Adverse drug reaction reporting controversy
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* W.C. Appel

Volumes have been written on the limitations of spontaneous reporting systems as means of identifying and evaluating drug-induced disease. However, when *CMAJ*'s editors commented that “when serious drug interactions are discovered, physicians, pharmacists and patients appear to remain unaware of them”1 and that in spite of 4 *Dear Health Professional* advisories and articles in 3 issues of the C*anadian Adverse Drug Reaction Newsletter* (published in *CMAJ*), a young woman died from taking cisapride2 — they shot the messenger. Some of the remedies proposed in the editorial for postmarking surveillance in Canada have merit, but other comments are simply regurgitations of past sentiments that fail to appreciate how our current system works.

No evidence exists that mandatory adverse drug reaction reporting for physicians provides any better data than what is available presently. In fact, those who have worked in this field for some time suggest that a reporting system be based on direct communication between clinicians and professionals at the monitoring centres.3 Countries with mandatory reporting for physicians provide no better “signals” from adverse drug reaction data than those without mandatory reporting. The intention of the Canadian Adverse Drug Reaction Monitoring Programme (CADRMP) Regional Centres is to provide the close link with practitioners necessary for encouraging reporting as well as providing feedback regarding the reports that are received.

More is not necessarily better. Although Canada has a respectable reporting rate compared to other countries with well-recognized regulatory programs (176 per 1 000 000 population, in the range of 56-429),4 the quality of reports is of more concern. A recent study by Liu and colleagues5 shows that among 97 cases of fatal adverse drug reactions, 70% did not include information on medical history, and 42% did not have adequate information to assess time of onset of the adverse drug reaction. These are perennial problems with adverse drug reaction reporting that are not solved by simply increasing the number of reports provided by practitioners.

In the first reorganization of the CADRMP between 1990 and 1995, effective aspects of pharmacovigilance programs in various countries were incorporated: regional reporting centres, an expert advisory committee and the *Canadian Adverse Drug Reaction Newsletter*. These programs cost money and require a continued commitment. The regional centres struggle on paltry budgets to provide minimal service, the expert advisory committee has been all but abandoned and the use of high- quality provincial health databases is beyond the program's financial reach. Evidently, Health Canada does not understand that drug-induced illness is a major public health concern.

Setting up proactive surveillance programs would be a worthwhile endeavour in any country.6 The New Zealand Intensive Medicines Monitoring Program7 is a good example of what can be done at a reasonable cost. Health Canada would do well to explore this option once it decides to support pharmacovigilance in our country.

**W.C. Appel** Principal Kusuri Canada Corp. Ottawa, Ont.

## References

1.  1. Postmarketing drug surveillance: what it would take to make it work [editorial]. CMAJ 2001; 165 (10): 1293.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMToiMTY1LzEwLzEyOTMiO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTY2LzcvODg0LjMuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

2.  2. Sibbald B. Cisapride, before and after: still waiting for ADE-reporting reform. CMAJ 2001; 165 (10):1370.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMToiMTY1LzEwLzEzNzAiO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTY2LzcvODg0LjMuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

3.  3. Wilholm BE, et al. Spontaneous reporting systems outside the US. In: Strom BL, editor. *Pharmacoepidemiology*. 2nd ed. New York: Wiley & Sons; 1994, p. 142.
    
    

4.  4. Wilholm BE, et al. Spontaneous reporting systems outside the US. In: Strom BL, editor. *Pharmacoepidemiology*. 2nd ed. New York: Wiley & Sons; 1994. p. 145.
    
    

5.  5. Liu BA, Knowles SR, Mittmann N, Einarson T, Shear NH. Reporting of fatal adverse drug reactions. Can J Clin Pharmacol 2001;8(2):84-8.
    
    [PubMed](http://www.cmaj.ca/lookup/external-ref?access_num=11493936&link_type=MED&atom=%2Fcmaj%2F166%2F7%2F884.3.atom) 

6.  6. Bortnichak EA, Wise RP, Salive ME, Tilson HH. Proactive safety surveillance. *Pharmacoepidemiol* *Drug* Saf 2001;10:191-6.
    
    

7.  7. Coulter DM. The New Zealand Intensive Medicines Monitoring Program. *Pharmacoepidemiol* *Drug* Saf 2000;4(9):273-80.