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Oral penicillin: children’s dosage recommendations

January 26, 2012 by admin 

How many of the 5 million children in England who receive oral penicillins each year really need them, and what are the effective doses? It is time to replace the rule of thumb used for dosing with up-to-date evidence, according to a paper published on behalf of the improving Children’s Antibiotic Prescribing UK Research Network (iCAP).

The authors used a literature and formulary search to find out where the current, sometimes confusing, recommendations come from. It appears that, ‘a general recommendation to use age banding for all antibiotics in children, irrespective of the type of penicillin or disease indication, was published in the BMJ in 1963…Critically, these recommendations have remained unchallenged and unchanged to this day’.

Does a big child = half an adult? The BNF recommendations to halve doses between successive age bands for children have remained unchanged, for penicillin V, flucloxacillin and amoxicillin since they first appeared in it in the 1960s and 1970s. Adult penicillin doses have increased substantially but those for children have not. The mg/kg doses may also now be even lower than they were, because of an increase in average children’s weights. When the authors analysed the actual doses that would be received today, they found that at the older age/weight ranges, the doses are ’strikingly low’. Many of the older children’s medicines do have a limited evidence base, but these authors were surprised at how little recent evidence supports the current recommendations.

They warn of the risks of low dosing - for antimicrobial resistance, severe complications and need for retreatment, and conclude that work is needed to determine the effective doses for children of all weights and ages, and also to, ‘establish more clearly which children really need antibiotics in the era of pneumococcal conjugate (PCV 13), Haemophilus influenzae B, and meningitis C vaccines’.

Ahmed U et al. Dosing of oral penicillins in children: is big child=half an adult, small child=half a big child, baby=half a small child still the best we can do? BMJ 2011;343:d7803

http://dx.doi.org/10.1136/bmj.d7803

RCN indemnity changes - further reactions

January 26, 2012 by admin 

The RCN has said that it is ‘unacceptable’ for  GP employers to insist that nurses buy indemnity cover, or cover any costs to the practice. In a briefing issued in December (see here for the RCN briefing and here for news of the announcement and initial reactions), the RCN has hit back, saying that this is poor employment practice, that it is commonly accepted that the costs of running a business should be carried by the employing organisation, and that it will help its members resist the move. It also claims that many GPs do not know about the benefits of RCN membership and that it is important they understand that the RCN provides legal support and advice to its members for any case before the NMC - this is separate from the indemnity scheme.

As for independent prescribers, the statement stresses that the employer is vicariously liable for the actions of employed nurses, and that independent prescribers are not required to have personal cover either professionally or legally: if the GP or the medical defence organisation that covers them wishes it, then that is the employer’s responsibility.

The Medical Defence Union (MDU) has now met with the RCN and says that it believes there are implications for practice nurses who were indemnified by the RCN, because their role is changing (see here.) It claims that increased responsibilities come with greater accountability, and that although employed nurses could choose to rely on the indemnity provided by their employers’ vicarious liability, ‘many may be concerned that as professionals in their own right a claim or complaint may be brought directly against them in person, and so decide they need to join a medical defence organisation themselves for their own peace of mind.’

No news is bad news on CD changes

January 26, 2012 by admin 

After hopes were raised in the autumn (see here), the Home Office said on 9 January that it is still unable to provide a date for the long-awaited amendments to the Misuse of Drugs Act about independent prescribers and controlled drugs. The statement was made in correspondence with pharmacist prescriber Mark Hutton, who specialises in the management of chronic pain, in the East Midlands, and who has been pursuing the Home Office since 2008 about these amendments. He said,’It is ridiculous that I cannot prescribe a drug such as co-codamol yet a patient can purchase it in a pharmacy, and that as a qualified independent prescriber, I have to use supplementary prescribing to prescribe controlled drugs for patients. There is a shortage of pain consultants compared with the number of people with chronic pain, and the Home Office has given no reason for the delays in allowing non-medical prescribers to provide a better service to patients in pain.’

Matt Griffiths, visiting professor of prescribing and medicines management at the University of the West of England, who has also been urging the Home Office to act and highlighting the consequence of delay for some years, had this to say:

‘We have been promised these changes since 2008. As well as non-medical prescribers and their patients, this also affects nurses who want to mix medicines that include a controlled drug, as these amendments will be made at the same time. There are daily restrictions on my practice, where legislation has not kept up with the needs of the modern day health service. I can work as a visiting clinician on a daily basis. I can prescribe certain controlled drugs for palliative care patients, but I can’t carry them out to their homes unless it is on a named patient basis. Despite correspondence with Lord Henley, the Home Office minister responsible, and earlier promises from the Home Office, no date has been given, and the reasons behind the delays of nearly four years do not justify them. I believe that Secretary of State for Health Andrew Lansley, or Prime Minister David Cameron need to intervene as patient care is being affected on a  daily basis’.

The statutory instrument was most recently promised for the end of October 2011 (see here) and will allow nurse and pharmacist prescribers to prescribe controlled drugs, within their competence, as well as making the promised changes on mixing medicines, where one or more is a controlled drug (see here).

ANP Chair Barbara Stuttle, who wrote to David Cameron about this issue last year, points out the anomaly involved in this long delay: ‘We keep being told about the £20 billion that needs to be saved in the NHS but something that could so easily address some efficiency concerns - but relies on Ministers - is constantly delayed! All the relevant bodies agree about these legislative changes: all it needs is the statutory instrument. If the government is serious about supporting clinicians to work efficiently and effectively, then I urge the Home Office to make these legislative changes urgently. This will enable nurses to do their job and look after patients by providing the right care at the right time.’

Where is the evidence base: NMP in primary care?

January 3, 2012 by admin 

A review of the literature on non-medical prescribing  (NMP) in primary care that looked for evidence of patient outcomes has found that most such studies were undertaken in the UK, and that there are ’substantial gaps’ in the knowledge base that could inform evidence-based policy making.

The authors identified 17 empirical studies providing patient outcome evidence of NMP in primary care, with only two looking at clinical outcomes. Some papers were surveys, had qualitative designs, few participants, or reported on prescribing from limited formularies, and the authors comment that, ‘the strength of evidence they provide on the whole is limited’.

NMP in primary care does seem to improve: ‘patients’ understanding of treatment, condition and self-care and provides a better level of care’, was well accepted by patients and professionals, and improved access to medicines and healthcare professionals. Other indicators of effectiveness such as clinical outcomes or patient safety had very limited evidence, and papers on health economics and efficiency were also lacking.

Bhanbhro S et al. Assessing the contribution of prescribing in primary care by nurses and professionals allied to medicine: a systematic review of literature. BMC Health Services Research 2011; 11:330.

http://dx.doi.org/10.1186/1472-6963-11-330

Medicines for Children website launched

January 3, 2012 by admin 

Medicines for Children, a website for parents and carers with lots of information about specific medicines, has been developed by a partnership of the Royal College of Paediatrics and Child Health (RCPCH), Neonatal and Paediatric Pharmacists (NPPG) and WellChild. The leaflets about individual medicines contain detailed advice about missed doses, administration and side effects and there are also leaflets about different formulations and administration methods.

NRLS to transfer to NHS Trust

January 3, 2012 by admin 

The day-to-day operation of the National Reporting and Learning System, said to be the largest source of patient safety incident data in the world, looks set to transfer to Imperial College Healthcare NHS Trust for a period of two years (see here).  The National Patient Safety Agency is being abolished and its patient safety function will go to the new NHS Commissioning Board, which will provide oversight of the NRLS.

RCN indemnity changes

November 22, 2011 by admin 

The changes announced recently to the RCN’s indemnity scheme have provoked much debate online, in the press, and at the recent ANP annual conference. There appears to be confusion about whether practice nurses in extended roles, such as prescribing, will now need their own indemnity insurance and, if so, who will pay for it.

The RCN has updated its information in response to questions since the announcement. The statement stresses that nothing has changed for individual nurses. Indemnity for charitable or Good Samaritan work is still included in the RCN subscription. The change means that if an RCN member employed by a GP practice is found to be at fault in a clinical negligence action, medical defence organizations such as the Medical Defence Union (MDU),  the Medical Protection Society (MPS) and the Medical and Dental Defence Union of Scotland (MDDUS) will no longer be able to try to recover some or all of the costs from the RCN.

The RCN says that the change only affects the medical defence organisations, that GP practices should have group indemnity cover and accept vicarious liability for all staff, and that nurses employed by GP practices (not a partner or self-employed) do not need personal cover.

The MPS has provided some information about this on its website where it says that it is, ‘unlikely that GP members would be granted assistance from MPS’ for negligence claims ‘against nurses working in extended roles’ and that practices are therefore strongly advised to ensure that ‘these nurses have and maintain their own indemnity arrangements’.  Wessex Local Medical Committees, for example, echoes this, saying practice nurses ‘may want to get their own insurance’ in case of actions against them that do not ‘fall under vicarious liability’ and that ‘this may be even more relevant for nurse prescribers’. The MDU has told the ANP that it was surprised to hear of the change, and that it is planning to meet with the RCN. It says, ‘It may well be that nurses as professionals in their own right will need membership of the MDU to secure their peace of mind for their exposure to liabilities arising from their work as regulated healthcare professionals’ and adds that nurse practitioners and nurses in an extended role can obtain personal membership including indemnity insurance.

The RCN says that it is a ‘myth’ that independent prescribers need personal cover and that employers should not be asking nurses to undertake any duties not covered by the defence organisation. The BMJ has reported that practices will have to upgrade to practice-wide cover, at some expense, but that these schemes may not cover nurses working in extended roles, such as prescribers, quoting Dr Vautrey, deputy chair of the BMA’s General Practitioners Committee. The report says that in these cases practices may have to pay for personal insurance for their nurses, given the RCN advice to its members.

In the ‘Standards of proficiency for nurse and midwife prescribers’, the NMC recommends, that ‘every nurse/midwife prescriber should ensure that she has professional indemnity insurance by means of a professional organisation or trade union body. …Registrants are strongly advised to contact their professional body, to ensure that their indemnity insurance covers them for the scope of their prescribing practice.’

Medicines legislation to be consolidated

November 22, 2011 by admin 

The MHRA is consulting on plans to consolidate and review UK medicines legislation to provide a clear, coherent regulatory framework (see here for the consultation details - the deadline is 17 January 2012).

About 200 statutory instruments and much of the Medicines Act 1968 could be replaced with one set of regulations that will be shorter and simpler - much of the existing law is obsolete - and provide a platform for future changes. Some policy changes are also included, with the proposal to remove the need for pharmacists to attempt to contact the prescriber before making certain changes to prescriptions probably attracting the most comment. The aim is to allow pharmacists to optimise the use of medicines - for example by adjusting an antibiotic schedule. At present, pharmacists can only make these changes if they have tried to contact the prescriber but failed. This suggestion has attracted questions about where the legal responsibility lies, whether there is a conflict of interest for the pharmacist as the seller of drugs, and whether adverse events reporting would be compromised.

Another change will remove statutory warnings and replace them with warnings in the relevant marketing authorisation, a speedier and more flexible system. A different proposal will remove some of the current exemptions from the Act that allow health professionals and other people to sell, supply and/or administer medicines, and extend or introduce others, for example about water for injections. The suggestion that the appropriate professional bodies should hold and maintain the list of medicines that can be accessed by their particular professional group, rather than the lists being specified in statutory instruments, with all that implies, is being considered separately.

Finally, what will happen to Patient Group Directions (PGDs)? Well, their current general structure and requirements will be retained, and only registered health professionals will be able to use them. But it is proposed that NHS bodies should be able to supply medicines not from pharmacies according to the directions of independent nurse, pharmacist and optometrist prescribers, as they can currently for doctors and dentists. Other proposals relate to the way independent hospitals, clinics and agencies are registered with the Care Quality Commission, and removing the distinction as far as PGDs are concerned between NHS-funded dental services and others. Unlicensed medicines will continue to be excluded from the scope of PGDs.

ANP Chair, Barbara Stuttle, said, “The law has certainly become confusing - this is a chance for us all to influence the system we work under - and it could produce something we can all work with!”

ANP annual conference: diversity, change and standards

November 22, 2011 by admin 

The nursing profession can congratulate itself on the way it has handled non-medical prescribing, as other professional groups now take on these responsibilities, said Dr June Crown CBE, President of the Association for Nurse Prescribing (ANP), at the start of its annual conference held in London recently. Despite the frustrations accompanying the occasionally slow progress made since the Cumberlege review 25 years ago, much has been achieved. The course is set now, even if it is slow: no more battles lie ahead.

Dr Crown added that prescribing “is of its time”: we have an ageing population whose multiple chronic diseases are increasingly being managed outside hospital by non-medical health professionals, often using prescribing to deliver the full range of care. When non-medical prescribing was first introduced, it was not defined by the setting in which it occurred: how prescient this has proved now, as different settings become intertwined and the boundaries blurred. Huge challenges lie ahead in healthcare given the financial regime, but this does provide opportunities to develop how care is delivered even further and prescribing will be central to this.

Of course, regulation and professional standards must be robust, whatever the setting, and keep pace with the changes -  this was a theme reiterated throughout the day.

Much has happened since 2006, and Fiona Culley, Professional Adviser to the Nursing and Midwifery Council (NMC), explained that work has now started on revising the NMC standards, both for prescribing and for medicines management. They will be combined, clarified and updated, with new education standards also underway. Consultation will be wide - do look out for developments and contribute. The National Prescribing Centre (NPC) is developing a single competency framework for all prescribers, with publication due in March 2012.

Most of the calls received by the NMC advice centre relate to prescribing and medicines management: remote prescribing, private prescriptions, methods of supply and administration, storage of drugs and controlled drugs are particular favourites. The bottom line is that meeting regulatory and legal requirements is not optional - whatever the setting or circumstances - and there can be no private agreements. The NMC is the regulatory body for nurses and midwives - it is irrelevant if GPs, for example, disagree with its standards. And different professional bodies adopt different lines, on self-prescribing for example. The GMC has consulted recently on medicines and prescribing standards and has asked about sports medicine in particular - the final version is due out soon.

The NMC is now hearing more fitness to practise cases than in the past, probably reflecting greater reporting because of increased media attention and public awareness. Only a handful of these have concerned prescribers, but many more relate to people who are not prescribers but think that they might be! As of September 2011, there were 57 838 nurse and midwife prescribers recorded by the NMC.

The conference included two workshop sessions with several choices for each, so delegates could follow their interests. One was a sobering but fascinating account of the state of diabetes care by Dr Rowan Hillson MBE, National Clinical Director for Diabetes, focussing particularly on the scale of the problem from a public health perspective and on some of the failures of the system when people with diabetes end up in hospital - as they so often do.

The scale of the problem is shown starkly with the Association of Public Health Observatories prevalence model: the 2010 estimate for people over 16 with diabetes is 3.1 million; by 2030 this figure is 4.6 million. Dr Hillson highlighted the importance of integrating services across settings in the NICE Quality Standards for Diabetes, stressing that for patients there should be no boundaries between care settings; and for professionals taking responsibility when they notice problems, ranging from getting specialist foot teams to see people with foot problems, to immediate referral for children with high blood glucose who may have diabetes. Dr Hillson also raised the question of why the under 55s are not doing better with their glucose control - and why they do not seem to be getting statins - are services really set up to meet the needs of the working population? Who influences your prescribing decisions and why do you make the decisions you do? All sorts of factors come into play here - local formularies, representatives of pharmaceutical companies, consultants and GPs, and NICE.

The 2010 National Diabetes Inpatient Audit captured data about the people in hospital on one day, with some exclusions. This revealed that up to a quarter of beds were occupied by people with diabetes but 31% of sites had no inpatient diabetes specialist nurses, with nearly as many having no inpatient dietetic provision for people with diabetes. The foreword pulls no punches about the report’s findings: “compared to the general inpatient population, people with diabetes in hospital are older, sicker, have more complex disease and stay longer. It also shows that they suffer frequent medication errors and not infrequently come to harm as a consequence…..many hospitals have under-staffed and under-resourced diabetes teams.”

Dr Hillson finished as she began - with the powerfully simple message that everyone with diabetes deserves the highest standards of personalised diabetes care. The discussion which followed highlighted the importance of good communication and joined-up care, and how nurse prescribers need to ensure their patients receive this, particularly with all the changes.

Another hot topic at the moment is prescribing and medicines management in aesthetic medicine, where the workshop was led by Karen Ford, Senior Lecturer and Non-Medical Prescribing Lead at De Montfort University.

Some aesthetic nurses work in large organisations and some on their own but whatever the setting, practice should be professional and the laws and regulations on prescribing and medicines management followed to the letter. Nurses are professionally accountable to the NMC for their practice - what the GMC says is irrelevant - they have to follow their own standards and regulations. Professional accountability and reporting concerns are professional duties.

The workshop looked at some of the issues around stock management, stressing that stock becomes the patient’s property when a prescription is issued, the use of patient specific directions and patient group directions, where there has been confusion, and the use of the same drug under different names because of licensing. The whole remote prescribing issue again brings out the importance of professional standards: nurses must follow the NMC advice whatever other professionals may say.

How can non-medical prescribing in mental health be developed and sustained? What actions are needed to deliver safe, high quality prescribing within an organisation? Steve Turner, a nurse prescriber, director of  a social enterprise company and Associate Lecturer at the University of Plymouth, led a workshop looking at these issues.

He started by looking at three key documents (see here and here) and discussing how a model of successful change can be applied to the situations faced by delegates. With this as a basis, the discussion then turned to the remaining difficulties and obstacles in the implementation of non-medical prescribing in mental health, and what is needed to make it successful. A common quality assurance framework incorporating best practice from all service areas is needed, and it is important at a time of change to demonstrate the value of non-medical prescribing including involving patients and public in service developments, perhaps using audits and national and local patient and staff satisfaction surveys. It is also important to educate staff, patients and the public about non-medical prescribing.

The workshop discussion produced a checklist of items vital for adequate planning and for support for newly qualified non-medical prescribers, which delegates felt should all be included in local policies. Items included dedicated medical supervision and consultant/medical support; peer support (including within specialties); regular non-medical prescribing meetings; induction packs and preceptorship; access to continuing professional development (CPD); the issue of  CPD portfolios which can be used in review sessions; involvement in audit and service evaluation; mentoring and buddying; development of career pathways; and education about the benefits of non-medical prescribing for the entire workforce.

Another workshop that highlighted the importance of CPD and education for professionals, and also good education and resources for patients, was on breakthrough cancer pain (BTcP). It was facilitated by Ray Bunn, Community & Palliative Care Pharmacist, Kamsons Pharmacy and St Catherine’s Hospice, Crawley, West Sussex.

After a presentation on the definition, assessment, diagnosis and management options for BTcP, participants discussed and identified key issues that should be addressed to improve the management of BTcP in secondary, hospice and primary care settings.

For healthcare professionals, one issue was inconsistent understanding of the terms ‘breakthrough cancer pain’ and ‘end of dose’ pain. Other issues and barriers included: inadequate understanding of the role of opioids in BTcP, including which options are appropriate; the indications, prescribing and baseline opioid dosing if a ‘rapid release fentanyl’ is considered; the fact that primary care has not really embraced the increased profile of rapid release fentanyls with, perhaps, the exception of Actiq; concerns about their use and the potential for tolerance and addiction; and potential side effects and how to manage them.

For patients, better understanding of dose titration for the various opioids used for BTcP and the relative complexity of titration would be helpful. There are also some availability issues for some preparations from pharmacies, especially rapid release fentanyls.

All this led to the conclusion that more education and educational resources are needed: for professionals, including more accredited CPD; more verbal patient education including one to one patient and carer education by healthcare professionals; and more patient education resources, for example Patient UK information leaflets, which are used extensively in general practice and community pharmacies.

Dr David Edwards is a GP with an interest in sexual medicine - he is president elect of the British Society of Sexual Medicine and has a post-graduate degree in medical anthropology. He led workshops on sexual health that followed the interests of the participants using case studies as a starting point for discussion.

Something that emerged as a common issue was getting the patient comfortable in talking about sexual matters and the discussion also touched upon the difficulties that the healthcare professional might have in asking about such matters. Many aspects of female sexual problems were covered, particularly vaginismus, which many delegates had encountered.

The importance of erectile dysfunction and testosterone deficiency syndrome were discussed, along with the lifestyle issues that are often found and the importance of encouraging patients to help themselves, using a COSH (contract of sexual health). This metaphorical tool enables the patient to help himself whilst the healthcare professional encourages him on lifestyle issues and adjusts factors such as glucose and blood pressure monitoring for example. The clinician, in return, helps the patient deal with the medical treatment aspect of the sexual dysfunction.

The need to demonstrate the impact of non-medical prescribing on patient care, and examine how it works, was raised several times at the conference so the presentation towards the end of the day by Non-Medical Prescribing Lead Sam Sherrington about the audit of non-medical prescribing in NHS North West was very timely. The results demonstrate reductions in GP appointments, consultant appointments, unscheduled care episodes, length of hospital stays, and medicines-related admissions. Clinicians really were prepared to participate and the results demonstrated how non-medical prescribing can support the QIPP agenda.

As other sessions had highlighted, the legal aspects of prescribing can be a complex area and clarity is vital. Emma Galland, a solicitor-advocate at Weightmans LLP who trained at a hospital trust, provided a robust and clear outline of the current situation.

She highlighted those parts of legislation and of the NMC Code and standards that are particularly relevant to prescribers working in different settings. For example, colleagues must be informed when care is shared; this is especially relevant if prescribing is in the community but the patient may need admission. Professional judgement must not be influenced by any commercial considerations. The 2010 Bribery Act is relevant here and prescribers should always be clear that there is a clinical basis for decisions.

The NMC also recommends that nurses have professional indemnity insurance, and this is even more important if extra responsibilities such as prescribing are involved. In her view, having indemnity cover is part and parcel of being a professional. There was a lot of discussion about the change announced recently by the RCN (see here for further information on this). ,

Using abbreviations is one example of the risks involved in writing prescriptions: one example was someone moving from intensive care to the ward coming off a sliding scale who was prescribed 6U of insulin, despite the BNF specifying that U should not be used for units. He was given 60 units and subsequently died. Another example is the security of prescription pads - best practice is to return pads at the end of the day or session so that they can be stored securely.

Another tricky area is that of consent and capacity to consent. Capacity involves the ability to understand the information provided, to retain it, to weigh it up in making a decision, and to communicate the decision by any means. Consent is needed specifically for supplementary prescribing, which must be explained to the patient preferably by the independent prescriber. The patient’s agreement needs to be documented. Consent is also needed for any treatment. If treatment is given without consent, it is an assault.

If an adult is assessed as not having consent, their best interests must be assessed holistically, taking a range of factors including social, religious and cultural, into account. To a limited extent, it is possible in these circumstances to talk to family and friends, but as little confidential information as possible should be disclosed. She also discussed the issue of children consenting or refusing to consent, and what Gillick competence means. This can depend on the consent required and the consequences of the decision.

CD changes promised by end of October

October 20, 2011 by admin 

The Home Office says it is finalising the long-planned regulatory changes to the Misuse of Drugs Regulations 2001 about controlled drugs (see here and here) and that the appropriate statutory instrument will be laid before parliament by the end of October. The changes would then be expected to come into effect in November.

The most recent parliamentary answer can be seen here and Fiona Culley of the NMC told the ANP at its annual meeting on 19 October that she had received similar assurances from the Home Office. Professor Matt Griffiths, who has been pursuing this matter over the years, has told the ANP that he, too, has been given this information. So…..watch this space!

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