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Substitution Treatment - Treatment Regimes

Does the legal framework establish admission criteria for ST programmes? Does the legal framework establish limitations in terms of durations for treatment? Does the legal framework establish maximum individual dose size? Does the legal framework establish a system for taking home a limited number of doses of the drug?
Country Legal basis Content Legal basis Content
Czech Republic YES:
The Standard of Substitution Treatment (Decree of Ministry of Health No. ZD07/2001)
Methadone: severe and long-term addiction to opioid-type substances, repeated unsuccessful attempts to undergo abstinence-oriented treatment, age >16 years.
Buprenorphine: opioid addiction with a daily dose not higher than an equivalent of 60 mg of methadone, abstinence-oriented treatment is not feasible, age > 15 years
NO NO NO
Denmark YES: National Board of Health, Guideline of June 8, 2007 concerning the prescription of addictive substances paragraph 7 ST with opioids can only be used for patients with an opioid addiction as defined in WHOs ICD-10. ST is part of a social plan and therefore the decision to offer ST has to be made taking into account whether ST is relevant in relation to realizing the goals in this plan. Furthermore the patient must want the treatment and other relevant treatment alternatives must have been considered. Pregnant women, who wants to carry through the pregnancy, should be offered ST if detox is not realistic. NO NO: There is no maximum dose stipulated in the guidelines. It is only mentioned that most patients can manage with 120 mg or less methadone or 16 mg or less buprenorphine. YES:National Board of Health, Guideline of June 8, 2007 concerning the prescription of addictive substances paragraph 7 If the patient is stabilised. As a general rule not for more than 1 weeks use, exceptions are made in relation to vacations etc.,
Germany YES: Section 5 subsections 1 and 2 of the Narcotic Drugs Prescription Ordinance establish admission criteria. They are specified in the guidelines of the Federal Medical Board for ST and the guidelines of the Federal Association of Physicians and Public Health Insurance Organisations. Substitute drugs may be prescribed to patients suffering from an opiate dependence. The objectives of the ST are: 1. treatment of the opiate addiction with the goal of step-by-step recovery to abstinence inclusive of improvement and stabilisation of the general health status; 2. treatment of patients addicted to opiates who have to undergo medical treatment for severe medical illnesses and 3. to reduce the risks associated with opiate addiction during pregnancy and after birth. NO. Neither the Narcotic Drugs Prescription Ordinance nor the guidelines developed by the Federal Medical Board establish time limitations for the ST. However, the guidelines introduced by the Federal Association of Physicians and Public Health Insurance Organisations provide for the review of every ST after 5 years at the latest. Section 2 of the Narcotic Drugs Prescription Ordinance establishes a maximum prescription per patient within 30 days for up to 2 of the following substitution substances: levomethadone (1,500 mg), methadone (3,000 mg), levacetylmethadol (2,000 mg), buprenorphine (800 mg) and in particular exceptional cases codeine (40,000 mg) or dihydrocodeine (40,000 mg). YES: Section 5 subsection 8 of the Narcotic Drugs Prescription Ordinance Up to seven days' quantity may be prescribed for own use if and as long as the course of the treatment allows it and this does not impair the security and control of the traffic in narcotic drugs. Exceptionally, in the case of a period of stay abroad, the patient may be prescribed a quantity for that period. The sum of these prescriptions per year shall not exceed the quantity of the substitute needed for up to 30 days.
Estonia NO: Criteria is establishes in National Drug Treatment Guidelines but they are not endorsed legally The admission criteria are: -minimum age over 20 years, opiate dependence (by intravenous use) for 5 years. NO NO NO: Guidelines have been prepared by NIHD and are obligatory to all services financed by NIHD from state budget. Once a week up to two days' doses of the drug can be taken home based on the written agreement. Drug is not given to the patient but to the parent, close relative, support person. All cases of extraordinary situations are reviewed individually.
Greece The admission criteria are: -minimum age over 20 years, certified opiate dependence (by intravenous use), for users under 35 to have unsuccessfully undergone treatment in a dry programme, sign a contract accepting the conditions of the participation, not suffer from mental illness which makes participation impossible. NO NO
Spain YES: RD 75/1990 and RD 5/1996 article 1 Previous confirmed diagnosis of opioid dependence. In cases of pregnancy, HIV infection or serious systemic disease, these criteria did not apply. NO NO NO: It depends on the regulation by each centre depending on Autonomous Communities.
France L.5111-1, L.5121-8, R.5121-23 and R.5121-36 CSP Detailed conditions for the use of the four health products (Methadone, Subutex, Buprenorphine Arrow, Buprenorphine Merck) are described in the Summary of Product Characteristics (SPC). R.5132-30 CSP- Methadone: 14 days maximum duration of prescription, Buprenorphine high dosage: 28 days maximum duration of prescription SCP- Methadone: 100 mg as an advice, Buprenorphine high dosage: 16 mg max. dose YES: Methadone: decree of 8 February 2000. Buprenorphine: decree of 20September 1999 Methadone: Delivery in pharmacy in batches for maximum periods of 7 days with the possibility of a single delivery for a maximum period of 14 days at the request of the doctor. Buprenorphine: Delivery in batches for maximum periods of 7 days with the possibility of a single delivery for a maximum period of 28 days at the request of the doctor.
Ireland YES, The Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations, 1998. Proof of opiate dependence; birth cert; letter of residence; 2 passport photos; 3 counselling sessions prior to dispensing; pregnant women given priority; Under 18 must be interviewed by psychiatrist NO: Discretion of clinician NO: Discretion of clinician NO. Not in legislation but guidelines exist for dispensing criteria
Italy Yes. Italian law provides for substitution therapy for opioid-addicted patients. Medications with methadone or buprenorphine bases are available on the market with specific market introduction authorization (AIC) for withdrawal treatments outlined in the Presidential Decree 309/90, art. 43, 113, and 122. The decision to put the patient through pharmacological treatment is at the discretion of the specialist, who must reach agreement with the curative team, who define an ad hoc therapeutic plan. The therapeutic plan is designed according to the clinical conditions of the patients and can contain, from time to time, enough medication (methadone or buprenorphine) to sustain a curative programme of no more than thirty days. Yes, it does. Buprenorphine has a daily dose of 32 mg. Methadone can be prescribed in doses of up to 120 mg daily, depending on the patient’s tolerance and ability to metabolize the medication; maintenance doses are determined on an individual basis and verified periodically by the attending physician. Yes.(Presidential Decree. 309/90, art. 43, paragraph 5).
Cyprus There are no such criteria as there is no legal framework for ST No special provision for ST. Reg. 11(1), regarding prescriptions in general. in the case of a substance that will be needed for continuous treatment in doses, the doses may not be provided by the pharmacist, if they exceed 13 weeks of treatment. NO: This must be stated in the prescription. No provision.
Lithuania YES: Order No V-653 of Ministry of Health of the Lithuania as of August 6, 2007; Order No 204 of the Minister of Health of the Republic of Lithuania as of May 3, 2002 Regular opiate using for the last 2 years, two or more unsuccessful addiction treatments in healthcare or rehabilitation institutions; drug - related complications (urgent status, viral hepatitis B, C, tropic ulcer, sepsis, abscesses, HIV/AIDS); dual diagnosis (oncological diseases, mental troubles, diabetes and other somatic nasty illness; drug user’s pregnancy; minimum age - 18; other individual reasons in accordance to the decision of the medical examination commission. NO: Limitation in terms of duration for treatment is defined individually depending on clinical indication, but no less than 1 year. NO YES: Order No V-653 of Ministry of Health of the Lithuania as of August 6, 2007 Stable patients of ST programme are allowed to take home a dose of methadone on weekends or other extraordinary situations by the decision of the medical examination commissions.
Luxembourg YES: Article 3 of the grand-ducal decree of 30 January 2002 Acute opiate dependence following international criteria and diagnosed by toxicological analyses, not treatable by another method; If ST client under 18, parental or parental authority consent is needed; to reside in Luxembourg or have Luxembourgish nationality. (Also possible for a non-resident if she/he is currently in substitution treatment in another Member state of the EU.) NO: The grand ducal decree of 16 March 2006 modifying the grand ducal decree of 19 February 1974 defines prescription lengths in the framework of the substitution treatment programme: 21 days for oral morphine, transdermal fentanyl, transdermal buprenorphine and hydromorphone and 14 days for methadone. NO YES: Article 14 of the grand ducal decree of 30 January 2002 The intake of ST substances has to take place, at least the two first months of the beginning of ST treatment, inside pharmacies or accredited associations. These conditions can be modified due to specific circumstances as professional or geographical constraints and health status of the participant.
Hungary NO: Methodological Guideline The admission criteria is certified opiate dependence and age above 18 years. NO: Methodological Guideline. There are 2 types of methadone treatment: methadone detoxification (1-6 months) and long-term substitution methadone treatment (no limit). NO: Methodological Guideline states The maximum dose size is individual. The average individual dose size is between 50-150 mg/day. NO: Methadone cannot be taken home.
Netherlands No: National guideline of 2005 Consent for medical surveillance, restrictions for pregnant women, restrictions for alcohol use, minimum age 18 NO: There is no (legal) limit on the duration for treatment. NO: National guideline of 2005 states "...adequate dosage" YES: National guideline of 2005 includes ... criteria for taking home (only suitable for very stable patients) etc. Patient is stable, no misuse in the past
Austria YES: Article II Substitution Decree specifies entry criteria.
Article III Substitution Decree also specifies obligatory criteria
Art II: a) one year of opiate addiction, as well as a failed detoxification/ withdrawal treatment or b) opiate addiction and HIV infection or c) opiate addiction and pregnancy or d) a patient with a one-year opiate addiction who is the spouse/partner of either a) or b)
Art III: 1) consent of the patient to oral application of the substitute, and 2) consent to medical surveillance, such as urinalysis, and 3) consent to additional psychological and psychosocial treatment, and 4) consent and a declaration that the patient will abstain from abuse of drugs (such as intravenous use) or from passing on the drugs to others, and 5) consent to have the patient's treatment registered at the Ministry of Health and the health department.
NO: Article IX.4. Substitution Decree specifically states there will be no limitations in terms of durations of treatment NO YES: Article V.7 together with Article VII. Substitution Decree Taking home of the daily dose for Sunday and Holiday is possible. Further exceptions for patients under ongoing treatment under certain conditions are possible (e.g. no misuse during longer treatment periods, job reasons, problems regarding the place of residence etc when the patient cannot reasonably be expected to turn up in the pharmacy).
Poland YES: § 2 pass. 1 and 2 of the Regulation of the Minister of Health of 6 September 1999 (with the amendments of 16 May 2001) Drug dependence from at least 3 years, patients are of at 18 years old, all previous other ways of treatment were unsuccesful and the patients agreed to process their personal data. These conditions have to be fulfiled jointly. However, the head of addiction treatment programme may decide to admit the patient to the programme if he agrees to processing of personal data and does not fulfil other conditions but important health reasons justify such a decision. NO: The Regulation does not stipulate the term of treatment, thus the decision is within the responsibility of particualr head of addiction treatment programme. NO: According to the Regulation, the substance shall be gived in day doses only. The exact amount is within the responsibility of particualr head of addiction treatment programme. NO The substances may exceptionally be used in the patient's residence personally where there are obstacles to come to hospital. The decision to allow personal use is within the competence of the head of addiction treatment programme.
Portugal Article 45 nº 1 and 2 of the Decree-Law Nº 183/2001 Access to the programme shall be restricted to adult persons addicted to opiates, as confirmed by a doctor, and who are not undergoing a specific therapeutic programme. Access to the programme shall depend, in all cases, on the decision of the respective technical manager, such decision being taken after a consultation NO: Not in the law but clinical guidelines exist for both methadone and buprenorphine NO: Not in the law but clinical guidelines exist for both methadone and buprenorphine NO Not in the law but clinical guidelines exist.
Slovenia NO, it is settled by doctrine, adopted by Health Council The recommendations exist for such treatment. The criterion is certified opiate dependence. Recommended age limits are as follows: 15 years old for Subutex and 16 years old for methadone and Substitol. NO NO, it is settled by doctrine, adopted by Health Council. Doses above 150 mg of methadone must be approved by treatment coordination team. There are no other limits. NO There are no law limitations. On the basis of doctrine the patients could take home the doses of methadone for one week.
Slovakia YES: "Methodical Instruction on providing methadone maintaining therapy for opiate addicted patients with persistent development of desease” in Ministry of Health gazette (year 2004, unit 21-27, No. 31) -Art. III For ST methadone programme: - certified opiate addiction (by a psychiatrist); minimum age – 18 years (exceptions admissible by persons of 15-18 years after recommendation of special commission); voluntary written agreement (or agreement of legal representative for persons under 18). Methadone: no legal limits, there is only a recommendation for a minimum duration of 1 year. Buprenorphine: Subutex treatment is limited only by limitations stated by health insurance which covers costs for 3 months. NO: Maximum individual dose size is not regulated, there is only a recommendation of dose rate - 10mg of a substance / 1 ml of liquid YES: take- home system is limited by provisions of the Instruction. Daily dose is allowed for maximum 3 days, ie a person (in a stage of stabilization) has to be under supervision at least 2 times per week.
Sweden YES: The National Board of Health and Welfare`s Code of Statutes SOSFS 2004:8 A person must be at least 20 years old, have a certified opiate dependence for a minimum of two years, understand the information given and accept the substitution treatment. (Younger than 20 is exceptionally possible). Substitution treatment may not be given if there is reason to believe that the treatment cannot be given in accordance with the program, some other treatment will be sufficient, substitution treatment would be an unacceptable medical risk due to use of alcohol or other drugs than opiates, or a substitution treatment has been terminated during the last six month-period due to infractions specified. Substitution treatment is in most cases not allowed when the patient is in compulsory care due to mental illness or drug addiction NO NO YES: The National Board of Health and Welfare`s Code of Statutes SOSFS 2004:8 After 6 months and an evaluation, the patient may get a prescription for a limited supply of methadone or buprenorphine from a pharmacy to take home.
United Kingdom No No No No No, nothing legal There are limitations however on the length of time a prescription can be for
Norway YES: circular I-35/2000. The Directorate for Health and Social Affairs is currently working on proposals for new guidelines. Minimum age (25), long term misuse of drugs for several years prior to applying for ST, the misuse must have been dominated by opiates, to a reasonable degree, drug free treatment, without substitution remedies, should have been tried. Exceptions can be made if the patient has major problems, for example has mental problems, is in danger of losing custody or visiting rights, has destructive behaviour and/or severe, long-lasting pains which can lead to invalidity. NO NO: It is up to the professional judgement, Max. Individual dose size: recommended methadone max 100 ml. NO (guidelines) After several negative urine analyses the patient will be allowed to take several doses back home, and take them unsupervised.

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Page last updated: Friday, 23 November 2007