Nomination and patient consent
Nomination and patient consent
A number of safeguards have been introduced to ensure that patient choice is maintained when the system is in use:
- The patient can always request a paper FP10: Even after EPS nomination, the patient can choose to have a paper prescription rather than an electronic one . An electronic prescription can only be issued to a patient’s nominated dispensing site. Patients who have not nominated a dispenser or who do not wish to have a particular script sent to a nominated dispenser will receive a paper prescription to take to any pharmacy.
- GP Practices must comply with patient choice: Regulations require* that a prescriber must not seek to persuade a patient to nominate a dispensing site recommended by the prescriber. If a patient asks for a recommended pharmacy, the prescriber is to provide a list of all R2 dispensing sites in the area. The information about which pharmacies are R2-anabled is provided by the NHS Choices Website therefore it is essential that pharmacy contact details held there are up-to-date and accurate.
- Contractors must comply with patient choice: Regulations** prohibit dispensers from providing patients with inducements to encourage nomination of a dispenser.
- NHS England should proactively monitor issues: NHS England have a duty to act on complaints about abuse of the service where the GP or pharmacy Terms of Service may have been breached. The NHS Digital are providing the NHS with both summary and detailed reports about nominations to support the investigation of complaints.
*The National Health Service (Primary Medical Services) (Miscellaneous Amendments) Regulations 2005
**The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
Patient consent form templates
PSNC nomination form (NHS Digital suggested text):
- RPS form (MS Word)
- Both the NPA and Numark have developed pre-printed EPS nomination patient information leaflet/consent forms which are available to purchase
The Department for Work & Pensions and the Office for Disability Issues have issued guidance on Accessible communication formats. The guidance contains a section on ‘accessible print publications’ which offers best practice guidance on font size, design, layout, etc for printing publications. This may be useful for contractors when looking to amend downloadable documents from the PSNC website.
Although nomination is not required to be captured in writing, PSNC strongly recommends using a written nomination consent form and for the audit trails to be kept, in case of future queries that relate to the setting of the nomination.
Obtaining consent for nomination: Messages to communicate
Pharmacists or their staff must obtain informed consent, and the following information is to be communicated when obtaining this:
- Nomination is not mandatory. Patients do not have to nominate a pharmacy in order to receive their prescriptions.
- If nomination is set, prescriptions are sent electronically to the nominated dispenser unless the patient explicitly opts for paper, or the item can only go on paper (e.g. an item not listed on the NHS database, dm+d)
- Nominating a pharmacy and using the EPS means there is no need to collect a paper prescription from the GP
- The patient can choose which pharmacy to nominate (if at all) and is not restricted to a nearby dispenser
- Patients can ask to set, change or remove their nomination at any time, at any Release 2 site including whilst part way through a repeat dispensing cycle. Any remaining repeat prescriptions, which have not been pulled down to the local system, may be accessed by the new nominated dispensing site.
- Patients do not need computer access to nominate a pharmacy or use EPS.
Is an SOP needed? RPS have confirmed a requirement that pharmacies should put in place a SOP for Nomination (RPS Good Dispensing Guidelines)
What are the benefits with an SOP? This ensures that nomination is both:
- communicated consistently to patients
- captured in an auditable way so that, if challenged, processes are in place to back up information following on from a customer complaint or from an audit perspective.
Where can a template be found? Both the NPA and Numark have developed template SOPs.
Can the AT sign-off on an SOP? It would not be appropriate for a local NHS England team to request to individually sign-off a pharmacy nomination SOP or state that a pharmacy cannot begin to collect consent for nomination until the team has seen a SOP. In joint PSNC/NHS PCC Guidance on monitoring the contract’s Essential Services, it was agreed that the monitoring should only extend so far as to whether a pharmacy has an appropriate SOP, for example ask to see it during a monitoring visit. The guidance stated that it would be unwise for a local NHS England team to carry out any detailed examination, because it will be unable to determine what is appropriate for the individual pharmacy concerned, and any shortcomings not identified, or suggestions made which themselves cause problems in delivery of the services, could lead to the local NHS England team itself being involved in litigation.
EPS Release 2 sign
To support patients in recognising which sites are Release 2 enabled, the NHS Digital has developed a sign which can optionally be displayed within prescribing and dispensing sites. The sign will be supplied to a site at the time of going live with Release 2 and will be available in three different formats, A5 window sticker, A4 poster or A5 counter-top sign. If this sign has not been received, it can also be obtained from Department of Health and Social Care’s Publications Orderline while stocks last.
Guidance explaining the four principles of nomination are set out within this factsheet (endorsed by NHS Digital): EPS nomination core principles.
More detailed national Nomination guidance has also been published by NHS England and NHS Digital. The guidance is designed to support all EPS users including pharmacies.
EPS users ensuring they comply with these nomination guidelines may reduce the frequency of need to use the EPS Return to Spine feature.
Poster on freedom of choice (updated Oct 2015)
Patients should be able to choose their own pharmacy, based on the convenience to them and the quality of service that is provided. A poster which sets out the right for patients to make their own choice has been produced and pharmacies are asked to display this prominently and as close as practicable to the location where patients receive prescriptions. Distance selling and internet pharmacies should display this information prominently on their websites and take reasonable steps to bring this notice to the attention of all patients, for example by including copy of this notice with dispensed medicines that are delivered to patients.
In October 2015, NHS England wrote to all general practices and pharmacies to ask for their help in ensuring that all patients are aware of their right to choose freely without influence. The poster can be downloaded below and a copy has been sent to all pharmacies in the October edition of Community Pharmacy News which will arrive later during October 2015.
Q. Does consent have to be obtained to change a patient’s nomination settings?
A. Yes, it is a professional requirement. The Code of Ethics states that pharmacists must obtain consent for the professional services, treatment or care they provide and the patient information they use. The RPSGB document, ‘Professional Standards and Guidance for the Sale and Supply of Medicines’ contains standards for prescription collection services and the RPSGB document, ‘Professional Standards and Guidance for Patient Consent’ details more general requirements on collecting consent from patients for the provision of services, including guidance on providing sufficient information and presenting this to patients. Failure to adhere to these standards could form the basis of a complaint of professional misconduct.
Q. Does consent always have to be given by the patient?
A. No, in some circumstances, consent can be obtained from the patient’s representative on behalf of any:
- child by either parent, or in the absence of both parents, the guardian or other adult who has the care of the child;
- person under 18 years of age who is in the care of an authority to whose care he has been committed under the provisions of the Children Act 1989, by a person duly authorised by that authority or in the care of a voluntary organisation, by that organisation or a person duly authorised by them;
- adult who is incapable of nominating a pharmacy, by a relative or the primary carer of that person;
- person by any duly authorised person.
A pharmacy contractor is not able to provide consent on behalf of a patient nominating his pharmacy.
Q. My pharmacy serves a large care home. Do the patients need to provide their consent to nominating my pharmacy or could this be done by care home staff?
A. The regulations state that patients or in some cases their carers can set a patient’s nominated dispensing site, therefore the care home staff can on behalf of the patient provide the required consent for the patient’s nomination setting to be changed.
Q. Do I have to change my Standard Operating Procedures?
A. Pharmacies must have ‘local accountable auditable processes’ for obtaining explicit consent before changing a patient’s nomination settings.
The RPSGB publication ‘Professional Standards and Guidance for Patient Consent’ advises that processes for obtaining consent must be taken into account when developing SOPs and that consideration needs to be given to which members of staff may obtain consent, the information that should be provided in obtaining consent and the way that consent is collected (e.g. written, verbal).
Both the NPA and Numark have developed template Nomination SOPs.
Q. How long should I keep a nomination consent form that has been signed by the patient?
A. Pharmacies must have ‘local accountable auditable processes’ for obtaining explicit consent from the patient or their representative before changing a patient’s nomination settings. Whilst it is not mandatory for a pharmacy to collect a patient signature to confirm consent, this has been recommended by the Royal Pharmaceutical Society. The collection of a signature will support the pharmacy by providing an audit trail in the event that a complaint is made about the pharmacy’s use of the service.
It is for a contractor to judge how long forms should be kept for, balancing the need for an audit trail against the 5th Data Protection principle of not keeping information longer than necessary. Note, if the patient chooses to change their nomination setting at another pharmacy, the original nominated pharmacy will not be alerted to this. There is scope for PMR systems to generate reports of patients regularly receiving prescriptions at the pharmacy via the nomination functionality which will help identify patients with ‘active’ nominations.
Q. I have an existing repeat prescription collection service. Do I need to obtain consent to change the patient’s nomination settings to nominate this pharmacy as their preferred pharmacy for electronic prescriptions?
A. Yes. Explicit consent must always be obtained from the patient or their representative before changing a patient’s nomination settings.
Explicit consent can be collected in advance of the pharmacy deploying Release 2. If there is a delay between collecting consent and changing the patient’s preference on the Personal Demographics Service, the pharmacy contractor should ensure there has been no change in the patient’s circumstances, including their choice of nominated dispensing site, since the original consent was obtained.
Q. Can I provide patient’s with loyalty points or a free gift if they choose to nominate this pharmacy?
A. No, the Terms of Service prohibit pharmacies and appliance contractors from providing patients with inducements to encourage nomination of a pharmacy. A breach of the Terms of Service could result in the Primary Care Trust taking disciplinary action against the pharmacy contractor.
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