Pharmacy Assurance

It is important to note that any amendments to your trial will not be reviewed through Pharmacy Assurance.

If the information contained within the technical pharmacy review form becomes outdated, for example due to a change in the protocol or other supporting documents, then you should refer to the guidance provided on this page for how to notify participating NHS/HSC sites.

This page also provides recommendations for how NHS/HSC sites manage these amendments locally.

The guidance on this page is divided into the following sections:

• Changes that affect the Pharmacy Assurance and constitute an amendment to notify to pharmacy departments at participating NHS/HSC sites
• What to do when amendments affect the Pharmacy Assurance

Changes that affect the Pharmacy Assurance and constitute an amendment to notify to pharmacy departments at participating NHS/HSC sites

Any changes to the study that will affect the information in the pharmacy technical review form constitute an amendment that should be highlighted to pharmacy departments. This includes, but is not limited to, any changes to the following:

• The study treatment regimen: doses, dispensing schedule, route of administration, blinding or use of placebos.
• Study end date where this affects the number of dispensing per participant or duration of the study treatment.
• Addition or removal of study arms and/or investigational medicinal products (IMPs) or auxiliary medicinal products (AMPs) (previously called non-investigational medicinal products or NIMPs).
• The number of dispensing per participant or duration of the study treatment.
• Whether out of hours dispensing will be required.
• The receipt and re-ordering of the study IMP(s) and/or AMP(s).
• The level of control required on the trial stocks, for example pack numbers, stock control and reporting on stock balance.
• The disposal requirements for the study drugs; this could be due to changes required by the sponsor or as requested by a new or existing site.
• If there are formulation or manufacturing changes (e.g. from IV to capsules).
• Where there are formulation changes, whether the buy availability of bulk formulations is the same.
• The treatment allocation and/or randomisation; this includes whether there is a change to the blinding requirement, whether Pharmacy is blinded or whether local pharmacies will be involved in re-packaging and/or re-labelling open-label medication to blind.
• The process for treatment allocation and how Pharmacy will be notified of the details.
• The emergency un-blinding process and/or whether there is Pharmacy involvement.
• The funding arrangements for pharmacy, excess treatment costs or other local funding implications have been identified.
• Standard care as described in the protocol.
• The method(s) used for estimating body surface area (BSA) or whether sites will be able to use alternative methods if these are normal practice or built into their systems.
• The method(s) for estimating glomerular filtration rate (GFR) or whether sites will be able to use alternative methods if these are normal practice or built into their systems.
• The required blood test validity periods.
• Whether dose banding is permitted and the procedure for this.
• What dose capping protocols are permitted.
• Product labels.
• Safety effect profile where additional medication may be required to manage those effects.
• Changes to inclusion/exclusion criteria – for example the inclusion criteria may be widened to include more sub-groups of a disease type.
• Updates to key documents that pharmacy hold - for example new versions of the protocol or IB. Pharmacy should be informed and which version they should be working to, highlighted.
• The name of an IMP/AMP; this will also affect the labels.
• The packaging of an IMP/AMP.
• The license status of an IMP.
• Source of any product in the study.
• Storage conditions for the product and space required. The latter could change as a result of an extension to the study length or increase in participants.
• The preparation or reconstitution of an IMP/AMP.
• The stability and storage requirements of reconstituted / diluted / prepared IMP/AMP or those requiring aseptic manipulation.
• Any changes to the accountability required for any IMP/AMP.
• Post-trial access to any IMP/AMP, this may be affected by the length of the study, introduction of an extension study or change in licensing status of an IMP.
• The description and storage of the IMP dosage form, for example changing from tablets to capsules.

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What to do when amendments affect the Pharmacy Assurance

If you make any of the above changes you should continue to notify the amendment according to the guidance for "Amendments for projects conducted in the NHS/HSC". The guidance in this section gives additional information about how you can assist sites in assessing continuing capacity and capability.

Amendments affecting active NHS/HSC sites

• Sponsors: When preparing the amendment please consider whether any of the changes affect pharmacy and, in particular, the information contained within the technical pharmacy review form. Where the amendment does affect the pharmacy aspects, this should be highlighted in a covering letter to the site or in the Pharmacy Assurance Amendment Site Notification form so it is clear to them that their pharmacy department should review the changes.
• Sites: When receiving amendments, where it is not clear whether the pharmacy aspects of the trial will be affected we would suggest contacting your local pharmacy department for clarification.

Adding a new site

• The technical pharmacy review form should be provided to the new site in order for capacity and capability to be conducted.
• If any amendments have been submitted that affect the pharmacy aspects of the trial a summary of these should also be provided, whether in a covering letter or as part of the Pharmacy Assurance Amendment Site Notification form.

For further information regarding whether an amendment will affect the pharmacy aspects of the trial, we recommend in the first instance that you speak with the pharmacy department involved in the design of the study. Alternatively please see the list of changes above or contact pharmacy.assurance@hra.nhs.uk for additional guidance.

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Page last updated: 14 February 2020