World Health Organization Expert Committee on Addiction-producing Drugs : Eleventh Report
Pages: 44 to 47
Creation Date: 1961/01/01
The Expert Committee on Addiction-producing Drugs of the World Health Organization held its eleventh session in Geneva from 10-15 October 1960. Extracts from the report of the Expert Committee are reproduced with minor modifications. An important part of the Expert Committee's task is to advise the World Health Organization in making findings or decisions under the international treaties on narcotic drugs envisaging extension of control to new drugs or exemption of drugs from control. Actions modifying the scope of the international control of drugs resulting from the eleventh session of the Expert Committee are not included here, but in the note at the end of this volume of theBulletin.
Work of International Bodies concerned with Narcotic Drugs
The Secretary summarized the report of the fifteenth session of the Commission on Narcotic Drugs of the Economic and Social Council, the relevant resolutions of the Economic and Social Council,2and the latest reports of the Permanent Central Opium Board and the Drug Supervisory Body.3 Among the items of interest, note was taken of the use and abuse of ( - )-l-dimethylamino-l,2-diphenylethane (SPA) in Japan, particularly its use by narcotic addicts. The compound appears to have a mixed pharmacological action, in some respects resembling both amphetamine and morphine. Tests are under way to determine the possibility of physical dependence properties in ( - )-l-dimethylamino-l,2-diphenylethane. Meanwhile the situation appears to be a local one, but it illustrates a danger inherent in the control of narcotic addicts since such individuals have a tendency to abuse any new psychically active drug when they are restricted in the availability of narcotics. The Committee drew the attention of governments to the necessity to watch very closely the development of new psychically active compounds to restrict the possibility of abuse such as is illustrated by ( - )-l-dimethylamino-l,2-diphenylethane.
In this connexion, the Committee's attention was drawn to reports on cases of abuse of amphetamines and amphetamine-like substances contained in many weight-reducing medicines. The Committee emphasized the need for appropriate control measures (similar to those recommended previously by international bodies for amphetamines 45and1
W.H.O., techn. Rep. Ser. (1961) No. 211.2
See Bulletin on Narcotics, vol. XII, No. 4.3
See pp. 39-43, above.4
Wld Hlth Org. techn. Rep. Ser., 1954, 76, 11 (section 8); 1956, 102, 12 (section 7).5
United Nations, Commission on Narcotics Drugs (1956) Reports of the eleventh session (23 April-18 May 1956) - Official Records of the Economic and Social Council, Twenty-second session. Supplement No. 8), Geneva (document E/2891) p. 37.
In connexion with the dangers which may arise from the free distribution of medical samples, the Committee continued to be concerned by the inadequacy in many instances of information and warning on the possibilities of addiction liability of new drugs, particularly where analgesic and antitussive properties are claimed. The Committee emphasized the need for improvement in this situation.
In some areas evidence on addiction liability is regarded as part of the evidence for the safe use of new drugs intended for pain relief. Extension of this principle to consideration of abuse liability in connexion with the introduction of psychically active drugs would seem also to be desirable.
Considering the possibility of preparing a code of practices by which at present addiction-producing properties of drugs are established as contained in the invitation to the World Health Organization by the Economic and Social Council,8 the Committee emphasized its objective when it deals with a notification with respect to a new drug. The international narcotics conventions specify certain characteristics to be ascertained for purposes of control, the over-all purposes of which are the furtherance of public safety and prevention of abuse of drugs so far as addiction liability pertains thereto.
Whereas not so long ago prolonged clinical experience was the only source of information on addiction liability and the risk therein to public health, there are now available6
Wld Hlth Org. techn. Rep. Ser., 1957, 116, 10 (section 9).7
United Nations, Commission on Narcotic Drugs (1957) Report of the twelfth session (29 April-31 May 1957) - Official Records of the Economic and Social Council, Twenty-fourth session, Supplement No. 10, Geneva (Document E/3010/Rev.1), p. 39.8
United Nations, Official Records of the Economic and Social Council, Thirtieth session, Supplement No. 1; Resolutions, Geneva, p. 9, resolution 770 (XXX) D (document E/3499).
tests in animals and in man 9 which give information on these points. Each of these tests, however, has limitations which affect its interpretation and applicability.
The extent of testing required will vary with the substance in question. Addictive qualities of a drug meeting the specifications of the international conventions may become apparent at a very early stage. On the other hand negative results are least convincing. The degree of testing in a specific case is that which establishes beyond reasonable doubt that a substance does or does not exhibit addiction liability or risk of abuse which would warrant control as provided for in the international conventions. For these reasons a more precise code of practice cannot be outlined at present.
The Committee drew attention to the suggestions in its tenth report 10 for extension of research in the field of drug addiction. These included development and calibration of methods for assessing addiction liability. In addition it would be desirable to prepare a review of the methods designed to evaluate addiction and abuse liability, which should include a discussion of their applicability and limitations.
Antibiotic Substances from Cannabis
The Committee considered the information available regarding substances with antibacterial activity which can be extracted from cannabis sativa. The Committee concluded that at present the case has not been proved in favour of making cannabis available for the extraction of useful drugs, particularly of the antibiotic type.
As regards the question of the therapeutic usefulness of cannabis the opinion expressed in the third report of the WHO Expert Committee on Addiction-producing Drugs 11 remains unchanged. Cannabis and its preparations are practically obsolete and there is no justification for their medical use.
This conclusion does not affect the Committee's opinion as expressed in its 10th report.12 The prohibition or restriction of the medical use of a drug representing a particularly high danger to the community should continue to be recommended by the international organs concerned, but should not be mandatory.9
Such as: suppression of abstinence in morphine-addicted monkeys or dogs; direct addiction experiments in various animal species; evaluation of opiate-like properties in man; suppression of abstinence phenomena in addicted individuals; substitution for the drug of addiction in addicts; direct addiction observations in man; precipitation of abstinence phenomena by a morphine antagonist in an addicted individual (animal or man).10
Wld. Hlth. Org. techn. Rep. Ser., 1960, 188, 10 (section 4).11
Wld. Hlth. Org. techn. Rep. Ser., 1952, 57, 11 (section 7).12
Wld. Hlth. Org. techn. Rep. Ser., 1960, 18814 (section 6.4).
Medical Control of Addicts
The Committee considered in some detail attitudes towards drug addicts and their treatment. Its attention was drawn to a proposal for civil commitment of an addict (like that appropriate to mental patients generally) to the authority of a medical panel which would provide supervision and direction for his treatment from the time of the initial diagnosis to his rehabilitation.
The Committee approved the principle of civil commitment considering that its general application would be a distinct forward step in the handling of the problem. The Committee added that civil commitment is intended for adequate and complete treatment. It does not replace penalties for law violations nor excuse such violations.
The Committee pointed out that such a procedure would be in line with and be greatly facilitated by the lines of research suggested in its tenth report. The civil commitment procedure would also involve information on and development of diagnostic procedures including, inter alia, identification of addicting drugs in body fluids.
Proposed Single Convention on Narcotic Drugs
Bearing in mind the provisions now outlined in the third draft of the Single Convention 13 applicable to preparations to be included in schedule III annexed to that draft, the Committee considered that the criteria for inclusion of preparations of schedule II drugs should be as follows: ( a) a specified quantity or concentration of the drug; ( b) the presence therewith of at least one other therapeutically active ingredient which does not fall under the provisions of international control.
For the substances at present listed in schedule II (i.e., acetyldihydrocodeine, codeine, dihydrocodeine, ethylmorphine, pholcodine) the quantity should not be more than 0.1 g per unit in dry preparations (pills, tablets, etc.) and the concentration should not be more than 2.5% or 0.1 g per dose in liquid preparations.
Further, the Committee believed that with regard to preparations of substances which may be added to schedule II or of any substance for which exemption is contemplated the procedure outlined in the operative part of resolution 4(XV) of the Commission on Narcotic Drugs 14 is practicable.13
United Nations, Commission on Narcotic Drugs. The Single Convention on Narcotic Drugs (third draft) (mimeographed document E/CN. 7/AC.3/9).14
United Nations Commission on Narcotics Drugs (1960) Report of the fifteenth session (25 April-13 May 1960). Official Records of the Economic and Social Council, Thirtieth session, Supplement No. 9, Geneva, p. 23 (document E/3385).
CHANGES IN THE SCOPE OF CONTROL
The international treaties on narcotic drugs make provision for changes in the scope of control by means of a procedure which involves governments, the Secretary-General of the United Nations and the World Health Organization, in particular its Expert Committee on Addiction-producing Drugs. The procedure may be applied not only in respect of the extension of control to new drugs, but also in respect of exemption from control of drugs or their preparations.
The international procedure for extending control to new drugs is put into motion upon an application being made by a government to the Secretary-General of the United Nations, who transmits it immediately to all states parties to the relevant convention and the international bodies concerned, including the World Health Organization. The latter subsequently decides whether the substance considered is susceptible of producing addiction. If so, it is placed under one of the two existing control r?gimes provided in the conventions. Any positive decision is ultimately communicated by the Secretary-General of the United Nations to all governments, whereupon the drug in question enters the control system.
In the case of the exemption from control of drugs or their preparations, the procedure is similar except that as regards exemption of preparations, the World Health Organization can act on its own initiative.
During 1960, several requests were received from governments regarding extension of control to new drugs or for exemption from control of drugs or their preparations. The World Health Organization decided that:
The drugs hydromorphinol; diampromide; phenampromide; clonitazene; etonitazene; diphenoxylate; phenoperidine; and their respective salts should be placed under the more severe of the two principal r?gimes of control applying to narcotic drugs, viz., under that which is applicable to morphine or morphine-like drugs, in view of their dangerous addiction-forming properties. It may be noted that the drug diphenoxylate and its salts had previously been placed provisionally under the same control r?gime by the Commission on Narcotic Drugs at its fifteenth session, 25 April to 13 May 1960.
The drug (+)-3-hydroxy-N-phenethylmorphinan should remain under the r?gime of control applicable to morphine or morphine-like drugs.
There is no obligation to place the following drugs under the system of control envisaged in the international treaties on narcotic drugs as they are not capable of producing addiction nor of conversion into a product capable of producing addiction: ethoheptazine; 1-cyclohexyl-2,2-didiethylamino-methyl-l-phenylethane; 7-(p-methoxybenzoyl)-2-morpholinomethyl-l,4-benzodioxane; and 7-benzoyl-2-piperidinomethyl-l,4-benzodioxane.
Two preparations containing the drug diphenoxylate should be exempted from control as they cannot give rise to addiction, in particular on account of the medicarnents with which diphenoxylate is compounded and which in practice preclude the recovery of the narcotic drug involved.
Vol. XII, No. 1
Page 36, 2....
V. S. SOKOLOV & P. L. SENOV, A course in pharmaceutical chemistry should read:
P. E. SENOV, A course in pharmaceutical chemistry, Medgiz (1952).
V. S. SOKOLOV, Alkaloid-producing plants of the USSR (1952).
Vol. XII, No. 3
Page 12, left-hand column, fourth paragraph. The formula is as follows:
Vol. XII, No. 4
Page 19, left-hand column, fourth paragraph, should read:
"The corrected values for morphine and codeine bases are 68.8% and 9.4% respectively as found in the '999' bars. Subsequently, in September 1960, fifty-seven such bars were confiscated from an individual passing through customs at Seoul, Korea. Three of the bars were submitted to this laboratory for examination and the average values obtained by the same method showed that they contained 67.1% morphine and 10.4% codeine bases. Inasmuch as these bar samples contained a proportionally greater amount of morphine than codeine, a separate chromatogram was prepared for each component."