Context
As part of UK-wide work to streamline research, the HRA Pharmacy Assurance process for studies involving Investigational Medicinal Products (IMPs) is being rolled out across the UK
The process involves the completion of a single pharmacy technical review per study, which can be used by all participating sites.
This streamlined approach to pharmacy assessment will allow local NHS/HSC organisations to assess and confirm local capacity and capability more effectively, for example by standardising relevant information into a single comprehensive technical review and reducing the number of queries sites need to raise. This makes study set-up more efficient.
Individuals reviewing as part of the HRA Pharmacy Assurance process will be undertaking a professional role supporting a UK-wide process, and contributing to improved healthcare in the UK. The HRA will coordinate the service in England and Wales, to a process agreed across the UK.
Role details
Accountable to:
HRA/HCRW/HSC/NRS, as appropriate.
Liaises with:
- HRA technical assurance team
- Pharmacy Assurance Four Nations Working Party
- HRA pharmacy reviewers
- Sponsors (for self-managed only)
Time commitment:
It is anticipated that reviewers will conduct approximately five reviews of HRA-managed studies per year. For those reviewers undertaking self-managed reviews on behalf of their trust/health board, the number of reviews conducted per year may vary.
Role description
To work collaboratively as part of a network of HRA pharmacy reviewers to deliver the Pharmacy Assurance process.
Completion of the HRA’s pharmacy technical review form to include:
- assessment
of medicinal products, including review of information on how these
products will be supplied, delivered, stored, prepared, dispensed and
disposed of, to ensure compliance with relevant medicines legislations
and Good Clinical Practice standards
- a summary of the
general operational context of the medicinal products within the trial;
their proposed dosages and the way in which these products will be
prescribed and administered, identifying generalisable operational
practicalities raised by this, and relating to research participant
variables (e.g. age, clinical conditions) and operational
practicalities, though not embarking on clinical review of the pharmacy
implications which will be completed at NHS/HSC organisation level as
part of the capacity and capability review
- identification of essential information which is required by local pharmacy sites for delivery of clinical trial activities
- identification
of pharmacy operational elements which could present challenges for
delivery at NHS/HSC organisations for further evaluation
- identification
of resource considerations (only in relation to medicines, e.g. excess
treatment cost, additional equipment cost) which will need to inform
local delivery decisions at sites.
- liaison with HRA technical assurance team regarding queries raised during the technical review.
To ensure reviews are completed in line within HRA Pharmacy Assurance timelines.
To report and highlight to the HRA technical assurance team any issues/concerns regarding the Pharmacy Assurance processes as part of the continuous quality improvement cycle.
To perform quality assurance checks on reviews conducted by other pharmacy reviewers, should the need arise, according to guidance and within the timelines specified by the HRA. It is anticipated that this should be no more than two quality assurance checks per year.
Person specification
Education and qualifications
| Education and qualifications | Evidence |
| Registered as a pharmacist or pharmacy technician with the General Pharmaceutical Council when professionally based in England, Scotland or Wales or registered as a pharmacist with the Pharmaceutical Society of Northern Ireland when professionally based in Northern Ireland or registered with the Health and Care Professions Council (radiopharmaceutical scientists only) | Current GPhC registration renewal confirmation or Current Pharmaceutical Society of Northern Ireland registration renewal confirmation or Current Health and Care Professions Council registration renewal confirmation, as appropriate |
Professional appointments
| Professional appointments | Evidence |
| Employed as a pharmacist, pharmacy technician or radiopharmaceutical scientist within a research active NHS/HSC organisation | Letter of recommendation from chief pharmacist and/or line manager, CV |
Knowledge, skills and experience
| Knowledge, skills and experience | Evidence |
|
Demonstrable experience in undertaking pharmacy review and set-up of clinical trials Knowledge and understanding of data protection requirements, in particular regarding the use and sharing of personal data |
Letter of recommendation from chief pharmacist and/or line manager Covering letter, including number of studies reviewed in last 12 months CV |
Pharmacy areas of experience
| Pharmacy areas experience | Evidence |
|
Specialist knowledge in at least one of the following: oncology (paediatric and/or adult), non-oncology (paediatric and/or adult), radiopharmacy, ATIMPs May also be acquainted with some of the areas above which are not own area of expertise |
CV Covering letter Letter of recommendation from chief pharmacist and/or line manager |