PCA(P)(2024)35 - 37: Serious Shortage Protocol for Estradot®

Published: 24/12/24

Introduction

To advise of a Serious Shortage Protocol (SSP) in place for Estradot® (estradiol) 50mcg, 75mcg & 100 mcg / 24 hour transdermal patch, from 19 December 2024 to 28 January 2025.

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.

To assist in alleviating the current supply issues with a number of Hormone Replacement Therapy (HRT) products availability, various UK-wide SSPs have been issued by the Department for Health and Social Care (DHSC), in consultation with the Scottish Government. The DHSC frequently reviews which HRT products should be under an SSP and for how long they need to be in place.

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.