Background
The Royal Pharmaceutical Society is concerned about the impact that medicines shortages are having on patient care.
We are aware that pharmacists and GPs are having to spend increased time dealing with medicines shortages1, with community pharmacists legally obliged to contact prescribers or refer people back to prescribers to amend original prescriptions, even for minor adjustments.
This is frustrating for the patient, pharmacist and prescriber. The process can cause significant delays in patient access to medicines and take up valuable health professionals time.
Our members have expressed that this situation is now a regular occurrence in their daily practice. Furthermore in times of pandemic or emergency situations the effect on patient care can become particularly acute.
The introduction of the Serious Shortage Protocol (SSP) legislation in 2019 aimed to mitigate the impact of serious national shortages in certain medicines. It enables community pharmacists in the UK to supply a medicine against the protocol issued2. The protocol can authorise a supply of a different formulation, strength and/or quantity of medicine.
Consistent and widespread feedback from our members to date however suggests that SSPs are rarely used and when they are issued, they are bureaucratic, professionally frustrating and inflexible. They are not supporting continuity of care or minimising the burden across the healthcare system as intended. A more pragmatic approach is required.
In Scotland shortages are published on the ‘Scotland health on the web’ (SHOW) website3. The website hosts 37 medicines supply notices published since September 2019. These are not official SSPs but do raise awareness of a medicine shortage with recommendations for actions.
Times of uncertainty will significantly exacerbate medicines shortages issues. These include events such as pandemic outbreaks and major constitutional or political changes. However, it must be emphasised that medicines shortages occur for a wide variety of reasons and are now a regular occurrence in community pharmacy. A solution is required to address everyday shortages which ensures continuity of patient care without an unnecessary bureaucratic burden on prescribers and pharmacies dispensing the prescriptions.
Legal context
It is a requirement of The Human Medicines Regulations (HMR) 2012 as amended that the sale or supply of a prescription-only medicine can only be in accordance with a prescription given by an appropriate practitioner. It does not authorise pharmacists to amend prescriptions in any way unless the prescriber changes the prescription.
Regulation 214
214.(1) A person may not sell or supply a prescription-only medicine except in accordance with a prescription given by an appropriate practitioner.
The above regulations include a set of exemptions such as supplies made through Emergency Supply, under Patient Group Direction and under current SSPs.
To enable pharmacists to support people with medicines shortages we require an amendment to the regulations to allow pharmacists to make minor amendments to allow the prescription to be dispensed, without the requirement to contact the prescriber.
Such an amendment will capitalise on the clinical expertise of pharmacists and their knowledge of the particular medicine shortage situation in question and enable patients to have access to the treatment that they require in a timely manner.
Policy asks
The RPS believes there is a better solution which uses the clinical expertise and professionalism of pharmacists to help manage the continuity of care for people prescribed medicines that are in short supply. This solution will also minimise the burden across the healthcare system and provide parity across the UK.
To improve patient access to medicines and to mitigate the negative effects the medicines shortages, legislation should be amended to allow pharmacists to make minor amendments without a protocol. Amendments would include changes to as:
- Different quantity
- Different strength
- Different formulation
- Generic version of the same medicine (generic substitution).
Such substitutions have been standard routine practice for pharmacists in secondary care for years and are used in Scotland for medicines on the recognised shortages list ( see above). Similarly, in Wales the All Wales Pharmacist Enabling and Therapeutic Switch Policy enables pharmacists, to make certain changes to prescriptions without contacting the prescriber.
*Please note: We are not calling for therapeutic substitution. If such changes are necessary due to medicines shortages, pharmacists should notify the prescriber of potential alternatives to help them make appropriate changes to medicines that are currently in stock.
The changes would allow community pharmacists to:
- Change the formulation of a prescribed medicine if they have assessed it to be clinically appropriate. For example, Omeprazole 20mg capsules to Omeprazole 20mg tablets
- Change the strength and quantity on a prescription to achieve the same dose and duration of supply to the patient. For example: Against a prescription for 28 Fluoxetine 40mg capsules to take one a day, pharmacists may dispense 56 Fluoxetine 20mg capsules and change the directions accordingly to take two daily.
Changes will be made based on the pharmacist’s professional and clinical judgement. Pharmacists must be aware that they are responsible for any changes made. Importantly, a thorough consultation with the patient is essential to ensure understanding of the necessary change.
The changes would not allow pharmacists to:
- Change formulations or generic substitutions of medicines with considerable bioavailability differences such as some antiepileptics, mood-stabilisers and blood pressure medication
- Amend prescriptions for controlled drugs schedule 1, 2 and 3.
Any amendments will need to be;
- Endorsed by the pharmacist to show the change to the original prescription for pricing purposes.
- Clearly made and attributed to the pharmacist making them
- Recorded and stored at the pharmacy. The record should describe why the amendment was needed and provide a robust audit trail.
Benefits of the proposal:
- Patients will receive more efficient, and timely, access to their medicines
- A decrease in workload on prescribers being contacted to make minor amendments to prescriptions
- Pharmacists will be using their professional skill and judgement to safely support people with their medicines
- Pharmacists will be better able to help people manage medicines during periods of medicines shortages with consistency across the UK
- It will avoid unnecessary bureaucracy and the need for an SSP to be developed, signed and authorised by a Minister. This allows the system to respond quickly and with flexibility should medicines shortages worsen due to supply chain issues.
[1] https://www.pgeu.eu/publications/press-release-pgeu-medicine-shortages-survey-2019-results/
[2] https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/serious-shortage-protocols-ssps
[3] https://www.sehd.scot.nhs.uk/index.asp?name=MSAN&org=&keyword=&category=1&number=10&sort=tDate&order=DESC&Submit=Go&offset=-1