The Impact Of Electronic Drug Accountability


What is drug accountability?

In a clinical trial, drug accountability is essentially tracking the whereabouts of the drug.  This includes storage, shipping to sites and depots, dispensing and administering to patients, as well as returns and destruction.  The accountability process is a requirement, and investigator sites that do not manage this process or manage it poorly are considered noncompliant and subject to fail FDA inspections.  In addition, poor drug accountability can have an impact on patient safety, as insufficient records may cause site staff to dispense the wrong dose or the wrong drug to the patient.

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The process of accounting for and reconciling the use of the investigational product by patients has historically been conducted manually at investigator sites.  Not only is the manual process error-prone and burdensome for site staff, but it also has a significant impact on the site’s ability to monitor patient drug compliance.  And we all know that patient compliance has a direct impact on patient safety and clinical trial data integrity.  Managing the drug accountability process electronically is a great way to start improving compliance. 

How does electronic drug accountability improve patient drug compliance?

When investigator sites use a manual process to monitor drug accountability, it’s difficult to determine how rigorous and timeline-compliant they are. And it’s even more challenging to keep track of patient drug compliance, or the patient’s ability to adhere to his/her treatment regimen. 

Track patient drug compliance in real time.  When sponsors or CROs introduce an electronic drug accountability process at the site level, site staff and monitors can build a live picture of drug quantities being consumed or returned by the patient to the investigator site.  Sites have a real-time record of patient drug compliance.  Accountability data is immediately centralized and available for review.  

Save time, money, and headaches.  There’s no guarantee that simply tracking the drug’s whereabouts will improve patient compliance, but the site will receive an immediate warning if there appears to be a compliance issue.  This means that sites can react quickly and take steps to improve adherence instead of waiting until the trial is finished and realizing that there were compliance issues.  This saves sites and sponsors precious time, money, and headaches while they collect the final clinical trial data. 

Easily manage drug accountability in long-term trials with complex dosing regimens. Sponsors see the benefits of electronic drug accountability especially when they are conducting long-term clinical trials with complex dosing schemes.  If patients are assigned medication and taking it home with them or making frequent return visits to the investigator site, having real-time visibility of the drug’s whereabouts is critical.  Longer term trials with multiple dispensing events or daily doses often reap the most benefits from an electronic method of accountability, as the site is responsible for checking which materials the patient has used and what they have not each time the patient comes in for a visit.  The sponsor also has complete visibility on whether or not the site has been dispensing drug in accordance with the dosing instructions.