Medicines Supply Alert Notices and Serious Shortage Protocols

Introduction

Medicines shortages can occur at a local, regional, national or global level and can affect some or all dispensing settings, including community and hospital pharmacy, dispensing doctors and home care. It is standard practice for the four UK Administrations to cooperate to detect and manage shortages, drawing upon clinical advice as and when necessary.

The UK Government receives regular reports from the pharmaceutical industry about impending medicine supply issues that may affect patients across the UK. It has well established processes in place to manage and mitigate supply problems that can arise at any time due to manufacturing or distribution issues. The UK Government, via the Department of Health and Social Care, alerts the Scottish Government and other Devolved Administrations about any supply issues.

The purpose of this webpage is to provide access to general advice on managing Alert Notifications (MSANs) and Serious Shortage Protocols (SSPs).

In addition, Community Pharmacy Scotland and Health Boards have developed additional guidance on managing medicines shortages which sets out the processes and tools that pharmacy teams already have available to in order to minimise any unnecessary additional workload when managing shortages or dealing with a situation when the market price exceeds the reimbursement price. This is available at:

Review exceeds the reimbursement price (external link)

Medicines Supply Alert Notices

In September 2019, the Scottish Government, in collaboration with the Scottish Medicines Supply Response Group, introduced a new process to alert community pharmacists, Health Boards and other healthcare professionals about medicine supply shortages. These alerts are sent out from the Chief Pharmaceutical Officer as Medicines Supply Alert Notices (MSAN).

Priority definitions for alerts have been agreed (levels 1 – 4)

Access the definitions of classifications

For levels 2, 3 and 4, an MSAN will be issued directly to healthcare professionals, and published on SHOW. They will also be issued to Community Pharmacy Scotland (CPS) and the Scottish Prescribing Advisors network. Level 1 shortages will not be reported.


Published MSAN can be found by following the link below.

Published MSAN (SHOW) (external link)

Serious Shortage Protocols

Changes made to the NHS (Pharmaceutical Services) (Scotland) Regulations 2009, allow the use of Serious Shortage Protocols (SSPs). These changes will be effective from 31 October 2019.

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 will cover prescription only medicines and another that will cover 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.

Further guidance on the operation of SSPs will be added in due course along with each SSP.

SSPs will be issued directly to healthcare professionals and also issued to Community Pharmacy Scotland (CPS) and the Scottish Prescribing Advisors network. These are published as an MSAN on SHOW

Published SSPs (SHOW) (external link)