Abstract
Good practice recommendations (GPRs) for outpatient parenteral antimicrobial therapy (OPAT) in the UK were first published in 2012 and 2015 for adult and paediatric OPAT, respectively, and then updated in 2019 as a combined set of recommendations for OPAT in all age groups. Since then, there has been ongoing expansion in national and global experience of OPAT. Here, we provide updated 2026 GPRs developed through a further review of the literature, expert consensus, and extensive consultation. As previously, these updated GPRs for OPAT in adults and children will support delivery of safe and effective OPAT by providing a set of quality indicators for OPAT in the UK regardless of the setting or service model.
Introduction
Outpatient parenteral antimicrobial therapy (OPAT) involves administration of parenteral antimicrobial therapy in a non-inpatient setting to patients who require this for significant infections but who are well enough not to require inpatient care. Since its development in the 1970s, OPAT has expanded in the UK and globally, and there is now general acceptance that, when delivered within a formal service model with appropriate clinical governance, OPAT is safe and clinically effective, preferred by patients and cost-effective compared with inpatient care.1–4
Globally OPAT is now offered in many middle and high-income countries across the world.5–14 Some of these have developed their own good practice recommendations (GPRs).15–18 Models of OPAT delivery globally vary hugely, from national OPAT services with a single OPAT pathway, for example in the Republic of Ireland,15 to countries where OPAT remains ‘ad hoc’ without formal service models.19–21 In the UK, OPAT GPRs have been in place since 2012 and were most recently updated in 201922: the importance of a formal service model and appropriate clinical governance and managerial lines of accountability are emphasized. The British Society for Antimicrobial Chemotherapy (BSAC) OPAT initiative continues to develop resources to support UK OPAT development. These include: support for service set-up and expansion (e.g. business case models and cost calculator); clinical resources (including the GPRs, antimicrobial stability data and educational modules); and input into national OPAT resources.23,24
Several studies have described how OPAT services in the UK and abroad have changed over the past two decades.3–5,25,26 There has been a shift from less complex infections, such as skin and soft tissue infections, to more complex infections, including endocarditis, bone and joint, intra-abdominal and neurological infections. In addition, patients themselves are increasingly more complex and co-morbid. Both of these developments imply that OPAT services in the UK are maturing in experience and expertise regarding patient selection, acceptance of increased clinical risk and confidence in managing adverse events.
Furthermore, the current literature review provides evidence that many OPAT services are extending their scope, including the administration of injectable HIV antivirals, complex outpatient antimicrobial therapy (COpAT) with oral agents,27 and subcutaneous antibiotics.28 A small number of services now offer penicillin allergy ‘de-labelling’; it can be argued that OPAT services, with their infection and antimicrobial stewardship (AMS) expertise and (in most cases) clinic-based structure, offer an ideal opportunity to do this. However, there is a need for appropriate clinical governance for these extended roles.
In recent years, there has been renewed focus on alternatives to hospital-based clinical care, with the development of hospital at home (H@H) models of care and virtual wards.29 These involve the development of new pathways for hospital admission avoidance and early discharge of appropriate patients. These more general pathways align well with the service structure and processes involved in OPAT and offer opportunities for OPAT services to expand and to collaborate, both in delivery of care for patients with infection, and in ensuring good AMS principles are observed in emerging interface settings.30,31
Finally, the previous GPRs stressed the importance of OPAT in AMS. The prudent use of antimicrobial agents is essential to maintain the effectiveness of our antimicrobial armoury against increasing global antimicrobial resistance. OPAT offers the opportunity to optimize AMS in patients receiving OPAT—although with the well-recognized ‘stewardship dilemma’ of OPAT, that is, balancing the risk of using once daily broad-spectrum antimicrobial agents with the benefit of dosing convenience. OPAT also offers the opportunity to give wider infection advice for patients who are not accepted for IV antimicrobial therapy, including appropriate antimicrobial prescribing, facilitating IV to oral switch, limiting duration of therapy and advice on laboratory monitoring. Furthermore, OPAT is only one element of a patient’s management and there needs to be consideration of other aspects of care, including surgical or radiological intervention and determination of clear treatment goals, including, when appropriate, long-term suppression or palliation in incurable infection.
In this updated version of the UK GPRs, we present a review of recent global OPAT literature with updated recommendations based on the literature and expert consensus from a panel of UK OPAT specialist physicians, nurses and pharmacists. In addition, the panel included some members from overseas: there is increasingly a desire to collaborate across nations to share good practice in areas such as AMS, antimicrobial stability in infusion devices and quality accreditation of services.32
As previously, the GPRs are intended to provide minimum standards across a range of OPAT domains, in order to act as a benchmark for existing services to maintain good practice, and to support new and developing services.
Methods
Scope and purpose
This update covers both adult and paediatric OPAT. The updated GPRs are presented as a literature update followed by updated recommendations for each of the five key areas used in the original GPRs. Revised or amended recommendations are depicted using italics.
Stakeholder involvement
BSAC was the host organization. Working party membership comprised adult and paediatric infectious diseases (ID) physicians, medical microbiologists, antimicrobial pharmacists and OPAT clinical nurse specialists.
Literature review
The Cochrane Library issues 8 of 12 (including the Central Register of Controlled Trials), CINAHL, EMBASE, PubMed and Web of Science (science citation index expanded) databases were comprehensively searched from 1 January 2017 to 17 April 2024 (Table S1, available as Supplementary data at JAC-AMR Online). A further search covering the period 18 April 2024–22 June 2025 was completed shortly before the consultation process to capture any additional papers published. Terms were searched and collated for adults and run again with search terms specific for paediatrics (Table S1).
A total of 5802 references were identified from the first literature search (4890 references for adults and 912 for paediatrics) and 1306 references (1115 adult and 191 paediatric) in the second search (Figure 1). An initial screen identified and excluded non-relevant and duplicate references. The remaining references were divided into several key areas relating to the areas of the previous GPRs (Figure 1). Where references were deemed to be relevant to all key areas, they were allocated to the ‘general’ category; references related to the use of OPAT for specific infections were allocated to the ‘OPAT for specific infections’ category and papers relating specifically to the paediatric population were categorized into a ‘paediatrics’ category. Once references had been divided into the appropriate groups, full text articles in the English language were obtained and reviewed. Where evidence on a particular recommendation was lacking in the literature this was noted. As most reviewed references described non-interventional, observational studies or case series, levels of evidence have not been included in this review.
Figure 1.
Flow diagram illustrating the process of the literature search.
Consensus process and guideline development
A core working group was established (A.L.N., M.G., R.A.S. and S.P.). Clinicians from across the range of professional groups involved in OPAT—including nursing, medical and pharmacy—were invited to appraise the literature identified through the searches. The evidence appraisal was reviewed in detail by the core working group at a meeting in April 2025, and subsequently by video call and email communication. Changes to the initial GPRs were made (annotated as italic text) and new GPR statements were written. The revised recommendations were circulated to all reviewers for comments. Following further revision, the draft updated GPRs were sent to a comprehensive list of stakeholders and uploaded to the BSAC website (www.bsac.org.uk). A formal 4-week consultation process was completed. The GPRs were revised in light of the comments received.
Recommendations
OPAT team and service structure
Formal OPAT programme
It is clear from the literature summarized in previous versions of the GPRs that OPAT is safe and effective when administered in the context of a formal OPAT service structure with clear clinical and managerial accountability.22 The more recent literature supports this point and emphasizes the importance of a team-based approach and clearly defined managerial, clinical and governance responsibilities.33–37 One retrospective cohort study involving 77 patients discharged with OPAT/COpAT through home health services over a 3-month period found that a dedicated OPAT programme, which incorporates multiple disciplines, could potentially reduce hospital readmissions and adverse events related to antimicrobial therapy.33 Another retrospective chart review compared 45 patients with Staphylococcus aureus bacteraemia enrolled in an OPAT programme to 106 patients who were not enrolled. Patients in the OPAT programme were more likely to attend ID follow-up appointments (56% versus 38%; P = 0.04), whilst emergency room visits and readmissions were more frequent amongst non-OPAT patients; however, these differences were not statistically significant (13% versus 4%; P = 0.11% and 11% versus 4%; P = 0.18, respectively).34
A retrospective quasi-experimental study compared OPAT-related admission and clinical cure rates before and after the implementation of a structured OPAT programme. Unplanned readmissions attributable to OPAT-related problems, including recurrence of infection, adverse drug reaction or adverse events associated with intravenous lines, were significantly lower (17.8% versus 7.0%; P = 0.003) post-implementation. The clinical cure rate was significantly higher following structured OPAT implementation (69.8% versus 94.9%).35 Similarly, the implementation of another structured OPAT programme demonstrated decreased unplanned 30- and 60-day OPAT-related readmission rates from 15.1% and 17.8% to 5.9% and 6.2%, respectively.36
The importance of a formal OPAT service structure was reiterated in a retrospective review of 50 OPAT episodes analysed using a Lean Six Sigma framework to identify process defects.38 The authors identified heterogeneity and inconsistency in OPAT delivery with an over-reliance on memory. Key learning points were the importance of clear documentation and of arranging timely follow-up of patients.
Additional evidence indicates that many OPAT services globally lack a formal service structure.19,21,39–41 A survey across European countries revealed that, out of the 28 participating nations, four (14.3%) did not have structured OPAT teams or infusion services. Instead, parenteral antimicrobial administration in non-inpatient settings was carried out through infusion services involving community-based health professionals (e.g. pharmacies, nurses and general practitioners) without centralized hospital oversight, or through ad hoc arrangements.19 Another survey looked at a broader range of countries worldwide (including the 28 European countries above) and found that 22% of respondents were unable to provide anti-infective therapies in non-inpatient settings. Only 42% of the hospitals with OPAT services had specialized OPAT teams. Practices are still very heterogeneous, with multiple barriers to OPAT, particularly in accessing reimbursement for implementing OPAT programmes.39
A 2018 survey of US ID physicians found that only 36% of the 507 respondents had a formal OPAT programme or service to monitor patients. Although this still reflects a minority, it marks an increase from the 26% of ID physicians who reported having a dedicated OPAT team in 2013.40
Whilst OPAT is distinct from NHS England’s virtual ward and H@H initiatives that utilize home care and remote monitoring technology,29 it closely aligns with the broader NHS strategy of decentralizing care, bringing services to patients’ homes and fostering an integrated, community-based approach to healthcare provision.41 Virtual ward care may involve the administration of IV antimicrobials, creating opportunities for collaboration with OPAT teams. Infection specialists and antimicrobial pharmacists within OPAT teams are essential to the virtual ward model, ensuring expert infection management and optimizing antimicrobial therapies within the AMS framework. Additionally, the infrastructure of virtual wards is well suited to offer enhanced monitoring and support for selected patient groups receiving OPAT.30
OPAT team composition
Several recent studies have reinforced the earlier GPR recommendations that a multi-disciplinary OPAT team should include, at a minimum, a medically qualified responsible clinician, an infection specialist (who may be the responsible clinician), a specialist nurse and an antimicrobial pharmacist.35,36,42–46 Infection consultation during OPAT was associated with significantly reduced odds of emergency department (ED) admissions (odds ratio: 0.449) and hospitalizations (OR: 0.661), along with significant cost savings.42 Another retrospective study compared 428 patients discharged on IV antimicrobials before and after implementation of a structured ID physician and nurse-led OPAT programme A significant reduction in unplanned OPAT-related hospital readmission rates (17.8% versus 7%; P = 0.003), and a marked improvement in clinical cure rates (69.8% versus 94.9%; P < 0.001), were observed, highlighting the importance of multi-disciplinary teams (MDTs).35
Further studies have concluded that Infection specialist involvement in OPAT improves care. One reported that care was optimized in 247/260 (95%) of OPAT episodes when an optional ID/AMS consult was requested.47 The most frequent interventions included managing transitions of care (n = 247), arranging additional testing (n = 141) or source control (n = 94), IV to oral switch (n = 50), management of adverse drug or line events (n = 46) and recognition of non-urgent medical problems (n = 33). Another study using remote ID physician review resulted in recommendations in 58% of evaluations.48 Nursing teams responsible for planning homecare services following hospital discharge were the biggest requestors of the service. An Australian prescribing survey of hospital in the home programmes found that 87% of prescriptions were appropriate; however, the survey identified cases of unnecessarily prolonged antimicrobial therapy, and also use of unnecessarily broad-spectrum agents. ID consultation resulted in significantly improved guideline compliance and antimicrobial appropriateness, compared with prescriptions without ID consultation.49
In the adult literature, several studies demonstrated positive clinical outcomes with nurse-led OPAT services,50–52 with a low risk of readmissions and significant cost savings. Furthermore, there are reports of specialist nurses running specific aspects of OPAT, for example, a self-administration service53 and a virtual vancomycin clinic.54 A nurse-led paediatric OPAT service managing children requiring short courses of IV antimicrobial therapy, under the supervision of a general paediatrician and with oversight by the paediatric ID and AMS teams, demonstrated improvement in IV antimicrobial management decisions. Ninety-six percent of decisions at 48 h were judged appropriate and 64% of children on IV antimicrobial agents were ambulated during their treatment course, compared with 75% of IV antimicrobial decisions and 19% ambulation rates prior to the introduction of the OPAT service.55
A survey of community nurses in France, however, identified multiple problems in delivery of OPAT, including logistic challenges, lack of knowledge about drug administration and challenges in maintaining prescribed dosing intervals for patients on multiple daily doses.56 The authors concluded that community nurses should be involved at an early stage in planning OPAT episodes, with access to training and equipment, and development of robust protocols and clear lines of communication.
A retrospective review of 399 OPAT patients demonstrated the value of antimicrobial pharmacists in OPAT. Two hundred and forty three patients, discharged to OPAT following a pharmacist consultation, were compared with a control group of 156 patients who did not have a pharmacist consultation prior to discharge. Patients discharged on vancomycin and managed within the programme had significantly lower 30-day readmission rates compared with the control group (19.4% versus 39.1%; P = 0.004), with associated reductions in cost. The study demonstrated the crucial role of antimicrobial pharmacists in the OPAT setting, particularly regarding guidance on therapeutic drug monitoring (TDM).43 A community hospital-based OPAT study in Thailand examined patient outcomes discharged before and after the creation of a pharmacist-led intervention. Over 14 months, 50 patients were enrolled in each group. The study found, between pre- and post-phases, a significant decrease in unfavourable outcomes (26% versus 6%; P = 0.006), a significant increase in the dose optimization of antimicrobial agents (78% versus 100%; P = 0.000) and greater laboratory monitoring (60% versus 100%, P = 0.000). Medical colleagues universally accepted the pharmacist intervention.44 A further study reported that of 137 OPAT prescriptions reviewed by a transition of care pharmacist prior to hospital discharge, 67 (49%) required an intervention, mainly relating to the dose or frequency of the antimicrobial agent.57 A paediatric single centre study highlighted the role of an AMS pharmacist in reviewing OPAT prescriptions, making recommendations in 68% prescriptions (93 prescriptions) over an 18-month period. Of note, 45% of patients had not been reviewed by an ID physician prior to discharge.58
These studies of pharmacy- and nurse-led OPAT interventions illustrate that OPAT roles may be shared across the OPAT team and that different OPAT services may adopt different staffing models depending on their context. However, it is critical that there is always medical infection specialist involvement in order to optimize AMS.30,59 This may involve developing guidelines, reviewing patients prior to acceptance and/or providing clinical support during OPAT.
Patients receiving OPAT should be under the care of a ‘responsible clinician’ who has overall responsibility for that patient’s care. In UK, this is usually a senior clinician based in secondary care, who may also provide infection expertise. However, in some European countries, primary care physicians may take this role.19 Two studies reported outcomes of ED-based paediatric OPAT services where patients were discharged directly from the ED and demonstrated low rates of OPAT failure; neither younger age (above 3 months) nor the presence of systemic features was independently associated with need for admission.60,61 The authors concluded that paediatric emergency-based OPAT is a safe and effective practice, with reduction in hospital admission for patients requiring short courses of antimicrobial therapy.
The previous GPRs identified as an evidence gap data on optimal OPAT staff-to-patient ratios.22 No new peer-reviewed data on staff-to-patient ratios were identified for OPAT specialist nurses or physicians. Rivera et al. conducted a survey of US pharmacists, reporting a median of 0.6 full-time equivalent (FTE) pharmacists managing a median of 43 active OPAT patients per day. They suggested a ratio of one OPAT pharmacist FTE for every 45–70 patients receiving OPAT.62
The ideal staff-to-patient ratio can vary based on patient case complexity, the OPAT setting, and the delivery model. In the absence of comprehensive studies on the required time commitment for OPAT team members, it is advisable for both new and existing OPAT services to assess their staffing needs and plan for any anticipated increase in patient volume and change in case mix.
OPAT and telemedicine
There are a limited number of studies on the use of telemedicine to support OPAT delivery (tele-OPAT). A systematic review, published in 2024, assessed the existing literature on the clinical efficacy, safety, acceptability and cost-effectiveness of tele-OPAT.63 The meta-analysis included 2572 OPAT patients, with over 1245 receiving telemedicine, and found tele-OPAT to be more cost-effective than conventional methods as well as being associated with high levels of patient satisfaction. The review also found a significantly lower risk of hospital readmission in patients who received tele-OPAT compared with those who received conventional OPAT methods (risk ratio, 0.58; P = 0.01). The clinical cure and complications rates were found to be comparable in both groups.
Huggins et al. conducted a retrospective study in which OPAT patients were enrolled in a post-discharge transitional care process that included repeat automated phone calls and notifications to the care transitions pharmacist or nurse regarding any concerns. A total of 148 patients were included, 61% (n = 90) of whom were successfully reached. Patients who were reached by the automated voice system were less likely to be readmitted than those not reached (18.9% versus 41.4%; relative risk, 0.46; 95% CI 0.27–0.77; P = 0.003).64
Although the adoption of telemedicine into OPAT has been somewhat slow and limited, it is likely to be used increasingly, particularly in the context of virtual wards and to support patients residing in remote and geographically isolated locations, such as those in rural communities, nursing homes and socioeconomically disadvantaged groups. OPAT services should look for local opportunities to integrate telemedicine into their services to support specific patient groups and to supplement current care delivery with appropriate plans for escalation and safety netting.
OPAT in new settings
OPAT self-administration in the patient’s home
Self-administration models in OPAT (S-OPAT), already widely established in many UK services, are gaining increasing interest, driven by patient autonomy, reduction in primary care district nursing provision and cost efficiency. Growing data suggest that S-OPAT is as safe and effective as health professional-administered OPAT.65,66 A retrospective UK study of 1084 completed patient episodes in 958 patients showed increasing S-OPAT activity from 39 episodes in 2014 to 265 in 2019. The proportion of patients or family members trained to self-administer increased from 25% to 75%. Clinical cure/infection improvement rates remained consistently high, ranging from 84.6% to 92.8%, and serious adverse events related to vascular access device remained low throughout (range 0%–3.15% patient episodes per year).53 Another study retrospectively compared 165 patients receiving healthcare-administered OPAT with 100 patients undertaking S-OPAT and found that modality of treatment had no impact on outcomes. OPAT failure was more likely in older, more co-morbid patients and they stressed the importance of careful patient selection in both groups.65
A large cohort of 2870 patient episodes in a 10-year review from a large London OPAT Service found 92% successful completion with an adverse drug event rate of 3.3/1000 days and 1.78/1000 days for line related adverse events. In this cohort, 252 patients self-administered antimicrobial therapy and their outcomes were similar to other groups: 233 (92.5%) had a successful outcome, compared with 96.3% of patients having clinic administration (total number = 362) and 90.1% of patients receiving treatment by community nurses (total number = 1165).67
A survey of patients in a USA clinic assessed risk factors for low adherence with OPAT treatment. Patients were discharged to OPAT with planned review at 2 weeks by an Infection specialist. Responses were received from 65 patients, of whom 18 patients were self-administering, 39 had antimicrobial therapy administered by family or friends, and six had nurse-administration. Overall, 90% of patients reported strict adherence to therapy, whilst 10% of patients reported missing one to two doses per week. Reduced adherence was associated with younger age, lower income and more frequent dosing; patients who had family members or friends administering their treatment were more likely to have good adherence.68 A UK study assessed cost-effectiveness of various OPAT delivery methods using a decision-analytic model.69 The ‘specialist nurse home visit’ model was the most cost-effective for short-term treatments, whilst the ‘self-administration’ model was more cost-effective for long-term care.
Overall, the published experience shows that S-OPAT is as safe and effective as nurse-administered OPAT and offers significant operational and financial benefits, particularly for patients on longer antimicrobial courses. However, clear communication, proper role delineation, and adequate training for patients and/or their caregivers are essential for ensuring safety and enhancing the quality of care.70,71 A structured educational toolkit for self-administered OPAT has the potential to address these challenges.72
OPAT in skilled nursing facilities/long-term care facilities
Increasingly, older and co-morbid patients are cared for in skilled nursing care facilities (SNFs) and long-term care facilities. Several studies from the USA highlight the increased potential for loss of follow-up at transitions of care, for example on transfer to a long-term care facility.73 This is relevant for OPAT services that are distinct from inpatient services and so less applicable to the current models of care for OPAT in the UK. However, it is important to consider potential weak points in the patient’s transition through the healthcare service as a whole and develop processes, particularly relating to communication, to ensure the best outcomes for these patients.74 The inclusion of a system that flags or tracks admission and transition into OPAT within the patient’s electronic medical record could enhance communication amongst various healthcare delivery units, supporting OPAT programmes in ensuring that care is safe and effective.75,76 A failure mode and effects analysis was used to identify barriers to the safe and effective completion of OPAT. One barrier identified was communication with SNFs, and one of the solutions proposed to overcome this was the creation of a pharmacist on-call pager system for SNFs.77
Expanded role of OPAT services
There is new evidence that other infection-related services are now being delivered within existing OPAT programmes. One study reported that a collaboration between an AMS programme and an OPAT unit in the USA enabled the rapid, safe, and effective administration of COVID-19 monoclonal antibody treatments for mild-to-moderate infections.78 It is anticipated that other infection-related services, such as long-acting injectable antiretroviral therapy79 and antimicrobial desensitization/allergy de-labelling programmes,80 will increasingly be provided within OPAT settings. Consequently, it is important for OPAT teams to develop local protocols and algorithms to deliver these additional services safely.
Evidence gaps
OPAT staffing ratios
Although the recent literature has provided support to most of the themes of the previous GPRs, there is a need for additional research in some areas. As noted above, more data are needed regarding the time commitment required for OPAT team members. Determining the optimal staffing ratios between patients and OPAT nurses, pharmacists and physicians is crucial, not only for ensuring high-quality care, patient safety and operational efficiency, but also for securing the funding needed to sustain an OPAT service.
Telemedicine
Tele-OPAT interventions are highly variable. It would seem important to assess which practices are best suited to different groups of patients and are most cost-effective, with a view of formalizing this practice in OPAT.
Paediatric OPAT (p-OPAT)
The p-OPAT literature is less extensive than the literature relating to adult patients. A review in 2018 concluded that there was a need for further data on effectiveness of different models of OPAT, parent-administered OPAT comprising the majority of episodes, on outcomes, using standardized outcome measures, and on parents’ and children’s views of OPAT.81 The more recent p-OPAT literature identified through this update of the GPRs remains limited.
OPAT bundles
Finally, the last GPRs presented evidence on OPAT ‘bundles’, that is, a defined sequence of actions required for effective management of a patient. No further papers on OPAT bundles were identified. However, two recent papers described the use of a standardized tool for undertaking multi-disciplinary case conferences (OPTIONS-DC) in the infection and addiction management of people who use drugs and found improved rates of antimicrobial course completion.82,83
Recommendations on OPAT team and service structure
Text highlighted in italics indicates a new/amended recommendation
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Patient selection
Identification of patients
Active case finding
The previous GPRs commented on the need to move from ‘passive’ to ‘active’ case finding of patients for OPAT. This could be done through OPAT team presence at multi-disciplinary meetings in relevant clinical areas, such as virtual ward or H@H services, diabetic foot service or orthopaedics; or through initiatives such as acute medicine liaison, bacteraemia reviews and AMS ward rounds. Awareness-raising activities targeting primary and secondary care teams, and the development of care pathways for specific infections, can enhance referrals for OPAT. However, no literature specifically relating to active case finding was identified in this literature review.
OPAT for patients with cellulitis
There were several papers describing clinical criteria for acceptance of adult patients presenting with cellulitis for OPAT.84–87 A prospective cohort study of patients presenting with limb cellulitis to the hospital reported that 52 of 100 eligible patients could be treated with OPAT. Those who remained in hospital were older, had more co-morbidities and a higher frequency of acute renal failure.85 A survey of 130 clinicians found that advancing age, failure of previous antimicrobial therapy and the presence of co-morbidities increased the likelihood of a decision to admit a patient with cellulitis.84 Another study found that 67/220 (30.5%) of all cellulitis referrals were declined for OPAT, with vulnerable adults accounting for the highest proportion (22.4%).88
A high proportion (39%) of patients given a diagnosis of cellulitis is misdiagnosed, with the majority having a non-infectious cause.86 In a retrospective study of 307 patients with cellulitis, 36 patients (11.7%) required a change to their treatment plan (either a change in antibiotics or readmission due to poor clinical response); increasing age, a high pain score and immunocompromise were associated with an increased likelihood of treatment amendment.87
A randomized non-controlled trial of 190 children presenting to the ED with moderate to severe cellulitis demonstrated lower rates of adverse events and equivalent rates of treatment failure when children were discharged from the ED on IV ceftriaxone (admission avoidance) versus being admitted for IV flucloxacillin.89 There were no major clinical differences between the two groups following randomization and the authors concluded that the standard of care for the IV treatment of uncomplicated cellulitis in children should be home or outpatient care when feasible.
There is also support for home-based therapy for children with moderate periorbital cellulitis: a prospective single-centre cohort study, incorporating a risk-stratification approach, demonstrated ambulatory care with IV antibiotics to be a safe and effective management strategy.90
Prediction models
The previous GPRs summarized the evidence on patient characteristics that may be useful in predicting a successful outcome for the individual undergoing OPAT. A number of more recent papers have attempted to develop uni-variate and multi-variate prediction models.74,91–97 Some of these were based on OPAT populations derived from USA hospital populations and as such may not be directly referable to the UK situation. Overall, 30-day readmission was 20%, and 36%–50% experienced any adverse event.74,95–97 Risk factors for an adverse event included current tobacco use95 and discharge to a subacute rehabilitation centre.74,97 One risk score identified that use of a midline catheter, using the catheter for chemotherapy, treatment for infections caused by Enterococcus sp. or fungi, or receiving vancomycin were predictive of a poor outcome.97 Another risk model, potentially of more relevance to UK OPAT programmes, suggested that age, Charleston co-morbidity index (CCI), prior hospitalization in the previous 12 months and endovascular infection predicted unplanned hospitalization.93,94 In another cohort study of 741 OPAT patients, 15.1% required readmission. The CCI score for those with unplanned readmission was 4.22 compared with 3.28 in those not readmitted, but this difference did not reach statistical significance.98
Overall, these studies conclude that risk assessment models may be useful although may require adaptation to meet local needs in order to provide most benefit.91
Ability to perform OPAT/hazards in the home
A significant selection criterion in eligibility for OPAT is that the patients are able to comply with the requirements of OPAT. A semi-structured patient questionnaire was designed to understand whether individuals would succeed with OPAT.99 The authors concluded that the questions were helpful in supporting the decision to accept a patient for OPAT. The same group found in a separate study that home hazards such as protection of IV lines whilst bathing, care of household pets, temperature extremes, household clutter, soil and food exposure and travel may all have a negative impact on delivery of OPAT.100
The use of social risk screening tools may be of use in optimizing plans for patients receiving COpAT. A paediatric study demonstrated its feasibility and provided examples of how care plans were altered to accommodate new social risk information, generating changes in antimicrobial use, provision of caregiver education and follow-up plans, including referral to social work services.101
Patient engagement in care
Recommendation 2.6 states that patients and carers should be fully informed about the nature of OPAT and should be given the opportunity to decline or accept this mode of therapy. An additional recommendation has been added which reinforces the importance of patient education about their antimicrobial therapy and, where appropriate, their intravenous access device. This new recommendation is based on two recent publications outlining new quality indicators for OPAT (see Outcome Monitoring and Clinical Governance section).
OPAT in specific groups
OPAT for persons who use or inject drugs (PWUD)
Historically, people who inject drugs have been excluded from OPAT programmes. However, there are many papers reporting that PWUD can be safely enrolled into OPAT programmes.102–112 Several studies conclude that OPAT completion rates and outcomes can be comparable between non-PWUD and PWUD.113–118 However, concerns over increased likelihood of non-adherence by PWUD may be well founded. An observational study of orthopaedic infections found significant variance in IV antibiotic therapy compliance between PWUD (61.5%) and non-PWUD (85.1%) (P = 0.0012).119 It would seem reasonable that recreational drug use should not be a definitive exclusion criterion and patients should be assessed on a case-by-case basis. The risk of non-adherence should be balanced with the risk of total disengagement from medical care.120,121
Several papers described views of healthcare workers on managing PWUD in OPAT programmes.122–125Reasons cited for reluctance to accept PWUD included: insufficient resources such as transportation, unstable living conditions and concerns over non-adherence; they worried that patients would not make wise decisions if they remained in the community; concerns were raised on how responsibility would be shared across healthcare practitioners; and that patients would tamper with their peripherally inserted central catheter (PICC). However, 71.9% of respondents in the larger survey reported that OPAT was offered to PWUD in their institution, reflecting an increasing view that it can be safe, feasible, effective and cost-saving when appropriate support is offered.123
Mid- to long-term venous access devices are generally avoided in people who inject drugs due to concerns over their potential for misuse.124 However, one retrospective cohort study showed that only 2.1% of 48 PWUD who had housing exhibited evidence of line tampering, as determined using tamper-evident line stickers, compared with 36% of 53 homeless PWUD.126 Another study demonstrated comparable catheter-related complication rates between patients with or without a history of intravenous drug use.116
Given concerns about potential line misuse, long-acting lipoglycopeptides are increasingly being used in PWUD to avoid the need for long-term venous access. Several papers describe retrospective cohort studies where dalbavancin was prescribed in PWUD for infections including acute skin and soft tissue, bloodstream, bone and joint infections and infective endocarditis.104,109 Further data are needed, however, to describe outcomes for off-label indications as some studies have reported variable cure rates.127,128 Management of PWUD via OPAT with dalbavancin will also require greater coordination of care and close liaison with other professionals outside of the core OPAT team, so it is important that such ‘hidden costs’ to optimize adherence and patient outcomes should be considered.129
One small retrospective study described use of oritavancin in PWUD to treat various gram-positive infections with mostly good outcomes.130
There is evidence that collaboration between OPAT and addiction services can improve outcomes amongst this patient population.82,83,102,103,105–107,112,120 In one study, a nine-point risk assessment tool was used to determine eligibility for OPAT: cravings, unstable home environment, dual psychiatric diagnosis, history of drug overdose, history of multiple relapses, polysubstance abuse, family history of addiction, history of trauma and limited willingness to change. A point score of three or less was deemed eligible for OPAT inclusion.102 Continuing care whilst on OPAT was through an ‘intravenous antibiotics and addiction team’ involving multi-disciplinary care. Another example of such collaborative working involved prescribing replacement opioids to patients who required long courses of IV antimicrobials to treat infections.105 In this pilot study, 20 eligible PWUD who required IV antimicrobial therapy for at least 14 days and who had accepted opioid therapy were randomized into receiving OPAT or usual care. Both arms had similar infection outcomes, whereas the OPAT group surprisingly had lower rates of measured illicit opioid use. A similar trial involved prospective enrolment into a ‘comprehensive care of drug addiction and infection’ programme, compared with historical controls. Thirty-five participants were enrolled and 16 completed the full OPAT programme.106 Eligibility included: mandatory ID consultation, being medically stable for discharge, having stable mental illness, being independent with activities of daily living, physical and cognitive ability to self-infuse antimicrobial therapy, tapering regimen if opioids were needed for pain. In another example, self-administered OPAT was deemed possible in 10 patients with substance use disorder when they were cared for by a MDT involving addiction and ID services.107 Eligibility criteria included mild-to-moderate addiction without drug use in past 3 months, no intravenous drug use, access to transportation, stable housing and caregiver support. An alternative model was to offer IV antimicrobial therapy at a residential facility providing addiction services.103 However, of 45 patients that were eligible, only seven patients enrolled and only three completed the course.
Successful IV antimicrobial treatment for this vulnerable group, therefore, reflects the need for integrated services with collaboration between OPAT, addiction treatment and others to appropriately identify, and then support, patients who are at lower risk for relapsing from the addiction perspective.
OPAT for the elderly
OPAT in the very elderly was evaluated in a number of studies.65,131–134 In a retrospective matched control study of 126 nonagenarians receiving OPAT over 5 years in Ohio, USA, the process was as safe for those over 90 years of age as it was for younger patients.133 There was no difference in OPAT-related visits to ED, readmissions for OPAT-related reasons, nor adverse drug reactions. Similar findings were observed in another cohort study of 420 OPAT patients (139 patients aged less than 65, 182 aged 65–79 and 99 patients aged greater than 80 years): those older than 80 years did not experience an increased number of OPAT-related readmissions compared with younger patients.134 Furthermore, the risk of adverse drug events was the same across the three age groups. Another retrospective matched cohort study found that age over 90 years was not associated with an increased risk of OPAT-related ED visits or OPAT-related readmissions during treatment.131 Some concerns associated with OPAT in patients of advancing age can be mitigated by daily nurse-administered OPAT, providing enhanced oversight and potential for earlier intervention.65 Collaborative care with local frailty services may also improve outcomes, although no data on this were identified.
Neonatal OPAT
Recent evidence suggests that OPAT is a safe and effective way of facilitating discharge from hospital of clinically stable neonates and young infants with invasive bacterial infections, including those with meningitis, bacteraemia and upper urinary tract infections.135,136 Data suggest that ceftriaxone is not associated with a bilirubin-displacing effect in term infants.137,138
Palliative OPAT
Palliative OPAT can be defined as the administration of lifelong IV antimicrobial therapy for incurable infections or for infections co-occurring with life-limiting terminal conditions. Two case series describe palliative OPAT.139,140 Two reviews summarized the issues involved in undertaking OPAT in this group.141,142 Whilst all of these studies suggested that it is possible to provide OPAT safely, all highlighted the impacts, including those on antimicrobial resistance and stewardship. Shared decision-making, defining goals of therapy and regular review of these are of particular importance in palliative OPAT as in antimicrobial therapy at end of life more generally.142
Thromboprophylaxis
The previous version of the GPRs included a recommendation that patients who have been assessed as being at risk of venous thromboembolism (VTE) as inpatients should be considered for further prophylaxis during OPAT if assessed as being at ongoing risk. Since then, a large systematic review and meta-analysis of VTE risk in OPAT has been published.143 This included 43 studies reporting on nearly 24 000 adult patients who had received parenteral antibiotics via OPAT. The pooled risk of non-catheter-related and catheter-related VTE was 0.2% and 1.1%, respectively. They concluded that the risk of VTE in OPAT is low and that the evidence does not support universal thromboprophylaxis. Furthermore, tools for risk assessment of VTE risk in hospital inpatients are not applicable to the OPAT setting. They suggested that high risk OPAT patients, for example those with recent orthopaedic surgery, could be considered for extended post-operative thromboprophylaxis.
Given these findings, the previous recommendation on thromboprophylaxis has been amended in this update. OPAT teams should consider the benefits and risks of thromboprophylaxis on an individual patient basis.
Evidence gaps
Hard to reach groups other than PWUD
As outlined above, there has been an expansion in the literature on OPAT in PWUD. However, the data on other hard to reach groups are less comprehensive, particularly alcohol addiction. It would be useful to have evidence on OPAT in this group, exploring selection criteria and outcomes. Furthermore, there are few data on people who are homeless, although some reports of use of long-acting lipoglycopeptides do include patients with difficult housing circumstances.127,129,130,144 Lower cure rates in PWUD and the homeless have been reported in a study that also reported evidence of line tampering in 13.2% of 45 patients who were both homeless and used drugs.126
OPAT referrals from primary care
Although an established function of many OPAT services, there were no papers in this timeframe describing selection of patients directly from primary care, that is, focusing specifically on admission avoidance for patients requiring IV antimicrobial therapy.
OPAT for patients on renal replacement therapy
Increasingly patients on renal replacement therapy, in particular haemodialysis, are receiving IV antibiotics through dialysis units and this should be recognized and managed as OPAT, particularly in terms of pharmacy and infection specialist input, monitoring during therapy and clinical governance. More evidence is needed on management of such patient cohorts within OPAT services, including on factors influencing outcomes.
Selection of patients suitable for COpAT
Increasing focus has been placed on the delivery of COpAT with oral antimicrobial agents. A summary of the available literature suggested that the same principles and best practice that apply to OPAT should also apply to COpAT.145 More high-quality research is required to determine which patients and infections can be appropriately treated with oral, rather than IV, antimicrobials.
Broader impact of OPAT assessment on patient outcomes
Infection specialist led assessment/vetting of referrals is recognized as an important function of an OPAT service. Limited published data suggest that a significant proportion of patients referred to OPAT services are not accepted for OPAT.47 There is a gap in published data evaluating the potential impact of OPAT assessment on patient management and outcomes for patients not accepted for OPAT. Publication of such data would be useful to complete the picture of the OPAT service and its role in a comprehensive AMS programme.
Recommendations on patient selection
Text highlighted in italics indicates a new/amended recommendation
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Antimicrobial management and drug delivery
Continuous antimicrobial infusions via elastomeric devices
A review of antimicrobial stability in elastomeric devices published in 2017 found no published studies complying with UK national standards for drug stability testing.146 As a result, an antimicrobial OPAT stability testing work stream was created within the BSAC OPAT initiative. BSAC drug stability testing studies are open-access and designed to allow OPAT services to use these agents where the clinical need exists.147 Since the 2019 OPAT GPRs, further papers have been published via this group offering guidance around continuous infusions of antimicrobials for OPAT,148–152 adding to two papers previously cited.153,154 All new agents were tested against a 5% degradation rate to the original compounds to meet UK national stability standards, thus allowing for either once or twice daily administration via elastomeric devices in OPAT. A further study involving fosfomycin, outside of UK testing, was undertaken as a continuous infusion.155 Other papers demonstrated real world evidence of using other antibiotics, including flucloxacillin,156,157 meropenem158 and ceftolazone/tazobactam.159 One study combined ampicillin with ceftriaxone in OPAT160; whilst ceftriaxone is known to be stable in elastomeric pumps, previous amoxicillin testing has proven unreliable. A further study cited administering ceftazidime/avibactam in OPAT together with performing TDM to gain assurances of therapeutic efficacy.161 Further papers reported real world experience with elastomeric devices in OPAT.162–166
It remains the position of the GPRs that adopting the UK limits with regard to stability standards should be the aspiration for any OPAT programme. However, it is acknowledged that in some jurisdictions up to 10% degradation is accepted and there may be a need for the UK to review national guidance. A debate has opened on this point, however; an international consensus, which considers the more favourable pharmacokinetic/dynamic factors associated with continuous infusion of antimicrobial agents, has not yet been agreed.
Numerous papers have examined aspects of drug stability in elastomeric devices, for example, efficacy and safety of continuous infusions,167–170 differing storage times and temperatures,171–173 potential under-dosing,174 pH differences and flow rate changes,175 together with whether TDM could be helpful in reducing stability concerns.176 A number of papers reviewed previously published data on ceftazidime degradation and pyridine toxicity177,178; benzyl penicillin and ampicillin,179 ,180 cefepime181 and meropenem.182 They re-examined if the degradation rate standards applied at the time were too stringent. In particular, there remains a question over which meropenem stability protocol should be used in clinical practice—one paper cites administration at lower temperatures as a possible option to increasing stability in elastomeric devices.182 In addition, separate comparisons have been made to stability studies that have been carried out in intensive care units,183 however, it was recognized that elastomeric pumps in these settings are not in contact with/near the body, and are changed daily/multiple times per day rather than being pre-made. In the p-OPAT literature, one paper explored paediatric antimicrobial stability for buffered benzyl penicillin and flucloxacillin.184
Bolus administration
Medications given as a 2- to 5-minute IV bolus may offer advantages over other administration methods, such as elastomerics. One study of OPAT self-administration (S-OPAT) retrospectively compared IV push administration of cefazolin, cefepime, ceftriaxone and daptomycin to traditional drip administration. The authors found that inpatient length of stay was reduced by one day, and that patient mastery of administration technique was quicker with the IV-bolus administration. Other outcomes, such as 30-day and 1-year readmission rates, rates of 30-day and 1-year ED visits, and mortality, were similar. Additionally, 96% of patients and nurses with experience in both administration methods would choose IV bolus in the future if they required IV antimicrobial therapy again.185
Vascular access
Several papers examined safety of PICC and midline catheters in the context of OPAT. Two papers186,187 looked at PICC line safety data. One of these was a retrospective case control study examining risk of catheter-related thrombus (CRT).187 Incidence of CRT ranged from 0.23 to 0.58 per 1000 PICC days and had a higher frequency, compared with matched controls, of malposition of the catheter tip and complicated catheter insertion. Ultrasound-guided insertion was found to reduce the risk of complications. Common complications also included occlusion and exit site infection, which had an incidence of 1.08 per 1000 PICC days and 0.32 per 1000 PICC days, respectively. One further recent paper examined PICC and midline catheters and concluded that the latter are safe alternatives to PICCs for OPAT, particularly if infusions were planned for 14 or fewer days.188 There is also evidence to suggest that midline catheters are an alternative to central venous access for children requiring relatively short courses of IV antimicrobials.189,190 A further paper presented evidence that PICC lines can be safely inserted under sedation in a significant proportion of children, rather than requiring insertion under general anaesthetic in theatre.191
One paper looked at the implementation of an adult vascular access team and found this had a positive impact on both patient safety and satisfaction, and was also cost-effective, with benefits at patient and institutional levels.192 Similarly, the paediatric literature supports close collaboration between the OPAT and vascular access teams within a hospital setting as an opportunity for enhanced AMS, in particular use of oral antimicrobial agents when appropriate.193
Complex outpatient antimicrobial therapy (COpAT)
Following publication of the POET and OVIVA trials, there is now established evidence that oral antimicrobials are appropriate for complex infections that were previously managed predominantly with intravenous agents.194,195 Highly bio-available oral agents should be considered as alternatives to traditional OPAT therapies when there is sufficient evidence to support safety over existing options without detriment to efficacy and when they continue to be managed using the same structures and follow-up inherent within established OPAT services.27,196,197 Additionally, by avoiding IV medications, patients may be spared intravenous line complications and adverse reactions such as nephrotoxicity.198
In neonates with early onset or late onset sepsis, there is recent evidence, including randomized controlled trial data, supporting the safety of IV to oral switch strategies.199,200 In older children, p-OPAT teams should encourage pill swallowing in children; in children unable to swallow tablets, the taste and tolerability of oral suspensions need to be considered when deciding upon an oral switch agent.201–203
The 2019 GPRs clearly identified the need for close monitoring and follow-up of OPAT patients, and highlighted the challenge for OPAT services of developing clear clinical pathways and individual management plans when complex oral regimens are being used.22
Antifungals
There is recognition that drugs previously considered higher risk have successfully been introduced into OPAT services.204 The previous GPRs included echinocandins as agents that may be increasingly used in future.22 Several papers considered the use of antifungals in OPAT, mainly focusing on the use of echinocandins and amphotericin.204–208 The key themes from these papers are that, firstly, patient selection is critical, impacting on treatment success and readmissions206,209; and secondly, antifungal OPAT is safe only when appropriately monitored as there are high rates of adverse events when compared with traditional OPAT.205–208 The development of the once-weekly echinocandin, rezafungin, lends itself well to OPAT administration.210,211
Subcutaneous
There is emerging evidence that subcutaneous antimicrobials can be safe and effective alternatives when the intravenous route proves challenging.212,213 The use of outpatient subcutaneous antimicrobial therapy (OSCAT) reduces the risk of catheter complications and creates an opportunity for patients with swallowing difficulties, poor venous access, and behavioural considerations to receive appropriate treatment without the need for hospital admission. OSCAT can be advantageous when very prolonged treatment is required, such as for treatment or suppression of prosthetic joint infections where other treatment options are contraindicated.212 Drug selection is a key determinant of success. Although the pharmacokinetics/pharmacodynamics of each agent can help predict suitability in this setting, other drug characteristics may increase risk of adverse events such as skin reactions.214,215 Antimicrobials with a long half-life, which are fully absorbed, and have good tolerability, are most likely to be successful when using this route. Safety, tolerability and pharmacokinetics of OSCAT agents are published215–218 but further research is required to evaluate clinical outcomes and to determine whether bespoke dosing regimens may be necessary to achieve their full benefit.
Long-acting glycopeptides
There has been a significant increase in data surrounding the use of long-acting semi-synthetic glycopeptides such as oritavancin, dalbavancin and telavancin for patients with gram-positive infections since the 2019 recommendations.130,219–226
These agents remain useful in patients who would not be suitable for traditional OPAT, including those at risk of non-compliance or line misuse (See Patient Selection section). The use of these agents for OPAT during the COVID-19 pandemic adds to the evidence of their efficacy and cost-effectiveness.219,222,223,225 They remain useful agents in harder to reach patients and in services with limited capacity and staffing.
There is also growing evidence for off-licence use of these agents for more deep-seated infections,130,219–222,224–226 including as suppressive therapy.221 However, where possible, good source control improves clinical outcomes.22 In p-OPAT, an observational study over 4 years found that use of dalbavancin was safe, feasible and effective in shortening hospital stay. Thirty-one children and adolescents with osteomyelitis and acute bacterial skin and skin structure infections were treated with dalbavancin with no treatment failures or adverse effects observed.227
OPAT teams will need to ensure local pathways are in place to determine appropriate clinical governance and follow-up, particularly when these agents are used off-licence.
Antimicrobial stewardship
The previous GPRs highlighted the importance of AMS in OPAT and more recent literature continues to stress this as a central theme of good clinical practice in OPAT.228 It is recognized that once daily agents with broader spectrum may be favoured in OPAT, allowing for easier at home administration and increased likelihood of regimen adherence. In one study, 46% of S-OPAT patients were discharged on ertapenem and/or daptomycin explicitly for their once daily administration schedule.229 Another study concluded that 50% of ceftriaxone S-OPAT prescriptions could have been rationalized, usually to penicillin.230 However, the use of IV benzyl penicillin over ceftriaxone in one study was estimated to incur an additional US$68 000 annually.231 More agents are being studied with novel dose/dosing regimens to facilitate OPAT. Thrice weekly teicoplanin, once daily and continuous tigecycline, and continuous infusion vancomycin are examples of emerging OPAT data.232–235 Outcome data relating to manipulating agents for less frequent dosing are needed for other agents.
In addition, recent evidence highlights the need to embed the principles of OPAT within paediatric H@H services.58 In one study, the introduction of AMS oversight by the OPAT team reduced the median duration of IV antimicrobial therapy for children being managed within a H@H service from 10.5 (5–18) to 8 days (4–15).236 A systematic review of interventions to reduce hospital and ED length of stay for paediatric patients found that OPAT resulted in reduced healthcare costs and length of stay. However, some studies reported increases in the total antimicrobial duration, highlighting the need to ensure that the convenience of OPAT does not compromise good AMS practice.237
First dose administration
The 2019 GPRs highlighted a lack of data on the safety of administering the first dose of an antimicrobial agent in the home setting. The Infectious Diseases Society of America OPAT guidelines17 recommend administering the first dose of an IV antimicrobial in a controlled or extended monitoring setting, admittedly only as a weak recommendation. Since then, one study reviewed 93 patients receiving 115 first dose infusions in their outpatient infusion centre.238 Six patients (5.2%) developed an immediate reaction—four on vancomycin, one on ertapenem and one on ceftriaxone. Reactions were itching and/or erythema in five cases, and nausea in one. All patients were able to continue receiving the antimicrobial for their course of therapy, suggesting that the practice of increased monitoring or utilizing a supervised setting for first dose infusions may not be necessary.
Evidence gaps
Vascular access
Vascular access is an integral part of an OPAT service for administering IV therapy safely in the community/outpatient setting. OPAT teams require a level of knowledge about vascular access devices to help manage patients on their caseloads. Currently, there is an evidence gap of vascular access data specifically related to OPAT services. Research papers currently mostly discuss vascular access as a general topic and their general uses rather than being specific to OPAT. Research looking at the types of devices suitable for the infusion methods of administration (for example, 24-h infusers) is required to help direct future recommendations and improve standardization of practice for OPAT services. Furthermore, there is a paucity of data on the longevity of midline catheters in children on OPAT.
Drug stability
One review paper highlighted that there is a need for harmonization of antimicrobial testing and proposed a global OPAT specific regulatory framework looking at areas of variation.32 The authors concluded that there is variation in antimicrobial stability testing guidance, particularly relating to temperature, and that there is a lack of regulatory guidance specifically within some global regions. The UK is currently the only country providing non-regulatory OPAT-specific advice on antimicrobial stability testing. OPAT drug stability is likely to be a topic of interest over the next couple of years particularly relating to fresh filled versus compounded devices and temperature regulation of these.
Recommendations on antimicrobial management and drug delivery
Text highlighted in italics indicates a new/amended recommendation
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*For example Royal Pharmaceutical Society, Royal College of Nursing, National Infusion and Vascular Access Society (NIVAS), etc.
Monitoring of the patient during OPAT
General considerations
Adverse drug reactions and drug–drug interactions pose an increasingly important challenge in healthcare worldwide, due to increasing complexity of therapies, involvement of multiple different clinical specialities and an increasingly aged and co-morbid population. One study found a 20% unplanned readmission rate in their retrospective cohort (n = 200), but over 50% were for ‘non-OPAT causes’, for example, deteriorating renal function in the context of chronic kidney disease.239
In OPAT specifically, monitoring of patients has been demonstrated as essential for early detection of adverse events. The 2019 GPRs22 emphasized the not insignificant risks associated with OPAT and the need for a formal service structure, incorporating processes for detecting and managing adverse events. This was echoed in more recent papers.240–245 Some papers examined timing of adverse events. In general, adverse events are most likely between 2 and 4 weeks after treatment initiation and the risk may continue to increase thereafter, depending on the nature of the patient cohort, antimicrobials and vascular devices used.246–248 The recent literature again emphasizes that OPAT patients should be seen soon after discharge from hospital and then reviewed regularly throughout their OPAT episode. This could be done face-to-face or through telemedicine.63
The p-OPAT literature highlights the importance of training parents to recognize potential complications prior to discharge as well as offering proactive support whilst the child is being managed within a p-OPAT service.249 A single-centre cohort study also demonstrated that longer duration of intravenous therapy was independently associated with increased OPAT-associated adverse events in children, highlighting the importance of converting to oral antimicrobial therapy as soon as feasible.250
Adverse events due to antimicrobial agents
Recent studies have highlighted the importance of awareness of, and monitoring for, specific drug- or class-specific adverse events. There was no significant difference in adverse events, including neutropenia, thrombocytopenia and elevated liver enzymes, in patients on standard (2 g/d) and high dose (4 g/d) ceftriaxone in one study.251 Other papers report haematological adverse events secondary to a range of beta-lactam antibiotics, with risk increasing with treatment duration.252–254 The paediatric literature suggests higher rates of adverse drug events associated with oxacillin compared with ceftriaxone.255
There have been multiple publications reporting daptomycin-induced eosinophilic pneumonia.256,257 Vancomycin has been reported to be associated with higher risk of adverse events.258–262 A retrospective review of vancomycin in OPAT found that adverse events increased steadily during the first 4 weeks of treatment: nephrotoxicity was the commonest adverse event, followed by neutropenia, rash and thrombocytopenia.248 This study highlighted the importance of avoiding other nephrotoxic drugs in patients receiving vancomycin. Another study found that patients on vancomycin or aminoglycosides were at highest risk of readmission from OPAT, yet only around half of these patients had adequate TDM.263 One group compared different methods of vancomycin TDM and found that pharmacist-led monitoring of area under the concentration/time curve resulted in reduced nephrotoxicity compared with traditional trough-based monitoring.264
There are limited data specific to TDM in p-OPAT; one study reported that TDM was used in less than a third of p-OPAT episodes where drug levels would be indicated (patients receiving aminoglycosides, linezolid, teicoplanin and voriconazole).265 They highlight the need for toxicity surveillance in addition to TDM to enhance patient safety and optimize treatment efficacy.
Adverse events due to vascular access lines and devices
Several papers described adverse events due to vascular access lines and infusion devices: vascular access complications are a common cause of ED attendances, most frequently for occlusion or dislodgement.246,266 Another study267 also reported that IV catheter-related adverse events were more frequent than adverse drug events, occurring overall at a rate of 5.7 per 1000 catheter days. Midline catheters inserted without radiological guidance had the highest rate of adverse events, and there was an association with self-administration, something that has not been reported in previous studies. They recommended regular and expert line care and limiting the duration of IV antimicrobial therapy as much as possible.
A retrospective cohort of 265 patients in a US setting268 found a high rate of vascular access complications (21.1%) with a particular risk factor for vascular access difficulties being obesity. Unlike previous data, adverse drug events (30.9%) outnumbered vascular access complications There were overall high rates of OPAT-related ED attendances (21.9%).
In a review of 100 randomly selected OPAT episodes using elastomeric devices (n = 98) or electronic infusion devices (n = 2), there were 45 occasions in 23 patients of incomplete emptying of an elastomeric device, equating to an incomplete infusion rate of 2.4 infusions per 100 treatment days.269 The clinical significance of this was unclear.
Laboratory test monitoring for patients on IV antimicrobial therapy
There is further evidence that patients on IV antimicrobials via OPAT need regular blood test monitoring within the structure of a formal OPAT service model. Absence of these increases the risk of adverse events and unplanned readmission.270
The previous GPRs recommended weekly blood test monitoring for patients on IV antimicrobials and there is general support for this in some more recent papers.246,251,263 However, there is new literature exploring whether it would be feasible to develop a more individualized approach to blood test monitoring. Several papers have advocated the use of clinical risk-stratification tools such as the CCI or Clinical Frailty Score to target enhanced monitoring to patients already on OPAT who could be at increased risk of adverse events.97,240,259 Another study concluded that patients with few co-morbidities (CCI < 5), who were on ceftriaxone alone and whose OPAT duration was 4 weeks or less could have laboratory monitoring less frequently than once a week.271 Similarly, a retrospective study looking at OPAT patients on cefazolin or ceftriaxone found an overall incidence of laboratory monitoring-detected clinically significant OPAT-related adverse events of 2.7 per 1000 sets of weekly blood tests.272 The authors calculated that 370 sets of weekly blood tests were required to detect one OPAT adverse event requiring a change in antimicrobial therapy. Adverse events occurred a median of 26 days after commencing therapy, suggesting that patients receiving these antibiotics may not need blood tests in the first 2–3 weeks of therapy.
A Dutch multi-centre study found high rates of laboratory test abnormalities in patients on OPAT; however, only 2% of these abnormalities led to OPAT discontinuation.273 The median time to first laboratory abnormality was 7 days, with hepatotoxicity being the most common abnormality in the initial days of OPAT. With longer treatment courses, nephrotoxicity became more frequent. They again advocated a more personalized approach to blood test monitoring in OPAT.
However, another study of adverse events in patients receiving ceftriaxone via OPAT reported that approximately one in five patients on ceftriaxone for over a week developed cytopenia, and around 10% liver function test abnormalities. The time to haematological abnormality was 7–17 days and 3–13.5 days for liver function test abnormalities. However, again, few patients had to discontinue therapy due to blood test abnormalities. The authors concluded that regular monitoring was required, their own practice being to undertake weekly blood tests.251
A further study examined the impact of serial monitoring of the erythrocyte sedimentation rate and C-reactive protein. These tests rarely influenced decision-making and the authors concluded that less frequent monitoring could reduce costs without impact on clinical care.274
Overall, these studies indicate that an individualized approach to frequency of blood test monitoring may be possible. However, given conflicting data and the lack of clear evidence for less frequent blood test monitoring for OPAT patients on IV antimicrobials, there is no change to the recommendation for at least weekly blood tests.
Laboratory test monitoring for patients on complex oral regimes or long-acting intravenous agents
Increasingly, OPAT services in the UK are delivering complex oral antimicrobial therapies, based on high profile studies such as those in patients with endocarditis194 or bone and joint infection.195 Oral antimicrobials offer the advantages of reduced costs, shorter hospital stays, avoidance of vascular access complications and improved patient experience. However, some oral antibacterial agents are associated with significant risk of adverse events, for example linezolid, fluoroquinolones and co-trimoxazole. Patients on oral therapy may receive less intensive monitoring, including blood tests: a small survey of US pharmacists involved in OPAT suggested that COpAT patients were more likely to have non-standard follow-up arrangements than OPAT patients on IV therapy.62 This raises concern about detection of adverse events and also about compliance. Indeed, in the POET endocarditis study, patients randomized to oral therapy who were discharged from hospital were reviewed in clinic two to three times per week, which is unlikely to be the case in routine clinical practice.194
There are limited research data on how frequently blood monitoring should be undertaken for oral antimicrobials. No papers on this were identified in this literature search, and similarly, no papers were identified that included data on monitoring regimens for patients on long-acting intravenous antibacterial/antifungal agents.
Evidence gaps
Protocols for monitoring patients on complex oral/subcutaneous/long-acting intravenous antimicrobial agents
As noted above, there is a need for data on the optimal monitoring strategies for complex oral antimicrobial courses within the OPAT service, and similarly evidence-based protocols for patients receiving subcutaneous and long-acting intravenous agents.
Elastomeric devices
Whilst there are some early data on safety and efficacy of elastomeric devices, more evidence is required, particularly on incomplete infusions and how to mitigate against this.
IT tools to support patient monitoring
Thirdly, there has been a rise in the use of telemedicine and virtual monitoring systems within H@H services, but data relating specifically to OPAT are limited.63 Telemedicine could be used for virtual reviews and for regular or real-time remote monitoring of vital signs. Other IT tools may be of value in supporting OPAT teams in monitoring their patients, for example by highlighting significant changes in blood tests or enabling more accurate TDM; however, data on these in practice are lacking. Finally, a review of machine learning/artificial intelligence models to predict adverse outcomes in OPAT summarizes preliminary studies in this area but concluded that more research is needed to develop valid and generalizable models.275
Recommendations on monitoring of the patient during OPAT
Text highlighted in italics indicates a new/amended recommendation
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Outcome monitoring and clinical governance
Outcome monitoring for quality, service development and research
It remains imperative that OPAT services monitor and benchmark themselves to ensure they are providing high quality, evidence-based care. Since the last OPAT GPRs, several other groups have developed their own recommendations in the form of quality indicators, which are either OPAT specific or contain areas relevant to OPAT practice.
A group in the Netherlands group used a literature review and modified Delphi method to produce 33 quality indicators organized into four domains: Organization, Initiation, Continuation and Outcome.276 Comparison to the 43 recommendations in the 2019 OPAT GPR shows a high degree of concordance. Twenty recommendations were identical between the two documents. Variance in the other indicators was principally around phrasing and specification of what would be considered standard practice in UK healthcare, but is not specified in the GPR.
A further set of quality indicators was developed by a French group assessing antibiotic use in the outpatient setting, again through a modified Delphi method.277 This generated 32 indicators, grouped into process, structure and outcome. OPAT specific recommendations were that ‘antibiotics should be prescribed according to documented guidance’, and ‘OPAT patients should be educated on their antibiotics, including dose, administration, sideeffects and natural history of disease’. This latter point is especially pertinent in light of increased scrutiny around consenting and monitoring patients for adverse outcomes around antimicrobials, for example the fluoroquinolones,278 and has led to a new recommendation in this GPR in the Patient Selection section. In addition to patient education on their antimicrobial therapy, it is also important to provide information on their vascular access device, including awareness of potential complications, particularly since vascular access complications account for a high proportion of ED attendances in patients receiving OPAT (see section on Monitoring of the Patient during Therapy).
There was little information from the literature review on novel tracking/data collection systems for recording outcomes. One study described the development of an automated registry within the patient’s electronic medical record, highlighting its value in collecting and displaying activity and outcome data.279 In another paper, respondents to a survey ranked items on a panel of outcome metrics by importance; they also reported barriers to outcome monitoring, including lack of IT infrastructure/support, lack of administrative support, staffing shortages and lack of funding.280
Equitable provision of care
Inequity of access to OPAT was the subject of a large, retrospective, cross-sectional study in Scotland.281 The study included 4944 individuals treated for 6295 episodes of cellulitis via OPAT. Inpatients from the most affluent SIMD (Scottish Index of Multiple Deprivation) quintile were more than twice as likely to have received an OPAT referral compared with those resident in the most deprived quintile (adjusted OR 2.08, 95% CI: 1.60–2.71, P < 0.0001). Women were almost a third less likely to receive an OPAT referral than men (adjusted OR 0.69, 95% CI: 0.58–0.82, P < 0.001).
OPAT services may inadvertently deliver medical care that is less accessible or available to some patient groups, resulting in inequity. In practice, patient access should be provided for all those who would benefit from a service, and OPAT teams should identify and address inequity. Parity between adults and children should also be ensured.
Standard outcome measures
No data were identified to inform a change in the UK OPAT GPRs standard outcome measures.22
Patient experience
There were a number of publications exploring patient experience and patient reported outcomes and feedback, with an emphasis on providing good, patient-centred care. Patient preference for OPAT continues to be high when compared with inpatient care.282 One group examined health-related quality of life (HRQoL) in 33 OPAT patients before, and 1–2 weeks after, discharge, using a standardized HRQoL tool.283 They found significant improvements in three of the four domains of the tool: emotional well-being, emotional role and social functioning. They noted that 82% of patients felt adequately involved in decision-making. 58%, 76% and 79%, respectively felt that they were adequately informed about potential side effects, the aims of their treatment course, and ‘red flags’ relating to their treatment.
However, a qualitative study through structured interviews with patients and staff, with a focus on the hospital to home transition, demonstrated that patients were insufficiently aware of the rationale for antibiotics, duration, potential for side effects and follow-up arrangements.284 The data suggest that hospitals and OPAT programmes should focus on patient education at the point of hospital discharge to ensure patient understanding of their treatment, to reduce risk of adverse outcomes. As noted previously, this has now been included as a UK GPR.
A Netherlands focus group study of 16 adult patients (11 male) explored patient views of ‘high-quality care’.285 Domains with the highest value were ‘Freedom’ and ‘Safety’, which could be specifically addressed and delivered through MDT working, patient-centred care, a responsible OPAT lead and good hygiene practice.
Similarly, semi-structured interviews with 28 patients found that patient feedback is not universally positive and can be coloured by the patient’s personal situation and material circumstances.286 Communication and service delivery that accommodate the diversity of the local population are key to improving perceptions of the service, and conversely, it is important to incorporate patients’ perspectives in service development activity.
One qualitative study used semi-structured interviews conducted with parents and young people to identify themes associated with improved p-OPAT experience. These included offering support relating to return to school/nursery, reducing disruptions to home-based routines including the timing of doses of antimicrobials, and enhancing preparation and information prior to discharge home.287
It is important that OPAT care is either evidence-based or, alternatively, evidence-generating and therefore the acceptability of OPAT research to patients is important to quantify. A survey of UK OPAT users assessed patient acceptance of research within OPAT and COpAT networks.288 They found high acceptability of research around issues such as IV to oral switch.
Evidence gaps
No significant evidence gaps around outcome monitoring were identified. The argument for OPAT services is principally around healthcare cost minimization, avoidance of hospital-associated harm and patient preference. There is a significant evidence base now around the economic advantages of OPAT and patient preference.289 A systematic review of randomized controlled trials comparing clinical outcomes for home versus inpatient therapy, however, found only six trials, which were graded as low or very low evidence.290
As highly bio-available oral antimicrobial therapy replaces IV therapy in conditions traditionally treated within OPAT services and as COpAT becomes more established, there needs to be consideration of how activity and outcome data are compared with ensure consistency. Data on ‘bed days saved’ may be a less useful outcome measure for patients on complex oral regimens.
Recommendations on outcome monitoring and clinical governance
Text highlighted in italics indicates a new/amended recommendation
|
Conclusions
Since the last update of the UK GPRs, OPAT activity in the UK and globally has continued to expand, with continuing dissemination of learning and best practice through the published literature. The original GPRs, published in 2012 (adults) and 2015 (paediatrics), were developed to provide a set of (where possible) evidence-based recommendations for OPAT services and over the course of two updates there have been limited changes to these initial recommendations, suggesting that they mostly covered the key issues when setting up and delivering OPAT. In this update, the core principles of OPAT development and delivery remain unchanged, despite the ever-increasing volume of publications relating to OPAT.
The healthcare climate has changed over the years since the first GPRs were published. There has been increasing focus on AMS and a recognition that OPAT has an important role in AMS and in mitigation of antimicrobial resistance, particularly through shortened or avoided hospital stays and expert-led infection management. The pattern of patients receiving OPAT has changed over the years, with a shift from high volume, low complexity patients, predominantly with skin and soft tissue infections, to increasingly co-morbid patients with more complex infections requiring prolonged antimicrobial courses. It has been recognized that OPAT can play a role in keeping patients with terminal illness or incurable infections as well as possible, and out of hospital, and in the 2019 GPRs the outcome measures for OPAT were altered to include these groups of patients. As well as directly supporting AMS activity, OPAT will increasingly be important to health services in supporting efficient patient flow, early discharge, admission avoidance and optimizing healthcare resource utilization.
There have been technological advances, for example new infusion devices, improved vascular devices and new antimicrobial agents, including oral agents with high bioavailability and the ability to penetrate well into tissues, and also long-acting intravenous agents, which improves access to OPAT for harder to reach patient groups. There is more evidence and experience of using antimicrobial agents in devices, in particular relating to stability of agents via prolonged infusion as well as emerging data on subcutaneous administration of antimicrobials.
One further change has been the increased focus on OPAT as ‘shared care’ with patients and their relatives. There is increasing evidence that self- or carer-administration is safe, and a greater focus on engaging patients in their treatment through education and information.
Despite these advances, there are still many evidence gaps, and the authors hope that the delineation of these in this document will encourage researchers across the world to respond and develop research studies or share experience to fill these gaps. In particular, we call for further research on p-OPAT, where there is a relative paucity of data compared with the adult literature.
Finally, it is important to be aware of the wider context in which OPAT services function. In the UK, specifically with the expansion of admission avoidance initiatives including ‘H@H’ and ‘Virtual Wards’, there is a need for OPAT services to engage and integrate. These developments offer opportunities to expand infection and AMS expertise across the virtual hospital interface, ensuring that the principles of good clinical governance and excellence in patient care are embedded in infection management wherever clinical care is being delivered.
Supplementary Material
Acknowledgements
We thank Dr Vittoria Lutje for conducting the literature searches. We also thank the BSAC secretariat for their help in coordinating the consultation process, and also colleagues who submitted responses. We acknowledge the contribution of authors of the previous versions of the UK adult and paediatric GPRs.
Contributor Information
Ann L Noble, Department of Infectious Diseases, University Hospital Monklands, NHS Lanarkshire, Lanarkshire, ML6 0JS, UK.
Sanjay Patel, Southampton Children’s Hospital, Southampton, UK.
Ellie Birnie, University Hospitals of Derby and Burton NHS Foundation Trust, UK.
Eileen Dorgan, Northern Health and Social Care Trust, Antrim, NI.
Oyewole C Durojaiye, Sheffield Teaching Hospitals NHS Foundation Trust/University Hospitals of Derby and Burton NHS Foundation Trust, UK.
Caroline Emilie, Service des Maladies Infectieuses et Tropicales, Metz, France.
Achyut Guleri, Mid Yorkshire Teaching Hospital NHS Trust, Wakefield, UK.
Helen Green, Southampton Children’s Hospital, Southampton, UK.
Sara Hedderwick, Craigavon Area Hospital, Portadown, NI, UK.
Lucy Hinds, Sheffield Children's Hospital NHS Foundation Trust, Sheffield, UK.
Monica V Mahoney, Beth Israel Deaconess Medical Center, Boston, USA.
Katie McIntyre, NHS Lothian, Edinburgh, UK.
Fekade B Sime, UQ Centre for Clinical Research, The University of Queensland, Brisbane, Australia.
Owen Seddon, Public Health Wales, Cardiff, UK.
Julie Statham, South Warwickshire University NHS Foundation Trust, Warwick, UK.
Marie Woodley, Buckinghamshire Healthcare NHS Trust, Aylesbury, UK.
Mark Gilchrist, Imperial College Healthcare NHS Trust/Imperial College London, London, UK.
R Andrew Seaton, Department of Infectious DIseases, NHS Greater Glasgow and Clyde, Glasgow, UK.
Funding
The OPAT GPRs were produced by a working group on behalf of the BSAC. BSAC provided administrative and logistic support for the working group’s activities but had no involvement in the content of the recommendations. There was no specific funding for this work.
Transparency declarations
E.D. has received honoraria and sponsorship for educational events from Tillotts. A.G. has received sponsorship for an educational event from Menarini. M.V.M. has received a consultancy fee from GSK. F.B.S. has received a research grant from Pfizer and a Fellowship from Gilead, Australia. M.G. and R.A.S. are co-leads of the BSAC OPAT initiative. R.A.S. is also President of BSAC. M.G. has received educational/consultancy grants from Advanz, Baxter, Eumedica, Menarini, Napp and Pfizer. R.A.S. has received fees for speaking/consultancy from Advanz, Infectopharm, Menarini, Napp, Pfizer and Shionogi. All other authors: none to declare.
Supplementary data
Table S1 is available as Supplementary data at JAC-AMR Online.
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