Occupational Health Service exemptions

Schedule 17 of The Human Medicines Regulations 2012 provides specific exemptions for occupational health services (OHS) from some of the restrictions that apply to prescription only medicines.

Written instructions

Under Schedule 17 medicinal products can be supplied or administered in the course of the OHS by a registered nurse acting in accordance with the written and signed instruction of a doctor. This instruction is commonly documented as a written instruction.

An exception to this is those staff members who become occupational health vaccinators, working within an NHS body or a Local Authority-operated OHS to administer influenza or coronavirus vaccines in accordance with a written instruction. Seasonal influenza vaccination and occupational health services contains further information.

The written instruction is different to a PGD and is an arrangement between the named registered nurse(s) and the authorising doctor. Written instructions are not subject to the legislated framework of a PGD and therefore PGDs and written instructions are not interchangeable.

Organisational use

The following organisations can use a written instruction:

• NHS Body or Local Authority providing an OHS to their own employees
• NHS Body or Local Authority providing an OHS to employees of another organisation (NHS, publicly funded non-NHS, private or independent sector healthcare provider or any other private person(s) or business)
• an independent or other healthcare provider providing an OHS to their own employees
• an independent or other healthcare provider providing an OHS to employees of another organisation (NHS, publicly funded non-NHS, private or independent sector healthcare provider or any other private person(s) or business)

Examples of use

The BMA Guide for the Occupational Physician and the SPS article Influenza vaccine written instruction templates for adoption provide examples of written instructions.

Medicines included in a written instruction

Any medicine with a UK marketing authorisation that is to be used for the purpose of an OHS can be included in a written instruction for an OHS.

Authorisation

Before a written instruction can be used by an organisation, it must be signed by a doctor and set out the circumstances in which a medicine is to be used in the course of the OHS.

With relation to an OHS written instruction, the doctor signing the written instruction must be a doctor with an OHS specialism. The only exception to this relates to a written instruction for the administration of seasonal influenza/coronavirus vaccination to staff. Seasonal influenza vaccination and occupational health services contains further information.

The doctor signing the written instruction on behalf of the organisation they are employed by must be working within their own competency when signing.

Roles and responsibilities of medical signatories

Signatories are recommended to consider the SPS advice Understanding roles and responsibilities of PGD signatories to support their role. Although the document pertains to PGDs, the roles and responsibilities of those authorising a written instruction would be similar.

Use within organisations

Once signed and adopted, the written instruction allows named registered healthcare professionals included in the legislation to supply or administer the medication to the organisation’s staff within the terms of the written instruction. Those operating under the written instruction must be trained and competent to work in accordance with it.

Registered healthcare professionals operating under a written instruction should complete a practitioner authorisation sheet (or local equivalent) to declare themselves as having completed the required training and as being competent to work under the written instruction. This may be countersigned by the individual’s line manager/clinical supervisor following the local process. This is not a legal requirement but is recommended to facilitate a good governance process for the authorisation of those working under a written instruction.

Roles and responsibilities of healthcare professionals

Registered healthcare professionals operating under a written instruction must act within their own professional competency and the bounds of the written instruction at all times.

Written instructions for occupational health services explainer video

This short video explores written instructions in occupational health services, including what they are and who can work under them.

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