Viva Viagra?

     Pfizer will begin offering online sales of their popular selling erectile dysfunction treatment. The company believes this will help combat online sales of counterfeit Viagra. While a prescription will still be required, this is supposed to help men avoid "embarrassment" by saving them a trip to the pharmacy to pick up the medication. Currently there are dozens of online sites that sell the little blue pill for a fraction of the price without a prescription. Unfortunately, these pills are often counterfeit containing very little of the active ingredient and even potentially harmful components. Pfizer believes by offering discounts to online consumers they can try to push out the black market vendors.

Photo: Niko J. Kallianiotis for The New York Times (link to article)

     Personally, I think cutting out the pharmacist sets a horrible precedent in the pharmaceutical industry for several reasons. Of course, I'm concerned by anything that threatens the role of the pharmacist in a retail setting. I don't know where I'm going to end up after pharmacy school and I don't want to see pharmacists taken out of more and more patient interactions. It may just be Viagra today, but what other medications will be available directly from the manufacturer if this is allowed? Secondly, this could potentially be dangerous. Many people think of Viagra as a harmless treatment for erectile dysfunction akin to the "treatments" we see advertised on late night TV. Viagra is a serious drug with serious side effects and the potential for deadly interactions with other commonly prescribed drugs. For example: many men with erectile dysfunction are also on blood pressure medications and these two mixed together can cause an unsafe, dramatic drop in blood pressure that can even lead to cardiac arrest. That's great men still need a prescription from their doctor to acquire this drug, but a doctor is not a drug expert and may not catch potential drug interactions like a pharmacist would. Pharmacists are also more accessible than physicians to answer patient concerns and address patient issues on the spot.

     Finally, I don't really think this will stamp out the problem of counterfeit, black market Viagra. One of Pfizer's main arguments is that patient embarrassment will be avoided. I can't speak from personal experience, but I would think a patient that would be embarrassed to pick this up from the pharmacy would be too embarrassed to bring this issue up to their doctor in the first place. That's the nice thing about black market drugs: you can order them without ever having to bring up your erectile dysfunction to even a doctor. I work in a retail pharmacy and I have never had a guy act embarrassed about picking up their Viagra. In fact, most of them act proud (for lack of a better word). They should be proud that they can even afford to take it, since insurance often doesn't cover it. Which brings me to another point: the black market drugs are so much cheaper. Even with their discounts Pfizer can't compete with the prices of the counterfeit Viagra.

In my opinion if Pfizer wants to help combat black market sales of Viagra they need to educate their potential customers on the dangers of counterfeit medications AND the danger of using a drug without their doctor/pharmacists knowledge. Stick with what you know Pfizer. You keep cranking out your little blue pill and let the pharmacists sell them.

The Future of Pharmacy = Provider Status



ASHP article

Ram Samudrala and his CANDO attitude!

     Straying from the topic of compounding... sort of. Recently, I went to a seminar hosted by the Medicinal and Natural Products Chemistry department in the College of Pharmacy. I think I mentioned this in a previous post, but my interests tend to be like love affairs: I'm instantly enchanted by something, spend all my time with it and profess my undying love for this topic then move on to something else the following week. This week it is definitely the Computational Analysis of Novel Drug Opportunities or CANDO. This is a computer program/database created by Ram Samudrala (http://en.wikipedia.org/wiki/Ram_Samudrala). You know you've made it when you have a Wikipedia page, right? Anyways, the database contains all known drug target structures and all known drug structures. The analysis comes in by screening all of these targets against the known compounds. Picture a database full of literally thousands of nuts and bolts, the computer then goes through all of these to see which nut fits which bolt and makes connections between similar nuts and/or similar bolts in a large web of information.
    The compounds and their targets are broken down to the active fragments of their molecules. Here's where the compounding part comes in: with this program it is possible to take components of active drug compounds and fit them together in new way to possibly hit new targets or optimize their efficacy and safety. I don't know about you, but this stuff blows my mind. It's like something from science fiction! Of course further testing in vitro and in vivo would be required to confirm the compounds actually work as we would like them, too. For example just because a drug will kill a bacteria doesn't mean it can even get to the spot it needs to. Bacteria can develop ways to evade active compounds like efflux pumps and other defense mechanisms.
     If the compound studied is already FDA approved, but is discovered to work on another illness then many steps in the drug discovery and testing process can be skipped. This creates a faster, cheaper method of discovering new drugs. The program can even run all known homo sapien proteins against bacterial proteins and drug compounds. This way researchers can see what compounds act on bacteria and not humans predicting toxicities and efficacy. Check out the links below for more information.


http://compbio.washington.edu/
http://cando.compbio.washington.edu/

Learn to Compound...on the Internet?

     I was surfing around looking for some interesting pharmacy related news to blog about when I came across this http://www.criticalpoint.info/index.php?option=com_content&view=frontpage&Itemid=1.
The skeptic in me immediately thought, "how can you possibly learn how to compound from the internet?" I realize these days you can take online courses in practically everything. I myself have taken several online courses for college, but this strikes me as something that would be more beneficial hands on. I remember in undergrad they offered Biology and Anatomy and Physiology online. For my chosen career path these were not acceptable courses to obtain the credits I needed. I had to take the live lectures and lab. If I had the chance to take the classes online I still would have decided against it.

      I looked around on the site a little and it seems to be a legitamate resource for sterile compounding training. The site  says, "CriticalPoint is the only training company that meets or exceeds all of the training (and testing) standards specified in USP <797>. Our flagship Course in Sterile Compounding plus The Virtual Compounder^TM contain 42 lessons designed specifically to teach and reinforce the necessary skills.

All of our courses are written by leading industry experts (including members of the <797> and NIOSH expert committees), and our courses always include the latest updates to the standards.
CriticalPoint courses are delivered over the Internet, offering convenient anytime/anywhere training. Our engaging, self-paced format makes it easy for your staff to learn and means that new hires don’t have to wait to get up and running. Plus, the testing after each lesson and our unique Virtual Compounder assure that your staff has mastered the required skills. Also, all of our courses are ACPE-approved, so your staff members receive the added benefit of earning up to 42 Continuing Education Credit Hours."

    This seems to me like a good resource for brushing up on compounding skills or reviewing some things you may have forgotten, but unless you work in a compounding facility or have a hood and clean room at your disposable you won't be able to get that hands-on experience. I for one need to actually do something before I grasp it entirely. I know even in PPL we do sterile compounding so rarely I feel like every time is the first time. I will say, though, I would love to play around with critical point's virtual compounder program!

Veterinary Pharmacy

     Now that I've got that NECC debacle out of the way, I'd like to talk about something else I'm passionate about besides justice for companies that overstep their bounds: animals. Every since I was a little kid I have loved animals. Not just the cute and fuzzy ones either, I mean ALL animals. Growing up my dad had snakes and iguanas and I've had my share of "creepy" pets, too. I used to dream that I would grow up to be Dr. Dolittle (the old school Rex Harrison Dr. Dolittle). Maybe I should have been a veterinarian, but I have found a way I can fuse my interest in chemistry and pharmaceuticals with my love of animals: veterinary pharmacy.
     Veterinary pharmacy is a small, but growing field right now. Many veterinary pharmacists work with cattle, pigs and other livestock. They are mostly working large scale providing antibiotics and the like for animals that will end up on the dinner table. I have also seen quite a few veterinary pharmacists that work with race horses and some that work with the companion animal population. There are a very lucky few who get jobs being pharmacists for some of the larger zoos in the country. They work closely with veterinarians to care for and treat exotic species from all over the world.
     Every once in awhile I will look at job search websites for jobs in veterinary pharmacy and I don't find a whole bunch. It seems like this field is still very small, but hopefully it will continue growing. Pet owners now treat their animal companions like part of the family. When these family members become sick they don't go to a regular MD, so why would a regular pharmacist be able to best serve them? I believe in the future animal pharmacists will be more common. They will offer a unique service, because they don't only understand the mechanisms of action and kinetics of a drug; they also understand how it will work on various species. One of the main jobs of veterinary compounders is making sure the drug is delivered in a vehicle that is appealing to the animal. I'm sure everybody has had the unfortunate experience of trying to give a dog or cat a pill they don't want. The University of Florida offers an online class in veterinary pharmacy. I am planning on taking it this fall and hope to learn more about this exciting career path.


Related Links:
http://pharmchem.cop.ufl.edu/electives/vetpharm
http://pharmacy.vethospital.ufl.edu/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690882/
https://vetmeds.org/default.aspx

New Bill: Compounding vs Manufacturing

The US Senate
 HELP Committee link
 

     I have been following the NECC meningitis outbreak since
it was first identified in the fall of 2012. I even attended a 5 hour
long meeting in January about this topic held by the Iowa College of Pharmacy. That event really helped answer a lot of my questions about how
something like this could happen. What it couldn't answer was, "Where do we go from here?" and "What does this mean for the future of compounding pharmacy?" I knew that regulations would change and their enforcement would be stricter, but I was anticipating a change for the worse. I was afraid that this would be such a negative blow to the world of pharmacy that it would force smaller, independent compounding pharmacists out of business.
     While looking around for any updates about the meningitis outbreak and its effect on pharmacy law, I found news that a new bill is being drafted addressing these issues. I was very pleased to see it included a point I thought about from the onset of the tragic events: the NECC was not acting as a compounding pharmacy. It was acting as a manufacturer and therefore should be subject to inspection and oversight by the FDA not the state of Massachusetts. Also, compounding pharmacies in general should not get a bad reputation for what this one greedy company did.

•      A compounding pharmacy by law operates as such:
• receives specific written order for a drug product from a licensed prescriber
• this drug product is for a specific patient
• this drug product is not made until the pharmacy receives the order to make it (some products that are shown to "move" in the pharmacy may be made ahead of time in limited quantities)
• they DO NOT produce large amounts of drug products to sell and ship all over the country!

If a "compounding" pharmacy is making huge batches of injectable steroids without doctor's orders or for a specific patient, selling and shipping them all over the country they cease to be a compounding pharmacy and are now a drug manufacturing facility.
     The HELP committee is writing this bill to help define "compounding" versus "manufacturing" and who is responsible for overseeing each of these entities. The bill will see to it that compounding pharmacies are still held up to the highest standards and answer to the state. Compounding pharmacies that stray into the area of manufacturing will answer to the FDA and must uphold the even more strict standards of a drug manufacturing facility.

http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf

Side note: Iowa's own Senator Tom Harkin serves on the HELP committee. Go Iowa!

Compounding in the News

Image Source: Wikipedia
Entry: New England Compounding
         Center meningitis outbreak link

     Recently the field of compounding pharmacy was put in the national news spotlight. This was, for many people, the first time they had even heard of compounding pharmacy and what it entailed. Unfortunately, compounding pharmacy was not shown in a good light. For those of you not familiar with the New England Compounding Center and its involvment in a recent meningitis outbreak please see the link below the image. This link will take you to a Wikipedia page that gives the basic rundown of events that occurred without too much of a media bias.
     In October of 2012 there was an outbreak of fungal meningitis that affected patients in 23 different states. When the CDC began checking into possible causes of the meningitis outbreak they discovered all of the patients had received epidural steroid injections. The methylprednisolone acetate for injection had been produced at the NECC. The NECC immediately recalled this product and two others that may have been contaminated. As of March 2013, 48 patients had died from meningitis and over 700 people were injured or currently being treated for meningitis and other injection related infections.
     Like I said before, for many people in the public this was their first time learning about compounding pharmacies. The NECC has since closed its doors and is facing hundreds of lawsuits from families effected by their error and penalties from the US government. This tragedy was not only a huge blow against the NECC, but all pharmacists. It took away a level of trust the public has in our profession.
     Also, with the way the media presented the findings many people were terrified that any injection or any medication they received could kill them. True, all medications have their risks, but I really disagree with the media always using sensationalism and fear tactics to whip the public into a frenzy over any little thing. Simply by surfing around the internet and reading various message boards I see the paranoia and misinformation about this issue. Many people are asking, "Where was the FDA? Aren't they the ones supposed to be protecting us from the pharmaceutical companies?" Of course people demanded that compounding pharmacies now be inspected and subject to harsher laws. The NECC debacle lead to several other compounding pharmacies being shut down in Massachusetts and other states. This really scared me. I knew that soon every compounding pharmacy would be scrutinized and looked upon as a potential problem. The public would lose trust in pharmacy and the government would respond by driving independent compounding pharmacists out of business.
     I completely agree that compounding pharmacies should be held to high standards of safety as patients health and even lives are on the line. Unfortunately, the NECC was not operating as a compounding pharmacy in the true definition. In my next post I will get into the details of what constitutes "compounding" versus "manufacturing".  I think the NECC should be harshly punished to make an example for other pharmacies who may try to stray into the area of manufacturing.  I don't agree that more laws and regulations will necessarily prevent future tragedies of this nature. Case in point: the New England Compounding Center was violating tons of compounding pharmacy laws and this was not brought to light until they killed or injured hundreds of people.