Country Report for:

ALBANIA

DR. KRISTO HUTA

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Demographic DatDemographic Dataa

Albania: PopulationAlbania: Population» Year 1990: 3.380.000 inhabitantsYear 1990: 3.380.000 inhabitants ..» Year 2010: 3.120.000 inhabitantsYear 2010: 3.120.000 inhabitants

Area : 28748 km2Area : 28748 km2 Average Age : 32 year-old.Average Age : 32 year-old. Age group up to 45 years old : 43,8 % of population.Age group up to 45 years old : 43,8 % of population. Age group 60 –79 year-old : 6,9 % of population.Age group 60 –79 year-old : 6,9 % of population. 45 % of population live in urban areas.45 % of population live in urban areas. Mortality rateMortality rate all causes, all ages 847/100.000 inhabitantsall causes, all ages 847/100.000 inhabitants Level of fertility (per 1000) 13.8Level of fertility (per 1000) 13.8

Surce: INSTATSurce: INSTAT

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Epidemiology data on tumors Epidemiology data on tumors Period 1986 – 1990 Period 1986 – 1990 Average number of cases per year - 2.800Average number of cases per year - 2.800

Population - 3.387.000 inhabitantsPopulation - 3.387.000 inhabitants ((ref. National Register of Tumors)ref. National Register of Tumors)

2001:2001:-3.000 new cancer cases diagnosed-3.000 new cancer cases diagnosedPopulation- 3.087.000 Population- 3.087.000 ((ref. Inter Hospital Cancer Registry)ref. Inter Hospital Cancer Registry)

2010:2010:- About 5000 new cancer cases diagnosed- About 5000 new cancer cases diagnosed Population- 3.127000Population- 3.127000

(Ref. GLOBOCAN)(Ref. GLOBOCAN)

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Mortality causes (2010)Mortality causes (2010)

Cardio-vascular Cardio-vascular 50.2 %50.2 %

Oncology Oncology 16.6 %16.6 %

Traumas and accidents Traumas and accidents 6.8 %6.8 %

Other Other 11.3 % 11.3 %

Surce: Ministry of HealthSurce: Ministry of Health

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Epidemiological data on tumors in Albania Epidemiological data on tumors in Albania 20082008

Women

Estimated incidence, mortality and 5-year prevalence: men

Estimated incidence, mortality and 5-year prevalence: woman

1.1. Cancer pain and palliative careCancer pain and palliative care

December 2009 – 10 Member Steering Committee established (Chairman: Vice Minister of Health)

May 2011 - NCCP finished/submitted to Ministry of Health

June 2011 - NCCP finalized and endorsed by the Minister of Health

National Cancer Control Programme Chairperson/Coordinator/Manager to be nominated

Objectives for pain relive and Palliative Care included

Availability of opioid analgesics specifically addressed

Only 30% of terminal cancer patients have benefit palliative care Only 30% of terminal cancer patients have benefit palliative care service.service.

Currently, palliative care in Albania is provided mainly by non Currently, palliative care in Albania is provided mainly by non profit sector. profit sector.

There is only one public service (Oncologic Home Service)There is only one public service (Oncologic Home Service)

There is a lack of inpatient and bed hospice unit.There is a lack of inpatient and bed hospice unit.

Very few non cancer patients receive palliative care .Very few non cancer patients receive palliative care .

1.Cancer pain and palliative care1.Cancer pain and palliative care

1.Cancer pain and palliative care1.Cancer pain and palliative care

Pediatric palliative service is given in Pediatric Hospital in University Pediatric palliative service is given in Pediatric Hospital in University Hospital Center in TiranaHospital Center in Tirana

Very few pediatric patients are treated from NGOsVery few pediatric patients are treated from NGOs There are no specialist for pediatric palliative care There are no specialist for pediatric palliative care

Pediatric patients have access to opioid anPediatric patients have access to opioid analgesics algesics

The government has not endorsed the WHO method for relief of cancer pain and has not sponsored or endorsed training programs in cancer pain relief, palliative care and medical use of opioid analgesics.

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1.Cancer pain and palliative care (PC)1.Cancer pain and palliative care (PC)

. For the first time PC was provided in 1993 only form non profit sector and 1997 from the state sector.

. In 2002 it is established the AAPC

. In 2003 it is founded the first inpatient hospice.

. Since 2010 there are optimistic developments

in PC in the country.

. Currently there are only 4 home care

providers of PC in Albania

- Sue Ryder Care (Tirane , Durres)

- Mary Potter (Korce)

- Caritas (Shkoder, Elbasan, Lezhe)

- SOB (Tirane)

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The National Strategy for the Prevention and Control of HIV/AIDS The National Strategy for the Prevention and Control of HIV/AIDS in Albania (updated in 2010).in Albania (updated in 2010).

There is National AIDS Program, as part of Institute of Public Health There is National AIDS Program, as part of Institute of Public Health structure. structure.

Pain relief and palliative care are not included in the above strategy.Pain relief and palliative care are not included in the above strategy.

Neither opiod analgesics are addressedNeither opiod analgesics are addressed

2. HIV/AIDS pain and palliative care2. HIV/AIDS pain and palliative care

2. HIV/AIDS pain and palliative care2. HIV/AIDS pain and palliative care

It is still a small number of patients with HIV/AIDS ,without a significant weight for It is still a small number of patients with HIV/AIDS ,without a significant weight for palliative care health structurespalliative care health structures

Treatment and follow-up is done in Infectious Service in University Centre Hospital in Treatment and follow-up is done in Infectious Service in University Centre Hospital in TiranaTirana

Only few terminal patients are followed up by NGOs Only few terminal patients are followed up by NGOs

The government has not endorsed the WHO method for relief of HIV/AIDS pain and has not sponsored or endorsed training programs in HIV/AIDS pain relief, palliative care and medical use of opioid analgesics.

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3. Opioid availability

National Competent Authority for narcotics control for the country is part of the Pharmaceutical Department at the Ministry of Health.

The person in charge of this office is the Director of Pharmaceutical Department.

The Pharmaceutical Directorate and Drug issues Department are in charge of submitting the annual estimate of medical requirements for narcotic drugs, including morphine, to the International Narcotics Control Board.

A representative of this office is present at this meeting .eeting .

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3. Opioid availability3. Opioid availability

National Competent Authority has not a method for calculating National Competent Authority has not a method for calculating estimates of annual need for opioids that they submit to INCBestimates of annual need for opioids that they submit to INCB

Therefore does not address unmet actual needs for opioids analgesics Therefore does not address unmet actual needs for opioids analgesics

Estimation of annual need for opioids relies mainly in consumption ofEstimation of annual need for opioids relies mainly in consumption of

previous year .previous year .

Our NCA reports annual statistics on the consumption of opioid Our NCA reports annual statistics on the consumption of opioid analgesics to the INCB.analgesics to the INCB.

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3. Opioid availability3. Opioid availability WHO recommends an essential list with 33 drugs for palliative care, from WHO recommends an essential list with 33 drugs for palliative care, from

which 26 of them or 79% are available.which 26 of them or 79% are available.

In reimbursed drug list of Insurance Institute of Health Care, 15 drugs In reimbursed drug list of Insurance Institute of Health Care, 15 drugs are included or 45%.are included or 45%.

20% of this group of drugs ( Reimbursed for Palliative care) have limited 20% of this group of drugs ( Reimbursed for Palliative care) have limited in usage dosage and quantity. in usage dosage and quantity.

Availability of drugs to the WHO essential list is satisfactory, but Availability of drugs to the WHO essential list is satisfactory, but nevertheless should be improved. nevertheless should be improved.

Terminal patient donTerminal patient don’’t access these drugs due to lack of knowledge of t access these drugs due to lack of knowledge of physiciansphysicians

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3. Opioid availability3. Opioid availability

Morphine is only available in 10 Morphine is only available in 10 mgmg injection and in 10 injection and in 10 mgmg long long acting tablets acting tablets

Fentanyl is available, but too expensive to afford .Fentanyl is available, but too expensive to afford . Methadone is only available for injecting drug users as part of Methadone is only available for injecting drug users as part of

the HIV program .the HIV program . Petidin very rarely usedPetidin very rarely used No immediate release morphine preparations No immediate release morphine preparations The current company that provides slow release morphine is The current company that provides slow release morphine is

Albtrade Pharma Albtrade Pharma The injection morphine is produced in Albania by a local The injection morphine is produced in Albania by a local

company(Propharma)company(Propharma)

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3. Opioid availability3. Opioid availabilityOpioid Available Not available Reimbursed Not

reimbursed

Codeine X X

Tramadol, injectable X X

Propoxyphene X X

Hyrdocodone X

Morphine immediate release X

Morphine sustained release X X

Morphine injectable X X

Oxycodone immediate release X

Oxycodone sustained release X

Methadone X

Methadone injectable X

Fentanyl transdermal X X

Fentanyl transmucosal X

Fentanyl Injectable X X

Hyrdomorphone immediate release X

Hyrdomorphone sustained release X

Hyrdomorphine injectable X

Buprenorohine X

Buprenorphine transdermal X

Pethedine injectable X X

3. Opioid availability3. Opioid availability The opioids are not sufficiently available . There are shortages . No special training required for opioid prescribing ,but NGO offer

trainings Prescribing is limited to doctors of NGO, authorized doctors in districts

where there is no palliative care service and GP’s with recommendation from specialist

To prescribe opioids is required a license and signed a contract with Insurance Institute of Health Care.

Nurses are not authorized to prescribe Prescription forms required are special and approved from Insurance

Institute of Health Care .

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3. Opioid availability3. Opioid availability

The physicians working in Palliative Care can prescribe opioid without dosage limitations

General practitioners can prescribe opioid no more than 100 mg /per day Prescriptions are limited up to seven days There is no a maximum length of time that a patients can receive opioids The validity of a prescription for an opioid such as morphine is 3 days Only cancer patients benefit opioids ,so prescribing regulations exclude

patients populations and diagnoses

There are no different legal requirements for prescribing ,dispensing or purchasing different dosage forms of the same opioid, i.e., oral, transdermal , injectable.

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3. Opioid availability3. Opioid availability The national law or regulation does not require reporting names of The national law or regulation does not require reporting names of

patients who receive opioid prescriptions to the government.patients who receive opioid prescriptions to the government.

The new law is under the processThe new law is under the process

Health insurance coverage is a barrier to patients accessibility to opioid Health insurance coverage is a barrier to patients accessibility to opioid analgesics because of limited value of reimbursement analgesics because of limited value of reimbursement

The minimum penalty for physician or pharmacist who violates the The minimum penalty for physician or pharmacist who violates the prescribing laws or regulations is 10$ -200$prescribing laws or regulations is 10$ -200$

The maximum penalty is removal of license The maximum penalty is removal of license

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DRUG DISTRIBUTING SYSTEM

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Level 1:International Narcotics Control Board

Level 3 :Importer/Manufactures/DistributorsLevel 3 :Importer/Manufactures/Distributors

Level 2: National Competent Authority

Level 4: Hospitals/Pharmacies/Pc ProgramsLevel 4: Hospitals/Pharmacies/Pc Programs

Level 6 :PATIENTSLevel 6 :PATIENTS

Level 5: Physicians/Pharmacists/OtherLevel 5: Physicians/Pharmacists/Other

MedicationMedication InformationInformation

The symbol… against The symbol… against pain and suffering is an pain and suffering is an Albanian.Albanian.

THANK YOU !THANK YOU !