Legislation

The MHRA states that the mixing of two separate medicinal products will result in a new, unlicensed product if one product cannot be described as a vehicle for the administration of the other e.g. as a reconstitution or diluting agent.

Unlicensed products cannot be supplied or administered under a PGD – please refer to Unlicensed medicines and use of PGDs

Example scenarios

The SPS PGD Service Advisory Board has worked with the MHRA to provide the example scenarios below to help organisations and practitioners make an informed decision as to whether a scenario would result in an unlicensed product.

The scenarios are not comprehensive and it is advised that any practitioner or organisation contact their relevant professional body or regulator to obtain further advice on whether a particular practice is lawful when considering an appropriate method to prescribe, supply and administer medicines.

In addition, appropriate advice must always be sought from a pharmacist and/or Medicines Advisory service on safety, stability and compatibility prior to carrying out any practice that involves mixing or altering the form of any product.

Scenarios:

Mixing Atrovent® nebulising solution with a beta-agonist nebulising solution, prior to administration.

Allowed under a PGD? No

Explanation: Creates an unlicensed product. Both have a medicinal purpose and neither is being used as a vehicle for the other.

Ceftriaxone Injection reconstitution with lidocaine when administering by the intramuscular route.

Allowed under a PGD? Yes

Explanation: SPCs refer to lidocaine as a vehicle to administer the ceftriaxone i.e. as the reconstituting agent.

Mixing a corticosteroid injection with a local anaesthetic injection prior to administration.

Allowed under a PGD? No

Explanation: Creates an unlicensed product. Both have a medicinal purpose and neither is being used as a vehicle for the other.

Crushing two separate medicines in tablet/capsule form and mixing prior to administration

Allowed under a PGD? No

Explanation: This creates an unlicensed product i.e. it is mixing two separate products prior to administration and one is not a vehicle for the other.

Note: Crushing a tablet or opening a capsule prior to administration without mixing with another product is considered “off label” i.e. outside of the terms of the SPC. If this practice was to take place under a PGD, the PGD would need to specify the circumstances under which this would be a safe and appropriate course of action.

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