Current System of Drug Control In Georgia

Current System of Drug Control

In Georgia

Prof. D. Kordzaia – Georgian National Association for Palliative Care

VIENNA - March 5-6, 2013

“Making Oral Opioids Available in Eastern Europe and Central Asia”

COUNTRY POPULATIONCOUNTRY POPULATION

ill, but ill, but curable peoplecurable people

people with people with chronic incurablechronic incurable

diseasediseasehealthy peoplehealthy people

Health Care Health Care SystemSystem

MedicineMedicine

palliative

palliative

cura

tive

cura

tive

preventive

preventive

Palliative Care in its modern understanding started the

integration into Healthcare and Social Affair systems of Georgia

in 2000

WHO Public Health Model

3. Education

4. Implementation

1. Policy1. Policy

2. DrugAvailability

International Palliative Care InitiativeOpen Society Foundations

Decrees, reports, declarations for Palliative Care; Palliative Care as a human rights

UN, WHO, EC, IAHPC, EAPC, OSI

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)

In 2006, seven countries together accounted for almost In 2006, seven countries together accounted for almost 84% of global consumption of morphine. 84% of global consumption of morphine.

These countries represent less than 12% of the world’s These countries represent less than 12% of the world’s population.population.

What do the data say?What do the data say?

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: 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 PrincipleBalance” 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 In 1961 the single convention on narcotic substances identifies the following substances identifies the following mechanisms of control:mechanisms of control:

1) Creation of the Estimate System, to 1) Creation of the Estimate System, to evaluate the demand on narcotic drugsevaluate the demand on narcotic drugs

2) Continuous renewal and provision of 2) Continuous renewal and provision of information to the statistical return information to the statistical return system of narcotic substances in the system of narcotic substances in the country 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.

Drug availability

Normative orderNormative order

ProtocolsProtocols

InstructionsInstructions

Governmental Budget

Governmental Budget

Education of medical professionals / social workers / students, etc.

Education of medical professionals / social workers / students, etc.

PolicyPolicy

LawLaw

Public AwarenessPublic Awareness

Education of decision makers


COMPONENTS OF DRUG CONTROL SYSTEM

Opiod Consumption Analysis and Quota Request


Opioids Importation and Distribution throughout the Country

Dabble-Monitoring and reporting

Storage Of Opioids In Hospitals And Pharmacies

Opioids Dispense

Opioids Administration and Prescription








Opioids Dispense



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

Pla

sm

a C

on

ce

ntr

ati

on

Pla

sm

a C

on

ce

ntr

ati

on

Pla

sm

a C

on

ce

ntr

ati

on

000 Half-life (t1/2)HalfHalf--life (tlife (t1/21/2)) TimeTimeTime

IVIVIV

PO / prPO / prPO / pr

SC / IMSC / IMSC / IM

CmaxCCmaxmax

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

Next dose of analgesics must be given before entire neutralization of previous dose – this schedule allows long term analgesia

Opioid method of application Ecvianalesic Doses

Morphine Parenteral Enteral

10 mg 30 mg

Codeine Parenteral Enteral

130 mg 200 mg

Table of analgesic effect identityTable of analgesic effect identity

Drug availability

Normative orderNormative order

ProtocolsProtocols

InstructionsInstructions

PolicyPolicy

LawLawEducation of decision makers


Healthcare system in Georgia is regulated by hierarchy:

a) laws of Georgiab) Normative orders c) Instructionsd) 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

No “Palliative Care” in Laws of Georgia No “Palliative Care” in Laws of Georgia

Normative Order of Two Ministers

20062006

No Instructions and Protocols on Palliative careNo 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 non-cancer 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

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

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 2008-2011.

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).

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.

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







Opioids Dispense




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 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).

“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).







Opioids Dispense




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 end-of-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) P/O (SRM) P/E Others

30% 60% 5% 5%

10mg

20mg

30mg

60mg

(100mg)

2 mg/ml

10 mg/ml

50 mg/ml







Opioids Dispense




RELATIVE COST OF OPIOIDSRELATIVE COST OF OPIOIDS

DRUG MORPHINE FENTANYL

Drug form per oral

(IR M)

Rapid action

per oral

Slow action

( SRM)

Parenteral Trans - cutaneous

Relative cost 1x 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

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







Opioids Dispense










Opioids Dispense




To be impro

ved and Standard

ized

To be impro

ved and Standard

ized

To be impro

ved and Standard

ized

To be impro

ved and Standard

ized

Thank you for your attention !

Current System of Drug Control In Georgia

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