Pharmacy Law Notes

[All4MyDaughter]

PHARMACY LAW NOTES
VOL. 8 NO. 2
PETER P. COHRON, BSPHARM, JD
Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

Law Quiz: Accident Responsibility

Paul Pharmacist was on his way home after a shift. As he approached a four-way stop intersection, witnesses report that he slowed almost to a stop, then edged forward slowly. Witnesses thought he may have been watching a car coming up the road to his left at a fast rate of speed, wondering if
it was going to stop (lets call that driver Betty).

A car coming up behind Paul saw his brake lights go on then off, so that driver (who we will call Carl) presumed Paul was going on through the intersection and timed his braking to come to a stop at the intersection. But Paul did not speed up and go through the intersection, so Carl rear ended Paul, pushing Paul’s car out into the intersection. Betty indeed did not stop and broadsided Paul’s car, killing Paul.

In the ensuing lawsuits against Carl and Betty, both defendants claimed the other was the real cause of Paul’s death. Carl contended that Paul would have had minor, if any, injuries from being rear ended. Betty claimed that if Paul had not been rear ended, she would not have hit him and Paul would have suffered no injuries.

The law does hold that a tortfeasor is responsible only for the negligent damage that can be reasonably foreseen. What cannot be reasonably foreseen can have no liability attached to the party being negligent.

Do Betty and Carl get off?

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[All4MyDaughter]

When do workers compensation benefits begin? Terry Technician was at her pharmacy and was walking inside when she slipped on a piece of ice and broke her hip. She lost several weeks’ wages due to being laid up and incurred medical bills. When she applied for workers compensation, she was
denied as she “was not yet at work and the time was ten minutes before the start of her shift.”

There is no end to this story. Terry is awaiting a court to decide. Case histories have found state courts going both ways, often the case hinging on how far the employee was from the place of employment and, in some cases, the amount of time before the shift was to begin. Quite often,
being in an automobile on the way to work has been found to NOT be under the auspices of workers comp, though a minority see otherwise: the employee would not have been injured had he/she not been on the way to work. At the same time, several cases with fact situations like Terry’s, on
foot on the premises, have held that the injured employee was entitled to workers compensation.

It is a precept of almost every employer that employees be on-site and ready in all manners (dressed appropriately, in possession of needed tools or materials, etc) when their shifts begin. This does require the employee to be on-site before that time and to probably be engaged in some activity of preparation to work. What the courts lack is a definitive answer and this may be good; vagueness occasionally benefits the injured in that it forces the court to view the circumstances of that incident alone rather than be stuck in a written-in-stone formula. NOTE: almost all cases on this issue have to do with GOING TO work; almost NONE have to do with LEAVING FROM work.

 

[All4MyDaughter]

In 1994, Medicare expenditures for prescription drugs were $1.4 billion. In 2005, this grew to $10 billion.

Seven out of ten people who should have a Will (or some type of estate planning) do not. The common reason for not doing so is “I don’t have that much stuff.” My problem with that excuse is, having only a little stuff and having to go through intestate (no Will) probate in order to get it
is far more time-consuming and expensive. It is not how much stuff you have; it is whether you decide what happens to it or a court does.

The FDA estimates 1% of the US drug supply is counterfeit.

RN magazine reports that it is not a HIPAA violation to disclose PHI where nondisclosure could injure the patient.

Finasteride causes men to have lower PSA readings from 40 to 50 %.

Since 1983, approximately 1.5 million people have had adverse reactions to a herbal product.

In Virginia, pharmacy permits are not applied for nor granted to corporations like the big drug chains. The permit is granted to the PIC. If the PIC ceases to work for the company, the permit must be surrendered to the Board.

Americans spend $30 billion per year on weight loss products, yet two-thirds of Americans are still overweight.

 

[All4MyDaughter]

I get a lot of questions these days about cell phone usage near and at the pharmacy counter. I consider waiting on a customer using a cell phone as a privacy issue (not to mention whether or not you really have the patient’s attention). The pharmacist does not know who is on the other
end of the call. Counseling that patient while taking a call is unprofessional and any sense of privacy is voided.

And, even worse, what if there are two people at the counter and the person on the phone is not the patient being counseled? Patients can see a need for counseling, and may even recognize that counseling is occurring in a public forum, but patients also probably consider it the pharmacist’s
duty to minimize the amount of information other people hear. In short, the patient relies on the pharmacist to handle the cell phone privacy issue.

And yet even worse, what if a cell phone picks up a discussion between pharmacy staff that is confidential in nature?

Some stores have signs telling their customers to please end their cell phone calls before approaching the pharmacy counter. However, to avoid offending customers, most do not. I know of some pharmacists in two different chain pharmacies who were told to remove such signs.

Let me be clear. I think pharmacists should be pre-emptive on this and act. But the chain pharmacy argument not to take a step that could be offensive to customers prior to a real problem arising is a viable stance. My problem with the chain argument is that 1) something will happen and it might well be expensive, and 2) as stated above, my thought is that pharmacists should be
pro-active. Doing so only reinforces the high regard the public holds for us now.

 

[All4MyDaughter]

Betty and Carl commit separate acts of negligence that result in Paul Pharmacist’s death. Both contend that their single act of negligence was not the cause of Paul’s death and that the other’s act was not reasonably foreseeable. They move for dismissal.

The court does not allow the motion, though it acknowledges that no single act of negligence cause Paul’s death. The case goes to trial and the jury is instructed in comparative negligence. Under this doctrine, the jury can view the different acts of negligence and attribute a percent of the fault for the injury (here it was death) to each party based on how much the jury considers that party’s negligence led to the injury. Here, the jury found Betty 60% at fault, Carl 35% at fault, and Paul himself 5% at fault, the jury considering that Paul’s edging forward might have created the impression that he was about to cross the intersection and leave it open for Carl. Thus, if the jury award is $1 million, Betty must pay $600,000; Carl must pay $350,000; and Paul’s estate must pay (probably to itself so it is really a loss) of $50,000.

 

[All4MyDaughter]

PHARMACY LAW NOTES
VOL. 7 NO. 5
PETER P. COHRON, RPH, JD
Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

Law Quiz

Jack and Jill sell Hill’s Pharmacy to MNO Pharmacy, a retail chain. Both pharmacists sign non-compete contracts that state Jack and Jill cannot work in a pharmacy that direct or indirectly interferes with the operations of MNO for 2 years within a 2 mile radius. Jack goes to work only two blocks away from MNO at an institutional pharmacy that only does IV pharmaceuticals. Jill
retires and fulfills her lifelong dream of being a soda jerk at Sam’s Independent Pharmacy a block and a half from MNO.

Pharmacists Tom and Dick desire to leave Home Infusion Pharmacy, which only does IV nutrition, and go to work at IV RX, an institutional pharmacy four blocks away. All IV RX does is simple IV solutions like D5W, Lactated Ringer’s, Normal Saline, etc., as well as some IV narcotics. Home Infusion had Tom and Dick sign non-compete contracts.

Have any of the above pharmacists violated their non-compete contracts?

 

[All4MyDaughter]

John Patient has a prescription for Drug A, an analgesic controlled substance. Polly Pharmacist misfills the medication with Drug B, a benzodiazepine controlled substance. John takes the wrong medication and suffers injuries when his pain is unrelieved. John's estranged wife, Sarah, calls and asks Polly what the medication was that John got, telling Polly that John has taken drugs for his condition for over a year without ill effects. Polly discovers the error and tells Sarah of the misfill.

Sarah did not actually know that John was taking narcotics but was looking for dirt for their divorce hearing. Now that she knows of his analgesic use and that he has recently taken another controlled substance, she has her attorney demand a drug screen to show that John may be a drug addict and an unfit parent of their two children. The presiding judge for the divorce allows the drug screen request.

John sues Polly Pharmacist for the error and also for revealing Protected Health Information to Sarah, a HIPAA violation. John sues the hospital lab staff for drawing an illegal blood sample. Finally, John sues the presiding judge for inappropriate behavior and violating HIPAA.

Polly's attorney has Polly call John's prescriber for a copy of John prescription history. Before sending it, prescriber informs John, who amends his lawsuit against John to add in harassment and moves the court to deny Polly the history. The judge overrules John. When the history arrives, there are no controlled substances on it. Polly checks with prescriber who denies ever writing John any controlled substances.

As there is no confidentiality for illegal acts, attorneys for all the defendants (except the judge) move for dismissal and all the cases are granted this motion. Upon the evidence, the judge issues a warrant for John's arrest for obtaining controlled substances by fraud and possessing forged instruments.

But just when all the attorneys (except John's) are breathing a sigh of relief and preparing their bills, John's doctor rushes everyone back to court. He had looked at John Patent's chart, not John Patient's. John Patient's prescriptions for controlled substances are legal. Once the judge got his jaw off the floor, he reinstated all the civil cases.

Like all stories, even this convoluted tale comes to an end. The warrant for John's arrest is dropped. Attorneys argue that reinstatement of the cases is improper but the judge holds to his stance "in the best interests of justice." This is upheld on appeal. John prevails against Polly for the error and for the HIPAA violation in telling Sally about the error and the two drugs involved. As it was pursuant to a court order, Polly has no liability for giving his prescription history to Sally and the hospital is off the hook for drawing the blood.

In Kentucky, evidence of marital misconduct is not admissible in a divorce hearing. John argues that his drug use is legal and is therefore not marital misconduct. The judge holds that drug use is not considered part of marital misconduct. Since there are children involved, the judge states that while the drug history is "fruit of the poisonous tree" he is still going to consider the drug history under the "in the best interests of the child" standard as it may have a bearing on the safety and well-being of the children. As the "best interests of the child" doctrine is widely interpreted because of the important need to protect children of divorced parents, the judge is confident of not being overruled on appeal. But it will not be appealed, as the judge
quickly adds that John's health history shows a condition requiring the analgesics and thus child custody will not be determined based on John's prescriptions.

Finally, John (and his attorney) erred in suing a judge. Judges have immunity from lawsuit for their official acts. John should have reported his complaint to the Judge's Retirement Board, which oversees judges' discipline and citizen's complaints. John does not exercise this option after the judge's holding on his drug history.

 

[All4MyDaughter]

Refusal clauses are parts of laws enacted by 47 states so far that grant immunity from liability health care professionals who refuse on moral grounds to take part in procedures that result in abortion or end of life. Before pharmacists rely on these, they should note that few courts have upheld the clauses and most do not mention pharmacy or pharmacists.

“Oh, I have slipped the surly bonds of earth….” High Flight poet John Gillespie Magee was only 18 when he wrote this oft-cited line. He was killed a year later when his fighter crashed into the English Channel during World War II.

Twenty percent of prescriptions written in a doctor’s office are never filled. One of eight heart patients will, after a hospitalization, stop taking an essential medication within a month.

There is a “medical error” in GONE WITH THE WIND. Ashley Wilkes’s wife, Melanie, gets pregnant during Ashley’s leave after the Battle of Gettysburg, meaning that he was in Atlanta in either late July-early August of 1863. Melanie does not deliver until after the fall of Atlanta, in September 1864, thus making her pregnant for a term of about 14-15 months.

New drugs? Between 1998 and 2003, 487 “new” drugs came on the market. Actually, 32 contained new active ingredients. The rest were new combinations or strengths of existing drugs.

Antibiotic resistance is increasing at an alarming rate. Some infectious disease specialists predict that the majority of outpatient infections will require dual or triple therapy, two or three antibiotics prescribed and taken together, in the next five years. The percent of antibiotics being written that patients do not really need is still around 78%; just under 4 out of 5 antibiotic prescriptions are unnecessary.

 

[All4MyDaughter]

Jack did not violate his non-compete contract. An institutional pharmacy and a retail pharmacy do sufficiently different types of business that he will neither directly nor indirectly interfere with MNO’s operations.

Jill did violate. While she is now not a pharmacist, part of the sale of her pharmacy included her “goodwill,” her customers and her good relationship with them. It is possible, if not probable, that her customers could discover Jill working as a soda jerk at Sam’s. They could impute that if Sam’s was good enough for Jill to seek any kind of employment at Sam’s then Sam’s
should be the place for their prescriptions.

Tom and Dick also violated. The court reasoned that even if the two institutional pharmacies did separate activities, Tom and Dick would then be in an environment that possessed the equipment to easily and readily add in the activities Tom and Dick previously engaged in. Now, their new
employer would also have the employees who possess the knowledge to engage in those activities.

 

[All4MyDaughter]

PHARMACY LAW NOTES
VOL. 8 NO. 1
PETER P. COHRON, BSPHARM, JD
Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

Law Quiz

A patient comes up to a chain pharmacy prescription counter and requests a single large volume syringe and a long needle. The pharmacist asks the patient what the needle and syringe are to be used for. Patient replies that he has fluid on the knee and is going to use the needle and syringe to draw off the excess fluid.

Pharmacist calls me and expresses a concern over the “ethics” of selling the needle and syringe for this purpose. What do I say?

 

[All4MyDaughter]

Adverse Drug Events (ADEs) send elderly people to the ER almost as often as automobile accidents. Of the ADEs, one-third are caused by only three drugs: warfarin, digoxin, and insulin.

The Food and Drug Administration is expected to expand access to experimental medications for terminally ill patients later this year, but is resisting an attempt by a patient-advocacy group to make access to unapproved drugs a constitutional right.

The sixty day expiration date for C-II prescriptions in Kentucky does not preclude the practitioner from writing for a supply of 30 days, 90 days, or more. A Board inspector told a pharmacist I know that a year’s supply would probably be the most you should dispense.

Celery is a negative-caloric food. Eating celery requires more calories than there are in a stalk.

 

[All4MyDaughter]

The KASPER regulation has been modified. Data required by this regulation is now required to be transmitted within eight days of dispensing unless an extension is granted by CHS. A patient or the person picking up the prescription must disclose to the dispenser the patient’s Social Security number. The old provision allowing the use of 000-00-0000 is no longer an option.

 

[All4MyDaughter]

The environment for counseling is always an issue for the caring pharmacist who seeks to provide the maximum amount of pertinent information in the allowable time. While courts continue to haggle over the existence of a duty to counsel in the law, almost every jurisdiction holds to the concept that once counseling is initiated, the pharmacist has assumed a legal duty and must do all reasonable counseling.

One factor previously mentioned in PLN is counseling outside the pharmacy. A recent case, another in a long line, reiterates that counseling and the duty assumed exist outside the pharmacy when the person seeking the counseling is aware of the pharmacist’s professional status, has a reasonable knowledge of the pharmacist’s type of practice (retail, independent, institutional, consultant, etc), and the pharmacist provides the counseling.

One court recently held that a plaintiff seeking counseling could not prevail in a lawsuit when the plaintiff acknowledged that the pharmacist, replying to questions regarding the plaintiff’s retail prescription drug use, also included in his counseling a caveat that his knowledge of these drugs was limited because he was a hospital pharmacist. Another pharmacist was also not held liable for a “corner consult” when he professed to have not even heard of one of the drugs mentioned by the patient and that this lack of knowledge could influence his thinking in another direction, even though he gave counseling about those drugs he did have knowledge of.

The moral of the story is that when counseling, especially outside the pharmacy environment, recognize first that people seeking counseling give what you say the same emphasis as that heard at the pharmacy. Second, to protect against liability, provide some caveat or warning against full reliance on the counseling (I like to say “I’m not at the store with all my resources, where I would be better prepared to answer your questions.”)

 

[All4MyDaughter]

I tell pharmacist to refuse to sell the needle and syringe. I agree with the ethical dilemma but state that I am more concerned about possible civil and criminal liability. It is my thought that the act of selling these items to a person who is going to perform a medical procedure without benefit of a healthcare professional constitutes aiding and abetting the practice of medicine without a license.

Pharmacist is unsure, so I analogize: what if the patient had come up to the counter and stated that he had a fever, congestion, cough, and was expectorating greenish material. Would pharmacist provide patient with either an antibiotic or a prescription blank on which patient could write an order for an antibiotic? Pharmacist replies, “No.” In the question at hand, my worry is that the patient would hit a nerve, blood vessel, etc and really damage the leg, then suing the pharmacist for selling the needle in the first place. Is a jury going to be sympathetic to you? They may feel the person was stupid, but you even more so.

 

[All4MyDaughter]

PHARMACY LAW NOTES Vol. 8, No. 3
Peter P. Cohron, BSPharm, JD
Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

 

[All4MyDaughter]

The ongoing debate as to whether pharmacists have a duty to warn customers of the possible or probable common and clinically significant adverse effects of medicines goes on and on. New cases seem only to take muddy water and make it even more cloudy. The different states have their own versions of the federally mandated OBRA '90 which clearly state that pharmacists have this duty. Still, state courts where this law is in effect have, in a majority of opinions, held that pharmacists have no such duty. Most often, the courts rely on the informed intermediary doctrine (IID), which states that a party injured by a medicine may not sue the manufacturer of such medicine. Rather, so long as there is an informed intermediary between the manufacturer and ultimate consumer, the manufacturer is shielded from liability. The problem here is that, including Kentucky just a couple of years ago, courts stick with the original interpretation of the IID that the prescribing physician is the informed intermediary.

So, while there is a statutory basis for pharmacists to warn, two questions arise: first, which one, IID or OBRA, trumps the other?
And, second, if a pharmacist fails to counsel, does he or she have a liability shield in that the IID?

With the first question, the Alabama Supreme Court, in a case where the IID and that state's version of OBRA were in conflict, held that pharmacists have no duty to warn unless there existed a statutory requirement. And, as the saying goes, statutes trump court decisions. But the Alabama Supreme Court, after making this less than bold statement, refused here to say whether OBRA trumped IID. The court's reason for this hesitation is not explained in the opinion, but one can guess (perhaps not the best thing to do!) that one factor was the long history of the IID (decades) versus the relatively short one for OBRA (now in effect for about 14 years). This factor lends its credence to different courts longstanding reliance on and reluctance to surrender the sacred physician-patient relationship as a basis for decisions regarding health care cases.

With no judicial answer to this question, let us move on to the second one. Imagine a scenario where Joe Pharmacist offers to counsel, the offer is accepted and counseling is given though flawed. There is an omission of information that leads to the patient being injured. Can Joe claim that his error of omission is no more than harmless error as his counseling, of which really only an offer to counsel is required by law, was merely an add-on to the prescriber's counseling required under the IID? First, throw out Joe's mention that his legal requirement is merely to offer to counsel. Once that offer is accepted, Joe's duty is now as full as that of the prescriber's under the IID.

But, then look to the situation. Indeed, what counseling Joe is now providing could be interpreted as merely reinforcing what the prescriber has already said. Under the IID as interpreted by the courts, it is my legal opinion that Joe could be saved from liability if he can show that prescriber also was required by law to provide the same counseling. Thus, his omission should have been covered. Alternately, I also consider it viable that a patient accepting counseling could lose a case against a prescriber if said prescriber failed to mention a salient counseling point that was subsequently covered by the pharmacist.

My problem with this, professionally, is that pharmacy is again being relegated to being a secondary health care provider. All we are doing is backing up someone else, not providing a valuable service equal to other professionals; indeed, I can hear defense attorneys using those very words as part of their defense! While this may help pharmacists in lawsuits, it demeans the profession and places an obstacle in the way of an evolution that has seen pharmacy step out of the shadows and become a peer with all other healthcare professionals.

 

[All4MyDaughter]

A new case out of Rhode Island also complicates the waters on counseling. Lady Patient was prescribed metoclopramide for a gastrointestinal disorder. Over the next five years, the prescription was renewed over and over, though Lady Patient showed signs of tardive dyskinesia (TD) and tardive akesthesia (TA). Prescriber noted the symptoms in her chart but told the pharmacy to continue the medication, which it did. For some reason unrelated to the metoclopramide, Lady Patient changed pharmacies. Early on, the pharmacist saw the TD and TA symptoms. He called the prescriber, who told pharmacist to fill the prescription anyway. Pharmacist refused.

Ultimately, Lady Patient saw a specialist who diagnosed her condition, which unfortunately by this time was irreversible. She sued prescriber and the first pharmacy. On the second day of trial, pharmacy settled for an unknown amount. The trial continued and Lady Patient got an almost $3 million award from prescriber.

The court held that what the prescriber had done wrong was not so much ignoring symptoms known to be associated with metoclopramide, but that prescriber had not obtained informed consent from the patient for the duration of therapy prescribed (TD and TA are most often seen from long term use of metoclopramide). Informed consent from a patient to take a prescribed drug is universally accepted doctrine, but now a court is saying that after some nonspecific time period, a new informed consent must be obtained and it must consider not only the use of the drug but also what effects, good and adverse, there are from long term use.

Remember, pharmacy dropped out of the case on the second day. It chose not to fight the issue. In effect, what this says to pharmacists is that it is no longer enough to offer counseling on each new prescription or performing a drug utilization review for the last twelve months (the legal standard) may no longer be enough. A new factor in counseling may well now be recognizing the need to ask, "How long have you been on this medication?" and then reviewing the literature for possible adverse effects from an extended duration of therapy. What is not common and clinically significant with the first fill may become so a few years later.

 

[All4MyDaughter]

Handel is most often remembered for the great opera, MESSIAH. After the first performance, though, the composer turned ambivalent to the work and allowed almost every suggested change to be made for subsequent performances. It was a few years later that Handel saw the much different "perverted" version, through a fit, and only then moved to preserve this wonderful composition.

Most states now recognize the fourth year rotations of pharmacy school students as adequate for meeting all of the state Board of Pharmacy's required internship hours. A few states still require some hours be obtained outside these rotations, usually around 200 to 300.

Napoleon is said to have met his final defeat at Waterloo. And, indeed, it was his final defeat. However, many historians have long held that even had Napoleon won what the Duke of Wellington called "a near run thing," the French emperor had too few soldiers left to have carried out his plans to take Brussels. The Grand Armee fielded less than 80,000 troops at Waterloo, a fraction of the 150,000 to 200,000+ soldiers present in past campaigns. What decimated Napoleon's army and probably made victory impossible? The little studied but yet highly important battle of the day before Waterloo, a few miles south at a crossroads named Quatre Bras.

A startling percentage of Coumadin patients do not have an INR, or clotting time, check even once a year. The vast majority of these patients are under the care of a general practitioner, not a specialist. Usually, both patient and prescriber are in a rural setting.

 

[All4MyDaughter]

Alex Pharmacist called me several months ago. His employer was threatening to fire him and Alex wanted to know if he had any legal recourse.

I asked what problem Alex was having. Turned out that he had instituted a new policy with customers. Recognizing that these people were often tired, ill, mad, sad, and/or frustrated with their health and doctors and insurance companies and co-pays and waiting and and and …, Alex said he had no problem when a customer would employ the use of a curse (usually four letter) word. However, when the "cuss" words were aimed at the pharmacist or pharmacy employees, Alex drew the line. "You d—n people" and "son of a b---h" and other such aimed epithets got several customers invited to change their attitude or take their prescriptions elsewhere.

Some complained to Alex's pharmacy supervisor, who told Alex and staff not to "threaten" customers again. When Alex persisted, he was told to stop it or face termination.

Well, once again, Alex is employed in an "at-will" employment state, so his employer can fire him without stating any cause or reason for the termination. Employer will prevail in any lawsuit unless Alex is in some type of protected class and discrimination results due to his firing. People-not-wanting-to-be-cussed-out is not a protected class.

Alex is currently still employed and is still enforcing his new policy. Employer continues to threaten but has not fired him yet.

And I adopted Alex's policy. I like it, and I agree with it. Get mad or frustrated, but express your anger or emotion without aiming it at me or my staff. So far, three customers: two apologized and are still with me; the third went elsewhere.

 

[All4MyDaughter]

PHARMACY LAW NOTES​

​

VOL. 8 NO. 4​

​

PETER P. COHRON, BSPHARM, JD​

​

Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

When Damages Are Missing

John Doe was an orienteering fanatic. He loved to be dropped off in the middle of nowhere with a full backpack, a map and a compass, left on his own resources to find his way back to “civilization.” Almost a year ago, John was dropped off in the wilds of New Jersey. He did not show up at his pre-planned destination on the set date; indeed, John has never been seen or heard from again.

In trying to discover what may have happened to John, his parents went over his apartment with a fine tooth comb. There they discovered that John’s prescription bottle for his asthma medication had the wrong drug in it (John would remove enough medication for the estimated time for his hike, put it in a plastic baggy, and leave the bottle at home). Looking into this with John’s pharmacist, it also turned out that John had received tablets of lisinopril that resembled his asthma medication.

John’s parent sued on behalf of his estate and on their own behalf for loss of consortium, claiming that there were two possibilities: first, that John died of an asthma attack in the wilds where there were plenty of asthmatic triggers and/or, second, the lisinopril caused dizziness and/or disorientation that caused John to be unable to find his way out of the wilds. Pharmacy was the cause of John’s disappearance and likely death due to pharmacy’s negligence.

The pharmacy countered by admitting their mistake, conceding that the pharmacist had a duty to fill the prescription correctly and that the pharmacist did not do so. However, the pharmacy claimed that there was not enough evidence to show that its error was the cause of John’s disappearance. Further, pharmacy argued that since there was no live body or corpse, damages could not be established.

With pharmacy’s first claim, it is well established that the breach of the duty—here the incorrect filling of the prescription—must have sufficient evidence to show that it was the direct or proximate cause of the ensuing damages. Damages must be compensable, thus measurable to some degree. But how can damages be established where there is no injured or dead person?

Pharmacy moved for dismissal or summary judgment. The court denied both. In a civil suit, the burden on the plaintiff is the “more likely than not” standard, a much lower reliance than the criminal “beyond a reasonable doubt” standard. Despite a heavy burden, courts have held that the lack of a body, dead or alive, is no basis for dismissing a case. Further, the court held that whether the plaintiffs could show enough evidence as to meet these contested criteria for negligence was a matter of fact, not law, and thus needed to be heard by a jury.

Parents brought forward doctors who testified as to John’s health; their testimony left little doubt that John, except for his asthma, was in good enough health to go orienteering. The idea was to show the jury that only an aberration like a misfilled prescription would cause John to disappear. John’s parents and other people associated with John gave testimony as to his years of orienteering, his numerous successful treks, his teaching others, his safety measures, etc. The jury was being shown that it was not likely that John did something wrong to cause his own disappearance.

Jury found for the parents. NOTE: as mentioned above, the onus was on the parents to show pharmacy was negligent and that was a particularly heavy burden where there was no body. A review of such cases over several jurisdictions would likely show parents losing as many times, if not more, than they won.

Tidbits

Some reports estimate that the total retail value of professional samples dispensed annually exceeds $11 billion.

In a poll, the book most people would like to see made into a movie or TV mini-series that has never gone to either medium: Ayn Rand’s ATLAS SHRUGGED.

Demographics indicate that, on average, each prescriber supports about 26 pharmacies.

Got a new automobile? If so, and you have a flat tire, do not use Fix-A-Flat. Once this product is used on newer types of tires, especially SUV tires, the tire may be reparable but the tire cannot be properly balanced again.

The pharmaceutical companies allocate approximately 30% of revenues to promotion, marketing and administration while on spending 13% on research and development. Before this sounds too much like criticism, keep in mind that without the revenue produced due to promotion and marketing, there could be even less for R & D.

Dextromethorphan abuse is on the rise, and so is misuse among younger children by their parents. Studies continue to support the use of NO drugs for mild hayfever, allergy, or coughing problems in children.

Board Merry-Go-Round

Al Attorney, a lawyer in a western state, told me this story:

Irving the pharmacy intern was asked questions about a certain medication. Paula Patient listened but actually got skeptical about the advice. So when she got home she called another pharmacy, where the pharmacist was adamant that Paula got the wrong advice. Paula called a second pharmacy, and that pharmacist also told her Irving’s counseling was 100% in error. Upset, Paula called the Board of Pharmacy and reported Irving the intern.

The pharmacy inspector investigated. She determined that when Irving gave that bad advice, the pharmacist preceptor was way out in the parking lot of the shopping center gathering up shopping carts left by customers.

The inspector turned the matter over to the Board, who issued an Agreed Order stating that the pharmacist preceptor was in violation of pharmacy for being off the premises (the pharmacy was still open and engaged in the business of the pharmacy). Pharmacist preceptor’s AO called for a fine of $2500 and suspendion from the practice of pharmacy for ten days.

In an ensuing administrative hearing, pharmacist preceptor argued through Al that he was not off the premises. He contended that if a patient out in a car, who was incapable of walking, desired counseling, the Board would not punish him for going outside to perform such counseling. The Board agreed that it would not do so, if the car with the patient in it was parked reasonably close to the front door of the pharmacy. The Board explained that it decided pharmacist preceptor was off the premises in that he was more than 100 yards away from the building doing a job (collecting shopping carts) that distinctly was not a pharmacy-related business. The Board upheld its earlier punishment.

Al and pharmacist preceptor then met with Irving to discuss what the Board had done to him. Irving told the surprised gentlemen that he was not being punished. He produced a Board letter saying that Irving was not responsible for giving erroneous advice “when under the supervision of a pharmacist.”

Al immediately informed the Board that he was appealing pharmacist preceptor’s case. Before the higher court, Al argued that either pharmacist preceptor was on the premises or he was not. If he was not, as the Board claimed, then Irving was acting outside the scope of his delegable duties by counseling when there was no pharmacist on duty. As the Board had refused to punish Irving, even stating that he was under the supervision of pharmacist preceptor, then the latter had to have been on the premises when the bad counseling was given. Al concluded that the Board was trying to have its cake and eat it too, rather cliché ! but it worked. The court agreed and remanded pharmacist preceptor’s case back to the Board for “findings not inconsistent with our opinion.”

The Board refused to change pharmacist preceptor’s punishment. Instead, it decided to revisit Irving’s matter and hold him in violation of pharmacy law: acting as a licensed intern without pharmacist supervision.

Irving turned to Al, who vomited rage against the Board. As it was a quasi-judicial proceeding before an agency empowered to sanction persons for violations of the law, Al roared that Irving’s case could not be revisited as that would be in violation of double jeopardy (a person may not be tried twice for the same crime). Al promised to appeal again, this time on behalf of Irving. The Board relented and all charges against both Irving and pharmacist preceptor were dropped.

The moral of the story is to have an attorney present when the Board acts against a pharmacist. The Board, pharmacists and a citizen-at-large, were not lawyers and were able to produce inconsistent holdings, which a non-lawyer might have missed. And, yes, despite his win, pharmacist preceptor is having someone else collect errant shopping carts.


REQUEST: Are you or do you know a pharmacist who went to pharmacy school, then went into another field for a number of years before actually practicing? I am gathering data on pharmacists who “re-enter” the profession after an absence of a long period of time. Please have these people contact me.

 

[All4MyDaughter]

PHARMACY LAW NOTES
VOL. 9 NO. 2
PETER P. COHRON, BSPHARM, JD​

Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

Conditions of Inheritance

In 1930, Sam Pharmacist opened Sam’s Pharmacy. The business did real well and in 1955, Sam Jr took over. Then Sam III became the pharmacist/owner in 1985. The business continued to flourish and made a lot of money. Sadly, all the work exacted a horrible toll and Sam III died of a massive MI in 2006.

Sam III left three children, none of whom wanted to be pharmacists. Sally became a nurse, Sam IV became a lawyer, and Saul went into the United States Army, rising to the rank of major at the time of Sam III’s death.

Wanting the best for his children, and believing that only came with a proper education, Sam III had provided in his Last Will and Testament that all the accumulated money from Sam’s Pharmacy and the sale thereof be divided equally between those of his children who completed a college education. From this, Sally, with a BS in Nursing, and Sam IV, with a BA and JD, thought that the money would be split 50-50 between them. Sally and Sam IV both quit their jobs as they were too busy greedily rubbing their hands in wait.

Saul contested the Will. And the court agreed.

Wills may have conditions for taking under them, but the conditions must be acceptable to reasonable people. For instance, a requirement that children be married before taking under a Will is not considered reasonable, but a requirement that children be of a certain age is. Courts generally hold these conditions to three factors: the desires of the Testator (person whose Will it is), the reasonableness of the conditions, and fairness. Here, the court held that all three factors pushed a decision for a three-way split of the funds. First, Sam III’s desire indicated he wanted the best for his children. While the court saw Sam III’s indication that education was the manner for obtaining the best life, the court saw Saul’s service as more than analogous to a college education and his rank of major as adequate indication that Saul was successful in his chosen career. The court held that the college education requirement was unreasonable in light of Major Saul’s service, though did comment that this was not absolute—in other situations, the requirement might be upheld. Finally, in fairness, the court saw three children, not two, who had good and successful careers.

Specific Pharmacy

Can a prescriber determine which pharmacy a patient goes to for prescriptions? This question has been flying around as a bit of an addendum to the $4 per Rx question (can or should prescribers refer patients to $4 pharmacies?).

The answer, like the $4 question, is “No.” For a prescriber to refer or limit a patient to a specific pharmacy is illegal, even more so if the prescriber has a financial interest in the pharmacy.

However, like most laws and rules, there are some exceptions. Prescribers, especially pain treatment clinics, may demand a patient contract that limits the patient to filling their prescriptions at a specific pharmacy to allow better oversight of the patient’s use of medication. Still, even then the choice of the specific pharmacy should be left up to the patient.

Prescribers may refer patients to a certain pharmacy if, in the best knowledge of the prescriber, this is the only pharmacy that compounds a certain formula or stocks a certain expensive medicine. The prescriber should state that this is the only pharmacy that does this compounding to the best of his/her knowledge, avoiding an outright show of favoritism.

Finally, can a prescriber name a pharmacy that he/she does not want the patient to take their business to? Rarely. The only time I saw a prescriber not lose a lawsuit on this type of matter was when the prescriber was able to show a pattern of errors at that location.

Tidbits

Tennessee has joined other states in limiting the substitution from one generic manufacturer to another of an anti-epileptic drug. Both the patient and prescriber must receive advance notice. There is a drive to make this a national law.

The Civil War Battle of Shiloh in April, 1862, had more casualties than all those suffered during the American Revolutionary War.

Two-thirds of the human brain is fat.

The law requiring pharmacy technicians in Kentucky to register with the Board of Pharmacy has passed. The law does not require pharmacy technicians be certified.

The most prolific politician/authors: Prime Minister Winston Churchill and President Theodore Roosevelt.

The new issue many Boards of Pharmacy are facing: when does an inspector/investigator have a duty to inform a pharmacist that he/she is being investigated for violation of pharmacy law. Probably to be determined by a court, the crux of the issue is that inspectors are persons with police powers. At some point in an investigation, “regular” police officers determine there is sufficient evidence for an arrest; further questioning is then subject to the Miranda warning. With pharmacy inspectors, the question is whether, once the inspector has determined there is a violation of pharmacy law, there is a responsibility to state this to the affected pharmacist before continuing forward with further investigation/questioning.

 

[RxWildcat]

PHARMACY LAW NOTES​

VOL. 9 NO. 3​

PETER P. COHRON, BSPHARM, JD​

Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they please.

When the Pharmacist Gets Ill

My recent illness and diagnosis brought a few questions from colleagues aware of my problem who wanted guidance as to how to address a pharmacist suddenly falling ill at work. Two scenarios emerged. Readers should note that these are not actual circumstances and that state laws do vary in how some of the aspects of these scenarios should be handled. Kentucky law and my legal opinion are relied on here.

Paul Pharmacist becomes ill at work. The first issue should be, of course, getting immediate help for Paul if the illness and symptoms require. Then, the issue becomes whether or not pharmacy business may continue. Business may continue in any pharmacy when the pharmacist on duty is actually "on duty" or, as the law in Kentucky states, is "on the premises." If the pharmacist is not on the premises, pharmacy business must cease; all employees must leave the pharmacy; and the pharmacy area must be locked and secured.

Scenario No. 1: Paul is so sick that he cannot perform any pharmacist duties. While awaiting a replacement pharmacist, an intern verifies a prescription at Paul's request. The prescription has been misfilled and is dispensed without anyone catching the error.

Scenario No. 2: Paul is so sick that he cannot perform any pharmacist duties. While awaiting a replacement pharmacist, a technician dispenses a prescription filled and verified before Paul fell ill. The prescription has been misfilled and is dispensed without anyone catching the error.

It is my legal opinion that when a pharmacist is so ill that he cannot perform any pharmacist duties that he is no longer "on the premises." If he cannot perform professionally, the law applicable to a pharmacy without a pharmacist goes into effect. In Kentucky, this means that the pharmacy should be closed. Employees (excepting those providing care to the sick pharmacist) should leave the pharmacy and the pharmacy should be locked and secured. All pharmacy business should cease.

As to the scenarios, in No. 1, Paul is delegating a non-delegable duty—the final verification--to a non-pharmacist. As much as Paul may not want to send a patient elsewhere, the circumstances demand this. Paul and the intern share liability (the intern under the doctrine of contribution for not refusing to verify the prescription).

In No. 2, though the misfilled prescription was dispensed at a time when the pharmacy should not be conducting pharmacy business, some courts might find this to be "harmless error". The actual error had already passed through the verification process and would likely be dispensed without further investigation by a pharmacist. Paul may well escape liability under these circumstances in some jurisdictions.

In both scenarios, Paul Pharmacist would be subject to sanctions by his state board of pharmacy. Ditto for the intern in scenario no. 1.

Tidbits

Approximately 7,000 children under the age of 5 years are taken to the ER every year due to improper use of cough and cold medicines.

The anti-smoking drug Chantix may increase suicidal thoughts in people taking the drug. Anyone want to bet we'll be seeing TV commercials from lawyers wanting to sue the manufacturer by the time this PLN is sent out to you?

A poll of historians concluded that the primary cause of World War II in Europe was the 1919 Treaty of Versailles ending World War I and its harsh conditions laid upon Germany and its allies, conditions that would have been difficult to meet under any circumstances, but conditions impossible for Germany to meet in post-war Europe. The rise of Adolf Hitler was second.

Studies continue to conclude that the older now-generic anti-psychotic drugs do as much good as the newer more expensive medications.

Studies now suggest that an interaction between warfarin and glucosamine, the latter either used alone or taken together with chondroitin.

Attractive Nuisance

Kathy Pharmacist had worked for years and saved her money to the point that she decided to realize her dream of owning her own independent pharmacy. She did extensive research, finding a prime location in a large suburban area amid a number of residential properties and little competition. She set up and opened Kathy's Apothecary a few months later.

On Kathy's property, in the back away from the pharmacy and parking lot, was a large hole with crumbling concrete walls, the remnant of a swimming pool from years and years ago. Kathy immediately put up a six foot high chain link fence around the pool and chained and padlocked the only gate. Further, Kathy put four "No Trespassing" signs on the fence equidistant around the pool on the fence.

Nevertheless, three children aged 6, 7, and 8 years scaled the fence a few weeks later. One fell into the hole, where recent rains had accumulated several feet of water. The other children tried to help their friend, both ultimately falling into the hole also. The first child drowned before the combined screams attracted a passerby; the other two required medical care for injuries sustained in climbing over the fence and falling against the concrete wall of the former swimming pool.

All the parents sued.

Kathy, by and through counsel, argued at trial that Kathy was well aware of the potential harm that could come to people in the concreted hole and that is why she had taken more than adequate measures to keep people from access to that area on her property. The parents' lawyer countered by claiming that Kathy's measures were rather inadequate in that children had gotten into the swimming pool and one of them was now dead. The lawyer labeled the area as an attractive nuisance. An attractive nuisance is an area where harm may be reasonably expected if people—especially children--enter into it; thus, the children were so attracted to the idea of a hole and "playing and exploring" that they ignored the "No Trespassing" signs and climbed the fence. This is what children do, the lawyer claimed. A reasonable measure for Kathy would have been to fill in the hole fully and perhaps even paved over the top.

Kathy countered by asking what kind of parents let their children roam unattended in today's world, with all the other dangers that exist, such as child stealers, drugs, etc.

The jury held Kathy liable under the "attractive nuisance doctrine," many jurors in post-trial interviews stating that during deliberations they had considered antics of their own childhood. Their conclusion was that Kathy had not done enough to prevent harm to children. However, the same jury bought into Kathy's argument. Ultimately, Kathy was held 85% liable for the damages and death and the parents 15% liable. Kathy's insurance also threatened her with cancellation unless she filled in the hole, which she promptly did (a short time after, she also put up a large solid fence between her pharmacy and the area to block the view of that area).

 

[RxWildcat]

PHARMACY LAW NOTES​

VOL. 9 NO. 4​

PETER P. COHRON, BSPHARM, JD​

Pharmacy Law Notes is a result of my ongoing research into pharmacy law related issues. Readers are reminded that this is a general review and that the law is fluid; this is not legal advice; there is no final answer to any issue discussed herein. Readers are encouraged to respond with comments or constructive criticism, and are encouraged to forward this to whomever they desire.

Workplace punishment

I have hit on this topic once before but a new situation brings it back into the spotlight and it is worth going over again. The scenario is actually based on two situations amalgamated into one.

Pharmacist Sally, nearing the end of a hectic trying day, was at her counter waiting to offer counseling to a young woman holding an infant. This woman was talking to another young woman; it was obvious they had known each other in the past and were getting re-acquainted.

The first woman held up the infant and said, "You haven't even seen my check baby."

The second woman responded, "What a cute child! But what do you mean, ‘check baby'?"

The second woman answered, "The state was about to cut off my welfare check so I had a baby to keep it coming. So this is my check baby."

Here Sally growled, "Another welfare baby I have to pay for. Why didn't you practice birth control and get a job?"

Of course the first young woman demanded to see the store manager and reported this "insult." A few days later Sally's pharmacy supervisor showed up. First, Sally was to be suspended a week without pay; second, she had to attend counseling on being more sympathetic; and third, she was told to apologize to the young woman or face termination.

Sally claimed that she had as much right to enter into the conversation as did the two women as they were in a public place. Had another customer, Sally contended, said the same words, the employer could not have done anything.

The supervisor conceded the latter point but emphatically pointed out that Sally was not another customer, but a representative of the store. As such, her words could be construed as a corporate attitude against the disadvantaged and needy. Supervisor used as an example a case out of Illinois—the pharmacist at a store there was a fill-in and as such was unaware of how to process Illinois Medicaid prescriptions. During a rush, pharmacist had shoved aside all the Medicaid prescriptions and handled everything he knew how to do in order to move along as many customers as possible. Still, the Medicaid patients sued and won. The drug store had not, the court held, prepared adequately for Medicaid patients and thus the pharmacist had acted in a discriminatory manner, even if not done purposely.

Based on this, supervisor had a legitimate basis for punishing pharmacist: to avoid future acts which could be construed as discriminatory. Further, the supervisor would be able to show the aggrieved patient that remedial measures had been taken, a step in avoiding future discrimination and easing the patient's "pain."

Pharmacists do not have freedom of speech or opinion in their place of employment where their speech may be construed as the opinion of the employer, and drug stores that accept Medicaid and/or Medicare may not do anything that even has an appearance of discrimination.

Tidbits
A controversial draft regulation by the Department of Health and Human Services would require hospitals and other health-care entities that receive federal funds to allow workers to opt out of providing care that violates their moral and religious convictions
Basil Rathbone and Jeremy Brett, the two actors most well known for their portrayal of Sherlock Holmes, neither particularly liked playing the great detective. After more than ten movies, Rathbone refused to do more. Brett, who signed on to do the entire set of short stories and novels, at first did interviews like a good trouper, but as time went by started telling anyone who would listen what a difficult chore it was to play Holmes. (Brett would die untimely at the age of 54 after having done only 41 shows, but they are considered classics in Sherlockiana.)

The claim on the Oprah Winfrey show that there is an aspirin "tolerance" and the lowest recommended dose should be changed from 81 to 162 mg seems to have no reliable basis.

As to actors, Mickey Rooney turned down the role of Archie Bunker in "All In The Family" as he did not want to play a racist. Harrison Ford was passed over for the role of Bunker's son-in-law, "Meathead."

The average family of four will pay about $16,000 in medical bills in 2008, up from about $11,000 in 2004.

Using the football sports BCS criteria, Germany won World War II.

Many third part insurers are opting out of paying for prescription eye drops for seasonal allergies, but patients claim that the now-OTC Zaditor drops sting. Have them place the drops in the refrigerator a short while before instilling the drops—no sting and the cool drop is comforting too. (This was not solicited by the makers of Zaditor and you may have other drops you prefer to recommend.)

The new tamper resistant Medicaid prescription blank requirements went into effect in October.

Pre-paid Legal Services

A new pharmacy school graduate has been offered pre-paid legal services by his employer and asked my opinion. Below is my response. I will not name the company involved.

"This is a good question. I have some doubts as to the necessity of it, as well as other issues.

"First of all, it is not free--you pay a fee, then you get a discount on the usual and customary fees, if I remember correctly. You will buy a house at some point in your life but most often closing costs are covered these days. You will want to create a Will and probably some other estate planning documents--to protect your family and see to it that everything is done right. Do you want to pick and get to know--at least to some degree--the attorney who does this? Same question if you face civil litigation or an administrative hearing. The costs of paying a local attorney, one who you can get to know and whose reputation is going to rely on his/her being a zealous advocate for your cases or needs probably outweighs whatever savings you might have.

"Second, once you've used an attorney in the network, there is no guarantee that the same lawyer will be available the next time--sort of like going to an Urgent Treatment Center--you get whoever is "on" at the time. There is no "closeness" developed between you and the attorney who is "on" at that moment. A corollary to this is that the attorney does not have the incentive to be that good an advocate for you--like a pharmacist, he/she will make most of their money off a salary which means they get paid whether they're busy or not.

"Third, this attorney may not even be in your state. Not only is communication a problem (face-to-face may never occur) but his/her familiarity with KY law may be minimal and haphazard.

"Fourth, a major area for concern for a pharmacist is representation when he/she makes a devastating error, causing significant harm or death. This often creates an adversarial relationship between employee and employer--who do you think the attorney is going to be more inclined to seek the favor of--you or the company who has thousands of other potential clients and who pays most of the costs?

"Fifth, take a hard look at what is not covered. Domestic relations law (divorce, alimony, child custody) a major source of legal need in this country; anything where there could be an employee/employer conflict (see "Fourth" above--wouldn't you be happy to seek legal representation after making an error that caused harm only to be told that kind of service was not covered?!); appeals--many cases today are difficult and require an appeal to a higher court; etc etc

"Keep in mind that I am an attorney and that I would like some or most of this work from you for myself, so I am prejudiced in this matter."