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zondag 20 augustus 2017

DTB: Glycopyrronium for severe drooling in children

Glycopyrronium for severe drooling in children

Drooling of saliva is common in children with physical, intellectual and learning disability, and with poor neuromuscular coordination and oral control.1 It can cause skin breakdown, damage to clothes and equipment and psychosocial problems for the child and family. For many years, glycopyrronium has been prescribed off-label using the injection solution given orally or tablets crushed and suspended in water, or as unlicensed products that were imported or manufactured as pharmaceutical specials.2,3 In January 2017, a glycopyrronium oral solution (Sialanar�CProveca Limited) became available in the UK as the first licensed product for the treatment of severe drooling (sialorrhoea) in children and adolescents aged 3 years and older with chronic neurological disorders.4-6 Here, we consider the place of this new product in the management of severe drooling.

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Strontium ranelate discontinued

This month we are including a CPD/CME activity Activity: review prescribing of strontium

The makers of strontium ranelate (Protelos/Osseor), Les Laboratoires Servier, will cease the distribution of the drug in August 2017.1

Patients currently taking strontium will need to be reassessed and alternative therapeutic options considered. Specialist advice may be required for those patients in whom alternative drugs are not suitable.

1. Servier, 2017. Cessation of marketing of Protelos/Osseor: Extract of the letter sent to European Medicine Agency (EMA) and national European Agencies on 10 February 2017 [online]. Available: http://www.servier.com/content/cessation-marketing-protelososseor-extract-letter-sent-european-medicine-agency-ema-and [Accessed 19 July 2017].

  • Action: review prescriptions for strontium ranelate

  • Actions to be taken: (what am I going to do?)

  • Reflection: (what have I learnt?)

  • Follow up: (what will I do next?)

    As evidence of continuing medical education, this form may be used to record the key learning points and actions resulting...

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    T Eluxadoline for IBS-D

  • Question 1 Miss LH is 40 years old. She has been diagnosed with diarrhoea-predominant IBS (IBS-D). Which one of the following dietary recommendations is the most appropriate?

  • Increase dietary fibre intake

  • Increase intake of fresh fruit

  • Replace refined sugar with artificial sweetener

  • Reduce caffeine intake

  • Increase intake of resistant starch

  • Question 2 Which one of the following drugs is not licensed in the UK for the management of IBS?

  • Loperamide 2mg capsules

  • Mebeverine 135mg tablets

  • Fluoxetine 20mg capsules

  • Peppermint oil 0.2mL capsules

  • Alverine 120mg capsules

  • Question 3 In two double-blind phase III randomised controlled studies that were used to support the application for licensing, the primary composite outcome was the proportion of people who had a response of decrease in abdominal pain and improvement in stool consistency. What was the difference between eluxadoline 100mg and placebo...

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    {blacktriangledown} Eluxadoline for IBS-D

    Irritable bowel syndrome (IBS) is a chronic relapsing gastrointestinal problem characterised by intestinal pain and associated alterations of defecation and/or bowel habit (constipation: IBS-C or diarrhoea: IBS-D).1,2 Opioid receptors in the gut have a role in gastrointestinal motility, secretion and sensation.3 T Eluxadoline (Truberzi-Allergan) is a locally acting, mixed opioid receptor agonist/antagonist licensed for the treatment of IBS-D in adults.4 Here, we consider the evidence for eluxadoline and how it fts with current management strategies for IBS-D.

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    Nystatin dose change - much ado about nothing?

    A freedom of information (FOI) request from DTB has sought to clarify why the recommended doses for Nystan (nystatin 100,000iu/mL oral suspension) for some age groups were substantially increased before reverting to their previous levels with no apparent explanation. Historically, the recommended nystatin dosage in the UK for all age groups (including children and adults) was 1mL four times/day.

    In September 2015, in alignment with recommendations from a European public assessment report that looked at paediatric studies (although not at new evidence), the dose for prevention and treatment of oral candidiasis was increased in the summary of product characteristics (SPC) for Nystan to 2mL four times/day for infants aged 1 month to 2 years, and to 4�C6mL four times/day for children aged over 2 years and adults. 1,2 These doses are more in line with those recommended in the USA. However, dosing information for nystatin suspension...

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    Delayed antibiotic prescription for lower respiratory tract infections

    The impact of different antibiotic prescribing strategies for lower respiratory tract infections (RTIs) in people aged over 16 years has been assessed in a new prospective cohort study.1 Antibiotics continue to be commonly prescribed for RTIs, despite repeated advice to GPs to curb prescriptions owing to lack of efficacy and concerns over resistance. Possible reasons include GPs' reluctance to antagonise patients, patients' unrealistic expectations about time to resolution of cough symptoms and GPs' concerns about distinguishing between a self-limiting RTI and the early manifestations of more dangerous diseases.2

    The new study assessed 28,883 UK patients with lower RTIs. Of these, 25.5% were not prescribed antibiotics 61.3% were given a prescription for immediate antibiotics and 13.3% received a prescription for delayed antibiotics. The main outcome measures were reconsultation with symptoms of lower RTI within 30 days of the index consultation, hospital admission and death. After exclusion...

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    Support for WHO standards on reporting clinical trial results

    The World Health Organization (WHO) has reported that some of the world's largest funders of medical research and international non-governmental organisations have agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.1

    In a joint statement, a wide range of bodies, including the Indian Council of Medical Research, the Norwegian Research Council, the UK Medical Research Council, Médecins Sans Frontières and Epicentre (its research arm), the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation and the Wellcome Trust, have agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry.1,2 They also agreed that:

  • all results will be disclosed within specified timeframes on the registry and/or by publication...

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    Does doxycycline delay the next COPD exacerbation?

    A possible, long-term prophylactic effect of antibiotics given to patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) in the outpatient setting has been investigated in a randomised controlled trial.1 Although antibiotics are recommended for some patients for the management of acute exacerbations, systematic reviews and clinical trials have shown conflicting results.2�C4 Results of studies that have examined the effect of antibiotics have been inconsistent.4 There is evidence demonstrating that antibiotics result in some short-term improvement in patients who are hospitalised for the treatment of a COPD exacerbation, and to a lesser extent in outpatients. However, observational data has suggested that the time to the next exacerbation is increased if exacerbations are treated with antibiotics in addition to oral corticosteroids.1

    The new study assessed whether doxycycline added to prednisolone delayed the next exacerbation in patients with...

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    Finasteride drug safety alert

    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert after receiving reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1mg.1 The MHRA has also reminded healthcare professionals that depression is also associated with finasteride 5mg.

    Finasteride is a 5α-reductase-type-2 inhibitor. The 1mg dose is licensed for the treatment of male pattern hair loss (androgenetic alopecia) but is not available on the NHS and can only be prescribed privately.1,2 The 5mg dose is licensed for the treatment and control of benign prostatic hyperplasia.3 In England in 2016, more than 3.1 million prescriptions for finasteride 5mg were dispensed.4

    Men, with and without a history of depression, have reported episodes of depressive illness and suicidal thoughts while using 1mg finasteride for male pattern hair loss.1 While depressed mood has been previously...

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    Limited treatment options for molluscum contagiosum

    Treatment options for cutaneous molluscum contagiosum have been re-examined in an updated Cochrane review.1 The review (22 studies, 1,650 participants) assessed treatments aimed at eradicating molluscum contagiosum lesions, including physical interventions, systemic treatments and topical agents, as well as the effect of awaiting natural resolution. Twenty studies evaluated topical therapies with two studies that included curettage as a treatment arm. Two studies investigated systemic treatments.

    Eleven new studies were added for this update, including three large unpublished studies. The review found a lack of effect of 5% imiquimod compared with vehicle (placebo) on clinical cure at 12 weeks (four studies, 850 participants; risk ratio [RR] 1.33, 95% CI 0.92 to 1.93), 18 weeks (two studies, 702 participants; RR 0.88, 95% CI 0.67 to 1.14) and 28 weeks (two studies, 702 participants; RR 0.97, 95% CI 0.79 to 1.17), moderate-quality evidence. High-quality evidence showed a lack of short-term...

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    {bigtriangledown} Strontium ranelate discontinued

    Strontium ranelate discontinued Limited treatment options for molluscum contagiosum Finasteride drug safety alert Does doxycycline delay the next COPD exacerbation? Support for WHO standards on reporting clinical trial results Delayed antibiotic prescription for lower respiratory tract infections Nystatin dose change - much ado about nothing?

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    What price drugs online?

    Earlier this year, the Care Quality Commission (CQC) issued advice to encourage people to act with caution when using websites that sell prescription-only medicines (POMs) through online primary care services. The CQC also issued sanctions against, or suspended operation of, several service providers that it has inspected.1,2 CQC criticisms relate to inadequate identity checks, poor history taking, inappropriate prescriptions and lack of communication with the patient's GP.2 What is the role of these online primary medical services?

    The main reasons given for the existence of online primary care services are that they offer a convenient way to access healthcare and save time for patients. Another attraction of online services is that they may save embarrassment for people with conditions such as premature ejaculation or sexually transmitted infections. Furthermore, they provide access to prescription-only drugs that the NHS will not fund, such as treatments...

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