„Controlled substances”

• Narcotics (substances and preparations)

• Psychotropic substances

• Precursor substances

Narcotic issues

UN Single convention on narcotic drugs 1961

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UN Single convention

• Issued in 1961 in New York and as amended

• Signatories (“Parties”) >100 countries

• only the medicinal affairs are outlined here

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Preamble

• medical use of narcotics indispensable

• narcotic drugs can be serious evil

• effective measures against their abuse = international co-operation needed under the aegis of United Nations

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Definitions

• [narcotic] drug = substance in the Schedules of the Convention (legal definition!), organic or synthetic

• licit traffic = for medicinal/scientific purposes

• illicit traffic: for any other purposes• UN Economical and Social Council

(ECOSOC) for general supervision

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Schedules (lists)• Schedule I substances = full control (as

specified in the text)• Schedule II substances = some exemptions• Schedule III preparations = the same plus

more exemptions• not Schedule III preparations = other

exemptions • Schedule IV substances = as Schedule I plus

special measures and complete prohibition

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Other substances

• If not scheduled but may be illicit use: the same measures apply

• But not applicable for industrials which can not be used as narcotics or denatured

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As we have seen:

• the “narcotic drugs” are not defined by their biological action. Narcotic is what is scheduled!

• Why? There is no strict borderline, sometimes it is difficult to decide!

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The WHO is...

• ...to advise whether a new substance is liable to abuse UN Commission on Narcotic Drugs scheduling

• UN Economic and Social Council - Commission (amending the Schedules) - International Narcotic Control Board (INCB)

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INCB, 1

• Executive Body• setting limits for Parties (signatoree

states: export/import, production, etc. of narcotic drugs)

• collecting and evaluating country estimates and statistics, etc.

• May alter the Governments’ estimates

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INCB, 2

• It may require Governments to explain if the Convention is violated. Calls to adopt measures.

• If problem, refers it to the ECOSOC, recommend other Parties to stop export/import from this country, publish its report openly

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Political will

• The Parties implement and enforce the measures in their legislation, co-operate with each other

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Parties

inform UN Secretary-General on

• their annual reports

• texts of laws concerning narcotic drugs

• any other requested issues (illicit traffic, etc.)

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The parties send annually

to the INCB

• statistics of the preceding year

• estimates for the next year

on their factual/expected narcotic consumptions, stocks, imports, exports, etc.

EstimatesSent by the Parties to INCB annually. (Not

needed for Schedule III and not-III preparations!) Estimations for the next year on

• quantities needed for medicinal purposes

• the same for manufacture of other drugs

• stocks expected to remain on 31 December

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Estimates (continued)

• specific stocks (catastrophe, etc.) • the area (hectares, acres, km2) and

location for cultivation of opium poppy• expected quantities of opium to be

produced• number of factories manufacturing

synthetic narcotics, quantities by each

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Estimates (continued)

• Estimates can be modified during the year explaining the reason (e.g. seizing narcotic drugs and directing it to licit use)

• Estimates published by INCB annually

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Statisticsfrom the Parties to INCB. )Not needed

for Schedule III and not-III preparations, only for their substances!) Statistics of the preceding year on

• quantities manufactured• the same for manufacture of other

drugs• Consumption

(continued)18

Statistics (continued)

• stock on 31 December • import and export quantities (also for

poppy straw) • the area (hectares and location) of

cultivation of opium poppy• seizures and disposalAnnually (except import/export:

quarterly)

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Limitation of manufacture and import, 1

• Quantities of manufacture + import not more than

• consumed + used for manufacture of other drugs + export + added to special stocks + estimated + seized and directed to licit use

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Limitation of manufacture and import, 2

If INCB finds it exceeds the limitation set by INCB:

• notifies the Party

• it shall be deducted next year

• notifies other concerned Parties (be careful when import or do not import…)

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Limitation of production of opium

National Opium Agency

• (not detailed, no significance from medicinal point of view)

• only see the next 2 slides

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Special provision to cultivation

• Opium poppy (Papaver somniferum L. with high alkaloid content), Coca bush, Cannabis plant

• Should be kept under control. If danger of illicit use, complete prohibition!

• Increasing opium production: only when reasoned and accepted by INCB (no overproduction!)

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In Hungary, e.g.

• cultivation of high alkaloid poppy (varietas listed in a Decree) and cannabis with >0.3% THC: only with licence

• Concession holders and its contractors only

• seeds from certified sources, unused/not contracted poppy straw wasted, etc.

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Manufacture

• In possession of special licence or by State enterprise

• Persons and enterprises under control

• Periodical permits (kind and amount) - not applicable for Not-Schedule III preparations

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Trade and distribution, 1

• In possession of special licence

• Persons and enterprises under control

• Premises also licensed (not for preparations!)

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Trade and distribution, 2

• Should prevent accumulation at traders and distributors

• Require medical prescription

Special prescription (Form)

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Trade and distribution, 3

• All written material (package, info): also INN and exact quantities should appear (not applicable to Schedule II substances and magistral preparations)

• Possible: double red band in the inner package/leaflet

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International trade

Not applicable if transit by air without landing

Export only if

• it is lawful in the importing country

• it is within the estimates (not for Schedule III preparations)

The same for freeports, etc.

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International trade, 2

• Control export/import (unless State enterprises), all persons, enterprises

• separate import/export authorisation for all consignments, accompanying the consignments, the importing Government shall return them to the exporting one

(not for Schedule III)

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International trade, 3

• No export to P.O.Box or bank account

• warehouses for export certified• even transit (passing through the

country untouched) needs authorisation

• destination controlled and kept(Not for Schedule III)

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International trade, 4

• no process to change the drug, no packing alteration what is not certified

• every user (even medical, scientific) records of use, kept for 2 years

Not for Schedule III, only info on the substance quantities used for manufacture

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Specific provisions for first-aid kits of ships/aircraft

• if limited for passenger use: not taken as narcotic drugs

• Subject of law and permit of the home country and inspection of the transit countries

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Inspections

• All persons licensed or governmental inspectors must have adequate knowledge

• at every concerned establishments, records on quantities kept at least for 2 years

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Action against illicit traffic, Penal provisions, Seizure

and confiscation

• (not detailed - no pharmaceutical significance)

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Measures against abuse of narcotic drugs

• early identification

• treatment

• education

• rehabilitation

• social integration...

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Closing remarks

• Stricter measures than required by the Single Convention possible, especially put Schedule II substances and Schedule III preparations under the same control as Schedule I, if it seems necessary for the protection of public health

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The languages

Chinese, English, French, Russian and Spanish texts are equally authentic (UN official languages!)

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Transitional reservationsA Party might reserve the right to permit

temporarily (detailed and with further limitations)

• quasi-medical use of opium• opium-smoking• coca leaf chewing• use of cannabis for non-medical purposesto the extent they were traditional in the

country

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Schedules

In case of substances, their any isomers, esters, ethers or salts including the salts of any esters, ethers and isomers!

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Schedule I (examples)

Controlled substances

...cannabis, coca leaf, cocaine, ecgonine, fentanyl, heroin, morphine, opium, pethidine, thebaine...

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Schedule II (examples)

(Less controlled substances)

...codeine, ethylmorphine, dihydrocodeine...

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Schedule III (example)

(Preparations with a limited amount of narcotic substance)

Preparation of codeine, ethylmorphine, dihydrocideine containing not more than

• 100 mg per dosage unit or

• 2.5% in undivided preparation

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Schedule III (example)

Preparation of • cocaine, not more than 0.1% (cocaine

base)• opium or morphine, not more than

0.2% (anhydrous morphine base) in such a way it can not be recovered in a yield that constitutes a risk to public health

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Schedule III (example)

Pulvis ipecacuanhae et opii compositus

• 10% opium powder

• 10% ipecacuanha root powder

• well mixed with other inactive ingredient

(Why?)

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Schedule IV (example)

(Substances from Schedule I that have no medical use)

...cannabis, heroin...

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Thus, what should be identified in your country

• Who issues narcotic licences to manufacture and distribution

• who can be the responsible person?• who inspects narcotic licence holders

(MoH? Police?)• who controls the licit traffic and transit

(Police?)• who amends the national Schedules

(MoH?)

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Regulation of psychotropic substances

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UN Convention on psychotropic substances

(Vienna, 21 February 1971, as modified)

Many similarities with the Single Convention on narcotic drugs!

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What is similar to the Single Convention? 1

• The Preamble• The same definitions (e.g. illicit traffic)• The same UN Organs (ECOSOC, INCB)• The WHO is to recommend scheduling of

new substances• It is not valid to personal use of

international passengers (except this Schedule I)

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What is similar to the Single Convention? 2

• If the substance is used for manufacture of other substance, it must be controlled until its characteristics changed to the extent the new substance is not psíchotropic or it can not be recovered

• Otherwise psychotropic substance is permitted to use for scientific or medical purposes exclusively

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What is similar to the Single Convention? 3

(Except this Schedule I for, as a rule, use of these substances are banned)

• Production, distribution: authori-sation of persons and enterprises

• Medical prescription-only• Annual statistics of INCB, decisions of

INCB• Similar reservations (e.g traditional

consumption of herbs)

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Psychotropis substance• Legal definition: scheduled in one of Schedules

I-IV of this Convention• When is it recommended by WHO:suitable for addiction and causes agitation or depression of the central

nervous system, that - gives rise to hallucination, motion or

judgement or understanding or mood disturbances, or

- its harmful effect is similar to any of already scheduled substances

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These Schedules

Depending on the control level of substances:

• General limitations for all psychotropic substances (e.g. authorisation of activities, record keeping, medical prescription-only, penalties)

• Special limitations for the given Schedule

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Special limitations to Schedule I

• Only scientific (and some restricted medical) use permitted

• Any activity only when possessing special authorisation, under strict control, export-import only when the competent authorities in both countries permitted

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General limitations 1 For preparations: • those for the psychotropic ingredient

must apply, if more the one, the strictest limitations

• If only a very small quantity or can not be recovered, may be exempted from the limitations

The substances should be authorised for certified persons, under strict control, to catch animals (via their narcosis)

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General limitations 2

• Detailed instruction for use on the label or package insert

Prescription only

Indication motion sickness

Maximum three times a day

It may not be used together with the following medicinal products:

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Records• Schedules I–III: producer, distributor: all

manufactured or bought batches, dated, according to required rules or Forms

• For Schedul II: the same also in hospitals and pharmacies

• For Schedule III: these date are to be accountable in hospitals and pharmacies

• For Schedule IV: only producers and importers and only the quantities

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International trade

• Using the INCB Form, with special authorisation, this accompanies the consignment, one copy is sent back

• Schedules I-II: further limitations, very similar to narcotics

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Statistics• To the UN Secretary General, on national

legislation and special events• Statistics annually:-Schedules I-II: produced quantities, by

countries export-import quantities, stocks-Schedules III-IV: only the total quantities of

produced and export-import -Not for preparations!

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Schedule I (examples)

(Only for scientific purposes!)

...mescalin, psyilocibin, certain THC isomers...

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Schedule II (examples)

(Psychotropic substances

under full control)

…amfetamin („speed”), methaqualone, methylphenidate (Ritalin), ketamin…

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Schedule III (examples)

(Less controlled psychotropic substances)

…amobarbital, buprenorfin, gluthetimid…

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Schedule IV (examples)

(Psychotropic substences under the weakest control)

…alprazolam, barbital, diazepam, phenobarbital, mazindol, triazolam…

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What should you identify at home:

• Is your country a signatoree?

• If so, which laws implement the Convention and regulate this field? (E.g. MoH or Ministry of Interior Decrees?)

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Hungarian example: the task of MoH

• Issue/modification of the Schedules• Regulation of the medical prescrip-tion of drugs

containing psychotropic substances • Export/import licences• Permission of use for scientific purposes• Statistical data, collection and sending to INCB• Authorisation for further manufacture and for

catching animals, etc.

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„Precursor substances”(those that can be used in the production of narcotic

drugs or psychotropic substances)

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Basis:UN Convention on

combating illicit transport of narcotic drugs and

psychotropic substances on 20 December, 1998 in

Vienna

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This Convention

• Following the former Conventions, assessing the situation again, strengthening the former ones

• New measures to introduce and new types of substances to subject to international control

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More or less, only strengthening the former Conventions

• Preamble

• Major definitions, INCB

• Illicit growing of narcotic herbs

• Trade (including free ports and zones as well as postal services)

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New/stricter measures

• Criminal actions (including those by gangs) and penalties

• Confiscation

• Extradition of criminals

• Mutual legal assistance

• Close international cooperation

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New category:

• Introducing substances that can be used in production of narcotic drugs and psychotropic substances (precursors)

• Thes in Schedules I and II

• Control measures against diverting them from licit to illicit use

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Precursor control

• persons and enterprises, control and authorisation to establish the latter

• to hinder accumulation of stocks not needed for normal activities

• documented export/import, to be sent to competent foreign authorities

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Schedules

• Scheduling of substances: similar mechanism similar to narcotics and psychotropic ones

• Schedule I: starting materials

• Schedule II: chemicals often used for manufacture of narcotic and psychotropic substances

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Schedule I (examples)

(typical starting materials)

…ephedrin, pseudoephedrin, ergometrin, ergotamin, safrol, isosafrol, lizergic acid...

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Schedule II (examples)

(often used chemicals)

…aceton, acetic anhydrid, diethyl ether, potassium permanganate, sulfuric acid, piperidine, hydrochloric acid, toluene...

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This is the principle

It is almost sure that a local law gives more concrete

measures. Identify it!

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The rather because it may have consequences to the activities of pharmacies!

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„Precursor” law

Definitions

• What are the controlled substances (probably those scheduled in the UN Convention, except mixtures they can not simply re-gained)

The competent authority that decides whether a concrete mixture is under control or not

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Documentation

• General requirements covering all activities (import, export, production, selling, storage, even agents)

• Differences for Schedules/substances?

• Quantity limitations (e.g. used annually)?

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Purchaser Declarations

• Introduced by many countries

• Needed when buying precursors (Purchaser, substance, quantity, declaration about the named licit use, declaration that such declaration will be requested when re-selling, etc.)

• Differences according to Schedules/substances/quantitites?

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(Documentation, followed)

• Often label requirements for Schedule I, sometimes also for some Schedule II

• All kind of documentation stored for a specified period of time

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Production, storage

• Pre-authrisation? Notification?

• Differences according to Schedules/substances/quantities?

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(excemption for pharmacies?)

Typical: exempted, if precursor is

• used for compounding (magistral) drugs in pharmacies

• purchased from drug wholesale licence holders in smaller annual quantities than specified in the law

ready pharmaceutical preparations (dosage-forms) are, as a rule, not precursors

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Statistical reporting mandatory for pharmacies?

• If so, for which Schedule/substances?

• Content

• Retrospectively, also prospective estimations? Frequency?

• to whom? (MoH, MoInt., Public Health Service, Police, etc.)

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Controlling authorities?

• Ministry, Police, Customs authority. Public Health Service...

• Who inspects precursor storage and handling in pharmacies?

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Waste

• Is it controlled? If so, which documentation, reporting, time-schedules?

• Whom to report, notify?

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Hungarian examples from the real life

Physicians/vet.s, with their professional ID may purchase some drugs in pharmacies

Could they buy also ephedrine substance in a community pharmacy?

No, for...

…first, ephedrine has no medicinal use as undivided powder (it would be enough, but) second, it is also Schedule I precursor!

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(KMNO4 in Hungarian community pharmacies)

Exempted from the detailed documentation requirements? (Purhase: invoices, use: compounding record, poison-like documentation, selling: invoice plus purchaser declaration if >5 kg)

• Schedule II substance• If annual stock of the pharmacy is <5 kg:

yes!

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Exam topic

Regulation of narcotic issues

• Which Convention regulates it• Its Preamble and definitions: narcotic, illicit, ECOSOC,

INCB• The Schedules with examples• The role of the WHO• The tasks of the INCB• Estimates and statistics• Limitations on manufacture and import• The Parties’ annual report• Provisions to cultivation• Responsible person• Inspections/controls• Describe the situation in your country

Regulation of psychotropic issues

• Which convention regulates it• Definition of a psychotropic substance• Similarities to the Single Convention• Psychotropic Schedules with examples• General limitations, records, international

trade• Statistics• Describe the situation in your country

Regulation of precursor substances

• Which Convention regulates it• What are the precursors• Schedules with examples• Why stricter measures are needed for

these materials• Content of the precursor control• What is Purchaser Declaration• Controlling authorities• Precursors and pharmacy administration