Taking certain higher-potency statins could put patients at a higher risk of developing diabetes than taking lower-potency statins, a BMJ study indicates (online, 23 May 2013).
Over a 14-year study period, researchers in Canada analysed database records for over 470,000 patients with no history of diabetes who were newly treated with a statin for primary or secondary cardiovascular prevention.
Compared with use of pravastatin (the reference for comparison), use of atorvastatin, simvastatin and rosuvastatin was associated with an increased risk of new-onset diabetes (atorvastatin adjusted hazard ratio 1.22, 95 per cent confidence interval 1.15–1.29; simvastatin 1.10, CI 1.04–1.17; rosuvastatin 1.18, CI 1.10–1.26). Conversely, patients taking fluvastatin and lovastatin were no more likely to develop diabetes than those taking pravastatin.
According to the researchers, the raised risk with rosuvastatin decreased significantly after covariate adjustment and became non-significant once dose was taken into account. They conclude that, compared with pravastatin, treatment with higher-potency statins, especially atorvastatin and simvastatin, might be associated with an increased risk of new-onset diabetes.
However, the researchers acknowledge that they were unable to identify and account for potentially important risk factors for diabetes, such as weight, ethnicity and family history.
The authors of an accompanying editorial write: "These findings may be interpreted to support a true pharmacological class effect of statins on the development of diabetes. However, an alternative explanation — prescribing bias — cannot be ruled out. Patients with an unfavourable risk profile and higher risk of developing diabetes may have been more likely to be prescribed a more potent statin and at a higher dose."
Medicines optimisation is a term with which many readers will be familiar. For the past couple of years it has been a well publicised concept used to describe how pharmacists, and other professionals, can improve patient outcomes by helping patients get the most out of their medicines.
Although medicines optimisation is not just an agenda for pharmacy, the profession is ideally placed to lead it and last month the Royal Pharmaceutical Society published guiding principles on medicines optimisation for healthcare professionals (see Box).
Revolutionising patient care
“For once, the pharmacy profession is ahead of the game,” said Keith Ridge, chief pharmaceutical officer for England, at last month’s Guild of Healthcare Pharmacists and United Kingdom Clinical Pharmacy Association annual joint conference (Harrogate, 17–19 May). He was referring to the four RPS medicines optimisation principles, describing them as “simple but robust” with the potential to “revolutionise” medicines use in the NHS. He encouraged pharmacists to adopt the RPS principles and work alongside other professions to ensure patients get the most from the medicines they are prescribed.
“There is an overwhelming desire for quality in healthcare . . . which puts patients’ needs and experience right at its heart,” remarked Dr Ridge. He later added: “With a new health and social care system built on quality, and one which is patient-focused, clinically led and outcome-driven, medicines optimisation has appeared just at the right time.”
So, how is the recently reformed NHS in England now approaching the medicines optimisation agenda, and what support is there to help organisations ensure patients do get real benefits from their medicines and the care they receive?
In the new NHS England commissioning system a dedicated medicines optimisation clinical reference group, led by deputy chief pharmaceutical officer for England Clare Howard, will provide medicines optimisation skills and expertise to specialised medicines commissioning.
The NHS Trust Development Authority is another new NHS organisation that became fully operational in April 2013. It has been charged with overseeing the process of ensuring all NHS trusts reach foundation trust (FT) status — a target set by the Health and Social Care Act 2012 — and has made medicines optimisation one of its key priorities.
There are around 100 NHS trusts across England — representing a variety of healthcare services including community, mental health and ambulance services, as well as acute care — that are currently pursuing FT status. The NHS TDA will provide support and oversight to these organisations at every stage in the process of becoming an FT, from strategic planning and systems development through to approval for assessment by Monitor, the regulator responsible for granting FT licences.
“The scale of the challenge is quite significant,” said Richard Seal, chief pharmacist at the NHS TDA, speaking at a later session. “We aspire to have sustainable, high-quality services in every part of the NHS.”
Mr Seal likened discharging patients from hospital without considering what happens with their medicines to pushing a patient out the door of an aeroplane without a parachute.
He explained that, in contrast to FT approval processes in the past, quality is sitting alongside finance in the NHS TDA as something that is “extraordinarily important” to obtaining FT status, and this includes quality in the delivery of medicines optimisation and pharmaceutical services.
Medicines optimisation principles
Embedding the concepts
Although Mr Seal acknowledges that many NHS trusts already have strong policies and approaches to medicines optimisation, he believes the concepts are not yet embedded in their everyday business — which is something he will be encouraging in his work as clinical lead for medicines optimisation at the NHS TDA.
“Medicines are still the most common therapeutic intervention but, from my perspective, we do not support patients enough to take the medicines they are intended to take,” commented Mr Seal.
With the support of other healthcare bodies, the NHS TDA is in the process of developing a medicines optimisation and pharmaceutical services framework. Expected to be published in the coming months, the framework will be consistent with the RPS principles for medicines optimisation and be used specifically by NHS trusts seeking FT status.
Mr Seal explained that, by using the framework, NHS trusts will be able to establish a baseline of current performance to allow benchmarking of success. It will help identify areas of good practice as well as areas for development, and will provide the NHS TDA with assurance that, when the NHS trusts they have been supporting go forward for assessment by Monitor, they will have robust and effective medicines optimisation systems in place.
Unsuccessful "no cheaper stock obtainable" (NCSO) claims are mostly due to administrative errors made by contractors, a new Pharmaceutical Services Negotiating Committee survey has discovered. A further 27 per cent are due to errors made by the NHS Business Services Authority (see Panel).
The PSNC said that the current NCSO system urgently needs to be reviewed, adding that it is currently in talks with the Department of Health on the matter.
PSNC head of pricing Harpreet Chana told PJ Online that the PSNC hopes its study and analysis will help contractors to review their endorsement processes and to minimise disallowed claims. "The study also identifies other issues the PSNC is working to resolve with the Department of Health and the NHSBSA. These are the identified errors in claims processing, and the problem with enabling a simple way of making NCSO claims for electronic prescription service prescriptions. We hope to resolve these soon," he said.
Only 40 per cent of eligible items claimed for
The survey examined the impact of the NCSO arrangements using the PSNC’s new electronic auditing system, PRISM. Prescriptions for 14 different products that were granted NCSO concessions and submitted between November 2011 and November 2012 were analysed. In total, the survey encompassed 3,233 items, all of which were eligible for the concessions, from 333 different pharmacies. It found that only 1,284 NCSO claims were made, 39.7 per cent of the claims that could have been submitted.
Of the claims that were submitted, 75.9 per cent were successful, up from 16.3 per cent in a similar survey conducted in 2011. Of the successful claims, 66.5 per cent were paid as endorsed, 16.9 per cent were underpaid and 16.5 per cent were overpaid.
The PSNC suggested that contractors may not be claiming for NCSO items because they have purchased products in short supply at or below the Drug Tariff price or because the prescription was filed away before the NCSO concession was granted. It pointed out that the electronic prescription service is compounding the problem because the electronic claim message cannot be recalled once submitted.
"At present we would advise contractors dispensing electronic prescriptions to either delay submission of the electronic claim message until after the NCSO concessions are announced or make a claim in advance of an announcement being made," said Mrs Chana, who also advised visiting the PSNC website for information on NCSO lines and reading the top tips on endorsement and submission in the May Community Pharmacy News.
The survey was prompted by the rise in the number of supply issues affecting generic products and the subsequent increase in the number of times pharmacies are claiming for NCSO concessions. In addition, the PSNC said there has been a substantial increase in shortages since November 2012.
Reasons for unsuccessful claims
For claims that were not successful, the following reasons were found:
The shake-up of the way NHS dentistry services are commissioned has been botched, a Conservative peer – and former dentist – warns
Research to support British Dental Health Foundation's National Smile Month reveals 80% of dogs over three will have gum disease
India may be a leading producer and exporter of vaccines, yet the government's immunisation programme fails to reach an estimated 28% of babies born there.
'The cough that paralysed me and left me in constant pain'