Clinical Pharmacist’s monthly news round-up: the top 10 in the past month
What’s been happening in the world of pharmacy? Here’s our pick of must-read news from the past month.
Pfizer loses Lyrica patent infringement case
US pharmaceutical company Pfizer has lost its patent infringement case against generic firms Actavis and Mylan over the use of pregabalin, marketed as Lyrica. The UK High Court ruling in September 2015 means that doctors can continue to prescribe the drug generically and pharmacists can dispense generic pregabalin without fear of patent infringement litigation. Pfizer developed Lyrica for the treatment of generalised anxiety disorder (GAD) and epilepsy but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could relieve pain, it took out a second medical use patent for Lyrica to cover this use. After the first patent expired, Actavis and Mylan launched generic versions of the drug to treat GAD and epilepsy. However, since UK physicians tend to prescribe generically, in December 2014 Pfizer claimed that its second medical use patent was being breached. The Pharmaceutical Services Negotiating Committee says the judgement will come as a relief to contractors. Pfizer has announced its intention to appeal the ruling.
Calcium supplements do not reduce risk of fractures
Increasing calcium intake beyond a normal balanced diet does not prevent fractures, according to two studies published in The BMJ on 29 September 2015. The first study was a review of trials of dietary sources of calcium or calcium supplements, with or without vitamin D. It showed that increased dietary or supplementary calcium produced only limited improvement in bone density and that these small increases were unlikely to lead to any meaningful reductions in fractures. The second study looked at the evidence for current recommendations to increase calcium intake through diet or calcium supplements to prevent bone fractures. It found no association between dietary calcium and risk of fracture; calcium supplements have meagre, inconsistent benefits on preventing fractures; and increased calcium intake through diet or supplements should not be recommended for fracture prevention. A spokesperson for the National Osteoporosis Society says calcium supplements may increase bone density, but on their own do not reduce the risk of fractures.
Disparity between pass rates for community and hospital trainees is cause for concern, says pharmacy regulator
The continuing difference in pass rates between hospital and community trainees for the pharmacy registration assessment has been described as a “cause for concern” by General Pharmaceutical Council (GPhC). Out of the candidates who sat the assessment paper in June 2015, the pass rate for trainees from the hospital sector was 91% — 20 percentage points higher than the pass rate for their peers from the community sector. The regulator says hospital trainees traditionally have a better pass rate than those in the community but the difference between the two sectors this year was “particularly pronounced”.
First self-administered injectable contraceptive approved for use in the UK
Women in the UK will be able to self-administer an injectable contraceptive for the first time after the Medicines and Healthcare Products Regulatory Agency approved new labelling for Sayana Press (medroxyprogesterone acetate). The updated label adds that healthcare professionals can consider the option of self-injection by women when appropriate, instead of them having to attend a clinic or GP surgery to receive the injection. It is a long-acting, reversible, contraceptive supplied as a prefilled syringe, which prevents ovulation and provides contraception for at least 13 weeks. It was approved for use as a contraceptive by the MHRA in 2011. A spokesperson for the Faculty of Sexual and Reproductive Healthcare says: “After initial injection from a healthcare professional, the contraceptive can be self-injected by the patient every 13 weeks, if they are comfortable doing so.” The product has been associated with significant loss of bone mineral density; the most common adverse events include amenorrhea, heavy intermenstrual bleeding, weight gain and headache.
Taking blood pressure medication at bedtime reduces risk of developing diabetes
Patients are at a greater risk of developing diabetes if they take blood pressure therapies first thing in the morning than if they take their drugs as they settle down to sleep, researchers have shown. In two studies published in Diabetologia, researchers show that lowering blood pressure while a patient sleeps represents a target for intervention to prevent new cases of diabetes, and that taking an entire daily dose of hypertension medications at bedtime reduces a patient’s risk of developing diabetes compared with taking medications after waking. A spokesperson for Diabetes UK says the results are worth noting, but are unsurprising: “We already know that high blood pressure is linked to a greater risk of developing type 2 diabetes and that changing the time of day when you take blood pressure medications can affect their impact.” These new studies add to our understanding by suggesting that night time blood pressures are more closely linked to type 2 diabetes risk than daytime blood pressures, the spokesperson adds.
Diabetes drug empagliflozin cuts cardiovascular deaths by nearly 40%
A new study shows that the diabetes drug empagliflozin could cut the number of cardiovascular deaths by almost 40% as part of the treatment for type 2 diabetes. Empagliflozin (Jardiance) acts by selectively inhibiting the sodium-glucose cotransporter 2 (SGLT-2), and so increasing glucose excretion in the blood. “This drug has the potential to be a game-changer in the treatment of diabetes,” says Partha Kar, a diabetes consultant at Portsmouth Hospitals NHS Trust. The product received European approval in May 2014 and was recommended by the National Institute for Health and Care Excellence in March 2015 as part of a dual or triple therapy for type 2 diabetes.
Antioxidant shows promise in preventing hearing loss caused by aminoglycoside antibiotics
Researchers are calling for a clinical trial to determine the protective effects of N-acetylcysteine in reducing the risk of deafness in patients taking aminoglycoside antibiotics for multidrug-resistant tuberculosis (MDR-TB). The call comes after their review of the literature found the antioxidant had otoprotective effects when given with aminoglycosides, antibiotics known to induce death of the inner and outer hair cells within the cochlea. Studies showing N-acetylcysteine gives auditory protection against aminoglycoside-induced ototoxicity have only evaluated its use for a matter of weeks, but if it were to be used in MDR-TB, it would need to be given over several months. “Deafness clearly has a great impact on the lives of patients, and the review offers tantalising evidence that there is a role for N-acetylcysteine in preventing ototoxicity,” said Mike Brown, consultant at the Hospital for Tropical Diseases at University College London Hospitals. Side effects were reported that said N-acetylcysteine increased the risk of abdominal pain, nausea and vomiting, diarrhoea and joint pain.
Heart failure treatment Entresto recommended for approval in Europe
The European Medicines Agency has recommended the heart failure treatment Entresto for marketing authorisation approval. Entresto is a combination of the angiotensin receptor blocker valsartan and the novel neprilysin inhibitor sacubitril. The drug was recommended for an EU licence on the back of results of a trial of patients who had heart failure with reduced ejection fraction. Researchers found that 13.3% of patients treated with the therapy died from cardiovascular disease compared with 16.5% taking enalapril. The trial also found that Entresto reduced the number of patients who had to be hospitalised for heart failure. The most common side effects noted were hypotension, hyperkalaemia and kidney impairment. John McMurray from the University of Glasgow, a principal investigator in the trial, says the drug has the potential to extend the lives of “thousands” of patients as well as prevent hospital admissions. The move towards achieving a market for Entresto in the EU comes at the same time as an ongoing debate in the United States about its price.
Cancer Drugs Fund needs overhaul, NAO investigation finds
The Cancer Drugs Fund is unsustainable in its current form because of overspending and a lack of evidence on the results it yields, a National Audit Office (NAO) report says. Set up to improve access to cancer therapies not routinely available on the NHS, the scheme has exceeded its budget by 50% and no data exist to show whether it is having any effect on the health of patients. The report comes ahead of a consultation on proposals from NHS England and the National Institute for Health and Care Excellence on reform of the scheme.
Focus on dispensing in remuneration model is holding back expansion of pharmacy services, FIP report finds
A continued focus on dispensing in pharmacy remuneration systems across the world is stifling the provision of wider services, says a report by the International Pharmaceutical Federation (FIP). Remuneration in community and hospital pharmacy remains predominantly linked to products in most cases and provides little incentive for changes in pharmacy practice, the study found. “Pharmacy remuneration models need to value what pharmacies already bring to patients’ use of medicines, public health, health systems and the economy, as well as to embrace extended roles and collaborative practices within primary health care and hospital care,” the report says.
Citation: Clinical Pharmacist DOI: 10.1211/CP.2015.20069528
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