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Subscribe to RSSTwo people blinded in Washington, D.C., in 2005. Three dead in Virginia in 2006 and three more in Oregon the following year. Twenty-one dead polo horses in Florida in 2009. Earlier this year, 33 people in seven states with fungal eye infections. And now, at least five people dead and 35 sickened with fungal meningitis that has been linked to steroid shots for back pain.
All these disasters involved medicines that had been custom-mixed at what are called "compounding pharmacies" — laboratories that supply hospitals, clinics and doctors to a much wider degree in the U.S. than many people realize.
These pharmacies mix solutions, creams and other medicines used to treat everything from menopause symptoms and back pain to vision loss and cancer. Unlike manufactured drugs, these products are not subject to approval by the Food and Drug Administration. And some have turned out to be dangerously contaminated.
Compounding pharmacies often obtain drugs from manufacturers and then split them into smaller doses, or mix ingredients sold in bulk. Any of those steps can easily lead to contamination if sterile conditions aren't maintained. For example, the fungus suspected in the current meningitis outbreak can spread in the air.
The risks from these products have long been known but are being amplified now by a national shortage of many drugs that has forced doctors to seek custom-made alternatives to the usual first-choice treatments. The steroid suspected in the current outbreak has been in short supply.
"Because of the incredible number of drugs that are out of stock or back-ordered, compounding pharmacies are working with local hospitals, clinics and physicians to fill that gap," said David Miller, executive vice president of the International Academy of Compounding Pharmacists, a trade organization.
These products have had remarkable growth. More than 7,500 compounding pharmacies operate in the U.S., up from 5,000 in 2009, Miller said. They account for a $3 billion segment of the drug market and 3 percent of all prescriptions filled.
Some say this industry needs more regulation.
"There's not a lot of oversight of compounding pharmacies" compared with drug manufacturers, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a suburban Philadelphia advocacy group that tracks medication errors.
Dr. William Schaffner, an infectious-disease specialist at Vanderbilt University, agreed.
"They fall into this gray area and no one supervises in a rigorous fashion their manufacturing processes. The state pharmacy boards don't have the resources or the knowledge or experience," and the FDA does not get involved unless a problem occurs, he said.
The FDA has said the steroid in the current meningitis outbreak came from the New England Compounding Center, based in Framingham, Mass. The company recalled three lots of the drug last week and has said it has voluntarily suspended operations and is working with regulators to identify the source of the infection. Investigators also are looking into the antiseptic and anesthetic used during the injections.
On Thursday, investigators urged doctors nationwide to avoid all products from the New England company. At least 23 states have received vials from the three recalled lots.
Compounding pharmacies are supposed to supply products to meet unique patient needs, and to prepare drug products that are not available commercially, based on an individual prescription. They may cross a line if they supply a product on a large scale to a clinic or hospital without individual prescriptions, Miller and other experts said.
"They, in effect, since they do this on a large scale, have become mini-pharmaceutical companies," Schaffner said.
That appears to be the basis for an FDA warning to the New England company and four other firms in December 2006. The FDA told them to stop compounding and distributing anesthetic creams "marketed for general distribution rather than responding to the unique medical needs of individual patients." Too much anesthetic in a rubbed-on cream can cause seizures and irregular heartbeats, and at least two deaths have resulted, the FDA said.
Miller said that in the current outbreak, it appears that the New England company was dispensing drugs widely to clinics and hospitals instead of filling individual prescriptions.
Some compounding pharmacies have had more than one troubling episode. And some products seem to have problems over and over again.
In May, officials reported 33 cases in seven states of a fungal eye infection caused by products mixed in a Florida pharmacy that also prepared supplements that killed 21 elite polo horses in 2009.
The same steroid in the current outbreak was also tied to five cases of a different type of fungal infection in North Carolina in September 2002. Those patients also had shots from pain clinics, and one died.
Related links:
Fungal outbreak spreads to six states
Four dead in fungal meningitis outbreak
Rare outbreak of fungal meningitis
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just another case of the almighty dollar in front of common sense...
Just another case of government interference creating false scarcity filled in by black and grey markets.
Just another case of a brain infection that might lead to zombies.
Irradiation should be used more often as a means of sterilization in the medical industry. It is cheaper and more effective than any other method.
Sadly this is not the first time patients have been harmed by pharmacists who make unapproved drugs nor will it be the last as long as compounded is a self regulated industry. In 2008 after an investigation into pharmacy companies who were substituting compounded nebulizer medications and NOT telling doctors and patients they weren't FDA approved, CMS and some insurance companies refused to reimburse for compounded nebulizer medications. Some of these nebulizer medications were also found to be contaminated with fungus. It's a shame, in this day and age, there are patients with other diseases still suffering from drugs that are not FDA approved for safety, efficacy or sterility.
Isn't this the same pharmacy that had a problem a few years ago substituting compounded avastin for FDA approved Lucentis?
#1 - The FDA is a joke. They are no more looking out for our health, than the man on the moon is.
#2 - Don't get sick and go to the doctor. It could be your last visit.
#3 - Big pharmacy, compounding pharmacy; it makes no difference, the bottom line is money.
Healthcare in this country can be more hazardous to your health than just staying sick. I have not been to a doctor since 2009. The only reason I went then was because I had pneumonia really, really bad. They took an x-ray and threw the big C word at me. Cancer. Sent me to a cancer center for all these test to find out it was just pneumonia. Now, when I get sick I look for alternative remedies and natural medicines to get better. So far, it's working for me.
And the FDA wants to police vitamins! Sounds like they should turn their attentions to the
compounding pharmacy industry.
Nodoff. Refer to #1. Enough said.
excellent comment. for the best nutritional suppliment in existince, get "an alex pack" at infowarsteam.com .... reasearch shows it beats 900 "physician created diseases". most diseases are just like scurvy.. ive done the research, and no other company offers this formula, AND NO, IM NOT SELLING THIS, THIS IS NOT AN AD OR SPAM, its crucial info... google dr. joel d. wallach ... save your loved ones with the truth. most sickness is just a god damn scam.
I'm sorry tom jefferson2 but joel d. wallach is an outright quack.
Isn't it odd how some folks are already blaming the FDA, yet are so quick to agree with the repconservaTeas that there are too many regulations/oversight etc and govt is too big blah blah blah.
Well how about those budget cuts and underfunding leading to understaffing of these regulatory agencies like the FDA amoung others? If they do not have the funding how are they to employ more inspectors and scientists and really oversee these various manufacturers etc?
It would seem that there needs to be rules, regulations and oversight and thus that the federal government have a role in our lives after all, doesn't it...... lol
Peace.... blah blah blah......
Just saying...
lacywild feels we should get rid of Doctors, FDA, and pharmacists? I would be interested to see if that makes everything better.
LOL @ conspiracy theorists rejecting cocktail drugs and mainstream medical science because it's "pushing an evil agenda" and then taking cocktails from their own people and believing their own medical "science" as the absolute truth. The general public are sheep for following "their people" but you aren't sheep for blindly following your own?!??!
I am a pharmacist (no longer practicing) and I did a lot of compounding while working for the VA. I can attest to the very serious difficulties encountered when compounding sterile products. To do this job safely requires extreme attention to detail, very carefully controlled conditions, and some very expensive equipment. Sterile compounding is a job that a pharmacist can do efficiently and safely but it is not simple, nor easy and you must spend a lot of time assuring that conditions are just so or you end up with a lethal concoction instead of a safe and effective medicine. Constant quality controls and sterility testing are a must and even the very best compounding labs encounter occasional contamination so if you are not constantly checking and occasionally discarding possible contamination you will eventually kill or injure someone.
I fully suport the idea of applying the same strict regulations and quality reporting to compounding pharmacies that apply to pharmaceutical manufacturing by the large pharmaceutical companies. These companies also had problems with contamination until the strict regulations that they must observe today were enacted. Problems with compounding pharmacies are, sadly, not a surprise to me.
No FDA control over Compounding Pharmacies? Yet the FDA takes their sweet F#%king time to ok a new cancer treatment drugs or any other life saving drug. These are sold to hospitals and clinics, as the article reads, yet hospitals and clinics charge up to 100 times more for medication, should it then not be top grade medication, again where is the FDA. Why is the medication, in question currently, not being returned to the Centers for Disease Control instead of it being shipped back to the manufacturer, could this be the same comparison as: Feds handing over evidence in a murder trail to the murderer.
The FDA, like any federal government agency, only has jurisdiction over drugs in interstate commerce. If a compounding pharmacy only operates within a single state then the FDA will have no legal jurisdiction.
Another problem is expense. Budgets only go so far and if you don't fund enough inspectors then inspections just don't happen. Remember this the next time someone suggests that the FDA budget should be cut. When it comes to the availability of oversight you only get what you are willing to pay for.
Spoken like a true Politician or a FDA employee. There have been 5 deaths along with 35 people showing symptoms, is this not a concern to the FDA or Centers for Disease Control, if not why do we have them at all. Are you saying if I manufacturer a Cancer treatment drug in the State of Ohio I can skip the 4 stage FDA check? Don’t you think that there is a remote possibility that the medication has been tampered with, thus the hell with budgets?
G-3303506
The CDC certainly has a reason to be involved but the FDA may be prohibited by law or are you someone who doesn't believe in the law and limiting the reach of powerful government agencies?
Read my earlier post - I know all about the issues of compounding pharmacies and let me assure you that knee jerk responses will only get more people injured or killed.
If you want good quality oats free from stones and chaff you must pay the fair market price. Of course, the oats are a lot cheaper after you run them through the horse.
Which oats do you want to buy?
Hmmmm
It's pathetic who can go to jail on RICOH laws against organized crime, but those who kill people because of drug contamination will face NO criminal charges. Returning evidence to murderers? This should NEVER happen. If a corporation is allowed to give unlimited campaign dollars to a political PAC, it is a person, and as a person, should be tried in criminal courts for murder. Capital punishment? If it was Murder #1.
At the same time, the FDA takes a "fee" of a million and a half dollars for every new drug developed by big pharmaceutical companies, and then screams poverty. The FDA has the resources to test these drugs, they just have no will power. This problem has been growing worse; it is not a Democrat or Republican problem, but while the Republican Congress tried to repeal Obamacare 33 times, this Republican Congress has not done one thing to fix the FDA.
Interesting how the people who whine and complain about too much government oversight are the same people who complain when there isn't enough. Hypocrisy rules.
G.....et al... you cannot have it both ways, either you want the FDA to really review all docs presented and all the data etc regarding these new cancer drugs i.e. do their job of protecting the public, or you want them to just rubber stamp these drugs and allow then on to the market, no matter it they may not work, is not effective enough, may have too many life threatening side effects that outweighs whatever little good they may do, etc.
Many of these drugs that are sold in this country are manufactured abroad in countries like Pakistan, India etc because it is supposedly cheaper. Not so long ago many of these drugs used to be manufractured in Puerto Rico if I am not mistaken, but many of the manufacturing factories were shut down and moved elsewhere.
It was noted not so long ago that if all the pharmaceutical manufactoring companies that supply the USA with drugs/meds/pharma were to be inspected it would take 8 years to inspect them all. Why, because we do not have enough inspectors etc to inspect all these places in a timely fashion i.e. do the job, especially with the various T'Repconsevas ignoramis continuously calling for less regulations and even lesser oversight, and smaller government, and to get their way out comes the old underfunding, defunding, laying off public employees etc and then expecting a different result. LOL What about medical devices etc manufacturing, they have to be inspected etc too. Now add into the mix compounding labs who probably may not employ enough pharmacists/pharmacologists etc.. Oh well these folks can self police I suppose.. .LOL..
Anyhoo, think these sort of problems have not happened before? Wasn't there some issues pertaining to incorrect dosage compounded and delivered etc. So it is not only contamination, it is about the actual dosages of the drugs, labelling etc. Plus now that generics are being dispensed more often than not these days, that has to be factored in too, as some of these drug names are so close that they may be separated only by the position of a couple of letter while dosage may be affected by just the position of a point/dot and a /or the zero especially when it comes to pediatrics dosages.
Hospitals have their own pharmacies and pharmacists but places like nursing homes and at home iv meds etc are done by others.
No wonder there is always some recall or other usually after the fact when the med/pharma has already been dispensed to the public.
Might as well keep checking the FDA website and check all your meds and medical devices against their recall list, just to be on the safe side.
So as a Pharmacist, so you claim, have you ever knowingly killed anyone in your field, quote " the very best compounding labs encounter occasional contamination so if you are not constantly checking and occasionally discarding possible contamination you will eventually kill or injure someone."end
What do you mean by this, Quote: “Read my earlier post - I know all about the issues of compounding pharmacies and let me assure you that knee jerk responses will only get more people injured or killed.”end
Are you threating me?
As far as my oats I prefer them cooked
Calm youself.
No - I have never knowingly relaesed any product that could do harm if used properly. I have discarded drugs that were not proven to be contaminated just on the chance that they could be contaminated and possibly harmful. This is what any prudent and honest person would do.
I never threaten anyone - it is pointless to do so.
By knee jerk responses I mean we all have the obligation to think carefully about just what does and does not work well and make rational decisions. Nothing comes for free and no solution is perfect.
Diogenese: You may be a person of integrity, but there are plenty of labs who use their autoclaves only when the boss is looking. And very often, compounding pharmacies compound their business with walk-in customers who sneeze across the counter in or near the room where drugs are being compounded.
I'm always struck by hospital sterilization methods too. My husband is a cancer patient, and when he gets his infusion of chemo therapy, there is a ritual of steps the nurse takes to be thoroughly sterile. But no similar mask is applied to his face (and he is breathing near the place where the port is on his arm). He is not in a special gown, but his street clothes. The sterile wash solution is applied to a small area, and dust could land in those seconds between that wash and port access. People walk into the infusion area with their street shoes, and whatever dust came with them. It is a lovely ritual, but really it is not 100 percent sterile. There really isn't any such thing, but cutting down the risk is very important, and it is almost impossible to cut down the risk in a location that is taking walk-in business in a pharmacy at the same time that important medicines are being compounded.
The only reason we have a drug shortage is because big pharma is seeing a drop in their profits. By witholding, they can tip the law of supply and demand...add in a little fear or a lot and...
Rubbish.
Most drug shortages are caused by quality assurance requirements. Learn how the system really works before making unfounded comments.
Sterile products are held in quarantine until tested to be safe according to several different criteria (sterility, free from particulate contamination and free from pyrogens if you want the details).
If the tests show even as much as a 1 in 1 million chance of any single dose in a lot of millions of doses being contaminated then the entire lot is discarded.
There have been cases where such contaminated lots were sold to countries that did not have such stringent standards. Even though these sales were legal in the coutries they were sold to they were illegal in the US and the companies were prosecuted and found guilty. They paid billions in fines.
You are SO RIGHT jb98degrees. For example: methotrexate. This drug (which lowers folic acid in the body, slowing cell metabolism) is used in childhood cancer. But a few months ago, the supply was almost completely unavailable. Methotrexate is also used for rheumatoid arthritis, and has been used for many many years. That's the key: the patents have long run out, so the big profits aren't there. Instead, a pharmaceutical company must settle for a reasonable price for manufacturing the medicine.
There should be more oversight. Lack of regulation always leads to shortcuts, and people making judgement calls that shouldnt be made. Regulations set the bar on safety and quality, regulators make sure the rules are followed.
I disagree with other posters on the FDA. They have done enormous good making sure food is safe and clean. People dont realize what garbage some would try to sell, if it wasnt for the FDA. They may not be perfect, but they do far more good then some want to give credit.
Look up TAP Pharmaceuticals, which had members of its company on the FDA board. Look up the fine that TAP got when it was found that they were overly pushing Lupron both for prostate cancer and also reproductive problems in women. Lupron is a GNRh agonist (affecting the pituitary gland), and the side-effects were not taken seriously. The FDA takes some drugs very seriously if they don't get their "fee," but if a drug company pays them off and also has its own people on the FDA board, the FDA allows almost anything. Until a company is caught and fined (which is rare). That was a $800 million fine, by the way.
Freedom4Everyone, I agree with you. The FDA has historically been underfunded and understaffed. One examiner at the FDA may have, in his or her cramped, stifling office, a stack of applications for new-drug approval that they are required to scrutinize word by word. These applications can be thousands of pages long, filled with arcane chemical formulae, statistical charts of drugs tests performed on hundreds of people in controlled situations - it is a nightmare. Yet in spite of these obstacles the Agency functions far better than others that are bloated with money and people.
Diogenese, thank you for giving us the benefit of your personal experience in such an important matter, and giving it in a clear and articulate way that can be understood by everyone. It is serious enough to make all of us want to seek further information on our own to better understand such an crucial process as compounding pharmacies and the FDA in general.
They already have a cure for cancer but they will never use it. Too much money will be lost for useless treatments.
Not true. The trouble with "a cure for cancer" is that cancer is not one disease. Within any given patient, you can be fighting multiple diseases at the same time given the rate of mutations which caused the cancer in the first place. I hate to be a downer, but I don't think a "cure for cancer" will ever be possible. There will not be one magic bullet for everything. Can we eventually cure specific types of cancer caused by specific mutations? Maybe, and probably, but you'll never get a pill or a shot or anything like that can cure all cancer.
They probably have a cure for cancer,but its not because they would loose money on treatments,its to have a little control on population.There are to many people adding up in the world.And we are always trying to make things safer,and extend life,well this will backfire on us evenually.The governments know this so they dont cure certain deseases.Like all things on the planet,every species is controled by food chain,except the human species,it will be out of control if something dont even us out.
W.T.F.101: Not really; most people who have cancer are older, and are not reproducing, not adding to population growth. There is only one little agreement: the tobacco industry (knowing that it cannot be charged for murder as organized crime because it is made of legal corporations) has actually stated that we should be glad of the deaths caused by tobacco because we won't have to support all those elderly people.
Well, elderly are a bit messy, but cost? They don't add to population. They eat a bit less. And they employ lots of people who take care of them. Sure, that costs a lot of money, but even though many elderly may not know the names of their own children, they are still providing a service. They are the cheerleaders for our society. They are usually very grateful, and polite. A lot of people who don't care if they run you over on the street could take some lessons from them.
Cancer is a very painful, slow way to die. You wouldn't want the worst criminal to die that way. I would hope that some cures are found.
More Regulations? What would Romney say to that? So what is a few peasants die, these places create jobs!!!
This story surprises me.
There was just a news story on earlier that stated the meningitis came from the needles that were used in the steroid injections.
I am wondering what steroid medications they are referring to as I get monthly injections for my physical ailments. I haven't been feeling well as of late and though it most likely is due to the change in seasons, I may need to get checked for any symptoms of meningitis just to be sure. The FDA regulates and looks over simple things like vitamins, but will not oversee medications like these? They need to just be shut down as they do nothing, but occupy a few buildings and play solitaire on the damned PC. Those damned jerks! If I do get sick from the outbreak I'll know who to go after in court for not paying attention. I know the jury will take my side, and anyone's side for that matter when it comes to showing the FDA we're not taking this garbage anymore of them all not doing their jobs right.
Not only should abortion be legel,abortions should be free.There are to many people in this world,and need to be controled.We should do like they did in China,and limit parents to two childen.People who have 4 and 5 and 6 and more kids who cant afford them especially,should be executed and neutered after 2 kids.
They should have abortion clinics on every corner like McDonalds,and stop giving out more tax payers money for every kid families cant afford.In FACT,if your on welfare already and have more kids,you should have money taken away.This might be the hardest on mexicans and blacks,but at least the blacks kill themselves in the getto's over drugs and territory.The mexicans and latino's have a baby everytime there is a change in the weather.
This is off-topic. You might want to refer to the article about free contraceptives reducing unwanted pregnancies and abortions. Medically necessary abortions should be easy to obtain, without having to go to a court hearing, but it is best to provide contraceptives free of charge and hope that it prevents abortions.
OMG!!!!! I had a prescription years ago from a compounding pharmacy that was prepared for me, and purchased by me directly from that pharmacy, all very well done. Many hospitals have such pharmacies in-house too, as some cancer drugs must be compounded on site with IV solutions; but, those drugs are very carefully prepared, not in a public pharmacy where people might walk in off the street sneezing. While many people hate government regulation, it is needed for compounding pharmacies.
Back in the early 20th century, before antibiotics, it was common for children to contract meningitis as a complication of the measles. My mother lost a sister that way. It is shocking that in 2012 people are still losing loved ones from preventable meningitis.
abortions should stay legel,abortions should stay legel
its not murder,its not murder
Another ridiculous article by a numbskull journalist probably working for big pharma to drum up fear of these local, small-time community compounding pharmacies. What big pharma really wants is tax payer subsidies to pay for any losses they may end up with by producing drugs with below average demand. Compounding pharmacies are already highly regulated, especially with regards to sterile compounding. No system is going to be perfect (lord knows large scale manufacturing isn't) but if anyone advocates imposing super tight restrictions on small-time compounders who generally only compound 1 or 2 scripts at a time, that service will go away because it'll be impossible for them to meet regulations and still be profitable. Big pharma is playing you like a violin.
We need MORE government regulation on Business, not less. Remove Oversight, and Chaos immediately ensues. If the Business can't endure the Oversight, screw 'em - let 'em move to China, and peddle their toxic wares there. This country USED to have adequate Regulation, until George W. Bush de-funded and dismantled a lot of it. It needs to be rejuvenated, not relaxed.
It is the too much oversight which has created false scarcity for which the next alternatives are the one we've seen. In and insane drive for 100% perfection, the 99.99%ers have been driven from the market place to be filled in with the 95% the are not regulated. Insane regulation against the best have now driven the consumer to the second tier. And, of course, the ignorant demand MORE regulation. The law of unintended consequence rules in every form of government interference. Just like the quixotic war on drugs has done very little by way of cutting off supply, created a whole universe of designer replacements, and has turned the better part of the entire country of Mexico in Chicago of the 20's. The more Force that is used in the wrong areas for the wrong reasons leads to a WORSE environment than had previously existed. Crippling the best producers among us in a quest for unobtainable perfection has had the logical result of appealing to the next, dirtier level.
Every time a compounding pharmacy has an issue, it winds up getting an extreme amount of press. My heart goes out to the injured (or worse) in this tragedy. However, when you consider how much compounding is going on, these incidences are far and few between. The prescription drug manufacturers "FDA regulated" have a far greater incidence of adverse and fatal reactions to the US population. That being said, I do agree there needs to be more regulation for compounding pharmacy. But when taking medications you will always have a slight risk weather it be with a compounded med or from the drug industry. I've been a pharmacist since 1982 and remember many drugs that the FDA approved only to get dispensed and have grave consequences.
Again uninformed readers will believe any story that is based on fear -
The CDC said:
Soil in Southwestern United States and northern Mexico contain the fungus Coccidioides which can cause fungal meningitis. Although anyone can get infected with coccidioidal meningitis, people at higher risk include African Americans, Filipinos, pregnant women in the third trimester, and immunocompromised persons.
Unfortunately traditional pharmacy compounding, making one prescription for one person with the patient, prescriber and pharmacist working together (the triad) is not what is happening anymore in compounding. If the compounders were making one prescription for one patient they would only harm one patient. Instead, they are acting as manufacturers making batches and affecting many people who may not even know they are using a medication that is not FDA approved. Compounded drugs are not subject to FDA manufacturing requirements, but instead the compounders have created self accreditation and fought regulations as simple as being required to put a label on compounded medication stating the medication is not an FDA approved drug and if you have any questions to speak to your doctor. They are in business to make a profit like every other business and literally getting away with murder while claiming state boards of pharmacy can regulate them just fine......and many of the compounders and chemical suppliers to the compounders sit on the state pharmacy boards doing the regulation. Conflict of interest? Who is looking out for the patients?
I believe the reasons for the "compounding company" is because big pharmaceuticals refuse to make the medicines because they are no longer extremely profitable! IMHO this is where the problem is not the fact that they are "out of stock" or "back ordered"!
I have come to learn, through close experience working around pharmacists, that pharmacists need to be monitored very closely. The assumption is made that they have a good education for what they do and they are paid well. They are paid well, but one really has to wonder what is taught during the 5-6 years of college they go to and given that education, why they cannot perform the basics of their jobs, which is dispensing medications. They are not chemists, they do not create the medicines they dispense. Given a prescription, they locate the appropriate medicine container, count out the prescribed doses and put them in a bottle for the customer. It's not rocket science, and there are many, many pharmacists out there who bear that truth out. However, with 5-6 years of college, could they at least count correctly and even more importantly, use the proper container when dispensing prescriptions? Seems like a day doesn't go by without news stories of customers being given the wrong medicines and people becoming very ill or dying as a result. Then there are the endless stories of pharmacists who are themselves abusers of the controlled substances they dispense, stealing from the stock, opening liquid controlled substance bottles and taking a swig and more. The very last thing I would ever entrust to a pharmacist would be compounding a substance. Never, ever. As a "profession", they do not demonstrate the capabilties to be entrusted with this. They need to acquire basic counting skills, for starters. This is one "profession" that needs closer policing and enforcement.
I am a "pharmacist", and I am relatively offended that you seem to know so little about "pharmacists" considering you work around them. I am more curious which "pharmacy" school turned down your application, but that is neither here nor there.
Pharmacists are the experts in a field called "drug information". They know the medications mechanism of action, side effects, dosing, and risks better than the physicians that prescribe them. In addition, they provide education to the patients regarding the medications that physicians don't have time to or don't want to do.
Pharmacy school is medical school, with a more specific focus (less diagnosis/anatomy, more drug effects on the body (called pharmacodynamics) and the bodies effect on drugs (pharmacokinetics). They are specialized in identifying drug interactions, therapeutic duplications, and understanding patient specific risk factors. All this information for over 10,000 different drugs. Many pharmacists go on to work in hospitals (like me) directly working with the physicians to achieve good patient outcomes, and helping to choose the best medication and doses for each individual patient.
I am concerned that your focus is on such a "menial" task such as pill counting. A normal retail pharmacist fills 300 prescriptions a day, or roughly 10,000 prescriptions a month. Even at an unhuman error rate of 99.99% that is one medication error a pharmacist a month. Derek Jeter has a career fielding percentage of 97.64%... Is he as bad as all the pharmacists you 'work with'. To err is human, and while we as a profession and medical field spend a ton of money, effort, and training, to reduce errors... we will never eliminate them. Last quarter my hospital registered 14 errors that reached a patient. 7 were nursing, 5 were pharmacy and 2 were physicians.
In all the time you have spent working with pharmacists, it seems you've never bothered to understand what they do versus what you see them doing. Entering prescriptions and dispensing pills is easy; it is reviewing the doctor's chosen medication and dose for appropriateness and therapeutic efficacy and then checking that against the rest a patient's medication and disease profile for drug interactions, synergistic or antagonistic reactions, and potential disease state complications that is difficult and takes both time and concentration. Many people have multiple doctors who often don't know what the other is prescribing. As a pharmacist, it's my job to make sure everything a patient is prescribed can be taken together safely and that doctors prescribe appropriate medications and doses for what they are treating. For this, all pharmacists graduate today with doctorates (PharmD) after six years of rigorous study.
The problem is not pharmacy compounding in general. If it is done responsibly and with attention to detail, it can be a great service, especially in times of drug shortage. A few years ago, during a shortage of Tamiflu suspension, I compounded many suspensions from the available oral capsule formulations, tailoring the strength to the age of the children who needed them. I've prepared antibiotic creams that are no longer available from manufacturers for doctors in the ER across the street from my pharmacy. I've even prepared antibiotic IVs under a sterile flow hood for a nearby nursing home at a different pharmacy. Thousands of other pharmacists do the same every day. In all my time practicing, I've never had anyone injured or sick from something I have compounded.
It sounds like the problem with the pharmacy featured in this story is that they are trying to compound on a large scale without adequate infrastructure. Compounds in a retail setting take a lot of time. You have to do the required calculations first (I do them twice, forward and backward). Then sterilize the work area and wash up. Finally, allow yourself adequate, distraction-free time to make the compound (no easy feat in a retail setting). As with any industry and profession, there are always those who cut corners or don't pay enough attention to what they are doing with dire consequences. In the pharmaceutical field, just look at McNeil's recent problems. But this story does not speak to the industry as a whole and the vast majority of pharmacists take their jobs very seriously.
In reply to both of the above, I understand why you would be offended. It was not my intention to offend any one individual but rather to point out serious discrepancies in this profession as a whole. First, let me say to Gus that no pharmacy school turned down my application. I'm sure if I had any desire, for whatever reason that I cannot comprehend, to become a pharmacist I would have been accepted into the school. I have been accepted into other schools and positions that had much higher and more rigorous standards than pharmacy profession. If it was your intention to insult me by suggesting that I have any desire to be a pharmacist, you succeeded. To be honest, I've never met a person who actually aspired to be a pharmacist. I know that pharmacists are always trying to gain acceptance into the medical field, just as you did by saying that pharmacy school is a medical school, wth a specific focus. While it is true that it is a focused discipline, you really should not try to compare it to a medical school with a specific focus such as neurology, cardiology, etc. Not even general practicioner. While there are margins of error in those disciplines, thankfully it is not nearly as high as pharmacology. I know that you will not admit to it in this forum, but we both know that if the public ever knew what goes on with the abuse of controlled substances by pharmacists, and others in the medical profession, they would be shocked.
Wow, ProudtobeAmerican. If you've been paid to troll this article, you've been successful. As a pharmacist, I am also very insulted at your view and interpretation of my profession. You say "pharmacists are always trying to gain acceptance into the medical field"...we are not trying to gain acceptance, because we have already been accepted! I work as a pharmacist in an 800 bed hospital. We have pharmacists in all of the intensive care units, neonatal intensive care, emergency room, orthopedics, oncology, cardiology, etc, and all of our pharmacists are part of a multidisciplinary team that includes doctors, nurses, nutrition, physical therapy, etc. We look for drug interactions, change drug doses based on kidney function to minimize side effects, recommend switching to a better antibiotic (or discontinuing them when they are no longer necessary), dose highly toxic antibiotics that can cause kidney damage if not dosed appropriately, etc. We are required to review all medication orders after the MD prescribes the medication, and you'd be surprised at how many errors or inappropriate drugs we get orders for.
We are always consulted by DOCTORS, who trust in our expertise of medications. Doctors and residents call us with questions constantly. The doctors trust us to make sure the patient is on the correct doses and the correct drugs, so the physician can spend that time on other aspects of patient care. We function as a TEAM.
In my shift tonight, the doctor prescribed a dose that was too high for a little 9 year old boy. I found the error, and called the doctor to get the order changed. In addition, just this shift I've answered questions about drug infiltration, I've dosed possibly toxic antibiotics for two patients, and I've ordered doses of anticoagulants for 4 patients. That is in addition to reviewing hundreds of orders throughout the night.
If our job was "counting pills" as you say, we wouldn't have to go to school for 6-8 years. I encourage you to look at a pharmacy school curriculum.
All that being said, and back to the article, I am usually a fan of less government babysitting, but when it comes to instances like this, where an unregulated company is compounding a medication for use in multiple people, there definitely needs to be some sort of routine monitoring and regulation. As the article stated, the drug shortages these past few years have been disastrous. In order to provide our population with certain medications, we have had to rely more and more on these compounding pharmacies, rather than government controlled drug manufacturers. I'm sure 99% of compounding pharmacies make sure their product is safe, but there will always be the minority of those who are dangerous. The FDA definitely needs to step in to regulate these companies, and they need to assure us that the products we are giving to our patients are safe.
Proud:
The reason I mention that pharmacy school is a specific type of medical school is very simple....
My pharmacy school WAS a medical school! The school offers both MDs and PharmDs degrees, and ALL of the first 2 years is spent as combined classes. I took the same anatomy as my MD counter parts. I took the same Immunology as my MD counterparts. We sat in the same class, took the same test, and studied together.
Once I graduated I did a residency, which is the same as a physician. Then I did a second residency to specialize, just like a physician. Sure... I don't have the same level of expertise in Neurology, but thats because my specialty ISNT neurology (but I know pharmacists who that is their specialty).
Your description of medical school (with specific focuses, etc) shows how little you understand about medical education. Physician's only have 2 years of classroom training, after that its all "on the job" training. Further- they dont get any specializing until several years after graduation when then enter fellowships.
I had 3 years of classroom work (post B.S. Degree in chemistry) plus 3 years of on the job training. That puts at 4+3+3 = 10 years of post HS training.
Hmm...compounding pharmacies...they are just witch doctors known by a fancy name...and making a ton of $.
BZe1 and Richard in CO
You know, maybe the best thing to do is to rescend all laws that require governmental regulations and oversight, just start from scratch. That way the American public can reexperince the reason we have so many government regulations and rules to start with.
@ G 3303506 --- I'm with you / understand your posting -- No FDA control over compounding pharmacies yet they take their sweet "ss time to approve something for cancer. I will say this , my opinion , they take their time on all drugs and indeed people will and are dying when there is a possible drug that might help them live longer. Therein is the catch 22, if you will --- a drug that might POSSIBLY save their lives. Playing the devils advocate -- so to speak -- I am sure the FDA would tell you the reason they take so long to APPROVE a new medication -- they want it to be as safe as possible so that their is little to no harm or deaths caused by the medication, the problem though , we are all different in the way we react to any medicine and, no medication is 100 % safe for all. NOW to the funding issues as mentioned by Diogenese's posting, it is my opinion that when you talk in terms of funding any FEDERAL regulatory agency, if you give them / fund them 10 million or 1 billion one year --- it will never be enough --- they will always need more , more , more. The sad truth is that no matter how much money is funded --- again --- it will never be enough and though it is a fact that money and research will save lives, it is also a fact that not all lives will be saved because of money and research. I myself am not a fan of more regulation but in the case of drug safety , no matter what you call it , there has to be some oversight for safety sake. I suppose this is the big catch 22 again and also keeping in mind that where BIG money is involved there will always be corruption from people wanting to steal to get rich quick.