Rescue Me

How many of you have heard sponsors say that accountability of rescue medication is not required because the study endpoints, data, etc are not concerned with that information?  If you haven't consider yourself lucky because I believe that anybody who tells you that is not correct and is potentially hanging a site out to dry with that advice.

Rescue medication, if dispensed by the site pharmacy, is technically investigational  product and subject to the same rules and accountability logs as the actual study medication.  For example, if a sponsor for a GERD study provides Gelusil or Tums as the rescue medication to be dispensed by the site, then the site is responsible for ensuring that subjects are dosing properly and not causing themselves harm by overusing the medication.  So what's the big deal, you ask?

Well, these medications/products are being dispensed as part of a government regulated clinical research trial and the subject is receiving the medication free of charge from the site.  Basically this means that the product should be considered and evaluated under the same umbrella as the actual investigational product being examined in the trial.  Taking 50 Tums that are expired and have been stored on a hot windowsill at the coordinator's desk with no regards to temperature monitoring could be as risky for trial participants as unmonitored study drug.  Okay, so maybe that was an over-exaggeration, but the bottom line is that any medication provided by the site for ANY use in an clinical trial is regarded as investigational product, no matter what your sponsor says.

So, to make a long story short and to potentially avoid ssues down the line, (I'm sorry if this leads to more work) consider the following:

ALWAYS keep a master accountability log of ANY medication leaving/returning to the site, even if the sponsor says you do not have to do so.  Thank me later if you get audited.

Monitor compliance with the rescue medication at each visit, even if not required by the protocol.  Diligence in this regard is important even if it takes up more of your time

Thoroughly educate the subject on the use of the rescue medication, even if it is something with which they are familiar.  Think Acetaminophen for example: most people know you can get extra strength over the counter, but how many are aware of the maximum dosing guidelines (4 grams by the way, at this time but subject to change based on FDA recommendations)?

These suggestions will serve the site's purposes better if they are followed, and sponsors can learn from it too because if they are providing sites with rescue medication, then they should very well be treating it just like an actual study medication...no ifs, ands, or buts.