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Position statement on bodychecking in youth ice hockey

https://policybase.cma.ca/en/permalink/policy10758

Last Reviewed
2020-02-29
Date
2013-05-25
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Policy endorsement
Last Reviewed
2020-02-29
Date
2013-05-25
Topics
Population health/ health equity/ public health
Text
Hockey is one of the most popular sports for Canadian children and youth. While the health benefits of physical activity and sport participation are well recognized, there is increasing concern around the frequency and severity of hockey-related injuries, particularly concussion. Studies consistently identify bodychecking as the primary mechanism associated with youth hockey injuries, including concussion. Policy to delay bodychecking until bantam league play (when participants are 13 to 14 years of age) will reduce the risks of injury and concussion in young ice hockey players. Bodychecking should be eliminated from non-elite youth ice hockey. The age at which bodychecking is introduced in competitive hockey leagues must be reconsidered. Both initiatives require policy change in many provinces/territories, and must be re-evaluated prospectively in light of emerging research. More than 4.5 million Canadians are involved in ice hockey, as coaches, officials, administrators or direct volunteers, and hockey is the most popular winter sport among Canadian children and youth.[1] Hockey Canada reported over 550,000 registered players under the age of 19 in 2008, and participation rates are increasing, especially among girls and young women.[1] While the health benefits of physical activity and sport participation are well recognized, there is increasing concern around the frequency and severity of hockey-related injuries in youth, particularly concussion. The American Academy of Pediatrics (AAP) classifies hockey as a collision sport because of unintentional and intentional body contact, including bodychecking.[2] The AAP published a policy statement on youth ice hockey in 2000, recommending that bodychecking not be allowed for children younger than 15 years of age.[3] There is passionate debate about the risk factors for injury in youth hockey and the relative merits of early or later introduction of bodychecking. Because bodychecking is not allowed in girls' or women's hockey in Canada, the present statement pertains to play in boys' and men's hockey leagues. It reviews the scientific literature on bodychecking injuries, outlines positions in the current debate and makes recommendations on when bodychecking should be introduced into the game. DEFINING BODY CONTACT AND BODYCHECKING Body contact is an individual defensive tactic designed to legally block or impede the progress of an offensive puck carrier. The defensive player moves to restrict action by the puck carrier anywhere on the ice, by skating, angling and positioning. The defensive player cannot hit the offensive player by travelling in an opposite direction to him or by physically extending toward him in an effort to initiate contact. There must be no action where the puck carrier is pushed, hit or shoved into the boards. In contrast, bodychecking is an individual defensive tactic designed to legally separate the puck carrier from the puck. The defensive player physically extends his body toward the puck carrier while moving in an opposite or parallel direction, a deliberate and forceful move not solely determined by the movement of the puck carrier.[1] Bodychecking is taught based on a four-step skill development program outlined by Hockey Canada, with progression through positioning and angling, stick checking, body contact and bodychecking skills.[4] Instruction in bodychecking includes techniques for receiving bodychecks, adhering to rules, and safe play. BODYCHECKING LEGISLATION Hockey Canada groups children and adolescents by age into six play levels: initiation (5 to 6 years of age), novice (7 to 8 years), atom (9 to 10 years), peewee (11 to 12 years), bantam (13 to 14 years), and midget (15 to 17 years). Historically, from the early 1980s until the 2002/2003 season, bodychecking was introduced at age 12 years in Canadian boys' ice hockey. In 2003, four of 13 provincial/territorial branches allowed checking for players as young as nine years old. Hockey Canada mandated the introduction of bodychecking in peewee leagues (ages 11 to 12) in 2009. Quebec has delayed bodychecking until bantam (age 14 from 1978 to 2002, then age 13 following an age change mandated nationally). THE DEBATE Despite lack of evidence, proponents of bodychecking argue that it is a fundamental skill which, learned early, may prevent future injuries. However, the evidence supports that bodychecking is the most common mechanism of injury. The Canadian Academy of Sports Medicine recommends that bodychecking be introduced only in boys' competitive hockey, and no earlier than the bantam (ages 13 to14) or midget (ages 15 to 17) level.[5] The AAP recommends a ban on bodychecking for male players younger than 15 years of age.[3] The present statement marks the first CPS position on this issue. BODYCHECKING AND INJURY Hockey is recognized as a high-risk sport. The speed of play, body contact and bodychecking all contribute to injury risk.[6][7] The injury rate is also high, with Canadian data suggesting that hockey injuries account for 8% to 11% of all adolescent sport-related injuries.[8][10] Unfortunately, serious injuries such as concussion, other brain injuries and spinal cord trauma are not uncommon in hockey.[6][11] The incidence of traumatic brain injury appears to be rising.[12][13] Ice hockey-related fatality rates are double those reported in American football, and catastrophic spinal cord and brain injury rates are almost four times higher for high school hockey players than for high school and college football players.[14][15] Bodychecking is the predominant mechanism of injury among youth hockey players at all levels of competition where it is permitted, accounting for 45% to 86% of injuries.[8][16]-[18] Several published studies, including two recent systematic reviews, reported on risk factors for injury (including bodychecking) in youth hockey.[19][20] Emery and colleagues conducted a systematic review of 24 studies and a meta-analysis including only studies which examined policy allowing bodychecking as a risk factor for injury. Policy allowing bodychecking was found to be a risk factor for all hockey injuries, with a summary incidence rate ratio (IRR) of 2.45 (95% CI 1.7 to 3.6). Furthermore, policy allowing bodychecking was found to be a risk factor for concussion, with a summary OR of 1.71 (95% CI 1.2 to 2.44). These data confirm that bodychecking increases the risk of all injuries and the risk of concussion specifically.[20] Nine of ten studies examining policy allowing bodychecking provided evidence to support a greater risk in bodychecking leagues.[20] The second systematic review found the RR of injury associated with policy allowing bodychecking ranged from 0.6 to 39.8; all but one of these studies found an increased risk of injuries associated with bodychecking.[19] Since the publication of these systematic reviews there have been five additional studies. A Canadian prospective cohort study compared injury rates between peewee ice hockey players in a league where bodychecking is permitted at age 11 years (Alberta) versus players in a league where bodychecking is not permitted until age 13 (Quebec).[21] During the 2007/2008 season, a validated injury surveillance system was used to capture all injuries requiring medical attention and/or time loss from hockey (ie, time between injury and return to play) in 2154 players. There was a threefold increased risk of all game-related injuries (IRR =3.26 [95% CI; 2.31 to 4.60]) and of injury resulting in >7 days time lost from sport (IRR=3.30 [95% CI; 1.77 to 6.17]) in 11- to 12- year-old peewee players from Alberta when compared with Quebec. There was also an almost fourfold increased risk of game-related concussion (IRR=3.88 [95% CI; 1.91 to 7.89]) in Alberta peewee players.[21] Further evidence was reported in a five-year cohort study (2002 to 2007) including all age groups, which demonstrated that injury risk increases 3.75 times (IRR=3.75 [95% CI; 1.51 to 9.74]) in leagues that allow bodychecking compared with those that do not.[22] A second prospective cohort study by Emery et al examined whether the introduction of bodychecking at 11 years of age (Alberta) or 13 years of age (Quebec) affected injury rates in later years (at 13 to 14 years of age).[23] During the 2008/09 season, the same injury surveillance system cited above was used to study 1971 bantam players (13- to 14-year-olds). There was no reduction in game-related injury risk (all injuries) for this age group (IRR=0.85 [95% CI 0.63 to 1.16]), of concussion specifically (IRR=0.84 [95% CI 0.48 to 1.48]), or of concussions resulting in >10 days time lost from sport (IRR=0.6 [95% CI 0.26 to 1.41]) in the Alberta league, compared with Quebec. In fact, the concussion rate found in Alberta peewee players was higher than in bantam players in either province.[22][23] Injuries to bantam players resulting in >7 days time lost from sport were reduced by 33% (IRR=0.67 [95% CI 0.46 to 0.99]) in the Alberta league, where players had had two years of bodychecking experience. However, these findings must be interpreted in light of the three- to fourfold greater injury and concussion risk among peewee players in Alberta, along with a possibly higher 'survival effect' among peewee players moving on to bantam in Quebec when compared with Alberta, where bodychecking is allowed in peewee league play. Recent retrospective studies have examined the influence of policy change based on the Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) surveillance data. Injury rates among boys presenting to emergency departments in the Kingston, Ontario area both before and after the 2002 rule change to allow bodychecking in younger players, were reported. There was no change between bodychecking injury rates in 1997 to 2002 (with bodychecking introduced at 11 years of age) and 2003 to 2007 (when bodychecking was introduced at nine years of age).[24] Overall rates of injury actually declined over the later period.[24] However, this retrospective study may also be biased by stronger rule enforcement, better coaching certification and temporal declines in emergency department use for this type of injury over that period. In contrast, retrospective research of CHIRPP data from 1994 to 2004 in five Ontario hospitals examined injury risk following a rule change in 1998 that allowed bodychecking in nine- and 10-year-old hockey players. A 2.2 times greater risk of injury in atom players (9 and 10 years of age) after the rule change was reported (OR=2.2 [95% CI 1.7 to 2.84]).[25] Another retrospective study using CHIRPP data (from 1995 to 2002) compared hockey injuries in children 10 to 13 years of age playing in Ontario, where bodychecking was allowed, with data from Quebec, where bodychecking was not allowed. There was a 2.6 times greater risk of bodycheck-related injuries reported for this age group when bodychecking was allowed (OR=2.65 [95% CI 2.21 to 3.18]).[26] OTHER RISK FACTORS After policy that permits bodychecking, the most commonly investigated risk factors for injury in the scientific literature are: age, session-type (ie, a practice versus a game), level of play, player position, physical size, and a previous history of injury and/or concussion. Most studies examining age found that injury risk increased with age;[8][20][27][29] others suggest no elevated injury risk in older age groups.[30]-[33] Relative age has been examined to "describe the potential advantages (or disadvantages) that result from age differences between peers within one age group".[31] One study examining relative age among hockey players found no evidence that younger (or older) players within a grouping were at elevated injury risk.[31] Additional research supports this finding at the peewee level, where no increased risk was found in first-year players. In bantam leagues, however, there was a 40% greater risk of injury in first-year players when compared with players in their second year.[21][23] Based on session-type, injury risk is reported to be consistently higher in games than in practices, with RR estimates ranging from 2.45 to 6.32.[16][18][27][34] One study also indicated that injury rates were higher in regular season play than during preseason, postseason or tournament games.[30] In general, studies examining level of play have found that injury risks rise with increasing skill levels across all age groups.[31][35][36] However, one study reported that only peewee players in the highest skill division were at the greatest risk of injury, with no significant increase by skill level in other age groups.[8] Larger cohort studies confirmed a consistently greater risk of injury among peewee players who were more highly skilled, but this trend was not observed in the bantam age group.[21][23] When examining player position, some researchers found that forwards were at higher risk of injury than defencemen or goalies, [30][32] while others reported the relative risk of injury was 2.18 times higher for defencemen than forwards.[27] In all three studies, goalies were shown to be at much lower risk than other players. Additional research shows a consistent protective effect for goalies at both the peewee and bantam levels.[21][23] Research on player size has shown conflicting results, with some studies citing increased risk for smaller players in some age groups. Prospective Canadian data show a significantly greater risk of injury in peewee players in the lowest 25th percentile by weight, [21] though this finding was not reflected in the bantam cohort.[23] However, additional research has found lighter bantam players to be at greater risk, while other studies report a significant weight difference, at all levels, between players who sustained a bodychecking-related injury and those who did not.[16][30] Other research examining body weight as a risk factor for shoulder injuries found that heavier players were at greater risk for these injuries.[37] One study looked at height as a possible risk factor for injury and found no evidence of effect among bantam players.[16] By contrast, a history of previous injury or concussion is consistently reported as a significant risk factor for reinjury and further concussion, respectively.[20] One recent Canadian peewee cohort study showed that the risk of injury doubled for players who reported being injured within the past year (IRR=2.07 [95% CI 1.49 to 2.86]), while the risk of concussion tripled for players reporting any previous concussion (2.76 [95% CI 1.1 to 6.91]).[21] The bantam cohort also showed greater risk of reinjury and concussion in players reporting previous injury within the past year (IRR=1.39 [95% CI 1.13 to 1.71]) or any previous concussion (IRR=1.87 [95% CI 1.19 to 2.94]), respectively.[21] INJURY PREVENTION AND RISK REDUCTION Injury prevention and risk reduction programs have been implemented but have not been evaluated rigorously. The STOP (Safety Towards Other Players) program (www.safetytowardsotherplayers.com) is supported by the Ontario Minor Hockey Association (www.omha.net), and includes an education component and the "STOP patch", which is sewn on the back of players' uniforms to remind opponents not to hit from behind. A study evaluating another injury prevention program, "Fair Play", which awards points for sportsmanlike play (based on penalty minutes), suggests an approximate 60% reduction in the risk of injury (OR=0.41 [95% CI 0.11 to 1.47]) where the program is in effect, but the results were not statistically significant.[38] EDUCATION Players, parents, coaches, officials and trainers must be mindful of the potential risks of playing hockey. Hockey Canada has player development, coaching, education and safety promotion programs and resources for coaches, officials, players and parents at www.hockeycanada.ca. Concussion awareness is vital. Athletes and all those involved in their care need to know about the risks, symptoms/signs and how to manage concussive injuries. The CPS statement on concussion evaluation and management is essential reading [39], with additional information available from the Canadian Academy of Sport and Exercise Medicine (www.casm-acms.org), ThinkFirst Canada (www.thinkfirst.ca) and the US Centers of Disease Control and Prevention (www.cdc.gov/ncipc/tbi/Coaches_Tool_Kit.htm). CONCLUSION Studies consistently identify bodychecking as the primary mechanism of hockey-related injuries, including concussion. It is expected that delaying the introduction of bodychecking until the bantam level and restricting bodychecking to elite leagues for older age groups will reduce the risks of injury and concussion substantially. Delaying bodychecking until bantam will have a clear benefit in reducing the risks of injury and concussion in young ice hockey players. Bodychecking should be eliminated from recreational youth ice hockey and the age at which it is introduced in competitive hockey leagues should be reconsidered. Both initiatives require policy change in many provinces/territories in Canada, and policy changes will need to be evaluated on a regular basis in light of emerging research. RECOMMENDATIONS The Canadian Paediatric Society recommends the following: * Eliminating bodychecking from all levels of organized recreational/non-elite competitive male ice hockey. (Grade II-2A evidence) * * Delaying the introduction of bodychecking in elite male competitive leagues until players are 13 to 14 years of age (bantam level) or older. (Grade III-C evidence)* * Implementing Hockey Canada's four-stage skill development program for bodychecking (body positioning, angling, stick checking and body contact) for all leagues. * Educating coaches and trainers, schools, and policy-makers in sport about the signs and symptoms of common hockey injuries, especially concussion. * Improving injury surveillance to better identify the risk factors for, and mechanisms of, hockey injuries. * Policies to reduce injury and promote fair play in hockey, for all age groups and league levels. Clinicians who see young hockey players in their practice should offer the following advice: * Girls and young women should continue participating in non-bodychecking leagues. * Boys should play in recreational/non-elite hockey leagues that do not allow bodychecking. * Elite male players should play in hockey leagues that introduce bodychecking later, when players are 13 to 14 years of age (bantam level) or older. * All players should adhere to fair play and a non-violent sport culture. * Parents and caregivers should learn injury prevention and risk reduction strategies, including concussion prevention, recognition and management. *The levels of evidence and strength of recommendations are based on the Canadian Task Force on Preventive Health Care (See Table 1). [40][41] TABLE 1: [SEE PDF] Levels of evidence and strength of recommendations Level of evidence Description I Evidence obtained from at least one properly randomized controlled trial. II-1 Evidence obtained from well-designed controlled trial without randomization. II-2 Evidence obtained from well-designed cohort or case-controlled analytical studies, preferably from more than one centre or research group. II-3 Evidence obtained from comparisons between times and places, with or without the intervention. Dramatic results in uncontrolled experiments could also be included in this category. III Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees. Grade Description A There is good evidence to recommend the clinical preventive action. B There is fair evidence to recommend the clinical preventive action. C The existing evidence is conflicting and does not allow a recommendation to be made for or against use of the clinical preventive action; however, other factors may influence decision-making. D There is fair evidence to recommend against the clinical preventive action. E There is good evidence to recommend against the clinical preventive action. F There is insufficient evidence to make a recommendation; however, other factors may influence decision-making. ACKNOWLEDGEMENTS This statement was reviewed by the Community Paediatrics and Injury Prevention Committees of the Canadian Paediatric Society. Thanks to Drs. Claire MA LeBlanc, Stan Lipnowski, Peter Nieman, Christina G Templeton and Thomas J Warshawski for their input as past members of the CPS Healthy Active Living and Sports Medicine Committee. HEALTHY ACTIVE LIVING AND SPORTS MEDICINE COMMITTEE Members: Catherine Birken MD; Tracey L Bridger MD (Chair); Mark E Feldman MD (Board Representative); Kristin M Houghton MD; Michelle Jackman MD; John F Philpott MD Liaison: Laura K Purcell MD, CPS Paediatric Sports and Exercise Medicine Section Principal authors: Kristin M Houghton MD; Carolyn A Emery PT PhD May 2013 REFERENCES 1. Hockey Canada, Annual report 2008: www.hockeycanada.ca/index.php/ci_id/55192/la_id/1.htm (Accessed July 4, 2012). 2. Rice SG; American Academy of Pediatrics, Council on Sports Medicine and Fitness. Medical conditions affecting sports participation. Pediatrics 2008;121(4):841-8. 3. American Academy of Pediatrics, Committee on Sports Medicine and Fitness. Safety in youth ice hockey: The effects of body checking. Pediatrics 2000;105(3 Pt 1):657-8. 4. Hockey Canada. Teaching checking: A progressive approach. 2002: www.omha.net/admin/downloads/Teaching%20Checking.pdf (Accessed July 4, 2012). 5. Canadian Academy of Sport Medicine. Position Statement: Violence and injuries in ice hockey. 1988. www.casm-acms.org/forms/statements/HockeyViolEng.pdf (Accessed July 4, 2012). 6. Emery CA, Risk factors for injury in child and adolescent sport: A systematic review of the literature. Clin J Sport Med 2003;13(4):256-68. 7. Caine D, Caine C, Maffulli N. Incidence and distribution of pediatric sport-related injuries. Clin J Sport Med 2006;16(6):500-13. 8. Emery CA, Meeuwisse WH. Injury rates, risk factors, and mechanisms of injury in minor hockey [comment]. Am J Sports Med 2006;34(12):1960-9. 9. Emery CA, Meeuwisse WH, McAllister JR. Survey of sport participation and sport injury in Calgary and area high schools. Clin J Sport Med 2006;16(1):20-6. 10. Emery C, Tyreman H. Sport participation, sport injury, risk factors and sport safety practices in Calgary and area junior high schools. Paediatr Child Health 2009;14(7):439-44. 11. Tator CH, Carson JD, Cushman R. Hockey injuries of the spine in Canada, 1966-1996 [comment]. CMAJ 2000;162(6):787-8. 12. Proctor MR, Cantu RC. Head and neck injuries in young athletes. Clin Sports Med 2000;19(4): 693-715. 13. Kelly KD, Lissel HL, Rowe BH, Vincenten JA, Voaklander DC. Sport and recreation-related head injuries treated in the emergency department. Clin J Sport Med 2001;11(2):77-81. 14. Mueller FO, Cantu RC. Catastrophic injuries and fatalities in high school and college sports, fall 1982-spring 1988. Med Sci Sports Exerc 1990;22(6):737-41. 15. Cantu RC, Mueller FO. Fatalities and catastrophic injuries in high school and college sports, 1982-1997: Lessons for improving safety. Phys Sportsmed 1999;27(8):35-48. 16. Brust JD, Leonard BJ, Pheley A, Roberts WO. Children's ice hockey injuries. Am J Dis Child 1992;146(6):741-7. 17. Bernard D, Trudel P. Marcotte G. The incidence, types, and circumstances of injuries to ice hockey players at the bantam level (14 to 15 years old). In: Hoerner E, ed. Safety in Ice Hockey. Philadephia: American Society for Testing and Materials, 1993:44-55. 18. Benson B, Meeuwisse WH. Ice hockey injuries. In: Maffulli N, Caine DJ, eds. Epidemiology of Pediatric Sports Injuries: Team Sports. Basel: S Karger AG, 2005:86-119. 19. Warsh JM, Constantin SA, Howard A, Macpherson A. A systematic review of the association between body checking and injury in youth ice hockey. Clin J Sport Med 2009;19(2):134-44. 20. Emery CA, Hagel B, Decloe M, Carly M. Risk factors for injury and severe injury in youth ice hockey: A systematic review of the literature. Inj Prev 2010;16(2):113-8. 21. Emery CA, Kang J, Shrier I, et al. Risk of injury associated with body checking among youth ice hockey players. JAMA 2010;303(22):2265-72. 22. Darling, SR, Schaubel DE, Baker JG, Leddy JJ, Bisson LJ, Willer B. Intentional versus unintentional contact as a mechanism of injury in youth ice hockey. Br J Sports Med 2011;45(6):492-7. 23. Emery C, Kang J, Shrier I, et al. Risk of injury associated with bodychecking experience among youth hockey players. CMAJ 2011;183(11):1249-56. 24. Kukaswadia A, Warsh J, Mihalik JP, Pickett W. Effects of changing body-checking rules on rates of injury in minor hockey. Pediatrics 2010;125(4):735-41. 25. Cusimano M, Taback N, McFaull S, Hodgins R, Tsegaye B; Canadian Research Team in Traumatic Brain Injury and Violence. Effect of bodychecking on rate of injuries among minor hockey players. Open Medicine 2011;5(1):e59: www.openmedicine.ca/article/view/246/389 (Accessed July 4, 2012). 26. Macpherson A, Rothman L, Howard A. Body-checking rules and childhood injuries in ice hockey. Pediatrics;117(2):e143-7 [Erratum in Pediatrics. 2006;117(6):2334-6]. 27. Stuart MJ, Smith AM, Nieva JJ, Rock MG. Injuries in youth ice hockey: A pilot surveillance strategy. Mayo Clin Proc 1995;70(4): p. 350-6. 28. Mölsä, J, Kujala U, Myllynen P, Torstila I, Airaksinen O. Injuries to the upper extremity in ice hockey: Analysis of a series of 760 injuries. Am J Sports Med 2003;31(5):751-7. 29. Björkenheim JM, Syvähuoko I, Rosenberg PH. Injuries in competitive junior ice-hockey. 1437 players followed for one season. Acta Orthop Scand 1993;64(4):459-61. 30. Wiggins W. Implication of introducing body checking in ice hockey at different ages. OpenThesis. Lakehead University, 1998: www.openthesis.org/documents/Implication-introducing-body-checking-in-182710.html (Accessed July 4, 2012). 31. Wattie N, Cobley S, Macpherson A, Howard A, Montelpare WJ, Baker J. Injuries in Canadian youth ice hockey: The influence of relative age. Pediatrics 2007;120(1):142-8. 32. Roberts WO, Brust JD, Leonard B. Youth ice hockey tournament injuries: Rates and patterns compared to season play. Med Sci Sports Exerc 1999;31(1):46-51. 33. Williamson IJS. An epidemiological investigation of concussion in youth ice hockey. Simon Fraser University: MSc thesis, 2006. 34. Smith AM, Stuart MJ, Wiese-Bjornstal DM, Gunnon C. Predictors of injury in ice hockey players. A multivariate, multidisciplinary approach. Am J Sports Med 1997;25(4): 500-7. 35. McKay C, Emery CA, Campbell T, Meeuwisse W. The effect of premature return to play on re-injury risk in elite adolescent ice hockey and associated psychosocial predictors [Abstract]. Br J Sport Med 2008;42(6):532-3. 36. Willer B, Kroetsch B, Darling S, Hutson A, Leddy J. Injury rates in house league, select, and representative youth ice hockey. Med Sci Sports Exerc 2005;37(10):1658-63. 37. Finke RC, Goodwin Gerberich S, Madden M, et al. Shoulder injuries in ice hockey. J Orthop Sports Phys Ther 1988;10(2):54-8. 38. Brunelle JP, Goulet C, Arguin H. Promoting respect for the rules and injury prevention in ice hockey: Evaluation of the fair-play program. J Sci Med Sport 2005;8(3):294-304. 39. Canadian Paediatric Society, Healthy Active Living and Sports Medicine Committee. Identification and management of children with sport related concussion (Principal author Laura K Purcell). Paediatr Child Health 2012;17(1):31 www.cps.ca/en/documents/position/concussion-evaluation-management. 40. Canadian Task Force on Preventive Health Care, New grades for recommendations from the Canadian Task Force on Preventive Health Care for specific clinical preventive actions. CMAJ 2003;169(3):207-8. 41. Canadian Task Force. Quality of Published Evidence. www.canadiantaskforce.ca/_archive/index.html (Accessed July 19, 2012). Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.

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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295

Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.

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Proposed amendments to the marihuana for medical purposes regulations

https://policybase.cma.ca/en/permalink/policy11293

Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014. The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications. While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes. There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients. The CMA recommends that Health Canada further revise the proposed amendments to the Marihuana for Medical Purposes Regulations to: 1) Enable consistent and best practice oversight In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances. For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners. Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes. It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority. However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 2) Safeguard protection of privacy As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information. In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended. In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment. 3) Clarify and enforce consumer advertising requirements Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards. Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act: 3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. 9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations: 70. No person shall (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof; (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or (c) advertise in a pharmacy a preparation referred to in section 36. While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations. The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. Overview of recommendations 1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. 2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. 4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations. 5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. 6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards. List of Appendices: * Appendix A - CMA Policy Statement: Medical Marijuana * Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information * Appendix C - CMA Policy Statement: Principles Concerning Physician Information

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Response to the consultation paper Pension Innovation for Canadians: The Target benefit plan

https://policybase.cma.ca/en/permalink/policy11213

Date
2014-06-23
Topics
Physician practice/ compensation/ forms
  1 document  
Policy Type
Response to consultation
Date
2014-06-23
Topics
Physician practice/ compensation/ forms
Text
The Canadian Medical Association (CMA) is pleased to provide the comments below in response to Finance Canada's consultation document Pension Innovation for Canadians: The Target Benefit Plan. The CMA is the professional voluntary association representing over 80,000 physicians across Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. The CMA has participated in, and made recommendations to, Finance Canada over the course of the government's multi-year consultation process on Canada's pension framework. Indeed, in light of the importance of the pension framework to our membership, the CMA has been an active participant in previous consultations regarding the pension framework. The CMA's participation in the current, multi-year initiative included responding to the 2010 consultative paper Ensuring the Ongoing Strength of Canada's Retirement Income System as well as participating in the legislative and regulatory consultation on the Pooled Registered Pension Plan (PRPP) framework. While the CMA recognizes that this consultation is focused narrowly on the federally regulated pension plans governed by the Pension Benefits Standards Act 1985, the CMA supports additional consultation on Canada's pension framework. The CMA recommends that Finance Canada expand its consultation to explore options to address weaknesses in Canada's pension framework, including a focus on the third pillar: tax-incentivized savings vehicles. As part of a consultation on the third pillar, the CMA recommends that Finance Canada explore three issues, as elaborated further below: * Increasing the combined contribution limit for registered retirement savings plans (RRSPs); * Enabling well-governed professional organizations that represent a particular membership as pension plan sponsors; and, * Possible impacts of registered retirement income funds (RRIF) mandatory drawdown rates. Like the Canadian population at large, physicians represent an aging demographic - 42% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles. The Summary Report on Retirement Income Adequacy Research presented to the F/P/T Ministers of Finance in 2009, suggests that higher-earning Canadians may not be saving enough for retirement. This report highlighted that income replacement rates in retirement fall below 60 per cent of after-tax income for about 35 per cent of Canadians in the upper income quintile. This is related to the effect of maximum contribution limits on tax-incentivized retirement savings vehicles. Tax-incentivized private saving vehicles are a critical element of Canada's pension framework. As highlighted in the 2010 interim report of the Senate Banking Trade and Commerce Canadians Savings for Their Future: A Secure Retirement, the introduction of the RRSP framework in 1957 sought to address a tax inequity due to the ineligibility of private savings for tax-incentive in comparison with registered pension plans. From 1972 to 1991 the RRSP contribution limit was set at 20 percent of earned income and in 1991, the government reduced the contribution limit to 18 percent of earned income; further, over this time period the real value of the absolute dollar limit reduced significantly. Recent increases to the absolute dollar limits have been strongly welcomed. To ensure that contribution limits do not pose a barrier to saving for future retirement income needs, the CMA recommends that Finance Canada initiate a consultation on future increases to the RRSP contribution limit, both absolute and percent of earned income. As part of the 2010 Finance Canada consultation and as reiterated during the legislative and regulatory consultation period on the PRPP framework, the CMA highlighted its support for exploring measures to enable organizations to sponsor plans on behalf of the self-employed. During the PRPP consultation, the CMA recommended amending the legislation such that well-governed professional organizations representing a particular membership are able to sponsor and administer PRPPs for their own members, including self-employed members. Once again, the CMA supports an extension of this recommendation to the broader pension framework. Finally, the CMA has taken note of the concerns regarding the registered retirement income funds (RRIF) mandatory drawdown rates expressed in the C.D. Howe Institute's recent pension policy e-brief Outliving our savings: Registered retirement income funds rules need a big update. The CMA recommends that Finance Canada include RRIF mandatory drawdown rates as part of a consultation. The CMA appreciates the opportunity to provide comment as part of Finance Canada's consultation on enabling target benefit plans within the federally regulated pension framework. The CMA supports further consultation on Canada's pension plan with an aim to ensure optimization of the third pillar, tax-incentivized savings vehicles, to ensure it enables adequate savings levels by self-employed individuals for their future retirement income needs.

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Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations

https://policybase.cma.ca/en/permalink/policy11114

Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.

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