Monthly Archives: July 2014

PIC: To Be or Not To Be

Three scenarios #1:  Jack Pharmacist shows up for work.  Three hours into his shift he suddenly jumps up and says, “I forgot to renew my license!”  It is March 28 and he has been practicing for almost a month on an expired license.

#2: While doing a routine pharmacy inspection, Pharmacy Inspector notices certified tech Sam take a new prescription over the phone.

#3: Sarah Pharmacist is working one day when a loss prevention guy from the corporate employer comes in and has her take a drug test.  It is positive for hydrocodone.  Sarah breaks down and admits she has stolen somewhere in the neighbourhood of 2,000 tablets over the last eight months.

What do these have in common?  Yes, Jack, Sarah, and Sam are going to get in trouble with the Board.  But that is not the answer.  The answer is that the Board is also probably going to punish the PIC.  All three scenarios are covered under Kentucky’s Pharmacist-In-Charge regulation, and the usual Board interpretation is going to be that the PIC failed to 1) see to it all personnel required to be licensed are licensed in a timely manner, 2) failed to limit the scope of the technician’s duties to those permitted by law, and 3) failed to maintain proper security for the drugs in the pharmacy.

PICs have been trying to figure out just what their position is in the overall pharmacy hierarchy ever since the position was created.  Why was it created?  State Boards of Pharmacy kept trying to stop questionable and/or illegal activities by pharmacies but were more often than not stymied by (1) the corporate headquarters being outside the state and thus outside the Board’s jurisdiction and (2) not having a specific person to make responsible for a pharmacy following the state’s pharmacy laws.  The PIC is now that person.

Once created, the chains saw the potential liability before pharmacists did and made the position higher paying along with a better bonus.  Pharmacists (including me) flocked to it. It was a position of prestige and it commonly called for nothing more than making the schedules for all pharmacy employees. But that was then.

The issue with the position is where does a PIC’s responsibility begin and end?  Check with a state board of pharmacy and the PIC is the person in full and actual charge of the pharmacy and responsible to the state for the pharmacy being in compliance with all state and federal laws pertaining to the profession.  A review of the KY regulation 201 KAR 2:205 shows

The pharmacist-in-charge shall be responsible for:

(a) Quality assurance programs for pharmacy services designed to objectively and systematically monitor care, pursue opportunities for improvement, resolve identified problems as may exist, and detect and prevent drug diversion;

(b) The procurement, storage, security, and disposition of drugs and the provision of pharmacy services;

(c) Assuring that all pharmacists and interns employed by the pharmacy are currently licensed;

(d) Providing notification in writing to the Board of Pharmacy within fourteen (14) calendar days of any change in the:

1. Employment of the pharmacist-in-charge;

2. Employment of staff pharmacists; or

3. Schedule of hours for the pharmacy;

(e) Making or filing of any reports required by state or federal laws and regulations;

(f) Responding to the Kentucky Board of Pharmacy regarding identified violations or deficiencies; and

(g) Filing of any report of a theft or loss to:

1. The U. S. Department of Justice Drug Enforcement Agency as required by 21 C.F.R. 1301.76(b);

2. The Department of the Kentucky State Police as required by KRS 315.335; and

  1. The board by providing a copy to the board of each report submitted.

 

And this shows how the PIC has responsibility for the three scenarios above.

Problems abound, some minor, some major.  One PIC pharmacist was told his required literature was out of date and if it as not updated, the PIC would be cited.  Pharmacist referred the matter to his supervisor, who told him the company was not going to put out that kind of money; he had to pay for new references out of pocket.  A more recent matter has been where the controlled substance counts have been off at two stores—the PICs were cited and fined because of inadequate security, even though both had identified the cause of the shortage (theft) and taken remedial measures (termination of employee and heightened security).  Currently, I have a case of where a conversation went sour between a tech and a prescriber.  The prescriber complained to the Board and the Board is looking into disciplining both the tech and the store’s PIC.

What is becoming clear is that the position holds as much liability as it does responsibility.  The pharmacist assuming the position today needs to carefully review his or her decision to do so.  In the three scenarios above, all three PICs will face substantial fines and a permanent black mark on their record.  I harp on this topic a lot, but with the pharmacist shortage at an end, these black marks will be judged against other pharmacists for all future employment opportunities.  During the shortage, most pharmacists took a ho-hum attitude toward getting sanctioned by the Board.  At most, an employer would say “Please don’t do that again. Now get back to work.”  Those days are over, folks.

 

 

In the corporate environment, other issues arise.

In the mid-2000s, I was attending a meeting of PICs and store managers for my then-employer, one of the Big Three Chains.  The Loss Prevention guy for the other half of Kentucky was giving his usual talk re: theft, shrinkage, etc.  LP guys, if you do not know, are the internal police for major corporations, and a law unto themselves.  They can fire a pharmacist for any violation of law or policy.

This LP was making the point of his near-omnipotence.  “I was visiting a store.  After finishing up front, I went back to the pharmacy.  When I was about to enter, the PIC held up his hand and said, ‘We’re too busy.  Come back later.’” He threw up his hands in mock despair.  “He was telling ME to come back later.  He was telling ME what to do!”

I noted the laughter that followed was of various types.  Store managers loved the story and were guffawing with relish.  PICs were laughing in that forced sort of way.  I kept silent, stone faced.

The LP guy noticed.

At a break later in the morning he caught up with me in a corridor.  My pharmacy supervisor knew something was up, got off his phone call, and hurried over.

The LP guy growled, “You didn’t seem to like my story.”

“No,” I replied.  “I must have missed the humor.”

He leaned in close.  “Just see to it you got the point.”

“Let me see if I can explain it to you, so we’ll both know if I got it.  In Kentucky, a PIC is by law in ‘full and actual charge’ of the pharmacy.  He or she is the boss.  Period.  That person has all the legal responsibility that comes with running that particular drug store.  Without a PIC the store cannot function, cannot do a thing prescription-wise, cannot even open the doors.  (name deleted) may own the store, (name deleted) may hire the employees, purchase stock, pay the utilities and make policies but the PIC is the legal person responsible for the store, not (name deleted) or any of its other employees, including—I might say—you.”

LP started to object but I held up my hand.  “Not done. Second, despite whatever you may say or think or tell at a meeting like this, the law can and does supercede and override any company policy that is found to be in conflict with the law.  But what you did and what you just told a bunch of people—a bunch of people who, by the way, don’t like you—is that you consider (name deleted)’s policy to be above the law.  A PIC responsible for a pharmacy told you to stay out of the pharmacy and you went in anyway.  You put company policy above the law.  It will take just one phone call to the state to start an investigation and someone—probably a lot of someones—will repeat the story you just gave.  And then (name deleted) will be under a microscope with the state looking through the eyepiece.”

Though I have spread this story to corporate entities, no change in LP policy has been seen.  And don’t think that you can get away with telling off an LP guy today is anywhere as easy as it was eight years ago.

To be repetitive, the issue with the position is where does a PIC’s responsibility begin and end?  Place this question before a corporate official and she will tell you that a store’s PIC is responsible for compliance with all company policies and meeting goals as set forth in corporate “metrics.”

In the corporate environment, PICs are being held responsible for meeting corporate goals.  If the store fails to do so, the PIC faces demotion or termination.  PICs are responsible for ensuring all new policies are presented to pharmacy employees and their compliance with afterwards.  Again, any failure to follow policy can come back and find a PIC without a job.  Moreover, PICs are being held responsible for customer complaints.  I have PICs contacting me almost regularly these days because their store manager, DM, or other corporate person is demanding to know why Patient A cannot have her Norco now or why Customer B could not have a box of Sudafed.  These are dangerous intrusions into the realm of professional judgment and should be stopped cold.  Instead, the number of instances seems to me to be on the rise.

The responsibility a PIC faces today between the governing body and employer has created an environment where pharmacists shy away from the PIC position.  Many (like me) have left the position with a change of jobs and refuse to take it on again.  Indeed, some chains that were entertaining the idea of ending the PIC “bonus” pay due to the pharmacist shortage ending are now considering increasing that pay to hold onto the PICs they currently have.

Like prescribing and dispensing drugs, pharmacists should employ a risk-benefit ratio before accepting the PIC position.  Too often they are telling me they see far more risk than benefit.  Being PIC was once a measure of stature in the profession.  Today, it is viewed more for its liabilities.  If you take the position, make sure you know the possible consequences.

When there is no law….

Pharmacist A: Hey Lawyer Pete.  I have a prescription for ketorolac for a 30 day supply.  I know that I should only dispense a 5 day supply, but I do not know what the exact law is on this

Pharmacist B: Hey Lawyer Pete.  Interesting question, I hope.  I called a doctor after I got a fentanyl patch prescription for post-op pain, which the package itself says fentanyl is not indicated for.  The doc reminded me that prescribers are not limited to the Indications listed in the package insert.  What is the law on this?

In both cases above, there is no law.  Nothing on the books.  Nada.  But can both pharmacists face liability if they were to dispense the prescriptions (30 days on the ketorolac rather than 5)?  Absolutely.

How, you say.  Lets use an example.  Pharmacist A dispenses the 30 day supply of ketorolac and the patient suffers 50% loss of kidney function.  Patient files a lawsuit and sues.  Patient’s lawyer needs a pharmacist expert witness—a pharmacist with similar education, skills, and experience as Pharmacist A—who will testify that a reasonable pharmacist would have followed the black box warnings and not dispensed the prescription as written.  Finding that pharmacist is not going to be hard—ignoring a black box warning is unreasonable more than 99% of the time.

So Pharmacist A’s first liability arises from dispensing a 30 day supply.  But this situation gets worse.  Pharmacist A should have reviewed her liability insurance before dispensing the 30 day supply.  Worded in her policy (and > 90% of the malpractice polices in existence today) is a phrase informing Pharmacist A that unreasonable acts are not covered.  Pharmacist A is not going to be supplied with an attorney by the malpractice insurer and the award to the injured patient is going to come out of her wallet.

And Pharmacist A’s problems are not over.  While there is no law on the books about ketorolac per se, every state has a “coverall” statute or regulation on the books that covers the exercise of poor professional judgment.  The state board of pharmacy will have a foundation for acting against Pharmacist A.  Ignoring a black box warning + injured patient will generally equal a huge fine and a suspended license, more money out of Pharmacist A’s bank account.

While we are at it, lets go over the dispensing rules for ketorolac:

  1. The prescription must be subsequent to the use of either IM or IV ketorolac. If the patient has not had an injection or IV of the drug, refuse the prescription.
  2. No more than a 5 day supply. As the maximum daily recommended dose is no more than 40 mg, this means a prescription for no more than 20 tablets, less if the patient instructions are for fewer doses per day (15 tabs for a TID prescription, 10 tabs for a 1 Q 12 H prescription, etc).
  3. If the patient requests counseling, include the need to stay well hydrated. If the patient refuses counseling, make sure this is documented and tell him anyway to stay well hydrated.

With Pharmacist B, the same liability for an injured (both cases I have been involved with the patient died) patient exists.  Here, the doctor was arguing over the “Indications” part of the medication package insert.  But the black box warning against the use of fentanyl for post-op pain is not under “Indications,” so the argument there is faulty.  The prescriber was not arguing to use the drug for something other than severe pain; he was seeking to use the drug for a reason proscribed in the literature.  Two different arguments—Pharmacist B should refuse the prescription.

Is it possible to safely ignore a black box warning?  Very very rarely.  If you decide to take that chance, do the following: a) speak to the prescriber as to why the warning is being bypassed, b) check with other pharmacists and see if they agree that this might be a sound basis for bypassing the warning, c) document everything in detail, and d) if the patient ends up injured, realize that the first three steps are only going to provide a partial basis at best for minimizing your liability.

There is a doctrine that holds that whatever the law does not forbid is therefore legal.  But do not assume this, especially in the field encompassing health care.  So, even when it seems like the law does address a point, beware having that point turn around and bite you in the (rear end).  It might cost you a lot more than you would imagine.

And while you’re at it, review your malpractice insurance policy.  E-mail me with any questions