Australian Medication Safety Services

Muscle symptoms don’t necessarily preclude further statin treatment

AdminChris — Thu, 25 Feb 2021 22:29:58 +0000

British researchers have used an interesting study technique to address the perennially vexed question of the possible effect of statins on muscle symptoms, targeting individuals previously reported muscle symptoms during treatment. Effectively, the research was a series of randomised, placebo controlled n-of-1 trials, involving 200 subjects who had recently stopped or were considering stopping treatment with statins because of muscle symptoms – these people were randomly assigned to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo, rateing their muscle symptoms on a visual analogue scale (0-10). 151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis, but no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo −0.11, 95% confidence interval −0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. The researchers advocate that if an elderly person does report muscle symptoms during statin treatment, cautious consideration for re-introduction of treatment might be considered, albeit the limitations of the study design did not allow differentiation of the effects of different statins or higher doses of the drugs. See the paper, published in the British Medical Journal, here.

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PPIs associated with increased risk of asthma in children

AdminChris — Thu, 18 Feb 2021 00:21:04 +0000

Proton pump inhibitors (PPIs) are medications that are very widely used, including use for children with reflux. A recent study from Sweden used national registry data in Sweden over a decade to examine clinical details for children and adolescents 17 years or younger, matched by age and propensity score into 80 870 pairs of those who initiated PPI use and those who did not. The primary analysis examined the risk of incident asthma. The cohort included 63.0% girls; of a mean [SD] age of 12.9 [4.8] years),. Children who initiated PPI use had a higher incidence rate of asthma (21.8 events per 1000 person-years) compared with non-initiators (14.0 events per 1000 person-years), with an HR of 1.57 (95% CI, 1.49-1.64). Risk of asthma was significantly increased across all age groups and was highest for infants and toddlers. The hazard ratio was highest with pantoprazole at 2.33 (95% CI, 1.30-4.18). More details of the study, published in JAMA Pediatrics, can be viewed here.

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Anticoagulation and Covid19 infection

AdminChris — Mon, 15 Feb 2021 01:52:38 +0000

In view of the observation that Covid19 infection as associated with VTE at an incidence of up to 30%, researchers have recently examined the possibility that early initiation of prophylactic anticoagulation may decrease the likelihood of death among hospitalised patients infected with the virus.In an observational study of a nationwide cohort of patients a complete cohort of 4297 patients admitted to hospital from 1 March to 31 July 2020 with laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and without a history of anticoagulation were followed. 3627 (84.4%) received prophylactic anticoagulation within 24 hours of admission (mostly SC heparin or enoxaparin.) 622 deaths occurred within 30 days of hospital admission, and 513 of those who received prophylactic anticoagulation died. The cumulative incidence of mortality at 30 days was 14.3% (95% confidence interval 13.1% to 15.5%) among those who received prophylactic anticoagulation and 18.7% (15.1% to 22.9%) among those who did not. Prophylactic anticoagulation was not associated with increased risk of bleeding requiring transfusion (hazard ratio 0.87, 0.71 to 1.05). The researchers advocate that the early use of anticoagulation appears warranted for those infected and hospitalised. See the study details here.

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Semaglutide for weight loss

AdminChris — Fri, 12 Feb 2021 04:21:08 +0000

New drug treatments for obesity are urgently needed. The results from a trial of once-weekly subcutaneous semaglutide injections at a dose of 2.4 mg as an adjunct to lifestyle suggest that this approach may yield sustained benefit. Adults with a body-mass index of 30 or greater (≥27 in persons with ≥1 weight-related coexisting condition), who did not have diabetes, and randomly assigned to receive 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle intervention. The mean change in body weight from baseline to week 68 was −14.9% in the semaglutide group as compared with −2.4% with placebo, for an estimated treatment difference of −12.4 percentage points (95% confidence interval [CI], −13.4 to −11.5; P<0.001). A greater proportion of people treated with semaglutide achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1%] vs. 69 [12.0%]), and 15% or more (612 [50.5%] vs. 28 [4.9%]) at week 68 (P<0.001 for all three comparisons of odds. Semaglutide produced a greater improvement in cardiometabolic risk factors and a greater increase in participant-reported physical functioning. Nausea and diarrhea were the most common adverse events with semaglutide; they were typically transient and mild-to-moderate in severity and subsided with time. Given the grave consequences of obesity, this approach appears worthy of greater deployment. See the paper, published in the New England Journal of Medicine, here.

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Involving pharmacists as prescribers improves prescription accuracy in hospitals

AdminChris — Fri, 12 Feb 2021 03:49:08 +0000

It has been mooted that pharmacists working in hospitals could assume responsibility for prescribing medications to be issued at the time of discharge. A study of conventional (control) prescribing or pharmacist-led prescribing (intervention) has explored this possibility in two phases, including with handwritten prescribing and digital prescribing. The primary outcome was the percentage of patients with a medication error on their discharge prescription. 95% of control patients and 29% in the pharmacist prescribing arm had at least one medication error at discharge (p < 0.0002, RR 0.31, CI 0.16—0.58. Items associated with at least one error reduced from 69 to 4%; p < 0.0001, RR 0.06, CI 0.03—0.11 and fewer items had at least one clinically significant error (11% vs 2%, p = 0.0004, RR 0.15, CI 0.04—0.30). In the second phase (digital prescribing), 100% of control patients and 62% in the intervention arm had at least one medication error (p = 0.005, RR 0.62, CI 0.44—0.87). Items with at least 1 error decreased from 21 to 7% (p < 0.0001, RR 0.34, CI 0.44—0.56), there were fewer items with at least 1 clinically significant error (13% vs 5%, p < 0.003, RR 0.4, CI 0.22—0.72). It seems that this model of practice enhances safety and could also yield other benefits (e.g. cost-effective care and diminished medicolegal liability). See more details here.

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Metformin may reduce age-related macular degeneration

AdminChris — Tue, 02 Feb 2021 23:22:25 +0000

Age-related macular degeneration (AMD) is the most common cause of irreversible blindness for older people. A recently published case-control study examined people 55 years and older with newly diagnosed AMD , enrolling 312 404 people with AMD and matching them with 312 376 controls. Those with AMD had a slightly higher percentage of participants with diabetes (26.0%) compared with the control group (25.5%). The use of metformin was found to be associated with reduced odds of developing AMD (odds ratio [OR], 0.94 [95% CI, 0.92-0.96]), and moreover the association was dose dependent: low to moderate doses of metformin showing the greatest potential benefit (dosages over 2 years: 1-270 g, OR, 0.91 [95% CI, 0.88-0.94]; 271-600 g, OR, 0.90 [95% CI, 0.87-0.93]; 601-1080 g, OR, 0.95 [95% CI, 0.92-0.98]). Doses of more than 1080 g of metformin over 2 years did not have reduced odds of developing AMD. Both the reduction in odds ratio and the dose-dependent response were preserved in a cohort consisting only of patients with diabetes. The authors suggest that metformin may help to prevent AMD and advocate for prospective clinical trials. See more details here.

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Clinical trial reveals modest benefit for pharmacotherapy of methamphetamine use disorder.

AdminChris — Thu, 14 Jan 2021 23:59:14 +0000

There has been a dearth of options available to clinicians when it comes to the pharmacological management of methamphetamine use disorder. On this background, a group from the USA have conducted a multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. Urine samples were obtained from participants twice weekly was used as a measure of outcomes, and the primary outcome was defined as at least three methamphetamine-negative urine samples out of four samples obtained at the key milestones in the study. The weighted average response across the two stages of the study was 13.6% with naltrexone–bupropion and 2.5% with placebo. Serious adverse events were uncommon. Although the response rate was low, this study at least provides an indicator that the approach offers some degree of benefit and could be further explored. See more details here.

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Analysis of fatal adverse drug events encountered in the ED

AdminChris — Thu, 14 Jan 2021 00:52:19 +0000

Recently published research from Italy was conducted to describe the characteristics of adverse drug events (ADEs) with a fatal outcome encountered in the ED setting, including the drugs involved, the frequency of the events and an estimate of the preventability of the issues, with data collected over a period spanning 2012-2018. The study did exclude cases with vaccine-related ADEs, overdose or suicide, and ADEs that occurred during the hospitalisation. The data addressed 429 cases, 92 of which were ultimately excluded leaving 187 cases involving women and 150 where the subjects were men (mean age of 79 and of 77 years, respectively). Anticoagulants and antiplatelet agents accounted for more than 40% of all cases and the most frequent issue was haemorrhage (37.5%). 25% of the reactions were adjudged to have been preventable. See more details here.

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COVID19 and remdesivir reactions.

AdminChris — Wed, 13 Jan 2021 11:42:39 +0000

Remdesivir has been the focus of much attention in the context of the COVID-19 pandemic. A recent examination of the WHO VigiBase® has focused on Adverse Drug Events (ADEs) amongst COVID-19 patients. 1086 ADEs were reported from the 439 individual case reports up to July 19, 2020, in the VigiBase® (1004 after elimination of duplicates). Most involved men > 45 years and were serious (82.5%). An increase in hepatic enzymes (32.1%), renal injury (14.4%), rise in creatinine levels (11.2%), and respiratory failure (6.4%) were the most frequently reported issues. Although perhaps difficult to distinguish from some features of COVID-19, the reports provide an early safety signal for the attention of clinicians. Read more here.

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Risk of atypical hip fracture increased with extended duration of treatment with bisphosphonates

AdminChris — Mon, 11 Jan 2021 00:22:09 +0000

Bisphosphonates are widely used because of their effectiveness in reducing hip and osteoporotic fractures, but there have been concerns about atypical femur fractures. In study of women 50 years of age or older who were receiving bisphosphonates, researchers examined a primary outcome of atypical femur fracture, assessing risk factors (including bisphosphonate use) from electronic health records. This large study examined data from 196,129 women, and 277 atypical femur fractures were documented. After multivariable adjustment, trends in the data did emerge. When compared to short term use for < 3 months, the risk of atypical fracture increased with longer duration of bisphosphonate use: the hazard ratio was 8.86 (95% confidence interval [CI], 2.79 to 28.20) for 3 – 5 years, and 43.51 (95% CI, 13.70 to 138.15) for 8 years of use or more. Asian ethnicity was another factor that also increased risk (HR for Asians vs. Whites, 4.84; 95% CI, 3.57 to 6.56). Bisphosphonate discontinuation was associated with a rapid decrease in the risk of atypical fracture. Notwithstanding this, the absolute risk of atypical femur fracture remained very low as compared with reductions in the risk of hip and other fractures with bisphosphonate treatment. See details here.

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