Business opportunity leads for pharmaceutical

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welcome to today's webinar discovering new business opportunities for your pharmacy is presented by eric tosh vp compounding support services with letco medical and brian kelly director of business development with arl biopharma eric tosh has led the letco medical professional services team for 20 years and his pharmacy career spans over 30 years he is an adjunct faculty member of the western university college of pharmacy a published author and an industry leader in compounding brian kelly has led arl's business development team for five years and his professional background includes 10 years of research development and project management in the biotechnology industry including analytic chemistry tissue culture and pre-clinical pharmacokinetic and pharmacodynamic studies today's webinar is accredited through acpe and is worth one ce credit hour ce credit is applied following completion of an evaluation link found on the last slide and the presentation handout you can find the handout on the lower portion of the go to webinar toolbox under handouts we are recording this session and will include the recording and evaluation link and a follow-up email that will be sent today questions may be submitted throughout the webinar using the go to webinar toolbox on the right side of your screen under the questions tab we'll answer the questions submitted following the presentation if we do not get to your question today a list of questions and answers will be emailed to all attendees following the webinar thank you for joining today's session good morning this is eric tosh it's a pleasure working with everyone and it may be afternoon for some of you i want to thank everybody again for taking time out of your busy day and brian give you an opportunity to say hello as well hello brian thank you brian again want to thank american college of apothecaries for accrediting this program brian and i have no conflict of interest and again look forward to hearing from you as we go through this please be sure and post your questions and comments and we'll get to as many of them as we can and again one contact hour uh cpe monitor should have everything posted within 60 days of the event all right so we really want to talk about in this program this is ends up being a two-part presentation where you talk about the niche markets are available as well as in part two there'll be a follow-up on just the marketing mechanics how do you get out there and get the word out and make sure that patients and prescribers know what you can do so at least today what we're going to look at is identify the niche markets we're going to talk about more than three but some of you know three that you want to look at some resources information resources how to become an ex subject matter expert in an area you may not be familiar with looking at facility and equipment requirements for different types of compounding if you've been doing one type what kind of changes you need to consider and then looking at quality in terms of how that plays into the new markets and how this really can distinguish yourself from other compounders i really want to start in this first slide this is a picture of the university of the philadelphia college of pharmacy for those of you who are not history folks this was our first college of pharmacy founded in 1821 i believe uh somebody a year after usp was founded in 1820 and when we think about marketing of compounding in the 1820s you're either went to the barber to have your medical work done you went to the apothecary and for those again who are into this sort of thing what we would call pharmacognosy or weeds and seeds everything was done by the pharmacist you didn't really have to market people knew that if you needed a poultice or needed something um there you either went to the uh what we would now call the tribal shaman or the what we now hopefully are all pharmacists and this is really the the beginning of the science and professionalism of pharmacy was with uh philadelphia college of pharmacy so this is a picture of their i think their original building uh just kind of provides some context and thought about where compounding came from and at the root of this um you know what are compounders we're problem solvers so part of this solving the clinical issue for a patient or a prescriber but in this case looking solving the problem of business you know we've got got to take care of patients you've invested in your business there are headwinds or challenges things going on in compounding that some people are throwing up their hands and saying ah i'm out of here forget it the reality is is there a lot of opportunities compounding is not going anywhere we're going to go over some of the niche markets things that people should consider if you've been working in one area and how you analyze potential opportunities within your own demographic area what are those opportunities either locally or broader if you may be a subject matter expert in one area how do you then make people outside your immediate geographic area aware of what you can do for them we're going to go through these niches again with this a breadth of material we can't go into a lot of depth on the clinical side but i do want to touch on some key components of each of these things to think about and analyze we should be much more analytical you know we think about sports and the analytics uh with sabermatics and baseball and what people do we really need to be much more analytical in our approach not only to how we make a formula but how we really run our business and consider where opportunities are in new and new areas that we may not have thought about and you know you guys can read these i'm not going to read the slides for those of you who haven't listened to my presentations before the slides really are an outline and i'll discuss around it i'm not going to read these to you so under hormone therapy when you go out and do a survey the alliance for pharmacy compounding many of y'all may have known them as the international academy of uh international academy of compounding pharmacists they've done studies others have done studies hormone therapy has just been a bread and butter core part of most compounders practice so most of this should not be new to you i really want to kind of break down some key things to think about though some of the things that maybe people are considering a challenge and why they don't want a compound anymore maybe looking for other opportunities certainly the common things menopause andropause thyroid a little bit more specialty but still hormone therapy anti-aging and we'll talk a little bit more about anti-aging as we get further in and then really want to touch on the nason report that came out recently uh and addressing concerns that likely will come up for some context though uh looking for instance and i'm not don't read a lot of statistics off but just to keep people aware of where uh where we are from a business side and these are u.s data before the women's health initiative study came out that really scared a lot of practitioners as well as patients away from using hormone therapy because of some of the concerns about the risk associated with hormone therapy for cardiovascular disease prior to that there are somewhat over 30 million women uh and accounted for about 25 billion dollars now that's really pharma dollars we've never had a good handle on total dollars in the bio dental hormone compounding side but it gives you an idea that before the women's health initiative this market space was about 25 billion dollars and again u.s population's over 300 million we had 30 million women alone on hormone therapy so we've now gotten past the women's health initiative have a little more understanding of what the risk factors were and guess what it wasn't the bioidentical hormones it really was the use of of the uh the analogs that uh whether it's an estrogen analog uh or the uh some of the progestins madroxy progesterone acetate that really looked like these were some of the problems and not going to delve into the science on it but it does look like we've we've seen a recovery more women there and men as well they're using bioidentical hormone therapy as an example on the men's side i think this was from around 2017 or 18. there is one clinic chain that focuses on treating men 49 clinics in 11 states they have about 45 000 men reportedly uh this is actually from 2014 uh approximately two billion dollars in just treating uh the the andropause so testosterone therapies again this is primarily going to be the more traditional pharma therapies but it does include some of the bioidentical now most folks by now are aware that the fda over a year ago about 18 months ago funded a study by mays from the national academy of science engineering and medicine to look at the clinical utility of bioidentical hormone replacement therapy well we realized that you're not going to find many studies on compounded bhrt because we're not really set up in terms of we're dealing with ends of one you may have 10 million ends of one but there's no large trial with 12 hospitals and 20 000 nurses like we saw with pepe study or women's health initiative so the real challenge for us is uh and with this report is mason came in if you look at the makeup the credentials of the people all you know scientifically their credentials were impeccable but they don't come from the background that we do as practitioners uh dealing directly with patients in compounding therapy so the report to kind of cut to the chase there were recommendations only some key points where there wasn't enough data to really make a decision about safety and efficacy although i think any of us who've compounded for patients the the real outcome whether it's a pharma product or a compounded product is did the female patients hot flashes go away i mean you know how many of the ob gyns and family practitioners and internists out there are actually measuring hormone levels other than the initial annual physical post once they start a perimenopausal patient on their hormone therapy they're just asking are you feeling better did your hot flashes go away they're really looking at subjective measures no different than what the compounders did but the the key point in the nasam study is hey we don't have studies there needs to be more data they also looked at and a key recommendation was educational prescribers and patients a real concern that there was not being enough discussion with patients and prescribers about what compounding is and the fact it's not the same as an fda approved drug product so you know there there were some real concerns about the committee on educating the population on what it is that compounders do and this really gets into and bridges over to our discussion on marketing unfortunately not many but some of our peers were making claims that compoundings better than pharma products either making claims in writing or going in and talking you know they've had marketers go and talk to prescribers we just can't say those sorts of things we don't have data and to understand fda's position for instance the label is not the sticker on the bottle the label is all printed material it's what you say in writing so if your website makes a claim that estriol is better than a pharma approved product that gets you crosswise and that was one of the real concerns is how a lot of the marketing was done for bioidentical hormone therapy so one of these we'll loop back to throughout the course of this discussion is the how critical it is that you maintain uh your focus on your marketing so i don't want to spend too much more time on this slide but this kind of provides context for all the others so again if you're going to work with hormone therapy make sure you're not making claims gather data so that we can if you will push back and educate the prescribers educate fda educate others to the utility that patients really do benefit from these next few slides we'll go through a little more quickly because the same things apply don't make claims don't do stuff that gets you crosswise veterinary is a huge area of compounding companion animals cats and dogs account for about 90 percent of veterinary compounding right now we're seeing more and more small animals exotics birds reptiles other mammals and don't forget your large animals and we'll talk about a resource a bit later on but uh you know things to get back with problem solving is two points how do you compound this depository for an elephant what do you use for the mold and then how do you market to the zoo that you can compound for the elephant or for the giraffe so just a little context and this is from a uh american veterinary medicine medical association executive summary in 2016. almost 60 of households own a pet um and you know that equates to about 71 million households across the country dogs still outnumber cats slightly uh and that's kind of followed by horses and birds and exotics interestingly we're seeing more and more poultry in folks raising poultry you know to be home home sufficiency get their own eggs you have to be real careful though compounding for what's considered a food chain animal and certainly things like even though they're a pet the pot belly pig fda considers you know goats and pigs and a lot of things are becoming pets now as food chains so compounding for those animals can be real tricky it's not that you shouldn't do it just understand what you've got to do demographically you have to understand uh where the most of the animals are well that's what's where the populations are highest so texas california florida and interestingly out of this um this avma executive summary there are some uh ethnic differences and types of pets in their own so when you're doing your demographic analysis in your neighborhood consider what those differences are because it also leads into how one goes out and does their marketing um and again in the next slide we'll provide links to these so you can do a little deeper dive but the the summary is about 28 billion dollars is spent on vet care certainly a small portion of that is going to be compounded but there is plenty of opportunity people love their pets i haven't seen it in a while but there's a survey you're in and you're out asking people between your pet and your spouse who would you keep and basically year over year a third of the people say they'll keep their their pet over their spouse so just keep that in mind again here's the uh the information uh that the statistics come from uh these two and i include this third uh list this is an organization that provides some detailed information on that compounding it's a great group uh it's the american college of veterinary pharmacists and that's their website so i would encourage you to check that out for more on veterinary compounding we're all very familiar with pain management uh broke it down into some general categories chronic palliative and hospice most we should be familiar unfortunately like the mason study on hormone therapy because of some of the you know sort of wonky stuff that was done with pain creams fda funded a parallel study on pain creams and this is a link to that study in the assessment that was done on topical pain creams but again it was a problem people were making claims there were some outrageous amounts of money being billed for topical pain creams they absolutely have a role to play anyone who's done hospice care knows and palliative care knows that we can provide topical pain management uh certainly chronic pain management so this is an opportunity that doesn't go away a third party is not going to pay for it but you need to understand the mechanics of pain the formulation strategies don't get carried away and try and shove 50 api into a cream you're just going to leave a lot of drug on the skin so do your homework as an example though in 2016 medicare spent 16.5 billion dollars on hospice care alone and that's significant portion is going to be pain management and anyone who's had a family member in hospice knows that it's quite common to have compounded preparations for those pain patients so again be careful of your claims um certainly related to chronic pain management but there is opportunity in the pain area one that people don't really think about as a niche sometimes but i i would encourage you to look at geriatric and pediatric compounding number of similarities certainly very different but when you think about it both patient populations they're very young and very old have trouble swallowing they have issues with dosage forms have issues with dosing especially young children going back to our old clinical days or any of you who may work in a hospital you use different dosing guidelines for dosing the very young things like body surface area body mass dosing and in some ways to back up same type of dosing is done with veterinary uh the dosing for animals is very similar to what it is for humans it's just much smaller so it's done really much more on a milligrams per kilogram so very similar also whether your pediatric geriatric sometimes liver function kidney function are very different uh either it's different function or there's dysfunction so you have to make changes in dosing based on that so again as a problem solver this is where you can work with geriatricians you can work for family practitioners pediatricians to addressing this niche and how to provide specialized therapies for patients that are that and it's not always very young think about culturally a 14 year old that's got nausea vomiting and diarrhea um may you know may not want mom trying to give him a suppository uh if you know if it's a male or female but you know very often you know as people as you get to teen years you're just not real keen on someone coming in and giving you a spot story and if you've got nausea vomiting and diarrhea how effective is that promethazine going to be if you trigger the vagus reflex and the individual you know you put the spots right in the immediate and they've got diarrhea already going they immediately uh defecate now you you know you don't know how much dose got in or you try to give them a pill to throw it up so here you've got a solution that's not your traditional very young or very old but it's a way to address patients that need an alternate route of delivery so again think about these niches and how you go out and market this and think about the the types of products you get out to them dermatology bread and butter don't necessarily make a lot of money at it but i'd rather have a 70 or 80 year old dermatologist who loves coal tar and everything than just anything else because a lot of your peers don't want to mess with coal tar it's messy it's stinky but i used to i had a couple of older derms that loved coal tar i was one of the only pharmacists that would was willing to stock it and work with it and you know can make this stuff all day long and they loved it over the steroids because it didn't cause any other problems that steroids do and now we've got these expensive biologics it's an opportunity it's an option wound care is huge uh in terms of dollars spent um you know right now in like as of 2012 uh from medicare data there's about 50 billion dollars spent on wound care and this is all all kinds of wounds so surgical wounds diabetic wounds everything so you know there's a lot there but diabetic wound infections accounted for about 3.4 of the patients treated under medicare and the medicare spend on diabetic food foot infections alone is uh right around 19 billion dollars so just because insurance won't pay for it doesn't mean you shouldn't consider it and talk to wound care specialists we can do a lot what's the cost of cutting off someone's foot or lower limb because uh an infection never got healed properly um you know i mean so there's some real things that we consider and then anti-aging and again we'll talk about it a little bit more but it's an area that certainly has got opportunity for dermatology and again need to work on your expertise be familiar with what's there but there are still plenty of opportunities in wound care anti-aging really is kind of crossover it relates to hormone therapy rebalancing hormones lean muscle support we know that as lean muscle mass goes down particularly in folks over age 65 70 start to have more problems with uh controlling balance they don't have enough strength to recover from a a stumble and then they fall and break a hip and all the consequences for that so there are some opportunities with it primarily in the lean muscle support area it's going to be sterile compounding some of the testosterone esters that are used to help and and then related components that help patients maintain lean muscle mass certainly dermatology kind of talked about that previously as a component of anti-aging a little different but again there are some opportunities there for the nutritional support this is one that's a little bit i will say a gray area it's a challenge right now there's some doctor offices that like to do chelation therapy some other anti-aging iv therapies and with the fda restriction off issues it really is an issue but there's there there are efforts to open this back up in terms of office use compounding um so certainly work with organizations like uh in a um in in cpa and then apc alliance for pharmacy compounding is they try to bring and rein in fda's oversight of compounding and make sure patients don't lose access to critical compounded support but just as an idea 122 billion was is spent on all anti-aging products a lot of this is some topical creams you've got things like uh the the various injections collagen injections and uh you know so on that are used to help keep healthy looking skin and keep people young but again where people get in trouble is their marketing claims so be very careful have the science back up what you say and just for heaven's sake don't make a lot of wild claims in print because that will definitely get you in trouble weight loss certainly health and obesity think about all the health conditions assigned that are really tied to obesity in this country and the little map that you see here uh 1990 a lot of light blue and blue that indicates lower rates of obesity 2000 more dark blue and tan and then by the time we get 2010 those states are really dark red that's more than 30 percent of the population considered that has a bmi higher than 30 uh or about 30 pounds overweight for a five foot four person so any of us in practice it's obvious that obesity and and now that we're all stuck at home getting people to work out is even harder um so there are some opportunities in weight loss in the old days i've got highlighted here hcg that's a biologic that's now been moved into a category that one can't compound anymore but there are some things that are being compounded as appetite suppressants there's commercial products on the market a combination of centromere topiramate as well as naltrexone bupropion um commercial pharma approved products for weight loss but you're really the doctor stuck with the dose and what if the patient is just very sensitive to phentermine still want to use it but they need to tweak that dose for a particular patient this is where compounders have an opportunity to come in and help that smaller set subset of patients that just don't tolerate the off-the-shelf doses and you really can work with prescribers make them aware of your ability to work with these components and take care of their patients and then nutritional support again gets a little bit back to some of the office use compounding for anti-aging fda is really restricted what can be compounded in a traditional community pharmacy it has to either be a component of an fda approved product or on what they call list one and there are some nutritional support items on this list that will be reviewed by the pharmacy compounding advisory committee so more to come on nutritional support there is some compounding that can be done but right now it's so i won't say gray but you really need to know what you're doing and again be careful of claims and going too far afield but there's still an opportunity what's the cost of uh obesity diabetes heart disease everything associated with it uh there will be they'll continue to be pushed back from prescribers and patients saying i want x because i that's what i need to help with my uh get my health back where i want it one area that's really evolving most of us are familiar with department of genomics and i was hoping to get a couple of software links to software platforms i'm aware that there are some pharmacists that are able to take the raw data from 23andme and some of the other dna collection companies and actually crunch that raw data down into what are your cytochrome p450 pathway uh variants so they can really look at an in-depth level at what you do in terms of uh you know metabolizing drugs where you're a slow metabolizer fast metabolizer what's going on and this will be a huge area for us as we go forward to really customize care certainly fda and the medical practice groups have identified pharmacogenomics as a great opportunity to manage patient care get people customized care and compounders can have a great role in that we can in fact be the ones that that really drill down work with patients and certainly if i can uh you know over the as soon as i can track down this information post uh lecture i'll get this included in so we can get it out to you but just be aware that there's some software platforms either in beta phase or that are just being tried out now by pharmacies to manage patients and identify how they can uh integrate this into their compounding practice so that like i say there's some great opportunities here with pharmacogenomics as we go forward sterile i think most of us are aware that sterile is a highly specialized area you do have to be patient specific under the uh the the federal law that was passed so some of the old sterile things that were done that were off issues are really off the table for now but continue to work with prescribers and the pharmacy association so that we can point out the fda things that really are not suited to the 503b outsourcing facility market space because maybe nationwide you need a hundred units some small number and it just doesn't fit the 503b model and it's really difficult to do patient specific every niche we mentioned about us have at least one sterile product so it's something that you need to look at certainly there is a more significant capital investment you know you really need to think about this from a manufacturing process standpoint you need to do process validation more training more equipment validation you need more equipment but these are some of the some of the different probably one of the main different areas for compounding in terms of facility design is you're going to add sterile compounding but again there are some states because of the necc event and how the state boards have cracked down have one or only two sterile compounders in the whole state so look at your area look at what the opportunities are you may find that there's a need that you're not aware of and you can move into there's also now a national board of pharmacy or a um a board of pharmaceutical specialty for sterile compounding so look at that if you've been thinking about it the the board of pharmaceutical city pharmaceuticals especially compounding certification is well worth looking at especially if you're going to make this a part of your practice and from a marketing standpoint that's a key thing to be able to say hey i'm board certified in sterile compounding uh yes some of us have been compounding sterile for two decades um but you're gonna get edged out by the the new uh certification person because they've got that extra little stamp to put on their their wall we'll pause here catch my breath i want to be able to move on leave time for brian for his slides facility design we have to be much more thoughtful about our facility design the old days of uh when i started compounding uh some of us were just putting a cream on an ointment slab throwing some progesterone on it and levitating it in with a spatula you really do need to design your lab and the nice thing is the lab designs don't necessarily require everything look like a sterile lab but with the changes in usp things like usp 800 and hazardous drugs and the equipment available you really it's it's almost impossible now to compound in in a three-foot section of your countertop uh in the back room next to the bathroom you've really got to give thought to designing a proper lab workflow processes how things flow through there are companies that provide those consulting services many of the chemical providers uh provide support on how to do it but you you really do need to give thought to it and just kind of put on your radar one of the draft versions of usp 795 which was a non-sterile compounding at one point in addition to the discussions everybody's had about buds also had they had to have a separate essentially what would be a separate lab for your uh non-sterile non-hazardous as well as your hazardous compounding so if you work with progesterone and the estriol and the hormones you'll have that would be an 800 lab and then your keto protein pain gel that's not a hazard which can be done in your non-hazard but you essentially have to have two foot print two foot prints two sets of equipment um so luckily much of this equipment now is really affordable in the context of patients and how many patients you're going to have plus we've got new technologies coming i know that there's some pharmacies they're working their beta sites for testing benchtop 3d tablet printing perfect space for compounding to be able to customize and dial in doses particularly if you tie this to the pharmacogenomic compound that's going on so i would encourage you to consider the uh the opportunities to work with the you know the these consultants and design a state-of-the-art lab some exceptions to think about really mostly most your compounding there's not a lot of difference from human to animal for anti-aging across the board you can use the same equipment same types of balances there's just not a lot of difference with the exception of things like small animals large animals you're going to use extremes of capsule sizes again using elephant example uh a two mil or two gram suppository is not going to work for an elephant you're going to have to figure out how to do that it might mean using something like empty caulk tubes to make a suppository mold that would be suitable for a very large animal or using number four capsules or number five capsules for a very small animal same capsule machine you have to have new plates that allow you to accommodate those smaller uh capsule sizes but fortunately for the most part you're still going to use an alignment mill or a capsule machine or electric mortar and pestle balances you know you really are going to have a lot of similar equipment if you do really uh high potency drugs things like glyph irony probably ought to consider getting something like a four or five place balance instead of your traditional three place balance so it makes your titration measurements a little easier and and more predictable uh in terms of your weighing but for the most part equipment's going to be the same across the the various niches a key thing to any of these niches you need to develop expertise a lot of literature anyone's never if you haven't been to the library of congress in washington dc i know we've got challenges with travel go to library congress amazing place that's the picture here but you need to have your tertiary references think back to your old pharmacy school medical physiology books and pharmacology textbooks review the niches and how they tie into that i would encourage you that if you're going to compound for hormone therapy you should take the journals that ob gyns take if you're going to compound for for pediatric patients take the pediatric journals know what the doctors are seeing yes you aren't a prescriber necessarily but there's no reason why you can't take those journals and get ex know what they're seeing on a monthly basis and be familiar with it certainly there's some company specific resources things like the journal of pharmaceutical science ijpc's website compounding today secunda martium these are just some limited number of examples but there's a lot of information out there that some of its subscription some of it's free um yeah in fact i don't have it here and my apologies to usp if you're on the call but usp has compounding monographs uh excellent monographs so the last time i counted the north of 120 compounding monographs and that's literature that's expertise you can refer to for formulation and understanding and some of those are for veterinary purposes too so don't forget about these uh websites that are available to you oh i do have usb here on the next slide pubmed you know be very familiar with how to do lit searches and pubmed a lot of good information there chem id plus physical chemistry these are just a number of the websites talked about elephants there's an elephantcare.org and if you go to their top menu there's a pull down that talks about compounding and it lists compounding pharmacies as well as a formulary for elephants so just kind of noodling around on the web you can come across an interesting information the ibis website is an international veterinary information website they've got a essentially sort of a pubmed version abstracts and articles on veterinary medicine it's geared for vets but there's information you can pull out so uh if you're you know i know your days are busy you're filling a lot of reports but get staff engaged and involved because this is where um you know you can really develop a lot of expertise and use that in your marketing develop your personnel you know you may not be interested in a particular niche but you may have a staff member that has a personal love for a particular patient cat subset and there will likely be compounding that needs to be done in that area get your staff engaged let them become experts in particular area and let them help you grow that practice so make sure you're training your staff and consider that there are now pharmacies engaging bringing nurse practitioners in or health advocates let them be experts and and help you with your compounding absolutely engage as a preceptor older folks like myself i'm not as you know it takes me to work to whip through some of these websites if you get a pharmacy student in there they can you can assign research projects find the abstracts find the literature create white papers you can take out the practitioners about the things that you that really tie into your compounding how you can help solve problems for them and that becomes part of your marketing you can provide peer-to-peer white papers or summaries of studies that are then an indication of how a compound of preparation might match what was in that study so make sure you're doing the staff training uh why do we have a flying boat on this slide if you google images for pbm you get the uh the the old navy uh patrol bomber martin i tried to find images for each of these slides to kind of fit and when i googled pbm i didn't get any of the big uh big pvms but i got this so just a little change of pace be careful you know this is really also a caution be careful googling and web searches uh not everything you see on the web is uh accurate contrary to the tv ads um so you know there there's an homage to the old uh old pvms from world war ii um but understand for third party billing this is where a lot of pharmacists got in trouble both with their marketing and what they did doesn't mean you can't build compounded preparations there are still some opportunities to do it but you better read that contract very carefully right now apha ncpa the alliance for pharmacy compounding and other organizations are really working hard with the tricare express scripts claw back uh over compounded preparations some of things were going on were just kind of crazy so if you're going to do third-party billing you really need to know what's going on and be very prepared uh and understand that they are very strict and any errors in submission will you know definitely declaw backs and penalties so it's not that you can't do it but it's an area that if you're going to do it really develop the expertise the business expertise to do it right i think i skipped a slide sorry regulatory considerations again just want to touch on that need to know your federal law dqsa the drug quality security act how fda is using that implications of office use the memorandum of understanding dea issues osha this is usp 800 anti-trust laws particularly the stark law and things like kickbacks and so on this where a lot of the folks who are doing crazy stuff with pain creams are now dealing with federal indictments because they did stuff that was just not there you know phony drug studies and and crazy stuff that we're you know providing kickbacks to prescribers uh you work too hard for your license and for your business you don't want to be you know uh losing that over uh trying to figure out a way to to scam and do a little you know do a quick because it will come back and bite you some state considerations some states i've got more strict requirements on compounding uh certainly i haven't seen too many address marketing but their their understand if your state has rules about marketing and co-ownership of a pharmacy by a practitioner and how they perhaps tell patients where to go get prescriptions and again we talked about insurance and the considerations there but you really need to understand those and and work with pharmacy organizations that can help you and your state pharmacy associations on what your state rules may be related relating to compounding the niches you may want to work in like sterile shipping across state lines licensure in more than one state all those come back into play and because and are used in your marketing of your practice if you can go out to a neighboring state and say i'm a specialist in autism compounding and uh you're you've got a neighbor state they want to send you stuff understand what the rules are from an fda standpoint on shipping across state lines the state board rules in both states for having licensure uh pharmacists in charge but that also plays back into the marketing and how you say hey i'm properly licensed in every state that i ship into and you know follow all the guidelines so that is part of your marketing piece and we'll be addressing more detail in the in the second section one final thing for a hand off to brian please don't put a compound of preparation out before you get your test results back just because you feel confident that you did everything right we've seen problems where they weren't so remember our first oath whether it's hippocratic or pharmacist so in summaries we're not you do no harm remember that the drug quality security act bqsa what happened with new england compounding sooner or meridose really resulted in quality failures and it went back to some if you will ethics and and how their their business model was designed and technology plays a huge role in quality and uh and using that that technology to ensure your your quality your end product at this point i think it turns over to brian okay thank you eric so regardless of which new market segment you decide to pursue keep in mind there are quality standards that apply eric mentioned that you need to obtain expertise and facility design staff training billing etc but you also need to become an expert in quality regulations if you're an expert in quality you can use that expertise as a sales tool for your pharmacy that's a little about what we're going to talk about today so you know there's the gmps for the outsourcing facilities as eric just talked about the 503as have regulations that vary state to state so make sure you know the the laws for all states you're selling your compound preparations also whether you're a 503a or a 503b federal regulations say that drugs cannot be prepared packed or held under insanitary conditions in sanitary conditions seems to be a favorite term for fda and they're using it in a variety of situations make sure you read their unsanitary conditions at compounding facilities guidance doc and apply policies and procedures to prevent unsanitary conditions it would be impossible to cover the various requirements of the different states in this webinar but most states have adopted some degree of two major uh compounding usp chapters those chapters are usp 795 for non-sterile and 797 for sterile next slide please eric okay so here's a quick reference guide for the required and recommended test per 795 and 797 on compound preparations 7i5 and 797 have a lot of information about quality systems please understand that performing testing is not in and of itself a quality system it's part of a quality system testing is a lagging indicator that all the other things you are doing are working correctly okay i'm not going to go through these these tests but i do want to mention that not all tests listed here applied all formulations um usb 51 is an example that that test only applies to products with an antimicrobial preservative so to determine which tests apply to your product you need to understand the tests um something else i also want to point out is that there are microbiological tests required for non-steroidal preparations those tests are usp 61 and 62. learn about those tests and and perform them or have them performed if they're relevant to your products so keep in mind fda's and sanitary conditions their concerns about insanity conditions apply to non-sterile preparations next slide eric so when i began working on this presentation i was thinking about how am i going to talk about quality in a business development presentation so i was sitting at my desk and i looked around at a couple of things that were sitting on my desk and with the current covid situation the two items on my desk i looked at were a bottle of hand sanitizer and a bottle of multivitamins i picked them up and looked at them and the hand sanitizer had a claim that it killed 99 percent of jurors on the label so it's a label claim as to the quality of the hand sanitizer the other item was the multivitamins that i had on my desk and they had this usp verified mark on the label i recall that i purposely chose that brand of multivitamins over other brands because of this mark and why did i do that because this mark is a claim to the quality of the vitamins so it was kind of my aha moment was you know what i can talk about is that quality sells you know these two claims of quality kills 99 of germs and the usp verified mark influenced my purchasing decision and gave these two products an advantage over their competition so as i continued on i focused on the vitamins with the usp mark because i chose to buy these vitamins because of that usb mark but i didn't even really know what that usp mark meant yeah so next slide eric so got into the usp website on nutritional supplements to figure out what that usp verified marked means what's required to attain that mark but the usp verified marked means that the manufacturer had potency testing performed remember that the potency testing really tells you two things and that is did you use the correct ingredients and are they at the right concentration second thing is that the product does not contain harmful levels of specified contaminants this includes microbiological contaminants so remember the usp 61 and 62 i mentioned that's two microbiological tests on non-sterile preparations um these are an oral solid dose right um the third thing is that the product releases properly the fourth is that the product is made using sanitary there's that concept again and well-controlled procedures one of eric slides mentioned process validation that's proof that you have a well-controlled procedure so in short testing is required to place the usp verified mark on nutritional supplements companies that have put forth the money to be able to use the usb mark believe that'll help them sell more vitamins right because it's a competitive advantage so i'm sure many of you have seen the commercials on tv where they mentioned that their usp vitamins are you are that their vitamins are usb verified um they want to make sure that you know their products are usb verified and even briefly explain who usp is right as eric mentioned i'm not suggesting the compounders um you know try to put some kind of logo on their label you gotta be careful about claims you make um i mean compounders aren't gonna qualify for this usb verified logo on a compound preparations because the logo is limited to dietary supplements so but what i am suggesting is that the mark this this usp logo or mark is one way companies use proof of quality as a sales tool right as a competitive advantage work to influence my purchasing decision right and why and that's because quality sells so again got to be careful about what's on your label and what claims you're making and things in your marketing materials but speaking of labels next slide eric be sure to include all the required information on your labels here's a list of the requirements of what much what must be on your label i'll let you read through those but uh my recommendation is to make your label look nice right it's a representation of the quality of the compound preparation so make it nice also be careful about shorthand labeling or abbreviating abbreviating drug names may create avoidable problems medication errors and things so be careful with those next slide eric is some additional state requirements for labeling again make sure you follow the label requirements for all states you sell into again the label should be well organized and easy to read the printing shouldn't smear when it gets wet as an example labels that overlap need to be on straight so there's not adhesive backing sticking to everything so again the labels of visual representation of the quality of the compound preparation make it nice and that may give you a competitive advantage there next slide is an example of a of a nice label we pulled this off the web when this particular 503b facility was announcing their their new label notice how the drug names clearly listed as the salt form the concentration information is easy to obtain you basically get the full dose and the and the per ml basis there but notice how the drug name and concentration can be easily seen from either orientation of the syringe it's hard to tell from these pictures but this is like a plastic type label that's resistant to moisture and smearing it's a very nice label that makes a good impression as to the quality of the drug product um so again take take some pride in your labels and make sure they're they're accurate have the required information but uh also that present themselves well um so you've done you've done your market research you know what products you're going to make you have your proper environmental controls you've all educated yourself and your staff have your label figured out and everything but how can you how can you differentiate yourself to when markets share you may be competing against some well-established competition and so you have to have an ability to to separate yourself from those guys so again back to my theme on this is is the quality cells right remember the usp verified logo and the and the 19 kills 99 of germs well you're not gonna be able to put a usp logo on your label and you can't make fse claims so what tool could you have um to get to give yourself a competitive advantage next slide eric that um competit that tool you can use for a competitive advantage is a certificate of analysis right a c of a is a document that speaks directly to the quality of the compound preparation so presenting a c of a to a prescriber or a patient may help distinguish you from the competitor down the street that doesn't perform any testing right quality cells um remember to be able to put the usp logo on a nutritional supplement the company making the product must test potency this is an example of a potency testing c of a on a testosterone pellet um now you're not gonna be able to put a again you're not gonna put the usb logo on your testosterone pellet but you can get a cfa right and to get a cfa you must test the product um the c of a can be an effective sales tool but for it to be an effective sales tool you must understand the cfa and they will explain it to the prescriber or the patient so you need to be able to explain what information is on there what the specification is what that means where it comes from as an example same with the result you need to be able to explain what the result is and what it means um so i realize there's there's situations where having a certificate of analysis on every compound preparation is impractical um so but there's still opportunities for you to use cfas as a sales tool so if you're in a situation where where you cannot get a cfa for the exact lot you're dispensing to a patient you could present a cfa from a recently made law then explain to the patient that their lot was made um you know by the same compound or you can talk about staff training using the same procedures you can talk about process validation and that the lot was made with the same quality agreements because your quality systems require that you only purchase usb grade apis right so even if the situation is that you can't get a cfa because of timing and things you can use a previous c of a as a sales tool kind of a side note here in the state of oklahoma where i live medical marijuana was was legalized a couple years ago just this month they now require cfas to be on hand at the dispensary for all products um and and those cfas must be shown to the patient if requested i'm not sure if this is a requirement in other states that have medical marijuana but there's a potential that this service level may be something more patients expect to receive for all their medications so it's kind of a side note there next slide here so this is an example of a sterility test cfa so with the appropriate quality systems in place and a passing surely test result you have proof that the product tested was free of harmful microbiological contaminants i could have uh inserted a c of a here for a non-sterile product with usp 61 and 62 test results it basically be the same concept it'd be proof that there were no harmful microbiological contaminants in the product right cfa's can be used as a as an effective sales tool next slide eric so the two previous cfas were for com the compounder preparations um it's like what if someone asks about chemical contaminants chemical contaminants is not something that's tested on the finished product level for for compounders so i thought well you could also use your cfa for your starting material or your api this is another c of a that shows your dedication to quality and can be used by as a sales tool so you can you can show that you're using usp grade material be able to explain what that means who is who usp is what usp does why that's important right if it's not usp grade what does that mean so be able to talk about your quality systems of your api vendor also think about your vendors um are they just releasing test results by the overseas manufacturer or or your vendor testing again in the us right know those things and be able to talk about them right uh just to kind of clarify on this c of a in this particular case tall eulene was the chemical contaminant of concern um intel um was not content uh not detected in the api so you could explain to them what a residual solvent is and how anything you did to create the finished product would not have generated more toluene um you know if you're using a cfa for your api so if that if that prescriber or that facility is educated by you they will know what questions to ask next time they consider another pharmacy so next slide eric so in summary having passing test results a c of a it's it shows your commitment to quality um passing test results show that you have the procedures and environmental controls in place uh and you know training staff training and supplies and things that you're using to produce quality products right everybody wants a quality product so if you are testing use the test results use the c of a as a competitive advantage over those compounders that do not test okay that's it for me i think we're pretty much out of time yes um we had a couple questions come in and we'll answer those uh following the following this session if you have any additional questions feel free to submit and then um we also you can also send those to our contact information as well um thank you for attending today's session this session will be recorded and you'll receive a recording link with the follow-up email that will go out today for ce credit fill out the survey on the last slide of the handout for the slides there's also a qr code in there if you'd like to scan that the link will also be included in your email that will go out to all attendees this afternoon thank you very much for attending today's session thank you you