NDSAC Minutes: November 3-4, 2001

A meeting of the National Drug Scheduling Advisory Committee was held on Saturday and Sunday, November 3^rd and 4th, 2001, at the office of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Ottawa.

1. Chair’s Opening Remarks
   Dr. Metge called the meeting to order at 9:15 am.

   1.1 Welcome to Joan Sayer

   The Chairman welcomed Joan Sayer to the meeting, appointed to replace Jean Jones as the Consumers’ Association of Canada observer.

   1.2 Extension of terms for L. Jardine and J. Webb

   The Chairman announced that the appointment terms for Ms. Jardine and Ms. Webb had been extended to February 2002, for continuity.

   1.3 M. Caughlin agrees to second term

   It was noted that Dr. Caughlin was entering into her second term on the committee.

   1.4 Approval of the minutes of the November 18, 2000 meeting

   It was moved by M. Brown, seconded by J. Webb that the minutes of the November 18, 2000 meeting be accepted as circulated. Motion carried.

1.5 Approval of the agenda

Dr. Metge called for any additions to the agenda. There was agreement that correspondence from Novartis (October 22/01) regarding cyclosporine, and from Health Promotion Research (October 31/01) regarding sibutramine, be added under "Other Matters".

It was then moved by M. Brown, seconded by J. Webb that the agenda be approved as amended. Motion carried.

1.6 Declarations of conflict of interest

Ms. Wells confirmed that there were current, signed conflict of interest statements on file from all Committee members, and the Chairman asked if there were any conflicts to declare with respect to specific matters under discussion at this meeting.

Dr. Brown reported his executive position with the Canadian Pharmacists Association, one of the sponsors of the Plan BÒ scheduling request (#4.16) and it was therefore decided that he would be excused from the meeting room during the sponsor’s presentation, and discussion and voting.

No other conflicts or perceived conflicts of interest were reported.

2. For information

   2.1 Status of pending de-regulations

Ms. Wells reported on the status of two pending federal de-regulations as per the Therapeutic Products Directorate:

• Schedule 1240 pre-notification re: nicotine by inhalation is on course for Gazette Part I publication.
• Schedule 1248 Gazette Part I notification re: ibuprofen 400 mg is on track for Gazette Part II publication.

2.2 Federal status of Vitamin K (topical)

The committee reviewed July 12/01 correspondence from Health Canada, clarifying that the Schedule F entry for Vitamin K should pertain only to drugs for internal or parenteral use, with formulations for topical use excluded. According to established drug scheduling policy, Vitamin K for topical use will remain in Schedule I, pending NDSAC review.

2.3 Required non-Rx product references

As initiated at the previous meeting, the committee discussed the need for health professionals and the public to have ready access to reliable and comprehensive information on drug products, particularly non-prescription drug products.

It was moved by J. Taylor, seconded by J. Webb that NAPRA Council be alerted to the need for greater access to current drug product monographs, particularly for non-prescription products available in Canada. Motion carried.

2.4 Administrative improvements to the National Drug Schedule listings

Ms. Wells reported that the previous separate listing of Unscheduled drugs (i.e. those reviewed and determined by NDSAC) was now incorporated into the Schedule I, II and III master list. She also noted that in accordance with a request from the Pharmacy Registrars, federally scheduled controlled/narcotic drugs were also being incorporated into the schedule listing.

3. Business from previous meeting(s)

   3.1 Meningococcal vaccine scheduling decision

   Dr. Metge noted that in keeping with the earlier decision, the committee would need to ratify the fax vote taken on March 30/01 resulting in the placement of meningococcal vaccine in Schedule II

   It was moved by M. Armstrong, seconded by J. Taylor that the deletion of meningococcal vaccine from Schedule I and the addition of meningococcal vaccine to Schedule II, be approved. Motion carried.

   The committee expressed concern about possible inconsistencies in the drug schedules with respect to vaccines, and agreed that this should be reviewed at the next meeting. M. Belanger was asked to prepare background information on the vaccines, and Ms. Wells indicated that she would ensure that relevant stakeholders were notified of the upcoming review.

   3.2 Consumer drug product package sizes (Sask. Pharmaceutical Association)

   The committee referred to correspondence from the Saskatchewan Pharmaceutical Association in which, citing the availability of unscheduled ibuprofen 200 mg in 500 and 1000 unit packages, they wondered whether package size was a factor in scheduling decisions.

   The committee agreed that OTC package sizes, especially of this magnitude, are a concern. There was consensus reached that non-prescription drug product package sizes should reflect the indication and duration of use of the drug.

   It was moved by M. Armstrong, seconded by J. Taylor that package sizes should be a consideration in the scheduling process and in the context of recommended courses of therapy and indication(s) for use.

   Further, it was moved by M. Armstrong, seconded by J. Taylor that labelling should be a consideration in the scheduling process and in the context of recommended courses of therapy and indication(s) for use. Motion carried.

   It was decided that at the next meeting the Committee would undertake to devise how these principles should be addressed in the scheduling factors. The Committee concurred that Health Canada should be contacted regarding the above in considering dual status of non-prescription drugs, understood to be associated with different indications but also applicable to labelling. There was also support for Ms. Wells’ suggestion that industry be broadly consulted on how the issues of package size and labelling might be dealt with in the future when decisions for unscheduled status are made.

   3.3 Addition of a "public interest" scheduling factor

   The Committee discussed the value of one or more factors relating directly to an over-riding "public good" being incorporated into the scheduling factors. This matter was referred to the next meeting for further discussion.

4. New Business

   4.1 Gentian Violet

   The committee reviewed a request from the Nova Scotia Pharmaceutical Society for advice on the conditions of sale of gentian violet when promoted as a treatment for oral thrush in the infants of nursing mothers.

   After reviewing the background papers prepared by the consultant and concurrent discussion, it was moved by J. Webb, seconded by L. Jardine that Gentian violet for application to skin or mucous membranes should be assigned Schedule II status due to the applicability of Factors II – 1,5,8, and 9. Motion carried.

   4.2 Topical ibuprofen

   The Committee reviewed a request from the BC College of Pharmacists for clarification on the applicability of unscheduled status to topical forms of ibuprofen being compounded extemporaneously by pharmacists.

   It was agreed that the unscheduled status of ibuprofen up to and including 200 mg per dosage form applies to oral formulations only, given that there are no approved indications for topically applied ibuprofen in Canada.

   4.3 Exempted codeine products

   The Chairman outlined a matter referred by NAPRA Council, regarding a request from the Manitoba Pharmaceutical Association to review the risks, benefits, safety and efficacy profile of nonprescription products containing 8 mg of codeine available on the Canadian market.

   There was general agreement that the status of exempted codeine products should be formally reviewed by the Committee, with full participation from manufacturers and other stakeholders. There was also discussion about the need to verify if the matter was of product risk vs benefts or a pharmacist standard of practice enforcement issue. Ms. Wells was asked to consult with the federal government and industry on this matter, and it was agreed that a formal review would be undertaken at the next meeting.

   4.4 Placement of prenatal vitamins

   The Committee reviewed correspondence from a physician in Regina, forwarded by the Saskatchewan Pharmaceutical Association, regarding public access to prenatal vitamins. Prenatal vitamins are typically assigned Schedule II status due to the iron content (commonly over 30 mg elemental iron), and the physician is concerned that women in the early stages of pregnancy may not be aware of their availability.

   There was support for the correspondent’s suggestion that pharmacists alert the public via in-store signage, of the availability of prenatal vitamins through the pharmacist and that folic acid supplements are available in the self-selection professional products area of pharmacies. It was agreed that this suggestion should be referred to the Inter-provincial pharmacy regulatory committee (IPRC) of NAPRA. Ms. Wells was asked to include an explanation of the Schedule II status of iron in prenatal vitamins, in her response.

   4.5 Scheduling of saccharin

   The Committee reviewed a request for clarification from the University of Alberta Faculty of Pharmacy regarding the conditions of sale for saccharin, given that the federal Food and Drugs Regulations (E.01.002) prevent saccharin from being sold to the general public "except on the premises of a pharmacy".

   After discussion and consideration of background material prepared by the consultant, it was agreed that saccharin does not fall under NDSAC’s mandate for scheduling drugs. It was also agreed that based on the committee’s research it should be recommended to Health Canada that this restriction of sale is not warranted.

   4.6 Clarification re: consistency in the scheduling of parenteral nutrition products

   The Committee discussed on a preliminary basis, requests from the Alberta College of Pharmacists and the BC College of Pharmacists for clarification on the status of parenteral nutrition products in general and individual ingredients specifically.

   It was agreed that this matter would be tabled for discussion at the next meeting.

   4.7 Correspondence (August 24/01) re: re-scheduling of lactic acid

   The Committee considered a request from Stiefel Canada to amend the current Schedule III threshold for lactic acid set at 10%. It was agreed that Steifel Canada would need to make a formal submission to NDSAC to have this matter reviewed.

4.8 Clarification re: Schedule II entry for Children’s ASA

The Committee reviewed an inquiry from the Saskatchewan Pharmaceutical Association regarding correlation between the Regulations to the Food and Drugs Act [(C.01.037 (1) b) "No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains more than 1.92 g of acetylsalicylic acid…." and the Schedule II listing.

After discussion it was agreed that the Schedule II listing for acetylsalicylic acid be changed to read, "…Acetylsalicylic acid and its salts (in oral preparations containing 80 mg or less per dosage unit and intended for pediatric use or rectal preparations containing 150 mg or less per dosage unit)."

4.9 Scheduling and standards of practice for sale of Schedule F,
      Part II (veterinary use) drugs

Ms. Wells reported on inquiries received by the Registrars from pharmacists regarding conditions of sale of Schedule F, Part II drugs for veterinary use, which are available on a non-prescription basis. The Registrars wondered if the Committee could comment on this matter. It was decided that pending further clarification of the issue and examples, it would be considered at the next meeting.

4.10 Status of ethanol with respect to the drug schedules

The Committee considered a request from the BC College of Pharmacists to add ethanol to the national drug schedules. In some provinces, pharmacists are authorized to purchase ethanol from the government liquor stores, upon presentation of the pharmacist registration card. However, since it’s not listed in the schedules, pharmacists wonder if they can sell it on a non-prescription basis. Pharmacists have reported on some medical indications for its use, as cited in various references.

The Committee asked M. Belanger to compile the current information regarding medical indications for 95% ethanol and to cite appropriate references for presentation at the next meeting of NDSAC. Ms. Wells also agreed to seek additional information about this request from the Registrar of the BC College.

4.11 Status of ranitidine for injection

Ms. Jardine noted that the current Schedule I listing for ranitidine (which mirrors that of Schedule F, Part I) exempts ranitidine "when sold in a dosage form containing not more than the equivalent of 75 mg of ranitidine". Ranitidine injections are available in vials containing 50 mg, and according to our drug schedules they would be unscheduled. After discussions it was agreed that the Schedule II listing for ranitidine should be modified to read, "..when sold in an oral dosage form containing not more than the equivalent of 75 mg of ranitidine."

4.12 Health Canada warnings re: famotidine and re:warfarin & vaginal miconazole interaction

Dr. Metge referred the committee to recent advisories issued by Health Canada and it was decided that no action related to scheduling was warranted. For information.

4.13 Requests for unscheduled status for ibuprofen up to 400 mg

From 1:10 pm to 2:00 pm on Saturday, McNeil Consumer Healthcare representatives Todd Breedon, Dr. Nancy MacDonald, and Dr. Jim Swann attended the meeting and made a presentation summarizing their request for unscheduled status for ibuprofen in strengths up to 400mg.

From 2:15 pm to 2:35 pm on Saturday Whitehall Robins representatives Dave Bichen and Narinder Grewal attended and presented their request for unscheduled status for ibuprofen in strengths up to 400 mg.

The Committee also considered information and questions submitted by Bayer Inc. (who had been granted Interested Party status), as well as responses from Whitehall-Robins and McNeil Consumer Healthcare.

After the presentations, the committee discussed various aspects of the scheduling requests, and applied the scheduling factors. The Committee agreed with Schedule III status for ibuprofen in strengths over 200 mg and not exceeding 400mg per oral dosage form pending federal de-regulation and the applicability of Factors III-1, 2,4, 5 and 6.

4.14 Request for non-prescription status for Plan BÒ

From 10:10 am to 10:30 am on Sunday, the Committee heard a presentation from representatives of the four co-sponsoring agencies of the request for Schedule II status for Plan BÒ emergency contraception. In attendance were: Dr. Vyta Senikas (Society of Obstetricians and Gynaecologists of Canada); Janet Cooper (Canadian Pharmacists Association); Anne Tomalin (CanReg Inc.); and Dr. Sharon Camp (Women’s Capital Corporation).

After considerable discussion, it was agreed that levonorgestrel in a 1.5 mg per course dosing, packaged and labelled for emergency contraception similarly to that of the Women's Capital Corporation product Plan BÒ , would meet the requirements for Schedule II status, after applying Factors #1, 2,8, and 9.

The Committee agreed that the Women’s Capital Corporation should be advised, however, that final confirmation of Schedule II status would be reserved until such time as the federal government’s intention to de-regulate is published and final labelling is confirmed. This particular Schedule II decision applies only to the product prototype presented by WCC, with labelling specifying indication for use, risks and side effects, effectiveness, contraindications and overdose sequelae.

5. Other Matters

   5.1 2002 Tentative Meeting Dates

   Tentative meeting dates were set for the following Friday and Saturdays in the early new year:

   • February 1-2
   • April 19-20
   • May 31-June 1

   
   5.2 Review & fine-tuning of new process

   Ms. Wells agreed to prepare a flow chart for the committee, to clarify the revised NDSAC notice, review, decision and appeal processes.

   There was also discussion about the need for more narrative regarding NDSAC's scheduling decisions, to help all stakeholders understand and implement decisions to the best of their ability.

   5.3 Quality Assurance Processes

   Discussion of a quality assurance process/identifiers for drug scheduling system was deferred to the next meeting.

   5.4 Sibutramine abuse potential

   The committee reviewed correspondence from Dr. Robert B. Coambs, Health Promotion Research Inc. regarding the alleged abuse potential of sibutramine. It was noted that the submitted material was based on research funded by Hoffman-LaRoche Limited.

   The Committee agreed that no further action would be taken at this time.

   5.5 Cyclosporine interchangeability

The Committee reviewed correspondence from Novartis Pharmaceuticals Canada regarding the interchangeability of cyclosporine formulations. Received for information.

6. Adjournment

The meeting was adjourned on Sunday, November 4^th, 2001 at 2:40 pm.