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Digging Deeper #1 - Pharmacy Law

"Pharmacy law places the responsibility for the provision of adequate patient care directly in the hands of the pharmacist." That was the opening line of the first point in my first blog post. I tried to make that post as succinct as I possibly could to reach the greatest number of laypeople possible, but now that the original post has been seen so many times, it seems appropriate to dig a little deeper into those talking points, for those who are interested in longer-form discussion. So, I've decided to create a new series of posts - digging deeper into each of those original talking points.

Let's start with pharmacy law.

Way back in the days of fledgling pharmacy practice, putting complete responsibility in the hands of the practicing pharmacist was appropriate and reasonable. We accomplished this by creating a legal position called the Pharmacist-in-Charge and forming Boards of Pharmacy to regulate and oversee pharmacist and pharmacy licenses.

If you are a layperson reading this and wondering what in the heck the Pharmacist-in-Charge (or PIC) is, it's the person legally responsible for compliance with state and federal law at any given practice site (pharmacy location). Often the person can only serve as PIC for one location, and must work on-site a minimum number of hours per week or sometimes >50% of the opening hours of the location - the specifics depend on the state the pharmacy is licensed in. That means the "PIC" is many times a different pharmacist at each corner drug store, mail-order facility, compounding pharmacy, hospital pharmacy, nuclear pharmacy, on and on.

This person's name is supplied to the Board of Pharmacy as the responsible party for that location. The crux of the issue is that while this person is responsible for legal compliance, often their supervisors make that compliance unattainable, through corporate policies, staffing decisions, and unspoken hostile employment situations (i.e. meet the metrics which are impossible to attain while maintaining legal compliance, or lose your job). These supervisors do not shoulder the same legal responsibility or impingement on their pharmacy license as their employees, if they even have one (which is a whole new topic for another day) .

This means that in today's chain-dominated environment, it is less appropriate to place the entire legal burden on the individual practicing pharmacists and PICs. Why give someone the full weight of responsibility for something they cannot control? Of course they should be responsible for their own practice-related actions, but how can they be held responsible for the corporate level policies they are forced to work within?

The main example of impossible compliance that I referenced in that first blog post was that of required prescription counseling, a job function pharmacists are legally obligated to perform in many states. It consists of educating patients with the need-to-know information about the medication they are receiving. In school, they teach you how to counsel thoroughly. Ask these questions, provide these bits of info, assess this patient's understanding, meet the patient-specific needs, etc. Unfortunately, in practice this gets drilled down to, "Take one capsule twice a day for 7 days, get a probiotic, feel better soon," or worse, just "Any questions? Ok, have a good night."

Now, I'm not arguing that the counseling methods taught in school aren't necessarily exactly practical for community practice. But I am arguing that the legal (and practical) requirement is very often not fulfilled. As pharmacists, we know that this counseling is both our best chance to positively affect the patient's medication use AND is our last chance to catch an error before it reaches the patient.

Yeah, maybe it gets old, counseling the same information on the same drugs over and over again. But maybe...just maybe...

...maybe of all those monotonous conversations you had about statins, the 60-year old patient you talked to last Tuesday night thought reducing his cholesterol was silly and arbitrary until you told him that due to his diabetes diagnosis, he is at a higher risk of heart attack and stroke and that this medicine helps reduce that risk, not just change a number on his lab reports. That patient decided to actually take his statin regularly instead of just when he thought about it (which was about twice a week, maybe).

...maybe that other patient on Monday morning that was afraid to take their glimepiride because it sometimes gives them low sugar episodes now understands that they shouldn't take the medication in the morning if they don't eat breakfast, and should instead move their dose to the first main meal of the day.

...maybe the patient you educated on Saturday afternoon about a NuvaRing was too embarrassed to tell you she'd been wearing it on her wrist before you explained how to use it (yes, for real).

The sad part is, if you work at a busy chain pharmacy, none of these conversations may have ever taken place.

...that man from last Tuesday? He quit taking that statin at all and has an ischemic stroke three years from now. He loses a great deal of function at the ripe old age of 63 (and has drastically increased medical costs).

...the glimepiride patient's A1C keeps going up because they can't afford any of the more expensive treatment options and they're still afraid of sugar drops. They have an amputation in a few years and their eyesight and renal function are declining severely (and they have drastically increased medical costs).

...the 19-year old first-generation college student using NuvaRing has an unplanned pregnancy and she doesn't graduate her program because she's raising a child alone (which costs drastically more than a monthly NuvaRing).

All of these patients have experienced not only those drastically increased financial costs, but have also endured more suffering, reduced quality (and possibly quantity) of life, and/or impeded agency and independence.

Sounds dramatic and oversimplified right? Shouldn't the rest of those patients' care team members be stepping up? Truth is, they're just as understaffed and overworked as we are. How can we expect them to take up what is within the exact purview of our specific contribution to patient care, simply because we're too busy checking hundreds of prescriptions with cursory glances in a desperate bid to meet the metrics?

Even aside from poor medication-use related sequelae, don't forget the other function counseling serves--error prevention. Maybe you've never counseled a patient on their new antidepressant clomipramine only to discover they were expecting a clomiphene regimen (yes, I've seen that error made, and no, it wasn't caught prior to dispensing). Neither was the time a patient picked an emergency department prescription for Cipro, and the pharmacist was unaware the patient also received warfarin via mail-order. And yes, the patient was hospitalized with a sky-high INR.

There are all kinds of ways to categorize and quantify these varying economic costs (the direct, indirect, and intangibles you may remember from healthcare economics), but the gist is, they're all going up, up, up and away...

Meanwhile, you as the pharmacist are legally responsible for ensuring these counseling conversations happen. The legal responsibility falls on YOU and your PIC. But YOU and your PIC aren't the ones making the staffing decisions that make these conversations impossible, are you? When the Board of Pharmacy comes calling, who is personally getting fined for counseling violations?

Not your DM, not your corporate compliance department, not your CEO.


So you decide to take up the mantle of true patient care. Counsel every patient. Make DUR notes. Document interventions.

What happens to you?

Let's just say, you're not going to hold your position for long.

You decide you want to keep your job. You check faster, only counsel when a patient requests it.

You miss an allergy, or an interaction.

The patient is hospitalized.

They sue.

By the off chance it somehow doesn't land on you, the company gets hit with that lawsuit. They shrug it off. What are some legal expenses compared to the cost of appropriately staffing thousands of pharmacies on a day to day basis? Nothing. It'll come out in the wash. Keep going. Check faster, now we need to cut more hours to pay court fees. Most of the errors will never be pinned on us.

Extrapolate these examples to cover the millions of people served by America's pharmacies every day. Extend those consequences to an entire population over decades of poor patient care. Is it any wonder that the costs of medical care are rising? If we can't be bothered to make sure the first-line treatment is used properly, it's less likely to work and we progress through all the options, never asking if we really got the full benefit of the first treatment, or *gasp* the preventative care. The expense, both economical and humanitarian, balloons across an entire generation.

But we can't be bothered to change the pharmacy laws. They've always been this way. That's just how community practice is. There isn't enough time in the day to thoroughly counsel every patient.

I have a secret though. If we staffed in accordance with how many people it takes to fulfill the law there would be enough time. If we staffed and practiced in accordance with our pharmacy practice oath there would be enough time. If we staffed based on ethical patient care there would be enough time (and less unemployment and underemployment for today's pharmacists as a big bonus).

That's impractical. We can't staff pharmacies that way. It's too expensive.

I'm here to tell you, YES, it IS expensive. Do you know what's more expensive? It's what happens when the current standard of patient care is allowed to be the norm. When it escapes regulation. When doctor's appointments are 15 minutes long for the management of six chronic conditions and the provider assumes the patient will be educated on drug-related topics at the pharmacy. Then the pharmacist has 15 seconds to counsel and assumes the patient was educated at the doctor's office.

I don't need to tell any pharmacist here that the billions of dollars going into the pockets of pharmacy benefit managers and their own pharmacies would be better spent making sure patients actually got revolutionary (read: basic and thorough) care. But I do need all of you to tell your lawmakers. Do we need Rx verification maximums? Do we need minimum technician hours? Do we need required rest breaks? Do we need pharmacist overlap? Do we need to outlaw patient steering and forced mail-order? Do we need to change WHO is legally responsible for these shortcomings? Do we need PBM reform? Do we need a complete overhaul in how we practice pharmacy day-to-day?

If medical error is truly the third leading cause of death in America, we need all of the above, and more. I know, I know, I'm radical and absolutely insane. How dare I suggest that 8.76 Billion (yes, billion with a capital B!) dollars in gross profit for one PBM in one year could be better utilized elsewhere?

But if you agree with my radical insanity and think that patients should come first, come on board and help get the word out. Share this post or others, share social media images available below, contact your legislators, check out the other site resources linked below. Public knowledge CAN make a difference, and we are the only ones who are going to tell. We all took a professional practice oath, likely the one that includes, "I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct," and, "I will embrace and advocate changes that improve patient care."

Here's your chance.

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Eloquently said, PA. Here's the other thing, though. Our patients need to understand that quality pharmacy services, including education and counseling, are worth paying for AND waiting for. We as pharmacists need to recognize that too, and be willing to charge for appointment-based medication coaching and education. It's a paradigm shift, yes, but as you say the knowledge we can share with patients will keep them healthier and help them spend less on healthcare. We need to advocate for that along with changes in dangerous staffing and metrics requirements.

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