1. Self-monitor coagulation status, says NICE
Patients receiving long-term warfarin therapy should be given devices to help them monitor their coagulation status, says guidance issued on 24 September 2014 by the National Institute for Health and Care Excellence (NICE).
The guidance recommends two point-of-care coagulometers — Roche Diagnostic’s CoaguChek XS system and Alere’s INRatio2 PT/INR monitor. Both devices are recommended for use by adults on long-term warfarin who have atrial fibrillation or heart valve disease, provided they are willing and able to use the monitors.
An estimated one million people in the UK take warfarin to prevent blood clots. Currently, patients must make regular — sometimes weekly — clinic or hospital visits to have their international normalised ratio (INR) measured.
Self-monitoring means that patients can test their INR themselves and adjust their warfarin dose by following an agreed protocol. This approach is “highly cost-effective” compared with standard monitoring, the guidance states. By contrast, self-testing — whereby patients test their INR but contact their healthcare professional for advice on warfarin dose adjustment — is not cost-effective.
2. Scotland’s new drugs fund evolves
A £40m fund to make new medicines available to people with rare conditions or those at the end of life has been announced by the Scottish government.
The New Medicines Fund replaces the Rare Conditions Medicines Fund set up in March 2014 with a £20m budget.
The fund has been paid for by the rebate given to the government by the pharmaceutical industry through the Pharmaceutical Price Regulation Scheme (PPRS) — the UK-wide branded drugs pricing scheme.
“Industry has agreed to do its part by keeping NHS expenditure on branded medicines across the UK flat for two years, with the industry underwriting any further expenditure by the NHS within agreed boundaries,” explains Andrew Powrie-Smith, director of the Association of the British Pharmaceutical Industry Scotland. “I am glad to see that the Scottish government is leading the way in re-investing money from PPRS in new medicines.”
The Scottish government has guaranteed funding for the New Medicines Fund until at least 2015/2016.
3. Change to ADR reporting rules
It will no longer be compulsory for pharmacists, doctors and other healthcare professionals in the UK to report all suspected adverse drug reactions (ADRs) in children to the Yellow Card scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
Instead, it will only be necessary to report suspected ADRs that are serious, medically significant or result in harm, as well as all reactions associated with newer drugs and vaccines.
An MHRA-led workshop with paediatric specialists, pharmacists and patient organisations found that reporting all suspected ADRs in children was impractical and potentially acted as a barrier to the reporting of reactions.
4. Value-based assessments on hold
The National Institute for Health and Care Excellence (NICE) will not push ahead with its proposed introduction of value-based assessments for new drugs for use by the NHS.
NICE made the announcement on 17 September 2014, when it also unveiled the results of a public consultation on the proposed changes.
Any revamp of NICE’s current methods should now be part of a wider review of the innovation, evaluation and adoption of new treatments, including those for cancer. Until then there will be no changes to the way that NICE evaluates drugs, including those for patients at the end of life.
5. New antibiotic for hospital-acquired pneumonia
Telavancin (Vibativ) is now available in Europe for the treatment of adults who have contracted pneumonia in hospital, including ventilator associated pneumonia (VAP), caused by meticillin-resistant Staphylococcus aureus (MRSA).
Telavancin was approved by the European Medicines Agency in 2011. However, its marketing authorisation was suspended in 2012 before launch because the contract manufacturer did not meet Good Manufacturing Practice requirements. Following transfer of production to a new contract manufacturer, the suspension was lifted in early 2014.
Marketed by the Clinigen Group, telavancin is a lipoglycopeptide antibacterial agent. Like vancomycin, it binds to and prevents polymerisation of bacterial cell wall constituents, weakening and then killing the cell. It also interacts with the cell membrane, causing depolarisation and cell death.
Telavancin is authorised for the treatment of hospital-acquired pneumonia in adults, including VAP, known or suspected to be caused by MRSA, when other treatments are not suitable. It is administered once daily by IV infusion and, unlike vancomycin, does not require therapeutic drug level monitoring.
6. Neurologists warn against long-term opioid use
The risk of death, overdose, addiction and serious side effects from opioids outweigh their pain relieving benefits in chronic non-cancer conditions, says the American Academy of Neurology (Neurology online, 30 September 2014).
The academy recommends that both the patient and the prescriber sign an opioid treatment agreement at the outset of treatment and then annually, outlining the risks of chronic opioid use. Before chronic therapy is started, patients should be screened for current or past drug abuse, depression and anxiety. The daily morphine equivalent dose – and the patient’s pain and function – should be monitored to assess tolerance and treatment effectiveness.
Roger Knaggs, a member of the British Pain Society council, says there has been an increase in opioid prescribing in Europe. “However, it remains unclear as to whether the harms and public health consequences of this increased prescribing are the same [as in the United States].” This uncertainty is partly because the UK has fewer data sources on opioid misuse.
7. ’Accountable GP’ for all patients
All patients in England will have a named GP responsible for coordinating their care under changes to the national contract for GPs announced on 30 September 2014.
As part of their obligations under the 2015 contract, negotiated by NHS Employers and the British Medical Association’s General Practitioner Committee, GPs will be expected to offer patients online access to medical records and deliver more online services, including appointments.
Initiatives that help avoid unplanned hospital admissions — offered as an enhanced service by GPs — will also be funded for another 12 months, NHS England announced.
8. Fluoxetine endorsed for use in bipolar disorder
Fluoxetine is the only antidepressant that is effective in treating bipolar depression, and only in combination with the atypical antipsychotic olanzapine, says an updated clinical guideline from the National Institute for Health and Care Excellence (NICE).
This marks a change from NICE’s 2006 bipolar guideline, which did not specify any particular drug, but recommended that a drug from the antidepressant and antimanic drug classes should be used in combination to treat bipolar depression. Another first-line treatment option is monotherapy with quetiapine. Olanzapine or lamotrigine monotherapy can also be considered, says NICE.
For mania, the antipsychotics risperidone, haloperidol, olanzapine and quetiapine are recommended.
9. New COPD inhaler
A combination inhaler has been launched for the treatment of chronic obstructive pulmonary disease (COPD), adding to a growing number of products that combine two long-acting bronchodilators.
Anoro Ellipta, marketed by GlaxoSmithKline, contains the novel long-acting muscarinic receptor antagonist (LAMA) umeclidinium, and the selective long-acting beta2 adrenergic receptor agonist (LABA) vilanterol. The product is licensed as a maintenance treatment to relieve symptoms in adults with COPD.
It is unclear where products that combine a LABA and a LAMA fit into the management of COPD, says Anna Murphy, consultant respiratory pharmacist at University Hospitals of Leicester NHS Trust. In the current COPD guideline from the National Institute for Health and Care Excellence, a combination of a LABA and LAMA is restricted to patients with a forced expiratory volume in one second (FEV1) of more than 50% who cannot be prescribed an inhaled corticosteroid.
Anoro Ellipta is designed to be used once daily at the same time each day.
10. UK pharmacists asked to volunteer in Ebola outbreak
UK pharmacists have been urged to volunteer in the fight against Ebola in West Africa in an open letter from senior figures in UK healthcare.
The letter, signed by Dame Sally Davies, chief medical officer at the Department of Health, says that staff wishing to help should register with the UK International Emergency Medical Register. It said that NHS funded organisations will have individual “leave policies” in place, but cautioned that “safe staffing levels and services are maintained”.
A range of healthcare professionals may be required, including doctors, nurses, paramedics, pharmacists, psychologists, health information managers, logisticians and outreach managers, says the letter.