- 0Aug 4, '08 by KuhranowskyI am a clinical research coordinator in the university setting. I am looking for information regarding the dispensing of medications for patients who need to substitute for prohibited meds. In particular, legal issues concerning dispensing medications not supplied by a sponsor. (ie: substituting an ICS for ICS/LABA combo in an asthma trial.) Would this be similar to dispensing samples in a physicians office?
Do any of you experienced research coordinators know where i can locate this information. I work in PA, and I know some state regulations will apply. any direction would be appreciated.
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- 1Aug 5, '08 by anc33We would normally write the patient a new prescription. A copy of that order would then go in the chart. Dispensing meds other than the study medication is not common practice where I have worked. Beyond that, did you clear the med change with the sponsor? If the combo they were on was exclusionary and you change it to suit the study then you have a deviation. As for your question, you would have to look in your state laws to see what they consider dispensing to be and then who it can be done by. I wish I could be of more help.