Patient group directions (PGDs) are now part of the landscape of clinical care in the UK, but has the NHS become too reliant on such mass 'prescriptions' and is there a better way?
For what some viewed as a 'quick fix' solution on the road to nurse prescribing has boomed into what one observer has called a PGD 'industry'.
The National Institute for Health and Care Excellence (NICE) has criticised the over-use and sometimes misuse of PGDs in current practice and has issued new guidance to regulate and control this industry.
Despite this, PGDs are still widely used, particularly in national vaccination programmes, so alarm bells sounded when it appeared that some clinical commissioning groups (CCGs) were not ready with PGDs to begin administering the rotavirus vaccine in July.
A PGD allows a specified medication to be administered to a particular group of patients by non-prescribing health professionals. For example, practice nurses can vaccinate target group patients on the practice list without need for a prescription for each named individual.
History of the PGD
The Crown Review in 1999 opened the door to prescribing by nurses and some other non-medical professionals. This change could only occur once sufficient prescribing nurses were trained, so a number of other mechanisms were introduced. Among these were patient specific directions (PSDs), which are written instructions from an independent prescriber for a medication to be administered to a named patient, and PGDs.
In 2000 PGDs were enshrined in law, in contrast to the ad-hoc protocols previously used. A PGD must be signed by a doctor (or dentist) and a pharmacist and be authorised by CCG, NHS trust, local authority or NHS England. A further restriction is that PGDs only give authority for administering medication to regulated professionals such as nurses, midwives, health visitors and pharmacists.
Recent changes allow some controlled drugs to be given under PGDs, such as morphine and diamorphine, by nurses in cases of immediate need (but not in addiction treatment), along with midazolam, benzodiazepines, ketamine and codeine.
Draft NICE guidance makes it clear that PGDs are sometimes being deployed where independent prescribing is the more appropriate option but has not been funded.
The guidance states: 'Barriers to developing independent prescribing such as a lack of allocated funding and staff commitment may have contributed to the unnecessary or inappropriate development of PGDs. PGDs should not be seen as a direct substitute for independent prescribing.'
A cheap substitute for training?
According to figures from the Nursing and Midwifery Council (NMC) there are 63,556 nurses in the UK who are prescribers, which is almost 10 per cent of the registered workforce. Most hold the Community Practitioner Nurse Prescriber or the Nurse Independent/Supplementary Prescriber qualifications.
Barbara Stuttle from the Association for Nurse Prescribing said: 'People used PGDs because it was cheaper and quicker than training nurses to prescribe within their competency. Some employers don't want to invest in that. Some organisations have not wanted people to be released and have prescribing training-instead they have used PGDs. Now they are reaping what they have sown.'
Ms Stuttle added: 'PGDs were set up as a quick fix, but we are using them routinely when they are not meant for that. They have become a big industry in themselves. Do people actually read them? I would question that. People think that working to a PGD is prescribing, and it's not. Most nurse prescribing courses are spread over six months, and you have a doctor as an assessor. That can be difficult to get, as some doctors still have some concerns about it.'
Rebecca Cheatle, RCN adviser for primary and community care, said: 'There are situations where PGDs are a useful adjunct like vaccinations and emergency contraception. They have their place in clinical practice, but that's not to say we should be replacing prescribing by nurses.'
More seriously, NICE also found some evidence of 'ineligible' groups such as healthcare assistants or students administering medications under PGDs. 'That is actually illegal,' said Cheatle. 'HCAs are not able to legally supply or administer medications under a PGD, and registered nurses can't delegate administration of medications under a PGD.'
Using PGDs appropriately
However, there is widespread agreement that PGDs are appropriate in some contexts, such as national vaccination programmes and emergency contraception.
Ms Cheatle said: 'PGDs are used in situations where it offers an advantage for patient care without compromising patient safety. In a flu vaccination programme you have a straightforward cohort that needs immunising, like the over-65s.'
Until April this year, templates for PGDs for nationally commissioned services, like vaccinations, were produced by the Health Protection Agency. However its successor, Public Health England, will no longer perform this function. A spokesperson said that all PGDs should now be developed at the CCG level.
A letter from NHS England to GPs and CCGs says that PGDs for nationally commissioned services will not be developed by NHS England, 'and with current infrastructure are unlikely to be developed nationally.'
However, there is a link to a PGD website where templates of PGDs like rotavirus and menginococcal group C conjugate vaccines, have been posted and shared.
'Under no circumstances should issues related to PGDs and their authorisation stand in the way of patients receiving their immunisations. Where PGDs have expired or are not current, alternatives such as PSDs should be used,' the letter says.
Professor Matt Griffiths, independent nurse consultant argues that using PSDs for vaccinations is impractical. 'It's very time consuming and hard to put everything in place with a PSD. It means that every patient has to be identified in advance. In certain communities-the more vulnerable members of society who lead chaotic lives-vaccination is sometimes opportunistic and not always planned. Without a PGD in place that will reduce the amount of vaccinations done and then you will have reduced herd immunity.'
Professor Griffiths also feared that without a PGD, general practice staff may feel pressured to act illegally due to the financial incentives to immunise as many people as possible.
He was concerned that many practices may find themselves without valid PGDs in the transition to CCGs. 'Things are in a state of flux. The new organisations haven't necessarily handed out their responsibilities yet. PGDs have a life of two years. CCGs need to make sure they are ready, or people won't know what to do when the PGD runs out.'
To help organisations decide whether to develop a PGD to provide a particular service, NHS England has produced a flow chart-To PGD or Not to PGD-to assist them.
But there is concern that the list of organisations able to develop PGDs is too narrow. NICE specifies CCGs, NHS trusts and independent providers to deliver NHS services, but the BMA argues that GP practices should be added to this list. A BMA spokesperson said: 'We strongly recommend that general practices are included in the bodies that can develop PGDs, especially given that even private healthcare organisations are now able to do so.'
| To PGD or Not to PGD? |
PGDs may be appropriate when:
The medicine's use follows a predictable pattern, such as for patients attending for contraception
Patients with an acute need seek unscheduled care, such as in a walk-in centre
Managing a discrete treatment episode where supplying or administering a medicine is needed, such as treating chlamydia
There is a homogeneous patient group, such as at-risk groups of patients needing immunisation
PGDs should be considered carefully when:
The medicine is being used off label
The medicine is a black triangle medicine
The medicine is a controlled drug (only some controlled drugs are eligible for consideration)
The medicine is an injectable preparation for self-administration
Treatment or response to treatment needs careful monitoring
Managing a small number of patients in a specific patient group, because the appropriate resources and expertise may not be available
Supplying and/or administering a range of medicines to the same patient (this may be appropriate in some cases when a discrete episode of care involves treatment with more than one medicine)
The clinical situations where alternative options to PGDs should be used:
Managing complex long-term conditions, such as hypertension or diabetes
In a particular setting, significant uncertainty remains about the differential diagnosis
An antimicrobial is needed (this may be appropriate in some circumstances, such as chlamydia treatment in a sexual health clinic)
The medicine needs frequent dosage adjustments, for example warfarin
The medicine needs frequent or complex monitoring, for example, immunosuppressants
The medicine is a high-risk medicine, for example insulin
Source: NHS Patient Group Directions (PGDs)
Not if complex or high-risk
NICE says that PGDs should not be used for administering complex drugs or high-risk medications.
Nor should they be used to manage long-term conditions such as hypertension or diabetes, such as insulin.Although dose ranges can be specified in PGDs, they should not be used where the dose needs frequent monitoring or adjustment, says NICE. In such cases, prescribing or a PSD would be more appropriate.
'In intensive care virtually every medication going through syringe drivers will be adjusted by nurses every hour depending on the response of the patient,' said Professor Griffiths. 'That's perfectly legal to do if the medication is prescribed within a range and is the most appropriate way for nurses to dose adjust. That's happening every day in hospital and it needs to be done more in the community. But these kind of dose adjustments are not appropriate with a PGD.'
Ms Cheatle concluded: 'PGDs are about offering advantages to the patient without compromising safety and making sure it is done within the letter of the law. Where you have complex individual care, the majority of prescribing should be provided on an individual, patient-specific basis.'
Rosalind Godson, professional officer with the CPHVA agreed. 'If GPs want nurses to do these things, then nurses need to be prescribers out in the community. You do see some bad practice, but it's not the fault of the PGD but of the people in the GP practice. In a lot of instances where there's bad practice it points to the need to train nursing staff in prescribing. Then it's got to be funded and supported by the clinicians. PGDs are very useful provided that they are nailed down appropriately. They tend to be used more in the community setting.'
Ms Godson added: 'If you think about people who don't come to the doctors, children who are missing school, people who can't get out much, or who move about because they are fleeing domestic violence, travellers, people who are not mainstream; it would be more useful if a nurse prescriber could track those people and give out medications. It would solve a lot of problems.'
| What should a PGD include? |
The period during which the direction is to have effect
The description or class of medicinal product
The clinical situations in which medicinal products of that description or class may be used to treat or manage in any form
Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion
The clinical criteria under which a person is eligible for treatment
Whether any class of person is excluded from treatment and whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances
The pharmaceutical form or forms in which medicinal products of that description or class are to be administered
The strength, or maximum strength of medication
The applicable dosage or maximum dosage
The route and frequency of administration
Any minimum or maximum period of administration
Whether there are any relevant warnings to note
Whether there is any follow up action to be taken
Arrangements for referral for medical advice
Details of the records to be kept of the supply, or the administration, of products under the direction
Source: NICE Good Practice Guidance PGDs (Draft, April 2013)