Prescribing And Administration Of Unlicensed Medication

The Medicines Act 1968 and the Human Medicine Regulation 2012 provides restrictions on how human medicines are licensed, manufactured, advertised, administered, sold and supplied. (MEP, 2018) All medicines supplied through a pharmacy have a product license that outlines terms of use: indication, recommended dose, contraindications, special warnings and precautions. A licensed medicine must meet acceptable standards of efficacy, safety and quality. [MHRA, 2014] This means the patient and the public, have assurance that the prescribed medicine is effective and meets the needs of the patients. There are exceptions where unlicensed medicines are prescribed and supplied to patients but several legal and ethical implications when prescribing medicines in this manner. In certain clinical situations the medicine may be used outside the terms of the license i.e. off label or obtained as a special when no licensed suitable alternative is available. Unlicensed medicines do not meet safety, efficacy and quality assurance in comparison to a licensed product. Unlicensed medications are usually prescribed for the patients best interest provided that there is sufficient evidence available.

All independent prescribers can prescribe an unlicensed medicine and licensed medicine for off label use. However, only in certain circumstances, supplementary prescribers can prescribe unlicensed medicines. [MHRA, 2014] All HCPs:

Must have individual competence

Follow professional codes and ethics of their statutory bodies

Follow prescribing policies of their employers. [MHRA, 2014]

If a decision is made to prescribe an unlicensed medicine, then the responsibility is much greater than if a licensed medicine was prescribed. Prescribing an unlicensed medicine has risks associated with it and therefore, each prescriber will need to manage the risks. Some risks include adverse reaction, patient information leaflet inconsistent with the intended use and product quality.

Although there may be lacking in evidence to support the use of an unlicensed medicine, it may be appropriate to prescribe it to meet a patient s need. As a prescriber I must ensure that:

There are no alternative licensed medicine available

There is enough evidence base

Have enough experience of using the medicine that proves its safety and efficacy

Patient has been informed

Take responsibility and monitor the patient

Documenting the reasoning for the choice in medication. [Hosur, 2018]

Before prescribing an unlicensed medicine the patient must be given:

Sufficient information for them to be able to make an informed decision.

Explain the reason for doing so

Be honest and fully explain any risks or benefits

Explain how the medicine works. (MHRA, 2014)

In my area of practice (OOHs service), I may have to prescribe a repeat prescri ption for an unlicensed medicine already initiated by the patients GP. I am very unlikely to start a therapy with an unlicensed medicine but I will still need to discuss risks associated with unlicensed medicines. As pharmacist prescriber, I will likely to see off label use in patients who need advice about crushing tablets for ease of administration. The patient/carer or person administering will need to be informed that crushing tablets is outside of license terms and therefore may have risks associated to it, as it has not undergone rigorous tests. Other healthcare professionals administering the unlicensed medicine will need to be informed if prescribed in this manner, as they will need to follow professional codes and ethics of their own statutory bodies. [MHRA, 2014]

References

GMC (2019) Prescribing unlicensed medicines [Online] Available at: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines [accessed 26/7/19]

Hosur, S. (2018) Non-medical prescribing policy (v3.1). Chippenham, Wiltshire. Medvivo.

MHRA (2014). Off-label or unlicensed use of medicines: prescribers responsibilities. Medicines and Healthcare products Regulatory Agency. [Online] Available at: https://www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities#contents [accessed 26/7/19]

RPharmS. (2018) Medicines, ethics and practice. (MEP). 42nd ed. London: Royal Pharmaceutical Society.