Reporting drug side effects - One click away!
Filed under: Type 1, Type 2, Childhood, Adult Onset, Drugs, Allie Beatty, Support, Personalities
A recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this?
The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc.
Your doctor is too busy to file the necessary paperwork to notify the FDA a drug is potentially harmful. What is a patient to do? Good question and here's an answer! If you experienced any adverse side effects from the use of a prescription drug, please let the FDA know. Click BEGIN and bring this monkey business to an end!
Read | Permalink | Email this | Linking Blogs | Comments[RESEARCH] Duplex ultrasonography, magnetic resonance angiography, and computed tomography angiography for diagnosis and assessment of symptomatic, lower limb peripheral arterial disease: systematic review
Objectives To determine the diagnostic accuracy of duplex ultrasonography, magnetic resonance angiography, and computed tomography angiography, alone or in combination, for the assessment of lower limb peripheral arterial disease; to evaluate the impact of these assessment methods on management of patients and outcomes; and to evaluate the evidence regarding attitudes of patients to these technologies and summarise available data on adverse events.
Design Systematic review.
Methods Searches of 11 electronic databases (to April 2005), six journals, and reference lists of included papers for relevant studies. Two reviewers independently selected studies, extracted data, and assessed quality. Diagnostic accuracy studies were assessed for quality with the QUADAS checklist.
Results 107 studies met the inclusion criteria; 58 studies provided data on diagnostic accuracy, one on outcomes in patients, four on attitudes of patients, and 44 on adverse events. Quality assessment highlighted limitations in the methods and quality of reporting. Most of the included studies reported results by arterial segment, rather than by limb or by patient, which does not account for the clustering of segments within patients, so specificities may be overstated. For the detection of stenosis of 50% or more in a lower limb vessel, contrast enhanced magnetic resonance angiography had the highest diagnostic accuracy with a median sensitivity of 95% (range 92-99.5%) and median specificity of 97% (64-99%). The results were 91% (89-99%) and 91% (83-97%) for computed tomography angiography and 88% (80-98%) and 96% (89-99%) for duplex ultrasonography. A controlled trial reported no significant differences in outcomes in patients after treatment plans based on duplex ultrasonography alone or conventional contrast angiography alone, though in 22% of patients supplementary contrast angiography was needed to form a treatment plan. The limited evidence available suggested that patients preferred magnetic resonance angiography (with or without contrast) to contrast angiography, with half expressing no preference between magnetic resonance angiography or duplex ultrasonography (among patients with no contraindications for magnetic resonance angiography, such as claustrophobia). Where data on adverse events were available, magnetic resonance angiography was associated with the highest proportion of adverse events, but these were mild. The most severe adverse events, although rare, were mainly associated with contrast angiography.
Conclusions Contrast enhanced magnetic resonance angiography seems to be more specific than computed tomography angiography (that is, better at ruling out stenosis over 50%) and more sensitive than duplex ultrasonography (that is, better at ruling in stenosis over 50%) and was generally preferred by patients over contrast angiography. Computed tomography angiography was also preferred by patients over contrast angiography; no data on patients' preference between duplex ultrasonography and contrast angiography were available. Where available, contrast enhanced magnetic resonance angiography might be a viable alternative to contrast angiography.
Does your doctor take side-effects seriously?
Filed under: Drugs
A recent study has come up with some results that don't bode so well for doctors: it seems more often than not they "write off" concerns expressed by their patients regarding medication side-effects. The study included 650 adults who believed they were experiencing adverse drug reactions related to their cholesterol meds, and the majority of their doctors blew off the concerns and denied the possibility that the symptoms and the medications could be connected. This trend rings true even for the most commonly seen side-effects for the most commonly prescribed drugs -- what's up with that?The study wasn't designed to find out why this happened, just that it does. Some experts guess that it's simply because there are no laws (and no way to regulate) that doctors learn the side-effects of every medication they prescribe.
So I guess it's up to you, as the patient, to educate yourself and make sure you have a doctor who listens.
[RESEARCH] Doctors' versus patients' global assessments of treatment effectiveness: empirical survey of diverse treatments in clinical trials
Objective To examine whether doctors’ global assessments of treatment effects agree with patients’ global assessments.
Design Survey of trials included in systematic reviews of treatments for diverse conditions.
Data sources Cochrane database of systematic reviews.
Data extracted Data on patients’ global assessments and on doctors’ global assessment for the same treatment against the same comparator.
Main outcome measures Relative odds ratio (ratio of odds ratios of global improvement with the experimental intervention versus control according to doctors compared with patients), and improvement rates according to doctors and patients.
Results Doctors’ global assessments were compared with patients’ global assessments for 63 different treatment comparisons (240 trials) in 18 conditions. The summary relative odds ratio across the comparisons was not significant (0.98, 95% confidence interval 0.88 to 1.08; I2=0%, 95% confidence interval 0% to 30%). In 62 of the 63 comparisons the effects of treatment rated by patients and by doctors did not differ beyond chance, but for single comparisons the confidence intervals were large. Rates of improvement on average did not differ between doctors’ assessments and patients’ assessments (summary relative odds ratio 0.98, 0.88 to 1.06; I2=0%, 0% to 24%).
Conclusion Doctors’ global assessments of the effects of treatments are on average similar to those of patients.
[RESEARCH] Cumulative funnel plots for the early detection of interoperator variation: retrospective database analysis of observed versus predicted results of percutaneous coronary intervention
Objective To use funnel plots and cumulative funnel plots to compare in-hospital outcome data for operators undertaking percutaneous coronary interventions with predicted results derived from a validated risk score to allow for early detection of variation in performance.
Design Analysis of prospectively collected data.
Setting Tertiary centre NHS hospital in the north east of England.
Participants Five cardiologists carrying out percutaneous coronary interventions between January 2003 and December 2006.
Main outcome measures In-hospital major adverse cardiovascular and cerebrovascular events (in-hospital death, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accident) analysed against the logistic north west quality improvement programme predicted risk, for each operator. Results are displayed as funnel plots summarising overall performance for each operator and cumulative funnel plots for an individual operator’s performance on a case series basis.
Results The funnel plots for 5198 patients undergoing percutaneous coronary interventions showed an average observed rate for major adverse cardiovascular and cerebrovascular events of 1.96% overall. This was below the predicted risk of 2.06% by the logistic north west quality improvement programme risk score. Rates of in-hospital major adverse cardiovascular and cerebrovascular events for all operators were within the 3 upper control limit of 2.75% and 2 upper warning limit of 2.49%.
Conclusion The overall in-hospital major adverse cardiovascular and cerebrovascular events rates were under the predicted event rate. In-hospital rates after percutaneous coronary intervention procedure can be monitored successfully using funnel and cumulative funnel plots with 3 control limits to display and publish each operator’s outcomes. The upper warning limit (2 control limit) could be used for internal monitoring. The main advantage of these charts is their transparency, as they show observed and predicted events separately. By this approach individual operators can monitor their own performance, using the predicted risk for their patients but in a way that is compatible with benchmarking to colleagues, encapsulated by the funnel plot. This methodology is applicable regardless of variations in individual operator case volume and case mix.
Many doctors aren't bothered when their patients can't lower cholesterol
Filed under: Prevention
Although you may be frustrated when your efforts to lower your cholesterol don't work, your doctor may not be. In a recent study of general and family practitioners there seemed to be a scary number of doctors who weren't surprised or frustrated when their patients were unable to get cholesterol levels down. 61% of doctors stated they don't feel frustrated when they are unable to lower cholesterol levels in their patients, despite understanding the severe health risks that go along with it. Are they not taking it seriously? Is it that they just don't expect their patients to take it seriously? Whatever the issue, make sure you have a doctor that takes a personal interest in you and your health.
[RESEARCH] Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial
Objective To determine the effect of calcium supplementation on myocardial infarction, stroke, and sudden death in healthy postmenopausal women.
Design Randomised, placebo controlled trial.
Setting Academic medical centre in an urban setting in New Zealand.
Participants 1471 postmenopausal women (mean age 74): 732 were randomised to calcium supplementation and 739 to placebo.
Main outcome measures Adverse cardiovascular events over five years: death, sudden death, myocardial infarction, angina, other chest pain, stroke, transient ischaemic attack, and a composite end point of myocardial infarction, stroke, or sudden death.
Results Myocardial infarction was more commonly reported in the calcium group than in the placebo group (45 events in 31 women v 19 events in 14 women, P=0.01). The composite end point of myocardial infarction, stroke, or sudden death was also more common in the calcium group (101 events in 69 women v 54 events in 42 women, P=0.008). After adjudication myocardial infarction remained more common in the calcium group (24 events in 21 women v 10 events in 10 women, relative risk 2.12, 95% confidence interval 1.01 to 4.47). For the composite end point 61 events were verified in 51 women in the calcium group and 36 events in 35 women in the placebo group (relative risk 1.47, 0.97 to 2.23). When unreported events were added from the national database of hospital admissions in New Zealand the relative risk of myocardial infarction was 1.49 (0.86 to 2.57) and that of the composite end point was 1.21 (0.84 to 1.74). The respective rate ratios were 1.67 (95% confidence intervals 0.98 to 2.87) and 1.43 (1.01 to 2.04); event rates: placebo 16.3/1000 person years, calcium 23.3/1000 person years. For stroke (including unreported events) the relative risk was 1.37 (0.83 to 2.28) and the rate ratio was 1.45 (0.88 to 2.49).
Conclusion Calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates. This potentially detrimental effect should be balanced against the likely benefits of calcium on bone.
Trial registration Australian Clinical Trials Registry ACTRN 012605000242628.
[RESEARCH] Understanding help seeking behaviour among male offenders: qualitative interview study
Objective To explore the factors that influence help seeking for mental distress by offenders.
Design Qualitative study based on in-depth interviews with prisoners before and after release.
Setting One category B local prison in southern England.
Participants 35 male offenders aged 18-52, a quarter of whom had been flagged as being at risk of self harm.
Results Most respondents reported that they would not seek help from a general practitioner or other healthcare professional if experiencing mental distress. When followed up after release, none had sought medical help despite the fact that many had considerable emotional problems. Many participants were hesitant to seek help because they feared being given a formal diagnosis of mental illness. Some of these men feared the stigma that such a diagnosis would bring, whereas others feared that a diagnosis would mean having to confront the problem. Lack of trust emerged as the most prominent theme in prisoners' discourse about not seeking help from health professionals. Distrust towards the "system" and authority figures in general was linked to adverse childhood experiences. Distrust directed specifically at healthcare professionals was often expressed as specific negative beliefs: many perceived that health professionals (most often doctors) "just don't care," "just want to medicate," and treat patients "superficially." Those men who would consider going to a general practitioner reported positive previous experiences of being respected and listened to.
Conclusions Distrust is a major barrier to accessing health care among offenders. Like most people, the respondents in this study wanted to feel listened to, acknowledged, and treated as individuals by health professionals. By ensuring that a positive precedent is set, particularly for sceptical groups such as ex-prisoners, general practitioners and prison doctors may be able to encourage future help seeking. Information specifically designed for prisoners is needed to help to de-stigmatise mental illness, and preparation for release should include provision of information about access to health and social services. Awareness training for health professionals is recommended: trust might be fostered in this population by seemingly trivial gestures that indicate respect.
[RESEARCH] Oral chemotherapy safety practices at US cancer centres: questionnaire survey
Objective To characterise current safety practices for the use of oral chemotherapy.
Design Written questionnaire survey of pharmacy directors of cancer centres.
Setting Comprehensive cancer centres in the United States.
Results Respondents from 42 (78%) of 54 eligible centres completed the survey, after consulting with 89 colleagues. Clinicians at 29 centres used handwritten prescriptions, two used preprinted paper prescriptions, and six used electronic systems for most oral chemotherapy prescribing. For six commonly used oral chemotherapies, on average 10 centres required a diagnosis on the prescription, 11 required the protocol number, four required the cycle number, nine required double checking by a second clinician, 14 required a calculation of body surface area, and 14 required a calculation of dose per square metre of body surface area. Only a third of centres requested patients' written informed consent when oral chemotherapy was given off protocol. Nearly a quarter (10) of centres had no formal process for monitoring patients' adherence. In the past year respondents at 10 centres reported at least one serious adverse drug event related to oral chemotherapy, and respondents at 13 centres reported a serious near miss.
Conclusion Few of the safeguards routinely used for infusion chemotherapy have been adopted for oral chemotherapy at US cancer centres. There is currently no consensus at these centres about safe medication practices for oral chemotherapy.
Charges dropped against Mr. Universe
Filed under: Type 1, Childhood, Events, Support
Last week Amy Tenderich, creator of Diabetes Mine and co-author of Know Your Numbers, Outlive Your Diabetes, sent out an email asking us to speak out on behalf of Mr. Universe. I remembered the gist of the story when it first happened, back in April. What I didn't realize was the ensuing atrocities for Mr. Burns after the event.
Back in April, Doug Burns was maced by police during a hypoglycemic event at a movie theater. During the episode, the police assumed he was intoxicated, despite a bystander's insistence that it might be a diabetes issue. He was handcuffed, thrown into a car, and driven to a nearby ER without proper treatment for his hypoglycemia. Officers arrested him for assault and resisting arrest. Prosecutors initially insisted Burns needed to provide more medical evidence that he was a Type I diabetic suffering from insulin shock at the time. For some unknown reason -- a blood sugar of 40 isn't proof enough? The records from the event show that Doug never struck anyone, and in fact, he was the only party injured in the incident. However, the case was raised to assault and resisting arrest when one of the policemen suddenly reported an injury -- week-and-half later.
Turns out the county prosecutors have dropped misdemeanor charges against Mr. Universe. Ladies and gentleman, this is proof of how misinformed the general public is of the hurdles diabetics must overcome to continue life, uninterrupted. I'm proud to say that when issues are raised, awareness prevails. Thanks to everybody who called into the DAs office last week and thanks to Amy for calling out for the help.