Aproved by order No 702 as of by the Ministry of Health Care

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1 Translation form Lithuanian THE MINISTRY OF HEALTH ORDER OF THE REPUBLIC OF LITHUANIA No 702 Vilnius Conformation of the application procedure of Substitution therapy to opioid addicts In September 1995, the methadone programme was launched in Lithuania for opioid addiction treatment. The experience of two years has proved the efficiency of the (methadone) substitution treatment by attracting to health institutions drug addicts who earlier were unwilling to undergo the treatment. In October 1997 Vilnius Narcological Centre had 124 drug addicts among its patients, the figures of Narcologic Dispensary Department of Kaunas Psychiatric Hospital and Klaipëda Addiction disease Centre were 71 and 73 respectively. The research of treatment efficiency yielded the following results: two thirds of drug addicts under treatment felt the improvement of their health state, difficult cases of tuberculosis and venereal diseases were ascertained and successfully treated. Many HIV positive people are ascertained among intravenous drug addicts, part of whom are in methadone programme. Approximately 70 per cent of the methadone programme patients successfully integrate into society. In drug addicts in Klaipëda and 1 drug addict in Ðiauliai became HIV positive through syringes. The world-wide experience proves the most effective measures of HIV prevention be the substitution treatment of intravenous drug addicts. This is why it is reasonable to enhance the accessibility of the substitution treatment for Lithuanian citizens. In order to enlarge the variety of drug addiction treatment programmes and to make medical aid accessible for drug addicts, to improve their health care and to prevent the spread of HIV, hepatitis B and C, and other blood infectious diseases, I hereby ORDER: 1. Chief Doctor of Vilnius Narcological Centre Mr E. Subata, Chief Doctor of Kaunas Psychiatric Hospital Mr G.Èebelis, and Chief Doctor of Klaipëda Addiction Disease Centre Mr A. Slavickas to: 1.1. proceed with the substitution treatment of opioid drug addicts; 1.2. implement the treatment with substitution drugs (long-term substitution treatment and detoxification) as provided in appendixes 1 and 2; 1.3. safeguard and account for substitution medicine to Narcotic Commission as provided in appendix No Chief doctor of Vilnius Narcological Centre Mr E. Subata to organise the registration, information accumulation, and assessment of substitution therapy patients. 3. Chief of Medicine department of the Ministry of Health of the Republic of Lithuania Miss O. Abraitytë and Chief Doctor of Vilnius Narcological Centre Mr E. Subata to assess the needs of and to submit proposals on the application of substitution therapy in other towns of the country. 4. Chief of Narcotic Commission of State Medicine Control Service Mr V. Basys to constantly assess the demand for substitution medicine and to order the necessary amount from the UN International Narcotic Control Committee. 5. To invalidate the order No 252 of of the Ministry of Health of the Republic of Lithuania. 6. The control of the order enforcement is hereby charged to deputy chairman Mrs R. Baranauskienë. Minister /seal/ O. Abraitytë, Juozas Galdikas Aproved by order No 702 as of by the Ministry of Health Care

2 Annex 1 Application procedure of the substitution therapy for opioid addiction treatment The opioid substitution therapy is implemented following the law on Narcological Care of Narcotic and Psychotropic Substance Control of the Republic of Lithuania and other legal acts. Concepts 1. Substitution therapy (substitution treatment) - the treatment of opioid addicts substituting opioids by medicinal materials registered in the Republic of Lithuania in the established order. 2. Substituting opioid medicine - medicinal materials of synthetic origin belonging to the class of opioids registered in the Republic of Lithuania. They are prescribed by a doctor according to medical indications to treat opioid addicts. A lot of medicine used for substitution therapy in the world, such as methadone hydrochloride, buphrenorphine, LAAM, morphine sulphate and others are of a low toxicity and well tolerated. Medicinal materials used for the substitution therapy are regulated by Narcotic and Psychotropic Medicine List adopted by State Medicinal Control Office at the Ministry of Health of the Republic of Lithuania (approved by Head of SMCO on , and other normative acts). Objectives of the Substitution Therapy The substitution therapy for opioid addicts is prescribed in order to: 1. gradually improve the physical and mental condition of opioid addicts, to improve their social adaptation and integration into the society; 2. better organise HIV, hepatitis B and C, and other disease prevention among people using drugs; 3. treat more effectively contiguous diseases, such as tuberculosis, diabetes, contiguous mental disorders; 4. treat more effectively drug injection complications, such as sepsis, purulent infections, hepatitis B and C, trophic ulcers, etc., or to help to avoid them; 5. create more favourable conditions for prenatal and postnatal care of pregnant women using drugs; 6. attract drug users to health care institutions; 7. create a possibility to stop using intravenous drugs for HIV positive drug addicts;

3 Indications of the Substitution Therapy 1. chronic cases of opioid addiction (regular injection of opioids for more than 2 years, several unsuccessful attempts to undertake the out- or inpatient treatment in health care institutions and rehabilitation communities); 2. complications of opioid addiction (various urgent states, hepatitis B and C, trophic ulcers, sepsis, abscesses, utter physical exhaustion, HIV and AIDS); 3. contiguous diseases (oncological diseases, contiguous mental disturbances, diabetes and other difficult somatic states); 4. pregnancy when intravenous opioids are injected; 5. other individual indications laid out by DCC. The Order of Prescribing Substitution Treatment In the territory assigned to a municipality the substitution treatment is guided and implemented by local narcological care institutions (addiction disease centres), or by mental health centres when addiction disease centres are absent. A health care institution is granted permission to apply substitution treatment by the Ministry of Health Care of the Republic of Lithuania as provided by order defined. A doctor may start substitution treatment after having passed a definite course in Vilnius University Psychiatric Clinic. General Requirements for Substitution Therapy: 1. The Chief Doctor of a health care institution establishes Doctors Consultation Commission (DCC) to be in charge of substitution treatment prescription, continuation, efficiency assessment and discontinuation. 2. Substitution treatment is prescribed by a decision of DCC, which assesses the soundness of diagnosis given by psychiatrist and of indications for substitution therapy. An agreement is signed between a patient and a health care institution which provides the rights and commitments of both parties. Substitution therapy cannot be prescribed anonymously. 3. DCC informs Vilnius Narcologic Centre about a patient having started the substitution treatment (first name, family name, place of residence) within the period of three days. The information about a person having finished the substitution therapy shall be passed DCC to Vilnius Narcological Centre within the period of three days via telephone: (8-22) Vilnius Narcological Centre under the guidance of law on Mental Health is responsible for confidentiality of people undergoing the substitution therapy. 4. Patients starting the substitution therapy will have an individual treatment plan drawned for them. This plan provides: a) screening procedure for tuberculosis, hepatitis B and C, HIV, veneral and other diseases; b) medical complications and treatment of contiguous illnesses; c) psychological and social rehabilitation measures. A treatment plan is adjusted every three months under the supervision of DCC. DCC records the conclusions about the treatment efficiency into medical records. 5. In case of difficult somatic states and urgent indications, the substitution therapy may be prescribed by a psychiatrist licensed to practise the substitution treatment. His/her decision on the substitution treatment shall be approved by DCC during a two week period. 6. The substituting opioid medicine is taken in the presence of medical staff. In case of a patient s illness when he/ she receives an out-patient treatment (and the prove of such treatment being taken has been obtained from primary or any other health care institution of a respective person), DCC may pass a decision to give the substituting medicine to the relatives of a person being ill

4 after having recorded this fact in a patient s medical record. In case of stable remission, DCC may pass a decision to let patients carry methadone away with them during public holidays, Sundays and specific occasions. The giving out procedure of medicine is provided by a health care institution. 7. During the course of the substitution treatment it is recommended to make urine tests in order to detect the use of other drugs and to objectively assess the treatment efficiency. 8. People, having reached health and social state stabilisation, may be directed by DCC to a general practitioner in a primary health care institution centre after the agreement between care institutions had been concluded. A general practitioner is consulted by psychiatrists following the treatment plan which is coordinated with DCC, controls work of nursing staff and giving-out procedure of the substituting opioid medicine. 9. Patients can have the substitution treatment discontinued following the decision of DCC. 10. The length of the substitution treatment is determined according to clinic indications. 11. When the substitution treatment is discontinued, the out- or inpatient detoxification shall be applied to a patient. Control of the Substitution Treatment Medicine used for the substitution therapy are subject to control by valid legal acts of the Republic of Lithuania. The order, storage and accounting for opioid medicine is regulated by appendix 3 of law no 702 of that reads The Procedure of Methadone Prescription, Storage and Accounting in Health Care Institutions. Every case of giving opioid medicine and its dose shall be accounted in medical records and signed by a member of medical staff. Medicine is given only after identifying the person. The Financing of the Treatment Opioid substitution therapy is financed out of obligatory state and municipal programmes, as well as charity and private funds. The substitution treatment may be paid by patients themselves or their relatives. In the latter case the procedure of payment for and control of the substitution treatment is established by Head of a health care institution.

5 The Procedure of Detoxification with Opioid Medicine Annex 2 Concepts 1. Detoxification - renovation of human body functions having been previously disordered in the course of poisoning with materials affecting the mentality through the removal of these materials or their splitting products out of the human body; the removal of the abstinence syndrome caused by addiction to materials affecting the mentality; the removal of alcohol. Detoxification from opioids can be carried out either in out- or inpatient clinics, as well as be combined with out- or inpatient detoxification. Outpatient clinic detoxification can be of a short term - up to 1 month - as well as of a medium term - up to 3 months. 2. Substituting opioid medicine - medicinal materials of synthetic origin belonging to the class of the opioids registered in the Republic of Lithuania in the order defined. A lot of medicine used for the substitution therapy in the world, such as methadone hydrochloride, buphrenorphine, LAAM, morphine sulphate and others are of a low toxicity and well tolerated. Indications for Outpatient Detoxification Diagniostics of addiction to opioids and motivation to stop using opioid materials. Procedure of Outpatient Detoxification from Opioids by Substituting Medicine 1. Outpatient detoxification can be carried out in those health care institutions which prescribe the substitution treatment. 2. Outpatient detoxification from opioids by substituting medicine is prescribed by a psychiatrist who has assessed the state of a patient. 3. Outpatient detoxification is carried out after an agreement between a patient and a health care institution has been signed providing the rights and commitments of both parties. 4. Persons belonging to outpatient detoxification drink the opioid substituting medicine in the presence of medical staff (in a health care institution or at home) every day. Prior to public holidays and weekends, in specific occasions, or when a patient is supported by his/ her family, the medicine may be given to a member of the family when the permission is granted by DCC. 5. Persons belonging to outpatient detoxification shall be tested against the use of other psychoactive materials. 6. Having detected the use of other psycho-stimulants, or in any other breach of an established order (the agreement), these persons may be directed to an inpatient detoxification department, the substitution programme, or the outpatient detoxification may be discontinued. 7. During the outpatient detoxification, when necessary, an additional symptomatic treatment is prescribed, and a psychological correction to patients and their family members is carried out.

6 Annex 3 The Procedure of Methadone Prescription, Storage and Accounting in Health Care Institutions Prescription 1. The requirements for methadone as for any other narcotic drugs and medicinal materials shall be written on a separate form with the following properties: a stamp, a seal of a health care institution, the signature of the Head or of deputy director for treatment pragrammes of the institution; in the requirement the name of the department or cabinet and the purpose of the medicine shall be indicated. The Giving-out Procedure at the Chemist s 2. Methadone is given at a chemist s to a person from health care institutions on the basis of an extraordinary authorisation stating the name of a drug and having the amount of a drug spelled. The authorisation shall be signed by Head of the institution and accountant and be confirmed by a seal of the institution. Storage 3. Methadone shall be kept in a separate, locked room with the window bars or in a windowless room, in safes which are fixed to the walls or the floor. Stocks 4. Methadone stocks in health care institution departments (cabinets) assigned for storage purpose shall not exceed the three-day amount, and in chemist s of a health care institution - the amount of two weeks. Accounting 5. Health care institutions shall carry out a daily quantity accounting of methadone in a special numbered book with bound pages (Accounting Book for Narcotic Drugs in Departments and Cabinets of Health Care Institutions). The book shall be approved by the Chief Doctor s signature. On the first day of each month a person in charge of methadone accounting shall check the methadone quantity on hand with the methadone quantity in the book; the balance of methadone is computed according to the data in the book. At the end of the quarter, by the 15th of the following month, data on methadone use shall be submitted to Narcotic Commission of Lithuanian Pharmacology Committee (Gedimino av. 27, 2600 Vilnius, tel.: , fax: ). Responsibility 6. The reasonable use, storage and giving of methadone to patients belongs to the responsibility of Chief Doctor or a person authorised by his / her order. Narcotic Commission of LPC, tel.:

7 THE MINISTRY OF HEALTH ORDER OF THE REPUBLIC OF LITHUANIA No 68 Vilnius On the supplement of the Ministry of Health order No 702 as of The Law on Narcotic and Psychotropic Substances having come into effect, and seeking to specify the procedure of substitution therapy prescription established by the Ministry s of Health order as of December 22, 1997 on Conformation of the Application Procedure of Substitution Therapy to Opioid Addicts I hereby ORDER: 1. In Annex 1: 1.1. To add the following sentence to the second paragraph Substituting Opiod Medicine, section Concepts : In the Republic of Lithuania only methadone hydrochloride is allowed to be used for the substitution therapy ; 1.2. to cross out the last paragraph of section Concepts ; 1.3. to formulate section Substitution Therapy Procedure in the following way: In the territory assigned to the municipality the substitution treatment is guided and implemented by available narcological care institutions (addiction disease centres), or by mental health centres when addiction disease centres are absent. A health care institution is granted permission to apply substitution treatment by the order of Ministry of Health Care of the Republic of Lithuania. A doctor may start substitution treatment after having passed a definite course in Vilnius University Psychiatric Clinic. While applying the substitution therapy, to be guided by the teaching aid Opioid Addiction: Diagnostics, Detoxication, Methadone Substitution Treatment, Alleveation of Damage Caused by Drugs (Vilnius University, Vilnius University Psychiatric Clinic, Vilnius Narcological Centre: 1997) which is prescribed for doctors, students of medice, and residents ; 1.4. In section General Requirements for Substitution Therapy : to add the following to the first item: Management and direct responsibility of the performance of Doctors Consultation Commission shall be borne by a manager or his authorised representative from a person s health care institution ; to formulate item three in the following way: DCC informs Vilnius Narcologic Centre about a patient having started and completed a substitution therapy (first name, family name, place of residence) within the period of three days. Vilnius Narcological Centre under the guidance of law on Mental Health is responsible for confidentiality of people undergoing the substitution therapy to formulate item six in the following way: The substituting opioid medicine is taken in the presence of medical staff. In case of a patient s illness when he/ she receives an out-patient treatment (and the prove of such treatment being taken has been obtained from a primary or any other health care institution of a respective person), DCC may pass a decision to give the substituting medicine (for no more than one day) to the relatives of a person being ill after having recorded this fact in a patient s medical record. In case of a stable remission, DCC may pass a decision to let patients carry methadone away with them during public holidays, Sundays and specific occasions. The giving out procedure of medicine is provided by a health care institution. 2. In annex 2: 2.1. to add the following sentence to first paragraph, section Concepts : In the Republic of Lithuania only methadone hydrochloride is allowed to be used for the out-patient detoxication to cross out second paragraph of section Concepts. 3. In annex 3: 3.1. to formulate the fourth section Stocks in the following way: Methadone stocks in health care institution departments (cabinets) assigned for storage purpose shall not exceed the five-day amount, and at the chemist s of a health care institution - the amount of two weeks; 3.2. to formulate the fifth section Accounting in the following way: Health care institutions shall carry out a daily quantity accounting of methadone in a special numbered book with bound pages which shall be

8 provided to every department and cabinets of health care institutions which use such substances. The book shall be approved by the Chief Doctor s signature and seal. (The Ministry of Health of the Republic of Lithuania, order No 705 as of , annex 3, p. 1). On the first day of each month, a person in charge of methadone accounting shall check the methadone quantity on hand with the methadone quantity in the book; the balance of methadone is computed according to the data in the book. At the end of the quarter, by the 15th of the following month, data on methadone consumption shall be submitted to Narcotic Commission of State Medicine Control Office (Gedimino av. 27, 2600 Vilnius, tel./fax: ). Minister of Health Care Juozas Galdikas Translated by translator of UAB Vertimai Sigita Tupèiauskaitë

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