Managing risks

There are risks associated with all aspects of healthcare. Healthcare providers, including hospitals, accept responsibility for the management of these risks through their governance processes. The approach to defining governance arrangements may vary, but should be defined in a local policy. For example, Integrated Care Systems may include unlicensed medicines governance in their formulary.

The role of pharmacy

The decision to use any medicine should involve the patient, prescriber and pharmacist, and this is especially important for unlicensed medicines. Pharmacy professionals have a unique knowledge of medicinal products and professional responsibilities. They have a key role in recognising the use of an unlicensed medicine, ensuring that the prescriber is aware of this, and advise accordingly in the context of other potential treatment options.

Governance system

A formal governance system should clearly define the responsibilities for all aspects of the prescribing, purchasing and use of unlicensed medicines. Policies, and standard operational procedures where necessary, should cover:

• prescribing
• sourcing and purchasing
• quality assessment of purchased unlicensed medicines
• receipt checking
• storage to differentiate between unlicensed and licensed medicines
• record keeping
• monitoring and review of patients being treated with unlicensed medicines
• responsibilities of the organisation and all staff
• training and competence of all staff
• multidisciplinary review of the use of unlicensed medicines
• patient transfer between care settings
• escalation of incidents
• pharmacovigilance, including the use of the Yellow Card system
• prescribing systems

Unlicensed medicines are often absent from electronic prescribing systems. This can lead to added risks in terms of prescribing accuracy and selection of the correct formulation. This also means that clinical decision support software may not be available.

Risk assessment

Organisations should undertake a rigorous risk assessment before a new unlicensed medicine is used. This assessment should focus on the additional risks and issues that may be associated with the use of an unlicensed medicine. This includes whether the medicine is clinically safe and effective (“fit-for-purpose”) and of acceptable quality. It should also take into account risks presented by the presentation, packaging and labelling, including the possibility of mis-identification and inappropriate use instead of the intended licensed medicine.

The assessment should be undertaken by an expert in medicines; pharmacy professionals are best placed to carry out this risk assessment.

As unlicensed medicines are only appropriate to meet the special clinical needs of individual patients, the risk assessment should be updated whenever the patient’s needs change.

Any risks, and actions to mitigate them, must be clearly documented and communicated to the prescriber.

Transfer of care

If the unlicensed medicine becomes a long-term treatment for the patient, arrangements must be made to ensure continuity of supply. Depending on local policy, organisations may maintain long term supply or transfer the responsibility for supply to the primary care team.

Primary care

If care is to be transferred, this must be planned and agreed in advance with the primary care team to ensure optimal treatment and continuity of supply. The patient should be discharged with a sufficient quantity of medicines to allow time for re-supply, which may take longer for Specials than for licensed medicines.

The primary care prescriber must be made aware of the special clinical need of the patient and the implications of continuing to prescribe the Special. The secondary or tertiary care prescriber must document and communicate the rationale, formulation, expected duration of treatment and ongoing monitoring requirements for the Special to the new prescriber.

Community pharmacy

Community pharmacies may struggle to source a suitable quality product in a timely fashion, risking the patient running out of supply before new stock is obtained. Effective communication and advanced planning are required, particularly where the supply of a specific formulation is critical for patient safety.

Implementation and monitoring

When procuring and implementing a new unlicensed medicine, the conditions or limitations on its use must be clearly communicated to staff. It is also necessary to monitor the use of the unlicensed medicine in line with legislation and organisational policy to be assured that it is being used within the conditions set out in the approval.

Organisations should have processes in place to review the continued use of unlicensed medicines and re-evaluate in an appropriate time frame, considering new evidence or new licensed products.

Organisations should conduct regular audits regarding the use of unlicensed medicines. These may include, but are not limited to:

• audits of special clinical needs
• compliance with the approval process
• patient review
• record keeping

The organisation’s policy for the use of unlicensed medicines should specify suitable audits and timetables, along with the reporting mechanism and the responsible committee.

Update history