written instruction vs pgd

Tips for Writing a Product Instruction Manual

For an instruction manual to be effective, it needs to be logically organized, easy to navigate through and written in clear language. People don’t typically read an entire user manual, according to Online-Learning. It’s more likely that users will pick up a manual looking for information about one specific detail.

When you’re writing a product or service manual, the target market for the product is the audience for the user manual. Keep your language in line with the average reading level of your target audience, and limit technical lingo unless you know the main readers are likely to have knowledge of industry-related terminology. For example, a user manual for operating a computer for an average person may explain basic details about how to operate it, while a user manual for a complex computer add-on may be geared toward a user with advanced technical knowledge. Overall though, keep sentences short and simple. Focus on explaining how to use the product in a way that answers common questions about it.

Use Short Headings

Headings that are highlighted with bold lettering make it easy for users to scan through sections of the manual and find specific information. It’s best to choose one type of phrasing and use it throughout the manual, according to Microsoft. Try leading with a verb and then the details. For example, ‘Add the Headers’ and ‘Format Each Header the Same Way’ both lead with a verb and then the details, which makes it easier for users to follow the formatting and find the information needed.

Write in Active Voice

When you write a product user manual, you’re talking directly to the reader, according to Online-Learning. So, using language that skirts around a topic could be confusing to the reader. For example, if you’re trying to tell someone they need a Phillip’s head screwdriver, you would, ideally, say “You’ll need a Phillip’s head screwdriver” rather than “To complete this task properly, a Phillip’s head screwdriver may be needed.” When you make it clear who will be performing the task, it draws the reader in and makes the manual more relevant to the reader.

Adding Steps

If you’re adding a step-by-step tutorial, you should number each step and begin each step with an imperative verb, according to Microsoft. Use full sentences and avoid fragmented sentences to make sure the message is clear. Hold each step-by-step procedure to seven or less steps, if possible, and keep each step as simple as possible. If you notice step-by-step sections getting too long, see if you can break them into more than one procedure to reduce the number of steps.

When to Use Right Angle Brackets

If you’re writing a user manual for something computer related, where the user may click through a series of steps, right angle brackets may be used shorten the commands and to indicate the click pattern, as noted by Microsoft. For example, directions with right brackets may look like this: Select Dashboard > User Accounts > Register New Account.

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An introduction to PGDs: definitions and examples of use

This page explains what a Patient Group Direction (PGD) is and describes how they are used in clinical practice.

Definitions and guidance

Nice guidance, appropriate pgd use, when a pgd can be used, when a pgd cannot not be used.

A Patient Group Direction (PGD) is a written instruction for the sale, supply and/or administration of medicines to groups of patients who may not be individually identified before presentation for treatment.

May or may not be identified means an individual can either be known to the service/have an appointment (e.g. a baby immunisation clinic) or not be known in advance of presenting at a service (e.g. a walk in centre).

PGDs are not a form of prescribing. PGDs allow health care professionals specified within the legislation to supply and/or administer a medicine directly to a patient with an identified clinical condition without the need for a prescription or an instruction from a prescriber. The health care professional working within the PGD is responsible for assessing that the patient fits the criteria set out in the PGD.

The supply and/or administration of medicines under a PGD cannot be delegated – the whole episode of care must be undertaken by the health care practitioner operating under the PGD.

Organisations should have policies and processes in place to consider all aspects of medicines management for patients within the service or pathway. Before a service is designed or commissioned using PGDs and before a PGD is developed, you must ensure that PGDs are appropriate, legal, and that relevant governance arrangements are in place.

NICE guideline MPG2 (2017) Patient Group Directions  gives guidance on when to use a PGD, stating that the majority of clinical care should be provided on an individual, patient-specific basis. The supply and administration of medicines under PGDs should be reserved for those limited situations where this offers an advantage for patient care without compromising patient safety, and where it is consistent with appropriate professional relationships and accountability.

Examples include:

• Seasonal and other types of vaccination.
• For groups of patients who have not previously presented to e.g. minor injury units and other first contact services.
• In well established services where assessment and treatment follows a clearly predictable pattern (e.g. NHS immunisation clinics and contraception and sexual health services).
• For long-term management of a patient’s clinical condition such as in chronic or long-term conditions
• For medical devices
• For supply or administration of radiopharmaceuticals (Administration of Radioactive Substances Regulations 1978)
• For supply or administration of dressings and medical devices
• For supply or administer abortifacients (Abortion Act 1967)
• For training or as part of training
• For unlicensed medicines
• Where there is delegation of responsibility to supply or administer the medicine
• When two or more licensed medicines are mixed together as this results in an unlicensed medicine

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• Health and social care
• Medicines, medical devices
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• Patient group directions (PGDs)
• Medicines & Healthcare products Regulatory Agency

Patient group directions: who can use them

Updated 4 December 2017

© Crown copyright 2017

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected] .

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them

Patient group directions ( PGDs ) are written instructions to help you supply or administer medicines to patients, usually in planned circumstances. They take a significant amount of time and resource to develop and implement.

You can only supply and or administer medicines under PGDs if there is an advantage for the patient without compromising their safety.

PGDs should be put together by a multi-disciplinary group including a doctor, a pharmacist and a representative of any professional group expected to supply the medicines under the PGD . It’s good practice to involve local drug and therapeutics committees, area prescribing committees and similar advisory bodies.

The expiry date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised.

Who can supply or administer under a PGD

You can do this if you are a qualified healthcare professional. These are::

• chiropodists and podiatrists
• dental hygienists
• dental therapists
• occupational therapists
• optometrists
• orthoptists
• orthotists and prosthetists
• pharmacists
• physiotherapists
• radiographers
• speech and language therapists

Legal requirements

What a pgd must include.

According to the legal requirements, a PGD must include:

• the name of the business who owns the direction
• the start and end date of the PGD
• a description of the medicine(s)
• the class of the health professional who can supply or administer the medicine
• a signature of a doctor or dentist (as appropriate) and a pharmacist
• authorisation by an appropriate organisation: Authorising PGDS
• the clinical condition or situation to which the direction applies (eg the specified condition/conditions that can be treated)
• a description of patients excluded from treatment under the direction
• a description of when you should get more advice from a doctor (or dentist, as appropriate) and arrangements for referral
• details of appropriate dosage, maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period to administer the medicine
• relevant warnings, including potential adverse reactions
• details of any necessary follow-up actions
• a statement of the records to be kept for audit purposes

See the Human Medicines Regulations 2012 for the legal requirements for PGDs .

Medicines you can supply under a PGD

All medicines are classified according to three legal categories which are:

• prescription only (POM)
• pharmacy (P)
• general sale list (GSL)

POM and P medicines can generally only be sold or supplied at a registered pharmacy premises by or under the supervision of a pharmacist. POMs must be sold or supplied according to a prescription prescribed by a health practitioner. This can be a doctor, dentist, or other independent or supplementary prescriber. GSL medicines can be sold from a wider range of premises such as supermarkets as long as those premises can be closed to exclude the public (i.e. they are lockable) and the medicines are pre-packed.

PGDs provide an exemption from these restrictions. Only certain controlled drugs can be included in a PGD according to The Misuse of Drugs Regulations (2001). See the controlled drugs that can be supplied under a PGD on the NICE website .

Under a PGD you cannot supply:

• unlicensed medicines
• dressings, appliances and devices
• radiopharmaceuticals
• abortifacients, such as mifepristone.

Further guidance

A PGD should have a senior person to ensure only competent, qualified and trained professionals oversee and follow the directions.

The required documents in a PGD need to be signed by each member of the multi-disciplinary group, the clinical governance lead on behalf of the NHS organisation authorising the PGD and the individual health professionals working under the direction.

You need to ensure arrangements are in place for the security, storage and labeling of all medicines. You should supply medicines in pre-packs made up by a pharmacist. There must be a secure system for recording and monitoring how medicines are used including stock control. You must also record names of the health-care professionals supplying or administering treatment, patient identifiers and the medicines provided.

You must use medicines according to the summary of product characteristics for the product (with some exceptions) and any relevant authoritative good practice guidance.

Use of medicines with ‘risk minimisation measures’ in PGDs

Risk Minimisation Measures (RMM) are a regulatory requirement for some medicines, and are a critical part of the product licence (marketing authorisation) to help maintain a favourable benefit-risk profile. Medicines with a requirement for RMM may not be suitable for inclusion in a PGD .

As well as information on contraindications, warnings/precautions and possible side effects routinely described in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), some medicines have an extra regulatory requirement for additional ‘risk minimisation measures’ (RMM). RMM are designed to facilitate informed decision making to support risk minimisation when prescribing, dispensing and/or using a medicinal product, and may be imposed on a product at the time of licensure, or at any time thereafter. RMM may differ in their purpose, design, target audience and complexity, and might include measures to guide appropriate patient selection with the exclusion of patients where use is contraindicated, to support on-treatment monitoring relevant to important risks and/or management of an adverse reaction. The format, content and method of distribution of RMM are agreed on a product-specific basis by MHRA. Examples can range from extra information for patients, such as ‘alert’ card, or checklists for health professionals, to the imposition of a controlled access scheme.

When developing a PGD for a medicine, it is important to determine whether the medicine has any RMM associated with the licence.?].

In accordance with NICE guidance, medicines needing frequent dosage adjustments or frequent or complex monitoring, should not be included in a PGD . In line with this, a medicine with RMM for close monitoring and supervision of patients may not be suitable for inclusion in a PGD .

If a decision is taken to include a medicine with RMM in a PGD , the requirements of the RMM must be included in the PGD . As well as routine reference to the important particulars of the SmPC and PIL, the relevant sections of the PGD template should make specific reference to the key points of the RMM where applicable. If RMM has been developed specifically for patients, the PGD should include instructions to give verbal information to the patient on the important risks described in the RMM, as well as the provision of any written RMM for the patient to take away (along with the PIL), and where additional information may be found. If the RMM includes a checklist for prescribers, the use of the checklist should also be incorporated into the RMM.”

Arrangements for independent healthcare providers in Scotland

Currently, PGDs can only be set up for use in independent hospitals and hospices in Scotland. From 1 April 2017, changes in Scottish law will also allow independent clinics to set up PGDs .

A PGD signed by a provider of an independent health care service registered in England and Wales cannot be used to authorise the supply or administration of medicines in Scotland.

An independent healthcare provider registered in England and Wales can enter into an arrangement with a pharmacist based in a Scottish community pharmacy to operate under a PGD .

This applies even if the provider is not registered in Scotland. The same applies pharmacists in England and Wales operating under PGDs authorised by a provider who is only registered in Scotland.

More information

See the Specialist Pharmacy Service website for guidance on how to set up and follow a PGD .

Follow the good practice guidelines on the National Institute for Health and Care Excellence (NICE) website .

Email MHRA customer services inf[email protected] or call 0203 080 6000 with any queries with PGDs .

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• Guidance and advice

Patient group directions (PGDs)

2 November 2022

A patient group direction (PGD) is a written instruction that allows named, authorised and registered healthcare professionals to sell, supply or administer named medicines in an identified clinical situation legally, without needing a written, patient-specific prescription from an approved prescriber.

PGDs can be used by dental hygienists and dental therapists in:

• NHS practices in England, Wales and Scotland and their equivalent in Northern Ireland
• private dental practices in England registered with the Care Quality Commission
• private dental practices in Wales, providing the individual dentists are registered with the Health Inspectorate Wales
• private dental practices in Northern Ireland registered with the Regulation and Quality Improvement Authority
• private dental practices in Scotland registered with Health Improvement Scotland.

The Human Medicines Regulations 2012 require a PGD to be signed by a dentist and a pharmacist. As the requirements for an NHS PGD are slightly different to those for a private PGD , it's important to check that the PGD is valid for its purpose.

For example, for practices providing NHS primary dental services , it must also be signed on behalf of the authorising body . As regulations may vary in the different countries of the UK, it's sensible to check the PGD is signed by the appropriate persons in the area in which you're working.

Requirements

PGDs need to contain the following:

• the period when the PGD will have effect
• the description or class of medicinal product it relates to
• the clinical situations when medicinal products of that description or class can be used
• whether there are any restrictions on the quantity of medicinal product that can be sold or supplied on any one occasion - and if so, what those restrictions are
• the clinical criteria under which a patient is eligible for treatment and whether anyone is excluded from treatment under the PGD
• the circumstances in which further advice should be sought from a doctor or dentist
• the pharmaceutical form or forms in which the medicinal products of that description or class are to be administered
• the strength or maximum strength at which the products can be administered, the applicable dosage or maximum dosage, the route and frequency of administration and the minimum or maximum period of administration
• relevant warnings
• the circumstances in which any follow-up action is needed
• referral arrangements for medical advice
• what records should be kept of the supply, or the administration, of products.

Before administering drugs under a PGD, dental hygienists and therapists should be sure it is valid. This means checking they are named on the PGD, that the patient meets the clinical criteria, and that it applies to the POM concerned. It's also important to be aware that the expiry date of a PGD should " not exceed 3 years from the date the PGD was authorised ".

The dental hygienist and dental therapist should be fully trained and competent to perform the procedure, and are professionally accountable for their actions or omissions. They should also make sure they have adequate indemnity arrangements in place to cover their work.

If you're a DDU member and have specific queries about PGDs, contact our helpline for individual advice.

Helpful links

• Human Medicines Regulations 2012
• Nice PGD medicines practice guidelines and template
• MHRA guidance, PGDs: who can use them (updated 2017)
• Consultation on Proposals for Legislative Changes to the Human Medicines Regulations 2012

This page was correct at publication on 02/11/2022. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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Patient Specific Directions (PSDs) and Patient Group Directions (PGDs)

A patient specific direction (psd) is a written instruction, signed by a prescriber for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis., patient group directions (pgds), useful resources.

• Royal Pharmaceutical Society (2019)  Professional Guidance on the Administration of Medicines in Healthcare Settings
• Royal Pharmaceutical Society (2019)  Practical guide for independent prescribers
• National Institute for Health and Care Excellence (NICE) has published a suite of guidance, advice and support for delivering quality, safety and efficiency in the use of medicines . 
• BMA has updated their guidance for Patient Group and Patient Specific Directions . This guidance is for England only.
• CQC Myth buster on Patient Group Directions and Patient Specific Directions 
• Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. 
• MHRA yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users. Reports can be made for all medicines including vaccines, and all medical devices available on the UK market.
• Specialist Pharmacy Service. Guidance on  written instruction for the administration of seasonal flu vaccination .
• Specialist Pharmacy Service.  To PGD or not to PGD? – that is the question . This tool is intended to be the first stage in the process to help colleagues consider whether a PGD is appropriate.
• Specialist Pharmacy Service.  Patient Group Direction use in End of Life Care .
• Specialist Pharmacy Service.  Patient Group Direction (PGD) use in a service provided by multiple organisations .
• Specialist Pharmacy Service.  Advice on the preparation and/or administration of contrast agents supplied under a Patient Group Direction .
• Specialist Pharmacy Service.  Patient Group Direction use by temporary/provisional professional registrants .
• Reproductive health national PGDs
• PGD templates to support national immunisation programmes provided on the NHS
• The Role of Nursing Associates in Vaccination and Immunisation. Position statement (April 2019)
• Health Care Support Workers Administering Inactivated Influenza, Shingles and Pneumococcal Vaccines for Adults and Live Attenuated Influenza Vaccine (LAIV) for Children

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• Practice resources
• Occupational therapy topics

Patient Group Directions (PGDs) and Occupational therapists

The development of new skills and roles in practice is encouraged within occupational therapy.  Occupational therapists’ transferable skills are valued in many settings, and diverse practice is acknowledged by The Royal College of Occupational Therapists 1 and within Health and Care Professions Council (HCPC) standards of proficiency 2 . 

One area of increasing diverse practice for occupational therapists is related to medicines management, which is part of the wider medicines optimisation agenda.  A working knowledge of medication and its effect on occupational performance on people is a vital element to occupational therapists’ knowledge.  With increased diversity in practice, more occupational therapists are becoming involved in medicines optimisation, as such it is important that occupational therapists understand their responsibilities 3 .

Medicines legislation is clearly defined under the Human Medicines Regulations 2012. There are a number of legal options for the prescribing 4 , supply and administration of medicines.

These are (reference NICE MPG2 PGDs):

• Independent prescribing – the prescriber (a doctor, dentist or non‑medical independent prescriber) takes responsibility for the clinical assessment of the patient, establishing a diagnosis, the clinical management needed and prescribing.
• Supplementary prescribing – a voluntary partnership between a doctor or dentist and a supplementary prescriber, to prescribe within an agreed patient‑specific clinical management plan 5 with the patient's agreement.
• Patient Specific Directions (PSDs) 6 – written instructions, signed by a doctor, dentist, or non‑medical prescriber for a medicine to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis. Writing a PSD is a form of prescribing.
• Patient Group Directions (PGDs).
• Exemptions 4 from medicines legislation.

The preferred option in the majority of care is the prescribing of medicines on an individual, patient-specific basis by way of writing a prescription or by writing a PSD. 

The supply and administration of medication under PGD “…should be reserved for situations in which this offers an advantage for patient care without compromising patient safety, and there are clear governance arrangements and accountability.” ( Medicines practice guideline [MPG2], 2017 7 )

This is a guide to support occupational therapy staff, who are considering whether there could be an advantage for patients in developing a PGD within their service.

What is it?

A Patient Group Direction (PGD) is a signed, written document supported by a legal framework that allows named, authorised and registered health professionals (including occupational therapists 8 ) to supply and/or administer specified medicine(s).  The specified medicines are supplied/administered to a pre-defined group of patients with conditions described and detailed within the PGD.  An authorised PGD within a service enables the named, authorised health professionals to supply and/or administer medicines without the requirement to consult a doctor or dentist.

Prior to developing a PGD the following must first be considered:

• The preferred way for a patient to receive a medicine is via a prescriber directly to a patient on a one-to-one basis.  This might be by individual prescription dispensed by a pharmacist, or by a Patient Specific Direction (PSD).
• There may also be further options to explore administration of medicines using General Sales List (GSL) or Pharmacy (P) medicines under local protocols.More details are available here .
• PGDs should not be seen as a direct substitute for prescribing and there must be clear rationale and multi-disciplinary team (MDT) support, ensuring full adherence to relevant national legislation and local guidelines, procedures and governance related to the PGD. 
• MDT approach – PGDs should be developed by a multidisciplinary team and must be signed off by a doctor or dentist and a pharmacist .  Prior to developing a PGD, occupational therapists must obtain full agreement to do so within their organisation with key professionals who have the clinical and governance expertise (for example pharmacist leads) and authority to proceed, supported by a knowledge of the service where the PGD is to be delivered.
• Patient Safety – evidence to support development of a PGD must demonstrate that it is safe, with improved outcomes, be clinically effective and cost effective. It should ensure patient choice and provide an optimum patient experience. 
• PGDs take a significant amount of time and resource to develop, implement and review.  As such any organisation developing a PGD must make full consideration about whether it is the most appropriate option to deliver safe and timely care for patients.  For this reason, occupational therapists must ensure that they adhere to any organisational PGD policies and procedures when embarking on this process.
• Occupational therapists involved in PGDs from development to delivery must abide by the Royal College of Occupational Therapists 9 Professional standards for occupational therapy practice, conduct and ethics  and requirements under the HCPC.

If you are considering a PGD within your service or are going to be authorised to use a PGD in practice, you are advised to complete this e-learning A to ensure that you have an understanding of the whole process and factors to consider. 

You may also wish to have look at and complete the NICE PGD Competency Framework B which is relevant to your needs.

In addition, we would strongly recommend Quality PGDs -  7 stages to success resource C as an essential reference source.  This document clearly breaks down the seven steps needed in the PGD process cycle which are as follows:

• Think about finding the safest route for patients to receive their medicines within the service or pathway 
• Think about the process, the people to involve and the medicine
• Getting ready to write the PGD
• Writing and agreeing the PGD for submission
• Authorising the PGD
• Getting ready to use the PGD
• Monitoring and reviewing the PGD in practice

United Kingdom nation specific variations

The above guidance applies generally across all nations within the United Kingdom.  As stated above, it is essential that members refer to local procedures, governance and policies within their specific setting and prior to commencing any work on PGDs.

Acknowledgements: 

Support for the development of this guidance was provided by the NHS Specialist Pharmacy Service PGD Lead.

For further questions on any of the above please contact:

Paul Cooper, Professional Adviser, The Royal College of Occupational Therapists.  [email protected] .

Essential further reading:

A . Patient Group Directions.  An e-learning programme for people and organisations who are considering, developing , authorising and using patient group directions. CPPE.  October 2016.  https://www.cppe.ac.uk/e-learning/pgd/story.html .  Accessed 26.04.2019.

B. Patient Group Directions.  Medicines practice guideline [MPG2].  https://www.nice.org.uk/guidance/mpg2/resources .  Accessed 26.04.2019.

C. Quality PGDs – 7 steps to success.  Specialist Pharmacy Service. Medicines Use and Safety ‐ Patient Group Directions. July 2016.   https://www.sps.nhs.uk/articles/quality-pgds-7-steps-to-success/ .  Accessed  26.04.2019.

References and further resources:

• FAQs: Professional Enquires.  Enquires FAQ Diverse Practice – What do I need to consider (Feb 2015).  https://www.rcot.co.uk/practice-resources/professional-practice-enquiries-service/professional-practice-faqs   Accessed  26.04.2019.
• Health and Care Professions Council – HCPC.  (2013). Standards of proficiency for occupational therapists.  Available at:  https://www.hcpc-uk.org/standards/standards-of-proficiency/occupational-therapists/ .  Accessed  26.04.2019.
• Royal College of Occupational Therapists.  Good Practice briefing - Medicines management and Administration responsibilities.  Page on RCOT website:  https://www.rcot.co.uk/practice-resources/occupational-therapy-topics/me... Accessed 26.04.2019.
• Medicines and Prescribing.  Health and Care Professions Council –HCPC.  Available at:  https://www.hcpc-uk.org/about-us/what-we-do/medicine-entitlements/ . Accessed 26.04.2019.
• The Human Medicines Regulations 2012, SCHEDULE 14.  Clinical management plan.  Available at: http://www.legislation.gov.uk/uksi/2012/1916/schedule/14/made . Accessed 26.04.2019.
• Patient Specific Directions – Q&A. Specialist Pharmacy Service.  July 2015.  https://www.sps.nhs.uk/articles/patient-specific-directions-qa/ .  Accessed  26.04.2019.
• National Institute for Health and Care Excellence (NICE) Patient Group Directions (MPG2).  Available at:  https://www.nice.org.uk/Guidance/MPG2 .  Accessed 26.04.2019.
• Medicines & Healthcare products Regulatory Agency.  Patient group directions: who can use them.  Available at: https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them  Accessed 26.04.2019.
• Royal College of Occupational Therapists (2015a) Code of ethics and professional conduct London, UK: College of Occupational Therapists Ltd.
• Medicines Matters: A guide to mechanisms for the prescribing, supply and administration of medicines (in England).  Specialist Pharmacy Service.  October 2018. https://www.sps.nhs.uk/articles/medicines-mattersa-guide-to-mechanisms-for-the-prescribing-supply-and-administration-of-medicines-in-england/ .  Accessed 26.04.2019.

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What is a Patient Group Direction (PGD)?

With the flu vaccination season almost upon us, I thought I would highlight the need for – and use – of PGDs. PGDs are the legal mechanism by which a prescription only medicine (POM) can be supplied or administered to a patient for whom no individual prescription exists. All vaccines come under the legal category of POMs. PGDs were introduced through legislation in 2000 and are written agreements for the supply and administration of medicines to groups of patients who may not be identified before presentation for treatment.

What is the difference between a PGD and a PSD?

PGDs can be used for patient groups where general requirements are sufficiently consistent to be provided for by such a non-specific direction e.g. childhood immunisations. A Patient Specific Direction (PSD) is the traditional written instruction, signed by a doctor, dentist, or non-medical prescriber for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis. Where a PSD exists there is no need for a PGD. Practices are able to develop their own PGDs if they need to but they must have an agreement with an authorising body such as NHS England or the local Clinical Commissioning Group (CCG).

Who can use PGDs?

We’ve received a few PGDs lately, including the administration of Men C for children aged 2 months to 10 years, and the new Men ACWY vaccine. PGDs can only be provided for specific health professionals and generally includes nurses, midwives, pharmacists, ambulance paramedics, occupational therapists, and dental therapists. Whoever is responsible under the PGD for the supply and administration of medicines must be named on the PGD and this responsibility cannot be passed to others. Implementation of the PGD must be outlined in the specification and only trained and competent staff can administer medicines and vaccines under the PGD.

What should be in a PGD?

Besides the name of the service provider and individuals to whom the PGD applies, other information which should be contained in PGD documentation includes:

• The valid from and expiry date of the PGD
• The medicines to which the PGD applies
• The clinical condition or situation to which the PGD applies
• The criteria for exclusion under the PGD e.g. patient’s aged and medical history
• The description of treatment, including the name, strength and formulation
• The dose and frequency of administration
• The disposal of the medicine
• Any drug interactions, and the management of adverse reactions

Further information about PGDs can be sought from NICE  and the RCN .

Alison Lowerson – QCS Expert GP Practice Manager Contributor

*All information is correct at the time of publishing. Use of this material is subject to your acceptance of our terms and conditions .

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GP mythbuster 19: Patient Group Directions (PGDs)/Patient Specific Directions (PSDs)

Coronavirus (covid-19).

There have been no changes to the legislation relating to PGDs during the COVID-19 pandemic.

Organisations will need to consider local governance arrangements and perform local risk assessments if there is any divergence from their usual PGD related processes during a pandemic to ensure that PGD use remains within the legislation and that patient safety is protected.

COVID-19 Guidance has been provided by the Specialist Pharmacy Service for use of PGDs in pandemics (for example COVID-19) .

Staff who administer and/or supply prescription only medicines should have appropriate authorisation. Full details are listed in the information sources below. Providers should be aware of the requirements, but some of the key points are:

Patient Group Directions (PGDs)

PGDs are governed by the Human Medicines Regulations 2012 and later amendments. They allow specified health professionals to supply and/or administer medicine without a prescription or an instruction from a prescriber. The majority of clinical care should be provided on an individual basis using prescriptions or patient specific directions.

PGDs in commissioned NHS services

• Most PGDs are authorised before they are supplied to the practice for use in a commissioned service.
• These include PGDs authorised by the NHS England regional team to support the national immunisation programme.
• PGD is not valid until signed by a senior member of staff to adopt it for use by the provider.

Who can operate under a PGD?

Health professionals who may supply and/or administer medicines under a PGD are listed in the regulations . They include registered nurses, paramedics and pharmacists.

Examples of staff groups who cannot work under a PGD are:

• healthcare assistants
• nurse associates and
• physician associates.

The health professional who carries out the assessment under the PGD cannot delegate supply and/or administration to another member of staff.

Health professionals who will be using the PGD must be named and authorised before they use it to provide care. An appropriate member of staff, for example GP, practice manager or lead nurse should be responsible for authorising the health professionals in each organisation. Practitioners should keep a copy of their individual authorisation and have the current authorised PGD available for reference.

PGDs in Primary Care Networks (PCNs)

Where using patient group directions across primary care networks , each practice should adopt the PGD and authorise their staff to use it. Each practice is responsible for making sure their staff are trained, competent and complete necessary records.

There must be an agreement in place across the network to set out responsibilities and governance arrangements. Staff can then provide care under the PGD to patients of other practices covered by the agreement.

The provider must keep a record of all the health professionals authorised to practise under the PGD. Authorised health professionals must record an agreement to follow the PGD. They must provide assurances they are trained and competent to do so.

Electronic systems may be used to record authorisation, agreement and declarations of competence. If buttons or tick boxes are used it must be clear what the individual is confirming or signing up to. There must be a record of who has made the entry, the date and the time and an audit trail of any alterations.

Labelling and leaflets

• Medicines administered by the person operating under the PGD do not need to be labelled.
• Medicines do not need to be labelled if supplied under a PGD for immediate administration. For example, a flu vaccine nasal spray administered in the clinic to a child by their parent.
• Medicines supplied and taken away by the patient must be labelled in line with the regulations.
• Patient information leaflet must be supplied in every case, whether or not the medicine has to be labelled.

Developing PGDs for NHS or private services

A GP practice can develop their own PGDs to use for their NHS patients. There must be a formal agreement in place between the commissioner (the CCG or NHS England) and provider (the GP practice). This may be outlined in a service level agreement or contract specification.

GP practices and other providers can use PGDs in their private practice. For example, for the administration of travel vaccines such as yellow fever, rabies and Japanese B encephalitis. They can develop their own PGDs or buy authorised PGDs from an external organisation.

When developing their own PGDs providers should make sure they are aware of and follow the regulatory requirements for all areas of development, authorisation and use. Guidance is available in NICE MPG2 Patient group directions .

When buying a PGD the provider should make sure the organisation supplying the PGD has developed it in line with:

• regulations
• national guidance
• current clinical practice and
• is legally able to authorise the PGD.

Patient Specific Directions (PSDs)

A PSD is an instruction to supply and/or administer a medicine written and signed by the prescriber. It could be an electronic record made in the patient notes where it is identifiable to the prescriber.

A PSD can also be an instruction to administer a medicine to a list of patients. Each patient on the list must be individually assessed by that prescriber. The prescriber must have knowledge of the patient's health and be satisfied the medicine meets the individual needs of each patient on that list. For example, a healthcare assistant may be running an influenza immunisation clinic. The prescriber must review the patients attending the clinic and sign a list of those who they authorise to be immunised.

The PSD must include the:

• name(s) of patient(s) and/or other individual patient identifiers including age if a child
• name, form and strength of medicine
• route of administration
• date of treatment/number of doses/frequency/date treatment ends as applicable
• signature of prescriber.

During inspections we have seen cases where staff have mistakenly believed they were administering/supplying a medicine with the authority of a PSD. While it is not possible to list them all, the following are examples that do not meet the requirements of a PSD. They are not a legal authority for the administration or supply of medicines:

• a Patient Group Direction (PGD) template renamed a “PSD” and used to instruct healthcare staff.
• a generic instruction to be applied to any patient who may be seen by a healthcare professional or who has an appointment on any particular day. For example, an instruction to administer a flu vaccine to any patient who fits the criteria attending clinics on a specific day.
• a verbal instruction.

Responsibilities and accountabilities

• The prescriber is responsible for assessing the patient and making the decision to allow the supply or administration of the medicine.
• The prescriber must be satisfied that the person to whom administration is delegated has relevant qualifications, experience, knowledge and skills.
• A person supplying or administering medicine must be trained and competent.
• They must act in line with their level of competence and the directions of the prescriber.

What clinical governance arrangements should be in place?

In law, anyone whom the prescriber has:

• assessed as competent
• has the necessary knowledge and skills, and
• has been delegated the task may follow a PSD.

Some organisations may extend or limit those who are authorised to supply or administer medicines under a PSD. This must be documented in their local medicines policies and governance arrangements.

The practice has a duty of care to the patient and staff. They are responsible for making sure staff are properly trained and undertake only those responsibilities written in agreed job descriptions. If expecting non-regulated staff, for example healthcare assistants, to administer medicines, those delegating the duty must make sure these staff are competent to do so safely.

A locally approved procedure or guideline would support the safe administration of medicines by a suitably trained and competent healthcare professional.

What if a patient brings in prescribed medicines that have been dispensed for them elsewhere?

The practice may issue a prescription to a patient to have the medicine dispensed at a pharmacy or dispensary for administration at the practice. For example, the patient may obtain an injection such as vitamin B12 or Zoladex from a community pharmacy. The patient returns to the practice for it to be administered by the practice nurse. In these circumstances the responsibilities of the prescriber and the delegated member of staff administering the medicine are the same as for a PSD.

Further information

• Human Medicines Regulations 2012
• Patient Group Directions  (Specialist Pharmacy Service)
• Questions about Patient Specific Directions (Specialist Pharmacy Service)

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