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TORONTO, Jan. 9 /CNW/ - The Office of the Chief Coroner has issued six
recommendations after reviewing the deaths of 11 Hamilton patients for whom
the drug Norvasc (amlodipine) had been prescribed.
The Coroner's Office investigated the deaths of 11 people thought to have
had amlodipine prescriptions filled by a Hamilton pharmacy using a substitute
drug not approved for use in Canada. The deaths investigated occurred between
October 2004 and June 2005. The deceased were of both sexes, all residents of
Hamilton and ranged in age from late 40's to early 90's. All the deaths were
initially believed to be due to natural causes.
"As a result of the investigation, we have made six recommendations,"
Dr. Barry McLellan, Chief Coroner for Ontario, said. The recommendations have
been sent to Health Canada, the Ontario College of Pharmacists and the Ontario
Ministry of Health and Long Term Care.
The recommendations are:
1. All medications dispensed by pharmacists to members of the public
should have a clear provenance, such that the date and location of
manufacture, expiry date, and conditions of storage and handling are
fully documented and readily traceable. In order to facilitate this,
the scope and responsibilities of each component of the drug
distribution chain (e.g., manufacturer, wholesaler, pharmacist) in
assuring the provenance should be clear.
2. The criteria by which pharmacists may acquire medications, other than
through wholesalers licensed by Health Canada, should be reviewed and,
if necessary, restricted.
3. Current resources allocated to the identification and elimination of
counterfeit and non-approved medication should be reviewed and, if
necessary, modified, in order to minimize the risk of entry into
legitimate distribution channels.
4. Existing statutes and regulations regarding counterfeit medications
should be reviewed, taking into account emerging trends in criminal
methodology, and perhaps statutes and enforcement strategies that have
proven effective in other jurisdictions.
5. The classification of counterfeit and non-approved medications should
be reviewed to determine whether they should be prohibited items for
import into Canada.
6. The Ministry of Health and Long Term Care should consider providing
colleges constituted under the Regulated Health Professions Act the
legal authority, subject to appropriate safeguards, immediately to
modify or suspend licensure of a member if the college has adequate
proof of the risk of imminent and serious harm to the public.
Following the Coroner's Office's extensive investigation, it was
determined that amlodipine substitution could be excluded as a factor, to a
high degree of confidence, in seven of the deaths under investigation.
In the remaining four cases, while amlodipine substitution was both
possible and plausible, the extent, if any, to which substitution had
contributed to each death could not be determined with confidence. In these
four deaths, the manner of death was classified as "undetermined" and the
medical cause of death included the phrase, "possible unauthorized medication
substitution in ..."
"My office will be reviewing all responses received to these
recommendations and will be producing a report within one year outlining the
status of implementation of our recommendations," Dr. McLellan said.
Disponible en français
www.mpss.jus.gov.on.ca
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For further information: Dr. Barry McLellan, Chief Coroner of Ontario, (416) 314-4000
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