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Reply To: Coronavirus impact on returns & reconciliationMay 14, 2020 at 11:47 am
We are managing a significant number of protocols that have transitioned from a traditional “site supply” model to a “Direct-to-Patient” model. Some of these protocols include returns and others are leaving any unused medication with the patient until their next visit. The later is the EMA recommendation (end of section 9: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf ) As with everything in the current circumstance a risk based approach is necessary and inevitably varies by the unique requirements of each protocol/location etc.
For the projects where the IMP needs to be returned it it usually being returned to the clinical site, either:
1. Immediately following administration (same day – common if nurse administered)
2. Collected when delivering the subsequent supply
3. A dedicated uplift purely for the return.
The 3rd option is the least cost effective.
The process is relatively straightforward when returning IMP within country (usually to the clinical site or central pharmacy), although more challenging for international moves, contaminated items (used pre-filled syringes) or dangerous goods.
Clinical sites are also use to receiving returns from patients, hence its not a huge change for them to receive via courier. Clearly this doesn’t help if the sites are closed or unwilling to accommodate, in that scenario in would be worth engaging your depot partner concerning a potential direct return. Again I think this comes down to Risk based approach, although as per the EMA guidance “Procedures for the accountability of the IMP must be in place”.