What kind of doctor can prescribe secobarbital

(1) Substitution within the meaning of this Ordinance is the use of a substitution agent. Substitution drugs within the meaning of this ordinance are medically prescribed narcotics that are used in an opioid-dependent patient as part of a therapy concept for the medical treatment of an addiction that is caused by the abuse of legally acquired or the abuse of illicitly acquired or obtained opioids.

(2) As part of medical therapy, the patient should aim to abstain from opioids. The main goals of substitution are in particular
1.

ensuring survival,

2.

the improvement and stabilization of the state of health,

3.

abstinence from illicitly acquired or obtained opioids,

4.

the support of the treatment of comorbidities or

5.

reducing the risks of opioid addiction during pregnancy and during and after childbirth.

(3) A doctor may prescribe substitution drugs for a patient under the conditions of Section 13 (1) of the Narcotics Act if he meets the minimum requirements for an addiction medicine qualification, which are determined by the medical associations according to the generally recognized state of medical science (doctor qualified in addiction medicine) . In addition, he must meet the reporting obligations according to Section 5b (2).

(4) If the doctor does not meet the minimum requirements for an addiction medical qualification according to paragraph 3 sentence 1 (doctor not qualified in addiction medicine), he must in addition to the prerequisite according to paragraph 3 sentence 2
1.

coordinate with a doctor qualified in addiction medicine at the beginning of treatment and

2.

ensure that the patient presents himself at the beginning of treatment and at least once every quarter to the doctor qualified in addiction medicine according to number 1 as part of a consultant treatment.

A doctor who is not qualified in addiction medicine may treat a maximum of ten patients with substitution drugs at the same time. He may not carry out any treatment according to § 5a.

(5) In the case of substitution, the substituting doctor should be represented by a doctor qualified in addiction medicine. If the substituting doctor does not succeed in appointing a representative according to sentence 1, he can be represented by a doctor who is not qualified in addiction medicine. In this case, the representation may cover a continuous period of up to four weeks and a maximum of twelve weeks per year. In principle, the representative must coordinate with the doctor to be represented before the start of the substitution case. Emergency decisions remain unaffected in all representation cases. The representative shall add the correspondence and other records between the doctors involved in the representation to the documentation in accordance with paragraph 11. The representative according to sentence 2 may not carry out any treatment according to § 5a within the framework of his representation.

(6) The substituting doctor may only prescribe the following as substitution agents within the meaning of paragraph 1:
1.

a drug approved for substitution that does not contain the substance diamorphine,

2.

a preparation of levomethadone, methadone or buprenorphine or

3.

in justified exceptional cases, a preparation of codeine or dihydrocodeine.

The substitution agents mentioned in sentence 1 must not be intended for intravenous use. The prescription of a substitution agent mentioned in sentence 1 must be marked with the letter "S". For the drugs approved for substitution with the substance diamorphine, Section 5a applies.

(7) The substitution agent prescribed by the doctor is to be given to the patient by the persons referred to in paragraph 10 sentences 1 and 2 or by the personnel referred to there in the facilities referred to in paragraph 10 sentences 1 and 2 for immediate consumption or to be used in accordance with the procedure provided for in the licensing of medicinal products. In the case of prescribing codeine or dihydrocodeine, the patient can be given the additional amount of the substitution agent required for one day in divided individual doses after a dose has been given for immediate consumption and he can be allowed to take it on his own responsibility, provided the doctor has no indications of improper use You are taking the substitution drug.

(8) Notwithstanding paragraph 7 sentence 1, the substituting doctor may, as an exception, prescribe the substitution agent for the patient to take on his own responsibility in accordance with the findings of the Federal Medical Association according to paragraph 12 sentence 1 number 3 letter b, if
1.

the continuity of the patient's substitution treatment cannot be guaranteed in any other way,

2.

the course of treatment allows this,

3.

Risks of endangering oneself or others are excluded as far as possible and

4.

the safety and control of narcotics traffic are not impaired.

In this case, the substitution drug may only be prescribed in the following quantities:
1.

in the amount required for up to two consecutive days or

2.

in the amount that is required for the weekend days Saturday and Sunday and for the holidays preceding or following the weekend, including any working day in between, but no more than the amount required for five days.

The substituting doctor may not give the patient more than one prescription within a calendar week. He may only hand over the prescription as part of a personal consultation. The prescription must be marked with the letter “Z” after the letter “S”.
(9) As soon as and for as long as the substituting doctor comes to the conclusion that it is no longer necessary to provide the substitution agent for immediate consumption in accordance with paragraph 7, he may give the patient substitution agent to be taken independently in accordance with the findings of the Federal Medical Association according to paragraph 12 sentence 1 number 3 Prescribe letter b in the following quantities:
1.

basically in the amount required for up to seven days or

2.

in justified individual cases in the amount required for up to 30 days.

An individual case according to sentence 1 number 2 can be justified by medical or other circumstances. An individual case justified by another circumstance exists if the patient, for important reasons relating to his participation in social life or his employment, is dependent on receiving a prescription for the substitution drug to be taken independently for up to 30 days. The patient has to make these facts credible to the substitution doctor. Medical facts that justify an individual case are determined by the German Medical Association within the framework of paragraph 12 sentence 1 number 3 letter b. The substituting doctor may only hand over the prescription according to sentence 1 numbers 1 and 2 to the patient as part of a personal consultation. The prescription must be marked with the letter “T” after the letter “S”. The substituting doctor can specify patient-specific points in time at which partial quantities of the prescribed substitution agent are to be given to the patient or to the practice of the substituting doctor in the pharmacy or left for immediate consumption.
(10) Substitution drugs according to Paragraph 6 Clause 1 may only be made available to the patient for immediate consumption by the following persons, administered to him or used on him in accordance with the procedure provided for in the licensing of medicinal products:
1.

the substituting doctor in the facility in which he is working as a doctor,

2.

the medical staff employed by the substituting doctor in the facility according to number 1 or

3.
the medical, pharmaceutical or nursing staff in
a)

an inpatient medical rehabilitation facility,

b)

a health department,

c)

an old people's or nursing home,

d)

a hospice or

e)

another suitable institution, which for this purpose must be recognized by the competent state authority,

provided that the substituting doctor is not active in the respective facility himself and he has made an agreement with the respective facility.
In addition, a substitution agent according to Paragraph 6 Clause 1 may be made available to the patient for immediate consumption, administered to him or used on him in accordance with the procedure provided for in the drug approval
1.
during a home visit
a)

by the substituting doctor or the medical staff employed by him, or

b)

by medical or nursing staff employed by an outpatient nursing service or by a facility for specialized outpatient palliative care, provided that the substituting doctor does not work for this nursing service or this facility himself and he has made an agreement with this nursing service or this facility,

2.

in a pharmacy by the pharmacist or by the pharmaceutical staff employed there, provided that the substituting doctor has made an agreement with the pharmacist,

3.

in a hospital by the medical or nursing staff deployed there, provided that the substituting doctor is not active for this hospital himself and he has made an agreement with the hospital, or

4.

in a state-recognized addiction aid facility by the staff deployed and trained for this purpose, provided that the substituting doctor does not work for this facility himself and he has made an agreement with the facility.

The substituting physician must ensure that the staff is properly instructed in accordance with sentences 1 and 2 in the provision of the substitution agent for immediate consumption, in its administration or its use in accordance with the procedure provided for in the drug approval; Invasive administration may only be carried out by the personnel specified in the drug approval. The agreement according to sentences 1 and 2 must be made in writing or electronically and must determine how the personnel employed by a facility are instructed in accordance with sentences 1 and 2 and must also name at least one responsible person in the respective facility as well as regulations on the control options included by the substituting doctor. The substituting doctor may store the required substitution drugs in the facilities named in sentences 1 and 2 under his responsibility. The consent of the person entitled to dispose of the respective premises remains unaffected.

(11) The substituting doctor has to document the fulfillment of his obligations according to paragraphs 1 to 10 as well as according to § 5a paragraphs 1 to 4 and § 5b paragraphs 2 and 4 in accordance with the requirements specified by the German Medical Association according to paragraph 12 sentence 3. The documentation must be presented or sent to the competent state authority for inspection and evaluation on request.

(12) The German Medical Association establishes the generally recognized state of the art in medical science for substitution in a guideline, in particular for
1.

the objectives of substitution in accordance with paragraph 2,

2.

the general requirements for the initiation and continuation of a substitution in accordance with paragraph 1 sentence 1,

3.
the creation of a therapy concept according to paragraph 1 sentence 2, in particular
a)

the selection of the substitution agent according to paragraph 1 sentence 2 and paragraph 6,

b)

the prerequisites for prescribing the substitution drug to be taken independently according to paragraphs 8 and 9,

c)

the decision on the necessity of including psychosocial care measures as well as

d)

the evaluation and control of the course of therapy.

In addition, according to the generally recognized state of the art in medical science, the Federal Medical Association can determine other essential substitution objectives than those specified in paragraph 2 sentence 2 in this guideline. It also determines the requirements for the documentation of the substitution according to paragraph 11 sentence 1 in this guideline. Compliance with the generally recognized state of the art in medical science is assumed if and to the extent that the findings according to sentences 1 and 2 have been observed.

(13) Before the decision of the German Medical Association on the guideline according to Paragraph 12 Sentences 1 to 3, the Joint Federal Committee according to Section 91 of Book Five of the Social Security Code must be given the opportunity to comment on the generally recognized state of the art in medical science for substitution. The opinion is to be included by the German Medical Association in its decision on the guideline according to paragraph 12 sentences 1 to 3.

(14) The German Medical Association must submit the guideline pursuant to Paragraph 12 Clause 1 to 3 to the Federal Ministry of Health for approval. Changes to the guidelines approved by the Federal Ministry of Health must also be submitted to the Federal Ministry of Health by the German Medical Association for approval. The Federal Ministry of Health can request additional information and additional statements from the German Medical Association as part of the approval process. The Federal Ministry of Health publishes the approved guideline and approved changes to the guideline in the Federal Gazette.

(15) Paragraphs 3 to 11 are to be applied accordingly if the substitution agent from the stock of practice or ward requirements is made available for immediate consumption or is handed over in accordance with paragraph 7 sentence 2.