Research Pharmacy

Pharmacy services in NHSGGC work in tandem with the Research and Innovation (R&I) department, reviewing all clinical trials to ensure the appropriate standards for conducting research involving medicines are met and also that the study is clinically appropriate and operationally viable. As part of the review process, the Portfolio Pharmacy Clinical Trials Team will liaise with fellow staff e.g. Quality Assurance, Aseptic Services, Clinical Pharmacists and Lead Directorate Pharmacists, whereupon satisfactory completion of the review, Pharmacy approval is given and forms part of the R&I management approval process.   Where NHSGGC are sponsor or co-sponsor for a clinical trial, Pharmacy will assist you from the very early stages of preparing your protocol, assisting you with your medicines related aspects of regulatory applications and setting up your study. Pharmacy can also help prepare the necessary documentation and assist you with IMP management processes at all stages from receipt into Pharmacy to administration to the patient.   For all other clinical trials, Pharmacy work to facilitate multi-site clinical trials as a single working stream and provide information and training to you and your study Team to ensure the trial meets the appropriate standards. We also have close links with Pharmacy clinical trial colleagues throughout Scotland via the Clinical Trial Special Interest Group (CTSIG), sharing best practices in developing our service.   A very visible part of the Pharmacy contribution to clinical trials and research is in the dispensing of medicines to patients or study subjects. Pharmacy work to Standard Operating Procedures (SOPs) and have processes in place to deal with problems such as temperature deviations or medicine defects. Medicines are generally dispensed from the local hospital pharmacy where the patient is attending for their study visits.   All Pharmacy sites in NHSGGC currently provide or have the potential to provide local services to support research.  

R&I work closely with Pharmacy to ensure you are given the best advice.

To help ensure your trial receives Pharmacy approval as quickly as possible, you should approach R&I and Pharmacy in the early planning stages.  Often there is a site selection process by the Sponsor and the Pharmacy Team should be included in that process.   Pharmacy staff will often need to ask some follow-up questions and it is very helpful if researchers keep in contact with Pharmacy staff and update them on their progress and proposed start dates.

A system of single pharmacy review and approval is in development for multi-site clinical trials within NHSGGC. If you are aware your study is going to run over two or more sites, you should contact the R&I-Pharmacy Pharmacy Project Officer/Facilitator in the first instance. 

The first point of call should be your local site Portfolio Pharmacy Clinical Trials Team contact, alternatively you can contact the R&I Pharmacy Team if you have a general query.

Pharmacy work with R&I Finance to cost of the Pharmacy service undertaking a research project, using nationally agreed costs and processes. Pharmacy Clinical Trials Services are required to charge for their involvement in all commercial clinical trials.  Similarly there are costs for participating in non-commercial research – also cited as per nationally agreed process using AcORD.  Depending on the design of non-commercial research, some Pharmacy support services may be free-of-charge to researchers undertaking non-commercial research.  

Pharmacy should receive notification of protocol amendments for hosted trials by R&I and the Sponsor, however, investigators are responsible for ensuring all relevant staff have access to the correct study protocol. It would be helpful if you verified this with the local Pharmacy site. If you need advice relating to the potential impact of your amendment on Pharmacy, you should contact your site Portfolio Pharmacy Clinical Trials Team or the R&I Pharmacy Project Officer/Facilitator if your clinical trial involves multiple sites. 

The Pharmacy Clinical Trial Teams throughout NHSGGC are composed from a mix of Pharmacists, Pharmacy Technicians, Pharmacy Support Workers and a Pharmacy Project Officer/Facilitator.  In addition to each staff group’s professional and vocational qualifications, all Pharmacy clinical trial staff undergo regular Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) training.  Many of our staff have significant experience of working within research and clinical trials over several years. 

The R&I Sponsor Pharmacy Team are based in the R&I Management Office in the grounds of Dykebar Hospital. This team forms the central hub of communication between R&I and the wider Portfolio Pharmacy Clinical Trials service. Communication is also conducted directly between R&I and the Pharmacy sites in acute hospitals as necessary.

IIt is helpful if you let Pharmacy know when you are planning to stop recruiting new patients and/or when patients have completed active treatment involving medicines. This can help Pharmacy ensure they have sufficient supplies to the end of the study in the most cost-effective way. It is standard practice for the Pharmacy file to be archived with the investigators file and arrangements will need to be made with your local Portfolio Pharmacy Clinical Trials Team.

If you are planning a new clinical trial or research where medicines are used then you should contact the relevant R&I Co-ordinator in the first instance. The co-ordinator will then alert the R&I Sponsor Pharmacy Team who will work with you to develop the IMP management processes for your clinical trial and liaise with the relevant site Portfolio Pharmacy Teams that may host the research within NHSGGC.

IMP stands for Investigational Medicinal Product and is the special term used for medicines when they are studied as part of a clinical trial or used as part of a study protocol. Any medicines used within a clinical trial or research study must be of an appropriate quality and this is governed by UK/EU legislation. A key role of Pharmacy is to ensure the medicines used within research are always of a suitable standard for administration to study subjects. 

Pharmacy reviews all hosted clinical trials and research studies where medicines are used. This will ensure the proposed study meets standards around the management of medicines in research e.g. they are the appropriate quality, and the study meets the requirements of NHS GG&C Safe and Secure Handling of Medicines Policy.

Yes, R&I Sponsor Pharmacy will work closely with R&I to assist you with the design and IMP related aspects of your protocol.   We will be involved from grant application to close out of your research project.  We will provide costs in relation to the medicines and pharmacy aspects of the trial for inclusion in the grant.  This will include the pharmacy costs for participating sites, as per ACoRD.  Real costs incurred such as manufacturing costs and the cost of additional medicines over standard care need to be met out of the study funding and these will be provided for inclusion in the grant application.   In addition, we will provide IMP Management documents,  prescription forms, accountability logs and any other documents required to ensure the safe handling and administration of medicines in projects sponsored or co-sponsored by NHSGGC.  We will provide support in relation to the medicine to participating sites and to the trial management group for the life of the research project.

The R&I Sponsor Pharmacy Team will be able to assist you with sourcing IMPs and any other medicines that may be required for your research.   There may be option to use NHS licensed manufacturing units, but R&I Sponsor Pharmacy will advise you on potential contractors to deliver the medicines required for your project. 

If the clinical trial is to be run at only one site within NHSGGC, you should contact the site Pharmacy as soon as possible. However, Pharmacy will not undertake a formal review for approval or begin setting up your study until notified by R&I.   If the clinical trial is to be run over two or more sites within NHSGGC, contact the R&I-Pharmacy Team as soon as possible.