Improving access to opioid analgesics: Ukraine

March 5-6, 2013

Vienna

Narcotic medical substances registered for pain relief in Ukraine

INN Form of production

Morphine sulfate Tablets 5mg, 10mg

Morphine hydrochloride

Solution for injections: 10mg 1ml

Codeine phosphate Tablets : 30mg

Tramadol

50mg tablets/capsule of fast effect

100mg/ml peroral solution

50 mg/ml solution for injections

Rectal suppositories 100 mg each

Methadone

5mg tablets

1mg/ml peroral solution

Fentanyl

Transdermal plaster 25mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hourSolution for injections, 0.05 mg/ml

Narcotic medical substances registered for pain relief in Ukraine

INN Form of productionBuprenorphine hydrochloride

Solution for injections 0.3 mg/ml 1 ml each

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)

Hydromorphone Prolonged-action tablet 8 mg, 16 mg, 32 mg

Omnopon

Solution for injections 1 ml in ampules (Morphine hydrochloride 11.5 mg, noscapin, papaverine hydrochloride, codein, tebaine)

Promedol (trimeperidine hydrochloride)

Solution for injections, 20 mg/ml 1 ml each

Butorphanol tartrate

Solution for injections0.2%

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 substances-License on production, Лицензия на производство, wholesale and retail trade of MS

State service of Ukraine on medical substances

- 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.

2. Issues licenses for carrying out activities with narcotic substances

3. Forms quota on NS based on MoH data4. Issues Permission for import, export and transit of NS on

territory of Ukraine

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.

2. Issues licenses for carrying out activities with narcotic substances

3. Forms quota on NS based on MoH data4. Issues Permission for import, export and transit of NS on

territory of Ukraine

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

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

Acting order of MoH №11 Draft decree

Doctors according to position and existence of medical indications

Prescription is prohibited by doctor of different specialization with exception when there are no narrow-purpose specialists in the areas

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

Prescribed by doctor or paramedic in defined cases

Prescription for more than 10 days is done by doctor with reasoning and writing in medical records

Prescription of NS

As a rule NS are prescribed by oncologists

Acting order of MoH №11 Draft decree

Doctors according to position and existence of medical indications

Prescription is prohibited by doctor of different specialization with exception when there are no narrow-purpose specialists in the areas

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

Prescribed by doctor or paramedic in defined cases

Prescription for more than 10 days is done by doctor with reasoning and writing in medical records

Use of NS

Acting order of MoH №11 Draft decree

Patients receive Ns through MTI.

Administration of parenteral forms is done only by medical personnel

Other forms - without assistance according to prescription of doctor

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

PrescriptionsDecree 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 prescriptionMorphine – 0.1gTablets 10 mgAmpoules 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