PCA(P)(2022)42 - Serious Shortage Protocol for Phenoxymethylpenicillin 250mg tablets

Published: 19/12/22

Summary

To advise of a Serious Shortage Protocol (SSP) in place for Phenoxymethylpenicillin 250mg tablets, from 16 December 2022 to 31 January 2023.

Background

Changes made to the Human Medicines Regulations 2012 and the NHS (Pharmaceutical Services) (Scotland) Regulations 2009, the latter of which became effective from 31 October 2019, allow the use of Serious Shortage Protocols (SSPs).

An SSP is an additional tool to manage and mitigate medication shortages and may be used when other measures have been exhausted or are likely to be ineffective. There are two types of SSP; one that covers prescription only medicines and another that covers pharmacy and general sales list medicines and appliances.

Each SSP is individually developed and authorised clinically, to enable community pharmacists and dispensing doctors to dispense a different strength or formulation or alternative medicine or appliances in accordance with the protocol, rather than having to refer prescribing decisions back to the original prescriber. These protocols are time limited.

Community pharmacists are expected to use their professional skill and judgement to decide whether it is reasonable and appropriate to substitute a person's prescribed medicine using the SSP. The person will also have to agree to the alternative supply.

Certain classes of medicines, for example cytotoxic medicines, biologics, anti-epileptic medicines and certain antipsychotic medicines, are not considered to be suitable for SSPs due to concerns about ensuring bioequivalence. In these cases, people should be referred back to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.

The addition of new SSPs and any amendments or extensions to existing SSPs are documented on the NHS Business Services Authority website using the following link: Serious shortage protocols (SSPs) | NHSBSA.

Medicine supply situation requiring the use of an SSP

A supply issue with Phenoxymethylpenicillin 250mg tablets has been identified. In order to manage stock supplies fairly and effectively, there is a UK-wide SSP in place.

Where Phenoxymethylpenicillin 250mg tablets are not available and prescribed for a duration of no longer than 10 days, the following antibiotics, in order of decreasing preference, can be substituted depending on availability and the dosing needs for the patient as specified in Annex B. Please also review Annex A for the standard dosing of phenoxymethylpenicillin by age range

• Amoxicillin 125mg/5ml oral suspension

• Amoxicillin 125mg/5ml oral suspension sugar free

• Amoxicillin 250mg/5ml oral suspension

• Amoxicillin 250mg/5ml oral suspension sugar free

• Amoxicillin 250mg capsules

• Amoxicillin 500mg capsules

OR

• Clarithromycin 125mg/5ml oral suspension

• Clarithromycin 250mg/5ml oral suspension

• Clarithromycin 250mg tablets

• Clarithromycin 500mg tablets

OR

• Flucloxacillin 125mg/5ml oral solution

• Flucloxacillin 250mg/5ml oral solution

• Flucloxacillin 125mg/5ml oral solution sugar free

• Flucloxacillin 250mg/5ml oral solution sugar free

• Flucloxacillin 250mg capsules

• Flucloxacillin 500mg capsules

OR

(Broader spectrum antibiotics with increased risks of side effects and antimicrobial resistance – reserve for when alternatives unavailable.)

• Cefalexin 125mg/5ml oral suspension

• Cefalexin 125mg/5ml oral suspension sugar free

• Cefalexin 250mg/5ml oral suspension

• Cefalexin 250mg/5ml oral suspension sugar free

• Cefalexin 250mg capsules

• Cefalexin 250mg tablets

• Cefalexin 500mg capsules

• Cefalexin 500mg tablets

OR

• Co-amoxiclav 125mg/31mg/5ml oral suspension

• Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free

• Co-amoxiclav 250mg/62mg/5ml oral suspension

• Co-amoxiclav 250mg/62mg/5ml oral suspension sugar free

• Co-amoxiclav 400mg/57mg/5ml oral suspension sugar free

• Co-amoxiclav 250mg/125mg tablets

• Co-amoxiclav 500mg/125mg tablets

For prescriptions of Phenoxymethylpenicillin 250mg/5ml oral solution sugar free longer than 10 days, the preferred substitution is one of the following erythromycin formulations, with reference to Annex C for dosing information. In the event erythromycin is unavailable in a suitable formulation/dosage, pharmacists should refer the patient back to the prescriber.

• Erythromycin 125mg/5ml oral suspension

• Erythromycin 125mg/5ml oral suspension sugar free

• Erythromycin 250mg/5ml oral suspension

• Erythromycin 250mg/5ml oral suspension sugar free

• Erythromycin 250mg gastro-resistant tablets

• Erythromycin 250mg tablets

• Erythromycin 500mg tablets

This SSP can be accessed using the following link: SSP047 Phenoxymethylpenicillin 250mg-5ml oral solution 161222 v9.pdf (nhsbsa.nhs.uk)

Operational overview

Between 16 December 2022 and 31 January 2023, for patients presenting with an NHS or private prescription for a supply of Phenoxymethylpenicillin 250mg/5ml oral solution, community pharmacists may substitute this product with the products and formulations as outlined above.

Total quantity supplied in accordance with this protocol is to be equivalent to the number of days treatment prescribed on the original prescription. The quantity supplied may be different due to different dosing regimens for different antibiotics.

For the substituted antibiotic, the quantity and strength supplied is to be determined by the recommended dosing regimen as set out in Annex B and C accordingly

Community pharmacists are asked to review and familiarise themselves with the scope and the clinical situation to which this SSP applies, as outlined in the guidance provided within SSP 047.

Pharmacists must ensure that the patient’s prescriber and/or GP practice is notified within 24 hours when supplying a patient in accordance with this SSP.

Patients considered to be unsuitable or at higher risk as outlined in the “Criteria for exclusion section of SSP 047 need to be referred back to their prescriber promptly for further advice.

Additional information

The Royal Pharmaceutical Society has issued an infographic: PowerPoint Presentation (rpharms.com).

For diabetic patients, pharmacists should supply sugar free options where possible. If this is not available, patients/carers should be informed that there is a small amount of sugar contained in the product supplied but do not withhold treatment.

Ensure that patients considered unsuitable for inclusion are promptly referred to their prescriber for further advice.

If a patient/carer declines to receive medicine in accordance with this SSP, then they should be referred back to their prescriber promptly.

Switching from liquid to solid phenoxymethylpenicillin

When the medicine is for a child and the pharmacist deems it appropriate to substitute to the tablet form in accordance with this SSP, patients/carers should be directed to the following guidance: Using solid oral dosage form antibiotics in children – SPS - Specialist Pharmacy Service.

Supporting information on notifying other healthcare professionals

Any items supplied in accordance with an SSP in response to an NHS prescription also needs to be supplied in accordance with NHS Pharmaceutical and Local Pharmaceutical Services Regulations.

Those Regulations provide that where a therapeutic equivalent is supplied, a pharmacist will need to inform a patient’s GP practice. This would generally be expected within the next working day, but further guidance would be given in any case where this applied.

Where a different quantity, an alternative pharmaceutical form, an alternative strength or a generic equivalent is provided, it may not always be necessary that the patient’s prescriber is informed, as the existence of the SSP may be enough for the prescriber to be aware that these changes in dispensing may take place, unless national arrangements agreed with the relevant representative bodies state otherwise. However, guidance may be issued on particular SSPs to indicate that prescribers should be informed of any patients that receive supply under it.

In the absence of any preferred local alternate communication channels, all feedback to prescribers should be sent by NHSmail. The NHS Service Finder is a way for pharmacies to look up the email address of the patient’s GP.

Fees and Endorsements

When an SSP is introduced, the pharmacist should use the Other endorsement function quoting SSP and the relevant reference number – in this case add SSP 045. A community pharmacy contractor will receive a multiplier per item of 5 (x5), via the dispensing pool, for any necessary supply in accordance with SSPs. Endorsements must be made in line with the SSP to be eligible for payment.

The paper form should be endorsed PMR with details added of what was supplied as well as ‘SSP 045’ annotated. This is to ensure accurate reimbursement for non-barcoded forms or where an electronic claim message is unavailable.

Enquiries

For any queries on the detail of this SSP, please contact the Scottish Government Pharmacy Team at PharmacyTeam@gov.scot.