Where do we need to draw the line? — it is about patient safety…. stupid !

Are we individually and collectively being walked toward an legal abyss?  More and more states are taking the term “Pharmacist in Charge (PIC)” out of the practice act and replacing it with terms like “Qualifying Pharmacist” or “Pharmacist Manager”.. what they haven’t changed is that this person is still legally responsible for the legal operation of the Rx dept. It is almost like the definition has been changed to express that this person has all the responsibilities – to the board or other legal authorities – as a OWNER…. yet it is quite plain that they are an EMPLOYEE.

Does this allow the BOP to look to this RPH as they would a owner…when something goes wrong… while letting the permit holder to “call all the shots”..even turning a “blind eye” to infractions of the basics of the practice act.. as long as no one is getting hurt.

For those of you who have not been paying attention… there is a incident unfolding in North Carolina between a former “PIC” and one of the major chain stores.. won’t say which one.. but it is the second largest – by store count – and owns a PBM… This all started July 1, 2011.

A little back ground… NC in 2007 notified the industry that a RPH was to be limited to a 12 hr work day… and mandatory rest/meal breaks…

Here is :
Reprinted from the July 2007 North Carolina Board of Pharmacy Newsletter.

21 NCAC 46.2512 became effective on April 1, 2007. The rule, entitled “Pharmacist Work Conditions,” provides:

A permit holder shall not require a pharmacist to work longer than 12 continuous hours per work day. A pharmacist working longer than six continuous hours per work day shall be allowed during that time period to take a 30 minute meal break and one additional 15 minute break.

At its April 17, 2007 meeting, the Board voted to allow a six-month “grace” period for implementation. Accordingly, Board staff will begin enforcing the rule on October 1, 2007. Board staff strongly encourages employers to use this time to make any necessary changes to work schedules.

North Carolina BOP also has a rule that they consider 150 Rx/shift as a point where the potential for medication errors and patient harm increases.

This whole incident in NC, evolves around the “PIC” control over the legal operation of the Rx dept. On this particular day ,the “PIC” was down one tech – one called in sick.. it was the Friday before a long three day FOURTH OF JULY WEEKEND.

It is reported that the Rx projected for this week was ~ 2800 Rxs and the allotted RPH hours was 96… recently reduced from 105. The allotted RPH hours provided little more than one RPH being on duty at one time during the store’s normal hours of operation.

At hour seven of that day, the Rx dept staff had filled 300 Rxs… ~ one every 80 seconds…… no mandatory rest/meal breaks were provided the RPH. At this point… the RPH decided that the drive thru window needed to be closed because at this volume and staffing level it was consider a safety issue… one less distraction/interruption…

Apparently the non-Pharmacist store manager took exception, entered the Pharmacy and re-opened the drive thru window… against the “PIC’s” wishes…  before it was all said and done the non-Pharmacist DM reportedly got involved and demanded that the drive thru window remain open.

When no one would listen to the RPH’s concerns about patient safety issues.. the RPH closed the pharmacy…  One has to wonder where the Pharmacist DM was during all this? In the end the RPH was fired.

The NC BOP is finally going to address this situation in MAY. There are several issues that are going to have to be addressed. A rational person should consider that if the BOP considers Rx volume above 150/shift (~ 20/RPH manhr) as potentially dangerous… the higher the hourly volume goes does the potential for medication errors and patient harm increase  from potentially dangerous… to  risky… to careless… to reckless… to negligent… where the break points between those is.. is anyone’s guess…

According to the Rx plan for the week.. the anticipated volume and staffing was ~ 30 hrs/RPH manhour.. where does the pointer stop along that risk spectrum… does a 50% increase in volume cause .. on this particular day.. the RPH by hour seven was averaging > 40 rxs/RPH manhour… are we off the scale yet?

Also … due to the allocated RPH manhours… and the store’s hours of operation… it was mandatory that a RPH work one 14 hr day each week… which is against the NC practice act and had been in effect for FOUR YEARS !

In this author’s opinion.. this BOP – and eventually all BOP’s are going to have to decide if the Pharmacist manager has legal authority over the Rx dept operation.. or is an employee and that in reality… the “person in charge” of the legal operation of the Rx dept operation is NOT A PHARMACIST and that the permit holder is going to have to accept full responsibility for medication errors and harm to patients from these medication errors… from staffing/volume/fatigue issues…. the system they have put in place. We are not in the 20th century anymore.. where the majority of pharmacies were independents where the “PIC” and the owner were one and the same.

I posed the question back in Feb... IS IT TIME FOR A CORPORATE PIC ?

Here is a list of numerous studies on fatigue and errors in pharmacy.

In NC… it is clear what the BOP considers safe … 150 Rxs/shift and 12 hr days… with mandatory meal/rest breaks… In an incident in a Rx dept where the Pharmacy Manager is an employee… could the PM or the staff pharmacist be charged with unprofessional conduct.. when working beyond what the BOP considers safe hours and volume?  Especially if medication errors occur?

When medication errors in other states… could plaintiff attorneys use NC’s guideline limitations as argument for RPH’s working at above those levels as being unprofessional conduct and knowingly doing something that could cause patient harm via medication errors?

A few months ago the Oregon BOP did a survey, where ~ 75% of the chain pharmacists that participated stated that their work environment did not promote patient safety. If a RPH admits that he/she is working in a unsafe work environment and fails to express concerns to PIC/management… when a medication error happens… could the RPH be guilty of unprofessional conduct?

If you are operating under some optimism bias – this won’t happen to me – many of you are going to end up getting bit in the ass … for not paying attention to what is going on around you.


2 Responses

  1. No compounding, good! Lobby money better than NABPdirty chain money.

  2. Maybe DEA or FDA should take the boards of pharmacy over!
    If the FDA took over… compounding would be history
    Any Federal agency takes over pharmacy licensing… do we just give corporate pharmacy one entity to focus their lobbying money on to get things changed to their benefit?

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