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Prescriber Update Vo.39 No.2. June 2018

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Prescriber Update Vo.39 No.2. June 2018 Prescriber Update Vol. 39 No. 2 June 2018 www.medsafe.govt.nz ISSN 1172-5648 (print) ISSN 1179-075X (online) Contents Spotlight on Codeine 18 Making Medicines Safer: New e-Learning Module on Reporting Adverse Reactions Launched 19 Tenofovir Disoproxil – a Salty Tale 20 Medicines Interacting with Methadone 20 Hyoscine Butylbromide Injection and Cardiovascular Adverse Reactions 22 Using New Zealand Data to Review the Risk of Venous Thromboembolism with Combined Oral Contraceptives 23 Hypocalcaemia – a Risk with Zoledronic Acid 24 Pharmacogenomics – Helps Reduce Rash Decisions 25 MARC’s Remarks: March 2018 Meeting 27 Gathering Knowledge from Adverse Reaction Reports: June 2018 28 Medicines Monitoring: Dabigatran and gout or gout-like symptoms 29 Recent Approvals of Medicines Containing a New Active Ingredient 29 The Medsafe Files – Episode Six: Global Pharmacovigilance 29 Correction: Adverse Reaction Reporting in New Zealand – 2017 30 Medicine Classification Update – November 2017 31 Quarterly Summary of Recent Safety Communications 31 Report Adverse Drug Reactions 31 Subscribe to Prescriber Update 32 Spotlight on Codeine Key Messages phenotypes varies between populations. The relative frequencies of these phenotypes in the z The following patients should not use New Zealand population are not known. codeine as the risks of harm outweigh Poor metabolisers are unable to convert codeine any benefit: to morphine and receive little if any, analgesic – children aged under 12 years benefit. Extensive metabolisers convert 5–15% – adolescents aged under 18 years: for of codeine to morphine via the CYP2D6 enzyme. pain following surgery to remove In these patients, a 30 mg dose of codeine tonsils or adenoids, for symptomatic phosphate would yield approximately 1.5 mg to relief of cough, or in patients whose 4.5 mg of morphine. Ultra-rapid metabolisers respiratory function might be convert codeine to morphine very efficiently, compromised which can lead to morphine toxicity, such as respiratory depression and death. – breastfeeding women. Both codeine and morphine are excreted into z Genetic polymorphism in the CYP2D6 breast milk. This is of particular concern for gene results in significant variation breastfeeding mothers who are ultra-rapid between individuals in the metabolism metabolisers. Exposure of the infant to breast of codeine to morphine. milk containing morphine may lead to opioid z Ultra-rapid metabolisers are at increased toxicity in the infant, with the potential for risk of morphine toxicity (including respiratory depression and death. Furthermore, respiratory depression), while poor opioid toxicity in the mother (such as metabolisers obtain little analgesic somnolence) may compromise her ability to benefit from codeine. identify signs of opioid toxicity in her infant. z Clinical genotyping to determine CYP2D6 Deaths associated with the use of codeine metaboliser status is not widely available. The United States Food and Drug Administration Therefore, any patient prescribed (FDA) undertook a review of adverse events codeine should be advised of the risks of submitted to the FDA Adverse Event Reporting morphine toxicity and to seek immediate System from 1969 to 2015. The review identified medical advice if these occur. 64 cases of serious breathing problems, Codeine is a weak opioid analgesic indicated including 24 deaths, associated with codeine- for the relief of mild to moderately severe containing medicines in children aged under 18 2 pain. Codeine also has antitussive properties years . Many of these cases concerned children and is used in some cough and cold medicines with obstructive sleep apnoea who received to control non-productive cough. Codeine is codeine after surgery to remove tonsils or 3 metabolised in the liver to the active compounds adenoids . Since these children already had morphine and morphine-6-glucuronide. underlying breathing problems, they may have been particularly sensitive to morphine-induced respiratory depression. Codeine metabolism Metabolism of codeine to morphine In New Zealand, 53 deaths were recorded in predominantly involves the cytochrome P450 the National Coronial Information System enzyme CYP2D6. Genetic polymorphism in the for the period 1 January 2008 to 31 December CYP2D6 gene results in significant variation in 2014 in which codeine was assessed as the the ability of individuals to metabolise codeine primary contributor (JS Fountain, personal to morphine. Individuals may be classified as communication, April 2018). The median age a poor, intermediate, extensive or ultra-rapid of death was 48 years (range 18–86 years). In metabolisers1. 26.4% of cases, death was considered to be unintentional. Overall, codeine phosphate The extensive metaboliser phenotype represents ranked fourth as the primary contributor to normal (wild-type) enzyme activity, and most deaths due to pharmaceuticals. people fall into this category. The frequency of poor metaboliser and ultra-rapid metaboliser 18 Prescriber Update 2018; 39(2) June Pain management in children Read more on the recommendations in the Codeine is no longer recommended by the World minutes of the 173rd meeting www.medsafe. Health Organization or the Australian and New govt.nz/profs/MARC/Minutes.asp. Medsafe Zealand College of Anaesthetists for analgesia is working with the New Zealand sponsors of in children4,5. codeine-containing medicines to update the data sheets in line with the MARC’s recommendations. CYP2D6 status is not routinely determined therefore it is not possible to predict whether Although the MARC only reviewed the use of codeine will provide an analgesic effect or a toxic codeine in children, health care professionals effect. are advised to inform all patients about the signs and symptoms of morphine toxicity when Changes to age restrictions and prescribing codeine. contraindications for codeine-containing References medicines 1. Crews KR, Gaedigk A, Dunnenberger HM, et al. 2014. The Medicines Adverse Reaction Committee Clinical Pharmacogenetics Implementation Consortium (MARC) recently reviewed the benefits and risks Guidelines for Cytochrome P450 2D6 Genotype and Codeine Therapy: 2014 Update. Clinical Pharmacology of using codeine in children. and Therapeutics 95(4): 376–82. The MARC recommended: 2. US Food and Drug Administration. 2017. FDA Drug Safety Communication: FDA restricts use of prescription codeine the use of all codeine-containing medicines pain and cough medicines and tramadol pain medicines in should be contraindicated in: children; recommends against use in breastfeeding women. URL: www.fda.gov/Drugs/DrugSafety/ucm549679.htm – children aged under 12 years for all (accessed 7 May 2018). indications 3. US Food and Drug Administration. 2013. FDA Drug Safety Communication: Safety review update of codeine use in – adolescents aged under 18 years for pain children; new Boxed Warning and Contraindication on use following surgery to remove tonsils and after tonsillectomy and/or adenoidectomy. URL: www.fda. gov/downloads/Drugs/DrugSafety/UCM339116.pdf adenoids (accessed 7 May 2018). – adolescents aged under 18 years in whom 4. World Health Organization. 2012. WHO Guidelines on respiratory function might be compromised the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses. Switzerland: World Health – adolescents aged under 18 years for cough Organization. 5. Schug SA, Palmer GM, Scott DA, et al (eds). 2015. Acute Pain the warning to avoid using codeine in Management: Scientific Evidence. Melbourne: Australian breastfeeding mothers should be strengthened and New Zealand College of Anaesthetists and Faculty of to a contraindication. Pain Medicine. The MARC noted that codeine-containing cough 6. Medsafe. 2016. Reminder: Using cough and cold medicines in children is inappropriate. Prescriber Update. 37(2): 18. and cold medicines are already contraindicated URL: www.medsafe.govt.nz/profs/PUArticles/PDF/ in children aged under 12 years6. Prescriber%20Update%20June%202016.pdf (accessed 7 May 2018). Making Medicines Safer: New e-Learning Module on Reporting Adverse Reactions Launched Medsafe is pleased to announce the launch of a There is an assessment at the end to check how new e-learning Module, Adverse Drug Reactions: much you’ve learned, and you can also download Reporting makes medicines safer, available on a certificate of completion. the Medsafe website (www.medsafe.govt.nz/ The module is endorsed by the Royal New profs/ADR-training/story.html). Zealand College of General Practitioners This new online course for health professionals (RNZCGP) and has been approved for up to 2.0 explains why adverse drug reaction (ADR) hours Continuing Medical Education (CME) reporting is important, and how and when to for General Practice Educational Programme report an ADR. 2/3 (GPEP) and Continuing Professional Development (CPD) purposes. Prescriber Update 2018; 39(2) June 19 Tenofovir Disoproxil – a Salty Tale same (tenofovir disoproxil 245 mg). The different Key Messages brands are clinically equivalent. z On 1 June 2018, the funded brand of Medsafe and PHARMAC have decided to link all tenofovir disoproxil changed from products back to the active ingredient (tenofovir Viread (supplied by Gilead) to Tenofovir disoproxil 245 mg). This will clearly describe Disoproxil Teva (supplied by Teva). the different tenofovir disoproxil medicines, and avoid confusion if alternate salt forms z The tenofovir disoproxil brands approved (eg, phosphate) and medicine strengths are in New Zealand contain the same
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