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Subscribe to RSSA single compounding pharmacy, one that mixes up drugs to order, appears to be the source of contamination that has killed 12 people and made more than 100 sick with a rare form of fungal meningitis. Some consumer advocates want the Food and Drug Administration to crack down harder on such pharmacies, but the legal battle to regulate them has been long and convoluted.
The question is whether the New England Compounding Center, which made and sold the contaminated steroids blamed for the outbreak of rare fungal meningitis, is truly a legal compounding pharmacy, or an illegal drug manufacturer. NECC has voluntarily closed and recalled all of its drugs. Reuters reported on Wednesday that a second pharmacy, Ameridose LLC, which shares common ownership with NECC, plans to shut down voluntarily for a week as a precaution.
So-called compounding pharmacies are frequently at the center of controversy. They’ve been heroes to advocates of “bioidentical” hormones such as actress Suzanne Somers, who sells her own books, DVDs and blogs promoting the idea. Professional medical associations including the Endocrine Society and American College of Obstetricians and Gynecologists say these individually mixed hormone remedies are bogus.
“One of the big problems is that we just don't know what risks are associated with these so-called 'bio-identicals’,” said the FDA’s Steve Silverman.
The pharmacies were also folk heroes for a while in a battle over a drug that prevents preterm births. It’s a synthetic form of the hormone progesterone called hydroxyprogesterone caproate. Compounding pharmacists can make it for just a few dollars a dose, or about $400 per pregnancy. Then KV Pharmaceutical of St. Louis came up with an FDA-approved version last year and priced it at $1,500 a dose – dropping that to $690 a dose after a prolonged outcry, but still nearly $14,000 to preserve a pregnancy to term.
The FDA sat on the fence for a while, but eventually chased down some pharmacies making compounded versions. “We are writing to ensure that Wedgewood Pharmacy is not operating under the misimpression that there is a ‘green light’ to compound large volumes of copies of Makena,” FDA told the president of one New Jersey compounding pharmacy last June. FDA said its main concern is that the products sold aren’t contaminated, and that they actually work safely.
Compounding pharmacies can also step in when there’s a shortage of a vital drug.
Under the FDA’s definition, compounding pharmacists are supposed to mix drugs to order only on an individual basis in response to a prescription from a doctor. For instance, if a child is allergic to one of the inactive ingredients in a pill, or if a medicine tastes bad, a compounding pharmacist can remix the product to make it safe or palatable.
Under this definition, the New England Compounding Center was not operating as the FDA prescribes. State pharmacy boards are supposed to regulate this activity but the FDA can step in when there’s contamination, as in this case, or when the agency believes pharmacies are breaking the legal limits.
The consumer group Public Citizen says FDA failed this time. “The large-scale production of a drug -- in this case, a drug that is intended to be sterile and injected into patients -- appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce,” Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group, says in a statement. NECC’s products, now recalled, were distributed to pain clinics in at least 23 states.
"However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients.”
Members of Congress are paying attention, too. Reps. Ed Markey, a Massachusetts Democrat, and Rosa DeLauro, a Connecticut Democrat, say they intend to introduce legislation that would more closely regulate these pharmacies. They can’t do anything without Republican support – the House is controlled by Republicans – but the Republican-led Energy and Commerce Committee says it will call in the FDA and the Centers for Disease Control and Prevention for a hearing this week.
“These compounding pharmacies are operating as factories, mass-producing and packaging specialized new drugs in large quantities and then sending them over state lines,” Markey says. “These compounding pharmacies are compounding risk -producing complex drugs in bulk and then distributing them across the country. Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer.”
Congress tried to strengthen FDA oversight of compounding pharmacies in 1997, but the law fell apart under challenge. It prohibited the pharmacies from advertising, something that the Supreme Court ruled was unconstitutional. Jonathan Berman of the law firm Jones, Day says the status of the remainder of the law is unclear now. “Nobody knows whether that law is valid or not,” Berman said in a telephone interview.
He thinks the Supreme Court could and would make a ruling – if someone would bring an appropriate case. "The question is whether there will be another case that presents the same issue. The government hasn't brought many cases against compounding pharmacies," Berman said.
Despite the absence of clear rules, Berman says, some compounding pharmacies have grown much larger. "More and more these days you see pharmacies trying to fill a niche by compounding large quantities,” he said. They should have a lawful way of doing business, because what they do is important.”
While the NECC could argue that it was filling a shortage, the FDA denies it. The drug doctors believe was to blame is called methylprednisolone, a steroid injected into the back for pain. “There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives,” the FDA says in a statement. “FDA’s drug shortage office has confirmed that NECC’s voluntary shutdown will not affect the nationwide supply of methylprednisolone acetate.”
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Just follow the Big Pharma money trail. Obviously this particular compounding pharmacy is in for it and apparently desevedly so, but Big Pharma and its minions will use this as an opportunity to eliminate competition.
This compounding pharmacy obviously had a major problem, but all compounding pharmacies should not be painted with the same brush. There are many compounding pharmacies that operate in a completely responsible manner and provide a much needed service. I personally take medication that I get every month from a compounding pharmacy. It is the only way to get this particular medication because it is a combination of two other drugs which are not readily available in a form that a person can take at home. The pharmacy I deal with is a local one that makes up medications in response to a specific prescription from a doctor, they do not manufacture large quantities to sell wholesale. It would be a disaster for many people if the government was to take some knee jerk action in response to what is an isolated incident with one pharmacy and shut down these compounding pharmacies. Of course the big pharmaceutical companies will try and throw fuel on the fire to try and shut down, or at least add much stronger regulation of these pharmacies. In many cases, these compounding pharmacies can make up medication for patients at a much lower cost than what big pharma charges for the same compound medication. They can also make up the compounds in dosages that are tailored to the needs of the individual patient, instead of doctors being forced to prescribe some predetermined mix based on what the big companies manufacture. Any changes that impact people's ability to get compounded medications would have a serious negative effect on many people's lives. It might make sense to place more controls on these pharmacies and I agree that they should not be making large batches of drugs for resale, however there is still a legitimate need for these compounding pharmacies. I hope that this one incident does not lead to some knee jerk reaction by the FDA or Congress that creates more problems than it solves.
You hit it right on the Bulls Eye recovering Democrat!
The basic problem is that one compounding pharmacy allowed several batches of one compounded drug to become contaminated with not one, but two, fungi. This sort of error in incredibly rare, mostly because the intensive checking for toxic, viral and bacterian contaminants is usually sufficient to catch fungi.
While it is easy to blame the everyone from the FDA to the users of the drug, the truth is that compounding pharmacies are a good way to help hold down drug costs in a small free-market way. Most of the time compounding pharmacies take multiple existing drugs and combine them in such a way as to make them easier to administer. If the drug companies themselves did it, they would first have to overcome patent and licensing difficulties, but would have to have dedicated production resources that would increase the cost of the drug by at least four times.
There obviously is a need for better regulation of compounding pharmacies, but most of this is just insuring that quality control is better and that one cannot assume that mixing two sterile drugs will result in a sterile compound.
But this would also be a goot time to re-think the pharmacy vocation in general. In times past, pharmacists "compounded" everything. A physician might recommend a drug, but it was a pharmacist who had the final say and translated the physician's diagnosis into a prescription. In those times a pharmacist could prescribe without the intervention of a physician at all.
But times have changed. The AMA stopped pharmacists from being able to prescribe. And the need for compounded drugs dropped dramatically. (It is coming back somewhat as "cocktail" drug therapies are being shown to be more effective in lots of treatments.)
Right now you have around 5,000 pharmacists who do actual compounding. Most of these work in large hospitals. You have another 3,000 or so "consulting pharmacists" who help researchers and physicians with such issues of dosages. There are about 300,000 pharmacists in the country averaging about $105k in salary.
But are these pharmacists really necessary? If you watch them they are just counting pills and that's it. They don't have to check for drug interactions --- the computer does that. They answer some patient questions, but a technician making $30k can answer them just as easily. In large mail-order pharmacies, there may be as few as one part-time pharmacist "supervising" as many as 400 pharmacy techs. It could be asserted that pharmacists supervise techs, but why would a degree in pharmacy be necessary to supervise semi-skilled labor? Right now this country is seeing outrageous increases in medical costs. One way to reduce these costs would be to get rid of as many as 280,000 pharmacists, replacing them with techs with an Associates Degree. That would be a savings of $110k a person (assuming benefits to be equal) times 280,000 or $30,800,000,000 a year.
If some careful common sense were applied, over $30 billion a year could be saved in the healthcare delivery system by simply getting rid of this deadwood.
Similar savings could be achieved by giving nurses the ability to prescribe and treat low-level injuuries and illnesses and checkups.
Another huge potential saving would come by allowing physicians to screen patients online via email. About one-third of all office visitscould be eliminated and a say $10 charge made for the online screening and possible calling in a prescription instead of a $100+ office visit. (And that doesn't take into account the illnesses caused by sitting in a waiting room filled with sick people.)
There are plenty of ways to cut medical costs.
Obviously you are a consumer who NEVER asks a pharmacist a question. We are constantly asked about over the counter medications interacting with Rx medications as well as reviewing all facets of a patients health. We are responsible for reviewing ALL steps in the Rx filling process performed by technicians. It takes years of schooling to be able to detect an incorrect dosage of a medication, a potential interaction that the "computer" would not detect. You propose allowing individuals with a minimum of education review orders made by physicians who are more than unlikely be unaware of other meds a patient takes, ordered by his/her other healthcare providers, and also physicians DO make mistakes when they order prescriptions.
I'd love to see you work a day in the life of a pharmacist. If you think all they do is "count pills", you're incredibly wrong. There's a reason pharmacy became a doctorate level degree a few decades back. Most technicians have no clue what some of the drugs do or how to properly dose them or take them. Being a pharmacy intern myself who is about to graduate, I've worked both as a technician and as a pharmacist, and let me tell you, there is a huge difference. There are thousands of drugs out there, which is why a pharmacist obtains a doctorate level degree. You can get a job as a technician as a high school dropout. You make your choice where you'd rather get advice from. When's the last time your doctor told you everything you needed to know about a drug? In most cases, he hands you a slip of paper, says get this filled, and might mention "it's for pain" or "it's an antibiotic" and nothing else. Oh, you realized you had questions about it after the fact? Maybe you wanted some more info on a side effect? Your pharmacist will happily help you out when you come by to pick up your medication or via phone. Your doctor? He'll probably want another expensive copay. You're right about the fact that drug interactions come up on computer software - but a good pharmacist never depends on software alone to catch everything. They might not tell you how severe the interaction is or if it's even relevant for a particular person. Just working day-to-day, I can't tell you how many countless times I've had to call a nurse or doctor back to verify a dose or directions because they happened to write it wrong. A pharmacy technician isn't going to know the common doses or directions for drugs. Sometimes, computer software doesn't pick up on it. Also, a doctor may write for a perfectly acceptable prescription - but for that person, it might way too much or too little (liver disease, renal function, weight, age, concomitant drug therapy can all be reasons to alter drug therapy, and those are just SOME reasons). Another point: yeah, your prescription bag or the bottle itself may have the top two or three important warnings or side effects. But there's no way you can fit all of the drug information on there. Some drug interactions are extremely rare, but extremely dangerous, and its our duty to warn patients about risks/benefits. Other interactions may be very common, but not a big concern. Knowing the differences and which patients are more at risk to which side effects is very important. Technicians don't know those things. Many times, doctors don't know how much drugs cost. Working in the field, we do. There are many, many times where I've had to consult with a doctor to change to a different medication because a patients insurance wouldn't cover it or it was too expensive. You think a technician would be able to recommend another option without proper schooling? Doubtful. As a technician, I maybe knew the bare minimum drug therapy (ex. this is an antibiotic) but not how to switch it over to another drug just as effective. I could go on and on and on about what else pharmacists do in the real world...And to think, this is just RETAIL pharmacy we're talking about, among the many other classifications of pharmacy...
You are right. I used to work for AdvancePCS. They handled prescription information electronically. They never actually touched any medicine. All they did was transfer data from pharmacies to insurance companies. The company made $15,000,000 a month pure profit, after taxes. Everyone drove a BMW. We had on site chefs and company hired nannies and even our pets had health insurance. Most of upper management had personal shoppers. The suits were so expensive, they literally glowed from the silk as the men walked through the halls. The owner was able to put this business together and put big deals together with companies like Blue Cross and Aetna in the course of just a decade. I worked in accounting and heard whispers about questionable political contributions, but never had privy to data to prove it. The owner was a Bush 2.0 college roommate.
Totally agree with Recovering Democrat. This story will be all over the news to make people afraid of getting alternative forms of medication through compounding pharmacies. The FDA loves to instill fear in us all, meanwhile the stuff they do approve is only available to us because it's making big pharma and the FDA rich! Being the conspiracy theorist that I am it wouldn't surprise me if the FDA had a personal vendetta against this particular pharmacy and planted the fungus themselves.
Chris-749391, all of the health care vocations need to be redone. This country needs health care reform, but this reform will only amount to shuffling money around if several medical professions are not restructured.
The FDA used to regulate compounding pharmacies in the 90's. Then in 2002 SCOTUS struck down the law that did that because there was something in the law that stated compounding pharmacies can't advertise. The SCOTUS struck it down because this violates free speech. But the whole thing was struck down and nothing has taken its place. In the absence of federal regulations, it's been up to the states to do it.
Since certain members of congress are small government fewer regulations kind of people, it's unlikely that any law ever will replace the one that was struck down, no matter how many people die.
Being a biologist, I know it's pretty darn easy for microscopic stuff to sneak into things you think are sterile. Of course, I don't have a QC department checking my petri dishes. These guys should have.
Private industry makes huge mistake, killing many and sickening thousands, blame government for it.
REPUBLICAN LOGIC!
Compounding pharamcies are to regular pharmacies what going to walmart to get your eyes checked is opposed to seeing an opthamologist. Yeah this one messed up big, but on the whole if you want the real deal they are the place to do business.
Just to clarify - when you go to WalMart to have your eyes checked, you are actually going to a private eye doctor whose office is located in WalMart. When you get your eye glass or contact prescription filled, then you are again using WalMart. Those doctors inside WalMart are just as trained as those in a private building somewhere else. They have the same medical degree, had to pass the same boards, etc.
Compounding pharmacies were actually used - legally - during the H1N1 flu in the fall of 2009. Tamiflu suspension/liquid for children was critically low, and most mainstream pharmacies could not get shipments for weeks as it was on backorder. Those same mainstream pharmacies had pediatric doses in pill form, but could not legally crush them into a liquid. Enter compounding pharmacies, who were authorized to crush those same pediatric dose pills into a suspension/liquid. There is a niche for compounding pharmacies.
The blame lies primarily with the doctors and the DEA. Opioids have been shown effective for these pain syndromes for over a century. Yet a doctor would rather put the life of their patients at risk and earn a nice $500 injection fee than simply write a prescription to fill at the pharmacy. The opioid "epidemic" being pushed by the media is also to blame. They solve the problem and only a small % become addicted. Stopping the addiction is easier than the life-long damage from meningitis. It's easier than stopping cigarettes.
Too bad you are way off base. Epidural steroid injections have an overall effectiveness rate of 78%. And with FAR fewer side effects than using narcotics, and at a LOWER total cost to the patient. Your addiction figures are bogus, as well.
You don't know what you are talking about. I had pain in my back that kept me out of work for weeks. No type of pain killer would help - not even oral steriods. One shot later and I'm up right and walking and back to work the next day. The day before I was hugging the walls or the floor and could barely make it to the bathroom. Have you ever taken strong pain medication. I must not have an addictive personality because I would rather die than have to take them long term.
I had a series of three lumbar trans-foraminal steroid injections for intractable sciatica that failed medical treatment and physical therapy. It was very effective, and should I find myself in a similar predicament, I would probably do it again. Speaking as someone who was on long-term oral opioids subsequent to major chest surgery, I can tell you with absolute certainty that stopping opioids is not easy. It is actually a kind of hell on earth that gives you a much better understanding of why drug addicts don't want to kick the addiction.
It took me eight weeks of a very slow taper off them, and I still hit the point where I was writhing on the floor in pain with the cold sweats and the jitter shakes awaiting my next dose. Nothing easy about it whatsoever, and I was not on a high dose, but taking four or five pills daily for ten months sets up the dependency (addiction). I haven't touched an opioid since, and unless I get a severe enough pain from trauma or surgery, I won't.
Opiods mask pain, but they do not TREAT the cause. Epidural steroids stop the pain by so reducing the internal swelling that the nerves can finally calm down. I never resorted to opioids for my herniated disks/facet joint degeneration, but when I had a big decline, with severe nerve imingement and loss of control over one leg, before they would resort to surgery, a series of three epidural steroid injections which was done IN-HOSPITAL over a period of weeks finally got me to the point that I could walk without a cane, and eventually had enough range of motion that I could start meaningful physical therapy to get the area stronger. Now, no medications at all for it for the last 10 years, nor surgery.
NOTHING in this news article addresses the problem of the contamination -which has been the whole horrifying problem in this current story - in this compound which has killed people and infected so many others. No comment presented about "legislation " addresses contamination in custom formulations as opposed to the famous wholesale drug manufacturers who also have to protect and beware of adulterated or contaminated products coming from their manufacturies. Does a legal rulling ever protect the public without policing and oversight?? Where is the thinking in this reportage? This company's administration should be up on charges of murder, at this point.
I would say that big pharma does not want to see such a legal precedent set.
Well, well, well. Let's really look at the events here. Most of the victims of the tainted drugs are in TN. Anyone care to guess why? Does Bill Frist ring a bell? Frist's hospitals are regular "customers" of the sheisters at NECC. Perhaps Frist and his cronies are pulling some real leverage to get NECC out of hot soup, since this isn't the first time NECC has had issues with the FDA.
Things the republicans call free-enterprise;)
I understand that contamination is a problem and absolutely the offenders need to be shut down but as someone who recommends compounded progesterone, mentioned in this article, I hope that compounded progesterone is not taken away.
I have many patients with no pharmacy benefits, the FDA approved progesterone is 700 per dose, and they need it 25 times in pregnancy. That's 17,500 dollars out of pocket. Versus I charge my patients $15 dollars per shot in my office.
No one that doesn't have great insurance is going to be able to get this medicine. Maybe when the FDA is working on the contamination problem they can work on profiteering by drug companies.
This may sound really 'trite', but if people were eating right maybe women would not need something 25 times during their pregnancy, especially a medication that never even used to be prescribed in the past.
There is no evidence that a healthy diet can prevent preterm birth, but there is for progesterone.
Also this is new evidence, and it's incredibly beneficial. I have seen people that have repeatedly delivered preterm infant be able to make it to term and it's great for everyone, kids, parents, society, everyone.
Follow the money.
If they are preventing the drug companies from making a killing (literally and figuratively) then the will be outlawed. Everyone will get screwed, except the rich who can afford to get around this.
The compound pharmacy I frequent saved my life. I can see why big pharm would want to get rid of them. They provide services that can actually heal for way less than what most of the shyster med companies would charge. What we need to do is break the stranglehold these and other companies have over our government. We are paying for dishonest and morally ambigious people to get insanely rich.
And if you were to get to know a few, you would not begin to believe how ". . . how dishonest and morally ambigious . . ." some of them are.
The big problem is that these compounding pharmacies are supposed to be making single doses made to order. Many do. But this outfit was in effect a mini-drug company because they were making entire batches of doses. But because they were listed as a compounding pharmacy and not a drug company, they weren't subject to FDA oversight. They would be regulated were it not for a 2002 Supreme Court decision.
FDA approved Big Pharma drugs directly cause over 300 American deaths per day.
The rhetorical headline question from NBC should be "FDA - Political Tool of Big Pharma or Genocidal Nazis belonging in prison".
There's a difference between a side effect and a contaminate. Really bad side effects such as death are not always foreseen. It depends on the person's individual body chemistry and a bajillion other factors. What's proven safe for 10,000 people may not be safe for 1 in 100,000 people.
The contaminate is 100% preventable because it shouldn't be there in the first place. Fungus is really easy to detect if you do even the most basic quality control.
One bad apple shouldn't spoil the whole bunch. Big Pharma drugs kill people all the time... just watch tv for a little while and you'll see countless class action lawsuit commercials that accuse different drugs of causing severe injury and death. As a whole, if the compounding pharmacies can provide cheaper, but equally effective medication, there should be a place for them. That being said, they do need to be regulated to ensure that they are following all of the necessary safety procedures so that tragedies like this do not happen. What I find disturbing is how many people are potentially affected by this particular case. Was it because this was all made up in a single batch or because the equipment/processes used to make multiple batches was tainted/improper? If the former is the case, then there should be some limit on how large each batch should be manufactured at a time in order to limit the potential size of impact.
testing mic 123
more safe drugs
Contamination isn't a small company problem only, the FDA just shut down a large production facility that made alcahol and iodine prep. pads and other products for hospitals. They were contaminated with some virus which they were suppposed to eliminate. Cutting corners or using lax safety standards for the sake of higher profits has become endemic in all industries, health care just happens to cost lives when they don't have proper oversight and let something slip through.
Interesting.
Safety issues are a big concern and really does need to be addressed but lumping all compounding pharmacies in one group because of this recent incident is not right. After struggling for two years to get various medications for a genetic health condition I have I finally found a physician that was willing to help me get my medications "specifically" made for me. Now mind you they have to be injected which I can do myself but the cost of the pharmaceutical companies product with side effects was 10 times as much as my individually made prescription. It was a radical change in my health once I got off the big pharma drugs, in less than 90 days my health stablized and no side effects!! So if the FDA wants to go to TN and investigate this compounding pharmacy for negligence in this particular case that is fine, I agree, however, putting ALL compounding pharmacies under this umbrella is wrong.
It is truly amazing, and disgusting, the complete lack of respect the people on this board and the person writing this article has for Doctors of my trade. I say Doctor because Pharmacists are Doctors. While a physician spends 2 weeks studying pharmacology we spent 4 years. Counting tablets is not in the job description of my profession. The truth is that infinitely more people are harmed by the errors of physicians and surgeons. The truth is that the general public would be terrified by the questions I get asked by Nurses and Physicians. They literally have no idea what they are doing in the realm of Pharmacology. I once had a discussion with a patient who had heart surgery done by a local cardiologist and after the conversation he said that I had told him more useful information in our 10 minute talk than in the entire process of his surgery. The truth is that Medicine is as much an art as it is a science. The idiot who stated that Pharmacists are "deadwood" should do research on the fact that multiple studies for many years have shown how much money Pharmacists save the healthcare system. Naturally he also thinks Nurses should be able to prescribe medication. Again... the general public would be terrified to know the truth about Physicians and Nurses knowledge regarding medications. Learn to show some respect for the people who spent just as much time as a Physician in school doing nothing but "learning how to count pills."
Thank you for being the self-appointed apologist for the trade, Doctor P. Counter.
He's right - Doctors don't know much about the medicine they prescribe. In comes the drug rep and who does he talk to? The receptionist. Not the doctor. Then he hands his samples with the prescribing information to her and walks away. All the doctor knows is what's on the leaflet that comes with the pills. I have a very good friend that works in a doctors office and she says it happens all the time. She says the doctors rarely read the info and don't know the interactions. I went to my doctor for a sinus infection and walked out with a paper bag full of 'free' medicine. After reading all the information for the pills it was clear that I shouldn't take those medications together. When I told the doctor about it he looked shocked. Don't get me started about geriatric medicine - I was a nurses aide for 13 years and I could tell you horror stories.
As is the case with the so-called 'idiot', you are not totally right about what is going on everywhere. I conjectured that the so-called 'idiot' tends to be right more often than not.
I am currently back in school working towards becoming a Pharmacist after working as a CPhT (Pharmacy Technician) for 8 years. If you disrespect the value and knowledge of any pharmacist you are severely naive and/or uneducated. Pharmacists are the specialty doctors who other doctors turn too to know what to prescribe you. Doctors (and Nurses), as the Pharmacist above stated, have mere weeks of education in pharmacology, versus years. The PharmD mentioned you would be frightened of the questions he/she is asked NUMEROUS times a day by doctors and a Pharmacy Intern also mentioned the amount of errors computers do not catch. They are both telling you people the truth.
Pharmacists are also often the most accessible health care provider available to people and the one that knows a patient with multiple health care issues the best (as also mentioned by the intern, if you have a specialist(s) and a primary care doctor, guess what, they probably never speak to each other.) Anyone can walk into a pharmacy and ask the Doctor of Pharmacy there a health question. No insurance or money required for them to share their vast knowledge with you and they will provide you with the assistance you need or point you to the correct type of Doctor you need for your situation.
A good technician can also be a valuable member of the pharmacy safety net, we work as a team to keep the patients safe. The Pharmacist examines every prescription that goes out the door but often a tech will notice the first sign of problems when doing the data entry and alert the Pharmacist so they can correct the issue with the Doctor. There are many technicians who are little more then data entry, counters and cashiers though and have no desire to know more. Another person mentioned they could ask the lower paid technician advice instead of the high dollar pharmacist just as well, so why do we need those high paid pharmacists.... well technicians can not give consults or advice because they do not have the complete wealth of knowledge your Pharmacist does. I can point you toward the OTC pain section but I cannot tell you what drug you should buy for your particular condition legally.
The deadliest and scariest error I personally caught as a technician was a prescription called in by a Nurse for a newborn baby. The nurse called in Imuran instead of AZT for a baby with HIV to be compounded. Imurans generic name is azathioprine so she thought they were the same drug.... It would have further immune suppressed the baby with HIV and most likely caused its death. Think about situations like that the next time you think the only thing going on behind the counter at your pharmacy is counting to 30 and slapping on a computer generated label. The phone rings off the hook all day long for the Pharmacist with Doctors and Nurses getting valuable consultation advice on what to prescribe you, the patient.
I eagerly await the day I meet my goal of being a Doctor of Pharmacy and joining the ranks of this noble group of men and women who aid communities throughout the world daily maintain better health and quality of life. It is a very long road and I am not exactly young but it will be well worth all the additional years of college in the end.
I also plan on learning compounding despite some peoples negative attitude behind it, I worked in a compounding pharmacy and saw the difference it makes in peoples lives.
Actually the FDA is a paid advocate for the big pharma outfits. It's surprising they let the little guys run as long as they did.
Well, it's over now, with reason.
The few deaths caused by this one compounding pharmacy, while tragic and negligent, pale in comparison to the thousands who die every year from prescription drugs properly prescribed.
Do not make the error in logic of emotion-based risk assessment. Any unusual risk is emotionally tagged as "big and dangerous." Habitual actions that really are terribly risky, such as getting in a car and going somewhere, are not so tagged and we think nothing of them.
I wasn't even aware that we had compounding pharmacies any more in this country.
In case others aren't aware, some of us who have environmental-induced illnesses-as in Toxic mold exposure-resulting in food, chemical sensitivities along with some preservative/additives allergies; we need these compounding pharmacies desperately for certain drugs or supplements because of the compounding process available. Nutriets, drugs and other supplements we need for out health recovery involves removing dyes/BHT, sulfites, sugars,msg, alcohols & many other chemicals which are toxic to our bodies. We get well by removing these chemicals & reducing our exposure to such intolerances that trigger symptoms. If it weren't for these pharmacies & what they do, many of us would never overcome our health challenges. Hopefully these steroid drugs that were contaminated will now ensure the needed oversight and/or regulation necessary to make sure all future drugs/presritions from these pharmacies safe for use, without harming my ability to utilize & benefit from their services for more natural products.
Compounding is still necessary for many people, for the reasons others have listed. Keep in mind, it's not the compounding itself that is the problem - it is how it is performed. If you have just one person not take the right steps to ensure sterility, problems such as these happen. Only takes one "bug" - virus, bacteria, fungi, what have you - to endanger the lives of patients. Guess what though? Pharmacists are making up medicines in hospitals (not compounding pharmacies) all the time, and this is MUCH more common - they may not be compounding "new" ones like compounding pharmacies, but they are mixing things together to be made into a dosage form (such as putting together an IV bag or an injection). Same tragic consequences can happen if somebody screws up in the hospital.
This does not seem so difficult. A compounding pharmacy has historically compounded drugs on a per-patient basis, just as your neighborhood pharmacist may combine ingredients on occasion. If they're now doing so on a massive scale, then they have become drug manufacturers and should be regulated as such.
Well i am sure there are allready some attorneys and others who are cleaning up there keypads and notebooks of dust. It wont take long now the company will be sued and then bankcruptcy will follow. And cost of medication will go up.
Chris- that's a huge leap to blame pharmacy costs on the high cost of medical care. How 'bout unnecessary tests, treatments/therapies that are ineffective. At any hospital, it's the pharmacists who are most likely to be the ones keeping you from a drug overdose or misdose. My brother just died this year. If I happened to call him while he was at work, I'd almost always hear him stating that yet again he saved another doctor's butt. He'd been doing this line of work since the 70's & he loved it & was good at it. He was respected by his peers, many of whom I met at his funeral. Kiss a pharmacist next time you're hospitalized buddy!
My husband had necrotizing fasciitis and came very close to dying and losing his limbs. At one point in time we desperately needed a compounding pharmacy in order to transport him from one facility to another. I remember thanking GOD and being so grateful to find someone who would mix his medicine after hours and help us. Moving him to another hospital saved his life. Later on we needed a compounding pharmacy in order to do some of his treatments at home and save money. Our expenses AFTER insurance were $80,000, so we were eager to stop the bills and after so many weeks in the hospital we needed him home. I don't know what the right answers are and I know there are problems, but to me, the compounding pharmacists are life savers.
Though the outbreak is horrible, it's still rare. Follow the money for the real answer! This about sums it up: "Compounding pharmacists can make it for just a few dollars a dose, or about $400 per pregnancy. Then KV Pharmaceutical of St. Louis came up with an FDA-approved version last year and priced it at $1,500 a dose – dropping that to $690 a dose after a prolonged outcry, but still nearly $14,000 to preserve a pregnancy to term."
So...$400 vs.$14,000 for the same medication? Seems pretty obvious why Big Pharma has an axe to grind. This is a prime example of what's wrong with the current health care system.