Patient Group Directions
Jane Swan
Senior Medicines Management Advisor
Nursing and Governance
Health Partnerships
Aims & Learning Outcomes
of the Session
Learning outcomes
Aims
 Develop an
understanding of PGDs
 Discuss how to use
PGDs safely
 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 GSL
o P
o 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
Drug Details
 Generic name, form and
 Indication
strength of medicine
 Inclusion criteria
 Route or method of
 Exclusion criteria
administration
 Cautions/ need for further  Dosage
advice
 Frequency
 Action if patient declines or  Duration of treatment
is excluded
 Maximum or minimum
 Advice to patient/carer
treatment period
 Quantity to supply or
 Follow up/referral
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 Pharmacist
o Doctor
o 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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Competency Framework
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
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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
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