Patient Group Directions

Jane SwanSenior Medicines Management Advisor

Nursing and GovernanceHealth Partnerships

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Aims & Learning Outcomes of the Session

Aims

Develop an understanding of PGDs

Discuss how to use PGDs safely

Learning outcomes

Describe the background to Patient Group Directions (PGDs)

Learn about some of the legal aspects of PGDs and how this impacts on your practice

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The Crown Report

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HSC 2000/026

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What is a PGD?

A specific written instruction

for the supply and/or the administration

of named medicines

in an identified clinical situation.

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Who do PGDS apply to?

To groups of patients

or other service users,

who may not be individually identified

before presentation for treatment.

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Legislation

1968 Medicines Act and the Human Medicine Regulations 2012 regulate the use of medicines in the UK.

There are 3 subsequent classifications of drugs once they have marketing authorisation.

o GSLo Po POM

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Drug Classifications

GSL – (general sales list)

Medicines sold in general shops as well as pharmacies

P – (pharmacy medicine)

Medicines sold in pharmacies by or under the

supervision of a pharmacist

POM – (prescription only medicine) Medicines only obtained on a prescription through a

pharmacy

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Restrictions on classes of drugs on PGD

Controlled drugs○ Some can be used – see later – but we do not

encourage it

Unlicensed medicines [unlicensed] ○ e.g. Mantoux test

Off-label drugs [unlicensed] ○ If in line with current clinical practice e.g. NICE PGD

must state product is outside licence and reasons for using.

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Restrictions on classes of drugs on PGD

Black Triangle drugs○ Can be used in exceptional circumstances

e.g. national guidelines. Yellow card reports for all side effects/adverse reactions

Antibiotics○ Can be used as long as measures to combat

resistance are not compromised. A microbiologist should be involved in the construction of the PGD

Appliances/dressings ○ Not licensed medicines

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Who can work under a PGD? Pharmacists Registered dietitians Registered midwives Registered health visitors Registered nurses Registered occupational therapists Registered ophthalmic opticians Registered orthotists and prosthetists Registered speech and language therapists Registered chiropodists Registered orthoptists Registered physiotherapists Registered radiographers Registered paramedics

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Which organisations can use PGDs?

Special Health Authorities NHS Trusts A GP or dental practice, (providing NHS services) Non-NHS organisation providing treatment made under an

arrangement with NHS trust/PCT Services funded by the NHS but provided by private,

voluntary or charitable sector Independent hospitals, agencies or clinics registered under

Care Standards Act 2000 Health care services provided by prison service Health care services provided by police service Health care services provided by armed forces

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What information must a PGD contain?

Clinical

Indication Inclusion criteria Exclusion criteria Cautions/ need for further

advice Action if patient declines or

is excluded Advice to patient/carer Follow up/referral

Drug Details Generic name, form and

strength of medicine Route or method of

administration Dosage Frequency Duration of treatment Maximum or minimum

treatment period Quantity to supply or

administer

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What information must a PGD contain?

Organisation The name of the organisation to

which the direction applies (e.g. CHP, CityCare)

The date the PGD comes into force and when it expires

Signatures:o Pharmacisto Doctoro Organisation (Governance)

Statement of the records to be kept for audit

Staff Characteristics Each PGD will specify the

professional group that is allowed to work under it

Qualifications Specialist competencies and or

qualifications Continuing training and

education The professional who is to work

with the PGD must sign the documentation before using the PGD

You should tell your indemnity insurer you are using PGDs

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Your responsibility

Accountable○ Required to answer for one’s conduct

Responsible ○ Dependable, trustworthy, morally accountable

Individuals using PGDs are accountable and responsible for their actions to:

○ The law○ The patient/public○ Their employer○ Their professional body

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To prescribe or to PGD?

Prescribers see a patient after assessment and diagnosis, the need for a medicine is established as part of the treatment plan. A prescription is issued and dispensed.

This is still the preferred route for patients to receive their medication and the only way to manage chronic disease.

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To prescribe or to PGD?

A PGD allows a range of healthcare

professionals to supply and/or administer to a

patient if they fit within an identified clinical

criteria given in the PGD.

The patient does not have to see a prescriber.

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Process for Production and Implementation

Identify a need for a PGD

Complete proposal form and submit to the HCW PGD Group

Once approved, the professional will devise and prepare PGD using the organisations template with assistance from a Pharmacist

Submit draft PGD to HCW PGD Group for approval and Medicines Management Group informed

Authorised for the organisation

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Process for Production and Implementation

Approved PGD signed, added to database, PDF’d and put on intranet. Author notified.

Training and Competency assessment initiated for relevant staff

Implement, monitor and audit.

Review every two years or sooner if there are any evidence based changes to clinical practice which affect the PGD

Medicines Management Group informed of any changes to PGD

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Frequently Asked Questions

Are PGDs appropriate for managing chronic disease? No.

If a patient falls out of the inclusion criteria, can professional judgement be used to supply or administer a medicine?

No. They must fall exactly into the criteria or be referred as per PGD guidelines.

How long is PGD documentation kept for? Adults is eight years, Children until they are 25 or for eight

years after their death.

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Frequently Asked Questions Should patients receive patient information leaflets with any medicine

supplied? Yes

Can controlled drugs be supplied under the PGD framework? Some can: All drugs in schedule 4 except anabolic steroids. Recent

changes authorise the supply of morphine and diamorphine by registered nurses and pharmacists under PGDs in any setting

Can unlicensed medication be used under the PGD framework? No. Unlicensed medicines cannot be used. However an unlicensed

indication of a licensed medicine can be used.

Are prescription charges payable? Yes, unless usual exemption

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PGD Document and Competency Framework

Available at:http://www.npc.co.uk/

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THE CONSULTATION• Clinical and pharmaceutical knowledge• Establishing options• Communicating with patients

EFFECTIVE SUPPLY AND ADMINISTRATION WITHIN A PGD•Safe PGD use•Professional standards•Practice development

PGDs IN CONTEXT•Information in context•The NHS in context•The team and individual context

Competency Framework

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Intranet

All HP & NottsHealthcare NHS Trust PGDs are posted on the intranet

See Handout-

http://inottshc/sitefiles/data/getmaindata.asp?cat=Patient Group Directions (PGDs)&id=4400&desc=PGDs that have been approved for use within Nottinghamshire Healthcare Trust&department=Pharmacy - Forensic Division

If a service wants to start using them they must contact the Senior Medicines Management Advisor