Adverse effects of slimming drug orlistat were underreported

Adobe Spark (5)A new study comparing the protocols, clinical study reports (CSRs) and published papers on anti-obesity drug orlistat, has revealed a disparity in how adverse events were summarised and reported (Schroll et al, 2016).

Orlistat, which is manufactured by pharmaceutical company Roche, was approved by the European Medicines Agency (EMA) in 1998 but, along with other slimming drugs, has since encountered regulatory barriers. Nearly all slimming pills (but not orlistat) have been withdrawn from European markets because of harms.

Researchers at the Nordic Cochrane Centre in Copenhagen used a Freedom of Information Act request to the EMA to acquire the CSRs, which describe the results of studies conducted as part of the application for marketing authorisation of the drug.

Seven randomised placebo controlled orlistat trials were included in the application for marketing authorisation for the drug, and involved a total of 4,225 participants. Adverse events outlined in the CSRs were then compared by the researchers to each corresponding published trial paper identified on PubMed.

It was revealed that due to post hoc filters, only 3–33% of the total number of investigator-reported adverse events from the trials were outlined in the publications, though six of seven papers stated that ‘all adverse events were recorded.’

The investigators noted that none of the protocols to investigators for reporting harms or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were ‘bothersome,’ a condition that was not specified in the protocol for two of the trials. Events falling under the bracket of bothersome included ‘fatty/oily stool,’ ‘liquid stools’ (which term the protocol suggested to be used instead of diarrhoea), ‘increased defaecation,’ ‘stools soft,’ ‘decreased defaecation,’ and ‘pellets.’ Results sections in the core reports of the CSRs often stated that most of the adverse events were considered unrelated to the drug and that they were generally mild to moderate. The many gastrointestinal adverse events were explained as part of the pharmacological effect of orlistat. The researchers suggested that since gastrointestinal complaints are normal in healthy people, this type of censoring might have made it more difficult to detect gastrointestinal adverse events caused by orlistat.

Additionally, serious adverse events were assessed by the researchers for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group.

The researchers also revealed that in one trial, both the number of adverse effects and the number of days with adverse effects in participants taking the drug were understated in the corresponding publication. While 1,318 adverse events were not listed or mentioned in the CSR itself, the researchers were able to identify them through manually counting individual adverse events reported in an appendix.

Overall, the analysis revealed that participants treated with orlistat had experienced almost twice as many days with adverse events as those treated with placebo (22.7 days versus 14.9 days). Additionally, it was noted that the adverse events that occurred in the orlistat group were more severe compared with the placebo group. However, none of this information was stated in the CSR or the corresponding published paper.

A statement issued by Roche said: ‘Since the 1990s, technology for analysing data has changed and society’s desire and expectations for access has increased and so our practices have evolved.

‘We understand and support calls for the pharmaceutical industry to be transparent about clinical trial results, this is why we expanded our policy in 2013 to better share data from clinical trials across Roche medicines.

‘Roche are now at the forefront of the data sharing movement and now release all clinical study reports, periodic safety reports and summary reports of clinical data for all licensed, terminated or discontinued medicines.’

Based on the characteristics of harms observed and reported in these trials, the researchers at the Nordic Cochrane Centre suggested that reports of harms include duration of adverse effects. They also suggested that systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.

They highlight how even though publication bias is well covered in the medical literature, few studies have analysed clinical study reports. They argue that in the future this could be a very important source of information. Other studies have found that only a fraction of adverse events were reported in published papers compared to the CSRs. For example, a study carried out by the German government’s Institute for Quality and Efficiency in Health Care looked at the CSRs for treatments assessed over a 5-year period and found that CSRs contained more information on adverse events and treatment effects than was published in trial reports and journal articles (Wieseler et al, 2013).

As mentioned by Schroll et al (2016), their research emphasises the ‘need for detailed analysis plans for harms data.’

References:

Schroll JB, Penninga EI, Gøtzsche PC (2016) Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis. PLoS Med 13(8): e1002101. doi: 10.1371/journal.pmed.1002101

Wieseler B, Wolfram N, McGauran N et al (2013) Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 10(10): e1001526. doi: 10.1371/journal.pmed.1001526

Taken from Nurse Prescribing, published 13 October 2016.

Demand on district nursing services leaving staff ‘on their knees,’ says King’s Fund

Adobe Spark (4)A growing gap between capacity and demand in district nursing services has led to staff feeling ‘broken’, ‘exhausted’ and ‘on their knees’, the King’s Fund has said.

A new report (Maybin et al, 2016) published by the think tank has examined the care for older people who receive district nursing services in their own homes. It considered what good-quality care looks like from the perspective of people receiving care, their carers and district nursing staff. This was done by conducting a review of existing policy and research literature, having scoping conversations with national stakeholders, conducting focus groups with senior district nursing staff, and carrying out interviews with patients, carers and staff in three case study sites.

By seeing how patients’ preconceptions of good-quality compared with their actual experiences, the think tank sought to establish what factors support ‘good care’, and figure out what is getting in the way.

Their research indicated that activity has increased significantly over recent years. This applies both to the number of patients seen and the complexity of care provided. From 2005–2014 the number of people living in England has increased by almost 20%, with the most substantial growth seen in the oldest age groups. Additionally, the population aged 85 years and above has increased by just under a third.

It is anticipated that that is set to increase, with the number of people aged 65 years and over expected to rise by almost a half and those aged 85 years and over set to almost double (Mortimer and Green, 2015; Office for National Statistics, 2015). With this increase in age, the likelihood this population will live with chronic disease, multiple health conditions, disability and frailty also rises (Health and Social Care Information Centre, 2014; Oliver et al, 2014).

While demand for services has been increasing, available data on the healthcare workforce suggests a decline in the number of nurses working in community health services over recent years. Additionally, the number working in senior ‘district nurse’ posts has fallen dramatically over a sustained period.

Compromise in quality of care

The result of these pressures is that quality of care is being compromised. Examples highlighted in the report indicate an increasingly task-focused approach to care, staff being rushed and abrupt with patients, reductions in preventive care, visits being postponed and lack of continuity of care. This in turn has caused a deeply negative impact on staff wellbeing, with unmanageable caseloads being increasingly reported. In many cases, staff are leaving the service as a result. Additionally, the King’s Fund has argued that if the ability of district nursing services to deliver appropriate care continues to be undermined, there will be consequences in terms of additional hospital admissions, delayed discharges and dependence on social care.

The King’s Fund have warned that those most likely to be affected by the pressure faced by district nursing staff are often the most vulnerable members of society, who will therefore most likely be affected by cuts in social care and voluntary sectors. They warn that what is more concerning is that this is happening ‘behind closed doors in people’s homes, creating a real danger that serious failures in care could go undetected because they are invisible’ (Maybin et al, 2016).

Recommendations outlined in report

As a result of the issues identified in the report, the King’s Fund have issued the following recommendations as immediate priorities:

Match the stated intention to move care into community settings with greater attention to this service area. Despite intentions by policy makers and regulators to deliver ‘care closer to home’, the direction of resources, monitoring and oversight remains distinctly focused on the hospital sector. The report therefore recommends that community services must be involved in, and central to, the development of new care models and Sustainability and Transformation Plans.

Involve district nursing service leaders in local plans for service redesign. Too often the voice of district nursing service leaders is absent at the system level. The report highlights the valuable role of district nursing and how it is of central importance to the wider health system. The service enhances the health and wellbeing of people living in their own homes, often caring for people with complex and multiple health needs, and helps prevent deteriorations in health and the need for additional services. Therefore now, more than ever, this important but pressured service needs to be part of discussions about future service redesign.

Respond to the issues facing community health and care services, and the needs of people who depend on these, in the round. To address the wide-reaching problems faced by all services, not just district nursing, the report recommends NHS England and Health Education England, together with local commissioners and providers, look in the round at the staffing and resourcing of community health and care services for the older population, taking into account the capacity of people receiving care, their unpaid carers and local communities.

Renew efforts to establish robust national data on capacity and demand in district nursing services. This would include establishing a standard for demand–capacity and workload planning tools in this area, as is currently being undertaken by The Queen’s Nursing Institute and NHS Improvement. The report highlights that the absence of robust national data on activity levels in district nursing services and of a clear dataset on trends in staffing numbers, makes it very difficult to demonstrate, understand and monitor the demand–capacity gap within this service area.

Accelerate the uptake of digital technologies and support implementation. The report argues that adopting new technologies should remain high on the agenda of providers and local service leaders as a strategic area for development, as district nursing stands to benefit significantly from enhanced digital support, if it is designed and works well. Technologies that enable remote working, such as iPads and other tablets, have the potential to improve efficiency and productivity, as well as enhancing quality and safety through timely access to notes at the point of care and supporting communication between professionals.

Develop a meaningful form of oversight for care delivered in people’s own homes, which is sensitive to the unique characteristics of this care. The report stresses the need for national oversight systems to be developed in order for their frameworks to meaningfully capture and reflect care quality. Current national mechanisms of quality assurance and accountability, which are largely designed to assess hospital care, are poorly suited to measuring quality in the community.

Develop a sustainable district nursing workforce. Undoubtedly the most important recommendation, the King’s Fund warns the shortage of suitably trained staff to fill roles in district nursing services is a major cause for concern. Services are increasingly unable to recruit and retain staff. With many of the current district nursing workforce approach retirement age, and others choose to leave due to service pressures, it is understood that this situation will likely worsen.

Conclusions

District nursing services have a key role to play in the national health system, allowing patients to be treated in their own homes and avoid unnecessary hospital admissions. They allow patients to maintain their independence, maintain long-term conditions and manage acute conditions. However, this is only possible through a sustainable workforce. Insufficient staff numbers place unmanageable pressures on the existing workforce as well as other areas of the health service. This report highlights a dissonance between the policy drive to move more care out of hospitals into community settings, and the capacity problems being experienced in district nursing services. It presents a number of recommendations for addressing these issues and calls for the need to develop a robust framework for assessing and assuring the quality of care in the community.

References:

Health and Social Care Information Centre (2014) Focus on the health and care of older people. NHS Digital, Leeds. http://digital.nhs.uk/catalogue/PUB14369 (accessed 23 September 2016)

Maybin J, Charles A, Honeyman M (2016) Understanding Quality in District Nursing Services. The King’s Fund, London. http://www.kingsfund.org.uk/publications/quality-district-nursing (accessed 22 September 2016)

Mortimer J, Green M (2015) Briefing: The Health and Care of Older People in England 2015. Age UK, London. http://www.ageuk.org.uk/professional-resources-home/research/reports/care-and-support/the-health-and-care-of-older-people-in-england-2015/ (accessed 22 September 2016)

Office for National Statistics (2015) Population estimates for UK, England and Wales, Northern Ireland: Mid-2014. Office for National Statistics, Newport. http://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/bulletins/annualmidyearpopulationestimates/2015-06-25 (accessed 22 September 2016)

Oliver D, Foot C, Humphries R (2014) Making our health and care systems fit for an ageing population. The King’s Fund, London. http://www.kingsfund.org.uk/publications/making-ourhealth-and-care-systems-fit-ageing-population (accessed 23 September 2016)

Taken from British Journal of Community Nursing, published 3 October 2016.

Ensuring the district nursing role does not die out

Adobe Spark (2)Recent figures published by the Welsh Government have revealed a 42% reduction in the number of district nurses in Wales between 2009 and 2015 (BBC News, 2016). The number of district nurses has fallen from 712 in 2009 to 412 in 2015, with six of the seven health boards in Wales reporting a reduction.

This follows trends seen in England in recent years, which has reported a 47% reduction in the number of qualified district nursing staff in the past decade (Royal College of Nursing (RCN), 2014). Frequent figures such as these have resulted in a warning from the RCN that district nurses are ‘critically endangered’ and face possible extinction by the end of 2025 (RCN, 2014). Consequently, it has called on the Government to fulfil its commitment to increase the number of community staff to 10000 by 2020.

Origins of district nursing

The district nursing role originated in 1859, when a wealthy Liverpool merchant, William Rathbone, employed a private hospital-trained nurse to care for his dying wife. He was struck by ‘the great comfort and advantage derived from trained nursing, even in a home where everything which unskilled affection could suggest was provided.’ Following the death of his wife, Rathbone set up a training home in Liverpool to give nurses the skills necessary to treat patients in the home.

The title came from the fact that Liverpool was split into 18 districts based on the parish system, so the nurses became known as ‘district nurses’.

There is little research, but a publication from the Department of Health revealed that more than 2.6 million people receive care from district nurses each year, in England and Wales alone, according to statistics gathered nationally (Department of Health, 2004). It is anticipated that this number will only increase.

Due to the increasing elderly population and number of people with long-term conditions, district nurses make a notable contribution to the NHS. Having specially qualified staff who are trained to deliver care to patients in their own homes, should reduce pressures on GP surgeries and emergency departments. However, the shortage of district nurses means many feel they are being pushed to breaking point. Reports of regular additional hours, activities left undone due to lack of time and a desire to leave the job are not uncommon.

The RCN have said the reduced numbers of district nurses has placed extra pressure on GP surgeries and emergency departments. Increases in caseloads from 30 patients to up to 150 means contact time is kept to an absolute minimum. This results in patients not receiving the appropriate care they need and therefore feeling they require further consultation by their GP or at the emergency department.

The future vision of district nurses

In 2009, The Queen’s Nursing Institute (QNI) published its 2020 Vision of the future of district nursing (QNI, 2009). It marked the 150 year anniversary of district nurses and highlighted their role in health care. Fundamentally, the principles of district nursing have changed little in 150 years and consist of ‘better care, closer to home’, ‘patient choice’, ‘integrated care’, and ‘co-production’ (QNI, 2009). As a specialism, district nurses are ‘practitioners, partners and leaders’ of care in the home (QNI, 2009).

Some of the issues identified in the QNI report surrounding district nurses included: ‘loose use of the title, wide variations in pay banding and career structure, reduction in leadership opportunities and lack of recognition of the value of their specialist education’ (QNI, 2009).

It is important to highlight that there is a notable difference between nursing found in clinics, surgeries and other areas of primary care; and that found in patients’ homes. It is for this reason that the district nursing role remains an important part of the NHS.

The British Journal of Community Nursing and the QNI carried out a survey in 2008, gathering information and views from district nurses in England, Wales and Northern Ireland about the state of their specialism. The survey found that 13% of respondents’ employing organisations no longer use the title ‘district nurse’ at all. It also revealed that in those organisations that still use the title, more than 30% do not limit its use to those with a district nurse qualification (QNI, 2009). In some cases, the title was given to team leaders or case managers, with or without the qualification. Additionally, the survey revealed that only 48% of employing organisations continue to require district nursing team leaders to have the district nursing specialist practitioner qualification. Another 19%, who did at the time the report was published, plan to discontinue this requirement.

A follow-up report from the QNI published 5 years after the 2020 Vision, revealed an increase in the level of confusion about job titles, qualifications and roles concerning district nurses (QNI, 2014). As a result, one of the key recommendations of the the report was for a renewed investment in the district nursing specialist practitioner qualification.

Focus surrounding qualifications for district nurses was raised at the most recent RCN Congress, which passed a resolution calling on RCN council to lobby for all district nurse caseload holders to have the relevant specialist practitioner qualification (Ford, 2016). This arose amid concerns over the future of the district nursing role and its protected title. The Forum called for a practitioner who is ‘equipped with skills to manage a role that is highly complex and requires skills in negotiating, coaching, teaching and effective team management’ (Ford, 2016).

The current climate

The situation surrounding the place and role of district nurses within the NHS has gradually changed over the years. For example, it is no longer the sole role to be found delivering nursing care in the home as there are now a multitude of community roles working at different levels. The issue with this is that the meaning attributed to the district nurses’ unique title has eroded somewhat. As mentioned, some employers are using the title without the accompanying specialist qualification, further muddying the waters. District nurses are excellently placed to offer leadership over other health professionals in the home. However, if they have not received adequate training they will struggle to have the strong leadership skills required.

Within Simon Stevens’ Five Year Forward View he called for the introduction of a new care model known as Multispecialty Community Providers. One of the benefits of this model is to allow for the expansion of primary care leadership to include nurses and other community-based professionals. This new way of delivering care and ability to offer a wider scope of services is made possible by allowing the formation of extended group practices as federations, networks or single organisations.

Conclusions

District nurses offer a much-valued service to the NHS through their ability to treat large numbers of people at home, allowing patients to avoid having to go to hospital if they receive the appropriate level of care first-time around. However, this is only possible if the number of district nurses does not continue to fall. The reality is that those still in the role are under increasing pressure, as they find their workloads ever-increasing. The Government must fulfil its commitment to increase the number of community staff, and in particular, the number of district nurses.

Now, more than ever, is the time to reinstate the district nurse.

References

BBC News (2016) Royal College of Nursing concern over fall in district nurses in Wales. BBC News. http://www.bbc.co.uk/news/uk-wales-36828072 (accessed 17 August 2016)

Department of Health (2004) Patient Care in the Community: NHS District Nursing Summary Information for 2003–04, England. The Stationery Office, London. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4092113.pdf (accessed 17 August 2016)

Ford S (2016) All district nurses ‘should have specialist qualification’. Nursing Times. http://www.nursingtimes.net/news/community/all-district-nurses-should-have-specialist-qualification/7005789.fullarticle (accessed 18 August2016)

Health Education England (2015) District Nursing and General Practice Nursing Service Education and Career Framework. HEE, London. https://hee.nhs.uk/sites/default/files/documents/District%20nursing%20and%20GP%20practice%20nursing%20framework_0.pdf (accessed 17 August 2016)

Royal College of Nursing (2014) District nurses face ‘extinction’ in 2025. RCN, London. https://www2.rcn.org.uk/newsevents/press_releases/uk/district_nurses_face_extinction_in_2025 (accessed 17 August 2016)

The Queen’s Nursing Institute (2009) 2020 Vision: Focusing on the Future of District Nursing. QNI, London. http://www.qni.org.uk/docs/2020_Vision.pdf (accessed 15 August 2016)

The Queen’s Nursing Institute (2014) 2020 Vision Five Years On: Reassessing the Future of District Nursing. http://www.qni.org.uk/docs/2020_Vision_Five_Years_On_Web1.pdf (accessed 15 August 2016)

The Queen’s Nursing Institute, NHS England (2014) Developing a National District Nursing Workforce Planning Framework: A Report Commissioned by NHS England. https://www.england.nhs.uk/wp-content/uploads/2014/05/dn-wfp-report-0414.pdf (accessed 15 August 2016)

Taken from British Journal of Community Nursing, published 2 September 2016.

The A&E crisis: the burgeoning effect on paramedics

As demands rise and resource pressures grow, NHS emergency services have found themselves placed under increasing pressure. This culminated in the failure of emergency departments to meet national waiting time targets in the early months of this year. The combination of these trends with claims concerning the improved outcomes that are possible by specialist trauma centres, begs the question as to the future of community and primary care services, ambulance services and hospital A&E departments. As a result, the NHS Commissioning Board (NHS England) is reviewing the future configuration of urgent and emergency services in England.

The report, drawn up by the House of Commons Health Committee, suggests that growing demand on A&E departments will make them unsustainable if effective action is not taken quickly to relieve the pressures they face (House of Commons Health Committee (HCHH), 2013a). Concerns were also raised by the committee as to the low numbers of staff in emergency departments, and the role of NHS 111.

Urgent Care Boards
The Government’s response to the pressure in emergency and urgent care revolves around improving local system management in the short term and restructuring care for the medium term. Urgent Care Boards (UCBs) have been created to implement emergency care improvement plans in the local area. However, it was felt by the Committee that UCBs would not be able to implement reforms and influence commissioning. Confusion over a number of features of UCBs, including whether they are voluntary or compulsory, temporary or permanent, established structures or informal meeting groups, has led the committee to conclude that although UCBs have the potential to provide local system management, they currently lack clear direction or executive power (HCHH, 2013a).

NHS 111
NHS 111 is the three-digit telephone service that was introduced earlier this year in an attempt to improve access to NHS urgent care services. At a critical time in the NHS when health economies are facing financial and clinical constraints, its aim is to provide patients with a number they can call when they need help or advice that is not urgent enough to use the conventional 999 service. NHS 111 operates 24 hours a day, 365 days a year, and is free to use from a landline or a mobile.

However, the Health Committee report emphasises the consensus that NHS 111 was instated by ministers prematurely, without any real understanding of the impact that it would have on other parts of the NHS, including emergency and urgent care (HCHH, 2013a). It is felt that because NHS 111 is based around triage by a call handler who is not clinically trained, it does not embody the principle of early assessment by a clinician qualified to a level where they can appropriately quantify the balance and risk. The outcome is a potential for patients to remain dissatisfied or unsure of the instructions they have been given and so remain inclined to attend A&E when it really isn’t necessary.

Despite this, it can be argued that a number of potential benefits could be seen were the ambulance service to assume a more significant role in national 111 provision. Some of the more notable benefits include (HCHH, 2013b):

  • Confidence in a universally recognised professional
  • Experienced and capable function l Whole system effectiveness and value for money
  • Appropriate management of demand across the urgent and emergency care system.

Ambulance services
Along with emergency departments, ambulance services are also being met with ever increasing demands. According to the Association of Ambulance Chief Executives (AACE), in 2011–12, the total number of emergency calls was 8.49 million; this was an increase of 415 487 (5.1%) over 2011–12 (HCHH, 2013b).

Delays in ambulance to A&E handovers or transfers within urgent care are a major everyday issue for ambulance services. Currently, patients have found themselves having to wait up to eight hours in ambulances outside A&E departments. Official figures from eight of England’s ten ambulance trusts show that 3 424 patients waited more than two hours before being handed over to hospital staff during 2012/13, compared with 2 061 patients the year before (Donnelly, 2013).

The AACE recognise that the cause of these delays varies from hospital to hospital but include:

  • Ownership by hospital/health system leaders
  • A&E capacity
  • A&E integration with the rest of the hospital
  • Timeliness of in-Trust escalation
  • Reductions in physical bed capacity within hospitals and the community
  • Attitude and behaviour towards handover delays within the hospital
  • The effectiveness of urgent care pathways keeping demand away from the front door (HCHH, 2013a).

As the paramedic profession takes on broadening responsibilities, ambulance services need to be recognised as a care provider and not simply a transport service for emergency departments. The committee believes that this can be achieved in part through increasing the number of fully qualified paramedics (HCHH, 2013a). By having paramedics who are able to treat patients on-scene, conveyance rates to emergency departments can be reduced, and, therefore, pressure alleviated. In addition, paramedics would be in a position to make the difficult judgement about when to bypass the nearest A&E in favour of specialist units that offer stroke, heart attack, major trauma and specialist children’s services.

In comparison to ambulance technicians, paramedics are trained to make better clinical judgments and administer care more appropriately. It is therefore imperative that ambulance services demonstrate a commitment to establishing a ratio of paramedics to technicians, which ensures that ambulance crews are able to regard conveyance to an emergency department as only one of a range of clinical options open to them (HCHH, 2013b). The report recommends that NHS England undertakes research to establish the precise relationship between more highly-skilled ambulance crews and reduced conveyance rates (HCHH, 2013a). By making full use of the potential of ambulance services, demand pressures in emergency departments could be more easily managed and new care models developed.

References:
Donnelly L (2013) Patients facing eight-hour waits in ambulances outside A&E departments. The Telegraph. http://www.telegraph.co.uk/health/healthnews/10150635/Patients-facing-eight-hour-waits-in-ambulances-outside-AandE-departments.html

House of Commons Health Committee (2013a) Urgent and emergency services: Second report of session 2013–14. Vol 1: Report, together with formal minutes, oral and written evidence. The Stationery Office, London

House of Commons Health Committee (2013b) Written evidence from Association of Ambulance Chief Executives. ES 19. The Stationery Office, London

Taken from Journal of Paramedic Practice, published 2 August 2013.