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1

Patient Group Directions (PGDs)

• In use since August 2000
• A legal framework which allows certain health care professionals to supply and administer medicines to groups of patients that fit prespecified criteria without the need for a prescription or an instruction from a prescriber
• They are not a form of prescribing

2

Definition of a PGD

“A written instruction for the sale, supply and / or administration of named medicines in an identified clinical situation. It applies to groups of patients who may not be individually identified before presenting for treatment.”

3

PGDs
Examples of use:

• Travel clinics – vaccinations
• Emergency hormonal contraception
• Treatment of sexually transmitted diseases
• Emergency treatments by paramedics
• Seasonal influenza vaccinations administered by community pharmacists

4

For PGDs to be valid certain criteria should be met

• Used by specified groups of healthcare professionals
• Does not need to relate to a specific location – E.g. patient’s home, surgery, health centre, pharmacy, walk-in centre
• Can be used by non-NHS organisations
• Patients must meet inclusion criteria but often not identified prior to presentation
• All professionals must be fully qualified, competent and trained to use PGDs however no additional qualifications are required
• Individual practitioners using a PGD must be named
• Organisations have a responsibility to ensure that only fully competent and trained registered healthcare professionals use PGDs

5

Classes of persons allowed to supply /
administer under PGDs

• Paramedics
• Pharmacists
• Dietitians
• Nurses and Midwives
• Dental hygienist and dental therapists
• Occupational therapists
• Orthotists (make foot drops and walking, feet wedges) and prosthetists
• Speech and language therapists
• Optometrists
• Chiropodists and podiatrists
• Orthoptists
• Physiotherapists
• Radiographers

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What should a PGD contain?

• The name of the body to which it applies e.g. Kettleton CCG
• Date it comes into force and date it expires
• Description of medicine(s) covered
• Clinical conditions covered
• When to seek further advice and arrangements for referral
• Patients excluded
• Appropriate dosage & max total dosage, quantity, pharmaceutical form & strength, route and frequency of administration, minor max period over which medicine should be administered
• Relevant warnings, including potential adverse reactions
• Details of any follow-up action and the circumstances
• Statement of records to be kept

Records must be kept, but may be a copy of the records needed by PGD authorising body

7

Producing a PGD

• PGDs should be produced by a multi-disciplinary group
• Must be signed by:
– Senior doctor or dentist (can be two)
– Senior pharmacist
– Authorising authority for organisation (e.g. from within CCGs, LA, or NHS Trusts)

multi-disciplinary group – doctor or dentist, pharmacist, representative of professional group expected to supply and/or administer under the PGD. Good practice to involve local DT/med man committees, APCs or similar.

(eg clinical commissioning groups, local authorities, NHS trusts or NHS foundation trusts, special health authorities, the NHS Commissioning Board)

Senior doctor and pharmacist should be involved in developing the PGD – if across CCGs, must be signed by CG lead from each CCG

• The PGD must relate to medicines with a product license, but it can be for an “off-license” use
• Can include black triangle drugs
• PGDs cannot be used for appliances, dressings, medical devices, radiopharmaceuticals, abortifacients (Mifepristone) or unlicensed medicines

PGD must state that the product is being used outside SPC and why

8

Special considerations
Controlled drugs

• The Misuse of Drugs (Amendment No.2) Regulations 2012 states:
– Nurses and pharmacists can supply Morphine and Diamorphine in any setting “where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction)
• Any of named professions can supply or administer:
– A schedule 5 drug
– Midazolam, Schedule 3
– Any Schedule 4 Part (1) as long as it is not in parenteral form for treatment of addiction

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Special Considerations
Antimicrobials

• Resistance is a major public health concern
• Only to be used if absolutely necessary
• Must involve a local microbiologist or public health specialist in creating PGD
• Local DTCs/APCs to ensure PGD consistent with local policies
• PGD needs to be audited regularly

E.g. not for minor viral diseases without good evidence of bacterial infection e.g. sore throats

10

Other considerations

• All medicines should be appropriately pre- packed
• Security and storage needs to be considered
• Need to provide PIL with each supply
• Audit of the PGD system should be undertaken regularly
• When using a PGD, pharmacists must:
– Be satisfied the PGD is valid and approved
– Ensure supply follows protocol and maintain records – Have up to date knowledge on clinical area
– Have undertaken relevant training
• When writing a PGD, a pharmacist is accountable for their content and must:
– Be familiar with their role, responsibilities and relevant guidance
– Ensure approved PGDs comply with guidance
– Ensure staff are appropriately trained
– Ensure appropriate people approve and sign the PGD
– Ensure they have up-to-date knowledge in the subject area

Should be ‘appropriately’ pre-packed i.e can be split if labelled as a dispensed medicine.

Exemptions from section 52 and 53 of Medicines Act 1968 allow supply of P and GSL medicines on PGD

11

Indemnity insurance

• As a pharmacist you will be required to have appropriate professional indemnity insurance cover to allow you to practice
• This was explicitly stated in the previous GPhC Standards of Conduct, Ethics and Performance; although it is not in the new standards, it is part of the annual registration declaration

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Non-medical prescribing

• Prescribing by individuals other than doctors or dentists
• Maybe ‘supplementary’ or ‘independent’ prescribers

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Aims of NMP

• Improve patient care without compromising patient safety
• Make it easier for patients to get the medicines they need
• Increase patient choice in accessing medicines
• Make better use of the skills of health professionals
• Contribute to the introduction of more flexible team working across the NHS

Benefit to GPs/medics – reduce their workload so they can focus on the more complex cases.

Studies have shown it to be safe, acceptable to patients and acceptable to other clinicians

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Amending law

• Originally, the Medicines Act 1968 allowed only doctors and dentists to write prescriptions for POMs
• The Crown Report: ‘Review of prescribing, supply & administration of medicines’ (1999)
• Changes in legislation followed

15

NMP and the law

• Nurse prescribing introduced in The Medicinal Products: Prescription by Nurses etc. Act 1992
• Section 63 of the Health and Social CareAct 2001
– Extended prescribing responsibilities to other health professions, including pharmacists
– Introduced new types of prescribers, including the concept of a supplementary prescriber
• 2006: Further regulatory change enabled introduction of independent prescribing

The nurse prescribing scheme for district nurses and health visitors was based on the recommendations contained in the Report of the Advisory Group on Nurse Prescribing 1989, which advised Ministers how patient care in the community might be improved by introducing nurse prescribing.

The Medicinal Products: Prescription by Nurses, etc. Act 1992 which amended the National Health Service Act 1977 (section 41) and the Medicines Act 1968 (section 58)];

The necessary legislation to enable community nurses in Scotland with either a district nursing or health visiting recordable qualification to prescribe from a limited formulary was passed in 1996.

2001 – supplementary prescribing

Changes to regulations in May 2006 enable nurses who train and qualify as 'nurse independent prescribers', to be able to prescribe any licensed medicine (i.e. products with a UK marketing authorisation) for any medical condition they are competent to treat.

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Supplementary prescribing

• Supplementary prescribing is “a voluntary partnership between an independent prescriber (doctor or dentist) and a supplementary prescriber to implement an agreed patient- specific Clinical Management Plan with the patient’s agreement”

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Who can practice as an SP?

– Pharmacists, nurses, optometrists, chiropodists, podiatrists, physiotherapists, radiographers and dieticians

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Supplementary prescribing

• Requires a written Clinical Management Plan (CMP) relating to a named patient and to that patient’s specific conditions
• The SP must record agreement to the plan by the IP before supplementary prescribing can begin
• The patient also needs to agree to the arrangement

19

Supplementary prescribing
• The CMP must contain details of:

• The CMP must contain details of:
– Individual patient
– Their condition
– Treatment with medicines
– Monitoring required
– When to refer back to IP
• May include controlled drugs

radiographer and optometrist supplementary prescribers can prescribe any schedule 2-5 controlled drugs for any condition within their competence, as part of a patient specific, written clinical management plan (CMP) agreed with a doctor

20

Independent prescribing

• Independent prescribing is “prescribing by a practitioner (e.g. doctor or pharmacist) responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing”

Applies to both NHS and private practice

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Who can become IPs?

– Pharmacists, nurses, optometrists, physiotherapists and podiatrists, radiographers

22

Independent prescribing

“Independent prescribing is one element of the clinical management of a patient. It requires an initial patient assessment, interpretation of that assessment, a decision on safe and appropriate therapy, and a process for ongoing monitoring. The IP is responsible and accountable for at least this element of a patient’s care”

Prescribing only one element
Initial assessment of patient
Interpretation of assessment
Decide therapy monitoring

23

Community practitioners

• Community practitioners (formerly District Nurses and Health Visitors) can prescribe from the Nurse Prescribers’ Formulary for Community Practitioners
– This is a limited formulary comprising a limited range of medicines, dressings and appliances suitable for use in the community setting

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What can IPs prescribe?

Community practitioner nurse prescribers: the Nurse Prescribers’ Formulary for Community Practitioners
Nurse independent prescribers: any licensed medicines, including Sch 2 – 5 CDs* for any medical condition (*except diamorphine, cocaine and dipipanone for the treatment of addiction)
Optometrist independent prescribers: any licensed medicine for ocular conditions affecting the eye, and the tissue surrounding the eye (except CDs or medicines for parenteral administration)

Community practitioner nurse prescribers (formerly district nurse and health visitor prescribers) can prescribe from the Nurse Prescribers’ Formulary for Community Practitioners (formerly the Nurse Prescribers’ Formulary for District Nurses and Health Visitors). This formulary includes dressings, appliances and a limited number of medicines relevant to community nursing and specialist community public health nursing practice. The formulary can be found at the back of the BNF or at BNF.org


“Nurse and pharmacist independent prescribers may prescribe medicines independently for uses outside their licensed indications/UK marketing authorisation (so called ‘off-licence’ or ‘off-label’). They must, however, accept professional, clinical and legal responsibility for that prescribing, and should only prescribe ‘off-label’ where it is accepted clinical practice.
A local policy for the use of off-label medicines should be approved through mechanisms such as drug and therapeutic committees or the equivalent. The prescriber should explain the situation to the patient/guardian, where possible, but where a patient is unable to agree to such treatment, the prescriber should act in accordance with best practice in the given situation and within the policy of the employing organisation”. (‘Improving patients' access to medicines: A guide to implementing nurse and pharmacist independent prescribing within the NHS in England’ - Paragraph 54).

Supplementary prescribers may prescribe products used outside their UK licensed indications (i.e. “off-label” use). Such use must have the joint agreement of both prescribers and the status of the drug should be recorded in the clinical management plan (CMP).

25

What can pharmacist IPs prescribe?

• Any licensed medicine for any condition within their clinical competence
• Any controlled drug listed in Schedules 2-5 for
any medical condition within their competence (except Diamorphine, Cocaine and Dipipanone for the treatment of addiction)
NB: Pharmacist IPs are able to prescribe other controlled drugs for the treatment of addiction

Pharmacist independent prescribers can prescribe any licensed medicine for any condition within their clinical competence,

Pharmacist independent prescribers are able to prescribe any controlled drug listed in schedules 2-5 for any medical condition within their competence, except diamorphine, cocaine and dipipanone for the treatment of addiction (pharmacist independent prescribers are able to prescribe other controlled drugs for the treatment of addiction).


NB if prescribe unlicensed meds have to take responsibility

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Becoming a prescriber

• Pharmacists should have at least two years’ experience practising post registration, as a pharmacist in a clinical environment, in a hospital or a community setting
• Organisations should assure themselves that the pharmacist is competent to prescribe in the area in which they will prescribe following training
• Courses have to be GPhC accredited
• Education and training consists of:
– 25-27 days, including attendance at classes
• Not all days spent in class – e.g. Keele IP course has only 6 days attendance in 6 months
– At least 12 days (90 hours) learning in practice under supervision of a medical practitioner

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IP learning outcomes

• 16 learning outcomes set by GPhC – Currently under review
• Cover legal, ethical and professional aspects • Clinical examination and diagnosis
• Communication and consultation skills
• Evidence based medicine

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Role requirements

• Access to patient’s records–single set of records
• Should report ADRs to Yellow Card Scheme • Need professional indemnity insurance

The Royal Pharmaceutical Society of Great Britain’s ‘Professional Standards and Guidance for Pharmacist Prescribers’ states:“In order to prescribe for a patient you must satisfy yourself that you have undertaken an adequate assessment of the patient by taking a history, performing an appropriate examination and/or by accessing the appropriate parts of their clinical records. You are accountable for your decision to prescribe and must prescribe only where you have relevant knowledge of the patient’s health and medical history and of the medicines required for treating their condition(s)”. [Mandatory Professional Standard]
“Whenever possible, when prescribing for a patient you should have concurrent access to the patient’s full health records.’ [Good Practice Guidance]

Organisations have vicarious liability too – need to ensure competence of prescriber

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NMP in practice

• Pharmacists:
– Hypertension clinic/COPD clinic in GP practices
– Minor ailments clinics
– Medicines review (e.g. in care homes)
– Rheumatoid arthritis management/ cancer treatment management / liver and renal impairment management in acute trusts

30

NMP in practice

• Pharmacists:
– Hypertension clinic/COPD clinic in GP practices
– Minor ailments clinics
– Medicines review (e.g. in care homes)
– Rheumatoid arthritis management/ cancer treatment management / liver and renal impairment management in acute trusts
• Nurse:
– Urgent care / outreach and inpatient urgent mental health/ specialist neonatal/ palliative care/ smoking cessation
• Physiotherapist:
– severe chronic lung disease management/ elderly rehab
• Podiatrist:
– rapid access foot protection
• Radiographer:
– radiotherapy treatment management