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

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