Preparations Listed in Schedule III of the 1961 Single Convention On

Home , Acetyldihydrocodeine, Ethylmorphine, Nicodicodine

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Preparations listed in Schedule III of the 1961 Single Convention on Narcotic Drugs Definition: This questionnaire is about the preparations listed in schedule III of the 1961 single convention on narcotic drugs:

 Acetyldihydrocodeine  Codeine  Dihydrocodeine  Ethylmorphine  Nicocodine  Nicodicodine  Norcodeine  Pholcodine

By definition, preparations are mixtures, either in solid or liquid form, that contain the drug. These may, for example, be in the form of tablets or capsules containing various excipients in addition to the active drug. Hereinafter, the preparations listed in Schedule III of the 1961 Single Convention on Narcotic Drugs are referred to as ‘preparations listed in Schedule III’.

The questionnaire will take about 15-25 minutes to complete. You may return to the questionnaire to amend your responses at any time until the closure of the questionnaire.

To commence the questionnaire, you will first be asked to indicate that you agree to the WHO data sharing policy.

The responses to this questionnaire will be compiled into a report that will be made publicly available on the WHO ECDD website. The name of your country may be attributed to the information provided unless you indicate that you wish for your country name to be anonymized in the final report.

If you wish to submit any additional information to the attention of the ECDD Secretariat to be considered for inclusion in the final questionnaire report, you will have an opportunity to upload documents at the end of the questionnaire.

Any sensitive, confidential or unpublished documents should be emailed to [email protected]

We thank you in advance for taking the time to complete this questionnaire.

WHO Questionnaire 42nd Expert Committee on Drug Dependence

General data

1. Your country name [this item requires a response] …………………………………….

2. Focal point name [this item requires a response] …………………………………….

3. Please confirm that you agree for the information provided in this questionnaire to be published. [this item requires a response]

 I agree for the information provided in this questionnaire to be published  I agree for the information provided in this questionnaire to be published, but my country name is to be anonymised in the final report  I do not agree for the information provided in this questionnaire to be published (end this survey)

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Statement of policy on data sharing

Data are the basis for all sound public health actions and the benefits of data sharing are widely recognized, including scientific and public health benefits. Whenever possible, WHO wishes to promote the sharing of health data, including but not restricted to surveillance and epidemiological data.

In this connection, and without prejudice to information sharing and publication pursuant to legally binding instruments, by providing data to WHO, the focal point of ______[Country]:

Confirms that all data to be supplied to WHO (including but not limited to the types listed in Annex 3 1) hereunder have been collected in accordance with applicable national laws, including data protection laws aimed at protecting the confidentiality of identifiable persons;

Agrees that WHO shall be entitled, subject always to measures to ensure the ethical and secure use of the data, and subject always to an appropriate acknowledgement of ______[Country]:

 to publish the data, stripped of any personal identifiers (such data without personal identifiers being hereinafter referred to as "the Data") and make the Data available to any interested party on request (to the extent they have not, or not yet, been published by WHO) on terms that allow noncommercial, not-for-profit use of the Data for public health purposes (provided always that publication of the Data shall remain under the control of WHO);  to use, compile, aggregate, evaluate and analyse the Data and publish and disseminate the results thereof in conjunction with WHO's work and in accordance with the Organization's policies and practices.

Except where data sharing and publication is required under legally binding instruments (IHR, WHO Nomenclature Regulations 1967, etc.), the focal point of [Country] may in respect of certain data opt out of (any part of) the above, by notifying WHO thereof in writing at the following email address, provided that any such notification shall clearly identify the data in question and clearly indicate the scope of the opt-out (in reference to the above), and provided that specific reasons shall be given for the opt out. [email protected]

4. Do you agree to the ‘statement of policy on data sharing’ as outlined above? [this item requires a response]

 Yes  No (end this survey)

1 Policy on use and sharing of data collected in Member States by the World Health Organization (WHO) outside the context of public health emergencies (Provisional). Geneva: World Health Organization; 2017 (https://www.who.int/publishing/datapolicy/Policy_data_sharing_non_emergency_final.pdf), accessed 14 August 2019

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 0. INFORMATION ON SUBSTANCES

5. Do you have any information on the use of any of the 8 listed preparations listed in schedule III in your country either for medical, scientific, industrial or other professional purposes, or for non-medical consumption or recreational purposes, or any other purpose? [this item requires a response]

o Acetyldihydrocodeine o Codeine o Dihydrocodeine o Ethylmorphine o Nicocodine o Nicodicodine o Norcodeine o Pholcodine

 Yes  No

6. For which substance do you have information? [this item requires a response]  Acetyldihydrocodeine  Codeine  Dihydrocodeine  Ethylmorphine  Nicocodine  Nicodicodine  Norcodeine  Pholcodine  No information on any of the specific preparations listed in Schedule III available

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 1. APPROVED MEDICAL OR SCIENTIFIC USE

7. Do you know if approved medical products containing any of the 8 preparations listed in schedule III are available in your country for human or veterinary indications? (Please select all that apply)

 Human medical product  Veterinary medical product  Not available in medical products  Do not know

8. What are the therapeutic indications approved for any of the 8 preparations listed in schedule III in your country?

………………………......

9. Please indicate the marketed name, dosage form(s) and strength(s) of the 8 preparations listed in schedule III available in your country; also indicate the exact substance name and any special properties such as slow release, etc.

Drug 1 Drug 2 Drug 3 Drug 4 Drug 5 Drug 6 Drug 7 Drug 8 Drug 9 Drug 10

10. Are any of the eight listed preparations listed in schedule III currently used in medical or scientific research (excluding use as an analytical reference standard) in your country (e.g. is it in clinical trials for any human or veterinary indication)?

 Yes  No  Do not know

WHO Questionnaire 42nd Expert Committee on Drug Dependence

11. Please specify the preparations listed in schedule III and its use(s):

Acetyldihydrocodeine

Codeine

Dihydrocodeine

Ethylmorphine

Nicocodine

Nicodicodine

Norcodeine

Pholcodine

12. What types of professionals are allowed to prescribe any of the 8 listed preparations listed in schedule III?

 Medical doctor/psychiatrist  Osteopath  Nurse/nurse prescriber  Pharmacist  Psychologist  Physiotherapist  Healthcare worker  No prescription is required  Other (please specify)

13. Are any clinical guidelines used in your country for the prescription of any of the 8 preparations listed in schedule III?

 Yes  No  Do not know

14. Please specify

…………………………………………………………………………………………..

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 2. NON-APPROVED MEDICAL AND NON-MEDICAL OR NON-SCIENTIFIC USE

15. Are any of the 8 preparations listed in schedule III used for industrial or other non- medical/non-scientific purposes in your country?

 Yes  No  Do not know

16. Please specify: ……………………………………..

17. What is the origin/source of the 8 preparations listed in schedule III when used for legitimate non-medical/non-scientific use?

 Manufactured in your own country  Imported  Both manufactured in your own country and imported  Do not know

WHO Questionnaire 42nd Expert Committee on Drug Dependence

18. What is the estimated amount of the 8 preparations listed in schedule III used annually in your country for any legitimate non-medical/non-scientific use? Please specify by substance where information is available, referring to the specific amounts (kg/litre) and the reference year. Also, please give the sources.

Acetyldihydrocodeine: amounts and reference year

Acetyldihydrocodeine: information available from

Codeine: amounts and reference year

Codeine: information available from

Dihydrocodeine: amounts and reference year

Dihydrocodeine: information available from

Ethylmorphine: amounts and reference year

Ethylmorphine: information available from

Nicocodine: amounts and reference year

Nicocodine: information available from

Nicodicodine: amounts and reference year

Nicodicodine: information available from

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Norcodeine: amounts and reference year

Norcodeine: information available from

Pholcodine: amounts and reference year

Pholcodine: information available from

19. Please provide any additional information related to any of the questions in Section 2.

…………….…………….…………….…………….…………….…………….…………….…………….…………….……………..

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 3. CULTURAL, RELIGIOUS OR CEREMONIAL USE

20. Are any of the 8 preparations listed in schedule III used for cultural, religious or ceremonial purposes in your country?

 Yes  No  Do not know

21. Please specify by whom, for what purposes, route of administration and typical amounts used Please specify by substance where information is known):

Acetyldihydrocodeine: population and purpose

Acetyldihydrocodeine: route of administration

Acetyldihydrocodeine: typical amount used

Codeine: population and purpose

Codeine: route of administration

Codeine: typical amount used

Dihydrocodeine: population and purpose

Dihydrocodeine: route of administration

Dihydrocodeine: typical amount used

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Ethylmorphine: population and purpose

Ethylmorphine: route of administration

Ethylmorphine: typical amount used

Nicocodine: population and purpose

Nicocodine: route of administration

Nicocodine: typical amount used

Nicodicodine: population and purpose

Nicodicodine: route of administration

Nicodicodine: typical amount used

Norcodeine: population and purpose

Norcodeine: route of administration

Norcodeine: typical amount used

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Pholcodine: population and purpose

Pholcodine: route of administration

Pholcodine: typical amount used

22. Please provide any additional comments related to any of the questions in Section 3.

…………….…………….…………….…………….…………….…………….…………….…………….…………….……………..

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 4. EPIDEMIOLOGY OF NON-MEDICAL/NON-SCIENTIFIC USE – PSYCHOACTIVE PURPOSES/RECREATIONAL USE

23. Are any of the 8 preparations listed in schedule III misused for their psychoactive properties (as a recreational drug) in your country? [this item requires a response]

 Yes  No  Do not know

24. By what route(s) of administration are any of the 8 preparations listed in schedule III used for non-medical/non-scientific purposes in your country? (Please select all that apply)

 Oral  Injection  Inhalation  Sniffing  Smoking  Do not know  Other (please specify) ………………………...

WHO Questionnaire 42nd Expert Committee on Drug Dependence

25. What is the most common route of administration for the 8 preparations listed in schedule III (please specify by specific substance)?

Acetyldihydrocodeine

Codeine

Dihydrocodeine

Ethylmorphine

Nicocodine

Nicodicodine

Norcodeine

Pholcodine

26. In which formulations are the 8 preparations listed in schedule III used for non-medical/non- scientific purposes in your country? (Please select all that apply)

 Powder  Tablets  Liquid or solution for oral administration/use  Solution for injection  Other (please specify): ………………………………………………………………………………….

27. Please indicate if any formulation is different from the usual pharmaceutical application in your country:

…………………………………………………………………………………………………………………………………

WHO Questionnaire 42nd Expert Committee on Drug Dependence

28. What is (are) the source(s) of the 8 preparations listed in schedule III for non-medical/non- scientific use in your country? (Please select all that apply)

 Legal manufacturing  Legal trade  Illegal manufacturing  Diversion (from legal supply chain)  Smuggling (from other countries)  Do not know  Other (please specify): ………………………………………………………………………………………………

29. Are there any specific subpopulations in your country known to misuse any of the 8 preparations listed in schedule III?

 Yes  No

30. Please specify which groups: ……………………………………………………………………………………………………………………………………….

31. Please provide any information on the extent and magnitude of public health problems or social harm caused by the use of any of the 8 preparations listed in schedule III in your country:

……………………………………………………………………………………………………………………………………………

32. As an expert, what negative health impact do you believe the non-medical consumption of the 8 preparations listed in schedule III has in your country?

 Negligible  Substantial  Serious  Do not know

33. Please specify details including the name of the specific preparations listed in schedule III: ………………………………………………………………………………

WHO Questionnaire 42nd Expert Committee on Drug Dependence

34. Are you aware of any emergency room/department visits related to the use of any of the 8 preparations listed in schedule III in your country?

 Yes  No

35. Please specify details including the name of the specific preparations listed in schedule III: ………………………………………………………………………………

36. Please list the adverse effects (non-fatal intoxications, etc.) patients have presented with at emergency rooms/departments in your country after use of any of the 8 preparations listed in schedule III:

…………………………………………………….…………………………..…………………………..…………………………..

37. If available, please provide the number of deaths where any of the 8 preparations listed in schedule III was involved (provide data for the most recent completed year available):

Please write in the answers using numerals

Please write in the year in the Common Era, e.g. 2018 CE rather than 1440 AH.

Number of deaths Year Preparations listed in Schedule III were the only substance involved Other substances were also involved Unknown if other substances were involved

Total number of deaths

38. Please provide details, including the name of the specific preparations listed in schedule III involved:

…………………………………………………………………………………………………………………………

WHO Questionnaire 42nd Expert Committee on Drug Dependence

39. Are you aware of people presenting for drug dependence treatment due to the use of any of the 8 preparations listed in schedule III in your country?

 Yes  No  Do not know

40. Please specify details, including the name of the specific preparations listed in schedule III involved: ………………………………………………………………………………

41. Please provide any additional comments to any of the questions in Section 4.

…………….…………….…………….…………….…………….…………….…………….…………….…………….……………..

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Section 5. CURRENT CONTROL

Questions in Section 5 are intended for the national competent authority for drug control.

42. Are any of the 8 preparations listed in schedule III currently controlled under national legislation in order to regulate its availability in your country? [this item requires a response]

 Yes  No  Do not know

43. Please indicate on which legislation the current control is based:

Medicines Act Controlled Substances Act Tobacco or Alcohol Control Act Other Consumer Protection Act Criminal Law Act Other specific legislation (analog; generic; temporary/emergency; etc.) Other

Please provide the exact title of the legislation.

______

44. What is the scope of this control: (Please select all that apply)

 Production  Manufacture  Export  Import  Distribution  Use  Possession  Do not know  Other (please specify): …………………………………………………………………………………………………….

WHO Questionnaire 42nd Expert Committee on Drug Dependence

45. Is the current control a temporary provision in your country?

 Yes  No  Do not know

46. When was this provision put into place? ______

47. Have there been challenges to implementing controls of any of the 8 preparations listed in schedule III in your country?

 Yes  No  Do not know

48. Please specify in which area and explain for those that apply:

Forensic laboratory capacity Resources to implement and/or enforce Expertise to detect or enforce Other

49. Are there illicit activities involving any of the 8 preparations listed in schedule III? (Please select all that apply)

 Manufacture of the substance by chemical synthesis  Manufacture of the substance by extraction from other products  Production of consumer products (dosage forms, packaging)  Trafficking  Diversion  Internet sales (seller or website located in your country)  Internet sales (from abroad to buyers in your country)  Internet sales (other or location of sellers and website unknown)  Sales to people who use preparations listed in schedule III  Do not know  Other (please specify): …………………………………………………………………………………………………

WHO Questionnaire 42nd Expert Committee on Drug Dependence

50. Seizures of any of the preparations listed in Schedule III s in your country for the years specified below (please provide the name of the preparations listed in schedule III seized):

Please write in the answers using numerals

Number of seizures No data available Acetyldihydrocodeine:  amount seized in 2016 Acetyldihydrocodeine:  amount seized in 2017 Acetyldihydrocodeine:  amount seized in 2018

Codeine: amount seized in  2016 Codeine: amount seized in  2017 Codeine: amount seized in  2018

Dihydrocodeine: amount  seized in 2016 Dihydrocodeine: amount  seized in 2017 Dihydrocodeine: amount  seized in 2018

Ethylmorphine: amount seized  in 2016 Ethylmorphine: amount seized  in 2017 Ethylmorphine: amount seized  in 2018

Nicocodine: amount seized in  2016 Nicocodine: amount seized in  2017 Nicocodine: amount seized in  2018

WHO Questionnaire 42nd Expert Committee on Drug Dependence

Nicodicodine: amount seized  in 2016 Nicodicodine: amount seized  in 2017 Nicodicodine: amount seized  in 2018

Norcodeine: amount seized in  2016 Norcodeine: amount seized in  2017 Norcodeine: amount seized in  2018

Pholcodine: amount seized in  2016 Pholcodine: amount seized in  2017 Pholcodine: amount seized in  2018

WHO Questionnaire 42nd Expert Committee on Drug Dependence

51. If any of the 8 preparations listed in schedule III were to be placed under international control, will your country have the capacity to enforce the control at the national level?

 Yes  No  Do not know

52. If any of the 8 preparations listed in schedule III were to be placed under international control, does your country have the forensic laboratory capacity to analyse the substance (identification, purity)?

 Yes  No  Do not know

53. Please provide any additional information related to any of the questions in Section 5.

…………………………………………………………………………………………………………………………………….

This is the end of the preparations listed in Schedule III questionnaire.