Pharmacy Day on the Capitol in Arizona

The Details:
Pharmacy Day on the Capitl here in Arizona is coming up on Wednesday, January 25th. The main goal of this day is to give the profession of pharmacy a presence before those individuals who have influence in decisions made in the direction of our state.

It is a good idea to know who your legislators are prior to going to this event, since, it might be good to A) let them know you are coming and B) look for them there and let them know you are a voting member in their district and the issues you feel are most pressing to you (hopefully pharmacy has something to do with those issues).

If you heard last year, due to the US census data that came out, Arizona needs to redistrict the areas from where representatives are elected. There also was some not-so-nice political moves done to influence the outcome (more info. here and here), and the process is still being completed. That all being said, your representatives now might change, but still is good to know who they are.

To find your representative:

1. Go here
2. Enter your zip code in the bottom left hand corner
3. You will be shown a map with your district number, remember that
4. Next go here and find your one senate representative and your two house representatives.
5. Email, or even better call, your representatives and say "Hi, my name is ____________. You're my representative and I just wanted to let you know I will be outside the Senate/House on January 25th, next Wednesday from 10 AM to 2 PM, and I am excited to have you come out and let me show you the important benefits pharmacy can offer the state of Arizona, and how using pharmacists can alleviate some problems in the health-care issues you are facing. We can talk over lunch; we'll provide. Thank you so much and I look forward to seeing you."
6. Be ready to talk to your representatives about your passion for your profession. (You're spending at least $80,000 on it; you have to have some passion for it! Sorry, wrong section to say that in =P)

I will post information on what issues specifically the UoA will be talking about when I know which issues are considered most prominent.

My Feelings:
Pharmacy Day at the Capitol can be a very useful day. It gives some of us the first opportunity to get the nerve up to actually speak face-to-face with our legislators. This is government in the United States in action. Be a part of it; it is part of who you are being here. On the flip side, it can also become a pointless bit of show-and-tell, much like an elementary school science fair. The difference between the two is the passion you have for what you will do, not what you have done. Legislation is all about the future, as Mike Huckabee put it at the NCPA trade show in Nashville, it is about "aiming for the next bend." What you've done will demonstrate what you can do in the future, so use it as such. When you go to to Phoenix, have solidly in your mind the reason you are going into pharmacy. Yes, I think many of us want a good pay check and a stable career, but why did you choose pharmacy specifically, and what can you offer Arizona in the future? An personal and honest answer to that will make legislators sit up and listen, especially when they know you vote for them.

Making It Dot.pharmacy

The Details:
The Internet Corporation for Assigned Names and Numbers (ICANN), which is the international regulator of domain names on the Internet, is starting to accept applications to purchase new domain areas. Previously they limited the domains to .com, .edu, .net, .gov, and a few more, however; now they are opening it up to basically anything provided it is reviewed and found favorable.

More Information

My Feelings:
Its a new way of looking at the Internet. Previously you would have the entity's name followed by the suffix domain which described the entity. Now the suffix would be the entity. For big entities this is a boon, but for smaller entities this is a huge, near essential, resource purchase ($185,000 just to apply) that may never come to any use outside of simply protecting yourself. Does the pharmaceutical sphere as a whole buy that suffix? Who gets to control it then? Academia? Commercial pharmacy? Pharmacy Benefit Managers? Does one group buy it simply to stockpile it against another group? I don't know, but it seems to open up a concern for competition of that which is incredibly scarce, yet potentially useful in the increasing ubiquity of the Internet.

Drug Shortages, Retoric, and Super Committee Failure, Oh My!

The Details:
Most of what to report are big news items, but it might be good to bring them together to see how pharmacy may be impacted in the coming months.

First off, starting even last year, drug shortages continue. Debate continues over the reasons, and likely it is a combination of factors. One of those factors may be that as demand exceeds supply, regulations do not allow production to be increased at the same rate. The FDA sees the mass illegal production of medication and thus tightens its demands on all production. Coupled with this may be the 2003 Medicare drug law, which limits price increases on drugs to doctors and hospitals. This in turn makes it so producers have to make a profit by means of quantity, but if expansion is sluggish at best, it leads to a deficit in supply.

Being the huge problem that it is, it has been addressed politically on a number of fronts. On October 31, President Obama's We Can't Wait speech addressed the drug shortage issue by commanding the FDA to look into the problem and make any form of price gouging illegal. Congress also enacted two bills, similar in nature H.R. 2245 and S. 296 to also make it a federal directive to address drug shortages.

Great Britain is also having drug shortages seemingly because the US is importing more to meet its shortfalls.

Finally, from Thanksgiving week, we have found out the Super Committee failed to come to a budget deduction agreement. This would mean an across-the-board budget cuts for all areas of government spending. Given that healthcare is one of the governments biggest money expenditures, it is definitely going to impact pharmacy.

My Take:
Regarding the drug short fall, it still needs to be determined what exactly the issue is. If it is FDA stickiness, preventing expanding production, this would have to be an area looked at to be fixed. Obviously we want strict guidelines on medication, but if it is not improving medication quality and only increasing a burden on production, makes sense to relax it.

The President's speech and Congress bills are good, but really are easy political bandwagons, which may not really address the issue. I don't see these bills not passing.

The Super Committee failure may be unfortunate, but again, was probably the easiest move politically to do. It is easier to commit the crime of omission in politics, because then you blame the other guy. Sadly though this means both the more efficient and less efficient expenditures will be cut equally. And given that many talk about the $1.2 trillion the Super Committee looked at as not even being the $4 trillion that is needed, we're on the way for some rocky traveling.

113th NCPA Annual Convention and Trade Exposition Update

The 113th Annual National Community Pharmacists Association Convention and Trade Exposition was phenomenal. It was an excellent mix of learning and fun, with plenty of both. If you did not get an opportunity to attend this year, please keep it in mind for next year when the 114th will be in San Diego, CA.

As always with these events there is a lot of information on the morphology of pharmacy in politics. So without further ado, let us get to the updates:

The Obama Administration's stance on PBMs

In President Obama's Plan for Economic Growth and Deficit Reduction, on page 41, the President starts indicating that drug deal programs (both PBMs and pharmaceutical manufacturers) need to be audited to make sure the government is getting the savings that they are supposed to be getting. On page 43, the President implies that using current PBMs is not a very efficient means of saving money, and suggests the government negotiate directly for coverage of employees. (Plan for Economic Growth and Deficit Reduction)

My thoughts: While this is not a "slam dunk" against PBMs, it definitely shows that the hard questions which need to be asked are starting to be asked.

DME bill being kicked around by the "Super Committee"

The Diabetic Medical Equipment reimbursement through Medicare and Medicaid and how it will be done by competitive bidding and if independent pharmacies of size 10 stores or less will be exempt is currently part of the larger debate of how to cut costs which the congressional "super committee" is contemplating. For more information on the specifics of the DME issue, click here.

My thoughts: What is at issue here is access to diabetic equipment (test strips, testers, and lancets) from smaller pharmacies, since obviously the larger pharmaceutical chains will be able to bid lower being able to supplement losses by sheer volume of sales. Living in Arizona, our senator, Jon Kyl is on the super committee and while he is not seeking reelection, it does provide us with some say in what is going on.

To contact Jon Kyl, click here.

Continual push against mandatory mail order

The popular trend to save money in healthcare is the concept that if mail order medications can save money for some individuals, then it must be able to save money for everyone. Thus there is a trend toward making mail order medication mandatory in insurance plans. NCPA has continued to push against this, demonstrating that in many cases mandatory mail order actually costs the taxpaying public far more than it saves. NCPA information

My Thoughts: In some rare cases I could see mail order medication saving money, such as a pharmacist ordering his or her own medication (if they don't own their own pharmacy). The need to have a personal relationship with a pharmacist who will take your medication list seriously cannot be overstated. My mother is a good and experienced pediatrician; she and my father both get their medications via mail order since it does cost less, but even still she let's me review their medication to look for issues that might come up.

Continual push toward transparent MACs

Maximum Allowable Costs are the ceiling price that pharmacies can get back for the product they have allowed to be sold in their store. Under the current system, there can be multiple MACs for different situations and PBMs can change MACs without letting pharmacies know of the change until after the product has been sold and gone. The government has begun to get involved in solidifying and making MACs transparent under a new system called NADAC (more information).

Continual push toward PBM transparency

There appears to be some progress in this front given the latest push from the Federal government (more information). NCPA stance, click here

Push toward collective bargaining rights

The issue here is if independent pharmacies can join together against contracts where because an individual pharmacy is so "small" the larger insurance company (PBM) can make it a take-it-or-leave-it contract, where the pharmacy has no choice but to accept the terms because it would hurt its patients' options.

5 Star rating system

The Centers for Medicare and Medicaid Systems (CMS) is implementing a 5 star rating system for insurance plans in order to promote consumer health and information. (Sadly, Wikipedia has a good summary )

My Thoughts: While this star rating system might be good, given that it takes patient opinion into account, it does not seem to take pharmacy and pharmacist opinion into account (I'm also fuzzy on if they take doctor opinion into account). This seems to leave those professionals who know the system, know how it works and how it can be played out of the rating system.

Continual push toward pharmacists being reimbursed for professional time

This continues to be the aim of most pharmacy organizations. Medicine Therapy Management has helped push towards this goal, but there continues to be a long way to go.

Updates from DEA

The focus of the DEA right now is shutting down "pain clinics" specifically in Florida, where individuals are being prescribed abuse potential controlled substances in large and uncontrolled quantities. (more information) The DEA is also holding manufactures and distributors accountable for selling and shipping such large quantities of drugs when it should be clear from the volume it is intended for questionably legal purposes.

The DEA is also aware of and disturbed by the current trend in society in thinking that pharmaceuticals are safe and ok to take, specifically referencing drug parties, where social goers bring random pills to add to a "candy bowl." Also they see an alarming number of high profile deaths due to prescription drug over dose.

The DEA is also very disturbed by the concept of medical marijuana, specifically referring back to the trend in society, they see it as associating two concepts, medicine and illegal drug, which only further strengthens the current trend in society, which leads to dangerous results.

My Thoughts: I really have nothing to add to the DEA's stance.

Use of NPI in reimbursement

When submitting claims for reimbursement specific information needs to be on the claim in order for the pharmacy to receive its claim. The environment seems to be shifting towards the NPI, National Provider Identifier, being the main means of identifying the prescriber in the claim.

That was a large update. Thank you for taking time to educate yourself on what's going on in pharmacy and as always, keep sending me information you find so I can incorporate it.

Do Secret Deals Create Savings? Uh-huh...

The Details:
The US Government is beginning to tackle the need for PBM's to be more transparent in their negotiations, sales and rebates. The PBM's claim this transparency would not allow them to get special discounts to pass savings on to their customers. (More info.)

My Feelings:
Normally I don't like using expletives, but this is one of the biggest lines of (insert your choice of a colorful metaphor here) I have ever heard. Basic rules of supply and demand indicate that initially when the consumer does not know roughly where the intersection of the two curves are, the consumer usually overpays. The seller can undersell too, but let's be honest here, if you run a business which is driven by stock market pressures to increase stock price, you are going to do your own studies to know where the intersection could lie. Thus they can claim to give the "best price" but nobody can prove it. And if you cannot prove it, given stock market pressures, you're going to try to get as much money as possible, whatever the means. How quickly will people do something against the law if they know they will not get caught? Same principle.

Also, thinking who the biggest consumer is, the government, it means more tax dollars of ours being spent on a non-transparent system.

Aggravating.

Victory for Compounding

Background:
In 2009 a president of a Venezuelan Banking Association sent his team of polo horses to compete in the 2009 U.S. Open Polo Championships. While in the US, a veterinarian prescribed a supplement for the horses to prevent rhabdomyolysis (more info. here). The prescription contained an error, far too high of a dose (oral sources indicate the pharmacist called the veterinarian to verify the high dose and was told it was correct), the pharmacy compounded the prescription as stated and 21 horses died. (More details) The both the FDA and the Florida State Board of pharmacy investigated the compounding pharmacy, Franck's Lab, Inc., which had been compounding veterinarian medication for nearly 25 years. The Florida Board was content with its investigation, but the FDA continued to investigate the pharmacy, including bringing the lawsuit US vs. Franck's Lab, Inc. against the pharmacy and all compounding pharmacies in general.


Results:
On September 13th, Judge Timothy Corrigan of the US District Court for the Middle District of Florida has issued his ruling:

• The FDA does not have authority over compounded medications dispensed by a licensed pharmacy so long as the pharmacy’s activities are not manufacturing. That authority rests with individual state Boards of Pharmacy.
• Congress did not give FDA jurisdictional authority, when it enacted the Food, Drug and Cosmetics Act (FDCA) in 1938, to take enforcement action against a pharmacy that is engaged in traditional compounding practice.
• The FDA cannot use its Compliance Policy Guidelines (CPG) for veterinary compounding issued in 2003 as the basis for enforcement action.
• The regulations enacted by the FDA based on the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA) are in error. This legislation did not give FDA authority to prohibit the use of bulk active pharmaceutical ingredients APS) in veterinary compounding.
• The size and scope of a compounding pharmacy does not mean the pharmacy is a manufacturer.
• The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.

This ruling is a huge event for compounding pharmacies in that it sets the degree to how much the FDA can intervene in traditional compounding activities.

Medco-Express Scripts Too Big?

The background to this update is the acquisition of Medco Health Solutions Inc. by Express Scripts (more info.)

Both Medco and Express Scripts are large Pharmacy Benefit Managers (more info on PBMs) and the combined acquisition would result in a single PBM having a huge share of the market. This has led many to cite the merger as a monopolistic practice.

At the end of August, the Justice Department blocked a merger between AT&T and T-Mobile (video info here). Given the Justice Department's stance on this merger, some are wondering if it is a harbinger of their stances on other mergers which exist.(Cracking the Door)

A number of consumer advocacy groups are filing complaints against the merger, arguing that such a conglomeration would harm consumers. (More info.) Oddly enough NCPA is not one of the groups in this formal proposal.

Express Scripts is already taking the offensive and arguing that such a merger would not harm consumers/patients. (More info.)

My Feelings:
Coporations are under a tremendous amount of pressure to "knuckle under" to increase their bottom line. Basically: increase stock prices or investors will move to a different company. The larger you make a company, the higher the incentive is for the company either to perform ethically questionable activities to increase stock value or to throw its weight around to eliminate the competition, neither of which really helps patients or consumers. Given that the pharmaceutical development/distribution sphere is already highly convoluded and shrouded from public scrutiny, this only encourages larger companies to perform the above stated activites. Competition and economic destruction/creation is good, so long as the playing field remains transparent and balanced. If a few select companies get special privilages due to their size or political power, its the same as a sports team cheating in a game, and the referees looking the other way.