Ministry of Health of the Republic of Armenia Feb 2013

O pioid analgesics registered in the Republic of Armenia NameDosage, Prescription Form Producing country, Company Registration Date Valid to 1.Morphine hydrochloride 1% solution for infusion 10 mg/ml; (100/20x5/) 1 ml ampoule “Zdorovye narodu” OJSC, Ukraine Omnopon-ZN (Morphine hydrochloride, papaverine hydrochloride, codeine, noscapine, tebaine) 11,5 mg/ml + 0,72 mg/ml +1,44 mg/ml + 5,4 mg/ml + 0,1 mg/ml ; (100/20x5/) 1 ml ampoule “Zdorovye narodu” OJSC, Ukraine Fentanyl 0.005%, solution for infusion 0,05 mg/ml ; (100/20x5/) 2 ml ampoule “Zdorovye narodu” OJSC, Ukraine Promedol- ZN(trimetoperidine hydrochloride) 20 mg/ml (100/20x5/) 1 ml ampoule “Zdorovye narodu” OJSC, Ukraine

NameDosage, Prescription Form Producing country, Company Registration Date Valid to 5. Durogesic Matrix 25mcg/h TDTS, 4,2 mg, 5 in a box Alza Ireland Ltd, Janssen Pharmaceutica l N.V Durogesic Matrix 50 mcg/h TDTS, 8,4 mg, 5 in a box Alza Ireland Ltd, Janssen Pharmaceutica l N.V Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP 5 mg, bottles of 100 tablets Mallinckrodt Inc., USA Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP 10 mg; bottles of 100 tablets Mallinckrodt Inc., USA Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP 40 mg; bottles of 100 tablets Mallinckrodt Inc., USA O pioid analgesics registered in the Republic of Armenia

NameDosage, Prescription Form Producing country, Company Registrati on Date Valid to 6 Tramadol, solution for injection 100 mg /2 ml; (5) ampoules 2 ml CRCA, Novo Mesto, Slovenia Tramadol, capsules 50 mg (20/2x10/) blisters CRCA, Novo Mesto, Slovenia Tramadol-M 50 mg/ml (1 ml);1 ml ampoules (10) “Zororvye narodu” OJSC, Ukraine Tramadol-M 50 mg/ml (2ml) 2 ml ampoules (5) “Zororvye narodu” OJSC, Ukraine Tramadol, solution for injection 100 mg/2 ml; (5) ampoules 2 մլ Hemopharm AD - Serbia Tramadol 50 մ mg (20/2x10/) blistersHemopharm AD - Serbia Tramadol Alcaloid, capsules 50 mg; (20) in bottlesAlcaloid AD - Skopje Tramadol Alcaloid, solution for injection 50 մգ / մլ ; (5) ampoules 2 ml Alcaloid AD - Skopje O pioid analgesics registered in the Republic of Armenia

Armenia is not a major drug-producing country and because of conservative social mores domestic abuse of drugs is relatively modest; Some use (secondary route) as a transit country for drug trafficking; Opiates, are the second most abused drug group (after hashish and cannabis) ; In 2009 Armenia implemented new legislation towards EU standards, decriminalization of the use of illegal drugs (emphasizing prevention & treatment of drug users) and adopted a three year national drug strategy; In 2011 the Monitoring Centre for Narcotic Drugs and Drug Addiction was established under the National Institute of Health; Armenia is a party to the 1988 UN Drug Convention. R egulation of Drug Circulation In Armenia

International treaties - UN Single Convention on Narcotic Drugs of UN Convention on Psychotropic substances of UN Convention against Illicit traffic in Narcotic Drugs and Psychotropic Substances f 1988 Domestic Regulatory documents - The Law of the Republic of Armenia on the Narcotic & Psychotropic Substances (Dec 26, 2002), The Law on Pharmaceuticals - Decrees of the Government on licensing of agencies on drugs importation, exportation, production, warehousing, and distribution: on lists of controlled drugs and their precursors and on the order of their circulation, decree of the MoH on prescriptions, etc

R egulation of Drug Circulation In Armenia Agencies involved - The Government of Armenia (approves the lists of controlled drugs and their precursors, their circulation order and annual quotes for the Armenia) -Ministry of Health of Armenia (responsible for registration and licensing) - Police Department at the Government of Armenia -Customs Service -National Security Service -Prosecutor’s Office

T esting and registration, importation, warehousing, distribution, storage, prescribing, dispensing, monitoring of prescription usage Testing and registration of narcotic drugs is not different from other pharmaceuticals. - Testing is done at the laboratory of the Drug Expertise Center of the MoH - Registration is done by the MoH - Activities of importation, warehousing, distribution of narcotics should be licensed by the Ministry of Health (special condition requirements). Currently only one organization “Armpharmacia” JSC, holds the license for importation and warehousing of narcotics. - Dispensing of narcotics is done through prescriptions by the order of prescriptions and distribution of pharmaceuticals approved by the Ministerial decree #100 of Feb 26, 2002 on the order using prescription form #1 approved by the Government of Armenia (forms 2 and 4 are used for psychotropic substances). - Monitoring of narcotic drugs dispensing and usage in pharmacies and health care institutions is done by the Ministry of Health. - Annual reports on narcotics circulation are submitted to the MoH and Police Dept by institutions licensed for circulation of narcotic drugs.

R estrictions on prescribing, i.e. route of administration, dose, length of prescription? The acting Law on narcotics does not stipulate a special procedure and condition of the use of narcotics/psychotropic substances for medical purposes. Only One opioid or psychotropic substance may be prescribed at each prescription form Prescription of narcotics in out-patient facilities is only available to cancer patients (morphine injectable form only) Prescriptions of narcotic drugs are issued for 2 days (Prescriptions of narcotic and psychotropic drugs is valid for 20 days). The process of prescription is cumbersome (through a decision of a committee, each prescription to be validated by signature and personal stamp of the prescribing physician, the prescription stamp, the signature and stamp of the director or deputy director and round seal of the facility).

M ain activities carried out in Armenia in towards development of palliative care (in cooperation with the GF and OSF) Situational analysis, draft guidelines in pain management and national guidelines on palliative care developed Pilot testing of different models of palliative care in four sites implemented and in progress patients included home visits, 1388 out-patient vists and 4697 emergency calls served. - Regulated by Ministerial decree the patients enrolled in pilots receive methadone procured under the GF funded HSS project.

E xpert assessment of the oral morphine requirement for Armenia Assumptions: -Current usage of morphine is Kg for injectable only - Oral morphine will replace 75% of the injectable and we need more mg for oral than injectable - Estimated 25% increase annually due to education and pilot projects Estimates: kg (2.475 kg oral, inj.) kg (3.11 kg oral, 1.04 kg inj.) (3.89 kg oral, 1.3 kg inj.)

W hat is the projected need for morphine in the country by dosage form (IR, SR, and injectable) The quotes of narcotic and psychotropic medication to be produced, imported to or exported from the Republic of Armenia are implemented by the Government of RA. Quotes of 2013: - Morphine (all forms) g - Codeine – 3000 g - Phentanyl (all forms)-21 g - Methadone (all forms) g - Tebaine --10g, Trimetoperidine g

A ctivities foreseen for 2013 Registration of oral morphine (included in the list of essential medicines of low demand) is underway Pilot projects continue, evaluation expected end of 2013 Comprehensive review of legislation on narcotic drugs aimed at improved conditions and increased availability of opioid analgesics for patients in need in Armenia. THANK YOU!!!