Friday, October 15, 2010

I've hit the big time baby!

So, my last post suggested I'm going solo.

And I've done that, so I've been preoccupied.

But now, I've clearly made the big time with a shout out in the October 2010 issue of Drugstore Canada magazine.

I guess my little blog was getting more attention than I thought (which is why I stopped blogging for a while).

When I have more time, I will put up another post.

Tuesday, June 22, 2010

I'm going solo.

That's right.

There's been a lot of talk (and crying) in Ontario about how the retail pharmacy industry is in trouble thanks to the new drug reform It's true, the drug reform will hurt the retail pharmacy industry. But let's be serious, does a company like Shoppers Drug Mart or Rexall really need more money? I mean these guys have more money than some small countries!

So, while all the pharmacy owners out there have been crying foul about how their bottom lines will be hit hard with the implementation of these changes, I've been quietly taking notes and figuring out how I can take advantage of this new shape of the industry.

And, I'm confident that opening up an independent pharmacy in the immediate future is the right move to make from a professional and business perspective.

There is still lots of dollars in the industry to be had. I know I won't be making billions like SDM, but even if I can take a small percentage of what one of their stores makes, then I will be doing just fine. My overhead and expenses will be lower because it will be just me, and I know for certain that I can out-customer-service a Shoppers or Pharma Plus Rexall with my eyes closed and hands tied behind my back any day of the week.

Don't get me wrong, this isn't going to be easy, I know. But the bottom line is that all these changes were inevitable...and this isn't the last major change to the industry in my lifetime. But it was now or never.

So here I go, wish me luck.

Thursday, April 29, 2010

Small pharmacy is really screwed, but that doesn't mean I can't be only a little screwed.

So, it's been a while since I last posted.

What's happened since then? Well, I've had some excitement in my personal life, but this is not the forum for that.

And in my professional life, well, all has gone to hell, as they say. The Ontario Government has decided they aren't happy with how well the retail pharmacy industry is doing these days, so they've decided to slit our wrists, give us a bandaid, and let us all bleed out slowly. And by "us" I mean pharmacists in Ontario. Go to www.stopcuts.ca or http://ontario.communitypharmacies.ca for more info. Educate yourself, but in the meantime, here's my take.

The government has announced they will be eliminating all forms of professional allowances to pharmacies from generic drug companies (which is about 750 million bucks/year), while slashing the allowed cost of generic drugs to 25% of the brand name price. They did, however, agree to increase the Ontario Drug Benefit (ODB) reimbursed dispensing fee from $7 to $8 - which is very nice since they've only increased it by $0.56 over the past 21 years. Hrmmmmm....maybe its cus they knew the funding model for drugs in Ontario was screwed up and they were okay with letting pharmacies and generic drug companies work out their own deals. So now the government wants a piece of the action...or probably is thinking, "if we can't have a piece of the action, no one can". They did agree (but haven't given specifics yet) to fund pharmacists for the provision of certain professional services. Who knows what that will be and how much it will pay or even when it will take effect.

Bottom line is this: they are removing about $750 million from the industry and only giving back $250 million....where the heck is the difference coming from? The answer is the public. The innocent bystander who hears from their elected government that they will be saving money on drugs. But if pharmacies are going to lose money on every prescription they fill, either someone will pay, or pharmacies will start cutting back and going out of business.

It's happening already. People are getting laid off. Hours are harder to come by. Previously free services are being charged for (eg, $5 per delivery of a prescription). And the smaller pharmacies who aren't 17,000 square feet with 5000 square feet of high end cosmetics (and aren't receiving kickbacks to stock those cosmetics, by the way), will get hit the hardest. The independent pharmacy. Not the large/public corporations like Shoppers Drug Mart or Rexall Pharma Plus (Katz Group).

Thanks Premier Dalton McGuinty and Health Minister Deb Matthews....you have officially solidified your role in Canada's history as the government that destroyed the pharmacy as we know it, and as we have known it for the past 20 years or even longer. Wait you two. One day soon you or someone you love will likely need a pharmacist... And by then these changes will have had time to have their full effect on the industry. And when you need the assistance of your pharmacist and don't get it or have to pay out of pocket or have to wait a very long time, I hope you curse yourself. I can only imagine what you would do if someone came along and said "you are not allowed to make the salary you have been getting for the past 20 years anymore, so now will earn 50% less for yet to be determined increase in workload." Ya, good luck with that.

I'm not really all that upset with making changes. Seriously, I agree we need lower drug prices. I'm just upset with how they went about doing it. The government created these "professional allowances" in 2006...it was their idea!! And now they are making pharmacists look bad for using that. And they are being vague and unwilling to negotiate or discuss possible resolutions with any of the pharmacy associations/groups. They are making drastic changes to and industry they know little about. And just because they pay for the largest insurance plan in the company and want to reduce their debt, they figured that by paying less for drugs, their debt will decrease. So why not legislate lower prices? Genius they thought. Meanwhile they will screw millions of people in the coming years.

Until then, I'm not going to let you burst my bubble. I am still going to open my own pharmacy. I will modify my business model to account for your stupidity and arrogance and future inevitable stupidity. I will do whatever I can to prove myself and the services I provide to my patients are worth their time, loyalty, and business. I will let them know that the government doesn't really care about anyone but themselves. I will succeed whether you try and stop me or not.

That was my rant on the current situation in the retail/community pharmacy industry in Ontario.

Until next time,

The Canadian Pharmacist.

Monday, February 1, 2010

Hey Ontario, why can't you be more like Alberta?

The article below is cut and pasted from the Canadian Healthcare Network's website (but you may need to log in to view it...so I inserted it below)

This is kind of what I've been talking about. Except it's a resolution that kind of makes sense for the future of pharmacies. Although it will never be like it was 10 years ago, it's better than things look....



Alberta pharmacy agreement inked
Written by Barbara Kermode-Scott on January 29, 2010

Collaboration has proven key in negotiating a good deal for Alberta’s pharmacists, pharmacies, public, patients and provincial government, argues Margaret Wing, acting CEO of the Alberta Pharmacists’ Association (RxA).

“This is a great story,” said Wing in response to the Alberta government’s January 28 announcement of a new pharmacy funding and services model agreement for the province. “We feel that the collaborative approach is what has helped us achieve this agreement… Other provinces need to learn from what Alberta did that collaboration is a great path. It’s better than fighting!”

In October, 2009, a joint Ministry-pharmacy transition team was established in Alberta to seek a common approach to addressing prescription drug costs, rising drug utilization, and the need to maintain a solid economic foundation for community pharmacies. The goal was to identify and implement a sustainable, long-term model for pharmacy services and compensation, and to address transition issues arising from phase two of the Alberta Pharmaceutical Strategy. This group included representatives from RxA, the Canadian Association of Chain Drug Stores (CACDS) and Alberta Health and Wellness. Together, RxA and CACDS memberships represent more than 90% of Alberta community pharmacies, says Wing.

Other provinces need to learn from Alberta that collaboration is a great path. It’s better than fighting!”

Phase 2 of Alberta’s provincial pharmaceutical strategy is a win-win, suggests Wing. Patients will benefit as they will have access to lower priced generic drugs and a wide array of pharmacy services. Pharmacies win as they will have stable, predictable, sustainable funding over the coming years, and the government wins as they will reduce rising prescription drug costs.

“The government showed real leadership on a challenging issue,” said CACDS chair Mark Dickson. “The need to modernize pharmacy funding and services is not unique to Alberta. But the solution and co-operative nature of our discussions show that this province understands the growing importance of community pharmacy care, and that the government wanted to build a system that would serve Albertans well over the long-term.”

On April 1, the price of currently available or existing generic drugs will be reduced from 75% to 56% of the price of comparable brand name drugs.

The Alberta Government anticipates saving about $100 million through reduced new and existing generic drug prices as well as through other related cost saving initiatives contained in the pharmaceutical strategy.

Under the new agreement, Alberta Pharmacies will have a new remuneration model that goes beyond fee for service to compensate pharmacists for additional services they offer, such as patient consultations, medication reviews and immunizations.
The government is providing $75 million over three years to help pharmacies move to the new compensation model. Through the transitional allowance government will provide additional payments to pharmacies on top of their current $10.93 dispensing fee for prescriptions less than $75:

* $3 per prescription ($13.93) from April 1, 2010 through March 31, 2011
* $2 per prescription ($12.93) from April 1, 2011 through March 31, 2012
* $1 per prescription ($11.93) from April 1, 2012 through March 31, 2013

Rural and remote pharmacies will be eligible for additional funding based on criteria such as proximity to an urban centre and number of pharmacies in the community. The Alberta Government has established a $5 million fund for this purpose.

The new payment model will be announced later this year after a pilot project has been completed and evaluated.

More information regarding Alberta’s Pharmaceutical Strategy can be found at:
www.health.alberta.ca/initiatives/pharmaceutical-strategy-2.html

Sunday, January 31, 2010

Call To Action

In Ontario over the past several weeks, the major players in the retail pharmacy industry have banded together to deal with the current state of affairs. The big three involved are: The Canadian Association of Chain Drug Stores (CACDS), the Independent Pharmacists of Ontario (IPO), and the Ontario Pharmacists Association (OPA). They have even collaborated and formed a website (http://ontario.communitypharmacies.ca/) to convey their messages and spread the word via facebook groups.

Why? Money, obviously.

And don't get me wrong, I'm all for improving the future financial situation of my profession. It's just funny how these things play out. In reality, the independent pharmacists despise the chain pharmacies, and the chain pharmacies want to wipe out independent pharmacies. Both bad mouth the other to their patients (I've seen and witnessed this on several occasions; and doing relief for both the chains and independents, I can say that confidently).

So why all this hooplah? The government is toying with the idea of getting rid of all rebates, or setting a very pathetic cap on the whole thing. This would cripple pharmacy as we know it. I won't get into the details, but trust me. You think we stay alive making $7.00 on a prescription? Umm, no. It's the rebates we get behind the scenes...it's always been the rebates. It's no secret. Think about it...has the dispensing fee for ODB (ODB is the government funded drug plan) gone up in the past decade? No. Has inflation...hell yes. Does there seem to be a problem here? Yes.

So picture this. The government never raised the dispensing fee for the past 20 or something years because they knew pharmacies were getting money elsewhere (the rebates from the drug companies). Yes, the government knew all along!! And now, they're saying no more rebates, and we're not going to increase the dispensing fee to make up the difference in revenue. What will happen? Well, patients will suffer and so will pharmacies who focus on prescriptions (and not cosmetics).

So the Ontario Community Pharmacies have banded together to create awareness and try and get the government to change what they are proposing. What are they proposing exactly? Well the people who are meeting with the government won't tell us. Seriously. Even at one of the "Call to Action" meetings which are still taking place at various places across the province, there is some confusion. We are being urged to get our patients to "help us" and have them sign postcards and fax forms to send to the government to "save pharmacy". But even as all of the major players band together and urge the pharmacists of Ontario to do these things, each of the different groups has their own agenda. The meeting told pharmacists to collect signatures and send them off. But then the head office of the chain pharmacies say something different like "ignore what you heard, and do what we tell you instead".

Huh?

How is anything ever going to get accomplished if the people getting together to speak on behalf of all pharmacists, will sit down at meetings, look each other in the eyes, make a plan, and then do something different?

Call to action? Ya, good luck with that.

The fate of the future of pharmacy in Ontario is in the hands of a bunch of boneheads.

Sunday, January 17, 2010

Long break...

Well happy 2010 world.

I took some vacation time. And since you were staring, tapping your fingers, and pacing back and forth, I decided to take a little longer than necessary. ;)

So, what have I been up to? Well, I'm still thinking about, thinking about, opening my own pharmacy. Being a pharmacist and never taking a business course ever in my life, not even in high school way back, learning how to go about starting a business has been...fun! So it may take me longer to understand concepts or terms that come second nature to many business-types. But I've read a couple books on business plans, which inevitably lead me to the internet to search out definitions and further explanations of terms and concepts. Did you know that pro forma means "completely made up"? Why can't they just call it a "made up financial statement" instead of a pro forma? That would be way easier for the average person to understand.

One of the main problems I foresee in this potential venture is the future of pharmacy in Ontario. The government in the past couple years has decided to make the drug rebate side of the business "transparent". So by doing this, they also thought it wouldn't look so good if the transparency showed that pharmacies are getting 60% rebates...so now pharmacies can only get 20% on drugs purchased for publicly funded people (seniors and welfare). In some cases, the reimbursement for some drugs was less, yes less, than the actual acquisition cost. WTF? This left the field wide open for the brand name drugs...so that's how pharmacies have been making it up over the past couple years. Now, they're discussing capping the brand name rebates to 20% or something also! What does this mean? It means the future of pharmacy as we know it in Ontario is in jeopardy. It means only the big box stores who buy in large enough volume to make a 20% rebate worth it, and who have a large enough front shop to supplement their sales with high-end cosmetics, will survive. It's almost like the government is angry with pharmacists for making a living over the last 40 years.

The problem I see, is that dispensing fees have been the "transparent" side of how pharmacists make money. The average consumer hates the dispensing fee and thinks a $9.99 fee or (gasp) $10.99 is absurd! The reason these fees haven't gone up over the past couple decades? You got it, cus pharmacies were making money in rebates and didn't bother passing on the inflation in the cost of dispensing to the customer in the form of a fee. What happens next? Well, if you raise your fee, you upset your customers and eventually lose business. If you don't, you'll eventually go broke anyway.

So, the state of pharmacy affairs in Ontario is uncertain and grim. Do I start a pharmacy or not?
Do I risk everything I have to start something I've been dreaming about for years with a 50:50 chance of making it. And even if I "make it" will it be "worth it". I mean, I love being a pharmacist, but let's be serious, this venture would be a business decision. Is it worth it?

Who knows. 2010 just got underway. I've got a feeling this year will be a tough one, but a memorable one.

So happy 2010 world.

Thursday, December 3, 2009

Apotex Shortages Explained

Good Morning.

I woke up this morning to rain. Not snow. I guess that's okay for this time of year.

First guy that walks into the pharmacy was looking for his Oxycontin. Sorry, still too early. And tomorrow will also be too early. See you in a few weeks.

Funny how when there was a shortage of pharmacists a few years ago, the media didn't cover it like they cover the doctor shortage, eh?

Seriously, I know we're not preceived as more important, but why not at least give us some recognition for what we do for the public.

In other news, I spoke with a rep from Apotex yesterday about all the drug shortages that pharmacies all over Ontario (and probably Canada) have been experiencing. Here is basically what he told me: Apotex applied for approval of it's Canadian facilities to manufacture drugs for sale in the US. The FDA told them to change a bunch of things to get up to their standards (uh, oh). So then the rest of the world decided we want to do what the FDA does. Now, Apotex is going through major process, SOP, and QA adjustments in all of it's plants. For example, they found traces of penicillin in one of the plants that isn't supposed to have penicillin in it (big uh, oh.) And so during this whole process, they have shut down or slowed down manufacturing certain lines or drugs or whatever. End result, pharmacies can't get product they rely on, and patients are suffering.

That's all I've got on that. I guess this is good for all the other generic companies.

What else is happening in the world of health today? There's been some talk about increased incidence of infection in ICU's. They're saying infections in half of the world's ICUs!!? I have a good friend who is an ICU doctor. His nick name in Univeristy was "filthy". Coincidence?

I also got some good gossip on where various people in the industry are today (ie, job changes, etc). But, I'll save that for another day.

Wednesday, December 2, 2009

Wed. Dec. 2nd, 2009

I usually have amazing things to say or write about with respect to the pharmacy world and industry. The problem is, I'm usually in over my head behind the counter with multiple people waiting, the phone ringing, and not a second to logon to my blog and tell the world about my brilliant idea or thoughts.

I have to wait until much later in the day when I've separated myself from the dispensary. Unfotunately, those spontatneous moments of passionate thoughts about something related to pharmacy, are long gone by about now.

All day long, I come across interesting current events, breaking news, funny stories, weird patient interactions, and moments of epiphany. My other issue, is which of these things are appropriate for this type of forum? Do I want to tell you about the crazy corn factory worker who burned his arm then put scotch tape over the burn because he truly thought that was the right thing to do? Or do I want to tell you about the new study that showed most hand sanitizers aren't going to kill 99.9% of germ like they advertise? Or do I want to discuss that for all the relief pharmacy work I've done, I could have spent most of that time planning on opening my own pharmacy and worked for myself all this time?

OR do I want to talk about whatever people will read about?

Ya, I think that's the best option because without the reader, a blog is nonexistent.

So, tell me. Until then, I will write about whatever and see what comes out of it.

Saturday, November 28, 2009

Shoppers Drug Mart Politics

Usually, when a company asks an employee to take over a position that has been held by the same person for many many years, that new employee should adapt to their new environment and staff, right? Well, not if you're talking about Shoppers Drug Mart.

Last night I worked relief in a Shoppers Drug Mart (SDM) that has a new "Associate Owner" (slash "sucker"). The staff filled me in on all the gossip. The old Associate left the store to take on a cushy head office job. And the new guy comes into the new store for not even 2 weeks and has already started digging his own grave.

You think that as the new guy and new boss of a pretty large and decent staff, you'd want to keep them on your good side. But not this genius. He comes in and as one of his first acts of business, he decides to end the store's methadone program!! WTF?!?! Those meth patients are trying to get clean, and you walk in and mess everything up!! Of course, I'm working the first full day after they started telling their patients that they're going to have to find a new methadone store. Thanks asshole, now I'm working until midnight with a bunch of pissed off recovering drug addicts and the staff and I are getting an ear full.

So, why would this idiot choose to take over a store where there's methadone if he's to big of a pussy to deal with it? My guess: he's an idiot. But, an even better question: Why would SDM let a new associate take over a new store and start changing things around so drastically? My guess: they're idiots. But he's all they've got, and they're all he's got. Why? Say it with me: They're all idiots!

The whole situation gets worse because the staff are the ones telling the patients that they are closing the program and so the staff are getting yelled at. And who do the staff blame? The new guy. The idiot. And head office. The idiots.

This isn't an isolated incident. Every time I go to a SDM, there's some sort of political nonsense pissing all the store level staff off. Listen up Shoppers: don't piss off your store-level staff. They are your bread and butter...not the stupid idiots at head office in their cushy desk jobs with fancy offices and furniture (I've seen the fancy head office by the way).

So, what did I do? Naturally, I stirred shit up. I told the nice ladies, the technicians, to be empowered. I told them to say something to the new guy. And if that doesn't work, then speak to their regional manager. Worst case, get the pissed of patients to complain to head office and if necessary, complain to the college.

Call me a shit disturber. Seriously, call me that. Because that's what I am.

All Shoppers stores have issues. And the issues are typically all the same.

Too bad this hugely successful company are not smart enough to recognize it and do something about it. It's only a matter of time before it all comes crashing down.

Sunday, November 22, 2009

Opening a new pharmacy

So, all this work makes me wonder if it's time.

Is it time to consider opening my own pharmacy?

What's the deal with new pharmacies nowadays anyways? How does one compete for business with the likes of Shoppers Drug Mart and Rexall (and the slowly being phased out, Pharma Plus)? Is it stupid to think I can compete for the pharmacy business? And without a medical clinic in my back pocket, is it stupid to think I will survive?

Now what types of things am I thinking about? Well, location, location, location. Where the heck would I open? The area I live is pretty saturated with chains, independents, banners, and other types of pharmacies. So how far do I want to open a business from my home? What's reasonable?

And what would my pharmacy look like and what would I sell? What are people looking for in an independent store? What do you think? How much money and inventory do I need? And how much time and planning should I allow for?

What about past relationships? Do I worry that people I used to work for/with will get upset if I open within a certain distance of them? I'm not one to burn bridges, but seriously, space is finite.

And how does a pharmacist market themselves once open? I mean, you can't leave the store during business hours, so how do you go visit doctors when they're more likely to be able to meet with you? Or do I dig my financial hole deeper and hire someone to cover me when I call on docs? Its a catch-22.

So, anyone out there have any tips or advice for me? Any good resources?

Anyone done it already and want to get in on this action? Or know anyone who wants to do it?

Is this the start of a new thought process? Or is this just a timely blog that will fall by the waist side in an hour?

I predict this is the start of something massive.

Saturday, November 14, 2009

Hint hint, nudge nudge...

Anyone into compounding?

I've done my share...actually, much more than the average. I'm trained in non-sterile and aseptic compounding, and I really enjoy it.

There's much more brain cells being used with each prescription compounded than a typical rx filled. I mean, there's calculations, technique, stability, sterility, QA, etc. etc. Not just count, check, counsel. I feel more complete and more professional satisfied when I've actually done something that requires my expensive brain cells. I mean even a good DUR identification is better than just checking an inhaler refill. Wait, unless you're at the tail end of a 14 hour shift and you're feeling light headed because all the blood has rushed to your feet from standing forever.

So compounding, for those who don't know is the art of customizing medications for the patient to suit their needs. In Canada, its much less of a big deal than in the States. We only have "guidelines", nothing legislated about the standards a pharmacy must maintain if/when compounding. So yes, that means no USP 795 or USP 797. But like most things, Canada (or each province one-by-one) will eventually adopt the US standards and call it slightly different (just so people think they thought of it on their own).

What does that mean right now. It means compounding in Canada is like the Wild West! Anyone can do whatever the heck they want under any circumstance - although most don't. There are some who are pushing the envelope. Most pharmacists have enough respect for their patients that they do follow the guidelines, but some don't and think its okay to bend the rules once in a while and enter the gray area.

What is the gray area? Well, it's kind of gray.

So, compounding pharmacies aren't as prominent as in the US, but I foresee it going that way. Should I hop on that train? I'd love to, but it would be nice to have someone who has done it before and has the experience and $$ to help.

Know anyone?

Friday, November 13, 2009

The wrong way in a one way...

Whats the deal with drive thru pharmacies? (feeling like seinfeld right about now)

I know the concept has taken off in many places. Whatever, I still don't love it...that's speaking from the guy behind the window. I mean, I love the Tim Horton's drive through (by the way, that's an amazing Canadian coffee and donut and sandwich etc. place...if you're in the States, google it...or visit it in NYC).

So tonight I'm working in a store that has a drive-thru window. Its my first time. Its kind of cool for the first 2 customers, but once you have a line up at the drop-off and the pick-up counters, who the heck needs another line up of people staring through a window at us too? So, now there's 3 lineups, all wanting a piece of me. Oh wait, there goes the phone too.

Some guy pulls into the drive-thru lane, the wrong way. The wrong way!! I mean, there's gotta be a few dozen signs and even markings on the pavement letting you know the right way to do it. So this is what is said when the guy in the passenger seat, now closest to the window, pulls up:

Me: Hi, you drove through the wrong way.

Guy in the passenger seat: Well I'm not driving.

In my head: #$%@#!%@#$%@#!!!!!!!!!

Anyways, my point is that no matter what you do in a pharmacy to make people's lives easier, there will always be a select few messing it up for everyone else.

Where did this whole idea start anyways? Probably in the States somewhere. And like everything else, someone in Canada had to eventually follow. Now they're all trying to keep up with eachother. It's hilarious watching these companies compete with eachother. I'm no marketing genious or anything, but isn't the idea of these big box stores to get people IN the store? If they can get what they need by driving it up and taking time and attention away from the customers in the store who are probably spending more "per basket" at the end of the day, why do the big guys care so much about pleasing these people? Am I going to have to break out the "would you like fries with that?" line in the future? If that happens, I'll probably just actually go and serve fries...at least I'll be doing what I'm there to do. And not, going the wrong way down a one way.

Thursday, November 12, 2009

Men are pigs

I have many great stories from my days of working in an area of Toronto, known primarily as the gay area. I am not gay, but I can confidently say that of all the places across Ontario I've worked as a pharmacist, this area is my favourite. Not only because it hosts some of the friendliest people and some of the most taboo everythings, but also because it has provided me with some of the best stories.

For example, I began working there as an intern. Early in my rotation, and not quite as confident and knowledgeable as I am today, I was working away in the busy dispensary. Along comes some guy who starts staring at me from in front of the counter. It took me a moment to notice because I was diligently rechecking my work. When I finally looked up, this is how the conversation went:

Me: Hi, can I help you?

Guy: Are you "The Canadian Pharmacist"? (sorry, I'm leaving out names for a reason)

Me: Ya, that's me.

Guy: Oh....(smirk)....I got an email about you from a friend... (bigger smirk)

Me: ....?.... (awkward blank stare)

Guy: He told me to come check out the new pharmacist (still smirking)

Me: (back to work)


I'm not really sure if a blog is the best way to get that story across, but I can honestly say that was the first time I ever thought to myself, and with good reason: "Men are pigs". I've heard stories about relationship woes between guys and heard stories of same-sex weddings.

I have lots more stories about dudes hitting on me. I won't lie, its a big confidence booster when you get hit on frequently. Call it what you will, I'm the best damn pharmacist some of those guys ever had the pleasure of being counseled by!

Wednesday, November 11, 2009

Are Bioidentical Hormones Safe?

So, I'm cutting and pasting an article for people who don't want to log into Medscape. I'm pretty sure this could be frowned upon, but I'm referencing it.
This isn't exactly how I saw myself using this blog, but hey, why not use it for whatever I want?



From Medscape Nurses > Ask the Experts
http://www.medscape.com/viewarticle/711157?src=mp&spon=30&uac=129409ER
Are Bioidentical Hormones Safe?
Susan J. Wysocki, RN-C, NP, FAANP
Published: 11/02/2009

Question

Many patients ask me to prescribe compounded hormones, which they believe are safer. Some bring in saliva test results, and complicated charts and graphs with a suggested prescription attached. How should I respond?

Response from Susan J. Wysocki, RNC, NP, FAANP
President and CEO, National Association of Nurse Practitioners in Women's Health, Washington, DC

There is no evidence that so-called bioidentical hormones compounded in a pharmacy are safer than other hormone products. Furthermore, unlike insulin or thyroid hormone, female hormones cannot be titrated to customize a formula for an individual woman.[1] Female hormone levels are very dynamic and no single measurement can capture what the hormone levels might be the next day or even later on the same day. In some circumstances, blood levels may help a clinician understand why a woman might not be responding to therapy.[1] Overall, however, the woman herself is her own best "bioassay" for determining whether she needs hormonal therapy or when the dosage should be adjusted. Listening to her describe her menopausal symptoms and how well she has responded to therapy gives the clinician the best idea of what is going on in the target tissues.

In January of 2008 the FDA sent warnings to a number of large compounders of bioidentical hormone replacement therapy (BHRT) products, expressing concern about these manufacturers' claims about the safety, effectiveness, and superiority of their products. In that same memo, the US Food and Drug Administration (FDA) warned about the use of estriol, a weak estrogen that has not been approved by the FDA for use in any product.[2] Nevertheless, countless Websites, celebrities, other individuals, and pharmacies continue to make claims about BHRT. The FDA considers the term BHRT a marketing term.

Saliva tests are not a valid measure of female hormone levels. Female hormones that are found in saliva do not reflect what might be going on in the target tissues -- including the brain, the bones, etc.[2] It is in my opinion that these tests and products are a waste of money that would be better spent on something like a massage. Again, listening to a woman and what she says about her symptoms is the best way to "titrate" female hormones.

There are several issues about which clinicians should be aware. First of all, compounded products do not come with the class labeling that is mandated for any other menopausal hormone product, including warnings, black box, and other information. The absence of this label places on clinicians the burden of describing to the patient and documenting all these warnings. Second, there is no guarantee of the contents or purity of the compounded products. There is not enough oversight by the FDA to inspect all compounding pharmacies to determine if their products contain what they claim to contain.

Overall, there are no studies that demonstrate the superiority of any hormone product over another -- compounded or not. The labels for all FDA- approved menopausal hormones are the same. There are some intriguing data from a case-controlled study of transdermal estrogens (not a compounded product) that suggest that there are fewer associated risks for blood clots even among women who are at higher risk for blood clots.[3] The results are biologically plausible because of the lack of first-pass liver effect. However, as intriguing as these data are, I caution clinicians about making any absolute statements about the safety of transdermals. We need more data.

A wide variety of FDA-approved products is available to American women. These include oral forms, various transdermal forms, and a systemic vaginal ring. A wide range of doses is available. Many products fit the definition of bioidentical as used by the compounding pharmacies. Most of these products are covered by insurance. Compounding is very legitimate when a patient cannot take or tolerate FDA-approved medicines.

Ultimately, the clinician's job is to help the menopausal woman ameliorate her symptoms, feel well, and have a good quality of life. The current range of FDA- approved options meets the needs of most women. Compounding claims have been a marketing ploy to seduce women and clinicians into taking or prescribing something for which the evidence of benefit is lacking.

A Welcoming Counsel.

For starters: this is my first blog, so thanks for reading.

I'm not really sure how these things are supposed to work, so I plan on just writing about all things Pharmacy and Pharmacist...and maybe even things that aren't really.

For those who haven't thought much about the profession of pharmacy, it's probably time you did. We all know you've been into a pharmacy at some point or another - even if you sell out and go to Wal-Mart, Shoppers Drug Mart, or large grocery stores for your pharmacy-related stuff, you still have been to a pharmacy. (Don't even get me started on the negative effect Shoppers Drug Mart has on the profession of pharmacy - that will come soon). And even if you just grabbed cough syrup, eye drops, or picked up your grandmother's prescriptions, you probably have noticed the common theme in these pharmacies - the pharmacy counter. And if you have been unlike the typical consumer, you may have even looked past the busy dispensary counter and seen a head or two bobbing around frantically from phone to counter and back to the phone. Somewhere back there, amidst all that seemingly organized chaos, there is a pharmacist.

We are primary healthcare professionals. We have all been to University for a 4 year pharmacy degree - and in most cases, we also earned another bachelor degree prior to entering pharmacy school. Myself, I have 2 university degrees over 7 years.

Why start a blog now? Well, why not? People blog about anything and everything. I have lots to say and the people close to me just can't handle listening to it anymore. So this is more of a vice in letting me discuss my thoughts, frustrations, and whatever with whoever chooses to listen.

Things may get nasty. I may even divulge some of the industries best kept secrets. Like what really happens if a pill falls on the floor? Or, is the pharmacist judging you for having gonorrhea? The answer to that second question, is probably yes, by the way.

Stay tuned...I will try and be regular...like Mr. Oldman thanks to the stool softener I gave him last week.

Have a nice day.