Failure to file an adverse drug reaction report…say what!?

Our pets, living it large!!

Failure to inform of Convenia risks
  1.          The Committee noted that the manufacturer’s product insert for Convenia included a list of possible side effects that were very rare and did not include sudden death, although anaphylactic shock is possible to any drug without warning. The panel did not take action on this aspect of the complaint.
  2.          Given that the Committee found that sudden death was not a known risk of a Convenia injection, the Board finds it was reasonable for the Committee to take no action on the complaint that the Respondent failed to inform the Applicants of Convenia’s risks.

False claim of pancreatitis

  1.        In considering this aspect of the Applicants’ complaint, the Committee addressed Pudditat’s treatment with the anti-anxiety medication, fluoxetine. The Committee noted that fluoxetine may have caused urinary retention. The Committee had concerns that the medical records did not indicate that the Applicants were informed that the use of fluoxetine in cats is considered off label. The Committee reminded the Respondent, “he must discuss off label use of a medication, its potential side effects, and receive consent from the owner for the treatment prior to using an off label drug, such as the fluoxetine.”

False claim of pancreatitis

25.            In considering this aspect of the Applicants’ complaint, the Committee addressed Pudditat’s treatment with the anti-anxiety medication, fluoxetine. The Committee noted that fluoxetine may have caused urinary retention. The Committee had concerns that the medical records did not indicate that the Applicants were informed that the use of fluoxetine in cats is considered off label. The Committee reminded the Respondent, “he must discuss off label use of a medication, its potential side effects, and receive consent from the owner for the treatment prior to using an off label drug, such as the fluoxetine.”
  1.            At the Review, the Respondent submitted that the Committee had misapprehended the records because he was not the veterinarian who had prescribed fluoxetine to Pudditat. Therefore, if there was a failure to discuss the use of fluoxetine with the Applicants, it was not his failure. However, the Respondent did not object to the reminder because it also applied to the use of other off label medications and was a fair statement of his obligation.

  2.            With regard to the diagnosis of pancreatitis, the Committee noted that the diagnosis was presented to the Applicants after the Respondent received the histopathology report. The report indicated evidence of pancreatitis and suggested this might explain Pudditat’s death. The Panel was not of the opinion that the Respondent attempted to deceive the Applicants, but that he was providing the necroscopy results.

  3.            In reviewing the records, the Committee was of the opinion it was possible that Pudditat had suffered from a rare reaction to the cystocentesis. The Committee was of the opinion that performing a cystocentesis to obtain Pudditat’s urine was reasonable and did not believe that the Respondent could have predicted such a rare outcome. However, the Committee had concerns with the lack of evidence of informed consent regarding the cystocentesis. The Committee reminded the Respondent, “that obtaining written or verbal consent, and documenting this consent in the medical record is required before performing a medical procedure.”

  4.            The reminders issued by the Committee formed the basis for the advice it issued to the Respondent:

[The Respondent] is advised by the Complaints Committee panel of the panel’s concerns with regard to the importance of obtaining informed consent from pet owners prior to prescribing off-label medications and performing medical procedures on their pets (i.e. cystocentesis). [The Respondent] is advised to consider this advice carefully and to ensure that a similar situation does not recur in the future.

  1.            The Applicants submitted that the advice from the Committee to the Respondent was not enough of a warning to the Respondent and would not bring about changes to his practice.

  2.            The Respondent submitted that the Committee’s decision was reasonable and that he accepted the Committee’s advice.

  3.            In response to a question from the Board, the College representative stated that the Committee’s decision would remain on the Respondent’s record with the College and would be considered by the Committee in the case of any other complaint regarding the Respondent.

  4.            The Board finds the Committee’s decision on this aspect of the complaint to be within the range of possible, acceptable outcomes and therefore to be reasonable. Providing advice to a veterinarian is among the array of educative, remedial options available to the Committee. The Committee’s disposition is designed to improve the Respondent’s practice and thereby protect patient safety.

 

'I didn't say it was a miracle drug. I said it's a miracle if you could get him to take it!'


Failure to file an adverse drug reaction report with the original drug that caused the blockage
34.            The Respondent informed the Committee that he had filed an adverse report on Convenia, but had not filed a report on fluoxetine because he had no proof it had caused an adverse reaction. The Committee understood the complaint to mean that the Respondent had failed to file an adverse drug reaction report on fluoxetine and not on the Convenia injection. The Committee stated that as the use of fluoxetine in cats is considered off label, it would not be subject to filings of adverse reactions. The Committee took no action on this aspect of the Complaint. The Board finds this decision to be reasonable and supported by the information in the Record, in particular the record of prescription use and the Respondent’s clarification in his response regarding this issue.

 

Failure to offer an autopsy…..

Citation: Marinacci v Elahi-mollod-aval, 2016 CanLII 46766 (ON HPARB), <http://canlii.ca/t/gsn4p>, retrieved on 2016-07-26
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