Tiny Pharma actually. Microscopic Pharma almost. Specifically, the "custom compounding pharmacies" that have proliferated, in the rich parts of town, over the last 20 years or so.
"Oh, here's where the Drugmonkey tells us how we are the last bastions of the profession, keeping the flame of pharmacy alive as it comes under assault from the chain corporate beast who envisions the profession as nothing more than a glorified fast food cashier. Yay Drugmonkey!!" The proprietors of these compounding pharmacies are saying to themselves.
Except that's not what I'm going to say. Not even close.
Now there's nothing wrong with a lot of what these places do. Like the name implies, they butter their bread by making specialized preparations of things not commercially available. Odd strengths of prescription meds, making a liquid when there is only a capsule on the market, capsules when there is only liquid on the market, unique flavors so your pet and/or child can get their medicine down. Some of their work is actually laudable. Some of it is simply catering to the more money than brains demographic, so the affluent and stupid can say things like "MMMYYY Prozac is custom made just for meeeeeeeeee!!!! Because I am a special person who can take neither 10 nor 20 milligrams. Neither can someone of my social status be expected to break a tablet in half. So I shall pay 3 times as much as you for my meds. Because I am rich and special and you are not. " Which isn't really laudable, but is kinda funny and karmic.
Then there are the products that take advantage of the loophole that these compounds don't have to be proven effective. Like the promethazine gel this month's Pharmacist's Letter says hasn't been proven to be absorbed or to actually work. That's neither funny nor karmic.
Oh but it gets worse. Many of these places have built up a good part of their business hawking "bioidentical" hormones. Estrogens and such. When I first made my break for the coast I interviewed with one of these compounding places, and as part of his recruiting package, the store's owner handed me the brochure he gave to customers asking about his "bioidentical" estrogens. They were the exact same hormones found naturally in your body it said, and stated unequivocally that therefore his compounded stuff was safer than commercial products such as Premarin and Prempro. There were no studies that backed this up that I was aware of, so I asked the owner on what basis he was making this claim.
"The amount of money I make on the compounds" was his reply. Which was merely unprofessional back then.
Today however, we know there is an undisputed link between estrogen exposure and breast cancer. We know that the number of breast cancer cases fell almost immediately when this news broke and doctors backed off on the estrogen prescriptions.
"But our stuff is different!!! Say the compounders."It is natural and bioidentical!!"
Except that we also know that women who have a higher lifetime exposure to estrogen naturally, such as those who started their menstrual cycles early and/or ended them late...also have a higher than average risk of breast cancer. Which would imply the "bioidentical" stuff really isn't all that different as far as the breast cancer goes. If you have a pharmacy license you should know this. If you don't you are negligent and should be out of our profession. If you do, and are marketing these things anyway by implying they are safer, in my eyes you are criminal, and belong in jail.
Because loving your money more than your mother should most definitely be a crime.
19 comments:
This issue cuts to the quick of modern-day pharmacy.
Do we provide a SERVICE that ONLY we (as pharmacists) can 'do' (and, reap benefits of a manufacturing loophole within our scope of practice) by doing something desired by our patient that might not be necessarily in the best interest of that patient, or do we go ahead with providing the best SERVICE possible within our judgment of what is best for the patient?
I think it is ethical to think that compounding pharmacists are pharmacists first, preparing medications for humans, not chemists just mixing up chemicals.
We can heed a line from the Pharmacist's Oath "I will consider the welfare of humanity and relief of human suffering my primary concerns." Providing potentially dangerous substances by compounding pharmacists cannot be justified with a benignly benevolent 'opinion' of placating patients with a 'placebo' even as we work under a doctor's prescription. We would refuse to fill a script for a contraindicated drug e.g. retinoic acid for a pregnant woman, or a drug known to cause anaphylaxis in a patient, or an overdose of digoxin, etc., why risk performing a pharmaceutical act outside the scope of pharmaceutical care and obligation?
Actually, next line in Pharmacist's Oath is more appropriate, "I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve."
You are not as informed as you think you are. Would you argue that human insulin is no better for a person than pig or beef insulin? Hopefully not.
Any UNOPPOSED "estrogen" is dangerous, bioidentical or not. But monitored treatment with bioidentical "estrogen" is much better for a woman than horse "estrogen." Start here: www.mwpc-mi.com Also, educate yourself on the difference between Provera and natural progesterone.
Oprah was big on the bioidentical bandwagon, at least at one point. I don't know if she still is, because she drives me completely bug-nuts and I try to avoid her. It troubles me that one word from her can drive thousands of women to action, unless she's endorsing the Presidental candidate I support. ;-) Seriously, I fear she's done some harm with her hormone talk. She claimed it made Everything Instantly Better.
So this happened when you "first made your break toward the coast?" Wasn't that a while ago? Before these studies came out? Yeah, he was a tool for pushing the compounds he made the most money on, rather than the ones he would help the most people with, but has he continued saying that it's safer?
If he is, yes, it's criminal. If he isn't, well, then he's just a guy who likes money...
I realize that that isn't the point of the post, but you failed to provide evidence that this practice is still going on... Just that it might be going on.
Pharm D student, meet anonymous 5:11.....:)
They don't come out and say it anymore, as that would actually land them in jail. They have gotten very good, however, at implying it.
My favorite part of anonymous 5:11's rant is where he extols the virtues of human insulin while leading you to to a website that says:
"BioIdentical Hormones have the same structure as the hormones made by your body. By contrast,
synthetic hormones are intentionally different. Drug companies cannot patent something natural so they invent synthetic hormones"
Because Lilly totally never made any money off of Humulin.
Oh, wait, just found this on his little website:
"Are BioIdentical Hormones safer than Synthetic Hormones?
European medical studies suggest YES, BioIdentical Hormones are safer than synthetic. But we need to be cautious here because BioIdentical Hormones have not been well-studied, especially for long term use.
The studies showing the health risks of Hormone Replacement Therapy we (sic) based on SYNTHETIC
Hormones."
God forbid that webmaster put in a link to those European studies. I understand though, because putting a link on a website is really hard.
So is doing something like putting a footnote at the bottom of your webpage citing these "studies"
And warning the visitors of your website that "Any UNOPPOSED "estrogen" is dangerous, bioidentical or not." The way he said that to me. That would be really hard to put on that website somewhere.
Just like how it must be hard for these fuckers to sleep at night.
Alright, but you still haven't said that the original pharmacist you mentioned hasn't changed his ways... The post would be better with some continuity...
That's all I'm saying.
Pharm D,
The point I was trying to illustrate by including that first guy was that the practice was unprofessional in the best of days, and far worse than that now.
Honestly I don't know if *he's* still plugging the bioidenticals as safer now or not. If he isn't, there are still those that are.
Send me a rewrite. Maybe I'll put it up and give you a cut of the royalties generated....:)
Can you just end the post with...
"So I called the guy up, and he still gives out those brochures. Fucker."
Just because it isn't true doesn't mean you can't say it. This isn't Fox news ya know... ;)
Wow pharm. student, you're making a big deal out of something not really relevant to the theme of the post. You must be preparing for a career in chain pharmacy management, where you go nuts about meaningless crap and ignore actual patient safety issues.
I worked in a pharmacy that produces "bioidenticals". It is largely b.s. and not supported by concrete evidence. I believe there is a role for compounding in today's market, but as long as the market is people who get medical advice from Suzanne Summers, pharmacists must suffer.
Pharm D Student:
Anti-aging is, in fact, a section in ACCP's Pharmacotherapy Self-Assessment Program. It comes in the book titled "Men's and Women's Health." Why they didn't just call it "Women's Health: How to Look Pretty"...I'm not sure.
The summary says to wash your face twice a day and wear sunscreen. There, I saved you $400 bucks.
I've found the course as a whole to be worth it, but they might as well have left out that section and sent me a letter that said, "Dear professional pharmacist lady. Fuck you. Sincerely, ACCP."
Any place you find lots of sCAM
artists with Rx privileges, there
will be lots of 'bioidentical'
hormone peddlers.
If synthetic hormones are so evil,
what keeps levothyroxine on the
market? Heaven forfend that compounders going to
start grinding up pig thryoids since
Armour and the like are virtually
unavailable...
Yeah, all the 'bioidentical' stuff creeps me out. "It's just like Premarin in terms of efficacy...maybe even better...except it doesn't have any of the side effects. In fact, it's magic, pooped out by unicorns who eat nothing but pure, organic rainbows and stars." If it's equally efficacious and acts by the same mechanism, chances are it causes the same side effects. If it isn't, you may dodge the bullet on side effects but you've just admitted you're selling tubes full of nothing. Either way, give me data from a clinical trial.
My favorite natural compound is opium. It's drug of choice for vegetarians.
Well, the point of the matter is that we as modern-day pharmacists graduating with degrees in a field where we are the most knowledgeable, and provided the most information about human use of chemicals, and the only ones legally allowed to compound prescriptions, it speaks to our professionalism to not be out there compounding arsenic gumdrops for gout or iridescent beetle wings (cantharides) ointment and marketing our specially compounded products above the law to Mrs. or Mr. Gullible TV viewer, just because Mrs, and Mr. Gullible will pay good money to us since there are no FDA-approved products available by prescription.
Out of my league here and off topic but some women will sacrifice their lives to have smooth skin longer and still demand estrogen therapy. And docs will do it. Sad. I also remember when estrogen replacement therapy was all the rage to protect women's hearts until that house of cards came crashing down. Between profit and bad science, it's all kinda scary.
So do you drug monkey refuse to fill premarin for menopausal women or birth control for 15 year olds for fear of giving them cancer? If total accumulation of hormone increases the risk of cancers (which I believe does) how can you sleep at night dispensing BCs to still developing girls? I used to work at then own a compounding pharmacy and I can attest all our bioidentical hormone replacement patients recieved far more counseling on benefits vs risks than you give to teens starting on BCs. How can you in one sentence say making a capsule into a liquid is laudable when it is probably giving a medication off label to begin with? Just keep slapping stickers on vials and collecting your fat paycheck. I made less per year as a compounding pharmacy owner then I could have at large chain, but I am much happier and never worked weekends!
Anon. 8:26, the point being that there is irresponsibility involved in the ethics of being the only guy that could possibly sell the hand-formulated hormone mixture, and then, markets it and whips it up for all those uninformed that can pay. (Maybe worse scenario compared with unlicensed pharmacists that sell catnip on the web to humans, or the jokers that flooded the internet with 'I can get it for you wholesale' with regard to FATBUSTER, etc..
(Tell me that a woman's health will be severely compromised without access to oral or vaginal hormones, and as a fellow HEALTH care provider, I would daresay tell you that is false. There are alternative.)
Notice, this is a different scenario? There is NO criticism of compounders that formulate liquid dosage forms from solids for kids that can't swallow seizure meds, or other perfectly legitimate and helpful assistance based on pharmaceutical and 'kinetic principles.
And, please, don't give us all hilarious gas with a complaint of how much money you lost on your endeavors! I know several pharmacies in my town, that do provide special compounded formulations for patients based on strict necessity. And, how often have I compounded Mary's Magic, and Riley Butt Cream in my hospital?
When did I say I lost money on my endeavors? I only said I made less than working for a large chain, but the hours and time I got to spend with my patients was worth it. If you took that as complaining, I apologize. I unlike most posters am very happy with pay and work schedule.
Last I checked, estradiol and progesterone USP were FDA approved for use in compounding. Estradiol can be absorbed in a patch, but not in a cream? Physicians have been able to eliminate multiple meds their patients were on by getting the right hormone balance. Take the time to talk to your menopausal patients and tell them their HRT is nonessential. You must have never counseled a women with severe vaginal atrophy. Women who bleed during intercourse because it is so painful. Women who have an incresed risk of cystitis. Estriol vaginal cream has given many women their lives back. Many have debilitating symptoms which lead to overwhelming stress, depression, fatugue and failing marriages. To your earlier suggestion that we are unethical by implying we are the only ones who can make their products, you must not be too familiar with good compounding pharmacies. You forget we are not prescribing the product, only making and dispensing it. You think women would keep refilling it if they saw no success. Good physicians would incorporate or try manufactured products like estradiol patch, progesterone in oil capsules before trying compounded products. We must use critical thinking sometimes. The vets are far ahead of our medical community. Almost all the medications are weight based for dosing, but we limit our dosing to what the manufacturer has suupplied. How many times have see premarin 0.625 prescribed for both a 100 pound 80 year old and the same dose for a 300 pound 45 year year old? Cancers were increased because the majority were overdosed.
Lets not beat up on our own profession or peers nor forget that all pharmacies were compounding pharmacies not too long ago. BHRT is just one aspect of a compounding pharmacy, we also make topical creams with lorazepam, diphenhydramine, haloperidol, metoclopramide for terminal hospice patients whose family is in tears they were so thankful for the product. I am sure you have studies backing up your Mary's Magic and butt cream of which we also make. We at least use an ointment mill to get a finer product.
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