PCA(P)(2022)28 - Serious Shortage Protocol Extension: Estraderm MX® 25 microgram patch
Published: 29/09/22
Summary
To advise of an extension to the Serious Shortage Protocol (SSP) in place for Estraderm MX® 25 microgram patch, in place from 8 September, extended to 30 September 2022.
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 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.
Medicine supply situation requiring the use of an SSP
A supply issue with Estraderm MX® 25 microgram patch has been identified. In order to manage stock supplies fairly and effectively, there is a UK-wide SSP in place, which allows community pharmacists to substitute a prescription of this product with the same quantity of Evorel® 25 microgram patches. The original SSP can be accessed using the following link: SSP035 Estraderm MX 25mcg patches ANNEX A FINAL 06092022.pdf (nhsbsa.nhs.uk).
Operational overview
The original SSP has been extended to 30 September, for patients presenting with an NHS or private prescription for a supply of Estraderm MX® 25 microgram patch, community pharmacists may substitute this product with the same quantity of Evorel® 25 microgram patch in accordance with the SSP for eligible patients. The extension is documented on the NHS Business Services Authority website using the following link: Serious shortage protocols (SSPs) | NHSBSA.
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 035.
When a substitution is made, pharmacists need to ensure that the patient’s prescriber and/or GP practice is notified in accordance with this SSP within 24 hours.
Particular care and caution should be taken to provide advice to patients who are considered at higher risk of experiencing the nocebo effect. Patients should be reassured as to the appropriateness and effectiveness of this alternative treatment as per the counselling points noted under this SSP. If there are significant concerns, patient needs to be referred back to their prescriber for further advice.
If a patient or their carer declines to receive the medicine under this SSP, the pharmacist should use their professional judgement to determine if other courses of action are appropriate whilst taking into consideration wider supply issues. If this does not address their concerns, the patient should be referred back to their prescriber for advice.
Additional information
Please see links for further advice on alternative hormone replacement therapies:
Please see the link for advice on the availability of alternatives.
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 035. 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 035’ annotated. This is to ensure accurate reimbursement for non-barcoded forms or where an electronic claim message is unavailable.