During the set-up phase, three GP Surgeries in Bolton were indentified and selected as recruiting sites. In order to ensure they could store and prescribe the study drug – which must be dispensed at a low temperature – an innovative shared, central pharmacy system was set-up.
This central pharmacy is a community-based retail pharmacy that takes delivery of the investigational product and stores the drug on site. When it is requested by a GP, it dispenses and delivers it to the requesting practice.
Dr Ian Caldwell, GP at Swan Lane Medical Centre and Principal Investigator for the three sites gives his view on the new system.
“The idea for a central, shared pharmacy for GP Surgeries came around because of a need for improvements around drug accountability and storage within primary care, especially if there were special considerations around the drug, such as it needing to be kept in a temperature-controlled environment. We also looked at how we could streamline the system so it could deal with three GP Surgeries as one centre and what this would mean for the sponsor in terms of delivery of the trial drug, for the GPs in terms of prescribing the drug and for the patients in getting their medication in a timely and convenient way.
“In terms of drug storage, the shared pharmacy approach has, without doubt, improved this. The pharmacy has the required storage facilities and they have experienced pharmacists with the necessary skills to manage the drug supplies. For this study the drug has to be maintained at the correct temperature up to the point when it is dispensed to the patient, and we have to demonstrate the maintenance of the “cold chain”.
“The pharmacy we used was conveniently located for the three GP practices. However, one point we had to overcome was that the pharmacy was new to research and clinical trials. We worked with both NIHR Greater Manchester Comprehensive Local Research Network (GMCLRN) and the sponsor pharmaceutical company to make sure pharmacy staff received GCP training. As the new central pharmacy was, in many ways, ‘mimicking’ what happens in hospitals, GMCLRN arranged access to hospital pharmacy staff and departments who were experienced in research so they could see and learn how the system works and develop appropriate operating procedures.
“GMCLRN also worked with pharmacy on how the drug would be delivered and whether there would be a delay for patients while they waited for the study drug, and if there were any problems with the system what were the contingency plans. “For a totally new system, we’ve been very impressed with how it works. The GP faxes a prescription to the pharmacy when seeing the trial participant and most times the drug is ready for the patient before the visit has been completed. The drug is delivered to the surgery in a temperature-controlled box to ensure it can be given at the correct temperature. It’s a safer and more appropriate system as study drugs are being stored and dispensed by pharmacists with the right skills and facilities.
“There were a few teething problems early on, which is to be expected with a new system, but we had contingencies in place that dealt with them. The back-up system for re-dispensing had to be used for the first patient and it worked very effectively. Since then it’s been very smooth with no real delay for patients. Once the drug has been ordered from the pharmacy to it being delivered generally takes around 10-15 minutes. “The system also makes monitoring for the study sponsor simpler in that they don’t have to monitor drug storage and accountability at the three GP sites, just one site at the pharmacy. Another positive is that this gives the sponsor longer at the sites to concentrate on any other issues.
“We have been very pleasantly surprised at the performance of the pharmacy especially as it’s been such a steep learning curve for them. While it did take a while to set-up the whole process, now we’ve done it once we’d been keen to do it again. Obviously, it is a system that could be replicated elsewhere for studies that require a number of GP Surgeries that are located close together and with a pharmacy that is easily accessible to each site.”
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