Use of Patient Group Directions for the supply and administration of antimicrobial agents

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www.sps.nhs.uk | Use of PGDs for the supply and administration of antimicrobial agents May 2018 (PG) 1

Contents Executive Summary 2

Background

Patient Group Directions

Carter Review

Antimicrobial Resistance

3

Methods

Purpose

Data collection

Data analysis

4

Results

Number and type of Trusts included in cohort

Number of PGDs for antimicrobial therapy per type of Trust

Healthcare professional using PGD to administer and supply antimicrobial therapy

Number of Trusts using PGD to administer and supply antimicrobial therapy by agent

Number of Trusts using PGDs for antimicrobial agents by clinical conditions treated

5 to 8

Discussion

Limitations in methodology

Antimicrobial Stewardship

Governance

Operational productivity

Standardisation of PGDs

Standardisation of antimicrobial agents supplied on PGDs

9 to 11

Conclusion 12

Acknowledgements 12

References 13

Appendix 1 – PGD Proforma 15

www.sps.nhs.uk | Use of PGDs for the supply and administration of antimicrobial agents May 2018 (PG) 2

Executive Summary

A scoping exercise was undertaken to explore the extent to which Patient Group Directions are used to supply antimicrobials and determine whether there are areas of duplication that would meet the principles of operational productivity and performance in the NHS.

Requests for information on PGDs for the administration and supply of antimicrobial agents were made to pharmacists at 44 NHS organisations between November 2017 and February 2018.

22 organisations responded (acute, community and mental health trusts),

submitting a total of 199 PGDs.

The antimicrobial agents most commonly provided via PGDs were flucloxacillin, metronidazole, doxycycline, co-amoxiclav, amoxicillin, clarithromycin, and nitrofurantoin.

Common clinical indications treated included urinary tract infections; cellulitis;

animal and human bites; sexually transmitted infections and respiratory infections.

The pack sizes of antimicrobial agents supplied varied between different

organisations for the same clinical indications.

From a governance perspective, there is variation in the quality of PGDs across organisations and poor compliance with good practice guidance from NICE.

Across the Trusts there were 199 PGDs for provision of antimicrobial therapy, by removing duplication this could be reduced to 33.

This background work confirmed that there are areas of duplication and

variation with consequent opportunities for improved quality and efficiency through standardisation of PGDs. Routes to achieve this will be explored through joint working with other relevant bodies and organisations, whilst ensuring all actions support the anti-microbial resistance agenda.

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Background

Patient Group Directions A ‘patient group direction’ (PGD) is a written instruction that allows named authorised health professionals to supply and/or administer specified medicine or medicines to a well-defined group of patients requiring treatment for a specific condition, without the need for a prescription. Each PGD must be authorised by a doctor or dentist and a pharmacist, and approved for use by an authorising body1, 2. The preferred way for patients to receive the medicines they need is for a prescriber to provide care for an individual patient on a one-to-one basis. However PGDs have been used in the NHS since 2000 in various clinical settings. They are reserved for limited situations where they offer an advantage for patient care without compromising patient safety and where there are clear governance arrangements and accountability1. To facilitate timely access to medicines1,many NHS providers have introduced PGDs into the care pathway and this has led to many providers developing local PGDs, with duplication of effort across the NHS.

Carter Review The first Carter Review, published in February 2016, set out a vision with recommendations for improving both productivity and efficiency within the NHS3.This Review focussed on acute trusts and a further review looking at Mental Health and Community Health services is expected to be published in Summer 2018. The Carter methodology highlights where unwarranted variation exists within the NHS and tasks organisations to examine themselves against agreed benchmarking metrics. Specifically for Pharmacy the 2016 report suggested that organisations should ensure that their pharmacists and clinical pharmacy technicians spend more time on patient-facing medicines optimisation activities. With these principles in mind an initial scoping exercise into use of PGDs by NHS organisations was instigated.

Antimicrobial Resistance A key area of focus in both the Medicines Value Programme and medicines optimisation is to reduce the overuse of antibiotics to help tackle antimicrobial resistance. Thus this initial work focused on the provision of antimicrobial agents via PGDs to identify themes which could support the antimicrobial resistance campaign and reduce the overuse of antibiotics4, 5.

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Methodology

Purpose The aim is to undertake a scoping exercise to explore the extent to which PGDs are used to deliver antimicrobials and ascertain if there are areas of duplication that would meet the principles of operational productivity and performance in the NHS. In addition where variation is identified we will seek advice as to whether this is justified, especially with regard to the antimicrobial resistance programme.

Data collection In order to manage the data collection we limited the number of NHS organisations contacted. A list of chief pharmacists, antimicrobial pharmacists and medicines governance and safety pharmacists working in acute, community health and mental health trusts was devised by the Medicines Use Team at SPS. The list of pharmacists and organisations covered the four NHS geographical regions within England to help provide a snap shot of the current provision of antimicrobial agents via PGDs across England. Requests for information on PGDs for the administration and supply of antimicrobial agents were made to pharmacists at 44 organisationsvia email. Pharmacists either replied with copies of their current local Trust PGDs or sent a proforma (see Appendix 1) completed with the required information between November 2017 and February 2018. All copies of PGDs and proformas received were reviewed and the following data were collected;

Type of organisation – acute, community health, mental health

Antimicrobial agent – name, strength, formulation

Clinical indication

Length of course supplied and pack size of preparation

Name of service using the PGD to provide treatment

Healthcare professionals that were working under the PGD

Data analysis Data was recorded in a spreadsheet and the choice of antimicrobial agent and treatment of clinical condition was checked against national guidelines14, 15. The quality of PGDs was also reviewed against NICE Guidance on PGDs2. We consulted with national antimicrobial stewardship leads for any clinical practice or treatment that did not have national guidance in place for clinical appropriateness.

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Results The response rate to the request for PGDs was 50%, with 22 of the 44 organisations replying to the email request. A total of 199PGDs were collated from 18 organisations and 4 organisations responded to explain that they did not use PGDs to provide antimicrobial therapy; this included an acute trust and 3 mental health trusts. Table 1 shows number of the different types of organisations that made up the sample. Table 1: Number and type of Trusts included in cohort using PGDs for antimicrobial therapy

Type of trust and services Number of trusts

Range of PGDs per organisation type

Acute Trust 5 4 to 21

Acute and Community Health Trust 3 9 to 27

Community Health Trust 8 2 to 12

Mental Health and Community Trust 2 1 to 54

Total 18 -

From our cohort we found that mental health trusts do not use PGDs to provide antimicrobial therapy. Two organisations that are combined mental health and community health trusts use PGDs to provide antimicrobial therapy as part of their sexual health service. Table 2 shows the number of PGDs collected from the different types of organisations. PGDs from community health trusts made two thirds of the sample. Table 2: Number of PGDs for antimicrobial therapy per type of Trust

Number of PGDs (%)

Acute 41 (21%)

Acute and Community Health combined 44 (22%)

Community Health 62 (31%)

Mental Health and Community Health combined 52 (26%)

Total 199

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Table 3 shows that PGDs for antimicrobial therapy are used by both nurses and allied healthcare professionals, with nurses being the main healthcare professional group. Table 3: Healthcare professional using PGDs to administer and supply antimicrobial therapy

Healthcare professional Number of PGDs (%)

Registered Nurse 187 (82%)

Registered Paramedic 28 (12%)

Registered Podiatrist/Podiatric Surgeon 5 (2%)

Registered Physiotherapist 8 (4%)

It is important to note that total number of PGDs in Table 3 is higher than 199 collected because in many PGDs, antimicrobial therapy can be supplied and administered by more than one professional group. Table 4 shows the range of antimicrobial agents used by the cohort. The most common antimicrobial agents provided via PGDs included – flucloxacillin, metronidazole, doxycycline, co-amoxiclav, amoxicillin, clarithromycin, and nitrofurantoin. Less common antimicrobial agents provided via PGDs included - piperacillin+ tazobactam, ciprofloxacin, meropenem, Truvada® and raltegravir.

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Table 4: Number of Trusts using PGDs to administer and supply antimicrobial therapy by agent

Antimicrobial agent Number of Trusts using antimicrobial agent (n = 18)

Flucloxacillin 13 (72%)

Metronidazole 12 (67%)

Doxycycline 11 (61%)

Co-amoxiclav 11 (61%)

Amoxicillin 10 (56%)

Clarithyromycin 9 (50%)

Nitrofurantoin 8 (44%)

Chloramphenicol 8 (44%)

Azithromycin 7 (39%)

Phenoxymethylpenicillin 6 (33%)

Clotrimazole 6 (33%)

Ceftriaxone 5 (28%)

Benzylpenicillin 4 (22%)

Erythromycin 4 (22%)

Trimethoprim 4 (22%)

Aciclovir 3 (17%)

Ciprofloxacin 3 (17%)

Fluconazole 3 (17%)

Cefotaxime 2 (11%)

Clindamycin 2 (11%)

Fusidic acid 2 (11%)

Meropenem 2 (11%)

Piperacillin and Tazobactam 2 (11%)

Truvada and Raltegravir 1 (6%)

Betamethasone and Neomycin 1 (6%)

Cefalexin 1 (6%)

Gentamicin 1 (6%)

Nystatin 1 (6%)

Octenisan and Naseptin 1 (6%)

Otomize® (Neomycin, Dexamethasone and Acetic acid)

1 (6%)

Sofradex® (Dexamethasone, Gramicidin and Framycetin)

1 (6%)

Teicoplanin 1 (6%)

Table 5 shows the range of clinical conditions treated by antimicrobial therapy made available via PGDs and highlights where there is duplication. Common clinical indications include urinary tract infections, cellulitis, treatment and prophylaxis of animal and human bites, sexually transmitted infections and respiratory infections. Less common clinical conditions include provision of the initial dose of antimicrobial therapy to treat sepsis and meningitis.

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Table 5: Number of Trusts using PGDs for antimicrobial agents by clinical conditions treated

Clinical condition Number of Trusts with PGD for clinical indication (n = 18)

Urinary Tract Infection 16

Cellulitis 16

Prophylaxis and treatment of animal/human bite

15

Chlamydia trachomatis / Uncomplicated Neisseria gonorrhoea

12

Acute exacerbation of COPD 11

Acute otitis media / externa 10

Bacterial eye infection 10

Wound infection 10

Vulvovaginal candidiasis 9

Bacterial throat infection (tonsillar abscess, tonsillitis)

8

Prophylaxis of surgical site infection

8

Meningococcal septicaemia / Bacterial meningitis

7

Alternative treatment for patients with penicillin / beta lactam / cephalosporin allergy

7

Sepsis 5

Bacterial vaginosis 5

Dental infection 4

Community Acquired Pneumonia 4

Genital Herpes simplex infection 3

Respiratory Tract Infection 2

Neutropenic sepsis 2

Exposure to anthrax 2

Exposure to plague 2

Exposure to tularaemia 2

Pelvic Inflammatory Disease 2

Post-exposure prophylaxis 1

UTI prophylaxis post cystoscopy 1

Prevention and control of Group A streptococcal infection

1

Clostridium difficile 1

MRSA disinfection regime 1

Oral candidiasis 1

Post-operative ophthalmic surgery 1

Infected leg ulcers 1

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From a procurement perspective, there is variation in pack sizes (quantities) supplied. There are PGDs that supply the exact course length of the antimicrobial via pre-packs and PGDs where there is a supply of original packs with instructions to the patient to discard the remainder. Typically this was seen for the supply of amoxicillin, co-amoxiclav, cephalexin, clarithromycin, nitrofurantoin and trimethoprim. In terms of formulations supplied, most common were tablets and capsules for primary care infections, and injectable preparations were commonly used for sepsis and meningitis.

Discussion Eighteen NHS organisations shared 199 PGDs for supply and/or administration of antimicrobial agents. The cohort demonstrated areas of duplication and opportunities for standardisation of PGDs for the provision of antimicrobial therapy.

Methodology It is recognised that the cohort of organisations reported were not a representative sample of all NHS organisations in England, as the methodology involved a convenient sample approach. The response rate from organisations to our request for PGDs was 50%. Some providers were cautious about sharing PGDs outside their organisations and there were occasional concerns about document scrutiny.

Antimicrobial Stewardship The most common conditions where PGDs were used included sexually transmitted infections and primary care infection presentations to out of hours and urgent care services. The PGDs generally adhered to NICE, PHE and BASHH guidelines11, 14, 15. One possible exception was the supply of single dose amoxicillin for urinary tract infection prophylaxis post-cystoscopy procedure. In view of the high resistance rate to amoxicillin 6, 7, further investigation by antimicrobial experts would be needed to confirm suitability. Injectable antimicrobial agents were in use for the treatment of sepsis in six acute Trusts. The national antimicrobial stewardship leads considered the use of PGDs to support sepsis pathways can be clinically appropriate. In some circumstances PGDs enable the initial dose of the antimicrobial to be administered without delay meeting the one hour recommendation. Of the four organisations that did not have PGDs in place for the provision of antimicrobial agents it was noteworthy that one was an acute trust. We explored this further with the organisation and the view was that PGDs make it difficult to prove patients are considered on an individual level and that patients need to be reviewed and diagnosed by prescribers.

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Governance There was significant variation in the quality of PGDs across the organisations in the cohort. One Trust using a single PGD for the supply and administration of ‘sexual health medication’ to treat multiple clinical conditions. A PGD for multiple conditions and treatments is not in line with NICE guidance2. In some cases there was incomplete information relating to the antimicrobial agent such as strength and quantity to supply. There were also examples where the inclusion criteria made reference to internal organisation guidelines and therefore relied on the guidelines and PGD being updated simultaneously. It is important to consider the appropriate use of PGDs amongst healthcare professional groups. For example, some podiatric surgeons opted to use PGDs rather than become independent prescribers which would allow them to prescribe antimicrobial therapy for minor surgical procedures. In addition podiatrists have medicines exemptions under the Human Medicines Regulations 2012 whereby there are permitted to supply certain antimicrobial agents12.

Operational productivity There was duplication across the cohort in developing PGDs for many clinical conditions that follow national guidance, for example primary care infections and sexually transmitted infections. In line with principles of the Carter Review there is an opportunity to improve both NHS efficiency and productivity by standardising the development and distribution of PGDs across NHS organisations. This would create capacity within NHS organisations for pharmacists and pharmacy technicians to spend more time on patient facing activities. Furthermore, standardisation would help to address the known issue around the lack of access to specialist antimicrobial pharmacy advice within both community and mental health settings. Standardisation of PGDs would also reduce unwarranted variation in the quality of PGDs.

Standardisation of PGDs In terms of standardisation of PGDs for the provision of antimicrobial therapy to treat common primary care infections and sexually transmitted infections, there are several options:

1) Do nothing; continue with the current system of multiple PGDs across NHS organisations for the treatment of the same clinical conditions leading to duplication of effort, unwarranted variation and inefficient use of NHS resources.

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2) Develop a repository of quality assured example PGDs that are made

available to organisations via the SPS website. This would support and help organisations reduce the unwarranted variation and help to drive the quality of care for patients. However, this does not necessarily tackle the efficiency within the NHS and create extra clinical capacity.

3) Develop national PGD templates to standardise treatment and practice in line

with national guidance. This would also support organisations with antimicrobial stewardship and quality assurance of PGDs. An example of this is PHE’s immunisation templates’ that are adopted locally10 to ensure consistent standards of patient care. NICE have issued treatment pathway templates on primary care infections, (for example, treatment of sore throat and acute sinusitis) which could be supported with appropriate PGDs at time of publication.

National templates for common primary care infections and sexually transmitted infections could be developed by a working group including doctors, nurses and pharmacists to ensure the clinical content. The group would also need support from clinical leaders at national level to facilitate uptake. A similar approach was used by the pan-London sexual health PGD working group to produce PGDs for sexual health services. Importantly, it was recognised that PGD development requires significant resource, skills and expertise 9.

Standardisation of antimicrobial agents supplied on PGDs Original packs of antimicrobial therapy are frequently supplied by PGD. However, the quantity supplied can exceed that required, leaving the patient with the responsibility to discard the remainder. It is important to consider the impact of this on antimicrobial resistance where both PHE and NICE advise that the exact quantity of antimicrobial therapy should be supplied for the duration of treatment. We started to explore this further with the procurement team at SPS and there are well known challenges around supplying the exact amount of antimicrobial agents. These include challenges from commissioners, clinicians and organisations preferring to supply original packs as a cost-effective solution compared to bespoke pre-packs. Furthermore there is no general consensus or list of national standard pre-pack sizes of antimicrobial agents in England. In contrast, Scotland has implemented an out of hours formulary13 with standard quantities. This is an area that should be explored further for treatment of common conditions.

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Conclusion The scoping exercise has confirmed areas of duplication and variation and that there are opportunities for standardisation of PGDs for the provision of antimicrobial therapy. National templates for a limited range of common infections could bring benefits in terms of improving quality and productivity. Further steps should be taken to explore the options for national template PGDs. One potential starting point would be to trial the development of national PGDs for primary care infections and sexual health services with the necessary clinical leadership at national level via NHS Improvement

Acknowledgements We would like to thank all the individuals that have contributed to the report by sharing their organisations PGDs. Particular thanks to Emma Cramp (NHSI National Project Lead - Healthcare Acquired Infection and Antimicrobial Resistance), Elizabeth Beech (National Project Lead – Healthcare Acquired Infection and Antimicrobial Resistance) and Philip Howard (NHSE National Project Lead - Healthcare Acquired Infection and Antimicrobial Resistance) for their support.

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References: 1 Using effective governance to ensure safe use of patient group directions and improve

timely access to medicines.https://improvement.nhs.uk/resources/improving-quality-and-safety-healthcare-medicines-management/(accessed 12.05.18)

2 National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guideline (MPG2). https://www.nice.org.uk/Guidance/MPG2 (accessed 12.05.18)

3 Operational productivity and performance in English NHS acute hospitals: unwarranted variations (2016). https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499229/Operational_productivity_A.pdf (accessed 12.05.18)

4 NHS England Regional Medicines Optimisation Committees – Proposals for Establishment (2016). https://www.england.nhs.uk/wp-content/uploads/2016/08/rmoc-prop-for-establishment.pdf (accessed 12.05.18)

5 NHS England Medicines Value Programme https://www.england.nhs.uk/medicines/value-programme/ (accessed 12.05.18)

6 European Association of Urology – Urological Infections guideline accessed via http://uroweb.org/guideline/urological-infections/#3 (accessed 12.05.18)

7 Public Health England (2015). English surveillance programme for antimicrobial utilisation and resistance (ESPAUR) 2010 to 2014 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/477962/ESPAUR_Report_2015.pdf (accessed 12.05.18)

8 National Institute for Health and Care Excellence (2013). Case scenarios: Patient Group Directions: Implementing the NICE guidance on Patient Group Directions. Medicines Practice Guideline (MPG2). https://www.nice.org.uk/guidance/mpg2/resources/case-scenarios-pdf-13635181 (accessed 12.05.18)

9 Bussey A, French K. A pan-London approach to patient group directions in sexual health services: from aspiration to reality J Fam PlannReprod Health Care 2017;43:154-156. http://srh.bmj.com/content/familyplanning/43/2/154.full.pdf (accessed 12.05.18)

10 Public Health England (2015). PGD templates to support national immunisation programmes provided on the NHS. https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd (accessed 12.05.18)

11 National Institute for Health and Care Excellence (2018). Sore throat (acute): antimicrobial prescribing. NICE guideline [NG84] https://www.nice.org.uk/guidance/ng84 (accessed 12.05.18)

12 Health and care professionals council. Medicines exemptions for chiropodists and podiatrists. http://www.hpcuk.org/aboutregistration/medicinesandprescribing/medicinesexemptions/ (accessed 12.05.18)

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13 NHS Greater Glasgow and Clyde Area Drug and Therapeutics Committee. NHS Scotland Formulary of pre-labelled medicines for unscheduled care (2012). http://www.ggcprescribing.org.uk/media/uploads/other_formularies/pre-lablled_meds_formulary_-_1209.pdf(accessed 12.05.18)

14 Public Health England – Management and treatment of common infections: Antibiotic guidance for primary care: For consultation and local adaptation. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/664740/Managing_common_infections_guidance_for_consultation_and_adaptation.pdf (accessed 12.05.18).

15 British Association for Sexual Health and HIV guidelines. https://www.bashh.org/guidelines (accessed 12.05.18)

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Appendix 1:PGD Proforma

Name of organisation XXXXXX NHS Trust Type of organisation (Acute, MH, CH)

Drug name, strength and form

Indication(s) PGD title PGD serial number (if used)

Name of service using PGD (please avoid abbreviations)

Example: Co-amoxiclav 500/125mg tabs Co-amoxiclav 250/125mg tabs Co-amoxiclav 125/31 suspn Co-amoxiclav 250/62 suspn 1 x 21 tabs issued 1 x 100ml suspn issued for 7/7

Example: First line for: 1. Wound caused by human

or animal bite 2. Open tendon injury 3. Deep, contaminated wound 4. Wounds requiring surgical

debridement, involving joints, tendons, ligaments and underlying fractures

(Children >1 years and adults)

Example: PGD for the administration/supply of co-amoxiclav (strengths/forms) within various XXXX locations

Example:

Version 2.0

Example: Nurses and Paramedics working as Emergency Care Practitioners Minor Injuries Unit XXXXX Walk in Centre

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NHS Specialist Pharmacy Service www.sps.nhs.uk