Transcript Tajikistan_Country Presentation_March2013

Tajikistan
Making Opioids Available in Eastern Europe
and Central Asia
March 5-6, 2013 Vienna
General Information
S=143,100
sq.km
Population:
8000 000
people:
Number a birth
per year –
250000 alive
birth
Capital :
Dushanbe
TAJIKISTAN’S LEGISLATIVE FRAMEWORK REGULATING LEGAL
STATUS AND LIABILITY IN THE AREA OF DRUGS MOVEMENT.
• The following laws were adopted in Tajikistan
aiming to implement the undertaken
responsibilities that emanate from
international anti-drug conventions of the UN
and to regulate relations in the area of drug
control:
• - “On drugs, psychotropic substances and
precursors”
• - “On narcological assistance”
• - “On licensing separate types of activities”
What opioid analgesics are currently
registered in the country ?
Name
Form
Date of last
registration
Country of
origin
Fenthanil
injection
28.09.2012
Ukraine
Morphine
hydrochloride
injection
31.08.2012
Ukraine
Promedol
injection
04.02.2011
Ukraine
Promedol ZH
injection
31.08.2012
Ukraine
Lunaldin
tablets
23.02.2011
Sweden
Metadon
syrup
2011
Italy
The national quota for legal use of drugs -Government decree №381 August 29, 2003
Name
Codeine
Cocaine
Morphine
Trimeperedine
Fentanyl
Ethyl morphine
Etorphine
Main substance in gram
449 920
1 280
3 840
32 000
38
6 400
5
The system of drug control
Drug Control
Agency
Ministry Of
Internal Affairs
State Agency on
Pharmaceutical
Control
Ministry of
Health
Process of registration
1. Submission full set of the requested documents to
The State Service for Supervision of pharmaceutical
activity of RT(SSSPA) by the company with all related
certificates ( GMP , GPP, and etc)
2. Providing with sample of drugs for clinical testing (the
main substance)
3. Review by the respective departments of SSSPA (
standardization compliance)
4. Average period of registration from 4 months till 2
years
5. Payment of registration fees that valid for 5 years: for
CIS country – 675 USD, for other countries 2089 USD
Importation, warehousing
• First step is getting one time permission on
importation of opioids from State Service for
Supervision of pharmaceutical activity of
RT(SSSPA) (humanitarian purpose or business
fee 120 somoni=24 USD)
• Second step is purchases that centralized and
implemented by the Ministry of Health ( center
of pharmaceutical purchase) and storage on
the licensed warehousing
Distribution
• Distribution is through for
those organizations,
hospitals, outpatients
departments and firms,
who have a license for
activities for work on
narcotic drugs,
psychotropic substance
and precursors. License is
issued by the MoH that
valid for 5 years.
Control of licit drug trafficking
• The State Service for Supervision of
pharmaceutical activity of RT(SSSPA)
• Drug Control Agency
• Ministry of Internal Affairs
Regulatory document on legal use
narcotic analgesics
The order of the Ministry of Health RT from 21
December 2005, No.670 and MIA RT from 21
December 2005, No.3 “On approval of procedure for the
turnover of psychotropic substances” agreed with the
Drug Control Agency (DCA), which approves general
rules for receiving, storing and recording of psychotropic
substances in health care facilities, storage, accounting
and dispensing procedures for psychotropic drugs in
pharmacies, medical and prophylactic facilities,
pharmacy stores, research institutes and education
institutions of the health care system and in control and
analytical laboratories.
• To implement the Articles 8, 9, 11, 13, 15 and 16 of the
Law of Republic of Tajikistan “On drugs, psychotropic
substances and precursors”, to ensure procedures for
import, storage, distribution, prescription, dispensing,
use, destruction and recording of drugs in
pharmaceutical, medical, research institutes and other
organizations, regardless of their organizational and legal
status, ownership type and subordination, strengthening
the work on prevention drug addiction, the following
forms and regulatory and legal documents were
approved by the joint order of the Ministry of Health,
Republic of Tajikistan and the Ministry of Internal
Affairs, Republic of Tajikistan under # 202/437 dated 25
July, 2001 “On intensifying the work on prevention drug
addiction and ensuring legal movement of drugs”:
Who can write opioid prescriptions
• Opioid drugs can
prescribe a medical
worker with higher
medical education
according to the
norms for one
receipt set out in
Annex below ( but
not more than three
drugs in one receipt
and max lengths is 10
days)
Name
Quantity
Alnagon
20 pills
Buprenorphine 0,2 mg
20 pills
Codeine
.0,2 g.
Codthermops, Codterpin
20 pills
Cocaine hydrochloride
0,1 g..
Morphine hydrochloride morphilong
0,1 g..
Omnopon
0,1 g..
Procidol
0,25 g..
Promedol
0,25 g..
Fepranon 0,025
50 dragee
Estocine
12 pills
Ethyl morphine hydrochloride (Dionin)
0,2
Note:
• For treatment of incurable cancer patients,
the quantity of drug medicaments written
in one prescription can be increased for 2
times against the dose indicated in previous
table. In this case, the cancer patient will be
registered in the drugstore by the written
instruction of head of patient care
institution (according to attached form)
upon agreement with the owner or
managers of drugstore to supply him with
drug medicaments.
Costing in market
The cost of one vial of Morphine – 1.25 USD
one vial of Promedol – 1.35 USD
Calculation for projected need for
morphine in the country
• Requirements calculation made ​by
the following methods:
- A standard daily dose
-depending on the size of the
population (the standard method)
- Depending on the number of beds
Drop that flowed into the ocean can
rightfully call itself the Ocean
Thank you !!!!!!!