Serious Shortage Protocols

McKesson UK Clinical Director and LloydsPharmacy Superintendent Pharmacist, Steve Howard:

Last year’s urgent consultation by the Department of Health and Social Care (DHSC) has led to draft legislation which could allow pharmacists under a serious shortage protocol (SSP), to sell or supply a medicine of different strength, quantity or pharmaceutical form to the one prescribed without consulting a doctor.

An opportunity to extend our professional judgement is definitely welcome, but in the same way that there are implications for patients who don’t receive their medicine, there are also implications for community pharmacists and their businesses.

The recent global shortage of EpiPens prompted the DHSC to issue urgent guidance for the disruption to supply and community pharmacy stepped up to the plate at short notice. We were able to implement a reliable and consistent protocol that worked very well, validating with both patients and wholesalers.  However, any medicine could be in shortage and it might not be substitutable easily, so guidance needs to be extremely clear.

Dealing with a single shortage like EpiPen would seem relatively straightforward, but there are signs that shortages are becoming more frequent, part of business as usual. Even though SSPs would only be implemented ‘in exceptional circumstances’, there is a possibility of the protocols being required in the near future…

It’s important that the general public are aware when these situations arise so that patients know what to expect when they get to the pharmacy and that the NHS works with the pharmacy sector to help educate them on these potential changes to support them getting the medicines they need.

As has been highlighted by GP bodies, substituting with therapeutic equivalents presents some risk. Brand continuity is especially important with some classifications of medicines.

We are yet to hear from the regulator what view would be taken of a ‘dispensing error’ under such circumstances, nor have we received reassurance from government about breach in our terms of service. Both would be required to reassure pharmacists on the frontline.

Regardless of the specific medicines impacted by the shortage, or the protocol to be implemented, it’s obvious that there will be a requirement on the pharmacist to undertake the necessary checks and spend time with the patient. A detailed consultation could be required, and potentially reference to the SCR.  Comprehensive notes will be essential.  These clinical checks could be time consuming.

Pharmacists would also need time to understand the protocol.

So how does this impact business? Queues, possibly.    What about the impact on services?  If we need to spend extra time on these essential conversations with patients, there is bound to be an impact on services’ income.  If there are numerous protocols and service is severely impacted, the number of items could be affected.  If SSPs become a regular fixture, they should perhaps be recognised in our remuneration.

This legislation is empowering and could change positively the way we do things forever. It gives a sense of why it’s important to have a vibrant, successful community pharmacy network to work with the government in times of shortage.  It’s hard to see how an online pharmacy alone – without ‘bricks and mortar’ back up could provide this vital support.