Top 5 clinical developments of 2011

Clinical Switches, shake-ups and the new medicine service – Chris Chapman picks the stories you shouldn’t have missed this year

1 Tranexamic acid controversy

January ended with a POM to P launch – which quickly became perhaps the most controversial in recent years. Tranexamic acid became available over the counter… of Boots pharmacies. Meda, the first company to launch a product containing the period pain relief drug over the counter, had decided to offer it exclusively through the UK's largest pharmacy chain, with all other pharmacies having to wait until an alternative brand launched in March.

Cue outrage from pharmacy organisations, with the RPS stating it was "very concerned" and PSNC stating it did not support exclusivity arrangements. On the other side of the divide, Meda stated it was the best way to perform a switch to ensure pharmacists were trained to advise patients.

2 Missed pill advice

May saw new guidance on the combined oral contraceptive pill, with the MHRA, Faculty of Sexual and Reproductive Healthcare and the Family Planning Association combining their guidance to ensure all women receive the same advice. The key points are that there is no need for additional precautions if one active pill is missed, with additional precautions for seven days if two active pills are not taken. 3 Paracetamol for children

Suspensions were shaken up in June, when the MHRA announced changes to paracetamol doses for children. Well, actually, the doses didn't change – they were just tightened, with fixed amounts for each age group.

The move was widely welcomed by pharmacists, with Mount Elgon pharmacy's Raj Patel praising the "more accurate dosing, tailored to the individual". Overall, the new doses mean children of most body weights will be in the optimum dose range of 10-15mg/kg, and parents will be able to use paracetamol for mild pain and fever relief with confidence.

4 Hypertension changes

Nice changed its recommendations on hypertension management in August, heralding a radical shift in both assessment and management. Ambulatory blood pressure monitoring was in, providing a more accurate picture of a patient's blood pressure throughout the day, while diuretics fell truly out of favour, being relegated to a second-line therapy for all patients. Nice also recommends thiazide diuretics should not be used unless a patient is currently taking them, instead recommending thiazide-type drugs such as chlortalidone and indapamide.

The new guidelines mean that:

  • Stage one hypertension is defined as >=140/90mmHg AND daytime average of >= 135/85mmHg
  • Patients  less than 55 years old who are not of black African or Caribbean ethnicity should be prescribed an ACE inhibitor, or low-cost angiotensin II receptor blocker, at step one
  • Patients aged 55 years or older, or those of black African or Caribbean ethnicity, should be prescribed a calcium channel blocker at step one.

Nice also revamped diabetes screening. All high-risk patients over 25 years screened for type 2 diabetes by GPs, with the remainder of the adult population able to complete self-assessment questionnaires through pharmacies.

5 New services

October saw the biggest shakeup in pharmacy services since MURs were introduced, with the launch of a new advanced service for England. The new medicine service (NMS), which aims to improve patient compliance, involves two consultations with a pharmacist for any patient starting a new treatment for hypertension, type 2 diabetes, asthma/COPD or starting anticoagulants. The move also saw changes to MURs, with target groups introduced across England. At least 50 per cent of MURs now need to be in three groups: high risk medicines (anticoagulants/antiplatelets, diuretics and NSAIDs), respiratory medicines and patients recently discharged from hospital.

Not to be outdone, Wales introduced its own variation throughout November and December. The discharge medicines review (DMR) service aims to improve compliance in patients discharged from any care setting (including hospitals, prisons and care homes). And Wales launched its own target MUR groups, with antihypertensives, lithium and methotrexate and the puzzling ‘drugs no longer needed by the patient' in addition to the list used in England.

Catch-up with C+D's 14-part guide to the NMS and targeted MURs

Clinical forecast: how did we do?

At the start of the year, C+D CPD editor Chris Chapman made his predictions for 2011 – here's how he did...

Services: "Will pharmacies get a new advanced service this year?... it doesn't look likely". Oops, a little off the mark there. However, he correctly stated targeted MURs would come into force, and recommended "cautious optimism" for what became the new medicine service. He also predicted a rise in Healthy Living Pharmacies, correctly identifying early adopter sites.                                      


Drug shortages: "The problem in the pill pipeline isn't going to vanish overnight." Spot on, with a warning that anything other than economic shifts would have little impact. As C+D's Sort Out Stocks campaign has revealed, problems continue.


Prescription drugs: A correct prediction of the row over the patent for atorvastatin, although not the legal tussle throughout the summer. Also on target over the lack of impact of the government's cancer drugs fund.


NHS structure: Forecasts on GP consortia, Nice and confusion over DH plans were accurate – but that was about it. The listening exercise, Future Forum, and amended NHS structure are all absent from the forecast, while a predicted social care white paper never emerged.


Overall: "Overall, the prediction is ‘more of the same'.

"Expect chaos in the NHS restructures, more fights to get (or more likely hold on to) commissioned services, and more paperwork and pressure." It may not have been totally accurate, but it's pretty close. That said, it didn't exactly take a crystal ball to work out…


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