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Regulation Of Addictive Poison

Original Language Title: Änderung der Suchtgiftverordnung

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314. 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 136/2004, shall be amended as follows:

1. § 15 reads:

" § 15. ( 1) The doctor may prescribe the maximum amount in one day for the practical use:

1.

Alfentanil ..............................................................

0,1000 g,

2.

Cocain ........................................................

0,1000 g,

3.

Dextromoramide ..........................................................

0,1000 g,

4.

Fentanyl .....................................................

0,1000 g,

5.

Hydrocodon ...........................................

0.2000 g,

6.

Hydromorphon.......................................

1.0000 g,

7.

Methadone ................................................................

1.0000 g,

8.

Methylphenidate .........................................................

1,7000 g,

9.

Morphine .......................................................

6,0000 g,

10.

Nicomorphine ..........................................

0.2000 g,

11.

Opium .........................................................

2.0000 g,

12.

Opiumextrakt ...............................................

1.0000 g,

13.

Opium tincture ...............................................

20,0000 g,

14.

Oxycodone .....................................................

2,4000 g,

15.

Pantopone or similar preparations containing suchttoxic ..........

0,4000 g,

16.

Pentazocin ....................................................

0.5000 g,

17.

Pethidin ..............................................................

1.0000 g,

18.

Piritramid ...........................................................

0,1500 g,

19.

Remifentanil ..............................................................

0.0250 g,

20.

Sufentanil ...........................................................

0.0020 g.

(2) The restrictions imposed on paragraph 1 shall not apply to prescriptions for a patient or to the needs of hospitals. "

2. § 18 reads:

" § 18. (1) Suchttoxins of Annexes I, II and IV of this Regulation are, in so far as they are not prescribed in the context of substitution treatment (§ 21) and as far as the doctor is responsible for the preparation of pharmaceutical regulations at the expense of a social Health insurance carrier is entitled to prescribe on the prescription form of social health insurance. Others, as well as veterinarians, have to make 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 case of an emergency (medical first aid outside the ordination) is the prescription of narcotic venom by way of exception even without sticking to the addiction poison vignette referred to in paragraph 1 or, in the case of doctors with authorization to copy of pharmaceutical regulations at the expense of a social health insurance institution, on a basis 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". A clearing of the emergency prescription shall be sent by the dispensing pharmacy to the Federal Ministry of Health and Women at the latest at the end of the following month. If the emergency prescription cannot be connected in the form of the original in the form of the original document within the meaning of Section 9 of the Suchtgiftvormerkbuch for the purpose of accounting purposes, a copy or a copy of the original document shall be deemed to be the original document. .

(3) The regulation of the addiction poison is to be documented by the prescribing physician or veterinarian, the delivery of the addictive poison from the pharmacy. The documentation shall be made in a suitable form and shall contain the serial number of the Suchtgiftvignette applied to the Regulation and the information referred to in Article 19 (1) (1) (1) to (6). The documentation shall be kept for three years after the date of issue of the recipe, and shall be sent or submitted to the authorities at the request of the authorities. "

3. The rate of entry in Section 19 (1) reads as follows:

"Suchtgiftprescription shall be made with ballpoint pens, provided that it is not provided with support for automation, and shall contain the following information:"

4. § 19 (3) reads:

(3) Missing

1.

the literal particulars referred to in paragraph 1 (4) or (4)

2.

the indication cited in paragraph 1 (5), or

3.

the date of issue referred to in paragraph 1 Z 6, or

4.

the words "praescriptio indicata" or "praescriptio indicata", to be applied in accordance with Article 3 16

5.

the endorsement "on substitution treatment" to be applied in accordance with Article 21 (6);

The pharmacist may, after the doctor has obtained the doctor's instructions, be allowed to do so. At the same time, in the documentation of the prescription (§ 18 para. 3), the doctor has to make this supplement and to make it recognizable as a supplement. "

Section 20 (2) reads as follows:

"(2) The individual prescriptions of addiction poisons in Annexes I, II and IV of this Regulation shall, in so far as they are prescription forms of social health insurance, be drawn up after being made by the pharmacist or pharmacist leading to the skin."

6. § 20 (4) deleted. The previous paragraph 5 receives the sales designation "(4)" .

7. § § 21 and 22 are:

" § 21. (1) For addicts who, due to their state of health, are in need of substitution treatment for addiction, except for the substances referred to in § 14 or Cocain, are continuously required, except in justified individual cases (paragraph 1). 5 and 6) to issue permanent prescriptions with a maximum duration of one month. The prescription shall be made on the form for the substitution prescription (Section 22 (1) (3)), which shall be provided by:

1.

Marking of the heading "Substitution-long-term prescription" as well as

2.

Sticking of the Suchtgiftvignette for the Suchtgift-Permanent prescription (§ 22 para. 1 Z 2) on the front of the form

is to be marked as a permanent substitute for substitution. The doctor shall note the start of the period of validity for which a day before the end of the next month is to be laid down on the permanent replacement of substitution.

(2) The prescriptions of § 19 shall also apply to the permanent substitution of substitution. Before handing over to the pharmacy, the permanent prescription shall be submitted to the competent official for inspection and manufacture. Within the period of validity of the permanent prescription, the dispensing of the prescribed addictive poison may be repeated in accordance with the medical order.

(3) The replacement permanent prescription shall be retained at the first levy in the pharmacy and shall be marked with the stamp of the pharmacy as well as a note on the delivery. 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 a doctor of the skin pharmacist as far as this is necessary for the purpose of accounting purposes with the social health insurance.

(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. The physician must attach a statement of reasons justifying the issue of the individual prescription in the individual case on the form. It may, at most, prescribe the need for three days per individual prescription, which the addictive person has with regard to the substitution agent. A copy of the individual prescription shall be sent by the pharmacy after delivery of the substitution agent, at the latest at the end of the following month, to the Federal Ministry of Health and Women.

(5) Elections may be made by physicians who are entitled to copy pharmaceutical regulations at the expense of a social health insurance institution, for the individual prescriptions in the context of the substitution treatment (para. 4) in place of the form for the substitution prescription also the drug prescription form of the social health insurance (§ 18 para. 1) are used. 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. The provisions of paragraphs 3 to 5 of paragraph 4 shall apply.

(6) The regulation of the substitution agent is to be documented by the prescribing physician, the Vidation of the substitution permanent prescription from the official doctor, the delivery of the addictive poison from the pharmacy. The documentation shall be given in an appropriate form and shall include the serial number of the Suchtgiftvignette applied to the Regulation, as well as the information referred to in Article 19 (1) (1) (1) to (6) and the mode of delivery. In the case of substitution permanent prescriptions, the beginning and end of the period of validity must also be documented, in the case of substitution individual prescriptions, the justification justifying the issuance of the individual prescription in the individual case in question, as well as the number of days for which the substitution agent has been prescribed. The documentation shall be kept for three years after the date of issue of the recipe, and shall be sent or submitted to the authorities at the request of the authorities.

§ 22. (1) The Federal Ministry of Health and Women has the responsibility for the prescription of addiction venom in the Austrian State Printing Office

1.

Suchtgiftvignetten for the Suchtgift-solitary prescription,

2.

Suchtgiftvignetten for the Suchtgift-long-term prescription as well as

3.

Form sheets for substitution prescription

. The vignettes according to Z 1 and 2 are to be set up in consecutive numbering.

(2) The vignettes and forms referred to in paragraph 1 are, except in cases of justified suspicion of addictive drug abuse, by the district administrative authority on doctors and veterinarians entitled to self-employment, the doctors and veterinarians who are responsible for the self-employment of the profession. You need to take out a job or send it out free of charge to persons authorised by these persons and to hospitals, or to send them via a request. The local authority of the district administrative authority shall be determined by the place of occupation or place of service of the doctor or veterinary surgeon or the place of residence of the hospital, in the case of resident physicians after their place of residence.

(3) The search giftvignettes are to be kept safe from theft. Any loss or theft of search giftvignettes shall be without prejudice to any notification to the safety authority by the doctor or veterinarian or by the hospital, under the guidance of the relevant number sequence, to the Federal Ministry of Health and Health to inform women immediately. A copy of the notification made to the safety authority shall be notified to the announcement. "

8. The title before § § 33 to 35 reads:

"End-, In-Force-Tretens-as well as Out-of-Force-Tretensprovisions"

9. The following paragraphs 3 and 4 are added to § 35:

" (3) This Regulation in the version BGBl. II No 314/2005 occurs with 1. October 2005, in force.

(4) With the expiry of the 31 December 2005, § § 36 and 37 of this Regulation shall appear in the version BGBl. II No 314/2005 and lose their effectiveness in the form of the Suchtgift single prescription (Parts I, II and III) and the Form for the Suchtgift-continuous prescription (Parts I, II, III and IV). The supply of medicinal products on presentation of such forms shall no longer be permitted after that date. Authorities as well as doctors, veterinarians or hospitals have residual stocks of forms not used for use at the latest until the end of the 15. Jänner 2005 to destroy. "

10. According to § 35, the following § § 36 and 37 are added:

" § 36. (1) Without prejudice to § 18 (1), the three-part form for the Suchtgift-individual prescription (Parts I, II and III) laid down by the Federal Ministry of Health and Women may alternatively also be used for the individual prescriptions of the Suchtgift-Individual. Read-through procedures are used. In order to prescribe other medicinal products, this form may only be used if the prescription is not used in addition to an addiction gift.

(2) The forms for the Suchtgift-individual prescription issued by the Federal Ministry of Health and Women in consecutive numbering in the Österreichische Staatsdruckerei may, except in cases of justified suspicion of the Abuse of addiction, by the district administrative authority of doctors and veterinarians who are entitled to self-employment, who are in need of them in their professional practice, or by persons authorised by such authorities, as well as in hospitals against Acknowledgement of receipt shall be issued free of charge or sent via request. The local authority of the district administrative authority shall be determined by the place of occupation or place of service of the doctor or veterinary surgeon or the place of residence of the hospital, in the case of resident physicians after their place of residence.

(3) The forms shall be kept safe from theft. Any loss or theft of forms shall be without prejudice to any notification to the safety authority by the doctor or veterinarian or by the hospital, under the guidance of the number sequence concerned, to the Federal Ministry of Health and Women immediately to be announced. A copy of the notification made to the safety authority shall be notified to the announcement.

(4) Parts I and II of the form are intended for submission to the pharmacy; Part I may be used for accounting purposes; Part III shall remain with the prescribing person who has ordered these copies for three years after the date of issue. and, at the request of the authorities, to send or submit them.

(5) The individual prescriptions of addiction poisons in Annexes I, II and IV to this Regulation shall be drawn up after the pharmacist, hospital pharmacist or veterinarian has been made.

(6) Individual prescriptions of preparations of Annex III to this Regulation shall cease to apply if the first levy does not take place not later than one month after the date of issue, but in any case after six months. Unless otherwise indicated by the prescribers on the recipe, the levy may be repeated five times, with the exception of the preparations mentioned in paragraph 7.

(7) In so far as the prescribers have not expressly stated this on the prescription, the repeated delivery of the following preparations shall be prohibited:

1.

Preparations of codeine, which do not contain any other active substance,

2.

Preparations of Annex III, provided that they also contain substances whose repeated delivery is prohibited in accordance with the Prescription Act,

3.

Preparations of dihydrocodeine,

4.

Preparations of methaqualone,

5.

Preparations of Tramadol.

§ 37. (1) Without prejudice to Article 21 (1), the four-part form (Parts I, II, III and IV) laid down by the Federal Ministry of Health and Women may also be used in the procedure for the continuous circulation of the substitution. Each prescription shall contain the heading 'for substitution treatment'. The doctor shall note the beginning of the period of validity of which a day before the end of the next month is to be laid down on the subject of the continuous prescription of addictive vengeance.

(2) Without prejudice to § 21 (4) and (5), individual prescriptions may also be used in the context of substitution treatment, which may only be issued in justified exceptional cases, as well as the forms according to § 36 (1). They have to contain a justification justifying the issue of individual prescription in the individual case. The doctor may prescribe at most the need for three days for each individual prescription, which the addictive person has with respect to the substitution agent. A copy of the individual prescription shall be sent by the pharmacy after delivery of the substitution agent, at the latest at the end of the following month, to the Federal Ministry of Health and Women.

(3) The forms for the permanent registration of the Suchtgift-permanent prescriber, which are published by the Federal Ministry of Health and Women in continuous numbering in the Austrian State Printing Office, may, except in cases of justified suspicion, be Abuse of addiction, by the administrative authority of the district administration in the self-employed profession of authorised physicians who need them in their professional practice, or by persons authorised by such authorities and by hospitals with a view to receiving confirmation free of charge or sent via request. Section 36, para. 2, second sentence, shall apply.

(4) Parts I and II of the form are intended for presentation in the pharmacy. They shall be withheld from the pharmacy at the time of the first submission and shall be stamped with the stamp of the pharmacy as well as an endorsement of the levy. Each additional charge shall be provided with the date of delivery and the mark of the expedition. Parts I and II remain in the pharmacy, where Part I can be used for accounting purposes. Part III shall remain with the vidiating official. Part IV shall remain with the prescribers, who shall keep these copies in order of three years after the date of issue and shall, at their request, send or submit them to the authorities.

(5) § 36 (3) as well as the prescription provisions of § 19 shall also apply to the suchtgift-permanent prescriptions by means of a form according to § 37 (1). Before handing over to the pharmacy, the permanent prescription shall be submitted to the competent official for inspection and manufacture. Within the period of validity of the permanent prescription, the dispensing of the prescribed addictive poison may be repeated in accordance with the medical order. "

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