Minutes of the National Drug Scheduling Advisory Committee Meeting, December 8 - 9, 2002

A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on Sunday and Monday, December 8-9^th, 2002 at the NAPRA offices, 222 Somerset St. W., Ottawa. 

Participants

NDSAC members: Dr. Marilyn Caughlin (Chairman), Dr. Jeff Taylor (Vice-Chairman), Dr. Mark Armstrong, Phil Hudson (for Sunday), Dr. Larry Lynd, Dr. Colleen   Metge,  and Fred Rumpel

Observer:          Joan Sayer

Staff:                Denis Belanger (Drug Information Consultant, Ottawa Valley Regional Drug Information Centre), Louise Gaulin (NAPRA), Barbara Wells (NAPRA Executive Director)

Guests:             Pharmacia Canada: Dr. Edward Sellers, Daniela Jukic (Director of Scientific & Regulatory Affairs), Sylvie Poissant (Director of Marketing)

Whitehall Robins: Dr. Murray Brown, Vice-President of Scientific Affairs, Narinder Grewal, Director of Regulatory Affairs

McNeil Consumer Healthcare: Todd Breedon, Director of Regulatory Services, Peter Cummins, Vice-President of Scientific Affairs (for acetaminophen presentation only), Dr. Jim Swann, Vice-President, Medical Affairs, Brenda Wilson, Regulatory Affairs Associate (for loperamide presentation only)

Regrets:            Dawn Frail

1.         Chair’s Opening Remarks

1.1            Call to order

Dr. Caughlin called the meeting to order at approximately 9:10 am.  Fred Rumpel, newly appointed committee member, was introduced and welcomed to the group.

1.2            Approval of the minutes of the September 22-23 2002 meeting            

It was moved by P. Hudson, seconded by C. Metge that the minutes of the September 22-23, 2002 meeting be accepted as circulated.  Motion carried.

1.3            Approval of the agenda

The Chairman asked if there were any additions to the agenda.  Dr. Armstrong asked that the issue of branding and labeling be added to the agenda, and it was agreed that this would be considered under “Other Matters”.

It was moved by L. Lynd, seconded by P. Hudson that the agenda be adopted as circulated and amended.  Motion carried.

1.4            Declarations of conflict of interest

            Dr. Caughlin called for committee members to declare any real or perceived conflicts of interest. 

Mr. Hudson noted that due to a business arrangement with McNeil Consumer Healthcare, he would be in a conflict of interest position to participate in Monday’s discussions and decisions on the scheduling of acetaminophen SR and loperamide, and the committee agreed that he should not participate in these discussions.  Accordingly, Mr. Hudson did not attend the Monday session.            

            No other conflicts were identified or declared.

2.         For information

2.1               Status of pending federal switches and new drugs

2.1.1          17 new additions to Schedule F, Part I proposed (Amendment #1286 - Canada Gazette Part I) 

Ms. Wells outlined the proposed additions to Part I of Schedule F.  For information.

2.1.2          10 drugs added to Schedule F, Part I ( Amendment # 1251 - Canada Gazette Part II).

Ms. Wells outlined the additions to Part I of Schedule F.  These will be added to Schedule I of the National Drug Schedules.  For information.

2.1.3          Canada Gazette Part II announcement on precursor regulations. 

Ms. Wells briefly summarized the intent of the Precursor Control Regulations, published in Part II of the Canada Gazette on October 9, 2002.  The Regulations will require retailers selling specific drugs and chemicals in package sizes over certain amounts to be licensed, among other requirements.  The intent of these new laws is to limit the access of criminal elements to chemicals used in the production of illicit substances (such as LSD, heroin, cocaine, PCP).  Ephedrine, pseudoephedrine and potassium permanganate are three of the 17 drugs identified by the regulations.

The Committee agreed that no further action would be needed at this time with respect to the national scheduling of these drugs since the Regulations were designed to prevent diversion rather than address patient health and safety issues.    It was also agreed that a statement explaining this decision should be prepared and distributed.

2.2            Recent Health Canada drug advisories

      The Committee reviewed Health Canada drug advisories received since the previous meeting.  For information.    

2.3            Presentation to NDMAC Board of Directors October 9, 2002

Ms. Wells outlined the nature of a presentation given to the Non-prescription Drug Manufacturers’ Association of Canada Board meeting in October.  Her presentation included an update on NAPRA, drug scheduling and the extent of implementation of the national schedules by reference across Canada, and an outline of issues arising between drug scheduling request applicants and the committee.

With respect to industry acceptance of the scheduling model, Dr. Taylor spoke about an attempt by one company to circumvent the Schedule II status of xylometazoline in nasal preparations for pediatric use, by deleting the reference to pediatric use on their product packaging.  It was agreed that this move is not in line with the spirit of the schedule wording.  Ms. Wells was asked to follow-up with the regulatory authorities and the company on this matter.

2.4            Presentation to College of Pharmacists of BC Council

Dr. Taylor outlined the nature of his presentation to the Council of the College of Pharmacists of BC on November 22.  The presentation had been at the request of the College, to help Councillors better understand how drug scheduling decisions are made.  Dr. Taylor addressed the group to attempt to highlight the challenges often faced by NDSAC members in making these decisions.

There was discussion about how the scheduling factors and related scheduling processes needed to be better promoted to individual pharmacists.  Despite the fact that both are readily available to the public through the NAPRA website, it was apparent that many pharmacists and by extension, provincial Council Members, do not understand how NDSAC makes decisions or how the factors are applied.  It was agreed that M. Belanger and Ms. Wells would endeavour to develop recommendation summaries and explanatory commentary on the decisions from the pharmacist’s perspective, to the extent possible, and that scheduling announcements should be distributed as press releases to the pharmacy media.  Scheduling announcements should include a summary of how each particular drug is scheduled in other jurisdictions, to put the Canadian decision in its proper context.  As well, individual provincial Council Members and pharmacists across Canada should be invited to join the Drug Scheduling External Liaison Group (DSELG), to receive notices about upcoming scheduling matters and the opportunity to participate as an Interested Party.   Ms. Wells also agreed to advise patient advocacy groups about NDSAC’s role and the availability of Interested Party status, and to draft a “status report” article suitable for publication in pharmacy journals on the work to-date of NDSAC.

3.            Business from previous meeting(s)

3.1               Revision of current scheduling factors for clarification 

The Committee agreed to use the traditional scheduling worksheet along with a revised trial worksheet (#2) again for the decisions taken at the meeting, to continue to pilot test draft amendments to the scheduling factors.   There was some discussion about regulatory interpretations of the words “should”, “could”, “must” and “shall” in the scheduling factors and Ms. Wells agreed to survey the Registrars on the preferred terms.

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

Dr. Caughlin reported on the presentation made to NAPRA Council in November, regarding the implications of future possible switch drugs on the practice of pharmacy (NDSAC Report # 1).    Ms. Wells reported that the report had been referred to the Registrars Committee for study, with a response to be reported back to Council in April 2003.

3.3            Vaccines

At the September meeting 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. It was agreed that this would be deferred to next meeting.

3.4            Clarification re: scheduling of total parenteral nutrition products

At the previous meeting, the Committee considered the apparent inconsistencies between the Schedule I status of “electrolytes for parenteral use” and individual TPN additive entries.  There was general agreement that the Schedule I blanket statement “electrolytes for parenteral use” entry should be replaced with entries for individual TPN additives. 

M. Belanger presented a list of TPN additives commonly used in Canada, along with their current scheduling status. 

After discussion, it was moved by M. Caughlin, seconded by M. Armstrong that the entry “Electrolyte solutions for parenteral use” should be deleted from the schedules.  Motion carried unanimously.

The Committee then reviewed the individual TPN additives.  It was moved by M. Armstrong, seconded by F. Rumpel that the additives (identified in the Belanger document) in injectable form for use in parenteral nutrition be assigned Schedule I status.  Motion carried unanimously.

3.5            Exempted codeine products

The Chairman reported on her presentation to NAPRA Council in November, regarding the Committee’s recommendation that NAPRA not pursue a ban of exempted codeine products from the Canadian market.  Dr. Caughlin noted that a number of provincial licensing authorities had implemented programs to educate and encourage pharmacists to apply the expected Schedule II standards of practice in the distribution of these products.  Ms. Wells circulated material from the Nova Scotia College of Pharmacists, as an example.

4.                     New Business

4.1            Nicotine inhalation system

Pharmacia Canada representatives made a 20-minute presentation at 10:00 am on Sunday, to highlight the data submitted by the company in support of Schedule III status for nicotine by inhalation.   This was followed with a question-and-answer period.

Nicotine by an oral inhalation device is currently not on the Canadian market, but has been granted a Notice of Compliance from Health Canada.  Notice of a proposed amendment to exclude nicotine by inhalation from Schedule F was published in the Canada Gazette, Part I in June.

After considerable discussion, it was moved by C. Metge and seconded by M. Armstrong that when deleted from Schedule F, “nicotine in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit” should be granted Schedule III status.  Motion carried unanimously.

Applicable factors: Schedule III - # 2,4,5,6 and 7.

            4.2            Brompheniramine

Whitehall Robins representatives outlined their request for unscheduled status for brompheniramine, as presented in their submission.  A 20-minute presentation was made on Sunday at 1:30 pm, followed by a question-and-answer session.

It was noted that chlorpheniramine had been moved from Schedule III to unscheduled status in 1997, as part of a special review of 37 scheduled drugs with GP registration.  Health Canada had sponsored NDSAC to assign scheduling status to these drugs in view of the government’s decision to discontinue the GP registration program.  Brompheniramine had not been captured in this group assessment since no manufacturer of brompheniramine-containing products had applied for GP registration.  Whitehall Robins was now requesting that brompheniramine be granted unscheduled status.

While the Committee recognized the similarities between chlorpheniramine and brompheniramine, pediatric use of these and other agents has been of concern to the group, an aspect that may not have been deemed as significant earlier when the scheduling decision for chlorpheniramine was taken.

After considerable discussion, it was agreed that Factors # III – 1,4, 5, and 6 were applicable to brompheniramine as a single entity for the treatment of allergies.  It was therefore moved by M. Armstrong, seconded by F. Rumpel                                                                               that brompheniramine as a single entity for the treatment of allergies remain in Schedule III.  Motion carried.

It was then agreed that Factors # III – 2,5, and 6 were applicable for brompheniramine in cough and cold preparations.   Whitehall Robins representatives were asked to provide further information on brompheniramine with respect to the following:

1.       children’s dosing

2.       distribution of brompheniramine products

3.       patient information

Pending receipt of this information, the committee would reconvene by teleconference to conclude the scheduling decision.

4.3               Acetaminophen sustained-release

McNeil Consumer Healthcare representatives made a 20-minute presentation at 10:00 am on Monday, to highlight the data submitted by the company in support of unscheduled status for acetaminophen in sustained release formulations.  This drug is currently in Schedule III.   The presentation was followed with a question-and-answer period.

It was noted that Bayer Canada had been granted their request for Interested Party status and as such, had submitted a brief outline of the company’s perspective on how the scheduling factors should be applied to acetaminophen in sustained release formulations.  In keeping with protocol, the submission had been circulated to the Committee members and to McNeil Consumer Healthcare, which declined to respond.

After discussion, it was agreed that Factors # III – 2 and 4 were applicable to acetaminophen in sustained release formulations.

It was moved by C. Metge, seconded by M. Armstrong that acetaminophen in sustained release formulations up to and including 650 mg per unit and in package sizes of no more than 50 units, be granted unscheduled status.  Motion carried unanimously.  Accordingly, acetaminophen in sustained release formulations over 650 mg per dosage unit or in package sizes of more than 50 dosage units would remain in Schedule III.

4.4               Loperamide in solid oral dosage forms

The McNeil Consumer Healthcare representatives then made a second 20-minute presentation to highlight the data submitted by the company in support of unscheduled status for loperamide in solid oral dosage forms (currently Schedule III).   The presentation was followed with a question-and-answer period.

The Committee agreed that Factors III #1 and 2 applied to loperamide. 

After discussion, it was moved by C. Metge, seconded by L. Lynd that loperamide and its salts in solid oral dosage forms be granted unscheduled status.  Motion carried, with one member voting against the motion.

5.                     Other Matters

5.1               Rules of Procedure

Ms. Wells reported on an amendment approved by NAPRA Executive Committee in November, whereby the deadline for Interested Party applications was increased from 20 to 45 days prior to NDSAC meetings.  She explained that this had been sought to provide a more reasonable length of time for the necessary communications to take place between the scheduling applicant and Interested Party. 

She also circulated a diagram prepared to illustrate pre and post NDSAC meeting administrative processes.  The Committee suggested that a mechanism to appeal the Chairman’s decisions to grant or refuse Interested Party status be implemented, and Ms. Wells agreed to explore this with legal counsel.  There was also agreement with Dr. Taylor’s suggestion that the actual criteria for granting IP status be included in the diagram.

Ms. Wells then distributed a copy of the guidelines for scheduling request submissions, currently posted on the NAPRA website.  She said that in view of the fact that they had been developed in 1995, it would be prudent for the committee to now review and possibly update them according to experience over the past 7 years.  

The Committee agreed with the following additions to the six points currently posted:

§               to #3: ensure that exposure assessment and other aspects of the drug identified by Dr. Metge are captured.

§               to #6: consumer usage studies should be in a market consistent with the requested schedule status

§               add conditions for sale in other jurisdictions as an information requirement.

Ms. Wells and M. Belanger agreed to draft revised submission guidelines and circulate to the committee for approval.

There was also agreement with Dr. Taylor’s suggestion that for consistency, pre-meeting material should include a list of other drugs in the same therapeutic class as the entity under review.  He noted that a “scheduling map” showing the schedule category of agents used to treat various disease states or symptoms would be helpful.  Ms. Wells agreed to provide committee members with this background material for the next meeting.

There was discussion about the need for Committee continuing education and there was general agreement that one hour of each meeting should be devoted to learning about relevant issues.  Ms. Wells agreed to look into securing a Health Canada representative to speak about risk assessment for the next meeting, with other topics slated for future meetings.  Dr. Taylor suggested that Committee members be supplied with a reading packet of +relevant self-medication and regulatory articles (especially for newly appointment members) and that meetings include an environmental scan to ensure that the Committee keeps current with drug scheduling in other jurisdictions.

The Committee then briefly discussed an issue that had long been under consideration, that being whether a product containing a combination of two or more unscheduled drugs should automatically be considered unscheduled (“ U + U = U”).  Ms. Wells agreed to research how other jurisdictions address this.

5.2            Proposed Natural Health Products Regulations

Ms. Wells’ report on proposed regulations for natural health products was deferred to the next meeting.

5.3           Product Monograph Revisions

Ms. Wells’ report on the status of the federal government’s product monograph revision project was deferred to the next meeting. 

5.4           Branding and labelling                       

Dr. Armstrong spoke about his concerns about the confusion created for consumers when manufacturers apply a recognizable brand name to a line of products with varying ingredients and formulations. 

6.                     Date of next meeting

                        Saturday & Sunday, March 22-23 2003

7                      Adjournment

The meeting adjourned at 3:00 pm on Monday.  Dr. Caughlin noted that it was Dr. Metge’s last meeting as her 2^nd term of appointment had now concluded.  The Committee thanked Dr. Metge for her leadership and energy over the past six years.  Dr. Metge thanked everyone for their support during her time as Chairman and for the congeniality of the group.

Ms. Wells noted that a recruitment to replace Dr. Metge would be initiated early in the new year.  There was discussion about the need to ensure that as many committee members as possible attend the meetings and the challenges that this sometimes presents for staff.  There was support for the suggestion that NDSAC alumni be retained as alternatives if needed.  Ms. Wells agreed to look into the feasibility of this suggestion with legal counsel, former NDSAC members, and the Executive Committee.

Dr. Metge expressed her concern that the perspective of practising community pharmacists had not been available to the committee at the Monday session, due to Mr. Hudson’s early departure.  She wondered if the committee roster should be expanded to allow for the appointment of an additional practising pharmacist.  It was generally decided that the perspective of an additional practising pharmacist would be highly desirable, but may not need to be the defining criteria for the next committee member given the pharmacy backgrounds of a number of existing committee members