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Clinical Pharmacist's monthly news round-up: the top 10 in the past month

What has been happening in the world of pharmacy? Here’s our pick of must-read news from the past month.

Paracetamol use linked with cardiovascular risk


1. Paracetamol use linked with cardiovascular risk

Researchers have discovered a consistent dose-response relationship between paracetamol use and risk of mortality or cardiovascular, gastrointestinal or renal adverse events.

The risks associated with taking the standard adult dose of paracetamol for pain relief are similar to those commonly associated with non-steroidal anti-inflammatory drugs.

The finding suggests a considerable degree of paracetamol toxicity especially at the upper end of standard analgesic doses. “Prescribers need to be aware of patients’ individual responses to paracetamol and the observed increased toxicity with regular and higher dosing within standard analgesic dose ranges,” write the researchers in a paper published in Annals of the Rheumatic Diseases on 2 March 2015. “We believe the true risk of paracetamol prescription to be higher than currently perceived in the clinical community.”

The researchers based their conclusions on a literature review of adverse events and paracetamol use. They analysed data from eight observational studies that reported mortality or cardiovascular, gastrointestinal or renal adverse incidents in the general adult population.

Dispensing error protection will not apply in all hospitals


2. Dispensing error protection will not apply in all hospitals

Hospital pharmacists could still face criminal prosecution for making an inadvertent dispensing error, despite UK government proposals to change the Medicines Act 1968. The proposed reforms to medicines legislation, which could in future provide a defence to pharmacists who make a dispensing error, will only apply to pharmacists working from registered premises.

The body set up to oversee the changes to the law is looking for a solution so that hospital pharmacists will be given the same legal protection from criminal prosecution for making a dispensing error as their colleagues in the community. Although community pharmacies have to be registered in order to provide pharmacy services, hospital pharmacies do not. The board’s advisory group decided against recommending a change in the law to make it a statutory requirement for all hospital premises to be registered because it said the move would be out of proportion to the need. The current proposals are out for consultation until 14 May 2015.

3. Calls for a halt on NSAID use in heart disease patients 

The use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients receiving antithrombotic therapy after myocardial infarction (MI) doubles the risk of further heart attacks and significantly increases the risk of other thrombotic events and serious bleeding compared with those who do not receive NSAIDs, according to a study published in JAMA on 24 February 2015.

The findings have prompted calls for heightened caution when prescribing NSAIDs, or even a complete halt on their use pending better understanding of the mechanisms involved across different patient groups and therapy combinations. The study was based on patient data on myocardial infarctions obtained from Danish national registries.

4. Healthcare staff urged to share medicines information

Information about a patient’s medicines should be shared by health and social care staff when that person moves from one care setting to another to support high-quality care, urges new guidance from England’s National Institute for Health and Care Excellence (NICE), published on 4 March 2015. When people move from one care setting to another, between 30% and 70% of patients have an error or unintentional change to their medicines, says the ‘Medicines optimisation’ guidance. Information should ideally be shared within 24 hours of the person being transferred and medicines reconciliation should be carried out by a competent healthcare professional, NICE adds.

US FDA approves antibiotic combination for treatment of complicated intra-abdominal infections and complicated urinary tract infections. In the image, a urine analysis


5. US FDA approves antibiotic combination

The US Food and Drug Administration (FDA) has approved a new intravenous combination antibacterial product, Avycaz, for the treatment of complicated infections. It contains a third generation cephalosporin beta-lactam antibacterial, ceftazidime, and a new beta-lactamase inhibitor, avibactam. The United States will be the first market for Avycaz, with an expected launch date in the second quarter of 2015. An application to the European Medicines Agency is expected to be made in the first quarter of 2015.

The product is approved for the treatment of two conditions in adults: complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis, in patients with limited treatment options.

“The recent approval of ceftazidime-avibactam by the FDA adds another agent with activity against multidrug-resistant Gram-negative organisms to the potential armamentarium,” says Paul Wade, a consultant pharmacist at Guy’s & St. Thomas’ NHS Foundation Trust. The FDA says decreased efficacy, seizures and other neurological events were seen in patients with poor renal function.

Older patients taking anticholinergic drugs are at risk of dementia


6. Older patients taking anticholinergic drugs are at risk of dementia

People aged over 65 years who take some common over-the-counter (OTC) or prescribed medicines for allergy, depression or an overactive bladder have an increased risk of developing dementia if they take them at high dose for a long time, according to research published in JAMA Internal Medicine on 26 January 2015.

The data confirm a dose–response relationship to developing dementia and show that the risk remains even if the patient stops taking the medicines. Researchers analysed dispensing data for more than 3,400 patients, who were monitored for signs of dementia for around 7.3 years. The researchers found that 23.2% of patients developed dementia. Of that group, 79.9% had possible or probable Alzheimer’s disease.

Patients taking the highest daily dose of an anticholinergic agent had a significantly increased risk for dementia. Older patients should be made aware that many drugs have “strong anticholinergic effects” and that they should ask their pharmacist or prescriber for alternatives, says Shelly Gray, the lead researcher.

7. First-in-class oral psoriasis drug approved in Europe

The European Commission has authorised apremilast (Celgene’s Otezla), a first-in-class oral drug for the treatment of chronic plaque psoriasis and psoriatic arthritis in patients who have failed first-line systemic therapies, following its approval by the European Medicines Agency in November 2014. Apremilast selectively inhibits phosphodiesterase-4, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and helping to downregulate the inflammatory response.

Uniquely among treatments for psoriasis and psoriatic arthritis, Otezla is taken orally and does not require laboratory monitoring before or during treatment. Apremilast is well tolerated, with the most common adverse events being diarrhoea, nausea and infections of the upper respiratory tract.

8. Hydroxyzine safety measures loom after heart risk review

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that hydroxyzine is associated with a “small but definite risk” of serious heart rhythm anomalies, in a review published on 13 February 2015.

The review has confirmed that hydroxyzine — which has been used as an antihistamine, antipsychotic and sedative — poses an increased risk of QT-interval prolongation and of torsade de pointes, which can cause arrhythmia and cardiac arrest. The PRAC has recommended a series of measures to minimise risks with the drug, including reducing the dosage, avoiding its use in the elderly and closely monitoring patients.

Common antibiotic taken with a diuretic linked to sudden death


9. Common antibiotic taken with a diuretic linked to sudden death

Spironolactone, a diuretic used to treat heart failure with side effects including hyperkalaemia (raised blood potassium levels), is associated with an increased risk of sudden death when combined with the antibiotic trimethoprim–sulfamethoxazole (co-trimoxazole), according to a study published in the Canadian Medical Association Journal on 2 February 2015.

Analysing health records for more than 200,000 patients prescribed spironolactone, researchers found that of the 11,968 patients who died of sudden death, 328 died within 14 days of exposure to certain antibiotics: trimethoprim–sulfamethoxazole, amoxicillin, ciprofloxacin, norfloxacin or nitrofurantoin. The researchers matched each case with up to four controls and found that sudden death was more than twice as likely for those taking trimethoprim-sulfamethoxazole as for those taking amoxicillin (adjusted odds ratio 2.46, 95% confidence interval 1.55–3.90).

The study’s conclusions are not surprising given that both spironolactone and co-trimoxazole on their own can cause hyperkalaemia, say the editors of Stockley’s Drug Interactions, a reference book of drug-interaction information.

The US Food and Drug Administration (FDA), pictured,  has approved palbociclib for metastatic breast cancer in postmenopausal women under its accelerated approval programme

Source: Wikimedia Commons

10. Palbociclib gets expedited approval in United States

The US Food and Drug Administration (FDA) has approved palbociclib (Pfizer’s Ibrance) for metastatic breast cancer in postmenopausal women under its accelerated approval programme. An application is expected to be filed with the European Medicines Agency in 2015. Palbociclib inhibits cyclin-dependent kinases (CDKs) 4 and 6, which promote the growth of cancer cells. It is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy, and is used in combination with letrozole.

In a trial of 165 such women, progression-free survival was 20.2 months in those randomised to palbociclib plus letrozole, compared with 10.2 months in the letrozole group. Palbociclib’s most common side effects include neutropenia, anaemia, upper respiratory infection, nausea and peripheral neuropathy. The recommended starting dose is 125mg for 21 days, followed by a seven-day break, with blood count monitoring at the start of every cycle and on day 14 of the first two cycles.

Citation: Clinical Pharmacist DOI: 10.1211/CP.2015.20068081

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Supplementary images

  • Paracetamol use linked with cardiovascular risk
  • Dispensing error protection will not apply in all hospitals
  • US FDA approves antibiotic combination for treatment of complicated intra-abdominal infections and complicated urinary tract infections. In the image, a urine analysis
  • Older patients taking anticholinergic drugs are at risk of dementia
  • Common antibiotic taken with a diuretic linked to sudden death

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