Monthly Archives: November 2015

Should the Board Intervene?

A couple of months ago, I had the opportunity to visit two pharmacies from the same chain shortly before they closed on a Monday night.  Both pharmacists looked horribly frazzled.  One had filled 600 prescriptions in a 12 hour day with no overlap, the other 610, also no overlap.  In describing their day, both used similar language:  The day had been a disaster waiting to happen.

Though employers still claim that staffing is adequate for the work load, chain pharmacy no longer makes any attempt to deny that there have been substantial cuts in tech hours and pharmacist overlap while at the same time new and additional duties are being heaped upon their pharmacists.  Immunizations, MTM, patient phone calls, Medicare, prescriber phone calls, etc, all of which have metrics by which the pharmacist (and continued employment) is evaluated.  Despite the increased workload, most chains still only use one criteria for the amount of tech help provided: the number of prescriptions filled.  The remainder of the workload is not considered worthy of tech help, even though these duties require significant portions of the pharmacist’s time.

This is occurring at a time when boards, legislatures, colleges of pharmacy, professional journals, et al, are all calling for provider status.  While the concept of enlarging the role of the pharmacist in the overall health care environment is more than a good thing, currently the pharmacists in the trenches are more often than not thinking “Oh great, what are they going to throw at me now?”  Currently, provider status in the front lines is desired only if it gets more help in the pharmacy.

Though often only anonymously or in speaking to each other, pharmacists are not quiet on this issue.  While many do not complain to superiors for fear of losing their jobs, dissatisfaction is widespread and growing.

One of the outcries by pharmacists is to bring in unions—strength through numbers.  A pharmacist union would force employers to provide adequate help.  But there are down sides to unions.  Union organizers are often non-professionals—will they truly understand the issues faced by the profession?  Is joining going to be forced or voluntary.  If the latter, how will the dues-paying members feel about others getting the benefits of unions for free?  Also, union dues are usually a big chunk and chain pharmacy, with its spreadsheets showing the actual and undeniably shrinking reimbursement all pharmacies face, would force other concessions to absorb the cost of additional help in the pharmacy.  Ready to trade your health insurance for more tech help?

Another call is for pharmacy boards to step in and save the day.  So far, according to what material I can find, only Oregon has taken a step and pretty much all that the board there did was poll its pharmacists about working conditions, then pass a mediocre regulation.

Should the Board of Pharmacy intervene?

This is a question with strong and compelling reasons for either a “no” or “yes” answer.

The board of pharmacy is here to protect the public, not the profession.  Bad working conditions (save issues like sanitation) are not the purview of the board.

One and perhaps the biggest argument against board action is that the profession allowed itself to be put in this position and the responsibility to make it right also falls upon us.  Too many voices refuse to speak however because the pharmacist shortage has ended and we fear for our jobs and our livelihood; we can be replaced easily today.  Even a decade ago, the shortage protected us.  Corporate kowtowed and failed metrics were brushed aside more often than not.

It is not like we did not see the number of pharmacy schools opening and could not guess that the end of our reign was coming—this writer has been.  Too many relied on the Pharmacy Manpower Report–which predicted a shortage until at least 2020–without reading said report, which predicated its premise of a continuing shortage on 1.5  new schools of pharmacy per decade instead of the 25+ we got.  But the truth was out there for all to see and it was pretty much overlooked and/or ignored.

Pharmacy as a profession has failed to unite and become an organized profession in the sense of possessing political and bargaining power.  We are a fractured profession with many types of associations and no binding force between them.  Flush with our past domineering position and high salary, few of us thought we would ever have need of these associations, so we did not join nor did we seek to join them into one powerful force for pharmacy.   That is our fault, not the board of pharmacy’s.

The solution to the overworked, understaffed and unfair situation in chain pharmacies is for the pharmacists themselves to step up and take action.  Slow the workflow to an acceptable level, speak up, refuse to do part or all of the added responsibilities until the workflow is deemed safe.  Beyond that, it is (way past) time for this profession to unite and organize as a profession, to become a strong political force that can protect the people in it, provide decent working conditions, and advance us in the health care environment.

Then look at what would be needed to ease the situation. A limit on the number of prescriptions a pharmacist could fill per day and a required number of tech hours based on prescription history.  A pharmacist-to-tech ratio.  Board action would meet substantial opposition.  The chains would bring to bear their considerable influence.  And once again, some pharmacists working for these companies are going to side with their employers, maybe because they want to protect their job, maybe for other reasons.

And what about independents?  These restrictions would force many of these one-pharmacist pharmacies to hire unneeded help, possibly a pharmacist that would only be truly needed a couple of hours at the end of the day.  For indies, the restrictions and limitations to protect overworked chain pharmacists could mean the difference between profit and no profit in these days of ridiculously low reimbursement.  The difference will be, for some, keeping the doors open and being forced to close  So make a law only for chains with metrics?  The chains would justifiably fill the board offices with lawyers ready to file lawsuits claiming 14th Amendment Equal Protection violations.  Most indies are not going to support board intervention, and the chains will fight new regulations aimed solely at them.

Another reason for no intervention is that the KY Board of Pharmacy has not done so yet.  The KY board is innovative and inventive and willing to take on issues.  I am a big fan.  That it has not done so indicates that they see no reasonable basis for doing so, at least at this time.

(And remember that this is coming from a pharmacist-attorney who makes a good portion of his income defending pharmacists and pharmacies when the Board comes after them.  A big fan, yes, but hardly a sycophant—just mention the board’s overzealous and wrong use of lifetime revocation of license as a punishment and I will get on my soapbox)

What reason is there for the board of pharmacy to intervene?  Currently, it is generally recognized that these staffing cuts and added duties have resulted in an increase in the number of prescription errors. (EG, see the popular pharmacy magazine DRUG TOPICS, but today on social media there is a story—the second one I have seen—about a lawsuit where an error occurred and the pharmacist is claiming the misfill was due to over work and too little help).  The health and well-being of our patients is being placed in peril by pharmacists, as above, having to be responsible for 600 prescriptions a day.  The danger in this is as apparent as a slap in the face.    Despite these articles, there have been no changes.

Should the board intervene?  I will make my answer  “Yes” the day pharmacists fail to get control of their work environment and I read or see where an error by an overworked pharmacist kills a child.  When we fail on that level, the board should and will intervene and we will just have to adjust.  Still, as with a union, I expect that any law dealing with overwork is going to have unwanted and unseen consequences as well as benefits.

OK.  Weigh in, readers

Patient Counseling–Duties and Pitfalls

Back in the 1990s when OBRA ’90 became law, I predicted that lawsuits about failure to counsel or failing to fully counsel would soon be the source of many lawyers’ income.  I was right.  Except for the word “soon.”  The 90s became the 2000s and then we aged into the 2010s before my prediction finally came true.  Today, and for the past few years, failure to counsel is the number two reason for lawsuits against pharmacists and pharmacies (number one remains misfiling a prescription).  Indeed, in California recently all three of the Big Three chains received six figure fines from the federal government for failing to counsel.

Let us start off by reviewing Kentucky law (pharmacists in other states can still rely on this for the most part as most states laws on this subject are very similar).  201 KAR 2:210 if you want to follow along with the actual regulation.

Counseling is not required in Kentucky.  What is required is an OFFER to counsel on all new prescriptions and on refills where professional judgment dictates.  Only by an acceptance of the offer does the duty to counsel arise.

Before we look at what counseling requires, what about if counseling is refused?  Kentucky requires documentation of the refusal.  There is no requirement to obtain an acknowledgement that counseling was done.  If such documentation is not present, a legal presumption exists that states counseling was offered, the offer was accepted, and reasonable counseling was provided.

Once counseling is accepted, the regulation provides the areas that must be covered

(a)The name and description of the drug;

(b) The dosage form, dose, route of administration, and duration of therapy;

(c) Special directions and precautions;

(d) Common and clinically significant adverse effects, interactions, or contraindications that may be encountered, including their avoidance and the action required should they occur;

(e) Techniques for self-monitoring of drug therapy;

(f) Proper storage;

(g) Refill information;

(h) Action to be taken in event of a missed dose;

(i) His comments relevant to the individual’s therapy; and

(j) Any other information peculiar to the specific patient or drug.

 

Legal issues arise from several areas.  First and foremost are a failure to offer to counsel and providing insufficient counseling.  With the failure to offer, it is most often an absolute failure to make any kind of inquiry to the patient about counseling.  Most states, including Kentucky, permit the phrase “Do you have any questions about your prescription?” even though the word “counseling” is not part of the question.  Plaintiffs’ lawyers have been battling that for a long time, arguing that this does not connote a true offer but only a desire to have the patient ask questions.

 

Insufficient counseling is providing counseling but failing to reasonably cover any of the above required criteria.  Talking about all of the above except for “action to be taken in the event of a missed dose” is not acceptable to state boards of pharmacy.  Omitting any provision, deliberately or inadvertently, in required counseling points does not mean that a patient was partially counseled—the patient was not counseled.  Period.

 

Example: Patient presents a prescription for acetaminophen with codeine and accepts the offer to counsel.  All the points are covered but the pharmacist fails to warn against mixing the medication with alcohol.  Patient does so and falls down a staircase.  Pharmacist is liable for failing to counsel on a common and clinically significant adverse effect.

 

The common and clinically significant adverse effect provision has been the basis for several lawsuits (in other states, not KY).  However, most of these lawsuits have resulted in no pharmacist liability as the patients were found to have counseled reasonably.  In one matter, the family sued because the patient was not warned of the possibility of developing Stevens-Johnson syndrome. In another, the male plaintiff contended he should have been warned of the possibility of priapism from trazodone.  Both courts, through the use of expert witnesses, found for the pharmacist as these adverse effects, though clinically significant, were uncommon to the point that they would not be found in reasonable counseling.

 

Special directions is another leading factor in lawsuits.  These are pretty clear cut where a pharmacist fails to tell the patient to refrigerate or not refrigerate, shake well or shake gently, etc.  A note here.  The KY regulation states that things like patient instruction sheets and auxiliary labels are supplemental to counseling and are not counseling in and of themselves.  The presence of these where there was a failure to counsel is not going to be very helpful in your defense.

 

Example:  At a dinner party, patient approaches Joe Pharmacist and asks if she can get a little advice on her medication, as she did not speak to her pharmacist when she first picked it up.  Pharmacist agrees though she is not really desirable of doing so, and her responses are short and abrupt.  Relying on the “advice,” patient ends up injured.

 

The example above is more often seen where a patient does a “corner consult” with a physician and is injured relying on that advice, but it has happened to a couple of pharmacists.  Yes, the pharmacist is liable here.  The place of the counseling is not important; neither is the fact that this is not at the pharmacy but at a dinner party.  The law holds that when a professional accepts a duty, no matter where, the duty must be fulfilled as if the pharmacist were behind the prescription counter.

 

Example: Patient presents a prescription for acetaminophen with codeine and accepts the offer to counsel.  Patient is warned not to mix the medication with alcohol but does so anyway and is injured.  At trial pharmacist shows that he warned against mixing the two but patient is able to prove the pharmacist did not cover other provisions of the counseling criteria.

 

I bring this example up to show you a twist on the situation.  Here, the pharmacist is not liable.  The court would hold that the failure to fully counsel is “no harm, no foul” as the lack to fully counsel has no effect on the issue before the court.  However, a complaint to the board of pharmacy could still see the pharmacist sanctioned for failing to fulfill a duty, the court’s holding notwithstanding.

 

Some states are playing with the concept of pre-emptive counseling, where a pharmacist would relate an important fact about a drug and then offer counseling.  “Sir, you will be taking metronidazole.  You should avoid all forms of alcohol while taking this.  Now, do you have any questions about your medication?”  “Your prescription today is for amoxicillin.  Make sure to take it until it is all gone.  Now, do you have any questions about your medication?”  Pre-emptive counseling is not in KY and most states.  Phrased as above, this meets the legal requirement, as the pre-emptive statement is followed by the offer to counsel.  However, if there is no offer included, the pharmacist has pre-emptively assumed the duty to counsel and must do so fully, covering all the required criteria.

 

Counseling on prescriptions is an important duty for pharmacists, and this importance has not shrunk even though many pharmacists today have problems finding the time to adequately counsel those patients who request such.  Pharmacists should keep in mind that boards do not consider being busy as an excuse for failing to offer or to counsel.  There are as many pitfalls to this duty as there are rewards.