3 November, 2016 NUMBER 264116 COLLEGE OF PHYSICIANS AND SURGEONS OF SASKATCHEWAN TO COUNCIL FROM: Registrar SUBJECT: Request for Support to Move Non?Prescription Codeine Products to Prescription Only Status For Your Decision MEMORANDUM DATE: 3 November, 2016 T0: Council FROM: Registrar RE: Request from the Canadian Health Professionals for Evidence Based Drug Policy to Move Non Prescription Codeine Products to Prescription Only Status Decision Council will need to decide whether it would like to send a letter of support to move non- prescription codeine products to prescription only status. Background Dr. Beggs in his capacity as President received a letter from Mr. Brett Sunku, a pharmacist representing Canadian Health Professionals for Evidence Based Drug Policy. Mr. Sunku is seeking the College of Physicians and Surgeons? support to move non-prescription codeine products to prescription only status. Mr. Sunku has provided the evidence to support the proposal and lists the evidence as follows: 1. Non-prescription codeine products are no more effective and have more risks than over the counter alternatives acetaminophen, ibuprofen, naproxen). 2. Codeine is an opioid, prone to abuse and addiction. There is clear documented misuse at even low doses in non-prescription products. 3. Due to wide inter-individual variability in codeine metabolism, a signi?cant number of individuals are at risk of sedation, respiratory depression, and death at even at risk. 4. Pharmacists have proven unwilling or unable to properly regulate the sale of non- prescription codeine products. 5. Non-prescription codeine products often contain acetaminophen and the resulting acetaminophen overdoses resulting from overuse is significant and incurs major costs to our public healthcare system. 6. Jurisdictions similar to Canada are also responding with up-regulation of codeine containing products. 7. There are no direct public costs to removing these drugs beside the legislative costs of amending the Controlled Drugs and Substances Act. Patient can easily be transitioned to other non-prescription alternatives. Mr. Sunku also provides a copy of an open letter and policy briefing note that is currently being reviewed by Prime Minister Justin Trudeau and Minister of Health Jane Philpott. Mr. Sunku and colleagues call upon the Minister of Health ?to have these ineffective and unsafe non- prescription codeine products removed from pharmacy shelves. Canadians, especially in the midst of the current opioid crisis, expect that strict limits are in place for all opioids, including codeine?. cpssear From: "Brett Sunku" To: "Gareau, Caro Subject: Canadian Health Professionals for Evidence-Based Drug Policy: Request for Support from Allan Beggs Dear President Allan Beggs, My name is Brett Sunku, and I?m a pharmacist representing Canadian Health Professionals for Evidence?Based Drug Policy. I would like the College of Physicians and Surgeons of Saskatchewan?s support to move non?prescription codeine products to prescription only status. Throughout my career as a pharmacist, I?ve felt powerless to prevent abuse of codeine and have watched numerous colleagues sell these risky products with no questions asked. This problem is societally pervasive and often goes unrecognized by policymakers and regulators, such that recent investigative journalism has shed a light on addiction to non-prescription codeine, and the lack of action taken by provincial pharmacy regulatory colleges to address substandard actions by pharmacists. Frankly, the evidence to support our proposal cannot be refuted: l. Non?prescription codeine products are no more effective and have more risks than over-the- counter alternatives acetaminophen, ibuprofen, naproxen). 2. Codeine is an opioid, prone to abuse and addiction. There is clear documented misuse at even low doses in non-prescription products. 3. Due to wide inter-individual variability in codeine metabolism, a signi?cant number of individuals are at risk of sedation, respiratory depression, and death at even recommended doses. Pharmacists cannot identify these individuals who are genetically at risk. 4. Pharmacists have proven unwilling or unable to properly regulate the sale of non?prescription codeine products. 5. Non?prescription codeine products often contain acetaminophen and the resulting acetaminophen overdoses resulting from overuse is significant and incurs major costs to our public healthcare system. 6. Jurisdictions similar to Canada are also responding with up?regulation of codeine containing products. 7. There are no direct public costs to removing these drugs beside the legislative costs of amending the Controlled Drugs and Substances Act. Patient can easily be transitioned to other non-prescription alternatives. 1 would ask that you kindly review the attached open letter and policy briefing note that are also currently being reviewed by Prime Minister Justin Trudeau and Minister of Health Jane Philpott. With your support, President Beggs, we can more strictly regulate harmful, and ineffective opioid containing drugs that are directly harming the Canadian public. Please reply with your formal statement of support or call me at the number below. Your time and attention is greatly appreciated. Sincerely, Brett Sunku Canadian Health Professionals for Evidence?Based Drug Policy (778) 938-1575 August 20165 An Open Letter to the Honorable Jane Philpott, Minister of Health Provincial College of Pharmacists Registrars The Toronto Star poignantly recounts a Toronto man?s dependency to non-prescription codeine, starting at the age of 16. Getting high daily, he would extract codeine from up to 80 pills and dissolve it in a bitter, cloudy drink. He described how he couldn?t endure a friend?s wedding without his ?pill juice?. After abusing non-prescription codeine on and off for more than a decade, and always acquiring it legally, be finally got help for his opioid addiction. He landed in the hospital, lost a long-term girlfriend and isolated himself from family and peers. He is now taking methadone, perhaps for the rest of his life. The current regulation of non-prescription codeine, also known as Exempted Codeine Products, is needlessly harming the public and is contributing to Canada?s opioid problem. The legislation allowing the sale of these products without a prescription must be changed. By consuming an ECP, a patient is at risk for opioid addiction, overdose, and hospitalization."3 Appallingly, there is evidence that ECPs is no more effective than safer, over-the-counter altemativesf?S begging the question: why are these products even on the market? At this time, there is little stopping an individual or groups of individuals from frequenting multiple pharmacies to purchase large quantities of ECPs, especially as not all provinces require the recording of ECP sales in their provincial prescription monitoring programs." Pharmacist assessment remains the only check prior to selling an ECP. In practice, all too often, this check can be completely absent, as was recently demonstrated by investigative journalists.? Having pharmacists as the gateway to access ECPs is clearly not working. One phamiacist can refuse to sell an ECP, but that doesn?t prevent the patient from walking across the street to the next pharmacy. Patients can easily bypass the pharmacist assessment with pie-rehearsed scripts and they may resort to aggression or intimidation even if a pharmacist is vigilant in their assessment.8 We are a group of Canadian pharmacists and physicians who are deeply concerned with the misuse of ECPS. We welcome the February 2016 decision of the Manitoba College of Pharmacists to remove these products from their non-prescription status." in addition, we fully support the plans of the Honorable Jane Philpott, Minister of Health to introduce regulatory changes to move all non-prescription codeine products to prescription only status.10 We are saddened with the reporting in ?Canada?s Invisible Codeine Problem?, published recently in the Toronto Star,6 and by CBC Marketplace which demonstrate, across Canada, the accessibility of the only non-prescription opioid.7 These works ofjournalism have confirmed our suspicions and the realities that many community pharmacists encounter on a daily basis. 1 Non-Prescription Codeine: A Canadian Public Health Emergency. HI We read stories like the ones above with a heavy heart. knowing that they may involve our own professional practice. We fear that the public is losing faith in the ability of our regulatory bodies to protect patient safety, as these stories are completely preventable. We recommend that the following occur to address non-prescription codeine abuse. 1. Require that all codeine containing products require a prescription. This would be accomplished by repealing Section 36 from the Narcotic Control Regulations of the Controlled Drug and Substances Act.? 2. Recording the sale of any codeine product in a single uni?ed provincial electronic health record, that is accessible to pharmacists, physicians, and other authorized prescribers, at the point of care. Such changes have already taken place in Australia for certain codeine preparations and are congruent with the best scienti?c evidence available, as discussed Exempted Codeine Products 5> Contain the opioid codeine and do not require a prescription for purchase Contain 8 mg of codeine per tablet or 20 mg of codeine per 30 mL of liquid product (see Appendix I for a list of products) Combined with 2-3 additional non-controlled substances in therapeutic proportions VV Risks of codeine are the same as any other opioid. such as fentanyl. and they include sedation. addiction, respiratory depression, and death 3* Addiction, resulting from euphoric side effects of codeine or uncontrolled pain, often leads to dose escalation and physiological tolerance which risks migration to potent opioids such as heroin or fentanyl 13'6? >3 One bottle of 200 tablets of non-prescription Tylenol No.l?" or 222?s contains 1600 mg of codeine, more than enough to harm a regular-sized adult Healthcare Vs. Business interests As most modi?cations to packaging and quantities in otherjurisdictions have been ineffective at curbing misuse,'5the concentration of policymakers has been on the regulation surrounding sale.8 The onus is currently on the pharmacist to refuse sale of ECPs if suspecting misuse. They are the only barrier and that barrier is ineffective. It is proving unrealistic to expect pharmacists to properly regulate the sale of ECPs. There are three major limitations: 3* Business interests to sell more product. Insuf?cient human resource allotment for interviewing patients in busy pharmacies.16 F-?r Retail pharmacists are not positioned to recognize nor assess opioid abuse and addiction. 2 Non-Prescription Codeine: A Canadian Public Health Emergency l*l ECPs are Ineffective at Suggested Dosing ECPs have a too low dose a of codeine; the minimum therapeutic dose of codeine is 30 mg in adults.[2 One can only attain a therapeutic dose by taking higher than recommended doses of non-prescription codeine products. thus overdosing on the other drugs within the preparation. such as acetaminophen. These formulations attempt to leverage the risk of overdose of the non?narcotic components in order to prevent dose-escalation of codeine. Unfortunately. drug abusers often overdose without regard to negative consequences.? Pharmacists aren?t Well Positioned to Address Opioid Misuse The abuse potential of opioids is well this applies to ECPs as A cross-sectional study found that among those reporting codeine use. 15.1% misused it and/or used it for a non-medical reason.20 Unfortunately, the majority of those addicted to non-prescription codeine begin using the products for a legitimate medical reason.2 At most a pharmacist can only refuse to sell and recommend treatment, they cannot prevent a patient from attempting to acquire ECPs from another pharmacy. in many cases, patients avoid discussions about treatment because of fear of their addiction being recorded.? Hazards with Codeine, in addition to Addiction More than 2% of Canadians convert codeine to morphine. its active form, at an accelerated rate: meaning approximately 700.000 Canadians can overdose even at low doses. Health Canada no longer recommends use in children under 12 years as well as pregnant or nursing women (for infant risk) due to risk of respiratory depression and death.?23 This has led to experts questioning if codeine should be phased out altogether due to its risks and weak painkilling effect.24 Codeine Use Requires Physician Oversight There are not currently any therapeutic guidelines that recommend codeine use without physician oversight. Current evidence indicates that the only conditions that have shown clinical response to codeine are chronic pain due to hip osteoarthritis and acute postoperative pain: the effective doses for these conditions being 30 mg and 60 mg respectively;25 both are prescription The director of the Addiction Medicine and Toxicology Service in Melbourne, Dr. Michael McDonough. has suggested that nobody should have access to codeine without a prescription.26 There are Safer Alternatives to ECPs Current clinical evidence demonstrates that ECP painkillers do not show a benefit over conventional over-the-counter pain medicines such as acetaminophen or ibuprofen?"5 3 Non-Prescription Codeine: A Canadian Public Health Emergency Acetaminophen Overdose Acetaminophen is the leading cause of acute liver failure in Canada.27 In order for a patient to attain a therapeutic dose of codeine (30 mg) from an ECP (8 mg), one would need to take at least 4 tablets. 1n the case onylenol? No.1, the most commonly purchased ECP, overdose of acetaminophen can cause acute drug induced liver failure, ultimately contributing to shortened lifespans and a burden on the public health system.23'3" According to a recent Health Canada safety review, acetaminophen-codeine combination products are often directly responsible for acetaminophen overdoses and acute liver failure.27 In addition, many experts have called for a lower daily dose limit of 2600 mg of acetaminophen, a dose easily surpassed in ECP abuse. Actions Taken in Other Jurisdictions Australia?s Therapeutic Goods Administration is reviewing their non?prescription codeine products.?l3 Policymakers see the need for review amid widespread outcry against codeine deaths??30 The College of Physicians and Surgeons in Alberta and British Columbia have also added scrutiny to the prescribing of opioids.?32 This is in response to their widespread opioid abuse epidemic. This represents a progressive approach to protecting the Canadian public from the risks of opioids. We believe that amending the Narcotic Control Regulations is the best way to solve the problem by setting a national standard for all codeine containing products. Conclusion Non-prescription codeine provides a false sense of security.? But as we, and others, have articulated, ECPs have tremendous risk and no evidence for efficacy. We call upon the Minister of Health to have these ineffective and unsafe non-prescription codeine products removed from pharmacy shelves. Canadians, especially in the midst of the current opioid crisis. expect that strict limits are in place for all opioids. including codeine. Sincerely, Brett Sunku, BPharm, (BC) Joseph Blais, ACPR, BCPS (AB) Gurneil Parmar, BPharm, (BC) Kevin Wang, BPharm, (BC) Mohamed Hasanine, BPharm, (BC) Lauren Marina Zolpys, MD, (BC) Philippe Boilard. BPharm. (AB) Kody Lee. BPharm student (AB) Kama] Alhallak, BPharm, (AB) Muffadal Shamshuddin, BPharm, (BC) Edward Fang, BPharm, (BC) 4 Non-Prescription Codeine: A Canadian Public Health Emergency Appendix I - Exempted Codeine Products sold in Canada Representative Brand Product Ingredients and strength DIN NO. I Codeine 8 mg Acetaminophen 300 mg Caffeine IS mg 0218106l 222' Codeine 8 mg Acetylsalicylic acid 3?5 mg Caffeine 15 mg 00108162 114111 Codeine 3.3.: :11ng mL Ammonium 125 mg/S mL 12.5 mg/5 mL 00535230 Codeine 3.33 mgf? mL Pseudoephedrine 30 mgi?S mL Guaifettesin 100 mg/5 mL 01944703 ACETAZONE Codeine 8 mg Acetaminophen 300 mg Chlorzoxazone 250 mg 008343 I 9 Codeine 8 mg Acetaminophen 325 mg Doxylamine 5 mg 02047667 C-lf8* Codeine 8 mg Acetylsalicylic acid 325 mg Methoearbamol 400 mg 01934775 Numerous generic versions exist and are marketed under the following labels: Exact?, Equatc", Stanley", Pharmasave", Life", Praxis". Preferred"; Rexall" Wampole", and Rougier" *Brand product no longer marketed in Canada. but generic versions are available. Non-Prescription Codeine: A Canadian Public Health Emergency Iivl 1O References IQ La) UI 16. Nielsen, 5., ct "Over the counter codeine dependence." Melbourne: Turning Point Alcohol and Drug Centre (2010). Codeine and Dihvdroeodeinc-containing Medicines: Minimising the Risk ot' Addiction." Medicines and Healthcare Products Regulatory Agency. Nov. 2009. Beaver. William T. "Aspirin and acetaminophen as constituents of analgesic combinations." Archives of internal .lledicine 141.3 (1981): 293. Charles, Christopher S. et al. comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient." Otolatj-?ngoiogi - Head and Neck Surgery 1 17.1 (1997): 76-82. Amy L., et al. randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain." Annals of Emergency Medicine 54.4 (2009): 553-560. Yang. Jennifer. and Diana Zlomislic. "Star Investigation: Canada's Invisible Codeine Problem." The Toronto Star.12 Nov. 2015. Russell, Jennie. "Investigation l-?inds Pharmacies Failed to Ask Questions Critical to Patient Safetv." CBC News. 22 Jan. 2015. Van Hout. Marie-Claire. and Ian Norman. "Misuse of non-prescription codeine containing products: recommendations for detection and reduction ofrisk in community pharmacies." internationaijournal of drug policy 27 (2016): 17-22. "Practice Direction: Exempted Codeine Products." Manitoba College ofPharmacists. 01 Feb. 2016. Retrieved from ?Speaking Notes for the Honourable Jane I?hilpott. Minister ofHealth - 2nd Charting the Future of Drug Policv in Canada Confluence" Heaith Canada. Government ofCanada, Jun. 2016. "Narcotic Control Regulations (C.R.C.. C. 1041)." Justice Laws Website. Government ofCanada. 15 Aug. 2016. "Interim Decisions on Matters Referred to an [Expert Advison? Committee Codeinet." Therapeutic Goods Administration (TGA). Australian Department of Health. 01 Oct. 2015. Supports Call for Codeine Unseheduline." Austraiian Medical/lssociation. 21 001- 2015. Web. Miller. Norman 8.. and Mark S. Gold. "Prescription Opioids and Addiction." Annais 45.10 (2015): 516-521. Cairns. Rose, Jared Brown, and Nicholas Buckley. "The impact of codeine re-scheduling on misuse: a retrospective review of calls to Australia's largest poisons centre." Addiction (2016). Resnik. David 13.. Paul L. Ranelli. and Susan P. Resnik. "The conflict between ethics and business in community pharmacy: what about patient counseling?." Journal of Business Ethics 28.2 (2000): 129-186. Everitt. Barr}r J.. and Trevor W. Robbins. "Drug addiction: updating actions to habits to compulsions ten years on." Annual Review 67 (2016): 23-50. Van Hout, M., et al. Scoping Review Ilse. Misuse and Dependence." Final Report. Project European Commission 7th Framework Programme. Brussels (2014). 5 Non?Prescription Codeine: A Canadian Public Health Emergency I?l'l 11 19. 20. 21. EN) 24. 26. 27. 28. 29. Jones. Jermaine D.. Shanthi Mogali. and Sandra D. Comer. "Polydrug abuse: a review ot?opioid and benzodiachine combination use." Drug and Alcohol Dependence 125.1 (2012): 8-18. Orriols. L., Gaillard. J.. Lapeyre-Mestre. M.. Roussin. A. ?Evaluation ofahusc and dependence on drugs used for self-medication: A pharmaco?epidemiological pilot study based on community pharmacies in France.? Drug .S'qfett?. 32(10) (2009): 859-323. Cooper. R. J. "Respcetable Addietion'?a qualitative study of?over the counter medicine abuse in the School of l-leallh and Related Research. University ot?SItelTield (201 1). Summan' Sal?etv Review - Codeine Prescription Products. Health Canada: Marketed Health Products Directorate. Health Products and Foods Branch. 9 Dee.. 2015. Friedrichsdorf. S. J.. A. P. Nugent. and A. Q. Strobl. "Codeine-associated pediatric deaths despite using. recommended dosing guidelines: three case reports." Journal ofopt'oid management 9.2 (2012): 151-155. MacDonald. Noni. and Stuart M. MacLeod. "Has the time come to phase out codeine?" Canadian ll'ledlml .tlssoclan?on Journal 182.1? (2010): 1825-1825. Murnion, Brodin P. "Combination analgesics in adults." Australian Prescriber 33.4 (2010). Wiscman. Heather. "Codeine Deaths Need Action." MJA Insight. Medical Journal oleuslralia. 5 Oct. 2015. ?Acetaminophen Special Project: Acetaminophen Overdose and Liver Injury in the Canadian Context." Health Canada: Marketed Health Products Directorate. Health Products and Foods Branch. 17 Jan. 2014. James LP. Acetaminophen. In, Kaplowitz N, DcLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier. 2013. pp. 331-42. Myers. Robert P., et al. "Impact ofliver disease. alcohol abuse. and unintentional ingestions on the outcomes of acetaminophen overdose."Cllnical Gastroenterologz and lleparologv 6.8 (2008): 918-925. Roxburgh. Amanda. et a1. "Trends and characteristics of accidental and intentional codeine overdose deaths in Australia." .-tled.l.-1u51203.7 {2015): 299. . ()etter. Heidi M.. MD. "Registrar's Message New CDC ()nioid Guidelines :1 (lame-changer." College of British Columbia. Mar.-Apr. 2016. Accessed 11 Aug. 2016. Gerein. Keith. "'l'oueher Rules on Opiate Prescribing Drafted hv College of Alberta thsicians and Surgeons." Edmonton Journal. 09 Sept. 2016. 7 Non-Prescription Codeine: A Canadian Public Health Emergency Intl For the Honourable Jane Philpott, The Federal Minister of Health The House of Commons Standing Committee on Health (HESA) August 31, 2016 POLICY BRIEF 12 Combating codeine misuse: Repeal of Section 36 from the Narcotic Control Regulations of the Controlled Drug and Substances Act. Brett Sunku BPharm Joseph Blais ACPR, BCPS Canadian Health Professionals for Evidence-Based Drug Policy 13 FOR ACTION To: The Federal Health Minister and The Standing Committee on Health From: Canadian Health Professionals for Evidence-Based Drug Policy Subject: Combating codeine misuse: Repeal of Section 36 from the Narcotic Control Regulations ofthe Controlled Drug and Substances Act. Non-prescription access to codeine is contributing to Canada?s opioid problem. in practice. the pharmacy profession has proven unable to prevent misuse of these products."3 Access to these drugs without physician oversight risks opioid addiction, overdose, and hospitalization."? in addition. current clinical evidence demonstrates that these products have no benefit over safer, over-the-counter pain-killers?7 Removing section 36 from the Narcotic Control Regulations stands to prevent harm to Canadians without reducing access and quality of care. Codeine 3* An opioid analgesic/antitussive in the same family as fentanyl that carries abuse potential and safety concerns.1 3> At doses above 8mg per tablet, its prescriptive requirements are controlled by federal and provincial regulations due to its abuse potential. Adverse effects include sedation, addiction, respiratory depression and death. ?r?r Addiction, resulting from euphoric side effects or uncontrolled pain, often leads to dose escalation and migration to more potent opiates (such as heroin or fentanyl).8 Exempted Codeine Products (ECPs) are available without a prescription. Defined in the Narcotic Control Regulations (see Appendix 1), ECPs contain no more than 8mg of codeine per tablet, combined with two or three additional non-controlled substances in therapeutic proportions. This is a subtherapeutic dose of codeine; the minimum effective dose in adults is 30mg. One can only attain a therapeutic dose by taking higher than recommended doses (4 tablets) and overdosing 0n the other components within the preparation. These products attempt to leverage the risk of overdose ofthe non-narcotic components in order to prevent dose-escalation of codeine. Nielsen, 5.. ct al. "Over the counter codeine dependence Melbourne: Turning Point Alcohol and Drug Centre (2010), Yang. Jennifer, and Diana Zlumislic. "Star lnvestteation' Canada's Invismie Codeine Problem The Toronto Star 12 Nov. 2015. Russell. Jennie. "Investieation l-?Inds Pharmacies l-?ailed to Ask (?rnical to Patient Safety CBC News. 22 Jan. 2015. MHRA. "l'l REPORT Codeine and Dihvdrocodclne-containinu Medicines Minimismu the Risk ofAddiction Medicines and Healthcare Products Regulatory Agency. Nov. 2009. Beaver. W. ?Aspirin and acetaminophen as constituents of analgesic combinations." Archives medicine 293. 6. Charles. Christopher S. et comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient." Otolaryngology - Head and Neck Surgery 1 17.1 (1997]: 76-82. Drendcl. Amy L., et randomized clinical trial ofibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain." Annals of Emergency Medicine 54.4 (2009}: 553-560. 8. Miller. Norman 5.. and Mark 8. Gold. Prescription Opioids and Annals 45.10 {2015): 516-521. Flu Canadian Health Professionals for Evidence-Based Drug Policy -2- iv 14 FOR ACTION The most commonly used ECPs are combined with acetaminophen (Tylenol No.l?) while others contain ASA (2253?), antihistamines or muscle relaxants. These additional drugs each have unique risks as well as safety concerns and overdose can lead to hospitalization?? In addition, codeine itselfis a drug with safety hazards. besides addiction risk. For a signi?cant portion of the population, they metabolize codeine dysfunctionally and risk overdose even from regular doses (representing more than 700,000 Canadians).' As not all pharmacies track sales of ECPs in their provincial pharmacy databases, patients can visit multiple pharmacies, acquiring large amounts from each.2 One 200 tablet bottle contains 1600 mg of codeine, equivalent to 890pg of IV fentanyl (enough to harm a regular adult).l3 Considerations Most studies concerning this subject come from Australia, where many codeine products have already been removed from non-prescription designations.? There. nearly 1 in 5 non?prescription codeine users were identi?ed as dependent with two thirds of this population overdosing regularly.l Previous modi?cations of regulation (explicit labelling, limiting the size of packages) while maintaining product non-prescription designation has not proven to reduce misuse.IS Removal of clause 36 from the Narcotic Control Regulations would result in the requirement of physician oversight and a prescription for access to all codeine products, including ECPs. This would be in line with current clinical guidelines recommending that codeine use should only be used with physician oversight.?16 While there are those bene?ting from ECP use without any adverse consequence. there are alternatives on the market that are available without a prescription, with equally demonstrated clinical ef?cacy and superior safety pro?les.? Switching analgesics would be a simple transition for retail pharmacies to undertake as the alternatives are similar in cost; this would not burden the public healthcare system nor contribute to suboptimal pain management. 9. Lane. Joshua E., et al. "Chronic acetaminophen toxicity: a case report and review ofthe literature." The Journal of Emergency Medicine 23.3 {2002): 253-256. 10. 'l?emplc, Anthony R. "Acute and chronic effects ofaspirin toxicity and their treatment." Archives ofinternal medicine 141.3 1981 )1 364. I l. Crews. K. R., et al. "Clinical Implementation Consortium guidelines for codeine therapy in the context of cytochrome P450 2D6 genotype." Clinical pharmacology and therapeutics (2012); 32L 12. MacDonald, Noni, and Stuart M. MacLeod. "Has the time come to phase out Canadian Medical Association Journal 132.1?r (2010): 1825-1825. 13. Anderson, Robert, et al. "Accuracy in equianalgesie dosing: conversion dilemmas." Journal of pain and management 21.5 39?-406. 14. "Interim Decisions on Matters Referred to an Expert Adi'lsorv Committee (11 Codeine) Therapeutic Goods Administration Australian Department ofllealth. Oct. 20l5. lo. Cairns. Rose. Jared Brown, and Nicholas Buckley. "The impact ofcodeinc re-seheduling on misuse: a retrospective review ol'calls to AiIStralia's largest poisons centre." Addiction (20l6). l6. Supports TGA's (Tall for ('odeine Upseheduline." Australian Medical/lssociation. 2 Oct. 2015. Web. Canadian Health Professionals for Evidence-Based Drug Policy -3- 15 FOR ACTION The onus is currently on the pharmacist to refuse sale of ECPs if misuse is suspected. Pharmacy regulation has been the concentration of policymakers,? though it is unrealistic to expect pharmacists to limit sales. There are three major limitations that affect unchecked ECP release: Business interests to sell more product. 3e Insuf?cient human resource allotment for interviewing patients in busy pharmacies.I8 3* Retail pharmacists are not positioned to recognize nor assess opiate abuse and addiction. Patients are furthermore easily able to bypass the pharmacist with pre-rehearsed scripts or they may resort to aggression or intimidation even ifa pharmacist is vigilant in their assessment.? Not surprisingly. as proven by investigative journalism. abusers are still able to acquire 1n addition to codeine risks. acetaminophen. the most common additional ingredient in ECPs, is the leading cause of acute liver failure in Canada.? Those that abuse these ECPs do so despite risk and negative consequence20 and are at risk for costly hospital stays. For every case of acetaminophen induced liver failure prevented, the public health budget stands to save $2.123.El According to a recent Health Canada safety review, acetaminophen-codeine combination products are often directly responsible for acetaminophen overdoses and acute liver failure.22 In addition. many experts have called for a lower daily dose limit of 2600 mg of acetaminophen, a dose easily surpassed in ECP abuse. With such risks with acetaminophen, it surely should not be combined with a drug with such abuse potential like codeine and made available without a prescription. Media scrutiny of opioid abuse is increasing in frequency and the public is looking to their government to take strategic action. In response, the Federal Minister of Health, the Honourable Jane Philpott, spoke at the 2nd Charting the Future of Drug Policy in Canada Conference in June 2016. She has explicitly endeavoured to delist non-prescription codeine from legislation.23 17. Van Hout. Marie-Claire. and Ian Norman. "Misuse of non-prescription codeine containing products: recommendations for detection and reduction ofrisk in community pharmacies." International joumal of drug policy 27 (2016): 17-22. 18. Resnik, David 13., Paul L. Ranelli, and Susan P. Resnik. "The con?ict between ethics and business in community pharmacy: what about patient counseling?" Journal of Business Ethics 28.2 {2000): 129-186. 19. Neil. "Acetaminophen 15 leading Cause ot'Aculc .ivcr Failure Mchage Today. 30 Nov. 2005. Website. 20. Everitt, Barry 1.. and Trevor W. Robbins. "Drug addiction: updating actions to habits to compulsions ten years on." Annual Review of 67 (2016): 23-50. 21. Mych, Robert P.. et a1. "impact ofliver disease. alcohol abuse, and unintentional ingestions on the outcomes of acetaminophen overdose. Gustroenterologp? and {-i'epuim'ogr 6.8 (2008): 918-925. 22. "Acetaminophen Special Project: Acetaminophen Overdose and Liver Injury in the Canadian Context.? Health Canada: Marketed Health Products Directorate. Health Products and Foods Branch. 1? January 2014. 23. "Sneaking Notes for the l-lonourable Jane I?lnlnou. Minister nl'llealth - 2nd Charting the Future ol'l)ruu Policy in Canada (.?onlerenee." Health Canada. Government of Canada. 17 June 2016. Canadian Health Professionals for Evidence-Based Drug Policy -4- 16 FOR ACTION Conclusion With prescribing regulation of opiates becoming more strict in Alberta and British Columbia. non?prescription codeine deserves similar attention. Removal of section 36 from the Narcotic Control Regulations will address Canada?s battle with opioid misuse and realize Health Canada?s mandate to protect the Canadian public. This will represent a progressive approach to protecting the Canadian public from the risks of opioids. We believe that amending the Narcotic Control Regulations is the best way to solve the problem by setting a national standard for all codeine containing products. Amendment of the Narcotic Control Regulations will ensure that a physician is consulted before release of any codeine preparation and pharmacies will be relied upon to transition ECP users to equally efficacious. safer, over?the-counter alternatives. This can be achieved without sacri?cing care and public healthcare budgets will stand to bene?t from fewer social and hospital costs associated with misuse and addiction. Canadian Health Professionals for Evidence-Based Drug Policy livl -5- i 17 FOR ACTION Appendix 1 - Legislation for Removal CONTROLLED DRUGS AND SUBSTANCES ACT Narcotic Control Regulations c. 1041 36 (1) Subject to subsection (2), a pharmacist may, without a prescription, sell or provide a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if 0 the preparation contains 0 two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-halfthe regular minimum single dose for each such ingredient, or 0 (ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient; and there is legibly and conspicuously printed on the inner label and the outer label. as those terms are defined in section A.01.010 ofthe Food and Drug Regulations, a caution to the following effect: 0 ?This preparation contains codeine and should not be administered to children except on the advice ofa physician, dentist or nurse practitioner.? (2) No pharmacist shall sell or provide a preparation referred to in subsection (1) if the pharmacist has reasonable grounds to believe that the preparation is to be used for purposes other than recognized medical or dental purposesCanadian Health Professionals for Evidence-Based Drug Policy -5-