The Top 10
What has been happening in the world of pharmacy? Here’s our pick of must-read news from the past month.
1. DPP-4 inhibitors show benefits over sulfonylureas
Diabetes patients who add dipeptidyl peptidase-4 (DPP-4) inhibitors to their metformin therapy have a lower risk of stroke and hypoglycaemia than patients who take add-on sulfonylureas, according to a study published in Annals of Internal Medicine on 13 October 2015.
The research shows that, compared with add-on sulfonylureas, DPP-4 inhibitors also confer lower risks for all-cause death and major adverse cardiovascular events (MACE) when used with metformin therapy in patients with type 2 diabetes.
There is a paucity of comparative data on these second-line drugs so the researchers investigated the relative risks for all-cause death, MACEs, hospitalisation for heart failure and hypoglycaemia among 10,089 matched pairs of DPP-4 inhibitor users and sulfonylurea users. Participants were aged 20 years or older with a diagnosis of type 2 diabetes between March 2009 and June 2012, and follow-up continued until death or until the end of 2013.
DPP-4 inhibitors were associated with lower risks for all-cause death, stroke and hypoglycaemia compared with sulfonylureas, but had no effect on heart attack risk and hospitalisation for heart failure.
2. Poor medicines management common in NHS services
Patient safety is being compromised by poor medicines management in NHS and adult social care services, finds a report by the Care Quality Commission (CQC) published on 15 October 2015.
The CQC’s annual State of Care report reveals that safety was inadequate at 13% of acute trusts, 10% of adult social care services, and 6% of GP practices and out-of-hours services inspected so far under its new regime.
Examples of issues of “intense concern” included medicines given without appropriate patient identification at a hospital and medication not administered properly at a care home, where some patients had their medicine delayed while others showed symptoms of overdose.
In general practice, CQC inspectors observed poor storage of medicines, fridges at the wrong temperatures, out-of-date medicines and insufficient emergency drugs.
So far, the CQC has inspected nearly half of acute hospital trusts, 17% of adult care services and 11% of GP surgeries and out-of-hours providers. Organisations that have high levels of risk have been targeted first.
3. Extra investment to employ pharmacists in GP practices
NHS England has confirmed that it is increasing the number of pharmacists employed directly in GP surgeries as part of the £15m pilot project announced in July 2015.
The organisation was unable to say how many more pharmacists would be taken on in addition to the 250 first planned when details about the scheme were released in the summer.
“There is some extra investment in the scheme to put pharmacists in GP practices coming, but it’s in the early stages and we can’t confirm any further information immediately as the details are still being worked out,” says a spokesperson for NHS England.
4. FDA approval for potassium-lowering drug comes with warning
The US Food and Drug Administration (FDA) has approved a drug to treat potentially fatal levels of potassium in patients with chronic kidney disease.
Patiromer for oral suspension (Relypsa’s Veltassa) is a polymer that binds potassium in the gastrointestinal tract, thereby decreasing its absorption.
The FDA has called for a boxed warning stating that the drug must be taken at least six hours apart from other oral drugs. In clinical trials, it was found to bind many other orally administered drugs, which could reduce their effectiveness.
Relypsa did not comment on when the company plans to file for EU approval.
5. Elderly patients taking too many medicines, GPs say
Around 50% of GPs are not confident that their elderly patients are taking their medicines correctly three months after their last consultation, according to a survey of 200 GPs conducted on behalf of lobby group Pharmacy Voice.
GPs also admit that their elderly patients are taking too many medicines — GPs were asked what percentage of their patients aged over 75 years who were taking four or more medicines would benefit from taking fewer medicines: the mean response was that half (50.3%) of patients could benefit from taking fewer drugs.
The survey findings appear in a report entitled ‘Dispensing health in later life’ published on 2 November 2015. They highlight that most GPs (92% of survey respondents) want more support from community pharmacy teams to help their patients with medicines management.
The report recommends medicine use reviews are carried out by pharmacists every six months for elderly patients taking four or more medicines and each time such patients are discharged from hospital.
6. Donepezil may delay nursing home admission
Discontinuing donepezil in Alzheimer’s patients as their disease worsens could double the risk of admission into a nursing home within a year, suggests a study published in The Lancet Neurology on 26 October 2015.
The study included 295 patients with moderate to severe Alzheimer’s disease who had taken donepezil continuously for at least three months. Patients were randomised to continue taking donepezil 10mg per day, discontinue donepezil, discontinue donepezil and start memantine 20mg per day, or continue donepezil and start memantine.
During the first year, fewer patients in both groups that continued taking donepezil entered a nursing home, compared with patients who stopped taking the drug (hazard ratio [HR] 2.09, 95% confidence interval [CI] 1.29–3.39).
After a year, the decision to continue treatment further was left to the doctor and patient; the analysis showed that donepezil did not reduce the likelihood of admittance to a nursing home in the following three years (HR 0.89, CI 0.58–1.35). Memantine had no impact on nursing home admittance at any stage.
7. FDA approves Factor X therapy for rare bleeding condition
The US Food and Drug Administration (FDA) has approved a purified clotting factor for patients with hereditary Factor X deficiency, the first drug to be approved for this rare bleeding condition.
Previously, patients had to rely on treatment with blood plasma or plasma concentrates. The new drug, marketed as Coagadex by Bio Products Laboratory, consists of purified Factor X extracted from blood plasma. It is indicated for patients aged 12 years and over for on-demand treatment and control of bleeding episodes, and for management of bleeding when patients need an operation.
The drug is currently under consideration by the European Medicines Agency.
8. Packaging of Alzheimer’s drugs to be redesigned
Blister packs of Alzheimer’s disease drugs will be marked with days of the week to reduce confusion when patients take their medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The move by the MHRA and the pharmaceutical industry aims to help patients maintain their independence as well as improve medicines adherence. The new packs are expected to be on the market from June 2016.
George McNamara, head of policy at the Alzheimer’s Society, welcomed the announcement. He points out that 75% of patients with dementia have other long-term conditions and he called on other drug companies to introduce dementia-friendly packaging.
Source: Wikimedia Commons
9. FDA approves idarucizumab as antidote to dabigatran
The US medicines safety watchdog has given fast-track approval to idarucizumab (Praxbind), a drug that can neutralise the effects of the anticoagulant dabigatran etexilate (Pradaxa).
The decision by the Food and Drug Administration (FDA) comes weeks after a similar recommendation by the European Medicines Agency (EMA) — the body responsible for recommending the licensing of drugs across the EU.
The FDA based its decision on the results of the same clinical trials that influenced the EMA’s recommendation.
Some 283 healthy volunteers — patients who did not require an anticoagulant — were given dabigatran etexilate. Among those who were also given idarucizumab, there was an immediate reduction in the amount of dabigatran etexilate in participants’ blood that lasted for at least 24 hours. Another trial included 123 patients taking dabigatran etexilate who were also given idarucizumab to manage uncontrolled bleeding or because they required emergency surgery. The anticoagulant effect of dabigatran etexilate was completely reversed in 89% of patients within four hours of receiving idarucizumab.
10. Low dose aspirin may boost fertility in some women
Taking low dose aspirin daily may increase the chance of conception in women with high levels of inflammatory markers, a US study has found.
The study, which included 1,228 women who had previously experienced a miscarriage, was presented at the annual meeting of the American Society for Reproductive Medicine in Baltimore, Maryland, on 21 October 2015.
Researchers assessed the women’s C-reactive protein (CRP) levels at baseline. The women then took low dose aspirin or placebo daily.
For women with high levels of inflammation (CRP levels at baseline > 2.1mg/L) taking an aspirin boosted their chance of pregnancy by 17% (67% vs. 57%; relative risk [RR]: 1.19; 95% confidence interval 1.01–1.41). Aspirin did not have the same effect in women with lower CRP levels.
However, Nicholas Raine-Fenning, medical director of Nurture Fertility at East Midlands Fertility Centre, Nottingham, says the evidence is far from clear. “Other studies have shown no benefit of its use and possibly a higher risk of miscarriage in some women.”
Citation: Clinical Pharmacist DOI: 10.1211/CP.2015.20200019
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