4th Mar 2014, 06:40 PM
Over-labelling of IMP
I work for a double blinded clinical study and the unblinded data has recently been reviewed for the first time since the beginning of the trial. The IMP has been seen to have a positive effect. Therefore, the trial steering committee has agreed to give all the participants the option of being unblinded. An amendment to the study protocol will soon be submitted to the competent authorities. I have a question regarding the labelling of the IMP: following the unblinding, the participants found to be on the active drug will continue with the trial treatment and take their current pot of trial medication until finished. Further supply for these participants will be labelled as 'active' rather than 'active or placebo'. Some supplies have already been shipped to the study centres and are ready to be dispensed. Can an over-labelling activity be done in hospital pharmacies? What would be the procedure to follow for an over-labelling of these supplies? One of my colleague contacted the MHRA helpline and she was told that local pharmacist would be able to change the label and no authorisation is needed because there is an exemption for hospital pharmacies. She was also told that the best thing would be for pharmacists to blackout the placebo part of the label rather than overlabel as this would be safest. We requested to have these recommendations in writting but we haven't received any email yet. Please, I would like your opinion on this topic. Any advice is greatly appreciated.
Many thanks in advance for your help
22nd Jan 2016, 05:51 PM
The currently-effective Annex 13 allows hospital/pharmacy labelling (Para 42), but I would suggest that the key wording in that section is:".... The sponsor is nevertheless responsible for ensuring that the activity is adequately documented and carried out in accordance with the principles of GMP and should seek the advice of the Qualified Person in this regard. "
The QP who Certified the product before release into the study is seen by a number of Agencies as having a moral duty (if not strictly a statutory one) to ensure that product remains in a fit state further down the supply chain.