Table 4:

Topics discussed at SAC/SAP meetings and summary of recommendations

Committee or panel	No. of meetings	No. of meetings where a record of proceedings was available	Date(s) of meeting(s) where a record of proceedings was available^*	Summary of topic(s) discussed	Summary of recommendation(s)^†
Oncology therapies SAC	7	1	August/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 SAC	4	0
Respiratory and allergy therapies SAC	11	3	Mar. 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 SAP	1	1	Oct. 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 SAP	1	1	June 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 SAP	1	0
Diclectin SAP	1	1	June 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 SAP	1	0
Opioid use and contraindications SAP	1	1	Mar. 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 SAP	1	1	Nov. 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 SAP	1	1	Nov. 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.