Monthly Archives: August 2014

Corresponding Responsibility

Dr Jones wrote a prescription for Vicodin ES 7.5/750, #50, 1 to 2 tabs every 3 to 4 hours PRN post-op pain, with a refill.  Pharmacist Smith fills the prescription as is and when the patient returns for the refill 5 days later fills and dispenses.  The patient sued the pharmacy and physician 3 months later when she discovered that she had suffered irreversible liver damage.

The pharmacist filed for a dismissal of the charges against him, claiming his duty was to fill as ordered and to offer counseling, which was refused.  The court, under the doctrine of corresponding responsibility, denied the motion for dismissal.  Both doctor and pharmacist were held liable.

The above example is corresponding responsibility as most of us know it, that when a presciber writes a prescription that is inherently dangerous to that patient, the pharmacist has a duty to step in and act to minimize or eliminate that danger.  Failure to do so results in equivalent liability—corresponding responsibility—for the pharmacist.

The Kentucky Board of Pharmacy has wisely been pushing the Commonwealth’s pharmacists to acquaint themselves with this concept for some time.  Up to recent times, pharmacist’s liability for filling a prescription as is has led to little or no liability.  In the past, if a doctor was sued for $100K, the pharmacist might be sued for a tenth of that.  No longer.  In the late 1970s, in both the McLaughlin v Hooks-Superx and American Home Products cases, courts held that pharmacist were professionals capable of more than “type, count and pour.”  Thus was born the duty to act as a safeguard for patients against dangerous prescriptions.  This duty has grown and expanded, as the profession has done the same.  Now, with pharmacists on the threshold of primary provider status, corresponding responsibility is at the forefront, indicating and reminding pharmacists that with increased responsibility comes a concomitant liability when things go awry.

In the most recent issue of Drug Topics, the article on corresponding responsibility focused solely on negligence.  This is how most pharmacists are introduced to this topic.  However, the original intent by the federal government was for pharmacists to share responsibility where forged or altered prescriptions were presented.  Early on, the feds sought to employ corresponding responsibility yin the war on drugs.  Now, hard evidence exists that both boards of pharmacy and courts are expanding the federal definition to related areas where liability may ensue.

Dr X runs a pain treatment facility and writes approximately 500 prescriptions a day, the average for each patient being 2 to 3 prescriptions.  Almost all of the patients go right next door to Creepy Drugs to get the prescriptions filled.  The pharmacist owner takes steps to stay inside the law: he regularly checks to see if Dr X is under investigation, whether the doctor’s DEA number is still valid, and requires a diagnosis on all prescriptions.  After almost two years of this, the Board came in, closed the pharmacy and revoked the pharmacist’s license.

Creepy Pharmacist defended himself aggressively, reminding the Board of his actions to determine the prescriptions were legitimate.  The Board demurred to accept this defense, stating that Creepy Pharmacist had to know that with an average of 2 to 3 Rxs per patient, Dr X had to be seeing between 175 to 250 patients a day.  This is impossible, the Board held.  Most docs see between 25-35 patients a day.  Dr X could not speak to, perform an exam, review charts, etc for this high number; he had to be writing Rxs without even seeing the patients.  Creepy Pharmacist should have known this.  Creepy Pharmacist appealed and the Board was upheld.

The above case shows us a couple of things.  First, as discussed before, corresponding responsibility for the physician’s illegal acts was expanded to include filling prescriptions which could not have been the result of proper medical practice; thus the prescriptions could not have been issued for a legitimate medical purpose.  Second, corresponding responsibility is not going to attach to pharmacists merely for wrong or bad acts they see, but also those that they should have been able to see.  Above, Creepy Pharmacist, merely from his prescription volume, should have been able to determine the prescriptions were not legitimate.

Corresponding responsibility demands action by the participating pharmacist.  In the first scenario above, pharmacist should have contacted the prescriber and suggested an analgesic with a much lower acetaminophen level.  If the doctor demanded the Vicodin ES, the pharmacist had two choices: 1) change the sig to read “1 to 2 tabs every 3 to 4 hours as needed for pain.  NO more than 5 tabs in a 24 hour period” or 2) refuse to fill the prescription. Ultimately, in order to avoid liability, the involved pharmacist must either eliminate the danger of the prescription or, at the least, make the danger significantly less than as written.  And, of course (as you have heard a thousand times before), document everything.

Corresponding responsibility also exists where the prescription has other illegal aspects to it.  My most common example here is a prescription written for an anorexiant where the patient does not meet either the legal or manufacturer’s BMI requirements.  I always advise getting the BMI before filling unless the patient’s appearance (size) removes doubt that the required BMI exists.  If the patient does not meet the requirements and suffers injury from the drug, pharmacist shares liability for failing to obtain the BMI prior to filling.  (For those of you about to argue that the Board makes obtaining the BMI optional, keep this in mind: the Board did not state that you shouldn’t get a BMI nor did it provide you protection from liability either from the Board or the patient if you fill a prescription where the BMI requirements are not met.)

As the profession of pharmacy expands and grows, so does responsibility and liability.  Corresponding responsibility provides as much liability to pharmacist as it does to prescriber.  Pharmacists should embrace the new duties but also be well prepared for when things go wrong. CYA well or keep my phone number handy.

The Legality and Ethics of Death

In the summer of 1976, I had a new job as an orderly at the local hospital.  I remember well one of the patients from that time, a gentleman in his mid-50s in the last stage of terminal cancer.  His pain was agonizing and when he was awake he screamed non-stop.  The days he was hospitalized were excruciating for him, the staff, and especially the family members who had to sit by and were unable to do more than watch and hold his hand.  One day I came to work and saw his face bandaged, his hands now tied to the bed railing; during the night, in his agony, he had clawed out an eye.  I found myself avoiding that ward as much as possible.  When he (finally) died, the overwhelming feeling of all was not of loss, but relief.

During those days, I heard over and over, “Why can’t we do more than this?  We’re more humane with suffering animals than we are people.”

Despite this horrific scene, or maybe partly due to it, it turns out that quite often we do more than just watch and wait.  In the early 80s, now a pharmacist working in a teaching hospital, I was on duty one evening with two other pharmacists, JT and LV, when I received the following order: “Morphine 1500mg in 50 cc saline.  Run in over 5 minutes.”  The doctor’s progress note read, “Discussed with family.  Will ease patient out.”  I had gotten my first order for human euthanasia.  I took the order to the other two pharmacists to discuss.  LV said it was illegal (she was correct) and she would have nothing to do with murder.  JT did not want to discuss the issue—he grabbed the order, filled it himself and sent the medication off to the floor.

Physician assisted suicide (I hate that term.  A lot more people like pharmacists, nurses, etc have to take part), clinically assisted suicide, or what I now prefer—Clinically Assisted Patient Demise (CAPD) is now legal in 3 states.  Several others are considering enacting laws that would permit CAPD.  However, the truth is that CAPD occurs often in all 50 states on a mostly regular basis, and pharmacists are taking part, usually knowingly and willingly.  They are just as aware that what they are doing is a crime.

But first, lets address pharmacists in those states where CAPD is legal.  Pharmacists have the right to refuse to take part in ending a patient’s life, and there can be no liability for this refusal, even if there is no other pharmacist on site who is willing to prepare the fatal cocktail.  There may no repercussions from the employer from either taking part or refusing.  For the pharmacist taking part, there can be no liability if her actions are in good faith and the fatal cocktail is prepared correctly.  Even if the drugs fail to bring about the death of the patient, the pharmacist is protected.  Still, the pharmacist should review all the law and protocols for the institution where the death will be brought about before agreeing to take part.  Any and all questions and concerns should be addressed with both the ordering physician and the institution to the pharmacist’s satisfaction.

Now, a few words about the rest of the nation.  Almost every other state permits the “living will” by which patients can state the conditions of treatment if they become terminal or are in a “persistent vegetative state.”  Several cases have gone through the court system all the way to SCOTUS, the result being that living wills may restrict treatment—drugs, nutrition, etc—but they may not require persons or institutions to engage in what the Court refers to as “affirmative steps” toward death.  Affirmative steps are those that seek to bring about death artificially early.  The Court considered the “hastening” of death to be illegal. (The 3 states to pass laws permitting CAPD did so under the auspices of the 10th Amendment.  Since the Constitution does not address medical care or the termination of life, laws regarding these topics rightfully belong to the states.  Thus, SCOTUS is overruled.)

Prosecutors in these states have taken two approaches in response to what seems to be a growing (with substantial opposition) movement to make CAPD legal.  Most DAs have eased back on prosecutions, recognizing the movement is headed their way.  Others, a minority, take the opposite view and energetically pursue, arrest, and try those involved in illegal CAPD.  Actual arrests or indictments are few; prosecutions are few and far between.

Pharmacists in states where CAPD remains illegal are nonetheless advised to strongly consider the consequences of taking part in CAPD.  If a prosecution ensued, it would likely see the pharmacist charged with second degree murder or something similar.  After that, the state board of pharmacy would then be free to act against the pharmacist’s license.  Even a sympathetic board would be required to take steps that would likely end a career.

Very aware of the possible consequences, many pharmacists still willingly take part in and support CAPD.  A study in the AJHP showed that just under 50% agreed that CAPD should be an option open to the terminally ill, most of this group also stating that using prescription drugs for ending a life was an appropriate use for the medications.  The decision to take or not take part is almost always based on the pharmacist’s ethics.  Pharmacists have employed both moral and professional considerations in their decision to engage in CAPD, citing a professional duty to their patient’s well-being, as determined by the patient.   However, ethics is most often the cornerstone for the decision. A lot of such thoughts relied on the SCOTUS ROE V WADE holding that a person has a right to decide how and what will happen with their own body.  Pharmacists reason this now includes treating certain medical conditions through the termination of life.  Further, they hold that if we have medicines to increase the quality and quantity of life, those same medicines can be used to end suffering, and pharmacists have a morl duty to ease suffering by all available means..

Pharmacists opposing CAPD, once again mostly for ethical reasons, rely on the arguments of the sanctity of life—any life—as well as religious convictions.  All life, no matter in what state of health, is sacred and should be preserved as long as possible no matter what..  Some religions hold that suicide, which they view CAPD as, is an unforgiveable sin, while others regard affirmative steps toward death as an intrusion upon God’s plan for that patient.  Two pastors I know, love and respect both stated the same sentence: it is up to God when you die, not up to you.  Many pharmacists share this tenet.  Thus, the most common basis for refusal to engage in CAPD is religious conviction.  Professional considerations also enter into the debate; pharmacists hold to the “do no harm” tenet as a basis for refusing to aid in the death of a patient.

However we may feel about this issue, it is out there.  People across this nation daily end their lives through clinically assisted patient death, and the pharmacist is an integral part of the process.  Retail pharmacists who believe this is solely an institutional issue should beware.  With the ever increasing restrictions of managed care, people who seek an escape from terminal conditions and horrific pain will be getting prescriptions to take at home, and this is coming sooner than most of us think.  In short, it is decision-making time for all of us.

I am sure you are wondering.  What would I have done back in the 80s in that hospital if JT had not taken the order away from me and filled it?  Would I have filled it?  Yes.  Do I support CAPD?  At this time, yes.  Do I feel morally right?  If I did not think I held the moral high ground, I would not support CAPD.  Do I feel religiously right?  No.  See the comment about those two pastors above.  But I do believe that ending suffering in certain situations is not a sin.

So, what would you do?