1. Domperidone back to prescription
Domperidone (Motilium) has been reclassified as a prescription-only medicine by the Medicines and Healthcare products Regulatory Agency (MHRA), which issued a class 2 medicines recall of the over-the-counter medicine on 3 September.
A recent European Medicines Agency (EMA) review found that the antiemetic was associated with a small increased risk of serious cardiac side effects.
In May 2014, the MHRA warned that domperidone should no longer be used for the treatment of bloating and heartburn and that the drug was contraindicated in people with underlying heart conditions and other risk factors.
The pharmacy-level recall follows discussions between the MHRA and the Commission on Human Medicines, which recommended that domperidone is safe for supply under medical supervision. It said that pharmacists would not be able to quickly and accurately assess which patients were at risk of cardiac side effects.
Patients currently taking domperidone who wish to continue taking the medicine should speak to their doctor or pharmacist, an MHRA spokesperson advised.
2. Extra £160m for cancer drug fund
The Cancer Drugs Fund (CDF) has been given a £160m boost over two years, increasing from £200m a year to £280m a year up to the end of March 2016. The fund will also start evaluating anticancer drugs for the first time to ensure its budget is spent wisely, after overspending £32m in the year up to April 2014.
The CDF was set up for England in 2010 to fund cancer medicines that had been rejected by the National Institute for Health and Care Excellence (NICE), which assesses cost-effectiveness of drugs for use in the NHS.
NHS England has now agreed that a panel of experts from the CDF will establish a process for re-evaluating drugs and removing those which represent the lowest levels of clinical benefit.
According to CDF chairman Peter Clark, the CDF will develop options for ensuring greater alignment between CDF and NICE assessment processes, and a new “evaluation through commissioning” option to allow real-world assessment of new cancer drugs.
3. Faculty assessment expands
Pharmacists with at least two years of experience will soon be able to join the Royal Pharmaceutical Society (RPS) Faculty, RPS President Ash Soni confirmed in the opening address of the RPS Annual Conference, held in Birmingham, on 7 September.
Since its June 2013 launch, the professional recognition programme’s assessment process has only been open to members with a minimum of ten years’ experience under a “recognition of prior experience” route to accreditation.
The expansion of the scheme in 2015 will allow pharmacists who have between two and ten years of experience to submit their portfolios for assessment to join the Faculty.
4. RPS Awards 2014
Julia Blagburn, senior lead clinical pharmacist for older people’s medicine and community health at Newcastle upon Tyne Hospitals NHS Foundation Trust, received the Royal Pharmaceutical Society Award for Clinical Pharmacist of the Year 2014. Also among the winners at the awards ceremony, held in Birmingham on 7 September, was Chima Olughu, public health programme manager for the Royal Borough of Greenwich, who scooped the award for public health pharmacist of the year. Theo Raynor received the lifetime achievement award for his work to improve how medicines information is communicated to patients. He is currently a professor of pharmacy practice at the University of Leeds.
5. New research funding available
Pharmacists will be able to apply for government funding from autumn 2014 to enrol in an internship scheme aimed at developing research skills. The new programme offers the opportunity to learn about all aspects of clinical academic research and to take part in a practical research project.
The internship scheme has been added to the reorganised clinical academic training programme, run by Health Education England and the National Institute for Health Research, which also offers pharmacists the chance to apply for funding at master’s level, clinical doctoral research fellowship, clinical lectureship and senior clinical lectureship.
“Research is central to all pharmacists’ practice and professional development,” said Beth Allen, head of research at the Royal Pharmaceutical Society. “This funding represents one route to a clinical research career, where the clinician works in both academia and practice, on translational research that has real potential to benefit their patients in the medium term.”
HEE is due to make a formal announcement on pharmacists’ eligibility for funding.
6. Decriminalisation delays recognised
The UK government’s minister for quality addressed the delay in two key documents for pharmacy in his speech to the annual Royal Pharmaceutical Society (RPS) conference on 8 September 2014.
Earl Howe, parliamentary under secretary of state for quality, said no one is more sorry than him that the work to “rebalance” medicines legislation and pharmacy regulation has been delayed. “The [RPS] has played a key role and this collaborative approach has resulted in a consensus that is acceptable to all,” said Earl Howe. “I will be the first to admit that this process has taken longer than anticipated.”
The intention remains to publicly consult on proposals concerning dispensing errors and pharmacy owners, superintendents and responsible pharmacists as soon as possible, he added.
He also acknowledged that the second stage of a government project from Higher Education Funding Council of England and Health Education England to reform pharmacy education has not materialised, despite being scheduled to go ahead at the beginning of 2014.
7. Call for extension of shelf life
Hospital pharmacists are calling on drug manufacturers to include more accurate shelf life limits on compounded parenteral products, such as those used for chemotherapy or palliative care pain relief, because many are just given an arbitrary 24-hour limit.
Peter Leslie, technical services liaison officer at the Princess Alexandra Hospital NHS Trust, believes the issue is a UK-wide problem and that securing an extended shelf life can have significant implications for patients. He says: “When you do your own research you find that the product is perfectly stable and could last days and sometimes actually a week.”
8. Cardiac risk from clarithromycin
Patients who take clarithromycin are at an increased risk of cardiac death compared with patients who take penicillin V or roxithromycin, according to results of a large cohort study.
In the study, published in The BMJ (online, 19 August 2014), researchers used data from a national Danish patient registry to track outcomes for patients prescribed one of the three antibiotics. They observed an increased risk associated with use of clarithromycin that was especially pronounced in women.
In absolute terms, 37 excess cardiac deaths occurred per 1 million treatment courses associated with the current use of clarithromycin compared with current penicillin V use.
9. New hepatitis C drug
A treatment estimated to cure chronic hepatitis C infection in up to 99% of cases when used in combination with other drugs has been launched in the UK.
Described as “an important step forward towards the holy grail of highly effective, short, tolerable and interferon-free therapy”, daclatasvir is the third new treatment for hepatitis C to be launched in 2014, following sofosbuvir and simprevir.
“This is the first in its class and is therefore a potent and needed weapon in an armoury that is improving all the time and presents an opportunity to eliminate hepatitis C within no more than 15 years,” said Charles Gore, chief executive of the charity the Hepatitis C Trust.
Used with sofosbuvir, daclatasvir has been successful in trials and is being used in England in an early access programme for patients who cannot wait for an appraisal decision from the National Institute for Health and Care Excellence because they have less than a year’s life expectancy, Gore explained.
10. NMS improves adherence
A service delivered by community pharmacists that helps patients take new medicines effectively has been found to increase the number of patients who are adherent to their treatment by about 10%. The authors of a long-awaited report, ‘Understanding and appraising the new medicines service in the NHS in England’, recommend that the new medicine service (NMS) should continue to be funded by the NHS.
The NMS is performed by community pharmacists when a patient is prescribed a new medicine for one of four therapy areas — hypertension, type 2 diabetes, anticoagulation/antiplatelet therapy and asthma/chronic obstructive pulmonary disease. Around 7 to 14 days after the patient presents at the pharmacy with the prescription, the pharmacist offers a consultation to find out if the patient is having any problems taking their medicine and provides support to improve adherence.
The report says that since the implementation of the service there has been wide adoption by community pharmacy, with 91.2% of community pharmacies conducting at least one NMS.