1. „Controlled substances” Narcotics (substances and preparations) Psychotropic substances Precursor substances

2. Narcotic issues UN Single convention on narcotic drugs 1961 2

3. UN Single convention Issued in 1961 in New York and as amended Signatories (“Parties”) >100 countries only the medicinal affairs are outlined here 3

4. 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 4

5. 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 5

6. 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 6

7. 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 7

8. 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! 8

9. 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) 9

10. 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 10

11. 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 11

12. Political will The Parties implement and enforce the measures in their legislation, co- operate with each other 12

13. Parties inform UN Secretary-General on their annual reports texts of laws concerning narcotic drugs any other requested issues (illicit traffic, etc.) 13

14. 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.

15. Estimates Sent 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 15

16. Estimates (continued) specific stocks (catastrophe, etc.) the area (hectares, acres, km 2 ) and location for cultivation of opium poppy expected quantities of opium to be produced number of factories manufacturing synthetic narcotics, quantities by each 16

17. 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 17

18. Statistics from 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

19. 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 disposal Annually (except import/export: quarterly) 19

20. 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 20

21. 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…) 21

22. Limitation of production of opium National Opium Agency (not detailed, no significance from medicinal point of view) only see the next 2 slides 22

23. 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!) 23

24. 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. 24

25. 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 25

26. Trade and distribution, 1 In possession of special licence Persons and enterprises under control Premises also licensed (not for preparations!) 26

27. Trade and distribution, 2 Should prevent accumulation at traders and distributors Require medical prescription Special prescription (Form) 27

28. 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 28

29. 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. 29

30. 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) 30

31. 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) 31

32. 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 32

33. 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 33

34. Inspections All persons licensed or governmental inspectors must have adequate knowledge at every concerned establishments, records on quantities kept at least for 2 years 34

35. Action against illicit traffic, Penal provisions, Seizure and confiscation (not detailed - no pharmaceutical significance) 35

36. Measures against abuse of narcotic drugs early identification treatment education rehabilitation social integration... 36

37. 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 37

38. The languages Chinese, English, French, Russian and Spanish texts are equally authentic (UN official languages!) 38

39. Transitional reservations A 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 purposes to the extent they were traditional in the country 39

40. Schedules In case of substances, their any isomers, esters, ethers or salts including the salts of any esters, ethers and isomers! 40

41. Schedule I (examples) Controlled substances...cannabis, coca leaf, cocaine, ecgonine, fentanyl, heroin, morphine, opium, pethidine, thebaine... 41

42. Schedule II (examples) (Less controlled substances)...codeine, ethylmorphine, dihydrocodeine... 42

43. 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 43

44. 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 44

45. Schedule III (example) Pulvis ipecacuanhae et opii compositus 10% opium powder 10% ipecacuanha root powder well mixed with other inactive ingredient (Why?) 45

46. Schedule IV (example) (Substances from Schedule I that have no medical use)...cannabis, heroin... 46

47. 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?) 47

48. Regulation of psychotropic substances 48

49. UN Convention on psychotropic substances (Vienna, 21 February 1971, as modified) Many similarities with the Single Convention on narcotic drugs! 49

50. 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) 50

51. 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 51

52. 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) 52

53. 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 53

54. 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 54

55. 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 55

56. 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) 56

57. 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: 57

58. 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 58

59. 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 59

60. 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! 60

61. Schedule I (examples) (Only for scientific purposes!)...mescalin, psyilocibin, certain THC isomers... 61

62. Schedule II (examples) (Psychotropic substances under full control) …amfetamin („speed”), methaqualone, methylphenidate ( Ritalin ), ketamin… 62

63. Schedule III (examples) (Less controlled psychotropic substances) …amobarbital, buprenorfin, gluthetimid… 63

64. Schedule IV (examples) (Psychotropic substences under the weakest control) …alprazolam, barbital, diazepam, phenobarbital, mazindol, triazolam… 64

65. 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?) 65

66. 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. 66

67. „Precursor substances” (those that can be used in the production of narcotic drugs or psychotropic substances) 67

68. Basis: UN Convention on combating illicit transport of narcotic drugs and psychotropic substances on 20 December, 1998 in Vienna 68

69. 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 69

70. 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) 70

71. New/stricter measures Criminal actions (including those by gangs) and penalties Confiscation Extradition of criminals Mutual legal assistance Close international cooperation 71

72. 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 72

73. 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 73

74. 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 74

75. Schedule I (examples) (typical starting materials) …ephedrin, pseudoephedrin, ergometrin, ergotamin, safrol, isosafrol, lizergic acid... 75

76. Schedule II (examples) (often used chemicals) …aceton, acetic anhydrid, diethyl ether, potassium permanganate, sulfuric acid, piperidine, hydrochloric acid, toluene... 76

77. This is the principle It is almost sure that a local law gives more concrete measures. Identify it! 77

78. The rather because it may have consequences to the activities of pharmacies! 78

79. „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 79

80. Documentation General requirements covering all activities (import, export, production, selling, storage, even agents) Differences for Schedules/substances? Quantity limitations (e.g. used annually)? 80

81. 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? 81

82. (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 82

83. Production, storage Pre-authrisation? Notification? Differences according to Schedules/substances/quantities? 83

84. (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 84

85. 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.) 85

86. Controlling authorities? Ministry, Police, Customs authority. Public Health Service... Who inspects precursor storage and handling in pharmacies? 86

87. Waste Is it controlled? If so, which documentation, reporting, time- schedules? Whom to report, notify? 87

88. 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! 88

89. (KMNO 4 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! 89

90. Exam topic

91. 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

92. 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

93. 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