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Yellow Card (yellow + card)
Selected AbstractsFactors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professionalJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2004Marķa T. Herdeiro BS Abstract Rationale, aims and objectives, The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. Methods, The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. Results and conclusions, The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors. [source] Adverse effects of neuromuscular blocking agents based on yellow card reporting in the U.K.: are there differences between males and females?,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2006FRCA, Karen Patricia Light MBBS Abstract Background Adverse drug reactions (ADRs) are known to occur during anaesthesia; in the U.K. such ADRs may be reported through the Yellow Card Scheme (YCS). Our aim was to determine the demographics of ADRs to neuromuscular blocking drugs without formal causality assessment. Methods A retrospective analysis of ADRs to seven neuromuscular blocking drugs reported via the YCS during a greater than 30-year period was performed. Sex and age were analysed in order to identify at risk groups. Results Of 998 reports, 969 included gender. Non-allergic suspected reactions occurred with almost the same frequency as those with an allergic component. The majority occurred in females 676 (70%), and significant sex differences were measured between drugs. Males were more likely to have suffered an ADR to atracurium (p,=,0.01) whilst females experienced more ADRs to suxamethonium (p,=,0.01). ADRs proved fatal in 81 (9%) of the 950 reports for single drugs. Mortality following suxamethonium was significantly higher in males at 22% compared with 9% females (p,<,0.001). More women than men were reported to have allergic reactions, 73% (362/499) compared with 27% (137/499) respectively. The female:male ratio for ADRs was reversed for subjects <,10 years compared with peak ADR reports during the decade from 31,40 years. Conclusions Sex differences in mortality exist in this analysis. The unexpected high frequency of non-allergic ADRs suggests that morbidity and mortality from reactions to established drugs is twice that expected from allergic reactions alone. Standards and guidance for the reporting of ADRs warrant urgent development. Copyright © 2006 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 11 2008Article first published online: 18 JUN 200 New asthma guideline The BTS/SIGN guideline for the management of asthma has been updated. The diagnosis section has been rewritten, there is a new section on difficult asthma and the treatment sections have been updated. A new option at Step 3 (initial add-on therapy) is now the use of a combined budesonide/formoterol inhaler (Symbicort) as a reliever in addition to regular use as a preventer. This reflects evidence from the SMART trials, which showed that an average of one extra puff per day significantly reduced exacerbations and admissions (Br Med J 2007;335:513). Metformin matches insulin in pregnancy Metformin does not worsen perinatal outcomes compared with insulin in gestational diabetes and mothers prefer it, a study from Australia and New Zealand shows (N Engl J Med 2008;358:2003,15). Of the women randomised to metformin treatment, 93 per cent were still taking it at term and 46 had supplemental insulin. The combined incidence of neonatal hypoglycaemia, respiratory distress, need for phototherapy, birth trauma, five-minute Apgar score less than 7 or prematurity was 32 per cent with both treatments. There were no serious adverse events. More women said they would choose the same treatment again for metformin than insulin (77 vs 27 per cent). Same CV protection with antihypertensives There is no difference in protection against major cardiovascular events between different types of antihypertensives in young or older (65 or over) adults, according to the Blood Pressure Lowering Treatment Trialists' Collaboration. Its meta-analysis of 31 trials involving over 190 000 patients (BMJ Online 2008; doi:10.1136/bmj.39548.738 368.BE) found no significant difference by age on blood pressure reduction or risk reduction. Treatment may be chosen according to tolerability and cost as long as effective blood pressure reduction is achieved, the authors conclude. Older people are at greater absolute risk and treatment therefore offers larger reductions in serious vascular events. HPV vaccination starts in September Vaccination against human papilloma virus will be part of the national immunisation programme from the start of the new school year in September. The vaccine, administered as three doses over six months, will initially be offered to girls aged 12,13 (school year 8) to reduce their risk of cervical cancer. A two-year catch-up campaign for all girls up to 18 years old will begin in 2009. MHRA: pancreatitis with exenatide warning The incretin mimetic exenatide (Byetta), licensed for the treatment of type 2 diabetes, may rarely be associated with pancreatitis, warns the MHRA (Drug Safety Update 2008;1:Issue 10). One case has been reported in the UK and 89 in the USA and Germany. The MHRA advises that patients should be warned of the symptoms of pancreatitis (severe abdominal pain, back pain). Treatment should be discontinued if pancreatitis is suspected and the case reported on a yellow card. 2007 prescribing bill Primary-care expenditure on drugs in England in 2007 totalled £8.37 billion, only 2 per cent more than in 2006, according to the latest statistics from the Information Centre (www.ic.nhs.uk). Prescription numbers increased by almost 6 per cent. Prescribing increased in most BNF categories but changed little in musculoskeletal drugs and immunological products and vaccines. Calceos: calcium/ vitamin D3 price match Manufacturer Galen has pledged to continue to price-match its calcium/vitamin D3 supplement Calceos with Adcal-D3 or Calcichew D3 Forte. If the price of either product falls below that of Calceos chewable tablets, Galen will match it within six months. The company says it will honour the pledge until at least 2011. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 4 2008Article first published online: 20 MAR 200 Suicide warning for all antidepressants All antidepressants are to include a warning of the risk of suicide in their product information, the MHRA says. The requirement formerly applied only to SSRIs but, following a US review of safety data, the Agency says the risk is similar for all classes of antidepressants. Patients at increased risk include young people with psychiatric morbidity and those with a history of suicidal ideation. Patients are at increased risk of suicide until remission occurs, and clinical experience shows that the risk is increased during the early stages of recovery. Confusion over type 2 diabetes management Contradictory findings have been reported from two studies of intensive management of type 2 diabetes. The STENO-2 study (N Engl J Med 2008;358:580-91) found that tight control of blood glucose, blood pressure and lipids plus low-dose aspirin in 160 patients with type 2 diabetes and microalbuminuria significantly reduced all-cause mortality, cardiovascular events, cardiovascular death and microvascular complications by 40-60 per cent. The US National Heart, Blood and Lung Institute has announced the end of the intensive treatment arm of the ACCORD study (unpublished). This study was comparing intensive lowering of blood glucose below currently recommended levels (target HbA1C <6 per cent) with conventional management in adults with type 2 diabetes at especially high risk for heart attack and stroke. Although mortality was reduced in both arms compared with other populations, intensive treatment was associated with increased mortality equivalent to three deaths per 1000 patients per year over four years. Another antibiotics campaign The Government has launched another campaign to promote public awareness that antibiotics are not appropriate for viral infections causing coughs, colds and sore throats. Get Well Soon , Without Antibiotics is supported by a national advertising campaign and leaflets and posters encouraging the public to ask advice rather than demand a prescription. Details are available at www.dh.gov.uk. Episenta: once-daily sodium valproate Following a launch to specialists last year, a new once-daily modified-release formulation of sodium valproate is being promoted more widely to GPs. Episenta is licensed for the treatment of all forms of epilepsy and is formulated as modified-release capsules of 150mg and 300mg and sachets of modified-release granules of 500mg and 1000mg. The dose may be administered once or twice daily. Patients may be switched from enteric-coated tablets of valproate to the same dose given as Episenta. Episenta costs £5.70 or £10.90 for 100 × 150mg or 300mg capsules, and £18 or £35.50 for 100 × 500mg or 1000mg sachets. Latest NICE agenda The Department of Health has referred a new batch of topics for appraisal by NICE. Six of seven technology appraisals are for cancer drugs; the last is for dabigatran etexilate for venous thromboembolism. There will be four new clinical guidelines: autism spectrum disorders, hypertension in pregnancy, bed-wetting in children and severe mental illness with substance abuse. Two combined public health and clinical guidelines will address alcohol misuse. Varenicline vs NRT Varenicline (Champix) offers slightly greater smoking cessation rates than nicotine replacement therapy (NRT) in the long term and better symptom improvement, an international study has shown (Thorax 2008; published online:10.1136/ thx.2007.090647). A total of 746 smokers were randomised to treatment with varenicline 1mg twice daily for 12 weeks or transdermal NRT (21mg reducing to 7mg per day) for 10 weeks. Continuous abstinence rates for the last four weeks of treatment were 56 vs 43 per cent. The corresponding rates for one year were 26 and 20 per cent. Varenicline was associated with greater reductions in cravings, withdrawal symptoms and smoking satisfaction, but more nausea (37 vs 10 per cent). Adverse reactions class effect of statins The MHRA has identified several adverse effects that it says are class effects of the statins (Drug Safety Update 2008;1:Issue 7). Following a review of clinical trials and spontaneous reports, it is now apparent that any statin may be associated with sleep disturbance, depression, memory loss and sexual dysfunction; interstitial lung disease has been reported rarely. Product information is being updated to include the new information. Depression, including suicidal ideation, has also been associated with varenicline (Champix), the MHRA says; affected patients should stop treatment immediately. The combination of transdermal nicotine replacement therapy (NRT) and varenicline appears to be associated with a higher incidence of nausea, headache, vomiting, dizziness, dyspepsia and fatigue than NRT alone. The MHRA has also announced that, following the suspension of marketing authorisation for carisoprodol (Carisoma), it is considering a phased withdrawal of the closely-related meprobamate , the main active metabolite of carisoprodol. Following a successful pilot study, the public are being encouraged to report adverse reactions on yellow cards; the MHRA notes that health professionals provide more complete reports but patients include more information about quality of life. The scheme will be promoted via community pharmacies throughout the UK from February 2008. Cochrane: evidence on back pain interventions The latest release of Cochrane reviews includes three meta-analyses assessing interventions for back pain. Overall, NSAIDs were found to be effective as short-term treatment for acute or chronic back pain but the effect size was small. They were comparable with paracetamol but associated with more adverse effects; COX-2 selective NSAIDs were similarly effective, with slightly fewer adverse effects. There was no evidence that antidepressants reduced back pain but intensive individual patient education (lasting 2.5 hours) was effective for acute and subacute back pain and comparable with manipulation and physiotherapy; its effects on chronic pain were unclear. Copyright © 2008 Wiley Interface Ltd [source] | ||||||||||