Improving access to opioid
analgesics: Ukraine
March 5-6, 2013
Vienna
Narcotic medical substances registered for
pain relief in Ukraine
INN
Morphine sulfate
Morphine
hydrochloride
Codeine phosphate
Tramadol
Methadone
Fentanyl
Form of production
Tablets 5mg, 10mg
Solution for injections: 10mg 1ml
Tablets : 30mg
50mg tablets/capsule of fast effect
100mg/ml peroral solution
50 mg/ml solution for injections
Rectal suppositories 100 mg each
5mg tablets
1mg/ml peroral solution
Transdermal
plaster
25mcg/hour,
mcg/hour, 75 mcg/hour, 100 mcg/hour
Solution for injections, 0.05 mg/ml
50
Narcotic medical substances registered for
pain relief in Ukraine
INN
Buprenorphine
hydrochloride
Form of production
Solution for injections 0.3 mg/ml 1 ml each
Hydromorphone
Prolonged-action tablet 8 mg, 16 mg, 32 mg
Omnopon
Promedol
(trimeperidine
hydrochloride)
Sublingual tablets 0.2 mg, 0.4 mg, 2 mg, 4 mg, 8
mg
Transdermal plaster 20 mg (35 mcg/hour), 30
mg (52.5 mcg/hour), 40 mg (70 mcg/hour)
Solution for injections 1 ml in ampules
(Morphine hydrochloride 11.5 mg, noscapin,
papaverine hydrochloride, codein, tebaine)
Solution for injections, 20 mg/ml 1 ml each
Solution for injections0.2%
Butorphanol tartrate
Registration of medical
substances
- Expertise of registration materials
-Development of medical standards,
clinical protocols
-Development of forms of MS
State expert Center of MoH of
Ukraine
-Control of quality and safety of MS
-Permission on import of unregistered
State service of Ukraine on medical
substances
substances
-License on production, Лицензия на
производство, wholesale and retail
trade of MS
- Registration of MS
-Order of prescription and selling of
medicine
Ministry of Health (MoH)
Permission for using premises for
circulation of narcotic substances
Ministry of Internal Affairs of
Ukraine (MIA)
CONTROL SYSTEM

State service on drug control (SSDC) - central body of
executive power in sphere of forming and implementing
politics on circulation of narcotic substances (NS)
1.
Forms the list of narcotic substances, psychotropic and
substances and precursors.
Issues licenses for carrying out activities with narcotic
substances
Forms quota on NS based on MoH data
Issues Permission for import, export and transit of NS on
territory of Ukraine
2.
3.
4.
CONTROL SYSTEM

State service on drug control (SSDC) - central body of
executive power in sphere of forming and implementing
politics on circulation of narcotic substances (NS)
1.
Forms the list of narcotic substances, psychotropic and
substances and precursors.
Issues licenses for carrying out activities with narcotic
substances
Forms quota on NS based on MoH data
Issues Permission for import, export and transit of NS on
territory of Ukraine
2.
3.
4.
Transportation of NS
 Based on license
 Performed by health institutions, actors which produce NS or carriers
if they insure the security of cargo
 With escort of responsible person
 Within city or district without permission of MIA
 In quantity more than 200kg - with escort of patrol car of State
automobile Inspection or state guard service of MIA
Import
 Permission for each separate operation issued by
SSDC, coordinated with Security Service of
Ukraine
 State control of quality of MS
Storage in health institutions
 Based on license
 In separate rooms, equipped according to requirements of
MIA (Order 216)
Pharmacy depot
 Walls – equivalent of density of 500 mm brickwall
 Floor and ceiling – armored concrete slab180mm
or
Strengthening the inside with grid-iron
 Door
-
Metal or wooden (covered by sheet of iron on both sides) solid with
two mortise locks– 40mm
Laced metal doors from inner side
 Windows – screened
 Multi-line security alarm system
Pharmacy and Medical Preventive
Institution
 Walls – equivalent of density of 500 mm brickwall
 Floor and ceiling – armored concrete slab180mm
or
Strengthening the inside with grid-iron
 Door
-
Metal or wooden (covered by sheet of iron on both sides) solid with
two mortise locks– 40mm
Laced metal doors from inner side
 Windows – screened
 Alarm system along the perimeter of the room
Outpatients’ departments/Posts in
Medical Preventive Institution
 Separate room with safe or metallic cabinet fastened to floor (wall)
 Doors – Metal or wooden (covered by sheet of iron on both sides)
solid 40mm with two mortise locks
 Windows – screened
 Autonomic alarm system with output of alarm to posts of central
surveillance or local sonic or light signaling devices
Prescription of NS
Acting order of MoH №11
Draft decree

Doctors according to position and
existence of medical indications

Prescribed by doctor or paramedic in
defined cases

Prescription is prohibited by doctor of
different specialization with exception
when there are no narrow-purpose
specialists in the areas

Prescription for more than 10 days is
done by doctor with reasoning and
writing in medical records

Permission for prescription for more than
three days is issued by commission on
reasonability of prescription with further
approval of chief doctor or deputy chief
doctor
Due to absence for a long time of peroral forms of morphine there is a fix
practice that doctors do not give prescriptions for strong opiods and
patients receive them in Medical Preventive Institutions
Prescription of NS
Acting order of MoH №11
Draft decree
Doctors according to position and
existence of medical indications
Prescribed by doctor or paramedic in
defined cases
Prescription is prohibited by doctor of
different specialization with
exception when there are no
narrow-purpose specialists in the
areas
Prescription for more than 10 days is
done by doctor with reasoning and
writing in medical records
Permission for prescription for more
than three days is issued by
commission on reasonability of
prescription with further approval
of chief doctor or deputy chief
doctor
 As a rule NS are prescribed by oncologists
Use of NS
Acting order of MoH №11
Patients receive Ns through MTI.
Administration of parenteral forms is
done only by medical personnel
Other forms - without assistance
according to prescription of doctor
Draft decree
Patient or person who conducts care can
receive substances in MTI or in
pharmacy by prescription in the
quantity not more that 10 day necessity
norm
Prescriptions
Decree of MoH 360
Draft decree on making amendments
Prescription blank is subject to strict reporting
Certified by additional round-type signet of an
institution and signed by head of MTI
Maximum quantity in one prescription
Morphine – 0.1g
Tablets 10 mg
Ampoules 1% 1ml
In providing palliative care to patients it
is allowed to prescribe on one
prescription blank medical substances in
quantity equal to 15 days necessity
norm
Validity of prescription – 5 days
10 days
Sold by pharmacies within one territorial region
of MTI
To exclude
Need in morphine for population of Ukraine
according to official data in 2011
need: 65-75 mg per day for 3 months
Number of
deaths because
of oncologic
diseases
2011
Number of
deaths because
of AIDS
2011
Number of
patients who
need pain relief
Quantity of
morphine
(peroral),
needed for pain
relief
(kg)
82,062
3,713
67,506
410
Need in different forms of morphine
 With fast effect
 With prolonged action
 Injection form
 Syrups
 Sprays
 Candles
 Patches
Thank You