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Non-Prescription Analgesic and Antitussive Medications Containing Codeine: a Review of Clinical Effectiveness and Safety

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Non-Prescription Analgesic and Antitussive Medications Containing Codeine: a Review of Clinical Effectiveness and Safety CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL Non-prescription Analgesic and Antitussive Medications Containing Codeine: A Review of Clinical Effectiveness and Safety Service Line: Rapid Response Service Version: 1.0 Publication Date: June 20, 2018 Report Length: 48 Pages Authors: Yi-Sheng Chao, Melissa Severn Cite As: Non-prescription Analgesic and Antitussive Medications Containing Codeine: A Review of Clinical Effectiveness and Safety. Ottawa: CADTH; 2018 Jun. (CADTH Rapid response report: summary with critical appraisal). Acknowledgments: ISSN: 1922-8147 (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH. CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information. This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors. About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system. Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec. SUMMARY WITH CRITICAL APPRAISAL Non-prescription Analgesic and Antitussive Medications Containing Codeine 2 Context and Policy Issues Codeine Codeine is an opioid analgesic that is often used to control acute conditions such as migraine, mild-to-moderate pain and cough.1-3 Codeine is also used for the long-term treatment of more chronic conditions, i.e. for more than one year.2,4 It can be administered both as scheduled, around-the-clock dosing and as-needed dosing.4 About 20% of codeine can be metabolized to its active metabolite, morphine and morphine- 6-glucuronide, with large between-individual variability in the metabolism dependent on cytochrome CYP2D6.5-8 In general, 30 milligrams (mg) of codeine is considered equivalent to 3 mg of morphine.8 However, age, sex, race, and genetic polymorphism are associated with the variability in metabolism.6 For those who are rapid metabolizers, a large amount of morphine can be formed, increasing the risk of adverse effects.7 The adverse effects of codeine include respiratory depression, nausea and vomiting, constipation, and increased pain sensitivity.1 With long term use, addiction and withdrawals may develop.1 The use of products containing codeine is generally not recommended for young children (aged six months to five years.9 Additionally, codeine is not recommended for children undergoing anesthesia in the USA or for children undergoing tonsillectomy in Europe.7 Regulation on the use of codeine in Canada In Canada, the use of opioids, including codeine, is currently regulated by the Controlled Drugs and Substances Act. Due to the potential of developing dependence among users, most codeine products are available by prescription only.5 Low-dose codeine (doses lower than or equal to 30 mg per tablet or 2 mg per milliliter [mL]), however, can be sold without a prescription if used in combination with at least two other medications.5 These are available as ‘over the counter’ (OTC) medications, but are usually stored behind the pharmacy counter.5 In Manitoba, low-dose codeine products are available only by prescription.5 Due to the risk of dependence and overdose, several European countries are considering regulating the use of low-dose codeine products.5 Requiring a prescription for all codeine products may help to restrict the access and monitor use, however, a concern is that those who abuse codeine may end up seeking out other narcotics as a substitute.5 Because OTC low-dose codeine products are paired with other medications, the dependence on low-dose codeine products can lead to excessive intake of not only codeine, but also the other medication, particularly acetaminophen and acetylsalicylic acid (ASA).5 Previous CADTH reports The effectiveness of codeine in combination with other medications for pain relief among pediatric patients and those experiencing tonsillectomy or adenoidectomy has been reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH).10,11 However, there were no trials on the combination of codeine and acetylsalicylic acid (ASA) SUMMARY WITH CRITICAL APPRAISAL Non-prescription Analgesic and Antitussive Medications Containing Codeine 3 for the pain control after tonsillectomy or adenoidectomy at that time.10 There were two non- randomized studies comparing codeine with other opioids for the pain relief in paediatric patients identified.11 Caution was recommended in prescribing opioids for children with compromised oxygen levels due to the adverse effect of respiratory suppression.11 The other study found no significant difference in pain control between morphine and the combination of codeine and acetaminophen, but noticed significantly more episodes of nausea in the morphine group the day after surgery.11 It has been suggested the access to codeine to be limited to avoid undesirable consequences.5 This requires a review of the benefits and harms associated with codeine use, particularly the low-dose formulations that are currently available over the counter. This report aims to review the literature on the safety and effectiveness of low-dose codeine-containing products for the treatment of pain and cough. Research Question 1. What is the clinical effectiveness of non-prescription medications containing codeine for the treatment of pain? 2. What is the safety of non-prescription medications containing codeine for the treatment of pain? 3. What is the clinical effectiveness of non-prescription medications containing codeine for the treatment of cough? 4. What is the safety of non-prescription medications containing codeine for the treatment of cough? Key Findings There were 12 systematic reviews, 13 randomized controlled trials, and four non- randomized studies included in the review. Three of the systematic reviews examined cough; specifically chronic cough, cough in children, and cough in cancer. The others studied the effects of codeine containing medication on pain, such as pain after dental procedures, cancer pain and chronic non-cancer pain. There is some evidence to show that low-dose codeine alone or combined with other non- opioid analgesics are effective to treat specific types of pain, compared to placebo, non- opioid analgesics, or opioid drugs. Codeine alone seems to be effective to treat chronic cough and cough in cancer. The adverse effects were not assessed in most studies and the most common were drowsiness, nausea, and constipation. There were several limitations to this review. Most importantly, codeine dose was not well-reported. Most of the SRs and RCTs focused on specific types of pain for codeine treatment. The outcomes and interventions were clinically heterogeneous, making it difficult to synthesize the results from different studies.
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