Improving access to opioid analgesics: Ukraine March 5-6, 2013 Vienna

Narcotic medical substances registered for pain relief in Ukraine INNForm of production Morphine sulfateTablets 5mg, 10mg Morphine hydrochloride Solution for injections: 10mg 1ml Codeine phosphateTablets : 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/hour Solution for injections, 0.05 mg/ml

Narcotic medical substances registered for pain relief in Ukraine INNForm of production Buprenorphine 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) HydromorphoneProlonged-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 data 4. 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 data 4. 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 №11Draft 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 №11Draft 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 №11Draft 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

Prescriptions Decree of MoH 360Draft 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 days10 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: 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) 82,0623,71367,506410

Need in different forms of morphine  With fast effect  With prolonged action  Injection form  Syrups  Sprays  Candles  Patches

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