Pharmacy Assurance

You should note that Pharmacy assurance will not review any amendments to your trial.

If the information within the technical pharmacy review form becomes outdated, for example due to a change in the protocol or other supporting documents, you should refer to  this page for guidance on how to notify participating NHS/HSC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'll affect the information in the pharmacy technical review form is an amendment that you should highlight to pharmacy departments. This includes, but is not limited to, changes to:

• the study treatment regimen (for example doses, dispensing schedule, route of administration, blinding or use of placebos)
• the study end date where this affects the number of dispensing per participant or duration of the study treatment
• the study arms (for example addition or removal) 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 is 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
• formulation or manufacturing changes (for example. from IV to capsules)
• the buy availability of bulk formulations
• the treatment allocation and/or randomisation; this includes whether there's 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
• the safety effect profile where additional medication may be required to manage those effects
• inclusion/exclusion criteria
• important documents that pharmacy hold - for example new versions of the protocol or IB. You should inform Pharmacy teams supporting your study of these changes and which version of the documents they should be working to
• the name of an IMP/AMP; this will also affect the labels.
• the packaging of an IMP/AMP
• the license status of an IMP
• the source of any product in the study
• the storage conditions for the product and/or the 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, or prepared IMP/AMP, or those requiring aseptic manipulation
• any changes to the accountability required for any IMP/AMP
• the post-trial access to any IMP/AMP, for example due to a change in the length of the study, introducing an extension study or a 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 notify the amendment according to the guidance for "Amendments for projects conducted in the NHS/HSC". The guidance in this section gives more information on how you can help sites in assessing continuing capacity and capability.

Amendments affecting active NHS/HSC sites

If you’re the sponsor of a trial and are preparing an amendment you should consider whether any changes affect pharmacy. In particular if it will affect the information contained within the technical pharmacy review form. Where the amendment does affect the pharmacy aspects you should highlight this in a covering letter to the site or in the Pharmacy Assurance Amendment Site Notification form. This will make it clear that the sites pharmacy department should review the changes. 

If you’re a site taking part in a trial and have received an amendment where it’s not clear if it will affect the pharmacy aspects of the trial we’d suggest contacting your local pharmacy department for clarification.    

Adding a new site

If you’re adding a new site to your trial you should provide this site with:

• the technical pharmacy review form for their capacity and capability assessment
• a summary of any amendments that you’ve previously submitted that affect pharmacy aspects of the trial. This can be in a covering letter or as part of the  Pharmacy Assurance Amendment Site Notification form.

For further information about whether an amendment will affect the pharmacy aspects of the trial, you should first speak with the pharmacy department involved in the design of the study for guidance. You can also review the list of changes above or contact pharmacy.assurance@hra.nhs.uk for additional guidance.

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Page last updated: 22 October 2024