SCHEDULING OF MEDICINES SAPRAA 13 June 2008

Scheduling of Medicines Ephedrine Pseudoephedrine D-nor-pseudoephedrine

Outline  International Narcotics Control Board  Build up to rescheduling  Process  Ruling  Objectives  Regulatory impact and cost compliance  Proposal for concession by DoH

Build up to rescheduling Capitalise on the growth in level of education Rapid increase in illicit manufacture of methamphetamine Diversion of precursors ephedrine, pseudoephedrine and d-norpseudoephedrine from licit channels to illicit manufacturing channels International pressure to meet obligations i.t.o, Convention Treaties INCB recommendation that controls of ephedrine and pseudoephedrine be expanded to pharmaceutical preparations INCB recommendation that controls of ephedrine and pseudoephedrine be expanded to pharmaceutical preparations

Build up to rescheduling Political pressure D-nor-pseudoephedrine not available as OTC medicine internationally Theft from raw material brokers and manufacturers Illicit drug manufacturers posing as NGOs from neighbouring countries

Process Capitalise on the growth in level of education Communication to Industry asking for comment on proposal Ephedrine and pseudoephedrine - limited maximum pack size 720 mg Limited dose size - 30 mg and 60 mg per dose respectively Not more than 240 mg per day and one pack per customer Not more than 240 mg per day and one pack per customer

Ruling Schedule 6: Regardless of pack Regardless of pack size or dose size or dose Schedule 6: Regardless of pack Regardless of pack size or dose size or dose Schedule 6: Single ingredient Single ingredient preparations preparations regardless of regardless of pack size or dose pack size or dose Preparations not Preparations not complying with complying with ruling in Schedules ruling in Schedules Schedule 6: Single ingredient Single ingredient preparations preparations regardless of regardless of pack size or dose pack size or dose Preparations not Preparations not complying with complying with ruling in Schedules ruling in Schedules D-nor-pseudoephedrine Pseudoephedrine & Ephedrine

Ruling Schedule 2 : NMT 30 mg per dose NMT 30 mg per dose Max pack size 720 mg Max pack size 720 mg One pack per customer One pack per customer Schedule 2 : NMT 30 mg per dose NMT 30 mg per dose Max pack size 720 mg Max pack size 720 mg One pack per customer One pack per customer Schedule 2: NMT 60 mg per dose NMT 60 mg per dose Not more than 240 mg Not more than 240 mg per day per day Max pack size 720 mg Max pack size 720 mg One pack per customer One pack per customer Schedule 2: NMT 60 mg per dose NMT 60 mg per dose Not more than 240 mg Not more than 240 mg per day per day Max pack size 720 mg Max pack size 720 mg One pack per customer One pack per customer EphedrinePseudoephedrine

Objectives Capitalise on the growth in level of education Meet obligations in terms of INCB recommendations In line with best International Practices as it relates to the use of these compounds Protect Public Health Protect Public Health Ensure continued availability of safe and effective medicines for patients Ensure continued availability of safe and effective medicines for patients

Regulatory Impact Cost Compliance Initially no phase out period Six month phase out period for packaging but S6 status at point of sale Pharmacists not prepared to purchase or sell Pharmacists not prepared to purchase or sell Companies holding large inventories of finished goods and raw material

Regulatory Impact Cost Compliance Industry supportive of measures to curb illegal use and abuse Highly concerned that not provision made phase out of existing inventory particularly single ingredient pseudoephedrine preparations Creates demand generation shift from community pharmacist to prescribing doctor Creates demand generation shift from community pharmacist to prescribing doctor Could take as long as 1 year to effect Could take as long as 1 year to effect

Regulatory Impact Cost Compliance Industry of view that supply chain can be phased out without exacerbating illicit trade potential Presents rare opportunity to highlight to Health Professionals the need for enhanced control of these and other and other substances with abuse potential Creates demand generation shift from community pharmacist to prescribing doctor Creates demand generation shift from community pharmacist to prescribing doctor Could take as long as 1 year to effect Could take as long as 1 year to effect

Proposal for concession by DoH  Consider 120 day phase out  All existing stocks in trade  Allow stock to be sold as Schedule 2 at point of sale  Accompanied by strong compliance and enforcement of Schedule 2 requirements  Industry participation in enhancement of compliance through education of pharmacists  Distribute Schedule2 registers  Embark on consumer education program in collaboration with expert agreed upon by Council

What does proposal set out to achieve?  Balance risk of redundant inventory in supply chain being returned to manufacturers and being stolen vs  Controlled phase out

What does proposal set out to achieve?  Create awareness professionals of their responsibilities  Pharmacy sales must be witnessed to be safe and effective in appropriately managing risk consumers on safe use of medicines

What does proposal set out to achieve? Make pharmacy profession aware of  Opportunity to demonstrate to Government how to best use clinical skills and judgment to provide safe and effective therapy to patients  Responsibility to be pharmacovigilant for the inappropriate use of all medicines

THANK YOU!