The South West Product Approval Accreditation Programme is a national training course that has been developed to deliver a functional and high-quality training and assessment programme for individuals who carry out the task of “product approval” for aseptic products, prepared within hospital pharmacies under section 10 exemption from the Medicines Act 1968.
The programme addresses the training requirements of both pharmacists and suitably trained and experienced, registered pharmacy technicians. As a result, the accreditation must be applied alongside an operating framework that ensures that pharmacist supervision and other governance and safety requirements are fulfilled.
The Product Approval Accreditation Programme consists of:
The course is open to applications from across the United Kingdom.
Entry Criteria for Participating Sites
Note that for pharmacists to go forward in the training and assessment programme there are no site specific criteria as participation is encouraged from all Aseptic Services units. For a unit wishing to go forward with Accredited Pharmacy Technician Product Approvers then the following will apply:
a) All relevant SOPs are in place and all worksheets approved by the Accountable Pharmacist
b) Risk Management arrangements are satisfactory including robust change control processes
c) Suitable staff training programmes and resources are available
d) Clinical checking by accredited pharmacists and prescription verification is carried out by Authorised Pharmacists1
e) A robust in-house system of dealing with errors including monitoring, reporting, managing and trending of errors is in place and the reviewing of data from the National Error Reporting Scheme. Sites should report to the National Error Reporting Scheme
There must be data to support the baseline error rate. Error rates must be part of the acceptance criteria for the Change Control when introducing the change to allow accredited pharmacy technicians to carry out final product approval
f) Robust Quality Management Systems, including deviations and untoward events reporting and investigation are in place
g) The management structure is compliant with the nationally agreed definition of supervision.
Entry Criteria for Pharmacists
The following criteria will apply:
The pharmacist is allocated to an aseptic unit for a suitable minimum period of time sufficient to complete the programme (3 months).
The individual should be committed to the process
Entry Criteria for Pharmacy Technicians
The following will apply:
The registered pharmacy technician is allocated to an aseptic unit for a suitable minimum period of time sufficient to complete the programme (3 months).
They should have least 2 years full-time or 3 years rotational aseptic experience and be accredited in line with the national framework, to perform pre & in-process checks in aseptic preparation.
The individual should be committed to the process.
Accountable Pharmacist Approval
Each trainee must be approved by the Accountable Pharmacist ahead of registration onto the programme.
Who can be the Educational Supervisor?
The Educational Supervisor can be:
Educational supervisors must be approved by the Chief Pharmacist and Accountable Pharmacist.
It is recommended that the educational supervisor is someone who has the opportunity to meet regularly with the trainee to discuss progress and give feedback.
Scope of the framework
This programme applies to section 10 aseptic services final product approval, including cytotoxics, biopharmaceuticals, parenteral nutrition and CIVAs products
Intrathecal products can be included as long as the final product approver is trained, competent and named on the intrathecal register for this task.
With suitable additional training this can be extended to cover final product approval of Clinical Trials under Paragraph 37 of the Clinical Trials Regulations where the medicines used are licensed products (but not for novel IMPs).
Subject to suitable training and understanding of the status and requirements to the release of outsourced named-patient ready-to-administer products.
Products made in anticipation of a prescription cannot be released until matched with a verified prescription
Exclusions from the process
The process applies to aseptically prepared pharmaceuticals only and with the following exemptions:
Please click the application button below to apply for the PAAP Programme. Once you have received your acceptance email and login details for the programme please apply for an Online Induction date that is most suitable for you. Please note: you must have completed all of the pre-induction activities and assessment prior to attendance at induction.
Please only apply for Online Induction if you have received confirmation that you have been accepted onto the PAAP programme.
The Online Induction will enable trainees to attend the day remotely via virtual classroom. Details of how to access the event will be sent out to you once your application has been processed.
Once you have completed your evidence collection and your e-portfolio you will need to apply for your Online Panel Assessment below.
For further information, please contact: Jen Gilliam, Programme Director, Jennifer.email@example.com tel: 0117 342 6677.