Transcript D.Kordzaya Current System of durgu Control in Georgia

“Making Oral Opioids Available in Eastern Europe and
Central Asia”
Current System of Drug Control
In Georgia
Prof. D. Kordzaia – Georgian National Association for Palliative Care
VIENNA - March 5-6, 2013
COUNTRY POPULATION
curative
healthy people
ill, but
curable people
Health Care
System
Medicine
people with
chronic incurable
disease
Palliative Care in its modern
understanding started the
integration into Healthcare and
Social Affair systems of Georgia in
2000
WHO Public Health Model
1. Policy
2. Drug
Availability
3. Education
4. Implementation
Decrees, reports, declarations for Palliative Care;
Palliative Care as a human rights
UN, WHO, EC, IAHPC, EAPC, OSI
International Palliative Care Initiative
Open Society Foundations
Standards and Educational Materials for
Palliative Care
IAHPC, EAPC, Pain & Policy Studies Group
International Experts sharing with us the
Experiences of different Countries
Single Convention
Establishes a
Framework to:
1. Prevent abuse and
diversion, and
2. Ensure the availability
of drugs for medical
purposes
“the medical use of
narcotic drugs continues
to be indispensable for
the relief of pain and
suffering…
adequate provision
must be made to ensure
the availability of
narcotic drugs for such
purposes.” (Preamble,
p. 13)
What do the data say?
In 2006, seven countries together accounted for almost
84% of global consumption of morphine.
These countries represent less than 12% of the world’s
population.
Pain & Policy Studies Group, 2008 (based on 2006 INCB data).
Pain is Curable and Controllable!
Thus:
The pain, which is not controlled and
continue to suffer patients, represents the
violation of Human rights.
So, it can’t be considered as only a medical
mistake, but as a crime
ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL
POLICY:
Guidelines for Assessment ( WHO - 2000)
ENSURING BALANCE IN NATIONAL POLICIES ON
CONTROLLED SUBSTANCES
Guidance for availability and accessibility of controlled
medicines (WHO – 2011)
“Balance” is the Fundamental Principle
National policy should establish a drug control
system that prevents diversion and ensures
adequate availability for medical use
Drug control measures should not interfere with
medical access to opioid
Pain control and management as a system
can not exist unless based on the rational
national drug policy
”The law and normatives must provide the full
availability to opioids for patients in suffering”
(WHO, 2002)
The health right implies:
(Universal declaration of human rights of UN General Assembly)
• Accessibility to essential medications;
• For chronic and terminal patients:
- Prevention of controllable pain
- Dying with dignity
• Prevention from drug diversion
In 1961 the single convention on narcotic
substances identifies the following
mechanisms of control:
1) Creation of the Estimate System, to
evaluate the demand on narcotic drugs
2) Continuous renewal and provision of
information to the statistical return
system of narcotic substances in the
country
PROBLEM in Georgia:
Pain Control and
Drug Availability
!
The factors impedeing opioid availability
(INCB 2002)
• Inadequate methods for evaluation of demands
• Over-strict regulations

• Complicated administrative procedures
• Fear to develop drug dependence


• Doctors fear for punishment and super-strict control 
• Lack of medical knowledge in pain management 
WHO’s recommendations:
Before beginning strategy implementation, we should be sure
that politics and drug availability has adequately
been
interested.
It is unrealistic to import opioids while special rules for
prescribing drugs will not be prepared and also spatial training
courses for patient care.
Do not start training if you have no politics and drug availability.
It will result desperation of doctors, patients, their families and
society.
Policy
Education of medical
professionals / social
workers / students, etc.
Law
Normative order
Education of
decision makers
Instructions
Protocols
Drug
availability
Public Awareness
Governmental
Budget
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
The pain management guidline was published
in 1986 by World Health Organization (WHO
1986) and was renewed in 1996
The mentioned guidelines became the gold
standard in the management of patients with
oncological pain, where the opioids represent
the necessary treatment
World Health Organization
Recommendations
• Oral opioids
– Morphine is an “Essential
Medicine” (since 1977)
– For relief of moderate to
severe pain
– Cancer, HIV/AIDS, other
conditions
•
Cancer Pain Relief
(1986)
- Three-step Analgesic ladder
Individual approach
There are no standard doses of opioid drugs. The dose which allow
effective pain relief is called the “Correct dose”
For example – per oral morphine dose is ranging from 5 mg to 1000
mg per 4 hours
Hourly
Plasma Concentration
IV
IV
00
SC
SC // IM
IM
C
Cmax
max
PO
PO // pr
pr
Half-life (t
)
Half
Half-life
(t1/2
1/2)
Time
Time
Next dose of
analgesics must be
given before entire
neutralization of
previous dose – this
schedule allows long
term analgesia
Table of analgesic effect identity
Opioid
method of application
Ecvianalesic
Doses
Morphine
Parenteral
Enteral
10 mg
30 mg
Codeine
Parenteral
Enteral
130 mg
200 mg
Policy
Education of
decision makers
Law
Normative order
Instructions
Protocols
Drug
availability
Healthcare system in Georgia is regulated by hierarchy:
a) laws of Georgia
b) Normative orders
c) Instructions
d) Protocols
-Adoption and acceptation of laws are the obligation of
Parliament of Georgia.
-Issuing of normative orders is an obligation of Government of
Georgia (in peculiar of Minister of Healthcare, Labor and Social
Affairs).
- Preparation of Instructions and Protocols is an obligation of
Professional Associations and/or Experts
2006
No “Palliative Care” in Laws of Georgia
Normative Order of
Two Ministers
No Instructions and Protocols on Palliative care
Prescription of medicine, determination of single and
daily doses or changing of dose is exercised by special
commission: Deputy director of out-patients' clinic is
the chairman of commission, family doctor and/or
oncologist are members of commission. (In case of noncancer diseases, the member of the commission is a
doctor according of disease type).
Commission’s decision about prescription of opioids
is recorded in special book (numbered and proved
by out-patients' clinic director), where is matched
name, surname, age, address, diagnose, name of
prescribe drug, single and daily dose, prescription or
dose increasing date, commission members
signatures.
One prescription form must be prescribed drug
reserve only for 3-4 days
In April 08, 2007 by Parliament of Georgia were approved
the changes in 4 laws of Georgia:
- Law of Healthcare;
- Law of medical activity;
- Law of patient’s right;
- Law of concerning the narcotics, psychotropic materials,
precursors and narcological aid.
According to these changes:
- Definition of Palliative Care (analogous to WHO definition) was
added to “Law of Healthcare” and “Law of patient’s right”;
- Pain relief in incurable patients was recognized as absolutely
necessary issue (“Law of Healthcare”);
- Palliative care was recognized as a necessary component of
continuous medical aid, receiving by patient during all his life (“Law of
Healthcare” and “Law of medical activity”);
- Government engages (takes under the obligation) to provide patients
by necessary amount and necessary forms of opioids, correspondingly
to international standards (“Law of concerning the narcotics
psychotropic materials”)
- The Ministry of Labor, Health and Social Affairs is obligated to create
and sign “The Instruction of Palliative Care for chronic incurable
patients (“Law of Healthcare”).
Decree of the Minister of Labor, Health and Social
Affairs
On Approval of the Instruction about “the Palliative Care
Providence for Chronic, Incurable Patients”
Registration code: 470.230.000.22.035.012.017
2008
On March 17, 2009 the policy round table dedicated to
improvement of drug availability and oral morphine
importation was organized with participation of
members of Parliament, representatives of MOH,
Organizations providing Palliative Care, WHO Country
Office, National Cancer Center, AIDS Center,
Insurance Companies, Mass media and international
experts: Mary Callaway,Karen Ryan, Katalin Muzsbek,
Martha Maurer.
The special recommendations to MOH were prepared;
The main recommendation was
to Import Oral Morphine
Normative documents currently
regulating legal turnover of opioids in
Georgia
In order to provide successful management of
chronic pain and improve the accessibility to
opioids for medical use, the Georgian
government made a number of changes in
regulating documents during the period of 20082011.
A single prescription (recipe) prescribed for chronic
incurable patient may cover the amount (dose) of narcotic
drug for 7 days (order N157/n, 2008).
Responsibiliy for relevant administration and presciption
of the drug lies only on the physician prescribing the
recipe. (order N157/n, 2008).
A primary care physician in rural area, providing the
ambulatory service for the population in country-side, is
personally responsible for the prescription, which is
confirmed by their signature and personal stamp placed on
the prescription form (26.02.2010 N55/n).
State program of “providing onco-incurable patients with
controled medicines” the term “onco-inucarble” is
replaced by “chronic incurable”, which gives physicians
the basis to prescribe opioids for the treatment of chronic
pain in somatic patients as well.
Resolution of Georgian government #77, by February
15, 2011
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
There are preliminary identified and established 2 days
in each week, when the pharmacy, placed in the Police
Station can issue opioids to patients or their family
members.
(Joint decree of two ministers (#32 and #102 – March 13/15,
2000)
Narcotic drug prescribed on the recipe must be distributed
during the 5 working days. After 5 working days the
pharmacist is legally disabled to give out the drug.
If the patient’s condition is changed during the course of
the treatment, needing the change in a drug, dose or the
form, a doctor must issue a new prescription (order
N157/n, 2008).
“Narcotic drugs of different brand and form can be
prescribed on the same single prescription form. No
changes or corrections can be made in the prescription
form after prescribing the medicine.
The pharmacy can only sell the narcotic drug on the
basis of the original form of the prescription” (order
N18/n – N 96, 2010).
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
Quota
Determining the
demand
G METHODS FOR CALCULATION OF THE AMOUNT OF
OPIOIDS NEEDED FOR PAIN CONTROLN
(Provided by the 1961 single convention on narcotic
substances and used by International Narcotic Control
Board
•
•
•
•
Population-based
Service-based
Expenditure-based
Expenditure / Consumption ratio
•
Population-based method relies on epidemiological
indices of prevalence of general diseases in population
•
Service-based method relies on the types of services
and resources in healthcares system
•
Expenditure (consumption) – based relies on the
consumption index of previous years; this method is
justified for the countries where the consumption index
is based upon actual demands.
Calculation of the needed amount of morphine
according to population-based method
(oral morphine)
The demand on narcotic drugs in Georgia is determined by
population-based method, i.e. by the incidence (morbidity)
structure;
•
•
•
For patients with cancer:
Yearly mortality rate X 80% (patients needing morphine at endof-life) X 90 days X 60 mg/day (oral morphine)
4033 X 80%= 3226.5
3226.4 X 90 days X 60 mg = 17 422,5 mg annually
Recommendations for Country Quota request
P/O (IRM)
30%
10mg
20mg
P/O (SRM)
60%
30mg
60mg
(100mg)
P/E
Others
5%
5%
2 mg/ml
10 mg/ml
50 mg/ml
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
RELATIVE COST OF OPIOIDS
DRUG
Drug form
Relative cost
MORPHINE
per oral
(IR M)
Rapid action
1x
FENTANYL
per oral
Slow action
( SRM)
Parenteral
Trans cutaneous
3x
5x
> 20x
Purchase of narcotic drugs in Georgia is based on the
rates of previous years
Opioids Purchase by Governmental Budget via STATE
TENDERS
The winner private companies are importing and
distributing opioids in the pharmacies placed in police
station buildings throughout the country
The transportation of opioids from country border to
central office of company and from central office to
pharmacies is accompanied by special police team
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
COMPONENTS OF DRUG CONTROL SYSTEM
Opiod
Opiod
Consumption
Consumption
Analysis
Analysisand
and
Quota
QuotaRequest
Request
DabbleMonitoring and
reporting
Opioids
Dispense
Opioids Importation and
Distribution throughout
the Country
Storage Of Opioids
In Hospitals And
Pharmacies
Opioids
Administration
and Prescription
Thank you for your
attention !