Introduction: Urinary tract infections (UTIs) are one of the most common conditions seen in female patients in general practice. Community pharmacy can supply antibiotics under minor ailment service patient group directions (PGDs) for a variety of indications, including uncomplicated UTI in women. The NHS Kernow Clinical Commissioning Group (CCG) funds such a locally commissioned minor ailment service.
Aim: As part of an antimicrobial stewardship element of the General Practice Prescribing Quality Scheme for 2019–2020, the medicines optimisation team at NHS Kernow CCG, working with GP practices, community pharmacy and Pinnacle, performed a service review of the community pharmacy service for management of uncomplicated UTI in women. The objectives were to assess whether notifications of antibiotic supply were reliably received and recorded by GP practices, share learning of the evaluation with GPs and pharmacists, and develop actions to further improve the service.
Methods: Women who received a community pharmacy supply of nitrofurantoin in July 2019 were identified from the PharmOutcomes platform and, where possible, the patient’s record in the GP system was reviewed.
Results: In July 2019, the PharmOutcomes platform recorded 271 women who had received a supply of nitrofurantoin from a community pharmacy via the PGD. There were 239 supplies to women aged 16–64 years, and 32 supplies to those aged 65–75 years. All 271 women were recorded as receiving a Treat Antibiotics Responsibly, Guidance, Education, Tools toolkit and advice from the community pharmacy. Data from those surgeries in Cornwall (n=174 women) identified that 12% (n=21) were noted on the GP systems as requiring further antibiotic treatment for their UTI.
Conclusion: This evaluation suggests that the service operated well from a community pharmacy perspective, although re-treatment levels may require further monitoring if possible. Increasing the quality of data recording in general practice with respect to such antibiotic use should be a high priority.
Keywords: Female, nitrofurantoin, patient group direction, pharmacy, urinary tract infections
Original submitted: 8 April 2020; Revised submitted: 19 August 2020; Accepted for publication: 21 November 2020.
- Urinary tract infections (UTIs) are one of the most common conditions seen in female patients in general practice;
- The community pharmacy UTI patient group direction service enables females to receive nitrofurantoin, which improves access for women and reduces pressure on GP surgeries;
- The review of the various stages of this service suggests that community pharmacists can respond in a timely manner to UTI symptoms, with appropriate use of nitrofurantoin.
Urinary tract infections (UTIs) are one of the most commonly seen bacterial infections in general practice. Butler et al. conducted a study of 2,424 females aged 16 years and over, of which 37% (n= 892) reported ever having had a UTI in their lifetime. Of those who had had a UTI, 95% consulted a healthcare professional for their most recent UTI and almost three quarters of these reported being prescribed an antibiotic. Data have suggested that women only consult a healthcare professional when the severity of symptoms, duration of illness or failed self-care is sufficiently severe to prompt a visit. A recent study by Smieszek et al. attempted to assess the appropriateness of antibiotic prescribing using guidelines and expert opinion; however, their findings were limited by classifying only 22.6% of all prescriptions. It was found that antibiotics for UTI do not appear to contribute substantially to inappropriate prescribing, but opportunities remain to optimise the management of UTIs in the primary care setting[4,5].
However, it is not just general practice that is involved in UTI management — antibiotics for UTIs are provided via community pharmacy as a means of improving patient access to treatment and reducing GP workload. In the UK, there are well established community pharmacy services utilising patient group directions (PGDs) for the supply of appropriate prescription-only medicines for patients seeking treatment for common clinical conditions, including UTI, that would generally require a GP appointment to obtain the treatment[6–9]. In other countries, pharmacists have the authorisation to prescribe an antibiotic for the treatment of uncomplicated UTI[10,11]. The NHS Kernow Clinical Commissioning Group (CCG) funds a locally commissioned minor ailment service which enables locally accredited community pharmacists to supply prescription-only medicines via a PGD for the treatment of several common conditions, including the treatment of uncomplicated UTI.
Minor ailments service
The aim of the service is to improve access and choice for people with minor ailments by promoting self-care through community pharmacy, including the provision of advice and, where appropriate, the supply of medicines under a PGD by community pharmacists without the need to visit a GP surgery. The service involves consultation, diagnosis and management, which may be via a PGD supply of a medicine, referral or self-care option. Practices are informed if a medicine supply has been made by a community pharmacist via the PGD. NHS Kernow CCG commissions and funds the service to improve primary care capacity by reducing GP surgery and out-of-hours GP workload, as well as possible emergency department attendance related to minor ailments.
To provide the service, community pharmacists are required to confirm that they have read the current PGDs for all of the minor ailment services and attend a training course or complete the Centre for Pharmacy Postgraduate Education minor ailment course and e-assessment, as well as make a declaration of competence. The service, which includes treatment of uncomplicated UTI, has been operating in Cornwall since 2007. In September 2015, all minor ailment services, PGDs and checklists were added as templates on the PharmOutcomes platform (provided by Pinnacle Health Partnership LLP). This enabled community pharmacies to enter details of supplies of medication made via the PGD and notify GP surgeries via a secure email notification (instead of a written report) when a medicine for a patient registered at that practice had been supplied via the PGD. A report of the service uptake can be produced over a particular time period via the PharmOutcomes platform.
The service is advertised to the public via posters displayed in community pharmacies, GP surgeries, and community and acute hospitals, as well as listed on the NHS Kernow CCG Facebook page.
Community pharmacy service for the management of urinary tract infection
Originally, the antibiotic of choice in a previous version of the PGD — which had no upper age limit — was trimethoprim, which could be supplied if women had at least two symptoms and a positive dipstick test. However, in 2017, the antibiotic of choice was changed from trimethoprim to nitrofurantoin in line with local guidelines, which had been updated following evidence of emerging local resistance to trimethoprim.
The new nitrofurantoin PGD, which is aligned with Public Health England and National Institute for Health and Care Excellence (NICE) guidelines, does not require the use of dipstick testing in those aged over 65–75 years and those aged 16–64 years with two or more symptoms. As renal function declines with age, an upper age limit of 75 years for this minor ailment service was agreed.
The PGD enables women aged 16–75 years, who are registered with a GP surgery within the UK and meet certain clinical criteria, to receive nitrofurantoin. As part of the service, the pharmacist questions the patient, assesses their treatment needs and determines whether they meet specific inclusion criteria to be supplied the antibiotic. The main inclusion and exclusion criteria are shown in Table 1. These criteria are based on the typical symptoms of lower UTI, including dysuria, urinary frequency and urgency, changes in urine appearance or consistency, nocturia and suprapubic discomfort/tenderness. If patients present with the first two symptoms: dysuria with urinary frequency, the probability of a UTI is greater than 90%, whereas if nausea, vomiting, fever, or flank, loin, or lower back pain are present, pyelonephritis is generally considered[17,18].
Table 1: Inclusion and exclusion criteria for the nitrofurantoin patient group direction
|Inclusion criteria||Exclusion criteria|
|Patient aged 16 years or over and under 75 years||All men|
|If patient is aged 16–64 years and presents with two or more of the following symptoms: dysuria, new nocturia and cloudy urine||Fever, pain in sides or lower back, chills, rigors, nausea, vomiting or headache|
|If patient is aged 65–75 years and presents with new dysuria alone, or two or more of the following symptoms: new urinary frequency, new urinary urgency, new suprapubic pain, visible haematuria with the naked eye||Previous treatment with any antimicrobial for urinary tract infection (UTI), including nitrofurantoin or trimethoprim, in the past three months|
|Already had two or more UTIs in the past six months or more than three during the previous 12 months|
|Women who are pregnant or breastfeeding|
|Women with renal disease, diabetes or liver disease|
The PGD also requires community pharmacists to ask patients whether they have hypertension or heart disease, or are taking medication that could affect renal disease and, if so, whether they have had a blood test for renal function and to confirm that the result was satisfactory. Patients are excluded from treatment via the PGD if they have not had a renal function blood test, or if they have had such a blood test and the patient understood the result was unsatisfactory. Those excluded from the service are signposted to their GP or out-of-hours service, depending on the severity of their symptoms. When a supply has been made in a community pharmacy, a record is entered on to the PharmOutcomes platform, resulting in the patient’s GP surgery receiving an email notification that a supply has been made for that patient.
Owing to the nitrofurantoin PGD and PharmOutcomes template being updated following the latest PHE update in 2019, the CCG medicines optimisation team and Cornwall local pharmaceutical committee held a training event early in July 2019, along with providing extensive communication to community pharmacists about the changes to the PGD. Two important messages were:
- to no longer dipstick test urine but to supply based on symptoms only;
- for mild symptoms suggestive of a UTI, to recommend the ‘watch and wait’ approach and hydration measures.
The service utilises resources from the Treat Antibiotics Responsibly, Guidance, Education, Tools (TARGET) toolkit by making the UTI patient information leaflet available, which was designed to be used by women who are experiencing urinary symptoms suggesting uncomplicated UTIs. A link to the TARGET UTI guidance leaflet for both age groups was added to the PharmOutcomes template and community pharmacies were instructed to provide a copy of the appropriate age TARGET UTI leaflet.
As part of an antimicrobial stewardship element of the General Practice Prescribing Quality Scheme for 2019–2020, the CCG medicines optimisation team chose to work with GP surgeries and community pharmacies to undertake a review of the minor ailment service for the management of uncomplicated UTI by supply of nitrofurantoin via a PGD. This review was part of the 2019–2020 work plan, which had been agreed with the relevant CCG prescribing forum and local medical committee in advance.
July 2019 was chosen as the target month as retrospective data obtained from the PharmOutcomes platform over the past four years identified July as the month when a large number of supplies were made, particularly for patients registered with practices in Cornwall. The medicines optimisation team, whose remit is to undertake confidential searches of GP records for the purpose of audit, had access to review patients’ records in GP practices in Cornwall only. The objectives were to analyse community pharmacy records for the supply of nitrofurantoin and ascertain if details of such a supply had been reliably received at the patient’s general practice, and if any patient outcomes were also recorded. Any shared learning from the review and important action points were to be developed to improve the future management of UTI by community pharmacists.
A report for nitrofurantoin supplies made by 64 community pharmacies in Cornwall in July 2019 was reviewed using data obtained via PharmOutcomes. This report identified 39 surgeries in Cornwall as having had patients who had received a supply. These 39 surgeries were contacted by the medicines optimisation team, who first instructed them to create an account by emailing Pinnacle. They were subsequently advised on how to obtain a patient identifiable report for the nitrofurantoin supplies made in July 2019 for their individual practice using the PharmOutcomes platform. The medicines optimisation team technicians aligned to each surgery then undertook data extraction and completed the report form in the practice. No patient identifiable information was included in the report forms. These forms were then reviewed by the authors.
The patient records were reviewed to identify whether the nitrofurantoin supply by the community pharmacist had been added to the GP surgery’s system and whether the UTI episode had been Read coded. Read codes are a comprehensive list of clinical terms intended for use by healthcare professionals to describe the care and treatment given to patients, although, more recently, SNOMED codes are being used in place of Read codes as the replacement structured clinical vocabulary for use in the electronic health record. Relevant data were exported to Microsoft Office Excel and descriptively analysed.
The study was deemed to constitute a service delivery audit; therefore, ethical approval was not required, as determined via Health Research Authority decision tools.
For July 2019, the PharmOutcomes platform recorded 271 women who had received a supply of nitrofurantoin from a community pharmacy via the PGD service. Of this total, 88% (n=239) of supplies were for women aged 16–64 years and 12% (n=32) of supplies were for those aged 65–75 years.
Presenting symptoms, listed in the PGD as inclusion criteria, are shown in Table 2 for women aged 16–64 years and in Table 3 for women aged 65–75 years.
Table 2: Prevalence of self-reported presenting symptoms in women aged 16–64 years
|Symptom||Number of women (n=239)|
|New nocturia||172 (72%)|
|Cloudy urine||148 (62%)|
Table 3: Prevalence of self-reported presenting symptoms in women aged 65–75 years
|Symptom||Number of women (n=32)|
|New urinary frequency||30 (94%)|
|New dysuria||27 (84%)|
|New urinary urgency||26 (81%)|
|New suprapubic pain||13 (41%)|
|Visible haematuria||3 (9%)|
When completing the template questions on PharmOutcomes, community pharmacists asked the women what single action they would have taken if they had not used the service. The women were only able to select one particular action. All women involved (n=271) provided responses, which are shown in Table 4.
Table 4: Declared action that would have been taken if the service had not been used
|Action||Number of women (n=271)|
|Seen their GP||182 (67%)|
|Attended out-of-hours service||33 (12%)|
|Phoned 111||33 (12%)|
|Managed without any treatment||12 (4%)|
|Attended another community pharmacy||8 (3%)|
|Attended emergency department||3 (1%)|
All women (n=271) were recorded as receiving a TARGET toolkit and advice from the community pharmacy. When asked how they had knowledge of the service:
- 157 (58%) identified self-referral;
- 96 (35.5%) were signposted to the service by the GP;
- 7 (2.5%) were signposted from the local out-of-hours service;
- 7 (2.5%) as a result of having phoned 111;
- 3 (1%) were aware of the service from the media;
- 1 (0.5%) from minor injury unit.
No patients received treatment from more than one pharmacy, although 0.4% (n=1) did receive treatment from a GP surgery and a pharmacy. In addition, 1% (n=3) of patients who received a supply were found not to be registered with the practice they had nominated.
Not all of the women identified as receiving a supply were registered at GP practices in Cornwall, with only 67% (n=181) of supplies made to patients from the 39 surgeries in Cornwall. The remaining 33% (n=90) of supplies were from patients registered with surgeries elsewhere.
Further antibiotic treatment
Data from surgeries in Cornwall were obtained and reviewed for 174 women. Despite repeat requests for the data, two surgeries did not manage to obtain a patient identifiable report, meaning that seven patients were not able to be reviewed. Of these 174 women, 11% (n=19) were aged over 65 years and 12% (n=21) were noted on the GP systems as requiring further antibiotic treatment for their UTI. Of these 21 women, 7 (37%) requiring further treatment were from the subgroup of 19 women aged over 65 years. We identified one patient, aged under 65 years, who required hospital treatment for a UTI within one month of the supply of nitrofurantoin. One patient aged under 65 years had an estimated glomerular filtration rate (eGFR) recorded on the GP patent’s notes as being 32mL/min/1.73m2 (a moderate to severe loss of kidney function).
Of the 174 women where a notification of the supply would have been sent to the patient’s surgery, only 32% (n=56) of consultations were Read coded in the GP patient record. However, 5% (n=6) of the 118 consultations that were not Read coded were still documented in the patient’s record.
The supply of antibiotics via a community pharmacy PGD is a service that continues to grow, both in terms of indication for the antibiotic and the volume of antibiotics supplied.
In this study of the local service for uncomplicated UTI in women, it was noted during the month of July 2019 that there were 271 community pharmacy supplies of nitrofurantoin. In contrast, for the same month, there were 3,966 GP prescriptions from the 59 surgeries in the CCG for nitrofurantoin, although it is not known if these were all for uncomplicated UTI in women. This means that only 6.4% of the total of supplies across the CCG for nitrofurantoin were provided by community pharmacists via the minor ailments service.
Results indicate that the service operates well from a community pharmacy perspective, with all 271 women recorded as having received the TARGET UTI leaflet and advice from the community pharmacy. This is an integral part of the service in that, to be able to complete the consultation via PharmOutcomes, community pharmacies must tick the box to indicate a TARGET leaflet had been supplied.
This study provides further limited evidence of the role of pharmacists in reducing workload pressures on primary care and possibly on emergency departments. More than three-quarters (n=215) of the women reported that they would have attended another primary care service — either their GP surgery or out-of-hours service — if they had not been able to receive the antibiotic under the PGD supply. However, the authors note that one patient apparently received treatment from a GP surgery and a pharmacy on the same day, and one patient received treatment despite having had a last eGFR blood test result that would have excluded them from the service.
It was disappointing that one important element of this service — that information on the supply of antibiotic is transmitted and recorded at the patient’s surgery – was less well implemented, with around only one-third (n=56) of the 174 supplies attracting a Read code for a suspected UTI. The possible implication of this lack of coding of the supply of nitrofurantoin is that patients re-presenting with UTI, or requiring additional treatment, should have a urine sample sent for culture and sensitivity, which may not occur if the GP is unaware of previous treatment — although questioning of the patient should reveal any previous supply via a community pharmacy. A possible reason for this absence of coding is that the practice staff, who scan in the email notification received from PharmOutcomes, have not been trained to code the supply as a suspected UTI. We have since informed practices on how to do this and it may be a role for the practice pharmacist to undertake. The study revealed that one practice did not always Read code patients, but did record that a consultation had occurred in the patient notes. In relation to coding of this type of patient episode, there is currently no SNOMED code for medicine supplied by a community pharmacist via PGD, although the lead author of this study has raised this with NHS Digital.
Our data, albeit based on a small sample, indicate that a further supply of an antibiotic for a UTI had to be made by the GP in 12% (n=21) of the 174 women registered in the CCG. This included 9% (n=14) of the 155 women aged 16–64 years and 37% (n=7) of the 19 women aged over 65 years. It is uncertain if this apparent requirement for the GP to make a further supply is a concern around our service. A similar service in Scotland reported that 5.3% of adult women under the age of 65 years required an antibiotic prescription after the pharmacy supply. It was recorded that resistance across England to nitrofurantoin was 4.3% in those aged 65 years and over, although this would be based on microbiology testing of samples. However, a retrospective population-based cohort study in England, by Gharbi et al., on older patients (mainly women) attending GPs between November 2007 and June 2015 showed that of 312,896 patient episodes, 38.2% (n=119,364) required multiple visits to the GP for the same UTI episode, which was not necessarily uncomplicated UTI. A further large study, again mainly conducted in women, observed that antibiotic re-prescription occurred in 6.3% (n=9,859) of episodes diagnosed in adults aged 65 years and over.
One consequence of this service is that there is no ongoing surveillance by the local microbiology laboratory of UTI resistance patterns through community pharmacy supply. Additionally, the way in which the service is currently configured means that community pharmacists do not have the facility to provide a delayed or back-up antibiotic supply in the manner that general practice is encouraged to do so.
We recognise that this community pharmacy supply of nitrofurantoin was based on symptoms alone, which can be subjective, both from the perspective of the patient and that of the pharmacist. However, in following the PHE and NICE guidance, this represents no difference as to how GPs diagnose uncomplicated UTIs[19,20]. Although diagnosis of a UTI is primarily based on the presentation of typical signs and symptoms, urine is the most commonly received specimen in microbiological laboratories and urinary dipstick tests are the most commonly used near-patient tests in primary care[17,18].
Routine urine culture is unnecessary in simple lower UTIs, unless diagnosis is in doubt, in which case urinary dipstick tests may be appropriate to guide treatment and establish if a UTI is present. The diagnosis of UTI in older patients can be problematic, as these patients are less likely to present with a typical clinical history and localised urinary symptoms, compared with younger patients. In addition, older patients are at greatest risk of complicated UTIs and developing ongoing sepsis. Therefore, an important component of the service, especially for this older cohort, is the provision of the TARGET toolkit and advice on what to do for unresolved and worsening symptoms.
It is interesting that community pharmacists participating in a sore throat test and treat (with antibiotics) service saw this service as an opportunity for pharmacists to implement antimicrobial stewardship, which could potentially contribute positively to the fight against antimicrobial resistance, in line with the recognised role of pharmacy in antimicrobial stewardship[31,32]. Two community pharmacies consulted about the UTI service did share this view, but we are unaware if other community pharmacists providing antibiotics for UTI adopt a similar view. However, there is a planned service evaluation of TARGET UTI resources exploring the views of pharmacy staff on giving advice to service users who present with UTI symptoms.
The major challenge in implementing this service evaluation was that it was logistically difficult and time-consuming to obtain the list of patients who had received a supply of nitrofurantoin supply by community pharmacies in Cornwall from the PharmOutcomes platform.
The generalisability of these results is limited, owing to the study being restricted to an evaluation of the minor ailments service in just one CCG. A potential limitation is that the study is based on the assumption that all patients who accessed the UTI PGD service were recorded on the PharmOutcomes platform. However, as pharmacists receive a payment for the UTI PGD service only when the interaction is recorded, the authors have confidence in the data. Another limitation is the reliance on incomplete recording in the GP surgery systems.
A patient satisfaction audit to determine how the service could be improved did not take place, although this could be a future development. Likewise, it was not possible to determine in detail any effect on GP appointments, especially if women subsequently visited their GP because of ongoing UTI but did not receive a further supply of an antibiotic. There is a potential risk of pharmacists providing nitrofurantoin for the treatment of uncomplicated UTIs for patients with impaired renal function, owing to a lack of access to GP records for community pharmacists.
The review of this service suggests that community pharmacists are able to respond under a PGD to UTI symptoms with appropriate use of nitrofurantoin. Re-treatment levels are in the expected range, although it would be prudent to monitor this further if possible. Increasing the quality of data recording in general practice with respect to such antibiotic use should be a high priority. Additionally, community pharmacies should ideally have full access to patients’ blood test results and conditions to enable them to refer patients where it would be inappropriate to supply.
Financial and conflicts of interest disclosure
The authors have no relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in this manuscript. No writing assistance was used in the production of this manuscript.
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