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Substitution Treatment - Prescription Regulations

Does the national legal framework establish who is allowed to prescribe? Does the national legal framework establish a system for controlling prescriptions? Does the national legal framework establish who is allowed to dispense?
Country Legal basis Content Legal basis Content Legal basis Content
Belgium YES: Royal Decree on the substitution treatments was adopted in 2004 (19 March 2004) Any practitioner prescribing substitution treatment should be registered in a day centre, a network for drug users or in a specialised centre for drug treatment. YES: Royal Decree on the substitution treatments was adopted in 2004 (19 March 2004) The delivery of the substitution treatments are gathered by the Tarification Office and anonymous data on the patient are sent to the Institute of Pharmaco-epidemiology (IPHEB). YES: Article 6 of the Royal decree of 19/03/2004 as amended by the Royal Decree of 06/10/2006 The substance is delivered by a pharmacist directly or via a center
Czech Republic YES: Act No. 379/2005 on Measures for Protecton from Harms Caused by Tobacco, Alcohol and Other Psychoactive Substances, s. 20, par. 2 j)


The Standard of Substitution Treatment (Decree of Ministry of Health No. ZD07/2001)
Doctors of any specialization in the ambulatory health facilities ("basic" substitution treatment).
(But, in principle, any doctor is allowed to prescribe - it was possible even before the law came into force in 2006).






Comprehensive substitution treatment (including psycho- and other forms of therapy) is provided in specialized centres contracted by the Ministry of Health ("complex" substitution treatment)
YES: Act No. 167/1998 on Addictive Substances, s. 13, par. 1 Prescription forms with a blue stripe (increased control for medicaments containing opioids and some other psychotropic substances) YES: Act No. 379/2005 on Measures for Protecton from Harms Caused by Tobacco, Alcohol and Other Addictive Substances, s. 20, par. 2 j)

The Standard of Substitution Treatment (Decree of Ministry of Health No. ZD07/2001)
Doctors of any specialization in the ambulatory health facilities ("basic" substitution treatment)








Comprehensive substitution treatment (including psycho- and other forms of therapy) is provided in specialized centres contracted by the Ministry of Health ("complex" substitution treatment)
Denmark YES: § 41 of the Law 451 of 22 May 2006 on Authorisation of Health Personel and on Health Professional Practice. The National Board of Health Guideline of June 8, 2007 concerning the prescription of addictive substances, including ST. Physicians employed by the municipialities, regions and The Prison and Probation Service, and if delegated from such a physician to other physicians. Also other physicians in the form of single prescriptions as part of abstinence treatment of short duration. YES: § 41 of the Law 451 of 22 May 2006 on Authorisation of Health Personel and on Health Professional Practice. The National Board of Health Guideline of June 8, 2007 concerning the prescription of addictive substances, including ST Prescriptions of ST not given in the special centres and the hospitals are supervised by the community physicians as part of a monitoring system regarding prescription of addictive drugs. YES: § 17 and 41 of the Law 451 of 22 May 2006 on Authorisation of Health Personel and on Health Professional Practice. The National Board of Health Guideline of June 8, 2007 concerning the prescription of addictive substances, including ST. Physicians and persons who acts as assistants of physicians.
Germany YES: Section5 subsection 2 number 6 of the Narcotic Drugs Prescription Ordinance Every General Practitioner who has completed an additional training on addiction medicine. A physician who does not meet this requirement may prescribe ST to up to 3 patients at a time provided that s/he has consulted at the beginning of the treatment another physician who meets the minimum requirements and has agreed to the ST. YES: Section 5a of the Narcotic Drugs Prescription Ordinance Central substitution register: Doctors who prescribe substitute substances have to register their patients at the Federal Insuitute for Drugs and Medical Devices (in particular to avoid double prescriptions). YES: Section 13 subsection 2 of the Narcotics Act; Section 5 subsections 6- 7 of the Narcotic Drugs Prescription Ordinance S.13(2) NA: Only pharmacies are allowed to dispense ST substances. Sec 5 (7) NDPO: The substitute shall be handed over to the patient for immediate use in a physician's surgery, in a hospital or in a pharmacy or other facilities approved by the competent Land authority. Sec. 5 (6) NDPO: The patient shall be handed over the substitute for immediate use either by the attending physician or authorised assistant, or by staff working in officially recognized addict support institutions and who have been trained for this job.
Estonia YES: Mental Health Act (consolidated text July 2002) (RT I 1997, 16, 260); All licensed psychiatrists. YES: Regulation No. 73 of the Minister of Social Affairs of 18 May 2005. (RTL 2005, 57, 807). YES: Regulation No. 73 of the Minister of Social Affairs of 18 May 2005. (RTL 2005, 57, 807). YES: Licensed medical personnel.
Greece YES: L2955/2002 MD 19546/2003 Antagonistic substances can be prescribed by public or private agencies and physicians. Prescription of substitute substances is prohibited. The prescriber of naltrexone uses a special prescription form which must be kept by the pharmacist. A special card is issued to patient where are notified his identity code and the name and the address of the prescriber. The control is assured by the competent service of the Ministry of Health. OKANA and some hospitals operating under the control of OKANA.
Spain YES: art 2 RD 75/1990 amended by Disposicion Adicional Segunda RD 5/1996. Public or non-profit-making centres or services licensed by the (autonomous or National) health services; these could also include prisons. Each Autonomous Community establishes the specific requirements. Certain centres, and not professionals, were licensed for both prescribing and dispensing opioid substitution treatment, and only doctors working in these centres could order this treatment. The amendment of 1996 permitted authorisation of certain professionals, independent of where they work, under the same conditions. YES: Art 10 of the RD 75/1990; later, the Autonomous legislation developed this RD and describes as well this notification process All specialised centres or services, private doctors and pharmacies involved in opiate substitution treatment programmes are required to report to the autonomous authority when individuals enter and leave the programme and to give the reasons for both. YES: RD 75/1990, amended by art 1 RD 5/1996 A pharmacist working in the treatment centre, or a licensed pharmacist who does not necessarily work in the centre.
France L.5111-1, L.5121-8, R.5121-23 and R.5121-36 CSP Marketing authorization within Summary of Product Characteristics Any General Practitioner can prescribe high-dosage buprenorphine and there is no special accreditation for the prescriber.
Methadone is initiated only in specialised services for substance users, although individual treatment programmes can be monitored by general practitioners after the initial stabilisation period.
R.5132-5 CSP
R.5132-30 CSP
L.324-1 and L.162-4-2 CSS
Special prescription forms (duplicate secure forms). Maximum duration of prescription. Part delivery for a maximum period of treatment. Moreover the national health insurance has implemented a survey on ST since September 2004. R.5132-33 & 35 CSP
D.3411-10 CSP
Buprenorphine and Methadone are available in pharmacies. Methadone can also be delivered in specialized care for addiction centres.
Ireland Misuse of Drugs (Supervision of Prescription and Supply of Methadone Regulations) 1998 General practitioners (GP) with special training designed by Irish College of GP's / Only consultant Psychiatrists are at present qualified to prescribe buprenorphine Misuse of Drugs (Supervision of Prescription and Supply of Methadone Regulations) 1998 Anyone on treatment must be on Central Treatment List Misuse of Drugs (Supervision of Prescription and Supply of Methadone Regulations) 1998. GP with specific training; Designated Pharmacists; Psychiatrist; Two nurses; Nurse and Orderly (in prison setting)
Italy YES: Presidential Decree 309/90, art. 43 Specialist in collaboration with the curative team. YES: Presidential Decree 309/90, art. 43 Methadone and burprenorphine are prescribed on ministry-regulated prescription forms (three-layered self-copying form) according to the therapeutic plan prepared by public structures and authorized private structures. A copy of the prescription is kept by the patient to justify possession of the medication. YES: Presidential Decree 309/90, art. 45 The pharmacist, when presented with a prescription (three-layered self-copying form), is required to confirm the identity of the patient and conserve a copy of the prescription for two years. Furthermore, the handling of the medication (entrance and exit) is recorded in the register as outlined by Presidential Decree 309/90, art. 60, paragraph 1.
Cyprus YES in general pharmaceutical legislation: Reg. 6 (2) Any registered doctor may prescribe to a patient any of the substances mentioned in the appendix to the regulations, which include methadone (the only substance used for ST). Methadone can only be found in governmental pharmacies, which will provide it if prescribed by a governmental (working for a public hospital) doctor. YES in general pharmaceutical legislation: Reg. 11, 14, Appendix 2 Reg. 11 provides for a special prescription form. Reg. 14 provides that the pharmacies must keep records for the authorities. Appendix 2 of these regulations provide that the pharmacies must inform the authorities of any «unusual» orders or prescriptions. YES in general pharmaceutical legislation: Reg. 7(2) Doctors, dentists, veterinary doctors, pharmacists (private or in the governmental institutions), authorized sales persons, nurses.
Lithuania YES:
Order No 702 of Ministry of Health of the Lithuania as of December 22, 1997, on Approval of Substitution Treatment Procedure for patients Suffering from Opiate Addiction (Žin., 1998, 13-326).
Methadone is prescribed by the decision of the medical examination commission. Stable and socially adapted patients may continue ST by the general practitioner at the primary healthcare centre. YES: Order No 702 of Ministry of Health of December 22, 1997 Each case of usage and prescription of ST substance should be noted in medical journal and confirmed by doctor’s signature. Before receiving medicament, patient surrenders his general identification document. YES:
Order No 702 of Ministry of Health of the Lithuania as of December 22, 1997
Centre for Addictive Disorders or Mental health provides and coordinates substitution treatment service in each municipality.
Luxembourg YES: Règlement grand-ducal du 30 janvier 2002 déterminant les modalités du programme de traitement de la toxicomanie par substitution Medical Doctors can prescribe ST substances in the framework of the substitution treatment programme following accreditation by the Minister of Health. YES: Art 30-1 of the modified law of 19 February 1973 and grand-ducal decree of 18 January 2005 (prescription forms); Art. 6-7 of the grand ducal decree of 30 January 2002 (surveillance commission, national register). Specific medical prescription forms are delivered or renewed by the director of health who also should control the prescription procedure. The prescription forms for narcotic-based pharmaceutics contain 2 annexes, one for ordinary medical treatment (e.g. pain) and the other for substitution treatment.
An ST surveillance commission decides upon the admission of clients in ST treatment, or is notified of admissions by accredited MDs. The commission currently implements a national ST register allowing a more effective and real time control of multiple prescriptions
YES: Arts 2, 14 of the grand-ducal decree of 30 January 2002 Associations and MDs accredited by the minister of health (Pharmacies or (for liquid methadone) via licensed agencies under the responsibility of a licensed MD)
Hungary NO: Methodological Guideline The methadone treatment is only available after the decision of a working group with 3 members of the treatment centres. The doctors of the treatment centres are allowed to prescribe. NO: Methodological Guideline The treatment centres ensure the registration of the clients participating in a long-term methadone treatment. NO: Methodological Guideline Only methadone therapy centres/ departments or treatment centres are allowed to dispense.
Netherlands YES: Opium Act and Opium Act Decree All doctors are allowed to prescribe (but nearly all ST substances are prescribed by doctors in addiction care centres). NO: Methodological Guideline (but may be legally binding in future) LCMR: national registration system for ST substances, includes prescription in prisons. YES: Opium Act and Opim Act Decree Addiction Treatment centres, pharmacies, hospitals and prisons.
Austria YES: § 8 together with § 11 SMG; Article V.2, V.3 Substitution Decree ST substances have to be prescribed by physicians with special experience or knowledge in the field of treatment of addicts. The relevant diagnosis shall be made by medical doctors familiar with the problem of addiction. The maintenance prescription dose may be determined in inpatient or outpatient departments. YES: §§ 13 to 23 SV [= Narcotic Substances Regulation] together with Article IV.2. Substitution Decree Special prescription forms; examination of long-term prescriptions by the public health officer; central registration system. YES: § 7 SV Any pharmacy
Poland YES: § 3 pass. 2 of the Regulation of the Minister of Health of 6 September 1999 (with the amendments of 16 May 2001) The prescription of the substance is within the competence of the head of addiction treatment programme and who operates in the hospital which has been given the permission to run such ST programme. YES: § 4 pass. 1, § 5 pass 7 and § 7 pass 7 of the Regulation of the Minister of Health of 6 September 1999 (with the amendments of 16 May 2001) The system of control consists of : special identification cards of the patients under ST programme which are registered in the central register in the Psychiatry and Neurology Institute in Warsaw and the supervision by the pharmacies of the amount of substances that are distributed during operation of the programme. YES: § 3 pass. 2 of the Regulation of the Minister of Health of 6 September 1999 (with the amendments of 16 May 2001) The substance is dispensed to the patient upon the decision of the head of addiction treatment programme.
Portugal YES: Art 44.1 Decree-Law Nº 183/20001 and Art 15 of the Decree Law 15/93 of the 22nd of January Medical doctors YES: Article 15 nº 1-nº 3 and Article 18 nº 1 and nº 2 of the Decree-Law 15/93 of the 22nd of January. Special prescription forms approved by the National Pharmacy and Medication Institute and the General Directorate of Health (Art 15) Monitoring of prescription books (Art.18) 1- The National Institute of Pharmacy and Medicine, in conjunction with the Directorate-General of Health, shall monitor used prescription books with the aid of a computerized system, all persons having access to the information being bound by professional confidentiality. 2- The State and private health services shall send the National Institute of Pharmacy and Medicine every quarter a list of the narcotic drugs used in medical treatment. YES: Art 44.1 Decree-Law Nº 183/20001 Methadone shall be administered by a health worker, in the dose at the intervals fixed by doctor’s prescription
Slovenia YES: Regulations on classification, prescription and administration of medicines for use in humane medicine (2003) - Chapter III First prescription of ST substances is always done in specialized treatment centres, later ST substances could also be prescribed by general practitioners and pharmacies. YES: Regulations on classification, prescription and administration of medicines for use in humane medicine (2003) - Chapter III The same system for controlling is valid for all narcotics. There is no special system for controlling prescriptions in the case of ST substances. The law envisages a supervision commission at the Ministry of Health, but at the moment there is an appointment of new commission in the procedure. YES: Regulations on classification, prescription and administration of medicines for use in humane medicine (2003) - Chapter IV Treatment centres, hospitals, prisons (preventive custody too) and institutions for juvenile delinquents are allowed to dispense ST substances if they provide medicinal services.
Slovakia YES: Measure of Min. of Health, which issues a list of medicines and medications fully or partially covered on basis of public health insurance Methadone – doctors in treatment, private general practitioners, treatment centers. Buprenorphine – general practitioners (recommendation of psychiatrist) YES: Act No. 140/1998 Coll. on medications and medical tools - S. 39 para. 3; and Act. No. 139/1998 Coll. on narcotic and psychotropic substances Methadone - special prescription forms. Buprenorphine – general control system YES: Act No. 140/1998 Coll. on medications and medical tools (general provisions) Methadone – treatment centres. Buprenorphine - pharmacies
Sweden YES: Medical Products Agency´s Code of Statutes LVFS 2004:15 (Läkemedelsverkets föreskrifter om förordnande och utlämnande av narkotikaklassade läkemedel för behandling av opiatberoende) Doctors with specialized knowledge in psychiatric illnesses and practising medicine at a treatment centre in compliance with the National Board of Health and Welfare´s Code of Statutes SOSFS 2004:8. (The doctor may in some cases and for a limited period delegate the possibility to prescribe.) YES: The Medical Products Agency´s Code of Statutes LVFS 1997:10 Special prescription forms (telling both the doctor's specialized knowledge and that he or she is practising at a treatment centre). YES: Medical Products Agency´s Code of Statutes LVFS 2004:15 A pharmacy (state-owned monopoly in Sweden) may sell methadone and buprenorphine if the substances have been prescribed by an authorised doctor. The treatment centres also dispense methadone and buprenorphine. The National Prison and Probation Administration may offer substitution treatment to prisoners.
United Kingdom YES: Section 7.3(a) of the Misuse of Drugs Act 1971 allows for prescription and administering of controlled drugs by medical practitioners (GPs). section 10.2(g)-(i) MDA allows for the development of regulations on the control and monitoring of prescriptions of controlled drugs. A consultation on whether Nurse and Pharmacist Independent Prescribers should be allowed to prescribe specific Schedule 2 drugs to addicts for the management of their addiction is currently underway. YES: The enabling legislation for substitution treatment is the Misuse of Drugs Regulations 2001. This allows medical practitioners to produce, supply, possess and administer certain controlled drugs. Any NHS-registered pharmacist is authorised to dispense.
Norway YES: Regulation 24 April 1998 no. 455 on the requisition and distribution of pharmaceuticals by a pharmacy art 2-1 (3) c and d Treatment must start in a ST-centre; The patient’s general practitioner and the social services can, in co-operation, refer to ST (the application must include a statement from the patient’s doctor and an overall treatment plan). A ST-centre must approve the application, and admit the patient. Secondly, doctors can prescribe, but must be sure that the patient is in a treatment program approved by the government (the patient must be approved for ST by a ST-centre) YES: The regulation on prescription of medication art 8-4 (2) The pharmacy handing out the remedy must make sure that the patient has been approved by a ST-centre. NO: varies according to municipality. It varies from one municipality from another: Pharmacies, treatment centers approved by the government and the patient’s general practitioner can always dispense. Some local governments also allow the community care and special offices for distribution of the drug.

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Page last updated: Wednesday, 21 November 2007