In 2019, we worked with NHS colleagues to agree on guidance that clearly describes what pharmacy teams can and cannot routinely do with the original prescription to ensure a patient’s supply of medication is maintained, without having to go back to the prescriber. The guidance should be read in full, but generally speaking, most possible courses of action are permitted, apart from:

1. Changing a part 7 drug for a non-part 7 equivalent (e.g. Metformin for Glucophage).

2. Changing one drug for another, different drug (e.g. Metformin for Gliclazide)

In relation to the second exception, the Human Medicines Regulations 2012 dictate that prescription-only medicines may only be sold or supplied in accordance with a prescription issued by an appropriate practitioner, such as a GP, so it would be illegal to make a change like this. However, this regulation is subject to some exemptions (for example, Patient Group Directions, which allow supply under specific conditions). Serious Shortage Protocols (SSPs) are another, new exemption to this rule which will give pharmacy teams further flexibility to support patients without going back to their prescriber (GP). If issued, SSPs will look very much like PGDs in format and will be time-limited while a serious shortage persists.

It is important to note that although legislation will permit the issuing of SSPs from 31st October 2019, an SSP will only be considered and issued by Scottish Government if there is a serious shortage of a specific medicine.  SSPs issued in England are not applicable in Scotland, and only Scotland specific SSPs may be acted upon.

If, in the Cabinet Secretary’s opinion, there is, or maybe, a serious shortage of a medicine or appliance then he or she may consult, for instance with medical experts, and decide to issue an SSP. The SSP will specify an alternative product or quantity that may be supplied (an alternative strength or formulation, or generic or therapeutic alternative or less of the product) by community pharmacies. Community pharmacy contractors must consider the SSP and, if, in the supervising pharmacist’s opinion – exercising his or her professional skill and judgment – the alternative product or quantity is reasonable and appropriate for the patient, they may supply the alternative product or quantity (only as specified in the SSP and subject to any conditions in the SSP), provided that the patient consents/agrees to the alternative SSP supply.

The dispensed SSP product must be labelled to show that supply has been made in accordance with the SSP and identify the SSP (usually by its number) and the prescriber of the original product (that has not been dispensed) may need to be notified. For reimbursement and remuneration, the appropriate endorsement must be made as provided for in the Drug Tariff and, following the supply of the alternative product or quantity, the prescription (in relation to which the SSP supply was made) is no longer valid.

Changes to certain medicines, even where they are in short supply, will not be suitable for some patient groups – for example, those with epilepsy, where changing a patient’s medicine brand or generic manufacturer could cause harm to the patient. SSPs will only specify changes to specific medicines that medical experts believe to be appropriate, and pharmacists will always have the professional discretion not to supply an alternative to any individual patient.

In advance of issuing an SSP, a Medicine Supply Alert Notice (MSAN) may be issued.  An MSAN provides information on the shortage of a specific item, or group of items. The Medicines Shortages Response Group (Scotland) has developed priority definitions for shortage issues and potential responses depending on the severity of the impact of the supply issue, increasing in severity from a level 1 to a level 4 MSAN.  MSANs will, in the first instance support prescribers and dispensers’ knowledge of supply issues and appropriate responses.  The CPS shortage guidance document produced with colleagues who lead pharmacy primary care services can also support community pharmacy teams with appropriate action to take.

1) Scotland’s Agreed Shortages Process Flow Chart

Click to download our flowchart outlining the steps which can be taken to manage shortages in Scotland. You should always start with this flowchart when faced with a shortage. This can be printed for use in your pharmacy.

2) Shortages Guidance Flow Chart

We have also produced a quick reference guide in the form of a flowchart. Both of these can be printed for use in your pharmacy.

3) Report a Shortage

Please report problems experienced in obtaining medicines. This includes generic items in the Scottish drug tariff part 7, non-part 7 items, and branded medicines. The feedback you give us is sent on a weekly basis to the relevant department at the Scottish Government regarding availability and price information, on lines where price can be an issue.

Report a Shortage

4) Current Part 7 Adjusted Prices

In recent years, the number of product shortages has increased due to a number of factors, including rationalisation of production sites, measures taken by manufacturers to control the market for their medicines, the growth in the use of generic medicines (nationally and internationally), and price pressures.

The shortage system was created to address very unusual cases where the generic could not be purchased at a price below the brand or for the price published in the Scottish Drug Tariff. The Scottish Government (SG) has also introduced an adjusted price system to deal with sudden price rises in high-volume lines.

We liaise regularly with SG based on information from contractors around lines to attempt to get shortage or adjusted price concessions. However, as the supply chain is UK-wide, it is actually driven very much by the Department of Health (DH) and its investigations as to whether a shortage or adjusted price is granted. Download the full Guide 'Drug Tariff Product Shortages & Adjusted Price Setting'