Dispensing Sealed Manufacturer's (MFG) Stock Bottle - Liability if MFG mixes medications within?

[RogerWilco]

Looking for insight into whether or not a pharmacy/pharmacist would share any liability for misdispensing in the following scenario:

Based solely on the manufacturer's bottle label, the pharmacist correctly dispenses a sealed manufacturer's bottle for the medication and qty as written by the prescriber ... but the manufacturer/repackager had mixed medications within the bottle being dispensed resulting in a subsequent recall (e.g. in this scenario - if the pharmacy would have broken the seal and poured the product out, they would have visually noticed two different products within the bottle).

Thank you.

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[confettiflyer]

Nice legal question, curious what people think.

Reality is this, plaintiff would sue all parties (manufacturer, pharmacist, and pharmacy), and the case would be settled with no fault/liability admitted/terms not subject to disclosure.

And massive recall initiated.

 

[owlegrad]

I seem to recall a case where a pharmacist dispensed a sealed manufacturer bottle that didn’t have a child proof cap and it was decided that the manufacture had no liability since they are not responsible for using child proof caps or how the product is dispensed.

This is different since the manufacturer is responsible for making sure the right pills are in the bottle but they still do not have responsibility for how the product is dispensed. I would think that legally the manufacturer would not be liable and the pharmacy would be.

Although some medications say to dispense in the original (unopened?) container - in this case I don’t see how the manufacturer could escape liability.

 

[Sparda29]

When I worked retail I always tried to dispense in amber bottles.

 

[APN-59 rph]

I suppose as a thought experiment it's worth a discussion..but the premise is one in a million million...Some shyster would really have to smell money on this one. I vaguely remember being snorted at by some low level mutt about dispensing in stock bottles..but as usual ignored the mope...

 

[RxPreceptor]

Well, this is quite the loaded question...keeping med in sealed mfr stock bottle if possible can significantly cut down loss prevention by keeping the mfr expiration date in tact (in cases of patient not picking up med, RTS...med would get default state regulated expiration date applied for RTS...6 months, 12 months, etc.)

A bit confused...have seen recalls involving MFR not using safety caps on products (no other defects)

 

[mentos]

OP worries too much. Just slap that label on unless you want to waste time transferring it into an amber bottle.

 

[owlegrad]

When I worked retail I always tried to dispense in amber bottles.

Why? Stock bottles are so much easier.

 

[johnpharm01]

Looking for insight into whether or not a pharmacy/pharmacist would share any liability for misdispensing in the following scenario:

Based solely on the manufacturer's bottle label, the pharmacist correctly dispenses a sealed manufacturer's bottle for the medication and qty as written by the prescriber ... but the manufacturer/repackager had mixed medications within the bottle being dispensed resulting in a subsequent recall (e.g. in this scenario - if the pharmacy would have broken the seal and poured the product out, they would have visually noticed two different products within the bottle).

Thank you.

This is an interesting question especially when some meds i.e. linzess have to be dispensed in the original manufacturers stock bottle. I think it's got to come down to legal duties. Ultimately I do not think a pharmacist can eliminate their duty to fill an rx correctly even if its in a manufacturer stock bottle. And a manufacturer certainly has a duty to ensure the meds in the bottle are what the label states or at very least it's misbranding.

 

[lord999]

For misbranded, you get sued, but you have a corresponding liability to the manufacturer.

 

[Sparda29]

When I worked retail I always tried to dispense in amber bottles.

One of my early preceptors told me a horror story about a patient eating one of those small dessicant things.

 

[RogerWilco]

Thanks all for the discussion and multiple points of view.

v/r

 

[RxPreceptor]

Just wanted to throw this out there...patient profile has a preference option for manufacturer packaging (as there are a handful of patients who only want sealed mfr stock bottles over amber vials). Seeing how so many RPhs are pushovers/get walked all over like rugs out of the whole "customer service" thing, you just can't win in a chain "community" setting

I have this one woman who wants her Brilinta in amber vials...I dispense in mfr packaging and throw in 2 amber vials for her due to her OCD preferences/ways and going over the whole reason why I can't break said mfr packages numerous times. You just can't fix stupid sometimes

 

[mentos]

Just wanted to throw this out there...patient profile has a preference option for manufacturer packaging (as there are a handful of patients who only want sealed mfr stock bottles over amber vials). Seeing how so many RPhs are pushovers/get walked all over like rugs out of the whole "customer service" thing, you just can't win in a chain "community" setting

I have this one woman who wants her Brilinta in amber vials...I dispense in mfr packaging and throw in 2 amber vials for her due to her OCD preferences/ways and going over the whole reason why I can't break said mfr packages numerous times. You just can't fix stupid sometimes

I used to have patients from other stores come over and ask for loaner pills of Truvada for the weekend.

 

[Sabril]

Liable, yes. Just like when you use a reference source that gives the wrong dose, you are still liable.

The extent of the liability depends on the damage and where you work. Do they have a legal department to handle this or are you on your own.

If no injuries, the worst is probably a public complaint.