PGDs affected by medicine shortages
Medicine Shortages can occur for many reasons including manufacturing and quality control problems, delays in supply chains and discontinuations.
Where a medicine supplied and/or administered under a PGD is subject to an interruption in supply a review of the PGD may be required unless a PGD has been written to account for potential shortages.
The below scenarios describe how PGDs can be managed when different types of shortages occur or how they can be pre-emptively written to improve their resilience.
A strength/formulation or pack size becomes unavailable
A strength/formulation or pack size of a medicine stated in a PGD becomes unavailable. The alternative is a different strength, formulation or pack size of the same medicine but it is not included in the current PGD.
The PGD must be amended and approved through the usual governance process before the differing formulation/strength/pack size can be administered or supplied.
Organisations may wish to pre-empt such situations when developing/reviewing their PGDs by including alternative strengths, formulations or pack sizes within the PGD where appropriate.
For example where a medicine is being administered or supplied under a PGD and multiple strengths of the product are available it is acceptable to state the dose to be given and then list the different strength products that may be used to achieve the dose e.g. state all strengths of a nebule available.
Similarly where the PGD is for a medicine usually given as an eye drop, but an eye ointment formulation is an available alternative then the PGD could also include the alternative formulation where this is pharmaceutically/clinically acceptable.
Crushing/dispersing of tablets/opening of capsules under PGDs
Where it is deemed that crushing or dispersal of a tablet or opening a capsule prior to administration is a suitable alternative it must be recognised that this is “off label” i.e. outside of the terms of the SPC and the PGD should be amended to reflect this. The reference(s) confirming pharmaceutical stability of the product once crushed/opened/dispersed and how it should be administered after crushing or dispersing (i.e. mixed with water etc) should be included within the PGD. The revised PGD should then be approved through usual governance processes before the medicine can be administered or supplied in this way. Using solid oral dosage form antibiotics in children has more information on this off-label practice.
Medicine completely unavailable – alternative product has a UK licence
A medicine included in a PGD becomes completely unavailable and the recommended/suitable alternative is a different UK licensed medicine.
Where it is agreed to be appropriate a new PGD will need to be produced for the alternative product and approved through the usual governance process.
Consider if a PGD is still required and that it remains the most suitable option for supply/administration or if any suitable alternative mechanisms to a PGD for administration or supply is possible – refer to When Patient Group Directions are not required
Medicine completely unavailable – alternative product is unlicensed
A medicine included in a PGD becomes completely unavailable and the recommended/suitable alternative product is not a UK licensed medicine.
A PGD cannot be used as unlicensed medicines cannot be supplied or administered under a PGD. Refer to Unlicensed medicines and use of PGDs
For example a PGD for a vaccine for which no UK licensed stock can be obtained and the only available alternative stock is unlicensed in the UK. As unlicensed medicines cannot be supplied or administered under a PGD, a PGD cannot be used and an alternative mechanism (e.g. a patient specific direction) will need to be considered.
Serious Shortages Protocols (SSPs)
In February 2019, the Human Medicines Regulations 2012 were changed to introduce Serious Shortages Protocols (SSPs).
If the Department of Health and Social Care (DHSC) determine that there is a serious shortage of a specific medicine or appliance, then an SSP may be issued. SSPs do not apply to supplies made under Patient Group Directions (PGDs).
Further guidance on SSPs is available via https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/serious-shortage-protocols-ssps