Reviewing a Study Prescription

Part of Trial Pharmacy (PHARM) Training: Prescription Review and Dose Verification.

About 2 minutes. Free, in your language, no account needed.

Why this matters

A study prescription is checked against the protocol, not only against good practice.

A dose that is clinically sensible can still be wrong for the study, and a dose that looks unusual can be exactly right.

What to verify

Participant identity and study number. Both, not one.

That they are randomized and due. A visit outside its window changes what should be dispensed, and sometimes whether anything should be.

Dose against the protocol, including any assigned dose level.

Dose modifications. Has a reduction been applied previously? Many protocols do not permit re-escalation.

Concomitant medications, where the protocol prohibits certain combinations.

Recent labs, where dosing depends on them.

The prescriber may not know the protocol as well as you do

That is common and not a criticism. The investigator carries medical responsibility for many things; the protocol's dosing rules are something pharmacy often knows best.

Querying is part of the role. A query before dispensing takes two minutes. A dispensing error takes weeks and a deviation report.

Dose level is not the same as dose

In dose-escalation studies, a participant is assigned a dose level. The milligram amount follows from the level and from any modification history.

Check the level in the study record, not the number on last month's prescription. Levels change and prescriptions get copied forward.

In practice

A prescription arrives for the full dose. The participant had a reduction at the previous cycle and the protocol does not allow re-escalation.

You do not dispense and raise it afterwards. You query it before preparation, in writing, and dispense only once it is resolved.

What this looks like when it goes wrong

A prescription is copied forward from a previous cycle and the dose reduction is lost. Pharmacy dispenses what is written.

The participant receives a dose the protocol prohibits. It is a major deviation, it may affect their evaluability, and the reduction existed precisely because of a prior toxicity.

Key takeaways