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Clinical developments catch-up 2012

anaken2012/dreamstime.comIn the first half of 2012 independent prescribers were finally granted the right to prescribe Controlled Drugs, a move that one pharmacist said would revolutionise practice. Pharmacists also increased their clinical offer through initiatives such as the national minor ailments scheme launched in Wales and HIV screening services. Use of private patient group directions grew, with Asda offering salbutamol inhalers and the Co-operative Pharmacy making EllaOne (ulipristal) available. Towards the end of the year, the National Pharmacy Association and the Day Lewis chain developed a whole series of private PGDs, although some have been scaled back. We also saw a number of new medicines launched (Panel 1).

Panel 1: New medicines launched in 2012

•    Aflibercept (Eylea; Bayer) for wet age-related macular degeneration

•    Argatroban (Exembol; Mitsubishi Pharma Europe), an antithrombotic for adults with heparin-induced thrombocytopenia type II who need parenteral treatment

•    Asenapine (Sycrest; Lundbeck), an atypical antipsychotic for moderate to severe manic episodes associated with bipolar 1 disorder

•    Axitinib (Inlyta; Pfizer) for advanced renal cancer where treatment with sunitinib or a cytokine has previously failed

•    Azilsartan medoxomil (Edarbi; Takeda), an angiotensin receptor II blocker for essential hypertension

•    Brentuximab vedotin (Adcetris; Takeda) for relapsed or refractory Hodgkin’s lymphoma or systemic anaplastic large cell lymphoma.

•    Crizotinib (Xalkori; Pfizer) for previously treated anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer

•    Dapagliflozin propanediol monohydrate (Forxiga; Bristol-Myers Squibb-AstraZeneca EEIG) for type 2 diabetes

•    Decitabine (Dacogen; Janssen-Cilag) for acute myeloid leukaemia in patients over 65 years

•    Ferumoxytol (Rienso; Takeda), an injectable solution for treatment of iron deficiency in adults with chronic kidney disease

•    Fidaxomicin (Dificlir; Astellas) for treatment of Clostridium difficile infection

•    Ivacaftor (Kalydeco;Vertex) for cystic fibrosis

•    Live attenuated influenza virus (Fluenz; Astrazeneca), a nasal vaccine

•    Pasireotide (Signifor; Novartis) for Cushing’s disease patients for whom surgery is not viable

•    Perampanel (Fycompa; Eisai), a first-in-class antiepileptic drug

•    Piperaquine and artemisinin combination antimalaria tablets (Eurartesim; Sigma-tau Pharma)

•    Racecadotril (Hidrasec; Abbott Healthcare) for acute diarrhoea

•    Ruxolitinib (Jakavi; Novartis Oncology), for disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis

•    Vemurafenib (Zelboraf; Roche Products) a targeted oral medicine for unresectable or metastatic melanoma


Novel oral anticoagulants for stroke prevention in atrial fibrillation have been the key development in cardiology during 2012, according to Helen Williams, consultant pharmacist for cardiovascular disease in South London. “The introduction of these agents into clinical practice demands a whole system review of anticoagulant services, as activity shifts away from regular INR [international normalised ratio] monitoring with warfarin to the newer options. The comparative effectiveness, safety and affordability of the different agents remains a subject of much debate but, that aside, there are many patients that will gain substantial clinical benefit from these agents,” she said.

Long-term adherence to the newer agents in the absence of regular ongoing monitoring remains a concern, said Mrs Williams. “This is an opportunity for community pharmacy to impact on patient outcomes through improving adherence through offering the new medicine service.”

Statins were also under the spotlight, with reports early in 2012 endorsing their use in all over 50s as the primary strategy to reduce heart disease. “This message, however, ignores the broader health messages around smoking cessation, diet, exercise and weight loss; hence patients should be encouraged to take a more holistic approach to cardiovascular risk reduction, of which statins may be a part,” said Mrs Williams.

September saw revised safety recommendations for simvastatin when used with amlodipine, due to an increased risk of myopathy; a maximum dose of simvastatin 20mg daily can now be prescribed when the two drugs are used concomitantly. “This represented a significant change in practice, since amlodipine and simvastatin 40mg are two of the most commonly prescribed drugs in the UK,” said Mrs Williams.


“New guidelines and outcome measures have led to increased awareness of the issues and risks of diabetes, and the introduction of yet more new drugs has led to the increased opportunity to individualise care,” said Victoria Ruszala, specialist pharmacist, North Bristol NHS Trust. She highlighted the availability, early in 2012, of once weekly exenatide and linagliptin. “This has been followed throughout the year by numerous licence extensions, which means that patients have the opportunity to use a range of drugs to suit their lifestyle.”

Dapagliflozin, the first of a new class of oral diabetes drugs — SGL2-inhibitors — was launched in November. “The National Institute for Health and Clinical Excellence has issued a number of technology appraisals on these new drugs and also launched the first diabetes public health guideline related to the prevention of type 2 diabetes,” Ms Ruszala pointed out. New e-learning modules and protocols related to inpatient care of diabetes have also come from NHS Diabetes. “These guidelines and protocols go a long way to standardising care around [England] and reducing the confusion about the range of treatments available.”

She added that there were a number of difficulties in 2012, “not least of which was the change to DVLA driving standards for patients on insulin and sulphonylureas. This is still being addressed and is likely to be in the public eye for the foreseeable future.”


Steve Tomlin, consultant pharmacist — children’s services, Evelina Children’s Hospital, and honorary senior lecturer, Centre for Paediatric Pharmacy Research, University College School of Pharmacy, London, highlighted the relaunch of www.medicinesfor, which now provides information leaflets to parents and carers on medicines being used in children, as well as administration videos and news. Mr Tomlin explained that the website is a joint venture between the Royal College of Paediatrics and Child Health, the Neonatal and Paediatric Pharmacists Group and the WellChild children’s charity. “The new site has been thoroughly evaluated during 2012 and is well used and appreciated by parents and healthcare professionals,” he said.

Another initiative that had an impact in paediatrics was the publication by the Children and Young People’s Health Outcomes Forum of proposals on how health-related care for children and young people can be improved. Mr Tomlin explained that the proposals emphasised the safety of medicines and the issue of young people often having to use unlicensed or off-label medicines.


“2012 has been quite a busy year for oncology, with a number of clinical and political developments taking place,” said Simon Purcell, lead haematology pharmacist, Wirral University Teaching Hospital.

A significant change to practice is that dose capping of chemotherapy is no longer recommended for all obese patients, following a paper published at the 2012 annual meeting of the American Society of Clinical Oncology. There have also been several recently introduced treatments that are impacting on practice. For example, crizotinib (Xalkori; Pfizer) is a “new drug development moving more towards individualised treatments for patients,” explained Mr Purcell.

Axitinib (Inlyta: Pfizer) for advanced kidney cancer, and vemurafenib (Zelboraf; Roche) for BRAF V600 mutation-positive unresectable or metastatic melanoma are emerging therapies, launched in 2012, said Mr Purcell, although their place in therapy remains unclear. Other uncertainties also emerged within the cancer field in 2012, said Mr Purcell. Moves towards value-based pricing and new commissioning arrangements are having an effect, as are uncertainties around the future of cancer networks and cancer network pharmacists.


Anna Murphy, consultant respiratory pharmacist, University Hospitals of Leicester NHS Trust, highlighted the launch of new antimuscarinics for chronic obstructive pulmonary disease, along with the new cystic fibrosis (CF) inhalers mannitol and tobramycin, and ivacaftor (Kalydeco; Vertex), the first in a new class of medicines, called CFTR potentiators, which target the underlying cause of CF.

Other developments have included new respiratory guidelines and a move across the healthcare community to improve outcomes for people with respiratory disease. “In particular,” she said, “high-dose inhaled corticosteroids being part of the Quality, Innovation, Productivity and Prevention agenda focused the attention of healthcare professionals on such prescriptions to ensure appropriate prescribing for people with asthma and COPD.” Dr Murphy also highlighted inhaler device technique as a focus for practice in 2012. “Although always part and parcel of respiratory care, inhaler technique was often not adequately checked … with many healthcare professionals not able to use an inhaler themselves. Finally, this simple intervention is recognised as essential by both commissioners and healthcare professionals — a perfect role for community pharmacists, which supports the new medicine service and targeted medicines use reviews, which have been instrumental to the improvements in respiratory care this year.”


One of the main areas of focus within psychiatry throughout 2012 has been continuing moves to limit the use of antipsychotics in dementia, Ian Maidment, senior lecturer, pharmacy, School of Life and Health Sciences, Aston University, told The Journal. He pointed out that recent research has indicated that official figures may underestimate such use. “The pharmaceutical industry is working on new treatments for dementia. However, the results from clinical trials reported in 2012 for medicines such as solanezumab and bapineuzumab, which bind to beta-amyloid, appeared mixed.”

He also highlighted the development of loxapine, an inhaled antipsychotic for the rapid control of mild to moderate agitation in adults with schizophrenia or bipolar disorder — this received a positive opinion from the European Medicines Agency towards the end of 2012 and a pharmacovigilance programme is to be established as part of the authorisation.

Mr Maidment conceded that mental health services had had some criticism in 2012 but pointed out that increased use of specialist pharmacy services were considered part of the solution to poor practice. “The Schizophrenia Commission, which was established by the mental health charity Rethink, highlighted failings in the way that severe mental illness is treated in the UK. The commission expressed serious concern about poor prescribing, felt that further steps should be taken to improve practice and that service users should have the opportunity to consult a specialist pharmacist regarding medication,” he said.


“Multidrug-resistant gram negatives have been the focus of discussion and debate through 2012, with old agents, such as colistin, being dusted off to fight this onslaught,” said Nick Cooley, lead clinical pharmacist, anti-infectives, Chelsea and Westminster Hospital. Clostridium difficile continues to be at the centre of everyone’s attention, with tighter national targets and the launch of promising therapies to treat this infection. He said fidaxomicin is a novel agent that has brought some benefits, but pointed out that its cost has hampered uptake.

Another big focus has been around the delivery of OPAT — outpatient parenteral antibiotic therapy. “There has been a move to get more patients treated at home,” explained Mr Cooley, who pointed out that this is at the heart of the NHS QIPP agenda, which is supported in the national guidance for antimicrobial stewardship in hospitals document “Start smart then focus”, published at the end of 2011, and through the CQUIN (Commissioning for Quality and Innovation) payment framework. “It can be used to prevent unnecessary hospital admissions and reduce patients’ length of stay in hospital, improve patient satisfaction and reduce potential harm, for example, by reducing the likelihood of a patient developing C difficile infection and errors. There has been a push this year to get everyone on board.”

Another development within microbiology, although not restricted to this field, has been the increased use of smart phone technology. “In previous years, we saw a move away from paper-based delivery to use of websites but in 2012 we are seeing more use of smart phone technology to deliver messages and get guidelines in to the hands of those who need them,” he said. “We are also seeing more trusts come on board with electronic prescribing systems which will, ultimately, have a positive impact on delivering and improving antibiotic stewardship.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11114426

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