Scope

This article is intended to be read as a complete document to help provide the full context in practice. In this article the term “prescriber” refers to doctors, dentists and independent prescribers, supplementary prescribers and community practitioner nurse prescribers.

Good practice principles for prescribing are the same for all prescribers and professional codes of conduct should always be referred to. Professionals should consider, where relevant, their own need for professional indemnity cover.

Patient Specific Direction (PSD)

Whilst not defined in legislation a Patient Specific Direction (PSD) is the traditional written instruction, signed by a prescriber for medicines to be supplied and/or administered to a named individual after the prescriber has assessed that individual on a one-to-one basis.

In practice a PSD is commonly referred to as a prescription by those who write them or use them as the legal basis to administer a medication because this indicates that it is written by a prescriber.

Examples of PSDs

Written authorisation to administer to an individual

Following a clinical assessment, a written and authorised instruction may be made by a prescriber to administer a medicine to that individual. In a GP practice this may be written in an individual clinical record; in an acute inpatient setting, this might be an instruction written on an individual’s medicine chart. Careful consideration needs to be given to how the instruction is incorporated in the clinical record to ensure that the medicine is given safely and in a timely manner. Written means either electronically added or handwritten by a prescriber.

Written authorisation to administer a medicine to multiple named individuals

A written and authorised instruction to administer a medicine to a list of individually named persons where each person on the list has been individually assessed by that prescriber. The prescriber must have adequate knowledge of each individual’s health and be satisfied that the medicine to be administered serves the individual needs of each person on that list. An example would be a list of individuals to receive a seasonal influenza vaccine during a pre-booked vaccination clinic.

Written authorisation to supply

A PSD for the supply of medicines is classified as a prescription form. This form is a legal document and must comply with the requirements for prescriptions as specified in the Human Medicines Regulations 2012. One example of a PSD for a supply is the hospital prescription form (TTO) detailing the medicines to be dispensed for an individual to take home on discharge.

Inappropriate PSDs

The following are not PSDs and are not a legal authority for the administration or supply of medicines:

Written authorisation to administer a vaccine to multiple unnamed individuals

A written instruction applying to a group of individuals where the individual/s are not individually identified i.e. a PSD could not state ‘All persons attending the practice’s ‘flu vaccine clinic on date dd/mm/yyyy’. To be a PSD it needs to be a list of all named individuals due to attend the clinic who have been individually assessed by the prescriber as suitable for treatment and be signed and dated by a prescriber (this does not need to be completed for each entry but can be done once for the entire list).

A verbal instruction

A PSD must be written.

Clarifications about PSDs

A PSD must be written

A PSD must be written and signed by the prescriber as required for all prescriptions.

Legislation states that all POM medications must have a written direction for administration, and this has been confirmed by the MHRA.

A PSD is prescribing

When a prescriber makes a decision based on the knowledge of an individual following a clinical assessment and writes an instruction for the supply and/or administration of the medicine, tailored to the needs of that individual, this is prescribing.

What a PSD must include

The information required in a PSD for administration of a medicine at a minimum should include:

• Name of the individual and/or other individual identifiers including age if a child
• Name, form and strength of medicine (generic or brand name where appropriate)
• Route of administration
• Dose
• Frequency
• Date of treatment/number of doses/frequency/date treatment ends as applicable.
• Signature of prescriber and date PSD written.

A PSD is individually tailored to the needs of an individual so more information may be required to enable safe supply and/or administration of some medicines and to manage identified risks.

If a PSD is for supply of a controlled drug (CD), the form must also meet the legal requirements for CD prescriptions.

Validity of a PSD

There is no legally valid period for a PSD for administration of a medicine. The prescriber should include a start and finish date as appropriate within the direction to ensure it is acted on within a time frame following the assessment which is appropriate to the needs of the individual. Where a PSD is for the administration of more than one dose this must be clearly indicated including the total number of doses to be given and the dosage intervals as appropriate.

A PSD for the supply of medicines is classified as a prescription form. This form is a legal document and supply must comply with the legislation of the validity of prescriptions.

Appropriate measures should be taken to ensure that the supply and administration of the medicine remains safe to the point of administration and beyond. For example, following local guidelines on correct administration and monitoring.

Using PSDs in remote consultations

Prescribers should refer to their professional regulatory body for advice if they are considering the need to write a PSD remotely during their practice – for example the General Medical Council (GMC) provides guidance for remote prescribing via telephone, video-link or online. This guidance also states that a physical examination of patients by a doctor must take place before prescribing non-surgical cosmetic medicinal products such as Botox®, Dysport® or Vistabel® or other injectable cosmetic medicines. Advice is also available from the General Pharmaceutical Council (GPhC) and the Nursing and Midwifery Council (NMC).

Administration or supply by the prescriber

There should, wherever possible, be separation of prescribing and supply/administration roles. If this is not practical, undertaking a local risk assessment should be considered. Advice is available from the Royal College of Nursing and Royal Pharmaceutical Society.

Where clinical circumstances make it necessary and in the interests of an individual, the same health care professional can be responsible for the prescribing, dispensing and/or supply/administration of medicines. Where this occurs, an audit trail, documents and processes must be in place to limit errors.

Standards for the safe and secure handling of medicines and local policies/SOPs must also be considered.

Responsibilities and accountabilities

Prescribers

The prescriber is responsible for assessment of the individual and the decision to authorise the supply/administration of the medicine(s) in question.

The prescriber has a duty of care and is professionally and legally accountable for the care they provide including the delegation of any administration of medicines they prescribe. The prescriber must be satisfied that the person to whom the administration is delegated has the qualifications, experience, knowledge and skills to provide the care or treatment involved. Advice is available from the GMC and the NMC.

Delegated staff

A person who supplies or administers a medicine is accountable for their own practice and must be trained and competent to undertake such tasks. They must act according to their level of competence and in accordance with the directions of the prescriber.

Governance

Whilst any suitably trained and competent person may follow a PSD for administration, some organisations may extend or limit those who are authorised to administer medicines under a PSD within their local medicines policies and governance arrangements.

The employing organisation has a duty of care to both the individual under their care and to the professionals they employ. The employer is responsible for ensuring that the healthcare professionals it employs are properly trained and undertake only those responsibilities specified in agreed job descriptions. If expecting non-regulated staff e.g. healthcare assistants to administer medicines, those delegating the duty must ensure that the non-regulated staff are competent.

PSDs may need to be supported by a locally approved procedure or guideline to support safe supply and/or administration of the medicine by an appropriately trained and competent healthcare professional. Prescribers and any person administering or supplying medicines must ensure that they adhere to local clinical governance policies and procedures and associated arrangements.

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