Table 4:

Topics discussed at SAC/SAP meetings and summary of recommendations

Committee or panelNo. of meetingsNo. of meetings where a record of proceedings was availableDate(s) of meeting(s) where a record of proceedings was available*Summary of topic(s) discussedSummary of recommendation(s)
Oncology therapies SAC71August/September 2011
  • Regulations prohibiting the use of arsenic as an ingredient in drugs sold for human use

  • The section of the Food and Drugs Act that prohibits the sale of drugs containing arsenic should be revoked.

Pharmaceutical sciences and clinical pharmacology SAC40
Respiratory and allergy therapies SAC113Mar. 14, 2012
Oct. 26, 2013
Feb. 23, 2018
  • Data requirements for safety and effectiveness of subsequent market entry inhaled products for use in the treatment of asthma

  • An in vitro data package is adequate in lieu of clinical data to demonstrate bioequivalence of a subsequent market entry budesonide suspension for inhalation using a suitable nebulizer.

  • Depending on the type of product, clinical outcome studies using FEV1 are acceptable as long as a difference in the mean of at least 12% is demonstrated.

Anti-infective therapies SAP11Oct. 6, 2016
  • Issues around the safety and efficacy of fluoroquinolones for different indications

  • The product monograph for fluoroquinolones should include a statement about disabling and potentially irreversible persistent adverse reactions.

  • Fluoroquinolones should not be used for acute sinusitis of less than 7 d duration.

Bioequivalence requirements for gender-specific drug products SAP11June 22, 2011
  • Requirements for market authorization of a second entry or subsequent entry gender-specific drug product

  • The current practice of using only males, males and females or only females for bioequivalence studies should be continued.

Bioequivalence requirements for modified-release dosage forms SAP10
Diclectin SAP11June 2, 2016
  • Data from study of Diclectin

  • The panel would not recommend any changes to the current labelling of Diclectin for the management of nausea and vomiting of pregnancy.

Opioid analgesic abuse SAP10
Opioid use and contraindications SAP11Mar. 24, 2017
  • Information about opioids that should be included in product monograph

  • Should low-dose codeine products be made prescriptiononly?

  • Information about a threshold dose for chronic noncancer pain should be in the dosing and administration section of the product monograph in such a way as to draw the attention of the prescriber.

  • The indication for extended/long-acting opioids should be changed to say that patients should first have tried a nonopioid medication.

  • Prescriptions for opioids for acute pain should be limited to 3 d.

  • No changes should be made to the nonprescription status of low-dose codeine products at present.

Opioids SAP11Nov. 15, 2016 and Nov. 16, 2016
  • Public information about opioid overdose and addiction

  • Risk management plan for opioids

  • A warning sticker should be placed on prescriptions for opioids to highlight the issues of physical dependence, addiction and overdose.

  • Industry involvement in risk management plans and educational programs should be monitored and limited.

Isotretinoin risk management SAP11Nov. 17, 2017
  • Pregnancy prevention program for isotretinoin

  • Although there is no evidence to show that the Canadian pregnancy prevention program is not ineffective, improvements should be made.

  • Note: FEV1 = forced expiratory volume in 1 s, SAC = special advisory committee, SAP = special advisory panel.

  • * A record of the proceedings of the meeting of the respiratory and allergy therapies SAC on Nov. 2, 2018, was not available at the time of writing.

  • Italics are as in the original text.