Country Report for: ALBANIA DR. KRISTO HUTA

2 Demographic Dat a Albania: Population Albania: Population »Year 1990: inhabitants. »Year 1990: inhabitants. »Year 2010: inhabitants Area : km2 Area : 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 rateall causes, all ages 847/ inhabitants Mortality rate all causes, all ages 847/ inhabitants Level of fertility (per 1000) 13.8 Level of fertility (per 1000) 13.8 Surce: INSTAT

3 Epidemiology data on tumors  Period 1986 – 1990 Average number of cases per year Average number of cases per year Population inhabitants ( ref. National Register of Tumors)  2001: new cancer cases diagnosed Population ( ref. Inter Hospital Cancer Registry)  2010: - About 5000 new cancer cases diagnosed Population Population (Ref. GLOBOCAN)

4 Mortality causes (2010) Cardio-vascular 50.2 % Cardio-vascular 50.2 % Oncology 16.6 % Oncology 16.6 % Traumas and accidents 6.8 % Traumas and accidents 6.8 % Other 11.3 % Other 11.3 % Surce: Ministry of Health

5 Epidemiological data on tumors in Albania 2008 Women Estimated incidence, mortality and 5-year prevalence: men Estimated incidence, mortality and 5-year prevalence: woman

1. Cancer pain and palliative care December 2009 – 10 Member Steering Committee established (Chairman: Vice Minister of Health) May NCCP finished/submitted to Ministry of Health June 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 service. Only 30% of terminal cancer patients have benefit palliative care service. Currently, palliative care in Albania is provided mainly by non profit sector. Currently, palliative care in Albania is provided mainly by non 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 care

Pediatric palliative service is given in Pediatric Hospital in University Hospital Center in Tirana Pediatric palliative service is given in Pediatric Hospital in University Hospital Center in Tirana Very few pediatric patients are treated from NGOs Very 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 an algesics Pediatric patients have access to opioid an 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. 8

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) 9

The National Strategy for the Prevention and Control of HIV/AIDS in Albania (updated in 2010). The National Strategy for the Prevention and Control of HIV/AIDS in Albania (updated in 2010). There is National AIDS Program, as part of Institute of Public Health structure. There is National AIDS Program, as part of Institute of Public Health 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 addressed Neither opiod analgesics are addressed 2. HIV/AIDS pain and palliative care

It is still a small number of patients with HIV/AIDS,without a significant weight for palliative care health structures It is still a small number of patients with HIV/AIDS,without a significant weight for palliative care health structures Treatment and follow-up is done in Infectious Service in University Centre Hospital in Tirana Treatment and follow-up is done in Infectious Service in University Centre Hospital in Tirana 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. 11

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. eeting. A representative of this office is present at this meeting. 12

3. Opioid availability National Competent Authority has not a method for calculating estimates of annual need for opioids that they submit to INCB National Competent Authority has not a method for calculating estimates 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 of Estimation of annual need for opioids relies mainly in consumption of previous year. previous year. Our NCA reports annual statistics on the consumption of opioid analgesics to the INCB. Our NCA reports annual statistics on the consumption of opioid analgesics to the INCB. 13

3. Opioid availability WHO recommends an essential list with 33 drugs for palliative care, from which 26 of them or 79% are available. WHO recommends an essential list with 33 drugs for palliative care, from which 26 of them or 79% are available. In reimbursed drug list of Insurance Institute of Health Care, 15 drugs are included or 45%. In reimbursed drug list of Insurance Institute of Health Care, 15 drugs are included or 45%. 20% of this group of drugs ( Reimbursed for Palliative care) have limited in usage dosage and quantity. 20% of this group of drugs ( Reimbursed for Palliative care) have limited in usage dosage and quantity. Availability of drugs to the WHO essential list is satisfactory, but nevertheless should be improved. Availability of drugs to the WHO essential list is satisfactory, but nevertheless should be improved. Terminal patient don’t access these drugs due to lack of knowledge of physicians Terminal patient don’t access these drugs due to lack of knowledge of physicians 14

3. Opioid availability Morphine is only available in 10 mg injection and in 10 mg long acting tablets Morphine is only available in 10 mg injection and in 10 mg long 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 the HIV program. Methadone is only available for injecting drug users as part of the HIV program. Petidin very rarely used Petidin very rarely used No immediate release morphine preparations No immediate release morphine preparations The current company that provides slow release morphine is Albtrade Pharma The current company that provides slow release morphine is Albtrade Pharma The injection morphine is produced in Albania by a local company(Propharma) The injection morphine is produced in Albania by a local company(Propharma) 15

3. Opioid availability OpioidAvailableNot availableReimbursedNot reimbursed Codeine XX Tramadol, injectableXX PropoxypheneXX HyrdocodoneX Morphine immediate releaseX Morphine sustained releaseXX Morphine injectableXX Oxycodone immediate releaseX Oxycodone sustained releaseX MethadoneX Methadone injectableX Fentanyl transdermalXX Fentanyl transmucosalX Fentanyl InjectableXX Hyrdomorphone immediate releaseX Hyrdomorphone sustained releaseX Hyrdomorphine injectableX BuprenorohineX Buprenorphine transdermalX Pethedine injectableXX

3. 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. 17

3. 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. 18

3. Opioid availability The national law or regulation does not require reporting names of patients who receive opioid prescriptions to the government. The national law or regulation does not require reporting names of patients who receive opioid prescriptions to the government. The new law is under the process The new law is under the process Health insurance coverage is a barrier to patients accessibility to opioid analgesics because of limited value of reimbursement Health insurance coverage is a barrier to patients accessibility to opioid analgesics because of limited value of reimbursement The minimum penalty for physician or pharmacist who violates the prescribing laws or regulations is 10$ -200$ The minimum penalty for physician or pharmacist who violates the prescribing laws or regulations is 10$ -200$ The maximum penalty is removal of license The maximum penalty is removal of license 19

DRUG DISTRIBUTING SYSTEM 20 Level 1:International Narcotics Control Board Level 3 :Importer/Manufactures/Distributors Level 2: National Competent Authority Level 4: Hospitals/Pharmacies/Pc Programs Level 6 :PATIENTS Level 5: Physicians/Pharmacists/Other MedicationInformation

The symbol… against pain and suffering is an Albanian. The symbol… against pain and suffering is an Albanian. THANK YOU !