Correspondance

that approving new drugs more rapidly Therapeutic Products Program internal constitute only 4.6% of drugs ap- does not compromise safety, we are processes was 188 days (range 74–376 proved in the United States at least 1 better off putting our limited resources days).2 Approval times are much longer year before approval in Canada in the into other areas such as improving for 2 reasons: considerable downtime 7-year period. Canada’s woefully inadequate postmar- occurs between the receipt of the appli- Finally, I endorse the recommen- keting evaluation system. cation and the start of the scientific re- dation that Canada’s inadequate post- view, and the separate assessment of marketing surveillance system should Joel Lexchin manufacturing and stability data is often be improved and have proposed new Emergency physician not coordinated with the safety and effi- approaches that could be adopted in University Health Network cacy evaluation. Canada.5–7 However, the unnecessary Toronto, Ont. An evaluation of the importance of a delays in Canada’s review and ap- Barbara Mintzes new drug’s therapeutic potential should proval system should also be elimi- Department of Health Care be based not simply on the lack of a nated and Canada’s performance stan- & Epidemiology current treatment, which is the practice dard of 355 days for all new drug University of British Columbia of the Patented Medicine Prices Re- applications achieved. In that way, Vancouver, BC view Board, but rather it should be Canadians will no longer have to ex- based on several factors. The US Food perience delayed access to potentially References 1. Rawson NSB. Time required for approval of and Drug Administration (FDA) classi- valuable medicines. new drugs in Canada, Australia, Sweden, the fies all new drug applications to receive United Kingdom and the United States in 1996–1998. CMAJ 2000;162(4):501-4. either a priority or a standard review Nigel S.B. Rawson 2. United States General Accounting Office. FDA based on the significance of the drug’s Division of Community Health drug review: post-approval risks 1976–85 “improvement” over currently mar- Faculty of Medicine (GAO/PEMD-90-15). Washington: GAO; 1990. 3. Lurie P, Wolfe SM. FDA medical officers report keted products. Improvement is shown Memorial University of Newfoundland lower standards permit dangerous drug ap- by increased efficacy, elimination or St. John’s, Nfld. provals. Washington (DC): Public Citizen’s Health Research Group; 1998 Dec 2. Report substantial reduction of a treatment- no.: 1466. Available: www.citizen.org/hrg/publi- limiting drug reaction, enhancement of References cations/fdasurvey/ fdasurvey.htm (accessed 2000 1. Rawson NSB. Time required for approval of Apr 14). patient compliance, or safety and effi- new drugs in Canada, Australia, Sweden, the 4. Patented Medicine Prices Review Board. cacy in a new subpopulation. Of the 87 United Kingdom and the United States in Eleventh annual report: year ending December 1996–1998. CMAJ 2000;162(4):501-4. 31, 1998. Ottawa: The Board; 1999. drugs approved in Canada, Australia, 2. Therapeutic Products Program: baseline assessment of 5. Therapeutics Initiative. Annual report Sweden and the United States in drug submission review process. Ottawa: Price Wa- 1996/1997. Vancouver: University of British terhouse Coopers; 1999. Columbia; 1998. 1992–1998, 37 (43%) received a prior- 3. Rawson NSB, Kaitin KI. New drug approval 6. Therapeutics Initiative. Annual report ity review in the United States. Cana- times and “therapeutic potential” in Canada, 1997/1998. Vancouver: University of British dian approval times were significantly Australia, Sweden and the United States in Columbia; 1999. 1992-1998. Can J Clin Pharmacol. In press. longer than those in Sweden and the 4. Woodcock J. The FDA maintains rigorous United States both for drugs that re- safety standards. Med Crossfire 1999;1:56-8. 5. Rawson NSB. An acute adverse drug reaction [The author responds:] ceived an FDA priority review and for alerting scheme using the Saskatchewan Health those that did not.3 Thus, applications datafiles. Drug Invest 1993;6:245-56. 6. Rawson NSB, Rawson MJ. Acute adverse event onger approval times in Canada for all drugs, including those most signalling scheme using the Saskatchewan ad- L cannot simply be attributed to likely to significantly affect the health ministrative health care utilization datafiles: re- sults for two benzodiazephines. Can J Clin Phar- fewer resources. Both the Swedish and of Canadians, are reviewed more expe- macol 1999;6:159-66. UK drug regulatory agencies have simi- ditiously in Sweden and the United 7. Rawson NSB, West R, Appel WC. Could “con- ditional release” of new drugs provide the infor- lar resources to those of the Therapeu- States than in Canada. mation required to study drug effectiveness? — a tic Products Program yet consistently No one wants to trade more timely discussion paper. Can J Clin Pharmacol. In press. review and approve drugs in a similar approvals for reduced safety. However, timeframe to that of the United States. more concrete evidence about the Although Australia has similar overall safety of drugs given earlier approval Implementing public-access approval times to those in Canada, its than the reports cited by Joel Lexchin programs for automated scientific review is completed in signifi- and Barbara Mintzes is available from cantly less time than Canada’s.1 an examination of drugs approved in external defibrillation The Therapeutic Products Program’s the United States, but not in Canada, own performance standard and its actual that were withdrawn for safety rea- rian Schwartz and Richard Verbeek performance on some drug submissions sons. Between 1992 and 1998, there Bhave provided a fine overview of indicate that a full scientific evaluation were only 4 such drugs.4 The approval automated external defibrillators can be completed in 6 months. The me- times of these drugs ranged from 469 (AEDs).1 We agree with their conclu- dian time consumed by the safety and ef- to 926 days; thus, their reviews were sion that defibrillation by lay respon- ficacy evaluation in a recent study of not rushed. Moreover, these 4 drugs ders is on the horizon and that it has

1804 JAMC • 27 JUIN 2000; 162 (13) Letters

the potential to increase survival after should urgently address the issue of ef- References 1. Schwartz B, Verbeek PR. Automated external sudden cardiac arrest. ficient transfer of care to EMS person- defibrillation: Is survival only a shock away? It makes little sense to us, though, nel. It should not be a barrier to the lay CMAJ 2000;162(4):533-4. 2. Eberle B, Dick WF, Schneider T, Wisser G, why the authors would suggest an use of AEDs: at present, over 95% of Doetsch S, Tzanova I. Checking the carotid emergency medical service (EMS) re- people in this country who have a car- pulse check: diagnostic accuracy of first respon- sponse time of 15 minutes for a deci- diac arrest outside of a hospital die, and ders in patients with and without a pulse. Resusci- tation 1996;33:107-16. sion to implement lay defibrillation efforts to improve the availability of a 3. Stiell IG, Wells GA, De Maio VJ, Spaite DW, when, at 10 minutes, the potential for treatment proven to increase survival Field BJ, Munkley DP, et al. Modifiable factors associated with improved cardiac arrest survival benefit from EMS defibrillation ap- should not be held back by concerns in a multicenter basic life support/defibrillation proaches zero. Lay defibrillation pro- about how to care for the survivors.3 system: OPALS study phase 1 results. Ann Emerg Med 1999;33:44-50. grams should be considered whenever Third, Gundry and colleagues’ study 4. Gundry JW, Corness KA, DeRook FA, Jorgen- the EMS system cannot provide effec- showing that grade 6 students can use son D, Bardy GH. Comparison of naïve sixth- grade children with trained professionals in the tive service and lay providers can. AEDs effectively and safely after 1 use of an automated external defibrillator. Circu- The effectiveness of AEDs, even minute of instruction4 goes a long way lation 1999;100:1703-7. when used by lay responders, is no toward alleviating concerns regarding longer in question. What holds back cost effectiveness of training and main- [The authors respond:] the widespread use of AEDs is the mis- tenance of skills. conception that AEDs require medical Fourth, the newest AEDs perform e thank Michael Shuster and delegation or physician supervision. their own maintenance, and a proactive W Wes Clark for their comments In 7 provinces and the 3 territories, EMS service can list all sites with AEDs about our article.1 Unfortunately, we AED use is not regulated, has already and can provide a random check of find no firm basis for their enthusiasm. been deregulated or is regulated but AEDs in their neighbourhood. While we have noted that the use of au- does not require delegation. AED use is After early treatment with fibri- tomated external defibrillators (AEDs) still regulated in Saskatchewan, Mani- nolytics was proven to increase survival by lay responders has the potential to in- toba and Quebec, but the Quebec Col- from acute myocardial infarction, it crease survival after cardiac arrest, we lege has recommended that the law took more than 10 years before physi- do not agree that its effectiveness is no governing the use of AEDs be cians were routinely providing the longer in doubt. amended. There is a widespread belief treatment in a timely manner to all who Only 5 studies, reporting outcomes that Ontario requires physician delega- should receive it. We mustn’t let the for 154 patients, have been published tion and supervision of an AED pro- same thing happen with AEDs. on public-access AED programs.2,3 gram, but the College of Physicians and These were either case series or poor- Surgeons of Ontario advised us that quality cohort designs. At best, this Michael Shuster “the use of an AED in the circum- would allow a grade C recommenda- Emergency physician 4 stances of a collapse is not a controlled Past chair tion based on level 4 evidence. Fur- act by virtue of ss.30(5)(a) of the Regu- Emergency Cardiac Care Coalition thermore, all programs required med- lated Health Professions Act. There is Banff, Alta. ical supervision and used trained lay therefore no need to make any legisla- Wes Clark responders who were otherwise ex- tive change to permit an AED or Manager pected to take command during an public-access AED program to be es- Emergency Cardiac Care emergency (e.g., security guards, flight tablished” (Dr. John Carlisle, College Heart and Stroke Foundation of Canada attendants). There is no report that de- of Physicians and Surgeons of Ontario: Ottawa, Ont. scribes AED use by the unsupervised personal communication, 2000). In most of the country, then, College reg- ulations support lay AED use. Submitting letters We would also like to address some Letters may be submitted by mail, courier, email or fax. They must be signed by all of the “problems” the authors list in authors and limited to 300 words in length. Letters that refer to articles must be their article. First, whether or not a lay received within 2 months of the publication of the article. CMAJ corresponds only provider can detect a pulse is not really with the authors of accepted letters. Letters are subject to editing and abridgement. an issue: Eberle and colleagues con- vincingly showed that neither lay peo- Note to email users ple nor health care professionals are Email should be addressed to [email protected] and should indicate “Letter to the very accurate in detecting a pulse.2 For- editor of CMAJ” in the subject line. A signed copy must be sent subsequently to tunately, as Schwartz and Verbeek CMAJ by fax or regular mail. Accepted letters sent by email appear in the Readers’ point out, the AED will only shock a Forum of eCMAJ (www.cma.ca/cmaj) promptly, and are published in a subse- shockable rhythm. quent issue of the journal. Second, EMS medical directors

CMAJ • JUNE 27, 2000; 162 (13) 1805 Correspondance

public, and concern has recently been The subsection of the Regulated grams. This is unlikely to be achieved in expressed that in some settings, a worse Health Professions Act quoted by the an unregulated environment. outcome may result.5 College representative indicates that We are not reassured that grade 6 It is worrisome that an organization the restriction against performing con- students can learn to give a single such as the Heart and Stroke Founda- trolled acts “does not apply with re- shock using an AED on a mannequin. tion would use a personal communica- spect to anything done by a person in It is inappropriate to extrapolate their tion (in this case, a personal email mes- the course of rendering first aid or success to situations in which adults sage) from the College of Physicians temporary assistance in an emergency.” are using an AED during a cardiac ar- and Surgeons of Ontario as a de facto We are unaware of any public direc- rest in a public setting, which are infi- means to declare that the use of an tion given to Ontario’s physicians by nitely more complicated and chaotic. AED by lay people is no longer a con- the College regarding the obvious Other research has shown that trolled act in Ontario. Defibrillation is dilemma caused by this contradiction. layperson training results in disap- considered by the Regulated Health Public clarification by the College is pointing AED competency after 1 Professions Act (1991) of Ontario to be urgently required. year7 and that cardiopulmonary resus- a controlled act requiring direct physi- While public-access AED programs citation performed by bystanders, in cian delegation. Policy I-99 of the Col- may not require direct physician delega- addition to early defibrillation, is es- lege of Physicians and Surgeons of On- tion, we believe physician supervision is sential if survival rates are to be im- tario indicates that “at all times, vital in establishing medically sound de- proved.8 accountability and responsibility for fibrillation protocols, transfer of patient Given the potential for public-access the delegation of a controlled act re- care, preservation of clinical data and AED programs to save lives, we cau- mains with the delegating physician.”6 continuous quality improvement pro- tiously embrace their promotion, but Letters

not in the way outlined by the Heart defibrillation: Is survival only a shock away? Correction and Stroke Foundation. We believe CMAJ 2000;162(4):533-4. 2. Kern KB. Public access defibrillation: a review. these programs must be implemented Heart 1998;80:402-4. he third sentence in the second under the supervision of responsible 3. Valenzuela T, Bjerke HS, Clarke LL, Hardman Tparagraph of a recent letter to the R, Spaite DW, Nichol G. Rapid defibrillation by 1 medical personnel to ensure integration nontraditional responders: the casino project. editor from Leo Kahana contained a with emergency medical service re- Acad Emerg Med 1998;4:414-5. copyediting error. It should have read: 4. Cook DJ, Guyatt GH, Laupacis A, Sackett DL, sponders (e.g., paramedics, firefighters, Goldberg RJ. Clinical recommendations using “In controlled studies the protective ef- police), who ultimately become respon- levels of evidence for antithrombotic agents. ficacy varies from –57% to more than Chest 1995;108 (4 Suppl):227S-30S. sible for every patient treated under a 5. Ornato JP, Hankins DG. Public-access defib- 75%, and it is not clear that averaging public-access AED program. Only then rillation. Prehospital Emerg Care 1999;2:297- such disparate results by meta-analysis can the public be assured that AED use 302. is of any significance.”2 Kahana’s affilia- 6. College of Physicians and Surgeons of Ontario. by lay people is safe and effective. The delegation of controlled acts [policy state- tion should have been given as Depart- ment]. Toronto: The College; 1999. Available: ment of Medicine, McMaster Univer- www.cpso.on.ca/faqanswer.asp?FAQNum=18 Richard Verbeek (accessed 2000 May 30). sity, Hamilton, Ont. 7. Asplin BR, Mosesso VN, Lejeune D. Evaluation Brian Schwartz of layperson competency and skill retention in Sunnybrook and Women’s College the use of automated external defibrillators. Acad References Health Sciences Centre Emerg Med 1998;5:414. 1. Kahana LM. TB among aboriginal Canadians 8. Stiell IG, Wells GA, DeMaio VJ, Spaite DW, [letter]. CMAJ 2000;162(10):1404. Toronto, Ont. Field BJ, Munkley DP, et al. Modifiable factors 2. Bloom BR, Fine PEM. The BCG experience: associated with improved cardiac arrest survival implications for future vaccines against tubercu- in a multicenter basic life support/defibrillation losis. In: Bloom BR, editor. Tuberculosis: patho- References system: OPALS Study Phase I results. Ann genesis, protection, and controls. Washington: ASM 1. Schwartz B, Verbeek PR. Automated external Emerg Med 1999;33:44-50. Press; 1994. p. 531-57.