Monthly Archives: February 2016

“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.

Drug Testing

Drug testing is now commonplace in the pharmacy environment.  A test before employment and the possibility of random testing is expected by job applicants these days.  And it is generally complied without a second thought.

This was not always so.  And it has not been that long since drug tests were a new thing.  When they were, drug tests were fought ferociously by many parties.

Arguments against drug testing were based on the Fourth Amendment of the US Constitution. The Amendment states “The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated” .  Early on, courts held that drug testing,–requiring an individual to supply bodily fluids such as urine or blood—constituted an unlawful taking.  If the individual did not want to voluntarily provide the fluids, the courts said, an employer acting against the employee’s refusal was violating his or her civil rights.  Forcing a person to supply these fluids, which are a part of the body or “person” was protected by the Fourth Amendment.

However, it was not long before courts began handing out exceptions to these holdings.  The first were not pharmacists, but they would soon follow.  Over the road truck drivers and train engineers were among the first.  Courts carved out the first—and most relied on—exception on the basis of public policy; protecting the people while traveling from drivers and engineers being impaired and endangering others on the roads and rails.  The Fourth Amendment is not substantially sacrificed nor endangered, the courts held, where the exception seeks to achieve the greater good for the greater number.

Health care was not far behind.  The exception followed the same course: we do not want the persons preparing and dispensing medications to be impaired when doing so.  Not long later, a second exception was created as diversion issues became a serious problem in the nation’s pharmacies.  Inevitably, pre-employment screening was permitted to weed out those persons who are or could be impaired before employment began.

Today, as written above, pharmacists expect a pre-employment drug test as well as the possibility of random testing during employment.  How do they do this?  Drug testing must be mentioned to the potential employer during the employment interview.  The requirement must be included in any policy and procedure manual and/or employment handbook and a copy of the latter must be given to the employee.

What about introducing drug testing into a pharmacy environment where it has not existed before?  This can be done.  Employees must be given notice prior to implementation.  This should be in writing but can be accompanied –not replaced—with verbal announcement.  The notice should state when the policy is going into effect and would best be no less than thirty days out.  Even if the policy is being implemented due to reasonable suspicions against a single employee, the initial use of the policy would best be to do all employees to avoid any hint of discrimination.  Should an employee choose to leave rather than submit to drug testing, nothing should be presumed from this departure nor should this be mentioned if a potential employer for that person should call for a reference.

Results of a positive drug test usually mean a suspension or termination of employment.  If a suspension, the employee may also be required during that time to attend a detox/rehab facility as a condition of returning to employment.  An employee who believes that a drug test is a false positive has the right to demand a second test, and nothing prevents the employee from doing so, at the employee’s expense, at even another facility.  If the tests differ in results, the employer may still suspend the employee until the situation is resolved.

What if an employee is taking a drug pursuant to a legitimate prescription that shows up on a drug test?  The employer can still suspend the employee if the legitimate drug shows reasonable evidence of impairment.  EG, a pharmacist returns to work after an orthopedic procedure but still takes hydrocodone for his pain at work.  If the employer notes slowness and slurring of speech and does a drug test, the employee may be sent home until he is no longer on the medication.  Termination here is inappropriate unless the pharmacist was hiding the fact that he was still taking the controlled substance.

Aside from employment, the Board of Pharmacy may require a drug test.  This must be in response to a complaint or be a condition of an Agreed Order between the Board and the affected individual.  This cannot be a part of a routine inspection unless something during the inspection indicates to the inspector that a pharmacy employee is impaired.

Drug testing is now a legitimate part of pharmacy.  The old arguments against such testing have lost their validity, for the most part.