Lawyer reveals how pharmacists could supply the COVID-19 vaccine
Lawyer Noel Wardle reveals how pharmacists could supply the COVID-19 vaccine lawfully whenever it becomes available under pharmacy requirements that come into force today
On October 19, the Department of Health and Social Care (DH) laid new regulations before parliament that will implement changes to the NHS terms of service for community pharmacy contractors, including amendments on how they should deal with the COVID-19 pandemic.
The first change – which comes into force today (November 9) – requires pharmacies in England to supply medicines in accordance with a “pandemic treatment protocol (PTP)”.
A PTP is an exemption from the usual legal requirement that a prescription-only medicine may only be supplied in accordance with a lawful prescription.
There are several conditions for a PTP, which are contained in the amendments to the Human Medicines Regulations 2012:
- Condition A is that the supply is made while a disease is pandemic, or anticipated to be imminently pandemic; and a serious or potentially serious risk to human health.
- Condition B is that the supply is in accordance with a protocol that has been approved by the government or an NHS body.
- Condition C sets out the requirements of a protocol including the recording and supervision requirements for healthcare professionals giving the vaccines to patients.
- Condition D is that the medicine supplied is authorised for supply.
Of course, while the amendments to the Human Medicines Regulations enable supplies to be made under a PTP, if the NHS wants community pharmacies to make these supplies then the terms of service have to be amended to enable – or, as in this case, require – pharmacists to make those supplies; hence the changes being implemented by the DHSC now.
The new terms of service provide that a pharmacy in England must supply medicines to a patient in accordance with a PTP “with reasonable promptness” where:
- The pharmacist receives, via a secure service approved by NHS England for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP.
- A person who is entitled to be supplied with that drug under the PTP requests the provision of the drug.
Where a PTP has been issued by the NHS, pharmacists will therefore need to consider the terms and scope of the PTP to ensure that a patient presenting at the pharmacy is entitled to be supplied in accordance with the PTP, otherwise the patient will need to get a prescription in the usual way to avoid the supply being unlawful.
Where a medicine is supplied under a PTP, the new terms of service require that the dispensing label must also contain “information to the effect that the product is being supplied in accordance with a PTP, identifying the particular PTP”.
Pharmacists will not be required to supply medicines under a PTP in circumstances, for example, where the pharmacist suspects it is not a “genuine order” or where providing it would be “contrary to the pharmacist’s clinical judgement”. This mirrors exemptions from the obligations to supply medicines on prescription. It is a reminder that pharmacists must exercise an independent clinical judgement before PTP supplies are made.
The second COVID-19-related change is intended to free up pharmacy staff to concentrate on pandemic vaccinations.
Ordinarily, pharmacies must provide all essential pharmaceutical services throughout the opening hours of the pharmacy. In terms of prescription medicines, these must be supplied “with reasonable promptness” during the full opening hours of the pharmacy. What is “reasonable” will, of course, depend on the specific circumstances in the pharmacy at the time that the patient requests a service (such as stock availability and busyness). The “reasonable promptness” requirement is generally interpreted as meaning that the pharmacy must be open to patients and appropriately staffed during all its usual opening hours.
The current terms of service obligations mean that the pharmacy cannot close its doors to its usual business to concentrate on a particular service, such as vaccinations, for prolonged periods.
It is hoped that a COVID-19 vaccine will become available in the next few months, but even if (or when) a vaccine does become widely available, vaccinating a population of almost 56 million people in England will be a huge logistical challenge that will require a significant effort across the whole of the healthcare system.
Community pharmacies are, of course, ideally placed to participate in this effort as they have proved time and time again with the flu vaccination service. However, in order to enable community pharmacists to play their part in a potentially vital mass-vaccination programme, the DH has realised that pharmacies may need to pause their usual service offering to free up resources.
The DH is therefore amending the NHS terms of service to enable pharmacies to limit the pharmaceutical services provided from the pharmacy premises during set hours to only the provision of “relevant immunisation services”.
To avoid NHS England having to deal with requests from every community pharmacy in England to provide only vaccination services at particular times, the amended terms of service will allow NHS England to announce that it is prepared to agree particular arrangements for all pharmacies – for example that pharmacies are permitted to provide only immunisation services for a certain number of hours a day or at particular times.
As long as the pharmacy complies with those pre-announced “particular arrangements”, then it can be assumed by the pharmacy contractor that it has the agreement of NHS England to proceed unless it receives a contrary notification.
The war against COVID-19 goes on but these changes from the DH, making medicine supply more flexible, provide community pharmacies in England with the ammunition needed for the next battle of mass immunisation.
Noel Wardle is a partner and head of healthcare regulation at Charles Russell Speechlys