More rigorous investigating needed to improve maternity safety

My Post (16)Coroners could be given powers to investigate stillbirths and help improve maternity safety, Health Secretary Jeremy Hunt has said. Currently, coroners only have jurisdiction to investigate deaths of babies who were alive at birth. The announcement comes after a recent report showed that three-quarters of birth-related deaths or brain injuries might have been avoided (Royal College of Obstetricians and Gynaecologists (RCOG), 2017).

Hunt also revealed that independent investigations are to be offered to families who suffer stillbirth or life-changing injuries to their babies. The Healthcare Safety Investigation Branch will look at 1000 cases each year to find out what went wrong and why, and encourage system improvements that will lead to fewer deaths and injuries in the future.

Health Secretary Jeremy Hunt said:

‘The tragic death or life-changing injury of a baby is something no parent should have to bear, but one thing that can help […] is getting honest answers quickly from an independent investigator. Too many families have been denied this in the past, adding unnecessarily to the pain of their loss.

‘Countless mothers and fathers who have suffered like this say that the most important outcome for them is making sure lessons are learnt so that no-one else has to endure the same heartbreak. These important changes will help us to make that promise in the future.’

Alongside the devastating impact of death or serious injury to mother or child at birth, maternity incidents dominate the NHS’ litigation expenditure. Half of the £1 billion negligence claims the NHS paid out in 2016/17 were in maternity services, largely due to the high value of claims arising from brain injuries at birth (NHS Resolution, 2017).

The Government’s maternity safety plans will also see its ambition to halve the number of stillbirths and deaths among neonates and mothers brought forward from 2030 to 2025 (Department of Health, 2017), saving an estimated 4000 lives.

The rate of premature births is also hoped to fall from 8% to 6% by 2025.

Gill Walton, chief executive officer and general secretary at the Royal College of Midwives (RCM), said:

‘Midwives are in a unique position to help achieve this, as they are the one healthcare professional whom all women will see during their pregnancy and birth, and therefore have a clear role in ensuring care is coordinated, safe and, most importantly, personal.

‘Much has been done already through an array of initiatives to improve the safety of maternity care, and this revised strategy will give everyone involved in maternity care the opportunity to reflect on past successes and focus on key areas where more still needs to be done.’

The RCOG ‘Each Baby Counts’ programme has used local investigations into stillbirths, neonatal deaths and brain injuries to inform national data and identify lessons learned across maternity services. One-quarter of local reports were deemed inadequate by the RCOG, with many NHS institutions listed as not sufficiently investigating incidents and learning from mistakes in their maternity services.

Commenting on the proposals, Professor Lesley Regan, RCOG president, added:

‘We are delighted that the Government has agreed to expand the RCOG’s Each Baby Counts programme, which has been hugely successful in securing the trust of both the midwifery and obstetric communities, with 100% of Trusts involved in providing maternity services engaging in this important work.

‘We are committed to sharing the expertise we have gained […] and our understanding of the complex interplay of factors that lead to stillbirths, neonatal deaths and brain damage during term labour, to work with partners such as NHS Improvement to expand the work and reach of the Maternal and Neonatal Safety Collaborative and the Healthcare Safety Investigation Branch as they undertake their investigations.

‘Expansion of the national strategy to include a focus on preterm birth and brain injury will likewise help provide a more complete picture of maternity safety, strengthening our evidence base to help us deliver ever more effective care’.

References

Department of Health. Safer Maternity Care: The National Maternity Safety Strategy— Progress and Next Steps. London: The Stationery Office; 2017

NHS Resolution. Annual report and accounts 2016/17. London: The Stationery Office; 2017

Royal College of Obstetricians and Gynaecologists. Each Baby Counts: 2015 Summary Report. London: RCOG; 2017

Taken from British Journal of Midwifery, published February 2018.

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Complications from medical cosmetic tourism result in costs to the NHS

My Post (15)While many patients venture outside of the UK for cosmetic surgery, due to the significant cost of private care in the UK, there is also a lucrative business for non-invasive aesthetic treatments abroad. In the UK, botulinum toxin injections or dermal fillers cost about £150–£350 per session, depending on the amount of product used (NHS Choices, 2016a). Chemical peels cost about £60–£100 for mild peels, with deeper treatments often costing over £500 (NHS Choices, 2016a). The cost of cosmetic micropigmentation varies from £75 for a beauty spot to £500 for lip liner (NHS Choices, 2016a). Microdermabrasion costs £40–80 for a single session (NHS Choices, 2016a).

By contrast, costs for treatments abroad can be substantially cheaper. For example, prices for botulinum toxin can be as low as £40 in Thailand, £50 in the United Arab Emirates and £60 in the Czech Republic (MEDIGO, 2017a). Chemical peels start from £22 in Thailand, £44 in Turkey and £45 in Malaysia (MEDIGO, 2017b).

Complications of non-surgical cosmetic treatment

Complications arising from non-invasive cosmetic treatments are less common and often less severe than those from surgical procedures. However, there is still a notable element of risk involved.

The most common complications from botulinum toxin and soft-tissue filler injections are bruising, erythema and pain (Levy and Emer, 2012). Erythema is also not uncommon following chemical peels, as well as irritation and burning (Levy and Emer, 2012). These side effects are generally temporary and easy to treat. More serious complications include muscle paralysis from botulinum toxin, granuloma formation from soft-tissue filler placement, and scarring from chemical peels (Levy and Emer, 2017).

Issues regarding regulation

In 2013, Sir Bruce Keogh was asked to undertake a review into the regulation of cosmetic interventions in the UK. It revealed that non-surgical interventions were almost entirely unregulated, with no restrictions on who may perform procedures (Department of Health (DH), 2013). This poses a significant risk to patients, as without accredited training, practitioners are unlikely to recognise complications of the procedures, or be able to treat them. The review committee therefore recommended approved training schemes were introduced, as well as accredited qualifications, and associated registers for both surgical and non-surgical cosmetic procedures.

The DH (2014) provided a response to this review, largely accepting many of the recommendations, but did not believe a new regulated profession for those performing cosmetic procedures should be introduced, as many practitioners were already members of professional registers and so subject to regulation. In 2015, Health Education England (HEE) unveiled new qualifications to improve the safety of non-surgical cosmetic procedures (HEE, 2015), but again did not go as far as to establish legal requirements for the administration of non-surgical cosmetic interventions.

Issues concerning regulation for non-surgical cosmetic interventions also exist in other countries. Due to differences in standards and qualifications, it can be difficult to establish the suitability of a practitioner to carry out an intervention. In Europe, dermal fillers are regarded as medical devices requiring only Conformité Européenne certification (Hachach- Haram et al, 2013). It is only in the US that dermal fillers are seen as medicines and are therefore required to be approved by the US Food and Drug Administration (Hachach- Haram et al, 2013).

Whose responsibility is follow-up care?

Follow-up care is an important part of treatment, particularly in the case of cosmetic surgery. The NHS advises that when making enquiries about treatment abroad, it is important to know how complications would be handled, what would happen if revision surgery was needed after the original procedure, and how much it might cost (NHS Choices, 2016b). Unfortunately, all too often the expectation in the UK is that if something goes wrong, the NHS will sort it.

It is believed the cost to the NHS of fixing botched botulinum toxin injections could be as much as £1 million a year (Savage, 2016). However, because of a lack of data, it is difficult to accurately gauge the cost to the NHS of fixing cosmetic complications, or to establish the numbers of complications attributable to UK private care, treatment abroad or self-administration.

It has been questioned whether cases should be considered individually, whether guidelines and standards of treatment need to be outlined, or whether treatment by the NHS should be strictly limited to acute cases only (Hachach-Haram et al, 2013).

Additionally, there is limited knowledge of public attitudes towards the regulation and safety of treatment. People considering this type of treatment need to be aware of the risks and thoroughly research the practitioners who will be carrying out their treatment. Many websites offer holiday packages of treatment, travel and accommodation, but can be misleading in what it is they are providing.

It is clear that tighter rules regarding regulation are needed globally, along with clear outlines of practitioners’ aftercare responsibilities and improved education around the possible risks for prospective patients. Without this regulation, it is evident the NHS will continue to pick up the bill when things go wrong.

References

Department of Health. Review of the regulation of cosmetic interventions: final report. 2013. https://tinyurl.com/b8qq6ek (accessed 11 January 2018)

Department of Health. Government response to the review of the regulation of cosmetic interventions. 2014. https://tinyurl.com/nnjvlym (accessed 11 January 2018)

Hachach-Haram N, Gregori M, Kirkpatrick N, Young R, Collier J. Complications of facial fillers: resource implications for NHS hospitals. BMJ Case Rep. 2013; pii: bcr-2012-007141. https://doi.org/10.1136/bcr-2012-007141

Health Education England. Qualification requirements for delivery of cosmetic procedures: non-surgical cosmetic interventions and hair restoration surgery. 2015. https://tinyurl.com/z43cs8s (accessed 11 January 2018)

Levy LL, Emer JJ. Complications of minimally invasive cosmetic procedures: prevention and management. J Cutan Aesthet Surg. 2012;5(2):121– 132. https://doi.org/10.4103/0974-2077.99451

MEDIGO. Botox injections and wrinkle treatment at clinics and hospitals worldwide. 2017a. https://tinyurl.com/yd3xzu34 (accessed 11 January 2018)

MEDIGO. Chemical peel at clinics and hospitals worldwide. 2017b. https://tinyurl.com/ycwe3y72 (accessed 11 January 2018)

NHS Choices. Your guide to cosmetic procedures. 2016a. https://tinyurl.com/yae8sdyt (accessed 11 January 2018)

NHS Choices. Your guide to cosmetic procedures: Cosmetic surgery abroad. London: NHS Choices; 2016b. https://tinyurl.com/ydckt79p (accessed 18 January 2018)

Savage M. Up to £1m a year spent fixing bad Botox. 2016. https://tinyurl.com/y7dfn9jh (accessed 11 January 2018)

Taken from Journal of Aesthetic Nursing, published February 2018.

Valvular heart disease: new evidence and updated guidelines

My Post (14)Following new evidence in recent years, updated guidelines have been published for the management of valvular heart disease (VHD) by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Since the last iteration of the Guidelines, randomised trials on percutaneous interventional techniques and risk-stratification regarding timing of intervention in VHD have made new recommendations necessary. Following new evidence in recent years, updated guidelines have been published for the management of valvular heart disease (VHD) by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Since the last iteration of the Guidelines, randomised trials on percutaneous interventional techniques and risk-stratification regarding timing of intervention in VHD have made new recommendations necessary.

ESC Chairperson, Professor Helmut Baumgartner said:

‘Since the 2012 Guidelines, a large amount of new data have accumulated, particularly in the field of catheter interventional treatment of valvular heart disease.’

Valvular heart disease

VHD is a leading cause of morbidity and mortality worldwide, and refers to conditions where the heart’s valves do not work properly (British Heart Foundation (BHF), 2017). This in turn can affect flow of blood to the heart. The estimated prevalence of VHD in developed countries is 2.5% (Lung and Vahanian, 2014). Causes of VHD can be congenital or acquired, with prevalence increasing markedly in those over 65 years of age (Lung and Vahanian, 2017).

Valve stenosis, or narrowing, refers to a valve that does not open fully, which will obstruct or restrict the flow of blood (BHF, 2017). As the heart has to pump harder in order to force the blood past the narrowing, it can put extra strain on the heart (BHF, 2017). By contrast, valve regurgitation, or leaky valve, concerns a valve that is not able to close properly, and so will allow blood to leak backwards (BHF, 2017). Again, this can put strain on the heart, but this is because the heart has to work harder to pump the required volume of blood (BHF, 2017). While many people may not experience any noticeable physical effects, commonly reported symptoms include:

  • Breathlessness
  • Swelling of the ankles and feet
  • Fatigue (BHF, 2017).

Echocardiography

As was discussed in a recent issue of the British Journal of Cardiac Nursing, echocardiography is the gold standard to confirm a diagnosis of VHD, as well as to assess its severity and prognosis (Hall, 2017). It is also key to assess valve morphology and function, as well as to evalu¬ate the feasibility and indications of a specific intervention. Aortic stenosis is the most common VHD, leading to surgery or catheter intervention in Europe and the United States (US). Its growing prevalence is attributable to the ageing population. Echocardiography is used to:

  • Confirm the presence of aortic stenosis
  • Assess the degree of valve calcification, left-ventricle function and wall thickness
  • Detect the presence of other associated valve disease or aortic pathology
  • Provide prognostic information.

Baumgartner said:

‘In aortic stenosis, there have been five randomised clinical trials comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) as well as large-scale registry data.’

The Guidelines strongly recommend early therapy in symptomatic patients with severe aortic stenosis. Exceptions are given to patients with severe comorbidities indicating a survival of less than a year, and patients in whom there are severe comorbidities, or their general condition at an advanced age make it unlikely that the intervention will improve their quality of life or survival.

SAVR and TAVI

SAVR is recommended in patients at low surgical risk, while TAVI is recommended in patients not suitable for surgery. For patients at increased surgical risk, the decision between SAVR and TAVI should be made by the heart team of surgeons and cardiologists, with TAVI being favoured in older patients suitable for transfemoral access.

The Guidelines stress that aortic valve interventions should only be performed in heart valve centres that include both cardiology and cardiac surgery on site. For asymptomatic patients, SAVR is indicated in those with severe aortic stenosis and systolic left-ventricular function not owing to another cause.

Baumgarter noted:

‘There is new evidence regarding predictors of outcome in asymptomatic patients with valvular heart disease and on antithrombotic therapy in this patient population among other innovations. This definitely required an update of management recom¬mendations.’

Baumgartner emphasised that risk score and age are not the only factors affecting the decision to use SAVR or TAVI:

‘The choice of surgical aortic valve replacement or transcatheter aortic valve implantation is not simply based on a risk score or age—the heart team must weigh the risks and benefits of both procedures, particularly in the intermediate risk situation. Discussion should include age, comorbidities, anatomy, and out¬comes of the centre for surgery and transcatheter intervention.’

Risk-stratification

Risk-stratification is an essential means of decision-making in this patient population in order to establish the risk of intervention compared with the expected natural history of VHD. The Guidelines call for the development of better risk-stratification tools, particularly for the decision between surgery and catheter intervention and for the avoidance of futile interventions.

In asymptomatic patients with VHD, studies suggest early surgery may improve outcomes. However, deciding when to intervene is controversial. For example, asymptomatic patients with aortic stenosis, who have pulmonary hypertension have been introduced into the criteria for being selected for surgery, following studies which showed it was a predictor of poor outcomes. But on the other hand, conflicting studies on the prognostic value of exercise echocardiographic parameters indicate the removal of asymptomatic patients with aortic stenosis and mitral regurgitation from the selection criteria.

Recommendations on the use of antithrombotic therapy have also been updated. Antithrombotic management should address effective control of modifiable risk factors for thromboembolism in addition to the prescription of antithrombotic drugs. The Guidelines state that there are now sufficient data to recommend non-vitamin K antagonist oral anticoagulants as an alternative to vitamin K antagonists in patients with atrial fibrillation who have aortic valve disease or mitral regurgitation. They do, however, point out that non-vitamin K antagonist oral anticoagulants remain contraindicated in patients with mechanical valves and in mitral stenosis.

Conclusion

These new Guidelines from ESC and EACTS represent a much-needed update on the management of VHD. They take into consideration new evidence on risk-stratification and the timing of intervention, as well as on percutaneous intervention techniques. They are aimed at both cardiologists and surgeons, and as Professor Volkmar Falk, EACTS Chairperson, highlights, it is important that both specialties follow the recommendations:

‘This is a joint guideline between cardiologists and surgeons. It is absolutely essential that both specialties follow the same recommendations because we are treating the same patients. Decisions in structural valve disease must be taken by a heart team of cardiologists and surgeons.’

References 

Baumgartner H, Falk V, Bax JJ et al. 2017. 2017 ESC/ EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739- 2791. https://doi.org/10.1093/eurheartj/ehx391

British Heart Foundation. Heart valve disease. 2017. http://tinyurl.com/yat7vjzt (accessed 15 December 2017)

Hall A. Suspected mitral valve disease: clinical assessment. Br J Cardiac Nurs. 2017;12(11):538- 546. https://doi.org/10.12968/bjca.2017.12.11.538

Lung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 30(9):962-970. https://doi.org/10.1016/j.cjca.2014.03.022

Taken from British Journal of Cardiac Nursing, published December 2017.

Flu vaccination guidance updated for older patients

My Post (13)Public Health England (PHE) has updated its national immunisation guidance following evidence that adjuvanted trivalent influenza vaccines (aTIVs) work better for older patients than other flu jabs (PHE, 2017a).

The Green Book (PHE, 2017a), which features the latest information on vaccines and vaccination procedures in the UK, has been amended after the Joint Committee on Vaccination and Immunisation (JCVI) recommended aTIV, FLUAD®, for the 2018–19 flu season in its October meeting.

The Committee agreed that use of aTIVs in those aged 65 years and over is ‘more effective’ than current nonadjuvanted vaccines and ‘highly costeffective’ (JCVI, 2017).

Dr George Kassianos, national immunisation clinical lead for the Royal College of General Practitioners, said:

‘I very much welcome this guidance by the JCVI. Year on year, it is becoming more and more evident that conventional non-adjuvanted influenza vaccines do not provide sufficient protection for our older patients, particularly in years dominated by the influenza A(H3N2) virus, which dominated the flu season last year and the year before. Use of this adjuvanted vaccine is expected to result in fewer infections, fewer GP consultations and hospital admissions, and a significantly reduced winter burden on the NHS.

‘On the basis of the recent JCVI Meeting minutes outlining the clinical and cost-effectiveness evidence in elderly patients, GP practices are now able to seriously consider the adjuvanted flu vaccine for their patients aged 65 years and over for the 2018–19 flu season.’

Sharon Graham, senior lecturer in nursing at Staffordshire University and a former practice nurse, said:

‘In primary care we need to ensure that we can offer the most effective prevention against influenza to our patients aged over 65 years. This JCVI guidance will, I hope, help vaccinating health professionals to make the best choice of flu vaccine for next year’s season.’

Reasons behind the decision

Last year, PHE (2017b) declared conventional non-adjuvanted influenza vaccines provided little or no protection for over 65s in the 2016–17 flu season in the UK. This was recognised by the JCVI, who acknowledged ‘low influenza effectiveness’ in those aged 65–74 years throughout seasons affected by the A(H3N2) flu strain, and ‘non-significant vaccine effectiveness’ for all types of influenza in the over 75s (JCVI, 2017).

By comparison, the JCVI said aTIVs have ‘better immunogenicity and effectiveness’ in the elderly. While vaccine effectiveness decreases with increasing age and immunosenescence, a study from British Columbia used multivariate analysis to show vaccine effectiveness of around 60% in the elderly for aTIVs (Van Buynder et al, 2013). Almost half of the patients enrolled were aged over 85 years. Conversely, non-adjuvanted trivalent influenza vaccine was deemed ineffective. This is not uncommon, ineffectiveness of non-adjuvanted trivalent influenza vaccines in this patient population has been previously reported (Treanor et al, 2012).

A systematic review and meta-analysis of trivalent inactivated vaccine adjuvanted with MF59 found it was effective in reducing several influenza-related outcomes among the elderly, especially hospitalisations due to influenza-related complications (Domnich et al, 2017). It was also reported to be superior to non-adjuvanted vaccines.

Evidence presented at the European Scientific Working group on Influenza (ESWI) meeting in Riga, Latvia last September, revealed 1700 flu-related deaths could be prevented in those aged over 65 years who switched to an aTIV (Nguyen et al, 2017). Additionally, estimations by the researchers show as many as 195 600 cases of flu could be avoided. According to the researchers, this could reduce the number of GP visits by 21,800.

Research consultant and lead author of the study, Dr Van Hung Nguyen, said:

‘The model demonstrated that the adjuvanted vaccine had an incremental cost-effectiveness ratio of £3540 per quality-adjusted life year if used preferentially in those aged 65 years of age and over in the UK.

‘This is well within, and actually considerably below, the National Institute of Health and Clinical [sic] Excellence’s guideline threshold of £20 000 per quality-adjusted life year for medicines.’

Dr Marco Barbieri, from the Centre for Health Economics at the University of York, said:

‘Health economic analyses consistently show that more effective flu vaccines are very good value in older patients.

‘They reduce the number of GP consultations, A&E visits and episodes of serious illness and, of course, they help older people to remain healthy and independent.’ Commenting on the research presented at the ESWI, he said: ‘These data suggest that use of an adjuvanted influenza vaccine is a cost-effective option for the NHS immunisation programme.’

Mathematical modelling by PHE indicates the adjuvanted vaccine would be highly cost-effective in both the 65–74 and 75 year and over age groups, even under conservative estimates (PHE, 2017a).

Marketing authorisation of FLUAD®

The aTIV FLUAD® gained marketing authorisation in the UK in August 2017. It has been licensed in some countries in Europe since 1997 and in the US since 2015. According to its manufacturer, Seqirus, aTIV has superior seroconversion rates (the time period during which a specific antibody develops and becomes detectable in the blood) in the elderly, and superior geometric mean titres (the central number in a geometric progression of the concentration of a solution as determined by titration) in clinical risk groups against all three influenza vaccine types, compared to non-adjuvanted inactivated influenza vaccines.

Dr Russell Basser MD, chief medical officer of Seqirus, said:

‘We understand the devastating human impact of influenza infection in adults aged 65 years and older, the substantial societal impact of influenza, as well as the cost to the NHS in preventable GP appointments and preventable hospitalisations.

‘We believe that our strong and robust data on FLUAD®’s clinical efficacy, real-world effectiveness, and well-established safety profile, built up over 20 years of use, demonstrates convincingly that this adjuvanted influenza vaccine has clear advantages for adults aged 65 years and over when compared to existing conventional non-adjuvanted vaccines. We consider that FLUAD® can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally.’

The company has recently announced a major investment in its Liverpool influenza vaccine manufacturing plant. This will allow-end-to-end manufacture of vaccines at the UK site, meeting growing demand and strengthening reliability of supply of FLUAD® for UK and global markets.

References

Domnich A, Arata L, Amicizia D, et al. 2017. Effectiveness of MF59-adjuvanted seasonal influenza vaccine in the elderly: A systematic review and meta-analysis. Vaccine. 35(4):513- 520

Joint Committee on Vaccination and Immunisation. 2017. Draft minute of the meeting on 4th October 2017. London: JCVI

Nguyen VH, Kelly C, Mansi JA. 2017. UK health economic model demonstrates use of adjuvanted trivalent seasonal influenza vaccine in older adults to be highly cost-effective [abstract]. Presented at the Sixth ESWI Influenza Conference, Riga, Latvia, 2017 September 10–13. http://eswi.org/ influenzaconferences/wp-content/uploads/ sites/13/2017/09/Nguyen_Kelly_Mansi.pdf (accessed 2 February 2018)

Public Health England. 2017a. Influenza: The Green Book. London: The Stationery Office

Public Health England. 2017b. Influenza vaccine effectiveness (VE) in adults and children in primary care in the United Kingdom (UK): provisional end-of- season results 2016-17. London: The Stationery Office

Treanor JJ, Talbot HK, Ohmit SE, et al. 2012. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Clin Infect Dis. 55(7):951-9

Van Buynder PG, Konrad S, Van Buynder JL, et al. 2013. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine. 31(51):6122-8

Taken from Nurse Prescribing, published January 2018.

Key areas of interest for paramedics in 2018

My Post (11)The most substantial development concerning paramedics this year is prescribing. Proposals to introduce independent paramedic prescribing were made to the Commission on Human Medicines (CHM) in 2015. However, the CHM did not support the proposals at that time. The College of Paramedics and NHS England went back to the CHM in July 2017 with case studies and an implementation plan to try and get further discussion. The following December the CHM decided to support independent prescribing by paramedics. It will now recommend implementation by making a submission to government ministers.

There is still a lot of work to be done and this is likely to be the key area for development of the profession in 2018. Legislation changes need to be made to enact the recommendation. Universities will have to develop their prescribing programmes and the Health and Care Professions Council (HCPC) will need to update its Standards for Prescribing. While it is unlikely there will be any paramedic prescribers until 2019 at the earliest, this marks a key progression in the development of the profession.

In September 2017, the HCPC began consulting on the threshold level of qualification for entry to the register for paramedics. The current level is outlined in the HCPC Standards of Education and Training at ‘equivalent to Certificate of Higher Education for paramedics’. However, the Paramedic Evidence Based Education Project (PEEP) report recommended the level to the paramedic register be raised to BSc (Hons) degree by 2019.
The consultation document proposes the level of qualification should be amended, due to the changing nature and complexity of the role of paramedics, and it illustrates the ongoing diversity in current qualifications across the UK. Any resultant change would not affect existing registered paramedics or students who are part way through pre-registration education and training programmes. The consultation closed on 15 December, with the outcome expected early this year.

Clinical practice

The UK Ambulance Services Clinical Practice Guidelines, last published in 2016, published supplementary guidelines last year. Although there will not be a new version of the guidelines this year, ongoing updates continue to be published online.

The National Institute for Health and Care Excellence (NICE) is updating its Quality Standard on Trauma. This quality standard covers assessment and management of trauma (complex fractures, non-complex fractures, major trauma and spinal injury) in adults, young people and children. It does not cover hip fracture or head injury as these topics are covered in a separate Quality Standard. The draft quality standard was open for consultation from 7 November to 5 December. The final Quality Standard is expected to be published on 29 March 2018.

Initial results from the AIRWAYS-2 trial are likely to be seen in spring 2018. This randomised trial is comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of patients suffering an out of hospital cardiac arrest.

At the time of writing, the final publication of the College of Paramedics’ position statement on paramedic intubation is still impending. Work began in May 2017 on the statement, with a group meeting in July to discuss and develop a first draft. This statement was reviewed and amended by several key clinical groups before being released to the membership and wider stakeholder organisations for comment. Consultation ran in September 2017, with final publication imminent.

Service delivery

NHS England and NHS Improvement have called on all A&E Delivery Boards to implement measures to reduce the impact of ambulance handover delays. They have outlined key principles concerning actions to be embedded as part of normal working practice, and actions to be taken should ambulances begin to queue.

Among the principles, they state acute trusts must always accept the handover of patients within 15 minutes of an ambulance arriving at the emergency department; that leaving patients waiting in ambulances or in corridors supervised by ambulance personnel is inappropriate; and that the patient is the responsibility of the emergency department from the moment that the ambulance arrives, regardless of the exact location of the patient. It will be interesting to see if the implementation of these measures will have an impact on reducing ambulance handover delays in 2018.

Ongoing feedback on the roll out of the Ambulance Response Programme (ARP) will continue throughout the year. The ARP saw changes to the triage of calls, known as dispatch on disposition, to allow more time for call handlers in cases that are not deemed as immediately life-threatening. Additionally, new call categories were introduced to better reflect the wide range of needs patients have when they dial 999. It is likely there will be national updates on the effectiveness of the ARP, hopefully with benefits of the change being seen, in 2018.

The NHS was promised £1.6 billion for 2018/19 and £900 million for 2019/20 in the autumn budget. While this is certainly welcome relief, it is still a far cry from the £4 billion health experts said the NHS needed. It is believed £1 billion of the cash pot for 2018/19 will be used to improve performance against the 18-week target for elective treatment and £600 million to help hospitals meet the 4-hour target in A&E.

Conclusions

These are just a few of the elements that will affect paramedics this year. Other areas not mentioned include the Assaults on Emergency Workers (Offences) Bill 2017–19, development of the nursing associate role, the national programme to support allied health professionals to return to practice, and the final report of the Asthma Audit Development Project. There are many challenges facing the NHS in the coming year, but with the upcoming developments in the profession, paramedics will find themselves in a key position to alleviate many of these pressures.

Taken from Journal of Paramedic Practice, published January 2018.

More nurses leaving the profession than joining, figures show

My Post (10)More registered nurses are leaving the profession than joining, analysis by the Nursing and Midwifery Council (NMC) has revealed. First published in July, the data showed that the overall number of leavers has increased from 23 087 in 2012/13 to 34 941 last year (NMC, 2017a). By contrast, the number of initial joiners was 29 025 for 2016/17.

Jackie Smith, NMC Chief Executive and Registrar, said: ‘At a time of increased pressure on the healthcare workforce to deliver quality patient care, we hope our data will provide evidence to support government and employers to look in detail at how they can reverse this trend.’

Recent figures reveal that the number of registered nurses has continued to decline, with 27% more people leaving the register than joining between October 2016 and September 2017 (NMC, 2017b).

‘These alarming new figures represent a double whammy for the NHS and patients,’ said Royal College of Nursing (RCN) Chief Executive Janet Davies.

‘Not only has the number of UK nurses quitting the profession gone up, but significant numbers of EU-trained nurses on whom the health service depends are leaving and there’s been a huge drop in nursing staff coming to work here from EU countries.’

The number of nurses and midwives from Europe leaving the register has increased by 67%, while the number joining the register from the EU has dropped by 89%.

Although the NMC does not have separate figures for the number of practice nurses leaving the profession, records show that in March 2017 there were 15 528 full-time equivalent practice nurses. This represents a decrease of 225 since March 2016 (NHS Digital, 2017). The number of European nurses joining and leaving general practice is unclear.

Why are nurses leaving?

One of the key reasons nurses are leaving the register is because an increasing number are reaching retirement. Nurses of the ‘baby boomer’ generation are now able to claim their NHS pension, and many are choosing to do so. Under the NHS pension scheme, nurses who were working on or before 6 March 1995 have the right to retire at 55 without any reductions in their pension.

‘Nursing and midwifery are widely acknowledged to be ageing professions, with significant numbers on the register coming up to retirement age,’ said Ms Smith.

It is this factor, combined with increasing workloads, that is encouraging nurses to leave the profession early said Crystal Oldman, Chief Executive of the Queen’s Nursing Institute. ‘I think what’s happening is with the increasing demands on individual nurses in their areas of practice, those at that age—between 55 and 65—are saying, “you know what, this is not what I joined to do,”’ she said.

‘“I am not able to give the care that I used to be able to give, so I’m going to retire now. I’m not going to revalidate, I’ll come off the register, I’ll take my pension.”’

Jenny Aston, Royal College of General Practitioners Nurse Champion, agrees that retirement is the main reason for increasing numbers of practice nurses leaving. ‘The QNI survey that was done a few years ago suggests that there are about 30% due to retire in the next 2–3 years,’ she said. ‘That’s going to be a massive number, unless for some reason they wish to stay on or are encouraged to stay on.’

Valerie Ely, 58, is a registered nurse and senior lecturer at Huddersfield University who is in the process of taking voluntary severance. She went part time at 55, because to remain a manager she was required by the university to do a PhD.

‘I am sad about it and to some extent a bit bitter, but I am 58 so have to accept it,’ she said. ‘A PhD would be 6 years part time and it’s really performance managed.’

‘The irony of my redundancy date is that it’s the same day I would have had to renew registration and revalidate. I have not been clinical for some years and it’s unlikely I’m going to get a job at another university, so I don’t feel that I have many options to stay on the register,’ she added.

But not all those leaving are of retirement age. Of those who didn’t cite this as their reason for leaving, the average age has reduced from 55 in 2013 to 51 in 2017. Additionally, the numbers of leavers aged 21–30 years has increased from 1 510 in 2012/13 to 2 901 in 2016/17.

A survey of 4 500 nurses and midwives carried out by the NMC revealed that working conditions, a change in personal circumstances, and a disillusionment with the quality of care provided to patients were also cited as reasons for leaving.

Sarah is a lead practice nurse at a GP surgery in South Yorkshire. She has been a practice nurse for 9.5 years but is leaving to take up a respiratory nurse role at a hospital trust. She is hoping the new job will bring back her passion for nursing.

‘As nurses experience tougher work conditions, the importance of ensuring they are valued cannot be understated’.

‘Although I enjoy the variety within the role, I am increasingly feeling overwhelmed with the extent of the knowledge and skills I need to be competent to do my job,’ she said. ‘There are only two nurses at my surgery, so we both need to be able to do everything within the practice nurse remit.’

As nurses experience tougher work conditions, the importance of ensuring they are valued cannot be understated. Kathryn Yates, Professional Lead for Primary, Community and Integrated Care at the RCN, thinks that the feedback from patients, families and carers about the outstanding care they receive from general practice nurses is incredibly important.

‘We need to continue to raise the profile of general practice nurses and how valued they are,’ she said. ‘I think we need more evidence to support that.’

Additionally, Dr Oldman says that, due to increased workloads, many nurses are finding themselves no longer doing the job they were trained to do. This understandably causes frustration and a decrease in job satisfaction. ‘They may not be leaving if the conditions were suitable for them to give the best possible care they want to give,’ she said. ‘We have a lot of anecdotal evidence from nurses who say, “I would stay, but I can’t do the job I was trained to do.”’

This lack of being valued is at the heart of why Sarah decided to leave practice nursing. ‘There is a lack of understanding and awareness of what practice nursing involves, which has an impact on others’ expectations,’ she said. ‘It is viewed by the public and other nurses/health professionals as an easy job, with nice hours and none of the pressures that are obvious in hospitals, emergency departments etc.

Our contribution is usually overlooked or any achievements attributed to GPs.’

Combatting the problem

Central to the issue of recruitment and retention is a workforce plan that ensures there are sufficient numbers of nurses now and in the future. A clear workforce plan also allows for accountability when those numbers aren’t met.

Crystal Oldman said: ‘I think the issue is about having a robust workforce plan and also having accountability for that somewhere centrally. Each individual provider must have its own workforce plan, but we are a national health service. What I would like to see is a national workforce plan for registered nurses.’

Kathryn Yates supports this but adds: ‘If we signpost to one particular organisation, it may devolve responsibility. I think there is also a sense of being mindful of how organisations work together to try and come up with real-time solutions.’

For Jenny Aston focusing on training the next generation and making nursing an attractive career is key. ‘Nursing isn’t going to change over the next 10 years: there are still going to be injections, there is still going to be lots of wound care, there is still going to be a need to monitor patients’ health,’ she said. ‘The work is not going away. There may be bigger practices, but I don’t see the nursing activity changing and, therefore, there is going to be an ongoing need to train up the next generation because 30% are going to be retired in 3 years’ time.’

Additionally, there need to be incentives for nurses not to retire early. ‘What lots of people don’t realise is that there are ways to stay on, claim your pension and make your pension arrangements different, so you don’t lose out on the final salary [pension benefits],’ said Ms Aston. ‘But I don’t think many nurses have good financial advice on how they get the best out of staying in work.’

Most importantly, nurses have to be listened to, so their concerns are understood and they feel valued. According to Kathryn Yates, it may be unclear what their needs are: ‘Going forward we may have a workforce that wants to work differently, and we must continue to make nursing an attractive and first destination career.’ she said.

Maria Caulfield, former nurse and Conservative MP for Lewes, said: ‘While I welcome the fact that more nurses are entering the profession than ever before, I am concerned that we are losing large numbers of our most experienced nurses, who are retiring or leaving the profession early. As a result, overall nursing numbers remain static at a time when the demand and need for nurses are increasing. There are a variety of reasons why nurses are leaving and certainly the pay freeze and cap have not helped morale, but from talking to colleagues it is the lack of overall recognition and feeling of worth that has led to many walking away. This is why I have lobbied ministers to ensure nurses are recognised. Lifting the pay cap is one way to show this.’

Health Education England oversees education and training of NHS staff. It has identified the need for additional supplies of nurses and improved rates of employment for graduates. Closing current shortages will also help with moderating increasing workloads.

NHS Improvement has launched a programme to improve retention of NHS staff by 2020. It will look at reasons why staff are leaving to help understand how to improve retention rates.

References

NHS Digital. General and Personal Medical Services, England March 2017. https://digital.nhs.uk/catalogue/PUB30044 (accessed 13 December 2017)

Nursing and Midwifery Council. The NMC Register: 2012/13–2016/17. 2017a. https://www.nmc.org.uk/globalassets/sitedocuments/other-publications/nmc-register-2013-2017.pdf (accessed 13 December 2017)

Nursing and Midwifery Council. The NMC Register: 30 September 2017. 2017b. https://www.nmc.org.uk/globalassets/sitedocuments/other-publications/the-nmc-register-30-september-2017.pdf (accessed 13 December 2017)

British Thoracic Society/Scottish Intercollegiate Guidelines Network. SIGN 153. British guideline on the management of asthma 2016. 2016. https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2016/ (accessed 19 December 2017)

National Institute for Health and Care Excellence. Asthma: diagnosis, monitoring and chronic asthma management. 2017. https://www.nice.org.uk/guidance/ng80 (accessed 19 December 2017)

Taken from Practice Nursing, published January 2018.

The use of anti-inflammatory canakinumab could reduce risk of heart attack

My Post (9)Results from a recent trial of the anti-inflammatory drug canakinumab have revealed it could help reduce risk of heart attack and mark the biggest breakthrough in cardiovascular treatment since statins.

The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) looked at people who previously suffered from a heart attack and tested whether administration of canakinumab  could reduce inflammation and reduce risk of future cardiovascular events (Ridker et al. 2017).

Speaking at the European Society of Cardiology Congress in Barcelona, where the findings were presented, Professor Paul Ridker of Harvard Medical School, said:

‘These findings represent the end game of more than two decades of research, stemming from a critical observation: half of heart attacks occur in people who do not have high cholesterol. For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk.’

According to Ridker this has far-reaching implications:

‘It tells us that by leveraging an entirely new way to treat patients—targeting inflammation—we may be able to significantly improve outcomes for certain very high-risk populations, he said.’

Outlining the trial

The trial was conducted by researchers from a wide range of international organisations, including the Center for Cardiovascular Disease Prevention and the Cardiovascular Division at Brigham and Women’s Hospital, Harvard Medical School, Boston; Novartis in East Hanover, NJ, and Basel, Switzerland; the Federal University of São Paulo; Universitätsmedizin Berlin; and the Academic Medical Center of the University of Amsterdam.

Participating centres in 39 countries enrolled patients who had a history of heart attack and an elevated blood level of high-sensitivity C-reactive protein. It is believed raised levels of this protein may lead to further heart attacks.

Participants received doses of 50 mg, 150 mg or 300 mg of either canakinumab or placebo. These were administered subcutaneously every 3 months. Patients were excluded from the study if they had any of the following:

  • History of chronic or recurrent infection
  • Previous cancer other than basal-cell skin carcinoma
  • Suspected or known immunocompromised state
  • History or high risk of tuberculosis or disease related to the human immunodeficiency virus
  • Ongoing use of other systemic anti-inflammatory treatments.

The 10,016 participants recruited to the study were then monitored over the next 4 years. The researchers predominantly wanted to see whether participants suffered from additional heart attacks or stroke, or died from cardiovascular disease during this time.

In total, 1,490 participants experienced the main combined outcome of heart attack, stroke, or death from cardiovascular disease within the 4 years monitored. Within the placebo group, there was an average of 4.5 of these main events per year per 100 people. The treatment groups revealed there was no statistically significant difference between the 50 mg group, compared with placebo. The 150 mg group indicated a 15% lower risk compared with placebo (3.86 events per year per 100 people), while the 300 mg group showed a 14% lower risk (3.90 events per year per 100 people). The researchers concluded that 150 mg of canakinumab taken every 3 months led to a significant reduction in recurrent cardiovascular events compared with placebo.

Considering the results

The potential implications for medicine of this study are considerable, with mainstream media hailing it as a remarkable breakthrough (BBC 2017) and calling canakinumab a ‘new wonder drug’ (Donnelly 2017). For a drug traditionally used in the treatment of arthritis it certainly makes for great headlines. However, there are a number of considerations that must be taken into account before the drug is hailed as the medical advancement some have claimed.

Highlighting limitations

As mentioned, the study only looked at patients who have already had heart attacks. This is something many of the media’s headlines failed to convey (NHS Choices 2017). The effect of the drug, therefore, on reducing inflammation in people who have not had a heart attack, remains unknown. Additionally, many newspapers claimed that canakinumab was ‘better than statins’, but this is unhelpful as it does not reflect the nature of the study. It is thought that if canakinumab was licensed as a preventative medication, it is likely it would be given to people who wouldn’t benefit from taking statins (NHS Choices 2017).

Most importantly, before any changes can be made to the current licensing of the drug, further research is needed to confirm both the beneficial effects and the optimal dose. This was highlighted in an editorial by Dr Robert A Harrington of Stanford University published alongside the study (Harrington 2017), who called the clinical benefit of canakinumab ‘modest’. He argues that ‘a better understanding of the risks and benefits of this form of therapy is needed’ and raised concerns about the fatal infections encountered in the trial and sepsis. He also cites concern over the cost of using canakinumab in patients with a previous heart attack.

Cost matters

Canakinumab is currently licensed in the United States to treat systemic-onset juvenile rheumatoid arthritis at a cost of approximately $200,000 per year (Harrington 2017). While this pricing may be suitable for rare diseases, it is unsuitable for common indications such as coronary artery disease. Given the study was funded by Novartis, the manufacturer of the drug, substantial evidence of its benefit is needed before wider licensing of the drug can be considered.

References

BBC News. Anti-inflammatory drug ‘cuts heart attack risk’ [Internet]. London: BBC News; 2017 Aug 28 [cited 2017 Sep 7]. Available from http://www.bbc.co.uk/news/health-41071954

Donnelly L. New wonder drug hailed as biggest breakthrough in fight against heart attacks and cancer [Internet]. London: The Telegraph; 2017 Aug 27 [cited 2017 Sep 7]. Available from http://www.telegraph.co.uk/science/2017/08/27/new-wonder-drug-hailed-biggest-breakthrough-fight-against-heart/

Harrington RA. Targeting inflammation in coronary artery disease. N Eng J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMe1709904

Ridker PM, Everett BM, Thuren T et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMoa1707914?query=featured_home&#t=articleTop

NHS Choices. Anti-inflammatory drug may help prevent heart attacks [Internet]. 2017 Aug 30 [cited 2017 Sep 6]. Available from http://www.nhs.uk/news/2017/08August/Pages/Anti-inflammatory-drug-may-help-prevent-heart-attacks.aspx

Taken from British Journal of Cardiac Nursing, published December 2017.