The FDA? Nope, probably still the doc!
 
Let them do it, if they don't want to see a physician, so be it. Of course I'm libertarian and think that adults have the right to make decisions, even dumb ones as long as they don't harm anyone else.
 
The idea is a 3rd class of medications (similar to PSE) that can only be obtained through the pharmacist.
As a licensed pharmacist and a medical student, I am quite torn on the idea.

Pharmacists are perfectly capable of determining which class of BP med is best for a particular pt (trust me ACE-i CI with renal artery stenosis is tested on the pharmacy licensure exam). We spend a fair amount of time in pharmacy school learning how to adjust asthma meds, anti-diabetic drugs and BP meds depending on the pt's control. Pharmacists are capable of BP testing, blood glucose monitoring, etc. I do think that an additional certification exam is in order, similar to administering immunizations. Also, it is a requirement (at least in AZ) that the PCP is informed within 48 hours of the immunizations given to the pt, including lot number, injection site etc. I believe this should and probably will be a requirement for these proposed drugs as well. We are also trained to recognize situations that are above our scope and refer to the PCP; this is essential to this proposal. Did you know that Insulin is already available without a Rx (and is a much more dangerous drug than the orals)?

However, pharmacists are not taught diagnosis of more complicated cases and here-in lies my concern. I would like to see a requirement that the patient be seen by the PCP for the initial diagnosis. Certainly every patient should be seen by their PCP yearly (esp if they have a chronic condition), which kinda makes this proposal pointless since all non-scheduled drugs have a year expiration on refills if the number is not specified (6mo for CIII-V to answer the previous question).

To answer the liability question, certainly the pharmacist would be sued (and we are already sued in certain cases), some are even jailed... Ohio pharmacist for a TPN error in a peds pt. I carry malpractice insurance, and so do all the other pharmacists I know.

Although I think there is potential, I don't think this will pass (esp considering the strong wording by the AAFP)... and I'm okay with that.
 
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