Distance selling pharmacies
Distance selling pharmacies
|Pharmacy Regulations 2013|
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 detail a number of conditions for distance selling pharmacies in addition to the regulations governing all pharmacies.
As compliance with the conditions is a pre-requisite for all distance selling pharmacies to remain on the pharmaceutical list, breach of the conditions could lead to removal from the Pharmaceutical List by NHS England.
The following is a guide to the regulations, available at legislation.gov.uk. Regulations 25 and 64 specifically apply to distance selling pharmacies.
1. A distance selling pharmacy must not provide Essential services to a person who is present at the pharmacy, or in the vicinity of it. In addition, the pharmacy’s SOPs must provide for the Essential services to be provided safely and effectively without face to face contact with any member of staff on the premises. NHS England could ask for sight of the SOPs when considering an application to satisfy itself that the conditions will be met.
A distance selling pharmacy receives a prescription via post and dispenses it the next day, sending it via courier. The pharmacist telephones the patient to counsel the patient on the medicine’s correct use. This arrangement satisfies the conditions as no face to face contact has taken place on the pharmacy’s premises.
A distance selling pharmacy returns a prescription to the patient saying that because it orders a controlled drug, the pharmacy will not be able to dispense it. In this case, the pharmacy is in breach of the terms of service which requires all pharmacies to dispense any drug that is ordered, ‘with reasonable promptness’. NHS England could issue a breach notice, could order a withholding of remuneration, and could in some circumstances remove the pharmacy from the pharmaceutical list.
2. A distance selling pharmacy may provide Advanced and Enhanced services on the premises, as long as any Essential service which forms part of the Advanced or Enhanced service is not provided to persons present at the premises.
A distance selling pharmacy receives a prescription and dispenses it the next day, sending it via post with a consent form and explanatory leaflet about the New Medicine Service, inviting the patient to contact the pharmacy. The patient lives locally and so makes arrangements to visit the pharmacy, to complete the NMS. The pharmacy would need to be very careful not to provide or offer to provide any of the Essential services whilst the patient is at the pharmacy. The patient brings some unwanted medicine back to the pharmacy at the same time as attending for the NMS consultation. The pharmacy is therefore in a dilemma, as accepting the waste at the pharmacy would breach the conditions.
3. The pharmacy’s procedures and SOPs must allow for the uninterrupted provision of Essential services during the opening hours of the pharmacy to anyone in England who requests the service. NHS England could ask for sight of the SOPs, during the application process, to ensure that adequate arrangements have been made to satisfy this condition.
A distance selling pharmacy provides NHS England with a SOP detailing how the pharmacy will receive prescriptions from a drop box in the local GP’s practice, and will have an advice hotline which will operate between 5-6pm during the week. NHS England refuses the application on the grounds that only patients who are local to the GP surgery will be able to send prescriptions, and the advice hotline (and so the Dispensing, Signposting and Support for Self Care essential services) will only operate for a proportion of the pharmacy’s core hours.
4. Nothing in any written or oral communication such as a practice leaflet or any publicity can suggest, either expressly or impliedly, that services will only be available to persons in particular areas of England, or only particular categories of patients will (or will not) be provided for.
A distance selling pharmacy publishes a leaflet which states ‘Our delivery vans are available within a 25 mile radius. We can arrange for delivery by post outside this area, but cold chain products, such as insulin cannot be sent this way’. The pharmacy is likely to be found in breach of the conditions, as patients with diabetes requiring insulin who live outside the area would be unable to obtain their prescriptions from the pharmacy.
Q. Is a distance selling pharmacy eligible for the Pharmacy Access Scheme?
A. No. Distance-selling pharmacies (e.g. internet pharmacies) are not included in the scheme; this is because the scheme is intended to protect physical access to bricks and mortar pharmacies.
Q. Can a distance selling pharmacy provide an Advanced service?
A. A distance selling pharmacy may provide an Advanced service such as the flu vaccination service on the pharmacy premises, as long as any Essential service which forms part of the Advanced service is not provided to persons present at the premises.
There is also the coincidental risk of providing related Essential services which is easy to slip into when seeing patients face to face at the pharmacy. For example, how would the DSP respond if the patient brings some unwanted medicine back to the pharmacy at the same time? Unwanted medicines is an Essential service and accepting unwanted medicines face to face at or in the vicinity of the pharmacy premises is likely to be a breach of the terms of service.
Another example is if the patient presents an NHS prescription to be dispensed – this is an Essential service. The pharmacy is therefore in a dilemma, as dispensing drugs or appliances at the pharmacy would again likely be a breach of the terms of service.
Q. Can a distance selling pharmacy provide locally commissioned services?
A. Technically, yes. The Regulations prohibit DSPs from offering to provide essential services to persons face to face at (which includes in the vicinity of) the pharmacy premises. Therefore, this would not apply to services commissioned locally by the local authority or CCG.
Nevertheless, the key question remains as to whether there is any possibility of a person being offered or provided with any element of the essential services during the course of the locally commissioned service? If yes, then it is likely to be a difficult decision on the part of the local authority or CCG to locally commission the service. NHS England are under a duty to enforce regulation 64 (with no discretion to do otherwise) and so a breach of this fundamental condition leaves the DSP liable to removal from the pharmaceutical list. An example of could be where a local authority intends to commission a supervised consumption service which necessarily involves an element of the essential services – dispensing of methadone for supervised consumption by the patient.
Q. The Local Authority (Public Health) have decided not to commission my distance selling pharmacy to provide the locally-commissioned smoking cessation service. Can I challenge this decision?
A. The decision of whether to commission or not is one for the local authority. If a pharmacy contractor wished to challenge a decision then they should be encouraged to seek independent legal advice as procurement law is a complex specialist field outside of the remit of PSNC.
Q. Does the European Regulation to inform customers about the existence of an online dispute resolution platform if they have a problem with their online purchase apply to me?
A. In February 2016, new European Regulations come into effect requiring traders engaged in online sales or services contracts to inform consumers about the existence of the online dispute resolution platform and the possibility of using that platform to resolve disputes.
No. These Regulations do not currently apply to “health care services” which are health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices (see Part (a) of Article 3 of Directive 2011/24/EU). A “Health professional” includes a pharmacist.
Q. The regulations state that distance-selling pharmacies are to provide essential services ‘without face to face contact’ between the contractor or their staff and the patient. Can a distance-selling pharmacy use a delivery driver to collect prescriptions and deliver medicine to patients?
A. The prohibition on face to face contact has been in place since 2005 and continues under the new regulations. The prohibition on face to face contact only covers the provision of essential NHS pharmaceutical services, at the pharmacy premises. This means that a delivery driver employed by the contractor could (a) collect a prescription from the GP surgery; and (b) deliver the dispensed items to the patient at their home.
Q. Can a distance selling pharmacy charge for delivery of prescriptions?
A. Under the National Health Service 2006 (Part 1 1(3)), all NHS services must be provided free of charge except where a charge has been expressly mandated by legislation. As no legislation has been passed that would allow this, it would be against the Act to request payment for the delivery of a prescription. Bricks and mortar pharmacies are able to charge for delivery as part of a private service (except where the item is a Part IXA specified appliance).
Q. I am a DSP. Do I need to display the EU common logo? A. Yes. From 1 July 2015, everyone (including traditional “bricks and mortar” pharmacies with an online presence) authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA) to sell human medicines online in the UK must display the EU common logo on every page of their website offering to sell human medicines. You also must be registered with and be on MHRA’s list of UK registered online sellers available here. Patients will be able to verify your entry on MHRA’s register of authorised online sellers of medicines as the EU common logo will contain a hyperlink to the seller’s entry on the register.
Persons selling human medicines online without MHRA registration and / or not displaying the EU common logo can be sentenced to up to two years in prison, or fined, or both.
Future changes to distance selling pharmacies
On 20th October 2016, in the two-year final funding package imposed upon community pharmacies in England, the Department of Health and Social Care recognises that there are different types of community pharmacy providers and, as part of their initial proposals, set out their intention to explore new terms of service for distance-selling pharmacies in recognition of their different service offering.
This will be the subject of further consultation with the PSNC.
PSNC Briefing 023/15: Providing pharmacy services at a distance (April 2015)
The General Pharmaceutical Council (GPhC) has issued guidance for registered pharmacies providing pharmacy services at a distance. This will apply to most community pharmacies, both distance selling and bricks and mortar, as many now provide collection and delivery of prescriptions as part of their dispensing process. This briefing summarises some of the key aspects of the guidance and how pharmacy contractors can ensure they are following them.