Questions about Patient Specific Directions (PSD)

Jo Jenkins, Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division Source NHS PGD WebsitePublished

The following Q&A is intended to be read as a complete document to help provide the full context in practice.   In this document the term “prescriber” refers to doctors, dentists and all other registered health professionals who are qualified independent non medical 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.

 

What is a Patient Specific Direction (PSD)?

Whilst not defined in legislation a Patient Specific Direction (PSD) is the traditional written instruction, signed by a doctor, dentist, or non-medical prescriber (hereafter referred to as “the prescriber” unless stated otherwise) for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis (1).  Where a PSD exists, there is no need for a Patient Group Direction (PGD).  In practice a PSD is commonly referred to as a prescription by those who write and follow them because this indicates that it is written by a prescriber.

 

Examples of PSDs

  • Following an assessment of the patient, a written and authorised instruction by a prescriber to administer a medicine to the patient. In a GP practice this may be written in the patient’s notes; in an inpatient setting, this might be an instruction written on the patient’s medicine chart (1). Careful consideration needs to be given to how the instruction is incorporated in the patient record to ensure that the medicine is given safely and in a timely manner. It may be electronic (i.e. an entry in a patient’s clinical record that is appropriately completed).
  • A written and authorised instruction to administer a medicine to a list of individually named patients where each patient on the list has been individually assessed by that prescriber. The prescriber must have adequate knowledge of the patient’s health, and be satisfied that the medicine to be administered serves the individual needs of each patient on that list. An example would be a list of patients to receive a seasonal influenza vaccine during a pre-booked vaccination clinic.
  • 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 (2). One example of a PSD for a supply is the hospital prescription form (‘TTO’) detailing the medicines to be dispensed for a patient to take home on discharge. If a PSD is for supply of a controlled drug (CD), the form must also meet the legal requirements CD prescriptions.

 

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

  • A written instruction applying to a group of patients where the patient/s are not individually identified i.e. a PSD could not state ‘All patients attending the practice’s ‘flu vaccine clinic on date dd/mm/yyyy’  – it needs to be a list of all named patients 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 once for the entire list).
  • A verbal instruction.

Commonly asked questions about PSDs

 

Question Advice
Does a PSD need to be written? Yes. 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 (11) (13).

Note the BMA guidance (3) differs in that it states that a PSD may be verbal but our guidance does not support this on the advice of the MHRA.

If a prescriber writes a PSD are they prescribing? Yes.  When a prescriber makes a decision based on the knowledge of an individual patient assessment, and writes an instruction for the supply and/or administration of the medicine to the individually tailored to the needs of the patient this is prescribing.  (3, 4)
What should the PSD include?

 

 

The information required in a PSD for administration of a medicine at a minimum should include (3, 4):
  • Name of patient and/or other individual patient 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 a single patient so more information may be required to enable safe supply and/or administration of some medicines and to manage identified risks.

 

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 (2). One example of a PSD for a supply is the hospital prescription form (‘TTO’) detailing the medicines to be dispensed for a patient to take home on discharge. If a PSD is for supply of a controlled drug (CD), the form must also meet the legal requirements CD prescriptions.

How long is a PSD valid for?

 

 

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 patient.

 

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 e.g. following local guidelines on correct administration and monitoring for medicines supplied or administered.

Can the prescriber write a PSD remotely without a face-to-face consultation with the patient? Prescribers should refer to their professional regulatory body for advice if they are considering the need to write a PSD remotely during their practice (6).

 

The General Medical Council (GMC) provides guidance for remote prescribing via telephone, video-link or online (3).  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 (3) (5).  There is also advice available from the General Pharmaceutical Council

Can a prescriber write a PSD and then supply and/or administer the medicine? There should, wherever possible, be separation of prescribing and supply/administration roles (7). If this is not practicable undertaking a local risk assessment should be considered.

Where clinical circumstances make it necessary and in the interests of the patient, 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 are in place to limit errors .

Standards for the safe and secure handling of medicines and local policies/SOPs must also be considered. (8)

What are the responsibilities and accountabilities of the prescriber who writes the PSD? The prescriber is responsible for assessment of the patient and the decision to authorise the supply/administration the medicine(s) in question.

 

The prescriber has a duty of care and is professionally and legally accountable for the care they provide.

 

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. (9, 10)

What clinical governance arrangements should be in place?

 

 

 

 

Whilst anyone 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 patient and to the staff and is responsible for ensuring that the staff 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 (8).   Prescribers and anyone administering or supplying medicines must ensure that they adhere to clinical governance policies and procedures and associated arrangements.

What are the accountabilities and responsibilities of the delegated staff? A person who supplies or administers a medicine is accountable for their own practice (5) 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.

 

Related advice on the use of Directions to administer see Direction to administer forms – use of electronic signatures during COVID-19

 

REFERENCES 

  1. Medicines Matters, 2006 http://webarchive.nationalarchives.gov.uk/20130123191451/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_064325
  1. Human Medicines Regulations 2012 http://www.legislation.gov.uk/uksi/2012/1916/contents/made
  2. British Medical Association. Patient Group Directions and Patient Specific Directions in general practice. January 2016. https://www.bma.org.uk/advice/employment/gp-practices/service-provision/prescribing/patient-group-directions
  1. General Medical Council. Good practice in prescribing and managing medicines and devices (2013) https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices/a>
  2. MHRA. Supply and administration of Botox®, Vistabel®, Dysport® and other injectable medicines outside their licensed medicinal uses such as in cosmetic procedures. 2005 http://webarchive.nationalarchives.gov.uk/20141206083310/http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/Frequentlyraisedissues/BotoxVistabelDysportandotherinjectablemedicinesincosmeticprocedures/index.htm
  1. The Chartered Society of Physiotherapists Practice guidance for physiotherapist supplementary and/or independent prescribers in the safe use of medicines (3rd edition) http://www.csp.org.uk/publications/practice-guidance-physiotherapist-supplementary-prescribers
  2. Department of Health Improving Access to Medicines April 2006 http://webarchive.nationalarchives.gov.uk/20130124072757/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4133747.pdf
  3. Royal Pharmaceutical Society of Great Britain. The Safe and Secure Handling of Medicines: A Team Approach. 2005 https://www.rpharms.com/making-a-difference/projects-and-campaigns/safe-and-secure-handling-of-medicines
  4. General Medical Council 2013 Good medical practice. https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practicep
  5. Nursing and Midwifery Council. Code of conduct 2015 http://www.nmc.org.uk/standards/code/
  1. Green Book Public Health England Chapter 5 https://www.gov.uk/government/publications/immunisation-by-nurses-and-other-health-professionals-the-green-book-chapter-5
  2. Royal College of Nursing Patient Specific Directions (PSDs) and Patient Group Directions (PGDs) https://www.rcn.org.uk/clinical-topics/medicines-management/patient-specific-directions-and-patient-group-directions
  3. Personal correspondence with MHRA January 2017/June 2018
  4. Royal College of Nursing and Royal Pharmaceutical Society Guidance on Prescribing, Dispensing, Supplying and Administration of Medicines https://www.rcn.org.uk/professional-development/publications/pub-009013