We are responsible for education and research concerned with Yellow Card reporting – one of the primary ways of discovering new adverse drug reactions to medicines and herbal products. (Yellow Cards) from within the area covered by NHS West Midlands.
The Yellow Card Centre West Midlands and the West Midlands Academic Health Science Network jointly hosted the Regional 50th anniversary celebration of the Yellow Card Scheme on 23rd February 2015. Yellow Cards have been a cornerstone of drug safety since the scheme was set up in 1964. The event celebrated the achievements of the scheme and also looked at exciting new developments for the future.
An audience of 83 doctors, pharmacists, nurses, and patients from across the region enjoyed an inspiring afternoon of case presentations, lectures, and patient accounts. One of the highlights was guest speaker Mick Foy from MHRA in London who delivered an extremely engaging keynote speech on future developments of the scheme. Feedback proved positive, and most thought it was a good day where they had learned a great deal; some of the comments were:
“The quality of speakers was excellent…topics were well lead and succinct…examples were all incredibly pertinent cases of potential ADR’s proving the need for the yellow card scheme.”
“A truly great day, well done!”
“All speakers were excellent, clear, concise and appropriate… 20 min sessions are perfect.”
“Excellent informative afternoon…presentations were good and a useful wake-up call. I would like to know more about the SCRIPT project.”
“Excellent – absolutely regarding patient safety.”
“Found the whole afternoon very interesting and informative.”
“Very interesting to hear a patients view.”
The successful event reinforced the importance of the Yellow Card Scheme within the West Midlands region, hence a warm thank you to all those who contributed and attended.
A brief guide to making sense of drug safety science has been published by Sense about Science. The document was developed in combination with the MRC Centre for Drug Safety Science at the University of Liverpool with support from the MRC.
Additionally the list of drug safety letters sent to healthcare professionals in January has been released, including fingolimod (Gilenya), Sodium Stibogluconate (Pentostam), dabigatran (Pradaxa), Tiseel and Artiss sprayable fibrin sealants, Bivalirudin (Angiox), combined laropiprant-nicotinic acid (Tredaptive), anagrelide (Xagrid), and Insulin degludec (Tresiba).
74 cases involving Polish and other medicines from Eastern European countries being sold in “corner shops” were investigated by the MHRA last year – these included medicines which fall into the category of pharmacy-only and prescription only medicines.
The MHRA have also started a new campaign to encourage the reporting of adverse drug reactions, with a particular focus on pharmacists.
There continues to be a fall in General Practitioner reporting. If you would like our centre to come and give a talk at your surgery, please get in touch.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a formal safety review of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35µg), associated names and its generics. This was requested by the French medicines regulatory agency (ANSM), who announced they would be suspending the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months. This was caused by concerns about reports of venous and arterial thromboembolism (VTE and ATE, the formation of blood clots in the veins or arteries) collated in the French national pharmacovigilance over a period of more than 20 years. Stakeholders, including patients and healthcare professionals may respond to the EMA consultation here.
The European Medicines Agency has also issued a press release concerning it’s decision to recommend that Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) should no longer be prescribed. Advice is provided at the previous link, as well as at the MHRA’s previously mentioned Drug Safety Update.
NSAIDS – all are not equal
The cardiovascular safety of non-steroidal anti-inflammatory drugs has been a subject of concern for a number of years. McGettigan and Henry have examined the use NSAIDs across 15 countries (low, middle and high income) in a recent paper in PLOS Medicine, and found that NSAIDs with the highest cardiovascular risks were commonly used within all. They argue that the evidence base for cardiovascular safety has not been translated into either evidence-based guidance or usage patterns of these drugs that reflect the cardiovascular safety profile of the drugs. For example, diclofenac and etoricoxib, two NSAIDs with the highest cardiovascular risk, are widely used. They draw attention to the recent EMA review of NSAID cardiovascular safety.
The MHRA website provides addition information about NSAIDs and cardiovascular safety and notes “Whilst, there is some evidence of an increased risk with naproxen and ibuprofen, this is still considered to be lower than the risk with diclofenac or selective Cox-2 inhibitors.”