Article Figures & Tables
Tables
- Table 1:
Description of the types of interests itemized in Health Canada’s Affiliations and Interests Declaration Form for Advisory Body Members
Type of interest Description Direct financial interests Current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares or bonds, with the regulated industry Indirect financial interests Within the past 5 years, payment from regulated industry for work done or being done, including past employment, contracts or consulting; or financial support including research support, personal education grants, contributions, fellowships, sponsorships and honoraria Within the past 5 years, materials, discounted products, gifts or other benefits, or attendance at meetings where all or part of the travel and accommodation costs were provided by the regulated industry Within the last 3 years, grants or other funding from the regulated industry to any of the organizations where you are currently employed or participate in internal decision-making Intellectual interests Within the last 5 years, any formal advice or opinion to industry, a government organization or a nongovernment organization on a matter of relevance to the scientific advisory committee or scientific advisory panel Within the last 5 years, any published or publicly stated point of view on issues of relevance to the scientific advisory committee or scientific advisory panel mandate Current professional or volunteer affiliations such as membership in professional societies, lobbying, public interest or advocacy groups, of relevance to the scientific advisory committee or scientific advisory panel Other interests Any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable grounds for concern regarding the integrity and objectivity of your participation Perspective/sector Total no. of members No. of members; type of interest Direct financial Indirect financial Intellectual Other Academia 13 3 10 10 0 Academia + health professional 22 3 20 18 1 Academia + health professional + research 8 0 6 7 1 Academia + research 8 1 3 5 0 Health professional; health professional + research 17 1 11 12 2 Industry; academia + industry 3 2 2 3 0 Infectious diseases 4 1 2 4 0 Patient/consumer 4 1 2 4 0 Pharmacy 2 0 0 2 0 Total 81 12 56 65 4 Note: SAC = special advisory committee, SAP = special advisory panel.
Advisory body Total no. of declarations No. (%) of declarations; type of interest Direct financial interest Indirect financial interest Direct or indirect financial interest Intellectual interest Other interest Oncology therapies SAC 21 3 (14.3) 18 (85.7) 18 (85.7) 16 (76.2) 2 (9.5) Pharmaceutical sciences and clinical pharmacology SAC 13 4 (30.8) 9 (69.2) 10 (76.9) 12 (92.3) 0 (0) Respiratory and allergy therapies SAC 19 3 (15.8) 14 (73.7) 14 (73.7) 16 (84.2) 0 (0) Anti-infective therapies SAP 6 1 (16.7) 2 (33.3) 2 (33.3) 6 (100) 0 (0) Bioequivalence requirements for gender-specific drug products SAP 7 0 (0) 4 (57.1) 4 (57.1) 6 (85.7) 0 (0) Bioequivalence requirements for modified-release dosage forms SAP 6 0 (0) 5 (83.3) 5 (83.3) 5 (83.3) 0 (0) Diclectin SAP 4 0 (0) 1 (25.0) 1 (25.0) 1 (25.0) 0 (0) Opioid analgesic abuse SAP 6 1 (16.7) 4 (66.7) 4 (66.7) 4 (66.7) 0 (0) Opioid use and contraindications SAP 6 0 (0) 1 (16.7) 1 (16.7) 6 (100) 2 (33.3) Opioids SAP 6 0 (0) 2 (33.3) 2 (33.3) 6 (100) 2 (33.3) Isotretinoin risk management SAP 5 0 (0) 2 (40.0) 2 (40.0) 3 (60.0) 0 (0) Total 99 12 62 63 81 6 Note: SAC = special advisory committee, SAP = special advisory panel.
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, 2018Data 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.