Scotland – Pharmacy Regulation Changes
In December 2021 the Scottish Ministers implemented changes to the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009. The changes recognise that premises that are not NHS pharmacies may be used as both collection points for patients to drop off prescriptions and also for patients to collect dispensed medicines. As the Scottish ministers put it
“[these changes] make provision for the collection of prescriptions for, and supply of, medicinal products in accordance with a collection and delivery arrangement as defined by regulation 248(2) of the Human Medicines Regulations 2012.”
However, the Human Medicines Regulations 2012 have applied in Scotland since their inception in 2012 – so why the need to formally recognise the provisions now?
The change came about because one of our clients wanted to operate a Medpoint machine (see www.medpointuk.com) that allows patients to collect their dispensed medicines from a machine rather than from a pharmacy. These machines are increasingly popular and provide patients with alternatives for collecting dispensed medication, including out of hours, but can also provide an opportunity for pharmacy contractors to expand their business by locating a collection point in a town, village, or any location where there may not be a pharmacy and the contractor wants to offer this service.
Our client installed a Medpoint machine at a location where they did not have an NHS pharmacy (or any sort of pharmacy) and was fairly quickly told by the Health Board that it needed to be removed. Our client relied on the Human Medicines Regulations 2012 as providing authority for such a collection and delivery system but the Health Board (possibly encouraged by some established pharmacy operators) argued that the relevant Regulations in Scotland did not permit such activity. In particular, they quoted paragraph 13 of the Terms of Service which states;
(13) A relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, supply any drugs or listed appliances ordered on a prescription form or serial prescription other than at a registered pharmacy which is included in the pharmaceutical list.
On the face of it this provision did stop our client from using the Medpoint machine, but our client argued that the Human Medicines Regulations 2012 took precedence and that paragraph 13 was unlawful as it sought to restrict an action that was specifically permitted by the Human Medicines Regulations 2012.
Ultimately the Health Board and Scottish Ministers had no choice other than to accept that the restriction in the pharmacy regulations was unlawful and they have now amended the Regulations to note that collection and delivery arrangements can happen at premises that are not NHS pharmacies.
What this means is that, for the first time in Scotland, the use of prescription collection machines like Medpoint can now happen even if they are located away from an NHS pharmacy. Similarly a pharmacy contractor could open a private pharmacy (ie one without an NHS contract) or any other type of premises and manage the collection of prescriptions and provision of medicines dispensed by an NHS pharmacy to patients.