Caution, Serious Shortage Protocol ahead: Seven things you need to know


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By Noel Wardle

07 Aug 2019

Pharmacy law expert Noel Wardle gives the run-down on the seven pressure points the SSP brings to pharmacists

Pharmacists are used to taking care when they supply medicines to their patients and working hard to make sure they get them as quickly and safely as possible. However, this care and effort is magnified when a supply is to be made under the new Serious Shortage Protocol (SSP).

By way of a reminder, SSPs enable patients to obtain alternative medicines (in terms of strength, formulation, brand/generic or therapeutic equivalence) where the Department of Health and Social Care (DHSC) has announced, in consultation with stakeholders, that there is a serious shortage of a particular product.

There’s no avoiding the fact that the person who is responsible for implementing the SSP will be the pharmacist. The requirements for supply under an SSP are complex and this creates a number of pressure points on pharmacists. They are as follows:

 

Pressure point 1: Is there an SSP? 

In order to apply an SSP, the pharmacist will have to know that there is one in place. The DHSC has said that they will be published on various websites and will also be notified to pharmacies through NHSmail. All well and good, but this requires pharmacists to check – and remember.

Pressure point 2: Does the SSP apply?

SSPs will be limited in their scope: by date; eligibility of patients; what can be supplied; what is excluded. The pharmacist is going to need the SSP in front of them when deciding whether to supply, because there will be too much to remember and apply.

Pressure point 3: Does the patient consent?

The patient has to agree to the switch. This means that the patient must have sufficient information to make an informed decision. That will take time, because it may require the pharmacist to explain the situation carefully to the patient.

Pressure point 4: Is the supply reasonable and appropriate?

The pharmacist is going to have to use their clinical judgement here, and the buck stops with them. If the supply isn’t reasonable and appropriate, the pharmacist then has to decide what to do – try and find the original prescribed medicine or refer back to the prescriber, perhaps?

Pressure point 5: Is the product labelled correctly?

The dispensing label must include wording to the effect that the product has been supplied in accordance with the SSP and give the number of the SSP.

Pressure point 6: Have you notified the prescriber?

This isn’t always going to be necessary but might be in certain circumstances, such as where there has been a therapeutic equivalence substitution.

Pressure point 7: Will you get paid?

Have you been paid the correct prescription charge? It’s best to check. Oh, and don’t forget to endorse the prescription accurately or you won’t get paid at all.

It seems unlikely that SSPs are going to be widely used, although that may change if there are serious supply chain issues following Brexit.

However, if they are used, then pharmacists are going to have to follow the rules carefully, because a failure to supply in accordance with the SSP could give rise to a claim for damages (if the patient is harmed), an allegation of misconduct by the General Pharmaceutical Council (GPhC), or even a criminal investigation.

The DHSC and Pharmaceutical Services Negotiating Committee (PSNC) have agreed an additional fee of £5.35 for every item supplied under the SSP. I’ll leave you to decide whether that is an appropriate fee for the additional work and responsibility that a supply under an SSP entails.

 

Noel Wardle is a partner at Charles Russell Speechlys LLP and heads the Healthcare Regulatory and Pharmacy Teams


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