Laws Driven By Tragedy

I know, I know, I just posted about pharmacy law, but I just can't seem to shut up about it. Mostly because it's so infuriating.


I stole this title straight from an educator that I learned from in the past, because there's not much of a better way to put it (thanks Doc, you'll know who you are). Without giving too much away about myself, before I was a pharmacist, I studied the laws surrounding the United States food supply including marketing, labeling, and handling, which incidentally are also subject to the United States Food, Drug, and Cosmetics Act. During those studies I learned that the US has always had a problem with taking preventive action. It's written right there in our law and history books. The very developmental laws relating to regulation of food and drugs were precipitated by major tragedy or revelation and the subsequent public outcry.


Pure Food and Drug Act of 1906? A response to Upton Sinclair's novel "The Jungle" publicizing the atrocious conditions in turn-of-the-century meat packing plants. This finally took place 25 years after the first national food and drug regulation act failed in Congress, and after 100 other subsequent bills had also failed.


The Federal Food, Drug, and Cosmetic (FDC) Act of 1938? Finally pushed to passage in 1938, five years after a recommendation to fully overhaul the previous Food and Drug Act. Successful likely in large part due to the previous year's Sulfonilamide Tragedy and the deaths of 107 people, largely children.


Harris-Kevauver Act of 1962? An expansion in the FDA's drug approval powers, rooted in the Thalidomide Tragedy - a narrow miss in the US, blocked by the fastidious resolve of one heroic woman, but a widespread medical misstep in Europe that resulted in severe birth defects in thousands of infants exposed to the drug without adequate safety and efficacy trials.


Drug Quality and Security Act (DQSA) of 2013? Response to a more recent tragedy, the fungal meningitis outbreak linked to the operation of the New England Compounding Center as a drug manufacturing facility under the guise of compounding patient-specific prescriptions.


"What is the point here?" you may be wondering.


My point is, WHY ARE WE WAITING FOR THE DISPENSING TRAGEDY?


No, I don't mean waiting for it to happen, I mean waiting for it to be identified, quantified, and exposed. Why are we waiting for an outside source to identify the costs to the public of operating America's pharmacies in the way that we do? Much as I mentioned in the previous post, it would be hard to quantify the true costs, because they come in so many flavors, but they are there nonetheless. WE, the profession of pharmacy, need to be the ones to call attention to this and change this, lest we become the villains who stood idly by. None of us want that. We came here to help people and use our superpowers of excessively nitpicky "detail-orientation" to save the world from med errors, but somewhere we've gone astray.


A great example of our profession absolutely turning a blind eye to the danger comes from a response I recently had the misfortune to read, coming from the Texas State Board of Pharmacy. The Board acknowledged the pleas of those they govern by publishing their response to numerous letters from concerned pharmacists. Now, I'll play the devil's advocate here for a minute and say, mayyyyyyybe, just maybe this is a "timely response" and the Board is working on some grander, more realistic or effective response that they're holding in their back pocket for some reason unknown to us simple dispensers. If that's the case, good on them.


BUT.


If this is the full and final response to the desperate calls from pharmacists, then

SHAME ON YOU TEXAS BoP. You have forgotten the face of your father (and the interests of those hapless citizens of the public you claim to serve).


Maybe if I was as intimidating as the gunslinger, they'd actually care? (Thanks GQ Australia)

"At least they responded?" you might say. That would be all fine and good, I'd say...except that it's a whole lot of nothing. Fluff with zero bite. In a discussion thread you can read here, one user comments, "It's like they aren't aware they are a REGULATORY BODY." Which basically sums up the whole problem, almost as well as pointing out that the final line of their response reads, "In summary, TSBP encourages pharmacists to be valuable employees and pharmacy owners to be good employers."


I hate to resort to memes, but sometimes there are just no words.

Yes, TXBoP, I am totally sure that a few words of encouraging morality are absolutely going to transform the business model of companies who have time and time again shown that they are more than willing to sacrifice the health of the American public at the altar of increased market share.

Pharmacy bandit is back at it again, running home with siphoned $$$

How about USING YOUR AUTHORITY, to do what the public TRUSTS AND EXPECTS YOU TO DO. Your claim is always that you exist to protect the public, not the pharmacists, so how about doing some actual protecting? Implement rules that will protect your beloved public from the mistakes of hungry, tired, overworked, balloon-bladdered, distracted, dehydrated, under supported, pained and fatigued pharmacists and technicians. Protect against the collapse of independent pharmacy due to unethical and unfair business practices. Protect your rural constituents from the loss of access to local pharmacies. Protect them from forced mail order and an astonishing lack of choice and access to any counseling and caring pharmacist.


The BoP response concludes with a compilation of irrelevant rules enacted by other states that supposedly accomplish what we are asking the Boards for help with. I say irrelevant here because they are rules in OTHER STATES, which have no bearing on the pleading pharmacists IN TEXAS (I just have to shake my head again on this one). They are additionally irrelevant, because many of them are unrealistic or unenforceable (or currently not being enforced).


A sampling, shall we?


NEBRASKA

Title 175 Ne Admin. Code Ch 8

Standards for the Operation of a Pharmacy

8-006.01 Staffing Requirements: Each pharmacy must maintain a sufficient number of staff with the qualifications, training, and skills necessary to meet patient needs. The pharmacy must ensure that the staff hired meets the following requirements:


TENNESSEE

TN BReg 1140-02-.01

Pharmacists and pharmacy interns

(7) A pharmacist shall not agree to practice under terms or conditions which tend to interfere with or impair the proper exercise of professional judgment and skill, which tend to cause a deterioration of the quality of professional service and patient care, or which require the pharmacist to consent to unethical conduct.


Nowhere are objective measures employed. Nowhere are corporate decision-makers held responsible for refusing to provide this "sufficient staff" or for creating ubiquitous environments that "tend to cause a deterioration of the quality of professional service and patient care." Interestingly enough the TN law for institutional pharmacy specifies that the PIC is to determine the adequate number of pharmacists to serve their patient census. We all know that doesn't happen in community pharmacy. The hours and scheduling are handed down by decree from our corporate overlords who haven't verified a prescription in decades, much less while juggling 6 phone lines, 4 technicians, hundreds in the queue, a patient angry about a misfill, and a two-lane drive-thru line wrapped around the building. While also having to pee (because they haven't been able to in 8 hours or more).


I'm sure a lot of people think I just sound really whiney, saying the same things over and over til I'm blue in the face. I'll just say again that...


When I'm double checking the dose of morphine for your child (because I already struck down the codeine Rx that could endanger their life), I bet you want my head as clear as possible.


When I'm reviewing the complex regimen of life-extending drugs your father takes for his heart, against what the urgent care prescribed him, I bet you want my head as clear as possible.


When I'm checking your OTC selections for your expectant wife for safety in pregnancy and interactions with her other medications, I bet you want my head as clear as possible.


When I'm trying to source a vital medication for you during a medication shortage and backorder, I bet you want me to have enough time and resources to exhaust every option.


So keep sharing, and keep talking about it. Don't let this issue get kicked back into a dusty corner where the PBMs, corporate pharmacy execs, and BoP members can throw an ugly tarp over it and pretend it doesn't exist.


What Could POSSIBLY Go Wrong?

Dangerous Practices

Take Action

Advocacy Made Easy


https://www.ag.ndsu.edu/foodlaw/overview/history/milestones

https://www.americannursetoday.com/fda-marks-50-years-of-kefauver-harris-amendment/

https://www.drugtopics.com/viewpoints/how-necc-case-changed-compounding-pharmacy

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