Fitness Information
Published on: 19th July 2013 | Updated on: 12th September 2024
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| Pharmacy Regulations 2013 |
Under the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, pharmacies are required to provide a Fitness to Practise declaration to NHS England (through their ICB) when they join a pharmaceutical list, and to keep the ICB updated if they are subject to any incident which may affect their Fitness to Practise.
Update – 6th September 2024:
Market Entry Applications Regulation Changes – comes into effect 1 October 2024
Regulations have been laid which come into effect from 1 October 2024 to ease the market entry application process.
Applications to open new pharmacies usually involve two parallel, related applications, the market entry application, for example, to establish a new NHS pharmacy, and a related fitness information application, to ensure that the new owner of the pharmacy (corporate or individual/partnership of pharmacist(s)) is a fit and proper person to own an NHS pharmacy. In many cases, fitness information is required from existing contractors.
The requirement for references (from referees nominated by the applicant) will no longer be required. References were considered to be of limited value and obtaining them often resulted in delays to the whole application process. This change should make this part of the process less onerous for applicants and help to reduce delays with market entry applications.
These changes apply to new and existing applications. However, with an existing application, if the ICB has relevant information that suggests a reference should be sought, it may do so.
Fitness Information Requirements – Briefing
We have produced a briefing that expands upon the requirements of the regulations for fitness and some of the issues relating to market entry applications.
New applications to ICBs
When an application is made to an ICB for inclusion in a pharmaceutical list, the application must be accompanied by a Fitness to Practise declaration, unless the applicant already provided that information and the information is up to date.
PCSE on behalf of NHS England publishes template forms (fitness to practise forms) which contractors can use to provide them with this information.
The duty to provide Fitness to Practise information arises from Part 1 of Schedule 2 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
Updating ICBs of fitness matters
All pharmacy owners who are the subject of new adverse fitness to practise incidents must notify their ICB within 7 days of the occurrence. Community Pharmacy England has produced an ‘e-form’ template, which can be completed in Microsoft Word by clicking the link below. The Fitness to Practise forms produced by Community Pharmacy England are not mandatory.
Fitness to Practice Update Form (formerly form FtP2) (MS Word e-form)
The duty to provide updated information about Fitness to Practise matters for pharmacists on pharmaceutical lists are dealt with under Paragraph 31 of Schedule 4 to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
All of the information that would be provided by a contractor using the Community Pharmacy England FtP Update form is either that required by the local NHS Team, as outlined in the Regulations, or is considered to be appropriate information to provide to the local NHS Team in order to serve as identifying information (e.g. Superintendent Pharmacist registration number).
Despite the length and complexity of the template, its completion will pose no difficulty for the majority of pharmacy owners.
FAQs
The fitness to practise provisions in the Terms of Service require pharmacy owners to notify their ICB within 7 days of an adverse fitness to practise incident. A pharmacy owner who is under investigation by a regulatory body into his professional conduct must report this to the ICB. The FtP Update form above may be useful as a template.
Yes, if NHS England is satisfied that it is necessary to do so for the protection of the public or is otherwise in the public interest, it may suspend a pharmacy owner from the pharmaceutical list.
Suspension means, that whilst the pharmacy owner is suspended, he/she is treated as not being included in the pharmaceutical list. Suspension is a neutral act and does not imply that the pharmacy owner has done anything wrong. It is a protective act – with the protection of the public or the public interest in mind – it should not be considered a punishment. The practical effect of suspension is that during this period, you will not be able to provide NHS pharmaceutical services – though see below for applications for temporary listing of another person (individual or body corporate) arising out of a suspension.
Yes, before NHS England decides to suspend, it must notify you of the intended action e.g. suspension and the grounds on which it is considering taking that action. NHS England must also confirm any allegation against you and advise that you may make oral representations to them with regard to the possible suspension on a specified day.
You may wish to notify NHS England that you intend to make oral representations on a specified day (which NHS England will state) within a specified period (set out in NHS England’s notification) – which cannot be less than 24 hours. If you do this, then NHS England must not suspend you until after an oral hearing, but may then suspend you with immediate effect.
If you do nothing then NHS England may suspend you with immediate effect.
It depends.
In suspension cases which suppose that the continued inclusion of the pharmacy contractor in the list would be prejudicial to the efficiency of those providing pharmaceutical services, fraud or is otherwise unsuitable to be included in the pharmaceutical list, NHS England must specify the length of the period of suspension.
In other suspension cases, whilst NHS England awaits a decision affecting the pharmacy contractor of a court or of a regulatory body anywhere in the world, NHS England may (but is not obliged to) specify that the pharmacy contractor remains suspended after the decision referred to for an additional period which NHS England must specify.
Yes, it is possible to apply for a temporary listing of another person (individual or body corporate) arising out of a suspension. This application should be determined by NHS England within 30 days from the date of receipt of all required information and documentation, unless there is good cause for a delay.
For more information on this topic please email comms.team@cpe.org.uk
