451. Regulation of the Federal Minister for Health and Women, amending the Suchtgiftverordnung

Pursuant to § § 2 and 10 (1) Z 5 and 6 of the Suchtmittelgesetz (SMG), Federal Law Gazette (BGBl). I n ° 112/1997, as last amended by the Federal Law BGBl. I No 134/2002, shall be assigned:

The Regulation on transport and the provision of narcotic poisons (Suchtgiftverordnung-SV), BGBl. II No 374/1997, as last amended by the BGBl Regulation. II No 227/2006, shall be amended as follows:

(1) The following paragraph 5 is added to § 1:

" (5) Provisions of the Suchtmittelgesetz (Suchtmittelgesetz) and this Regulation, which relate to the provision of drugs or drugs containing addiction in the framework of the medical profession, apply to the dental profession as far as the dental profession is Treatment with narcotic drugs or drug-containing medicinal products in accordance with the Dentist's Law, BGBl. I n ° 126/2005, which is covered by the 'dental profession'. '

2. § 18 (1) and (2) are:

' (1) addictive poisons in Annexes I, II and IV, unless they are prescribed in the context of substitution treatment (§ 21) and to the extent that the doctor is responsible for the regulation of medicinal products at the expense of a social health insurance institution or a Health care institution is entitled to prescribe on the prescription form of the social health insurance or the sickness care institution. Other doctors and veterinarians have to prescribe the prescription on a private recipe. In any case, the doctor or veterinarian has to mark this as a single vengeal prescription on the front of the prescription by sticking the Suchtgiftvignette for the Suchtgift-individual prescription (§ 22 para. 1 Z 1).

(2) Only in an emergency (in the case of danger to the life of the patient) is the prescription of narcotic drugs also without sticking to the addictive poison vignette referred to in paragraph 1 or, in the case of doctors with authorisation to prescribe medicinal products, at the expense of a medicinal product social health insurance institution or a health care institution other than the prescription forms referred to in the first sentence of paragraph 1. In these cases, the prescription shall be marked by the note "emergency". In the event of an emergency, only the smallest package commercially available may be used. The pharmacy has to inform the prescribing physician or veterinarian immediately after the submission of the emergency prescription and, if possible, before the submission of the addiction poison via the levy. It is obliged to immediately submit the prescription to the pharmacy which has been issued by the pharmacy on a Suchtgift-solitary prescription provided with a Suchtgiftvignette. A clearing of the emergency prescription shall be made by the dispensing pharmacy immediately after the release of the medicinal product, but at the latest before the end of the working day following the delivery, the Federal Ministry of Health and Women, or, if it is concerned is a substitution prescription to be sent to the patient who is responsible for the place of residence of the patient. The transmission of a clearing of the emergency prescription shall be the same as the transmission by means of fax or automation-assisted data transmission. If the emergency prescription cannot be connected in the form of the original in the form of the original document within the meaning of § 9 of the Suchtgiftvormerkbuch for the purpose of accounting purposes, a copy or obligation shall be deemed to be an initial receipt instead. "

Section 20 (2) reads as follows:

" (2) Individual prescriptions of addiction poisons in Annexes I, II and IV are, in so far as they are prescription forms of the social health insurance or a health care institution, after handling by the pharmacist or the hospital leading physician , to the extent that this is necessary for accounting purposes with the Social Health Insurance or the sickness insurance institution. "

4. § 21 (3) to (7) reads:

' (3) The permanent replacement of substitution shall be retained at the first levy in the pharmacy and shall be marked with the stamp of the pharmacy and a note on the levy. Each additional charge shall be provided with the date of delivery and the mark of the expedition. After the expiry of the period of validity, the prescription shall be withheld by the pharmacist or the hospital's leading physician, as far as this is necessary for settlement purposes with the social health insurance or the sickness insurance institution.

(4) Individual prescriptions may only be issued in justified exceptional cases within the framework of substitution treatment. As far as paragraph 5 does not specify otherwise, the prescription shall be made on the form for the substitution prescription (Section 22 (1) (3)), which shall be carried out by:

1.		Marking of the category "Replacement-Individual prescription" as well as
2.		Sticking up of the Suchtgiftvignette for the Suchtgift-Einzelprescription (§ § 18 para. 1, 22 para. 1 Z 1) on the front of the form

is to be identified as a single substitution substitution.

(5) Elections may be made by physicians who are entitled to copy pharmaceutical regulations at the expense of a social health insurance institution or a health care institution for the individual prescriptions in the context of substitution treatment in place of the form for the substitution prescription (para. 4) also use the prescription form of the social health insurance or the sickness insurance institution (§ 18 para. 1). In this case, the prescription shall contain the heading 'for substitution treatment', and it shall also be applied by applying the Suchtgiftvignette for the Suchtgift-individual prescription (Article 22 (1) (1) (1)) on the front of the Form the form sheet as a single vengeon individual prescription.

(6) The doctor has on the substitution single prescription (para. 4 and 5) to provide a justification justifying the issue of individual prescription in the individual case. It may, at most, prescribe the need for three days per individual prescription, which the addictive person has with regard to the substitution agent.

(7) A clearing of the individual prescription of substitution shall be sent by the pharmacy immediately after delivery of the substitution agent, at the latest on the following working day, to the official responsible according to the patient's residence. If the official doctor finds that the individual prescription is not in accordance with the prescriptions of paragraph 6, he has to send a copy of this prescription to the Federal Ministry of Health and Women. "

5. According to § 23, the following § § 23a to 23k together with headline are inserted:

" substitution treatment

§ 23a. (1) substitution treatment within the meaning of this Regulation shall be the medical treatment of opioid-dependent persons with opioid medicinal products to be administered orally as a substitute for abusive opioids with the aim of:

1.		to reduce the risk behaviour of addicts and to stabilise and improve their life in health and social terms,
2.		to gradually restore the abstinence of narcotic drugs,
3.		to support the treatment of a serious disease, in addition to opioid dependence; or
4.		to reduce the risks of opioid dependence during pregnancy or immediately after birth.

(2) The substitution treatment can be used as a bridging, reduction or maintenance therapy.

(3) If it is necessary for reasons of quality assurance of treatment or treatment safety, the Federal Minister for Health and Women's Health and Women's Health and Medical Sciences has to take care of the state of medical science and medical experience lay down detailed guidelines for the implementation of the substitution treatment.

(4) The assessment of the existence of an indication of substitution treatment shall be based on comprehensive diagnostic clarification in the light of medical science and experience, and on the treatment target, To carry out any direct abstinence-oriented treatment alternatives as well as security risks associated with the prescription of drug-containing medicinal products in the specific individual case.

(5) In the case of opioid dependence of less than two years, as well as in the case of persons who are 20 years old. The indication of the substitution treatment in the care given to this age group should be considered and the indication for abstinence treatment should be considered particularly carefully. For people who are the 20. In the case of an indication, the doctor may, if it appears to be necessary for the clarification of any alternative treatment alternatives, take the opinion of an oral substitution in accordance with the Ordinance on Continuing Education, BGBl. II No 449/2006, to obtain qualified specialist in psychiatry for the implementation of the substitution treatment. To the extent that this is not possible, the patient is to be supplied to the doctor of a suitable institution or association in accordance with § 15 of the Suchtmittelgesetz (Suchtmittelgesetz), which has to work for the collection of the psychiatric opinion.

(6) In the case of persons who are 18 years old. In the case of an indication, the opinion of a qualified specialist for the implementation of the substitution treatment is in any case in the case of an indication of an indication of the status of the person in question for the purposes of the training regulation. Psychiatry. In this age group, proprietary medicinal products containing retarded morphine may only be prescribed, provided that it is only in this way that further damage caused by dependence can be held.

§ 23b. (1) A substitution treatment may only be initiated if:

1.		the patient does not receive a substitution agent from any other doctor,
2.		the patient has been informed of the possible risks and conditions of the treatment, including possible side effects of the substitution agent,
3.		the patient has been shown to be in agreement with the conditions of treatment, and
4.		between doctor and patient, a written treatment contract after Annex VI completed. The requirement of the written contract conclusion can only be waived, for exceptional reasons, which are to be documented.

(2) Conditions of treatment within the meaning of Section 1 (2) are:

1.		compliance by the patient (§ 23e) of the intended acceptance modalities (dispensing mode),
2.		the completion of regular medical checks, including urinary controls (§ 23f para. 2),
3.		the treatment of the use of substances which endanger the substitution treatment or the state of health of the patient;
4.		the omission of the transfer of substitution funds by the patient,
5.		medical examination of the patient by means of criteria for discontinuation of treatment,
6.		the removal from the medical confidentiality obligation to the other bodies involved in the treatment;
7.		notification of the commencement and termination of the substitution treatment at the official's office, and
8.		the notification of the recruitment to the substitution agent as well as the beginning and termination of the substitution treatment at the Federal Ministry of Health and Women (§ 23j).

§ 23c. In the substitution treatment, methadone as well as buprenorphine, in each case in a preparation suitable for peroral ingestion and the i.v. use of this addictive agent, are agents of the first choice. Other substitution agents may only be prescribed if these medicinal products are intolerant.

§ 23d. (1) The post-treatment of the patient on the substitution agent shall be ensured by the adjuvant practitioner if he does not carry out the treatment himself. In the case of the physician who is to be treated, the physician who has been established has an exact dose recommendation and a recommendation of the mode of delivery of the medicine to the patient (§ 23e). In addition, the practitioner shall provide the patient with a proof of the following: Annex VII that the patient undergoes a substitution treatment, which will accompany the patient during the entire treatment. The proof has to be included

1.		the name, first name, date of birth, address and social security number of the patient;
2.		the substitution agent, including the daily dose, to which the patient is set,
3.		the name and address (telephone number) of the drug-aid facility, which may carry out the patient's psychosocial care,
4.		the name, professional title and address (telephone number) of the recruitment doctor;
5.		the date and the signature of the recruitment doctor,
6.		the name, professional title and address (telephone number) of the treating physician;
7.		the date and signature of the treating physician; and
8.		the address (telephone number) of the relevant district administrative authority (official).

(2) The Landeshauptmann shall be responsible for providing the forms for the proof referred to in paragraph 1 and section 23f (1) with the district administrative authorities as health authorities.

(3) The proof referred to in paragraph 1 shall be kept as a copy of a valid substitution permanent prescription (§ 21). To the extent that a proof of substitution is not issued, a copy of the substitution permanent prescription shall be handed out to the patient.

§ 23e. (1) When issuing the substitution prescription (§ 21), except in the case of prescribtion of buprenorphine, the doctor has to arrange a dispensing mode which takes the daily controlled use of the substitution agent in the pharmacist's view, Ordinance, hospital or in the drug-aid facility supervising the patient. Exceptions to the daily controlled intake are only allowed on weekends and holidays; in this case, the patient is no longer than a daily dose for Sunday or Sunday, respectively. to follow a daily dose per holiday.

(2) Without prejudice to paragraph 1, further exemptions from the daily-controlled intake shall be permitted only if, on a case-by-case basis, no indication of an unintended use of the substitution agent or a use of other substances, the the substitution treatment or the state of health of the patient is at risk. The co-administration of the substitution agent for self-responsible intake is only allowed if it is proven that the patient has

1.		on the basis of the time-scale of a professional activity or an education or training measure supported by the Labour Market Service; or
2.		from other temporally limited (such as temporary illness, holidays, temporary residency) or for reasons which are not limited in time, particularly for reasons of consideration.

it is not possible to take a daily dose at the point of delivery or not to be able to be taken care of. If the substitution agent is a medicinal product containing retarded morphine, co-administration is only permitted if there is no other, controlled intake of the patient, the patient's care with the Substitution agent is possible.

(3) In the case referred to in paragraph 2 (1), no more than seven daily doses may be followed; the condition for the co-administration of the substitution agent shall also be that the patient is already over a period of at least 12 weeks or, if so, where the substitution agent is a medicinal product containing retarded morphine, it is subject to substitution treatment with the same doctor over a period of at least six months.

(4) In the event of a temporary change of residence (para. 2), in particular for holiday purposes, the co-administration of the substitution agent is only permissible if no other care of the patient with the substitution agent, which is to be ensured in a controlled manner, is possible. The prerequisite for the participation for holiday purposes is that the patient

1.		a professional activity or measure referred to in paragraph 2 (1) and is already subject to substitution treatment for the same doctor over a period of at least six months; or
2.		if he does not engage in any professional activity or measure pursuant to paragraph 2 (1) (1), he/she is subject to substitution treatment for the same doctor over a period of at least six months.

In the case of Z 1, the patient should not be given more than 28 daily doses, in the case of Z 2, no more than 14 daily doses of the substitution agent.

(5) By way of derogation from paragraphs 3 or 4, exemptions from the daily controlled intake (para. 1) only if this is necessary on a case-by-case basis for reasons worthy of consideration, which are to be documented, and the agreement between the treating physician and the amtarzt has been established.

(6) In the case of an exception to the daily controlled intake, the arrangement of the co-administration of the substitution agent together with the justification on the substitution prescription shall be noted. The existence of the reasons justifying the arrangement of the exemption from the daily-controlled intake (paragraph 1). 2) and conditions (para. 3, 4, 5) shall be checked by the official. The official physician must ensure that the maximum permissible duration of the co-administration of the substitution agent is not exceeded during the Vidation of the substitution permanent prescription.

(7) The modification of the submission mode, which is prescribed for an already four-day search for addiction, is only permissible if it is essential in the short term for unforeseeable reasons (e.g. patient illness, unforeseen travel needs); They require the written justification and production of the treating physician as well as the Vidation by the competent physician. In all other cases, the doctor has proven to be able to cancel the already valid permanent prescription and to replace it with a new permanent prescription with the changed delivery mode.

(8) If, for compelling reasons (e.g. illness), the patient is prevented from taking the daily controlled dose at the prescription, the treating physician has to take appropriate precautions, such as the addition of the substitution agent to a A trustworthy person who has to be expunged by an official photo ID card. The doctor has to inform the issuing body (§ 23e para. 1), if he does not give the substitution agent himself, in good time to inform him of the settlement that has been taken. The co-administration of the substitution agent to a trustworthy person must be documented by the issuing body.

(9) In the event that the duration of the permanent prescription ends during a period of absence of the prescribing physician, the latter shall inform his representative of the duration of the term.

§ 23f. (1) Each continuing physician must control the patient's proof of substitution (Section 23d (1)). He has

1.		to mark the beginning of its treatment, its name including the professional title and address (telephone number),
2.		to update existing entries in the event of a change, and
3.		to make his entries with the date and his signature.
In so far as no proof of substitution is issued (§ 23d para. 3), a copy of the substitution permanent prescription is to be handed out to the patient.

(2) During treatment, the physician, in particular with regard to medically indicated dose adjustments, has to carry out regular, initially more frequent, treatment controls. In addition, reliable urinary controls are to be carried out in order to check whether other narcotic drugs which are not prescribed by the treating physician are misused in addition to the substitution agent.

(3) In the case of conversion of the patient from methadone or buprenorphine to another substitution agent and in the event of a change in the dose or signature, the doctor treating the patient, as far as possible and tunnable, is with the physician or physician who is to be established. the doctor who has so far performed the substitution treatment, to consult.

(4) In the case of treatment with a preparation containing a sustained-release morphine, the further-treating physician shall immediately, if necessary, take the opinion of a second, in accordance with the continuing training regulation, oral substitution for the implementation of the substitution treatment for the performance of the substitution treatment of qualified doctors, provided that:

1.		the patient's 20. Year of age has not yet been completed; or
2.		in the case of the patient being pregnant.
In the case of Z 2, a second expert opinion is to be obtained at least at the beginning of the pregnancy. Insofar as this is possible and possible in the circumstances, the search-specific facilities of hospitals active in the field of substitution treatment are to be used for this purpose.

(5) The institution in which the patient is responsible, where appropriate, for psychosocial support, should be informed of the patient's relapse into addictive drug abuse, in particular also of positive urine, in order to prevent the relapse of the patient. with the patient.

§ 23g. (1) The treatment shall be subject to control by the competent official. This has to examine the qualification of the physician (further training regulation oral substitution) and, if there are concerns about the conformity of the indication or treatment, to consult with the treating physician. The consultation is to be documented. The attending physician must provide the official physician with the necessary information and, in the cases deemed necessary, submit the treatment contract (Section 23b (1) (4)). If the consultation does not lead to any agreement, the official doctor has to refuse the production of the permanent prescription (§ 21 para. 2). The official physician must document the denial of the Vidation and justify it to the attending physician. It shall, if necessary, assist the patient in finding a suitable treatment alternative.

(2) If the official doctor determines obvious formal errors (e.g. typing errors, dating defects) or other obvious errors, defects or inconsistencies on the prescription, he shall correct them or supplement the missing information, which and to bring them to the attention of the attending physician.

(3) The official doctor has

1.		to ensure that, if necessary, the patient undergoes further health-related measures (§ 12 of the Suchtmittelgesetz), and
2.		if necessary, to motivate the patient.

(4) The official has to record the address and telephone number of the district administrative authority responsible for the control of the treatment on the substitution certificate (§ 23d) and to make the entry with his signature.

§ 23h. (1) The pharmacy has a suspicion of inconsistencies (such as, in particular, non-appearances to take or pick up the substitution agent, abusive intake of addictive agents, circumvention of controlled intake, aggressive behaviour, To submit recipes for addictive substances not provided by the doctor who carried out the substitution treatment, contact the attending physician and the competent medical officer immediately.

If the patient fails to take the daily intake, the non-related doses of the substitution agent may not be delivered on another day. If the patient indicates that the substitution agent has been lost or has been lost, the pharmacy should not be replaced by the pharmacy. In these cases, the prescribing physician should be notified. It is the responsibility of this person to assess whether a drug treatment with regard to withdrawal complaints is indicated.

(3) The distribution to several daily portions shall be carried out in the pharmacy, if this form of delivery is noted on the substitution prescription and the controlled intake is ensured.

(4) In the event that the patient is prevented from taking a controlled dose or collection of the substitution agent due to illness, the pharmacy may follow this to a trustworthy person. This person must be issued with an official photo ID and must prove the illness by means of a medical certificate. The application of the substitution agent must be documented by the pharmacy. The substitution agent must not be followed up to minors.

§ 23i. (1) The Landeshauptmann shall ensure the establishment of a Commission of Experts on the regional coordination of substitution treatment.

(2) The Commission in accordance with paragraph 1 shall be the subject of the drug or addiction coordinator, representatives of the Medical Association, the State Secretariat of the Austrian Pharmacists ' Chamber and the other professional groups involved in the substitution treatment. The Commission may also be associated with other experts knowledgeable in the field of safety or quality in substitution treatment.

(3) The Commission may, in order to clarify conflicts arising in the context of substitution treatment, as well as advice on all aspects and problems of substitution treatment, in particular by substituting doctors, doctors, patients or Cost carriers are called. The identification and use of personal patient data in order to clarify cases of conflict is only permitted by the Commission with the express consent of the patient. The parties to the conflict have to assist the Commission in clarifying the conflict situation and contributing to this. Decisions taken by the Commission are of a lack of character and must be brought to the attention of the Governor of the State.

(4) In fundamental questions of substitution treatment, the Committee on Quality and Safety in substitution treatment (§ 23k) may, if necessary, be referred to it.

§ 23j. (1) The Federal Minister for Health and Women has a substitution register for the retention of multiple prescriptions.

( 2) Any physician who recruits a patient to a substitution agent has the data necessary for the purpose referred to in paragraph 1 on the recruitment of a substitution agent in writing to the Federal Ministry of Health and Women. For this purpose, (Annex VIII) .

(3) Any physician who carries out the follow-up treatment of the patient with a substitution agent shall have the data necessary for the purpose referred to in paragraph 1 above and the end of the treatment provided to the Federal Ministry for Health and Women in writing with the relevant notification sheet for this purpose (Annexes VIII and IX) . The end of the treatment is to be communicated to the Federal Ministry of Health and Women by the treating physician even if the treatment is continued in the long term by another physician.

(4) The Federal Ministry of Health and Women may process the data collected in accordance with para. 2 and 3 automationsupported. It may provide information only on the purpose referred to in paragraph 1, in the case of questions relating to doctors, physicians, pharmacies or doctors. The information has to be restricted to those patients to whom the question of return relates.

§ 23k. (1) In order to advise the Federal Minister for Health and Women in matters of substitution treatment and the qualification of the doctors and doctors involved in this treatment, the Federal Ministry of Health and Women's Office is responsible for The Committee on Quality and Security in the substitution treatment, the competent representative of the offices of the state governments, the drug or addiction coordinations of the federal states, the Austrian Medical Association, the Austrian Medical Association Pharmacy Chamber, the main association of Austrian social insurance, of the medical universities and of the professional groups and institutions involved in the substitution treatment. The Committee may also be consulted by representatives of relevant research bodies, as well as other experts in the field of substitution treatment with regard to safety or quality. The members of the Committee shall carry out their duties on a voluntary basis within the framework of the Committee. "

6. The following paragraphs 5 and 6 are added to § 35:

" (5) This Regulation shall enter into force on 1 March 2007.

(6) The Federal Minister for Health and Women, with the assistance of the Committee in accordance with § 23k, has the experience of the effects of this Regulation on the treatment of substitution from the point of view of patient care, the Quality assurance of the treatment and safety of the building with the substitution materials up to the end of 30 June 2008. "

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