Availability of Opioids in Armenia

Ministry of Health of the Republic of ArmeniaFeb 2013

Opioid analgesics registered in the Republic of ArmeniaName Dosage,

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 05.12.2011 05.12.2016

2. 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

07.09.2012 05.12.20163. Fentanyl 0.005%,

solution for infusion0,05 mg/ml ; (100/20x5/) 2 ml ampoule

“Zdorovye narodu” OJSC, Ukraine

05.12.2011 05.12.20164. Promedol-

ZN(trimetoperidine hydrochloride)

20 mg/ml (100/20x5/) 1 ml ampoule

“Zdorovye narodu” OJSC, Ukraine 07.09.2012 05.12.2016

Name Dosage, 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 Pharmaceutical N.V 08.06.2009 08.06.2014

Durogesic Matrix

50 mcg/h TDTS, 8,4 mg, 5 in a box

Alza Ireland Ltd, Janssen Pharmaceutical N.V 08.06.2009 08.06.2014

6. Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP

5 mg, bottles of 100 tablets

Mallinckrodt  Inc., USA 17.12.2008 04.12.2013

Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP

10 mg; bottles of 100 tablets

Mallinckrodt  Inc., USA 17.12.2008 04.12.2013

Methadose™ Oral Tablets (methadone hydrochloride) Tablets, USP

40 mg; bottles of 100 tablets

Mallinckrodt  Inc., USA 17.12.2008 04.12.2013

Opioid analgesics registered in the Republic of Armenia

Name Dosage, Prescription Form

Producing country, Company

Registration Date

Valid to

6 Tramadol, solution for injection

100 mg /2 ml; (5) ampoules 2 ml

CRCA, Novo Mesto, Slovenia

27.03.2012

27.03.2017

Tramadol, capsules

50 mg (20/2x10/) blisters

CRCA, Novo Mesto, Slovenia

27.03.2012

27.03.2017

Tramadol-M

50 mg/ml (1 ml);1 ml ampoules (10)

“Zororvye narodu” OJSC, Ukraine

08.10.2008

02.10.2013

Tramadol-M50 mg/ml (2ml) 2 ml ampoules (5)

“Zororvye narodu” OJSC, Ukraine

08.10.2008

02.10.2013

Tramadol, solution for injection

100 mg/2 ml; (5) ampoules 2մլ

Hemopharm AD - Serbia

14.09.2011

14.09.2016

Tramadol

50մ mg (20/2x10/) blisters

Hemopharm AD - Serbia

14.03.2011

14.03.2016

Tramadol Alcaloid, capsules

50 mg; (20) in bottles Alcaloid AD - Skopje

13.12.2012

19.11.2017

Tramadol Alcaloid, solution for injection

50մգ/մլ; (5) ampoules 2 ml Alcaloid AD - Skopje

13.12.2012

19.11.2017

Opioid 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 .

Regulation of Drug Circulation In Armenia

Regulation of Drug Circulation In Armenia International treaties

- UN Single Convention on Narcotic Drugs of 1961- UN Convention on Psychotropic substances of 1971- 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

Regulation of Drug Circulation In ArmeniaAgencies 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

Testing 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.

Restrictions 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).

Main activities carried out in Armenia in 2011-2012 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

- 132 patients included- 3692 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.

Expert assessment of the oral morphine requirement for Armenia

Assumptions:- Current usage of morphine is 1.327 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 projectsEstimates:- 2013- 3.3 kg (2.475 kg oral, 0.825 inj.)- 2014- 4.15 kg (3.11 kg oral, 1.04 kg inj.)- 2015- 5.19 (3.89 kg oral, 1.3 kg inj.)

What 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)- 4500 g- Codeine – 3000 g- Phentanyl (all forms)-21 g- Methadone (all forms)- 10000g- Tebaine --10g, Trimetoperidine-- 650 g

Activities 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!!!