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 reschedulingBuild up to rescheduling
Capitalise on the growth in level of education
Rapid increase in illicit manufacture of Rapid increase in illicit manufacture of methamphetaminemethamphetamine
Rapid increase in illicit manufacture of Rapid increase in illicit manufacture of methamphetaminemethamphetamine
Diversion of precursors ephedrine, pseudoephedrine Diversion of precursors ephedrine, pseudoephedrine and d-norpseudoephedrine from licit channels to illicit and d-norpseudoephedrine from licit channels to illicit manufacturing channelsmanufacturing channels
Diversion of precursors ephedrine, pseudoephedrine Diversion of precursors ephedrine, pseudoephedrine and d-norpseudoephedrine from licit channels to illicit and d-norpseudoephedrine from licit channels to illicit manufacturing channelsmanufacturing channels
International pressure to meet obligations i.t.o, Convention Treaties
International pressure to meet obligations i.t.o, Convention Treaties
INCB recommendation that controls of ephedrine and INCB recommendation that controls of ephedrine and pseudoephedrine be expanded to pharmaceutical pseudoephedrine be expanded to pharmaceutical preparationspreparations
INCB recommendation that controls of ephedrine and INCB recommendation that controls of ephedrine and pseudoephedrine be expanded to pharmaceutical pseudoephedrine be expanded to pharmaceutical preparationspreparations
Build up to reschedulingBuild up to rescheduling
Political pressurePolitical pressurePolitical pressurePolitical pressure
D-nor-pseudoephedrine not available as OTC medicine D-nor-pseudoephedrine not available as OTC medicine internationally internationally
D-nor-pseudoephedrine not available as OTC medicine D-nor-pseudoephedrine not available as OTC medicine internationally internationally
Theft from raw material brokers and manufacturersTheft from raw material brokers and manufacturersTheft from raw material brokers and manufacturersTheft from raw material brokers and manufacturers
Illicit drug manufacturers posing as NGOs from Illicit drug manufacturers posing as NGOs from neighbouring countriesneighbouring countries
Illicit drug manufacturers posing as NGOs from Illicit drug manufacturers posing as NGOs from neighbouring countriesneighbouring countries
ProcessProcess
Capitalise on the growth in level of education
Communication to Industry asking for comment on Communication to Industry asking for comment on proposalproposal
Communication to Industry asking for comment on Communication to Industry asking for comment on proposalproposal
Ephedrine and pseudoephedrine - limited maximum Ephedrine and pseudoephedrine - limited maximum pack size 720 mgpack size 720 mg
Ephedrine and pseudoephedrine - limited maximum Ephedrine and pseudoephedrine - limited maximum pack size 720 mgpack size 720 mg
Limited dose size - 30 mg and 60 mg per dose Limited dose size - 30 mg and 60 mg per dose respectivelyrespectively
Limited dose size - 30 mg and 60 mg per dose Limited dose size - 30 mg and 60 mg per dose respectivelyrespectively
Not more than 240 mg per day and one pack per Not more than 240 mg per day and one pack per customercustomer
Not more than 240 mg per day and one pack per Not more than 240 mg per day and one pack per customercustomer
RulingRuling
Schedule 6:Schedule 6:
• Regardless of packRegardless of pack size or dosesize or dose
Schedule 6:Schedule 6:
• Regardless of packRegardless of pack size or dosesize or dose
Schedule 6:Schedule 6:
• Single ingredientSingle ingredient preparationspreparations regardless of regardless of pack size or dosepack size or dose
• Preparations notPreparations not complying withcomplying with ruling in Schedulesruling in Schedules
Schedule 6:Schedule 6:
• Single ingredientSingle ingredient preparationspreparations regardless of regardless of pack size or dosepack size or dose
• Preparations notPreparations not complying withcomplying with ruling in Schedulesruling in Schedules
D-nor-pseudoephedrine Pseudoephedrine & Ephedrine
RulingRuling
Schedule 2 : Schedule 2 :
• NMT 30 mg per doseNMT 30 mg per dose
• Max pack size 720 Max pack size 720 mgmg
• One pack per customerOne pack per customer
Schedule 2 : Schedule 2 :
• NMT 30 mg per doseNMT 30 mg per dose
• Max pack size 720 Max pack size 720 mgmg
• One pack per customerOne pack per customer
Schedule 2:Schedule 2:
• NMT 60 mg per doseNMT 60 mg per dose
• Not more than 240 mgNot more than 240 mg per dayper day
• Max pack size 720 mgMax pack size 720 mg
• One pack per customerOne pack per customer
Schedule 2:Schedule 2:
• NMT 60 mg per doseNMT 60 mg per dose
• Not more than 240 mgNot more than 240 mg per dayper day
• Max pack size 720 mgMax pack size 720 mg
• One pack per customerOne pack per customer
Ephedrine Pseudoephedrine
Objectives Objectives
Capitalise on the growth in level of education
Meet obligations in terms of Meet obligations in terms of INCBINCB recommendations recommendationsMeet obligations in terms of Meet obligations in terms of INCBINCB recommendations recommendations
In line with best In line with best International PracticesInternational Practices as it relates as it relates to the use of these compounds to the use of these compounds
In line with best In line with best International PracticesInternational Practices as it relates as it relates to the use of these compounds to the use of these compounds
PProtect rotect PPublic ublic HHealthealth PProtect rotect PPublic ublic HHealthealth
Ensure continued availability of safe and effective Ensure continued availability of safe and effective medicines for patientsmedicines for patients
Ensure continued availability of safe and effective Ensure continued availability of safe and effective medicines for patientsmedicines for patients
Regulatory Impact Regulatory Impact Cost ComplianceCost Compliance
Initially Initially nono phase out phase out periodperiodInitially Initially nono phase out phase out periodperiod
Six month phase out period for packaging but S6 Six month phase out period for packaging but S6 status at point of salestatus at point of sale
Six month phase out period for packaging but S6 Six month phase out period for packaging but S6 status at point of salestatus at point of sale
Pharmacists Pharmacists not not prepared to purchase or sellprepared to purchase or sell Pharmacists Pharmacists not not prepared to purchase or sellprepared to purchase or sell
Companies holding large inventories of finished goods Companies holding large inventories of finished goods and raw material and raw material
Companies holding large inventories of finished goods Companies holding large inventories of finished goods and raw material and raw material
Regulatory Impact Regulatory Impact Cost ComplianceCost Compliance
Industry supportive of measures to curb illegal use Industry supportive of measures to curb illegal use and abuse and abuse
Industry supportive of measures to curb illegal use Industry supportive of measures to curb illegal use and abuse and abuse
Highly concerned that not provision made phase out Highly concerned that not provision made phase out of existing inventory particularly single ingredient of existing inventory particularly single ingredient pseudoephedrine preparationspseudoephedrine preparations
Highly concerned that not provision made phase out Highly concerned that not provision made phase out of existing inventory particularly single ingredient of existing inventory particularly single ingredient pseudoephedrine preparationspseudoephedrine preparations
Creates demand generation shift from community Creates demand generation shift from community pharmacist to prescribing doctorpharmacist to prescribing doctor
Creates demand generation shift from community Creates demand generation shift from community pharmacist to prescribing doctorpharmacist to prescribing doctor
Could take as long as 1 year to effectCould take as long as 1 year to effect Could take as long as 1 year to effectCould take as long as 1 year to effect
Regulatory Impact Regulatory Impact Cost ComplianceCost Compliance
Industry of view that supply chain can be phased out Industry of view that supply chain can be phased out without exacerbating illicit trade potential without exacerbating illicit trade potential
Industry of view that supply chain can be phased out Industry of view that supply chain can be phased out without exacerbating illicit trade potential without exacerbating illicit trade potential
Presents rare opportunity to highlight to Health Presents rare opportunity to highlight to Health Professionals the need for enhanced control of these Professionals the need for enhanced control of these and other and other substances with abuse potentialand other and other substances with abuse potential
Presents rare opportunity to highlight to Health Presents rare opportunity to highlight to Health Professionals the need for enhanced control of these Professionals the need for enhanced control of these and other and other substances with abuse potentialand other and other substances with abuse potential
Creates demand generation shift from community Creates demand generation shift from community pharmacist to prescribing doctorpharmacist to prescribing doctor
Creates demand generation shift from community Creates demand generation shift from community pharmacist to prescribing doctorpharmacist to prescribing doctor
Could take as long as 1 year to effectCould take as long as 1 year to effect Could take as long as 1 year to effectCould 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