Serious Shortage Protocols

On Monday 1^st July 2019 legislation allowing an emergency measure to manage supply called the Serious Shortage Protocol (SSP) in the event of a serious shortage of a medicine came into force.

Usually, prescription only medicines can be sold or supplied only in accordance with an appropriate prescription from a healthcare practitioner under the Human Medicines Regulation 2012. Serious Shortage Protocols have been added to the regulation as an exemption to make a supply under specific conditions.

The intention is that an SSP will only be issued if a medicine has been judged by the Secretary of State from the Department of Health and Social Care (DHSC) after consultation with medical experts to be in serious short supply. The SSP will set out a clear protocol for community pharmacists to follow if they are unable to source a prescribed without the need to refer patients back to the prescriber.

Community pharmacy contractors will need to consider the SSP and if, in the opinion of the supervising pharmacist, using their professional skill and judgement the supply of an alternative product or quantity is reasonable and appropriate for the patient and that the patient consents to this alternative supply.

Current Live SSPs

 

Expired SSPs

Download Serious Shortage Protocol SOP

Types of SSPs

• An alternative quantity – to restrict the supply of a product if it may be subject to a serious shortage to help ensure that community pharmacies retain stock for supply to other patients who have a particular need for it
• An alternative formulation – if there is or may be a serious shortage of one formulation (e.g. capsule), another formulation may be supplied (e.g. tablet)
• An alternative strength – if there is or may be a serious shortage of one strength, a different strength may be supplied but the dose remains that prescribed on the prescription
• A generic equivalent – if there is or may be a serious shortage of a product, a generic equivalent (or branded equivalent) or the separate constituents parts of the product may be supplied
• A therapeutic equivalent – if there is or may be a serious shortage of a product, a therapeutic equivalent (i.e. A medicine with a different active substance) may be supplied

An SSP may be provided for one or more of these options and will be issued from a specific date and have an end date, which may be revised.

Only the alternative product or quantity specified in the SSP may be supplied in accordance with any conditions specified in the SSP and this protocol is only to be followed when the DHSC issues an SSP

Any SSPs will be published on dedicated sections of the following websites:

England and Wales: NHS Business Services Authority (NHSBSA) website.

Scotland: https://www.cps.scot/shortages

Northern Ireland: http://www.hscbusiness.hscni.net/services/3063.htm

SSPs will be broken down into various sections, in a similar way to Patient Group Directions, providing the following types of information:

 Other information contained within an SSP is likely to need the contractor to confirm that:

• the presented prescription is valid (complies with the Human Medicines Regulations) and in date
• the patient or their parent/guardian or carer consents to receive the medicine under the SSP
• the patient has no known previous hypersensitivity or severe reaction or clinically significant allergy to the alternative medicine to be supplied
• the prescription is not for a controlled drug
• the supply is not an emergency supply

Special considerations will also need to be taken for certain patient groups such as those of extreme age, with neurological disability or mental health conditions.

Making a Supply under an SSP

• The pharmacy must consider the SSP against any relevant prescriptions and is not obliged to make a supply if in the opinion of the supervising pharmacist it is not seen as reasonable and appropriate. The key to this is that while the instructions within the SSP may be generally applicable, are they both reasonable and appropriate for the supply of an alternative product or quantity to the individual patient.
• The patient must consent to the supply of an alternative product or quantity, in accordance with the SSP
• No prescription charge is payable if the patient receives a smaller quantity of the medicine or fewer appliances than the quantity originally ordered on the prescription so patients are not disadvantaged by having their medicines supplied under an SSP. For any other supply under an SSP the patient would still pay a charge if they are not exempt.
• The supply must be made with reasonable promptness.
• The dispensing label must include information to the effect that the product is supplied in accordance with an SSP and contain the SSP identifying number (this will need to be free typed in the directions field of the label).
• If the supply is in accordance with a therapeutic substitution SSP, and a different medicine of similar therapeutic effect is supplied, the contractor must notify the patient’s general practice of the alternative SSP supply.

Deciding not to make a supply under an SSP

If the supervising pharmacist considers that it is not reasonable or appropriate to supply in accordance with the SSP, the contractor has a number of alternatives to follow:

• The pharmacist may supply the originally prescribed medicine or appliance if able to do so within a reasonable timescale (not defined but not as urgent as supplying under an SSP with reasonable promptness)
• The pharmacist may refuse to make a supply, if they are unable to supply the originally prescribed medicine or appliance within a reasonable timescale. The patient or their representative must be provided with the appropriate advice, either to return to the prescriber for a review of the treatment or be directed to another community pharmacy which has stock of the originally prescribed medicine.

Endorsing a prescription when a supply is made under an SSP

Reimbursement will be for the medicine supplied in accordance with an SSP, not the originally prescribed medicine or appliance.

Endorsements may be applied:

• Electronic prescriptions
  • to the Electronic Reimbursement Message (EREM)
• Paper prescriptions
  • to the prescription itself

Endorsements to apply will depend on the type of SSP granted, either a single dispensed product SSP or a multiple dispensed product SSP

Single Dispensed Product SSP

This is where a prescribed item is replaced by one replacement item.

• Electronic prescriptions

• Paper prescriptions

Multiple Dispensed Products SSP

This is where the prescribed item is replaced by two or more items

• Electronic prescriptions

• Paper prescriptions

Numark has been assured by the PSNC that if a levy payment has not been taken on a chargeable prescription for a reduced quantity supplied in accordance with an SSP it will not be deducted by the NHSBSA.

SSP-endorsed paper FP10 prescriptions must be placed in the red separator (secured with an elastic band) at the top of the bundle.