California Pharmacy Labeling Law Rejection

The Los Angeles Times reports on a rejection of a pharmacy labeling rule in California. The pharmacy board was set to vote for new labeling rules for prescriptions until Governor Schwarzenegger appointed a CVS executive to the board the day before the vote but left three other spots vacant. The rule was defeated in a 5-4 vote.

Not only did CVS oppose the vote but so did one of Governor Schwarzenegger's largest campaign contributors- the California Retailers Association. The Association has contributed over $400,000 to his political committees.

What are your thoughts on this?

Early Education Changes

As changes to education standards are considered, I have a couple suggestions.

First, children should be taught how to think from an early age. If children know how to think, they can learn anything easier. Theories of logic, deductive reasoning and inductive reasoning are applicable across all subjects.

Second, in addition to practical finances, students need to learn practical probability and statistics. This will make them smarter with their finances, better citizens and lead to smarter medical decisions. Casino patrons will have a better idea that their chance of winning is slim. Voters will better understand political polls and concepts such as loaded questions leading to desired answers. Even medical decisions, such as new drug choices, will be affected because patients will understand studies regarding the effectiveness of new drugs.

Time for Change for Performance Enhancing Drugs?

Is it time for a new look at performance enhancing drugs? Should we make the drugs legal through prescription?

Look at any bodybuilding forum online and it is clear that their availability is widespread. If an athlete wants to use the drugs, he/she can. Their level of knowledge is quite impressive. Users combine multiple drugs to achieve the benefits while counteracting the side effects. Yet the manufacturing of the drugs can be suspect and their safety should be questioned.

But this knowledge comes from others’ trial and error and locker room talk. It would be safer for knowledgeable physicians to prescribe performance enhancing drugs. Physicians and pharmacists can monitor the long-term effects and ensure a safer supply of drugs.

I see performance enhancing drugs being especially important for motivating people to exercise. Why should we prescribe drugs like Lipitor to lower cholesterol but not prescribe drugs that will help and encourage people to exercise? The drugs can help people achieve and see results faster and encourage them to continue exercising.

Atypical Antipsychotics MOA

Do any of the physicians or pharmacists out there know the mechanism of action that causes weight gain in patients taking atypical antipsychotics?

Please let me know.

I would be interested in looking at the MOA and what suggestions this might hold for weight gain. Conversely, can we learn anything more about weight loss from the MOA?

Technology in Health Care

The Nashville Business Journal reports on a talk that Steve Ballmer gave at the Nashville Health Care Council. The main point of his speech was the distance that health care has to go to catch-up to technology. Yet, it is an area which can benefit extensively from improvements in health care.

“I’m optimistic. The money is coming. The national debate has been engaged. And now is the time where our industry may be able to step up with some enabling factors and make an even bigger difference,” Ballmer said.

It is amazing that health care technology seems to lag so far behind other sectors, yet technology offers so much that can improve our profession to improve patient safety and health. It can even allow us more time to interact with patients. After all, that is what we went into practice for.

Ohio Prescription Database Fight

According to the Cleveland Plain Dealer, the Buckeye State Sheriffs' Association is working with the Ohio State Board of Pharmacy to write a law requiring doctors, nurses, dentists and others who write prescriptions for narcotic pain killers to consult a database. This is meant to prevent patient drug abuse.

According to the paper, Ohio would be the second state after Nevada to have this requirement.

However, doctor groups are expected to oppose this law because it adds another requirement.

Jeff Smith, director of government relations at the Ohio State Medical Association, said the group would likely oppose any mandate on doctors forcing them to check a database for prescriptions.

"We're not ready to agree to that kind of administrative burden on the Ohio physicians," Smith said, adding that it would hit doctors at a time when they are seeing more patients and implementing their own electronic medical records.

Doctors receive training on what to look for and how to evaluate potential patients who are doctor shopping for dangerous pain medications, Smith said.

However, he said, the statewide doctor's association is willing to work with the pharmacy board to understand why physicians aren't already voluntarily participating.

What are your thoughts on this? It often is the pharmacist who is required to verify that patients are not doctor shopping and abusing prescriptions. This bill attacks the problem from another angle. Is it more effective this way or through pharmacies?

Medical Cost Database

A state representative in Colorado is pushing a bill to create a state medical cost database. Basically, this would allow for transparancy into medical costs at various locations across the state.

The database systems combine information from all patients, whether they paid through private health insurance, Medicaid or out of their pockets.

Kefalas said he'd like to see Colorado's system track the cost of various episodes of care and compare them to similar situations in other parts of the state.

This is a good idea to help illuminate some of our medical care costs and perhaps a step in the right direction to lower them.

Healthcare Reform Benefit

One of the greatest benefits that a true healthcare reform act can have is to prevent "job lock". This happens when employees fear leaving their employer to begin their own businesses because the employee fears losing health care.

But the opportunity cost of sticking around a larger company for the coverage can be steep. Job lock costs U.S. workers an estimated $3.7 billion every year in foregone wages, according to a 2009 report from the White House Council of Economic Advisers.

Imagine if we had true universal healthcare. The entrepreneurs in our society would have the freedom to pursue their dreams and reinvigorate business with new companies and ideas because they would not have to fear losing their healthcare.

FTC Ban on 'Pay to Delay'?

According to the USA Today, the FTC wants to ban drug companies from paying to delay generic alternatives.

Agency officials estimate the deals cost American consumers $3.5 billion per year in unnecessarily high drug prices.

The FTC advocates making this ban in the healthcare reform bills being negotiated.

Disturbing Quote

From the Seattle Post Intelligencer, this is a disturbing quote from a pharmacy robber:

A 14-time felon has been charged with robbing the Maple Leaf Pharmacy and the Ballard Walgreens with an illegally possessed handgun, and is suspected of robbing the Reckless Video in Maple Leaf last month.

Jacob Harley Shook, 29, was released from the Monroe prison about six weeks ago, and told a friend he met there "robbing pharmacies for OxyContin is the only way to go," according to court documents.

More Outsourcing

Walgreens and Genpact have reached agreement to have Genpact provide accounting service. Genpact is a business outsourcing company. Note where there company has centers. According to their website, "We strive to be the first mover in a location to corner talent and set industry standards. We eagerly adopt Tier-2 cities to expand the talent pool, while maintaining price advantage for our clients." In other words, they look to be "the first mover" to take advantage of cheap workers.

This is another sellout of jobs overseas when our economy needs it least.

South Dakota Database

South Dakota is taking steps to implement a database to prevent doctor shopping. With the economic problems, questions remain whether the project could receive long-term funding. Additionally, it remains to be seen which government agency would supervise the database. The Attorney General is a supporter-

Attorney General Marty Jackley doesn't see money as a problem. Federal grants are available for start-up, and a pool of money from legal settlements can pay the bills for as long as 10 years before the state would need to look for more federal money or increase fees or taxes to maintain the database.

What are your thoughts on these systems? Have you as a pharmacist been subjected to increased burdens and problems?

Asian Carp Invasion

I hope people have been following the ominous progress of Asian Carp towards the Great Lakes. We must do more to prevent invasive species from invading the Great Lakes. Not only do they ruin local ecosystems, but they cause BILLIONS of dollars in damages.

Zebra mussels and other invasive species have already taken hold, but we can still prevent the Asian Carp from ruining our precious resources.

FDA Scam

Multiple sources are reporting on a scam being run by individuals calling people posing as the FDA. The scammer tells individuals that they are violating law by purchasing their medicine from outside the country. If the individual doesn't pay, they will be punished. This leads to individuals paying thousands of dollars to the scammer out of fear.

Helping to prevent innocent people from being scammed is another reason for strong community pharmacists. A strong pharmacist-patient relationship is more valuable than a few dollars saved from buying questionable drugs from online.

Extortionists posing as federal agents have taken as much as $31,000 from frightened people who thought they would be prosecuted for purchasing their medications from outside the country, federal regulators say.

Nevada Supreme Court Case

I've discussed this case previously on the blog, but the Nevada Supreme Court rendered a decision in Walmart v. Sanchez. This decision has a positive outcome for pharmacists.

The Nevada Supreme Court has ruled that pharmacies are not liable for the actions of their customers when those medicated patients cause harm to third parties. The much-anticipated ruling comes in a case filed against Wal-Mart and other local pharmacies involving a Las Vegas woman who killed one person and injured another while driving under the influence of prescription drugs.

Happy Holidays and Happy New Years

I hope everyone enjoyed the holidays and had a wonderful New Year. Look for more activity on the blog now that the holidays are over.

Data Mining

Two Democratic Senators are attempting to end data mining of prescription records in order to prevent excessive influence from drug companies into prescription writing by physicians.

The amendment to the Senate health care bill would effectively ban pharmaceutical data mining, the drug company practice of buying prescription records to target sales pitches to doctors.

Sens. Herb Kohl of Wisconsin and Dick Durbin of Illinois say the measure will combat "harassing sales practices" and "restrain undue influence" of pharmaceutical salespersons.

Crime Prevention

The National Community Pharmacists Association and RxPatrol have released a short video to train pharmacy staff about "some of the pharmacy crimes occurring across the country. It also details low-cost measures to protect pharmacies and explains the steps to take if a robbery or other crime occurs."

The video is on RxPatrol's website and can be directly accessed here.

High Regard

Gallup does annual polling on Honesty and Ethics of Professions.

Can you guess the top three spots?

Nurses, Pharmacists and Medical Doctors are the top professions believed to have high ethics.

Great news for health care professions and a sign that your opinion is valued. Use it wisely.

Uh Oh

Bad news out of Pittsburgh. This article addresses an automated system to fill prescriptions. The writer questions whether robotic systems should be adopted to cut costs and possible lawsuits.

Where do the savings come from? Your job being cut.

Currently only three few hospitals in the United States have purchased and installed the one million dollar RIVA platform. Apparently, this long term investment pays itself out after two years by trimming a few lower level pharmacist jobs, reducing the number of medication errors and potential medical malpractice lawsuits, reducing wastes of doses and batches and avoiding disastrous cross contaminations of fluids.

Perhaps people need to read the articles from the LA Times to learn that a pharmacist does more than move pills from a bigger bottle into a smaller one.

Continuing Article

The LA Times carries several articles regarding the role of pharmacists in healthcare. Here is another.

Evidence shows that when clinical pharmacists collaborate with physicians, they improve health outcomes. And with their extensive knowledge of available drugs, pharmacists can help to save money by using the most cost-effective ones.

"Traditionally, pharmacists have not been seen as caregivers, says Dr. Paul Gregerson, chief medical officer for the institute. "But these days, they fill a gap that has been left in the current healthcare system where physicians are so rushed."

Underutilized Role of Pharmacists

The LA Times has an article describing the important, if underutilized, role that pharmacists can and should play in healthcare.

Physicians wholeheartedly agree about the importance of the pharmacist's role. "Pharmacists know more about medications than anybody else in the healthcare system," Gregerson says. "That's what they went to school for. . . . They're like walking encyclopedias."

Happy Thanksgiving!

I want to take the opportunity to wish everyone a Happy Thanksgiving. No matter what, we all have things to be thankful for.

Follow Up on Nevada Pharmacy Case

Here is a more recent article regarding Sanchez v. Wal Mart Stores et al. I posted an article from the Wall Street Journal earlier.

I was interviewed by USA Lawyer's Weekly regarding this case recently and I will post the article when it is online.

My thoughts on the defense are different. Rather than saying that this would be a burden on pharmacists and that not all pharmacies have Internet access, the focus should be on the woman. If the state had time to put her on a list of people suspected of doctor shopping, why couldn't the state bring charges against her? Target the offender, not the pharmacists.

How Does This Happen? Twice!

What is going on at these manufacturing centers to allow this type of contamination?

Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues.

The Food and Drug Administration said Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients.

Department of Justice Crackdown

The Department of Justice is warning drug companies that the DOJ is investigating them for corruption. The DOJ will be primarily focusing on foreign dealings.

The U.S. Justice Department plans to focus on prosecuting those in the pharmaceutical industry who try to bribe foreign officials for preferential treatment of their products, a senior official said on Thursday.

The department has been examining fraud and corruption in the healthcare system as part of the overall Obama administration drive to overhaul the system and reduce skyrocketing costs.

Another Wrinkle in the CVS-Caremark Story

The Wall Street Journal had an article in yesterday's paper reporting another wrinkle in the CVS-Caremark story.

Coventry Health, which is moving more than $1 billion a year worth of pharmacy-benefits-management business from CVS Caremark to a rival PBM, accuses the company of wrongfully paying hundreds of thousands of dollars or more in prescription drug claims.

The Coventry Health account is one of several "big client losses" amounting to a net $4.8 billion in erased business for next year that CVS Caremark discussed with investors last week. While investors already knew about some of the lost accounts, including Coventry, there were more than expected, and CVS stock swooned on renewed concerns about the company's hybrid drug retailer-PBM business model.

In a breach-of-contract lawsuit filed against CVS Caremark in September and moved to a U.S. district in Tennessee last month, Coventry alleges that Caremark incorrectly paid numerous drug claims to Coventry members that it should have denied.

Mississippi Court Ruling

Here is a story from Mississippi regarding Medicaid rates for pharmacists.

Mississippi Medicaid officials should have asked the Legislature for approval before tinkering with a law that would change reimbursements for pharmacists, the state Supreme Court has ruled.

The Supreme Court on Thursday upheld a chancery judge's ruling that the Division of Medicaid had no authority to change how pharmacists were paid to fill prescriptions for people enrolled in the program.

Justice Randy Pierce, writing Thursday for the Supreme Court, said while the courts usually bow to agencies on issues or rules and regulations, Medicaid officials acted outside their authority.

Compliment

I noticed this blog today. It praises my website. The blog is "dedicated to showing off the very best business law website designs from around the Country."

I welcome the compliment.

Speaking of my website, it is newly re-launched with new pages and some new layouts. I hope you like it.

Salary Discrimination

Some people have asked me whether employers can prevent you from disclosing your wages. The short answer is- No.

According to Michigan law, an employer cannot prevent you from disclosing your wages as a requirement of employment. Included is requiring you to sign a waiver denying your disclosure rights. Neither can an employer fire, punish or discriminate against advancement for employees who disclose their wages.

The importance of these rules is to prevent pay discrimination between employees based upon age, sex or race. In my most recent newsletter, I address a pay discrimination case out of Massachusetts. The woman involved in the case received a $2 million award because Walmart paid her less than her male colleagues.

Newsletter

For those who haven't received it, the newest Pencak Report is in the mail. You can also access it via PDF on my newly re-launched website.

If you are not on the mailing list for my newsletter, please send me an email at cpencak@pharmacylawpro.com with your name and address so that you can join the mailing list.

Sheepdogs Back on Duty

I was hoping that a Democratic President could change the culture of the executive agencies that had neglected their responsibilities to protect the public from predatory monopolistic corporations for more than eight years. I was beginning to lose hope. Then the following news was released.

CVS Caremark has come under criticism from various groups and lawmakers who have asked the FTC [Federal Trade Commission] to review the nearly $27 billion merger of a major drug-store chain and large pharmacy benefits manager that formed the company in March 2007.

In June, the FTC said it was referring to its Bureau of Competition a national independent pharmacists group's concerns that CVS Caremark's pharmacy-benefits-management operation, or PBM, had improperly shared patient information with the company's retail side to steer customers to CVS stores, to the detriment of competitors and customers.

The National Community Pharmacists Association called on the FTC to reopen the CVS Caremark merger, claiming the company engaged in anticompetitive behavior. State legislators and members of Congress this year also asked the FTC for a review.

In May, the National Legislative Association on Prescription Drug Prices, a nonprofit directed by state legislators, encouraged the FTC to open an investigation into CVS's acquisition of Caremark Rx "and the activities and conduct of the firm since the merger." The legislative group said CVS Caremark's conduct threatens to harm consumers by increasing prices and decreasing service and convenience.

While community pharmacists and lawmakers voice concerns that CVS Caremark has improperly wielded its power as a combined drug retailer and PBM, the company has had trouble keeping and winning PBM clients, a situation made clear Thursday as Chief Executive Tom Ryan said the company had some "big client losses" for 2010.

The client news sent CVS shares down nearly 21%, or $7.50, to $28.65, and left some Wall Street analysts questioning the company's retail-PBM business model.

Whether or not CVS Caremark is guilty of the allegations is to be determined. But I am greatly encouraged to see the FTC is back in the business of investigating violations of predatory corporate activities.

I has always struck me as inherently objectionable when a fox is allowed to guard a chicken, much less over the entire chicken coop. We citizens are essentially sheep at the mercy of large corporate wolves. It is a delight to see that sheepdogs are back.

HPRP Provider

I recently had lunch with Dr. Bruce Baker of West Brook Recovery Center in Grand Rapids—an HPRP provider. Dr. Baker is a fascinating person and genuinely cares about the best results for his patients and health professionals.

Dr. Baker told me about the increased usage of prescription drugs among high school students. Although illicit drug usage has fallen among high school students across the country, 15.4% of 12th graders have abused prescription drugs within the past year. The most popular drugs are Vicodin, amphetamines, tranquilizers and sedatives. The majority admit to obtaining the drugs from a friend or relative and only 20% admit to purchasing from a dealer or stranger.

Perhaps reminding patients to secure their prescription drugs at home as a routine part of your counseling may decrease availability of drugs to youth.

Lucrative Business Plan?

Veterinary drug filling could be a lucrative opportunity for pharmacies. If you wish to research this opportunity further, I would be happy to work with you.

Generic Tamiflu

An interesting scenario could unfold if the H1N1 outbreak worsens. NPR reports that the CDC is open to importing generic Tamiflu, named Antiflu, made in India. However, Tamiflu is under patent in the United States until 2016. Would the government override this patent if the outbreak worsens and Tamflu shortages persist?

Prescription Disposal

I know that the Wayne County Pharmacists Association has done some work to reach a solution to disposal of prescription drugs in Michigan. Here is an article about Iowa's new plans.

Pharmacy Liability Case

This blog post is from the Wall Street Journal. It addresses whether a pharmacy in Nevada is liable for the actions of a patient who abused pharmacy drugs. The pharmacies in the area were sent a letter warning them of this particular woman. Does this knowledge hold them liable?

A lawsuit filed by the victims and their families against Wal-Mart, who dispensed a painkiller prescription to Copening, asks whether drugstores must use information at their disposal to protect the public from potentially dangerous customers. In this case, state officials had sent letters to 14 pharmacies in the Las Vegas area warning that Copening could be abusing drugs.

Must Read from the Washington Post

As mentioned in my newsletter, this article is from the October 29, 2009 edition of the Washington Post. It is entitled, "DEA Crackdown Hurts Nursing Home Residents Who Need Pain Drugs".

Heightened efforts by the Drug Enforcement Administration to crack down on narcotics abuse are producing a troubling side effect by denying some hospice and elderly patients needed pain medication, according to two Senate Democrats and a coalition of pharmacists and geriatric experts.

Tougher enforcement of the Controlled Substances Act, which tightly restricts the distribution of pain medicines such as morphine and Percocet, is causing pharmacies to balk and is leading to delays in pain relief for those patients and seniors in long-term-care facilities, wrote Sens. Herb Kohl (D-Wis.) and Sheldon Whitehouse (D-R.I.).

The lawmakers wrote to Attorney General Eric H. Holder Jr. this month, urging that the Obama administration issue new directives to the DEA and support a possible legislative fix for the problem, which has bothered nursing home administrators and geriatric experts for years.

Alabama Supreme Court Case

In my upcoming newsletter, I address this Supreme Court case out of Alabama regarding the "learned intermediary" doctrine.

H1N1 Outbreak Tracking

Rhode Island is the first state to use electronic prescriptions to track outbreaks of the H1N1 virus.

"Surescripts is using information supplied by pharmacies to document how much Tamiflu and other antivirals are being dispensed to patients. The company is giving the data — categorized by zip codes of the pharmacies where the medicine is dispensed and the age group of the patient receiving it — to epidemiologists at the state health department."

American Pharmacy Educator Week

It is the inaugural American Pharmacy Educator Week. Celebrate the people that helped get you to where you are today.

DME

Here is a news story out of Montana regarding the official signing of the DME accreditation delay. I addressed this bill in a couple previous postings as well as my upcoming newsletter.

"Tester argued that the accreditation process can be expensive and time consuming for community pharmacies that are often the only option for seniors in rural communities. He also argued that accreditation is redundant, as pharmacies are already subject to oversight and regulation as medical professionals and as state-licensed businesses."

CVS GreenBag Tag

CVS is starting a program to reward users for turning down bags or using reusable bags. More information can be found here.

You know I'm in favor of moves that will protect trout habitats.

Prescriptions for OTC Decongestants?

As the meth problem continues, some communities are responding by requiring prescriptions for all medicines containing pseudophedrine. Oregon has a state-wide law and now a town in Missouri has passed a law locally requiring a prescription.

"The new law's critics include the Missouri Medical Association, Missouri Retailers Association and the Missouri Pharmacy Association. Many in the pharmacy industry say such laws will make it more difficult and expensive for those who are sick to get relief."

Donating Cancer Drugs

This is a helpful development for those who cannot afford cancer drugs.

Here is a link to Michigan's guidelines for its Cancer Drug Repository.

Continued Fight against Meth

The news lately is filled with communities and states trying to fight meth through tracking pseudophedrine purchases. It seems like it won't be long until a stricter federal law is enacted.

In August, Democratic Sen. Ron Wyden of Oregon drafted federal legislation calling for a nationwide prescription mandate for pseudoephedrine; he said he planned to introduce it this year. The White House Office of National Drug Control Policy, which establishes policies and priorities for drug-control programs, is examining Oregon's law, though it hasn't taken a position on it.

A Bill Threatening Wisconsin's Pharmacists

Here is another example of "big box pharmacies" driving independent pharmacists out of business. Obviously the "big box pharmacies" receive more income from other sales and can afford to sell prescriptions for lower prices.

Newsletter Announcement

I know it has been delayed, but the Fall 2009 newsletter is almost finished. It is in the final editing stages and will be going to the printer later this week.

We will also be posting an electronic PDF on my website soon so you can read it there too.

I hope you enjoy it as much as I've enjoyed writing it.

Georgia Pharmacy Audit Bill of Rights

Here are a couple links to the Georgia Pharmacy Audit Bill of Rights. I discuss the importance of this bill as an initial step in my latest newsletter.

Here is a link to a website with the text of the bill.

Here is a link to a savable or printable version of the bill.

A Fine Editorial

From the Hartford Courant, comes this editorial by Pharmacist Robert Bradley.

"Anyone who values having the option of going to a local independent pharmacy and dealing with a pharmacist who knows you personally and has the time to discuss your prescription needs should contact their state legislators and the governor's office and ask them to support small pharmacies by reconsidering this new state law on self-insurance."

And First off the Line is...Iowa

Iowa is making great strides in converting to electronic prescriptions.

"Iowa's largest integrated health care system and the nation's largest provider of electronic prescribing software today announced the launch of an initiative to convert a majority of the state's physicians from paper prescriptions- known to be the cause of costly medical errors- to electronic prescribing."

Liberty is not a Popularity Contest

This is a frightening precedent for civil liberties.

I have to agree with dissenting Judge Karen Nelson Moore, who wrote,

"I cannot think of any other circumstances where we have endorsed an invasion of a person's privacy with so few facts from which to draw an inference that the intrusion would likely uncover evidence of a crime."

U.S. District Judge Janet Neff wrote,

"There is no such things as a fair-weather Constitution, one which offers the harbor of its protections against reasonable search and seizure only in palatable contexts and only to worthy defendants."

Constitution liberties are not subject to popularity contests. Law enforcement has an innate tendency to expand its jurisdiction like a wildfire in the wind. Judges must be a firebreak to prevent harm and humans being consumed by that fire.

Judges must steel themselves against all-too-human, inner emotions and exercise mental discipline.

It is precisely where a defendant is unpopular or reviled that calm and levelheaded thinking in a judge is most required.

While this case involves the repugnance of child pornography, the law of this case will soon be applied to other searches for any alleged crimes. This holding is not limited to child pornography cases. Anything you ever searched is on a computer today.

Generic Replacements

The Alabama Attorney General has stepped in to prevent district attorney suits against CVS, Walgreen, Wal-Mart and Rite Aid. The attorneys allege that these pharmacies filled prescriptions with generic drugs, even when doctors did not specify the use of generics.

The district attorneys claim the Alabama AG is protecting big business and vow that voters will remember this in the next election.

"If that's the position he wants to take, good luck in the next election," said District Attorney Arthur Green of Jefferson County's Bessemer Division.

Follow H.R. 3663

You can follow the status of the DME Bill here.

Interesting Case

The Washington Post has an interesting story about World War II era war bonds. Several states have filed a suit against the Treasury Department seeking the repayment of war bonds. However, if the owners of relatives of these war bonds cannot be found, then the states stand to collect the money. This is interesting to the states in these difficult times.

The case should be an interesting Constitutional law issue.

Pro Bono Requirement

I see that the University of Michigan Law School is asking students to pledge to do at least 50 hours of pro bono work. Wayne State University and Cooley Law students volunteer their time also. I think the work done by the students will be an excellent asset to the community, especially in these difficult times.

DME Medicare Delay

For those concerned about the durable medical equipment accreditation Medicare deadline for pharmacies, a bill is awaiting signature by President Obama to push back the deadline until December 31, 2009. It has already been passed by the House and Senate.

"The Senate acted wisely to ensure seniors can continue purchasing essential medical supplies from their community pharmacies. Without it, thousands of independent community pharmacies would be forced to stop supplying diabetes testing supplies and other products to their patients." Bruce Roberts, National Community Pharmacists Association EVP and CEO

National Pharmacy Week

Remember that National Pharmacy Week is October 18-24 this year.

What will you do to celebrate your profession?

Lack of Updates

I apologize for a lack of updates lately, but I have been swamped at work recently.

However, I continue to work on the latest newsletter, changes to the website and another big project.

I look forward to sharing with you thoughts and the latest news on pharmacy law.

Health Care

When I graduated from WSU College of Pharmacy, I was skeptical of the HMO concept and, in particular, the promise that a health insurance company would actually try to maintain health under a capitation system. I figured the insurance company would try to provide as little service as possible to the patients and increase profit to the maximum. In the transpiring years, I have seen nothing to dissuade me from that viewpoint.

When I graduated, national health care was pejoratively called "socialized medicine" and was portrayed as "un-American", or at the very least, "French".

It did not take me too many years as a lawyer and pharmacist to see that the United States of America should have established national health care under a single-payer model 40-years ago, based upon the Medicare system or VA.

We are long overdue to have national health care and I am afraid that it may be too late, even now. The Senate, in particular, is owned by insurance companies and drug makers. We will hear a lot of canards and scare talk about single-payer and the problems it will cause, but it is clearly a smoke screen to preserve the tremendous profits made by insurance companies.

The biggest canard is the claim that in a single-payer system, government bureaucrats will make health care decisions for individuals. This contrasts with our current system in which an insurance employee makes health care decision for individuals- with profit maximizing in mind.

As a pharmacist, who would not agree that having one claim form and only one payer to deal with is infinitely preferable to applying for, being audited by and verifying coverage with 70 or more private insurance companies.

There is no free market anywhere on the planet and there never was. The reality of the matter is an individual citizen has no bargaining power versus an insurance company. Currently, we use private health insurance companies as middlemen, creating huge profit centers. Would it not be much less costly to use a government agency, such as Medicare, administering the system with employees who are paid a fixed salary?

I think this is an excellent time to start downsizing our military and intelligence expenditures and start spending it on health care for all of us. We have passed the point of diminishing returns on national defense. Currently, 21% of the national budget goes to the military-industrial complex. Yet, we are no safer and our perception of power is a drug that encourages Presidents to inject our forces into regions and problems that are insolvable by force and extremely expensive.

The Medicare system and VA system can be improved and they are capable of providing excellent administration for a single-payer national health care system. Will it happen? I honestly don't think it will, even though it makes total sense and is really needed. I think a watered-down and consequently doomed bill will pass. And then, the opponents to national health care will say they were right when the doomed plan fails.

I sure hope I am wrong about this prediction.

New Posting Soon

A quick note- I will post a new article shortly.

It will address some of my thoughts on the current health care debate.

Newsletter Sign Up

We are preparing the newsletter and preparing the delivery system for emailing it.

Just a reminder to send you name, address and email to cpencak@pharmacylawpro.com to receive a copy of the newsletter.

Newsletter Ideas

I am preparing a new newsletter to be ready in July.

Are there any topics that readers would like to see covered? Any new developments in pharmacy which you would like to see addressed?

If you have any ideas, please send me an email with it at cpencak@pharmacylawpro.com

Planning for the Future

I will probably speak more about this topic in my upcoming newsletter, but I want to remind everyone of the importance of planning for the future. We all work so hard to provide for our families. Yet, we don't spend the time to plan for the "What if?".

I urge everyone, especially pharmacists who might be "too busy for death", to spend some time and ensure your families future.

Newsletter

The office has been so busy lately and fly fishing season has arrived.

Nevertheless, I am working to put out a new newsletter for this summer. It will probably be distributed solely online through email and posted on my website.

Email me at cpencak@pharmacylawpro.com to ensure that you are included!

Updates to my Website are Coming

I am working on the language and design to update my website.

We hope the updates will improve the experience and use of the website to better serve you.

Foxes Guarding the Chicken Coop

My colleague Jesse Vivian wrote an interesting article, FDA Inspection of Foreign Drug Companies.

The article recounts the appalling failures of the FDA to protect the purity of foods and drugs we consume. I do differ with my friend, Dr. Vivian, when he states in his commentary:

What's going on here? Political pundits might take the low road to explain the situation. Dr. Woodcock works for Dr. von Eschenbach, who is a personal friend of President George W. Bush. President Bush reportedly does not like the idea of burdening members of the Pharmaceutical Research and Manufacturers of America (PhRMA) with additional costs and, of course, PhRMA opposes the legislation. That may be the skeptic's viewpoint. But there are two sides to every story. – Jesse Vivian

My Response to Vivian’s Commentary

The sole purpose of the FDA is to protect the public from unsafe food and drugs. That is why the agency was created. Remember Upton Sinclair’s book, The Jungle? The book told of the unsanitary conditions in the meat packing industry at the turn of the century. The public outcry led to the passage of acts to protect American consumers from reckless industry practices that poisoned our food and drugs. Who would think that today, toys for our children come from China with lead paint and heparin is purposely contaminated for profit? I am supposed to find this acceptable because big business profits?

Where, when and how did the FDA fail its mission? It can be traced to the Ronald Reagan administration and a now discredited philosophy that government is “the problem, not the solution” and big business not only can be trusted to police itself but can do everything better than the “public sector”.

We have lived long enough to see this naïve notion completely discredited by companies routinely poisoning consumers, cheating government and individuals by conspiring to overcharge for prescription drugs, exploiting home buyers with outrageous mortgages, usurious interest rates on credit cards and charging outrageous prices for gasoline.

The true “low road” is to fail to put the blame on those responsible. I hear cynics say both political parties are “the same”. I say that the Republican Party invented and implemented the concept of putting former industry lobbyists in charge of the very government agencies that are supposed to regulate the industries for your protection.

In short, President Bush handpicked foxes to guard all of our chicken coops. Now that most of the chickens are mysteriously missing, save for feathers on the ground, we are asked to believe the fat foxes had nothing to do with the missing chickens.

Announcement

Thank you to all who have sent contributions to Brent Pencak's campaign. The donations are greatly appreciated and be assured that every penny will be well spent well in pursuit of winning the election. As always, additional contributions are needed for signs and literature. Please donate what you can. The customary IRS Rules for campaign deductions apply. Checks can be made out to "Committee to Elect Brent Pencak" and sent to: PO Box 515, Richmond, MI 48062 If you are donating over $100.00 please include your occupation and business address. This is necessary for campaign finance laws. Contributions are limited to $500.00. His website can be found at http://pencak4mihouse.com

Big news soon! I am going to announce a new live seminar series on pharmacy law and practice that will be approved for continuing education. This will be unlike the boring and often impractical seminars that we have become accustomed to. In fact, I'm pretty excited about teaching this program.

The Solution

If you are like me, you have become disillusioned with the inability of pharmacy organizations and PACs to persuade the Michigan legislature to act in the interest of pharmacy and our own state economy.

Michigan State employees continue to receive their prescription medications from out-of-state mail order pharmacies. Our taxes pay for those prescriptions. Even more, it would be an economic boom to have Michigan pharmacies dispense those prescriptions to the Michigan State employees. You would be able to retain or hire new employees to process the flood of prescriptions. Your Michigan based pharmacy would pay taxes back into the system and this would create a cycle of self-perpetuating income.

There still is no law in the State of Michigan requiring mandatory lunch breaks for pharmacists who work incredibly long hours. There is ample empirical evidence to suggest that physically fatigued pharmacists are more likely to commit errors and this puts the public health at risk. This is a sufficient constitutional ground to enact such working condition legislation protection for pharmacists and the people of Michigan.

There are even more ideas I have that will advance pharmacists quality of life, prosperity, and to create more good jobs in Michigan.

As many of you are aware I have explored working within the MPA, forming a new pharmacy organization and other initiatives.

I am tired of waiting. We want change now. Do you realize that the only reason PACs ask for your money is simply to purchase time with our state legislators? That’s right, we are paying hundreds of thousands of dollars for a mere audience with people we elect that are supposed to serve the State’s interest and not their own. Yet, even as you write the check to the PAC, you know deep down inside, that the drug manufacturers and insurance companies and large employers write checks that dwarf your contribution into insignificance.

Does this mean we should quit the good fight? No, it means we have to do something different and effective. What is the plan?

My plan is to elect a Michigan Congressman who is incorruptible, highly intelligent with an excellent education and a thorough understanding of the issues holding back pharmacy and the economy in Michigan. A young man who recently graduated from the University of Michigan who majored in Political Science and minored in Philosophy and studied Arabic and German. A young man who as a child, read so many advanced books on the American Revolution, the Federalist Papers and our Constitutional system of government that he soon knew more than most college students about the principles of American Government. A young man who was taught by his father that the great strength of America is the strength of its middle class. His father taught him that the rich will always be able to protect themselves in any form of government but the middle class is always at risk.

It is with great pride that I introduce you to the man I hope will be the next Michigan Representative for the 81^st District, my son Brent Pencak. If pharmacists help Brent Pencak, you will not need to pay PACs to voice your needs. Brent already knows. Brent needs to win the primary in August

With your help, Brent Pencak will be your state representative with the power to introduce the legislation we have dreamed of for decades.

- Christopher Pencak

My name is Brent Pencak and I am running as a Democratic Candidate for State Representative of the 81^st District. A map of the 81^st District can be found here, and includes areas such as Marysville, St. Clair, Yale, Port Huron Township, Algonac, Marine City, and Clyde Township. My website is under construction, but I have a blog which can be found here- http://pencak4mihouse.blogspot.com/

I recently graduated from the University of Michigan with a degree in Political Science and I also studied courses in Philosophy, Arabic, and German. I was inspired to pursue public office because of my membership with a student-think tank, the Roosevelt Institution. We wrote and tried to implement our policy ideas, including hosting a regional conference addressing ways to reenergize the Midwest economy.

As the son of a pharmacist and lawyer, I recognize the unique challenges faced by pharmacists. Although I will be elected by members of my district, I will work to represent the interests of pharmacists across the state. As your representative, I will work as an advocate for the rights of pharmacists.

Some of the issues that I wish to focus on during my time in office:

Pharmacists, as professionals, should receive a mandatory, paid 30-minute minimum lunch break when working shifts of eight hours or longer. This policy will help ensure public safety through less fatigued and more focused pharmacists on the job. It will also increase retention rates, preventing mental and physical breakdown among overworked pharmacists.

Michigan state employees will be mandated to have their prescriptions filled in-state rather than through mail. To help ensure fair pricing, Michigan pharmacies will be allowed to price match out-of-state prices. This plan will keep businesses and employees in the state and result in more tax dollars staying in our state.

An embarrassing burden for pharmacists who have had their license sanctioned is having their name posted on a publicly viewable list on the Internet. This unnecessary shame should be resolved with a sunset provision requiring names be removed after 3 years.

I intend to work with the Board of Pharmacy to address these needs and future needs of pharmacists. For example, working with the Board, I want to encourage them to issue more declaratory rulings. A declaratory ruling is a binding decision to clarify issues. For example, many pharmacists invested in Internet pharmacies before knowing the legality. Wouldn’t it be great to receive judgments on legality before investing time and money? Increased cooperation between the Board and pharmacists can only help clarify rules and prevent future problems.

I recognize the needs of pharmacists not only as professionals, but as community leaders and economic anchors. In my Congressional district are many small towns and cities where often times the pharmacy is the economic center of town, serving the needs of the community year-round. Pharmacists still serve the traditional role as a respected community leader. Not only are consumers’ needs met, but pharmacies offer jobs for many in the community. The experience of working at a pharmacy encourages many to pursue a career in pharmacy.

Another focus of mine is protection of drinking water and the environment through mandated proper disposal of prescription drugs. Adverse affects on animals have been proven. Can adverse affects on humans be far behind? As the Great Lakes State, we have an increased reason for concern. Properly mandated disposal of prescription drugs can prevent further contamination of water.

Michigan’s primary will be on August 5, 2008 and the general election is November 4, 2008. Here is a link to the Michigan Voter Information Center with voter registration information.

I know that you might think that you cannot help or benefit from my campaign because you are not in my district. However, if I am elected, I will be representing the State of Michigan and will introduce bills to improve the entire state. Remember to spread the word to friends, other pharmacists, and pharmacist groups. This is the opportunity to create change for the entire state.

I will be grateful for any contribution that you can make for my campaign. Please make checks out to the “Committee to Elect Brent Pencak”. My address is:

PO Box 515
Richmond, MI 48062

Include your full name and address. Contributions are limited to $500.00. If you are making a contribution more than $100.0, please include your profession, employer, and business address. I apologize for the inconvenience, but it is required election law.

If you are interested in volunteering for the campaign, please email me at the address below.

If you have any questions or comments, please email at pencak4mihouse@gmail.com

Confidentiality Reminder

The LA Times had a recent article on the celebrity snooping scandal at the UCLA Medical Center. There have been 68 current and former workers implicated in this investigation, centering primarily on hospital staff searching the records of celebrities such as Britney Spears and Farrah Fawcett. One administrative specialist was indicted by a federal grand jury and is facing up to 10 years in prison.

Not only is snooping medical records a moral and ethical issue, but it is illegal. In the UCLA case, not only are the individuals facing punishment, but the State of California is looking at sanctioning the Medical Center. This serves as an important reminder to safeguard your records and computer systems and ensure employees are trained and reminded to follow privacy policies.

Big Money for Pharmacists

A settlement between CVS Caremark Corporation, the United States, and several states was approved by a Federal District Court in Northern Illinois. Between 1999 and 2006, CVS was alleged to substitute capsule of Ranitidine for tablets for Medicaid prescriptions, allowing them to evade the Federal Upper Limit pricing for Ranitidine tablets. This caused over-billing.

The settlement allowed CVS to deny wrongdoing or violation of state or federal law. The settlement sent $21 million to the federal government, $15.6 million to state plaintiffs, and $4.3 million to the qui tam relator, a part-time pharmacist of CVS.

I have experience in these cases and they can be very lucrative for persons who are aware of overbilling or other corporate fraud.

Expect a big announcement in the coming days.

Happy Memorial Day

I hope that everyone's holiday weekend was good and you enjoyed the weather.

We will be making several updates to the blog over the coming days, so I hope that you will watch for those.

Pencak Report Spring 2008 JUST PUBLISHED!!!

Pencak Report Summer 2007

Pencak Report Summer 2006

Pencak Report Summer 2005

Pencak Report Fall 2004

Pencak Report Summer 2004

Pencak Report Summer 2003

Pencak Report April 2002

Pharmacists Win

Here is the results of the case that I argued in front of the Court of Appeals-

The Majority Opinion

The Dissenting Opinion

Detroit Free Press Article

Here is a great article from Brian Dickerson of the Detroit Free Press dealing with insurance companies' control of the courts-

BRIAN DICKERSON: Fault lies with justices who pay back insurers
August 8, 2005
BY BRIAN DICKERSONFREE PRESS COLUMNIST

Michigan's shoreline may belong to the people. But its court system, and a majority of the state Supreme Court justices who oversee it, still belong to the insurance industry.
Late last month, even as it was upholding John Q. Public's right to walk the Great Lakes shoreline, Michigan's highest court handed insurance companies a license to defraud consumers.
The court's 4-3 ruling in Rory v. Continental Insurance commands renewed scrutiny of the way candidates for the appellate courts are financed.
Wouldn't it be more efficient, for instance, if insurance companies paid the justices' salaries directly? The companies would save the hassle of laundering payments through the soft-money campaign finance machine, and their water carriers in Lansing could dispense with the charade of judicial impartiality.
Shirley Rory, 53, and her elderly mother, Ethel Woods, both sustained neck and back injuries in a May 1998 car accident in Detroit. Fifteen months later -- well within the three-year time limit established by Michigan statute -- Rory and Woods sued Charlene Haynes, the driver of the other vehicle, for damages arising from their injuries.
The police report of the accident doesn't indicate whether either driver was insured. So it wasn't until several weeks after their lawsuit had been filed that Rory and Woods learned Haynes was driving bare.
Under Michigan's no-fault law, auto policyholders who carry uninsured motorists coverage can collect damages from their own insurance companies if an uninsured driver permanently injures them.
But in March 2000, when Rory filed an uninsured motorist claim against her insurer, Continental Insurance Co., the company balked, explaining that Rory's claim, though within the statutory time limit, was beyond the one-year time window her policy with Continental allowed.
For more than a century, Michigan courts have demanded that contractual limitations like the one contained in Rory's auto policy be reasonable. Everyone might agree that a 60-second time limit on uninsured motorist claims would be unreasonable. The question in Rory's case was whether the twelve-month limit in her auto policy made it practically impossible for her to collect on the uninsured motorist coverage she'd purchased.

A tradition of vigilance

In challenging Continental's refusal to pay, Rory had another venerable legal tradition on her side: the courts' long-standing distinction between negotiated contracts (like the one between Steve Yzerman and the Red Wings) and take-it-or-leave-it contracts like the ones most auto policyholders sign.
Michigan courts have long been skeptical of the latter, whose terms are typically skewed in the insurer's favor. Rory's lawyer, David Turfe, argued that a one-year time limit on uninsured motorist claims was unreasonable by any reckoning, because it provided too little time for policyholders like Rory to establish that their injuries were permanent or to discover that the other drivers were uninsured.
Under the heightened scrutiny to which one-sided form contracts were traditionally subjected, Turfe assured Rory a judge was certain to disallow the one-year time limit.
A Wayne County Circuit Court judge and three Michigan Court of Appeals judges agreed with Turfe's reasoning and ordered Continental to process Rory's uninsured motorist claim.
The one-year time limitation buried in Rory's policy, all four judges agreed, would effectively preclude most policyholders from collecting the coverage they had paid for, no matter how clearly an uninsured motorist was responsible for their injuries.
And that's where the matter stood -- until late last month, when four Republican Supreme Court justices whose re-election campaigns were heavily financed by insurance companies and other deep-pocket defendants turned decades of legal precedent on its head.
Before then-Gov. John Engler appointed him to the appellate bench in 1995, state Supreme Court Justice Robert P. Young Jr. served as general counsel to AAA Michigan, the state's largest auto insurer.
Since his elevation to the state's highest court, Young and three other justices appointed to the appellate bench by Engler -- Clifford Taylor, Maura Corrigan and Stephen Markman -- have collaborated in a series of 4-3 rulings whose combined effect has been to sharply curtail insurers' liability.
(Probably you've already noticed the resulting reduction in your auto policy premiums. Hahahahahaha!)
But the precedent-shattering principles enshrined in Rory v. Continental represent the Republican majority's most brazen assault yet on consumer rights.
"Unambiguous contracts, including insurance policies, are to be enforced as written," Young wrote in the court's majority opinion. "Judicial determinations of 'reasonableness' are an invalid basis upon which to refuse to enforce unambiguous contract provisions."
Elizabeth Weaver -- the only Republican justice to reach the appellate bench without Engler's sponsorship -- explained the significance of Young's ruling in one of three impassioned dissents.
In upholding the unreasonable one-year limit on claims, "the majority is eliminating over five decades of precedent that created specialized rules of interpretation and enforcement for insurance contracts," Weaver wrote.
Weaver's colleague, Justice Marilyn Kelly, was even more emphatic. "The burden of this rule is carried by the average individual who has little, if any, bargaining power when purchasing insurance," Kelly wrote. "The choice made by the majority regresses our judicial system by decades, if not centuries."
For consumers, the import of Rory's defeat is clear:
Read the small print. If you want a reasonable insurance contract, expect to pay an attorney several hundred dollars to scrutinize it.
Above all, don't look to Michigan's highest court for protection; it's already busy protecting somebody else.

Contact BRIAN DICKERSON at 248-351-3697 or dicker@freepress.com..

Here is the link to the article

Patient Safety and Quality Improvement Act

I just received this from the ASPL and wish to pass it on to you. Thanks to ASPL member Ed Rickert for writing the following-

This past Friday, July 29, President Bush signed into law the Patient Safety and Quality Improvement Act. The Act provides for the creation of Patient Safety Organizations, which will collect voluntary reports from providers, analyze the data and recommend steps to avoid future mistakes. The Act will cover medication errors, and includes pharmacies and pharmacists as providers. Most importantly, the Act provides that reports will be treated as privileged and confidential, and shall not be:

(1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(3) subject to disclosure pursuant to section 552 of title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.

The full text of the Act can be accessed at http://thomas.loc.gov/cgi-bin/query/C?c109:./temp/~c109qP5jwP. An analysis of the new law will be published in the next issue of RX Ipsa Loquitor.