Nelson Vergel
Founder, ExcelMale.com
Nelson Vergel: I'm very happy to have Shaun Noorian, the owner and manager of Empower Pharmacy in Houston. He's a member of ExcelMale.com, and answers a lot of questions there. He's also a member of our ******** group called Testosterone Replacement Therapy Discussion and I consider him an expert on different men's health related products, compounding, pharmaceutical regulations, as well as physician and patient education. We have become good friends since we both have the same goal of helping people live better. Like me, he is also an engineer and health nut.
Thanks a lot for joining us tonight, Shaun, and we're excited for you to explain to the audience the different things you guys do and the products you make and what makes your pharmacy unique.
Shaun Noorian: Thanks Nelson Vergel. It's my pleasure to be here.
Nelson Vergel: So, let's start by telling us a little bit about why you started Empower Pharmacy and what makes you different from the rest.
Shaun Noorian: I started Empower Pharmacy back in 2009 after being diagnosed with hypogonadism. Like most patients diagnosed with a condition, I absorbed as much information I could find on the subject. Of course, one of them was your great book, Testosterone: A Man's Guide amongst others. After reading all these books, papers and articles, and personally dealing with several compounding pharmacies that left a bad impression I knew I could add value to the industry and others diagnosed with the same condition. Using my background in engineering, manufacturing and quality control I created a pharmacy that concentrates on customer service, efficiency, and most important, quality.
Nelson Vergel: Tell us because a lot of physicians and patients are actually confused about what compounding means. What is the difference a compounding pharmacy and a regular pharmacy chain?
Shaun Noorian: Good question. Regular pharmacy chains like Walgreen's or CVS simply grab a mass manufactured drug off their shelves and dispense them to their patients. It's different with a compounding pharmacy.
Pharmacy compounding is the art and science of preparing customized medications for patients. Its practice dates back to the origins of pharmacy; yet, compounding's presence in the pharmacy profession has changed over the years. In the 1930s and 1940s, approximately 60 percent of all medications were compounded. With the advent of drug manufacturing in the 1950s and '60s, compounding rapidly declined. The pharmacist's role as a preparer of medications quickly changed to that of a dispenser of medications.
However, within the last two decades, compounding has experienced a resurgence as innovative treatments have allowed more pharmacists to customize medications to meet their patient's specific needs.
There are several reasons why pharmacists usually compound prescription medications. Many patients are allergic to preservatives, excipients, fillers or dyes, or are sensitive to standard drug strengths. With a physician's consent, we can change the strength of a medication, alter its dosage form to make it easier for the patient to ingest, or add flavor to make it more palatable. We can also prepare the medication using several unique delivery systems, such as sublingual troches or lozenges, injections, or a transdermal gel or cream that can be absorbed through the skin. We can also make backordered medications or orphaned drugs and make them available to patients that normally would not be able to get these medications anywhere else.
Nelson Vergel: Why do you think some physicians may be hesitant to prescribe compounded medicines or have their patients use a compounding pharmacy to fill a prescription?
Shaun Noorian: I usually find it to be one of two reasons. Usually, the physician is unfamiliar with compounded products. They either don't know how to prescribe them or what to prescribe and we get questions from doctors all over the country every single day curious about the latest ways to treat certain ailments that they're not familiar with because pharmaceutical companies haven't marketed that specific medication to them.
Other doctors have heard stories about compounding pharmacies lacking proper quality control or having sub-par service, which leaves a bad taste in their mouth. This is why we concentrate on quality control and making sure our patients not only know how to take their unique medications, but are also given all the tools and supplies to properly administer them.
Nelson Vergel: I know you dispense products not only related to men's health but also women's health as well. Obviously, we're going to concentrate on men's health related products in this interview.
When it comes to men's health, what are the most popular compounds prescribed by physicians in your network and give us a description of each and how they are used or how the doctors prescribe them to a patient?
Shaun Noorian: When it comes to men we see the most common prescriptions related to erectile dysfunction, testosterone replacement, hair loss, and infertility. I'll start off by talking about testosterone replacement therapy (TRT).
The most commonly prescribed medications for TRT are injectable versions of testosterone such as Testosterone Cypionate, Testosterone Enanthate and Testosterone Propionate. Then there are transdermal versions of testosterone, like Testosterone Cream, which can be rubbed onto your skin and absorbed topically, and then there are less popular dosage forms such as pellets and oral pills.
Of course with any therapy there can be side effects related to that therapy. Some patients get side effects such as accelerated hair loss, breast tenderness, fluid retention, lack of libido or acne. We have other products to treat those. For hair loss we make a high strength Minoxidil/Azelaic Acid or Spironolactone/Ketoconazole/Progesterone topical solution.
Of course, a lot of people are on TRT because they've been diagnosed with erectile dysfunction. While some men respond well to oral ED treatments such as Viagra or Cialis, others do not or they have uncomfortable or even dangerous side effects. In those cases custom compounded medications can often be used successfully to treat ED.
There are a several different medications used to treat ED and one of the great things about compounders is we can make extremely efficacious versions of ED medications for patients where traditional medications such as Viagra, Cialis, or Levitra are contraindicated due to allergies or a patient taking nitrates or simply them not working anymore because the patient has advanced ED.
So, for those patients, we're able to compound an injectable erectile dysfunction medication called Trimix. Trimix is a combination of three different prescription medications: papaverine, phentolamine, and prostaglandin that are injected intracavernously into the side of the penis. Trimix has been proven through numerous clinical studies to be one of the most effective medications available for achieving erections especially in populations where oral medications no longer work.
The side effect profile of Trimix is also reasonable when properly dosed as its effects are primarily local since it's injected directly into the site where it's needed, whereas other oral medications must become systemic affecting your entire body before they can reach the place where you want them to work. We also get a lot of requests from patients asking for buccal or sublingual versions of Sildenafil and Tadalafil, where the patient can put a lozenge in the side of their cheek or underneath their tongue and have the medication absorbed directly into their bloodstream compared to an oral version, which doesn't enter the bloodstream until it is processed through the hepatic system (liver), which can take up to 30 minutes.
We have human growth hormone related products for patients that are diagnosed with Adult Growth Hormone Deficiency. We see a lot of patients that are prescribed Sermorelin, GHRP-2 and GHRP-6, which are growth hormones secretagogues.
Secretagogues allow patients to create and release their own growth hormone instead of the traditional way of introducing exogenous forms of the hormone.
There are several advantages to using secretagogues vs exogenous HGH. One is cost. Growth hormone secretagogues are a fraction the cost of HGH. Another advantage is that secretagogues prevent your pituitary from lowering its natural growth hormone production due to inhibitory negative feedback.
Secretagogues also give the benefit of making it difficult for patients to overdose or attain supraphysiologic levels of growth hormone as their pituitary gland can only produce and secrete a finite amount of growth hormone no matter how much it's signaled.
Finally, and arguably most importantly, many doctors are more comfortable prescribing secretagogues because the FDA has not banned their off label use like they have with HGH.
Nelson Vergel: How about HCG? Do you get a lot of prescriptions for that product?
Shaun Noorian: Of course. We see a lot of prescriptions for HCG from urologists as well as doctors interested in preventing the suppression of their patient's natural testosterone production while on TRT. HCG is the hormone that is secreted by pregnant women, and in men it mimics Luteinizing Hormone, which is the primary hormone that our pituitary gland produces to tell our testes in turn to produce testosterone.
We all have a negative feedback mechanism in our bodies that prevents us from overproducing too much testosterone when our body senses there is too much in our system and to produce more testosterone when there is too little. Doctors use HCG to not only prevent testicular atrophy in patients on TRT, but also to prevent the resultant decrease in their own natural testosterone production when on an exogenous form of testosterone is introduced.
It's also used in male patients that are interested in retaining their fertility while on TRT. We see fertility patients taking HCG anywhere from 500 IUs all the way to 3,000 IUs every other day to prevent testicular atrophy and keep their testicles producing sperm and testosterone.
Nelson Vergel: On our ******** discussion group, testosterone replacement discussion group and on ExcelMale.com, we get people complaining about the fact that their physician does not want to prescribe a compounded product or they don't have a physician that utilizes compounding. What can we tell those patients on how to find a doctor that is actually familiar and educated on compounding related products?
Shaun Noorian: I recommend prospective patients looking for a doctor to check out Excelmale.com in the preferred doctors area to see to see what other doctors you're comfortable with. If patients can't find a doctor in their area, patients can always print out fact sheets and bring them to their own doctor. Our Fact Sheet Application is a great resource for patients wishing to do this.
Once doctors read the factsheets, become more knowledgeable on this subject and realize that the use of HCG is not only effective, but also approved by the FDA to prevent testicular atrophy and treat hypogonadism they are much more comfortable prescribing it.
Nelson Vergel: Some patients are always asking whether or not compounded products are covered by insurance. Can you tell us the restrictions or the usual surrounding insurance approval for compounded products?
Shaun Noorian: Great question. A lot of compounded products aren't covered by insurance, primarily because many compounds are prescribed for off-label use. When the FDA approves a specific drug as safe and effective, this determination applies only to the specific disease or condition for which the drug was tested. But physicians often prescribe medications for treatments for which they have not been specifically approved. Medical professionals do this because, in their judgment, the treatment is in the best interest of the individual patient. Similarly, medical professionals often prescribe compounded medications because they believe it is the best medical option for their patients. Also, many insurance companies won't cover compounds because they are not part of their approved formulary or they just don't reimburse for compounds at all.
So, in the case where that compound would be covered under insurance, we print filled-out reimbursement forms for our patients. All they have to do is submit those reimbursement forms to their insurance company and if that medication would have been covered then the insurance company will mail the patient a check for what they paid or an amount they would have covered.
Nelson Vergel: When you ship the product, do you include fact sheets or supplies with the product?
Shaun Noorian: I think that if you're giving medication to a patient that patient has to fully understand how to take it. They shouldn't have to go across the street and ask another pharmacy for supplies or directions on how to administer it, so we not only make sure that every patient is counseled and understands how to take their meds, but also is given the tools to be able to take them.
So, for all our compounds, including lyophilized or freeze dried products, we provide reconstitution kits, reconstitution instructions, syringes, alcohol wipes, bacteriostatic water and injection instructions.
And of course, we don't charge patients anything for any of these because I believe that a patient shouldn't be surprised with extra ancillary costs that end up costing just as much as the medication itself.
I believe that getting a compounded prescription should be as simple as sending your Rx to a pharmacy and that pharmacy sending everything you need to use it.
Nelson Vergel: Do you ship everywhere or are there a few places that you cannot ship to?
Shaun Noorian: We're currently licensed in 49 states and we'll be licensed in all 50 very soon. The 49 states that we're currently licensed in make up about 97 percent of the US population, so, chances are we're able to treat a patient that sends their prescription our way.
Nelson Vergel: What kinds of doctors use your pharmacy in general for their male and female patients?
Shaun Noorian: For women, we see a lot of OB-GYNs send us prescriptions as that's their primary physician when it comes to female related issues. We also fill prescriptions for a lot of general practitioners that have learned how to treat their menopausal patients with hormone replacement therapy.
For men, we'll usually see general practitioners, mid-levels, urologists and physicians that specialize in treating men's health related issues. We're starting to see that many primary physicians have learned about the benefits of testosterone replacement therapy and the different ways of treating men's health issues through the use of compounded products. This is one of the fastest growing areas of medicine as men are starting to become more aware of their health and taking charge of their wellness and vitality.
Nelson Vergel: A common complaint I hear from some of the guys on ExcelMale.com or on ******** is the fact that when they start using testosterone or HCG, their sex drive goes up, but then they have to deal with the fact that their wives or girlfriends don't share the same libido. Is there anything that men can do to improve their women's sex drive?
Shaun Noorian: You make a great observation. We see a lot of female patients because their husbands have sent them to see a doctor for Hormone Replacement Therapy after they've experienced the benefits Testosterone Replacement in their own lives. Of course this happens vice versa as well.
When it comes to female libido enhancement the two most commonly prescribed compounds through our pharmacy are Testosterone Cream that's applied topically and Scream Cream, which is applied clitorally. Scream Cream is a topical, hypoallergenic base mixed with six different prescription only vasodilators and blood flow enhancers that is applied clitorally and causes an increase in blood flow to the clitoris. Many female patients not only find it easier to reach orgasm with this compound, they also report an increase in the number of orgasms per sexual experience. As you can imagine it's been a very popular product alongside hormone replacement therapy, which consists of a combination of estrogen, progesterone and testosterone. Since every woman's body is different we customize different combinations of these hormones in a dosage form best suitable for the patient.
For that, we recommend seeing a specialist that deals with Female Hormone Replacement Therapy since it's a complex subject and requires an experienced doctor to tackle.
Nelson Vergel: We've had some media exposure about the recent outbreak of meningitis that killed over 60 people and injured hundreds more. Can you tell us what the case meant for the industry and what you see are the greatest challenges facing the future of the compounding?
Shaun Noorian: As you know a meningitis outbreak occurred across the country due to a tainted batch of steroid injectables that were meant to be injected in the endometrial cavity. Meningitis is often a result of microorganisms growing in the fluid around the brain and spine. This outbreak was due to a tainted compound made by the compounding pharmacy known as NECC or New England Compounding Center located in Massachusetts.
A number of things went wrong to cause this compound to become contaminated and distributed across the country. Because the product was a suspension with visible particles rather than a solution, the liquid couldn't be filtered in a way that could have removed bacteria and fungi. Also, because the product was being injected in the spine, no preservatives could be used that might have prevented fungal growth within the vial. This medication was being used in many sick and immunocompromised patients to treat their chronic pain. To make matters worse the drug itself was a type of steroid that decreases the body's response to microorganisms and this might have prevented some patients for fighting off the fungal infection on their own.
Finally, NECC was distributing the product in many states in extremely large quantities something that compounding pharmacies are not permitted to do under state laws.
So, after many people died and many others were left sick, the FDA came in and shut down NECC. After that they performed an investigation on the facilities and they found out that the vials were tainted with black particulate matter and also noted many things wrong with their facilities including rust inside the cleanroom, dirty work areas, a leaky broiler and a defective ventilation system, which is what is believed to have caused the fungi to enter their clean room in the first place.
The report also found that they were distributing extremely large quantities of these high risk compounds to hospitals and offices instead of individual patients and of course, United States laws requires compounding pharmacies to dispense compounds to individual patients only.
It was obvious that NECC was acting as a manufacturer under the guise of a compounding pharmacy. To prevent a tragedy like this from happening again the FDA recommended to Congress new rules for the compounding industry. Several months later the Drug Quality and Security Act was passed, which requires compounding pharmacies that are engaging in large operations and distributing non-patient specific prescriptions, like what NECC was doing, to become registered with the FDA and report on a quarterly basis the types and quantity of drugs that are making as well as adhering to the same cGMP standards that pharmaceutical companies have to meet. Due to the passage of this law I see the compounding industry going towards quality and the ones that can't meet these standards are going to get shut down or run out of business.
I see this as a good thing. It's eventually going to increase quality for the entire industry and patient care as well.
Nelson Vergel: Well, Shaun, thanks a lot for your time and I know you are available to answer questions on ExcelMale.com. We appreciate you taking the time to help everybody out and educate patients and physicians on the advantages of using compounded products.
Before we go, can you tell us about the regulatory environment that may change depending on where you live when it comes to controlled substances like testosterone or HCG?
Shaun Noorian: Testosterone is actually a Schedule III Controlled Substance in every state with the exception of New York, in which it is a Schedule II Controlled Substance.
HCG is a Schedule III Controlled Substance in nine states. We have a great map on our website located at empowerrxpharmacy.com/where-were-licensed.html that shows the entire United States and each state's rules that that deal with HCG and compounded products.
By clicking on each state, a patient can find out what the rules are for their specific state and whether HCG is considered a controlled substance and if we require patient identification information to fill these medications. Pretty much every rule that a compounding pharmacy needs to know to be compliant with each state's rules and regulations is on this map.
Nelson Vergel: All right. Well, thanks for those, Shaun. I appreciate your taking the time to answer questions tonight. Once again, if you want to ask Shaun any questions, please post them on ExcelMale.com. Make sure you direct them to him.
Shaun Noorian: It's always my pleasure. Thank you, Nelson.
Thanks a lot for joining us tonight, Shaun, and we're excited for you to explain to the audience the different things you guys do and the products you make and what makes your pharmacy unique.
Shaun Noorian: Thanks Nelson Vergel. It's my pleasure to be here.
Nelson Vergel: So, let's start by telling us a little bit about why you started Empower Pharmacy and what makes you different from the rest.
Shaun Noorian: I started Empower Pharmacy back in 2009 after being diagnosed with hypogonadism. Like most patients diagnosed with a condition, I absorbed as much information I could find on the subject. Of course, one of them was your great book, Testosterone: A Man's Guide amongst others. After reading all these books, papers and articles, and personally dealing with several compounding pharmacies that left a bad impression I knew I could add value to the industry and others diagnosed with the same condition. Using my background in engineering, manufacturing and quality control I created a pharmacy that concentrates on customer service, efficiency, and most important, quality.
Nelson Vergel: Tell us because a lot of physicians and patients are actually confused about what compounding means. What is the difference a compounding pharmacy and a regular pharmacy chain?
Shaun Noorian: Good question. Regular pharmacy chains like Walgreen's or CVS simply grab a mass manufactured drug off their shelves and dispense them to their patients. It's different with a compounding pharmacy.
Pharmacy compounding is the art and science of preparing customized medications for patients. Its practice dates back to the origins of pharmacy; yet, compounding's presence in the pharmacy profession has changed over the years. In the 1930s and 1940s, approximately 60 percent of all medications were compounded. With the advent of drug manufacturing in the 1950s and '60s, compounding rapidly declined. The pharmacist's role as a preparer of medications quickly changed to that of a dispenser of medications.
However, within the last two decades, compounding has experienced a resurgence as innovative treatments have allowed more pharmacists to customize medications to meet their patient's specific needs.
There are several reasons why pharmacists usually compound prescription medications. Many patients are allergic to preservatives, excipients, fillers or dyes, or are sensitive to standard drug strengths. With a physician's consent, we can change the strength of a medication, alter its dosage form to make it easier for the patient to ingest, or add flavor to make it more palatable. We can also prepare the medication using several unique delivery systems, such as sublingual troches or lozenges, injections, or a transdermal gel or cream that can be absorbed through the skin. We can also make backordered medications or orphaned drugs and make them available to patients that normally would not be able to get these medications anywhere else.
Nelson Vergel: Why do you think some physicians may be hesitant to prescribe compounded medicines or have their patients use a compounding pharmacy to fill a prescription?
Shaun Noorian: I usually find it to be one of two reasons. Usually, the physician is unfamiliar with compounded products. They either don't know how to prescribe them or what to prescribe and we get questions from doctors all over the country every single day curious about the latest ways to treat certain ailments that they're not familiar with because pharmaceutical companies haven't marketed that specific medication to them.
Other doctors have heard stories about compounding pharmacies lacking proper quality control or having sub-par service, which leaves a bad taste in their mouth. This is why we concentrate on quality control and making sure our patients not only know how to take their unique medications, but are also given all the tools and supplies to properly administer them.
Nelson Vergel: I know you dispense products not only related to men's health but also women's health as well. Obviously, we're going to concentrate on men's health related products in this interview.
When it comes to men's health, what are the most popular compounds prescribed by physicians in your network and give us a description of each and how they are used or how the doctors prescribe them to a patient?
Shaun Noorian: When it comes to men we see the most common prescriptions related to erectile dysfunction, testosterone replacement, hair loss, and infertility. I'll start off by talking about testosterone replacement therapy (TRT).
The most commonly prescribed medications for TRT are injectable versions of testosterone such as Testosterone Cypionate, Testosterone Enanthate and Testosterone Propionate. Then there are transdermal versions of testosterone, like Testosterone Cream, which can be rubbed onto your skin and absorbed topically, and then there are less popular dosage forms such as pellets and oral pills.
Of course with any therapy there can be side effects related to that therapy. Some patients get side effects such as accelerated hair loss, breast tenderness, fluid retention, lack of libido or acne. We have other products to treat those. For hair loss we make a high strength Minoxidil/Azelaic Acid or Spironolactone/Ketoconazole/Progesterone topical solution.
Of course, a lot of people are on TRT because they've been diagnosed with erectile dysfunction. While some men respond well to oral ED treatments such as Viagra or Cialis, others do not or they have uncomfortable or even dangerous side effects. In those cases custom compounded medications can often be used successfully to treat ED.
There are a several different medications used to treat ED and one of the great things about compounders is we can make extremely efficacious versions of ED medications for patients where traditional medications such as Viagra, Cialis, or Levitra are contraindicated due to allergies or a patient taking nitrates or simply them not working anymore because the patient has advanced ED.
So, for those patients, we're able to compound an injectable erectile dysfunction medication called Trimix. Trimix is a combination of three different prescription medications: papaverine, phentolamine, and prostaglandin that are injected intracavernously into the side of the penis. Trimix has been proven through numerous clinical studies to be one of the most effective medications available for achieving erections especially in populations where oral medications no longer work.
The side effect profile of Trimix is also reasonable when properly dosed as its effects are primarily local since it's injected directly into the site where it's needed, whereas other oral medications must become systemic affecting your entire body before they can reach the place where you want them to work. We also get a lot of requests from patients asking for buccal or sublingual versions of Sildenafil and Tadalafil, where the patient can put a lozenge in the side of their cheek or underneath their tongue and have the medication absorbed directly into their bloodstream compared to an oral version, which doesn't enter the bloodstream until it is processed through the hepatic system (liver), which can take up to 30 minutes.
We have human growth hormone related products for patients that are diagnosed with Adult Growth Hormone Deficiency. We see a lot of patients that are prescribed Sermorelin, GHRP-2 and GHRP-6, which are growth hormones secretagogues.
Secretagogues allow patients to create and release their own growth hormone instead of the traditional way of introducing exogenous forms of the hormone.
There are several advantages to using secretagogues vs exogenous HGH. One is cost. Growth hormone secretagogues are a fraction the cost of HGH. Another advantage is that secretagogues prevent your pituitary from lowering its natural growth hormone production due to inhibitory negative feedback.
Secretagogues also give the benefit of making it difficult for patients to overdose or attain supraphysiologic levels of growth hormone as their pituitary gland can only produce and secrete a finite amount of growth hormone no matter how much it's signaled.
Finally, and arguably most importantly, many doctors are more comfortable prescribing secretagogues because the FDA has not banned their off label use like they have with HGH.
Nelson Vergel: How about HCG? Do you get a lot of prescriptions for that product?
Shaun Noorian: Of course. We see a lot of prescriptions for HCG from urologists as well as doctors interested in preventing the suppression of their patient's natural testosterone production while on TRT. HCG is the hormone that is secreted by pregnant women, and in men it mimics Luteinizing Hormone, which is the primary hormone that our pituitary gland produces to tell our testes in turn to produce testosterone.
We all have a negative feedback mechanism in our bodies that prevents us from overproducing too much testosterone when our body senses there is too much in our system and to produce more testosterone when there is too little. Doctors use HCG to not only prevent testicular atrophy in patients on TRT, but also to prevent the resultant decrease in their own natural testosterone production when on an exogenous form of testosterone is introduced.
It's also used in male patients that are interested in retaining their fertility while on TRT. We see fertility patients taking HCG anywhere from 500 IUs all the way to 3,000 IUs every other day to prevent testicular atrophy and keep their testicles producing sperm and testosterone.
Nelson Vergel: On our ******** discussion group, testosterone replacement discussion group and on ExcelMale.com, we get people complaining about the fact that their physician does not want to prescribe a compounded product or they don't have a physician that utilizes compounding. What can we tell those patients on how to find a doctor that is actually familiar and educated on compounding related products?
Shaun Noorian: I recommend prospective patients looking for a doctor to check out Excelmale.com in the preferred doctors area to see to see what other doctors you're comfortable with. If patients can't find a doctor in their area, patients can always print out fact sheets and bring them to their own doctor. Our Fact Sheet Application is a great resource for patients wishing to do this.
Once doctors read the factsheets, become more knowledgeable on this subject and realize that the use of HCG is not only effective, but also approved by the FDA to prevent testicular atrophy and treat hypogonadism they are much more comfortable prescribing it.
Nelson Vergel: Some patients are always asking whether or not compounded products are covered by insurance. Can you tell us the restrictions or the usual surrounding insurance approval for compounded products?
Shaun Noorian: Great question. A lot of compounded products aren't covered by insurance, primarily because many compounds are prescribed for off-label use. When the FDA approves a specific drug as safe and effective, this determination applies only to the specific disease or condition for which the drug was tested. But physicians often prescribe medications for treatments for which they have not been specifically approved. Medical professionals do this because, in their judgment, the treatment is in the best interest of the individual patient. Similarly, medical professionals often prescribe compounded medications because they believe it is the best medical option for their patients. Also, many insurance companies won't cover compounds because they are not part of their approved formulary or they just don't reimburse for compounds at all.
So, in the case where that compound would be covered under insurance, we print filled-out reimbursement forms for our patients. All they have to do is submit those reimbursement forms to their insurance company and if that medication would have been covered then the insurance company will mail the patient a check for what they paid or an amount they would have covered.
Nelson Vergel: When you ship the product, do you include fact sheets or supplies with the product?
Shaun Noorian: I think that if you're giving medication to a patient that patient has to fully understand how to take it. They shouldn't have to go across the street and ask another pharmacy for supplies or directions on how to administer it, so we not only make sure that every patient is counseled and understands how to take their meds, but also is given the tools to be able to take them.
So, for all our compounds, including lyophilized or freeze dried products, we provide reconstitution kits, reconstitution instructions, syringes, alcohol wipes, bacteriostatic water and injection instructions.
And of course, we don't charge patients anything for any of these because I believe that a patient shouldn't be surprised with extra ancillary costs that end up costing just as much as the medication itself.
I believe that getting a compounded prescription should be as simple as sending your Rx to a pharmacy and that pharmacy sending everything you need to use it.
Nelson Vergel: Do you ship everywhere or are there a few places that you cannot ship to?
Shaun Noorian: We're currently licensed in 49 states and we'll be licensed in all 50 very soon. The 49 states that we're currently licensed in make up about 97 percent of the US population, so, chances are we're able to treat a patient that sends their prescription our way.
Nelson Vergel: What kinds of doctors use your pharmacy in general for their male and female patients?
Shaun Noorian: For women, we see a lot of OB-GYNs send us prescriptions as that's their primary physician when it comes to female related issues. We also fill prescriptions for a lot of general practitioners that have learned how to treat their menopausal patients with hormone replacement therapy.
For men, we'll usually see general practitioners, mid-levels, urologists and physicians that specialize in treating men's health related issues. We're starting to see that many primary physicians have learned about the benefits of testosterone replacement therapy and the different ways of treating men's health issues through the use of compounded products. This is one of the fastest growing areas of medicine as men are starting to become more aware of their health and taking charge of their wellness and vitality.
Nelson Vergel: A common complaint I hear from some of the guys on ExcelMale.com or on ******** is the fact that when they start using testosterone or HCG, their sex drive goes up, but then they have to deal with the fact that their wives or girlfriends don't share the same libido. Is there anything that men can do to improve their women's sex drive?
Shaun Noorian: You make a great observation. We see a lot of female patients because their husbands have sent them to see a doctor for Hormone Replacement Therapy after they've experienced the benefits Testosterone Replacement in their own lives. Of course this happens vice versa as well.
When it comes to female libido enhancement the two most commonly prescribed compounds through our pharmacy are Testosterone Cream that's applied topically and Scream Cream, which is applied clitorally. Scream Cream is a topical, hypoallergenic base mixed with six different prescription only vasodilators and blood flow enhancers that is applied clitorally and causes an increase in blood flow to the clitoris. Many female patients not only find it easier to reach orgasm with this compound, they also report an increase in the number of orgasms per sexual experience. As you can imagine it's been a very popular product alongside hormone replacement therapy, which consists of a combination of estrogen, progesterone and testosterone. Since every woman's body is different we customize different combinations of these hormones in a dosage form best suitable for the patient.
For that, we recommend seeing a specialist that deals with Female Hormone Replacement Therapy since it's a complex subject and requires an experienced doctor to tackle.
Nelson Vergel: We've had some media exposure about the recent outbreak of meningitis that killed over 60 people and injured hundreds more. Can you tell us what the case meant for the industry and what you see are the greatest challenges facing the future of the compounding?
Shaun Noorian: As you know a meningitis outbreak occurred across the country due to a tainted batch of steroid injectables that were meant to be injected in the endometrial cavity. Meningitis is often a result of microorganisms growing in the fluid around the brain and spine. This outbreak was due to a tainted compound made by the compounding pharmacy known as NECC or New England Compounding Center located in Massachusetts.
A number of things went wrong to cause this compound to become contaminated and distributed across the country. Because the product was a suspension with visible particles rather than a solution, the liquid couldn't be filtered in a way that could have removed bacteria and fungi. Also, because the product was being injected in the spine, no preservatives could be used that might have prevented fungal growth within the vial. This medication was being used in many sick and immunocompromised patients to treat their chronic pain. To make matters worse the drug itself was a type of steroid that decreases the body's response to microorganisms and this might have prevented some patients for fighting off the fungal infection on their own.
Finally, NECC was distributing the product in many states in extremely large quantities something that compounding pharmacies are not permitted to do under state laws.
So, after many people died and many others were left sick, the FDA came in and shut down NECC. After that they performed an investigation on the facilities and they found out that the vials were tainted with black particulate matter and also noted many things wrong with their facilities including rust inside the cleanroom, dirty work areas, a leaky broiler and a defective ventilation system, which is what is believed to have caused the fungi to enter their clean room in the first place.
The report also found that they were distributing extremely large quantities of these high risk compounds to hospitals and offices instead of individual patients and of course, United States laws requires compounding pharmacies to dispense compounds to individual patients only.
It was obvious that NECC was acting as a manufacturer under the guise of a compounding pharmacy. To prevent a tragedy like this from happening again the FDA recommended to Congress new rules for the compounding industry. Several months later the Drug Quality and Security Act was passed, which requires compounding pharmacies that are engaging in large operations and distributing non-patient specific prescriptions, like what NECC was doing, to become registered with the FDA and report on a quarterly basis the types and quantity of drugs that are making as well as adhering to the same cGMP standards that pharmaceutical companies have to meet. Due to the passage of this law I see the compounding industry going towards quality and the ones that can't meet these standards are going to get shut down or run out of business.
I see this as a good thing. It's eventually going to increase quality for the entire industry and patient care as well.
Nelson Vergel: Well, Shaun, thanks a lot for your time and I know you are available to answer questions on ExcelMale.com. We appreciate you taking the time to help everybody out and educate patients and physicians on the advantages of using compounded products.
Before we go, can you tell us about the regulatory environment that may change depending on where you live when it comes to controlled substances like testosterone or HCG?
Shaun Noorian: Testosterone is actually a Schedule III Controlled Substance in every state with the exception of New York, in which it is a Schedule II Controlled Substance.
HCG is a Schedule III Controlled Substance in nine states. We have a great map on our website located at empowerrxpharmacy.com/where-were-licensed.html that shows the entire United States and each state's rules that that deal with HCG and compounded products.
By clicking on each state, a patient can find out what the rules are for their specific state and whether HCG is considered a controlled substance and if we require patient identification information to fill these medications. Pretty much every rule that a compounding pharmacy needs to know to be compliant with each state's rules and regulations is on this map.
Nelson Vergel: All right. Well, thanks for those, Shaun. I appreciate your taking the time to answer questions tonight. Once again, if you want to ask Shaun any questions, please post them on ExcelMale.com. Make sure you direct them to him.
Shaun Noorian: It's always my pleasure. Thank you, Nelson.
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