Preparations Listed in Schedule III of the 1961 Single Convention On
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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 Any sensitive, confidential or unpublished documents should be emailed to [email protected] We thank you in advance for taking the time to complete this questionnaire. 1 WHO Questionnaire 42nd Expert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) 2 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 3 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 4 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 5 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 ………………………………………………………………………………………….. 6 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 7 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 8 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