Download General Guidance for the Administration of Vaccines

Patient Group Directions- Open
Learning & Resource Pack
PGD Resource Pack 2010
Introduction.
This package has been devised to ensure that all staff operating Patient Group
Directions (PGDs) are aware of, and feel confident with the changes that are
about to happen with the introduction of PGDs into the Trust.
It is intended that each member of staff will work through this package
independently, seeking help where necessary, or during a group training session.
When completed, s/he should contact his/her line manager to verify successful
completion. The line manager will retain a copy of the completed package. The
hours used to work on the package can be counted towards CPD requirements.
Medicines awareness is an important part of the role of the healthcare
professional, and as such, clinicians have a responsibility to ensure that her/his
knowledge is updated. It is essential that the safety of the patient/ service user is
maintained and that informed consent is obtained before the administration of
any drug. By working through this package the information required should be
accessible and therefore achieve the main aim of the learning process.
Healthcare professionals are reminded that their practice must comply with
standards as laid down by the professional body, i.e. for nurses the NMC with
particular reference to:
 Guidelines for the Administration of Medicines (NMC 2004)
 Code of Professional Conduct (NMC 2002)
PGD Resource Pack 2010
Patient Group Directions
What is a Patient Group Direction (PGD)?
A PGD is a written instruction for the supply or administration of a medicine to a
group of patients, who may not be individually identified before presentation for
treatment, by a health professional who is not able to prescribe this medicine.
In practice, a PGD can act as a direction to a health professional to supply and/or
administer Prescription Only Medicines (POMs) to patients without individual
prescriptions.
Homogeneous patient groups, where presenting characteristics and
requirements are sufficiently consistent, to be supplied or administered to under a
PGD are patients undergoing, e.g.:
 Child/Adult immunisation as part of the national programme
 Foreign Travel
 Contraceptive Services
 Patients appropriate for thrombolysis on-route to hospital in ambulance
 Analgesia prior to minor surgery or treatment for an injury
In summary, PGDs fit best within services where medicines use follows a
predictable pattern and is less individualised. PGDs are generally most
appropriate to manage a specific treatment episode (or episodes) where supply
or administration of a medicine is necessary. As opposed to taking responsibility
for managing an individual patient’s condition over the long-term, where a
prescribing relationship is likely to be more appropriate.
What they are not?
PGDs are not able to cover health professionals supplying/administering
medicines to individual patients prior to a prescription being written, nor do they
allow health professionals to re-authorise repeat prescriptions, or adjust dosage
of a medication on a repeat prescription. The demands or needs of health
professionals in these areas will be better met under developments in
supplementary (dependent) or independent prescribing. More information is
supplied in Appendix 4 - Frequently Asked Questions.
Are PGDs legal?
Yes, PGDs were made legal by modifications to the provisions in and under the
Medicines Act 1968. The legislation applies to the NHS, including private and
voluntary sector actively funded by the NHS, and came into force on 9 th August
2000.
Health Service Circular 2000/026
This contains the legal requirements and guidance for PGDs. Failure to comply
with the law could result in a criminal prosecution under The Medicines Act.
PGD Resource Pack 2010
Health Professionals
The qualified health professionals who are able to supply or administer medicines
under a PGD are:
 Nurses
 Midwives
 Health Visitors
 Optometrists
 Pharmacists
 Chiropodists
 Radiographers
 Orthoptists
 Physiotherapists
 Ambulance Paramedics
 Dieticians
 Occupational therapists
 Prosthetists and orthotists
 Speech and language therapists
They must all do so as named individuals on the PGD.
Drawing up PGDs
Trusts will identify a designated team of people including a senior doctor, senior
pharmacist and a senior nurse who will take responsibility for PGD development
in their area. In this Trust, the Medicines Management Committee ratifies all
PGDs. Health professionals who think they may need a PGD developed should
contact their line manager, who should then apply to the Head of Service (see
PGD Management Procedure - Appendix 1). Clarification of the appropriateness
of a specific medicine for administration or supply through operation of a PGD
may be sought using the flowchart found in Appendix 3.
All PGDs must be signed by the senior doctor (Medical Director) and the senior
pharmacist (Chief Pharmacist). The PGDs then have to be authorised by the
NHS Trust (e.g. Clinical Governance Lead), and it is best practice for the Head of
Service for the health professionals operating the PGD to sign the PGD.
Ratification is via the Trust’s Medicines Management Committee.
What details must PGDs contain?
The legislation specifies that each PGD must contain the following information:
 The name of the business to which the direction applies
 The date the direction comes into force and the date it expires
 A description of the medicine(s) to which the direction applies
 Class of health professional who may supply or administer the medicine
 Signature of a doctor or dentist, as appropriate, and a pharmacist
 Signature by an appropriate health organisation
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The clinical condition or situation to which the direction applies
A description of those patients excluded from treatment under the direction
A description of the circumstances in which further advice should be
sought from a doctor (or dentist, as appropriate) and arrangements for
referral
Details of appropriate dosage and maximum total dosage, quantity,
pharmaceutical form and strength, route and frequency of administration,
and minimum or maximum period over which the medicine should be
administered
Relevant warnings, including potential adverse drug reactions
Details of any necessary follow-up action and the circumstances
A statement of the records to be kept for audit purposes
Who is responsible for ensuring the competence of the health care
professionals supplying or administering medicines using PGDs?
The line manager (usually head of service) is responsible for ensuring that only
fully competent, qualified and trained health care professionals operate within
PGDs; where a range of health care professionals are using PGDs this may be a
senior representative from each of the professions. Particular focus is required
when a PGD is introduced, and thereafter it should form part of annual appraisal.
There is no current specific national training and development programme for
health care professionals using PGDs, however, the competency framework,
developed by the National Prescribing Centre (Appendix 5), can be used as a
starting point, and the Self-Test (Appendix 6) should be completed, and the
member of staff should contact their line manager to verify successful
completion.
PGD Resource Pack 2010
Required Training For Health Professionals Undertaking Immunisations
(Including Updates)
The nurse should ensure he/she has received accredited training and is proficient
and competent in undertaking immunisations and operating a PGD, these should
include the following:  Criteria for use
 Contraindications for vaccines.
 Safe Storage and handling of vaccines
o Cold Chain standards.
o Correct Temperature storage
o Transportation of Vaccines.
o Disposal of vaccines.
 Positioning a child/adult correctly when administering a vaccine.
 Advice given to the patient before and after treatment.
 Administration of vaccines under a group direction.
 Awareness of current DOH recommendations
CPR and Anaphylaxis Management.
 Recognition and Treatment of Anaphylaxis.
 Practical training in basic life support in adults and children.
 Competent and knowledgeable in the emergency administration of oxygen
and adrenaline.
Statutory Annual Training.
 Child Immunisation (if appropriate).
 Travel Immunisation (if appropriate).
 CPR and Anaphylaxis.
 Infection Control
All nurses are personally accountable and have a professional
responsibility to update their knowledge and skills in these areas, with
particular reference to recent and current changes in practice (NMC 1992)
and ensure standards for the administration of medicines (NMC 2000) are
met:
Scope of professional practice NMC 1992.
Standards for the administration of Medicines NMC 2000.
All local policies and procedures including: Medicines Management/ Medicines
Code,
Infection Control
Administration of Injections (where available)
PGD Resource Pack 2010
General Guidance for the Administration of Vaccines
General
1. The identity of the vaccine must be checked to ensure the right product is
used in the appropriate way on every occasion.
2. The expiry date must be noted. Vaccines must not be used after the
expiry date on the label.
3. The date of immunisation, title of vaccine and batch number must be
recorded on the recipient’s record. When two vaccines are given
together, the relevant sites should be recorded to allow any reactions to
be related to the causative site. It is considered good practice to record
all sites of administration.
4. The recommended storage conditions must have been observed.
Reconstitution of Vaccines
1. Freeze dried vaccines must be reconstituted with the diluents supplied
and used within the recommended period after reconstitution.
2. The diluent must be added slowly to avoid frothing, a sterile 1ml syringe
with a 21G needle should be used for reconstituting the vaccine and a
smaller gauge needle for injection, unless only one needle is supplied
with a pre-filled syringe.
3. Vaccines must not be mixed before administration. The only exception is
Hib and DTP from the same manufacturer.
Cleaning of Skin
If the skin is to be cleaned, alcohol and other disinfecting agents must be
allowed to evaporate before injection of vaccine since they can inactivate live
vaccine preparations.
Route of Administration
1. By Mouth – Oral polio vaccine (OPV) must never be injected. OPV must
not be allowed to remain at room temperature prior to or following
administration as this may decrease potency. Oral polio vaccine has
been largely replaced by inactivated polio vaccine, and is only available
during outbreaks.
2. Subcutaneous (sc) and Intra-muscular (im) injection – Most vaccines are
given by intramuscular or deep subcutaneous injection (with the exception
of BCG, oral typhoid vaccine). In infants, the antero-lateral aspect of the
thigh or upper arm is recommended. If the buttock is used, injection into
the upper, outer quadrant avoids the risk of sciatic nerve damage.
Injection into the fatty tissue of the buttock has been shown to reduce the
efficacy of hepatitis B vaccine.
Needle
For deep sc or im immunisation in infants 23 or 25G
PGD Resource Pack 2010
For adults a 23G needle
For intradermal immunisations 25G needle.
Delegation
A doctor may delegate responsibility for immunisation to a nurse under the
conditions of a Patient Group Direction, when the doctor is not writing a
prescription for a named patient.
In agreeing to undertake this work, nurses assume professional
accountability, and the following conditions should be fulfilled:
(i)
The nurse is willing to be professionally accountable for this work
as defined in the NMC guidance on the “Scope of Professional
Practice”
(ii)
The nurse has received training and is competent in all aspects
of immunisation, including the contra-indications to specific
vaccines.
(iii)
Adequate training has been given in the recognition and
treatment of anaphylaxis
A doctor who delegates the task of Immunisation to a nurse also has a
responsibility to see that they are adequately trained and have the
opportunity for regular updates.
Useful References:
 Immunisation Against Infectious Disease, DoH, 2006.
 www.immunisation.nhs.uk
Anaphylaxis and Adverse Reactions
See specific PGDs (e.g. oxygen and adrenaline 1 in 1000)
Reference - Immunisation Against Infectious Disease, DoH, 2006 (p.56-64).
It is important that health professionals involved in Immunisation are able to
distinguish between anaphylactic reactions, convulsions, and fainting. A
strong central pulse is maintained during a faint or a convulsion.
Recipients of any vaccine should be observed for an immediate adverse
reaction and should remain under observation until they have been seen to
be in good health and not to be experiencing an immediate adverse reaction.
As vaccines are mostly administered subcutaneously or intramuscularly, the
time of onset of anaphylaxis is variable and onset may be delayed for up to
72 hours. For this reason, it is not possible to give an absolute time period
that health professionals should stay with or near a patient or child after
giving an immunization. If true anaphylaxis or fainting does occur, it is most
likely to occur within 10 minutes following vaccination, and the majority of
adverse reactions to a vaccination will occur within two minutes. As a
general guide, ten minutes would seem an appropriate period to check for
PGD Resource Pack 2010
any immediate adverse reactions, and this will give sufficient time for nurses
to check the administration site for bleeding, the patient to replace clothing
and the “patient records” to be completed. Patients should be advised to
seek medical attention if they develop early symptoms such as
breathlessness, swelling and rash. Parents should be advised to seek
medical advice should unexpected symptoms develop after immunization.
Yellow Card System
All cases of anaphylaxis or other suspected adverse reactions (ADRs) should
be reported using the Yellow Card Scheme. Yellow Cards are found at the
back of the BNF, or can be reported electronically at www.yellowcard.gov.uk.
The Medicines and Healthcare products Regulatory Agency
(MHRA)/Commission on Human Medicines (CHM) encourage all adverse
reactions for black triangle drugs (including those that are considered not
serious) and only serious adverse reactions for established drugs to be
reported. For additional reporting advice please see page 10 of the BNF or
the MHRA website www.mhra.gov.uk. Do not be put off reporting because
some details are not known, or it is uncertain that the drug has caused it, or if
other drugs have been given/taken at the same time.
Record Keeping
Individual PGD requirements should be followed. Other useful guidance:
 NMC Guidance on Record Keeping
 Local policy on record keeping
The information should be recorded in any of the following places (as
appropriate/available), but there must always be a record held in the patient’s
records:
 Patient held record card/ Personal Child Health Record (PCHR)
(if appropriate)
 Base clinical system
Clinicians must ensure that all record keeping details are covered (as per
PGD) and the person who administers the vaccine is identified. Ideally, this
should be done by the person, administering the vaccine, completing the
record after each consultation.
Class
Live
Classification of Vaccines - Viral and Bacterial Vaccines
Viral Vaccines
Bacterial Vaccines
Measles
BCG
Mumps
Typhoid- oral
Rubella
Oral Poliomyelitis
Yellow fever
Varicella
Inactivated
PGD Resource Pack 2010
Influenza
Hepatitis A
Pertussis
Cholera*
Injectable poliomyelitis
Rabies
Tick-borne encephalitis
Japanese B encephalitis
Anthrax
Toxoids
Bioengineered
Polysaccharide extracts
Typhoid*
Plague
Diphtheria
Tetanus
Hepatitis B
Haemophilus influenzae
b conjugate
Meningococcal A & C
Meningococcal C
conjugate
Pneumococcal
Typhoid-Vi antigen
* These two parenteral vaccines are no longer available in the UK.
Ref. George C Kassianos. Immunisation Childhood and Travel Health. Fourth
Edition (2001) Chapter 11:41
Live Vaccines- special risk groups
There are some individuals for whom there may be risks if they are given live
vaccines. Inactivated viruses are not dangerous to these recipients but may
be ineffective. These individuals may not be able to make a normal immune
response to live vaccines and could suffer from severe manifestations from
vaccine virus. These individuals include:
 All patients currently being treated for malignant disease with
chemotherapy or generalized radiotherapy, or within 6 months of
terminating such treatment.
 All patients who have received an organ transplant and are currently
on immunosuppressive therapy.
 Patients who within the previous 6 months have received a bone
marrow transplant. Such individuals, irrespective of age, should have
their immunity to diphtheria, tetanus, polio, measles, mumps, rubella,
and Hib checked six months after transplantation and be immunized
appropriately. Such tests are difficult to interpret if performed within
three months after receipt of any blood product, including Human
Normal Immunoglobulin (HNIG).
 Children who receive prednisolone, orally or rectally, at a daily dose
(or its equivalent ) of 2mg/kg/day for at least one week, or 1 mg/kg/day
for one month. For adults, an equivalent dose is harder to define, but
immunosuppression should be considered in those who receive 40mg
prednisolone per day for more than one week.
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Corticosteroids, administered by other routes (e.g. inhalers, topicals,
intra-articularly) should not be considered immunosuppressive.
Administration of live vaccines should be postponed for at least 3
months after immunosuppressive treatment has stopped, or 3 months
after levels have been reached that are not associated with
immunosuppression.
Lower doses of steroids, given in combination with cytotoxic drugs
should be considered to cause immunosuppression. The advice of
the physician in charge should be sought prior to vaccination.
Occassionally, there may be individuals on lower doses of steroids or
other immunosupressants for prolonged periods, or who because of
their underlying disease, may be immunosuppressed, and are at
increased risk of infection. Seek specialist advice in such cases.
Patients with evidence of impaired cell mediated immunity, e.g. HIV
infection with current symptoms, Severe Combined Immunodeficiency
Syndrome. Patients with minor deficiencies of antibodies are not at
risk; those with major antibody deficiencies will be receiving antibodies
in their immunoglobulin treatment preparations and are not at risk from
receipt of live vaccines. Because the patient is receiving
immunoglobulins, live vaccines are likely to be ineffective (except
Yellow Fever).
For HIV positive individuals –further detailed guidance in Immunisation
against Infectious Diseases, 1996.
Live vaccines- Immunisation intervals
Live virus vaccine, with the exception of yellow fever vaccine should not be
given during the three months following injection of immunoglobulin because
the immune response may be inhibited. In travellers, where time is short and
there is a significant risk of exposure to polio, vaccine should be given even if
immunoglobulin has been given at any time in the previous three months.
If it is necessary to administer more than one live vaccine at the same time,
they should be given either simultaneously in different sites (unless a
combined preparation is used) or in theory be separated by a period of at
least three weeks. It is recommended that a 3 week interval should be
allowed between the administration of live virus vaccines especially measles
vaccine, and tuberculin testing. No interval needs to be observed between
the administration of live and inactivated vaccines.
PGD Resource Pack 2010
Guidelines For The Safe Transport , Storage And Disposal Of Vaccines.
Objective
Vaccines are sensitive to temperature. Some vaccines are damaged if they get
too hot, others if they are frozen. In order to maintain their effectiveness
vaccines have to be maintained within a specific temperature range from the time
of manufacture through distribution until they are administered. This is called the
cold chain. It is essential to ensure that the cold chain is maintained at all times
and that vaccines are stored in conditions specified by the manufacture to
prevent any deterioration in potency or effectiveness (Scade 1999).
Staff
All team Bases, Health Centres and establishments that store vaccines should
have a named, suitably trained person and a designated deputy who are
responsible for the ordering, receipt, storage and disposal of vaccines.
Ordering
Orders for vaccine are made via Pharmacy.
Receipt
Vaccines are transported from central depots or pharmacy departments to health
centres and team bases via the ‘cold chain’ system. This is to ensure vaccines
are not allowed to warm and lose their potency. To ensure this ‘cold chain’ is
continuous:
 The designated person or deputy should take delivery of the vaccine,
assess the integrity of the package and temperature control and ensure
that it is unpacked and stored correctly.
 Vaccines should not be accepted if they have arrived more than 48 hours
after dispatch (Reference - Whitefield L. (1995) Immunisation in General
Practice. Surrey. Reed Healthcare)
 The courier should hand the vaccines directly to a member of staff.
 Expiry dates must be checked on receipt of the vaccine as new vaccines
may have a shorter expiry date than those already in the fridge. Good
stock rotation is essential. Older vaccines should be used first.
 These should then be placed immediately in the designated fridge and not
left at room temperature.
 The courier should obtain the signature of the person to whom the
vaccines are handed at each clinic.
Storage
It is essential that vaccines are stored under the recommended storage
guidelines to maintain their potency and effectiveness, in a fridge designated for
the storage of medicines. Where a domestic fridge is used it should not contain
an icebox.
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All vaccine fridges should have a maximum and minimum thermometer in
order to keep a regular check on the temperature of the fridge.
A temperature check should be done daily and recorded by a designated
person.
If on recording the temperature, the maximum or minimum temperatures
are too high or too low it should be reported immediately and the
pharmacist contacted for further advice on usage of these vaccines.
The vaccine fridge should be defrosted regularly and checked every 6
months. When defrosting, alternative arrangements should be made for
storage of vaccines and the Pharmacist can be contacted for further
advice.
The vaccine fridge should be used for storing vaccine only. No food or
specimens should be stored in the fridge.
Vaccines should not touch the side of the fridge or be packed too tightly
together. They should not be stored on the shelves or in the storage
compartments of the refrigerator door.
Care should be taken to ensure that the electricity supply to the vaccine
storage refrigerator cannot be accidentally interrupted, e.g. by using a
switch-less socket or by placing cautionary notices on plugs and sockets.
Vaccines should not be allowed to freeze.
Stocks of vaccine should be rotated to ensure that ‘use by’ dates are not
exceeded. Expiry dates of vaccines should be checked on receipt, as new
vaccines may have a shorter expiry date than those already in the fridge.
Vaccines with shorter expiry dates should be used first, so good stock
rotation is essential in the vaccine fridge.
Domiciliary Immunisation.
Vaccines should always be transported in a cool box. Vaccines used for
domiciliary immunisation should be in their original packaging, transported in an
appropriate cool bag/box and protected from the direct contact of ice packs. A
thermometer should be kept in the cool bag/box and the cold chain should be
monitored and maintained between 2 – 8 degrees Celsius. Reference should be
made to the Manufacturer’s product leaflet, “Immunisation against Infectious
Diseases” handbook (DoH 20066), and NMC guidance on the “Scope of
Professional Practice” to ensure that the required temperature is maintained. If
the cold chain is broken, refer to the manufacturer’s guidelines. In certain
circumstances the vaccines should be disposed of as stated below.
Vaccine Spillage
 The vaccine should be wiped up using a paper towel soaked in 1% sodium
hypochlorite solution: the area should then be cleaned with general-purpose
detergent.
 The paper towel should be disposed of as clinical waste.
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Vaccine Disposal
 Unused and outdated vaccine should be returned to the Pharmacy for
disposal.
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Reconstituted vaccine must be used within the recommended period,
varying from one to four hours, according to the manufacturer’s
instructions. Single dose containers are preferable; once opened, multidose vials must not be kept after the end of the session, and any vaccine
left unused must be disposed of.
Reporting Problems
 Any problems with the refrigerator, thermometer, temperature recordings
or vaccine must be reported to the team’s designated lead or deputy.
 No vaccine, in the fridge at the time that the defect is noticed, should be
used until the problem has been resolved.
Audit
 The temperature log should be reviewed at the end of each month to
ensure that the temperature range is being maintained.
 The standards set out in these guidelines should be audited using a
recommended audit tool.
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Consent
All patients for whom vaccination is proposed should give their consent to
vaccination. Care should be taken to ensure that patients and parents feel that
their questions have been adequately answered and that their concerns about
immunisation have been sensitively considered.
SEE TRUST POLICY FOR CONSENT TO EXAMINATION OR TREATMENT
Any doubt, check patient or parent still consents
Reference - “Immunisation against Infectious Diseases” handbook (DoH 1996)
Reference - DH Good practice in consent implementation guide: consent to
examination or treatment. The twelve key points within this guidance are:
12 Key Points on Consent: the Law in England
1. When do health professionals need consent from patients?
Before you examine, treat or care for competent adult patients you must
obtain their consent.
2. Adults are always assumed to be competent unless demonstrated
otherwise. If you have doubts about their competence, the question to ask
is: “can this patient understand and weigh up the information needed to
make this decision?” Unexpected decisions do not prove the patient is
incompetent, but may indicate a need for further information or
explanation.
3. Patients may be competent to make some health care decisions, even if
they are not competent to make others.
4. Giving and obtaining consent is usually a process, not a one-off event.
Patients can change their minds and withdraw consent at any time. If
there is any doubt, you should always check that the patient still consents
to your caring for or treating them.
5. Can children give consent for themselves?
Before examining, treating or caring for a child, you must always seek
consent. Young people aged 16 and 17 are presumed to have the
competence to give consent for themselves. Younger children who
understand fully what is involved in the proposed procedure can also give
consent (although their parents will ideally be involved). In other cases,
some-one with parental responsibility must give consent on the child’s
behalf, unless they cannot be reached in an emergency. If a competent
child consents to treatment, a parent cannot over-ride that consent.
Legally, a parent can consent if a competent child refuses, but it is likely
that taking such a serious step will be rare.
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6. Who is right person to seek consent?
It is always best for the person actually treating the patients to seek the
patient’s consent. However, you may seek consent on behalf of
colleagues if you are capable of performing the procedure in question, or if
you have been specially trained to seek consent for that procedure.
7. What information should be provide?
Patients need sufficient information before they can decide whether to give
their consent: for example, information about the benefits and risks of the
proposed treatment, and alternative treatments. If the patient is not offered
as much information as they reasonably need to make their decision, and
in a form they can understand, their consent may not be valid.
8. Consent must be given voluntarily: not under any form or duress or undue
influence from health professionals, family or friends.
9. Does it matter how the patient gives consent?
No: consent can be written, oral or non-verbal. A signature on a consent
form does not itself prove the consent is valid - the point of the form is to
record the patient’s decision, and also increasingly, the decisions that
have taken place. Your PCT may have a policy setting out when you need
to obtain written consent.
10. Refusal of treatment: Competent adult patients are entitled to refuse
treatment, even when it would clearly benefit their health. The only
exception to this rule is where the treatment is for a mental disorder and
the patient is detained under the Mental Health Act 1983. A competent
pregnant woman may refuse treatment, even if this would be detrimental
to the foetus.
11. Adults who are not competent to give consent.: No-one can give consent
on behalf of an incompetent adult. However, you may still treat such a
patient if the treatment would be in their best interests. “Best interests” go
wider than best medical interests, to include factors such as the wishes
and beliefs of the patient when competent, their current wishes, their
general well-being and their spiritual and religious welfare. People close
to the patient may be able to give you information on some of these
factors. Where the patient has never been competent, relatives, carers
and friends may be best placed to advise on the patient’s needs and
preferences.
12. If an incompetent patient has clearly indicated in the past, while
competent, that they would refuse treatment in certain circumstances (an
“advance refusal”), and those circumstances arise, you must abide by that
refusal.
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Definition of Parental Responsibility
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Parental Responsibility is defined as all rights, duties, powers, responsibilities
and authority which by law a parent of a child has in relation to the child and
his/her property.
A person who has Parental Responsibility for a child may not surrender or
transfer any part of that responsibility but may arrange for some or all of it to be
met by one or more persons acting on his/her behalf.
Thus a relative, friend or childminder who presents written authority (one-off or
on-going) from any person who has Parental Responsibility for a child, may
lawfully consent, for example, to immunisations.
Not all parents have parental responsibility for their children, and if there is any
doubt, then it must be checked.
PGD Resource Pack 2010
Appendix 1
Patient Group Directions- Management Procedure
Many Patient Group Directions (PGDs) operate in the Trust across a diverse
range of services, and so it is important that they are managed correctly across
the Trust. This procedure explains how the Trust will assure itself that this will be
done properly:
Development
1. Patient Group Directions are only developed after agreement with the
appropriate professional head of service, and the appropriate manager
within the directorate, e.g. for PGDs operating in addiction teams- this
would be the Professional Head of Nursing for Specialist Services and the
Addiction Service manager. Development of the PGD(s) will be by
utilisation of the PGD template (Appendix 2), and undertaken by the Chief
Pharmacist.
2. NB On rare occurrences, there may be disagreement as to whether the
development of a PGD is appropriate. The Trust’s PGD Open Learning
Pack contains a flow chart advising as to when a PGD may be
appropriate. If it remains unclear, advice should be sought from initially the
Chief Pharmacist, and then if necessary, the Medicines Management
Committee.
3. Once the Chief Pharmacist is satisfied the PGD is appropriate and correct,
it will be sent to the Medicines Management Committee for approval and
the Quality, Effectiveness & Risk Committee for ratification.
4. If ratification occurs, the Chief Pharmacist assigns the PGD with a
registration number, and completes the details in the PGD Register. The
PGD then gets signed by the three main signatories, and the original is
kept in the master file by the Chief Pharmacist. A copy (together with a
copy of this procedure) is sent to the appropriate manager within the
directorate , who is responsible in ensuring that all professionals who will
be operating the PGD(s), sign the front sheet of the PGD as named
individuals. The manager’s responsibilities include ensuring that all PGD
operators:
 have access to an up-to-date copy of the PGD
 have access to the Trust’s PGD Open Learning Pack, and have
completed it satisfactorily, either through face to face PGD training or
electronic PGD training, and a record made in the Trust’s training
records to this effect; any issues that have arisen, through the selfassessment of competency to operate PGDs, must be clarified and
addressed as part of professional development
 have PGD competency included as part of the annual appraisal,
through discussion of for example, medicines incidents, complaints,
and compliments
 have access to a British National Formulary and Summary of Product
Characteristics for the medicine
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




can demonstrate that they meet the relevant professional
responsibilities and competencies stated on the PGD
have a copy of the signed front sheet of the up-to-date PGD(s) they are
operating (which includes the PGD number) in his/her personal file
that PGDs operating are in-date (exceptions reported to Chief
Pharmacist and on incident form)
that when staff report potential problems with the PGD, a responsible
professional is designated to inform the Chief Pharmacist
that a central file of operating PGDs is maintained as a resource (for
reference purposes) in the unit/base (or other appropriate place),
together with an up-to-date list of staff authorised to operate them.
5. The PGD Register is inspected quarterly by the Chief Pharmacist to
ensure that all PGDs operating are in-date. Breaches are viewed as
incidents, and reported appropriately.
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PGD XX
Appendix 2- PGD Template
Patient Group Direction
Administration/ Supply of XXXX
By Registered XXX employed by South Staffordshire & Shropshire Healthcare
Foundation NHS Trust
This Patient Group Direction for use in South Staffordshire & Shropshire
Healthcare NHS Foundation Trust and is authorised by:
Position of Signatory
Name
Signed
Date
Medical Director
Chief Pharmacist
Director of Nursing
The named below, being employees of
South Staffordshire Healthcare& Shropshire NHS Foundation Trust
are authorised to administer XXX
under this Patient Group Direction
Name
Job Title
Signed
Date
This Patient Group Direction is operational from XXX. Review date: XXX. Expires
on XXX.
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Professional Responsibility
All registered nurses and non medical prescribers being employees of South
Staffordshire & Shropshire HealthCare NHS Foundation Trust are authorised to
administer/supply XXX as specified under this Patient Group direction
following demonstration of the competencies below;
Professional Responsibility / competencies
1. The registered nurse will have undertaken appropriate training on an annual
basis in order to carry out clinical assessments of clients leading to medication
being given according to the indications listed in the PGD
2. All nurses will have received training in the management and treatment of
anaphylactic shock on an annual basis
3. Each nurse will keep a record in their professional portfolio of the updates
attended during every 12 month period – This information will also form part of
the team’s annual training plan
4. The nurse will have due regard for the NMC Code of Conduct, Scope of
Professional Practice and Standards for Medicines Management 2008
(Nursing & Midwifery Council)
5. Undertaken appropriate training and possess the competencies for working
under PGDs for the supply and administration of medicines
6. All registered nurses details and signature must be entered on the PGD
7. Following administration a record of the administration of the medicine should
be recorded in the clients records, and within the “as required” medication
sections of the medicine card (with PGD Number in place of prescriber
signature)
.
For full product information, always refer to the latest SPC
(Summary of Product Characteristics).
If the anaphylaxis is related to a medication, please remember to report to the
CSM, via a Yellow Card Report (http://emc.medicines.org.uk)
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Supply / Administration
of
Legal Classification
Black Triangle?
Type
Storage
Condition to be treated
Inclusion Criteria
Exclusion Criteria
Action if excluded or
patient declines
Reasons for seeking further
advice from doctor
Administration Route
Dose
Administration Schedule
Warnings/Adverse
Reactions
Advice/Management of
Adverse Reactions &
Follow-up Action
Use in pregnancy and
lactation
Records
For full details see Summary of Product
Characteristics
Administration:
The following should be recorded in the patient’s
records:
 Name of preparation
 Dose given
 Route and site of administration
 Date and time given
 Signature of person administering the medicine
and the administration also recorded in the once only
medication sections of the medicine card.
Supply:
Complete only if applicable
All medical discussions/advice should be recorded.
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Appendix 3
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Appendix 4
Frequently Asked Questions
For ease, these Frequently Asked Questions have been grouped so that
questions on similar topics are found together. The broad groupings are:
❒ Uses of PGDs
❒ Production of PGDs
❒ Medicines that can be included in PGDs
❒ Practical issues
❒ Training and evaluation
Uses of PGDs
a) Are PGDs appropriate for managing chronic illnesses?
General guidance and the legal definition of a PGD indicates that PGDs are not
meant to replace a heath professional prescribing for an individual patient on a
one-to-one basis. In general, individual patient prescribing is more appropriate
for patients requiring long-term management of their condition. Many chronic
conditions will therefore not be appropriate for PGDs and another option like
supplementary prescribing or, in some cases, independent nurse prescribing may
be more appropriate. There may be some situations in which using a PGD is
appropriate for the direct supply or administration of a medicine to a patient with
a chronic illness (for example an acute exacerbation of asthma so each case
needs to be considered individually.
b) Can a PGD be used to adjust doses of a patient’s medication?
Dose adjustment is allowed within a PGD as long as a dosage range is specified
in the PGD and the PGD is being used to supply and/or administer a medicine. A
PGD does not give a legal framework for health care professionals to adjust a
dose of medicine already in a patient’s possession. Health care professionals
may use written protocols to advise patients to adjust the dose of their medication
if that is what is required to maintain optimum treatment (e.g. a diabetes nurse
specialist advising a patient to alter insulin dose following a blood glucose check).
Written protocols have no legal standing in respect of medicines legislation and
are subject to local agreements between health care professionals and their
organisations. It is likely that written protocols which cover advice on dosage
would reflect many of the principles governing PGDs.
c) Can PGDs be used to initiate treatment for chronic disease?
Although this is possible within the legislation and supporting guidance, it is not
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recommended. Chronic conditions should be managed by health care
professionals prescribing for individual patients on a one-to-one basis.
d) Can PGDs be used to supply or administer medicines to patients prebooked into clinics?
Having pre-booked patients, and therefore ‘knowing’ who the patient will be, does
not preclude PGD use, assuming all other criteria for the use of PGDs are met.
e) If a patient falls slightly outside the criteria for inclusion in the PGD, can
professional judgement be used to supply or administer a medicine?
No, when supplying or administering a medicine under a PGD, the patient must
fall exactly into the criteria determined by the PGD. If not, the patient must be
referred in line with the guidelines in the PGD.
Production of PGDs
a) How often should PGDs be reviewed?
Legally, a PGD should be formally reviewed and reauthorised every two years
and the review date should be included in the PGD; after the review date the
PGD is no longer valid. However, the content of the PGD should be reviewed
immediately if there are evidence-based changes to clinical practice which affect
the PGD, regardless of the review date. In practice, some organisations set a
review date at least six months before a final expiry date to allow time for the
review process. Organisations should consider auditing the use of PGDs in
advance of the review.
b) How long should PGD documentation be kept?
The same rules apply to PGD records as to all other patient records. For adults
all PGD documentation must be kept for eight years and for children until the
child is 25 years old, or for eight years after a child’s death.
c) Who is responsible for finding and updating the clinical guidelines
underpinning a PGD?
It is up to the individual service using the PGD to find and update the clinical
guidelines underpinning the PGD. The NHS trust authorising the PGD is
responsible for ensuring that PGDs satisfy the legal framework in which they can
be used but not for finding and evaluating the underpinning clinical content.
d) When changes are made to the PGD does it always need to be
reauthorized and re-signed?
Yes and local arrangements should be in place to ensure that all health care
professionals working under a PGD are made aware of significant changes.
Medicines that can be included in a PGD
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a) Can more than one medicine be included in a PGD?
Yes, but all the requirements of the legislation must be included for each drug.
b) Can patients receive black triangle (▼) medicines under a PGD?
Yes, black triangle medicines (i.e. those recently licensed and so subject to
special reporting procedures for adverse reactions) may be included in PGDs,
provided such use is supported by best clinical practice. The PGD should state
that a black triangle medicine is being included.
c) Can patients receive medicines when they are used outside their
licensed uses?
Yes, medicines can be used outside the terms of their Summary of Product
Characteristics (SPC) (and so outside their license) provided such use is
supported by best clinical practice. The PGD should clearly state when the
product is being used outside the terms of the SPC and why this use is
necessary.
d) Can patients receive unlicensed medicines under a PGD?
No, the PGD framework does not allow for unlicensed medicines to be supplied
and/or administered.
e) Can patients receive controlled drugs under a PGD?
Certain controlled drugs can be supplied or administered under a PGD.
f) Can appliances and dressings be supplied and administered under a
PGD?
No, PGDs apply only to licensed medicines. For dressings and appliances,
consider using a protocol or guidelines.
Practical Issues of Usage
a) Where can the medicines supplied and administered be obtained from?
Local hospitals, community pharmacies and pre-packing units can all supply
medicines; however, appropriate licences may be required. Pharmacists will be
able to advise on requirements for the safe and secure handling of medicines, as
well as packaging and labelling requirements. Original packs are preferred,
where available, and appropriate audit trails should always be in place. The
Royal Pharmaceutical Society of Great Britain fact sheet on PGD use provides
further details: www.rpsgb.org.uk/pdfs/factsheet10.pdf.
b) Should all patients be given information leaflets with any medicine
supplied?
Yes, all patients should receive a patient information leaflet. There are various
sources of patient information leaflets and pharmacists should be able to advise
on this.
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c)If not included in existing exemptions to the medicines act, is a PGD
required for the supply of P and GSL medicines?
Medicines legislation states that a PGD is not necessary to supply a GSL
medicine, provided the supply takes place from lockable premises and the
medicines are pre-packed and fully labelled. For organisations supplying GSL
medicines in this way, good practice (from a clinical governance perspective) is
to use a simple protocol; simple protocols are not part of medicines legislation. A
PGD is necessary to supply P medicines, unless the supply is being made at a
registered pharmacy by or under the supervision of a pharmacist.
d) Can PGDs be used to supply and administer medicines to patients in
their homes?
Yes, the PGD need not relate to specific premises. All the requirements that
have been specified for a PGD must be complied with, but the supply or
administration could take place at locations including a patient’s home, a surgery
or health centre, a pharmacy or an NHS Walk-in Centre.
e) Can a health care professional administer a medicine, already in the
patient’s possession, which was supplied under a PGD by another health
care professional?
If the medicine is not an injection then the health care professional can
administer it. Injections can only be legally administered by the health care
professional who supplied it using a PGD, or in accordance with the directions or
prescription of an independent prescriber.
f) Can agency and bank staff working in the NHS use PGDs?
Any eligible professional using a PGD must be named and assessed as
competent to do so before they can use a PGD. Bank staff may be indemnified
by the NHS organisation they are working for but agency staff will need their own
indemnity cover.
g) Do the current exemptions which allow midwives, ambulance
paramedics, optometrists, and podiatrists and chiropodists to supply and
administer certain specified medicines without the directions of a doctor,
mean that a PGD is not required?
Yes, where exemptions exist, PGDs are not necessary and in some cases may
hinder existing practice.
k) Do patients receiving medicines under a PGD pay NHS prescription
charges?
Yes, standard prescription charge rules and exemptions apply to all patients
receiving a supply of medicines under a PGD from the NHS. Services supplying
medicines under a PGD need to make arrangements for collection of the
appropriate fees. If all the medicine is administered to the patient during the
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consultation, no charge is levied. If any part of the medicine is given to the
patient to take home, the patient should be charged.
Training and Evaluation
a) What clinical governance and audit procedures should be in place to
monitor PGDs?
Clinical governance and audit surrounding PGD use are local responsibilities.
There are no standard national arrangements.
b) Who is responsible for ensuring the competence of the health care
professionals supplying or administering medicines using PGDs?
Organisations using PGDs must designate an appropriate person within the
organisation (for example, a clinical supervisor, line manager, GP) to ensure that
only fully competent, qualified and trained health care professionals operate
within PGDs; where a range of health care professionals are using PGDs this
may be a senior representative from each of the professions. There is no current
specific national training and development programme for health care
professionals using PGDs, however, the competency framework, developed by
the National Prescribing Centre (Appendix 5), can be used as a starting point to
help organisations develop their own programmes.
c) Who is responsible for ensuring the competence of the health care
professionals producing the PGDs?
Organisations should ensure that individuals writing and authorising PGDs have
the appropriate competencies to do so; the health care professionals writing and
authorising the PGDs might not be the ones working with them. Currently there
is no specific national training for health care professionals producing PGDs,
however, many of the competencies in the framework, developed by the National
Prescribing Centre (Appendix 5), will be relevant and so, the framework can be
used as a starting point.
d) Are there any national training programmes for health care professionals
using PGDs?
There is currently no national curriculum for training to use and develop PGDs.
Many organisations and services have developed training programmes to meet
their own needs. The competency framework, developed by the National
Prescribing Centre (Appendix 5), provides a starting point.
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Appendix 5
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Appendix 6.
Self-Test- Open Learning Package for PGDs
Classification of drugs
1. What are the 3 classifications of licensed drugs under the Medicines Act?
2. Which class(es) of drugs can be administered when operating a PGD?
3. Where would you find the information about which class of drug, a product
falls into?
Safety Aspects of Administration
4. What checks would you make before administering a drug when operating
a PGD?
5. Identify reasons why you, as a health professional, might not administer a
drug covered by a PGD.
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6. In the event of non-administration, what actions would you take?
7. Describe the checking procedures for drugs to the point of administration.
Appropriate Actions with Drugs
8. Mrs Jones has received one dose of Hepatitis B vaccine, she now tells
you that she is pregnant (pregnancy is an exclusion criterion on this PGD).
What action could you, as a nurse take?
9. The refrigerator socket has come loose, and the maximum temperature
logged is 13oC. What do you do with the medicines stored in the
refrigerator?
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Drug Differences
10. What does the abbreviation POM mean? Please give an example of a
drug that is a POM.
11. Can you describe the meaning of a Patient Group Direction (PGD)?
Please give an example of a drug covered by this category.
Record Keeping
12. List the places where you would document the administration of drugs
covered by PGDs.
13.When you receive your copy of a PGD, what do you do administratively,
and where is it stored. How long does it need to be kept?
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