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Serious Shortage Protocols

  • Wales
  • England
  • Scotland
  • Northern Ireland

On Monday 1st July 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.

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 a dedicated section of the NHS Business Services Authority (NHSBSA) website.

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

SSP heading and number

This section will provide the number of the SSP.

Name of medicine Quantity (if applicable) Legal category

This section will specify inclusion criteria which must be met if an SSP is to be used.  It will include the prescribed medicine subject to serious shortage to which the SSP will apply.

Part of the country to which the SSP applies

There may be geographical restrictions on the use of the SSP, e.g. only for use in a specific region.

Scope

This section could specify community pharmacy.

Criteria for inclusion

This section could specify that the patient must present a valid prescription and consent/agree to receiving the alternative medicine

Criteria for exclusion

This section could specify that the SSP will not apply where the pharmacist determines that the patient is not suitable to receive alternative medication under this SSP.

Cautions including any relevant action to be taken

This section may include relevant reference to expert advice.

Special considerations for specific populations of patients

This section may include special considerations to be taken for certain patient groups.

Action to be taken if the patient is excluded

This section could include advice to refer the patient back to the prescriber.

Action to be taken if a patient or carer declines the supply

This section could include advice to refer the patient back to the prescriber

Valid from

Review date

 Expiry date

 Reference number

 Version number

 Gateway number

There will be dates between which the SSP is valid and any changes to the SSP since it was first issued will be identified.

Conditions

This section may state that the decision to supply against an SSP rests with the supervising pharmacist.

Details of the medication to be supplied under the SSP

In this section of the SSP, one or more of the following will be specified for supply: a) an alternative quantity of the medicine specified within the original prescription is to be supplied; b) an alternative formulation of the medicine specified within the original prescription is to be supplied; c) an alternative strength of the medicine specified within the original prescription is to be supplied; d) a generic version, alternative branded version or the separate constituent parts of the named medicine specified within the original prescription is/are to be supplied; or e) a therapeutic alternative to the medicine specified within the original prescription is to be supplied.

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.

Prescriptions can be presented either in paper format or electronically. Endorsement for an electronic prescription can be made in writing directly onto a printed copy of the dispensing token or using the EPS reimbursement claim message.

To ensure correct payments for both fees and product reimbursement for a supply made under an SSP, the contractor is required to endorse the prescription with the following information:

  • NCSO – this indicates that the supply was made in accordance with an SSP. It was selected by the DHSC because it has not used for its original purpose since April 2013 and has been superseded by the price concession system.
  • Details of the product supplied in accordance with the SSP – i.e. drug name, strength, formulation, brand or manufacturer. This may be different to the drug prescribed if in accordance with a specific  SSP
  • Quantity supplied – this may be less than the quantity on the prescription if in accordance with a specific SSP
  • Pack size – where multiple pack sizes are available
  • Invoice price – where no list price is available to the NHSBSA on dm+d (Dictionary of Medicines and Devices)

Paper-based method

  • A transitional provision permits the use of a dispensing token instead of the original electronic prescription to submit claims for payment to the NHSBSA. Where used, the dispensing token is regarded as the prescription for payment and charge recording purposes
  • When the endorsement is written on the dispensing token, the EPS reimbursement claim message should be marked as NOT DISPENSED for that item to ensure that there is no double-claiming
  • The dispensing token should be endorsed as above and the reverse of the token completed as usual by the patient
  • The token must be placed in the red separator for submission at the end of the month to the NHSBSA

Electronic method

  • All pharmacy system suppliers allow endorsement of NCSO using EPS, but the format is dependent on the PMR system used. Some systems will pre-populate the NCSO field with pharmacist’s initials, date and alternative drug whereas others will require this information to be manually added in the NCSO free-text field.
  • The correct exemption or charge declarations on the EPS reimbursement claim message should be applied and the token submitted in the usual way at the end of the month
  • The printed dispensing token should not be endorsed with NCSO as this could lead to delays in payment due investigations by the NHSBSA into double-claiming

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. By placing the NCSO prescriptions and tokens in the red separator they will be manually priced by an exception handler and based on the endorsement no charge will deducted.