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National Guideline Centre (UK). Emergency and acute medical care in over 16s: service delivery and organisation. London: National Institute for Health and Care Excellence (NICE); 2018 Mar. (NICE Guideline, No. 94.)

Cover of Emergency and acute medical care in over 16s: service delivery and organisation

Emergency and acute medical care in over 16s: service delivery and organisation.

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Chapter 10Community-based pharmacists

10. Community-based pharmacists

10.1. Introduction

Pharmacists are highly trained medical professionals, qualified to give advice on health issues and medicines, and ensure the safe supply and use of medicines by the public. Medicines prevent, treat or manage many illnesses or conditions and are the most common intervention in healthcare.

The traditionally role of pharmacists in the community has involved dispensing and supply of prescriptions that have been issued by doctors. However in recent years the role and locations from which pharmacists in the community (primary care) work from has evolved and pharmacists have been undertaking more clinical roles in addition to the traditional dispensing services.

Overall it would be of interest to see if there is evidence to support the clinical and cost-effective development of services by community based pharmacists.

10.2. Review question: Do enhanced roles of pharmacists in the community have clinical and cost-effectiveness benefits for patients at risk of an acute medical emergency or have a suspected or confirmed acute medical emergency?

For full details see review protocol in Appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

10.3. Clinical evidence

Thirty seven studies were included in the review;5,6,8,17,27,29,30,39,53,53,54,63,79,9193,103,115,116,120123,129,130,135,141,146,151,162,172,173,176,182,188,189,191,192,198,199,201,202,205,207,227,229,230,232,233 these were split in 6 stratifications based on both type of pharmacist (community pharmacist or clinical pharmacist) and the location the intervention takes place. These stratifications are summarised in Table 2 to Table 7 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 8 to Table 13). See also the study selection flow chart in Appendix B, forest plots in Appendix C, study evidence tables in Appendix D, GRADE tables in Appendix F and excluded studies list in Appendix G.

Table 2. Summary of studies included in the review for the strata: community pharmacist based within a community pharmacy.

Table 2

Summary of studies included in the review for the strata: community pharmacist based within a community pharmacy.

Table 7. Summary of studies included in the review for the strata: clinical pharmacist based within a GP practice.

Table 7

Summary of studies included in the review for the strata: clinical pharmacist based within a GP practice.

Table 8. Clinical evidence summary: Community pharmacist based within a community pharmacy.

Table 8

Clinical evidence summary: Community pharmacist based within a community pharmacy.

Table 13. Clinical evidence summary: Clinical pharmacist based within a GP practice.

Table 13

Clinical evidence summary: Clinical pharmacist based within a GP practice.

Table 3. Summary of studies included in the review for the strata: community pharmacist at the patients’ homes.

Table 3

Summary of studies included in the review for the strata: community pharmacist at the patients’ homes.

Table 4. Summary of studies included in the review for the strata: community pharmacist based within a GP practice.

Table 4

Summary of studies included in the review for the strata: community pharmacist based within a GP practice.

Table 5. Summary of studies included in the review for the strata: clinical pharmacist based within a community clinic.

Table 5

Summary of studies included in the review for the strata: clinical pharmacist based within a community clinic.

Table 6. Summary of studies included in the review for the strata: clinical pharmacist at the patients’ homes.

Table 6

Summary of studies included in the review for the strata: clinical pharmacist at the patients’ homes.

Narrative findings

Ali 2012: adverse events (total hypoglycaemic and hyperglycaemic events) at 12 months was 5/23 in the intervention group and 28/23 in the control.

Respect trial team 2010: emergency admission episodes per month at 2 years was modelled with the intervention effect estimate (SE): 0.049 (0.290) and the time-intervention effect estimate (SE): −0.042 (0.038).

BC Community pharmacy study: emergency visits during baseline and month 12: intervention - baseline: 0.165, final: 0.043, change: −0.122; control - baseline: 0.377, final: 0.213, change: −0.164.

BC Community pharmacy study: medical visits during baseline and month 12: intervention - baseline: 1.328, final: 0.386, change: −0.942; control - baseline: 1.429, final: 1.730, change: 0.301.

BC Community pharmacy study: hospitalisations during baseline and month 12: intervention - baseline: 0.123, final: 0.078, change: −0.045; control - baseline: 0.143, final: 0.160, change: 0.017.

Gordois 2007 (Armour 200): total GP visits at 6 months: intervention 309/162; control 278/185.

Table 9. Clinical evidence summary: Community pharmacist at the patients’ homes.

Table 9

Clinical evidence summary: Community pharmacist at the patients’ homes.

Table 10. Clinical evidence summary: Community pharmacist based within a GP practice.

Table 10

Clinical evidence summary: Community pharmacist based within a GP practice.

Table 11. Clinical evidence summary: Clinical pharmacist based within a community clinic.

Table 11

Clinical evidence summary: Clinical pharmacist based within a community clinic.

Table 12. Clinical evidence summary: Clinical pharmacist at the patients’ homes.

Table 12

Clinical evidence summary: Clinical pharmacist at the patients’ homes.

10.4. Economic evidence

Published literature

Ten health economic studies were identified from eleven papers with the relevant comparison and have been included in this review.26,53,61,63,79,94,103,151,161,172,191,214 These are summarised for each stratum in the health economic evidence profiles below (Table 14 to Table 17) and the health economic evidence tables in Appendix E.

Table 14. Health economic evidence profile: enhanced-role community pharmacists at community pharmacy versus usual care.

Table 14

Health economic evidence profile: enhanced-role community pharmacists at community pharmacy versus usual care.

Table 17. Health economic evidence profile: enhanced-role clinical pharmacists at GP practice versus usual care.

Table 17

Health economic evidence profile: enhanced-role clinical pharmacists at GP practice versus usual care.

Twelve economic studies relating to this review question were identified but were excluded due to a combination of limited applicability and methodological limitations or the availability of more applicable evidence. These are listed in Appendix H, with reasons for exclusion given.

The economic article selection protocol and flow chart for the whole guideline can found in the guideline’s Appendix 41A and Appendix 41B.

Table 15. Health economic evidence profile: enhanced-role community pharmacists at home versus usual care.

Table 15

Health economic evidence profile: enhanced-role community pharmacists at home versus usual care.

Table 16. Health economic evidence profile: enhanced-role community pharmacists at GP practice versus usual care.

Table 16

Health economic evidence profile: enhanced-role community pharmacists at GP practice versus usual care.

10.5. Evidence statements

Clinical

Community pharmacist

Fourteen studies comprising 2413 participants evaluated the role of community pharmacists (community pharmacist’s strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that enhanced role of a community pharmacists may provide a benefit in reduced mortality (6 studies, very low quality), ED presentations (7 studies, low quality), mean ED presentations (1 study, low quality), GP visits (2 studies, very low quality) and hospital admissions (7 studies, very low quality) and mean number of hospitalisation (2 studies, moderate quality).

Three studies comprising 1254 participants evaluated the role of community pharmacists (patient’s home strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that home visits from a community pharmacist were associated with higher mortality (2 studies, low quality) and more hospital admissions (3 studies, low quality) but no effect on quality of life (2 studies, low quality).

Four studies comprising 3824 participants evaluated the role of community pharmacists (GP practice strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that the community pharmacist within a GP practice may provide a benefit in reduced hospital admissions (2 studies, very low quality). However, the evidence suggested there was no effect on survival (1 study, very low quality), ED presentations (1 study, very low quality), mean number of hospitalisations (1 study, high quality) and GP visits (1 study, high quality). The evidence suggested a possible increase in adverse events (1 study, very low quality) and mortality (3 studies, very low quality).

Clinical Pharmacist

Five studies comprising 2805 participants evaluated the role of clinical pharmacists (community clinics strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that clinical pharmacists provided a benefit in reduced mortality (4 studies, moderate quality), hospitalisations (1 study, moderate quality) and number of ED visits (2 studies, low quality). The evidence suggested there was no effect on the number of GP visits (2 studies, low quality) or mean number of hospitalisations (3 studies, low quality).

Four studies comprising 1765 participants evaluated the role of clinical pharmacists (patient’s home strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that home visits from a clinical pharmacist may provide a benefit in reduced hospital admission (3 studies; 2 report relative risk and 1 reports a hazard ratio, very low quality) and GP visits (1 study, very low quality). The evidence suggested that there was a possible increase in mortality (1 study, low quality) with clinical pharmacists.

Eight studies comprising 2581 participants evaluated the role of clinical pharmacists (GP practice strata) for improving outcomes in adults and young people at risk of an AME, or with a suspected or confirmed AME. The evidence suggested that adverse events (2 studies, very low quality) and hospital admissions (4 studies reporting a relative risk, very low quality) were reduced by use of a clinical pharmacist but no difference was seen for GP visits (2 studies, low quality) or hospitalisations (1 study reporting a mean and 1 study reporting a hazard ratio (high quality). There was a possible decrease in mortality from 5 studies when reported as risk ratio (very low quality), but no difference from 1 study which reported a hazard ratio (high quality). There was a possible decrease in ED visits from 1 study which reported a dichotomous outcome (low quality), but no difference from one study which reported a continuous outcome (high quality).

Economic

  • Two cost-utility analyses found that enhanced-role community pharmacists at community pharmacies dominated usual care by reducing costs and improving health outcomes. Both studies were assessed as being partially applicable with potentially serious limitations.
  • One cost-effectiveness analysis found that enhanced-role community pharmacists at community pharmacies dominated usual care by reducing costs and improving health outcomes. The study was assessed as being partially applicable with potentially serious limitations.
  • Three cost-utility analyses found that enhanced-role community pharmacists at community pharmacies were cost effective compared to usual care (ICERs: £7,350; £2,121 and £10,000 per QALY gained). Two of these studies were assessed as being partially applicable with potentially serious limitations; one of these studies was assessed as being directly applicable with minor limitations.
  • One cost-utility analysis found that an enhanced role community pharmacist at the patient’s home was not cost effective (£54,454 per QALY) compared with usual care. The study was assessed as being partially applicable with potentially serious limitations.
  • One cost-utility analysis found that usual care was cost effective compared with community pharmacist at the patient’s home (£16,157 per QALY). The study was assessed as being partially applicable with potentially serious limitations.
  • One cost-effectiveness analysis found that enhanced-role community pharmacists at the GP surgery dominated usual care by reducing costs and improving health outcomes. The study was assessed as being partially applicable with potentially serious limitations.
  • One cost-utility analysis found that an enhanced-role clinical pharmacist at the GP surgery was cost effective compared to usual care (ICER: £5,567 per QALY gained). This study was assessed as being partially applicable with potentially serious limitations.

10.6. Recommendations and link to evidence

Recommendations
4.

For people who are at increased risk of developing a medical emergency:

  • provide advanced community pharmacy-based services
  • consider providing advanced pharmacist services in general practices

5.

For people at risk of an acute medical emergency, do not commission pharmacists to conduct medication reviews in the home unless needed for logistical or clinical reasons.

Research recommendations -
Relative values of different outcomes

Mortality, avoidable adverse events, quality of life, patient and/or carer satisfaction, number of ED presentations and unplanned GP attendances were considered by the guideline committee to be critical outcomes.

Hospital admissions were considered important outcomes.

Trade-off between benefits and harms

The review was separated into 6 strata split by both the provider of the intervention, either a community or clinical pharmacist, and the location. The locations of the intervention for the community pharmacist were at a community pharmacy, within the patient’s home, or within a GP practice. The locations of the intervention for the clinical pharmacist were at a community clinic, within the patient’s home, or within a GP practice. ‘Community clinic’ in this context refers to a service for patients with specific chronic conditions such as pulmonary disease or diabetes.

Thirty seven studies from 56 papers were included overall. The majority of these contain some type of medication review and patient education intervention, though there was significant heterogeneity in the individual elements across the identified evidence. The majority of studies either recruited patients who had a specific long-term condition requiring medications, or a heterogeneous population taking varied medications. Several of the latter studies restricted the population to the elderly.

Community pharmacist:

Twenty one randomised controlled trials were included within the community pharmacist strata overall:

Community pharmacist based within a community pharmacy

Fourteen randomised controlled trials were included for the community pharmacy stratum with the evidence suggesting a benefit for enhanced roles for community pharmacists in reduced mortality, ED presentations, GP visits and hospital admissions. No evidence was identified for quality of life, GP attendances or patient and/or carer satisfaction.

Community pharmacist at the patients’ homes

Three randomised controlled trials were included for the ‘at patient’s home’ stratum. The evidence suggested that home visits from a community pharmacist were associated with higher mortality and more hospital admissions but no effect on quality of life.

Community pharmacist based within a GP practice

Four randomised controlled trials were included for the ‘within a GP practice’ stratum. The evidence suggested that the community pharmacist within a GP practice may provide a benefit in reduced hospital admissions. However, the evidence suggested there was no effect on survival, ED presentations, mean number of hospitalisations and GP visits. The evidence suggested a possible increase in adverse events and mortality. No evidence was identified for ‘quality of life or patient and/or carer satisfaction.

Clinical Pharmacist

Seventeen randomised controlled trials were included within the clinical pharmacist strata overall:

Clinical pharmacist based within a community clinic

Five randomised controlled trials were included for the ‘within a community clinic’ stratum. The evidence suggested that clinical pharmacists provided a benefit in reduced mortality, hospitalisations and number of ED visits. The evidence suggested there was no effect on the number of GP visits or hospitalisations (reported as a mean). No evidence was identified for avoidable adverse events, quality of life, or patient and/or carer satisfaction.

Clinical pharmacist at the patients’ homes

Four randomised controlled trials were included for the ‘at patient’s home’ stratum. The evidence suggested that home visits from a clinical pharmacist may provide a benefit in reduced hospital admission and GP visits. The evidence suggested a possible increase in mortality with clinical pharmacists. No evidence was identified for avoidable adverse events, ED visits, or patient and/or carer satisfaction.

Clinical pharmacist based within a GP practice

Eight randomised controlled trials were included for within a GP practice stratum. The evidence suggested that adverse events (serious adverse events) and hospital admissions (reported as a relative risk) were reduced by use of a clinical pharmacist but no difference was seen for GP visits or hospitalisations (reported as a mean and a hazard ratio). The outcomes were reported using different methods in the evidence. There was a possible decrease in mortality from 5 studies when reported as risk ratio, but no difference from 1 study which reported a hazard ratio. There was a possible decrease in ED visits from 1 study which reported a dichotomous outcome, but no difference from 1 study which reported a continuous outcome. No evidence was identified for quality of life or patient and/or carer satisfaction. The committee discussed this apparent inconsistency when making their recommendation, and noted that the higher quality evidence consistently showed no difference from using a clinical pharmacist in a GP practice.

Overall

The committee discussed the evidence and felt that given the body of evidence and consistency in benefit, a strong recommendation could be made for the enhanced use of community and clinical pharmacists with interventions based within the community pharmacy. The committee agreed that the evidence was generalisable to recommend for all people at increased risk of developing a medical emergency.

Overall, there was evidence of effectiveness to consider introducing an advanced role for pharmacists within GP practices, however, without direct comparisons the committee were unable to make a judgement on the exact role or skills required when commissioning these services. The committee noted that there is a 3-year pilot study for clinical pharmacists in GP practice that has just started (The General Practice Forward View).152

The committee discussed the evidence concerning pharmacists travelling and performing an intervention within a patient’s home. They deemed that the evidence was weak, and often showed that these visits were detrimental compared to usual care (most often the usual service from a GP); even when clinical pharmacists were involved. They judged that a negative recommendation for the commissioning of services that take place at patients’ homes would be most appropriate at this time.

Trade-off between net effects and costs

Ten economic evaluations were included in this review, of which 6 were in the stratum of community pharmacists based in community pharmacies, 1 was a community pharmacist in a general practice, 1 was a clinical pharmacist in a general practice and 2 were for community pharmacists at the patient’s home.

Community pharmacists

For the community pharmacist interventions provided at a community pharmacy, the net costs ranged from cost saving to an increase in cost of £278 per patient. All the interventions showed a health benefit, which for all of the studies that showed an increase in costs was measured in QALYs, so cost effectiveness could be assessed. The ICERs went up to £10,000 per QALY and therefore this intervention was shown to be cost effective. Various sensitivity analyses showed that these results were robust to changes.

The committee discussed the economic evidence and agreed that there is strong economic evidence to support the cost effectiveness of enhanced role community pharmacists’ interventions at community pharmacies. The interventions described in the studies covered conducting medicines’ use reviews and providing support for those starting on newly prescribed medicines. These interventions reflected the advanced services currently provided at community pharmacists in England, which have been established for some time and the accumulated evidence strongly support the continuation of their provision. Thus, the committee felt that enhancing the role of community pharmacists to allow the expansion in the provision of these services represents good value for money by improving health outcomes while being either cost saving or cost effective; with ICERs well below the cost effectiveness threshold.

While all studies showed evidence of cost effectiveness, the ones in the UK (and in particular, the one study that was assessed as directly applicable and only minor limitations) indicated an increase in costs overall from this intervention.

Pharmacists at GP practices

For community pharmacist interventions at GP practices, 1 Canadian study showed that the intervention was dominant, as it led to saving of £102 per patient and improved health outcomes. However, the outcome was not measured in QALYs.

For clinical pharmacist interventions at GP practices, 1 UK study showed the intervention was cost effective with an ICER of £5,567 per QALY gained. When the intervention was delivered by a prescribing pharmacist, the ICER increased to £11,304 per QALY gained. No evidence was found for clinical pharmacist interventions at any other community-based setting.

The evidence for clinical pharmacists’ interventions was either positive or neutral in terms of health outcomes and has been shown to be cost effective. The committee noted that although there were no differences between prescribing and non-prescribing pharmacists based on the clinical evidence, 1 UK economic evaluation showed that prescribing pharmacists were not considered cost effective compared to non-prescribing pharmacists. The committee discussed this particular finding in detail and concluded that this could be due to the cost of the prescribing qualification, which would possibly require longer follow-up to be offset by improvement in outcomes. The committee also noted that both the interventions delivered by prescribing and non-prescribing pharmacists were still cost effective when compared to usual GP-delivered care, so did not believe that prescriber status should be specified in the recommendation. Overall, the committee felt that clinical pharmacist interventions provided at GP practices were at least as effective as usual care and could potentially have an additional positive impact on GPs’ workload by freeing up their time to focus on the more complex patients. The evidence from the clinical pharmacist role at community clinics, though not directly applicable to the UK setting, could also be extrapolated to the role at a GP practice. The committee was aware of the recently published GP Forward View, from NHS England, which supported this conclusion.152 The report outlined plans to provide an additional 1500 clinical pharmacists to join the GP practice workforce by 2020, acknowledging their role in the GP practice workforce and their expected positive impact on GPs’ workload.

For community pharmacists’ interventions at GP practices, the evidence of health benefit was weaker, with some outcomes showing harm (adverse events and mortality). However, the committee noted that this was based on low quality evidence, and could be interpreted as indicating that community pharmacists would need more training, in terms of their clinical skills (for example, physical examination and history taking), and more time to integrate into the GP practice team in order to realise the benefit of their adoption of practice-based roles. The committee was aware of current initiatives by NHS England supporting extended roles for pharmacists, including the introduction of the Pharmacy Integration Fund. This includes the recent creation of a new role of a “Practice Pharmacist”, by which pharmacists from any practice background (hospital, community or primary care) could work at GP practices as long as they have the necessary skills and competencies. The committee also noted that, given the favourable economic evidence, the initial investment to enhance the skills of pharmacists to undertake these practice-based roles would show positive returns in the long term.

Home setting

For the community pharmacist interventions at the patient’s home, 2 UK studies had contradictory results in terms of costs and health outcomes but had the same conclusion regarding cost effectiveness. One study showed that the intervention was cost saving (saving £307 per patient) but led to reduction in quality of life (loss of 0.019 QALYs), despite increasing adherence by 10%. The ICER for usual care in this study was calculated to be £16,157 per QALY gained, indicating that the pharmacist intervention was not cost effective compared to usual care. The second study showed that the pharmacist intervention increased cost (£407 per patient) and had a relatively small increase in QALYs of 0.0075, which meant it was not cost effective with an ICER of £54,454 per QALY.

The evidence of health benefit was contradictory and the economic evidence showed that these interventions were not cost effective. There was no economic evidence relating to the clinical pharmacist interventions at patients’ homes. Hence, the committee felt that these interventions should not be provided. The committee noted that the evidence, however, was primarily focused on visits to the patients’ homes and may not apply to pharmacists’ interventions at residential and care homes, the evidence for which was not specifically reviewed in this question. The committee was aware of on-going research in this area.

Quality of the evidence

Community pharmacist

For the community pharmacy stratum the evidence was graded at low or very low due to a combination of risk of bias and imprecision. Three out of 4 outcomes containing a pooled estimate were further downgraded for inconsistency. These were the outcomes mortality, hospital admissions and GP visits.

For the ‘at home’ stratum the majority of evidence was of moderate quality due to risk of bias, with the outcome mortality further downgraded for imprecision.

For the ‘within a GP practice’ stratum the evidence was either very low or high quality, with evidence downgraded for a combination of risk of bias and imprecision.

All economic studies of community pharmacists were assessed as partially applicable with potentially serious limitations.

Clinical pharmacist

For the clinical pharmacist in a community clinic stratum the evidence was graded at moderate or low due to risk of bias and/or imprecision.

For the clinical pharmacist at patients home stratum the evidence was graded at low or very low due to a combination of risk of bias and imprecision.

For the clinical pharmacist ‘within a GP practice’ stratum the majority of evidence was either very low or high quality, with evidence downgraded for a combination of risk of bias and imprecision. The outcomes mortality and hospital admissions were further downgraded for inconsistency.

The committee assessed the applicability of evidence to the UK practice. In particular, they noted that the evidence supporting the use of clinical pharmacists working within a community clinic, such as a stand-alone haemodialysis clinic, would not be applicable to UK. Therefore, they judged that a recommendation in this area would not be appropriate. All economic studies of clinical pharmacists were assessed as partially applicable with potentially serious limitations.

Other considerations

Advanced community pharmacy based services are services such as the Medicines Use Reviews (MUR) and the New Medicines Service (NMS) as defined in the NHS Community Pharmacy Contractual Framework.

Advanced pharmacist services in general practice are services such as level 3 clinical medication reviews where the pharmacist reviews the patient, illness and drug treatment during a consultation with access to patient notes, prescribing history, access to laboratory tests and with the patient present.190

The committee noted that there is no clear distinction between a clinical pharmacist and a community pharmacist. Historically a community pharmacist has been based within a community pharmacy and a clinical pharmacist within a hospital ward; however, recently the distinction has become more blurred. The committee noted that within the studies identified, a community-based clinical pharmacist, particularly outside a GP practice, was more established in North America. The committee noted that in the future it is likely that these 2 roles are likely to diverge, even when located within the same setting, with the expectation that community pharmacists will concentrate on medication adherence and/or patient education and therefore supporting the role of the GP, whereas clinical pharmacists will have a greater clinical involvement with patients, therefore replacing the involvement of GPs in some situations.

The committee noted that pharmacists should not be functioning in isolation and should be supported by other healthcare staff as appropriate, for example, the GP, hospital consultant or district/community nurse. In particular the committee judged that it would be more appropriate for a multi-disciplinary team led by other healthcare professionals, such as a district nurse, to be making home visits to patients, rather than a pharmacist but they could be supported by the pharmacist if needed.

The committee noted that this review did not specifically look at care homes so this would not be included within the pharmacists ‘at home’ recommendation. The NICE guideline: Managing medicines in care homes (2014)148 provides advice for this population group.

The committee noted that the recommendations will be impacted by the General Practice Forward View published April 2016.152 This report recommends an additional 1500 clinical pharmacists to be based within GP practices by 2020/21. This includes the current investment of £31 million to pilot 470 clinical pharmacists in over 700 practices, and is to be supplemented by a new central investment of £112 million to extend the programme for all practices not in the initial pilot.

This is to be further supplemented with an additional pharmacy integration fund153 to enable all pharmacists to provide more direct care to patients by expanding the range of clinical services they offer and integrating them into local care models outlined in the Five Year Forward View. The fund, worth £20 million in 2016 rising to a total of £300 million by 2020-21, is intended to help pharmacists and their teams to be fully incorporated across NHS planning and service delivery.

In addition, the DH launched a package of reforms in October 2016 to modernise community pharmacy services.60

There is an ongoing National Urgent Medicines Supply Advanced Service pilot for community pharmacy that runs from 1st December 2016 to 31st March 2018. At the end of the pilot an evaluation will be conducted by NHS England to test and evaluate the service in order to inform possible future commissioning.

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Appendices

Appendix A. Review protocol

Table 18Review protocol: Do enhanced roles of pharmacists in the community have clinical and cost-effectiveness benefits for patients at risk of an acute medical emergency or have a suspected or confirmed acute medical emergency?

Review questionCommunity pharmacist
Guideline condition and its definitionAcute Medical Emergencies. Definition: people with suspected or confirmed acute medical emergencies or at risk of an acute medical emergency.
Review populationAdults or young people (>16 years of age) who are at risk of, or have a suspected or confirmed AME.
Adults and young people (16 years and over).
Line of therapy not an inclusion criterion.

Interventions and comparators: generic/class; specific/drug

(All interventions will be compared with each other, unless otherwise stated)

Community pharmacists with enhanced roles in disease management; delivered at community clinics.

Community pharmacists with enhanced roles in disease management; delivered at general practices.

Community pharmacists with enhanced roles in disease management; delivered at patient’s home.

Community pharmacists with enhanced roles in disease management; delivered at community pharmacy.

Community pharmacists with enhanced roles in disease management; intervention delivered at other community-based location.

Clinical pharmacists with enhanced roles in disease management; delivered at community clinics.

Clinical pharmacists with enhanced roles in disease management; delivered at general practices.

Clinical pharmacists with enhanced roles in disease management; Delivered at patient’s home.

Clinical pharmacists with enhanced roles in disease management; delivered at community pharmacy.

Clinical pharmacists with enhanced roles in disease management; intervention delivered at other community-based location.

Usual care.

Outcomes
-

Mortality within the study period (Dichotomous) CRITICAL

-

Avoidable adverse events (incorrect diagnosis and treatment) within the study period (Dichotomous) CRITICAL

-

Quality of life within the study period (Continuous) CRITICAL

-

Number of ED presentations within the study period (Dichotomous) CRITICAL

-

GP attendances within the study period (Dichotomous) CRITICAL

-

Hospital admissions within the study period (Dichotomous) IMPORTANT

-

Patient and/or carer satisfaction within the study period (Continuous) IMPORTANT

Review strategySystematic reviews (SRs) of RCTs, RCTs, observational studies only to be included if no relevant SRs or RCTs are identified.
Unit of randomisation

Patient.

Pharmacist/Physician.

Practice.

Crossover studyPermitted.
Minimum duration of studyNot defined.
Other stratificationsType of pharmacist - clinical pharmacist, community pharmacist; location of the intervention.
Sensitivity/other analysis

Frail elderly.

UK versus non-UK.

Pre-specified study subgroups.

Subgroup analyses if there is heterogeneity
-

Frail elderly (frail elderly; non-frail elderly); population differs.

-

UK versus non-UK (UK; non-UK); different practice.

-

Pre-specified study subgroups (pre-specified by study1; pre-specified by study 2); may be important.

-

Prescribing power (prescribing; non-prescribing); pharmacists who can prescribe may be more effective at community-based interventions.

Search criteria

Databases: Medline, Embase, the Cochrane Library.

Date limits for search: 1990.

Language: English.

Appendix B. Clinical study selection

Figure 1. Flow chart of clinical study selection for the review of Community-based pharmacists.

Figure 1Flow chart of clinical study selection for the review of Community-based pharmacists

Appendix C. Forest plots

C.1. Community pharmacist based within a community pharmacy

Figure 2. Mortality.

Figure 2Mortality

Figure 3. ED presentations.

Figure 3ED presentations

Figure 4. ED presentations.

Figure 4ED presentations

Figure 5. Hospital admissions.

Figure 5Hospital admissions

Figure 6. Hospital admissions.

Figure 6Hospital admissions

Figure 7. GP visits.

Figure 7GP visits

C.2. Community pharmacist at the patients’ homes

Figure 8. Mortality.

Figure 8Mortality

Figure 9. Hospital admissions.

Figure 9Hospital admissions

Figure 11. Quality of Life (EQ-5D).

Figure 11Quality of Life (EQ-5D)

Figure 12. Quality of Life (EQ-VAS).

Figure 12Quality of Life (EQ-VAS)

C.3. Community pharmacist based within a GP practice

Figure 10. Mortality.

Figure 10Mortality

Figure 11. Survival.

Figure 11Survival

Adjusted for number of diseases.

Figure 12. ED presentations.

Figure 12ED presentations

Figure 13. ED presentations.

Figure 13ED presentations

Figure 14. Hospital admissions.

Figure 14Hospital admissions

Figure 15. Hospital admissions.

Figure 15Hospital admissions

Figure 16. Hospital admissions.

Figure 16Hospital admissions

Figure 17. GP visits.

Figure 17GP visits

Figure 18. Adverse events.

Figure 18Adverse events

C.4. Clinical pharmacist based within a community clinic

Figure 19. Mortality.

Figure 19Mortality

Figure 20. ED presentations.

Figure 20ED presentations

Figure 21. Hospital admissions.

Figure 21Hospital admissions

Figure 22. GP visits.

Figure 22GP visits

Figure 23. Total hospitalisations.

Figure 23Total hospitalisations

C.5. Clinical pharmacist at the patients’ homes

Figure 24. Mortality.

Figure 24Mortality

Figure 25. Hospital admission.

Figure 25Hospital admission

Adjusted for CMS risk score for hospitalisation, patient age, total number of medication, ability to use a telephone, and detection of medication-related problems during initial in-home assessment

Figure 26. Hospital admission.

Figure 26Hospital admission

Figure 27. GP visits.

Figure 27GP visits

C.6. Clinical pharmacist based within a GP practice

Figure 28. Mortality.

Figure 28Mortality

Figure 29. Mortality.

Figure 29Mortality

Adjusted for age, creatinine, grade of left ventricular systolic dysfunction, atrial fibrillation, respiratory disease, total number of medical treatments, and diuretic use.

Figure 30. ED presentations.

Figure 30ED presentations

Figure 31. ED presentations.

Figure 31ED presentations

Figure 32. Hospital admissions.

Figure 32Hospital admissions

Figure 33. Hospital admissions.

Figure 33Hospital admissions

Figure 34. Hospital admissions.

Figure 34Hospital admissions

Adjusted for age, creatinine, grade of left ventricular systolic dysfunction, atrial fibrillation, respiratory disease, total number of medical treatments, and diuretic use.

Figure 35. Adverse events.

Figure 35Adverse events

Figure 36. GP visits.

Figure 36GP visits

Appendix D. Clinical evidence tables

Download PDF (1.4M)

Appendix E. Health economic evidence tables

E.1. Community pharmacists based within a community pharmacy

Download PDF (732K)

E.2. Community pharmacist at the patient’s home

Download PDF (608K)

E.3. Community pharmacist based within a GP practice

Download PDF (495K)

E.4. Clinical pharmacist based within a GP practice

Download PDF (481K)

Appendix F. GRADE tables

Table 19Clinical evidence profile: Community pharmacist based within a community pharmacy

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCommunity pharmacist @ pharmacy versus usual careControlRelative (95% CI)Absolute
Mortality
6randomised trialsvery serious1serious2no serious indirectnessserious3None

41/1706

(2.4%)

3.2%RR 0.69 (0.46 to 1.02)10 fewer per 1000 (from 17 fewer to 1 more)

⨁◯◯◯

VERY LOW

CRITICAL
ED presentations
7randomised trialsserious1no serious inconsistencyno serious indirectnessserious2none

168/1336

(12.6%)

9.3%RR 0.63 (0.53 to 0.76)34 fewer per 1000 (from 22 fewer to 44 fewer)

⨁⨁◯◯

LOW

CRITICAL
ED presentations (follow-up 12 months; Better indicated by lower values)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionNone122192-MD 0.52 lower (1.43 lower to 0.39 higher)

⨁⨁◯◯

LOW

CRITICAL
Hospital admissions
7randomised trialsvery serious1serious2no serious indirectnessvery serious3None

90/621

(14.5%)

9.3%RR 0.92 (0.56 to 1.49)7 fewer per 1000 (from 41 fewer to 46 more)

⨁◯◯◯

VERY LOW

IMPORTANT
Mean number of hospitalisations (follow-up 12 months; Better indicated by lower values)
2randomised trialsserious1no serious inconsistencyno serious indirectnessno serious imprecisionnone749863-MD 0.02 lower (0.05 lower to 0.01 higher)

⨁⨁⨁◯

MODERATE

IMPORTANT
GP visits
2randomised trialsvery serious1serious2no serious indirectnessvery serious3None

91/151

(60.3%)

79.7%RR 0.6 (0.17 to 2.06)319 fewer per 1000 (from 662 fewer to 845 more)

⨁◯◯◯

VERY LOW

CRITICAL
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 or 2 increments because: The point estimate varies widely across studies, unexplained by subgroup analysis.

3

Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs.

Table 20Clinical evidence profile: Community pharmacist at the patients’ homes

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCommunity pharmacist @ home versus usual careControlRelative (95% CI)Absolute
Mortality (follow-up 6 months)
2randomised trialsserious1no serious inconsistencyno serious indirectnessserious2None

37/217

(17.1%)

12.9%RR 1.19 (0.77 to 1.85)25 more per 1000 (from 30 fewer to 110 more)

⨁⨁◯◯

LOW

CRITICAL
Hospital admissions
3randomised trialsserious1no serious inconsistencyno serious indirectnessserious2None

258/631

(40.9%)

32.1%RR 1.12 (0.98 to 1.29)39 more per 1000 (from 6 fewer to 93 more)

⨁⨁◯◯

LOW

CRITICAL
Quality of Life EQ-5D (Better indicated by lower values)
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone455428-MD 0.03 higher (0.02 lower to 0.07 higher)

⨁⨁◯◯

LOW

CRITICAL
Quality of Life EQ-VAS (Better indicated by lower values)
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone427406-MD 2.93 lower (6.06 lower to 0.21 higher)

⨁⨁◯◯

LOW

CRITICAL
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.

Table 21Clinical evidence profile: Community pharmacist based within a GP practice

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCommunity pharmacist @ GP versus usual careControlRelative (95% CI)Absolute
Mortality (follow-up 5-12 months)
3randomised trialsserious1no serious inconsistencyno serious indirectnessvery serious2none

11/628

(1.8%)

1.5%RR 1.26 (0.54 to 2.96)4 more per 1000 (from 7 fewer to 29 more)

⨁◯◯◯

VERY LOW

CRITICAL
Survival (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

0/364

(0%)

302/310

(97.4%)

HR 0.78 (0.13 to 4.68)32 fewer per 1000 (from 596 fewer to 26 more)

⨁◯◯◯

VERY LOW

CRITICAL
ED presentations (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

11/131

(8.4%)

8.5%RR 0.98 (0.44 to 2.19)2 fewer per 1000 (from 48 fewer to 101 more)

⨁◯◯◯

VERY LOW

CRITICAL
Mean number of ED visits (follow-up 5 months; Better indicated by lower values)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone431458-MD 0.03 lower (0.11 lower to 0.05 higher)

⨁⨁⨁⨁

HIGH

CRITICAL
Hospital admission (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

0/364

(0%)

10/310

(3.2%)

HR 0.5 (0.12 to 2.08)16 fewer per 1000 (from 28 fewer to 34 more)

⨁◯◯◯

VERY LOW

IMPORTANT
Hospital admissions (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

4/131

(3.1%)

3.9%RR 0.79 (0.22 to 2.87)8 fewer per 1000 (from 30 fewer to 73 more)

⨁◯◯◯

VERY LOW

IMPORTANT
Mean number of hospitalisations (follow-up 5 months; Better indicated by lower values)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone431458-MD 0.03 higher (0.03 lower to 0.09 higher)

⨁⨁⨁⨁

HIGH

IMPORTANT
Mean number of GP visits (follow-up 5 months; Better indicated by lower values)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone431458-MD 0.19 higher (0.59 lower to 0.97 higher)

⨁⨁⨁⨁

HIGH

CRITICAL
Adverse events (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2none

104/364

(28.6%)

23.6%RR 1.21 (0.94 to 1.57)50 more per 1000 (from 14 fewer to 135 more)

⨁◯◯◯

VERY LOW

CRITICAL
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.

Table 22Clinical evidence profile: Clinical pharmacist based within a community clinic

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsClinical pharmacist @ clinic versus usual careControlRelative (95% CI)Absolute
Mortality (follow-up 1-2 years)
4randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessserious2none

68/1276

(5.3%)

4.2%RR 0.8 (0.59 to 1.09)8 fewer per 1000 (from 17 fewer to 4 more)

⨁⨁⨁◯

MODERATE

CRITICAL
Mean number of ED visits (follow-up 1 years; Better indicated by lower values)
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone125106-MD 0.11 lower (0.37 lower to 0.15 higher)

⨁⨁◯◯

LOW

CRITICAL
Mean number of hospitalisations (follow-up 1-2 years; Better indicated by lower values)
3randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone186152-SMD 0.12 higher (0.1 lower to 0.33 higher)

⨁⨁◯◯

LOW

IMPORTANT
Mean number of GP visits (follow-up 1 year; Better indicated by lower values)
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone125106-MD 0.09 higher (0.18 lower to 0.37 higher)

⨁⨁◯◯

LOW

CRITICAL
Total hospitalisations (follow-up 1 year; Better indicated by lower values)
1randomised trialsserious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

11/114

(9.6%)

31%RR 0.31 (0.17 to 0.58)214 fewer per 1000 (from 130 fewer to 257 fewer)

⨁⨁⨁◯

MODERATE

IMPORTANT
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.

Table 23Clinical evidence profile: Clinical pharmacist at the patients’ homes

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsClinical pharmacist @ home versus usual careControlRelative (95% CI)Absolute
Mortality (follow-up 6 months)
1randomised trialsserious1no serious inconsistencyno serious indirectnessserious2none

17/77

(22.1%)

18.2%RR 1.21 (0.64 to 2.29)38 more per 1000 (from 66 fewer to 235 more)

⨁⨁◯◯

LOW

CRITICAL
Hospital admission (follow-up 60 days)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2None-

112/480

(23.3%)

HR 0.8 (0.6 to 1.07)42 fewer per 1000 (from 86 fewer to 14 more)

⨁◯◯◯

VERY LOW

IMPORTANT
Hospital admission (follow-up 3-6 months)
2randomised trialsserious1serious3no serious indirectnessserious1None

48/245

(19.6%)

31.7%RR 0.9 (0.68 to 1.19)32 fewer per 1000 (from 101 fewer to 60 more)

⨁◯◯◯

VERY LOW

IMPORTANT
GP visits (follow-up 12 months)
1randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2None

33/61

(54.1%)

74.6%RR 0.73 (0.55 to 0.95)201 fewer per 1000 (from 37 fewer to 336 fewer)

⨁◯◯◯

VERY LOW

CRITICAL
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.

3

Downgraded by 1 or 2 increments because: The point estimate varies widely across studies, unexplained by subgroup analysis.

Table 24Clinical evidence profile: Clinical pharmacist based within a GP practice

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsClinical pharmacist @ GP versus usual careControlRelative (95% CI)Absolute
Mortality
5randomised trialsvery serious1no serious inconsistencyserious indirectness2serious3none

23/1280

(1.8%)

2.5%RR 0.58 (0.34 to 0.97)11 fewer per 1000 (from 1 fewer to 16 fewer)

⨁◯◯◯

VERY LOW

CRITICAL
Mortality (follow-up median 4.7 years)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone-

331/1074

(30.8%)

HR 0.96 (0.8 to 1.15)10 fewer per 1000 (from 53 fewer to 37 more)

⨁⨁⨁⨁

HIGH

CRITICAL
ED presentations (follow-up 1 years)
1randomised trialsserious1no serious inconsistencyno serious indirectnessvery serious3none

4/33

(12.1%)

16.7%RR 0.73 (0.22 to 2.35)45 fewer per 1000 (from 130 fewer to 225 more)

⨁◯◯◯

VERY LOW

CRITICAL
Mean number of ED visits (follow-up 6 months; Better indicated by lower values)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone162164-MD 0.01 lower (0.06 lower to 0.04 higher)

⨁⨁⨁⨁

HIGH

CRITICAL
Hospital admissions
4randomised trialsvery serious1no serious inconsistencyserious indirectness2serious3none

116/694

(16.7%)

15.7%RR 0.86 (0.32 to 2.32)22 fewer per 1000 (from 107 fewer to 207 more)

⨁◯◯◯

VERY LOW

IMPORTANT
Mean number of hospitalisations (follow-up 6 months; Better indicated by lower values)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone162164-MD 0.01 lower (0.05 lower to 0.03 higher)

⨁⨁⨁⨁

HIGH

CRITICAL
Hospital admission (follow-up median 4.7 years)
1randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone-

695/1074

(64.7%)

HR 0.97 (0.87 to 1.08)11 fewer per 1000 (from 51 fewer to 28 more)

⨁⨁⨁⨁

HIGH

IMPORTANT
Adverse events (follow-up 2 years)
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious3none

0/270

(0%)

0.9%RR 0.29 (0.03 to 2.8)6 fewer per 1000 (from 9 fewer to 16 more)

⨁◯◯◯

VERY LOW

CRITICAL
GP visits(follow-up 6 months
2randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

57/83

(68.7%)

71.4%RR 0.96 (0.79 to 1.17)29 fewer per 1000 (from 150fewer to 121 more)

⨁⨁◯◯

LOW

CRITICAL
1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.

2

Downgraded by 1 or 2 increments because: The majority of the evidence was from studies that had higher/lower drug doses than the recommended dose

3

Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.

Appendix G. Excluded clinical studies

Table 25Studies excluded from the clinical review

StudyExclusion reason
ABULOHA 20162Paper not available
ADAMS 20153Inappropriate intervention- supervised undergraduate pharmacy student-led medication review (third year pharmacy students)
Aguiar 20164Incorrect setting- hospital affiliated secondary clinic. No extractable outcomes
Anon 20051Paper not available
Armour 20087Systematic review: quality assessment is inadequate
Aslani 20099Systematic review: quality assessment is inadequate
Avery 200911No outcomes of interest
Avery 201210No outcomes of interest
Bacchus 200912Systematic review: study designs inappropriate
Ballantyne 201113Commentary not primary study
Barr 201215Review non-systematic
Bayoumi 200916Systematic review: study designs inappropriate
Bell 200519Systematic review: quality assessment is inadequate
Bell 201018Systematic review: quality assessment is inadequate
Benavides 200920Systematic review: quality assessment is inadequate
BLACKBURN 201622No extractable outcomes (outcome reported in the study- statin adherence)
Blenkinsopp 200523Systematic review: study designs inappropriate
Bogden 199824Incorrect interventions. Hospital-based outpatient clinic
Bond 200025Not review population
Bond 200726No outcomes of interest
Butt 201631Incorrect setting -private counselling room of a medical centre
Cameli 201332Not available
Caro 200233Commentary not primary study
Carrier 200934Commentary not primary study
Carter 200137Incorrect setting: hospital-based ambulatory care
Carter 200438Systematic review: quality assessment is inadequate
Carter 200836Incorrect interventions. 2/5 sites were hospital-based clinics. No outcomes of interest
Carter 200935Not protocol outcomes
Carter 201040Editorial not primary study
Carter 201541Incorrect interventions. 2/5 clinics were hospital based. No outcomes of interest
Casteel 201142Does not report any of our outcomes
Cheema 201443Not protocol outcomes
Chin 201144Systematic review: quality assessment is inadequate
Choe 200545Incorrect interventions. Ambulatory care clinic
Chrischilles 201446Inappropriate comparison. No comparison of Medication management therapy versus usual care. Unknown number of patients received the intervention at a hospital
Clark 200747No outcomes of interest
Clyne 201548No extractable outcomes (outcome reported in the study- inappropriate prescribing)
Coburn 201649Inappropriate setting- ambulatory clinics. Inappropriate population- adult patients with gout
Cohen 201150No outcomes of interest
Coleman 199952Incorrect interventions. MDT with a majority team nurse component
Coleman 200151Incorrect interventions. Nurse led MDT
Crawford-faucher 201255Commentary not primary study
Davidson 200056Incorrect study design
De smet 200457Systematic review: quality assessment is inadequate
Delate 200858Incorrect study design
Dennis 200959Systematic review: quality assessment is inadequate
Doucette 200962No outcomes of interest
ELLIOTT 201664No extractable outcomes (outcome reported in the study- self-reported adherence in people starting a new medicine for long term conditions)
Elliott 201265Inappropriate comparison. Pharmacist-led home medication review versus GP-led home medication review. No outcomes of interest
Evans 201166No extractable outcomes
Fathima 201367Systematic review: quality assessment is inadequate
Fish 200268Systematic review: no papers of interest
Fornos 200670No outcomes of interest
Freemantle 200271No outcomes of interest
Gallagher 201572Not protocol outcomes
Gattis 199974Incorrect setting- general cardiology faculty clinic
Garcao 200273No outcomes of interest
George 200876Systematic review: no papers of interest
George 201077SR: not all RCTs, no extractable data
George 201175Literature review
Glynn 201078Systematic review is not relevant to review question or unclear PICO. SR: combines nurse-led and pharmacist-led programmes
Gourley 199880Not community pharmacy
Graffen 200481No extractable data
Grymonpre 200182Not protocol outcomes
Health 200983Systematic review: all papers included
Heisler 201084Incorrect interventions. Hospital-based outpatient primary care clinic
Heisler 201285Incorrect interventions. Hospital-based outpatient primary care clinic
Hennessy 200687No outcomes of interest
Hirsch 201488Incorrect interventions. Hospital-based primary care clinic
Ho 201489Incorrect interventions. Hospital-based clinical pharmacist
Hogg 200990Incorrect interventions. Nurse practitioner led MDT
Hugtenburg 200995Incorrect study design
Ifeanyi 201596Systematic review: study designs inappropriate
Jacobs 201297Not community pharmacy; not protocol outcomes
Jokanovic 2016104Overview of systematic reviews on pharmacist led medication review in community settings- checked for relevant references
Jahangardrad- Rafsanjani 201598No extractable outcomes
Jalal 201499Systematic review: screened for relevant references
Jarab 2012102Incorrect setting -out-patient clinic of a hospital
Jameson 2010100No outcomes of interest
Jamieson 2010101Crossover trial; no data first period intervention versus Control
Jones 2000105Not comparing intervention and control patients using same outcome measures
Kaur 2009106Systematic review: quality assessment is inadequate
Khdour 2009108Incorrect setting: hospital-based outpatient clinic
Khdour 2011107Not community pharmacy
Kirwin 2010109No outcomes of interest. Incorrect setting: hospital-based clinic
Kjeldsen 2015110No extractable outcomes
Kraemer 2012111No outcomes of interest
Krass 2006112No outcomes of interest
Kritikos 2007113Not typical community pharmacy
Krska 2008114No comparator
Kucukarslan 2011117SR: no extractable data
Kwint 2011118Not protocol outcomes
Lambert-kerzner 2012119Incorrect interventions. Hospital-based clinical pharmacist
Lim 2014124Incorrect setting: hospital-based clinic
Lindenmeyer 2006125Systematic review is not relevant to review question or unclear PICO
Lipton 1992126Not community pharmacy
Lowe 2000127No extractable outcomes (results from arms reported in combined format)
Lowrie 2010131Education of primary care professionals. Incorrect interventions. No outcomes of interest
Lowrie 2014128No outcomes of interest
Lund 2010132Incorrect setting: hospital-based primary care clinic
Machado 2007133Systematic review: study designs inappropriate
Mackeigan 2008134Systematic review: quality assessment is inadequate
Mansell 2016136No outcomes of interest
Martin 2015137Protocol only
Mcalister 2014138Not protocol outcomes
Mclean 2006139No outcomes of interest
Mclean 2008140No outcomes of interest
Milos 2013142Hospital-based pharmacist (remote intervention)
Mohammed 2012143Excluded by committee subgroup
Mossialos 2013144Systematic review: study designs inappropriate
Mott 2016145No extractable outcomes
Mott 2016145No outcomes of interest
Murray 2004147Incorrect setting: hospital-based primary care clinic
Nazar 2015150Systematic review of the role of community pharmacies in improving transition from secondary to primary care- checked for relevant references
Naunton 2003149Non-OECD country
Nkansah 2010154SR - no extractable data
Obarcanin 2015155Inappropriate population- adolescents –mean age 14.5 years
Okamoto 2001156Incorrect interventions. Not community pharmacy
Okumura 2014157Systematic review: no papers of interest
Olson 2009158Incorrect interventions. Hospital-based pharmacist (remote intervention)
Omran 2015159No outcomes of interest
Parker 2014163No comparator
Paudyal 2013164Systematic review: quality assessment is inadequate
Paulos 2005165No outcomes of interest
Petkova 2009166Not review population. Arthritis patients - not at risk of an AME
Pinto 2014167No outcomes of interest
Planas 2009169No outcomes of interest
Planas 2012168No outcomes of interest
Polack 2008170No outcomes of interest. Inappropriate comparison
Renders 2009171Systematic review: study designs inappropriate. SR: not all RCTs
Rothman 2005174Incorrect interventions. General internal medicine practice
Royal 2006175SR: not all RCTs
Rubio-valera 2014177Review non-systematic
Saastamoinen 2009178No outcomes of interest
Sadik 2005179Incorrect setting- hospital based
Saini 2004181Incorrect study design
Santschi 2011183Systematic review: no papers of interest
Santschi 2012185Systematic review: no papers of interest
Santschi 2014184Systematic review: no papers of interest
Schneiderhan 2014186No outcomes of interest
Sorensen 2004193Incorrect interventions. MDT with a large clinical pharmacist component
Spinewine 2012194Systematic review: quality assessment is inadequate
Stewart 2014195Not protocol outcomes
Stuurman-bieze 2014196Incorrect study design
Tan 2014197SR: no extractable data for our outcomes
Tjia 2013203Not protocol outcomes
Tonna 2007204Not protocol outcomes
Touchette 2012206Not protocol outcomes
Tsuyuki 2004209Incorrect interventions. Significant pre-discharge intervention component
Tsuyuki 2015208No outcomes of interest
Van boven 2014210SR: not RCTs
Van der meer 2015211Protocol only
Van wijk 2005212Systematic review: study designs inappropriate
Varma 1999213Incorrect setting- hospital based
Vera 2014215Protocol
Vermeire etienne 2005216SR: no extractable data for our outcomes
Viswanathan 2015217Systematic review: study designs inappropriate
Vivian 2002219Not typical community pharmacy
Vivian 2007218Systematic review is not relevant to review question or unclear PICO
Wagner 2001220No information on the role of the pharmacist
Watson 2001221Incorrect interventions. Educational outreach for GPs
Wentzlaff 2011222No outcomes of interest
Westberg 2014223Incorrect study design
Willeboordse 2014224Protocol only
Zermansky 2009231Systematic review: quality assessment is inadequate
Community Pharmacy Medicines Management Project Evaluation Team, 53Duplicate of the study53

Appendix H. Excluded health economic studies

Table 26Studies excluded from the health economic review

ReferenceReason for exclusion
Bevan 201321This study was assessed as partially applicable with very serious limitations. The analysis was a partial economic analysis that only focused on costs. The analysis built largely off assumptions and was not underpinned by a controlled study. A UK randomised controlled trial included in the review analysed the impact of pharmacists in the GP so more applicable evidence was available.
Baqir 201114This study was assessed as partially applicable with very serious limitations. A cost minimisation analysis was undertaken, assuming equivalent health outcomes, with no supporting evidence of equivalence. The comparator used in the study was a hypothetical scenario based on patient report. Intervention costs were not fully incorporated in the analysis.
Brown 201628This study was a non-UK study based on non-RCT data. Given there was more relevant data included in this review this evidence was excluded from this review.
Elliott 200863This study was assessed as partially applicable with very serious limitations. The main outcome of the paper was improvement in adherence. This is a very variable outcome that is likely to significantly change over time, meaning the 4 week analysis was likely not sufficient to capture the long term impacts. There is also uncertainty regarding the applicability of resource use and costs from 2004 to current NHS context. The evidence is based on one study and does not reflect all evidence in this area. The source of the unit costs used is not reported. It is unclear if the costs were calculated using national or local unit costs, which may limit generalisability. The follow-up is very short and different for health outcomes (4 weeks) and costs (2 months). It was assumed the effectiveness of the intervention persists beyond the 4 weeks and up to 2 months, with no evidence to support this assumption.
Elliott 201664This study was assessed as partially applicable with very serious limitations. The main outcome of the paper was improvement in adherence. This is a very variable outcome that is likely to significantly change over time, meaning the 10 week analysis was likely not sufficient to capture the long term impacts. EQ-5D was collected but not assessed. Although the intervention was cost saving the cost of medication had been excluded from the analysis, this is still a cost to the health service and should be included, making the cost saving conclusions potentially misleading.
Formoso 201369This study was a non-UK study based on non-RCT data. Given there was more relevant data included in this review this evidence was excluded from this review.
Hendrie 201486This study was a non-UK study based on non-RCT data. Given there was more relevant data included in this review this evidence was excluded from this review.
Krska 2001115This study was assessed as partially applicable with very serious limitations as hospital attendances were not included in the costs. Only medication costs were included.
Lenander 2014123This study was assessed as partially applicable with very serious limitations as only the cost of the intervention was reported.
Saini 2008180This study was assessed as partially applicable with very serious limitations. The perspective of the analysis is not reported and QALYs are not used as an outcome. Not all important health outcomes are reported. Intervention costs are not included in the analysis and the source of unit costs is not reported. No sensitivity analysis reported. Follow-up is short (6 months).
Taylor 2005A200This study was assessed as not applicable. The intervention is delivered by both hospital and community pharmacists in a hospital based clinic, rural and urban community pharmacies. The data was not reported separately for the community pharmacy-based intervention to allow estimating its cost effectiveness.
Wright 2015225,226This study (2 papers) was assessed as partially applicable with potentially serious limitations. However, the Committee judged that other available evidence was of greater applicability and methodological quality, and therefore this study was selectively excluded. The economic evaluation in the RESPECT trial172 was in the same strata but had a more generalizable population and was based on randomised evidence with a larger sample size.
Zermansky 2006228This study was assessed as partially applicable with very serious limitations as the cost of GP visits and hospitalisations were not included.
Copyright © NICE 2018.
Bookshelf ID: NBK564913

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