SCHEDULING OF MEDICINES SAPRAA 13 June 2008. Scheduling of Medicines Ephedrine Pseudoephedrine D-nor-pseudoephedrine

SCHEDULING OF MEDICINES

SAPRAA13 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 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


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


• Regardless of packRegardless of pack size or dosesize or dose


• 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


• 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 :


• Max pack size 720 Max pack size 720 mgmg




• Not more than 240 mgNot more than 240 mg per dayper day

• Max pack size 720 mgMax pack size 720 mg




• Not more than 240 mgNot more than 240 mg per dayper day

• Max pack size 720 mgMax pack size 720 mg


Ephedrine Pseudoephedrine

Objectives Objectives


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


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


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


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



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


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


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!

Documents

SCHEDULING OF MEDICINES SAPRAA 13 June 2008. Scheduling of Medicines Ephedrine Pseudoephedrine D-nor-pseudoephedrine