A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held Sunday and Monday, September 22 and 23^rd 2002 at the NAPRA office in Ottawa.

Participants

Committee members:     Dr. Marilyn Caughlin (Chairman), Dr. Mark Armstrong, Dawn Frail, Phil Hudson, Larry Lynd, Dr. Colleen Metge, and Dr. Jeff Taylor

Observer:                      Joan Sayer (Consumers Association of Canada)

Staff:                            Denis Belanger (Drug Information Specialist, OVRDIS), Barbara Wells (Executive Director, NAPRA)

Guests (for portions of the meeting):         

Barry Poole, President, drapharmadev Canada

Dr. Laura Pope, Avanir Pharmaceuticals

Jennifer Denomme, GlaxoSmithKline Consumer Healthcare Canada

Dr. Patrice Larose, Stephane Langevin, Rosy Sasso, Schering Canada

1.         Chair’s Opening Remarks

1.1            Call to order

                        The Chairman called the meeting to order at approximately 9:10 am.

1.2            Approval of the minutes of the June 1-2, August 12, and August 30, 2002 meetings                      

It was moved by C. Metge, seconded by D. Frail that the minutes of the three meetings be adopted as circulated.

Motion carried.

1.3            Approval of the agenda

It as moved by D. Frail, seconded by J. Taylor that the agenda of the meeting be approved as circulated. 

Motion carried.

1.4            Declarations of conflict of interest

            The Chairman called for declarations of conflict of interest. 

Mr. Hudson described a specific commercial relationship with McNeil Consumer Healthcare and as such, would need to continue to refrain from participating in any discussions regarding McNeil’s submission on dextromethorphan, should the issue come up.  No other conflicts were announced.

            Ms. Wells also circulated conflict of interest declaration renewal forms for signatures. 

2.         For information

2.1               Status of pending federal switches and new drugs

Proposed amendments to federal drug legislation were reviewed. 

2.2            Recent Health Canada drug advisories

      Recent Health Canada drug warnings and advisories were reviewed.

 2.3            Replacement for “industry” position

At the invitation of the Chairman, Ms. Wells outlined options to consider for recruiting the committee position left vacant with Murray Brown’s resignation.  

It was agreed that a two-pronged approach should be taken:

§          call for nominations would be issued as per past recruitment processes, with the caveat that individuals concurrently employed by a specific pharmaceutical company or related industry  would not be eligible for appointment and

§          discussions would also be undertaken with the Nonprescription Drug Manufacturers Association of Canada about the feasibility of an ex officio, non-voting position on the committee to serve as an industry resource. 

2.4.            NAPRA presentation to the House of Commons Special Committee on Non-Medical Use of Drugs

Ms. Wells outlined a recent presentation to a House of Commons Committee that included an outline of the work of NDSAC, the national drug schedules, and assistance that Health Canada could provide to make the scheduling system more effective in preventing non-medical use of drugs.

2.5            Category IV Monographs      

The Committee reviewed August 30/02 correspondence from Dr. Brian Gillespie, A/Director, Senior Medical Advisory Bureau, TPD, regarding plans to revise their non-prescription drug product monographs and labeling standards.  There was considerable support for, and interest in, this process.  Ms. Wells agreed to convey this to Dr. Gillespie. 

3.            Business from previous meeting(s)

3.1               Quality Assurance: Review of Scheduling Factors

3.1.1            Revision of current scheduling factors for clarification 

The Committee reviewed extensive work done by Dr. Taylor in drafting revisions to the current factor, for the purpose of improving clarity.  Dr. Metge then prepared a chart which grouped the factors according to their focus (e.g. “indications for use”, “risk reduction”, “dependency”), rather than by Schedule.  The Committee agreed to work with the revised factors and format concurrently with the regular worksheets, for the next few meetings, and then re-visit the proposed amendments.

It was moved by M. Armstrong, seconded by D Frail that Dr. Taylor’s efforts in preparing the draft revised factors be recognized.  Motion carried.

3.1.2.            Report to NAPRA Council on a potential new generation of de-regulated drugs.

The Committee reviewed a draft advisory report to NAPRA Council on prescription drugs expected to be switched to non-prescription status in the coming years in other countries and the impact this is expected to have on pharmacists’ practice.

It was agreed that Ms. Wells would finalize the draft, taking into account the comments made by Committee members during the meeting.  Dr. Caughlin agreed to present the final report to Council on behalf of the Committee.

3.2            Vaccines

There was considerable discussion about the history of vaccine scheduling and the applicability of the “drug” focused scheduling factors to vaccines.  It was agreed that there should be consultation with federal public health officials on Health Canada’s recommendations for the distribution of vaccines across Canada, and Ms. Wells agreed to research this and report back at the next meeting.

3.3            Magnesium glucoheptonate

In response to an inquiry from the BC College of Pharmacists about the appropriate scheduling of magnesium glucoheptonate the Committee had asked that a manufacturer of this drug be consulted on a preliminary basis. 

Ms. Wells reported that ratiopharm, the manufacturer of ratio-MAGNESIUM had advised that Schedule II would be an appropriate placement. 

According to protocol, a full scheduling review would be needed in order to alter the current unscheduled status.  Noting that this did not appear to be an urgent public health issue, Ms. Wells agreed to contact the College and seek direction on whether or not they intended to initiate a formal review.  

3.4            Clarification re: scheduling of parenteral nutrition products

At the request of the BC College of Pharmacists, the Committee considered the apparent inconsistency between the Schedule I status of “electrolytes for parenteral use” and individual electrolyte entries. 

There was agreement that the Schedule I blanket statement “electrolytes for parenteral use” entry should be replaced with entries for individual TPN additives.  M. Belanger agreed to prepare an exhaustive list of TPN additives for consideration at the next meeting.

3.5            Scheduling of amino acids

At the request of the Alberta College of Pharmacists, the Committee had been asked to consider the applicability of the national drug schedules to amino acids.  A decision was taken to defer consideration of this until the next meeting, due to time constraints.

3.6        “Wartner”

An inquiry about the scheduling status of this product had been received from the Alberta College of Pharmacists.   In response to direction from the Committee for background information, M. Belanger reported that this product was federally classified as a medical device and that there had been no reported cases of abuse in Canada to-date. 

The Committee agreed that no further action was warranted at this time. 

3.7            Exempted codeine products

NAPRA Council had asked the Committee to consider a matter referred by the Manitoba Pharmaceutical Association regarding the alleged misuse, risks and lack of efficacy of exempted codeine products. 

The Committee reviewed a draft report to NAPRA Council outlining their deliberations and recommendations.  Ms. Wells agreed to incorporate the Committee’s comments and finalize the report for presentation, by Dr. Caughlin, to NAPRA Council in November.

4.                     New Business

            4.1.            Request from GlaxoSmithKline for unscheduled status for docosanol cream 10%

The Committee heard a presentation from GlaxoSmithKline representatives at 9:00 am on September 23, requesting unscheduled status for docosanol cream 10%, and reviewed the submission supporting the request, along with related data.                       

On application of the scheduling factors, it was agreed that unscheduled status would be supported if the product labeling and package insert could be amended to show that the maximum duration of treatment was 10 days.  Ms. Wells was asked to advise the company and report back to the Committee prior to finalization of the recommendation.

                        Applicable scheduling factors: Schedule III # 1,4, and 7.

            4.2            Request from Schering Canada for unscheduled status for loratadine

The Committee heard a presentation from Schering Canada representatives at 1:00 pm on September 23, requesting unscheduled status for loratadine, and reviewed the submission supporting the request, along with related data.           

After application of the scheduling factors, it was moved by C. Metge, seconded by P. Hudson that loratadine and its salts and preparations in products marketed for adult use (age 12 and over) would be recommended for unscheduled status.  Motion carried.

Applicable scheduling factors: Schedule II - #6.  Schedule III - # 1,3, and 4.

Further, it was moved by D. Frail, seconded by J. Taylor that loratadine and its salts and preparations marketed for pediatric use (under 12 years of age), should remain in Schedule III. 

Applicable scheduling factors: Schedule II # 1,5, and 6.  Schedule III - # 1,3, and 4.

5.                     Other Matters

            5.1            Transdermal ibuprofen 10%

Ms. Wells outlined this matter, referred from the BC College of Pharmacists.  The Committee was asked to provide advice on the appropriateness of non-prescription status for topical ibuprofen 10%.  Given the lack of scientific data on safety and efficacy of this dosage form of ibuprofen and the fact that this has not been approved for use in Canada by the federal government, the Committee agreed that it would not be appropriate for them to advise.  

5.2            Tentative dates for 2003 meetings

                        The following dates were set for tentative meeting dates in 2003:

§          March: 22/23

§          June: 8/9

§          September: 21/22

§          December: 7/8

6.                     Date of next meeting

                        Scheduled for Sunday and Monday, Dec 8/9th

7                      Adjournment

The meeting was adjourned at 4:00 pm.  Ms. Sayer thanked Dr. Caughlin and NAPRA staff for their contributions to the meeting.