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Monday, January 5, 2015
Fourth Question of the Day January 5, 2015, Article discussing compounding pharmacies states "There is a fierce competition for your dollars, especially now as thousands of baby boomers seek relief from menopausal symptoms" Exactly how much money does compounding pharmacies and related business make off of compounded hormones?
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22 comments:
How much money is being made? I think a better question is if these therapies are effective, and what therapies are best. Also, how much money is being saved by compounding hormone medications to tailor-fit each patient.
Look at the $250 Estrace cream medication, and even the brand name tablets. Its not a compounded medication, but its cost has risen substantially each year.
I enjoy the repository of articles your website has, but I'm getting exhausted by the constant lopsidedness of your questions.
Maybe your final question should just be "Should we just outlaw compounding so I can close this website?"
I hope the website does not close, and the questions continue to be posed.
Questions regarding any industry is always needed to improve and refine said industry. However, I agree. Some of these questions are very anti-compounding. Rewording is necessary IMO.
I am glad someone is presenting a view other than the one always presented by the compounding industry. Talk about lopsidedness!
Thank you for your comments. I don't think I have ever said I was anti-compounding, but I also am not anti-big pharma either. I have written articles stating we need good compounding pharmacists and pharmacies. I pose questions for all to consider. Sorry, if you are exhausted by the questions. I am not a pharmacist. I don't represent pharmacies. I am a lawyer. I do play devil's advocate. I agree the questions are lopsided at times. Sometimes I think they need to be for various reasons. I think the blog is set up so you can pick and choose what articles, comments, questions, etc. you want to read, and you are not required to read everything posted. (If I am wrong about that please let me know). As I have stated before I do not advertise on the blog. I do not make any money from this blog. To date, I have always provided it as a free blog for all who want to read it. The readers are free to form their own opinion or respond to any question posed just as you did. Thanks again for all the comments.
Compounded drugs serve important public health roles; solving health care cost concerns is not one of them. If it were the solution, we'd have to accept substandard exposures as expected, tantamount to a playing a game of russian roulette with the public health, particularly in those states that do not randomly sample and test compounded drugs for purity, potency, and related manufacturing quality parameters. This often floated policy solution is untenable and made worse by the fact that while we can smell and see rotten produce, consumers (including sick and vulnerable patients) will not be able to detect poor quality, unsafe compounds and will have little if any opportunity to reject them.
It is my hope that this blog continues until pharmacists shift back to a professional pharmaceutical care model, where an unapproved drug made outside federal oversight (with no warranty on ingredient analysis results) would be a rare, well-vetted and rational solution, instead of the current sales and marketing driven merchant model.
Interesting conversation. The question posed is a complicated one, but here's some rough estimates:
Pharmacist hourly wage: $55-65 per 60 minutes, not counting costs of healthcare, etc.
Time to review the prescription and formulate the correct medication: 5-20 minutes.
Time to compound a typical cream: 15-20 minutes.
Costs of doing business (licensing, training, testing of compounds for purity, stability, concentration, etc): $5-15 per compound.
Cost of a typical hormone cream, ingredients ONLY: $12.00
Cost of device to accurately measure each dose: $5.00
So, let's say $17.00 for the cost of the ingredients and the device holding the cream. Add on $25.00 min for the cost of time, and add $5.00 min for the cost of remaining compliant with rules, regulations, etc.
$47.00 total COST to the pharmacy to produce one hormone cream. I've seen between $35 to $90 for different doses, etc.
Some pharmacies make very little, some make a little more. This doesn't include costs for rent, utilities, and so on.
I'm betting the average actual money-in-the-pocket for a compounded hormone cream is $10 to $15. Hardly a money-grubbing situation.
To many pharmacists its how can they best serve their local community. To others, sadly, is how much money can they put in their pocket. Just like any other business.....just like Doctors, just like mechanics, just like lawyers. A few bad apples...
The 5 to 20 minute estimate to review and formulate a "correct" prescription is very telling--pharmacists may wrongly assume the formulas they purchase and market to treat specific ailments are safe and effective and do not need vetting by multidisciplinary experts--the fact that the formulas exist in the marketplace without approval by FDA should send up flaming flares, indicating a proceed with extreme caution approach. If RPh's knew what they are likely not to know about the potential risks of the drugs they sell and then formulate, they would take a lot longer to judge "correctness".
For example, the topical formulations made reference to are impossible to deem "correct," because, even though suppliers say you can mix up to 6 ingredients in their base formulations, and patents echo these claims, it is impossible to know the extent to which the ingredients are actually absorbed into the systemic circulation and what their combined effects will be on humans. It is demonstrably difficult to get passed the "correct" step, if you have any awareness of the science involved in drug and formulation development, and the process for vetting safety and effectiveness. If there is no or little awareness, or if knowledge is dismissed in order to sell compounds, then 5-20 minutes is a reasonable estimate.
You would need to have some experience in formulating compounds to judge this process. 5 minutes may all it take to adjust a concentration of an existing formulation. A slight change in concentration (say from 1mg testosterone to 2mg testosterone) is far from needing an entirely new review of the formulation.
Some compounds may take a much longer process of research, from the 5 minutes to hours or even days. Not all compounded prescriptions that are written out by doctors can be compounded (due to complexity or other problematic issues), and communication is highly necessary in order to resolve those situations.
To suggest that each formulation needs to be FDA-approved is showing ignorance to the process of compounding and the time, cost, and overall complexity of the FDA-approval process for commercial medications.
Essential compounds are exempt from certain provisions of the Food Drug and Cosmetic Act for a reason, but those exemptions are not intended as a commercialization pathway. Under the traditional model, risk assessments and judgements are balanced against a level of urgency for a formulation when there are no commercial alternatives, like when manufacturers fail to make pediatric versions of important medications.
A slight change in the amount of an active ingredient (not stated as a concentration above) is a simple amendment that may take all but 5 minutes. The elephant in the room that may not even reach the radar for vetting by doctors or pharmacists involves more challenging and difficult to resolve concerns, i.e., a chemical ingredient that may include a disclaimer on the quality parameter readings stated in its certificate of analysis or a recipe that may include a disclaimer cautioning that the safety and effectiveness of the formulation has not been determined. When the pharmacist or sales staff ask for a doctor to prescribe a compound, such uncertainties may not be flagged and resolved, and they may never make it into a benefit-risk calculation for an individual patient.
Precisely because essential compounds don't undergo the review process, the benefit-risk calculation by doctors must be fully informed at a reasonably granular level, otherwise all parties may remain ignorant of relevant information that impacts benefit-risk assessments and related decision-making (which falls under the prescriber's authority and responsibility as documented in an authorized Rx).
And maybe more important to consider--without this information, patients are prevented from making decisions regarding what level of risk they may be willing to take.
While setting aside the NDA process for compounding a drug may be practical, setting aside the science and clinical medicine that underpins the process is not always practical or reasonable, and may not be knowable by a single-discipline professional. It is convenient, however, if the end game is to sell compounds.
Recipes on flour are there for a reason--to sell flour. Formulas for making drugs from scratch are also there for a reason--to sell chemicals which are at risk for sourcing from global grey markets, making the disclaimers all the more worrisome. But while flour companies are likely to test recipes for the end-product's intended use before placing them into the marketplace, for example, making a delicious and beautiful cake, formulas for making drugs from scratch disclaim all warranty on end use, i.e., to treat or prevent disease or symptoms.
Please keep posting, As a consumer, I will ask even more questions now as should other consumers.
Are there any concerns about USP-quality standards that the USP needs to address? I'm not talking about generic medications sold in India...I'm talking about the USP standards for each monograph.
Flour? What a horribly simplistic example. I doubt your local baker checks for levels of pesticides, bleaching agents, gluten levels, contaminants (insect parts, etc)...
Maybe the FDA should start issuing regulations on what your local baker can make.
There are rules and regulations as to what a baker can make although they may not be spelled out in a manner you find acceptable. For example, a baker can't legally make cocaine-laced cookies. They can't legally make and sell contaminated food. There are also inspections done of any place where food is made or served. It is done for the health and safety of the general public.
I thought compounding wasn't suppose to be about price, but that is what the first comment not only suggest but states.
Attorneys tend to ask questions and a lot of them. Questions during litigation are very much one-sided and can be very exhausting for a witness. Pharmacists might not understand that especially if they have never been sued. Trial attorneys love comments like the first one. If a witness is exhausted and makes such a comment it is not a bad thing in the legal world. In fact, in trial it might mean job well done.
True. Lawyers love to see weakness. They aint nicknamed blood suckers for nothing!
Like any good sold, cost will definitely be calculated in the mind of the consumer. To think otherwise is short sighted. It'll be part of the discussion whether one side likes it or not.
I use a compounded testosterone cream from my local pharmacist. I talked to him for about a half hour about some of these issues. here's his major points.
1. Compounding is customized for a patient for a better therapy outcome. Period.
2. Many big drug company therapies can't fit everyone's needs.
3. Cost should never be pushed by the doctor or pharmacist. You can't help that factor from a patient perspective though.
My pharmacist is a good guy. He knows a lot, talked to me about all the training and education he keeps up on in the field. I trust him more than most other people I deal with. I'm glad I have the option for my testosterone cream. Androgel did nothing for me.
Well I had an entirely different experience. My pharmacist suggested a doctor to me, saying at my age I might want to consider hormone replacement. The doctor kept pushing me to use hormone pellets. I haven't tried any other options. My doctor wanted me to go straight to using these pellets, which I was not comfortable doing. I no longer use that doctor or that pharmacy.
Wow, I didn't know my original reply would get sooo many follow ups!!!!
Let me just say there's no way i'm paying over $500 a month for a hormone therapy that doesn't match what I need. My pharmacist can make a cream for me that has the right hormones in the right dosing. ive wasted enough money on the fda stuff.
ive gone through so many scares about the fda not allowing me my therapy and i'm sick of it.
As for the person making the above comment, there are other blogs for you then where you can pour your energy into your cause. Not sure why you are reading this one if it is exhuasting you. As for the blogger why allows these comments. Most websites screen comments and block anything like this. You should consider doing that on your blog.
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