Beware Regulators Bearing Gifts

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February 12, 2013 | 2 Comments


  1. In Sweden until recently, the general rules circulated among physicians from basic training to advanced clinical practice, and circulated in the national formulary (FASS), stipulated that suspected serious side effects of any drug, suspected new unexpected side effects of any drug and any suspected side effect of a new drug was to be reported. “A new drug” was not explicitly defined (how long is a drug new?). “Serious” was well-defined, and easy enough for the ordinary physician to implement. It was also explicitly stated that trivial or commonplace side effects of older drugs were not to be reported.

    The Swedish reporting rules were changed on June 12, 2012, effective July 21, 2012 – timely considering that Rxisk came online just before. Now every physician in Sweden must report every suspected side-effect. On the Swedish Medical Products Agency website it is pointed out that the changes are predicated on EU Directive 2010/84/EU and Regulation (EU) No 1235/2010 which introduced new rules on pharmacovigilance.

  2. “Could it be that both regulators are responding to RxISK?”

    I think you hit the nail firmly on the head with this question.

    As you know I used to correspond with the MHRA via emails, phone calls and face to face meetings.

    They know their Yellow card reporting system is outdated, they just don’t know how to update it.

    A series of ‘advertisements’ that ran in select surgeries in some half-hearted pilot scheme proved fruitless.

    As long as they are seen to be trying to do something they will always have that cushion – thing is, they are merely appeasing their critics. They have done this for years.

    All of a sudden they have a threat in Rxisk, the threat, in their eyes, is also people promoting Rxisk.

    As for Health Canada, they are about as effective as playing snooker with a rope!

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