Transcript Kazakhstan 1

Ministry of Health
Republic of Kazakhstan
SALAMATTY
KAZAKHSTAN
Accessibility of Opioids
in the Republic of Kazakhstan
G.U. Raimkulova – Head of
Pharmaceutical Activities Administration ,
Medical and Pharmaceutical Activities Committee,
Ministry of Health of the Republic of Kazakhstan
Almaty 2012
1
State Regulation of Drug Distribution
Managed by the following:
1) state regulation of the pharmaceutical activities;
2) licensing the pharmaceutical activities and narcotic, psychotropic substance
and precursor distribution activities in the field of health;
3) state marketing authorization of the medicinal products, health products and
medical devices (MPHPMD);
4) safety and quality assessment of the marketed medicinal and health products;
5) state price control of medicinal products, purchased under the scope of the
guaranteed free medical care.
(Code of the Republic of Kazakhstan –On National Health and Health System)
2
Regulatory base of the provision of narcotic, psychotropic substances
and precursors
1.
Code of the Republic of Kazakhstan (RoK) “On National Health and Health care
System”;
2.
Law of the Republic of Kazakhstan as of July 10, 1998, No 279-I
“On narcotic, psychotropic substances and precursors, and countermeasures to
their trafficking and abuse”;
3.
Government Resolution of the Republic of Kazakhstan as of November 10, 2000, No
1693 «On adoption of regulations for state regulation of the narcotic, psychotropic
substances and precursors distribution in the Republic of Kazakhstan»;
4.
Government Resolution of the Republic of Kazakhstan as of March 30, 2012, No 396
“On adoption of regulations for medicinal use narcotic, psychotropic substances and
precursors, subject to control in the Republic of Kazakhstan”;
5.
Government Resolution of the Republic of Kazakhstan as of May 23, 2007, No 413
“On adoption of exclusion out of control regulations for medicinal products with low
narcotic, psychotropic substances and precursors content, whereof substances
mentioned above could not be extracted by immediate availability, and specified
products list’;
6.
Order of the Deputy Minister of Health of the RoK, as of November 4, 2011, No 786
“On approval of the medicinal products and health products list for free public outpatient provision with specialized medical products in selected diseases (conditions)
under warranted free medical care capacity “.
3
State regulation modes for narcotic, psychotropic
substances and precursors distribution (NPP)
•
1. quota allocation –
•
2. distribution – Republican internal market provision with specified remedies and
demand rate for the Republic of Kazakhstan in NPP based on
requirement computation. Is approved by Government of the Republic of Kazakhstan and
submitted in accordance with international treaties for international quota approval Republic of
Kazakhstan UN INCB);
professional activities guarantee for different agencies under allocated quota in
accordance with regulations:
- provision standard is to be approved for importing domestic manufacturers
and legal bodies.
- consumption standard is to be approved for republican administrativeterritorial units indicating standards for individual consumer organizations
(therapeutic, pharmaceutical, veterinarian, academic, and research organization
etc.);
•
3. licensing (narcotic, psychotropic substances, precursors distribution activities,
NPP import and export);
•
4. inspections (narcotic, psychotropic substances and precursors distribution order
compliance monitoring).
4
Formation of demands order for narcotic, psychotropic
substances and precursors in the Health system of the Republic of
Kazakhstan
State quota
Government
of Kazakhstan
MIF of the RK
Republican
consumption
standard
Health system
demand
INCB UN
International quota
MH of the RK
Composite bod
General request
MPAC MH of RoK
Territorial subdivisions
Bid
and demand calculation
Republican
medical
organizations
Oblast, Astana, and Almaty
health departments,
Bid
and demand calculation
Medical
organizations
5
Medicinal Provision System
in the Republic of Kazakhstan
Warranted free medical care capacity (WFMCC)
Medicinal products provision
Emergency care,
hospital and
hospital replacement care
Out-patient care
In accordance with approved medical
Organizations and drug formularies
duly coordinated with regulatory authority
(Medicinal product list,
compiled for WFMCC rendering
considering organization profile,
to be formed by medical organization itself)
In accordance with
the List of medicinal products
and specialized health products for free
provision of individual populations with
selected diseases (conditions), which is
a subject for regulatory authority approval
(approved by the order of the MH of RoK
No 786 as of 4 November 2011)
66
Republican Drug Formulary
International non-proprietary name
Pharmaceutical form*
No
Опиоидные анальгетики
1.
Morphine
solution for injection 1 %
2.
Trimeperidine
solution for injection 1 %, 2 %
Tramadol
solution for injection 100 mg/2 ml, 50 mg/mL, 5%;
oral solution 100 mg/1 mL; drops
1000 mg/10mL; film-coated tablet 50 mg;
retard tablet (film-coated tablet) 100 mg, 150 mg, 200
mg;
capsules 50 mg; rectal suppositories
4.
Fentanyl
solution for injection 0,005 %;
transdermal therapeutic system 12,5 mcg/hour, 25
mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hour;
sublingual tablet 100mg, 200mg, 300mg,
400mg, 600mg, 800mg
5.
Butorphanol
solution for injection 2 mg/mL
3.
*
All registered in the Republic of Kazakhstan pharmaceutical forms are to be
released
7
Palliative therapy for malignancies
• Morphine, solution for injection;
• Trimeperidine hydrochloride, solution for injection;
• Tramadol, sustained release tablet, capsule, suppositories,
solution for injection;
• Fentanyl, transdermal therapeutic system;
• Ketoprofen, capsule, tablet, suppositories, solution for
injection;
• Diazepam, tablet, solution for injection;
8
Opioids availability at the pharmaceutical market of the
Republic of Kazakhstan
(in accordance with State MPHPMD registry
as of 01.01.2013)
Nowadays, around 77 items of various pharmaceutical forms and dosages for following
medicinal products are present in the market of the Republic of Kazakhstan:
1. Morphine hydrochloride – 1 PP (solution for injection);
2. Fentanyl – 16 PP (solution for injection, transdermal therapeutic system and sublingual
tablet);
3. Trimeperidine– 1 PP (solution for injection);
4. Tramadol – 41 PP (capsule, drops, tablet, sustained release tablet, solution for injection,
suppositories);
5. Combined codein-containing drugs – 18 PP (tablet, syrup, capsule);
9
State marketing authorization procedure
for medicinal products in the Republic of Kazakhstan
Applicant
Pharmaceutical Control
Committee
Information, analysis
and marketing center
General Department
Department of Almaty
Pharmaceutical Control
Committee
Archive
Expert services
Marketing Authorization
Expert Advisory Body
Expert services
Marketing Authorization
Test Center
Pharmacopoeial Center
Pharmacological Center
10
State Marketing Authorization
for MPHPMD
 Upon expertise completion the Expert Report on Drug Safety,
Efficacy, and Quality is compiled
 Based on Expert Report the MPAC MH of the RoK makes
decision and issue an order on medicinal product state
marketing authorization
 All data on registered MP within 24 hours are entered in the
State MP Registry
An applicant is to be granted by:




Marketing Authorization
Approved Company Core Data Sheet
Medicinal Product Quality Regulatory document (AND)
Package design
11
Current opioids prescription and delivery procedure
Out-patient level
Prescription
(А6 format blank sheet with code,
number, protection level, and to
be certified by a seal of the doctor,
Medical Director’s or Deputy’s
signature and Medical
Organization seal).
Valid for 7 consecutive days
Patient
Pharmacy
Is provided by the list of
doctors eligible to
prescribe opioids
PHYSICIAN
In-patient level
Medication
administration record
of the Medical History is
certified by Head of
Department and/or
Organization Manager
Use (taking) of opioids is performed
strictly under the supervision of medical
staff at the moment of drug delivery: oral
taking, transdermal therapeutic system
application (plaster, patch, etc.) – in the
presence of the nurse, injection – in the
presence of the physician
Patient
12
Opioids storage and destruction requirements
1.
The persons, authorized to work with the opioids, shall prior get the conclusions from psychiatrist and narcologist regarding the
absence of narcotic, toxic substances, alcohol abuse, and Internal
Лица,affairs authorities conclusion regarding relevant inspection. List of
persons authorized to work with narcotic, psychotropic substances and precursors is to be approved by the order of the Health
допущенные к работе с опиоидными
organization Manager annually.
2.
Storage facilities, lock boxes, and cupboards
must психиатра
be in blocking
state.
Outside office
врачей
and
нарколога
об hours these are to be sealed up, keys and seal
press are to be kept in a responsible person.
отсутствии заболеваний наркоманией,
анальгетиками должны иметь заключения
3.
токсикоманией,
On the inside of the lock box door, cupboards the
check-list of keptхроническим
medicinal products indicating highest single and daily doses
алкоголизмом, а также о пригодности к
4.
All documents on the opioid income sideвыполнению
and consumption
are toдеятельности
be kept in a filed,
sealed form by months and years in responsible
данной
and
person in conditions providing their security
in the lockорганов
boxes andвнутренних
metallic cupboards
заключение
дел поwithin storage facility.
5.
Documents on the opioid income side and consumption are to be kept for five years.
6.
On the inside of the door of the lock box, cupboard the check-list of kept medicinal products containing narcotic, psychotropic
substances and precursors indicating highest single and daily doses.
7.
Medicinal products, containing narcotic, psychotropic substances and precursors are to be delivered form the storage facility only by
the responsible person.
8.
In the assistant room stock of narcotic, psychotropic substances from the Table II of the List should not exceed five-day demand, in
departments (offices) of health organizations – three-day demand, in pharmacy storage facilities — thirty-day demand, apart from
holidays and weekends.
9.
Unused special prescriptions given by dead patients relatives are to be kept with following destruction. Prescription destruction is to
be performed as far as prescription accumulation, but not less than monthly, by incineration of the ongoing committee, included
internal affairs body representative. Unused special prescriptions destruction fact is to be registered in relevant act.
10.
To destroy the expired opioids, provided by the deceased patients’ family, breakage, rejects, empty ampules and plasters (transdermal
therapeutic systems) as well, and ampules and plasters (transdermal therapeutic systems) with partially used content, under the order
of the Health Organization Manager, a constantly functioning committee is to be developed including internal affairs body and
sanitary-epidemiological services representatives.
проведению соответствующей проверки.
13
Ministry of Health
Republic of Kazakhstan
SALAMATTY
KAZAKHSTAN
THANK YOU
FOR YOUR ATTENTION
14