Transcript Slide 1

Ministry of Health of the Republic of Armenia
Feb 2013
Opioid analgesics registered in the Republic of Armenia
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Name
Dosage,
Prescription
Form
Producing
country,
Company
Morphine hydrochloride
1% solution for infusion
10 mg/ml;
(100/20x5/) 1
ml ampoule
“Zdorovye
narodu” OJSC,
Ukraine
05.12.2011
05.12.2016
11,5 mg/ml +
“Zdorovye
0,72 mg/ml
narodu” OJSC,
+1,44 mg/ml + Ukraine
5,4 mg/ml +
0,1 mg/ml ;
(100/20x5/) 1
ml ampoule
07.09.2012
05.12.2016
Omnopon-ZN (Morphine
hydrochloride, papaverine
hydrochloride, codeine,
noscapine, tebaine)
Fentanyl 0.005%, solution
for infusion
PromedolZN(trimetoperidine
hydrochloride)
Registration
Date
Valid to
0,05 mg/ml ;
(100/20x5/) 2
ml ampoule
“Zdorovye
narodu” OJSC,
Ukraine
05.12.2011
05.12.2016
20 mg/ml
(100/20x5/) 1
ml ampoule
“Zdorovye
narodu” OJSC,
Ukraine
07.09.2012
05.12.2016
Opioid analgesics registered in the Republic of Armenia
Name
Dosage,
Prescription
Form
Producing
country,
Company
Durogesic Matrix
25mcg/h TDTS,
4,2 mg, 5 in a
box
Alza Ireland
Ltd, Janssen
Pharmaceutica
l N.V
08.06.2009
08.06.2014
Durogesic Matrix
Alza Ireland
50 mcg/h TDTS, Ltd, Janssen
8,4 mg, 5 in a
Pharmaceutica
box
l N.V
08.06.2009
08.06.2014
Mallinckrodt
Inc., USA
17.12.2008
04.12.2013
Methadose™ Oral Tablets
(methadone hydrochloride) 10 mg; bottles of Mallinckrodt
Tablets, USP
100 tablets
Inc., USA
17.12.2008
04.12.2013
Methadose™ Oral Tablets
(methadone hydrochloride) 40 mg; bottles
Tablets, USP
of 100 tablets
17.12.2008
04.12.2013
5.
6.
Methadose™ Oral Tablets
(methadone hydrochloride) 5 mg, bottles of
Tablets, USP
100 tablets
Mallinckrodt
Inc., USA
Registration
Date
Valid to
Opioid analgesics registered in the Republic of Armenia
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Name
Dosage,
Producing country,
Prescription Form Company
Tramadol, solution
for injection
Tramadol, capsules
100 mg /2 ml; (5)
ampoules 2 ml
50 mg (20/2x10/)
blisters
CRCA, Novo Mesto,
Slovenia
CRCA, Novo Mesto,
Slovenia
Tramadol-M
50 mg/ml (1 ml);1
ml ampoules (10)
Tramadol
50 mg/ml (2ml) 2
ml ampoules (5)
100 mg/2 ml; (5)
ampoules 2մլ
50մ mg (20/2x10/)
blisters
Tramadol Alcaloid,
capsules
50 mg; (20) in
bottles
Tramadol Alcaloid,
solution for
50մգ/մլ; (5)
Tramadol-M
Tramadol, solution
for injection
Registrati
on Date
Valid to
27.03.2012
27.03.2017
27.03.2012
27.03.2017
“Zororvye narodu” OJSC,
Ukraine
08.10.2008
02.10.2013
“Zororvye narodu” OJSC,
Ukraine
08.10.2008
02.10.2013
Hemopharm AD - Serbia
14.09.2011
14.09.2016
Hemopharm AD - Serbia
14.03.2011
14.03.2016
Alcaloid AD - Skopje
13.12.2012
19.11.2017
Regulation of Drug Circulation In Armenia
 Armenia is not a major drug-producing country and because of
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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
 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 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
Testing and registration, importation, warehousing, distribution,
storage, prescribing, dispensing, monitoring of prescription usage
 Testing and registration of narcotic drugs is not different from other
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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
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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 projects
 Estimates:
- 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!!!