“But I Didn’t Know” The Implications of STERNBERG

In STERNBERG V CALIFORNIA STATE BOARD OF PHARMACY, 239 Cal. App. 4th 1159 (2015), the California Court of Appeals affirmed a decision by the California Board of Pharmacy to discipline a pharmacist-in-charge for bad acts by a pharmacy technician, irregardless of whether the PIC had knowledge of those actions.

Over an 18 month period, the pharmacy tech would regularly order 3,000 hydrocodone tablets.  When orders arrived, she would move as far away from the pharmacist as possible, hide the hydrocodone in a stock room, and destroy the paperwork.  The total amount of hydrocodone stolen over this time period added up to 216,000 tablets.

The theft was discovered when the PIC found a bottle of the hydrocodone in the stock room.  An investigation was launched; all the theft was discovered.

The Board acted against both the pharmacy and the PIC (Sternberg).  The latter was held liable on six counts, including failure to adequately supervise the technician, failure to maintain accurate records of controlled substances, and permitting techs to sign for deliveries.  Had there been proper supervision and random checks of the deliveries, “the thefts may have been discovered much sooner.”

The PIC denied liability in that he had no knowledge of the thefts, or even the ordering of the hydrocodone.  In a busy pharmacy, some duties are necessarily delegated, he claimed.  The Board did not deny this but rather referred to its Business and Professions Code that states that pharmacy owners and PICs possess joint responsibility for overseeing and keeping accurate records.

In his appeal to the Court of Appeals, the PIC claimed that the Board had misinterpreted the Code to create liability where there was no knowledge of the violation of law.  The CA disagreed and affirmed the Board’s disciplinary measures.

Cases in one state are often used as legal precedent in another, especially where the case is of “first impression” in the other state.

The first important point here is that this occurs in other states than California.  I have been involved in three such matters in Kentucky. Pharmacies and PICs may be held responsible for bad acts committed on the premises even when these entities have NO knowledge of the acts.  And now there is a Court of Appeals case that supports the stance taken by the Board.

In the Kentucky cases, the Board relied on KRS 315.121, as usual, to show that pharmacies and PICs are liable for bad acts.  Further, the Board cites the PIC regulation is responsible to “detect and prevent drug diversion” as well as the “procurement, storage, security…of drugs.”  201 KAR 2:205.

And, yes, the amount stolen in the case above is almost beyond belief.  But do not let your focus stop there.  None of the cases I saw in Kentucky got anywhere near that close and yet the stores and PICs were found liable.  In one, the amount of hydrocodone stolen was less than 1% of the annual supply of the drug in that pharmacy.  Very hard to detect, but this made no impression on the Board.

How is this avoided?  No doubt, especially in busy high volume pharmacies, these duties must be delegated.  Though many chains have policies in place requiring PIC or pharmacist participation, cutbacks and demanding duties, pharmacists tell me these policies are routinely ignored.  PICs and owners do this at risk of liability and a permanent black mark on their records at the Board.

Some advice on this matter:

–rotate people who order and check in orders

–do random checks when orders are being received

–require all deliveries to be signed for by the pharmacist.  Do a quick review of the paperwork to see if CS are in the order

–require TWO people to check in CS orders and have both sign the paperwork

–do routine and random checks on CS orders with the companies from which you order

We all grew up hearing the old adage: “Ignorance of the law is no excuse.”  As it turns out, ignorance of bad acts in the pharmacy is no escape from liability.  STERNBERG has established a legal precedent.  Take measures to prevent diversion/theft and protect your license.

2 thoughts on ““But I Didn’t Know” The Implications of STERNBERG

  1. This is likely a naive question, but how do these cases come to be? Does filing a DEA 106 for a significant theft or loss prompt the Board to take action? Or is it a pattern of losses that gets you above the radar? In your experience, what is the “trigger?”

    1. This is not a naive question. KY and most states require, as does the federal government, that theft or other losses of CS be reported through a Form 106. KY requires a copy be sent to the Board. If you do not report, the odds of getting caught rise with the number of pills, bottles, vials, etc that are stolen/missing.

      Do not take the chance of not reporting. Getting caught by the DEA would mean the revocation of your DEA license. Want to try and run a pharmacy with NO CS? Getting caught by the Board could mean a lifetime revocation of your license. Weighed against a permanent black mark on your record at the Board, there is no comparison.

      As for a trigger, what number of pills going missing constitutes a Form 106 and notification. The Board seems to have the attitude that ANY loss is reportable. However, if your monthly count is off ten hydrocodone, it is easy to see that some patient got an extra ten tablets. If your monthly count is off ten pills every month for six months, time to do some investigating. If theft is discovered, you must report, even if the 60 tablets is less than 1% of your annual hydrocodone inventory. Sorry but there is no hard and fast rule here.

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