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. Skin cancer drug fast tracked under early access scheme
Pembrolizumab, a drug for advanced skin cancer, has become the first medicine to be fast tracked to patients under the UK’s early access to medicines scheme.
The scheme is designed to allow access to innovative drugs without clinicians having to wait for them to go through the lengthy licensing process.
Pembrolizumab can be used to treat advanced melanoma that has either spread to other organs or cannot be operated on. The drug will be provided to patients whose disease has progressed despite treatment with ipilimumab and, where appropriate, a V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor.
Responsibility for use of pembrolizumab will rest with the prescriber, using information from the Medicines and Healthcare products Regulatory Agency. A risk management plan has also been implemented and healthcare professionals will be expected to report any adverse effects of the medicine.
Pembrolizumab is one of a new generation of drugs called immune checkpoint inhibitors.
2. GP and pharmacy leaders call for practice pharmacists
A pharmacist should work in every GP practice in England to offer specialist medicines advice and support to patients and take pressure off family doctors, according to a joint proposal from the Royal Pharmaceutical Society (RPS) and the Royal College of General Practitioners (RCGP).
The pharmacist would be part of the practice-based primary care team able to resolve medicines issues, especially for patients with long-term conditions. He or she would also be the practice’s link to care homes, according to the plan unveiled at a joint summit held by the RPS and RCGP in London on 17 March 2015.
“This isn’t about having a pharmacy premises within a surgery, but about making the full use of the pharmacist’s clinical skills,” says RCGP chair Maureen Baker, adding that the “hidden army of highly-trained pharmacists” could provide the solution to the national shortage of family doctors and the continuing rise in GP consultations, which is projected to reach 370 million in 2015.
3. EMA recommends restrictions on codeine for children
The European Medicines Agency (EMA) is recommending that codeine-containing products used to treat coughs and colds should be banned for those aged under 12 years.
The products — available on prescription and, in some countries, over the counter — should also no longer be made available to anyone under 18 years of age if they have breathing problems.
The EMA’s Pharmacovigilance Risk Assessment Committee has further recommended that codeine should not be used by anyone known to convert codeine into morphine at a faster rate than normal.
The recommendations have to be ratified by the EU’s Co-ordination Group for Mutual Recognition and Decentralised Procedures.
4. Antibiotic exposure linked to increased diabetes risk
Taking more than one course of some antibiotics is associated with an increased risk of developing diabetes, according to research published in the European Journal of Endocrinology on 24 March 2015.
Researchers looked at over 200,000 cases of patients with type 2 diabetes and the number of courses prescribed to them for the seven most common groups of antibiotics in the year before diagnosis.
Comparing the cases to over 800,000 matched controls, they observed an increased risk of diabetes with all groups of antibiotics, with the highest risk observed with previous exposure to more than five courses of penicillin (adjusted odds ratio 2.12, 95% confidence interval 2.08–2.17).
Source: Wikimedia Commons
5. EMA fast tracks approval of thyroid cancer drug
The European Medicines Agency (EMA) is recommending that Lenvima (lenvatinib) be available across Europe for the treatment of some patients with thyroid cancer, following a fast-track assessment.
The medicines safety regulator is proposing that the product be marketed for patients with differentiated thyroid carcinoma (DTC) whose cancer has progressed despite receiving radioactive iodine treatment.
The EMA considered the marketing application of lenvatinib, a tyrosine kinase inhibitor, via its accelerated assessment programme because the cancer is rare, patients have few treatment options and the prognosis can be poor as the disease is often undetected until an advanced stage.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) decided that lenvatinib’s safety profile was consistent with other similar therapies and that side effects were predictable and manageable. But it has requested a further study to investigate the most appropriate starting dose of lenvatinib in order to reduce risks for patients.
The CHMP recommendation now goes to the European Commission for final approval.
6. Study links macrolides in pregnancy to infant epilepsy
Taking macrolide antibiotics, such as erythromycin and clarithromycin, during pregnancy could increase the risk of babies being born with epilepsy or cerebral palsy, report researchers from the UCL Institute of Child Health (ICH) in London.
The study’s lead author points out that the harm caused by infection is much more significant than the low risk posed by antibiotics, but says the findings add weight to concerns over this group of antibiotics.
“If you have an infection, take the antibiotics,” says Ruth Gilbert, professor of clinical epidemiology at ICH. “But on a population basis, we need to consider whether we should recommend alternatives.”
The UCL study, published in PLOS One on 25 March 2015, used data from a cohort of 195,909 women. The researchers found no association between mothers who had been prescribed any antibiotic and cerebral palsy or epilepsy. However, there was a slightly increased risk of these conditions in the children of mothers who had been prescribed macrolides compared with penicillins.
7. EMA recommends drug for rare kidney condition
The European Medicines Agency (EMA) has recommended approval of tolvaptan (Otsuka Pharmaceutical Europe’s Jinarc) for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
Tolvaptan is indicated to slow down the progression of cyst development and renal insufficiency in adult ADPKD patients with chronic renal disease stages 1 to 3 — that is, normal to moderately-reduced kidney function — at the initiation of treatment, and who have rapidly progressing disease.
The EMA wants safeguards for patients taking the product, including hepatic monitoring as part of a registry, since study data showed an increase in liver adverse events (2.3% compared with 1% in the placebo group).
8. FDA grants priority approval for antifungal
Isavuconazonium sulfate (Cresemba), an antifungal developed by Astellas, has been given priority approval by the US Food and Drug Administration (FDA) to treat patients with the rare but serious infections invasive aspergillosis and invasive mucormycosis.
The drug is the sixth to be awarded qualified infectious disease product (QIDP) status, which means it was given priority review by the medicines regulator because of its potential to treat serious infections.
It has also been recognised as an orphan drug by the FDA for the two conditions and, because of its QIDP status, was given an additional five years of marketing exclusivity.
9. Glibenclamide use linked to morbidities in newborns
Treatment with glibenclamide is associated with an increased risk of adverse events for newborns compared with those whose mothers used insulin to treat gestational diabetes, a study published in JAMA Pediatrics on 30 March 2015 shows.
Looking at ten years of data, researchers identified 9,173 pregnant women with gestational diabetes who had been treated with glibenclamide (4,982 women) or insulin (4,191).
They found a higher risk of neonatal intensive care unit admission (relative risk [RR] 1.41; 95% confidence interval 1.23–1.62), respiratory distress (RR 1.63; 95% CI1.23–2.15), neonatal hypoglycaemia (RR 1.40; 95% CI 1.00–1.95) and birth injury (RR 1.35; 95% CI 1.00–1.82) among newborns whose mothers were given glibenclamide, compared with those who had been given insulin.
In the UK, the National Institute for Health and Care Excellence recommends doctors consider using glibenclamide for women with gestational diabetes in whom blood glucose targets are not achieved with metformin but who refuse insulin or for women who cannot tolerate metformin.
Source: Malcolm Chapman / Shutterstock.com
10. Gardasil 9 endorsed for European approval
A human papillomavirus (HPV) vaccine that protects against nine different strains of the virus has been given preliminary approval by the Committee on Medicinal products for Human Use (CHMP), part of the European Medicines Agency.
In addition to the four strains of HPV (6, 11, 16 and 18) that the Gardasil vaccine protects against, Sanofi Pasteur MSD’s Gardasil 9 vaccine protects against diseases caused by five additional HPV strains (31, 33, 45, 52 and 58). It is given as three separate injections.
Gardasil 9’s effectiveness was evaluated in four main clinical studies and its safety in seven studies, the CHMP reports. The committee endorsed Gardasil 9 for use in boys and girls from nine years of age to protect against cervical cancer and pre-malignant cervical lesions, vulvar and vaginal cancers and pre-malignant vulvar and vaginal lesions, pre-malignant anal lesions and anal cancers, and external genital warts.
The recommendation from the CHMP will now be passed to the European Commission, which will make a final decision on granting a marketing authorisation.
In the United States, the vaccine was approved by the Food and Drug Administration in December 2014.
Citation: Clinical Pharmacist DOI: 10.1211/CP.2015.20068347
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