The General Pharmaceutical Council recently published draft guidance for consultation that advises pharmacy owners and superintendent pharmacists how to achieve the relevant standards for safeguarding patients and the public when unlicensed medicines are prepared on their pharmacy premises (the Guidance).

Once finalised, the Guidance should be followed by any registered pharmacy, where unlicensed medicines are prepared by or under the supervision of a pharmacist. The Guidance covers the preparation of all unlicensed medicines in a pharmacy, however infrequently, and includes the extemporaneous preparation of methadone but excludes those unlicensed preparations which pharmacies have not prepared themselves but have obtained elsewhere from licensed manufacturers, importers or distributors (ie, specials).

Pharmacy owners should take careful note of the scope of the Guidance, which applies to:

• One-off preparation of an unlicensed medicine in accordance with a prescription for an individual patient
• Preparation of a stock of unlicensed medicines, which will later be supplied from the pharmacy, against a prescription for an individual patient
• Extemporaneous preparation of methadone for supply in accordance with a prescription (either for immediate supply in accordance with a prescription, or initially as stock to be supplied from the pharmacy in accordance with a prescription at a later time)
• Preparation of an unlicensed medicine based upon the pharmacist’s judgement
• Preparation of an unlicensed medicine by a pharmacist based on the specification of the patient.

The term ‘preparation’ refers to making a medicine from ingredients and does not include simply diluting or dissolving a product in a vehicle designed for that purpose as part of its marketing authorisation (MA), eg, reconstituting an antibiotic powder.

Considering standards

The GPhC’s ‘Standards for registered pharmacies’, which aim to create and maintain the right organisational and physical environment for the safe and effective practice of pharmacy, are grouped under the following five principles: 

1. Governance
2. Staff and training
3. Premises
4. Service delivery
5. Equipment and facilities.

The Guidance sets out, under each of these principles, the steps that should be followed when an unlicensed medicine is prepared in a pharmacy. If services are provided in a different way to those described in the Guidance, pharmacy owners should be able to demonstrate how the alternative ways of working safeguard patients, identify and manage any risks and meet the standards.

The circumstances under which unlicensed medicines may be prepared are covered by specific laws and, if the activity is not covered by a legislative exemption, a manufacturing specials (MS) licence is required. The Medicines Act 1968 and the Human Medicines Regulations 2012 set out restrictions on how medicines are licensed, manufactured, advertised, administered, sold and supplied. Most medicines supplied from pharmacies are licensed (ie, have an MA), are manufactured by licensed manufacturers and are covered by an approval process overseen by the MHRA.

UK and European law states that generally only licensed medicines should be placed on the market, but also governs the circumstances under which prescribers can prescribe unlicensed medicines, eg, to fulfil the special needs of a patient when no suitable licensed product is available. Unlicensed medicines may be manufactured by the holders of MS licences.

Five steps to manage risk

The law also recognises that pharmacists should have the requisite skill and knowledge to safely prepare and supply a medicine without the need to be licensed as a manufacturer, and allows pharmacists to prepare medicines in a registered pharmacy without the need for the product to be licensed. The Guidance sets out the steps to take to manage the risks associated with the preparation of unlicensed medicines by pharmacists, briefly summarised below:

Principle 1. Regular risk assessments and audits should be undertaken to ensure safe outcomes for patients and that prepared unlicensed medicines are safe, effective and of a suitable quality. A reactive review should also take place when changes in key staff occur, equipment changes, ingredients are changed, incidents occur, the environment or facilities are no longer fit for purpose, concerns are received or near miss reviews or error logs indicate concerns. Product recall systems must be put in place. There must be clear lines of accountability for staff preparing unlicensed medicines and detailed records of the preparation of the medicines should be kept for as long as you consider, and can demonstrate, to be appropriate.

Principle 2. Staff should be adequately trained and have completed recognised training courses before they can be involved in the preparation of unlicensed medicines. Evidence of such training should be documented and records kept for as long as you consider, and can demonstrate, to be appropriate.

Principle 3. Risks should be considered and assessed as to whether the pharmacy premises are suited to, and capable of, preparing unlicensed medicines. Measures should be taken to minimise contamination and ensure that premises are suitable for this task. Records should be kept of steps taken to ensure that the environment, conditions and equipment are clean enough for the preparation of medicines.

Principle 4. When an unlicensed medicine is prepared in a pharmacy, it is essential that the medicine is safe and fit for purpose. It should be made clear to the patient at the outset that an unlicensed medicine is being prepared and what this means. There is no legal requirement to provide a patient information leaflet for unlicensed medicines. Therefore, patients will rely on information provided by the pharmacy, which must be sufficient to ensure that they can use the medicine safely, eg, when the medicine should be disposed of or any special storage instructions.

Principle 5. Equipment and facilities should be suitable for their purpose and of sufficiently high specification and accuracy to produce high-quality, safe products. Maintenance logs for each type of specialist equipment should be kept for as long as you consider, and can demonstrate, to be appropriate.

Although extemporaneous dispensing and the supply of unlicensed medicines from pharmacies is now largely sub-contracted to specials manufacturers, pharmacists should be aware of the scope of this Guidance to ensure that certain practices at their pharmacies are not inadvertently caught. The consultation closes on March 14 2014.

_{Richard Hough is an associate solicitor and pharmacist at Brabners LLP. Contact him on 0151 600 3302 or at richard.hough@brabners.com}